Kornimate/medical-research-clean huggingface dataset:
5 years follow-up evaluation of deterioration kidney biomarkers of hiv patients

Conditions: HIV

Summary: the aim of this study is to compare the biomarkers levels as il-18, kim-1 and cystatin c for patients infected by hiv with failure in renal function at year 5. the main criterion will be a degradation of the glomerular filtration throughput measured. it will be compared to clinical scores of degradation risks of renal function for patients infected with hiv.

the aim of this study is to compare the biomarkers levels as il-18, kim-1 and cystatin c for patients infected by hiv with failure in renal function at year 5. the main criterion will be a degradation of the glomerular filtration throughput measured. it will be compared to clinical scores of degradation risks of renal function for patients infected with hiv. from 2011 to 2013, researchers realized a study called hivol, on the diagnostic performance of gfr (glomerular filtration rate) estimators in patients infected with hiv. it lead to a publication in aids, retaken in the rational of recommendations of infectious diseases society of america for the chronic renal diseases support for patients infected with hiv. 235 patients were involved, for everyone researchers have a gfr measure (by iohexol plasmatic clearance) and urinary and plasma samples.

Eligibility criteria:
inclusion criteria: * patient affiliated or entitled to a social security scheme * patient hiv infected * patient included in the hivol cohort with a gfr measure available * patients who have given their consent in writing exclusion criteria: * pregnant or lactating women * patients treated with metformin * patients with a known allergy, regardless the type of allergy * patients with a history of thyroid dysfunction * any biological anomaly in the selection, which in the opinion of the investigator, may indicate a contraindication to the patient's participation in this study * degradation recent (not older than three months) of renal function defined as the degradation of more than 25 % gfr. * estimated gfr of less than 15 ml / min / 1.73m2 * history of major immediate or delayed skin reaction known to the injection of iodinated contrast medium (omnipaque®) * manifest thyrotoxicosis * hypersensitivity to the active substance or to any of the excipients (omnipaque®) * patient who expressed his refusal to participate in the study * patient justice under protection
efficacy and safety of sublingual fentanyl tablets in treatment of breakthrough pain in cancer patients.

Conditions: Pain; Cancer

Summary: the purpose of this study is to determine the effectiveness and safety of sublingual fentanyl tablets in relieving breakthrough pain in cancer patients.


Eligibility criteria:
inclusion criteria: * males or females 17 years of age or older * stable cancer-related pain. * are receiving a stable, fixed-schedule oral opioid regimen equivalent to 60 to 1000 mg of oral morphine per day or transdermal fentanyl therapy equivalent to 50 to 300 µg/h, and are on a stable dose of opioid medication for relief of breakthrough pain for at least 14 days prior to screening. * experiencing 1-4 episodes of breakthrough pain per day. * meet the criteria defined in the eastern cooperative oncology group (ecog) performance status for grade 0, 1, or 2. exclusion criteria: * are pregnant or lactating. * have uncontrolled or rapidly escalating pain. * have moderate to severe ulcerative mucositis. * have a cardiopulmonary disease that would increase the risk of administering potent opioids. * have neurologic or psychologic disease that would compromise data collection * have any clinically significant condition that would, in the investigator's opinion, preclude study participation. * are currently taking monoamine oxidase inhibitors (maois), or have taken maois within 14 days prior to enrolling in the study. * have received strontium 89 therapy within 60 days prior to entering the study. * have received anti-neoplastic therapy within 2 weeks of study entry that, in the investigator's opinion, will influence assessment of breakthrough pain * have received any investigational drug (non-approved) within 30 days prior to the first dose of study medication, or are scheduled to receive an investigational drug other than en3267 during the course of the study. * have hypersensitivities, allergies, or contraindications to fentanyl. * have a significant prior history of substance abuse or alcohol abuse. * may have difficulty complying with the protocol, as assessed by the investigator.
the value of doppler study of central retinal artery in diagnosis of increased icp

Conditions: Increased Intracranial Pressure

Summary: the purpose of this study is to evaluate the diagnostic value of central retinal artery doppler study in case of increased intracranial pressure.

