Kornimate/medical-research-clean huggingface dataset:
gfap auto-immunity : a french cohort study

Conditions: Autoimmune GFAP Astrocytopathy

Summary: glial fibrillary acidic protein (gfap)-immunoglobulin g (igg) have recently been described as a biomarker of a novel inflammatory central nervous system (cns) disorder, termed autoimmune gfap astrocytopathy. thus far, four major clinical series have been published (two from mayo clinic usa, one from italy and one from china). gfap-igg detected in serum or in cerebrospinal fluid, by tissue-based assay and confirmed by cell-based assay, are associated with encephalitis or meningoencephalitis of acute or subacute onset, less frequently with myelitis or optic disk edema. the characteristic mri feature is brain linear perivascular radial gadolinium enhancement in the white matter perpendicular to the ventricle, consistent with the immunohistochemical staining pattern of gfap in rodent brain sections. approximately 20% of reported cases are associated with a neoplasm (ovarian teratoma mostly). coexisting neural autoantibodies are described in some patients, n-methyl-d-aspartate (nmda)-receptor (r)-igg mostly, followed by aquaporin 4 (aqp4)-igg. the disease is usually corticosteroid responsive although relapse can occur. in contrast, chinese patients display poorer outcomes. pathophysiology is not well understood but the intracellular antigen location makes gfap-igg unlikely pathogenic whereas animal models and neuropathologic data suggest a t-cell immune-mediated disorder. the aim of the investigators is to report the first french cohort of patients gfap-igg positive. investigators retrospectively assessed clinical, immunological and radiological features, treatment response and outcomes.


Eligibility criteria:
inclusion criteria: * positive gfap-ab in serum and/or csf tested by immunohistochemistry on mouse brain slices and confirmed by cell-based assay (cba) of hek293 cells expressing gfap. * diagnosis and follow-up in france * no age limit : from 0 to unlimited age exclusion criteria: * patients gfap-igg negative in serum and csf * absence of complete clinicopathological data * foreign follow-up

Keywords: acidic protein igg astrocytopathy meningoencephalomyelitis perivascular-radial parenchymal enhancement autoimmune paraneoplasic
pain ease spray in reducing needle pain associated with intravenous insertion in children

Conditions: Pain

Summary: the purpose of this study is to investigate the use of a new vapocoolant spray, pain ease, to reduce intravenous (iv) insertion pain in school-aged children receiving treatment in the emergency department.

inserting a needle into a child's vein is a distressing experience for children. reducing the pain of injection and avoiding the child's discomfort remains an important aim for both parents and health care workers. withdrawing blood and intravenous insertion (iv) in children is also time consuming, especially when the child is uncooperative and stressed. we, the researchers at children's hospital of eastern ontario, have been searching for an effective, rapid and inexpensive method to alleviate the distress associated with venipuncture and iv insertion. medications by mouth, such as anti-anxiety drugs, are helpful but usually do not significantly reduce the pain. the most commonly used anti-anxiety drug at our institution is midazolam, but unfortunately onset of action takes 20-30 minutes. there are various forms of topical creams that can numb the skin. emla, a mixture of two local anesthetics (lidocaine 2.5% and prilocaine 2.5%), is applied as a topical cream and is covered with an occlusive dressing. it requires at least 1 hour to be effective. it is not only time consuming but expensive (\~$1.30 per application). ametop (tetracaine ph. eur.4%w/w) is another effective topical cream, which works in 30 minutes, but it is more expensive than emla (\~$3.00 per application). vapocoolant sprays applied for \~10 seconds immediately before injection have been shown to be faster, less expensive and as effective as emla in reducing pain at the site of injection during immunization. the current investigation will evaluate the quality, efficacy and costs associated with the use of a new vapocoolant spray, pain ease, in reducing pain associated with iv insertion for school age children.

