Kornimate/medical-research-clean huggingface dataset:
feasibility of a software app for testing inattention in delirium

Conditions: Delirium

Summary: this qualitative study aims to evaluate the usability of a smartphone application called delapp. the study will assess usability and acceptability of the software app by asking 40 clinicians to administer the delapp assessment to consented patient and clinicians. feedback will be collected through semi-structured interviews with the clinicians. the feedback will be used to optimise the software application in preparation for formal validations studies.

delirium is an acute, serious syndrome involving abnormalities in attention, arousal and cognition. delirium affects 1 in 8 hospital patients. delirium is linked to a higher risk of death, increased length of stay, and substantial patient and carer distress. despite its massive medical importance, delirium is grossly underdetected, with rates of formal detection of 20% or less. investigators previously developed a new neuropsychological test for the objective measurement of inattention in delirium, implemented on a computerised device (delbox). a prototype software application for smartphones (delapp) has been developed based on the 'delbox' tests. findings from two pilot studies suggest that the delapp performs well as a method for objectively measuring attention in delirium. as part of a new programme of work on attentional tests for delirium, formally funded by the medical research council (grant value £1.01m), investigators plan further studies to refine the delapp before conducting larger scale formal studies. the reasons for doing these additional studies are to: (1) shorten the duration of the delapp assessment; (2) ask end users (i.e. clinicians) to evaluate the user interface; (3) gather feedback from end users regarding the ease of use of the test; and any other feedback from clinicians and patients; and finally (4) develop the delapp software application further based on user feedback. here investigators propose a preliminary qualitative study to evaluate feasibility of the optimised delapp test (points 2 and 3). investigators will assess usability and acceptability by asking 40 clinical staff to administer the delapp test to consented patients (n=10) and colleagues (approximately n=30). feedback will be collected from clinicians and patients through semi-structured interviews. the outcomes of this feasibility study will make further optimisation of the app possible, in preparation for formal validation studies.

Eligibility criteria:
inclusion criteria: * native or fluent english speaker * capacity to give consent to participate in the study * aged 65 or over exclusion criteria: * vision, hearing or speech impairment severe enough to preclude testing and interview. * known or suspected cognitive impairment including dementia * photosensitive epilepsy

Keywords: delirium feasibility study software application qualitative
vitamin d supplementation in obesity and weight loss (3dd study)

Conditions: Osteoporosis

Summary: in this study, we will provide supplemental vitamin d in postmenopausal overweight/obese women, and hypothesize that it will not affect areal bmd, but will alter bone compartments (trabecular and cortical bone). in addition, higher vitamin d intake will increase serum 25ohd and suppress serum pth and bone turnover during weight reduction. secondary outcomes include the influence of vitamin d and weight loss on markers of insulin resistance and on cognitive tests of attention, learning, and memory.


Eligibility criteria:
inclusion criteria: * body mass index of 25-40 kg/m2 * postmenopausal * age 50-72 years exclusion criteria: * women who are taking any medication known to influence calcium or bone metabolism, * evidence of diseases known to influence calcium metabolism (i.e. metabolic bone disease) * hyperparathyroidism * untreated thyroid disease * significant immune disease * hepatic disease * renal disease or a kidney stone in the last 5 years * significant cardiac disease * active malignancy or cancer therapy within the past year
safety of sonovue on pulmonary hemodynamics

Conditions: Pulmonary Hypertension

Summary: this is an intra-subject crossover comparative safety study to evaluate the effect of intravenous (iv) bolus injection of sonovue on pulmonary hemodynamics.

subjects will be divided into two groups based on their baseline mean pulmonary arterial pressure. each subject will receive two injections in randomized order during right heart catheterization: one administration of sonovue and one administration of placebo, either sonovue followed by placebo or placebo followed by sonovue. the purpose is to provide direct evidence on the presence or absence of pulmonary hemodynamic effect following iv administration of sonovue versus any effects following iv administration of the same volume of placebo.

