Kornimate/medical-research-clean huggingface dataset:
investigating neuroinflammation underlying postoperative brain connectivity changes, pocd, delirium in older adults

Conditions: Delirium

Summary: (from nih reporter) each year \>16 million older americans undergo anesthesia and surgery, and up to 40% of these patients develop postoperative cognitive dysfunction (pocd), a syndrome of postoperative thinking and memory deficits. although distinct from delirium, pocd (like delirium) is associated with decreased quality of life, long term cognitive decline, early retirement, increased mortality, and a possible increased risk for developing dementia such as alzheimer's disease. understanding the etiology of pocd will likely help promote strategies to treat and/or prevent it. a dominant theory holds that brain inflammation causes pocd, but little work has directly tested this theory in humans. the preliminary data of this team strongly suggest that there is significant postoperative neuro-inflammation in older adults who develop pocd. in this k76 award, the investigators will prospectively obtain pre- and post-operative cognitive testing, fmri imaging and csf samples in 200 surgical patients over age 65. this will allow the investigators to evaluate the role of specific neuro-inflammatory processes in pocd and its underlying brain connectivity changes.

each year \>16 million older americans undergo anesthesia and surgery, and up to 40% of these patients develop postoperative cognitive dysfunction (pocd), a syndrome of postoperative thinking and memory deficits. although distinct from delirium, pocd (like delirium) is associated with decreased quality of life, long term cognitive decline, early retirement, increased mortality, and a possible increased risk for developing dementia such as alzheimer's disease. understanding the etiology of pocd will likely help promote strategies to treat and/or prevent it. a dominant theory holds that brain inflammation causes pocd, but little work has directly tested this theory in humans. the preliminary data of this team strongly suggest that there is significant postoperative neuro-inflammation in older adults who develop pocd. in this k76 award, the investigators will prospectively obtain pre- and post-operative cognitive testing, fmri imaging and csf samples in 200 surgical patients over age 65. this will allow the investigators to evaluate the role of specific neuro-inflammatory processes in pocd and its underlying brain connectivity changes.

Eligibility criteria:
inclusion criteria: * age 60 and above * having surgery scheduled to last \> or = to 2 hours at duke university medical center (ie duke hospital, duke medicine pavilion, duke regional hospital, durham va, duke raleigh hospital) exclusion criteria: * anticoagulants (per asra guidelines) * current use of chemotherapeutic agents with known cognitive effects.
cognitive motor interference rehabilitation in persons with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: this study examines the effect of balance and walking exercise on cognition and mobility in people with multiple sclerosis.

walking and cognitive impairments are common in persons with multiple sclerosis (ms). approximately 85% of persons with ms report walking as a major limitation, whereas 65% experience cognitive dysfunction. traditionally, walking and cognition have been viewed as unrelated, but there is evidence of cognitive-motor interference (cmi). cmi is believed to stem from damage to common neural tracts. recent evidence supports cognitive-motor interference in persons with ms. for example, there is evidence that walking performance declines when performed in conjunction with a simultaneous cognitive task (i.e., dual task cost \[dtc\] of walking) and this decline in walking performance is greater in persons with ms compared to healthy controls. this elevated cognitive-motor interference during walking is mainly associated with walking performance in persons with ms although cognitive function does play a role. cognitive-motor interference during mobility tasks is of practical and clinical importance because it has been linked to decreased community mobility and a greater risk of falls in other clinical populations. despite the adverse consequences of elevated cmi there is ambiguity concerning prevention and rehabilitation strategies for cognitive-motor interference in individuals with ms. this study seeks to examine whether single and/or targeted dual task rehabilitation has a beneficial effect on cmi in individuals with ms. the results of this investigation will provide the foundation for future rehabilitation-based randomized control trials seeking to improve walking and cognitive function in persons with ms.

