Kornimate/medical-research-clean huggingface dataset:
muscular rehabilitation by eccentric exercise after severe covid-19 infection

Conditions: Covid19; Sarcopenia; Muscle Weakness

Summary: with the covid-19 pandemic, the number of patients to be treated in rehabilitation increased . hospitalization for severe infection can induce muscular atrophy and muscular dysfunction that persists for several months and rehabilitation capacities may be exceeded. exercises in eccentric mode could be performed, inducing greater muscular hypertrophy, muscle strength, power and speed than concentric exercises. the goal of this study was to compare functional recovery at 2 months after a training program in eccentric and concentric mode after severe covid-19. an effective rehabilitation could help reduce costs and duration of care.

this is a prospective, open, controlled randomized study (2 x 60 individuals) performed in 3 centers. participants will perform 24 exercise sessions on cycloergometer (3 sessions/week, 8 weeks). the experimental group (eccentric) will perform 5 habituation sessions: the initial power of the exercise will be set to 10 watts and then increased by 10% each session, depending on the muscle tolerance. the training power must correspond to 3 times that of the control group to obtain a similar metabolic stimulation. the control group (concentric) will perform exercise training at an intensity of 60% of the reserve heart rate determined during an initial cardiorespiratory test. the primary outcome will be the change in distance covered during the 6-min walk test between the initial assessment and month 2. secondary outcomes will include study of sarcopenia, muscle strength, general and muscular fatigue, quality of life, blood metabolomic data, ex vitro data for mitochondrial and histo-biochemical functionality from muscle biopsies of the vastus lateralis.

Eligibility criteria:
inclusion criteria: * male or female, 18 to 80 years old * diagnosed for sars-cov-2 infection (covid-19) requiring a rehabilitation program at least 1 month after the hospitalization * autonomy in daily life activities 1 month after diagnosis * able to walk for 6 min (discontinuous walking possible) * giving informed written consent to participate in the study * health insurance coverage exclusion criteria: * cardiovascular or respiratory contraindication to the rehabilitation program * difficulty to perform an eccentric exercise on a seated ergometer * pregnant or breastfeeding * under guardianship, curatorship or deprived of liberty * taking antivitamin k anticoagulation (muscle biopsy) * refusal to participate

Keywords: covid19 sarcopenia muscle weakness eccentric exercises rehabilitation
multiparametric echocardiography and cardiac biomarkers in pediatric inflammatory heart diseases

Conditions: Myocarditis; Pediatric Inflammatory Multisystem Syndrome; Kawasaki Disease

Summary: acquired inflammatory or infectious cardiac diseases, in pediatrics, include kawasaki disease, myocarditis, and covid-19-related pediatric multisystemic inflammatory syndrome (pims). these 3 inflammatory cardiac diseases have clinical, biological, and echographic similarities and differences. nevertheless their modalities of monitoring, management and evolution are different. the investigators wish to retrospectively analyze biological and echocardiographic data of kawasaki disease, myocarditis, pims patients managed at nancy children hospital from january 1, 2017 to june 31, 2023. the primary objective of this study is to identify, for these 3 pathologies, the prognostic factors of initiation of inotropic support. the secondary objective is to identify the prognostic factors of degradation of ventricular function.


Eligibility criteria:
inclusion criteria: * diagnostic of pims, myocarditis or kawasaki disease patients * age \< 18 years exclusion criteria: * uncertain diagnosis * other complex heart disease * management out of nancy university children hospital center
diffusion-weighted magnetic resonance imaging

Conditions: Hepatocellular Carcinoma; Spine Metastasis

Summary: recently, diffusion-weighted (dw) mr imaging has widened its application on various oncologic applications. especially, it is expected the dw mri could provide valuable information about early response evaluation after treatment using rapid apparent diffusion coefficient (adc) value change. it has demonstrated potential usefulness in response evaluation in the liver tumors after treatments such as transarterial chemoembolization (tace) and radiation therapy (rt). furthermore, it is a functional imaging technique that does not require a contrast agent, it can be safely used in patients with renal insufficiency or other medical contraindications for contrast agents. the optimal assessment of early response of rt could provide one of the most important information to prescribe patient and cancer specific rt dose. it might be also important in palliative rt of hcc bone metastasis which is related with painful aggressive mass formation. this study is performed to evaluate the usefulness of dw mri in early response evaluation after rt for hcc bone metastasis.


