Kornimate/medical-research-clean huggingface dataset:
eagle trial caddie artificial intelligence endoscopy

Conditions: Colorectal Cancer; Polyp of Colon; Adenoma Colon

Summary: the eagle study is a prospective randomized controlled multicenter parallel design trial, for the assessment of clinical performance of the caddie device and to confirm that the device performs as expected.

the eagle study will be conducted with a parallel design. patients who meet the study inclusion/exclusion criteria will be randomized in a 1:1 ratio to receive either computer-aided colonoscopy (caddie arm) using caddie or standard colonoscopy without cade (control arm). all resected polyps will be submitted for histologic examination.

Eligibility criteria:
inclusion criteria: 1. screening or surveillance colonoscopy 2. age 40 years or older 3. informed consent exclusion criteria: 1. emergency colonoscopies 2. inflammatory bowel disease (ibd) 3. colorectal cancer (crc) 4. previous colorectal cancer (crc) 5. previous colonic resection 6. returning for a planned elective therapeutic colonoscopy. 7. polyposis syndromes (familial adenomatous polyposis) 8. contraindication for biopsy or polypectomy.

Keywords: screening surveillance artificial intelligence colonoscopy
leukapheresis to obtain lymphocytes for studies on antiretroviral naive hiv-infected patients

Conditions: Human Immunodeficiency Virus

Summary: to further investigate differences in the immunologic function of various lymphocyte subsets in hiv-infected patients who are treated early in their infection and during the chronic phase of the infection. studies will also be done to further delineate the various antigen-specific and innate immune responses including characterization of soluble factors associated with primary hiv infection.

primary hiv-1 infected and chronically infected individuals will be recruited and leukapheresis will be performed. this one year study requires that patients be apheresed once before initiating therapy and on two other occasions (at month 6 and month 12) after suppression of plasma viremia. peripheral blood mononuclear cells will be isolated by sodium diatrizoate density centrifugation and subjected to immunologic and virologic studies.

Eligibility criteria:
inclusion criteria: * adult hiv-1 infected patient * for primary infected patients anyone with an exposure to a known source of hiv infected material or individual, with symptoms and signs if present consistent with primary hiv infection, a negative elisa, indeterminate western blot for hiv and a positive hiv plasma rna levels \> 10,000 copies/ml by either rt-pcr or bdna * chronic hiv-infected patients should have a positive elisa and a confirmatory western blot and willingness to give informed consent for the storage of blood. * willingness to be able to make follow-up visits for apheresis at 6 and 12 months for those who undergo antiretroviral therapy exclusion criteria: * pregnant women

Keywords: primary hiv infection chronic hiv infection
ex vivo multimodal imaging of upper aerodigestive epithelium

Conditions: Squamous Cell Carcinoma of the Oral Cavity; Oropharynx; Larynx; Hypopharynx

Summary: the purpose of this research study is to collect information on whether images made using investigational microscopes can improve researchers' ability to evaluate and distinguish between normal and abnormal areas in tissue samples surgically removed from patients with squamous cell carcinoma. the microscopes being used in this study are considered investigational because they have not been approved by the united states food and drug administration (fda) for finding abnormal or pre-cancerous areas.

the overall objective of this exploratory study is to evaluate whether noninvasive fluorescence and reflectance imaging of the upper aerodigestive tract can help clinicians more accurately determine intraoperative margins during ablative cancer surgery. this is an ex vivo study designed to evaluate the feasibility of using prototype optical imaging technology to enhance the discrimination between areas of noncancerous "normal" and cancerous mucosa. the results of this laboratory study will be used to further refine and develop this technology for in vivo application. primary aim: (1) to collect data to develop imaging algorithms to distinguish between normal and cancerous upper aerodigestive mucosa. secondary aims: 1. to compare the combination of wide-field fluorescence/reflectance and high resolution fluorescence microscopy images of upper aerodigestive epithelium to histopathologic analysis of biopsied tissue. 2. to compare the ability of sequential wide-field/fluorescence microscopy imaging to discriminate between normal and cancerous oral cavity mucosa with that of white-light images obtained after staining with toluidine blue.

Eligibility criteria:
inclusion criteria: * subjects with biopsy-proven squamous cell carcinoma of the oral cavity, oropharynx, larynx, and/or hypopharynx. * must be receiving surgical treatment for their cancer. exclusion criteria: • presence of medical or psychiatric condition affecting ability to give voluntary, informed consent.

