Kornimate/medical-research-clean huggingface dataset:
pre-operative screening of functional fragilities before open aortic surgery: a new area

Conditions: Aortic Aneurysm; Aortic Occlusion

Summary: aneurysmal or occlusive abdominal aortic pathology has seen its prevalence increase over the years despite the various cardiovascular risk factor management campaigns deployed. currently, a large proportion of these aortic pathologies require effective and definitive treatment by open surgery. in fact, minimally invasive endovascular treatment, which can provide good results in certain cases, cannot be generalized simply and can even lead to sometimes incomplete treatments requiring even more complex secondary open surgery. the preoperative assessment before open aortic surgery is relatively well coded with cardiological and respiratory assessments in particular. however, the literature has so far never focused on the overall vision of the patient with a complete functional assessment which would make it possible to consider a specific preoperative fragility scale and would thus give practitioners corrective targets before such an intervention. in order to simplify the patient's post-operative journey by limiting complications. the investigators therefore propose to collect a certain number of elements already collected in standard care in a systematic and prospective manner in order to create a risk scale. all of these elements being modifiable, they should ultimately make patients more robust for such an intervention.


Eligibility criteria:
inclusion criteria: * all patients undergoing open aortic surgery in the vascular surgery department exclusion criteria: * patient refusal
quality of life and acupuncture on chronic pain: a randomized study before and after performing

Conditions: Chronic Pain

Summary: chronic pains can affect the life quality. this study has performed in the first time in mashhad.the purpose of the present study was to examine the effect of acupuncture on the life quality of 150 patients who suffered from chronic pain. some people like performing acupuncture because they believed it's free of risks and beneficial. in order to achieve this purpose, we had examined the life quality of the patients before and after acupuncture. this study was randomly performed on 150 patients aged between 17-75. they were suffering from chronic pain. the questionnaire is based on who qol. the questionnaires were filled out once before acupuncture and once 12 weeks after it.

this study was completed on time.

Eligibility criteria:
inclusion criteria: * aged between 17 - 75 years old, * suffering from arthritis pains, * migraine backaches, * muscular spasms, * pains in the neck, and in the knee * duration of disease over 1 year exclusion criteria: * tacking pain relief * pregnant women

Keywords: acupuncture quality of life
a single center pilot study to assess the intra-observer reliability of measuring muscle strength using a hand held dynamometer in children and adults with neurofibromatosis type 1 (nf1) and type 2 (nf2)

Conditions: Neurofibromatosis 1 and 2 (NF1 and NF2)

Summary: patients with clinically confirmed neurofibromatosis type 1 (nf1) or neurofibromatosis type 2 (nf2) or a known neurofibromatosis (nf) mutation aged 5 years and above will be eligible to participate and will be recruited from the neurofibromatosis clinic. given the need for identifying measures that can reliably and sensitively measure focal muscle weakness and allow for measuring muscle strength as a functional outcome in therapeutic clinical trials in nf, this pilot study will assess the reliability of measuring muscle strength in nf1 and nf2 using a hand-held dynamometer.


Eligibility criteria:
inclusion criteria: * for cohort 1: * patients must have clinically confirmed nf1 using the nih consensus criteria or a known nf1 mutation * ages 5 years and above * \< 5/5 strength on manual muscle testing (mmt) testing in at least one muscle group tested on the day of enrollment * able to follow instructions and cooperate with exam to assess strength * for cohort 2 * patients must have clinically (nih or manchester criteria) or genetically confirmed diagnosis of nf2 * ages 5 years and above * \< 5/5 strength on mmt testing in at least one muscle group tested on the day of enrollment * able to follow instructions and cooperate with exam to assess strength exclusion criteria: * no orthopedic procedure or other major surgery that could influence extremity strength in past 6 months * no tibial dysplasia
user evaluation of bgm js200b

Conditions: Diabetes

Summary: performance evaluation by the user of the blood glucose monitoring system js200b in accordance with din en iso 15197:2015


