Kornimate/medical-research-clean huggingface dataset:
feasibility@48: cross sectional study of intensive care unit mobility practices across the united kingdom

Conditions: Critical Illness; Rehabilitation

Summary: intensive care unit (icu) patients commonly experience muscle loss at a rate of 2-3% day. traditionally, critically ill patients have been managed in bed, however current research suggests that prolonged bedrest cause mechanical silencing of the muscles and exacerbates this muscle wasting. this icu acquired weakness (icuaw) leads to poor functional outcome and higher mortality. research suggests that early out-of-bed mobilisation should occur within 48-hours of icu admission to militate against this risk, however, this is only achieved in 30% of cases. common barriers to mobilisation are unstable blood pressure, ventilation, sedation and fatigue. it is plausible that 48-hours is an unrealistic timeframe for mobilisation. the aim of this study is to explore the mobility practices on a given day in uk adult icus. the objectives are to: 1. determine the level of mobility that is achieved by each patient on adult icus, on a given day in the uk. 2. determine the typical physiological profile of patients on icu that are both able and unable to participate in antigravity exercise 3. determine the proportion of adult icu admissions that achieve out of bed mobilisation in the first 48-72 hours 4. explore clinician decision making about mobilisation this is a multi-centre cross-sectional study on one-day only. over a 24-hour period data will be collected for all icu patients at the participating centres. the lead physiotherapist will record the highest level of mobility achieved that day, and the physiological parameters from clinical observations. the reasons for the level of mobility achieved will be ranked in order of importance. these data are routinely collected. data will be anonymised. data will be analysed to determine feasibility of mobilisation at 48hours and develop a flow diagram of mobilisation decision-making.


Eligibility criteria:
inclusion criteria: all patients who are admitted to a participating icu on the study day will be included exclusion criteria: none

Keywords: physiotherapy rehabilitation mobilisation
detection of azole resistance inducing mutations on dna extracted directly from serum or plasma of immunocompromised patients with an invasive aspergillus infection azole resistance pcr optimalization-study

Conditions: Invasive Aspergillosis

Summary: invasive aspergillosis (ia) is the most common mould infection in immunocompromised patients with haematological disease. voriconazole, a triazole, improves overall survival of patients with an ia and is the mainstay of therapy. resistance of a. fumigatus emerged as an important clinical problem and infections with azole resistant aspergillus have a high mortality. nowhere in the world, azole resistance is more prevalent than in the netherlands. rapid detection of resistance is key to improve the patient's outcome but fungal cultures take time and are often negative. the investigators aim to detect azole resistance associated mutations in fungal dna extracted directly from serum or plasma to accelerate diagnosis and improve outcome of patients infected with azole resistant a. fumigatus.


Eligibility criteria:
inclusion criteria: * 18 years or older. * lung ct shows lesions that fulfil the eortc/msg radiological criteria of possible invasive fungal infection. * a bronchoalveolar lavage is planned or has been performed \<48hrs earlier exclusion criteria: - patients unable or unwilling to provide consent

Keywords: invasive aspergillosis pcr
safety of short hydration method for cisplatin administration compared with conventional hydration

Conditions: Renal Insufficiency; Cis-Platinum Nephropathy

Summary: the aim of the study is to evaluate safety of short hydration with cisplatin administration. the main outcome is renal dysfunction following cisplatin use with short hydration protocol. another group of patients received conventional hydration is the historical control for comparison (randomized phase ii design with a reference standard treatment control arm)


Eligibility criteria:
inclusion criteria: * cancer patient who has plan to receive first cycle of cisplatin \>= 60 mg/m2 * normal serum creatinine and creatinine clearance \>= 50 ml/min * age \< 75 years old * serum albumin \>= 3 g/dl * plan to receive optimal antiemetic regimen consisting of olanzapine or neurokinase 1 receptor antagonist exclusion criteria: * the patient who receives other chemotherapy with adminstration volume higher than 500 ml * prior heart failure or known left ventricular ejection fraction \> 50% * prior renal dysfunction within 3 months * uncontrolled renal disease * current use of diuretic or non-steroidal anti-inflammatory drug (nsaids) or starting angiotensin converting enzyme inhibitor (acei) or angiotensin receptor blockade (arb) within 3 months

