Kornimate/medical-research-clean huggingface dataset:
antimicrobial pharmacokinetics in critically ill adults during sustained low efficiency dialysis (sled)

Conditions: Critical Illness; Kidney Injury; Pharmacokinetics

Summary: severe acute kidney injury (aki) is a common complication of critical illness affecting almost half of all patients with septic shock. extracorporeal renal replacement therapy is a cornerstone in the management of aki in these patients. options for renal replacement therapy include continuous renal replacement (crrt) therapy, intermittent dialysis (ihd) or a hybrid form of the two called sustained low efficiency dialysis (sled). globally there is a push to switch from traditional crrt to sled. although there are resource and financial comparative benefits to sled there is almost no literature describing how to dose antimicrobials (or other drugs for that matter). it appears that drug clearance on sled may be more efficient than crrt but not as efficient as ihd making extrapolation from these bodies of literature inappropriate for sled. the investigators are proposing to conduct the population pharmacokinetic studies for the three most commonly used antimicrobials in critically ill patients receiving sled therapy (piperacillin-tazobactam, meropenem and vancomycin). population pharmacokinetic modeling of these drugs will provide estimates and sources of variability around pharmacokinetic parameters that will subsequently be used for monte carlo simulation to determine the most appropriate dosing regimens to achieve therapeutic targets while minimizing the risk of toxicity.


Eligibility criteria:
inclusion criteria: * critically ill adults \[age ≥ 18\] admitted to one of two of the medical/surgical intensive care units (icus) of the ottawa hospital, who require sled and are or will receive meropenem, piperacillin-tazobactam or vancomycin therapy at any dose. exclusion criteria: * patients for whom participation via the informed consent process is denied. * critically ill patients with a hypermetabolic state due to \>25% coverage of body surface area burn, cystic fibrosis, spinal cord injury, bariatric patients (defined as \>150kg total body weight) * patient is pregnant as per a positive serum or urine βhcg qualitative assay * patient does not have a closed-system arterial or central venous catheter (to minimize blood wastage) * patients receiving concomitant drugs known to interact with the metabolism or clearance of the antimicrobial of interest according to micromedex 2.0 (truven health analytics inc 2013)
investigating the acute effects of thc on functional brain systems

Conditions: Reward; Tetrahydrocannabinol; Endocannabinoids; Memory; Magnetic Resonance Imaging

Summary: the purpose of this study is to determine whether thc, the main psychoactive ingredient in cannabis, affects functional brain systems underlying memory and reward.

cannabis is by far the most frequently used illicit drug worldwide and has significant effects on memory. further, cannabis has an addictive potential. these effects are mediated by an action of thc, the main psychoactive ingredient of cannabis, on cannabinoid cb1 receptors. these receptors are particularly highly expressed in brain regions involved in memory and reward. therefore, in this study we will investigate the acute effects of thc on functional brain systems underlying memory and reward. we will visualize these effects using the latest non-invasive imaging technique: pharmacological mri (phmri).

Eligibility criteria:
inclusion criteria: * history of mild cannabis use for at least one year (\<1/week and ≥ 4/year) * history without psychotic experiences after cannabis use * age between 18 and 45 years * right-handedness, assessed with the edinburgh handedness inventory * written informed consent of the subject exclusion criteria: * any clinical significant abnormality of any clinical laboratory test, including urinary drug screening * impaired physical health evaluated by medical history, physical (including neurological) examination and screening laboratory tests * history of clinically significant psychiatric or neurological illness * history of clinically significant psychiatric or neurological illness in first- or second-degree relatives * history of alcohol and/or drug abuse (dsm-iv criteria) * body mass index (b.m.i.) \ 28 kg/m2 * paranoid ideation or psychoticism on scl-90 * any subject who received any investigational medication within 90 days prior to the start of the study or who is scheduled to receive an investigational drug * the use of any medication within three weeks prior to the start of the study, except for paracetamol * positive hiv or hepatitis b/c test * blood donation within 3 months before the start of the study * claustrophobia * metal objects in or around the body (braces, pacemaker, metal fragments)

Keywords: tetrahydrocannabinol memory reward magnetic resonance imaging endocannabinoids
evaluating an alternative clinical genetics cancer care deliver model

Conditions: Pancreas Cancer; Prostate Cancer; Hereditary Cancer; Genetic Predisposition to Disease

Summary: to evaluate an alternative clinical genetics cancer care delivery model, using non-genetic providers to introduce and order genetic testing. 250 prostate and 250 pancreatic patients will be recruiting. they will undergo genetic testing and complete study questionnaires. results from this pilot study will be used to inform the strategies used by the clinical risk evaluation program (crep) genetic counelors (cgs) and gi/gu physicians to deliver genetic testing and return genetic risk information to patients with prostate or pancreatic cancer.


