Kornimate/medical-research-clean huggingface dataset:
smart pain assesment tool based on internet of things

Conditions: Pain

Summary: this study is the second phase of a research project called "smart pain assessment tool based on internet-of-things". during the course of this project, a smart pain assessment tool (spa) to detect and assess pain employing behavioural and physiologic indicators will be developed. we aim to assess pain based on changes in electromyographic (emg) activity in facial muscles, i.e. changes in facial expressions and simultaneously use physiologic signs such as heart rate, respiratory rate and galvanic skin response as adjuvant measures to develop an algorithm for pain assessment in critically ill patients.

the aim of this "smart pain assessment tool based on internet of things" spa-research project is to develop an automatic and versatile pain assessment tool algorithm for detection and assessment of pain in a reliable and objective way in non-communicative patients. the final objective of the research project is to develop a smart pain assessment tool to detect and assess pain employing behavioural and physiologic indicators for a wide range of users/patients from infants to elderly people who are unable to communicate normally. the research project consists of three clinical phases (european commision. meddev 2.7/4/2010). the clinical phase i of the research project focused on developing pain assessment techniques involuntary working-age healthy study subjects. this current clinical phase ii includes the further development and research of the smart pain assessment tool in elective (non emergency) postoperative surgical patients during their stay after surgery in a recovery room.

Eligibility criteria:
inclusion criteria: * subject is scheduled for major surgery that requires general anesthesia and is likely to cause moderate to severe pain postoperatively which needs to be treated with systemic analgesics * ability to communicate * written informed consent * healthy facial skin exclusion criteria: * subject treated with local anesthesia during surgery * any diagnosed condition affecting cognitive functions * surgery affecting hands where pulse oximetry and galvanic skin reaction are recorded or areas where facial muscle activity is measured * any diagnosed condition affecting central nervous system, facial nerves or muscles. * significant facial hair growth in the area where the sensors will be attached * tattoos in the area where the sensors will be attached

Keywords: internet of things
indocyanine green for central nervous system tumors

Conditions: Suspected Central Nervous System Tumors

Summary: this study is a single center, open-label, two-part study to assess image guided surgery of intramolecular imaging in nervous system tumors. subjects with a diagnosis of a resectable nervous system tumor who are at risk of recurrence are included. the primary goal is to observe what tissues fluoresce in the or, and then to identify if that tissue is cancerous/tumor or normal when the histopathology is performed.


Eligibility criteria:
inclusion criteria: adult patients 18 years of age and older patients presenting with a cns tumor presumed to be resectable and are at risk for local recurrence on pre-operative assessment good operative candidate as determined by the treating physician and multidisciplinary team subject capable of giving informed consent and participating in the process of consent exclusion criteria: pregnant women as determined by urinary or serum beta hcg within 72 hours of surgery subjects with a history of iodide allergies vulnerable patient populations patients unable to participate in the consent process (children and neonates) patients with non-mri compatible implanted metallic foreign bodies patients who due to severe claustrophobia cannot tolerate mri scanning patients with a known allergy or hypersensitivity to mri contrast agents including gadolinium
obesity in sleep medicine - focusing on ohs phenotypes

Conditions: Obesity Hypoventilation Syndrome (OHS)

Summary: this study focuses on a comprehensive examination of obese patients with sleep-related breathing disorders including patients with osa, sleep hypoventilation and ohs. the aim of this study is to (1) evaluate characteristics of and differences between severity levels of obesity-related breathing disorders, (2) discuss pathophysiological variables associated with hypoventilation during sleep or at daytime and (3) find functional parameters indicating sleep hypoventilation.


