Kornimate/medical-research-clean huggingface dataset:
mental health of professionals of the silver economy of new aquitaine : online survey of accommodation establishments for old people and home assistance establishments

Conditions: COVID-19 Pandemic; Professional Stress

Summary: the purpose of this study is identify the psychological impact of the coronavirus-19 pandemic on professionals in residential care facilities for old people and home help professionals in new-aquitaine by : 1. large-scale screening for the prevalence of mental health disorders among staff. 2. identification of vulnerability and resilience factors. 3. improving access to early care for affected professionals.

this is a repeated cross-sectional descriptive study with two independent collection points six months apart, using socio-economic self-questionnaires and psychometric scales, which aims to measure the incidence of psychological disorders. this study included the completion of questionnaires in a non-clinical population. this is a study aimed at describing a profile of psychological condition in adults.

Eligibility criteria:
inclusion criteria: * be aged 18 and over, * have given their consent to participate in the study, * work in an accommodation establishment for the elderly or professional home help in new aquitaine. * master the french language. * accept online reviews * be a beneficiary of health insurance exclusion criteria: * bad understanding of instructions making consent or assessment impossible * refusal to participate * be under measure of legal protection: guardianship, trusteeship or safeguard of justice

Keywords: covid-19 health professionals psychological troubles health institution
interaction between host, microenvironment and immunity on gastrointestinal neoplasms

Conditions: Gastrointestinal Neoplasms

Summary: the primary objective: association study of characteristics of tumoral microenvironment and immunity of digestive cancers with patients' overall survival (os).

the study aims to explore relationship between the molecular subgroups (dna and rna analysis), tumor microenvironment, host (immunity system, premetastatic niche, microbiota, metabolism) and survival (prognostic value), response (predictive value) and tolerance (toxicities) to conventional treatments or immunotherapies in digestive cancers, in particular, in colorectal cancer and pancreaticobiliary cancer. this is a prognostic monocentric study which includes 2 parts: * one retrospective observational cohort for which 150 eligible patients (who have being diagnosed between 1998 to 2020) will be entered in the cohort per year during 22 years targeting 3300 patients and * one prospective interventional cohort in which 3000 patients (diagnosis will be done between 2020-2030) will be enrolled during 10 years. 10 years of follow-up for all patients. this cohort is non comparative, non randomized, non control. the enrollment will last 10 years in digestive surgery department, ambroise paré hospital, aphp. there is any change in management of patients' care who will participate to the study, all of the treatment modalities (i.e. surgery, chemotherapy, radiotherapy, immunotherapy, intra-arterial treatments and supportive care) are possible and choice of treatment will be made by investigator physician, after multidisciplinary meeting validation, and according to referential and recommendations of practice in department. statistic analysis the statistic analysis will be performed and reported according to the international guidelines strobe for the observational studies.

Eligibility criteria:
inclusion criteria: * carcinoma of colorectal, pancreatic, biliary tract or gastro-oesophageal, or neuroendocrine digestive tumors with cytologically or histologically proven, regardless of the stage; * diagnosis between 1998 and 2030; * be \>/= 18 years; * have obtained signed informed consent (exemption for dead patients); * affiliated to the french social security - welfare system in france (cmu included). exclusion criteria: * patient under tutoraship or curatorship; * foreign patient under ame schema, a medical help from the state in france; * pregnant or breastfeeding women (for prospective study); * any clinical, psychological or social reason which should influence patient compliance with protocol, according to investigator; * patient refusal.

Keywords: gastrointestinal cancer micro-environment immunity host microbiota
a study of suvorexant (mk-4305) for the treatment of insomnia in participants with opioid use disorder (mk-4305-098)

Conditions: Insomnia

Summary: people with opioid use disorder (oud) can have trouble falling or staying asleep. researchers want to know if suvorexant will help people with oud fall asleep and stay asleep. the goal of this study is to learn about the safety of suvorexant and how well people tolerate it. researchers also want to learn if suvorexant helps people sleep longer compared to people who take placebo. a placebo looks like the study medicine but has no actual study medicine in it.