Keywords: hrme high-resolution microendoscope optical imaging technology non-invasive fluorescence and reflectance imaging upper aerodigestive tract cancer surgery squamous cell carcinoma oral cavity oropharynx larynx hypopharynx squamous cell carcinoma of the oral cavity, oropharynx, larynx, and/or hypopharynx
the positive family support project - partnering with families for a successful transition to school

Conditions: Achievement

Summary: the positive family support project seeks to understand some of the factors that increase success for children in early elementary school, such as positive family support at home. this study will inform us on ways to help children learn and succeed in school.

the transition to elementary school is a critical time for the development of key skills that are necessary for school success, including sustained attention, self-regulation, initiating and sustaining successful peer relationships, and academic competence. parent support at home, such as positive parenting and support for learning, is associated with school readiness indicators that predict successful adaptation to the school context. for many children at risk for poor developmental outcomes this transition can be difficult and may lead to early academic problems, which in turn may define a trajectory that culminates in more severe forms of problem behavior and learning difficulties. the purpose of this study is to evaluate the efficacy of implementing the family check-up (fcu), a school-based, ecological approach to family intervention, during the transition into elementary school.

Eligibility criteria:
inclusion criteria: 700 kindergarten children and their families entering kindergarten in the clackamas school district in 2014 and 2015 - exclusion criteria: -
precision ablation for pulmonary vein isolation: targeting pulmonary vein myocardial sleeves (pvms) with omnipolar mapping technology

Conditions: Atrial Fibrillation

Summary: the purpose of this study is to compare procedural times and radiofrequency (rf)applications required for pulmonary vein myocardial sleeves targeted pulmonary vein ablation (pvs-pvi) , to compare the efficacy of pvs-pvi , to compare the safety of pvs-pvi and to assess other clinical outcomes of pvs-pvi in individuals with symptomatic paroxysmal atrial fibrillation (af) using omnipolar technology with conventional wide area circumferential ablation (waca).


Eligibility criteria:
inclusion criteria: * symptomatic paroxysmal af refractory to at least one class i or class iii antiarrhythmic medication, intolerance to antiarrhythmic medications, or a preference to not trial antiarrhythmic medications * a minimum of one documented af episode via 12-lead ecg, holter monitor, or loop recorder * capability to provide informed consent exclusion criteria: * persistent or permanent af * prior history of catheter or surgical ablation for af or left atrial ablation for atypical flutter * reversible causes of af * congenital heart disease * significant valve disease (moderate or severe mitral/aortic stenosis or regurgitation) * pregnancy * known presence of intracardiac thrombus * systemic oral anticoagulation therapy contraindicated, including a history of heparin-induced thrombocytopenia * broad vortex-like connections and no clear pvms to be targeted

Keywords: ablation symptomatic paroxysmal atrial fibrillation
safety, tolerability and pharmacokinetics of cobimetinib in combination with pictilisib in patients with locally advanced or metastatic solid tumors

Conditions: Solid Tumors

Summary: this is an open-label, multicenter, phase ib dose-escalation study designed to assess the safety, tolerability and pharmacokinetics of oral dosing of cobimetinib and pictilisib administered in combination in patients with locally advanced or metastatic solid tumors.


Eligibility criteria:
inclusion criteria: * histologically or cytologically documented, locally advanced or metastatic solid tumors for which standard therapy either does not exist or has proven ineffective or intolerable * evaluable disease or disease measurable per response evaluation criteria in solid tumors (recist) * life expectancy greater than or equal to (\>=) 12 weeks * adequate hematologic and end organ function * agreement to use an effective form of contraception for the duration of the study exclusion criteria: * history of prior significant toxicity from another mitogen-activated protein kinase (mek) pathway inhibitor requiring discontinuation of treatment * history of prior significant toxicity from another phosphoinositide 3-kinase (pi3k) pathway inhibitor requiring discontinuation of treatment * allergy or hypersensitivity to components of the cobimetinib or pictilisib formulations * palliative radiotherapy within 2 weeks prior to first dose of study drug treatment in cycle 1 * experimental therapy within 4 weeks prior to first dose of study drug treatment in cycle 1 * major surgical procedure or significant traumatic injury within 4 weeks prior to first dose of study drug treatment in cycle 1, or anticipation of the need for major surgery during the course of study treatment * prior anti-cancer therapy within 28 days before the first dose of study drug treatment in cycle 1 * history of diabetes requiring daily medication, or history of grade \>= 3 fasting hyperglycemia * current severe, uncontrolled systemic disease * history of clinically significant cardiac or pulmonary dysfunction * history of malabsorption or other condition that would interfere with enteral absorption * clinically significant history of liver disease (including cirrhosis), current alcohol abuse, or current known active infection with human immunodeficiency virus (hiv), hepatitis b virus, or hepatitis c virus * any condition requiring anticoagulants, such as warfarin, heparin, or thrombolytics * active autoimmune disease * uncontrolled ascites requiring weekly large volume paracentesis for 3 consecutive weeks prior to enrollment * pregnancy, lactation, or breastfeeding * known brain metastases that are untreated, symptomatic, or require therapy to control symptoms * no other history of or ongoing malignancy that would potentially interfere with the interpretation of the pharmacodynamic or efficacy assays