Eligibility criteria:
inclusion criteria: * age ≥18 years * bmi ≥ 30 kg/m² * indication for sleep lab admission or indication for bilevel or non-invasive ventilation therapy initiation due to existing hypoventilation/ohs exclusion criteria: * age \<18 years * pregnancy, lactation * any medical, psychological or other condition impairing the patient's ability to provide informed consent. * missing informed consent * participation in another clinical study

Keywords: obstructive sleep apnea sleep hypoventilation
the effects of bevacizumab and ranibizumab on ocular pulse amplitude in neovascular age related macular degeneration (amd)

Conditions: Neovascular Age Related Macular Degeneration

Summary: one concern about repeated intravitreal injections of bevacizumab (avastin) and ranibizumab (lucentis) in wet age related macular degeneration, is that in addition to blocking the proteins that triggers the development and proliferation of abnormal vessels in the center of the retina, they may also result in changes in the normal vessels that feeds the outer part of the retina. small vessels with fenestrations (such as those that feed the outer part of the retina, which are called choriocapillaris) appear to be especially sensitive to this protein (called vascular endothelial growth factor, vegf) withdrawal. it is estimated that global blood flow in the vascular layer under the retina (called choroid) may be indirectly assessed by measuring the amplitude of the ocular pulsation (the pressure inside the eye change according to the cardiac cycle, similar to the change in blood pressure) which is called ocular pulse amplitude (opa). the pascal dynamic contour tonometer (pascal dct) is a new tonometer (a device which measures the pressure within the eye) designed to measure intraocular pressure and ocular pulse amplitude. no published study has yet assessed the effect of bevacizumab (avastin) or ranibizumab (lucentis) treatment for wet amd (or on any other retinal disease) on opa. this is our aim in this pilot study, in which we will measure the pressure within the eye just prior to bevacizumab/ranibizumab treatment, followed by repeated measurements a week and a month after the treatment. for this purpose, up to 60 patients with wet amd will be recruited.


Eligibility criteria:
inclusion criteria: 1. male or female in the ages of 50 year or older 2. willing and able to sign an inform consent exclusion criteria: 1. any history, signs or symptoms of any retinal or optic nerve disease, except amd and mild hypertensive retinopathy 2. in the presently bevacizumab/ranibizumab treated eye, prior pdt and/or intravitreal kenalog, during the last 3 months. 3. history of ocular surgery with the following exception: extra capsular cataract extraction with implantation of a posterior chamber intra-ocular lens. 4. history of ocular laser treatment, with the following exceptions: posterior capsulotomy following cataract surgery. 5. cataract or other media opacity precluding adequate fundus visualization of both eyes

Keywords: iop opa amd bevacizumab ranibizumab choroidal blood flow dct ocular pulse amplitude change following anti vegf ocular pulse amplitude
the analysis of ocular deviations between dominant and non-dominant eye using video-oculography (vog) in intermittent exotropia

Conditions: Intermittent Exotropia; Strabismus

Summary: fifteen subjects with intermittent exotropia were included. the subjects were asked to fixate on a black-on-white optotype at 1 m, which subtended a visual angle of 50 min of arc, equating to a snellen optotype of 20/200. the video files and data about ocular deviations were obtained using vog with alternate cover test. investigators analyzed angles of ocular deviations in dominant and non-dominant eyes, compared with values of vog and deviation angles of the alternative prism cover test.


Eligibility criteria:
inclusion criteria: * visual acuity \>= 1.0/1.0 * intermittent exotropia * cooperative exclusion criteria: * other eye disease * have hyperopia, myopia \> 2 diopter * have horizontal strabismus \> 50 prism diopter * not cooperative, no agree

Keywords: video-oculography intermittent exotropia ocular deviation
safety of co-administration of ida and azithromycin for ntds ( combontds )

Conditions: Trachoma; Yaws; Lymphatic Filariases; Scabies; Strongyloidiasis

Summary: this is a cluster randomised trial evaluating the safety of co-administering azithromycin alongside the new ida (ivermectin, diethylcarbamazine, albendazole) combination treatment for lf. treatment will be provided as a single dose mass drug administration (mda) to the whole community. communities will be randomised to receive either treatment with ida and azithromycin on the same day or separately. active monitoring for adverse events will be conducted and the frequency of adverse events compared between individuals receiving combined mda or separate mda.