Keywords: renal impairment cisplatin hydration protocol
testing a family service navigator program for low-resourced families of young children with autism spectrum disorder

Conditions: Autism Spectrum Disorder; Mental Health Services

Summary: the purpose of this study is to develop and test a family navigator training and an app (a technology-based treatment support system) for low-resourced families of young children (aged 3-5) with autism. the hypothesis is that the navigator training and treatment support system will help enable navigators to support families of young children with autism in accessing needed services.

the purpose of this project is to determine whether access to a family service navigator/treatment support system improves outcomes among families of young children (aged 3-5) from low-resourced communities. pilot work includes interviews and pre/post surveys. then, a randomized controlled trial will be conducted by randomly assigning families to navigators/treatment support systems or the non-personalized comparison condition (information, training, and referral services). three-month, six-month, and nine-month follow-up survey data will be collected. each of the 20 navigators will support two families. intervention families will have access to the navigator and the treatment support system, which includes a dashboard showing their child's service needs, resources, and a platform to facilitate and document communication between navigators and families. the treatment support system will also allow the navigator supervisor to ensure fidelity of the navigators' support to the family. the statistician will randomize 55 families who meet the inclusionary criteria to each condition--40 individuals will receive navigator/treatment support system (intervention group) and 15 individuals will receive information, training, and referrals (comparison group).

Eligibility criteria:
for the families in the clinical trial, there are the following inclusion and exclusion criteria: inclusion criteria: * be a parent who is in some way from a low-resourced community, * be the parent a child with autism between the ages of 3-5, * be age 18 or older, * want assistance with navigating service delivery systems, * be english speaking or spanish-speaking, * be able to provide informed consent, * own a phone which can use the treatment support system (or be provided a phone from the public assistance office or from the grant) exclusion criteria: -individuals who do not meet all inclusion criteria are by definition excluded. for the navigators in the clinical trial, they must meet inclusion and exclusion criteria: inclusion criteria: * agree to participate in the navigator training and become an navigator, * be a parent who is in some way from a low-resourced community, * be the parent a child with autism who is older than 5, * be age 18 or older, be english speaking, * be able to provide informed consent, * own a phone which can use the treatment support system (or be provided a phone from the public assistance office or from the grant) exclusion criteria: -individuals who do not meet all inclusion criteria are by definition excluded.

Keywords: autism navigator services children low-resource
the "concussion or brain bleed" trial

Conditions: Head Injury

Summary: researchers are trying to understand the effect of educating patients and encouraging shared decision making on rates of ct scanning in head injured patients by using an already developed app and observing the effect on the health care provider.


Eligibility criteria:
inclusion criteria: * 18-65 years old * present to the emergency department with a blunt head injury within the past 24 hours * determined to be low risk by the canadian ct head rules (cchr), and are being considered for a head ct by the treating provider. exclusion criteria: * patients who are pregnant * non-english speaking * in police custody * undergoing psychiatric evaluation * found to have drug or alcohol intoxication
to assess the efficacy of investigational product on the neuropathic pain in individuals suffering from type ii diabetes mellitus.

Conditions: Diabetic Neuropathies; Insomnia Due to Medical Condition

Summary: this study is to be carried out to examine the effect of investigation product on diabetic individuals suffering from diabetic neuropathic pain.


