Kornimate/medical-research-clean huggingface dataset:
assessing the impact of covid-19 patients long distance transfers between intensive care units

Conditions: Covid19

Summary: the transcov cohort is a multicentre observational retrospective study aiming at assessing the health impact of extra regional transfers of critically ill covid-19 patients.

in spring 2020 four regions of france faced a surge of severe coronavirus (covid) patients which threatened to overflow local intensive care units (icu) capacities. as an emergency response, between 03/13/2020 and 04/10/2020, an estimated 661 patients were transferred from overcrowded icus to other french regions and neighbouring countries. the study aims at assessing the impact of these inter-icu transfers on the short and medium term physical and psychological outcomes in this population of severe covid 19 patients. all transferred patients between icus outside the origin region are invited to take part. for each transfer, up to four control patients will be selected among those admitted in the same icu during the same period (+/-4 days of transfer date). clinical data will be extracted from medical records and will include hemodynamic and respiratory parameters, as well as clinical severity scores before, during and after transfer. data linkage with medico-administrative data will enrich the clinical database and allow follow-up up to one year after initial admission.

Eligibility criteria:
inclusion criteria: * covid-19 patients diagnosed biologically or by imaging * admission in icu between 03/13/2020 and 04/10/2020 exclusion criteria: * none
environmental strategies & behavior change to reduce overeating in obese children

Conditions: Obesity

Summary: there is a need for effective weight control methods for obese children. environmental strategies such as reducing the size of dishware and serving utensils, storing food out of view and reducing food consumption while watching television may reduce food intake without requiring conscious, cognitive self-control. the investigators propose to test these methods when added to a current state-of-the-art behavioral program.

single blind study with outcome assessors (data collectors)and investigators masked (blinded) to intervention assignment. analysis is intention-to-treat.

Eligibility criteria:
inclusion criteria:inclusion criteria: 8-15 year old obese children (bmi \&#8805; 95th percentile on the 2000 cdc bmi reference) on the date of randomization. our standard stanford pediatric weight control program eligibility criteria will apply: both child and parent/guardian must want to join, both child and at least one parent/guardian must agree to attend sessions, and must agree to not miss more than 2 consecutive sessions. as we interested in testing generalizable strategies for weight control in diverse populations, the eligibility criteria are designed to be liberal, to maximize the generalizability of the results, but also maintain the internal validity of the test of the intervention. exclusion criteria:exclusions: to enhance internal validity, children will not be eligible if they: 1. have been diagnosed with a medical condition affecting growth (a genetic or metabolic disease/syndrome associated obesity, type 1 diabetes, type 2 diabetes taking medication, chronic gastrointestinal diseases, chronic renal diseases, uncorrected structural heart disease, heart failure, heart transplant, anorexia nervosa or bulimia nervosa or binge eating disorder \[present or past\], aids or hiv infection, pregnancy); 2. are taking medications affecting growth (systemic corticosteroids more than 2 weeks in the past year, insulin, oral hypoglycemics, thyroid hormone, growth hormone); 3. have a condition limiting their participation in the interventions (e.g., unable to participate in routine physical education classes at school, requiring oxygen supplementation for exertion, developmental or physical disability preventing participation in interventions, children or parents/guardians who cannot medically participate in mild dietary restrictions and/or increased physical activity for any reason); 4. have a condition limiting participation in the assessments (child or primary caregiver not able to read surveys in english or spanish, child two or more grade levels delayed in school for reading and writing in his/her native language); 5. are unable to read, understand or complete informed consent in english or spanish; 6. plan to move from the san francisco bay area within the next 18 months.
comorbidities resolution after mgb surgery and change in body composition

Conditions: Morbid Obesity; Type2diabetes; Sleep Apnea; Hypothyroidism; Hypertension; Lipid Disorder; Non-Alcoholic Fatty Liver Disease; Chronic Venous Hypertension With Ulcer

