Kornimate/medical-research-clean huggingface dataset:
eye-tracking technology for severe communication disability

Conditions: Communication Disabilities

Summary: the aim of this project is to develop an augmentative and alternative communication intervention through the use of eye tracker system.

the term "complex communication needs" includes all patients who present severe disturbances in speech and language production and/or in comprehension, in relation to oral or written communication modalities. the main purpose of augmentative and alternative communication (aac) is to promote the best possible communication for people with complex communication needs, through the use of techniques, methods and tools aimed not at replacing pre-existing communication methods but at increasing skills of natural communication through the enhancement of present skills. the eye tracker system, thanks to allows the recording and analysis of eye movements, could be used successfully to support communication in patients with severe communication disability. the goal of this study is to develop an efficacy augmentative and alternative communication intervention using eye-tracking technology for patients with severe communication disability. the secondary objective was to examine the psychosocial impact of technology for aac on parents' perspectives and quality of life.

Eligibility criteria:
inclusion criteria: * aged between 3 and 17 years affected by neuropsychiatric pathology presenting complex communication needs * control of eye motility and visual fixation * ability to maintain position in front of the monitor * availability of at least one member of the family nucleus to participate in the therapeutic process * cognitive skills appropriate to the task such as being able to recognize images and being able to memorize procedures necessary to use the various basic functions exclusion criteria: * age not between 3 and 17 years * difficulty in controlling ocular motility and visual fixation * the unavailability of at least one member of the family nucleus to participate in the therapeutic process * impaired cognitive skills on the task such as being able to recognize pictures and being able to memorize procedures necessary to use various basic functions

Keywords: augmentative and alternative communication, eye tracker, communication disabilities
seroquel stack study in schizophrenic or schizoaffective subjects

Conditions: Schizophrenia; Schizoaffective Disorders

Summary: the purpose of the study is to assess and compare the side effect profile, safety, tolerability and efficacy of schizophrenic or schizoaffective subjects non- or partially- responsive to 800 mg/day of quetiapine treated with either 800 mg/day or more than 800 mg/day of quetiapine during 8 weeks.


Eligibility criteria:
inclusion criteria: * inclusion criteria: men and women, age 18-65 years with persistent positive or negative symptoms with a panss total score of ≥ 70 and \< 110 and a clinical global improvement (cgi)- severity of illness score of at least 4 (moderately ill) at screening. subjects may be treated as in- or out-patients. subjects must give written informed consent. exclusion criteria: * subjects with other psychiatric, medical or behavioural comorbid disorder that may interfere with study conduct or interpretation. * female of childbearing potential, unless the subject is using a reliable method of contraception * subjects with alcohol or psychoactive-substance dependence not in full remission or with significant alcohol or substance abuse in the past 3 months will be excluded. * laboratory test results outside the range of reference considered by the investigator to be clinically significant. * inability to respect the visit schedule and known intolerance to quetiapine at 800mg/day.

Keywords: schizophrenia schizoaffective disorders
study to investigate the safety and efficacy of gc3107 (bcg vaccine) in healthy adults

Conditions: Tuberculosis

Summary: healthy adults will be once administered gc3107(bcg vaccine) intradermally.

healthy adults will be once administered gc3107(bcg vaccine) intradermally. tuberculin skin test(tst) will be conducted after 84+7 days after ip injection and tst result will be read in 48\~72 hours.

Eligibility criteria:
inclusion criteria: * healthy adults aged 19-64 years old * informed consent form has been signed and dated * able to comply with the requirements of the study * female subjects who have negative results in urine hcg test at screening, or menopausal women. exclusion criteria: * subjects who have positive results(;induration diameter over 5mm) in tuberculin skin test(tst) at screening * subjects who shown abnormal results(including inactive tuberculosis) on chest x-ray at screening * subjects who received a vaccination(including live vaccine) within 28 days before enrollment * subjects who are on antituberculosis drugs * immunocompromised subjects with immunodeficiency disease or subjects receiving immunosuppressive or immunomodulating therapy * subjects with severe chronic disease who are considered by investigator to be ineligible for the study * pregant or lactating women
effect of diet and physical activity on adipokines

