Kornimate/medical-research-clean huggingface dataset:
volume and vasopressor therapy in patients with hemodynamic instability

Conditions: Hemodynamic Instability; Shock; Septic Shock

Summary: this prospective observational study will include critically ill patients with hemodynamic compromise. it will compare passive leg raising and a mini volume challenge (mvc) carried out on every patient sequentially. the endogenous release of stress hormones will also be assayed in order to investigate their modifying effect on the hemodynamic reaction of the participants. the effect of fluid resuscitation on renal perfusion will also be assessed and the data compared with the release of cystatin c.

fluids are administered either before starting with or during ongoing vasopressor treatment in critically ill patients with hemodynamic instability. the endogenous release of stress hormones, namely renin, vasopressin, norepinephrine and cortisol, may be variable in critically ill patients, which may have a modifying effect on the hemodynamic response. passive leg raising (plr), a validated, simple and dynamic test, is currently recommended for testing fluid responsiveness. the test might possibly be false negative under extreme dehydration or increased intra-abdominal pressure. this prospective observational study aims to compare plr and mvc with 300 ml ringer acetate solution administered as a bolus within 5 minutes in critically ill medical patients with a hemodynamic instability. mvc will be carried out in every participant following plr. blood samples will be collected immediately before plr for measurement of renin, copeptin a, cortisol and norepinephrine in those patients not yet receiving a vasopressor. these biomarkers will be compared with the magnitude of fluid responsiveness. additionally, renal resistive index will be assessed with ultrasound immediately before plr and 1 and 24 hours after fluid challenge and the data compared with initial serum cystatin c in those patients who have not yet developed acute renal failure. blood samples for measurement of angiopoietin-2, a marker of capillary leak, will be drawn immediately before plr and the data will be correlated with the amount of fluid required for initial resuscitation.

Eligibility criteria:
inclusion criteria: * mean arterial pressure \<65 mm hg and/or * blood lactate \>2 mmol/l and/or * mottling or capillary refill \>3 seconds and/or * oliguria and * critical care decision for testing fluid responsiveness exclusion criteria: * cardiopulmonary resuscitation * uncontrolled bleeding * irreversible brain damage * pregnancy and lactation * age under 18 years

Keywords: fluid resuscitation shock volume challenge passive leg raising renal perfusion fluid responsiveness
local oestrogen versus placebo as preoperative treatment in patients with severe hypospadias: effects on post-operative complications

Conditions: Hypospadias

Summary: hypospadias is a congenital abnormality of the penis that is caused by incomplete development of the anterior urethra. this pathology is one of the most common genital anomalies in paediatric urology .the incidence is reported to be 1 out of 250 live male births and is increasing regularly. the hypospadias surgeries present a high risk of post operative complications requiring re-interventions. a great part of the post operative complications is related to imperfect healing issues. if androgen stimulation seems to be deleterious, at the opposite, oestrogen could impact positively on the skin healing process. this point leads to the hypothesis that local transcutaneous oestrogen stimulation on the ventral and dorsal penile faces decreases the number of skin healing post-operative defects. the objective of the study is to assess the effect of oestrogen (applied once daily for 2 months prior to surgery) on the post-operative complications.


Eligibility criteria:
inclusion criteria: * severe hypospadias with a division of the corpus spongiosum behind the midshaft of the penis and for which repair requires a urethral substitution by onlay urethroplasty. * subjects operated between 9 and 36 months old. * subjects operated in one of the departments of paediatric urology involved in the study. * surgery performed by a surgeon with at least 5 years of practical experience in the hypospadias surgery. * written informed consent obtained from parents or legal guardians prior to the participation to the study * all hypospadias aetiology (hormonal, karyotype or genetic) exclusion criteria: * refusal to participate * subjects with glandular hypospadias * subjects aged \ 36months old at time of surgery. * subjects who had prior surgery of penis (circumcision or hypospadias surgery) * subjects treated with androgens (human chorionic gonadotrophin or delayed testosterone) within 6 months prior to surgery. * intolerance to promestriene or its excipients. * not affiliated to a healthy or social security cover. * known tumoral risk * pure or mixed gonadal dysgenesis (45, x0/46,xy)

Keywords: severe hypospadias local oestrogen promestriene onlay-tube-onlay urethroplasty post-operative complications fistula dehiscence
morphine vs sufentanil pca: same same or different?

