Kornimate/medical-research-clean huggingface dataset:
risk factor of anterior cruciate ligament rupture after ligamentoplasty : what is the importance of a relative deficit of contralateral hamstrings assessed by isokinetic in postoperative ?

Conditions: Anterior Cruciate Ligament Rupture

Summary: anterior cruciate ligament (acl) is a common pathology (37 000 operations in 2006, nearly 43 000 in 2012 in france) justifying more and more operating indications in younger and younger patients. 70-80% of acl ruptures occur without contact, which makes it a major public health interest because of its frequency and accessibility in terms of prevention. the place of isokinetic assessment is important pre and postoperatively so that it has become systematic.

the main risk factors for known acl lesions are female gender, pivotal sports, neuromuscular deficits, proprioceptive, hormonal, morphological deficits ... moreover, there is also an increase in the number of contralateral fractures in patients who had a ligamentoplasty. there are many articles on the acl pathology but unequal on the potential risk factors. the only proven risk factor for contralateral rupture is the age of the first episode; the female sex also seems to be important in some studies but remains more controversial. however, many factors have been studied: the intensity of the sport, the sex, the operative technique of ligamentoplasty, the operating duration, the duration of recovery of the sports activity, the level of recovery (of this sporting activity ) ... isokinetics is used to measure the peak of strength of quadriceps and hamstrings, in concentric or eccentric, at slow and fast speed and to determine a hamstring / quadriceps ratio to highlight a deficit or imbalance.

Eligibility criteria:
inclusion criteria: * athletic patients all levels * victims of acl rupture during sports practice, * operated by the same surgeon * having been evaluated in isokinetic postoperative in the sports medicine department of rennes university hospital * having resumed a sporting activity * with the first acl rupture between 01/01/1994 and 12/31/2015 exclusion criteria: * patients with acl rupture outside of a sporting context * not having resumed post-operative sports activity on the maximum follow-up period of 15 years * not evaluated for isokinetic activity in the sports medicine department * minors at the time of inclusion

Keywords: anterior cruciate ligament ligamentoplasty isokinetics
preparation and feasibility of exams for expected studies

Conditions: Healthy Volunteers; Parkinson's Disease Patients; Para/Tetraplegic Patients

Summary: feasibility study: the examinations carried out as part of this protocol aim to carry out all the acquisitions and simulations of use, necessary for the development of the clinical research protocols to come to clinatec (in particular, configuration of the equipment, dimension of the examination time and the size of the cohorts etc ...)

to ensure the feasibility of a clinical trial, it is necessary to test the parameters as well as the sequence of the different examination times offered to participants. the expected results of this protocol are mainly the dimension of experimental paradigms and the optimization of the clinical management of subjects.

Eligibility criteria:
inclusion criteria: * age ⩾ 18 years * affiliated to a social security scheme * free and informed consent signed exclusion criteria: * subject in a period of exclusion from another study. * subject deprived of liberty by a judicial or administrative decision, or major subject subject to a legal protection measure (guardianship, curatorship and safeguarding of justice) referred to in articles 1121-6 to 1121-8 of the public health code. * subject who would receive more than 4500 euros in compensation because of his participation in other research involving the human person in the 12 months preceding this study. * pregnant woman, parturient, nursing mother (article 1121-5 of the public health code) * subject not reachable urgently.
pilot study assessing the feasibility of treating foot drop with the neurostep™ system.

Conditions: Stroke; Craniocerebral Trauma

Summary: this pilot feasibility study is assessing the safety and technical performance of the neurostep™ system for the restoration of independent gait in subjects with gait disorder (i.e. foot drop) secondary to a cns lesion (e.g. stroke).

the neurostep™ system is a neurostimulation investigational medical device. the entire system is designed to be implanted into the subject's leg via a surgical procedure, during which electrodes are attached to the peripheral nerves responsible for sensing and stimulating the proper muscles that lift the foot during normal walking.