recent studies have shown that single-dose combination therapy with three antifilarial drugs (ivermectin \[ive\] + dec + alb) called ida is superior to current regimens used in lf elimination and may help accelerate lf elimination. who guidelines have changed to recommend ida in countries endemic for lf outside sub-saharan africa like papua new guinea. additional benefits of ive are its activity against scabies and strongyloides. treatment with ive has shown to reduce the high prevalence of scabies in a village and in randomized control trials elsewhere in the pacific. of particular importance was the finding that ive was highly effective against strongyloides with a \>95% reduction in prevalence sustained for nine months. increasingly, the desirability of linking lf programs with other public health initiatives also based on mda is being appreciated. the existing programmatic infrastructure developed for lf campaign presents an attractive vehicle for a demonstration project of integration of mdas against multiple neglected tropical diseases (ntds). the macrolide antibiotic azithromycin (azi) has been demonstrated to be highly effective as mda for yaws control and azi is a highly effective and well-tolerated antibiotic treatment for trachoma that is able to clear ocular infection with a single oral dose and is well tolerated. currently lf/sth/scabies/strongyloides and yaws/trachoma are treated separately. integration of these existing mda programs has the potential to be highly cost-effective as a population health intervention. integration includes both the safe co-administration of medicines and operational planning, and it is currently advocated by who.

Eligibility criteria:
inclusion criteria: * able to give consent exclusion criteria: * unable to give consent. * less than 5 years of age (not eligible for ivermectin)\*\* * pregnant women (azithromycin only, not eligible for albendazole and ivermectin) * lactating women (only administered azithromycin and albendazole, not eligible for ivermectin)\*\* * history of allergies to the drugs being studied * residents who cannot swallow tablets note that patients that are not eligible for a specific drug will receive all other treatments and will be followed up through the same procedure as the other participants drug therapy to try to track any aes attributed to specific drug combinations

Keywords: neglected tropical diseases
transcatheter versus standard surgical mitral valve operation for secondary mitral regurgitation

Conditions: Severe Mitral Valve Regurgitation (Disorder)

Summary: the mechanical intervention is treating secondary mitral regurgitation (smr) which may be performed using the standard open surgical approach or transcatheter edge to edge repair (teer). the key question of this study is to establish the difference in left ventricular reverse remodeling after adjustment for death, as assessed by means of the left ventricular end-systolic dimension(lvesd), all-cause and cause-specific (cardiac vs noncardiac) mortality in patients who received the teer vs the standard surgical procedure for smr.

the target population enrolled in the registry includes patients with moderate to severe secondary mitral regurgitation due to cardiomyopathy of either ischemic or non-ischemic etiology who have had teer or standard surgical procedure of their mitral valves with or without cabg. individuals were adequately treated per applicable standards, including for coronary artery disease, lv dysfunction, mitral regurgitation, and heart failure. patients enrolled in the studies were nyha functional class ii, iii, or outpatient nyha iv. four groups of patients are included in the study. patients who were managed with teer, patients who received mitral valve replacement and recipients of mitral valve repair who underwent surgery with the use of restrictive annuloplasty alone or combined with subvalvular repair. four groups of patients are included in the study. patients who were managed with teer, patients who received mitral valve replacement, and those who received mitral valve repair who underwent surgery with the use of restrictive annuloplasty alone or combined with subvalvular repair

Eligibility criteria:
inclusion criteria: * adult * ischemic noischemic cardiomyopathy * eroa\> 0,2 cm2 or regurgitant volume \> 30 ml (esc guidelines). * eroa ≥ 0.4 cm2 with tethering (acc/aha) * mr grade 3/4 * eligible for tee, surgical repair and replacement of mitral valve * coronary artery disease with or without the need for coronary revascularization * average value lvedd 62 mm lvef 42% exclusion criteria: * pediatric * any echocardiographic evidence of structural (chordal or leaflet) mitral-valve disease * ruptured papillary

Keywords: smr; teer; mvrpl; mvr; rma; subvalvular repair
viscontour® serum med in hydration of facial skin

Conditions: Sodium Hyaluronate

Summary: the objective of this study is to confirm the clinical safety and efficacy of viscontour® serum med in the hydration of facial tissue.


