Kornimate/medical-research-clean huggingface dataset:
study of the colonic carriage of staphylococcus aureus in a prospective cohort of patients undergoing endoscopic screening for digestive cancer in the university hospital of saint-etienne

Conditions: STAPHYLOCOCCAL INFECTIONS

Summary: epidemiological study aiming to describe the carriage (nasal, throat, groin, rectal and colonic) of s. aureus in patients without chronic digestive disease who are going to have a colonoscopy for cancer screening. the carriage will be analyzed globally and the similarity of strains isolated from each site will be analyzed using molecular tools. the aim of this study is to better estimate the digestive reservoir of s. aureus to better prevent endogenous infections due to this bacterium.


Eligibility criteria:
inclusion criteria: * patient affiliated to french social security * written consent of the patient * patient needing a colonoscopy in the university hospital of saint-etienne, france exclusion criteria: * patient who decline to participate to the study * patient in the incapacity to give consent * patient receiving treatment with anticoagulant or antiaggregant platelets * patients with a known haemostatic disorder * pregnant woman * patients with a chronic disease of the gastrointestinal tract * patients receiving long-term corticosteroid * patient receiving anti staphylococcal antibiotics

Keywords: staphylococcus aureus digestive carriage mucosal colonization
effect of a very low calorie and low calorie diet on moderate to severe obstructive sleep apnea in obese adults

Conditions: Obstructive Sleep Apnea

Summary: the purpose of this study is to test the effectiveness of two different weight loss diets on obstructive sleep apnea (osa) severity.

sleep apnea is a sleep disorder in which breathing repeatedly stops and starts during sleep. the most common type is obstructive sleep apnea (osa), which occurs when the muscles in your throat relax and block your airway during sleep. the most noticeable sign of osa is snoring. osa is a risk factor for other chronic conditions like type 2 diabetes, cardiovascular disease, and high blood pressure. although anyone can develop osa, it commonly affects people who are obese. the more someone weighs, the more likely the osa is to be severe. weight loss is typically recommended for overweight individuals to help improve osa. however, not enough research has been done for doctors to be able make specific recommendations to their patients.

Eligibility criteria:
inclusion criteria: * ahi score of ≥ 5 * body mass index (bmi) between 30 to 49.9 kg/m2 exclusion criteria: * report serious medical risk such as insulin-dependent diabetes, active cancer, recent cardiac event * currently or planning to become pregnant during the next 9 months * not weight stable (-4.6 kg) for 3 mos. prior to intake * report current participation in a weight reduction program involving diet or pa * unwilling to be randomized to 1 of 3 study groups * report symptomology of an eating disorder as determined by the eating attitudes test * unable to participate in moderate intensity physical activity
evaluation of vqm phm on pulmonary health parameters for icu

Conditions: Ventilators, Mechanical; Stroke; COPD; Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS); Pneumonia

Summary: the goal of this observational study is to compare pulmonary health parameter measurements from the vqm phm™ to existing clinical measurements. the main questions it aims to answer are: * confirm the performance of non-invasive pulmonary health parameter shunt fraction value found on the vqm phm™ when compared to available reference measurements. * confirm the performance of non-invasive pulmonary health parameter pulmonary blood flow, functional residual capacity and physiological dead space found on the vqm phm™ when compared to available reference measurements.

this is a multi-site, international, prospective, non-blinded, non-randomized, observational study. this study aims to compare measurements from the vqm phm™ to existing clinical measurements, assess safety of the device and determine effects that standard clinical events have on the vqm phm™ measurements. this study does not include changes to clinical care based on measurements from the vqm phm™. each patient will serve as their own control.

Eligibility criteria:
inclusion criteria: * male or female 18 years old or above, at the time of the inclusion * patient currently admitted in the icu, who are indicated for cardiac output monitoring using a pulmonary artery catheter and who require pressure or volume controlled mechanical ventilation using an ett * provision of signed and dated informed consent form (icf) by the patient or a trusted person exclusion criteria: * male or female under the age of 18 years old, at the time of screening * patient under guardianship * patient who requires tidal volumes of less than 250cc * pregnancy * patient whose care requires the use of an anesthetic conserving device * patient whose care requires a closed-loop ventilator * patient who is unable to tolerate a transient increase in inhaled co2 * patient who is unable to tolerate a transient inhalation of n2o or is contraindicated to n2o use

Keywords: ventilation icu cardiopulmonary health
online trial examining validity of the shared decision making process survey with video vignettes