Eligibility criteria:
inclusion criteria: the main inclusion criteria include but are not limited to the following: * has a diagnosis of oud and is currently in treatment for oud. * is on a verified, stable dose of medications for opioid use disorder (moud) treatment. * has sleep complaints that meet diagnostic and statistical manual of mental disorder, 5th edition (dsm-5) criteria for the diagnosis of insomnia. * has a regular bedtime between 8 pm (20:00) and 1 am (01:00) and is willing to maintain it for the duration of the study. exclusion criteria: the main exclusion criteria include but are not limited to the following: * has current uncontrolled major co-morbid psychiatric illness including bipolar disorder, schizophrenia, or any psychiatric condition with psychotic features. * has current diagnosis or history within 5 years of any of the following: narcolepsy, sleep paralysis, severe periodic limb movement disorder, restless leg syndrome, cataplexy, circadian rhythm sleep disorder, parasomnia including nightmare disorder, sleep terror disorder, sleepwalking disorder, rapid eye movement (rem) behavior disorder, significant degree of sleep-related breathing disorder, excessive daytime sleepiness (eds), or primary hypersomnia. * is at imminent risk of self-harm. * has a known history of stroke that may confound the diagnosis of insomnia. * has a clinically significant movement disorder such as akinesia. * has a history of hepatitis or live disease. * has habitual use of central nervous system (cns)-depressants or stimulants that may be responsible for the participant's disturbed sleep. * has a history of malignancy, ≤3 years prior to start of study, with the exception of non-melanoma skin cancer, prostate cancer or localized carcinoma in situ of the cervix. * has a history of hypersensitivity to more than 3 chemical classes of drugs, including prescription and over-the-counter medications. * has donated blood products or had phlebotomy within 8 weeks prior to start of study. * has a history of trans-meridian travel within 2 weeks prior to start of study.
mcnair study: comparative effectiveness of in-person and telehealth cardiac rehabilitation

Conditions: Myocardial Infarction; Heart Failure, Systolic; Heart Valve Diseases; Angina, Stable; Coronary Artery Disease; Heart Transplant

Summary: cardiac rehabilitation is a medically recommended program for patients with certain heart conditions. it includes exercise training, health education, and counseling. unfortunately, many patients do not participate in cardiac rehabilitation. some find it challenging to attend the in-person sessions. this study aims to compare two methods of delivering cardiac rehabilitation: in-person and through telehealth. the investigators want to know if the effects of these two programs are alike and if certain individuals benefit more from one program over the other.


Eligibility criteria:
inclusion criteria: 1. age 18 or older 2. eligible for cardiac rehabilitation 1. diagnosis within 1 year prior to consent * myocardial infarction * percutaneous coronary intervention * coronary artery bypass * heart valve repair or replacement * heart transplant 2. chronic stable angina, or 3. chronic systolic heart failure (ejection fraction ≤ 35%) 4. referred to cardiac rehabilitation by a doctor or advanced practice provider for another indication that is covered by the participant's insurance, such as heart failure with preserved ejection fraction or aortic surgery. 3. willing to be randomized to in-person or telehealth cardiac rehabilitation 4. able to communicate in english or spanish exclusion criteria: 1. unstable arrhythmias which may make unmonitored exercise unsafe (e.g., history of ventricular tachycardia not on medical therapy and without an implantable cardioverter defibrillator) 2. unsafe for patient to participate in the opinion of the investigator 3. hospice 4. unable to consent for self

Keywords: cardiac rehabilitation, telehealth
a study to evaluate efficacy of cellcept (mycophenolate mofetil) in patients with lupus nephritis

Conditions: Lupus Nephritis

Summary: this study will compare the efficacy of cellcept \[0.5-2 grams per day (g/day) orally (p.o.)\] and cyclophosphamide \[0.5-1 grams per square meter (g/m2) quarterly\] as maintenance treatment for patients with lupus nephritis. all patients will receive induction treatment with cyclophosphamide (0.5-1g/m2 monthly) for 6 months, and will then be randomized to the maintenance phase of the study for a further 6 months, followed by 6 months of treatment-free follow-up. the anticipated time on study treatment is 12 months.