Eligibility criteria:
inclusion criteria: * hepatocellular carcinoma * spine metastasis * eastern cooperative oncology group (ecog) performance status 0 to 3 * 20 or older age * informed consent * consent to birth control during 6 months after treatment exclusion criteria: * less than 12 weeks of expected survival * indication of emergency operation * uncontrolled ascites or encephalopathy * previous rt field lesion (within in 1 month)
proficiency based stepwise endovascular curricular training: multicentric registry

Conditions: Vascular Diseases

Summary: the goal of this multicentric registry is to gather data from trainees completing prospect: a proficiency based stepwise endovascular curricular training to obtain basic cognitive and technical skills. the main goals are to identify if: * results from a previous randomised controlled trail can be reproduced in real life. * evaluate skills retention after program completion. * assess real life implementation of the training program.

a validated prospect (proficiency-based stepwise endovascular curricular training) training has been integrated into the training of surgical residents to teach basic cognitive, technical and non-technical endovascular skills. the program uses virtual reality simulation and e-learning. during the four modules of the program, formative feedback is given after each training session. only after achieving a predetermined benchmark score, trainees can progress to the next module. surgical trainees completing prospect showed superior real live endovascular performance compared to the traditionally trained in a single centre randomised controlled trial (rct). the curriculum was integrated locally, but also introduced in other centers: national and international. local tutors teach the curriculum to trainees after standardized training on the modalities of prospect by the researchers of the ghent. a registry is maintained and coordinated by the ghent research group in which all educational data regarding this training is collected and processed anonymously.

Eligibility criteria:
inclusion criteria: * surgical trainee * knowledge and technical skill level evaluated * demographics questionnaire and general mcq test completed * endovascular simulated exercise completed after familiarization with the simulator exclusion criteria: * n/a

Keywords: simulation based education endovascular procedures
safety and efficacy study of the ptma device to reduce mitral valve regurgitation in patients with heart failure

Conditions: Mitral Regurgitation; Heart Failure

Summary: improvement in heart failure with moderate to severe mitral regurgitation using a percutaneously delivered implantable device residing in the coronary sinus

device under test: the viacor® percutaneous transvenous mitral annuloplasty (ptma) system comprises a sterile implantable cardiac device and associated custom accessories to assist implantation. the ptma system is intended to treat functional mitral regurgitation (mr) in a heart failure patient by a less invasive method than surgical annuloplasty with greater relief of symptoms than medical management alone. study objective: functional mitral regurgitation is associated with an adverse prognosis in the heart failure patient. the objective of this study is to evaluate whether ptma is effective in reducing mitral regurgitation in heart failure patients and whether this reduction is associated with a moderation in the adverse progression of heart failure symptoms. hypothesis under test: reduction of the severity of functional mitral regurgitation from baseline, as defined by a composite improvement of quantitative echocardiographic metrics, can be achieved safely with the ptma device and will be associated with a measurable moderation of adverse progression of heart failure symptoms and a moderation of the deterioration of exercise capacity.

Eligibility criteria:
inclusion criteria: * patient has moderate functional mr: regurgitant orifice area \>/= 0.20cm2 or regurgitant volume \>/= 30 ml/beat or regurgitant fraction \>/= 30% * symptomatic heart failure nyha class ii to iv * lv dysfunction (25% \ 30mm exclusion criteria: * mr of organic origin * severe mitral leaflet tethering * history of mi or pci within 60 days of study procedure * inability to walk a minimum of 100 meters in 6 minutes * significant left main stenosis or proximal circumflex stent * indication of non-patent cso or discontinuous cs-gcv-aiv * bi-ventricular with leads in cs or other devices impeding device placement * severe aortic valvular disease * chronic corticosteroid use other than \< 20mg prednisone for arthritis * significant co-morbidities

