Kornimate/medical-research-clean huggingface dataset:
investigating the acute effects of flavonoids in blueberries on cognitive function.

Conditions: Healthy Adults.

Summary: this study was a controlled, cross-over, acute flavonoid intervention trial with younger and older adults. subjects consumed a blueberry beverage during one visit and a control beverage on another. cognitive function pre drink was assessed, blood and urine samples were taken as well as blood pressure and a measure of vascular reactivity. these outcome measures were taken at 2 and 5 hours post drink. it was predicted that the flavonoids in the blueberry drink would lead to improved performance on the cognitive tests and vascular reactivity measure compared to following the control drink. it was thought this could be due to increased vaso-dilation and improving blood flow to the brain which was investigated in an extension to the project where a sample of individuals underwent brain imaging in an mri scanner pre and post a blueberry and a control drink.

the control drink was matched to the blueberry drink for other bioactive compounds which may have affected cognition, specifically sugars and vitamin c. volunteers were healthy, not on any medication, without high blood pressure, high cholesterol, high bmi, diabetes or other medical conditions. older adults were aged 61-75 years and younger adults 18-26 years. blood and urine samples will be analysed for flavonoid levels and brain derived neurotrophic factor, a biomarker of memory and learning, flavonoids may lead to increased bdnf production through the erk-creb-bdnf pathway. flavonoids may also increase nitric oxide production and improve the flexibility of the blood vessels hence the measure of vascular reactivity using the digital volume pulse machine. this can lead to increased vaso-dilation and blood flow to the brain, therefore an fmri study was carried out the investigate this using arterial spin labeling following acute blueberry supplementation compared to a control drink.

Eligibility criteria:
inclusion criteria: * no medical conditions * not taking any medication or supplements (or willing to stop taking supplements for duration of study) * not lactose intolerant * willing to give blood and urine samples * not partaking in frequent vigorous exercise * not suffering from or history of depression exclusion criteria: * on blood pressure medication, taking aspirin or other blood thinning medication * bmi \> 30 * cholesterol \> 6 * diabetes or other serious medical condition * lactose intolerant * any learning difficulty e.g. dyslexia
herd immunity and influenza vaccine uptake

Conditions: Influenza, Human

Summary: the aim of this study is to test the effectiveness of communicating the concept of herd immunity on actual influenza vaccine uptake using a randomized controlled trial.

the investigators run a large-scale randomized controlled trial (rct) to understand behavioural processes that guide decisions to vaccinate and test alternative strategies to communicate the concept of herd immunity. the experiment varies the text of postal letters send to individuals eligible for free influenza vaccines. the experiment is run in collaboration with the municipal health authorities. the investigators identify from the population register all individuals who are born in year 1953 or before and resided in the participating municipality on october 01, 2018. the investigators will obtain the postal addresses of these individuals using the population register and randomly assign individuals to treatment conditions that differ in the wording of the information material and reception of a text message. importantly, the extract from the population register will also include an individual identifier (social security number) that can be used to match the received type of letter (treatment) with the actual vaccination decision recorded in the care register for health care to objectively evaluate the impact of received information on vaccine uptake. the matching of postal addresses and vaccination data will be conducted using pseudonymized identifiers. the pseudonymization of individual identifiers will be performed separately for both datasets by professional data management and data security staff of the national institute for health and welfare. the investigators conducting the data analysis will be able to access only pseudonymous data without a possibility to directly identify individuals from the data set. the data will be stored according to the data protection legislation and regulations of the national institute for health and welfare during the research project. the investigators randomly assign individuals to treatment conditions that differ in the wording of the letters. the authority's standard letter serves as the baseline condition (t1). this letter is extended by communicating the concept of herd immunity and appealing to pro-social preferences by highlighting the fact that vaccinations may effectively prevent infections among people who are not able to vaccinate themselves (especially babies) (t2). to summarize, this study includes a control treatment (t0, no letter) and two active treatment arms with the following contents: t1 (mailing) - standard letter t2 (herd) - herd immunity letter

Eligibility criteria:
inclusion criteria: * at least 65 year old citizens in the municipalities of espoo, maalahti, korsnäs, kristiinankaupunki, kaskinen and närpiö exclusion criteria: -
inflammatory mediators of acute kidney injury in intensive care

Conditions: Sepsis; Surgery; Acute Kidney Injury

Summary: acute kidney injury (aki) affects more than 50% of patients admitted to the intensive care unit. the most common underlying cause is sepsis. severe aki in combination with sepsis is associated with high mortality. the mechanisms for sepsis-induced aki are largely unknown. our hypothesis is that the inflammatory response to an infection cause collateral damage to host tissue and contributes to the development of aki. in this study we want to investigate the presence of novel inflammatory mediators in patients with sepsis, patients subjected to major surgery (sterile inflammation) and non-inflamed patients and correlate their levels with the risk for aki.


