Kornimate/medical-research-clean huggingface dataset:
a simple clinical tool for increasing enrollment on a kidney transplant waiting list for patients aged over 70 and initiating dialysis

Conditions: Kidney Failure, Chronic

Summary: the main objective of this study is to show that the systematic use of a prognostic score as early as possible after the initiation of dialysis in patients over 70 years of age and with a good prognosis at 3 years of dialysis results in an increase in the number of entries on a kidney transplant waiting list at 12 months after the initiation of dialysis. this prospective assessment is carried out as part of a historico-prospective before-after study in parallel with a survey of changes in national practices over the same time period via a here-elsewhere type study. historical data (i.e the. "before" period) will include incident dialysis cases during the calendar years 2013, 2014 and 2015 before the start of the prospective phase (i.e. "after" period, which is represented by the current declaration); since a preliminary study demonstrated that the data are comparable from 2011 to 2013, we will use the average of data thus obtained. historical data will be retrieved from the rein (the french renal epidemiology and information network) registry data and will be validated by investigators at each center.

the secondary objectives are: a. to show that the systematic use of the score at the initiation of dialysis can shorten the registration delay on a kidney transplant waiting list; to evaluate the time between initiation of dialysis and registration on a national waiting list for kidney transplants, while assessing the duration of the pre-transplant assessment. b. to identify barriers to registration on the kidney transplant waiting list as well as the related time delay in this population (medical and non-medical factors), the rates and causes of patient refusal for registration and the possible evolution this refusal over time. c. to evaluate the economic impact of the introduction of the renal transplant clinical prognostic score.

Eligibility criteria:
inclusion criteria: * the patient must have given his/her informed and signed consent * the patient must be insured or beneficiary of a health insurance plan * the patient is available for 12 months of follow-up * patient initiating chronic dialysis (incident cases) * patients with a 3 year prognostic mortality score less than (\<) 10 points (dusseux et al. 2015) exclusion criteria: * the patient is participating in another interventional study * the patient is in an exclusion period determined by a previous study * the patient is under judicial protection, under tutorship or curatorship * the patient refuses to sign the consent * it is impossible to correctly inform the patient * patient on preemptive kidney transplant waiting list (before the initiation of a chronic dialysis program)
auricular point acupressure to manage pain in patients with alzheimer's disease and related disorders

Conditions: Pain; Alzheimer Disease

Summary: pain is considered as one of the most important causal factors of behavioral and psychological symptoms in patients alzheimer's disease and related disorders (adrd). the investigators plan to examine the effectiveness of pain relief, pain sensory change and immune biomarkers change (measured by serum biomarkers) after the auricular point acupressure (apa). a waitlist will be used to examine the feasibility of a 4-week apa intervention. the investigators will also explore potential analgesic pathways and underpinnings of apa on pain relief.

a waitlist pilot study will be conducted to examine the feasibility of a 4-week apa intervention. participants and their caregivers will be enrolled into the study. following the baseline assessment (1st home visit), participants will wait one month and will be randomized to an interventionist or caregiver-training group. both groups will have a home/office visit at pre-intervention, followed by three home visits weekly, and a final home/office visit at post-intervention. participants in both groups will have 1 monthly follow-up phone call after the completion of apa.

Eligibility criteria:
inclusion criteria: * have a diagnosis of possible or probable adrd by national institute of aging (nia) and alzheimer's association guidelines, * have a caregiver who is able to help and manage apa, * pain that has persisted at least 3 months and pain on at least half of the days for the previous 6 months, * average intensity of pain ≥ 4 on a 10 point numerical pain scale in the past 7 days, * receiving care at the johns hopkins memory and alzheimer's treatment center (jhmatc), johns hopkins alzheimer's disease research center (jhadrc), * willing to commit to 5-weekly study visits (first office visits and followed by home visits) by the study coordinators and two follow-up home visits (at three- and six-months follow-up), * have any type of dementia, mild to moderate stages (montreal cognitive assessment, moca, ≥ 8), * caregiver is willing to participate. exclusion criteria: * concurrent major psychiatric disorder (e.g. major depressive disorder (as primary diagnosis), bipolar disorder, schizophrenia) or drug and alcohol abuse, * severe illness or pain that would lead to significant deterioration in health, or that would limit participation in the interventions (e.g. metastatic cancer, musculoskeletal disorders, etc.)