Keywords: mitral valve heart failure mitral regurgitation annuloplasty coronary sinus
preserving function in breast cancer patients

Conditions: Breast Cancer

Summary: breast cancer patients experience functional limitations related to the cancer and treatment side effects. early functional limitations affect short- and long-term quality of life, and may lead to long-term complications. patients living in rural areas are at particular risk because they do not have easy access to services. therefore, early intervention is indicated to have an impact on the overall public health. problem solving training (pst) is a standardized manual driven intervention that may be ideally suited to assist breast cancer patients to preserve their valued activities and to comply with recommended symptom management regimens (e.g., physical therapy, aerobic exercise and relaxation/guided imagery) that improve function. telephone-based pst provided from a centralized location (such as the comprehensive cancer center) may improve access and outcomes in a cost-effective manner. we propose to conduct a feasibility study of a pst intervention with 30 rural breast cancer patients undergoing adjuvant treatment randomly assigned to pst or to usual care. the intervention group will receive weekly phone-based pst sessions for six consecutive weeks. the specific aims of this r03 small grant application are to:1) test the feasibility of enrolling and retaining newly diagnosed breast cancer patients in a clinical trial to assess telephone-based pst. 2) collect preliminary data on outcome measures of function to determine effect size estimates that will inform power analyses for a full scale randomized controlled study. primary outcome measures will be acceptance rates for enrollment in the study, retention rates across both intervention arms, and satisfaction levels with the pst intervention. assessments will be conducted at baseline, and at six weeks (end of pst intervention) and 3 months following baseline. the long-term goal of this line of investigation is to develop practical, widely applicable rehabilitation models of care to preserve function and decrease distress in cancer patients undergoing treatment.


Eligibility criteria:
inclusion criteria: 1. females, age \> 18 years. 2. first breast cancer diagnosis, stages 1-3. 3. beginning the second chemotherapy cycle. 4. english speaking and literate. exclusion criteria: 1. previous or concurrent malignancy, except for non-melanotic skin cancers. 2. lifetime diagnosis of schizophrenia or bipolar disorder. 3. moderate-severe cognitive impairment indicated by a score \< 3 on a 6-item cognitive screener.

Keywords: health services research
serum magnesium and vascular calcification

Conditions: Vascular Calcification; Chronic Kidney Disease

Summary: both kidney transplantation (kt) and chronic kidney disease (ckd) patients have reduced kidney function. low serum magnesium is more prevalent in kt recipients. the present study examines the difference in vascular calcification between kt and ckd and its association with serum magnesium.

kidney transplantation (kt) improved quality of life and longevity of ckd patients. nevertheless, kidney function deteriorates overtime in a manner not different from ckd counterparts. hypomagnesemia is prevalent in kt recipients secondary to immunosuppressive therapy. in addition to serum calcium, phosphate and elemental calcium intake, the relationship between low serum magnesium and vascular calcification (vc) has been observed in small studies in ckd. whether low serum magnesium associates with vc in kt has never been elucidated. the present study compares vascular calcification between kt and ckd and its association with serum magnesium.

Eligibility criteria:
inclusion criteria: * kidney transplant recipients at least 1 year post surgery * predialysis chronic kidney disease with serum creatinine \> 1.1 mg/dl in female and 1.3 mg/dl in male exclusion criteria: * acute kidney injury * parathyroidectomy

Keywords: magnesium kidney transplantation hypomagnesemia
study of hierarchy of afferents in postural control of children with dyslexia

Conditions: Dyslexia

Summary: the purpose is to determine the hierarchy of sensory afferents according to different forms of dyslexia in children. the secondary purpose is to determine sensitive and sufficiently specific posturographic indexes for standard diagnosis of different types of dyslexia.

