Kornimate/medical-research-clean huggingface dataset:
neuro-orthopaedic disorders during aging in patients with neuromotor disability

Conditions: Disability or Chronic Disease Leading to Disablement

Summary: people with neuromotor disability (i.e. following an inborn or acquired spinal cord, cerebral or peripheral neurological lesion) are at risk of worsening their neuro-orthopaedic disorders during aging, including fracture risk. nevertheless, at the present time, the natural evolution of their neuro-orthopedic disorders and the long-term functional impact of their medical and surgical treatments is unknown. the aim of this study is to describe neuro-orthopedic disorders during aging of patients with neuromotor disability, their functional repercussions, their comorbidities and the therapeutic strategies used.

this is an ambispective, monocentric, cohort study of subjects with neuromotor disability followed in a physical medicine and rehabilitation department. all consecutive eligible inpatient and outpatient subjects treated in the neuro orthopaedic unit (upoh) of the physical medicine and rehabilitation department of our university hospital will be included. data will be collected from the patients' medical records, in particular data related to their clinical, radiological, biological and physiological examinations.

Eligibility criteria:
inclusion criteria: * patients \>= 18 years old ; * treated in the neuro orthopaedic unit (upoh) of the physical medicine and rehabilitation department of our university hospital ; * having a neuromotor disability ; * no opposition to be enrolled in the study from the patient, or from a legally authorized close relative if the patient's state of health does not allow it ; * affiliation to a social security scheme. exclusion criteria: * under court protection.

Keywords: neuromotor disability, neuro-orthopaedics
real time tissue characterisation using mass spectrometry rei-excise iknife study

Conditions: Breast Cancer; Surgery

Summary: rei-excise is a multicentre, prospective, non-randomised feasibility study, aimed to evaluate the diagnostic accuracy of rapid ionisation mass spectroscopy using an iknife device. the iknife will collect vapour, a by-product of surgery, which will pass through the mass spectrometer machine for analysis in order to evaluate what is "normal" and what is "cancerous" breast tissue.

there is an urgent need to address high rates of close or positive margins and re-operative breast cancer surgery, which commonly results from the inability of the surgeon to rapidly and reliably evaluate resection margin status intra-operatively. this study therefore seeks to address this problem by aiming to develop a method for near real time, in vivo intra-operative tissue classification that may be used by breast surgeons as an intelligent knife (or "iknife") to better guide oncological margin control. the method known as rapid evaporative ionisation mass spectrometry (reims) technology uses mass spectrometric and chemometric analysis of the tissue specific ionic content of the surgical diathermy smoke plume for the rapid identification of dissected breast tissues. there are no additional treatment interventions as part of rei-excise. the main study procedures are breast conserving surgery using the reims iknife for mass spectral analysis of each surgical margin and correlation between the results of a software recognition algorithm that capitalised on the spectral data (i.e. iknife margin = positive / negative) with conventional histopathological assessment. false positive iknife data will be further interrogated with digital droplet polymerase chain reaction and imprint cytology assessment.

Eligibility criteria:
inclusion criteria: * bcs for ductal carcinoma in situ (b5a) * bcs for invasive ductal carcinoma (b5b) * bcs for invasive lobular carcinoma (b5b) * b3 lesions undergoing surgical excision exclusion criteria: * pregnant or lactating * 18 years or younger * diagnostic excision biopsy for classical lobular carcinoma in situ (lcis) (current practice is that classical lcis at a surgical resection margin would not mandate wider excision) or if the patient is diagnosed with • non-epithelial breast tumour (phyllodes, lymphoma) note on patients receiving neo-adjuvant chemotherapy (nact): patients selecting to receive nact will be eligible for participation. however, the data for patients receiving nact will be analysed separately as a pre-planned subgroup and these patients will not contribute data to the n=35 patients with positive margins required for this feasibility trial. data from nact cases have not been used to generate the validated multispectral database since eccentric fibrosis made the histological analysis more complex, which limited the number of patients in whom tissue was available for research.