Keywords: gdc0941 gdc0973 mek mek inhibitor pi3k pi3k inhibitor pi3 kinase pi3 kinase inhibitor
uk surveillance of treated retinopathy of prematurity

Conditions: Retinopathy of Prematurity

Summary: currently, there is little recent data on regional variations in treatment methods, neonatal units that provide retinopathy (rop) treatment, facilities for treatment available at each unit including anaesthetic support for such preterm babies, facilities to transfer babies to units that offer treatment etc. while some parts of the uk have established neonatal networks and agreements among units for rop treatment, in other parts, such arrangements are illdefined. the number of babies needing rop treatment may be higher since the introduction of revised guidelines in 2008 as earlier treatment has been shown to be beneficial. collecting epidemiological data through the british ophthalmic surveillance unit (bosu) on the incidence of treatable rop, the treatment methods used and facilities for treatment will provide the foundation for effective planning of resources and manpower to deal with the additional demand.


Eligibility criteria:
inclusion criteria: * any baby with rop who is treated or referred to another unit for treatment either in the form of laser therapy, cryotherapy, antivegf agent or vitrectomy/scleral buckling (or a combination of above treatments) exclusion criteria: * none; we will monitor data to exclude duplication of cases which may arise from children being transferred between neonatal units or consultants
lde225 for patients with ptch1 or smo mutated tumors

Conditions: PTCH1 or SMO Activated Solid and Hematologic Tumors

Summary: the purpose of this signal seeking study is to determine whether treatment with lde225 demonstrates sufficient efficacy in hedgehog pathway-mutated solid tumors and/or hematologic malignancies to warrant further study


Eligibility criteria:
inclusion criteria: * patient has confirmed diagnosis of a select solid tumor (except medulloblastoma, basal cell carcinoma and pancreatic adenocarcinoma) or hematological malignancy (except cml, all and aml). * patient has pre-identified tumor with a ptch1 or smo mutation. * patient has received at least one prior treatment for recurrent, metastatic and /or locally advanced disease and for whom no standard therapy options are anticipated to result in a durable remission. * patient has progressive and measurable disease as per recist 1.1. or other appropriate hematological guidelines. * patient has an eastern cooperative oncology group (ecog) performance status ≤ 1 exclusion criteria: * patients has received prior treatment with lde225. * patients has neuromuscular disorders associated with elevated ck (i.e. inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis and spinal muscular atrophy) or are on concomitant treatment with drugs that are recognized to cause rhabdomyolysis * patients has primary cns tumor or cns tumor involvement * patient has received chemotherapy or anticancer therapy ≤ 4 weeks prior to starting study drug

Keywords: solid tumor malignancy, hematologic malignancy, mutation, translocations, signature, ptch1, smo, lde225, endometrial cancer, colon cancer, bladder, nsclc
visual pathways model in neuro-inflammatory disorders

Conditions: Optic Neuritis

Summary: in neuroinflammatory diseases of the central nervous system (cns) such as multiple sclerosis (ms), neuromyelitis optica spectrum disorders (nmosd) and anti-mog antibody-associated disorders (mogad), neuronal degeneration is the consequence of inflammatory and demyelinating lesions in the brain, optic nerve and spinal cord. both white and grey matter are systematically affected. lesions of the perivascular spaces containing cerebrospinal fluid (csf) and meningeal inflammation seem to play an important role in the pathophysiology of these neuroinflammatory diseases. currently, the interrelation of all these aspects is not clearly established in the pathophysiology of these diseases. in order to better understand the mechanisms that lead to and underlie the clinical disability of patients with these diseases, we need in vivo study models that allow the in-depth study of the neurodegenerative process and the identification of its causes. in this perspective, we make the hypothesis that the visual pathways model is very relevant to measure neuro-axonal loss and to explore the different mechanisms involved in neurodegeneration during ms and other cns demyelinating diseases. researchers have at their disposal many tools that allow them to analyse and quantify the neurodegenerative process in a reproducible and very precise manner from a structural and functional point of view, while taking into account possible vascular involvement (mri, optical coherence tomography - angiography, etc...).


Eligibility criteria:
inclusion criteria: * - male or female * aged between 18 and 65 years * presenting a clinical picture of optic neuritis for less than 4 weeks, confirmed by neuro-ophthalmological assessment * patient having given written consent to participate in the study * patient with social insurance * patient willing to comply with all study procedures and duration exclusion criteria: * - history of optic neuritis on the same side as the recent episode for which the patient is being treated * history of retinal pathology (retinal detachment, glaucoma, retinopathies, retinal surgery) * diabetes * chronic alcohol intoxication * contraindications to mri * pregnant women * persons under protective supervision (ex : guardianship) * minors * persons deprived of their liberty * administrative reasons: inability to receive informed information, inability to participate in the entire study, lack of social security coverage, refusal to sign consent a history of pre-existing cns inflammatory demyelinating disease is not a criterion for non-inclusion.