Eligibility criteria:
inclusion criteria: * adult patients \>=18 years of age; * diagnosis of systemic lupus erythematosus and lupus nephritis (class iii, iv or v). exclusion criteria: * patients who have received cytotoxic drugs in previous 8 weeks; * systemic infections; * hepatitis b or c, or hiv.
respiratory functions in parkinson's disease

Conditions: Parkinson Disease

Summary: the aim is to examine respiratory functions, inspiratory muscle strength, respiratory function, physical fitness and aerobic capacity in parkinson's disease patients. individuals between the ages of 50-80 who have been diagnosed with parkinson's disease by a neurologist and healthy individuals with similar demographic characteristics will be included in the study as a control group. in addition, patients will be divided into three groups as above and below 2.5 and healthy controls according to the modified hoehn and yahr scale. demographic information of the individuals will be recorded and clinical evaluations will be made. the staging of parkinson's patients will be done with the modified hoehn and yahr scale, and the severity of the disease will be done with the unified parkinson's disease rating scale. the inspiratory muscle strength of the individuals will be evaluated with the powerbreath k5, respiratory functions with the pulmonary function test device, and physical fitness and aerobic capacity with the senior fitness test.


Eligibility criteria:
inclusion criteria: * age 50 to 80 * mini mental state examination score of 24 to 30 * diagnosed with parkinson's disease by a neurologist exclusion criteria: * sözlü iletişim kuramama * yürüme yardımcısı kullanıma * ciddi görme bozukluğu, ek nörolojik bozuklukları ve/veya konjestif kalp yetmezliği olan yaşlılar * egzersiz yapılması tavsiye edilmeyen yaşlı yetişkinler.
the thrombotic potential of heart chambers in the presence or absence of atrial fibrillation.

Conditions: Atrial Fibrillation; Thrombosis Cardiac; Left Atrial Thrombosis

Summary: the investigators aim to test the thrombotic potential of various heart chambers including left atrium, left atrial appendage, right atrium and peripheral veins. blood samples will be taken from the different chambers in 50 patients admitted for standard pulmonary vein ablation and compared to patients without atrial fibrillation admitted for left sided supra ventricular tachycardia or mitral clip. thrombin generation parameters will be assessed by the calibrated automated thrombogram.

atrial fibrillation is the most common arrhythmia, there is a strong correlation between atrial fibrillation and embolic stroke. in order to lower the risk for embolic stroke anticoagulation is recommended for patients with chads-vasc score equal or above 2. the mechanism for thrombus formation in the left atrium is thought to be caused by various factors 1. blood stasis due to the loss of atrial kick 2. endothelial dysfunction 3. blood hemostatic alteration leading to procoagulant state. previous studies demonstrated increased thrombin generation in the left atrium in patients with atrial fibrillation, when compared to other heart chambers and when compared to control group in patients with structurally normal heart. in recent years calibrated automated thrombogram (cat) is considered a good indicator for total thrombotic activity in hypercoagulable states. in the current study the investigators aim to test the thrombotic potential of various heart chambers including left atrium, left atrial appendage, right atrium and peripheral veins. blood samples will be taken from the different chambers in 50 patients admitted for standard pulmonary vein ablation without changing the course of the procedure. thrombin generation parameters will be assessed by the calibrated automated thrombogram. a control group composed of 50 patients admitted for standard left sided supra ventricular tachycardia ablation or patients admitted to mitral clip procedure without the presence of atrial fibrillation. in addition demographic data,chads-vasc score, atrial fibrillation burden, echocardiographic and cardiac ct parameters will be collected.

Eligibility criteria:
inclusion criteria: * age above 18 * pulmonary vein ablation, svt ablation or mitral clip. * informed consent exclusion criteria: * left atrial thrombus * pregnancy * active malignancy * thrombophilia * anticoagulants 24 hours before procedure * active infectious disease * chronic kidney disease (egfr\<30)

Keywords: thrombin generation calibrated automated thrombogram atrial fibrillation
restrictive eating disorders: from childhood orality disorder to adolescent dysensoriality

Conditions: Eating Disorders in Adolescence; Avoidant Restrictive Food Intake Disorder

Summary: this study offers to determine whether adolescent patients with a restrictive eating disorder have variations in their sensoriality compared to a control group.