Eligibility criteria:
inclusion criteria:physician diagnosed ms, relapse free for 30 days, self reporting problems with multitasking - exclusion criteria:we will exclude all individuals with risk factors contra-indicative for undertaking strenuous exercise. participants will verbally respond to a health history questionnaire. those individuals who are asymptomatic and meet no more than one risk factor threshold including family history of coronary heart disease, cigarette smoking, hypertension, high cholesterol, diabetes, obesity, and sedentary lifestyle will be considered at low risk and included for participation. -
ezetimibe and atorvastatin therapy on tcfa

Conditions: Coronary Artery Disease

Summary: after successful coronary angiography and oct examination, patients with tcfas in non-culprit, mild-to-moderate stenotic lesions will be enrolled. then, they will be randomly assigned in a 1:1 ratio to receive either atorvastatin (20 mg/day) alone or atorvastatin (20 mg/day）plus ezetimibe（10 mg/day）by envelope method. angiographic and oct follow-up will be scheduled for the target vessel after 12 months.

this is a prospective, randomized , controlled, open-label, single-center study to evaluate the effect of ezetimibe added to atorvastatin on coronary thin-cap fibroatheroma(tcfa). after successful coronary angiography and oct examination, patients with tcfas in non-culprit, mild-to-moderate stenotic lesions will be enrolled. then, they will be randomly assigned in a 1:1 ratio to receive either atorvastatin (20 mg/day) alone or atorvastatin (20 mg/day）plus ezetimibe（10 mg/day）by envelope method. angiographic and oct follow-up will be scheduled for the target vessel after 12 months.the primary efficacy endpoint is the change in minimum fibrous cap thickness measured by oct from baseline to follow-up.the secondary endpoints include absolute and percent changes in the lipid, glycemic, and inflammatory profile. then, changes of these indicators above will be compared respectively in diabetic and non-diabetic patients.

Eligibility criteria:
inclusion criteria: 1.stable angina or acute coronary syndrome 2.18-80 years old 3.hypercholesterolemia :total cholesterol level \>220 mg/dl (5.7mmol/l) and/or ldl-c level \>140 mg/dl(3.6mmol/l), or previously receiving statins therapy 4. the target vessel for oct interrogation has not undergone angioplasty and has angiographic diameter stenosis from 25% to 75% 5.there are tcfas in non-culprit, mild-to-moderate stenotic lesions above exclusion criteria: 1. administration of lipid-lowering drugs other than statins before enrollment 2. significant stenotic lesions in all coronary vessels 3. severe congestive heart failure (new york heart association class iv) ,or left ventricular ejection fraction\<35% 4. more than 3 times of the upper limit of normal (uln) in the creatine kinase (ck) and the transaminase level before enrollment and no relation with myocardial infarction 5. renal failure (serum creatinine\>2.0 mg/dl） 6. hypersensitivity to x-ray contrast media, statin，clopidogrel or ezetimibe 7. others: terminal stage cancer,a positive pregnancy test
long-term consequences of admission for pediatric intensive care before one year of age

Conditions: Neurodevelopmental Disorders

Summary: this study is a retrospective cohort study. the picu children will include all surviving children who were admitted to the picu of copenhagen university hospital between 1st of january 2002 and 31st of december 2016. a link to a questionnaire including the strengths-and-difficulties parental questionnaire evaluating neurodevelopmental- and behavioral impartment as well as question on current impairments and health, will be sent to parents. for the children aged between 11 and 17 years an additional self-rated questionnaire will be provided.

this study is a retrospective cohort study. the picu children will include all surviving children who were admitted to the pediatric intensive care section of the department of neonatology of copenhagen university hospital between 1st of january 2002 and 31st of december 2016. the strengths-and-difficulties parental questionnaire evaluating neurodevelopmental- and behavioral impartment is web-based an hosted on a safe hospital server. the link will be sent to the universat digital post-box that all danish citizens use for contact to the public authorities. for the children aged between 11 and 17 years an additional self-rated questionnaire will be provided. furthermore, parents will answer questions on chronic illness, motor and sensory handicap, and special pedagogical support in day care institutions and school.

