Kornimate/medical-research-clean huggingface dataset:
trial of randomized antibiotic administration in percutaneous nephrolithotomy

Conditions: Kidney Stones

Summary: the investigators objective is to compare the clinical efficacy of a single-day protocol with a short-course protocol for pcnl. the investigator hope is to reduce the use of possibly unnecessary prolonged antibiotic use, reduce hospital costs and prevent the further propagation of resistant microbes.

for large renal stone burdens and/or complex stones, percutaneous nephrolithotomy (pcnl) has become the mainstay for treatment, replacing open kidney stone surgery since it's introduction in 1976. however, pcnl is not without its complications, specifically infectious. the procedure carries up to 25% incidence of infectious complications with approximately 1% rate of severe sepsis even with completely sterile conditions. therefore, the use of antibiotics becomes paramount, but to date there are no pncl specific guidelines for the appropriate duration and class of antibiotics. this fact leaves the practicing urologists to their own subjective experiences to the guide them. in addition, in an age where there are increasing numbers of resistant microbes the judicious use of antibiotics is in even more paramount. the investigators of this project, purpose a randomized intention to treat prospective study to explore the duration and type of antibiotics in a larger population then previously studied. the investigators hypothesize that there will be no difference in complications between two groups: 1) 24 hours of perioperative antibiotics versus 2) continued antibiotics until the removal of any external catheters. the investigators will model the antibiotics choices and duration after the 2013 american urological association, (aua) urologic surgery antimicrobial prophylaxis recommendations, modified by our local antibiogram as necessary. the investigators' objective is to compare the clinical efficacy of a single-day protocol with a short-course protocol for pcnl. our hope is to reduce the use of possibly unnecessary prolonged antibiotic use, reduce hospital costs and prevent the further propagation of resistant microbes. antibiotic detail: cephalosporins or aminoglycoside + metronidazole or clindamycin and the alternative for allergies being aminoglycoside/ sulbactam or fluoroquinolone looking at the same drugs and doses the variable is the timeframe of the medication

Eligibility criteria:
inclusion criteria: * patients \>18 years old * negative urine culture within 1 month prior to procedure * renal calculi which would optimally require pcnl for treatment. exclusion criteria: * patients \<18 years old. * patients who are not able to give consent for study * patients currently on antibiotics immediately prior to the procedure * previous history of sepsis or sirs from stone manipulations * foley catheter in place for greater than 1 week duration * patients under going planned, multi-staged procedures * immunosuppressed patients

Keywords: percutaneous nephrolithotomy kidney stones antibiotics
biib033 in acute optic neuritis (aon)

Conditions: Acute Optic Neuritis

Summary: the primary objective of the study is to evaluate the efficacy of biib033 in subjects with their first episode of unilateral acute optic neuritis (aon). the secondary objective of this study is to assess the safety, tolerability, and pharmacokinetics (pk) of biib033 in this study population.


Eligibility criteria:
key inclusion criteria: * ability to provide written consent and any authorization required by law. * confirmed diagnosis of aon * all male or female subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for at least 6 months after their last dose of study treatment. key exclusion criteria: * prior episode(s) of optic neuritis or loss of vision not due to aon. * subjects with an established diagnosis of multiple sclerosis are excluded except if newly diagnosed based on the current episode of aon and positive brain magnetic resonance imaging results consistent with the 2010 revisions to the mcdonald's criteria. * previous history of a clinically significant disease. * females who have a positive pregnancy test result, or who are pregnant, breastfeeding, or planning to conceive during the study. * history of human immunodeficiency virus (hiv), hepatitis c virus antibody, or hepatitis b virus. * history or evidence of drug or alcohol abuse within 2 years prior to screening. * current enrollment in any other study treatment or disease study within 3 months prior to day 1/baseline. note: other protocol-defined inclusion/exclusion criteria may apply.

Keywords: optic neuritis
effects of eicosapentaenoic acid on subjects at high risk for colorectal cancer

Conditions: Ulcerative Colitis

Summary: the aim of this study is to test eicosapentaenoic acid's effects on markers relevant to colorectal carcinogenesis, rna and dna profiles, and the possibility that eicosapentaenoic acid treatment might be associated with changes of the gut microbiota and metabolomic profiles in patients with long-standing ulcerative colitis.