Eligibility criteria:
inclusion criteria: * • penn patient age 18 years or older. * diagnosed with prostate cancer or pancreas cancer. * deemed to be clinically appropriate for multiplex genetic testing by their urologic cancer program (gu) physician or gastrointestinal cancer program (gi) physician at the abramson cancer * agreed to receive clinical multiplex genetic testing from their physician. * english-fluent; the surveys were designed and validated in english and are not currently available in other languages. exclusion criteria: * • patients who do not or will not receive their ongoing cancer care at penn * major psychiatric illness or cognitive impairment that in the judgment of the study investigators or study staff would preclude study participation. * any patients who are unable to comply with the study procedures as determined by the study investigators or study staff.
evaluate sage-547 in participants with essential tremor

Conditions: Essential Tremor

Summary: stage 1 is a double-blind, proof-of-concept study designed to evaluate the safety, tolerability, pharmacokinetics (pk), and efficacy of sage-547 injection in male and female participants with essential tremor in the upper limb. stage 2 is an open-label arm designed to evaluate the safety, tolerability, pk, and effectiveness of sage-547 injection at a higher dose than in stage 1. participants who completed stage 1 were invited to participate in stage 2.


Eligibility criteria:
inclusion criteria: * males and females, 35-75 years old with a diagnosis of essential tremor with symptoms clearly present in at least 1 upper limb; participant has had tremor present for at least 2 years prior to screening * off medication, or on a stable dose of medication for their tremor for at least 28 days prior to screening exclusion criteria: * recent history or active clinically significant manifestations of metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, musculoskeletal, dermatological, urogenital, eyes, ears, nose, or throat, psychiatric, or neurological (other than essential tremor) disorders * medical history of seizures
identification of gene and protein markers of kidney injury in aminoglycoside-treated children

Conditions: Infection; Renal Dysfunction

Summary: the purposes of this study are to identify potential gene and protein markers of aminoglycoside-induced kidney injury in infants, children and adolescents treated with aminoglycoside antibiotics.


Eligibility criteria:
inclusion criteria: (1) hospitalized male and female newborns, infants, children and adolescents (ages birth to 18 years) with a diagnosis of suspected or proven bacterial sepsis, meningitis or other indication necessitating aminoglycoside therapy (2) hospitalized and outpatient newborns, infants, children and adolescents (ages birth to 18 years) who are not receiving aminoglycoside therapy. exclusion criteria: (1) current treatment with inhaled or ophthalmic aminoglycosides (2) prior treatment with an aminoglycoside within the last 30 days

Keywords: infection renal dysfunction aminoglycoside protein child
monitoring glucose levels in patients with myocardial infarction

Conditions: Acute Coronary Syndromes; Hyperglycemia; Hypoglycemia

Summary: to evaluate the optiscanner® for continuous glucose monitoring as a tool to optimize glucose levels in patients hospitalized for acute coronary syndromes

methodology part a) explorative part b) randomised, parallel-group design

Eligibility criteria:
inclusion criteria: * acute coronary syndrome according to the joint recommendations by the european society of cardiology (48, 49) * signed written informed consent consistent with helsinki declaration and local legislations prior to participation in the trial. exclusion criteria: * \<18 years old. * congestive heart failure. * patients who, in the opinion of the investigator, will have difficulties to comply with the protocol (examples: alcohol or drug abuse, psychiatric disorder).

Keywords: acute coronary syndromes hyperglycemia hypoglycemia continuous glucose monitoring
exercise and diet for pediatric obesity

Conditions: Pediatric Obesity; COVID-19

Summary: the coronavirus disease (covid-19), is a communicable pandemic disease as stated by the world health organization (who), which has been affecting the world since december 2019. covid-19 infected children develop the signs and symptoms of the disease, which can be exaggerated or life-threatening when associated with comorbidities like; obesity, sickle cell anemia, immune disorders, chromosomal abnormalities, chronic respiratory or cardiac problems, and congenital malformations.3 it is observed that children affected with covid-19 who are physically inactive or in a sedentary lifestyle may induce and develop obesity. it is a major health concern in this pandemic situation, which can be addressed and treated with the use of appropriate physical training and proper dietary habits.

children confirmed with covid-19 infection have some systemic illness, that might lead to children with obesity. they are advised to perform regular physical training and consume a proper diet to prevent and treat negative consequences. therefore, different obesity management and weight reduction protocols are developed to control and prevent health problems and socio-economic issues associated with obesity. the management of this clinical condition has received very little attention, there is no well-defined exercise protocols or dietary prescription for this special population; therefore, there is a need for an elaborative trial in this field. hence, the aim of this trial was to investigate and compare the clinical and psychological effects of integrated physical training with a high protein diet versus a low protein diet in community-dwelling covid-19 infected children with obesity.

