Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the safety and tolerability of v114 and prevnar 13™ in healthy infants (v114-031/pneu-link)

Conditions: Pneumococcal Infections

Summary: this study is designed to evaluate the safety and tolerability of v114 and prevnar 13™ in healthy infants. this study will include both full-term infants (≥37 weeks gestational age) and premature infants (\<37 weeks gestational age). premature infants will be included in a premature infant immunogenicity substudy, which will assess immunogenicity and safety following administration of v114 or prevnar 13™.


Eligibility criteria:
inclusion criteria: * healthy (based on a review of medical history and physical examination) based on the clinical judgment of the investigator * male or female approximately 2 months of age, from 42 days to 90 days inclusive, at the time of obtaining the informed consent * have a legally acceptable representative who understands the study procedures, alternate treatments available, and risks involved with the study and voluntarily agrees to participate by giving written informed consent. exclusion criteria: * history of invasive pneumococcal disease (ipd) (positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture positive pneumococcal disease * known hypersensitivity to any component of the pneumococcal conjugate vaccine (pcv) or any diphtheria toxoid containing vaccine * known or suspected impairment of immunological function * history of congenital or acquired immunodeficiency * has or his/her mother has a documented human immunodeficiency virus (hiv) infection * known or history of functional or anatomic asplenia * failure to thrive based on the clinical judgment of the investigator * known coagulation disorder contraindicating intramuscular vaccination * history of autoimmune disease (including but not limited to systemic lupus erythematosus, antiphospholipid syndrome, behcet's disease, autoimmune thyroid disease, polymyositis and dermatomyositis, scleroderma, type 1 diabetes mellitus, or other autoimmune disorders) * known neurologic or cognitive behavioral disorder, including encephalitis/myelitis, acute disseminating encephalomyelitis, pervasive development disorder, and related disorders * received a dose of any pneumococcal vaccine prior to study entry * received a blood transfusion or blood products, including immunoglobulins, before receipt of first dose of study vaccine * participated in another clinical study of an investigational product before the beginning or anytime during the duration of the current clinical study. participants enrolled in observational studies may be included. * has any other reason that, in the opinion of the investigator, may interfere with the evaluation required by the study * has an immediate family member who is investigational site or sponsor staff directly involved with this study.
effects of a surgery-induced peripheral inflammatory response on the blood brain barrier

Conditions: Dissecting Aneurysm of the Thoracic Aorta

Summary: the purpose for this study is to determine if surgery (repair of descending thoracic aneurysm) causes a temporary decrease in the blood brain barrier's ability to remove drugs from the brain back into the blood. the blood brain barrier surrounds the brain and the spinal cord. this blood brain barrier acts as a filter and allows some things to cross into the brain and allows other matter to be removed. studies have shown the blood brain barrier is affected by inflammation. functions of the blood brain barrier in animals have been studied. human studies with multiple causes of inflammation (e.g. alzheimer's, epilepsy, trauma and severe infections in critically hypothesis: surgically-induced inflammation will temporarily reduce blood-brain barrier drug efflux transporter function in proportion to the degree of inflammation. the investigators anticipate that inflammation-mediated reductions in drug transporter function will be reflected by an increased cerebral spinal fluid (csf) concentration of morphine (a pgp substrate) and m3g and m6g (mrp1 substrates). the corresponding in vitro studies will allow us to elucidate the mechanism(s) by which inflammation alters blood brain barrier efflux transport of morphine, m3g and m6g.

study objectives: to determine the role of surgery-induced inflammation on the transport of morphine and its metabolites, m3g and m6g, across the blood-brain barrier. study phase: iv study design: this is a sequential enrolment study design in which elective surgical patients presenting for repair of an ascending thoracic aneurysm and fitted with a csf drain as part of their standard of care will be approached for permission to draw blood samples at specified times during their hospital course. concomitantly, samples of csf will be collected from the csf drainage system (csf is normally wasted). morphine will be used as the primary analgesic agent (this is within the standard of care). samples will be collected at specified time intervals for 5 days or until the csf drain is removed (whichever comes first). samples collected will be analysed for morphine, its 3- and 6- glucuronide metabolites, inflammatory cytokines, markers of cns injury and anatomical integrity of the bbb. area under the concentration vs. time curve will be calculated and the effect on morphine metabolism and penetration across the bbb will be determined using a repeated measures analysis of variance technique (as used in our previous study).

