Kornimate/medical-research-clean huggingface dataset:
splintless virtual surgical plan with mandible-first technique: 3d accuracy analysis

Conditions: Dentofacial Deformities

Summary: accuracy assessment through three-dimensional superposition of the post-operative volumetric ct and the digital therapeutic project files.


Eligibility criteria:
inclusion criteria: * men and women * age over 18 and under 60 * diagnosis of dento-skeletal dysmorphosis involving the middle third and lower part of the face * patients with consent to surgery * patients in good general health according to the evaluation of the pi and on the basis of the anamnesis and clinical examination exclusion criteria: * history of previous maxillomandibular fracture * treatment with anticoagulant drugs * treatment with intravenous bisphosphonates * treatment with anticonvulsants * patient's inability to maintain home hygiene standards in accordance with the study requirements * history of drug and/or alcohol abuse * chronic corticosteroid therapy * radiotherapy, chemotherapy and/or immunosuppressive treatment or radiotherapy in the last 5 years * psychosis * pregnant or breastfeeding * poor compliance * endocrinological disorders in poor pharmacological control * other uncontrolled systemic conditions that preclude performing surgical procedures
a study of the efficacy and safety of re-treatments with rituximab in patients with active rheumatoid arthritis who have had an inadequate response to anti-tnfa therapies

Conditions: Rheumatoid Arthritis

Summary: this study will assess the long-term safety and efficacy of repeating treatment with mabthera, in combination with methotrexate and steroids, in patients who were previously randomized into mabthera study wa17042. the anticipated time on study treatment is until mabthera is available on the local market and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * adult patients 18-80 years of age with active ra; * patients who participated in mabthera study wa17042, and completed to at least the week 24 visit; * eligible for re-treatment, based on clinical symptoms; * patients of reproductive potential must be using reliable contraceptive methods. exclusion criteria: * patients who participated in mabthera study wa17042 but withdrew into the safety follow-up; * current treatment with any other disease-modifying antirheumatic drug (apart from methotrexate), or any anti-tnfalfa, anti-il1, or other biologic therapies; * development of any new contraindications to receiving mabthera; * women who are pregnant or breast-feeding.
empagliflozin in heart failure with preserved ejection fraction and end stage renal disease

Conditions: Heart Failure With Preserved Ejection Fraction; End Stage Renal Disease on Dialysis

Summary: the presence of ckd has been linked to the development of hfpef. currently, the treatment for hfpef is limited. sglt2i are one of the few drug classes that have proven efficacy in hfpef in randomized controlled trials. the results of mechanistic studies suggest that the benefits of sglt2i on diastolic heart failure are independent of their glycosuric actions and may still be present in anuric subjects. despite the significance of hfpef in patients with ckd, patients with advanced kidney disease have been excluded from studies investigating anti-heart failure drugs. the effects of sglt2i in patients under maintenance dialysis are largely unknown. past pharmacokinetics and pharmacodynamics studies on empagliflozin in patients with end-stage renal disease (esrd) demonstrated that the use of empagliflozin in patients with esrd seemed safe, yet its efficacy remains to be explored.


Eligibility criteria:
inclusion criteria: * age ≥20 years old * esrd under chronic, maintenance dialysis with stable dry weight for the past 6 months * prior diagnosis of hfpef, as defined by a score of ≥5 on the hfa-peff diagnostic algorithm. exclusion criteria: * age \<20 years old * ongoing pregnancy * nyha class iv heart failure * any hospitalization for heart failure within the past month ongoing acute urinary tract infection at the time of screening * known acute genital infection * severe peripheral artery disease (rutherford category 4-6) * acute coronary syndrome, stroke or transient ischemic attack within the past month * recent initiation of chronic maintenance hemodialysis within 6 months * adjustment of dry weight with changes greater than 5% of body weight within the past month * documented left ventricular ejection fraction =\<40% by any imaging modality within 1 month of screening * refused informed consent