Keywords: pain acupressure alzheimer
study in icu patients regarding protein intake and ct-derived body composition

Conditions: Muscular Atrophy

Summary: the purpose of this study is to determine whether protein intake during the first days of intensive care admission, in relation to body composition at intensive care admission as assessed on computed tomography scans made during routine care, is are related to clinical outcome in critically ill patients.

optimal protein and energy intake have been shown to be relevant for reducing mortality in prospective observational studies in mechanically ventilated patients admitted to the intensive care unit. however, nutritional status (protein mass, muscle mass) of patients at admission and possible consequences for clinical outcome are largely unknown. computerized tomography scans can be used to assess muscle mass as a proxy for body protein mass. the investigators are especially interested in the effect of protein intake on clinical outcome in intensive care patients with different body protein mass at admission. this is relevant for appropriate formulation of clinical (protein) nutrition in this patient group. therefore, the relationship between protein intake and patient outcome is evaluated in intensive care patients with low muscle and normal muscle area, using muscle area from computed tomography scans as a proxy of body protein mass. additionally, data from computed tomography scans regarding muscle quality and muscle- and fat quantity are used to evaluate the prognostic value of body composition at intensive care admission. finally, abdominal computed tomography scans are compared with thoracic computed tomography scans.

Eligibility criteria:
inclusion criteria: * abdominal computed tomography scan made 1 day before up to 4 days after admission to the intensive care unit * length of intensive care stay of at least 4 days * mechanical ventilation during intensive care stay exclusion criteria: * computed tomography scan not eligible for analysis * missing data

Keywords: intensive care unit critical illness body composition protein nutrition
enhancing prehospital stroke diagnosis

Conditions: Stroke

Summary: current american heart association guidelines recommend that stroke patients be promptly rescued and identified so that the accepting hospital can be alerted and prepared to receive and treat them promptly. it is also recommend that stroke identification be performed using validated and standardized assessment scales. this study aims to analyze the possibility to increase the correct identification of stroke patients after implementation of several new operative procedures by the emergency medical service (ems) of the metropolitan area of milan (soreu). the interventions adopted include: 1. the evaluation of patients with suspected stroke via video call between the lay rescue personnel and the dispatch healthcare personnel 2. the training of lay rescue personnel, operating in the metropolitan area, aimed at implementing the application of the cincinnati prehospital stroke scale (cpss) scale and to expand the neurological examination with the addiction of the large artery intracranial occlusion stroke scale (lario) in the clinical evaluation.


Eligibility criteria:
inclusion criteria: * suspected stroke * rescued by basic life support vehicle * consciousness * informed consent exclusion criteria: * age \< 18 years * rescued by an advanced life support vehicle

Keywords: stroke video call
use of omega 3 oil emulsion for parenteral nutrition associated cholestasis

Conditions: Cholestasis

Summary: this is a clinical study designed to evaluate the safety and benefit of a fish oil based fat emulsion in the treatment of liver disease associated with prolonged use of intravenous nutrition.

specific aims of study 1. to determine the safety profile of an intravenous omega-3 fat emulsion (omegaven™) 2. to determine if established pn associated liver disease can be reversed or its progression halted by using a parenteral fat emulsion prepared from fish oil as measured by normalization of serum levels of hepatic enzymes and bilirubin.