eating disorders are a frequent reason for consultation in pediatrics at all ages. when they are small, children may have an orality disorder. there are multiple potential causes for this disorder: psychogenic, oropraxic but also sensory. the treatment is then adapted to the patient, with, among other things, an orientation towards professionals trained in sensory disorders. as they grow up, adolescents are particularly at risk of developing eating disorders, which are pathologies that correspond to a biopsychosocial model of understanding that includes psychogenetic, neuroendocrine and immune factors. despite major advances in the understanding of this disease, the sensory dimension for these patients is still little studied and is not taken into account in the treatment proposed to adolescents suffering from eating disorders.

Eligibility criteria:
inclusion criteria: * adolescent between 12 to 18 years old. * non-opposition of the adolescent and his or her legal guardians collected before the start of the study. * patient group: diagnosis of restrictive eating disorders (anorexia nervosa typical or atypical, arfid) meeting dsm-5 criteria. * control group: absence of eating disorders. exclusion criteria: * eating disorders secondary to another psychiatric pathology. * precarious health status with somatic and/or psychiatric instability that does not allow to answer the questionnaire. * language barrier. * opposition of the adolescent and/or his/her legal representatives obtained before the start of the study * patient under " ame " (medical state help)

Keywords: restrictive eating disorder anorexia nervosa avoidant/restrictive food intake disorder sensory modulation disorder sensory modulation symptoms sensory over responsivity sensory integration
neutralizing power of anti-sars-cov-2 (anti-covid-19) serum antibodies

Conditions: COVID-19; SARS CoV 2 Infection

Summary: natural infection, vaccines and treatments (like monoclonal antibodies) lead to the appearance of a neutralizing power in the serum (due to induced or injected antibodies). this neutralizing power is recognized as a correlate of protection against a (new) infection. this study aims to measure the neutralizing power of the serum of patients (whether or not they have been infected with sars-cov-2) according to the treatments and/or vaccines received and to assess the durability of this power in the time.

infection, vaccines and treatments (like monoclonal antibodies) lead to the appearance of a neutralizing power in the serum (due to induced or injected antibodies). this neutralizing power is recognized as a correlate of protection against (new) infection. the purpose of this study is to measure the neutralizing power of the serum of patients (whether or not they have been infected with sars-cov-2) depending on the treatments and/or vaccines received and to assess the durability of this power over time. the main objective is to measure and describe the evolution of the serum humoral response (titer and neutralizing capacity of anti-sars-cov-2 antibodies) following any intervention inducing or conferring neutralizing anti-sars-cov-2 antibodies (vaccines - whatever the mode of action -, monoclonal antibodies). the secondary objectives are: * to measure and describe the antibody response at the level of the nasal mucosa (titer and neutralizing capacity of anti-sars-cov-2 antibodies, collected by means of a nasal swab) following any intervention inducing or conferring neutralizing anti-sars-cov-2 antibodies sars-cov-2. * to describe the incidence of covid in the study patients.

Eligibility criteria:
inclusion criteria: * adult volunteers for the study, having received or about to receive any intervention inducing or conferring neutralizing anti-sars-cov-2 antibodies (vaccines - whatever the mode of action -, monoclonal antibodies). * having given their consent to participate in the study exclusion criteria: * minors * pregnant women * persons under tutorship or curatorship * protected adults * person under legal protection * person not affiliated to a social security scheme * persons unable to express their consent

Keywords: covid-19 vaccines monoclonal antibodies neutralization serum nasal mucosa
effect of personalized elimination diet on food sensitivity related symptoms

Conditions: Food Sensitivity

Summary: the goal is to identify food sensitivity in patients and assess whether the avoidance of the reaction-inducing foods via an 'elimination diet' leads to improvement in patient symptoms and overall well-being.