Eligibility criteria:
inclusion criteria: 1. females ≥ 18 years of age and in good general health condition 2. signed informed consent 3. existing viscontour® serum med recommendation (i.a. for hydration, soothing, nourishing and refreshing the complexion and for use in combination with a day cream) exclusion criteria: 1. known hypersensitivity to one of the viscontour® serum med components 2. known pregnancy or lactating females 3. subjects not capable of contracting and of understanding the nature, risks, significance and implications of the clinical investigation and unable to form a rational intention in the light of these facts 4. subjects unable to understand informed consent or having a high probability of non compliance to the study procedures and / or non completion of the study according to investigator's judgement (e.g. illiteracy, insufficient knowledge of local language)
revascularization in nonagenarian patients with critical lower limb ischaemia

Conditions: Critical Limb Ischemia

Summary: the rise in life expectancy implies an increased number of nonagenarian patients who need evaluation for critical lower limb ischaemia (cli). the study goal is to evaluate whether revascularization techniques in these patients fulfill a set of security and efficacy criteria generated from surgical results in a validated historical cohort.


Eligibility criteria:
inclusion criteria: * patients suffering from critical limb ischemia aged 90 year-old or above exclusion criteria: -
cognitive training for attention deficit hyperactivity disorder and developmental delays

Conditions: Attention Deficit Hyperactivity Disorders; Developmental Delays

Summary: to explore whether children with attention deficit hyperactivity disorder and developmental delays who receive cognitive training and conventional rehabilitation can improve executive function more than traditional rehabilitation alone. a magnetoencephalographic examination will be arranged to explore how brain network activation works. research method: 20 preschool children with attention deficit hyperactivity disorder and developmental delays under rehabilitation therapy will be collected. they will be randomly assigned to the experimental group (receiving rehabilitation therapy and three times per week for 15 minutes, a total of 12 weeks of interactive cognitive training) and the control group (receiving rehabilitation therapy only). therapeutic effects will be evaluated.

research method: 20 preschool children with attention deficit hyperactivity disorder and developmental delays under rehabilitation therapy will be collected. they will be randomly assigned to the experimental group (receiving rehabilitation therapy and three times per week for 15 minutes, a total of 12 weeks of interactive cognitive training) and the control group (receiving rehabilitation therapy only). therapeutic effects will be evaluated, including sensory profile, swanson, nolan and pelham version iv, conners kiddie continuous performance test, chinese childhood executive functioning inventory, and chinese version of wechsler intelligence scale for children-iv; and physical health conditions, including pediatric daily occupation scale, pediatric outcome data collection instrument (podci), child health questionnaire- parent form, pediatric quality of life inventory (pedsql)will be evaluated by an investigator who is blinded to the group's allocation at before treatment and after 12 weeks of treatment. all participants will be investigated by magnetoencephalography (meg) to identify the brain network connectivity while performing different tasks before and after 12 weeks of treatment. brain magnetic resonance imaging will be performed for brain mapping. possible results: the study will shed light on therapeutic effects and brain network connectivity by cognitive training for preschool children with attention deficit hyperactivity disorder and developmental delays.