Keywords: tumours breast conserving surgery margin assessment technology mass spectrometry
the role of genetic factors in the development of idiopathic scoliosis in the kazakh population

Conditions: Idiopathic Scoliosis

Summary: the purpose of this study is to identify genetic determinants of susceptibility to idiopathic scoliosis . it will assist in predicting individual risks of disease progression and would help to clarify pathophysiologic mechanisms of idiopathic scoliosis


Eligibility criteria:
inclusion criteria: 1. persons with a doctor-confirmed diagnosis of idiopathic scoliosis; 2. persons of kazakh nationality, whose paternal and maternal grandparents are kazakhs; 3. hereditary history of scoliosis; 4. persons who are able and willing to provide written informed consent; exclusion criteria: 1. patients diagnosed with idiopathic scoliosis under 4 and over 40 years of age; 2. representatives of the kazakh ethnic group less than 3 generations; 3. no family history of bilateral idiopathic scoliosis; 4. patients with an acute period of the inflammatory process (laboratory and clinical signs); 5. persons who, in the opinion of the researcher, are mentally or legally incapacitated, which prevents obtaining informed consent; 6. pregnant or lactating women; 7. tuberculosis of any localization in the active phase and in history; 8. severe and decompensated diseases of the liver and kidneys, cardiovascular system; 9. severe and decompensated course of endocrine diseases; 10. autoimmune diseases; 11. systemic diseases; 12. oncological diseases;

Keywords: snp
observation on the effect of sacubitril/valsartan in advanced chronic kidney disease（ckd）patients with heart failure

Conditions: CKD

Summary: this paper will mainly present the renal results from a clinical study aimed to observe the effect of sacubitril/valsartan in advanced chronic kedney disease patients with heart failure.all patients will receive lcz696.the results will be compared before and after treatment.

on trial entry, patients will first receive lcz696 50mg twice daily.according to the condition of disease and tolerance,the dose will be doubled every 2 weeks until the target maintenance dose 200mg twice daily is reached unless potassium or change in kidney function preclude a dose increase(reduction in dose will be permitted if the larger dose will not be tolerated, and temporary interruption will be permitted at any time if required for clinical reasons).the trial will be followed up for 12 weeks. study visits will be scheduled at 2,4,6,8,10and12 weeks (and additional visits will be arranged where necessary to monitor participant safety).

Eligibility criteria:
inclusion criteria: 1. patients diagnosed with chronic kidney disease (egfr\<60 ml/ min/1.73m²) and heart failure 2. documented history of heart failure with associated signs or symptoms 3. new york heart association (nyha) classes ii-iv 4. mean sitting systolic blood pressure (mssbp) ⩾140mmhg 5. good compliance exclusion criteria: 1. isolated right heart failure owing to pulmonary disease, dyspnoea from non-cardiac causes, primary valvular or myocardial diseases, or coronary or cerebrovascular diseases needing revascularization within 3months of screening or during the trial 2. acute renal failure 3. systolic blood pressure lower than 100 mm hg at screening (\<95 mm hg at the randomisation visit) 4. significant laboratory abnormalities at screening interfering with assessment of study drug safety or efficacy(such as serum potassium\>5.5 or \ 2 times the upper limit of the normal range) 5. history of angioedema（drug-related or otherwise) 6. any medications that have potential for drug-drug interaction with lcz696 will not be allowed during the study 7)pregnant female

Keywords: sacubitril/valsartan advanced ckd patients heart failure
use, effects and side-effects of second-generation antipsychotics in a naturalistic setting