Conditions: Obesity, Metabolically Benign

Summary: the prevalence of metabolic syndrome (mets) in young population continues to rise. obesity is a chronic inflammatory disorder in which leptin, adiponectin and c reactive protein (crp) play an important role. this study aimed to determine whether these adipokines are significant markers in defining mets in pediatric population and to assess the effect of hypocaloric diet and physical activity on serum concentrations of adiponectine, leptin, and high sensitivity crp (hs-crp).

the idea that adipose tissue is just a form of energy storage has changed dramatically in recent years. currently, adipose tissue is considered to be a true endocrine gland that fulfills multiple roles in regulating different biological functions. communication between adipose tissue and the rest of the systems is accomplished through bioactive mediators (adipokines) adipokines control energy homeostasis and are involved in metabolic, endocrine and immunological processes.the prevalence of metabolic syndrome (mets) in young population continues to rise. obesity is a chronic inflammatory disorder in which leptin, adiponectin and c reactive protein (crp) play an important role. this study aimed to determine whether these adipokines are significant markers in defining mets in pediatric population and to assess the effect of hypocaloric diet and physical activity on serum concentrations of adiponectine, leptin, and high sensitivity crp (hs-crp). the investigators tested the hypothesis that long-term lifestyle changes and moderate weight loss would reduce the plasma concentrations of adipokines involved in inflammation, angiogenesis, and chemotaxis and would increase adiponectin concentrations. material and methods: a prospective study was conducted over a period of 1 year, between january 2016 and december 2016, on 66 cases of obesity in children diagnosed at the louis ţurcanu emergency hospital for children timisoara. the patients diagnosed with mets were put on diet and physical exercise for 3 months.

Eligibility criteria:
inclusion criteria: * obese children (bmi\> 95th percentile) exclusion criteria: * obesity caused by endocrine disease, syndromic obesity, systemic disease or acute illness.

Keywords: diet metabolic syndrome obese children
thrombophilia screening after severe iugr

Conditions: IUGR; Thrombophilia; Pregnancy Complications

Summary: this retrospective study aims to assess the input of thrombophilia screening in pregnant women with severe intra-uterine growth restricted babies.


Eligibility criteria:
inclusion criteria: * women over 18 years old * pregnant women * iugr defined by an efw \<3rd centile * iugr before 25 gw exclusion criteria: * none
ppi supplementation to fight ectopic calcification in pxe

Conditions: Pseudoxanthoma Elasticum

Summary: pseudoxanthoma elasticum (pxe) is a rare inherited metabolic disorder (omim 264800, frequency 1/25000) characterized by progressive ectopic calcification of connective tissues. pxe mainly affects the skin (inesthetic papules and plaques in the skin folds), the retina (central blindness), the vasculature (peripheral arterial occlusive disease and stroke) and the renal system (renal lithiasis) in adulthood. although rarely, early lethal forms have been reported. this chronic and highly disabling condition results from a loss of function of the gene encoding for the abcc6 membrane transporter primarily expressed in the hepatocytes and renal tubular cells. recently, it has been reported that pxe was characterized by a 50-60% decrease in the plasma level of inorganic pyrophosphate (ppi), a major physiological anti-calcifying factor. pxe is an incurable disease which therapeutic options are limited to symptomatic treatments to stem the devastating effect of the ectopic calcifications. recently, encouraging proof of concept studies with animals pxe models and healthy volunteers have shown that, contrary to what was initially reported and thought, the oral administration of ppi salts are able to increase ppi plasma levels, opening up new therapeutic perspectives in pxe. therefore, we propose to perform the first phase ii randomized controlled trial (rct) to evaluate the safety and efficacy of a daily and oral administration of ppi salts against placebo in pxe patients.