Eligibility criteria:
inclusion criteria: * male and females aged ≥ 40 and ≤ 65 years of age. * participants with primary complaints of lower limb pain. * history of diabetes mellitus for more than one year. * participants with hba1c ≥ 7.1 and ≤ 9.5% exclusion criteria: * diagnosed with severe cardiac disease * uncontrolled hypertension defined as systolic blood pressure ≥ 139 and diastolic blood pressure ≥ 85. * type ii dm with history of foot ulcers in the last six months prior to the study * history of nerve damage not due to painful diabetic neuropathy.
addressing vaccine acceptance in carceral settings through community engagement

Conditions: COVID-19

Summary: the goal of this study is to reduce morbidity and mortality from covid-19 amongst people who are detained in and work in correctional facilities. the overall objective is to identify feasible and effective interventions to improve vaccine uptake in correctional facilities and study the effectiveness of these interventions through rapid cycle, cluster randomized trials in the pennsylvania prison system.

aim 1: to identify correctional system strategies to address covid-19 and influenza vaccine acceptance amongst incarcerated people and correctional staff. aim 2: to select feasible strategies for a statewide correctional system at the patient-, provider-, practice- and prison-level to address covid-19 and influenza vaccine uptake through a community engaged research approach. aim 3: to compare the effectiveness of interventions to address covid-19 and influenza vaccine acceptance using a rapid cycle cluster randomized trial design in prison. this study is highly innovative in its application of rapid cycle, cluster randomized trials in correctional systems to test the effectiveness of strategies identified using a community based participatory research approach. the results will serve as an evidence base for improving vaccine uptake that can be scaled nationally and adapted for other populations affected by the criminal legal system.

Eligibility criteria:
inclusion criteria: * all incarcerated people in the pennsylvania doc are included in the study population for these low risk interventions. in this each individual intervention, inclusion criteria will be based on where incarcerated people are housed and therefore what intervention they will be exposed to. exclusion criteria: * exclusion criteria will likely include severe physical or mental illness as these individuals are often incarcerated in special units which will not be included in the study (i.e. medical units).
12 week efficacy and safety study of empagliflozin (bi 10773) in hypertensive patients with type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2; Hypertension

Summary: this trial will evaluate safety and efficacy of bi 10773 in hypertensive patients with type 2 diabetes. since hyperglycaemia and hypertension are key risk factors for both micro- and macrovascular complications, assessment of both glucose and blood pressure lowering effects of bi 10773 in hypertensive patients with type 2 diabetes could provide clinically highly relevant, new information for the use of bi 10773


Eligibility criteria:
inclusion criteria: 1. patients \>=18 years with type 2 diabetes 2. hba1c of \>= 7.0% (53 mmol/mol) and =\< 10% (86 mmol/mol) 3. mean seated systolic blood pressure 130-159 mmhg and diastolic blood pressure 80-99 mmhg exclusion criteria: 1. uncontrolled hyperglycaemia with a glucose level \>240 mg/dl (\>13.3 mmol/l) after an overnight fast before randomization 2. known or suspected secondary hypertension 3. acute coronary syndrome (non-stemi, stemi and unstable angina pectoris), stroke or transient ischemic attack within 3 months prior to informed consent
efficacy of proprioceptive focal stimulation (equistasi) on gait parameters in parkinson. italian multicentric study

Conditions: Parkinson Disease; Gait, Shuffling; Effects of Vibration

Summary: it's already known the efficacy of gait analysis (ga) on evaluating gait modification on parkinson's disease (pd) patients (1). on the other hand proprioceptive focal stimulation seems be useful in symptoms amelioration in several neurological disease. few studies have been performed in parkinson's disease. a total of 126 patients suffering from pd will be recruited in 6 italian neurological centers. the study will be a cross-over multicenter study with the randomization of the sequence. the patients will be randomly assigned to 2 groups receiving for 8 weeks either the equistasi medical device, or an equivalent placebo. gait analysis will be recorded in each patient at the beginning and at the end of the treatment assigned. after 4 weeks of wash-out, the treatment will be crossed and a new gait analysis recording will be performed. finally a last recording will be taken at the end of the last 8 weeks. secondary outcome will be the mds-updrs (movement disorder society - unified parkinson disease rating scale), pdq-39 (parkinson disease 39 questionnaire ), abc (activity specific balance confidence scale).