Eligibility criteria:
arm: experimental inclusion criteria: * patients with ulcerative colitis (diagnosed based on clinical criteria, endoscopic and histological) lasting over 8 years, with no clinical activity (sccai = 0), and in stable treatment (without any change in treatment in the previous 3 months) with mesalamine, immunomodulators and / or biologics. * baseline fecal calprotectin\> 150 micrograms / g. * signed informed consent. exclusion criteria: * patients receiving systemic steroids in the two months prior to study entry. * patients taking concomitant warfarin or other blood thinners. * known or suspected hypersensitivity to eicosapentaenoic acid/omega 3. * women who are pregnant or of childbearing age who do not accept the use of contraceptive methods specified in the study (oral contraception, iuds) and breastfeeding women. * patients with severe medical conditions that, in the opinion of the investigator, contraindicate the patient's participation in the study. * changes of treatments and / or use of experimental drugs within 3 months before inclusion in the study. * use of probiotics arm: no intervention inclusion criteria * subjects undergoing screening colonoscopy within the regional colorectal cancer screening programme * signed informed consent * polypectomy with biopsy forceps. exclusion criteria * hbv-positive, hcv-positive, hiv-positive or otherwise affected by infectious diseases * subjects undergoing chemo and radiation therapy within six months prior to surgery * patients receiving systemic steroid in the two months prior to study entry * patients undergoing antibiotic therapy within three months prior to the study * patients treated with probiotics
meningitis with cerebral vasculitis in children

Conditions: Bacterial Meningitis

Summary: purulent meningitis are life-threatening diseases in childhood. cerebral vasculitis have been described in bacterial meningitis, but poor is known about their physiology and their impact on outcome. the investigators decide to realize a retrospective mono-centric study carried out at montpellier university hospital which looks back at a 7-year study(2009-2016). the investigators selected purulent meningitis cases based on the bacteriological data provided by the hdb (hospital data base). the investigators divides in two groups : group a if patients present a cerebral vasculitis ( radiologic diagnostic by rmi or tomodensitometry), in all, cases the diagnosis of vasculitis was confirmed by a radiologist specialised in neuropaediatrics by a second reading;group b purulent meningitis with a cerebral vasculitis imaging. tuberculous meningitis, meningitis in csf shunt, and in patients having chemotherapy were excluded. the investigators report clinical and biological finding, inflammatory marker at the onset. the investigators register also the clinical evolution and sequelae

meningitis steel are a cause of death in childhood. cerebral complication are often responsable of poor prognosis. one of these complication vasculitis is steel not weel understood. there are only few study about it on children. it is a retrospective study about 17 cases of chil which bacterial meningitis coupled wiethe cerebral vasculitis, the investigators will describe epidemiology, bacteriology, evolution and corticosteroid treatment in this patients.

Eligibility criteria:
inclusion criteria: * bacterial meningitis with lcr confirmation exclusion criteria: * tuberculous meningitis, immunosuppressor treatment, material like dvp

Keywords: cerebral vasculitis
efficacy of a standardised bilberry extract in improving the night vision of healthy volunteers

Conditions: Healthy

Summary: study to determine the efficacy of standardised bilberry extract in improving the night vision and to evaluate its tolerability and safety.


Eligibility criteria:
inclusion criteria: * healthy subjects (volunteers) with normal twilight and night vision * age 18+, young and collaborative men or women * having given their written informed consent * full visual acuity (vision 0.8 or better) according to din standard condition * refraction ≤ +/-10.0 in the highest main step * normal intraocular pressure (10-20 mmhg) exclusion criteria: * diabetes mellitus * epilepsy * abnormal visual acuity or abnormal morphological eye findings * glaucoma and macula degeneration * disease of the retina * consumption of anthocyan preparations during the past six months * opthalmologic pathology: cataract, visus \ 21 mmhg, known acute or chronic eye disease, use of hard contact lenses, eye surgery performed within the last 12 months * any serious disorder that might interfere with his/her participation in this study and the evaluation of the efficacy or safety of the test drug: e.g. diabetes mellitus, anamnestic indications of diabetic microangiopathy or polyneuropathy, renal insufficiency, hepatic or metabolic dysfunction, cardiovascular disease (hypertension \> 160/100 mmhg), psychiatric disorder, myasthenia gravis, delirious state, albino * any treatment that might interfere with the evaluation of the test drug, in particular drugs with known influence on eye sight or adaptation (e.g. chloroquine, digitalis, ethambutol, chlorpromazine, benzodiazepines or phenothiazine derivatives such as thioridazine, periciazine, perphenazine) * known hypersensitivity to any of the ingredients of the study drug * drug and alcohol abuse * pregnancy, lactation, women of childbearing potential who do not use an established contraceptive * participation in another trial within the past 30 days
an open label clinical trial of retinal gene therapy for choroideremia

Conditions: Choroideremia

Summary: a project has been developed in edmonton, alberta, canada to enable male patients with choroideremia to access a clinical trial that replaces the defective gene with a normal copy. this experiment is designed to show that the transfer of a normal copy of the gene to the eye is not only safe but may improve the sight of patients. only canadian subjects who meet criteria will be recruited.

this is an open label study involving a total of 6 male patients. screening and patient medical records will determine patient eligibility. patients will receive a subretinal injection of the raav2.rep1 vector by a trained vitreoretinal surgeon in one eye. each patient will be followed up for 24 months after treatment to assess the primary and secondary endpoints of this study using a number of outcome measures. however, further follow-up will continue after the study on an annual basis for a minimum of ten years. data will continue to be analyzed by members of the study group after this study is complete.