Summary: this observational study aims to learn about the correlation between the improving comorbidities associated with obesity after mgb (mini-gastric bypass) surgery and changes in body composition in morbidly obese patients. the main questions it aims to answer are: to study the correlation between the improving comorbidities associated with obesity after mgb(mini-gastric bypass) surgery and changes in body composition. other objectives are: * changes in the parameters of the metabolic syndrome after surgery * changes in the cardiovascular risk biomarkers after metabolic surgery * emergence in complications arising out of surgery requiring any intervention or causing a prolonged hospital stay, or requiring additional outpatient visits. type of study: an observational study in which participants with morbid obesity will undergo mini-gastric bypass surgery as per routine protocol. no separate experimental interventions will be done in the study for the participants.

evidence supports that bariatric or metabolic surgery is more effective than conventional therapy in controlling obesity and its related comorbidities. although bariatric surgery has been widely practised for many years worldwide, there is still a need to understand the correlation between improving comorbidities associated with morbid obesity and body composition change post-surgery. amongst the comorbidities, type ii diabetes, sleep apnea, hypertension, and hypothyroidism are the significant ones associated with morbid obesity. a disturbed quality of sleep results in daytime sleepiness, cardiac problems, renal problems, etc., which in turn grossly reduces the work efficiency of an individual and increases morbidity and mortality. from our experience, after a metabolic surgery (mini-gastric bypass -mgb), the investigators find comorbidities, especially sleep apnoea and type ii diabetes, getting controlled early before significant weight loss has started. also, there is an improvement in the parameters of the metabolic syndrome after metabolic surgery. the prospective cohort study aims to correlate the comorbidities resolution after mini-gastric bypass surgery for morbid obesity and change in body composition.

Eligibility criteria:
inclusion criteria: * all patients undergoing laparoscopic mgb surgery for morbid obesity and it's associated comorbidities exclusion criteria: * patients not giving consent for the study * all patients who were undergoing a redo-procedure for recurrence were excluded from the study

Keywords: morbid obesity osa mini gastric bypass metabolic surgery polysomnography metabolic syndrome dexa scan bioelectrical impedance body composition
endothelial dysfunction in chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease; Endothelial Dysfunction

Summary: objective: to investigate the potential role of endothelial dysfunction as a pathogenic mechanism of cardiovascular events in copd. hypothesis: endothelial function is abnormal in patients with copd, particularly during exacerbations of the disease. design: prospective and controlled study performed in an university hospital. population: we compare 4 groups of subjects, 44 patients with stable copd, 35 patients with acute exacerbation of copd, 10 smokers or former smokers with normal lung function and 10 never smokers matched by physical activity and bmi. study variables: a) clinical variables: clinical information, physical examination, pulmonary function tests, ecg and sputum culture; b) biological variables: number of circulating endothelial progenitor cells, vascular growth factors (vascular endothelial growht factor and erythropoietin), systemic inflammation (c-reactive protein, white blood cells), peripheral venous blood test (including hemogram, biochemical analysis with glycemia, cholesterol, ldlcol, hdlcol); and c) systemic vascular reactivity assessment.


Eligibility criteria:
inclusion criteria: * patients with moderate to very severe copd admitted in the hospital because of an exacerbation, and, * patients with moderate to very severe copd in stable condition. exclusion criteria: * patients with an exacerbation of copd who needed invasive or non invasive mechanical ventilation * patients with other chronic inflammatory diseases. * patients with other acute or active chronic systemic disease such as heart failure, renal insufficiency, etc.

Keywords: copd exacerbations epcs erythropoietin c-rp copd and endothelial dysfunction
prognosis stratification for advanced hcc receiving tace with pd-1/pd-l1 inhibitors and molecular target therapies

Conditions: Hepatocellular Carcinoma

Summary: the purpose of this study is to establish a personalized model of prognosis stratification for patients with advanced-stage hepatocellular carcinoma (hcc) receiving transarterial chemoembolization (tace) in combination with immune checkpoint inhibitors (icis) and molecular target therapies.

in patients with advanced-stage hepatocellular carcinoma (hcc), previous studies showed that transarterial chemoembolization (tace) in combination with immune checkpoint inhibitors (icis) and molecular target therapies exhibited better efficacy (pfs and os) as compared to the icis and molecular target therapies. however, there is a lack of effective tools to select those who will benefit the most from that combination therapy. the purpose of this study is to establish a personalized model of prognosis stratification for patients with advanced-stage hcc who receive tace and immune checkpoint icis plus molecular target therapies (including, vegf-tki/ bevacizumab). this real-world study may provide further information on treatment selection for clinical practice and trials.