Keywords: end-stage renal disease sodium-glucose co-transporter 2 inhibitors heart failure diastolic function empagliflozin
18ffdg pet/ct for early evaluation of chemotherapy efficacy in metastatic colic adenocarcinoma

Conditions: Metastatic Colorectal Cancer

Summary: the metastatic colo-rectal cancer (especially with hepatic metastatic lesions, but also peritoneal or pulmonary lesions) is a major public health issue, because of its frequency, the heavy treatments and the cost of new therapeutic molecules involved, in particular targeted therapies that can result in specific adverse events. the first-line treatment often consists of a polychemotherapy, which can be associated to a targeted therapy. according to the therapeutic response, patient condition and disease extent, some patients may benefit from prognosis-changing treatments such as surgery of metastases. however, the best morphological response is most of time evidenced after only 6 or 8 cycles of treatment, corresponding to 3 to 4 months. therapeutic evaluation with fdg pet/ct is validated in several neoplasia (lymphoma, breast cancer). data on fdg pet evaluation of colic cancer chemotherapy are currently insufficient to propose its use in the usual clinical setting. we thus are going to study the performance of early fdg pet therapeutic evaluation to predict response to first-line chemotherapy in patients with potentially resectable metastases. if early pet diagnostic performances prove satisfying, this approach could become of paramount importance to tailor therapeutic strategy for these patients, with the possibility of early modification of chemotherapy protocol, which is now possible thanks to the existence of therapeutic alternatives (chemotherapy intensification, replacement of oxaliptaine by irinotecan or conversely, replacement of an anti-egfr by an anti-angiogenic or conversely).


Eligibility criteria:
inclusion criteria: * histologically proved colo-rectal cancer * measurable metastatic disease according to recist 1.1 criteria * metastases considered potentially resectable (for example : hepatic, nodular peritoneal, lung lesions...) by the multidisciplinary committee meeting * ecog≤2 * patient candidate to a first-line chemotherapy± targeted therapy according to standard protocols : lv5fu2, folfox, folfiri, folfirinox +/- bévacizumab, aflibercept , cétuximab, panitumumab * in case of metachrone metastasis, adjuvant chemotherapy stopped for more than 6 months before relapse diagnosis * predictable life expectancy of more than 6 months * signed informed consent * age \> 18 years exclusion criteria: * patient with another evolutive neoplastic disease * patient participating in another study evaluating an imaging technique using ionizing radiations * brain metastasis * absence of health insurance coverage * pregnant of breastfeeding woman * hypersensitivity to fdg or to one of the excipients of used specialty
experimental and clinical studies of retinal stimulation

Conditions: Retinitis Pigmentosa

Summary: the study will evaluate new methods of retinal stimulation and training with the goal of improving the visual ability of retinal prosthesis participants.

the study will test new ways to make the retinal prosthesis visual perception easier with auditory-visual training and how to make the retinal prosthesis work better at perceiving shapes.

Eligibility criteria:
inclusion criteria: * must be implanted with an argus ii retinal prosthesis system. * have 5 or more electrodes that create a perception with stimulation. * must be willing and able to comply with the protocol testing requirements. exclusion criteria: * subjects participating in another investigatory drug or device study * any disease or condition that prevents understanding or communication of informed consent, study demands, and testing protocols.
pilot study of cognitive and functional outcomes following tavi

Conditions: Aortic Stenosis

Summary: narrowing of the aortic valve in the heart, known as severe aortic stenosis, can impede blood delivery and is associated with poor quality of life and death. in the elderly with considerable medical burden, a relatively new non-invasive valve replacement technique called transcatheter aortic valve implantation (tavi) can be used instead of open-heart surgery. however, long term changes in cognition after tavi remain unclear and previous studies have suggested an increased risk of cognitive decline in patients following the surgical procedure. in this pilot study, the investigators will characterize changes in cognition, physical capacity, overall quality of life and neuropsychiatric symptoms (depression and apathy) over 6 months after tavi.