Eligibility criteria:
inclusion criteria: * 6-12 years old * require an iv inserted in less than 30 minutes exclusion criteria: * allergy to vapocoolant sprays * vascular impairment * diabetes mellitus * developmental delay/inability to understand pain scale * received analgesia in last 24 hours * triaged as resuscitation

Keywords: iv cannulation injections, intravenous
effect of lyophilized cornus mas l. on anthropometric and biochemical parameters in metabolic associated fatty liver disease patients

Conditions: Fatty Liver Disease; Obesity; Liver Fat

Summary: the aim of the study was to evaluate the effect of lyophilized cornus mas l. fruit powder with/without diet therapy on biochemical parameters and anthropometric measurements in patients with metabolic associated fatty liver disease.

the main purpose of this study is to determine the efficacy of the lyophilized dried powder form of cornelian cherry (cornus mas l.) grown in our country on nutritional status and biochemical parameters in patients with metabolic-associated fatty liver disease. sub-objectives of the study; * determination of the effect of cornelian cherry on blood glucose, and lipid parameters, and liver enzymes. * determination of anti-inflammatory, antidiabetic, and antioxidant effects of cornelian cherry in metabolic fatty liver patients. * determination of the effect of cornelian cherry on anthropometric measurements. the aim of this study is to compare the anthropometric measurements and biomarkers of patients with metabolic-associated fatty liver disease as a result of the consumption of powdered cornelian cherry (cornus mas l.) that has been freeze-dried at -55 degrees with a lyophilizer device for 8 weeks.

Eligibility criteria:
inclusion criteria: * patients aged between 18 and 65 years with metabolic associated fatty liver. * those who applied to the gastroenterology clinic * volunteers * those who signed the consent form exclusion criteria: * those with \<18 to ≥65 years * those without ultrasonography results * those with \>20 g/day for men and 10 g/day for women alcohol consumption in the past 1 year * those with hepatitis b or c * those with chronic liver diseases associated with viral hepatitis, such as wilson disease, hemochromatosis, and cushing syndrome * those with autoimmune liver disease * those with a history of cardiovascular diseases, cancer, mental diseases, severe liver, and kidney dysfunction * those with thyroid diseases such as goiter, hypothyroidism, or hyperthyroidism * those with prolonged use of estrogen or regular consumption of drugs associated with fatty liver diseases, such as corticosteroid, methotrexate, tamoxifen, and amiodarone * pregnant, breastfeeding women * those with allergic to cornus mas fruit * those with an unwillingness to continue the study

Keywords: metabolic associated fatty liver disease cornus mas l. diet treatment nutrition therapy anthropometric measurements
treatment of diarrhea-predominant irritable bowel syndrome (ibs-d) with lacteol® 340 mg

Conditions: Diarrhea-predominant Irritable Bowel Syndrome

Summary: irritable bowel syndrome is a complex condition with a high unmet medical need for effective and safe treatment options. lacteol® is a lactobacillus product used for adjunctive and symptomatic treatment of diarrhea. in this study, lacteol® 340 mg will be evaluated as a potential therapy for the treatment of diarrhea-predominant irritable bowel syndrome (ibs-d).

this study will include the following phases: screening phase, run-in phase, double-blind treatment phase and open-label treatment phase. screening: eligibility of subjects will be evaluated following informed consent signature. screening procedures/evaluations (physical exam, concomitant medications, clinical laboratory tests) and confirmation of eligibility following rome iii diagnostic questionnaire will be performed. run-in: subjects will enter a 2-week run-in phase during which ibs symptoms and stool characteristics will be recorded. at the end of the run-in phase, data collected over the last week will be reviewed. upon confirmation of ibs-d severity status, subjects may be randomized. double-blind treatment: subjects will take study medication (either lacteol® 340 mg or placebo) for 28 days. during this time, ibs symptoms and stool characteristics and global assessment of relief will be recorded, and clinical laboratory tests will be performed. had score will be assessed at the end of the double blind treatment. open-label treatment: all study completers will be eligible for a second 28 day open-label treatment in the event that ibs-d symptoms remain or recur within the month following the end of double-blind treatment. subjects will take the study medication (lacteol® 340 mg) for 28 days. during this time, ibs symptoms and stool characteristics and global assessment of relief will be recorded, and clinical laboratory tests will be performed.