Conditions: Analgesia; Post Operative Pain; Patient Satisfaction; Chronic Pain

Summary: patient-controlled intravenous analgesia (pca) has already proven its quality. however, with new strategies starting to emerge and the current concept of opioid sparing, it is a goal to find the optimal pca strategy capable of improve patient satisfaction and, at the same time, individualize opioid dose. in a prospected randomized study, it was compared the use of sufentanil sublingual pca system with intravenous pca morphine in terms of postoperative pain control satisfaction, total dose of opioid required, adverse effects, impact on the quality of postoperative recovery and the incidence of postoperative chronic pain.

in a prospected randomized study, it was compared the use of sufentanil sublingual pca system (15mcg per tablet, 20 minutes lockout) with intravenous pca morphine based on 1mg morphine on-demand 10 minutes lockout and a baseline perfusion of 1mg/hour. 45 patients capable of comply a pca regime submitted to total knee arthroplasty, total hip arthroplasty and abdominal hysterectomy were enrolled in the study. during the first 48 hours, it was accessed daily pain scores, pca use, need for rescue therapy, adverse effects, global satisfaction as well as postoperative quality recovery. brief pain inventory was performed before surgery and 4 months later.

Eligibility criteria:
inclusion criteria: * informed consent signed; * age superior to 18 years; * physical status according to the american society of anesthesiology (asa) 1-3; * scheduled gynecological surgery: abdominal hysterectomy * scheduled orthopedic surgery: total knee arthroplasty or total hip arthroplasty. exclusion criteria: * patient refusal to participate in the study; * age \<18 years or legal dependence; * neurological or psychiatric pathology or altered state of consciousness that does not allow for the patient controlled analgesia strategy; * documented drinking habits and/or consumption of illicit drugs; * patients tolerant to opioid therapy (use of \>15 mg oral morphine or its equivalent per day for the last 3 months); * documented obstructive sleep apnea syndrome (osas); * patients on long-term oxygen therapy; * intraoperative use of intrathecal morphine; * use of anesthetic techniques in order to provide postoperative analgesia (eg, epidural catheter; peripheral nerve block; infiltration of the surgical wound with local anesthetic).
rehabilitation in parkinson disease cyclone in life

Conditions: Parkinson Disease; Physical Disability

Summary: comparison of two rehabilitation protocols in patients with parkinson's disease and, therefore, identification of innovative rehabilitation protocols of proven and validated efficacy, through which it is possible to achieve: * improved joint function and gait pattern * reduction of the risk of falling or reduction of energy expenditure during physiological gait evaluation of the increase in maximal effort tolerance · improved cognitive performances evaluation of the impact on the quality of life of the patient and family members identification of morpho-functional markers predictive of clinical and rehabilitative out-come through neuroimaging study.

rehabilitation protocols in patients with parkinson's disease and, therefore, identification of innovative rehabilitation protocols of proven and validated efficacy, through which it is possible to achieve: improved joint function and gait pattern reduction of the risk of falling or reduction of energy expenditure during physiological gait evaluation of the increase in maximal effort tolerance · improved cognitive performances evaluation of the impact on the quality of life of the patient and family members identification of morpho-functional markers predictive of clinical and rehabilitative out-come through neuroimaging study.