Eligibility criteria:
inclusion criteria: 1. has a diagnosis of hcc confirmed by radiology, histology, or cytology; 2. barcelona clinic liver cancer (bclc) stage c with the presence of extrahepatic spread and/or macrovascular invasion; 3. has not received any previous systemic therapy for hcc (including chemotherapy, molecularly targeted therapy, immunotherapy); 4. both pd-1/pd-l1 inhibitors and anti-angiogenesis drugs patients received only include marketed drugs but are not limited to hcc approval; 5. tace was performed after the first pd-1/pd-l1 inhibitor/anti-angiogenic drug treatment or before treatment (within 3 months); 6. received at least 1 cycle of pd-1/pd-l1 inhibitor/anti-angiogenic drug combination therapy after tace treatment; 7. has repeated measurable intrahepatic lesions; exclusion criteria: 1. cholangiocarcinoma, fibrolamellar, sarcomatoid hepatocellular carcinoma, and mixed hepatocellular/cholangiocarcinoma subtypes(confirmed by histology, or pathology) are not eligible; 2. unable to meet criteria of combination timeframe described above; 3. child-pugh c or ps\>2 or severe hepatic encephalopathy

Keywords: hepatocellular carcinoma transarterial chemoembolization immune checkpoint inhibitors molecular target therapies advanced stage prognosis model
study to assess the efficacy and safety of garetosmab in japanese adult patients with fibrodysplasia ossificans progressiva (fop)

Conditions: Fibrodyplasia Ossificans Progressiva (FOP); Heterotopic Ossification (HO)

Summary: the primary safety objective of the study is to assess the safety and tolerability of garetosmab in japanese male and female adult patients with fop. the primary efficacy objective of the study is to assess the effect of garetosmab on heterotopic ossification (ho) in japanese adult patients with fop, as determined by the number of new heterotopic bone lesions identified by computed tomography (ct).


Eligibility criteria:
key inclusion criteria: * clinical diagnosis of fop (based on findings of congenital malformation of the great toes, episodic soft tissue swelling, and/or progressive ho) * confirmation of fop diagnosis with documentation of any type i activin a receptor (acvr1) mutation * fop disease activity, as defined in the protocol, within 1 year of screening visit * willing and able to undergo pet and ct imaging procedures and other procedures as defined in this study * able to understand and complete study-related questionnaires and diaries (assistance from caregivers is allowed) key exclusion criteria: * patient has significant concomitant illness or history of significant illness such as but not limited to cardiac, renal, rheumatologic, neurologic, psychiatric, endocrine, metabolic, or lymphatic disease, that in the opinion of the study investigator might confound the results of the study or pose additional risk to the patient by their participation in the study * previous history or diagnosis of cancer * severely impaired renal function defined as estimated glomerular filtration rate \<30 ml/min/1.73 m2 calculated by the modification of diet in renal disease equation (1 retest is allowed) * uncontrolled diabetes defined as hemoglobin a1c (hba1c) \>9% at screening (1 retest allowed) * history of severe respiratory compromise, as defined in protocol * concurrent participation in another interventional clinical study or a non-interventional study with radiographic measures or invasive procedures * pregnant or breastfeeding women note: other protocol defined inclusion/exclusion criteria apply.
effect of probiotics on nasopharyngeal microbiome of children with otitis media with effusion

Conditions: Otitis Media With Effusion; Probiotics; Adenoid Vegetations

Summary: the aim of this study is to investigate whether the microbiota in the upper respiratory tract (nasopharynx, adenoids and middle ear fluid) of otitis media with effusion (ome) patients is changed after 4 weeks of probiotic product intake. therefore, bacterial dna from swabs, fluid and tissue will be isolated via commercially available dna extraction kits, followed by illumina miseq sequencing in order to identify the bacterial species present in these samples. furthermore, the concentration of specific pathogens will be monitored via qpcr.