cardiovascular disease including valvular heart disease, contributes to an estimated 36% of all deaths over the age of 70. in particular, severe aortic stenosis is the most common valvular heart disease in the elderly in the western world and is associated with reduced quality of life and increased mortality. tavi has been shown to improve survival, with an all-cause mortality at 1 year similar to surgical aortic valve replacement (savr) with favourable outcomes long-term including improved functional capacity and quality of life. recent evidence from randomized controlled trials suggests an increased risk of neurological events (e.g. cognitive decline) up to 1 year after tavi in comparison to both savr and medical treatment. studies have shown no change in short-term memory, working memory, verbal learning, delayed recognition and verbal fluency 3 months after tavi. in addition, patients with severe aortic stenosis have an increased risk of mortality and future health complications. this study will be an observational, prospective cohort pilot study to examine changes in cognitive performance and functional outcomes after tavi. we propose to recruit 34 patients for this study. cognitive performance will be measured using a standardized cognitive battery prior to tavi and 6 months post-tavi. functional capacity, changes in neuropsychiatric symptoms and quality of life will also be assessed prior to tavi and 6 months post-tavi. we hypothesize there will a change in cognitive performance, functional capacity, mood outcomes and quality of life over 6 months after tavi.

Eligibility criteria:
inclusion criteria: * diagnosis of severe symptomatic aortic stenosis * undergoing tavi * speak and understand english exclusion criteria: * emergency tavi * any medical conditions that will affect their ability to complete the protocol

Keywords: transcatheter aortic valve implantation severe aortic stenosis cognition functional capacity quality of life
stimulate study: anemia correction and health-related quality of life (hrqol) outcomes in elderly chronic kidney disease (ckd) patients

Conditions: Anemia; Chronic Kidney Disease

Summary: treatment of anemia associated with chronic kidney disease (ckd) during 36 weeks with safety follow up phase of 52 weeks

this is a multicentre, randomised, single-blind, placebo-controlled, two-arm parallel group study assessing the effect of anaemia correction and hb maintenance with darbepoetin alfa in elderly ckd patients for 36 weeks.

Eligibility criteria:
inclusion criteria: * stage 3-5 ckd not on dialysis * patients ≥ 70 years of age * haemoglobin \< 110g/l at screening * transferrin saturation ≥ 15% at screening exclusion criteria: * clinical history of type 2 diabetes mellitus * anticipating or scheduled to go on renal replacement therapy in the next year, including renal transplant * uncontrolled hypertension on two separate measurements during screening * use of any erythropoietic protein within 12 weeks of screening

Keywords: quality of life chronic kidney disease anemia
safety and efficacy study of topical bromfenac versus placebo to treat ocular inflammation after cataract surgery

Conditions: Postoperative Complications; Cataract

Summary: the primary objective of this study was to investigate the efficacy of bromfenac sodium ophthalmic solution 0.09% for treatment of post-operative ocular inflammation in subjects who undergo cataract extraction and intraocular lens implantation. the secondary objective was to investigate the safety and tolerability of the same.


Eligibility criteria:
inclusion criteria: * cataract surgery * summed ocular inflammation score (anterior chamber cell score plus flare score) of \>/= 3, 24 hours after the cataract extraction * agreed to avoid disallowed medications (meds) throughout the duration of the study exclusion criteria: * use of or need for non-steroidal anti-inflammatory agents (nsaids), steroids, anticoagulants, or other specific meds prohibited by the protocol * uncontrolled chronic ocular or systemic disease, active corneal pathology or scarring noted in either eye (except keratopathy, allowed in non-study eye) * extraocular/intraocular inflammation in either eye * clinically significant (who ctc grade 1 or greater) liver function tests

Keywords: cataract extraction anti-inflammatory agents, non-steroidal
leveraging an existing large-scale safe water program to deliver nutrition messages at a low marginal cost

Conditions: Child Malnutrition

Summary: the investigators are seeking to overcome the dual challenges of under-nutrition and diarrhea using an existing safe water supply platform to deliver nutrition information to targeted groups in western kenya. using a randomized evaluation, investigators will determine the impact on nutrition status and practices of delivering nutrition information. the evaluation results will enable evidence action to make strategic decisions regarding the potential scale-up of the combined program across kenya.