Eligibility criteria:
inclusion criteria: 1. age \< 18 years old 2. patients will be pn dependent (unable to meet nutritional needs solely by enteral nutrition) and are expected to require pn for at least another 30 days, may be inpatient or outpatient 3. patients considered eligible for study participation must have parenteral nutrition associated liver disease (pnald) as defined as a direct bilirubin of 2 mg/dl or more. other causes of liver disease should be excluded. a liver biopsy is not necessary for treatment 4. direct bilirubin \> 2.0 mg/dl 5. signed patient informed consent 6. the patient must have utilized standard therapies to prevent the progression of his/her liver disease including surgical treatment, cyclic pn, avoiding overfeeding, reduction/removal of copper and manganese from pn, advancement of enteral feeding, or the use of ursodiol (i.e., actigall®) exclusion criteria: 1. pregnancy 2. other causes of chronic liver disease (hepatitis c, cystic fibrosis, biliary atresia, and alpha 1 anti-trypsin deficiency) 3. enrollment in any other clinical trial involving an investigational agent (unless approved by the designated physicians on the multidisciplinary team) 4. the parent or guardian or child unwilling to provide consent or assent 5. patients known to be allergic to fish or egg protein and patients with the following contraindications to omegaven™ use: * impaired lipid metabolism * severe hemorrhagic disorders * unstable diabetes mellitus * collapse and shock * stroke/embolism * recent cardiac infarction * undefined coma status

Keywords: short bowel syndrome intestinal failure total parenteral nutrition associated cholestasis
ddi study of asc41 in hv and the pk, safety and tolerability in subjects with nafld.

Conditions: Healthy; NAFLD

Summary: the primary objective of this study is to evaluate the effect of itraconazole, a strong inhibitor)of cytochrome p4503a , and phenytoin a strong inducer of cytochrome p450 3a, cyp3a4, cyp1a2 and cyp2c19 on the pharmacokinetics of asc41, a thr beta agonist tables in healthy subjects. the pk, safety and tolerability of asc 41 in subjects with nafld will also be evaluated. approximately 24 subjects including 16 healthy volunteers (hvs) and 8 subjects with nafld will be enrolled. this study consists of 3 cohorts.

this multiarm study in hvs and subjects with nafld is designed to further characterize the pk, safety and tolerability of asc41. part i of the study will assess the effect of itraconazole and phenytoin on the single-dose pk of asc41 in hvs. part ii of the study will evaluate the pk, safety and tolerability of a single dose of asc41 in subjects with nafld. the pharmacokinetics of asc41 and its metabolite asc41-a will be assessed in both parts i and ii. the secondary objective of the study is to characterize the safety and tolerability of oral asc41 in subjects in the u.s. with nafld and in hvs. approximately 24 male and female participants will be enrolled. this study consists of 3 cohorts.

Eligibility criteria:
key inclusion criteria: * part i healthy subjects between 18 to 55 years of age * part ii 1. subjects with nafld 2. subjects between 18 to 65 years of age key exclusion criteria: * part i 1. a history of thyroid disease 2. a history of, or current liver disease, or liver injuries 3. platelet count \<150,000/mcl 4. inr\> 1.2 5. history of, or current electrocardiogram (ecg) abnormalities, arrhythmias or heart valve diseases judged to be clinically significant by the investigator * part ii 1. a history of thyroid disease 2. current or history of cirrhosis or decompensated liver disease 3. ast or alt \> 5x uln 4. dbil \> uln 5. acute or chronic liver disease other than nafld 6. a history of bariatric surgery 7. hba1c \>9.5% at screening 8. testosterone or estrogen replacement therapy 9. inducers or inhibitors of cyp3a4, including herbal therapies such as st john's wort (cyp3a4 inducer)

Keywords: healthy nafld ddi (drug-drug interaction) itraconazole phenytoin thr beta agonist asc41
pain after cesarean sectio.

Conditions: Pain; Analgesic Medication

Summary: to study the strength of postoperative pain 0-24 hrs after elective cesarean sectio in spinal anaesthesia.