Conditions: Colorectal Cancer; High Cholesterol

Summary: this study will recruit subjects online and randomly assigned them to one of four arms. the arms vary by clinical decision (colorectal cancer screening or treatment of high cholesterol) by video order (poor shared decision making followed by good or good shared decision making followed by poor). participants will view two videos and complete the shared decision making process survey along with a few other measures after each video. our main hypothesis is that respondents watching the good shared decision making videos will score higher on the shared decision making process survey compared to those watching the poor videos.

study staff are working with a national sampling firm to recruit subjects and obtain 400 responses. subjects were randomly assigned to one of four arms. (1) colorectal cancer screening good shared decision making video then poor video second (2) colorectal cancer screening poor shared decision making video then good video (3) treatment of high cholesterol good video then poor video and (4) treatment of high cholesterol poor shared decision making video first then good video. participants completed measures of shared decision making after each video. the sample size was determined to ensure sufficient power to detect differences between the good and the poor shared decision making videos in this repeated measure design and analyses were planned to be separate for each arm (i.e. one analysis for the colorectal cancer screening videos and a separate parallel analysis of the statins for high cholesterol video). to detect an eta2 effect size of .04 with an alpha of 0.05 with 80% power would require 190 observations per clinical condition. study staff rounded this to 200 observations per clinical condition, for a total required sample size of 400 patients. the interventions were short shared decision making videos that were developed as part of two training courses on shared decision making by investigators at massachusetts general hospital. for the analyses, study staff will examine the descriptives of the shared decision making process items for the two clinical conditions and orders. study staff will examine rates of missing data to determine acceptability, and will examine descriptive results to see whether the scores span the range of total possible scores, are normally distributed, and whether there is evidence of floor or ceiling effects. then, study staff examine discriminant validity of the measure by examining whether scores for the good videos are higher then for the poor videos. further, study staff will examine concurrent validity with the alternative shared decision making measure.

Eligibility criteria:
inclusion criteria: * speak english * no prior diagnosis of colorectal cancer * no history of heart attack * no history of stroke exclusion criteria: * none
long term vital parameter monitoring (lavimo)

Conditions: Sleep Apnea, Obstructive

Summary: the purpose of this study is to evaluate the feasibility of non-intrusive 24 hours non-invasive measurements with minimized lavimo sensor system. the lavimo-system is a photoplethysmographic device for reflective mode measurements of the optical damping upper skin layers inside of the ear canal at two different wave lengths. it consists of the in-ear sensor, the electronics and a pc. vital signs parameter like heart rate, heart rate variability, breathing and arterial blood oxygenation are monitored in patients with sleep apnoea and compared to measurements of standard polysomnography of these patients during one night in the sleep laboratory.

in 20 patients who routinely have to undergo a polysomnographic night in sleep laboratory lavimo measurements like heart rate, heart rate variability, breathing and arterial blood oxygenation are performed parallel to standard polysomnography measurements and subsequently compared to the data of the standard polysomnography. the lavimo sensor system consists of the in- ear sensor, the electronics and a pc; the individually formed sensor is embedded into an ear mould for proper fit inside the ear canal. inside two leds emit light into the adjacent skin at 760 and 905 nm wavelengths. the intensity of the backscattered light is detected by a photo detector. in the electronics, the control signals for the leds are provided, as well as the photo detector signal is further processed and a-d converted. the electronics also provide a wireless connection to the pc via bluetooth. data recording, post processing and displaying are tasks of the pc. the feasibility of non- intrusive 24 hours and non-invasive measurements like heart rate, heart rate variability, breathing and oxygen saturation is proved via this minimized sensor and electronics placed at a suitable place at the body guaranteeing high wearing comfort. this includes a wireless data communication for unrestricted mobility. subsequently the data are compared to the standard polysomnography data to extract vital signs or for example to recognize possible phases of sleep apnoea. the goal in future refering to preventive medical monitoring will be early detection of risk factors for patient's health and improvement of living conditions.