Keywords: optic neuritis optical coherence tomography, mri, demyelination, neuro-axonal loss. mri demyelination neuro-axonal loss
study of stress hyperglycemia as an indicator of diabetes mellitus

Conditions: Stress Hyperglycemia; Diabetes Mellitus Type 2

Summary: we hypothesize that stress hyperglycemia is an indicator that a patient will develop type 2 diabetes mellitus in the future. subjects who are not diabetic are enrolled and blood glucose readings reviewed during their intensive care unit stay. all subjects are consented and have a hba1c level drawn to determine if they have diabetes mellitus or not. they are then followed up in 1 year and the hba1c repeated to determine if they have developed diabetes mellitus over the course.


Eligibility criteria:
inclusion criteria: * all patients admitted to the intensive care unit at the yale new haven hospital st. raphael campus and norwalk hospital exclusion criteria: * patients with prior history of diabetes mellitus * elevated admission hba1c (≥6.5%) * age \>80 years * metastatic disease with expected life expectancy of less than 12 months * pregnancy or a woman who plans to become pregnant
to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of oral administration of azd8329

Conditions: Overweight; Healthy; Male

Summary: the purpose of the study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of azd8329 following multiple ascending dose administrations in in overweight to obese but otherwise healthy male subjects.

a phase i, single centre, single-blind, randomised, placebo-controlled, parallel-group study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of oral azd8329 after administration of multiple ascending doses in abdominally obese but otherwise healthy male subjects

Eligibility criteria:
inclusion criteria: * have a body mass index (bmi) between 27 and 35 kg/m2 and a waist circumference greater than or equal to 102cm. * provision of signed and dated, written informed consent prior to any study specific procedures * healthy male subjects aged =20 to =50 years with suitable veins for cannulation or repeated venepuncture exclusion criteria: * history of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate. * fasting serum (s)-glucose =7.0 mmol/l or non-fasting s-glucose =11.1 mmol/l at screening. * any eating disorder or actively attempting to loose weight within 3 months prior to enrolment

Keywords: safety tolerability pk healthy overweight obese
cleanser versus only water

Conditions: Premature Birth

Summary: the aim of this study is to determine the effect of the newborn's first bath with a cleaning product and only water on the barrier function of the skin.

studies in the literature on the effects of newborn bath types on the effects of body temperature on newborn crying times, on the effects of newborn behavior and stress, the views and practices of mothers with newborn babies on baby bathing, and the effects of bath types on the umbilical cord in term babies, and the effects of bath products on newborns. it seems that there are studies done. however, although studies on the effect of the cleaning product used in the first bath of late preterm and term newborns on the skin barrier are limited in number for term newborns, there are almost no studies for late preterm newborns. the hypotheses of this study are as follows; 1. in late preterm and term newborns, the first bath with cleaning product protects the newborns' transepidermal fluid loss better than the first bath with only water. 2. in late preterm and term newborns, the first bath with cleansing product keeps the skin ph levels of newborns at a more optimal level compared to the first bath with only water.

Eligibility criteria:
inclusion criteria: * born between 34 weeks + 0 days and 42 weeks + 6 days (late preterm and term), * with a body weight of 1800g or more, * spontaneous breathing, * preterms with stable physiological parameters will be included in the study. exclusion criteria: * receiving mechanical ventilation support, * mother's baby with hiv, hepatitis b, * preterms who had a bath before the intervention, * surgical operation and incision in any area, * preterms with a central catheter, * preterms with systemic infections, * preterms using sedatives and / or muscle relaxants, * preterms with congenital or chromosomal anomalies

Keywords: skin barrier function first bathing baby cleanser transepidermal water loss skin ph
the purpose of this study is to determine if eplerenone is effective in treatment of mild to moderate heart failure

Conditions: Heart Failure, Congestive

Summary: the purpose of this study is to determine if eplerenone is effective in the treatment of mild to moderate heart failure


Eligibility criteria:
inclusion criteria: * current symptoms consistent with mild to moderate heart failure (nyha functional class ii and iii) * lvef (left ventricular ejection fraction) of \<35% by equilibrium-gated rvg at screening * therapy with an angiotensin converting enzyme inhibitor (acei) or angiotensin receptor blocker (arb) and beta-blocker (bb) (unless documented intolerance) for at least 3 months duration and at dose that has not been adjusted within the previous 4 weeks exclusion criteria: * current decompensated heart failure or heart failure hospitalization or severe heart failure (nyha functional class iv) within 6 months of screening * use of eplerenone or spironolactone within 30 days of randomization or for more than 7 days within the previous 6 months