after seeking appropriate consent, patients' blood samples will be tested for the reactivity toward 262 foods using peptide and protein microarrays. food protein extraction will be carried out in different solvents such as water and alcohol. the peptide microarrays will synthesize the entire food proteins as peptides in situ while the protein microarrays will test for water-soluble and alcohol-soluble fractions. thus, food sensitivity testing will be carried out at 3 different levels including water-soluble proteins, alcohol-soluble proteins, and peptides. patients' blood samples can be tested at all 3 levels or a combination of these. this decision lies at the discretion of the physician. based on the test results and as per the physician's recommendations, a suitable elimination diet will be suggested to the patient. personalized diet suggestions for each patient will be made by the physician. the patient will follow the diet for 4 weeks and blood samples will be tested again on completion of the diet, using peptides and protein microarrays. additionally, based on the physician's recommendations, the time duration for which a patient follows the personalized elimination diet can be modified. the patients will periodically have to fill out diagnostic questionnaires which will help assess the changes in their food sensitivity-related symptoms. changes in the blood biomarkers and improvement in symptoms will be monitored during the study.

Eligibility criteria:
inclusion criteria: * patients aged between 18 to 65 years. * patients suffering from food sensitivity symptoms * patients having immunoglobulin g (igg) and immunoglobulin a (iga)-mediated food reactions leading to food sensitivity * patients agreeing to follow the diet per testing * patients willing to provide an informed consent exclusion criteria: * patients suffering from chronic medical conditions like cancer * pregnant subjects * patients who have recently used antibiotics * patients who have previously undergone treatments for food allergies/sensitivities * patients who have been assigned an elimination diet before * patients who are already following a restricted diet of any kind * patients unwilling/unable to provide informed consent

Keywords: food sensitivity elimination diet
switch to taf+ftc+bic in hiv-1-infected patients over 65 years old at risk of polymedication

Conditions: HIV Infections

Summary: patients infected and living with hiv are getting older and have more and more non-hiv co-morbidities. these expose them to polypharmacy that increases the risk of pharmacological interaction. bictegravir, co-formulated with emtricitabine (ftc) and tenofovir alafenamide (taf) (biktarvy) a new generation integrase inhibitor with a high genetic barrier and had no drug interaction may be a treatment of choice for participant over 65 years old who are hiv infected . biktarvy improve adherence and quality of life; and on the other hand it would limit the risks of pharmacological interaction. in addition, the use of taf reducing the risk of long-term renal toxicity and adverse effects on bone would be of interest in this aging population and more at risk of osteoporosis.

hiv-1-infected patients over 65 years old at risk of polymedication hiv-1-infected adults aged ≥ 65 years who are virologically-suppressed (hiv-1 rna \<50 copies/ml) on a regimen containing a pharmacokinetic enhancer as ritonavir or cobicistat evaluate the antiviral efficacy of 24 weeks treatment with the fixed dose combination(fdc) of taf/ftc/bic

Eligibility criteria:
inclusion criteria: * hiv-1-infected patient * age \> 65 years old * plasma hiv rna ≤ 50 copies/ml for ≥ 6 months: one blip between 50 et 200 cp/ml is allowed in the past 6 months before screening. * currently receiving an antiretroviral regimen containing a booster, ritonavir or cobicistat * no resistance mutation to integrase inhibitors on cumulative hiv rna genotype. the reverse transcriptase resistant mutations m184v plus one tam are allowed. * if no genotype is available, dna genotype will be performed at screening visit: no resistance mutation to integrase inhibitors, the reverse transcriptase resistant mutations m184v plus one tam are allowed. * patient enrolled in or a beneficiary of a social security program (state medical aid or ame is not a social security program) * informed consent form signed by patient and investigator exclusion criteria: * hiv-2 infection * currently receiving one of the following drugs: hypericum perforatum, rifampicin, rifabutin, carbamazepine, oxcarbazepine, phenobarbital, phenytoin, sucralfate, cyclosporine, primidone, ténofovir et adéfovir. * hemoglobin \< 10g/dl * platelets \< 100 000/mm3 * hepatic transaminases ast and alt \> 3x upper limit of normal (uln) * severe hepatic insufficiency (child pugh class c) * creatininemia clairance \< 30 ml/min (mdrd) * history or presence of allergy to the trial drugs or their components * patients participating in another clinical trial including an exclusion period that is still ongoing during the screening phase * patients under judicial protection due to temporarily and slightly diminished mental or physical faculties or under legal guardianship.