Eligibility criteria:
inclusion criteria: patients admitted to the intensive/post operative care unit * with septic shock or * post major surgery or * after intoxication with a chemical compund exclusion criteria: * pregnancy or * breast feeding or * chronic kidney disease or * intoxication with nephrotoxic compund or * lack of informed consent
the role of the omentum in the treatment of morbid obesity

Conditions: Obesity

Summary: the purpose of this research is to determine some of the reasons that blood sugar and insulin levels improve after bariatric surgery but before weight loss begins, as well as why people respond differently to weight loss surgery. it will also examine whether removing the fat around the stomach and large intestine (the omentum) will improve weight loss. finally, it will see why there are differences between whites and african americans who have weight loss surgery.

the purpose of this research is to tease out the mechanisms related to changes in insulin sensitivity, metabolism, hormones, and body composition following bariatric surgery. because preliminary data indicate differing responses to this surgery, both caucasian and african american adults, scheduled for rygb, are being recruited to participate. it is believed that the omentum contributes to hepatic insulin resistance, both because of the increased delivery of nefas via the portal vein, and the increased production of cytokines. because of this, it is postulated that removing the omentum as part of bariatric surgery will speed up the reversal of insulin resistance and diminish racial differences in response to the surgery. data are derived from tissue and blood samples obtained operatively (from individuals having bariatric surgery and other abdominal operations), as well as during hyperinsulinemic-euglycemic clamps, from indirect calorimetry, dexa, health-related quality of life surveys, and 24-hour urine samples. there were 66 participants randomized to omentectomy/no omentectomy. a post hoc data power analysis determined that this number of subjects is sufficient for data analysis.

Eligibility criteria:
inclusion criteria: * bmi \> 40 * bmi \> 35 with co-morbidities * normal creatinine/liver labs * insurance approval for rygb or resources to self-pay * proximity to nashville, tn exclusion criteria: * use of anticoagulants, steroids, therapeutic niacin * previous bariatric surgery
evaluate formation of iuas after third-generation endometrial ablation, with and without intrauterine adhesion barrier

Conditions: Asherman Syndrome; Intrauterine Adhesion

Summary: evaluate the formation of adhesions after third-generation endometrial ablation, with and without the intrauterine adhesion barrier.

the application of endometrial ablation (ea) has significantly increased in the past 10 years. it is an effective treatment for heavy menstrual bleeding with functional aetiology. however, the risk of post-ablative intracavitary scarring after ea is significant and can lead to long term complications, and the possible delay in diagnosing endometrial cancer. clean is a prospective, multi-center, randomized, controlled, two arm pilot clinical trial. the objective is to compare the formation of adhesions after third-generation endometrial ablation, with and without the intrauterine adhesion barrier. the study will be performed on women with heavy menstrual bleeding (menorrhagia) scheduled for thermal endometrial ablation with novasure system (hologic) a follow-up diagnostic hysteroscopy will be performed 4-8 weeks after the ablation procedure to determine the presence and severity of iuas according to the american fertility society.

Eligibility criteria:
inclusion criteria: * patient with refractory heavy menstrual bleeding scheduled for endometrial ablation with novasure system * women 30 years old or older; * subjects who are willing to provide a written informed consent as approved by the applicable ethics committee / irb prior to participating in this clinical investigation. * subjects who can comply with the study follow-up and other study requirements. exclusion criteria: * cavity length \ 8 * perforation during ablation procedure * previous adhesiolysis procedure or diagnosis of asherman's disease. * abnormal uterine cavity at the time of ablation according to eshre classification i to v such as unicornis, bicornis, septate, duplex * history of cervical or endometrial cancer * active pelvic infection or history of pelvic peritonitis * known contraindication or hypersensitivity to womed leaf component * current participation in another clinical investigation that has not yet received the primary endpoint * any other condition that makes participation in the study contrary to the patient's best interests.
expression of sodium-glucose co-transporter 2 in human heart

Conditions: Aortic Valve Stenosis

Summary: the aim of the study is to evaluate the expression of sodium glucose co-transporter 2 (sglt2) in myocardium from patients with aortic stenosis. 2 groups of patients will be defined: group a with diastolic heart failure and group b without heart failure. the expression of sglt2 will be measured on small myocardium specimens harvested during aortic valve replacement operation. this study should allow us to better understand the effect of glifozines in human heart failure.