Eligibility criteria:
inclusion criteria: * provides written informed consent male or female at least 18 years of age scheduled to undergo right heart catheterization for clinical reasons exclusion criteria: * pregnant or lactating females * significant arrhythmia or non-sinus rhythm that may affect the ability to assess pulmonary hemodynamics by catheterization * known allergy to one of the ingredients in the investigational product or to any other contrast agents including ultrasound contrast agents * previously entered into the study or received an investigational compound within 30 days before admission into the study * unstable pulmonary and/or systemic hemodynamic condition that would affect the ability to evaluate the pharmacological or hemodynamic effect of the investigational products

Keywords: pulmonary hypertension right heart catheterization
a national registry on chinese patients with lymphangioleiomyomatosis

Conditions: Pulmonary Function

Summary: pulmonary lymphangioleiomyomatosis (lam), a disease characterized by diffuse cystic changes in the lung, is a rare disorder that affects almost exclusively women. the main objectives of this study are to accurately evaluate the prevalence of lam, the status of disease, the diagnosis and treatment, the quality of care, and the health related outcomes in china.

pulmonary lymphangioleiomyomatosis (lam), a disease characterized by diffuse cystic changes in the lung, is a rare disorder that affects almost exclusively women. the main objectives of this study are to accurately evaluate the prevalence of lam, the status of disease, the diagnosis and treatment, the quality of care, and the health related outcomes in china. this is a register study lasting 4 years, aims to raise 800 subjects. primary endpoint is the annual change of forced expiratory volume in the first second (fev1) and forced vital capacity (fvc) in pulmonary function tests.

Eligibility criteria:
inclusion criteria: 1. gender: female. 2. age: no limitation. 3. diagnosis meets one of the following criteria, (1) definite or probable diagnosis of lam based on ats/jrs and ers criteria. (2) investigators recommend including of the patient. exclusion criteria: 1. suspected lam patients without other supporting evidence for lam diagnosis. 2. no diffuse cystic lesions in the lung. 3. patients with bilateral cystic lung lesions but the lam diagnosis cannot be established. 4. without signed informed consent. 5. difficult to follow up.

Keywords: registry china lymphangioleiomyomatosis
strategy of early detection and active management of supraventricular arrhythmia with telecardiology (setam)

Conditions: Atrial Fibrillation; Atrial Flutter; Atrial Tachycardia

Summary: this study investigates if the early detection and treatment of supraventricular arrhythmia (sva) may help to prevent the progression of the arrhythmia and improve the clinical outcome. the primary endpoint investigates the delay to implement treatment in two groups of patients : * active group: patients followed by telecardiology. * control group: patients followed in the conventional manner. it is assumed that the delay to implement treatment will be higher in the control group.

atrial fibrillation is the most commonly encountered sustained cardiac arrhythmia in medical practice and it is often associated with atrial flutter. in patients with the new pacemaker generation evia, the home-monitoring technology provides specific and clinical relevant notifications for detection of atrial arrhythmias. combined with holters memories, this can help to optimize the treatment of supraventricular arrhythmia (sva) such as atrial fibrillation or flutter. this study will compare in the two groups the delay to implement for the first time a treatment for the supraventricular arrhythmia (antiarrhythmic drugs and/or an antithrombotic treatment).

Eligibility criteria:
inclusion criteria: * dual chamber pacemaker with activated telecardiology * chad2ds2-vasc score ≥ 2 * sinusal rhythm at enrollment * patient willing and able to comply with the protocol * patient has provided informed consent * men and women \> 18 years-old * patients geographically stable exclusion criteria: * anticoagulation therapy * dual anti-platelet therapy * class i or class iii anti-arrhythmic drugs * contraindication to antithrombotic therapy * participation in another clinical study * have a life expectancy \< 6 months

Keywords: atrial fibrillation supraventricular arrhythmia antithrombotic treatment antiarrhythmic drugs medical reaction time telecardiology early detection holters memories pacemaker
antibiotic prophylaxis in high-risk arthroplasty patients

Conditions: Infections Joint Prosthetic; Overweight or Obesity; MSSA Colonization; MRSA; Chronic Kidney Diseases; Diabetes; Autoimmune Diseases; Inflammatory Disease; Tobacco Use