Eligibility criteria:
inclusion criteria: * preschool children with attention deficit hyperactivity disorder and developmental delays under regular rehabilitation programs intelligence quotient 70 or greater exclusion criteria: * age less than 4 or greater than 6 metal in teeth intelligence quotient less than 70

Keywords: preschool children developmental delay cognitive training attention deficit hyperactivity disorder
different cycles of cisplatin-5-fluorouracil for the chemoradiotherapy of esophageal squamous cancer

Conditions: Stage III Esophageal Squamous Cell Carcinoma; Stage II Esophageal Squamous Cell Carcinoma

Summary: a two-arm phase iii trial was started in oct. 2014. definitive chemoradiotherapy with cisplatin plus 5-fluorouracil is the standard in western countries in esophagus cancer. but in china because of its toxic reaction, most of patients stop the halfway. the purpose of this study is to confirm the difference of 2 and 4 cycles of cisplatin plus 5-fluorouracil in the definitive chemoradiotherapy for esophagus squamous cell carcinoma. a total of 210 patients will be accrued from china within 2 years. the primary endpoint is overall survival and the secondary endpoints include progression-free survival, response rate, pathologic complete response rate and adverse events.

we plan to recruit the patients who were pathologically confirmed with esophageal squamous cell carcinoma from the oct 2014. the patients will be divided into two groups.experimental group: two cycles of cisplatin plus 5-fluorouracil concurrent radiotherapy.control group:four cycles of cisplatin plus 5-fluorouracil and concurrent radiotherapy.to evaluate the overall survival of the 2 group. also observe the patient's progression-free survival, response rate, pathologic complete response rate and adverse events.

Eligibility criteria:
inclusion criteria: * age 45-75years old * histologically proven squamous cell carcinoma of the esophagus the tumor was in t2-4n0-2m0 * the patients have not received the surgery or chemo-radiotherapy. * hb≥80g/l, absolute neutrophil count ≥1.5×109/l, plt≥90×109/l, * alt、ast≤2.5\*n,cr≤1.5\*n. * performance status score 0-2 exclusion criteria: * pregnant, lactating women * oxaliplatin or fluorouracil allergy or metabolic disorders * radiotherapy contraindications * history of organ transplantation * brain metastasis * the peripheral nervous system disorders * severe infection * oral capecitabine who have difficulty with,such as dysphagia,the activities of digestive ulcer, gastrointestinal bleeding * severe chronic diseases, such as, hepatopathy, nephropathy, respiratory disease,high blood pressure, diabetes. * other malignant tumor in recent 5 years.

Keywords: chemoradiotherapy esophageal squamous cancer cisplatin-5-fluorouracil
prone positioning and high-flow nasal cannula in covid-19 induced ards

Conditions: COVID; ARDS; Acute Respiratory Distress Syndrome; Acute Respiratory Failure; Corona Virus Infection

Summary: prone position (pp) has been proved to be effective in severe ards patients. on the other hand, high flow nasal cannula (hfnc) may prevent intubation in hypoxemic acute respiratory failure (arf) patients. our hypothesis is that the combination of pp and hfnc in patients with covid19 induced ards may decrease the need of mechanical ventilation. primary outcome: therapeutic failure within 28 days of randomization (death or intubation). secondary outcomes: to analyze pp feasibility and safety in hfnc patients and to analyze effectiveness in terms of oxygenation. methods: multicentric randomized study including patients with covid19 induced ards supported with hfnc. experimental group will received hfnc and pp whereas observation group will received standard care. optimization of non-invasive respiratory management of covid19 induced ards patients may decrease the need of invasive mechanical ventilation and subsequently icu and hospital length of stay.


Eligibility criteria:
inclusion criteria: * covid-19 pneumonia according to the diagnostic criteria in effect at the time of inclusion or very strongly suspected. * patient treated by nasal high flow. * moderate or severe ards: bilateral radiological opacities not explained entirely by effusions, atelectasis or nodules; acute hypoxemia with worsening within the 7 previous days, not entirely explained by left ventricular failure; pao2 / fio2 ratio \<300 mmhg (or spo2 / fio2 equivalent). * informed consent. * beneficiary or affiliated to a social security scheme. exclusion criteria: * indication of immediate tracheal intubation * significant acute progressive circulatory insufficiency * impaired alertness, confusion, restlessness * body mass index\> 40 kg / m2 * chest trauma or other contraindication to prone position * pneumothorax * vulnerable person: safeguard of justice * pregnant or lactating woman

Keywords: prone position high flow nasal cannula