Conditions: Psychotic Disorders

Summary: despite different pharmacological properties, the scientific evidence is inconclusive regarding which of the first-line second generation antipsychotics (sgas) should be preferred for the individual patient suffering from psychosis. the limitations of the evidence base may be related to the highly selected samples, short duration, and rigid experimental designs of most randomized clinical trials of efficacy. moreover a high proportion of the clinical trials are drug company sponsored which could introduce funding bias. the purpose of this non-commercially funded study is to investigate whether effectiveness differences exist among the first-line sgas olanzapine, quetiapine, risperidone, and ziprasidone when the drugs are used in a representative clinical setting. eligible patients are those admitted to hospital for acute psychosis and candidates for oral antipsychotic treatment. the investigators hypothesise that in the naturalistic setting of every-day clinical practice and in a diverse sample representative of most patients admitted for symptoms of acute psychosis, differential effectiveness among the sgas could be disclosed when the patients are followed for up to 2 years. this could deliver valuable information regarding which sga should be the starting antipsychotic drug in order to facilitate the most beneficial outcome.


Eligibility criteria:
inclusion criteria: * psychosis * must be able to use oral antipsychotic drugs exclusion criteria: * mania * unable to cooperate with the assessments * unable to understand norwegian language * candidates for electroconvulsive therapy * use of clozapine at admittance

Keywords: antipsychotic drugs treatment effectiveness randomized controlled trial
timely prospective study

Conditions: Coronary Artery Disease

Summary: brief summary: cardiac rehabilitation (cr) is a multi-factorial intervention, designed to limit the physiological and psychological effects of cardiovascular disease such as coronary artery disease (cad), manage symptoms, and reduce the risk of future cardiovascular events. cr is a structured program not only addressing cad but also comorbidities including hypertension, dyslipidemia, diabetes and obesity as well as other risk factors. cr aims at long-term lifestyle changes to reduce modifiable risk factors, and it's success depends on a large number of interacting variables including biological, psychological and social factors. recently, the importance of patient-centered approaches to secondary prevention and cr success has been underlined but intra-individual factors and their interactions are not well understood. the timely prospective study aims to collect high-resolution data for data mining and artificial intelligence machine learning models to identify dependencies between factors and predict favorable outcomes of cr. data collection will include data documented during controlled center-based cr as well as remote-measurement of physical activity data, (central) blood pressure and pulse wave analysis as well as long-term ecg data during a 6-months period after discharge. follow-up assessments will be performed at least at 6 months and at 12 months after discharge. main objectives of the study: 1. to examine uptake and adherence to a healthy lifestyle (i. e. adherence to cr guidelines in cad) and the effects on long-term outcomes. 2. to identify potentially mediating mechanisms and predictive factors for long-term cr success in cad. 3. to investigate acceptance of different ehealth components as well as expectations and needs among cad patents in cr.


Eligibility criteria:
inclusion criteria: coronary artery disease (cad) patients after myocardial infarction (stemi/nstemi) and/or angioplasty and/or percutaneous coronary intervention (pci) and/or coronary artery bypass graft surgery who participate in phase ii cardiac rehabilitation (cr). exclusion criteria: * incapability to give informed consent * conditions that prevent patients from participation in cr including unstable coronary or cerebrovascular conditions and acute infections

Keywords: cardiac rehabilitation telemedicine healthy lifestyle preventive programs artificial intelligence predictive medicine continuum of care maintenance aftercare ehealth mhealth
evaluation of post-operative, nurse-based heart failure care in non-cardiac surgery

Conditions: Heart Failure，Congestive

Summary: patients with heart failure nyha \>= ii receiving non-emergent non-cardiac in-patient surgery will be randomized to receive either standard post-operative care (surgeon has to ask actively for specialist cardiological support) or a nurse-based heart failure management (nurses provide week-day support every day after surgery, if needed together with a heart failure doctor)


Eligibility criteria:
inclusion criteria: patients with heart failure nyha \>= ii (hfref and hfpef) or lvef \ 18 years written informed consent exclusion criteria: patients on intensive care life-expectancy \< 3 months
paired-comparison study evaluating the efficacy and safety of e6201 versus vehicle for the treatment of plaque-type psoriasis

Conditions: Chronic Plaque Psoriasis

Summary: this is a double-blind, multicenter study to assess the efficacy and safety of e6201 topical administration to pre-identified marker lesions in adult subjects with chronic plaque type psoriasis. treatment duration is 8 weeks, followed by a 4-week period without treatment. pharmacokinetic samples will be obtained pre-and post treatment.