Eligibility criteria:
inclusion criteria: 1. subjects who are to undergo elective surgery for thoracic aortic vascular disease requiring insertion of a lumbar csf drain 2. informed consent will be obtained from the subject or authorized legal representative - exclusion criteria: 1. unwilling or unable to provide informed consent 2. sensitivity or documented allergy to morphine 3. inability to place lumbar csf drain 4. dialysis dependent -

Keywords: morphine blood brain barrier surgery induced peripheral inflammatory response
a randomized controlled trial of geriatric emergency department innovations

Conditions: Frailty

Summary: this study evaluates the geriatric emergency department innovations (gedi) program at northwestern memorial hospital to care for older adults in the emergency department. half of the patients will be cared for by a standard ed team plus the gedi team, while half of the patients will receive usual ed care.

hospitalization is common for older adults in the emergency department (ed) but it carries significant risks including the development of delirium, falls, and nosocomial infections. the geriatric emergency department innovations (gedi) program at northwestern memorial hospital attempts to identify and address health related risks for older adults without exposing them to the risks of hospitalization,. gedi is a unique program consisting of a multidisciplinary team of transitional care nurses (tcn), social workers, pharmacists, occupational therapists and physical therapists who perform ed-based geriatric assessment and care coordination. to determine the impact of gedi on health services use and health related quality-of-life (hrqol) we will conduct a randomized controlled trial comparing gedi compared to usual ed care(which often involves hospitalization).

Eligibility criteria:
inclusion criteria: northwestern emergency department patients who are: * 65 years or older * living independently or with friends, family, or caregivers in the community * clinical frailty scale (cfs) score of 4 or greater exclusion criteria: patients will be excluded if they: * tested positive for covid-19 * are unable to complete the assessments in english * are unable to provide informed consent with no legally authorized representative present or are unable to complete follow-up participation * are held in the ed involuntarily as a prisoner or patient with a psychiatric complaint * are enrolled in another study to avoid patient fatigue and confounding * received a gedi, social work, pharmacy, or physical therapy consult outside of this trial during the current ed visit * leave the ed against medical advice or without being seen by a physician * are admitted to the icu * are too medically unstable to participate in the assessment
a trial of nicotinamide/pterostilbene supplement in als: the no-als extension study

Conditions: Amyotrophic Lateral Sclerosis

Summary: amyotrophic lateral sclerosis (als) is a serious rapidly progressive disease of the nervous system. the mean survival from the time of diagnosis is 2.5 years. apart from riluzole, there is no effective treatment. care of advanced als will have a cost of 4-8 million nok (norwegian kroner) per year. research i.a. from the investigators department has shown that increased activity in histone deacetylation enzymes (sirtuins) together with increased access to nicotinamide adenine dinucleotide (nad) can delay disease progression. nicotinamide riboside (nr) can increase cells' access to nad and pterostilbene will stimulate sirtuins. the investigators want to study whether combination therapy with nr and pterostilbene can inhibit neurodegeneration in als and thereby delay disease development, increase survival and improve quality of life in als. in the no-als extension study the investigators will follow the patients who completed the original no-als study. objectives are to evaluate adverse events and give patients possibility of compassionate use, and secondarily to see if the combination of nr and pterostilbene (eh301) will decrease progression of motor symptoms and loss of vital capacity, and increase survival time in patients with als.