Eligibility criteria:
inclusion criteria: * patients (\>18 years and \<65 years), men and women, presenting a clinically and biologically authenticated pxe (genotype + phenotype) according to the international diagnostic criteria (26). * efficient contraceptive method in woman of childbearing age at inclusion and during the overall study * patient affiliated to a social security insurance * signed informed consent * patient without acute complication linked or not to the pathology at the time of the study non-inclusion criteria * renal insufficiency (i.e. defined by a renal clearance \<30ml / min / 1.73 m²) * patients with osteomalacia * patients with chronic diarrhea (\> 1 month) * pregnancy, lactating or fertile women who may wish to become pregnant within three years. * any other medical condition that may be considered in the opinion of the principal investigator. * use of bisphosphonate during last 5 years. * hypocalcemia (calcium \<2.20 mmol/l and ionized calcium \<1.15 mmol/l) \*. * vitamin d deficiency \<35 nmol/l \* * enrollment in another inteventional clinical trial which could interfere with the present study * patients (\>18 years) protected by law * after correcting the hypocalcemia and/or vitamin d deficiency, a participant is again suitable for participation in the trial, as long as the participant meets the inclusion criteria.
pharyngeal electrical stimulation for the treatment of post-extubation dysphagia in acute stroke

Conditions: Stroke; Dysphagia

Summary: the purpose of this study is to evaluate whether pharyngeal electrical stimulation in addition to standard care can enhance swallowing recovery in severely dysphagic stroke patients post extubation compared to sham treatment plus standard care.


Eligibility criteria:
inclusion criteria: - severe dysphagia post extubation due to acute stroke exclusion criteria: * preexisting dysphagia * comorbidities that can possibly cause dysphagia * psychiatric comorbidities * pacemaker or other implanted electronic devices

Keywords: extubation
comparative efficacy of magnesium supplement and melatonin congener in young adults with primary insomnia

Conditions: Primary Insomnia

Summary: sleep is essential for our overall health and well-being, much like food and water. it plays a vital role in numerous bodily functions. many studies have been conducted to determine the efficacy of melatonin congeners and mg supplements in patients with insomnia separately. this study aims to compare the efficacy of melatonin and magnesium supplements in young adults with primary insomnia. most insomnia studies focus on older adults or individuals with comorbidities. targeting otherwise healthy young adults brings age-specific relevance and novel insight.


Eligibility criteria:
inclusion criteria: * age 18-40 years * gender: male and females (non-pregnant \& non lactating) * diagnosed cases of primary insomnia according to following criteria: * difficulty falling asleep, staying asleep or nonrestorative sleep * this difficulty is present despite adequate opportunity \& circumstance to sleep * this impairment in sleep is associated with daytime impairment or distress * this sleep difficulty occurs at least 3 times per week and has been a problem for at least 1 month exclusion criteria: * insomnia due to a known underlying cause * any psychiatric illness * active use of sedative hypnotics

Keywords: primary insomnia magnesium supplement melatonin congener
12-week study of plecanatide for cic (the national cic3 study)

Conditions: Chronic Idiopathic Constipation

Summary: the purpose of this study is to confirm that the investigational medication, plecanatide, is safe and effective in treating chronic idiopathic constipation.

this is a national, randomized, 12-week, double-blind, placebo-controlled, study in approximately 1350 adult male and female patients with cic comparing 2 doses of plecanatide to placebo. the study will be conducted at approximately 180 clinical study sites in the united states. the primary objective of the study is to evaluate the efficacy and safety of 3.0 and 6.0 mg of plecanatide administered once daily (qd) for 12 weeks in a population of patients with cic. the study population will include only patients without other causes of constipation or other chronic conditions that could interfere with study assessments. patients may not take laxatives (with the exception of the study-provided rescue medication, bisacodyl 5mg tablets), or a number of prohibited drugs that are known to cause constipation or diarrhea, during study participation. there are 6 scheduled study visits, including the screening and follow-up visits. the planned duration of participation in this study will be 112 days and up to 155 days, with washout and all visit windows considered.

