Kornimate/medical-research-clean huggingface dataset:
health, perception, practices, relations and social inequalities in the general population during the covid-19 crisis

Conditions: SARS-CoV 2

Summary: this study aims to quantify and follow the cumulative incidence of sars-cov-2 infection in the french population using serological tests and to assess the determinants of infection from constances, e3n-e4n, elfe-epipage 2 and nutrinet-santé cohorts.

the primary objective is to assess the cumulative incidence of infection in the general population using dried blood spot sampling. the secondary objectives are: * to identify factors associated with a positive sars-cov-2 infection (positive serology) and to characterize the durability of the serological response to sars-cov-2 * to identify associations of symptoms predictive of a sars-cov-2 infection * to estimate the health care use associated with a sars-cov-2 infection * to estimate the fraction of sub-clinical infections or infections not captured by the healthcare system; * to study the acceptability of a mass anti-sars-cov-2 serological testing and the impact of its result, linked with social inequalities in health; * to estimate the individual and collective impact of containment and other preventive measures on the risk of sars-cov-2 infection; * to study the impact of social and territorial inequalities on seroprevalence levels.

Eligibility criteria:
inclusion criteria: * non applicable, already enrolled in the cohorts exclusion criteria: * non applicable

Keywords: sars-cov2 cohort containment serology prevention
characterizing outcomes and real-world experience of cardiac physiologic pacing (the core-cpp study)

Conditions: Heart Failure

Summary: the purpose of this study is to use real-world evidence to validate that conduction system pacing (csp), delivered via a medtronic 3830 catheter-delivered lead and a medtronic dual-chamber transvenous pacemaker, is a safe and effective alternative to biventricular pacing (bvp) in patients indicated for cardiac resynchronization therapy (crt) to deliver cardiac physiologic pacing (cpp), as documented in the clinical literature.


Eligibility criteria:
inclusion criteria: dual-chamber csp cohort: * medicare beneficiaries implanted with a medtronic dual-chamber transvenous pacemaker on or after the study start date. * lead type and placement data indicating csp. * an indication for crt. bvp comparator cohort: * medicare beneficiaries implanted with a medtronic biventricular pacemaker (crt-p) on or after the study start date. exclusion criteria: dual-chamber csp cohort: * evidence of a prior cied device. * less than 12 months continuous enrollment in medicare part a and part b prior to implant date. * non-medtronic pacemaker (unable to link to medtronic device registration data). * missing lead type or placement data. * lead type and placement data indicating non-csp placement. bvp comparator cohort: * evidence of a prior cied device. * less than 12 months continuous enrollment in medicare part a and part b prior to implant date. * non-medtronic pacemaker (unable to link to medtronic device registration data). * missing lead type or placement data.
novel helmet design in patients with seizures

Conditions: Drug Resistant Epilepsy; Drop Seizures; Generalized Tonic Clonic Seizure; Complex Partial Seizure; Fall Due to Seizure

Summary: this is a two-part study that aims to determine the reliability and safety of the use of the hövding inflatable helmet in seizures, as evidenced by the deployment of the helmet during seizures, and qualitative patient reporting.

part 1: 4 healthy volunteers will fall from a standing position onto a padded surface to evaluate for consistent helmet deployment from a standing position. part 2: up to 20 patients with drug resistant epilepsy who do not use existing head-protective devices will be enrolled and assigned to first enter "helmet" or "no helmet" groups. when assigned to the "helmet" group, patients will wear the helmet until deployment during a seizure or up to 3 months. subjects will complete questionnaires about their seizures including any injuries sustained, post concussive symptom questionnaire, and the circumstances of inflation. patients will return to site after helmet deployment. while assigned to the "no helmet" group, patients will complete the same questionnaires, except those relating to helmet inflation. we will compare circumstances, injuries, and post concussive scales in seizures resulting in falls occurring while the helmet was worn versus seizures resulting in falls occurring while the helmet was not being worn.