Eligibility criteria:
inclusion criteria: * patients who fulfilled the criteria for the no-als study and have completed the study will be proposed inclusion in the no-als extension study protocol. patients from both arm 1 and arm 2 in the no-als study will be allowed inclusion in the prolongation study exclusion criteria: individuals will be excluded if any of the following exclusion criteria apply: * dementia, fronto temporal dementia (ftd) or other neurodegenerative disorder interfering with compliance. * metabolic, neoplastic, or other physically or mentally debilitating disorder. * patients who become tracheostomized as part of the treatment of als. * patients with short expected survival at the discretion of the investigator. such cases cannot be expected to follow protocol procedures. * use of vit b3 or blue berry extracts outside the study
comparison of brain network activation (bna™) analysis, clinical symptoms and neuro-cognitive performance in concussed children and young adults

Conditions: Traumatic Brain Injury

Summary: the use of event related potentials (erp) and neurocognitive performance in patients following concussion has been examined previously in small cohorts and relatively long after concussion occurred. however, little is known about the immediate changes in brain activity in specific brain regions and connectivity across them associated with performance on specific neurocognitive tests following a concussion, and the subsequent changes over time. the proposed study will provide initial evidence for the feasibility of an erp based biomarker for concussion reflecting temporal and spatial changes in brain activity as well as brain functional connectivity associated with concussion.


Eligibility criteria:
inclusion criteria: * aged 14-27 years * arm 1 only (concussed): over 2 days and below 10 days post-concussion (sports-related) * currently symptomatic * willingness to participate and able to give informed assent (child) and/or consent (parent for minors or adult 18+ years of age for self) exclusion criteria: * tbi (i.e., glasgow coma scale \<13) or brain surgery * any psychiatric disorder * substance abuse * special education * any neurological disorder * any medication affecting cns * significant sensory deficits such as deafness or blindness * clinically significant abnormal laboratory values or ecg * a history of more than 3 concussions in the past * a concussion within the last year * residual symptoms or deficits related to a previous concussion

Keywords: mild traumatic brain injury mtbi concussion
the effects nutrition status and body composition on peritoneal dialysis outcome

Conditions: Peritoneal Dialysis; Wasting and Malnutrition

Summary: a prospective long-term follow up of peritoneal dialysis patients' outcome correlates with nutritional status and body composition.

wasting and malnutrition are common and serious complications in patients on peritoneal dialysis and are strongly associated with adverse outcomes. techniques for assessing nutrition have limitations and, due to metabolic effects and confounding effects of altered hydration and other body composition abnormalities, these limitations are greater in the context of renal failure. bioelectrical impedance analysis is a promising method for the objective assessment and monitoring of body composition. body composition techniques subdivide the body into compartments on the basis of differing physical properties. the different compartments reflect hydration, nutrition/wasting, body fat, and bone mineral content, which are all of great importance in patients on peritoneal dialysis. we will conduct a prospective long-term follow up of pd patients' outcome correlates with nutritional status and body compositions. the patients will receive bia every three months, and other routine clinical data such as dialysis adequacy, peritoneal equilibration test and monthly biochemical data are collected to analyze. an additional blood sample 8 ml and 5 ml dialysate of overnight, 0 hour, 2 hour and 4 hour will be collected during annual pet for other inflammatory cytokines and nutritional markers such as adiponectin, leptin, ghrelin, prealbumin and transferrin. the follow up period will be as long as possible and the last recruited into this study is in the aug 2014. these data will be used for the morbidity and mortality analysis to see if body compositions will be more useful and timely than the other nutritional parameters.

Eligibility criteria:
inclusion criteria: 1. patients at national taiwan university hospital 2. patients who have received pd more than 3 months 3. patients who sign the informed consents exclusion criteria: 1. patients who have received pd less than 3 months 2. patients who refuse to sign informed consents 3. patients who refuse to draw additional blood for research

Keywords: peritoneal dialysis wasting and malnutrition nutrition status bioelectrical impedance analysis body composition
amino acid supplementation in recovery from traumatic brain injury