in neurocritical care, the detection of raised intracranial pressure (icp) remains crucial as it is associated with poor outcome . invasive ventricular devices are the gold standard for continuous and reliable measurement of icp however their placement could be challenging due to blood coagulation disorder or lack of surgical availability. moreover, malfunction or obstruction of ventricular catheters has been reported to occur as often as 6%. recently julie.et al. revealed in his met analysis that optic nerve sheath diameter (onsd) has a good level of diagnostic accuracy for detecting intracranial hypertension with a pooled sensitivity of 0.9. the central retinal artery (cra) is an end artery branch of the internal carotid artery that joins the optic nerve 1cm behind the globe and enters the retina on the optic nerve head . central retinal artery is located inside the optic nerve sheath, and the optic nerve is part of the central nervous system and the intraorbital subarachnoid space surrounding the optic nerve is subject to the same pressure changes as the intracranial compartment,so we should expect any increase of icp will compress the central retinal artery exactly the same as basal cerebral arteries. central retinal artery circulation is low resistance circulation with good diastolic flow and upper limit of resistivity index is 0.7. so, any compression of cra will decrease the diastolic flow and increase ri. kamil.et al. studied the blood flow velocity changes in orbital arteries by using doppler sonography in eight patients with brain death and increased icp. peak systolic and end-diastolic velocities and resistive indices of the ophthalmic and central retinal arteries were evaluated. they observed the absence or reversal of end diastolic blood flow in these arteries. if the intracranial pressure is higher than the end-diastolic pressure of the cerebral arteries diastolic flow reversal occurs. if the intracranial pressure exceeds systolic pressure blood flow is entirely ceased with complete and irreversible loss of brain function cra is a superficial, easy accessible without bony obstacle like transcranial doppler (tcd) and the learning curve of its doppler study can be very steep, so it could has a big role in management of cases with increased icp.

Eligibility criteria:
inclusion criteria: * all patients with cerebral stroke either ischemic or hemorrhagic * all patients with traumatic brain injury including those on mechanical ventilation exclusion criteria: * patients with eye trauma * patients with either arteritic or non arteritic central retinal artery occlusion
incidence of short-term urinary retention after fascial retropubic sling: prospective and randomized analysis.

Conditions: Stress Urinary Incontinence; Urinary Retention Postoperative; Urinary Retention After Procedure

Summary: the aim of this study is to evaluate the incidence of short-term urinary retention and the cure rate in patients with stress urinary incontinence undergoing surgical treatment with fascial pubovaginal sling with two tension adjustment techniques: the classic adjustment technique ("2 fingers") and measuring the distance between the fixation knot and the aponeurosis of 4 cm.

a randomized double-blind clinical trial will be conducted in women over 18 years of age with stress urinary incontinence and indication for surgical treatment, who have not undergone previous surgical treatment. postoperative follow-up will be 1 month when the incidence of urinary retention and the rate of cure after the procedure will be evaluated. the incidence of urinary retention in 1 month postoperatively will be evaluated in the two different techniques (post-voiding residue \> 200ml or the need for intermittent bladder catheterization) and the cure rate for urinary incontinence (cough test and response "no" to the question 3 of the urogenital distress inventory questionnaire).

Eligibility criteria:
inclusion criteria: * 18 years old and no improvement with conservative management exclusion criteria: * prior anti incontinence surgery

Keywords: stress urinary incontinence pubovaginal sling urinary retention
a study in patients with asthma

Conditions: Asthma

Summary: the purpose of the present study is to demonstrate the higher efficacy of foster® nexthaler® 100/6 extra fine (two inhalations b.i.d.) versus seretide® accuhaler® 250/50 (one inhalation b.i.d.), in terms of pulmonary function (change from baseline to the end of treatment in post-dose peripheral airway resistance) in patients with asthma.

asthma is a chronic inflammatory disease characterised by variable airflow obstruction and bronchial hyper responsiveness. asthma affects both the large and the small airways and there is a growing body of evidence that small airways impairment is an important contributor to the pathogenesis and clinical expression of the disease.