Eligibility criteria:
inclusion criteria: * the research subject is willing and able to give informed consent for participation in the study. * male aged 18 years or above. * diagnosed with choroideremia (with genotyping or evidence of lack of the gene product with immunohistochemistry) and in good health. * active degeneration of the retina (the expectation of significant decline in visual function without any intervention over the subsequent 5 years) with oct (optical coherent tomography) changes visible within the macula. * willingness to allow his general physician and ophthalmologist, if appropriate, to be notified of participation in the study. exclusion criteria: the participant may not enter the study if any of the following apply. * female or child research subject (under the age of 18). * men unwilling to use barrier contraception methods, if relevant. * previous history of retinal surgery or ocular inflammatory disease (uveitis). * grossly asymmetrical retinal disease or other ocular morbidity which might confound adopting the fellow eye as a long-term comparator. * any other significant systemic disease or disorder which, in the opinion of the investigator, may either put the research subject at risk because of participation in the study, or may influence the result of the study, or the research subject's ability to participate in the study. this would include a contraindication to oral prednisolone, such as a history of gastric ulcer). * research subjects who have participated in another research study involving an investigational product within the past year.

Keywords: choroideremia gene therapy gene transfer
a study to test how well different doses of bi 1356225 are tolerated by men and women with obesity or overweight

Conditions: Obesity

Summary: the primary objective of this trial is to investigate safety and tolerability of bi 1356225 in male and female patients with overweight and obesity following oral administration of multiple rising doses per day over 28 days. secondary objectives are the exploration of pharmacokinetics (pk) of bi 1356225 after multiple oral dosing. additionally, the relative bioavailability (ba) of midazolam and celecoxib in the presence and absence of bi 1356225 will be evaluated


Eligibility criteria:
inclusion criteria * male and female patients, age ≥ 18 and \< 70 * body mass index ≥ 27 kg/m2 and \< 40 kg/m2 at screening * stable body weight (defined as no more than 5% change) within 3 months prior to screening * further inclusion criteria apply exclusion criteria * females of childbearing potential * clinically relevant concomitant disease per investigator judgment * any condition or disease requiring permanent pharmacotherapy during the trial * any history of lifetime suicidal behaviour and any suicidal ideation of type 2 - 5 in the columbia-suicide severity rating scale (c-ssrs) in the past 12 months * further exclusion criteria apply
the effect of topical almond oil vs. topical retinol on the appearance of facial wrinkles

Conditions: Wrinkles; Skin

Summary: the purpose of this experiment is to analyze wrinkle severity, the skin barrier and facial pigmentation level after topical almond oil application, compared to the use of topical retinol. both the almond oil and the 0.5% topical retinol studied is investigational.

the natural cosmetic market is a multi-billion-dollar industry. nutraceuticals and foodbased cosmetics are a growing trend within dermatology. almonds are a rich dietary source of a range of fatty acids, phytochemical polyphenols, and antioxidants \[1\]. the previous study done by dr. raja sivamani was a double blinded study that compared oral almond intake to a calorie matched non-nut-based intake over 12 weeks.the study determined that that there was a statistically significant improvement in wrinkle severity and pigment intensity in the women that received almond supplementation. this proposal aims to now understand how the topical application of almond oil may influence the appearance of wrinkles and facial tone in post-menopausal women. almond oil is rich in fatty acids and alpha-tocopherol \[2\]. tocopherol inhibits melanogenesis in melanocytes \[3\] and topical alpha tocopherol has been shown to improve skin antioxidants and hyperpigmentation \[4, 5\].