Eligibility criteria:
inclusion criteria: * diagnosed with a unilateral gait disorder as a result of a specified cns lesion (e.g., stroke)with stable neurological deficit for at least 6 months * medically stable, able to and agree to undergo a surgery * able to stand and walk at least 5 meters * agree to attend frequent study scheduled visits * able to provide verbal or written feedback * have provided written informed consent * have intact tibial and common peroneal nerves exclusion criteria: * pregnant or nursing women * medically insufficiently stable to undergo surgery * poor range of motion of affected ankle or fixed ankle * foreseen need for magnetic resonance imaging (mri) * significant mental or psychiatric impairment * cannot understand or provide signed informed consent * cannot provide verbal or written feedback * have been implanted with a pacemaker or other active medical device * must continuously take anticoagulants * uncontrolled heart or cardiovascular-related disease conditions * have been diagnosed with muscle atrophy and/or peripheral polyneuropathy
impact of immuno-oncologic agent on neoadjuvant chemotherapy in triple negative breast cancer

Conditions: Triple Negative Breast Cancer; Neoadjuvant Chemotherapy; Pembrolizumab; Tumor Microenvironment

Summary: it analyzes the tumor microenvironment(tme) changes in non pathologic complete response(pcr) subjects among subjects who were administered neoadjuvant pembrolizumab and those who were not administered neoadjuvant pembrolizumab for triple negative breast cancer. (neoadjuvant weekly paclitaxel, carboplatin +- pembrolizumab followed by doxorubicin, cyclophosphamide +- pembrolizumab regimen)


Eligibility criteria:
inclusion criteria: * triple negative breast cancer * subjects administered neoadjuvant weekly paclitaxel, carboplatin followed by doxorubicin, cyclophosphamide add pembrolizumab or not * non pcr patients who are undergoing surgery after neoadjuvant chemotherapy * sign to informed consent exclusion criteria: * patients with difficulty in obtaining sufficient samples
antitussive effect of a naturally flavored syrup containing diphenhydramine, compared with dextromethorphan and placebo

Conditions: Cough Reflex Sensitivity

Summary: the purpose of this study is to evaluate the antitussive (cough-suppressing) effects of two liquid medications: a combination of diphenhydramine and phenylephrine in a naturally cocoa flavoring, and, dextromethorphan syrup, compared with placebo.


Eligibility criteria:
inclusion criteria: * healthy adult nonsmokers * onset of acute, viral upper respiratory tract infection (common cold) within 72 hours of enrollment exclusion criteria: * smokers * history of asthma or other respiratory disorders

Keywords: cough cough reflex capsaicin diphenhydramine phenylephrine dextromethorphan placebo
preventing adverse incisional outcomes at cesarean multicenter trial

Conditions: Surgical Wound Infection; Cesarean Section

Summary: the prophylactic negative pressure wound therapy in obese women at cesarean trial is a large pragmatic multi-center randomized clinical trial designed to evaluate the effectiveness, safety and cost-effectiveness of prophylactic negative pressure wound therapy (npwt) - a closed, sealed system that applies negative pressure to the wound surface via a single-use, battery-powered, portable device - to decrease surgical site infections (ssis) in obese women.

experimental evidence suggests that npwt promotes wound healing by removing exudate, approximating the wound edges, and reducing bacterial contamination. obesity (body mass index \[bmi\] ≥30kg/m2) increases the risk for both cesarean delivery and ssis compared to non-obese women. the increased risk of ssis is in part due to the increased thickness of the subcutaneous space, allowing collection of exudates and increasing tension on wound edges, promoting the growth of bacteria, and leading to wound infection and breakdown. thus, prophylactic npwt may be particularly effective in this patient population. during the 5-year project period, investigators from 4 collaborating perinatal centers in the united stated (two university and two community) will randomize 2850 obese women undergoing cesarean delivery to receive either prophylactic negative pressure wound therapy with the prevena device or standard wound dressing. women will be followed up to 30 days postoperatively to ascertain study outcomes. the primary outcome for the trial is superficial or deep ssi after cesarean according to the cdc's national healthcare safety network definitions. the investigators will also assess other wound complications, adverse events potentially attributable to npwt and cost-effectiveness as measured by incremental cost per case of ssi prevented and per quality-adjusted life year (qaly).