Eligibility criteria:
inclusion criteria: * admitted to the picu of copenhagen university hospital between 1st january 2002 to 31st of december 2016 * age of admission \> 28 days, if born \> 37 + 0 or have reached the gestational age of \> 40 weeks if the child is premature. * needing ≥ 2 days ventilator support during the picu stay * valid civil registration number exlusion criteria: - death before follow-up
phase i/ii trial of krn7000 in patients with chronic hepatitis c infection

Conditions: Chronic Hepatitis C

Summary: phase i/ii trial of krn7000 in patients with chronic hepatitis c. study objectives: to evaluate and compare the safety and tolerability of 3 ascending doses of a-galcer. the primary efficacy parameter: hcv-rna response at the end of treatment. secondary efficacy parameter: serum alt response. further objectives of the study are to evaluate the effect of a-galcer on serum cytokines ifng and tnfa and on inkt cells. number of dose levels: 3 investigational product: krn7000 route of administration: intravenous dosages and frequency: 0.1, 1, 10 mcg/kg, monthly injection, 3 times (day 0, day 28 and day 56)

phase i/ii trial of krn7000 in patients with chronic hepatitis c. this study is a multicenter double-blind randomized placebo-controlled phase i/ii dose-escalation trial. the protocol is conducted in the netherlands, belgium and germany. patients with chronic hepatitis c who met the inclusion criteria are assigned to receive a-galcer (krn7000 ((2s, 3s, 4r)-1-o-(a-d-galactopyranosyl)-n-hexacosanoyl-2-amino-1,3,4-octadecanetriol), kirin pharmaceutical co., ltd., gunma, japan) or placebo intravenously, thrice with intervals of 4 weeks. cohorts of 12 patients are entered at each of the three dose levels (0.1, 1 and 10 mg/kg body weight). three patients per dose level are randomized to the placebo arm. dose escalation to the next cohort are decided after evaluation by a safety review board of all the safety data collected on all the patients who had completed 3 weeks after the first injection in the preceding dose cohort. after completion of 8 weeks of treatment, with injections at 0, 4 and 8 weeks, patients are monitored without further therapy for an additional 16 weeks. study objectives: the objective of the study is to evaluate and compare the safety and tolerability of 3 ascending doses of a-galcer. the primary efficacy parameter is the response at the end of treatment, based on serum hepatitis c virus ribonucleic acid (hcv rna) levels. as a secondary efficacy parameter serum alt levels are evaluated. further objectives of the study are to evaluate the effect of a-galcer on serum cytokines ifng and tnfa and on inkt cells.

Eligibility criteria:
inclusion criteria: chronic hepatitis c liver biopsy within 3 years of entry into the study hcv rna \> 10000 copies/ml age 18-70 years alt \> 1.2 times uln written informed consent adequate contraception exclusion criteria: cirrhosis decompensated liver disease alt \> 10 times uln pregnancy major other illness

Keywords: chronic hepatitis c krn7000 a-galcer immunotherapy natural killer t cells interferon
impact of comprehensive dietary counseling on dietary quality, mental health, and quality of life in older adults

Conditions: Aging; Age Problem; Age-related Cognitive Decline; Age-Related Atrophy

Summary: as a person ages, an incidence of mental distress such as depression and anxiety increases while the quality of life decreases. singapore's population is aging rapidly and older adults may suffer from mental distress and deteriorated quality of life. recent evidence suggests that good nutrition is essential for mental health and quality of life in older adults. previous research reported that provision of nutrition education and cooking workshops to people with mental illness for 3 months achieved healthy dietary change and improved mental health. this proposed study aims to further assess the effect of comprehensive dietary counselling on dietary quality, cardio-metabolic, mental health, sleep quality, and quality of life through a 24-wk parallel intervention study in singapore older adults. the investigators hypothesised that older adults who receive comprehensive dietary counselling will improve dietary quality, cardio-metabolic health, mental health, sleep quality, and quality of life when compared to older adults who do not receive comprehensive dietary counselling.

fifty female chinese older adults (aged 60+y) will be recruited with the expectation that ≥ 40 subjects will complete the study. this is a 24-wk parallel, single-bind, prospective study design with subjects randomly assigned to either receiving comprehensive dietary counselling (intervention group) or not receiving comprehensive dietary counselling (control group). subjects in the intervention group will only receive comprehensive dietary counselling for first 12-wk and then they will be followed for another 12-wk without comprehensive dietary counselling. subjects in the control group will be followed for 24-wk without any intervention. dietary quality, mental health, sleep quality, daily physical activity and quality of life will be assessed and blood lipid-lipoproteins, glucose and insulin concentrations will be measured from the collected blood samples.