Eligibility criteria:
inclusion criteria: part 1: 1. age 18-60 at the time of enrollment. 2. have neck circumference between 34 and 42 cm. 3. can understand and provide written informed consent. 4. must be competent to follow all study procedures. 5. able to read, speak, and understand english. part 2: 1. have at least one seizure every 6 months that might result in a fall (generalized tonic clonic seizure, atonic seizure, and/or complex partial seizure resulting in a fall). 2. has a seizure frequency of at least once per 2 months. 3. be between ages 18-65 at the time of enrollment. 4. have neck circumference between 34 and 42 cm 5. must live in a home with electrical power supply. 6. if female and of childbearing potential, has negative pregnancy test at the beginning of the study and willing to use appropriate birth control for the duration of the study. 7. can understand and sign written informed consent. 8. must be competent to follow all study procedures. 9. able to read, speak, and understand english. exclusion criteria: part 1: 1. subject is currently pregnant part 2: 1. patient already wears a helmet for seizure safety. 2. subject is pregnant, planning to become pregnant during the study, or is unwilling to use an appropriate form of birth control during the study.

Keywords: head injury from seizures seizures resulting in fall helmet for seizures novel helmet design inflatable helmet hovding inc helmet device
surface emg biofeedback for children with cerebral palsy

Conditions: Cerebral Palsy; Dystonia; Hypertonia; Spasticity; Movement Disorders

Summary: movement disorders such as dystonia, hypertonia, and spasticity interfere with or prevent voluntary movement. studies have suggested that using biofeedback to increase awareness of muscle activation can improve motor function in patients with motor deficits. the investigators hypothesize that the daily use of a surface electromyographic (semg) biofeedback device for one month will improve motor function in children and young adults with dystonia, hypertonia, and/or spasticity. the semg biofeedback device is worn over the muscle(s) the subject has difficulty in controlling and provides vibratory feedback about muscle activation. groups of children and young adults (ages 3-21), with dystonia, hypertonia, and/or spasticity will be asked to wear a small (approx 1 square inch) sensory feedback device on their affected muscle(s) for 5 hours a day for one month. the device will vibrate and emit a blue light when the muscle is activated. at the start of the experiment, subjects will be tested on the goal attainment scale (gas), the pediatric/adolescent outcomes data collections instruments (podci), and the barry albright dystonia scale (bad). for one month, subjects will practice goals without device. after a month, subject will be assessed again and be given device to practice goals for a month. after one month, the subjects will be tested on the outcome measures again and return device.


Eligibility criteria:
inclusion criteria: * cerebral palsy, or associated movement disorders such as dystonia, spasticity, and/or hypertonia * able to wear device for given amount of time exclusion criteria: * unable to wear device for at least 5 hours day for a month.
sepsis post market observational study and potential reduction of time to antibiotics - washington university

Conditions: Sepsis; Adult Disease; Severe Sepsis; Emergency Department

Summary: the purpose of this study is to demonstrate that addition of the monocyte width distribution (mdw) parameter to current standard of care improves a clinician's ability to recognize sepsis in the emergency department, resulting in earlier decision to administer antibiotics from time of ed presentation for sepsis patients (simulated primary endpoint), with concomitant reductions in length of stay and in-hospital mortality for those patients (secondary endpoints).

the objective of this study is to develop a method for identifying sepsis patients from electronic health records (ehr) based on sepsis-2 criteria. sepsis patients will be identified using a sepsis definition which includes meeting sirs score of ≥2 within 12 hours of ed presentation and any microbial testing ordered within 24 hours of ed presentation. the patient will be enrolled if it meets the sepsis definition and additional emr data elements will be extracted to complete case report form. furthermore, objectives include to confirm the clinical validity and performance of mdw in a control population of sepsis patients where mdw is measured but not reported to physicians. this study is an observational study which will simulate the decision impact of mdw on sepsis identification and patient management

Eligibility criteria:
inclusion criteria: * all race and ethnicities * presenting to the emergency department with suspicion of infection * whose assessment includes a cbc with differential * meets emr sepsis definition exclusion criteria: * pregnancy * prisoners * transfers from other ed * previously enrolled
value of an integral color scale on urine collection bags versus use of a strip in description of hematuria.