Eligibility criteria:
inclusion criteria: * male or female outpatients aged ≥ 18, who have signed an informed consent form prior to initiation of any study-related procedure. * clinical diagnosis of asthma for a minimum of 12 months prior to screening confirmed by a chest physician according to international guidelines (gina). the evidence of asthma must be confirmed through a documented (in the last three years) positive response to the reversibility test, defined as δfev1 ≥ 12% and ≥ 200 ml over baseline, within 30 minutes after administration of 400 μg of salbutamol pmdi or through a documented (in the last three years) positive response to methacholine challenge test (pc20 \< 8 mg/ml or pd20 \< 1 mg). * baseline fev1 \> 80% of the predicted normal value after appropriate washout from bronchodilators (to be checked at screening and at randomisation visits). * asthma control test score ≥ 20 and \< 25 (to be checked at screening and at randomisation visits). * impaired small airways function defined as baseline peripheral airway resistance \[r(5hz)-r(20hz)\] ≥ 0.07 kpa/l/s (to be checked at screening and at randomisation visits). * patients on previous regular treatment with seretide® accuhaler® (fluticasone propionate 250 μg plus salmeterol xinafoate 50 μg per actuation, daily dose of fluticasone 500 μg plus salmeterol 100 μg) at a stable dose for at least 2 months prior to inclusion. * a cooperative attitude and ability to be trained to the proper use of dpi. main exclusion criteria: * patients with a diagnosis of copd according to gold guidelines. * current smokers with a smoking history of \> 10 pack/year. * patients who have a clinical or functional uncontrolled respiratory, haematological, immunologic, renal, neurologic, hepatic, endocrinal or other disease, or any condition that might, in the judgment of the investigator, represent for the patients an undue risk or that could compromise the results or interpretation of the study. * history or current evidence of uncontrolled heart failure, clinically relevant coronary artery disease, recent myocardial infarction, severe hypertension, uncontrolled cardiac arrhythmias. * patients treated with laba or ics/laba fixed combination in the 24 hours before the screening visit. * severe asthma exacerbation leading to intake of systemic corticosteroids (\> 10 days) in the month before the screening visit.
obesity cohort : medical follow-up of severe or morbid obese patients undergoing bariatric surgery

Conditions: Obesity, Morbid; Bariatric Surgery Candidate

Summary: the aim of this cohort is to evaluate the follow-up of morbidly obese patients treated by several types of bariatric procedures. in addition, this study could lead to the development of clinical trials on assessment of the bariatric surgery impact.

the main objective is to prospectively evaluate long-term efficiency of bariatric surgery in terms of weight loss. moreover, this cohort wants to assess the long-term effectiveness of bariatric surgery on comorbidities and quality of life, the medical and economic impact of bariatric surgery (before-after comparison using data from health insurance), estimates the incidence of mortality and morbidity of bariatric surgery and to finish describe the evolution of patients in case of new-surgery. from a methodological point of view, the obesity cohort is a prospective cohort study, single-center, open, with aftercare performed during life of patients. the number of inclusions is to 1500 patients. after surgery , patients will be followed at least 4 visits the first year and at least 2 visits a year then. the recommendations of the french health ministry (has), the frequency of visits may be increased according to the patient's progress. follow-up visits of patients after bariatric surgery will be performed by physicians or surgeons of the multidisciplinary team responsible for the care of the patient (digestive and reconstructive surgery, anesthesiology, endocrinology, medical imaging, gastroenterology, immunology and physiology) . it will be insured for life, obesity is a chronic disease and because of the risk of late complications.

Eligibility criteria:
inclusion criteria: * only be considered in patients operated and followed at chu montpellier with bariatric surgery * patients treated by bariatric surgery on chu montpellier * agreed to participate to the study by signing an informed consent * eligible to health insurance exclusion criteria: * unable to follow the patient in the long term (foreign patients, surgical use ...) * inability to follow in the long run

Keywords: weight loss sleeve gastrectomy gastric bypass gastric banding bariatric procedures cohort morbid obesity medical and economical impact severe obesity
effect of galactose ingestion on postprandial lipemia

Conditions: Cardiovascular Risk Factor; Lipemia

Summary: this study aims to assess the postprandial triglyceride response to the ingestion of a high-fat meal with co-ingestion of either galactose, or glucose.