Eligibility criteria:
inclusion criteria: * male or female patients with hypo-, eu- or hyperglycaemia * the written informed consent had to be signed * the volunteers must be older than 18 years * the volunteers have legal capacity and are able to understand meaning, nature and possible consequences of the procedures involved exclusion criteria: * pregnancy or lactation * acute or chronic diseases with the risk of aggravation by the measure * a current constitution that does not allow participating in the study * participation in another study or activity with the blood glucose measuring system evaluated in the present study * application of substances listed in appendix a of din en iso 15197:2015
radiofrequency ablation vs laser ablation of the incompetent greater saphenous vein

Conditions: Chronic Venous Insufficiency

Summary: the aim of this study is to perform a randomized, prospective trial comparing the two current methods of treatment for chronic venous insufficiency, in an effort to evaluate complications and outcomes for each method, and ultimately, to see if one is superior to the other.

chronic venous insufficiency (cvi) is estimated to affect 25 million americans. this condition leads to varicose veins, aching, fatigue, swelling, ulcerations, and bleeding in the lower extremities. the most common cause is a refluxing or incompetent greater saphenous vein (gsv). this condition results in pooling of deoxygenated blood in the lower extremities rather than successful transport of the blood back to the heart and lungs. the historical treatment has been to surgically remove or 'strip' the gsv so that blood is rerouted through the healthier deep veins. a less invasive treatment option, endovenous thermal ablation, has emerged over the last decade and has virtually replaced stripping. this involves advancing a catheter under ultrasound guidance through the gsv and then advancing a laser fiber or radiofrequency probe through the catheter. these devices then produce the energy to destroy the vein as the catheters are slowly pulled back. while both radiofrequency ablation and laser ablation are accepted treatments, neither technology has been definitively proved to have fewer complications or superior results. this is in part because very few practices have the ability to make a head to head comparison between the two technologies and must choose one or the other secondary to financial constraints. the aim of this study is to perform a randomized prospective trial comparing the two modalities so that more definitive information to evaluate complications and outcome can be obtained and then recommendations on which, if either, technology is superior can be made.

Eligibility criteria:
inclusion criteria: * patients with symptomatic chronic venous insufficiency. * patients in whom endovenous thermal ablation is clinically indicate. * have previously undergone at least 6 weeks of conservative treatment with compression stockings (unless they have venous ulcers, recurrent phlebitis, or bleeding varices). * have venous disease that meets ceap clinical class 2 through 6. * have symptoms secondary to greater saphenous vein insufficiency defined as reverse flow in the saphenous vein \>0.5 seconds after calf compression or while standing. exclusion criteria: * have previously undergone surgery, evta, or phlebectomy in that extremity (exclusive of spider vein injections or other cosmetic surface procedures). * have a history of dvt. * have a history of hypercoaguability disorder. * are pregnant or breastfeeding. * are nonambulatory.

Keywords: chronic venous insufficiency varicose vein greater saphenous vein
japanese treat and extend study of aflibercept in neovascular age-related macular degeneration

Conditions: Wet Macular Degeneration

Summary: to assess the efficacy of intravitreal (ivt) administration of aflibercept with two different approaches of treat and extend dosing regimens in japanese subjects with neovascular (wet) age-related macular degeneration (wamd) . to assess the safety of ivt administration of aflibercept with two different approaches of treat and extend dosing regimen in japanese subjects with wamd for up to 2 years.