Conditions: Hematuria

Summary: the investigators hypothesize that incorporation of a colorimetric scale on urine collection bags to estimate degree of hematuria would allow better characterization of urine by healthcare staff thus leading to improved patient care.


Eligibility criteria:
inclusion criteria: * the participant is at least 18 year old * nurses recruited voluntarily in the chu nimes outside of the urology department of any duration of experience * urologist working in the languedoc-roussillon region exclusion criteria: * the participant has color-blindness * nurse or urologist from the urology department of nimes
exploring the effect of baduanjin on the metabolic parameters and body mass index of people with schizophrenia

Conditions: Randomized Controlled Trial

Summary: baduanjin seems to be effective for improving body mass index and fasting sugar in male individuals with schizophrenia. aim this study was to explore the effect of baduanjin on the five metabolic parameters and body mass index in participants with chronic schizophrenia. methods we recruited 92 participants from 3 chronic wards and nursing homes in eastern and northern taiwan. participants were assigned by blocked randomization into experimental group and control group. those in the experimental group received 60 minutes, three times a week for 12 weeks of baduanjin program training, while those in the control group received physical activity for thirty minutes. we collected the blood pressure, fasting blood sugar, triglyceride, high density cholesterol, waist circumference, and body mass index three times: before the intervention, end of the intervention immediately and 3-month follow up. chi-squared and independent samples t test were used to compare the groups differences in the demographic characteristics and outcome indicators at the baseline for male and female separately. demographic variables were controlled. generalized estimating equations (gee) were used to examine the effects of groups, time, group and time interaction by sex.

this study explored the effect of baduanjin on metabolic parameters and body mass index in people with schizophrenia. we recruited 92 participants from 3 rehabilitation units in taiwan. participants were assigned by blocked randomization into an experimental group or control group. those in the experimental group received 60 minutes of baduanjin three times a week for 12-weeks, while those in the control group received physical activity for thirty minutes. we assessed five metabolic parameters and body mass index at three timepoints: baseline, posttest and 3-month follow up.

Eligibility criteria:
inclusion criteria: 1. diagnosis of schizophrenia 2. between 20-65 years of age 3. bmi ≥ 24 kg/m2 or at least one metabolic parameter abnormality 4. ability to listen, speak and write chinese 5. no additional exercise beyond normal exercise. exclusion criteria: 1. patients in acute phase requiring hospitalization; 2. patients with severe and unstable

Keywords: baduanjin body mass index metabolic parameters metabolic syndrome schizophrenia
stool biobanking and impact of antimicrobials on the gut microbiota in patients with bone and joint infection

Conditions: Infection, Bacterial

Summary: bone and joint infections (bji) is a public health issue in industrialized countries. implant-associated bji, are complex hospital-acquired infections and eradication of the pathogen is challenging in such patients. a prolonged antimicrobial therapy is usually required from 6 weeks to 3 months, but some patients are eligible to several years of treatment and most of patients report gastrointestinal troubles, such as nausea and mild to severe diarrhea (but very few developed c. difficile diarrhea). moreover, the host gut microbiota is probably largely affected in abundance, richness and diversity. indeed, it is known, that few days of antibiotics are sufficient to induce significant alterations of the gut microbiota, also called dysbiosis. severe dysbiosis, which is potentially irreversible and associated with a definitive shift in the gut microbiota metabolism and host homeostasis, may lead to and/or promote a large panel of severe diseases such as clostridium difficile infection, diabetes mellitus, obesity, inflammatory bowel disease (ibd), cirrhosis, neurological disorders and cancer. it may also be associated with bji recurrence and then impact global health costs. the main objective of this study is to constitute biobanking of stools and perform dna sequencing of the gut microbiota in patients with acute or sub-acute implant-related bone and joint infection (bji), caused by staphylococcus aureus.