Conditions: Traumatic Brain Injury

Summary: traumatic brain injury (tbi) is a leading cause of death and disability in young people. it has been called the "signature wound" of the iraq war because of its frequency among troops. tbi is associated with many chronic disabilities. physical alterations include reduced exercise tolerance and profound muscle weakness, whereas psychological alterations include diminished sense of well-being, depression, fatigue and anxiety. muscle and brain tissues rely upon circulating blood amino acids as precursors for metabolic functions. the investigators have shown that even one year after injury, plasma valine, an essential amino acid (eaa), was markedly reduced in patients with tbi compared to healthy controls. the investigators speculate that low plasma valine concentration contributes to chronic fatigue after tbi, since valine and tryptophan compete for the same transporter into the brain, and a low plasma valine concentration will allow more tryptophan to be transported. as a consequence, increased brain tryptophan will increase serotonin production, which may significantly contribute to the development of fatigue. thus, the investigators will test if restoring valine concentration in persons with tbi may reduce fatigue perception and improve physical and neuropsychological function. further, the investigators have previously shown that eaa intake has an anabolic effect in healthy young and elderly individuals. however, no data are currently available in persons recovering from tbi. thus,the investigators will also test if eaa and/or valine can improve muscle mass in patients with tbi.


Eligibility criteria:
inclusion criteria: 1. presence of traumatic brain injury 2. age 18-65 years 3. ability to sign informed consent 4. \>3 months post-injury, \<36 months post-injury 5. ambulatory or require minimal to moderate assistance for safe ambulation exclusion criteria: 1. subjects with cardiac abnormalities considered exclusionary by the study physicians 2. subjects with uncontrolled metabolic disease, including liver or renal disease 3. subjects with cancer or recently (6 months) treated cancer other than basal cell carcinoma 4. any subject currently on a weight-loss diet or a body mass index \>34 kg/m2 5. recent anabolic or corticosteroids use (within 3 months) 6. dementia 7. inability to tolerate an upright position 8. postural reflexes prohibiting ambulation and inability to follow 2-step commands 9. any other condition or event considered exclusionary by the pis and covering physician
clinical evaluation of visual field change in glaucoma: an assessment of different models of progression

Conditions: Glaucoma

Summary: the purpose of this observational study is to collect over time a series of data in patients with glaucoma in order to evaluate different approaches in defining the progression of this pathology. these data will be collected in repeated visits over a 36-months follow-up period. at each visit, the compass fundus perimeter and the humphrey field analyzer (hfa) perimeter will be used to assess retinal functionality; an optical coherence tomography (oct) examination will also be performed to evaluate and obtain clinical information about the structure of the retina.


Eligibility criteria:
inclusion criteria: * glaucomatous optic nerve head in both eyes; * age between 40 and 90 years; * best corrected visual acuity ≤ 0.3 \[logmar\]; * spherical refraction between -6d and +6d; * astigmatism between -2d and +2d. exclusion criteria: * any ocular surgery, except for: uncomplicated cataract surgery and/or glaucoma surgery in both eyes performed within 6 months before enrollment; * any ocular pathology that can affect visual field other than glaucoma; * use of any drug that can interfere with the correct execution of perimetry or that would produce visual field loss; * inability to obtain reliable perimetric examinations; * patients with advanced glaucoma for whom, according to the clinician, a 24-2 grid is not advisable to correctly monitor the patient.
investigation of neuro-hormonal mechanisms of hunger, fullness and obesity.

Conditions: Obesity; Gastric Emptying; Anxiety; Depression; Panic Disorder

Summary: the purpose of this study is to determine abnormal neuro-hormonal mechanisms that may impair the ability to feel full and which therefore, may lead to obesity.