Eligibility criteria:
inclusion criteria * gestational age ≥23weeks * bmi≥30 pre-pregnancy or bmi at first prenatal visit * planned or unplanned cesarean delivery exclusion criteria: * non-availability for postoperative follow-up * contraindication to npwt applicable to women undergoing cesarean: pre-existing infection around incision site, bleeding disorder, therapeutic anticoagulation, irradiated skin, allergy to any component of the dressing (e.g. silver, acrylic, silicone, adhesive tape)
angelman syndrome natural history study-fast uk

Conditions: Angelman Syndrome

Summary: the goal of this study is to conduct a prospective, longitudinal assessment of the natural clinical progression of angelman syndrome (as) in children and adults. this will be performed by acquiring baseline measurements, and developing effective outcome measures and diagnostic tools for the syndrome, to prepare the healthcare system for forthcoming clinical trials.

this study is being conducted in anticipation of several candidate therapies which are approaching clinical readiness for angelman syndrome. this study will comprehensively evaluate the natural clinical progression of the disease using scales and questionnaires for the assessment of motor function and global development, motor measuring devices (actimyo), and by collecting sleep and seizure diaries. in addition, proteomic analysis and electroencephalography (eeg) recordings will be collected to identify biomarkers which will indicate improvements in disease outcome following treatment.

Eligibility criteria:
inclusion criteria: for the candidate participants affected by as: * genetically confirmed diagnosis of as * 0-99 years * male or female * obtained consent forms and/or record of consultation by the carers. in this study, the two primary carers for each participant diagnosed with as will be also considered participants. carers will have to meet the following inclusion criteria: * male or female * \>18 years * legal carer of the patient diagnosed with as * willingness to follow study procedures, as assessed by the research team * willingness to sign the consent form * ability to understand all the information regarding the study, as assessed by the research team exclusion criteria: * the participant affected by as may not enter the study if there is any comorbidity (\*) that could potentially affect the results of the study. this will be subject to the clinical judgement of the chief investigator (ci) and/or the principal investigator (pi). participants of ongoing (interventional) clinical trials that assess the efficacy of potential treatments will be excluded as assessments need to be done on the basis that represent the natural progression of as. (\*) this includes any confirmed chronic or acute condition or disease affecting any system(s), which could interfere with the results of the study and/or the compliance with the study procedures.

Keywords: natural history eeg actimyo outcome measures proteomics
evaluation of a marine oxygen carrier for organ preservation

Conditions: End Stage Renal Diseases

Summary: preventing ischemia/reperfusion injuries (iris) is a major issue in kidney transplantation, particularly for transplant recipients receiving a kidney from extended criteria donors (ecd). the main consequence of iris is delayed graft function (dgf). the medical device hemo2life®, an oxygen carrier developed by the hemarina french company, is a natural extracellular hemoglobin (hb) isolated from the marine lugworm arenicola marina. this biopolymer of high molecular weight (\~3,600 kda) has a large oxygen binding capacity, carrying up to 156 oxygen molecules when saturated (4 for human hb). it releases oxygen according to a simple gradient and exhibits an intrinsic superoxide dismutase-like activity preventing both the occurrence of potentially harmful heme-protein-associated free radical species and the release of hb degradation products. recently a safety study in 60 renal grafts using hemo2life® as additive to organ preservation solution (oxyop study, nct02652520) was completed, that confirmed that the use of hemo2life® is safe for patients and grafts. in the oxyop study, even if the protocol was not designed to show a benefit of the use of hemo2life®, significantly less delayed graft function (dgf) and a shorter renal function recovery was observed. the present research focuses on the efficacy of hemo2life®, which is an oxygen carrier added in preservation solution in kidney transplantation.