Eligibility criteria:
inclusion criteria: * males and females 18 years or older with a clinical diagnosis of mild-to-moderate plaque-type psoriasis for ≥12 months prior to screening * female participants postmenopausal \>1 year or surgically sterile * two representative and similar target lesions for the condition, each of 15-25 centimeters squared (cm\^2), up to 50 cm\^2 in surface area * target lesion severity score of 4-8 on a scale of 0 to 12, where, in the opinion of the investigator, 0 equals no evidence of disease and 12 equals severe induration, erythema, scaling, and pruritus * prescription medications, if applicable, for chronic conditions allowed but must be on a stable regimen prior to and during the study; this is also applicable for dietary supplements and over-the-counter (otc) drugs * participants able and willing to give informed consent exclusion criteria * use of any, concomitant, topical treatment for psoriasis, excluding emollients * use of any, concomitant, systemic treatment for psoriasis, including ultraviolet radiation (uvr) light * evidence of significant hepatic, gastrointestinal, renal, respiratory, endocrine, hematological, neurological, psychiatric, musculoskeletal, rheumatologic, or cardiovascular system abnormalities * evidence of any clinically significant deviation from normal with respect to medical history, physical examination, vital signs, 12-lead electrocardiogram (ecg), or clinical laboratory determinations. if any participant has an abnormal clinical laboratory test finding that meets specified criteria, that participant will be re-tested by repeated blood draw and clinical laboratory assessment. if the abnormal test finding is confirmed, the participant will be excluded from the study.
effects of oral nutrition supplements in children with disease associated underweight

Conditions: Disease Associated Underweight

Summary: the purpose of this study is to test whether the provision of ons to malnourished children across europe, in addition to standard counselling, will improve weight gain and other outcomes. the hypothesis to be tested is: • supplementation with ons in malnourished paediatric patients will lead to increased wfh gain, as well as less malnutrition related complications (e.g. infections). primary outcome • the change in bmi z-score over the intervention period of 3 months secondary outcomes • the change in wfh-weight for height (z-scores) over the intervention period of 3 months


Eligibility criteria:
inclusion criteria: 1. children treated at the participating paediatric centres during the study period (inpatients or outpatients) 2. age between 24 months to 12 years at inclusion 3. wfh at inclusion \ -2,5 sd (based on who) or decrease in wfh z-score of ≥1 sd within the last 3 months, and underlying disease with high risk of undernutrition 4. children who would be considered candidates for oral nutrition intervention (but do not need tube feeding) 5. written informed consent of parents/caregivers exclusion criteria: 1. children in need of intensive care 2. inability to consume ons (e.g. major gastrointestinal dysfunction) 3. children, for whom normal nutrition intervention would be inappropriate (e.g. food intolerance, allergy) 4. use of parenteral feeding and/or enteral tube-feeding 5. severe edema (\>0.5 cm pitting edema on the dorsum of the foot) 6. participation in another intervention study involving investigational or marketed products concomitantly or within two weeks prior to entry into the trial. 7. children having received enteral nutrition treatment for underweight in the previous month 8. oncology patients during chemo-, radio-therapy 9. expected hospital stay at inclusion longer than 7 days -

Keywords: malnutrition underweight oral nutrition supplements children
the use of penicillin allergy clinical decision rule to enable direct oral penicillin challenge

Conditions: Hypersensitivity, Immediate; Hypersensitivity, Delayed; Hypersensitivity Response

Summary: whilst validated tools exist to enable inpatient penicillin assessment and de-labelling, limited evidence is available regarding the safety and efficacy in the outpatient clinic. the ability to deliver point-of-care penicillin allergy testing for a large cohort of patients, without skin testing, will improve patient access to testing and utilization of preferred penicillin antibiotics.