Eligibility criteria:
inclusion criteria: * ibs-d diagnosis using the rome iii questionnaire * ibs symptoms severity scale (ibs-sss) score ranging between 100 and 400 * bristol stool form scale score exceeding two (\> 2) but less than seven (\< 7) * stable diet * mental and legal ability to sign informed consent exclusion criteria: * diagnosis of inflammatory bowel disease (ibd) * chronic use of systemic steroids * diagnosis of autoimmune diseases or disorders * invasive abdominal surgery * use of antibiotics prior to screening * allergy to active substance or any other ingredient in lacteol® 340 mg * congenital galactosemia, glucose, fructose and/or galactose malabsorption syndrome, lactase deficiency or lactose intolerance * diagnosis of exocrine pancreatic insufficiency * use of any experimental drug within the 30 days prior to screening
efficacy of had induction with intensified cytarabine in newly-diagnosed cebpa double mutated acute myeloid leukemia

Conditions: CEBPA Double Mutation; Acute Myeloid Leukemia

Summary: acute myeloid leukemia is a heterogenous hematological malignancy, characterized by different cytogenetic or molecular features. cebpa double mutation acute myeloid leukemia （cebpadm aml）has favourite prognosis, especially in younger adult patients. but cumulative incidence of relapse of this group patients is still high, so the treatment options need to be optimized urgently.had(homoharringtonine(hht)+cytarabine+daunorubicin) with intermediate dose cytarabine improved the survival of aml, especially in patients with cebpa double mutation.

in this phase 2 study, 40 patients will be enrolled and treated with had induction regimen. high dose cytarabine will be given after complete remission achieved. the primary endpoint was event-free and relapse-free survival. genetic mutations and measurable residual disease (mrd) will be detected at diagnosis and after chemotherapy. the risk stratification according to genetic mutations and mrd will also be explored. induction chemotherapy:hht 2mg/m2/d,day 1-7 cytarabine 100mg/m2/d, day1-4；1g/m2 /q12h ，day5-7 dnr 40mg/m2/d，day 1-3 re-induction chemotherapy:ida 10mg/m2，day 1-3 cytarabine 100mg/m2，day 1-7 ctx 350mg/m2，day 2，day 5 consolidation chemotherapy: high dose cytarabine 3g/m2/q12h,day1-3,for three cycles

Eligibility criteria:
inclusion criteria: * newly-diagnosed of acute myeloid leukemia except acute promyelocytic leukemia * with cebpa double mutation * age≥ 14 years and\<55 years，male or female * ecog-ps score 0-2 * laboratory tests（within 7 days before chemotherapy） 1. serum total bilirubin≤1.5xuln； 2. serum ast and alt≤2.5xuln 3. serum creatinine≤2xuln； 4. cardiac enzymes≤2xuln 5. ejection fraction \>50% by echo。 * written informed consent。 exclusion criteria: * subject has received remission induction chemotherapy * secondary aml * with other hematological malignancy * with other tumors(needing treatment) * pregnant or lactating women * active heart diseases * severe active infection * unfit for enrollment evaluated by investigator
pannus assistance needed for obstetric ultrasound studies

Conditions: Obesity Complicating Childbirth; Fetal Anomaly

Summary: the goal of this randomized controlled trial is to evaluate whether use of a pannus retractor adhesive improves fetal anatomic ultrasound examinations. the primary question it aims to answer is: • does the use of a pannus retractor adhesive increase the rate of detailed anatomic survey completion, defined by satisfactory visualization of sixteen prespecified fetal anatomy views, for participants with a pannus and body mass index of at least 40 kg/m2?

pregnancies complicated by obesity have an increased risk of multiple pregnancy complications, including structural fetal anomalies. ultrasound is a critical tool for the detection of congenital anomalies; however, adequate visualization of fetal anatomy by ultrasound decreases as body mass index increases. placing a pannus retractor adhesive is a simple intervention that redistributes adiposity, providing better access to an important acoustic window for fetal ultrasound. the investigators will conduct a randomized controlled trial comparing outcomes between groups that undergo fetal anatomy ultrasound examinations with or without use of a pannus retractor adhesive. the adequacy of ultrasound visualization is the primary outcome of interest. secondary outcomes of interest include sonographer pain perception, participant satisfaction, adequacy of all detailed anatomy views, detection of fetal anomalies, skin to amniotic cavity depth, duration of ultrasound exam, and adverse reactions.