Summary: to determine the effectiveness of a 7-day course of an oral, prophylactic antibiotic on the incidence of periprosthetic joint infection and wound complications following primary total hip and knee arthroplasty in a high-risk patient population.

the purpose of this research study is to investigate whether a 7-day course of an oral, prophylactic antibiotic following elective, primary total hip and knee arthroplasty effectively decreases the risk of periprosthetic joint infection or wound complications following surgery in a patient population that is high-risk for these complications. patient with one or more of the following risk factors are considered high-risk for periprosthetic joint infection and/or wound complications: body mass index over 35kg/m\^2, diagnosis of diabetes, chronic kidney disease, active tobacco user, nasal colonization of methicillin-resistant staphylococcus aureus and/or methicillin-sensitive staphylococcus aureus, or autoimmune/inflammatory disease. study participants will be randomized to either a 7-day course of an oral, prophylactic antibiotic following surgery or no additional antibiotic. all other standard perioperative total joint arthroplasty care will remain the same for both groups, including 24-hours of perioperative antibiotics. outcomes assessed will include surgical wound complications occurring within 90-day of surgery and periprosthetic joint infection occurring within 90-day and 1-year of surgery.

Eligibility criteria:
inclusion criteria: * patient is a candidate for elective, primary total hip arthroplasties (tha) or total knee arthroplasties (tka). * patient is considered high-risk for developing periprosthetic joint infections (pji) based on having at least one of the following criteria: * body mass index (bmi) \> 35 kg/m\^2; * diagnosis of diabetes mellitus; * active tobacco smoker; * chronic kidney disease; * autoimmune disease; * nasal colonization with methicillin-resistant staphylococcus aureus (mrsa) or methicillin-sensitive staphylococcus aureus (mssa). exclusion criteria: * inability to consume oral antibiotics. * allergy to antibiotic alternatives in the protocol. * history of clostridium difficile colitis. * revision hip or knee arthroplasty procedure. * non-elective surgery. * hemiarthroplasty. * unicompartmental knee arthroplasty. * simultaneous bilateral tha or tka. * will have subsequent tha or tka within 12 weeks of the index study procedure. * pregnant.

Keywords: total hip arthroplasty total knee arthroplasty hip replacement knee replacement periprosthetic joint infection prophylaxis antibiotics
safety and efficacy of two-step radical prostatectomy

Conditions: Prostate Cancer

Summary: the goal of this observational study is to learn about the safety and efficacy of two-step radical prostatectomy in the treatment of low- to intermediate-risk prostate cancer patient with enlarged prostate and severe benign prostatic hyperplasia. the main question it aims to answer are: 1. whether two-step prostatectomy is safe enough to decrease the surgical difficulty of these patients? 2. whether the oncologic control is promising?


Eligibility criteria:
inclusion criteria: 1. diagnosed as prostate cancer pathologically by prostate biopsy 2. evaluated as localized prostate cancer by imaging studies 3. prostate volume\>70ml evaluated by transrectal ultrasonography or multi-parametric magnetic resonance imaging 4. gleason score≤ 4+3=7 5. preoperative psa\<20ng/ml 6. estimated survival\> 10 years； 7. informed consent is obtained from the patient exclusion criteria: 1. the patient has received other therapy including radical radiotherapy, transurethral resection of the prostate, cryoablation, hifu, etc. 2. any contraindication of surgery or anaesthesia
what is the allergy follow-up for children after anaphylactic reaction? afcar : allergy follow-up for children after anaphylactic reaction

Conditions: Anaphylaxis; Allergic Reaction

Summary: anaphylaxis is an allergic reaction potentially fatal. the treatment is based on injection of epinephrin as soon as possible. guidelines by the world allergic organisation highlight the importance of medical follow-up. this follow-up consists of an allergy consultation, the prescription and demonstration of epinephrin auto-injector and the implementation of specific measures in schools. there is no study about the recurrence of anaphylactic reaction outside the hospital. the purpose of this study is to evaluate the allergy follow-up of children after anaphylactic reaction. the secondary objective is to evaluate the use of medical advice in case of recurrence of anaphylactic reaction. investigators will use a phone call questionnaire for parents of children who underwent an anaphylactic reaction between the 1st july 2014 and the 31st june 2016 treated in the paediatric emergency department in femme-mère-enfant hospital in lyon in france. 179 children could be included in the study.