Eligibility criteria:
inclusion criteria: * cesearean sectio exclusion criteria: * none
bisoprolol plasma residual concentrations in chronic heart failure

Conditions: Heart Failure With Reduced Ejection Fraction

Summary: this study evaluate the dosage of bisoprolol plasma residual concentrations in chronic heart failure with mild to reduced ejection fraction adult patients by dose and renal function.

the clinical relevance of bisoprolol plasma residual concentration in the management of hf medical therapy and the impact of renal function on reaching the maximum tolerated dose has never been studied. the investigators will perform an observational study to answer this issue. in this study, there will be no changes of the doses of bisoprolol, whatever the bisoprolol plasma concentration, with the exception of vital threatening concentrations. this study is a pilot study. participants will be consecutive ambulatory chronic heart failure patients followed at the chu de caen, treated with maximum tolerated dose of bisoprolol with mild to reduced ejection fraction. participants can benefit of the other heart failure recommended treatment at the exception of ivabradine that would confound the bisoprolol effect on heart rate. participants will be subsequently studied by renal function. patients will be followed at one year with the electronic health record of the chu de caen for clinical events.

Eligibility criteria:
inclusion criteria: * consecutive ambulatory patients with chronic heart failure with mild to reduced ejection fraction (lvef \< 50%) at the chu de caen * aged 18 y.o. or older * with a stable heart failure (see exclusion criteria) * at the maximum tolerated dose of bisoprolol for at least one week (maximum dose reached without adverse tolerance event: orthostatic hypotension, symptomatic bradycardia, fatigue related to the treatment) exclusion criteria: * unstable hf, that are patients who presented in the last 3 months before inclusion an hospitalization for any cardiovascular event including hf, new onset or worsening of hf or coronary artery disease symptoms * patient refusing to participate * patients with a non maximum tolerated dose of bisoprolol * patients with ivabradine intakes * body weight \ 100kg * severe liver insufficiency * pregnancy * liberty deprived patients

Keywords: bisoprolol
interventions for parent caregivers of injured military/veteran personnel

Conditions: Stress Disorders, Post-Traumatic; Brain Injuries, Traumatic

Summary: this randomized clinical trial will test a behavioral caregiving intervention that has been used successfully for dementia and spinal cord injury caregivers to provide services to stressed and burdened parent caregivers of post 9/11 service members/veterans. this intervention is six intensive individual sessions that will teach problem solving, cognitive restructuring and stress reduction targeted to an individual assessment of the care dyad's needs. it will be compared to another method of delivering content, education webinar sessions, which are analogous to the usual standard of care and will function as an attention control arm. the objective of the study is to determine which of these delivery mechanisms is more effective at helping parent caregivers of injured post 9/11 returning troops to improve their depression, anxiety, and burden, and to determine the feasibility of using individual sessions with this population of caregivers.


Eligibility criteria:
inclusion criteria: 1. identify as a parent who serves as the primary/main caregiver for a post 9/11 service member or veteran with a diagnosis of traumatic brain injury or post traumatic stress disorder or physical injury and at least 1 activity of daily living limitation or 2 or more instrumental of daily living limitations; 2. provide 3 hours or more of care per day for at least 6 months; 3. endorse at least 2 caregiving stress behaviors (overwhelmed, often needing to cry, angry/frustrated, cut off from family/friends, moderate/high levels of stress, and declining health); and 4. have a telephone. 5. internet access is desirable but not mandatory. exclusion criteria: 1. current diagnosis of schizophrenia or other major mental illness; or 2. auditory impairment that would make telephone use difficult

Keywords: parents caregivers veterans
local fields potentials recorded from deep brain stimulating electrodes

Conditions: Parkinson's Disease; Essential Tremor; Dystonia

Summary: deep brain stimulation (dbs) is an fda approved, and widely used method for treating the motor symptoms of parkinson's disease (pd), essential tremor (et) and dystonia. over 100,000 patients worldwide have now been implanted with dbs devices. the dbs target regions in the brain are the subthalamic nucleus (stn), the internal segment of globus pallidus (gpi), or the ventral intermediate nucleus of the thalamus (vim). in order to place the dbs electrode in the target location, a combination of two 3d imaging techniques; 3d mri and ct, are used. data are also collected from individual nerve cells to help find the best location for the dbs electrode in each patient. this electrode recording takes place during the standard surgical implantation of the dbs electrode, and is part of the standard clinical technique. the investigators plan to collect additional data from populations of neurons during the dbs surgery in an effort to further improve the placement of the dbs electrode. these "local field potentials", lfps, represent the activity of the collection of neurons surrounding the tip of the electrode, and will be measured during surgery along the path used for the placement of the dbs electrode. the goal of this project is to determine whether this additional data from surrounding neurons will help with optimal placement of the dbs electrode.