Eligibility criteria:
inclusion criteria: * english or spanish speaking * bmi of at least 40.0 kg/2, calculated within 6 months of conception or at the first obstetric visit * pannus grade 1 or greater * gestational age between 18 weeks 0 days to 23 weeks 6 days, confirmed by prior ultrasound assessment exclusion criteria: * patients who have already had a routinely timed anatomy ultrasound during the same pregnancy with prisma health maternal-fetal medicine * patients with a known major fetal anomaly, confirmed by prisma health maternal-fetal medicine * tape/adhesive allergy * multifetal gestation * intrauterine fetal demise

Keywords: obesity fetal ultrasound fetal anatomy pannus
hypocholesterolemic effect of a phytosterol-enriched spreadable cream prepared with virgin olive oil

Conditions: Hypercholesterolemia

Summary: this study aims to evaluate the effect of the enriched extra virgin olive oil spread in plant sterols from the olive itself and demonstrate its effect anticholesterolemic and cardioprotective in children and adolescents with hypercholesterolemia.

a clinical study of nutritional intervention, randomized with double blind, adjusted by randomization blocks that consider age and sex, and crossover of 2 months duration each period, with 1-month washout period, in 50 subjects (25 per randomization group). the study will be carried out in the reina sofía universitary hospital of córdoba, as well as at the institute of nutrition and food technology of the university of granada. the effects of the enriched spread in patients on the lipid profile will be evaluated plasma and its action on biomarkers of cardiovascular risk and on the microbiota intestinal depending on the specific genotype of each subject. in addition, the presence of minor olive oil compounds present in plasma (metabolomic analysis). in this way, at the end of the project, scientific information will be available contrasted on the enriched product and its effects on cardiovascular protection, in addition to its palatability and acceptance. the main objective is to evaluate the effect of the enriched extra virgin olive oil spread in plant sterols from the olive itself and demonstrate its effect anticholesterolemic and cardioprotective in children and adolescents with hypercholesterolemia. as specific objectives will be determined: * to evaluate the effect of the enriched spread on the plasmatic concentrations of total cholesterol, ldlc and other parameters of the lipid profile * to evaluate the effect of the enriched spread on the oxidative status of ldl plasmatic * to evaluate the effect of the enriched spread on the antioxidant defense system * to evaluate the effect of the enriched spread on biomarkers of cardiovascular risk, including inflammatory and endothelial damage markers * to evaluate the effect of the enriched spread on the intestinal microbiota. * to evaluate the effect of the enriched spread on the metabolomic changes in plasma. * to analyze the specific genotype of each volunteer

Eligibility criteria:
inclusion criteria: * age between 6 and 18 years * familial hypercholesterolemia * acceptance to participate by signing the informed consent exclusion criteria: * children under 6 years of age * absence of hypercholesterolemia * children who receive some type of medication to control hypercholesterolemia, blood pressure, levels of glucose or dyslipidemia or any probiotic, which have invalid data for the variables of the present study * not to sign the informed consent.