this study evaluates the postural control and the importance of proprioception, evaluated by static and dynamic posturography, in dyslexic children compared to age-matched control group. posturographic data and a questionnaire for motion sickness disorder are used as proprioceptive disorder index. this study aims to better characterize the dyslexic population with techniques targeting central integration of sensory proprioceptive afferents. the purpose of this study is not to search for a postural deficiency syndrome, but to study proprioception with posturography, with quantitative and normalized data of analyzed population. moreover, these data could allow an objective evaluation of reeducation with quantifiable and reproducible parameters in order to judge its effectiveness. the demonstration of the existence of a relationship between proprioceptive disorders and dyslexia will imply a specific reeducation care of patients. a study using validated and standard indexes is necessary. the presence of postural disorders and a major susceptibility to motion sickness could contribute to distinguish different forms of dyslexia and thus be complementary to actual medical, orthophonic and neuropsychological criteria. in this evaluation, it is important to distinguish between visuo-attentional dyslexia from phonological dyslexia involving distinct anatomo-functional neuronal circuits.

Eligibility criteria:
inclusion criteria: all: * parents of child and child having given informed consent * affiliation to social security * preliminary medical examination dyslexia groups: - diagnosed and characterized dyslexia exclusion criteria: all: * medical pathology, especially neurological, ophthalmological, otorhinolaryngological or orthopedic, modifying postural control, detected with medical examination * insufficient compliance of child especially due to fatigue * contact allergy to cutaneous electrodes * current treatments: psychotropic drugs and all drugs diminishing awareness or causing dizziness or equilibrium disorders control group: - patient having a dyslexia or oral or written language disorder
vancomycin and cefoxitin during pediatric cardiopulmonary bypass

Conditions: Congenital Heart Disease

Summary: the aim of this study will be to evaluate vancomycin and cefoxitin blood levels during elective cardiopulmonary bypass (cpb) surgery in four pre-determined pediatric strata: neonates, infants, children weighting less than 40 kg and children weighting more than 40 kg.

few data are available in current literature about pharmacokinetics (pk) of antibiotics administered as surgical prophylaxis to children scheduled for cardiac surgery with cpb. in particular, vancomycin pk during cpb has been studied only in small case series, whereas no specific study has been conducted, so far, in the specific setting of children receiving cefoxitin during cpb. cpb affects patients' volemia and drugs pk is eventually altered. on the other side during and after surgery for heart defects, many risk factors may decrease renal and hepatic clearance, including altered renal perfusion, use of vasoactive agents, and use of concomitant nephrotoxic medications. primary objective of the study will be: • to study the pharmacokinetic profile of vancomycin and cefoxitin administered, as antibiotic prophylaxis to children undergoing elective cpb. secondary objectives will be: * to evaluate if a significant difference in blood levels will occur in the four predetermined patients' categories. * to evaluate the role of hemodilution during cpb on studied antibiotics' serum concentration * to verify the incidence of post-operative infections in the studied population with particular attention to sensitive bacteria * to evaluate the impact of ultrafiltration in studied antibiotics' clearance * to evaluate safety of the administered antibiotics this is a prospective monocentric, open label, not controlled clinical trial.

Eligibility criteria:
inclusion criteria: 1. elective cardiac surgery schedule with the planned application of cpb 2. parents of neonates, or their legal representative, able to consent and comply with protocol requirements. exclusion criteria: 1. urgent or emergent surgery 2. antibiotic therapy (any) administered before surgery 3. patients receiving, before surgery, any other ofr of extracorporeal treatment (i.e extracorporeal membrane oxygenation, continuous renal replacement therapy) 4. previous renal or hepatic dysfunction requiring need for antibiotic posology modification. 5. surgery requiring antibiotic prophylaxis with different drug combinations (i.e vancomycin and gentamycin) 6. extremely low birth weight neonates.