Eligibility criteria:
inclusion criteria: * subjects included in this study will be those who are planning to undergo dbs surgery because of their underlying idiopathic parkinson's disease, essential tremor, or dystonia--all fda-approved indications for the implantation of dbs devices. exclusion criteria: * subjects with the most advanced symptoms of pd (stage v in the hoehn and yahr rating scale). * subjects who are not planning to undergo dbs surgery. * subjects not candidates for dbs surgery based on clinical criteria.

Keywords: deep brain stimulation local field potential subthalamic nucleus
cardiovascular and autonomic reactivity in women with a history of pre-eclampsia

Conditions: Preeclampsia

Summary: a history of preeclampsia is associated with a low plasma volume and higher sympathetic activity. methyldopa will suppress sympathetic activity to normal values. in this study, the researchers will test that effect on the total cardiovascular balance.

this is a randomized double-blind placebo controlled cross-over study in formerly preeclamptic women with a contracted plasma volume. the researchers will test the effect of methyldopa on the cardiovascular balance and orthostatic tolerance in women with a history of preeclampsia and healthy controls.

Eligibility criteria:
inclusion criteria: * primiparous * history of preeclampsia * low plasma volume exclusion criteria: * thrombophilia * hypertension * auto-immune disorder * insulin dependent diabetes mellitus

Keywords: capacity trial preeclampsia plasma volume sympathetic activity hypertension cardiovascular system
safety and immune response of covid-19 vaccination in patients with basic disease

Conditions: Diseases, Chronic; Covid19; Adverse Reaction to Vaccine

Summary: on 11 february 2020, the international committee for the classification of viruses named the disease caused by saｒs-cov-2 infection in humans as the new coronavirus pneumonia (coronavirus disease 2019, covid-19).due to the decline of immunity and cardiopulmonary function in patients with basic diseases (hypertension, diabetes, chronic obstructive pulmonary disease, chronic kidney disease, cancer diseases, etc.), covid-19 's severe illness and mortality mainly increase in these special population. vaccination of covid-19 vaccine can effectively prevent covid-19 virus infection and delay or prevent patients from developing into critical illness and reduce mortality.to evaluate the safety and effectiveness of the population vaccinated with covid-19 vaccine, and to play a scientific and theoretical supporting role in guiding covid-19 vaccination scientifically, reasonably and effectively, so this study was carried out.

due to the decline of immunity and cardiopulmonary function in patients with basic diseases (hypertension, diabetes, chronic obstructive pulmonary disease, chronic kidney disease, cancer diseases, etc.), covid-19 's severe illness and mortality mainly increase in these special population. at present, there is no evidence that these special population have been vaccinated against covid-19, but cdc vaccination and the guidelines and consensus of various professional societies hold that: (1) the people with underlying diseases have low immunity and are easy to develop into severe patients with high mortality; (2) although there is no direct evidence of evidence-based medicine, it is best to be vaccinated with covid-19 vaccine in the absence of disease progression activities to reduce high risk. to evaluate the safety and effectiveness of the population vaccinated with covid-19 vaccine, and to play a scientific and theoretical supporting role in guiding covid-19 vaccination scientifically, reasonably and effectively, so this study was carried out.

Eligibility criteria:
inclusion criteria: * the selection criteria should follow the disease diagnosis guidelines developed by various colleges and the consensus of expert recommendations on vaccination. exclusion criteria: * the exclusion criteria should follow the disease diagnosis guidelines developed by various colleges and the consensus of expert recommendations on vaccination.

Keywords: covid-19 vaccine basic diseases cancer diseases