Eligibility criteria:
inclusion criteria: * patients \> 18 years who routinely have to undergo a polysomnography night * sleep apnoea patient * able to give informed consent exclusion criteria: * dementia * cochlea implant * severe lung diseases * allergy against material of the sensor * inflammation of the middle ear * inflammation of auditory canal * occlusion because of cerumen * electric implants

Keywords: polysomnography long term vital signs monitoring in-ear sensor system photoplethysmographic micro-optic device high wearing comfort
sleep to reduce incident depression effectively

Conditions: Insomnia, Primary; Major Depressive Disorder; Rumination

Summary: this project will assess the effectiveness of a stepped-care model (i.e. digital cognitive behavioral therapy for insomnia (dcbt-i) followed by face-to-face cbt-i) in improving severity of insomnia and sleep outcomes in an insomnia cohort. this project will also investigate the effectiveness of this stepped-care model in prevention of major depressive disorder, and will test rumination as a mediator of treatment response.

this project will assess the acute and long-term effectiveness of dcbt-i on research domain criteria (rdoc) sleep parameters: insomnia severity index (isi), sleep onset latency, and wake after sleep onset in an insomnia cohort including those at elevated risk for depression (e.g. low ses, minority). this will be tested by administering internet-based dcbt-i to people with insomnia and adding face-to-face cbt-i in non-remitters, as well as comparing the rdoc sleep outcomes to an attention control group post-treatment and at 1- and 2-year follow-ups. this study will also determine the acute and long-term effectiveness of face-to-face cbt-i in non-responders to dcbt-i on rdoc sleep outcomes relative to a comparison group post-treatment and at 1- and 2-year follow-ups. this study will also determine the effects of dcbt-i and cbt-i using a stepped-care model for prevention of major depressive disorder incidence and relapse across 2 years. specifically, rate of depression of both dcbt-i and cbt-i will be compared to a control group. this study will also evaluate changes in rumination as a modifiable behavior (post-treatment) that mediates the effect of insomnia treatment on depression risk.

Eligibility criteria:
inclusion criteria: * determination of insomnia (isi \> 14) * and no clinically significant depressive symptoms (quick inventory of depressive symptomatology \< 11) exclusion criteria: * age \< 18 * current use of antidepressants for depression * bipolar or seizure disorders * known sleep disorders other than insomnia (e.g. obstructive sleep apnea, narcolepsy, restless leg syndrome). * current dsm-5 major depressive disorder at baseline.

Keywords: stepped care
soliacs: solian solution in the acute setting

Conditions: Schizophrenia

Summary: during this study the efficacy and safety profile will be evaluated of the use of amisulpride in the form of a solution in schizophrenic patients with an acute episode. the main purpose of the study is to observe the anti-psychotic effect of amisulpride as a solution during the first days of an acute episode of schizophrenia.


Eligibility criteria:
inclusion criteria: * schizophrenic in-patients with an acute episode * aged between 18 and 65 years * written informed consent exclusion criteria: * pregnancy and breast-feeding * breast cancer, prolactinoma, pheochromocytoma * hypersensitivity to amisulpride or one of the other excipients * contra-indications when using amisulpride as per the smpc
clonidine versus tranexamic acid in reduction of blood loss

Conditions: Blood Loss

Summary: tranexamic acid is an antifibrinolytics agent that has been widely used in the reduction of blood loss at surgeries. oral clonidine is an alpha-2 adrenergic agonist that has been used in various surgeries including caesarean section.

summary background: primary postpartum haemorrhage is a leading cause of maternal mortality and morbidity. prevention of excessive blood loss at caesarean section is of utmost concern to the obstetrician. blood sparing modalities are useful in the reduction of the amount of blood loss at the caesarean section. tranexamic acid is an antifibrinolytics agent that has been widely used in the reduction of blood loss at surgeries. oral clonidine is an alpha-2 adrenergic agonist that has been used in various surgeries including caesarean section through its controlled hypotensive effect to reduce blood loss. objective: this study is designed to compare the effectiveness of premedication with oral clonidine versus intravenous tranexamic acid in the reduction of blood loss during elective caesarean section in abakaliki. methodology: this would be an equivalence double-blind, double-dummy randomized controlled clinical trial among parturients undergoing elective caesarean section in abakaliki.this will involve 112 pregnant women at term for elective caesarean section. they will be randomized into two arms(56 parturients in each arm). group a will receive 100mg of tablet vitamin c (placebo) and 1gram of intravenous tranexamic acid. group b will receive 0.2mg of oral clonidine 60 minutes before surgery and 10mls of sterile water (placebo) 10 minutes after skin incision. the data obtained will be analysed using a statistical package for service solutions (version 20, chicago ii, usa) and the consolidated standard of reporting trials with the intention to treat will be applied. continuous variables would be presented as mean and standard deviation (mean +sd), while categorical variables would be presented as numbers and percentages. relative risk and logistic regression will be applied where necessary. a difference with a p-value of \<0.05 will be taken to be statistically significant. results: the results will be presented in tables from where conclusions will be drawn. conclusion and recommendation: this will be drawn from the result. keyword blood loss, tranexamic acid, clonidine, caesarean section.