Eligibility criteria:
inclusion criteria: 1. the subject is willing, able to understand and comply to the protocol requirement 2. more than 18-years-old 3. subject with suspicion of implant-related bji within 3 months after surgery and treated by antibiotherapy for a maximal duration of six months 4. subject signed inform consent form 5. contraception for women of childbearing age exclusion criteria: 1. pregnancy 2. severe disease with a life expectancy \< 3months 3. any antibiotherapy treated all diseases in the 14 days before inclusion 4. guardianship, curatorship patients 5. patient non-affiliated to health care system 6. patient under the power of law

Keywords: bone and joint infections (bji) gut dysbiosis antimicrobial resistance antibiotic resistance gene mobile genetic elements
treatment of exercise-induced pulmonary vascular dysfunction after pulmonary thromboendarterectomy or balloon pulmonary angioplasty

Conditions: Chronic Thromboembolic Disease (CTED); Exercise Intolerance Post PEA Surgery

Summary: this is an open label study of riociguat in patients with continued exercise intolerance at least 6 months following pulmonary endarterectomy (pea).


Eligibility criteria:
inclusion criteria: * adult patients who underwent pte or bpa for chronic thromboembolic pulmonary hypertension (cteph) at least six months prior to screening and report ongoing subjective exercise limitation, * able to give consent * able to perform a exercise protocol exclusion criteria: * patients with known residual pulmonary hypertension (rph) by rhc following pte for cteph * ongoing pah-specific vasodilator therapy * known contraindication to riociguat * a physical limitation to completing an exercise protocol

Keywords: chronic thromboembolic disease cted treatment post pea surgery
assessment of v0018 2.5 mg effect on craving

Conditions: Healthy Highly Dependant Smokers

Summary: the purpose of this study is to evaluate the reduction of craving and its time course after administration of v0018 2.5 mg compared to placebo in healthy highly dependant smokers.


Eligibility criteria:
inclusion criteria: * male and female aged 18 to 64 years * smoking ≥ 20 cigarettes/day continuously for the last two years * with a first cigarette smoked within 30 min after waking * not currently in the process of quitting smoking exclusion criteria: related to pathologies * current or recurrent buccal lesions which, in the opinion of the investigator, would interfere with the assessment of the different parameters * hyposalivation or asialia * intolerance to lactose, or any pathology that could cause endogenous production of carbon monoxide (co) related to treatments * use of antidepressants within the last three months * use of sedatives, hypnotics, tranquilizers or any other addictive agents within the last 3 months * routine use of tobacco other than cigarettes * regular use for more than one week of any treatment for smoking cessation (gum, patch, inhaler, lozenge, tablet, bupropion, varenicline) and other smokeless tobacco products (including e-cigarettes) within three months * history of hypersensitivity to nicotine, peanut, soya or to any of the excipients of study treatment * intolerance to fructose * history of phenylketonuria (aspartame) for women of childbearing potential: * is pregnant or in post-partum period or a nursing mother

Keywords: nicotine replacement therapy craving
behavioral self-activation and virtual reality in depression

Conditions: Depression

Summary: depression is a major handicap in daily life and is often treated by behavioral activation (ca), including the brief behavioral activation treatment for depression (batd).the ca principle is to set up activities, in keeping with the values of the individual. other tools associated with the ca deserve to be explored as virtual reality (vr), which offers scenarios and sensations similar to real life and a sense of life. in a safe and controlled environment, with the support of the therapist.the main objective is to compare the effectiveness of the program "batd with rv" versus "batd without rv" on the intensity of the depressive symptomatology and ca in everyday life. methodology: this is a randomized, blinded study. inclusion criteria are: 18 to 70 years old; unipolar depression diagnosis; showing a score of ≥ 17 on the bdi-ii. 80 subjects will be recruited over 24 months and randomized into 2 groups: 1) intervention group program batd in vr; 2) batd program intervention group without rv, lasting 45 minutes. judgment criteria: the effectiveness of the intervention will be evaluated by the bdi-ii scale and the behavioral activation for depression scale (bads). outcomes: a new management of depression (ac with rv) to improve the quality of life of the patient; proof of its effectiveness; a generalization of this care; and recognition of its effectiveness in the scientific community.