Eligibility criteria:
inclusion criteria: 1. able to give an informed consent 2. age ≥60 years 3. no weight change \>3kg in the past 3 months 4. not exercising vigorously over the past 3 months 5. does not have any intestinal disorders, including lactose intolerance 6. no acute illness 7. non-smoker 8. non-vegetarian 9. not drinking more than 2 alcoholic drinks/day 10. not taking any lipid-lowering and blood pressure controlling medications less than 3 years exclusion criteria: 1. unable to give an informed consent 2. age \< 60 years 3. weight change \>3kg in the past 3 months 4. exercises vigorously over the past 3 months 5. have intestinal disorders, including lactose intolerence 6. having acute illness 7. smoking 8. vegetarian 9. drinking more than 2 alcoholic drinks/day 10. taking lipid-lowering and blood pressure controlling medications less than 3 years

Keywords: older adults dietary consultation mental health sleep quality dietary quality cardio-metabolic health
percutaneous cannulated screws versus open reduction and internal fixation in the treatment of displaced isolated medial malleolar fractures in adults

Conditions: Medial Malleolus

Summary: the aim of this prospective randomized controlled trial is to compare the functional and radiographic outcomes of closed reduction and percutaneous cannulated screws fixation and orif in treatment of displaced isolated medial malleolar fractures.

medial malleolar (mm) fractures occur in about 50% of all ankle fractures, and may occur as isolated mm fractures or as part of a bi- or tri-malleolar ankle fractures. mm fractures may occur following road traffic accident, twisting injury to ankle, assault, and falling from height. when mm fractures occurring as a part of a bi- or tri-malleolar ankle fractures, mm fractures are typically treated with surgical fixation. isolated non-displaced mm fractures can be treated conservatively by below knee cast application. displaced isolated mm fractures are usually treated surgically. many fixation techniques for mm fractures have been proposed including; unicortical partially threaded compression screws, bicortical fully threaded screws, buttress or neutralization plates, and tension band wiring. the choice of a particular fixation technique depends on the fracture geometry and the extent of comminution. surgical procedures can be done by open reduction internal fixation (orif) or closed reduction percutaneous fixation. in comparison to an orif, a percutaneous approach to mm fractures have potential advantages of decreased surgical morbidity, decreased postoperative pain, and decreased risk of wound complications. however, without direct fracture site visualization, it is possible that acceptable reduction could be hindered, leading to higher rates of nonunion and malunion. some studies have shown that even in unstable medial malleolus fractures percutaneous screw fixation is excellent technique. there is dilemma in the existing literature which treatment method is better for mm fractures management. up to my knowledge, there is no comparative prospective study of orif versus percutaneous approach in surgical treatment of isolated medial malleolar fractures.

Eligibility criteria:
inclusion criteria: * adult patients with closed, displaced (˃2mm), isolated medial malleolar fractures of herscovici type b or c. exclusion criteria: * comminuted fractures, open fractures, bi-, tri-, or quadri-malleolar ankle fractures, associated syndesmotic or lateral collateral ligament injuries, skeletally immature patients, any other ipsilateral lower limb fractures, or previously fractured ankle.