evidence action's dispensers for safe water program currently provides access to safe water for two million people. the program would be able to leverage the existence of this service delivery platform to provide promoters with training on proper nutrition and methods for delivering these messages to target groups. the intervention is a home visiting program that will provide nutrition advice on complementary feeding to households with children aged 6-24 months. two types of home visits will be evaluated, a 'traditional visit mode' in which the child's mother receives the visit; and a 'couples visit mode' in which the promoter attempts to involve both the father and mother. households in the control group will also receive home visits by promoters but the content of the visit will be restricted to safe water. the same information on safe water will also be provided to households in the treatment group. hence, the evaluation will measure the additional effect of providing nutrition information on top of information on safe water. promoters will provide advice on nutrition and food hygiene to target households, according to criteria established by evidence action. following the guiding principles for complementary feeding of the breastfed child (paho/who 2003), the intervention will include information on the maintenance of breastfeeding, safe/hygienic preparation and storage of complementary foods, amount of complementary food needed, food consistency, meal frequency and energy density, nutrient content of complementary foods, and feeding after illness. the home visits will be modelled on the maimwana infant feeding intervention (http://www.maimwana.malawi.net/maimwana/home.html) that has been taking place in mchinji (malawi) since 2005. households within the treatment group will be provided by a poster to hang in their dwellings with some basic information on nutrition. a random subset of households will be given a small poster in black and white, and the other subset of households will be give a larger color poster.

Eligibility criteria:
inclusion criteria: * children will be included if they are between 0 and 18 months at baseline and live within the catchment area of a water point in which evidence action installs a chlorine dispenser exclusion criteria: * none

Keywords: information provision
vista protein expression of monocyte and t cell subsets in multiple sclerosis and its clinical correlation

Conditions: Multiple Sclerosis, MS

Summary: the aim of this study is to investigate whether vista, a newly identified negative immune regulatory protein, differs in monocytes and t cells of patients diagnosed with multiple sclerosis (ms) and clinically isolated syndrome (cis) compared to the same cell types in healthy controls. additionally, the potential clinical correlation of vista expression in the follow-up of ms and cis patients will be examined. by elucidating the role of vista in the pathophysiology of ms, this study will contribute to the literature by exploring its potential as a biomarker and its relevance in the development of novel therapeutic strategies. specifically, this study will compare vista protein secretion in ms patients at the time of their first attack with that of healthy controls. furthermore, changes in vista protein secretion will be assessed in blood samples collected at 6- and 12-month follow-ups, and the correlations of these changes with clinical and laboratory findings will be investigated. finally, this study aims to determine whether cd4+ and cd8+ t cells, monocytes, and t regulatory (treg) subgroups in the first attack blood samples of ms patients exhibit similar functional properties in terms of vista protein secretion as their counterparts in healthy controls. to achieve this, monocytes and t cell subtypes will be stimulated, and their pro- and anti-inflammatory cytokine responses will be analyzed.


Eligibility criteria:
inclusion criteria: * patients aged 18 years or older diagnosed with ms or cis according to the 2017 mcdonald criteria. * no diagnosis of any autoimmune disease or malignancy. * no new diagnosis of autoimmune disease or malignancy during the 1-year follow-up period. * no use of antibiotics, nonsteroidal anti-inflammatory drugs (nsaids), or steroid treatments within one month prior to blood sampling. * no vaccination within one month prior to blood sampling. * not in the menstrual cycle at the time of blood sampling. exclusion criteria: * age below 18 years. * presence of a previous or newly diagnosed autoimmune disease or malignancy at the time of blood sampling. * use of antibiotics, nonsteroidal anti-inflammatory drugs (nsaids), or steroid treatments within one month prior to blood sampling. * vaccination within one month prior to blood sampling * being in the menstrual cycle at the time of blood sampling * patients without a definitive ms diagnosis according to the 2017 mcdonald criteria will not be included in the study.
cartilage adaptation and response to interleukins and exercise