Eligibility criteria:
inclusion criteria: * adults over 18 years-old * patient with surgical aortic valve stenosis, with or without heart failure, in two equal-sized groups (40 subjects in each group) * subjects affiliated with a social security health insurance plan * subject able to understand the objectives and risks of the research and to give dated and signed informed consent exclusion criteria: * infective endocarditis in aortic stenosis * severe coronary pathology associated with aortic stenosis * impossible to give the subject informed information (subject in emergency situation, difficulties in understanding the subject, ...) * subject under legal protection * subject under guardianship or curatorship * pregnancy and/or breastfeeding

Keywords: human heart myocardium aortic valve stenosis heart failure sodium glucose cotransporter 2
dietary prevention of photodamage in skin with grapes

Conditions: Non-melanoma Skin Cancer

Summary: to assess the effect of orally administered grape powder on the sunburn reaction in humans.

to determine whether oral grape powder will result in a reduction in biomarkers associated with basal cell carcinomas (bccs) and squamous cell carcinomas (sccs). biomarkers taken from non-sun-exposed skin and uv-exposed skin before and after treatment will be compared. the ultimate goal of this study will be to generate new knowledge of the photoprotective effect of grape powder on uv exposure. the results may be employed as the basis for a larger clinical trial to evaluate the potential of grapes to prevent non-melanoma skin cancers (nmscs) and sun damage.

Eligibility criteria:
inclusion criteria: * patient age 18 and older * patient able to understand requirements of the study and risks involved * patient able to sign a consent form exclusion criteria: * patients fitzpatrick iv-vi * a recent history of vitiligo, melasma, and other disorders of pigmentation with the exception of post inflammatory hyperpigmentation * a known history of photosensitivity disorders * a known history of melanoma or non-melanoma skin cancers * those planning on going to the tanning parlors * using any of the photosensitizing medication * a woman who is lactating, pregnant, or planning to become pregnant * patient planning on exposing the irradiated or control areas to the sun
cognitive processing slowness as a marker of cognitive impairment in non-central nervous system cancer patients

Conditions: Breast Cancer; Colon Cancer; Cognitive Impairment

Summary: cancer is a frequent disease considering that one person out of three will be confronted with it in their lifetime. cancer patients often express complaints related to cognitive impairment as an outcome of their oncological treatment. these cognitive disorders have a significant impact on the patient's and their carer's quality of life. therefore, it appears necessary to have a reliable, quick and simple tool in order to detect cognitive impairment. the rationale of this study relies on 3 main points : * the cognitive complaint frequently reported by cancer patients * the difficulty in reliably demonstrating the cause of this complaint through conventional neuropsychological tests * the interest of cognitive processing speed as an indicator of cognitive dysfunction the primary objective of the study is to evaluate a potential variation of cognitive processing speed at the saint-louis lille battery (sslib) between the beginning and during (4 months after the beginning) the oncological treatment of adults with breast cancer or colon cancer.


Eligibility criteria:
inclusion criteria: * beginning an oncological treatment for breast or colon cancer * patients of age ≥ 20 and ≤ 70 years old * cancer diagnosis announcement delivered since less than 3 weeks (+/- a week) * patient affiliated to french social security exclusion criteria: * patient's opposition to the study * notion of an abnormal cerebral scan or mri * drug use (alcohol, narcotics...) * chronic (≥ 15 days) treatment with corticosteroids \> 1mg/kg/j (prednisone or equivalent) * ocular pathology or cognitive disorder impairing comprehension and reading abilities * patients under curatorship, guardianship or under the protection of justice
toric contact lens digital performance and comfort study

Conditions: Astigmatism

Summary: this study seeks to quantify digital visual performance and subjective visual acceptance of toric contact lenses as compared to spherical lenses in low to moderate astigmatic patients.

this study seeks to quantify the near visual performance and subjective visual acceptance of toric contact lenses as compared to spherical lenses in an astigmatic cohort of patients. primary hypotheses: subjects will have better near visual acuity and near visual performance with toric, as opposed to spherical, contact lens correction. as such, the following hypotheses will be tested: h01: there is no statistically significant difference in near visual acuity or near vision performance between contact lenses corrections ha1: there is a statistically significant difference in visual acuity or vision performance between contact lenses corrections

Eligibility criteria:
inclusion criteria: * 18 to 39 years of age (inclusive) * pl to -6.00d vertexed sphere power and -0.75 to -1.50d vertexed refractive cylinder od and os * current/established full time (\>6 days week, \>8 hours/day) soft contact lens wearer * best corrected acuity of 20/25 or better in each eye * self-report of at least 4 hrs/day using digital devices * willing to wear lenses at least 8 hours each day during the study period * able to speak and read english at a high school level / have at least a high school diploma or equivalent (by self-report) enclusion criteria: * history of ocular pathology or surgery * binocular vision disorder (i.e., tropia, convergence or accommodative insufficiency) * gas permeable lens wear for at least 3 months * symptomatic soft contact lens wearer (cldeq-8 score \<12 at baseline)
a pilot study of vancomycin or metronidazole in patients with primary sclerosing cholangitis

Conditions: Primary Sclerosing Cholangitis

Summary: the purpose of this study is to determine whether vancomycin or metronidazole is safe and beneficial in the treatment of primary sclerosing cholangitis.

in this protocol, we propose the assessment of potential beneficial effects of the antibiotics vancomycin and metronidazole on liver biochemistries, liver related symptoms and mayo risk score in patients with psc. the patients will be randomized into four groups of ten patients: one group will receive low dose vancomycin, one group will receive high dose vancomycin, one group will receive low dose metronidazole and one group will receive high dose metronidazole. each group will be treated for three months.