Eligibility criteria:
inclusion criteria: * hoehn \& yahr between 2.0 and 3.0; * no need for a walking aid; * mini-mental state examination (mmse) score \>24; * effective dopaminergic pharmacological control; * absence of other relevant neurological comorbidities; * absence of postural deformities (and/or pisa syndrome); * absence of severe cardiological pathologies (exertional angina, severe decompensation). * ability to travel to the rehabilitation treatment site independently or with support exclusion criteria: * presence of deep brain stimulation (dbs); * presence of severe heart and/or lung disease; * presence of therapeutic regimen in the definition phase; * impaired joint and/or motor function to follow a proposed rehabilitation treatment programme * contraindications to performing mri scans * undergoing rehabilitation therapy in the 3 months preceding enrolment.
the changes of natural killer cells frequency and function during antiviral therapy

Conditions: Chronic Hepatitis B Infection

Summary: pegylated interferon α-2a(peg-ifn-α) not only inhibit viral replication, but also play an important role in immune regulation, while nucleoside analog(ue) drugs only inhibit viral replication. in hepatitis b infection, nks are the main effector cells in early antiviral innate immune response. this study was aimed at investigating the changes of nks frequency and function, and the expression of costimulatory molecules during peg-ifn-αand nucleoside analog(ue) therapy.meanwhile, investigators want to verify whether peg ifn - alpha suppressed the virus and the reduction of virus led to the recovery of nks function, or peg ifn - alpha enhanced nks function which gave rise to the decline of the virus.

pegylated interferon α-2a(peg-ifn-α)and nucleoside analog(ue) drugs can inhibit viral replication , but peg-ifn-α also play an important role in immune regulation . in hepatitis b infection, nks are the main effector cells in early antiviral innate immune response.peg-ifn-α recommended as the first-line treatment has a higher chance to achieve hbeag seroconversion and even hbsag disappearance than nucleoside analog(ue) drugs, which may be related to the functional activation of pdcs in the case of hepatitis and the function enhancement of nks during peg-ifn-α therapy. this study was aimed at investigating the changes of nks frequency and function, and the expression of costimulatory molecules during peg-ifn-αand nucleoside analog(ue) therapy.meanwhile, investigators want to explore whether the decline of hbsag and hbeag resulted in recovery of nks function, or recovery of nks function led to the decrease of hbsag and hbeag. several studies demonstrated that hbsag and hbeag could damage nks function, and the loss of hbsag and hbeag led to recovery of nks function.

Eligibility criteria:
inclusion criteria: * hbsag and hbeag positive for more than 6 months, hbv dna detectable with alt level abnormal lasted for three months and at least time190 iu/l or liver puncture biopsy demonstrated apparent inflammation, never treated before enrolled. exclusion criteria: * active consumption of alcohol and/or drugs * co-infection with human immunodeficiency virus, hepatitis c virus, or hepatitis d virus * history of autoimmune hepatitis * psychiatric disease * evidence of neoplastic diseases of the liver

Keywords: hepatitis b virus chronic hepatitis b infection pegylated interferon α-2a nucleoside analogues natural killer cells
long term follow up in pediatric supracondylar humeral fracture

Conditions: Supracondylar Humerus Fracture; Elbow Fracture

Summary: the goal of this clinical trial is to learn about long term outcomes in supracondylar humeral fracture in children after surgery. the main questions it aims to answer are: * how good is the elbow function * what are the post-operative complication * what is the time before return to sport * what is the aesthetic prejudice of the scar for the patient participants will answer questionnaries and send photographs of their elbows to the examinator

elbow fractures represent 5% of total fracture in children. supracondylar humeral fractures compound half of them. as distal humerus is responsible for only 20% of humeral growth, bone remodelage her is less important compared to other sites in children.. many different attitudes are possible : orthopedic reduction, open reduction, percutaneous pinning ... no methode as clearly demontrated a superiority. percutaneous pinning as been widely used the last years though we haven't find any study evaluating long term outcomes regarding functionnal and aesthetic outcomes in supracondylar humeral fracture treated by percutaneous pinning.