Conditions: Osteo Arthritis Knee

Summary: this study will examine the effect of exercise on the turnover of collagen in articular cartilage and the content of cytokines in the synovial fluid from human adults with osteoarthritis.

by using stabile isotope labelling, this study will track the formation and destination of newly formed cartilage collagen in adult humans scheduled for knee replacement surgery due to osteoarthritis. the collagen formation as well as the effect on the cytokine content of the synovial fluid will be examined both at rest and in response to 4 weeks of exercise/training. overall the project aims to improve the basic understanding of cartilage development and function in relation to osteoarthritis prevention.

Eligibility criteria:
inclusion criteria: * primary osteoarthritis of the knee scheduled for knee replacement surgery * must be able to perform physical exercise * age 40-90 years old * bmi 18.5-40 kg/m\^2 * none smoker for the last 6 weeks exclusion criteria: * regular intake of: * non steroid anti-inflammatory drugs (nsaid) * corticoid-steroids * disease modifying anti-rheumatic drugs (dmard) * cytostatic incl. chemotherapy * immune suppressive medicine * inflammatory diseases or cancer * recent trauma to the knee (\< 3 months) * previous knee surgery * regular strenuous exercise ( \> 1 pr. month) * previous exposure to tracers (e.g. from another study)

Keywords: exercise cytokines collagen
the effectiveness of acb-ip 1.0 convalescent plasma in covid-19 infection

Conditions: Covid19

Summary: pathogen-free, concentrated, pooled convalescent plasma has higher sars-cov2 antibody titers and neutralizing antibody activities, without requiring blood group compatibility that allows patient accessibility in a shorter time and has safe plasma characteristic.

the efficacy of sars-cov2 standard single donor convalescent plasma varied according to the application time and most importantly the amount of antibody that is administered. single donor plasma has some drawbacks; such as the insufficient levels of neutralizing antibody activities, the requirements of blood group compatibility, and the risk of infection transmission. in this study, the efficacy and safety of pathogen inactivated, isohemagglutinin-depleted (concentrated) and pooled convalescent plasma was investigated.

Eligibility criteria:
inclusion criteria: * are over the age of 60 or- * between the ages of 18-60, serious comorbidities (cancer, copd, cardiovascular illness, hypertension, dm) * clinically diagnose covid-19 or radiological diagnosed covid-19 pnemonia exclusion criteria: * multiple organ failure
sweetdreams sleep study for children with autism

Conditions: Autism Spectrum Disorder; Insomnia

Summary: this proposal will acquire preliminary data on the feasibility and effectiveness of an innovative and scalable strategy for improving access to effective sleep health care for preschool-aged children with autism spectrum disorder (asd). the investigators will develop and test an on-line delivery adaptation of the existing behavioral sleep interventions for preschool aged children.

access to effective treatments for sleep disorders is a persistent challenge. this is due to the lack of trained clinicians as well as caregiver resources to seek out and utilize such critical services. the sweetdreams intervention will solve this problem with on-line delivery of educational materials and treatment strategies for an evidence-based intervention. it will be readily available to caregivers at any time and through multiple outlets such a computer, tablet, and telephone, modes of delivery favored by and effective for parents of children in this age group. this adaptation will address key challenges to sleep health care for children with asd: (1) learning differences of children with asd by incorporating intervention principles from the teachh model; (2) overcome the challenge of treatment access due to the limited number of qualified providers by developing didactic videos for online and mobile device delivery (referred to as sweetdreams); and, (3) responding to the nih emphasis on developing "more effective interventions...by targeting interventions to the identified needs of community members," sweetdreams will use a dynamic process involving extensive collaboration with children, parents, developmental pediatricians, and other experts on youth with asd.

Eligibility criteria:
inclusion criteria: * have poor sleep health * have a diagnosis of asd exclusion criteria: * any regular sleep medication use (this does not include occasional over the counter sleep aid) * known sleep apnea * unstable major medical conditions (e.g. severe asthma, diabetes).

Keywords: sleep autism