Kornimate/medical-research-clean huggingface dataset:
study to evaluate safety, tolerability, and effect of al208 on mild cognitive impairment following coronary artery bypass graft surgery

Conditions: Mild Cognitive Impairment

Summary: the primary objective is to compare mild cognitive impairment in the al-208 group with the placebo group at 14 + - 3 days after cabg surgery


Eligibility criteria:
inclusion criteria: 1. males and females (of non-childbearing potential), 50 to 79 years of age. 2. undergoing cabg surgery with the use of extracorporeal circulation. 3. willing and able to complete cognitive testing. 4. score \< 16 on the center for epidemiological studies in depression scale (ces-d). 5. score \> or = 28 on the mini-mental state examination (mmse). 6. willing and able to provide informed consent to participate in this study 7. fluency in written and spoken english. exclusion criteria: 1. presence of any severe mental illness that could affect interpretation of efficacy data, such as schizophrenia or bipolar affective disorder; any untreated or unstable psychiatric condition including depressive disorder or anxiety disorder. 2. history of stroke or other significant neurological disorder 3. transient ischemic attack (tia) with ongoing cognitive sequelae 4. chronic atrial fibrillation or uncontrolled atrial fibrillation prior to surgery 5. myocardial infarction (mi) within the last 8 weeks and/or previous history of more than 3 mis 6. history of liver dysfunction with ongoing sequelae (including but not limited to liver enzymes \> 2.5 x upper limit or normal (uln) at screening). 7. history of renal dysfunction with ongoing sequelae (including but not limited to creatinine value \> 2.5 mg/dl at screening). 8. known active alcohol or drug abuse. 9. concurrent use of prescription medications known to enhance memory 10. general anesthesia (defined as anesthesia requiring intubation or ventilatory support) within 3 months prior to randomization. 11. cardiopulmonary bypass or thoracotomy within 2 years prior to randomization. 12. undergoing valvular repair or replacement during scheduled cabg surgery. 13. chronic obstructive pulmonary disease (copd) requiring oxygen therapy. 14. decompensating congestive heart disease 15. subjects on immunosuppressive drugs, such as azathioprine, chemotherapeutic agents, mycophenolate, monoclonal antibodies, or more than 20 mg/day prednisone, within the previous 3 months 16. receipt of any investigational agent or device within 30 days of screening.

Keywords: mci following cabg surgery
prospective comparison of breast mri vs contrast mammography prior to surgery in breast cancer patients

Conditions: Breast Cancer

Summary: in current clinical practice, women with biopsy proven breast cancer can be sent for breast magnetic resonance imaging (mri) or contrast enhanced mammography (cem) prior to surgery in order to delineate the extent of a known cancer and / or assess for the presence of occult secondary cancers. this study seeks to compare the global costs (based on actual reimbursement rates) of cem/breast mri, downstream imaging testing, and diagnostic procedures in women randomized to breast mri versus cem. secondary goals are to compare patient preferences for cem vs mri and clinically relevant outcomes (e.g. conversion from lumpectormy to mastecomy).

this is a pilot randomized controlled trial comparing the global costs of two standard of care imaging techniques in patients with a new breast cancer diagnosis and planned breast conservation surgery. patients enrolled in this study will be randomized to either cem or breast mri. the purpose of this study is to compare the global costs (based on actual reimbursement rates) of initial imaging modality (cem or breast mri), downstream imaging related to breast cancer evaluation, and diagnostic breast procedures in women randomized to breast mri versus cem. secondary endpoints include assessment of patient's reported satisfaction with the initial imaging technique received (cem versus mri), quantifying differences in health-related quality of life (as assessed by the patient reported euro quality of life 5d questionnaire), rate of conversion from planned lumpectomy to mastectomy, and rate of re-operation for positive margins.

Eligibility criteria:
inclusion criteria: * women aged 18 years or older with newly diagnosed breast cancer and planned breast conservation surgery * clinically indicated referral for breast mri or contrast mammogram prior to surgery * provision of informed consent exclusion criteria: * planned neoadjuvant chemotherapy * patients that are medically unstable * pregnancy * patients with known contraindication to contrast mammography, including: * glomerular filtration rate \<30 * known adverse reaction to iodinated contrast material * patients with known contraindication to breast mri including: * glomerular filtration rate \<30 * known adverse reaction to gadolinium contrast material * non-mri conditional device or catheter * brain aneurysm clip implanted before 1995 * cochlear implant * ocular foreign body (e.g. metal shavings) * insulin pump * patients unable to read and understand english or spanish (i.e. an inability to complete study questionnaires)
detection of colorectal adenomas in côte-d'or