Eligibility criteria:
inclusion criteria: * positively diagnosed covid-19 children * age group of 5 - 12 years * body mass index (bmi) between 85th to 99th percentiles exclusion criteria: * history of physical training, * taking medications, * recent surgeries, * fractures and joint problems in the lower extremity, * cardiac and respiratory problems, * neurological issues, * major psychiatric problems, * other systemic diseases, * contraindications for physical training and family with food restrictions

Keywords: aerobic training biochemical children with obesity covid-19 high protein diet
prevalence of wildtype amyloid after tavr

Conditions: Amyloidosis

Summary: those with abnormal vital signs after tavr need to be willing to obtain a bone scan to evaluate for wildtype amyloidosis. positive bone scan findings will require evaluation for primary amyloidosis with blood and urine monoclonal immunoglobulin testing. primary amyloidosis is a different type of disease which requires different treatment.

this research is interested in determining how common wildtype amyloidosis is after transcatheter aortic valve replacement (tavr). amyloidosis is a condition characterized by abnormal protein which can accumulate and impair various organs, including the heart. research suggests that amyloidosis might be common among tavr patients, but it is a condition that is not routinely evaluated for. we suspect that wildtype amyloidosis may be especially common among patients with abnormal vital signs after their tavr procedure.

Eligibility criteria:
inclusion criteria * patients that underwent a tavr procedure at the malcolm randall va medical center. * implant of current generation tavr (i.e. sapien s3, evolut r, or evolut pro). * willingness to obtain bone scintigraphy if evidence of impaired hemodynamics after valve deployment. * willingness to have blood drawn * willingness to complete sf12 quality of life kccq exclusion criteria: --patient that do not qualify for a tavr procedure as normal clinical care
what user-requirements need to be considered when developing a lower-limb exoskeleton? a qualitative study.

Conditions: Stroke; Sarcopenia

Summary: the goal of this study is to identify the needs and requirements of end-users regarding the implementation of a lower-limb exoskeleton in a remote home setting. the end-users include older adults with sarcopenia, post-stroke individuals and physiotherapists. the main question it aims to answer is: • what are the needs and requirements of the end-user population when developing a lower-limb exoskeleton that can be implemented in a remote home setting? participants will engage in three separate focus group sessions, in which they will discuss the predetermined topics. interactions between the participants will be guided by open questions.


Eligibility criteria:
people post-stroke: inclusion criteria: * \> 18 years old * ≥ 3 months ago stroke diagnosis * current difficulties during gait exclusion criteria: * serious speech disorder * lowered cognitive competence older adults with sarcopenia: inclusion criteria: * \> 65 years old * difficulties during chair sit to stand * current difficulties during gait exclusion criteria: * lowered cognitive competence physiotherapist: inclusion criteria: * currently active as a physiotherapist * experience in treating people with sarcopenia and/or post-stroke conditions exclusion criteria: * can't verbally answer

Keywords: assistive technology exoskeleton user perspective stroke sarcopenia
pain blocking during drug administration or blood collection with needles

Conditions: Pain, Intractable

Summary: there is a gating mechanism in the dorsal horn of the spinal cord that acts to facilitate or inhibit transmission of pain signals to the brain. the gate can be closed by mechanical stimuli such as touch and vibration.

the researcher develope a device that can use to reduce pain during drug administration or blood collection with needles.

Eligibility criteria:
inclusion criteria: * receiving an injection with a needle * able to score the pain on a scale of 0-10 using the universal pain assessment tool, preferably 7 years of age or older exclusion criteria: * current pregnancy * inability to understand and carry out instruction

Keywords: pain blocking
does access to an ehr patient portal influence chronic disease outcomes?

Conditions: Congestive Heart Failure; Diabetes; Cardiovascular Disease

Summary: the purpose of this study is to determine if patients with congestive heart failure, diabetes or secondary cardiovascular diseases, who access healthmedia's online tailored behavior change programs on the electronic health record patient portal have better clinical and behavioral change outcomes.