Eligibility criteria:
inclusion criteria: 1. adults aged 18 to 70, 2. having a diagnosis of unipolar depressive disorder characterized (diagnostic criteria of depression of dsm-v), 3. primary depression and not secondary to another disorder (eg social phobia, ocd, severe personality disorder, asd, tca, ect.) 4. showing a score greater than or equal to 17 points on the idb-ii, 5. followed by a psychiatrist from the university hospital of montpellier or a liberal, 6. can read, understand and speak french, 7. to be affiliated or beneficiary of a social security scheme. 8. collection of informed consent. exclusion criteria: (1) history of head trauma or recent central neurological conditions only (2) current treatment by seismotherapy or rtms or cbt. (3) exclusion from all substance-related disorders except tobacco-related disorder (dsm-v) -

Keywords: behavioral activation virtual reality depression
yoga and qigong for elderly patients with chronic low back pain

Conditions: Low Back Pain

Summary: the objective of this study is to evaluate whether yoga or qigong therapy is effective in treating low back pain in elderly patients compared to no therapy (waiting list control). the secondary aim is to compare yoga and qigong.


Eligibility criteria:
inclusion criteria: * men and women ≥ 65 years of age * chronic low back pain since 6 months at least * functional rating index (fri) ≥ 2 last 7 days * informed consent form signed exclusion criteria: * disc prolapse with acute neurological symptoms * previous spinal operations * severe organic or psychiatric disease conditions, not allowing to participate in the trial * use of opioids * drug- and alcohol-addiction * participation in another clinical trial within the last 6 months * participation in yoga or qigong training within the last 12 months * planned physical therapy within study duration

Keywords: elderly patients
administration of oxygen to cluster headache patients

Conditions: Cluster Headache Attacks

Summary: this study will investigate the possible difference in treatment effect between three different oxygen delivery systems in the acute treatment of cluster headaches.


Eligibility criteria:
inclusion criteria: * episodic cluster headache * regular occurance of attacks and cluster for 2 years * 2-8 attacks / day * cluster periods of over 14 days * duration of current cluster period max 14 days * ability to differentiate between attacks of ch and other forms of headache exclusion criteria: * changes in prophylactic treatment a week before trial * pregnancy or breastfeeding women * serious somatic or psychiatric disease * cold * chronic or primary or secondary headache \> 14 days / month other than ch * alcohol abuse

Keywords: acute treatment
evaluation of respiratory mechanics in supine and park-bench positions (spark)

Conditions: Ventilation Therapy; Complications; Ventilator-Induced Lung Injury

Summary: the primary objective of this prospective observational physiological study is to evaluate the variation in regional distribution of intrapulmonary volume in the dependent and non-dependent lung regions in patients undergoing neurosurgical intervention between supine and park-bench position.

the park-bench position is a variant of the lateral position used in neurosurgical interventions where lesions of the posterior cranial fossa and ponto-cerebellar angle need to be approached. the patient is placed in a lateral-oblique position with the arm on the side they are lying on extending out of the operating bed and supported by an external support. the head is fixed in flexion and rotation with the mayfield headrest immobilizing the head, allowing exposure of the surgical region of interest. in the lateral decubitus position, several factors contribute to changing respiratory mechanics: airway resistance increases and compliance decreases. furthermore, the gravitational gradient is altered, which is one of the main factors in the regional distribution of intrapulmonary air volume and tidal volume distribution: the phenomenon of overdistension of the non-dependent lung and collapse of the dependent lung could occur. fully understanding these physiological changes could optimize mechanical ventilation settings and thus avoid causing damage to lung parenchyma (ventilator-induced lung injury). the primary hypothesis of this physiological study is to evaluate changes in regional distribution of intrapulmonary volume when transitioning from the supine position to the park-bench position.

Eligibility criteria:
inclusion criteria: * age \>18 * patients scheduled for elective neurosurgery in park-bench position. exclusion criteria: * age \< 18 * bmi \> 30 kg/m2 * obstructive or restrictive lung disease with oxygen supplementation * pacemaker * pregnancy * absence of history of pulmonary embolism, thoracic surgery or chest wall abnormalities, organ transplant, lung metastases * new york heart association \>2 or hemodynamic instability (mean arterial pressure\<60mhg)