Conditions: Colorectal Adenoma

Summary: previous studies have shown geographic disparities in the detection of colorectal adenomas in côte-d'or, with an impact of the distance from the general practitioner and an ecological deprivation index (edi). on the other hand, the extremely low detection rates for these lesions in everyday practice before the implementation of organized screening for colorectal cancer in the côte-d'or were shown. one of the aims of this screening is to reduce socio-geographic inequalities in access to care and prevention. yet, participation in screening also varies depending on the socio-economic level. in this context, the côte-d'or polyps registry, the only body to have data for the pre-screening period (before 2003), will make it possible to determine whether the implementation of organized screening led to the elimination of socio-geographic disparities concerning the detection of adenomas.


Eligibility criteria:
inclusion criteria: * the study population will include all patients residing in côte d'or with a first colorectal adenoma (including in situ carcinomas) diagnosed between 01/01/1997 and 31/12/2008 exclusion criteria: * absence of address * history (or suspected history) of previously resected adenoma * personal history of colorectal cancer or colorectal cancer discovered in the year following resection of the adenoma (because the cancer was probably not seen at the initial colonoscopy) * familial polyposis or known hnpcc * chronic inflammatory bowel disease
low-fodmap diet for functional abdominal pain disorders in children.

Conditions: Functional Abdominal Pain Disorder

Summary: this single-center, randomized, controlled, quadruple-blinded, superiority trial is performed to test the hypothesis that children with ibs and fap-nos who receive a low-fodmap diet will have a lower mean abdominal pain intensity score compared with those who receive a regular diet after 4 weeks of intervention.

introduction. evidence from studies in adults documents that fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (fodmaps) may be triggers of symptoms in individuals with functional abdominal pain disorders. however, in children with fapds, there is a need for high-quality evidence regarding the dietary management. we aim to assess the effects of a low-fodmap diet compared with a regular diet for the management of children with fapds. methods. in this trial, seventy-four children aged 8 to 18 years with a functional abdominal pain disorder (irritable bowel syndrome or functional abdominal pain-not otherwise specified), diagnosed according to the rome iv criteria, will be randomly allocated to receive either a low-fodmap diet or a regular diet for 4 weeks.a primary outcome will be the percentage of the responders, defined as the participants who have at least 30% improvement in abdominal pain intensity on a visual analogue scale (vas) during the last week of the trial compared with baseline, that is at least equal to the reliable change index (≥ 25 mm change on vas).

Eligibility criteria:
inclusion criteria: * functional abdominal pain - not otherwise specified (fap-nos) or irritable bowel syndrome (ibs) diagnosed according to the rome iv criteria, * baseline average pain intensity at least 30 mm on a 100-mm visual analogue scale, * feeding via the oral route, * ability to read and comprehend any employed questionnaires/scales, * signed informed consent, * stated availability throughout the study period. exclusion criteria: * receiving any other intervention/treatment with regard to fap-nos or ibs or those who received any other intervention during the last 3 months, * an organic cause of symptoms or organic gastrointestinal disease, * chronic illness, receiving medications which affect gastrointestinal motility, * need for any other dietary management which could make the balancing or compliance with the diet troublesome, * previously diagnosed carbohydrate intolerance without symptoms of fapd after implementation of an exclusion diet, * undernutrition (defined as world health organization \[who\] growth charts \ 1 or \> 2 sd on the who growth charts, respectively), * unintentional weight loss greater or equal to 5% of subject' body weight within the previous 3 months, * pregnancy, * eating disorders, * prior surgery of the gastrointestinal tract (within last 3 months), * recurrent or unexplained fever, * developmental disabilities which impair the ability of the child to understand or communicate.

Keywords: functional abdominal pain disorders irritable bowel syndrome diet
development and validation of a screening score for the biliary atresia in infantile cholestasis: a prospective study

Conditions: Biliary Atresia; Neonatal Cholestasis; Infantile Hepatitis Syndrome

Summary: better survival and prognosis of biliary atresia (ba) depend on early diagnosis and timely kasai portoenterostomy. identifying ba from other causes of infantile cholestasis at early stage of the disease still remains a major challenge. in this study, the investigators aim to develop and validate a scoring system to screen ba in infants with cholestasis.