Eligibility criteria:
inclusion criteria: * children operated for a supracondylar humeral fracture in university hospital of grenoble from july 2011 to december 2019 exclusion criteria: * opposition from patient or parents to participate * children who did not effectively suffered a supracondylar humeral fracture

Keywords: long term follow up
peernaija: a mobile health platform incentivizing medication adherence among youth living with hiv in nigeria

Conditions: HIV/AIDS

Summary: the peernaija application will feature routine medication reminders, along with individual adherence monitoring with adherence scores, anonymized peer adherence scores (from peers attending the same clinic; social incentive), and a monthly lottery-based prize for youth with the highest adherence scores (financial incentive). the investigators will recruit a cohort of 50 hiv-infected adolescents and young adults (aya) to pilot the app and assess feasibility, acceptability, adoption, and preliminary efficacy of important clinical measures (including adherence and virologic suppression). the proposed study will provide important preliminary data for the role of mobile health (mhealth) platforms to harness and deliver social and financial incentives to promote adherence efforts, especially for vulnerable youth, and for a larger intervention trial evaluating this app among hiv-infected aya in nigeria.

the use of digital health solutions, especially medication reminders delivered via mhealth platforms, have shown promise as adherence support tools in sub-saharan africa (ssa). importantly, the proliferation of mobile phones in resource-limited settings and the early adoption of communication technologies by young people make mhealth technologies an ideal platform for this age group. the investigators propose to pilot a novel, mhealth peer-based intervention for aya living with hiv in nigeria that will utilize social and financial incentives to promote medication adherence. in addition to medication reminders and peer support, the proposed intervention will innovate within the mhealth arena to leverage the currency of social incentives through daily adherence monitoring with the provision of adherence scores for individual users in relation to their peers, and financial incentives through a monthly lottery for youth with the highest adherence scores with the prize delivered through the mhealth application itself. this proposal builds on the investigator's successful research collaborations in nigeria with apin public health initiatives, (apin, a multi-site non-governmental organization with solid president's emergency plan for aids relief-funded hiv infrastructure), the investigators expertise in building capacity for implementation research, and proficiency in developing and deploying mhealth-based interventions in ssa. this will be accomplished through the following specific aim: to establish the feasibility, acceptability, and preliminary efficacy of peernaija, an mhealth intervention designed to harness peer influence as an incentive to promote medication adherence among a pilot cohort of 50 aya living with hiv in nigeria. hypothesis: peernaija will be feasible, acceptable, and show preliminary efficacy in improving antiretroviral (art) adherence.

Eligibility criteria:
inclusion criteria: * own a smartphone (on which they are willing to download peernaija), * 16-27 years of age, * on art, and * demonstrate the ability read simple text language in english.

Keywords: hiv/aids sub-saharan africa
bread daily intake enriched with mix fibers in metabolic subjects: intestinal microbiota and metabolic profile impact

Conditions: Healthy Obesity, Metabolically

Summary: the level of fibre consumption in france is lower than the national and international recommendations (mean 18.8 g/d for men, 16.4 g/d for women (inca 2007 study) instead of 30g/d recommended). fibre have beneficial effects on health and interact with the intestinal microbiota diversity: a diet fortified with different structure fibres increase of 25 % the dysbiotic intestinal microbiota in obese patient (cotillard et al, dietary intervention impact on gut microbial gene richness. nature, august 2013). the study aim is to evaluate the impact of daily consumption of bread (150 g ) enriched with a mixture of fibres of different structure (15g) during two months on the intestinal microbiota composition in metabolic risk subjects (abdominal overweight or obese) and also, to assess the correlation between the microbiota change and their metabolic profile improvement.it is a mono centric study with a centre in lyon (centre de recherche en nutrition humaine rhône-alpes)


Eligibility criteria:
inclusion criteria: * body mass index of 25 to 35 kg/m2 * waist circumference greater than 80 cm for women and than 96 cm for men * low level of fibre intake (\<20 g /d) and low level of fibre nature diversity * daily bread consumption exclusion criteria: * bread products allergy or intolerance * digestive surgery history except appendicectomy * metabolic or gastrointestinal disease history * medication that could interfere with glucose and lipid metabolism or intestinal microbiota (for example, no antibiotics within the 3 months before the study) * smokers (5 cig/d or more)
the intervention effect and potential neural mechanisms of music therapy in children and adolescents with mood disorders