Eligibility criteria:
inclusion criteria: * children with otitis media with effusion * children with adenoid hypertrophy exclusion criteria: * no patients with trisomy 21
phageinlyon clinic cohort study: a descriptive study of severe infections treated with phage therapy at the hcl.

Conditions: Severe Infection

Summary: phageinlyon clinic cohort study is a single site non-interventional retrospective and prospective study, initiated by the hospices civils de lyon. population targeted are patients with a severe infection treated with bacteriophage in the hospices civils de lyon from 2015 to 2033. the primary objective is to describe the severe infections treated with phagotherapy. 250 patients will be included in the study.


Eligibility criteria:
inclusion criteria: * patient with severe infection treated with bacteriophage in the hospices civils de lyon from 01/01/2015 to 01/01/2033 * phageinlyon clinic cohort study information notice provided to the patient exclusion criteria: * opposition of trial participant

Keywords: bacteriophage severe infection
a pilot study to characterize bile acid metabolism and dysbiosis in primary sclerosing cholangitis

Conditions: Primary Sclerosing Cholangitis; Inflammatory Bowel Disease

Summary: the goal of this study is to assess if oral vancomycin can restore the normal bile acid metabolism of people with primary sclerosing cholangitis and inflammatory bowel disease. study participants will provide blood and stool samples in order to evaluate the bile acid metabolism before a short course of vancomycin and then again after to assess for change. the investigators will also assess the blood and stool of healthy people, and people with ibd (without psc) as a control group.

primary sclerosing cholangitis (psc) is a chronic inflammatory and fibrotic disease of the intra and extrahepatic ducts of unknown etiology that predominately occurs in people with inflammatory bowel disease (ibd). one hypothesis is that altered microbiome (bacteria in the gut) in people with ibd are responsible for the inflammation in the liver seen in psc. bile acids (bas) represent a unique mechanism of communication between the host and intestinal microbiome and the liver. synthesized in the liver, bile acids are metabolized by intestinal bacteria hydroxylases to secondary bas which then re-enter the portal circulation. altered metabolism of bas has been associated with gallstones and colorectal cancer and is hypothesized to play a role in the inflammatory response of certain disease such as ibd and psc. ibd has been associated with impairment of bile acid (ba) metabolism. in addition bas play a role in regulating bacterial growth of the intestine and thus have an effect on the integrity of the intestinal mucosa, which is an essential component of ibd. perturbations in this system could increase bacterial translocation into the portal system due to loss of protective mucosal factors or bacterial overgrowth. the overall goal of this study is to assess the changes in bas metabolism following administration of oral vancomycin. the investigators will also describe the relationship of the intestinal microbiome and ba metabolism in psc/ibd.

Eligibility criteria:
inclusion criteria: * documented diagnosis of psc made by typical clinical, radiographic and biochemical criteria. * diagnosis of psc \> 3 months exclusion criteria: * antibiotic use within 30 days of initial study visit * probiotic use within 30 days of initial study visit * extensive ileal disease * severe of fulminant ibd * diabetes and/or metabolic syndrome * chronic disease state deemed unacceptable for the study per investigator review * decompensated cirrhosis * females who are pregnant or breastfeeding
evaluation of electrical activity tibial muscle and postural control of individuals with hemiparesia post tdcs associated with fes

Conditions: Hemiparesis; Transcranial Direct Current Stimulation; Electromyography

Summary: introduction: it is suggested that increased cortical activity, induced by cerebral stimulation associated or not with other rehabilitation techniques, may potentiate the motor and functional therapeutic effects in individuals with neurological deficits. objectives: to evaluate the electrical activity of the anterior tibial muscle (ta) and postural control of individuals with hemiparesis due to stroke following treatment with transcranial direct current (tdcs) stimulation and functional electrical stimulation (fes), associated or isolated). (emg) and postural control by the balance evaluation systems test (bestest). both of which were collected at four different time points: pre-treatment, immediately after 10 treatment sessions, and 30 days follow-up after the interventions. patients will be randomized into 4 experimental groups: tdcs anodic active + active fes+ active contraction ta, tdcs sham + active fes+ active contraction ta, tdcs anodic active+ placebo fes+ active contraction ta, tdcs sham+ fes sham+ active contraction ta. tdcs (2ma) will be applied over the motor (cz) and cathodic vertex over the supraorbital region of the normal hemisphere and fes over hemiparetic ta by a researcher who will not be the one who will evaluate the anesthesia patient. the treatment will last 10 sessions, twice a week, with a time of 20 minutes.