Eligibility criteria:
inclusion criteria: - participants for the study include consenting parturients with singleton pregnancy at 37-42 weeks gestational age,admitted for elective caesarean section. exclusion criteria: * prior history of thromboembolism or bleeding disorder * renal disease * liver disease * antepartum hemorrhage * intrauterine growth restricted fetuses * patient refusal
automated cardiac arrest detection and alerting in daily life

Conditions: Cardiac Arrest (CA); Sudden Death, Cardiac

Summary: surviving a cardiac arrest that happens outside the hospital depends on quickly recognizing the event and immediately starting cpr. survival rates have improved when cardiac arrest is witnessed, but when it isn't, help often arrives too late. wearable biosensors, like special wristbands, could detect cardiac arrest automatically and alert emergency responders, providing faster help. in the already finished detect-1 study, the investigators developed a system that uses wrist-worn sensors to identify cardiac arrest. the goal of the current study is to test how well this system works in people who have an implantable cardioverter defibrillator (icd). an icd is a device that monitors and treats dangerous heart rhythms. study participants will wear a medical wristband with sensors that monitor the heartrate and movement during their daily activities to see if the system accurately detects cardiac arrest.

survival from out-of-hospital cardiac arrest (ohca) depends on fast recognition of cardiac arrest and immediate initiation of cardiopulmonary resuscitation (cpr). while survival chances for witnessed ohca have increased, unwitnessed cases still often receive help too late. wearable biosensor technology with the functionality of automated cardiac arrest detection and activation of the emergency medical chain would offer a potential solution to provide early help. in the recently published detect-1 study, an algorithm for automated cardiac arrest detection using wrist-derived photoplethysmography (ppg) was recently developed. the current study is a prospective multicenter observational cohort study to validate the sensitivity of the developed cardiac arrest detection algorithm in patients with an implantable cardioverter defibrillator (icd) during daily life. the study population includes patients with an icd. study participants will wear a medical wristband with ppg and accelerometer sensors during daily life.

Eligibility criteria:
inclusion criteria: * patients with an implantable cardioverter defibrillator (icd) * age 18 years or older * fitting the wristband * in possession of a smartphone that is compatible with the wristband exclusion criteria: * known hemodynamically relevant bilateral subclavian artery stenosis * medical issues that interfere with wearing of the wristband (e.g. skin disorders) * insufficient skills to operate with the device/app

Keywords: automated cardiac arrest detection wearable photoplethysmography sudden cardiac death
using kompas+ in the treatment of patients with intermittent claudication

Conditions: Intermittent Claudication; Peripheral Arterial Disease

Summary: intermittent claudication is the most common symptom of peripheral arterial disease (pad). the recommended therapy is supervised exercise therapy combined with lifestyle counselling, provided by a physiotherapist. ideally, during the treatment process patients' values and preferences are incorporated with evidence-based knowledge; shared decision making (sdm). evidence shows the use of sdm in daily practice is scarce. therefore, personalized outcome forecasts which provide insight into an individual's personal prognosis (called kompas) were implemented in 2020. now, as a next step, kompas is further developed into a guideline-based clinical decision support system. the result is called kompas+, a tool which integrates the person-centered approach of kompas with the guideline recommendations for the conservative treatment of people with intermittent claudication.the primary objective of this study is to evaluate the impact of implementing kompas+ in the physiotherapeutic treatment of patients with intermittent claudication on functional walking distance and health-related quality of life. secondary, the level of sdm and person-centeredness of physiotherapists using kompas or kompas+ will be assessed. third, the implementation process will be evaluated.


Eligibility criteria:
inclusion criteria primary objective: - all therapists affiliated with chronisch zorgnet and specialized in the treatment of people with intermittent claudication are eligible to participate. besides, all patients referred to a chronisch zorgnet therapist with intermittent claudication specialty are eligible to participate. inclusion criteria secondary objective: * provides written informed consent (both therapist and patients) * therapists should have finished two kompas (control group) or kompas+ (experimental group) e-learnings * therapists should have applied kompas (control group) or kompas+ (experimental group) to at least one patient with intermittent claudication inclusion criteria third objective: - all therapists affiliated with chronisch zorgnet and specialized in the treatment of people with intermittent claudication who are included in the experimental group are eligible to participate. exclusion criteria: * not applicable due to the "real world" setting of the study.