Eligibility criteria:
inclusion criteria: * male or female aged 18-80, inclusive * meets modified rome iii criteria for functional chronic idiopathic constipation for at least 3 months with symptom onset for at least 6 months * completed a colonoscopy in accordance with american gastroenterological association (aga) colon cancer screening guidelines (5 years), with no clinically significant findings * willing to maintain a stable diet during the study exclusion criteria: * loose stool (mushy) or watery (bristol score 6 or 7) stool in the absence of any laxative or prohibited medicine for \> 25% of bowel movements (bms) during the 3 months prior to screening visit or during the 14 day pre-treatment assessment * active peptic ulcer disease, diabetes or hypertension not adequately treated or not stable * history of cathartic colon, laxative, enema abuse, or ischemic colitis * fecal impaction within 3 months of screening * patient has had /has any: diseases or conditions associated with constipation (gi or cns), structural abnormality of the gi tract or gastric bypass surgery, pelvic floor dysfunction, pseudo-obstruction, active infectious gastritis, diverticulitis, anal fissures or any disease or condition that can affect gi motility or defecation or can be associated with abdominal pain * unexplained and clinically significant "alarm symptoms" including lower gi bleeding, iron-deficiency anemia, weight loss or systemic signs of infection or colitis * major surgery, stroke or myocardial infarction (mi) within 60 days of screening * participated in a previous plecanatide clinical trial

Keywords: cic constipation chronic constipation synergy plecanatide
clinical evaluation of the efficacy of a medical device in treatment of toenail onychomycosis

Conditions: Onychomycosis

Summary: this study evaluates the effect of the medical device "excilor® fungal nail infection" in the treatment of toenail onychomycosis. half of the participants will receive the tested product and the other half will receive a comparator (amorolfin 5%). patients will be followed during 6 months.


Eligibility criteria:
inclusion criteria: * subject having given her/his informed, written consent, * subject cooperative and aware of the modalities of use and the necessity and duration of the controls so that perfect adhesion to the protocol can be expected. * subject being psychologically able to understand information and to give their/his/her consent. * age: more than 18 years. * subject with superficial onychomycosis on at least one great toenail or light to moderate disto-lateral onychomycosis (without matrix involvement and involvement \<2/3 of the tablet). * subject with positive results of koh staining. * subject having stopped any systemic antifungal treatment since at least 6 months before inclusion and/or any topical antifungal treatment since at least 3 months before inclusion. * female subjects of childbearing potential should use an accepted contraceptive regimen since at least 12 weeks before the beginning of the study, during all the study and at least 1 month after the study end. exclusion criteria: * subject considered by the investigator likely to be non-compliant with the protocol. * patient enrolled in another clinical trial during the test period. * woman being pregnant, nursing or planning a pregnancy during the course of this study. * subject having a known allergy to one of the constituents of the tested products. * patient suffering from serious or progressive diseases (to investigator's discretion), such as diabetes, peripheral circulatory disease, hiv, psoriasis, lichen planus, immunosuppressive pathology.... * subject with cutaneous pathology on studied zone (other than onychomycosis like angioma, dermatitis...).
anser- the algorithm for neonatal seizure recognition study

Conditions: Neonatal Seizures

Summary: a multicentre clinical evaluation of a decision support algorithm for neonatal seizure detection: anser

this is a multi-centre study. it will be based on routine clinical practice but will also allow for the off-line retrospective application of anser to a well-defined clinical population in order to establish the potential diagnostic utility of the algorithm.

Eligibility criteria:
inclusion criteria: all term neonates at risk of seizures are eligible for the anser study. neonates ≥ 36 weeks gestation will be recruited if: they have a need for eeg monitoring. exclusion criteria: consent of parents not obtained.

Keywords: decision support algorithm neonatal seizures eeg
study to evaluate safety, tolerability, and efficacy of gs-5718 in participants with active rheumatoid arthritis who have an inadequate response to disease-modifying antirheumatic drug(s) (bdmards) treatment

Conditions: Rheumatoid Arthritis

Summary: the primary objective of the study is to evaluate the effect of gs-5718 versus placebo for the treatment of rheumatoid arthritis (ra) as measured by change from baseline in disease activity score (das) based on 28 joints using c-reactive protein (crp) (das28\[crp\]) at week 12.