Eligibility criteria:
inclusion criteria: clinical diagnosis of neonatal cholestasis age at first visit less than 90 days after birth exclusion criteria: severe congenital malformation subjects with missing data
the study of relationship of plasma concentrations of folic acid, vitamin b and homocysteine with carotid atherosclerosis and endothelium-dependent vasodilatation of geriatric and young patients in the ambulatory care department of ntuh

Conditions: Homocysteine; Coronary Artery Disease

Summary: elevation of plasma homocysteine has been recognized as one of the risk factors of atherosclerotic disease. the objectives of this study are: (1) to investigate the level of plasma homocysteine and the prevalence of hypehomocysteinemia (2) to find out the role of homocysteine in coronary artery disease and the proper cut-off point of plasma homocysteine to evaluate the presence of coronary artery disease; (3) to understand the control condition of tranditional risk factors of cardiovascular disease, especially hypertension, dyslipidemia, and diabetes mellitus. the study subjects were recruited from the ambulatory setting of cardiology in national taiwan university hospital.


Eligibility criteria:
inclusion criteria: patient \> 65 y/o or \< 50y/o scr\<=1.5mg/dl exclusion criteria: * scr\> 1.5mg/dl pregnancy alcohoism
'ai pono cooking demonstrations

Conditions: Type 2 Diabetes; Hypertension; Dyslipidemias; Overweight and Obesity

Summary: native hawaiians' traditional lifestyles and diets ensured the mutual health and well-being of the land and its inhabitants, which stand in stark contrast to the disproportionately high prevalence of diet-related, cardiometabolic diseases they experience today. in this project, the investigators will adapt and test an evidence-based multilevel intervention entitled pili 'āina to improve the self-management of prevalent cardiometabolic diseases and reduce risk factors for developing new diet-related illnesses and implement and evaluate the impact and sustainability of community-wide cooking demonstrations. the objectives of this project are to optimize the effectiveness and sustainability of pili 'āina, improve diet quality, cardiometabolic markers, promote traditional native hawaiian diets, and improve social cohesion.

in years 1 - 5, the investigators will hold quarterly cooking demonstrations and cultural lessons for a total of 36 events. the lessons will be aimed at improving family and community eating environments of participants and social cohesion of these communities. attendance at each lesson will be limited to 30 individuals. attendees will register via redcap using their names and email addresses. there is no limit to how many lessons an individual can attend, but after the first lesson the investigators reserve 15 of the 30 spots for people who have not attended previously, as identified by their registration information. at each quarterly event, the investigators survey participants to assess their reaction to the lesson, their vegetable and fruit intake, self-efficacy for healthy diet, and perceptions of community cohesion. surveys will take \~5-10 minutes to complete. additionally, the investigators will survey random samples of homestead households (n = 20 per homestead, total n = 140 per year) in projects years 1 - 5. total sample for this activity is 700. each sample will be selected independent of previous samples, and it is possible the same households will be sampled multiple times.

Eligibility criteria:
inclusion criteria: * age 18+ (looking for older adults) * native hawaiian resident in a participating homestead * overweight or obese (bmi ≥ 25 kg/m\^2) * prior diagnosis of type 2 diabetes or pre-diabetes, hypertension, and/or dyslipidemia (ldl cholesterol ≥ 130 mg/dl) * capable of 150 minutes of moderate physical activity (e.g., brisk walking) per week * willing and able to participate in all aspects of the individual and household-level intervention * fluent in written and spoken english exclusion criteria: * no children * pregnancy * serious illness such as cancer or chronic pain that may contraindicate full participation
evaluation of 18f-fluciclovine positron emission tomography - magnetic resonance imaging (pet-mri) in lgg

Conditions: Glioma; Low-grade Glioma; Low Grade Glioma of Brain; Glioma, Malignant; Glioma Intracranial

Summary: the purpose of this study is to see if 18f-fluciclovine (axumin®) is useful and safe in the management of children with low grade gliomas (lgg). imaging with 18f-fluciclovine pet-mri will be performed prior to initiation of therapy for lgg, and then 3 months, and 1 year after starting therapy. changes in 18f-fluciclovine uptake will be compared to changes in mri measurements at 3 months and 1 year as compared to baseline.


Eligibility criteria:
inclusion criteria: * lgg including the brainstem and supratentorial only , (who grade i-ii), confirmed by biopsy unless in neurofibromatosis type 1 (nf1) participants with classic appearance * participants must have evaluable disease (1x1 cm tumor on mri; enhancing + non-enhancing tumor) * scheduled to receive systemic therapy * performance score: karnofsky ≥ 50 for participants \&gt; 16 years of age and lansky ≥ 50 for participants ≤ 16 years of age. participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score. * age between ≥ 1 years but ≤21 years at time of study registration exclusion criteria: 1. inability to tolerate imaging procedures in the opinion of an investigator or treating physician 2. pregnant participants 3. patient who would require sedation or anesthesia for imaging beyond soc. 4. participants who weigh less than 8 kg. 5. participants who cannot avoid contact with a pregnant woman or infant for at least 12 hours following injection. 6. participants with a history of abnormal kidney function or creatinine \&gt;= ctcae v5.0 grade 2 at time of study registration. 7. participants with primary tumors of the spinal cord.