Eligibility criteria:
inclusion criteria: * age from 0 to 17 * anaphylactic reaction meeting the criteria of sampson et al. treated in paediatric emergency department of femme-mère-enfant hospital in lyon in france * anaphylactic reaction treated between the 1st july 2014 and the 31st june 2016 exclusion criteria: - no agreement from patient or parents to participate in the study
study of innovative drug strategies in improving left ventricular function after mitral repair

Conditions: Congenital Mitral Insufficiency

Summary: the goal of this observational study is to compare the safety and effectiveness of a modified drug therapy with traditional drug therapy in pediatric patients after mitral repair. the main questions it aims to answer are: * can a modified drug therapy improve both left ventricular and mitral valve function in pediatric patients after mitral repair? * can the adverse drug reactions caused by the modified drug therapy be non-inferior (clinically acceptable) to those of the traditional drug therapy? participants will be assigned to either the modified drug therapy group (comprising angiotensin-converting enzyme inhibitor (ace-i), beta-blockers, diuretics, potassium supplements, and spironolactone) or the traditional drug therapy group (diuretics and potassium supplements) based on personal preferences and clinical assessments by their attending physicians. they will undergo a 6-months course of medication. additionally, echocardiography, electrocardiograms, complete blood counts, biochemical tests, and measurements of n-terminal pro-brain natriuretic peptide (nt-probnp) were conducted before the initiation of medication therapy and at 1 month, 3 months, and 6 months after treatment commencement. researchers will compare the modified drug therapy group and the traditional drug therapy group to see if the recurrence rate of moderate to severe mitral valve regurgitation, as assessed by echocardiography after 6 months of treatment, is lower in the former than in the latter.


Eligibility criteria:
inclusion criteria: * under 14 years old * after mitral valve repair exclusion criteria: * patients with heart failure requiring ventricular assist or cardiac synchronization therapy * patients with severe pulmonary hypertension (pulmonary arterial pressure \>6 wood·u) * patients with severe liver and kidney failure * patients who are allergic to related medications * patients with symptomatic hypotension who cannot tolerate related drugs

Keywords: congenital heart disease mitral regurgitation mitral valve repair postoperative drug therapy
a study to investigate the comparative effectiveness of ibrutinib in steroid dependent/refractory cgvhd participants

Conditions: Chronic Graft vs Host Disease

Summary: the purpose of this study is to evaluate the effectiveness of ibrutinib compared to conventional salvage treatments in participants with steroid dependent/refractory chronic graft versus host disease (cgvhd) by measuring overall cgvhd response (modified national institutes of health \[nih\] response defined complete response \[cr\] and partial response \[pr\]) at week 24.


Eligibility criteria:
inclusion criteria: part a and part b * must have a confirmed diagnosis of steroid dependent or refractory classic cgvhd defined at any time post-hematopoietic cell transplantation (hct) as: a) refractory disease - progressive cgvhd manifestations requiring prednisolone at greater than or equal to (\>=) 1 milligram per kilogram per day (mg/kg/day) for at least 1 week or persist without improvement despite continued treatment with glucocorticoid (prednisolone at \>= 0.5 mg/kg/day or 1 mg/kg every other day) for at least 4 weeks; b) dependent disease: persistent cgvhd manifestations requiring glucocorticoid \>= prednisolone 0.25 mg/kg/day or \>=0.5mg/kg every other day for at least 8 weeks part a * treated at least 2 or more therapies for cgvhd (including glucocorticoids) * participants whose identified last line of conventional salvage treatment is second-fourth line of therapy * index date (initiation date of the identified last-line of conventional salvage therapy) at least 28 weeks before the study initiation date part b * treated at least 3 lines therapies for cgvhd (including glucocorticoids) * participants who are treated with ibrutinib in their second-fourth line of therapy exclusion criteria: part a and part b * known or suspected active acute gvhd * received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 28 days part a * treated with an investigational agent for their identified last-line of conventional salvage therapy * pregnant, breastfeeding during last-line of conventional salvage therapy part b * pregnant, breast-feeding, or of childbearing potential without a negative serum or urine pregnancy test within 7 days of enrollment. male or female participants of childbearing potential unwilling to use effective contraceptive precautions throughout the trial