patient-reported penicillin allergies result in poor health outcomes for patients and drive inappropriate antibiotic prescribing, antimicrobial resistance and healthcare costs. our group has internally and externally validated a novel penicillin allergy clinician decision rule (pen-fast) that is able to identify low risk penicillin allergies with a negative predictive value of 96% (95%; 94-98%). therefore, whilst validated tools exist to enable inpatient penicillin assessment and de-labelling, limited evidence is available regarding the safety and efficacy in the outpatient clinic. the ability to deliver point-of-care penicillin allergy testing for a large cohort of patients, without skin testing, will improve patient access to testing and utilization of preferred penicillin antibiotics.

Eligibility criteria:
inclusion criteria: 1. adult patients referred to the outpatient allergy clinic for a penicillin allergy history; 2. willing and able to give consent. exclusion criteria: 1. patient age is \< 18 years; 2. patients with a pen-fast score less than 3 3. pregnancy; 4. any other illness that, in the investigator's judgement, will substantially increase the risk associated with subject's participation in this study; 5. patients with history of type a adverse drug reaction, drug-associated anaphylaxis, idiopathic urticaria/anaphylaxis, mastocytosis, serum sickness, blistering skin eruption or acute interstitial nephritis; 6. patients where the allergy history was not able to be confirmed with patient; 7. patients on concurrent antihistamine therapy; 8. patients receiving more than stress dose steroids (i.e. \> 50mg qid hydrocortisone \[or steroid equivalent\]).

Keywords: penicillin low risk allergy direct oral challenge standard of care outpatient clinic
efficacy and safety of trans sodium crocetinate (tsc) for treatment of suspected stroke

Conditions: Stroke, Acute

Summary: this study will assess the potential efficacy and safety of tsc as early treatment for both ischemic and hemorrhagic stroke when administered while subject is in ambulance being transported to hospital.

this is a multicenter, randomized, placebo-controlled, double-blind, parallel group trial of intravenous trans sodium crocetinate (tsc) initiated by emergency medical service (ems) responders in the field within 2 hours of symptom onset in 160 subjects with acute stroke. the primary objectives of the study are to evaluate the efficacy and safety of field-initiated tsc in improving the long-term functional outcome of subjects with acute stroke. subjects with acute stroke will be identified and screened in the ambulance by (ems) responders who have received training in basic and advanced cardiac life support, stroke recognition, and specific procedures relevant to the proposed study. the ems responders will contact a study neurologist, who will enroll eligible stroke patients into the study. effort will be made to obtain prospective informed consent in the ambulance when deemed to be feasible. if not feasible, subjects will be enrolled under regulations for exception from explicit informed consent (efic) in emergency research circumstances, after public disclosure and community consultation. written informed consent to continue in the study is obtained from subjects or their legally authorized representatives as soon as possible after hospital arrival. ems responders will deliver the single, field, bolus dose of study agent, tsc at 0.25 mg/kg or matched placebo, followed after hospital arrival by standard of care (soc). no additional study drug will be administered in the hospital. follow-up assessments will be performed at emergency department (ed) arrival, 24 hours, 48 hours, day 4, day 30, and day 90. the study will be performed at up to 30 receiving hospital sites in los angeles county, ca, and central virginia.

Eligibility criteria:
inclusion criteria: 1. age 40-85, inclusive 2. last known well time 15-120 minutes before anticipated study drug injection 3. suspected stroke identified by the lapss 4. moderate to severe motor deficit, with los angeles motor scale (lams) 2 or higher 5. no seizure exclusion criteria: 1. coma 2. rapidly improving neurologic deficit 3. history of seizures or epilepsy 4. pre-existing neurologic, psychiatric, or advanced systemic disease that would confound the neurological or functional outcome evaluations 5. sbp \ 220 6. major head trauma in the last 24 hours 7. recent stroke within 30 days 8. known to be pregnant or lactating