Eligibility criteria:
inclusion criteria: * japanese men and women ≥ 50 years of age * active primary subfoveal choroidal neovascularization (cnv) lesions secondary to wamd, including juxta-foveal lesions that affect the fovea as evidenced by fluorescein angiography (fa) in the study eye * early treatment diabetic retinopathy study (etdrs) best-corrected visual acuity (bcva) of 73 to 25 letters (approximately 20/40 to 20/320 at snellen equivalent) in the study eye exclusion criteria: * prior treatment of the study eye with intraocular anti-vegf(vascular endothelial growth factor) agents, verteporfin photodynamic therapy (pdt), other laser, intraocular corticosteroids, surgical interventions (except cataract surgery more than 30 days prior to screening) or systemic use of anti-vegf products within 3 months prior to study entry * active or suspected infection in or surrounding of the study eye * active severe intraocular inflammation in the study eye * intraocular pressure (iop) ≥ 25 mmhg in the study eye * ocular condition in the study eye which may impact vision and confound study outcomes

Keywords: eylea, aflibercept treat and extend regimen age-related macular degeneration
a study lasmiditan (ly573144) in a single migraine attack in japanese participants with migraine

Conditions: Migraine

Summary: this study will assess the efficacy and safety of lasmiditan in the acute treatment of a migraine attack in japanese adult participants with or without aura.


Eligibility criteria:
inclusion criteria: * participants with migraine with or without aura fulfilling the international classification of headache disorders (ichd)-2. * history of disabling migraine for at least 1 year. * migraine disability assessment test (midas) score ≥11. * migraine onset before the age of 50 years. * history of 3-8 migraine attacks per month and \<15 headache days per month during the past 3 months. exclusion criteria: * known hypersensitivity to lasmiditan, or to any excipient of lasmiditan oral tablets. * history or evidence of hemorrhagic stroke, epilepsy, or any other condition placing the patient at increased risk of seizures. * history of recurrent dizziness and/or vertigo including benign paroxysmal positional vertigo, meniere's disease, vestibular migraine, and other vestibular disorders. * history of diabetes mellitus with complications (diabetic retinopathy, nephropathy, or neuropathy). * history of orthostatic hypotension with syncope.
study to evaluate 24 hour blood sugar control (24-hour mean weighted glucose) in subjects that are taking saxagliptin 5 mg added onto metformin xr 1500 xr mg compared to subjects taking metformin xr 1500 mg up-titrated to metformin xr 2000 mg

Conditions: Type 2 Diabetes

Summary: the purpose of this study was to compare effect of saxagliptin as add-on to metformin on 24-hour mean weighted glucose (mwg) to the effect of uptitrating metformin in subjects with t2dm inadequately controlled on metformin alone.


Eligibility criteria:
inclusion criteria: * type 2 diabetes * 18-78 years of age * taking stable dose of metformin immediate release (ir) or xr ≥850 mg and ≤1500 mg as monotherapy for at least 8 weeks prior to screening * glycosylated hemoglobin a1c (a1c) 7.5-11.5% at screening * fasting c-peptide: ≥1.0 ng/ml * fpg≥126 mg/dl obtained at the day -7 visit * body mass index (bmi): ≤ 40kg/m² * a1c ≥ 7.0% and ≤ 11.0% obtained at the day -7 visit for randomization exclusion criteria: * women of childbearing potential unable or unwilling to use acceptable birth control * women who are pregnant or breastfeeding * significant cardiovascular history * active liver disease * renal impairment
establishing the central and peripheral fatigue indexes and vr based anti-fatigue training paradigm for individuals with parkinson disease

Conditions: Parkinson's Disease (PD)

Summary: fatigue is one of the most common symptoms in individuals with parkinson's disease (pd). past researches indicated that more than half of the individuals with pd demonstrated fatigue symptom. the severity of fatigue was also correlated to the quality of life in individuals with pd. finding the contributions of the central and the peripheral factors to fatigue, building reliable fatigue indexes, and developing an effective training program for individuals with pd are very important. the purpose of this project is to develop non-invasive method to monitor central and peripheral fatigue, to establish virtual reality(vr) anti-fatigue ergo cycling training paradigm, and to evaluate the long term training effect in individuals with pd.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of parkinson disease * hoehn and yahr ≦3 exclusion criteria: * musculoskeletal injuries * osteoporosis * diabetes * any peripheral or central nervous system injury or disease patients