Keywords: chronic ibrutinib retrospective prospective
new enrollment post-approval study of the argus® ii retinal prosthesis system

Conditions: Retinitis Pigmentosa

Summary: this post-approval study is being implemented to monitor the use of argus ii system in a larger us population than available within pre-approval studies. an attempt will be made to include all eligible and willing subjects implanted with argus ii system in the united states.

safety data will be monitored to ensure continued acceptability of risks to study subjects. the utility (i.e. visual function and functional vision) and reliability of argus ii system will also be evaluated. there is no study hypothesis.

Eligibility criteria:
inclusion criteria: * are adults, age 25 year or older; * have severe to profound retinitis pigmentosa; * bare light or no light perception in both eyes; if the patient has no residual light perception, then evidence of intact inner layer retina function must be confirmed; * have previous history of useful form vision. * aphakic or pseudophakic. (if the patient is phakic prior to implant, the natural lens will be removed during the implant procedure.) * patients who are willing and able to receive the recommended post-implant clinical follow-up, device fitting, and visual rehabilitation; * have consented to the implantation of an argus ii retinal prosthesis and subsequently consent to participate in this study; * at the time of the baseline visit, do not suffer from non-ophthalmic serious adverse events (e.g. myocardial infarction, etc.) and exclusion criteria: * ocular diseases or conditions that could prevent argus ii system from working (e.g. optic nerve disease, central retinal artery or vein occlusion, history of retinal detachment, trauma, severe strabismus); * ocular structures or conditions that could prevent the successful implantation of the argus ii implant or adequate healing from surgery (e.g. extremely thin conjunctiva, axial length \ 26 mm, corneal ulcers, etc.); * ocular diseases or conditions (other than cataracts) that prevent adequate visualization of the inner structures of the eye (e.g. corneal opacity, etc.); * inability to tolerate general anesthesia or the recommended antibiotic and steroid regimen associated with the implantation surgery; * metallic or active implantable device(s) (e.g. cochlear implant) in the head; * pre-disposition to eye rubbing; * any disease or condition that prevents understanding or communication of informed consent, study demands, and testing protocols, including: * cognitive decline including diagnosed forms of dementia and/or progressive neurologic disease, * psychiatric disease including diagnosed forms of depression; * does not speak a principal language associated with the region, and * deafness; * pregnant or wish to become pregnant during the course of the study; * participating in another investigational drug or device study that may conflict with the objectives, follow-up or testing of this study; * conditions likely to limit life to less than 1 year from the time of inclusion.
thrombelastogram in patients receiving antiplatelet medication undergoing cardiac surgery

Conditions: Bleeding

Summary: study objective is to correlate the results of preoperative platelet mapping derived from modified teg with clinically significant postoperative bleeding and consumption of blood products.

study design: prospective observational study with blinded assessment of study endpoint variables. collection of information concerning study endpoints will be performed by the investigator blinded to the results of preoperative testing of platelet function. the information will be collected from 60 patients undergoing cardiac surgery in the department of cardiac surgery of sheba medical center. study endpoints 1. primary endpoint- resternotomy for bleeding after the surgery. 2. secondary endpoints- chest tube output during first 24 hours after the surgery; consumption of blood products during first 3 postoperative days.

Eligibility criteria:
inclusion criteria: * patients undergoing cardiac surgery with the history of aspirin and/or adp receptor antagonist for at least 7 days prior the surgery exclusion criteria: * emergent surgery * heart transplant surgery * implantation of ventricular assist devices * enrollment into conflicting study

Keywords: thrombelastogram microvascular bleeding antiplatelet medication cardiac surgery consumption of blood products preoperative platelet mapping derived from modified teg postoperative bleeding