the specific aims of the study are to determine if e-portal interventions influence: * measures of patient activation, patient self-management, treatment adherence, patient satisfaction with care, and disease specific knowledge. * process measures relevant to appropriate care for cvd, chf, and dm. * clinical markers of cardiovascular or diabetes morbidity and risk. these aims will be evaluated in one-year prospective study. patients who use the portal will be randomized to control (i.e., access to routine portal-related information) and intervention groups (i.e., targeted and periodic messages designed to capture data relevant to self-management; to improve knowledge of their specific disease, tests, and risks; to devise time-dependent goals; and to motivate self-efficacy). outcomes including activation, satisfaction, and adherence will be measured by telephone interview prior to and one year after intervention, and by lab and clinical measures and data available from the ehr. we will also evaluate potential selection issues among those who sign on to the e-portal by administering the same baseline interview to a matched (by disease and by age) random sample of patients who do not sign on to the e-portal. patients with chronic diseases are likely to experience particular benefit from online e-health resources as they have greater information needs and participate in self-management.(camer, 2000) unlike traditional office visits, online interactions eliminate the need to travel, are always available and give the patient access to a broad range of information, helping them actively participate in their own care.(brown, 1999) there is growing evidence that patient education and engagement using e-health applications results in improved patient outcomes in the care of chronic illnesses, improved patient-physician communication, and reduction of anxiety for caregivers.(brennan et al., 2001; bronson et al., 1986; bronson \& o'meara, 1986; ross et al., 2003a, 2003b) we anticipate demonstrating clinically meaningful improvements in chronic disease health status, using evidence-based science delivered in behaviorally-validated ways.

Eligibility criteria:
inclusion criteria: * adult age 18 years or older * have medical records in the geisinger electronic health record * have congestive heart failure and/or diabetes and/or cardiovascular disease

Keywords: electronic health record patient portal chronic diseases
vibratory pep device and hospital length of stay for acute exacerbation of copd

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this study is evaluating the use of a respiratory device, the acapella vibratory positive expiratory pressure (pep) therapy device, in patients admitted to the hospital with a chronic obstructive pulmonary disease (copd) exacerbation.

the investigators hypothesize that the pep-fv used as adjunctive therapy in patients hospitalized for an acute exacerbation of copd will result in decreased hospital length of stay and improvement of overall copd-related health outcomes.

Eligibility criteria:
inclusion criteria: * admitted with copd exacerbation as a primary diagnosis * subjectively produces more than 1 tablespoon (15 ml) / day of sputum * has the subjective feeling that he/she cannot cough up or clear her secretions * physical respiratory system exam by the physician with evidence of course ronchi suggestive of impacted secretions * \> 10 pack-year smoking history exclusion criteria: * cannot use the flutter device or unable to follow commands * altered mental status * known active malignancy * known systolic congestive heart failure (chf) with ejection fraction (ef) \< 40% or clinically in acute chf exacerbation as documented by cardiologist or primary diagnosis other than copd * pregnancy * patients in severe exacerbation (intubated, continuous use of nippv, unable to speak full sentences) * intracranial pressure (icp) \>20 mmhg * hemodynamic instability (requiring vasopressor support) * recent facial, oral, or skull surgery or trauma. * acute sinusitis. * epistaxis. * esophageal surgery. * active hemoptysis (more than 2 tablespoons of frank blood per day) * nausea. * severe earache or discharge from ear. (known or suspected tympanic membrane rupture or other middle ear pathology) * untreated pneumothorax.
long term, follow-on study of lomitapide in patients with homozygous familial hypercholesterolemia

Conditions: Familial Hypercholesterolemia

Summary: this was a long term follow on study to assess the continued long term safety and efficacy of lomitapide in patients with homozygous familial hypercholesterolemia.

this was a phase iii open label clinical trial to evaluate the long-term efficacy and safety of lomitapide at the maximum tolerated dose (for each patient) established during the clinical trial 733-005/up1002. subjects completing the 78-week treatment period in study 733-005/up1002 who have not met any of the stopping criteria will be eligible to participate in 733-012. the treatment period continued until a decision was made by the local competent authority regarding marketing authorization. lomitapide will be given orally once daily. patient specific doses will be carried forward from 733-005/up1002, but will not exceed the maximum tolerated dose the patient received during 733-005 /up1002. the maximum dose for any patient was 80 mg/day. there was no reference therapy in this trial. the effects of the study drug were compared to baseline data (from 733-005/up1002). concomitant lipid-lowering therapy including plasmapheresis or ldl apheresis is permitted. note that hereafter, week 0 in study 733-005/up1002 will be referred to as baseline and week 48 in study aegr-733-012 will be referred to as week 126 (of overall treatment).

Eligibility criteria:
inclusion criteria: 1. completed up1002 or 733-005. 2. willing and able to provide consent and comply with the requirements of the study protocol. exclusion criteria: 1. met any of the stopping rules for study discontinuation at the final visit of study up1002 or 733-005.

Keywords: homozygous familial hypercholesterolemia mtp apheresis lomitapide homozygous familial hypercholesterolemia (hofh)