Keywords: virgin olive oil plant sterols hypercholesterolemic children olive oil polyphenols
educate, assess risk and overcoming barriers to colorectal screening among african americans

Conditions: Colorectal Cancer

Summary: the burden of colorectal cancer (crc) is unequal among various populations within the united states. this inequality is most notable among african americans, who exhibit the highest crc mortality of all us populations. this study aims to evaluate a community-based intervention to educate, assess risk, and overcome barriers to screening among african americans who are 45 years or older with no personal history of crc, adenomas, or inflammatory bowel disease and have no family history of crc. barriers being assessed include: need for establishing care with primary care physician, need for financial assistance, need for reminder calls, need for transportation, need for appointment coordination, and need for education about colonoscopy preparation and procedure

after reviewing the existing literature this study team believes that the proposed strategy is inherently unique, thus amenable to experimental inquiry. the study will provide much needed data to define the extent to which the proposed multi-faceted approach may be effectively deployed to the target population. this includes the acquisition of data to evaluate the educational program, for which improvement in knowledge may be tested objectively using the study design, as well as survey and feasibility data which is pivotal for improving the strategy. the 11 steps for completing cancer screening are listed below: 1. demographic/socio-economic information 2. knowledge assessment and education 3. risk assessment questionnaire "am i average risk?" 4. do i need screening colonoscopy? 5. barriers to colorectal cancer screening 6. outreach program evaluation 7. participants data entered in redcap database 8. communication with primary care provider and navigator 9. participant navigation 10. evaluation of navigation services 11. program monitoring

Eligibility criteria:
inclusion criteria: * education only: african american individuals 18 years and older. * crc colonoscopy screening : average risk african american individuals ages 45 - 75 who did not have a screening colonoscopy or other screening modality within the past10 years, have no history of crc, adenomatous polyps or inflammatory bowel disease (ibd) and no family history of colorectal cancer. this will be identified during outreach events (steps 3 and 4). * it is important to note that this program may ultimately include all races as a community outreach event, however we will not analyze the data of non-african americans. exclusion criteria: * african american individuals under the age of 18 * colonoscopy within 10 years * history of crc, adenoma, ibd * family history of crc * fecal immunochemical test (fit) within the past year * cologuard test within the past 3 years * flexible sigmoidoscopy test within the past 5 years * colonography within the past 5 years

Keywords: health disparities african american risk assessment secondary prevention
effect of combined iv bolus amino acid supplementation and mobilisation on muscle mass in patients over the first week of icu care: rct

Conditions: Critical Illness

Summary: a single-centre, two-arm, parallel randomised controlled trial (rct) to compare the combined effect of early intravenous bolus amino acid supplementation and mobilisation versus standard of care on changes in muscle mass over the first week in icu. half of study participants will receive the study intervention (in-bed cycling followed by an intravenous bolus amino acid supplement), while the other half will receive standard of care only.

critical illness survivors often suffer from severe muscle mass depletion and a profound long-term functional impairment. hence effective strategies, or a combination of strategies, are needed to reduce skeletal muscle wasting during critical illness. although amino acids and mobilisation are both known to stimulate the mechanistic target of rapamycin pathway (mtor) pathway for muscle protein synthesis in healthy adults, there are no trials to date investigating the combined approach of combined cycle ergometry and bolus amino acid supplementation on muscle accretion in the icu.

Eligibility criteria:
inclusion criteria: * adult patient (≥18 years) admitted to medical/surgical icus of tygerberg academic hospital (tbh) * expected length of mechanical- or non-invasive ventilation \> 48 hours * receiving enteral (en) and/or parenteral nutrition (pn) as per standard care and for a minimum of 5 - 7 days * expected icu length of stay of 5 - 7 days exclusion criteria: * spinal cord lesion or intracranial process associated with muscle weakness * acute/chronic degenerative neuromuscular condition * fulminant hepatic failure/severe chronic liver disease (meld score ≥20) or renal failure (based on kdigo) not on renal replacement therapy * untreated thrombosis, or thrombosis where therapeutic levels of anticoagulants have not been reached at the time of inclusion * any condition deemed inappropriate by the overseeing doctor- such as precautions or contraindications related to the movement as a result of trauma and/or surgery to the spine, pelvis or lower limbs, or haemodynamic instability. * other: imminent death or withdrawal of treatment, pregnancy, lower limb amputation/s or fractures, readmission after previous randomisation, long-term corticosteroid therapy, morbidly obese (bmi ≥ 40kg/m2)