Eligibility criteria:
inclusion criteria: * for kidney graft: * any pair of kidneys retrieved in an adult donor in one of first line participating centers. * any pair of kidneys from a deceased donor after brain or cardiac death * for patient: * male or female renal allograft recipients at least 18 years old * patient who signed an inform consent form * patient receiving one graft from an included pair of kidneys exclusion criteria : * for kidney : * graft from a living donor * graft dedicated to a multi-organ transplantation or dual kidney transplantation,

Keywords: kidney transplantation organ preservation
role of ccl2 in alcoholic liver diseases

Conditions: Alcoholic Liver Disease

Summary: immune dysregulations, including cytokines and chemokines secretions occurs in alcoholic liver disease. serum levels and liver expression of ccl2 are increased in patients with alcoholic hepatitis but the role of this chemokine in the pathogenesis of alcoholic liver disease is nevertheless unknown. the aim of the study is to analyze plasma level and liver expression of ccl2 and their relation with liver disease severity and inflammatory infiltrate in our cohort of alcoholic patients. we studied also the association between -2518 ccl2 polymorphism and the severity of alcoholic liver disease.


Eligibility criteria:
ald patients inclusion criteria: * excess alcohol intake * abnormality of liver biopsy compatible with alcoholic aetiology * caucasian ethnicity exclusion criteria: * presence of any other chronic liver disease * co-infection with hiv controls inclusion criteria * caucasian ethnicity * presence of a disease
spinal cord stimulation versus instrumentation for fbss

Conditions: Failed Back Surgery Syndrome; SCS; Neuromodulation; Spinal Cord Stimulation; Spinal Fusion; Low Back Pain

Summary: low back pain affects people of all ages and has become the leading cause of living with disability worldwide. patients, suffering from persistent pain after spinal surgery in the absence of any clear spinal pathology are defined of having a "failed back surgery syndrome (fbss)" and treatment of fbss remains a great controversy in the spinal community. apart from conservative treatment, spinal fusion remains as therapeutic option. furthermore, minimal invasive neuromodulation techniques might be a promising alternative. aim of this randomized interventional multi center study is to compare treatment success in fbss patients with either spinal cord stimulation (scs) or fusion surgery, 12 months after intervention according to the oswestry disability index (odi) and other scales and scores. radiological and health economic outcome also will be analysed for thorough comparison of techniques. additionally, the safety of the interventions needs to be compared.


Eligibility criteria:
inclusion criteria: * age ≥18 years * symptomatic degenerative disc disease with lbp as a predominant symptom for at least 6 months following pervious surgery for disc herniation * odi score at least 21 * correctly signed informed consent form exclusion criteria: * spinal stenosis resulting in spinal claudication or neurological deficits * spinal instability (\> 3 mm motion on dynamic lumbar x-rays) * major psychiatric disorder
effects of neutrophil/lymphocyte, platelet/lymphocyte, crp/albumin and lactate on mortality in trauma patients admitted to intensive care

Conditions: Intensive Care

Summary: intensive care units are medical units where patients are closely monitored 24 hours a day due to critical health problems that threaten their lives and where rapid interventions are made when necessary. the clinical conditions of patients in these units can change rapidly. there are many studies in the literature indicating that inflammation indicators such as neutrophil/lymphocyte, platelet/lymphocyte and c-reactive protein/albumin ratios and blood gas values such as lactate and base deficit are simple, cheap and rapid biomarkers that can provide an early idea about the clinical course of patients.

intensive care units are medical units where patients are closely monitored 24 hours a day due to critical health problems that threaten their lives and where rapid interventions are made when necessary. the clinical conditions of patients in these units can change rapidly. there are many studies in the literature indicating that inflammation indicators such as neutrophil/lymphocyte, platelet/lymphocyte and c-reactive protein/albumin ratios and blood gas values such as lactate and base deficit are simple, cheap and rapid biomarkers that can provide an early idea about the clinical course of patients. the researchers aimed to evaluate the relationship between neutrophil/lymphocyte, platelet/lymphocyte and c-reactive protein/albumin ratios and biomarkers such as lactate and base deficit with the clinical course and survival of trauma patients admitted to the icu and to see the compatibility of our data with the existing literature.