Conditions: Mood Disorders in Children and Adolescents

Summary: this study plans to combine questionnaires, scales, electrophysiological and neuroimaging methods to comprehensively evaluate the effectiveness of music therapy for children and adolescents with emotional disorders and nssi, and explore the potential neural mechanisms of its effectiveness.

the subjects will be randomly divided into the conventional treatment group (tau) and the music therapy group (mt). the conventional treatment group will receive dbt group therapy 5 times a week, 1 hour each time, and individual personalized therapy twice a week; the music therapy group will receive individual music therapy twice a week, 30 minutes each time, for a total of 3 weeks on top of conventional treatment. during each intervention, near-infrared brain functional imaging, electrodermal and electrocardiographic equipment will be used to synchronously collect multimodal data from therapists and patients. the heart rate variability, electrodermal conductance response of therapists and patients, and the relative concentrations of oxygenated hemoglobin (oxy-hb), deoxyhemoglobin (deoxy-hb) and total hemoglobin in the brain tissue of the subjects and therapists were monitored during the treatment process.

Eligibility criteria:
inclusion criteria: * right-handed; * born and raised in china, with chinese as the only native language; * voluntary participation, with the consent of the family members of patients under 18 years old, and signed the informed consent form; * meet the diagnostic criteria of dsm-5 anxiety disorder or depressive disorder; * there have been two or more self-harm behaviors in the past six months. exclusion criteria: * meet the diagnostic criteria of dsm-5 psychotic disorder, manic episode, autism spectrum disorder, mental retardation, tic disorder, substance abuse and other mental illnesses; * severe organic brain disease; * hearing loss or loss of music-related pleasure; * those who have clear suicidal ideation, attempt and behavior in the past month.

Keywords: nssi music therapy children and adolescent mood disorders hyperscanning
epilepsy motion sensing

Conditions: Epilepsy

Summary: evaluate patient motion during seizures.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * diagnosed with epilepsy and expected to have at least one motor seizure in the emu * determined by the investigator to be an acceptable candidate for epilepsy evaluation with intracranial or scalp electrode monitoring * willing and able to wear 3 actigraph gt3x+ devices for the duration of their participation in the study and comply with the study protocol * have one of the following seizure types: (a) partial seizures with secondary generalization, which results in visible clonic or tonic-clonic motor behavior; (b) primarily generalized seizures (in patients with either primary \[idiopathic\] or secondary \[symptomatic\] generalized epilepsy), which may involve the following depending on the motor manifestation observed: myoclonic seizures, clonic seizures, tonic-clonic seizures, or atonic seizures. * be able to consent to participate by signing the informed consent document after a full explanation of the nature and purpose of this study * male or non-pregnant female * english speaking exclusion criteria: * currently enrolled in another investigational device, drug, or surgery study. concurrent physiologic study participation is acceptable * have an implanted device that may interfere with gt3x+ recordings, ecog/eeg recordings, ecg recordings, or video recordings * have a movement disorder that may affect gt3x+ recordings

Keywords: epilepsy seizure motor motion accelerometer
athermal nerve-sparing during robotic-assisted radical prostatectomy using a hemostatic matrix.

Conditions: Prostate Cancer; Erectile Dysfunction

Summary: the purpose of this study is to evaluate the use of a hemostatic gelatine-thrombin matrix during athermal nerve-sparing prostate resection compared to conventional hemostasis using electrocautery in patients with localized prostate cancer and to investigate effects on postoperative erectile function and continence.


Eligibility criteria:
inclusion criteria: * patient age \>18 * histologically proven prostate cancer ( gleason \<8; psa\<10ng/ml) * disease confined to prostate in clinical examination * preoperative ieef-5-score\>20 * patient is able to give informed consent exclusion criteria: * asa iv-v * prior extensive abdominal surgery * signs for metastatic disease * known allergy against bovine material * patient is unable to give informed consent

Keywords: radical prostatectomy robotic surgery erectile dysfunction continence