Eligibility criteria:
key inclusion criteria: * diagnosis of rheumatoid arthritis (ra) ≥ 3 months prior to screening fulfilling the 2010 american college of rheumatology (acr)/european league against rheumatism (eular) classification criteria for ra * rheumatoid factor (rf) and/or anti-citrullinated protein antibodies (acpa) positivity * individual fulfills all of the following minimum disease activity criteria: * ≥ 6 swollen joints (from a swollen joint count based on 66 joints \[sjc66\]) provided this would also fulfill ≥ 4 swollen joints (from a swollen joint count based on 28 joints \[sjc28\]) at screening and day 1, and * ≥ 6 tender joints (from a tender joint count based on 68 joints \[tjc68\]), provided this would also fulfill ≥ 4 tender joints (from a tender joint count based on 28 joints \[tjc28\]) at screening and day 1, and * hscrp \> upper limit of normal at screening * received at least one bdmard for the treatment of ra to which there is a lack of efficacy and/or intolerance. key exclusion criteria: * individuals who do not qualify per the tofacitinib label and/or local guidelines should not be enrolled. * prior exposure to any janus kinase inhibitor note: other protocol defined inclusion/exclusion criteria may apply.
multi-parametric imaging of the knee in obese patients with knee osteoarthritis; weight loss

Conditions: Osteoarthritis; Obesity

Summary: this is a substudy to a randomised trial investigating the effect of liraglutide on body weight and pain in overweight or obese patients with knee osteoarthritis (nct02905864). in the parent trial, patients will be subjected to an 8-week diet intervention phase including a low-calorie diet and dietetic counseling, after which. patients will be randomised to receive either liraglutide 3 mg or liraglutide 3 mg placebo as an add-on to dietetic guidance on re-introducing regular foods and a focus on continued motivation to engage in a healthy lifestyle. this substudy aims to investigate any changes in mri associated with the initial 8-week weight loss intervention, and the value of ct scans in predicting the effect of weight loss.


Eligibility criteria:
inclusion criteria: * same as parent trial (nct02905864) further exclusion criteria * same as parent trial (nct02905864) * usual exclusion criteria for mri (i.e. pacemakers etc.)

Keywords: liraglutide liraglutide 3 mg osteoarthritis obesity magnetic resonance imaging computed tomography dynamic contrast enhanced mri
efavirenz to nevirapine switch and low-density lipoprotein (ldl)-dyslipidemia

Conditions: HIV Infections; Hypercholesterolemia; Antiretroviral Therapy

Summary: dyslipidemia and coronary heart disease (chd) are increasingly recognized in persons with human immunodeficiency virus (hiv) infection. many antiretrovirals, including efavirenz (efv), are associated with increases in serum lipids. the investigators investigated whether stopping efv and replace efv by nevirapine can reduce significantly low-density lipoprotein cholesterol, while keeping virologic control of hiv.


Eligibility criteria:
inclusion criteria: * hiv-1 infected adults, who were receiving antiretroviral therapy including efavirenz for at least 6 months * plasma hiv rna\<400 cp/ml during the previous 4 months on 2 occasions 14 days apart * severe dyslipidemia with low-density lipoprotein cholesterol (ldl-c) \>3.4 mmol/l in the presence of at least one of the 3 following coronary heart disease (chd) risk factors: age\>45 among males or age\>55 among females, hypertension, current smoking, family history of chd * low-density lipoprotein cholesterol (ldl-c)\>4.1 mmol/l regardless of chd risk factors. exclusion criteria: * protease inhibitors use within the previous 6 months, * prior exposure to nevirapine * asparate aminotransferase (ast) or alanine aminotransferase (alt) \>2.5n if hepatitis virus b or c were negative * ast or alt\>1.25n if hepatitis virus b or c were positive * fasting glycemia\>1.26g/l, * current chd * triglycerides\>4.6 mmol/l * introduction of lipid lowering drugs, corticoïds, retinoïds and betablockers within the previous 3 months.

Keywords: efavirenz nevirapine dyslipidemia hiv