Eligibility criteria:
inclusion criteria: * 1. all trauma patients admitted to our general intensive care unit exclusion criteria: - 1. patients whose follow-up and treatment started and completed in the services. 2. patients whose data is missing or whose data cannot be accessed.
a study comparing quality of life in patients with lymphedema who undergo surgical treatment versus non-surgical management

Conditions: Lymphedema

Summary: this study is being done to see the long-term results for patients who choose to have surgery for lymphedema (with the vascularized lymph node transfer), compared to patients who choose not to have surgery.


Eligibility criteria:
inclusion criteria: * patients aged 18-80 years * primary and secondary lymphedema of the upper or lower extremity * international society of lymphology (isl) stage 1, 2, or 3 lymphedema * proficiency in english language exclusion criteria: * patients with clotting disorders, venous insufficiency, end-stage lymphedema unless they are on the non-surgical arm. * additionally, if the patient refuses to complete questionnaires, the patient will be excluded from the study and replaced at the discretion of the principal or co-principal investigator.

Keywords: quality of life (qol) 17-377
ebastine in combination with docetaxel as a treatment for castration-resistant metastatic prostate cancer

Conditions: Metastatic Castration-resistant Prostate Cancer

Summary: this is an open-label phase i/ii study evaluating the addition of ebastine to docetaxel in the treatment for metastatic castration resistant prostate cancer. patients will be randomized in a 2:1 fashion to receive ebastine daily during and after treatment with a maximum of 10 courses of docetaxel. the primary endpoint is change in the profile of urinary and blood lipids to indicate absorption and possible efficacy of ebastine. secondary endpoints include psa response and radiologic progression free survival.

the complete study protocol can be studied by contacting the authors.

Eligibility criteria:
inclusion criteria: * 1. have a histologically confirmed adenocarcinoma or poorly differentiated carcinoma of the prostate (carcinomas with pure small-cell histology or pure high grade neuroendocrine histology are excluded; neuroendocrine differentiation is allowed). 2. surgically or medically castrated, with serum testosterone levels of ≤ 50 ng/dl equivalent to 1.7 nmol/l. for patients, currently being treated with luteinizing hormone-releasing hormone (lhrh) agonists, i.e., patients who have not undergone an orchiectomy, therapy must be continued throughout the study. 3. have evidence of disease progression after prior therapy for mcrpc: disease progression after initiation of most recent therapy is based on any of the following criteria: * rise in psa: a minimum of 2 consecutive rising levels, with an interval of ≥ 1 week between each determination. the most recent screening measurement must have been ≥ 2 ng/ml * transaxial imaging: new or progressive soft tissue masses on ct or mri scans as defined by recist 1.1 * radionuclide bone scan: at least 2 new metastatic lesions 4. signed informed consent obtained prior to initiation of any study-specific procedures or treatment 5. age ≥ 18 years 6. life expectancy ≥ 3 months 7. performance status 0 - 1 8. adequate organ functions 1. hematological: absolute neutrophil count (anc) \>1.5 x 109/l, platelet count \>100 x 109/l, hemoglobin \> 6,2 mmol/l 2. hepatic: bilirubin within normal range, aspartate transaminase (ast) and alanine transaminase (alt) \ 25 g/l 3. renal: creatinine clearance \>30 ml/min/1.73m2 exclusion criteria: - 1. history of significant gastric or small bowel resection, malabsorption syndrome, or other lack of integrity of the upper gastrointestinal tract that may prevent compliance with oral drug administration 2. presence of any serious concomitant systemic disorders and/or psychiatric condition incompatible with the study (at the investigator's discretion) 3. presence of any active infection (at the investigator's discretion). 4. central nervous system (cns) disease including epilepsy or altered mental status precluding understanding of the informed consent process and/or completion of the necessary study procedures. 5. concurrent use of cationic amphiphilic drugs (see appendix a) including over-the-counter medication. 6. use of other investigational drug 7. allergic reaction to any of the included drugs