Keywords: glioma low-grade glioma low grade glioma of brain glioma, malignant glioma intracranial 18f-fluciclovine
community park-based programs for health promotion: active older adults prospective cohort study

Conditions: Hypertension; Overweight; Obesity; Cardiovascular Diseases; Sedentary Behavior; Low Physical Fitness

Summary: the active older adults prospective cohort study examines the effects of a park-based fitness program on cardiovascular fitness outcomes for older adults (aged 50 years and older). duke will perform a secondary analysis of the data collected as part of the active older adults prospective cohort study run by miami-dade county parks and recreation.

the active older adults prospective cohort study examines the effects of a park-based fitness program on cardiovascular fitness outcomes for older adults (aged 50 years and older). active older adults is designed to provide older adults of all fitness levels with physical activity, and aims to promote participant's abilities to maintain independent lifestyles. it is a low-cost, evidence-based group exercise and falls-prevention program. the program entails one-hour sessions two or three times per week including aerobic workout, strength training, balance and flexibility exercise delivered online or in-person. data are collected at eight miami dade department of parks, recreation and open spaces (mdpros) park locations where the program is offered every four months (fall, winter, spring). active older adults is a park-based fitness program offered by the miami dade department of parks, recreation and open spaces (mdpros) that is designed to provide older adults of all fitness levels with physical activity, and aims to promote participant's abilities to maintain independent lifestyles. it is a low-cost, evidence-based group exercise and falls-prevention program. the program entails one-hour sessions two or three times per week including aerobic workout, strength training, balance and flexibility exercise delivered online or in-person. exercise classes at each park location are offered by bilingual (english/spanish) licensed instructors and program classes had a consistent format across all parks.

Eligibility criteria:
inclusion criteria: * aged 50 years or older, residing in miami-dade county * all participants enrolled in the miami-dade active older adults study will be included in this secondary analysis exclusion criteria: * aged less than 50 years, not residing in miami-dade county * anyone not enrolled in the miami-dade active older adults study will be excluded from this secondary analysis
comparison of the effectiveness of a web fracture liaison service (e_fls) to fracture liaison services in france: the evab study (evab)

Conditions: Osteoporosis; Fracture

Summary: the purpose of this study is to compare web fls model (e_fls) to conventional fls in terms of increasing the proportion of patients receiving an antiosteoporotic treatment in the year after a low trauma fracture.

osteoporotic fractures such as hip fractures and severe fractures are associated with increased morbidity and mortality and impose a large financial burden on healthcare systems. patients with osteoporosis-related fractures are at higher risk of subsequent fractures. other severe fractures (pelvis, vertebrae, humerus) have similar consequences, pelvis. the risk of refracture after fracture depends on the time: it is 5 times higher in the first 2-3 years, and 2 times higher after. this notion of imminent fracture risk is the basis for the development of post-fracture care pathways called "fracture liaison. the implementation of fls is the most effective way to reduce the risk of secondary fracture. despite their success, fls programs are not an integral part of post-fracture care throughout the france. the investigators believe that the barriers to the implementation of such a pathway are multiple and are largely related to the lack of accessibility for patients to fls, and to the mobilization of important and unsustainable human resources. some french public hospitals or institutions are currently building some e_fls models based on an automatic detection of patients with fractures, and a on a cloud-based system where practitioners across the health care sector can communicate and jointly manage osteoporotic patients. the investigators' hypothesis is that this web fls (e_fls) is at least as effective as the classical fls for the secondary fracture prevention. the objective of the investigators' study is to compare web fls model (e_fls) to conventional fls in terms of increasing the proportion of patients receiving an antiosteoporotic treatment in the year after a low trauma fracture (evab project).

Eligibility criteria:
inclusion criteria: * men and women aged above 60 years, living in france, with fragility fractures in response to low-energy trauma (e.g., a fall from standing height). * the patient or his legal representative does not object to the patient's participation in the research note: patients in guardianship or curatorship can be included in this protocol exclusion criteria: * pathological fractures, high trauma fractures and per prosthetic fractures. * non registration with a social security scheme (holder or beneficiary).

Keywords: osteoporosis fracture fracture liaison service digital medicine