Eligibility criteria:
inclusion criteria: * individuals with hemiparesis due to stroke; * both sexes; * agree to sign the free and informed consent form. exclusion criteria: * positive cut-off point for the mini mental state examination (mmse) of less than 11 points already corrected for schooling; * ankle mobility reduced by history of fracture or use of ankle fasteners; * irreducible equine deformity; * muscle strength level of at less than 1 by the scale of kendall; * patients with reported severe visual impairment; * contraindications to the use of transcranial direct current stimulation (history of seizure or recurrent epilepsy, brain tumors at the stimulation site, metallic materials implanted in the brain); * individuals with cutaneous infection at the point of application of fecc or fes; * individuals who presented anesthesia or hyperesthesia at the point of application of the ects; * individuals diagnosed with deep venous thrombosis (dvt); * individuals diagnosed with degenerative diseases or polyneuropathies. * individuals who do not present complementary tests that diagnose the lesion site.

Keywords: functional electrical simulation
effect of lung protective one-lung ventilation with fix and variable peep on oxygenation and outcome

Conditions: Hypoxemia; Pulmonary Sepsis; ARDS, Human; Pneumonia

Summary: during one-lung ventilation, the use of lower tidal volumes (vt) is helpful to avoid over-distension, provide sufficient oxygenation, but can result in increased atelectasis. nevertheless, it is not known if, during one-lung ventilation with constant low vt, moderate levels of peep combined with lung recruitment maneuvers are superior to variable peep for intraoperative oxygenation and protection against ppcs. aim of the study is to compare a strategy using constant tidal volume with recruitment maneuvers versus variable peep with recruitment maneuvers during thoracic surgery in adults. the investigators hypothesize that in adult, non-obese patients undergoing thoracic surgery under standardized olv with variable peep and recruitment maneuvers as compared to constant peep without recruitment maneuvers prevent ppcs. patients will be randomly assigned to one of two groups: fix peep volume group (groupfix): mechanical ventilation with constant (6 ml/kgibw) tidal volume and peep of 5 cmh2o with recruitment maneuvers variable peep group (groupvar): mechanical ventilation with constant (6 ml/kgibw) tidal volume with variable peep with recruitment maneuvers.

lung separation will be performed by dlt technique. mechanical ventilation will be applied in volume-controlled mode. during two-lung ventilation, vt will be set at 8 ml/kg predicted body weight. during one-lung ventilation, in groupfix vt will be decreased to 6 ml/kg pbw with 5 cmh2o peep. in groupvar vt mechanical ventilation with constant (6 ml/kgibw) tidal volume with variable peep with recruitment maneuvers.

Eligibility criteria:
inclusion criteria: * patient scheduled for open thoracic or video-assisted thoracoscopic surgery under general anesthesia requiring olv (no emergency surgery) * bmi \< 35 kg/m2 * age ≥ 18 years * expected duration of surgery \> 60 min * expected duration of anesthesia \> 90 min exclusion criteria: * copd gold 3+4, lung fibrosis, documented bullae, severe emphysema, pneumothorax * uncontrolled asthma * nyha 3+4, ccs 3+4 * previous thoracic surgery * ards (berlin definition) * documented pulmonary arterial hypertension \> 40 mmhg syst * documented or suspected neuromuscular disease (thymoma, myasthenia) * planned mechanical ventilation after surgery * bilateral procedures * lung separation with other method than dlt (eg diff. airway, trachestomy) * surgery in prone position * persistent hemodynamic instability, intractable shock * intracranial injury or tumor * enrollment in other interventional study or refusal of informed consent * pregnancy (excluded by anamnesis and/or laboratory analysis)