Eligibility criteria:
inclusion criteria: * post-menopausal women of fitzpatrick skin types 1 and 2 exclusion criteria: * those with a nut allergy * smoking is an independent risk factor and serves as a confounder for the development of facial wrinkles and photoaging \[14\]. therefore, current smokers, those that have smoked within the past year, and former smokers with greater than a 20-pack year history of smoking will be excluded. * those with an autoimmune photosensitive condition or a known genetic condition with a deficiency in collagen production (such as ehlers-danlos syndromes) will be excluded as this can be a confounder for facial wrinkles. * those who have undergone any cosmetic procedures to the face in the 4 months prior to enrollment in the opinion of the investigator. people that have undergone deeper chemical peels (tca based peels) within 1 year prior to enrollment will also not be eligible. * individuals who are unwilling to discontinue vitamin e food sources during the washout and intervention. this includes * vitamin e containing supplements. * sunflower seeds or sunflower oil. * all nuts. * individual who are unwilling to discontinue topical cosmetic products during the duration of the study or unwilling to undergo a 2-week washout of topicals that are known to modulate collagen and pigment: * retinoids such as tretinoin, adapalene, retinol, except as provided by the study. * antioxidant ingredients such as vitamin c or vitamin e. * pigment reducing agents such as hydroquinone, a retinoid, azelaic acid, kojic acid, pomegranate seed oil, and other similar agents per the discretion of the investigator, except for the retinol that is provided in this study. * topicals that contain a nut oil or nut extract as part of their ingredient list.
physical activity and the risk of covid-19 infection and mortality

Conditions: Covid19

Summary: coronavirus disease 2019 (covid-19) is an infectious disease caused by the severe acute respiratory syndrome coronavirus 2 (sars-cov-2). currently, there is no cure for covid-19, except for supportive treatments. quarantine for a defined period is the best option to reduce the spread of covid-19. physical activity has been shown to reduce the risk of serious community-acquired infections. however, it remains unanswered is whether physical activity has protective effects against sars-cov-2 infection and covid-19 related mortality. this study aimed to examine the association of pa with the morbidity and mortality of covid-19 infection in the entire south korean population.


Eligibility criteria:
inclusion criteria: * all koreans who tested positive for sars-cov-2 * more than 18 years old * who underwent public health screening between 2014 and 2017 exclusion criteria: * missing values about physical activity

Keywords: physical activity
monitoring movement disorder symptoms with a mobile medical app on off-the-shelf consumer mobile devices

Conditions: Parkinson Disease

Summary: the purpose of this study is to evaluate whether new touch digital (ntd) neurorpm software installed on wearable devices can objectively measure and track symptoms in patients with parkinson's disease.


Eligibility criteria:
inclusion criteria: 1. subject is 18 years of age or older 2. subject is able to provide informed written consent 3. subject has been clinically diagnosed with parkinson's disease 4. subject is mentally and physically capable of performing tasks on the mobile device and related physical activities herein described exclusion criteria: 1. inability to give informed consent 2. presence of additional neurological disease aside from the diseases being studied 3. inability to understand and follow the directions for the study

Keywords: parkinson's disease
feasibility investigation of biometry and tomography measurements in a heterogeneous patient cohort

Conditions: Cataract; Lens Opacities; Artificial Lens Implant; Corneal Astigmatism; Corneal Defect; Corneal Deformity

Summary: the planned clinical investigation will be conducted to acquire raw data for the development of the algorithm. the data acquisition is intended to obtain first impressions of the potential performance of the changed hardware and software components and to confirm the safety profile assessed by risk analysis.


Eligibility criteria:
inclusion criteria: * male or female 21 years of age and older * able and willing to make the required study visit * able and willing to provide consent and follow study instructions * patients must have understood and signed the informed consent exclusion criteria: * any performed contact measurements or examinations in which the eye is touched on the same day prior to the investigation measurement * physical inability to be positioned at the study devices (e.g. torticollis, head tremor, injuries at forehead or chin, etc.) * principal investigator's determination that the subject is not suitable due to other medical condition (reasons to be listed on ecrf) * known pregnancy
the vascular and cognitive effects of chronic high-flavanol intake in healthy males

Conditions: Healthy

Summary: a randomised, placebo-controlled, parallel human dietary intervention trial conducted in 33 healthy males to investigate the vascular and cognitive effects of bi-daily consumption of high-flavanol (epicatechin-rich) milk chocolate over a 2-week intervention period. subjects visited the hugh sinclair unit of human nutrition on 3 separate occasions; at the beginning, end and post-intervention.


Eligibility criteria:
inclusion criteria * body mass index 18.5-27.5 kg/m2 * normal blood pressure (\< 150/90) * non-smoker * regular exercise routine * signed consent form exclusion criteria: * haemoglobin (anaemia marker) \< 125 g/l * gamma gt (liver enzymes) \> 80 iu/l * total cholesterol \> 6.5 mmol/l * suffered a myocardial infarction or stroke in the last 12 months * suffers from any cardiovascular or metabolic disorders * suffers from any blood-clotting disorder, and/or takes supporting medication * any dietary restrictions or on a weight reducing diet * on any lipid-modifying or blood pressure lowering medication * consuming any specific vitamin/ herbal supplements or fish oils

Keywords: flow-mediated dilatation (fmd) vascular function cognitive function