Eligibility criteria:
inclusion criteria: * diagnosis of psc established by alkaline phosphatase \>1.5 times and/or two fold elevation of liver transaminases (ast and/or alt) for at least 6 months duration. * cholangiography demonstrating intrahepatic and/or extrahepatic biliary obstruction, beading, or narrowing consistent with psc. * both genders. * age ≥ 18 years old and \< than 75 years old. * patient's informed consent for study participation. exclusion criteria: * treatment with systematic antibiotics, azulfidine, ursodeoxycholic acid, corticosteroids, colchicine, methotrexate, azathioprine, cyclosporine, chlorambucil, budesonide, pentoxifylline, tacrolimus, silymarin or prednisone in the preceding three months. * active drug or alcohol use. * prior history of allergic reactions to the antibiotics which will be used in the study. * any condition that, in the opinion of the investigator, would interfere with the patients' ability to complete the study safely or successfully. * evidence of decompensated liver disease such as recurrent variceal bleeding, refractory ascites or spontaneous hepatic encephalopathy. * anticipated need for transplantation in one year (mayo survival model \<80% one-year survival without transplant). * findings highly suggestive of liver disease of other etiology such as chronic alcoholic liver disease, chronic hepatitis b or c infection, hemochromatosis, wilson's disease, 1-antitrypsin deficiency, non-alcoholic steatohepatitis, primary biliary cirrhosis or secondary sclerosing cholangitis. * pregnancy or current lactation. subjects becoming pregnant during the study will be withdrawn.
the effects of patupilone on the pharmacokinetics and pharmacodynamics of warfarin in patients with advanced malignancies

Conditions: Advanced Malignancies

Summary: to evaluate the effects of patupilone on the pharmacokinetics of warfarin in patients with advanced malignancies.


Eligibility criteria:
inclusion criteria participation in study epo906a2120e1 * age ≥ 18 years of age * life expectancy ≥ 3 months * histologically documented advanced solid tumors which have progressed after standard systemic therapy or for which standard systemic therapy does not exist * completed all pk sampling in the core study exclusion criteria * known diagnosis of human immunodeficiency virus (hiv) infection, hepatitis * female patients who are pregnant or breast feeding * patients with a severe and/or uncontrolled medical disease other protocol-defined inclusion/exclusion criteria may apply

Keywords: cancer epo906 patupilone
pcv13 + hepatitis a vaccine for adults

Conditions: Measurement of Immune Response to Prevenar13; Measurement of Immune Response to Hepatitis a

Summary: the present study explores whether a simultaneously given hepatitis a vaccine (epaxal) will have an impact on the immune response to pcv13 (pneumococcal conjugate vaccine; prevenar13) vaccine in adults. the immune response to pcv13 is measured as levels of serotype specific serum antibodies and their opsonophagocytic activity. the results of volunteers receiving pcv13 and epaxal will be compared to that in a control groups of adults receiving either hepatitis a or pcv13 vaccines only.


Eligibility criteria:
inclusion criteria: 1. male or female subjects aged ≥50 2. general good health as established by medical history and physical examination 3. written informed consent 4. females of childbearing potential must agree to use an efficacious hormonal or barrier method of birth control during the study. abstinence is acceptable. 5. available for all visits scheduled in this study. 6. no previous pnc vaccination 7. no previous hepatitis a vaccine 8. no other vaccines administered 30 days prior to or during the study exclusion criteria: 1. previous pneumococcal or hepatitis a vaccination 2. immunization with any other vaccine (oral or parenteral) within 4 weeks prior to study start or planned vaccination during the study 3. chronic administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of vaccine; patients using oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent are excluded; inhaled or topical steroids are allowed 4. any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (hiv) infection 5. pregnancy or lactation 6. acute disease at the time of enrollment (defined as the presence of a moderate or severe illness with or without fever (fever is defined as body temperature of ≥38 °c). 7. alcohol or drug abuse 8. suspected non-compliance 9. use of any investigational drug within 30 days preceding the study vaccine, or planned use during the study period 10. any clinically significant history of known or suspected anaphylaxis or hypersensitivity reaction based on the judgement of the investigator 11. employee at the investigational site, relative or spouse of the investigator 12. any other criteria which, in the investigator's opinion, would compromise the ability of the subject to participate in the study, the subject's well-being, or the outcome of the study

Keywords: prevenar13 pneumococcal conjugate vaccine epaxal hepatitis a vaccine