Keywords: fatigue electromyography (emg) central fatigue cycling training
identification of prognostic biomarkers for progression of invasive squamous cell carcinoma

Conditions: Carcinoma, Squamous Cell; Carcinoma, Squamous; Squamous Cell Carcinoma; Lung Neoplasms; Cancer of Lung; Cancer of the Lung; Lung Cancer; Neoplasms, Lung; Neoplasms, Pulmonary; Pulmonary Cancer; Pulmonary Neoplasms

Summary: the study will utilize both retrospective and prospective data collection from patients that already had a bronchoscopy and lung resection or will have a bronchoscopy and lung resection for squamous cell carcinoma. the investigators plan to prospectively collect 5 bronchoscopic biopsies, 10ml blood and one tumor and adjacent normal samples from 200 qualified patients who meet the study criteria.

the study will utilize both retrospective and prospective data collection from patients that have already had a bronchoscopy and lung resection or will have a bronchoscopy and lung resection for squamous cell carcinoma. the investigators plan to prospectively collect 5 bronchoscopic biopsies, 10ml blood and one tumor and adjacent normal samples from 200 qualified patients who meet the study criteria. if a patient has already had a bronchoscopy and has consented to have samples stored for research at the mayo clinic rochester we will access them for the research study if available. otherwise, if the patient has already had surgery and tissue has not been stored for research the investigators will consent patients to use their clinical specimens for the research study. the investigators will then extract dna from tissue sections and blood and use a custom targeted sequencing panel of 23 cancer driver genes with significant mutations in squamous cell carcinoma that they have developed to find the prognostic biomarkers. the dna will be used in a pcr reaction to generate amplicons for library preparation using illumina nextera xt library preparation protocol and targeted sequencing on the illumina hiseq sequencer. the reads will be aligned to the hg19 using bwa aligner and variant detection performed with agilent surecall and gatk analytic tools.

Eligibility criteria:
inclusion criteria: * known or suspected squamous cell carcinoma of the lung * able to provide consent * could have already had a bronchoscopy or surgical resection with tissue saved at the mayo clinic rochester * will be undergoing a bronchoscopy and having a surgical resection at the mayo clinic rochester exclusion criteria: * unable to provide consent * pregnant
retinal pigment epithelium safety study for patients in b4711001

Conditions: Age Related Macular Degeneration

Summary: this is a safety follow-up study. patients enrolled in b4711001 will be followed for a further 4 years with regular visits to assess safety.


Eligibility criteria:
inclusion criteria: * evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study. * previous participation in protocol b4711001 and received treatment with pf-05206388. * subjects who are willing and able to comply with scheduled visits, and study procedures. exclusion criteria: * there are no exclusion criteria
determinants of vascular calcification in chronic renal failure : impact of pyrophosphate levels after renal transplantation

Conditions: Chronic Kidney Diseases

Summary: arterial calcifications (ac) are constant lesions in patients with chronic kidney diseases (ckd). renal transplantation would reduce their progression compared to dialysis. ac pathophysiology is a complex and finely regulated process that involves many local and systemic factors, both pro- and anti-calcification. the progression of the ckd is accompanied by an increase in phosphate levels as the renal excretion capacity of inorganic phosphates (pi) decreases while their digestive absorption remains unchanged. hyperphosphatremia is a well-identified calcifying factor contributing to acs in the ckd. on the other hand, pyrophosphate (ppi) is an anti-calcifying factor from the hydrolysis of extracellular atp by ectonucleotidases. while there are many factors that may contribute to a protective effect against ac progression of renal transplantation, no study has been yet analysed the role of ppi. plasma concentration of ppi is decreased in dialysis patients compared to non-kidney failure patients. the main objective of this monocentric, prospective and interventional pilot study will be to compare the progression of ca and \[ppi\]pl between a group of renal transplant patients over the past 24 months and a group of dialysis patients over the same period of time. the secondary objectives will be to compare the progression of acs and the ratio\[ppi\]pl/\[pi\]pl between transplanted and dialysis patients. transplanted patients will be included within 24 (±3) months of transplant. dialysis patients will be included at 24 (±3) months of the ct scan performed during the pre-transplant check-up. at inclusion, all patients will benefit from a ct scan without injection and a plasma dose of ppi, pi and other factors involved in controlling calcification.