Eligibility criteria:
inclusion criteria: * patient with rigid-acinetic bilateral pd form * at least 4 years of disease history * h\&y between 2-3 * stable drug therapy response without any change performed in the 3 months before the study. * presence of freezing (fog) and of postural instability not responding to parkinsonian therapy. * mmse\>24/30 (mini-mental state examination) exclusion criteria: * systemic illness * presence of cardiac pacemaker * presence of deep brain stimulation * presence of severe dysautonomia with marked hypotension * obsessive-compulsive disorder (ocd) * major depression * dementia * history or active neoplasia * pregnancy

Keywords: gait analysis proprioceptive focal stimulation parkinson
return to work after potential severe injury

Conditions: Multiple Trauma

Summary: in norway an estimated 10 % of the population is injured annually. of these 36.000 sustain permanent functional impairment, 1.200 receive disability pension, and approximately 2.500 die because of their injuries. mortality is the most common variable measuring trauma outcome. however, measuring only trauma mortality may be looking merely at the tip of the iceberg. for every trauma death, there are ten-folds suffering long term functional impairment. mortality is therefore a too crude variable to describe the impact of injuries - both for the individual trauma patient and for society as a whole. there is a need for variables describing long-term outcomes on a functional level. the aim of this study is to use the rate of return to work and education as an alternative outcome measure. the ability of returning to work after injury is a central indicator of individual functional outcome, combining both physical and mental skills in performing complex and compound tasks. previous studies on return to work after injury are limited by a combination of short follow-up times, the use of patient reported outcomes and having mainly been focusing on only severely injured patients (iss \> 15). this a population-based study including all patients in working age (16 - 65 years) received by a trauma team in any of the eight hospitals within the region of central norway in the time period from june 1st,2007 to may 30th, 2010. already collected trauma registry data will be linked with national register data on sickness and disability benefits, employment and education.


Eligibility criteria:
inclusion criteria: * exposed to traumatic injuries * received by trauma team attendance * received by trauma team activation protocol

Keywords: outcome assessment (health care) return to work registries norway
the effect of intravenous lidocaine on postoperative cognitive function in elderly patients

Conditions: Organ Protection

Summary: the purpose of this study is to investigate the efficacy of intravenous lidocaine on bdnf, ngf, mirna-206 and mirna-98 in serum in elderly patients undergoing abdominal surgery under general anesthesia.

postoperative cognitive dysfunction (pocd) is a major complication following surgeries and anesthesia, especially in elderly individuals. lidocaine, an inexpensive, widely available, and relatively safe compound, is a local anesthetic that readily crosses the blood-brain barrier. intravenous lidocaine can reduce the incidence of pocd. however, the mechanism is still unclear. brain-derived neurotrophic factor (bdnf) and nerve growth factor (ngf), which are regulated by mirna-206 and mirna-98 respectively, play a key role in learning, memory, and cognition. previous studies have shown that the levels of bdnf and ngf can be improved by lidocaine. the objective of this study is to investigate the efficacy of intravenous lidocaine on the incidence of early pocd, and the levels of bdnf, ngf, mirna-206 and mirna-98 in elderly patients undergoing abdominal surgery under general anesthesia.

Eligibility criteria:
inclusion criteria: * patients were scheduled by following abdominal surgery under general anesthesia * aged 65 - 80 years * asa physical status ⅱ-ⅲ exclusion criteria: * severe heart, pulmonary, hepatic and renal insufficiency * history of neurological diseases (including alzheimer's disease and stroke history) * psychological disorder, and drug or alcohol abuse * history of anesthesia and surgery * psychiatric illness * unwillingness to comply with the protocol or procedures * allergic to lidocaine * mini-mental state examination (mmse) score\<23 before surgery

Keywords: postoperative cognitive dysfunction lidocaine brain-derived neurotrophic factor nerve growth factor mirna-206 mirna-98
air barrier system for the reduction of airborne colony forming units during total knee arthroplasty

Conditions: Osteoarthritis, Knee

Summary: this objective of this study is to determine whether the air barrier system device reduces airborne colony-forming units (e.g., bacteria) present at a surgery site during total knee arthroplasty surgeries.

the air barrier system (abs) is a device that uses localized clean air flow to shield a surgery site from ambient airborne contamination. this study examines the hypothesis that the abs can reduce the presence of airborne cfu at the surgery site during total knee arthroplasty surgery.