Keywords: antibiotic prophylaxis pharmacokinetics cardiopulmonary bypass
single-anastomosis plication ileal bypass for morbid obesity

Conditions: Morbid Obesity

Summary: the present study aims to explore the impact of combining laparoscopic greater curvature plication with a single gastro-ileal anastomosis in the same manner of single anastomosis sleeve ileal bypass on weight loss and postoperative complications. the objective of this combined procedure is to reduce the high intraluminal pressure that results after laparoscopic greater curvature plication owing to reduced intraluminal space which can lead to suture line leakage, vomiting, and gastroesophageal reflux disease. another objective is to add a malabsorptive element to the restrictive effect of laparoscopic greater curvature plication and to induce early satiety in patients by distention of the distal bowel with nutrients immediately after meals, similar to the way that single anastomosis sleeve ileal bypass works.

the present study aims to explore the impact of combining laparoscopic greater curvature plication with a single gastro-ileal anastomosis in the same manner of single anastomosis sleeve ileal bypass on weight loss and postoperative complications. the objective of this combined procedure is to reduce the high intraluminal pressure that results after laparoscopic greater curvature plication owing to reduced intraluminal space which can lead to suture line leakage, vomiting, and gastroesophageal reflux disease. another objective is to add a malabsorptive element to the restrictive effect of laparoscopic greater curvature plication and to induce early satiety in patients by distention of the distal bowel with nutrients immediately after meals, similar to the way that single anastomosis sleeve ileal bypass works.

Eligibility criteria:
inclusion criteria: * adult patients of both genders aging between 18 and 60 years with morbid obesity will be included to the study exclusion criteria: * patients with secondary obesity due to endocrine disorders * patient unfit for general anesthesia. * patients who had not attempted non-surgical weight loss treatment in the past * patients with psychological conditions that influence his/her perception of the study protocol * patients with previous surgery for morbid obesity
a phase i dose-escalation study of bms-641988 in patients with castration-resistant prostate cancer

Conditions: Prostate Cancer

Summary: this is a phase i dose-escalation study of bms641988 in patients with castration-resistant prostate cancer.


Eligibility criteria:
inclusion criteria: * advanced castration-resistant prostate carcinoma with progressive disease * at least 4 weeks must have elapsed from major surgery * patient must be available for follow-up * adequate liver and kidney function * adequate blood values exclusion criteria: * uncontrolled or significant heart disease * history of seizures * history of head injury, loss of consciousness, or stroke * patients undergoing alcohol withdrawal * any concurrent cancer * a serious uncontrolled medical disorder or active infection * inability to swallow tablets
enhanced recovery program after a robotic-assisted surgery (raac) of radical prostatectomy. prosta-raac

Conditions: Prostate Cancer; Quality of Life; Recovery Programm

Summary: there are few published data on the benefit of enhanced recovery program in radical prostatectomy in the management of localized prostate cancer. all the studies available on the subject are retrospective (1-3). this randomized comparative study is proposed in order to compare in a homogeneous population (place and time) the interest of raac specifically in this surgery.

the implementation of raac programs in healthcare establishments would improve the quality and safety of patient care (functional development and rapid convalescence of patients and reduction in postoperative morbidity through active prevention of perioperative complications) and optimization of care costs for health establishments and for health insurance (reduction in length of stay and convalescence, reduction in postoperative complications). its implementation requires a strong involvement of all the teams and a transversal and multidisciplinary coordination, specifically dedicated to one type of intervention. this approach must therefore show its effectiveness by specialty and then by pathology within the same specialty. there are few published data on the benefit of raac in radical prostatectomy in the management of localized prostate cancer. all the studies available on the subject are retrospective (1-3). this randomized comparative study is proposed in order to compare in a homogeneous population (place and time) the interest of raac specifically in this surgery.

Eligibility criteria:
inclusion criteria: * male over 40 and under 75 * patient scheduled for a robot assisted radical prostatectomy within the center * affiliation to a social security scheme or beneficiary of such a scheme * patient having signed the free and informed consent exclusion criteria: * minor, age ≤ 40 years or ≥ 75 years * asa 4 or more * severe or poorly balanced associated conditions * covid + declared in the previous 3 months * refusal to participate in the study * protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision

Keywords: robotic assisted