Eligibility criteria:
inclusion criteria: * kidney transplant patients for 24 (±3) months or dialysis patients who have performed pre-transplant ct for 24 (±3) months * major patients * informed patients who have signed informed consent * patients of both sexes * patients affiliated to the social security system exclusion criteria: * pregnancy in progress (checked by a previous ßhcg pregnancy test) * patients whose clinical condition would not allow inclusion in the study. * patients not affiliated with social security * patients not consenting or unable to understand the protocol and its development * progressive cancer pathology * patients under guardianship, under curatorship, protected by law
cost-effectiveness of remote ischemic conditioning as an adjunct to primary percutaneous coronary intervention

Conditions: ST-elevation Myocardial Infarction

Summary: the aim of this study is to investigate the cost-effectiveness of remote ischemic conditioning as an adjunct to primary percutaneous coronary intervention from the perspective of a danish healthcare system.


Eligibility criteria:
inclusion criteria: (1) age ≥ 18 years, (2) symptom duration of ≤ 12 hours prior to admission, and (3) st-segment elevation ≥ 0.1 mv in two or more contiguous electrocardiogram (ecg) leads exclusion criteria: (1) diagnosis not confirmed during hospital admission, (2) history of previous myocardial infarction, (3) previous cabg, and (4) chest pain \> 12 hours prior to admission

Keywords: remote ischemic conditioning cost-effectiveness analysis
trabeculectomy with ologen collagen implant vs trabeculectomy with provisc in steroid induced glaucoma

Conditions: Steroid Induced Glaucoma

Summary: the purpose of this prospective randomized study is to assess and compare the clinical efficacy and safety of primary trabeculectomy with ologen® collagen implant and cohesive viscoelastic (provisc®) - augmented trabeculectomy in patients with medically uncontrolled steroid induced glaucoma.

steroid induced glaucoma is a well known and widely described disastrous clinical condition. however the subject of selection of most effective and safe treatment modality is still being discussed. sihota r et al reported that 26.5% cases required surgical treatment to control iop. unfortunately survival rate of successful blebs in 10 years after trabeculectomy varies from 40% to 60%. anti-fibrotic agent mmc as adjunct to filtration surgery was used to prevent postoperative scarring that could compromise surgical success of trabeculectomy. additional use of mmc in trabeculectomy leads to low final iop but could be associated with such complications as cataract formation, intraocular toxicity, avascular filtering blebs, wound leakage, subsequent blebitis and endophthalmitis. tissue-engineered biodegradable and biocompatible implant ologen® collagen matrix may be used as an alternative to mmc. ologen® is ce mark and fda approved artificial porcine extracellular matrix for modulating wound healing. ologen® has been tested in animal models and has triple action: 1. prevent the collapse of the subconjunctival space; 2. guides the fibroblast to grow through the matrix pores thus preventing scar formation; 3. may act as an aqueous reservoir (avoids post-op hyperfiltration and shallow anterior chamber). the filtering blebs scoring was performed by using moorfields bleb grading system and visante anterior segment optical coherence tomography.

Eligibility criteria:
inclusion criteria: * age \> 16 years (inclusive) * patients with medically uncontrolled steroid induced glaucoma exclusion criteria: * primary open angle glaucoma, angle-closure glaucoma, post-traumatic, uveitic, neovascular, or dysgenetic glaucoma * known allergic reaction to porcine collagen * preliminary conjunctival damage (trauma, vitreo-retinal surgery, previous glaucoma or strabismus surgery, etc)

Keywords: trabeculectomy glaucoma steroids ologen viscoelastic