Eligibility criteria:
inclusion criteria: * males and females 18 to 65 years of age. * obese subjects with bmi \>40. * normal weight subjects with bmi = 18.5-24.9 exclusion criteria: * age younger than 18 years and over 65 years of age. * current use of narcotics or morphine * previous gastric surgery * presence of the following disorders that are known to cause functional gastric stasis syndromes: diabetes mellitus, hypothyroidism, progressive systemic sclerosis, systemic lupus erythematosus, dermatomyositis, familial dysautonomia, pernicious anemia, bulbar poliomyelitis, amyloidosis, gastric ulcer, post-vagotomy, tumor-associated gastroparesis, fabry disease, myotonic dystrophy, post-operative ileus, gastroenteritis. * presence of the following disorders that are known to cause delayed gastric emptying: peptic ulceration, recent surgery, pyloric hypertrophy, post-radiotherapy, ileus, anorexia nervosa, acute viral infections. * presence of the following disorders that are known to cause rapid gastric emptying: pyloroplasty, hemigastrectomy, duodenal ulcer, gastrinoma (zollinger-ellison syndrome), hyperthyroidism * current use of thyroxine as it is known to cause rapid gastric emptying * current or recent (within the last 2 weeks) use of anti-spasmodics or pro-kinetic medications. * current use of hyperalimentation * presence of any metabolic disorder, such as: hyperglycemia, acidosis, hypokalemia, hypercalcemia, hepatic coma or myxedema. * current use of estrogen or progesterone * current use of the following drugs that are known to delay gastric emptying: nifedipine, beta-adrenergic agonists, isoproterenol, theophylline, sucralfate, anticholinergics, levodopa, diazepam, tricyclic antidepressants, phenothiazine, progesterone, oral contraceptives, alcohol, nicotine, opiates. * allergy to eggs or wheat. * pregnancy.

Keywords: obesity cholecystokinin oxytocin satiety gastric emptying anxiety depression panic disorder
near-death experience in icu survivors

Conditions: Critical Illness; Near-Death Experience

Summary: this observational study aims to describe the incidence of near-death experience (nde) in patients who survived a critical illness. in order to help determine the potential risk factors of nde, dissociative status and spirituality are also investigated. finally, in patients who experienced nde, a magnetic resonance imaging is performed to search for any structural modifications.


Eligibility criteria:
inclusion criteria: * all consecutive patients who survived critical illness exclusion criteria: * glasgow coma scale \< 15/15 * confusion (cam icu scale) * refusal
a study to evaluate the efficacy after allergen challenge, safety and tolerability of inhaled chf6001 dpi in asthmatics

Conditions: Asthma

Summary: the study is designed to look at the safety, tolerability and efficacy of 2 different doses of the study drug (chf6001, a pde4 inhibitor) in asthmatics, when given by inhalation, once a day for 9 days. the efficacy will be evaluated by measuring the protective effect of chf 6001 after an allergen challenge.


Eligibility criteria:
inclusion criteria: * written informed consent obtained * non smoking or ex-smokers from at least 1 year prior to study entry * males of females between 18 and 60 years inclusive * body mass index between 18 and 32 kg/m2 * ability to be trained about the proper use of the inhalation device and to perform spirometry * with mild to moderate allergic asthma as defined by the gina guideline, steroid naive * atopy to at least one common aeroallergen * positive allergen-induced early asthmatic response and late asthmatic response at screening * ability to produce an adequate sputum sample * post-menopausal women, women of not childbearing potential or males and females of childbearing potential willing (they or their partner) to use a reliable method of contraception. exclusion criteria: * worsening of asthma or respiratory tract infection prior to study entry * history of life-threatening asthma or hospitalization for asthma prior to the study entry * pregnant or lactating women * history of clinically significant hypotensive episodes or fainting, dizziness or light-headedness * history or symptoms of clinically relevant neurologic disease * symptomatic hay fever * unstable concurrent disease that may impact the feasibility of the study * use of systemic corticosteroids, nebulised bronchodilator or oral beta2-agonist * use of leukotrienes modifiers, roflumilast or cromoglycate * use of long acting beta2-agonist or inhaled corticosteroids * use of short-acting or long-acting non-sedatives antihistamines * use of any other medication for the treatment of allergic asthma other than salbutamol * having received an investigational medicinal drug within 30 days prior to study entry * blood drawn of at least 250 ml in the previous 45 days * ongoing use of tobacco * other lung disease * recent history of alcohol dependency * inability to comply with the study protocol

Keywords: pde4 inhibitor allergen challenge asthma