Keywords: isolated medial malleolar fractures, displaced, percutaneous fixation, open reduction, cannulated screws
clinical outcomes in men with prostate cancer who selected active surveillance using prolaris® testing

Conditions: Prostate Cancer

Summary: medicare is requesting outcome data on patients who received prolaris testing and were prescribed active surveillance (as). in order to ensure appropriate patient care, it is important to understand how this added prognostic information influences the selection and durability of as and corresponding clinical outcomes. to address this knowledge gap, this study will evaluate how frequently men with low disease-specific mortality (dsm) risk based on prolaris ccr score and who meet nccn low-risk criteria initially select as (as selection). this study also will assess how long prolaris-tested men who initially select as remain on this course before proceeding to definitive treatment (as durability), and whether as duration impacts biochemical recurrence (bcr) and metastasis risk in these men. this retrospective, observational and multi-site study will combine patient ccr scores with longitudinal clinical data to address these questions.

this is a multicenter, retrospective, observational study in men diagnosed with localized prca who had prolaris testing prior to the treatment decision. the study will collect demographic, clinical, pathologic, and prolaris test data from medical records and myriad's prolaris database. the primary objective of this study is to evaluate the rate of bcr or metastasis, whichever occurs first, among prolaris-tested men who were at low risk of dsm (≤3.2%), who also met nccn low-risk criteria, and who were initially treated with as. the secondary objectives of the study are to evaluate the frequency of as selection among all men who had low dsm risk, as determined by prolaris testing and as durability among prolaris-tested men with low dsm risk who selected and initiated this treatment.

Eligibility criteria:
inclusion criteria: * diagnosed with localized prca at participating sites between january 1, 2013 and august 1, 2017. * have undergone prolaris testing and have a ccr score with estimated dsm risk ≤3.2%. * have nccn low-risk disease2. exclusion criteria: * received any therapy other than 5α-reductase inhibitor (5-ari) prior to diagnostic biopsy. * over 80 years of age at diagnosis. * history of hypogonadism at the time of diagnosis. * co-occurring malignancy, excluding non-melanoma skin cancer. * enrolled in another investigational study.
implementation of bright light therapy id

Conditions: Depressive Symptoms

Summary: many adults with intellectual disabilities (id) have depressive symptoms, which negatively impact their quality of life. a lot of of the non-medicinal forms of treatment are not or hardly suitable for people with id. bright light therapy (blt) seems to be a good option. earlier research has shown that blt is applicable in this group and seems promising in terms of reducing depressive symptoms, without serious side effects. in part 1 of this project we investigate the implementation of blt at amarant. we will take the lessons learned into part 2 of this project: the implementation of blt at abrona. we will evaluate this process and the outcomes.


Eligibility criteria:
inclusion criteria: * involved in the implementation of blt (staff) or * involved in the prescription or application of blt (staff/relatives) or * receiving blt for their depressive symptoms (patients with id) * 18 years or older * informed consent exclusion criteria: * n/a

Keywords: depressive symptoms bright light therapy implementation intellectual disability
examining the role of executive functioning in family-based intensive health behavior and lifestyle treatment

Conditions: Pediatric Overweight

Summary: the objectives of this open trial feasibility study are to examine the impacts of intensive health behavior and lifestyle treatment (ihblt) on youth and caregiver executive functioning (ef), weight status, health behaviors (dietary intake, disordered eating, physical activity), and psychological functioning. investigators propose to enroll 10 youth 13 to 17 years of age who have overweight or obesity (ov/ob) and a primary caregiver. families will receive six months of evidence-based family focused group ihblt based on social, cognitive, and family systems theories. families will complete assessments of ef skills (objective and self-report), weight status, dietary intake, physical activity, and psychological functioning at pre- and post-treatment.


Eligibility criteria:
inclusion criteria: * youth 13-17 years old * youth with ov/ob (bmi≥85th percentile for age/gender norms) * participating caregiver must be the participating youth's legal guardian * participating youth and caregiver speak and read english * participating youth and caregiver agree to attend ihblt group meetings in-between the pre- and post-treatment assessments. exclusion criteria: * youth pervasive developmental disorder (e.g., intellectual disability) * youth or caregiver in commercial weight loss program or taking prescribed medications for the prior three months that impact appetite or weight * youth or caregiver with documented history of eating disorder or untreated severe depression * both youth and caregiver scores are two standard deviations or above the mean on the cpt-3 commissions and stroop interference, representing significantly higher than average ef skills.