Eligibility criteria:
inclusion criteria: * candidate for total knee arthroplasty exclusion criteria: * prior history of infection * revision surgery * screens positive for mrsa

Keywords: total knee replacement operating room airborne cfu
combined effects of early behavioral intervention and propranolol on asd

Conditions: Autism

Summary: the purpose of this study is to explore the effects of propranolol in combination with early intensive behavioral intervention on social interaction, and secondarily on language, anxiety, adaptive behaviors, and global function in children with autism in a double-blinded, placebo-controlled pilot trial.

the investigators' specific aim is to examine the effects of serial doses of propranolol in combination with early intensive behavioral intervention on social interaction, and secondarily on language tasks, anxiety, adaptive behaviors, and global function in children with autism in a double-blinded, placebo-controlled trial. the investigators will also examine whether response to treatment can be predicted based upon markers of autonomic functioning, such as pupillary light reflex and heart rate variability, and whether anxiety predicts treatment response. the investigators' hypothesis is that propranolol will augment the effects of behavioral therapy on social functioning and language abilities. the investigators have demonstrated benefits of propranolol on social functioning and language in previous single-dose studies in adults and adolescents with autism. the investigators also predict that those with the greatest degree of autonomic dysregulation will demonstrate the greatest benefit from the drug.

Eligibility criteria:
inclusion criteria: * diagnosis of autism spectrum disorder (asd), defined in this study by the dsm-v criteria plus autism diagnostic observation schedule (ados) criteria for autism. * aged 3-8 * participants must also be enrolled in an early behavioral intervention program at the thompson center or another institution in missouri for the duration of the study. exclusion criteria: * non-autism learning disability (e.g. dyslexia) * major psychiatric diagnosis (e.g. major depression, schizophrenia, bipolar disorder) * other neurological diagnosis * major head trauma * any of the following exclusionary criteria related to propranolol (diabetes, reactive airway/pulmonary disease, thyroid disease, bradyarrhythmias, unexplained syncope, narrow angle glaucoma, known hypersensitivity/adverse reaction to beta-blockers, potentially interacting drugs, underweight \< 15 kg) * any of the following exclusionary criteria related to the use of electrocardiogram (history of rash from adhesives) * any of the following exclusionary criteria related to the pupillary reflex measurement (uncorrectable visual acuity impairment). * participants with a heart rate of less than 60 or a systolic blood pressure of less than 75 at the outset of the study will be excluded.
real-world evidence of covid-19 vaccines effectiveness

Conditions: COVID-19 Pneumonia

Summary: this is an observational case-control study to evaluate covid-19 vaccine effectiveness against hospitalisation with covid-19 related conditions in st. petersburg, russia. two sets of cases and control will be retrospectively analyzed to compare vaccination proportions and other characteristics to infer vaccine effectiveness from odds ratios. the first set of cases will be extracted from the data on hospitalisation of patients with covid-19 to first pavlov state medical university of saint-petersburg hospitals, and controls will be patients hospitalised with other conditions. the second set of cases and controls will be based on patients referred to medical institute named after berezin sergey for computed tomography. cases will be patients with positive sars-cov-2 status computed tomography confirmed pneumonia or patients referred to hospitalisation, and control will be patients without pneumonia and not referred to hospitalisation.


Eligibility criteria:
inclusion criteria: * patients hospitalized to clinics of first pavlov state medical university of saint-petersburg * patients referred to medical institute named after berezin sergey for computed tomography * available vaccination status exclusion criteria: - refusal to provide information for research purposes at the time of hospitalization or reference to computed tomography