Eligibility criteria:
inclusion criteria: * male * 18 to 35 years old * body mass index \<30 kg/m2 exclusion criteria: * female * body mass index \>29.9 kg/m2 * any history of metabolic disease * allergies or intolerances to milk and/or cream
preliminary study to the conception of a non-invasive neonatal monitoring system with development of a database

Conditions: Infant, Premature

Summary: each year, 300 000 new borns are hospitalised in neonatology units in europe. this period is very sensitive as newborns are exposed to a high risk of morbidity and mortality, with severe impact on neuro-developmental prognostic. the rennes university hospital was granted a specific funding from the european union in the framework of the horizon 2020 programme (call personalising health and care 2015-single-stage - grant agreement number 689260) to develop the digi-newb project. this project aims to develop innovative non-invasive monitoring tools to support decision making in health. such tools include a new generation of real time monitoring in neonatology using composite indices made of cardio-respiratory variables, movements, sounds, and clinical data. the digi-newb cohort aims to gather all physiological data relevant for the creation of the composite indices.

the database will be used to answer the following specific objectives, with priority given to the two first ones (sepsis and maturation) : 1. early diagnosis of sepsis for the following cases : late onset sepsis of premature newborns, materno-fœtal sepsis, and newborn infection by chorioamnionitis 2. cardio-respiratory and neurobehavioral maturation (movements, sleeping cycles) 3. influence of environmental factors and developmental care on selected parameters 4. influence on care organisation of the possibility to access videos and movement analyses by medical teams 5. influence of glycemia on selected parameters 6. influence of neurological lesions and broncho-pulmonary dysplasia on selected parameters 7. indices correlation with medical images mri (t1, t2, diffusion, arterial spin labelling) from neonatal units and with health evaluated after 1 and 2 years with the ages \& stages questionnaires (asq) 8. evaluation of the acquisition system's user-friendliness

Eligibility criteria:
inclusion criteria: * newborn hospitalised in the neonatology services of participating hospitals * one of the legal representatives gave its signed agreement to take part to the study * new born aged of less than 6 weeks in corrected term exclusion criteria: * no signed agreement from the legal representative

Keywords: sepsis neonates cardio-respiratory maturation neurobehavioral maturation
oral immunonutrition therapy to reduce acute toxicity after neoadjuvant chemoradiotherapy pancreatic cancer patients

Conditions: Pancreatic Cancer; Neoadjuvant Chemoradiotherapy; Immunonutrition

Summary: a prospective, single-arm clinical trial is conducted to investigate the role of oral immunonutrion in reducing acute toxicity after neoadjuvant chemoradiotherapy among pancreatic cancer patients.

pancreatic cancer has a poor prognosis for its high malignancy. radical surgical resection is an effective means for prolonging survival. however, only a few patients can be directly treated with surgical resection. neoadjuvant therapy can reduce the tumor size, improve the relationship between the tumor and adjacent blood vessels，to gain surgical opportunities and prolonging patients' survival. nutritional treatment of cancer has been valued by more and more researchers. as an important branch of nutrition therapy, immunonutrition plays an important role in regulating the immune. studies have shown that immunonutrition can reduce antitumor treatment related toxicity among patients with head and neck cancer, esophageal cancer. at present, most studies on immunonutrition therapy focus on perioperative patients, and there is no study on patients with pancreatic cancer undergoing radiotherapy. this prospective, single-arm clinical trial aimed to explore the efficacy and safety of oral immunonutrition therapy in reducing acute toxicity after neoadjuvant chemoradiotherapy among pancreatic cancer patients. a total of 98 pancreatic cancer patients will be enrolled. all of the patients will receive oral immunonutrition therapy for 6 weeks from one week before radiotherapy. the total follow time is 4 months.

Eligibility criteria:
inclusion criteria: * 1. pathologically confirmed pancreatic ductal epithelial malignant tumors; * 2. resectable pancreatic cancer treated with neoadjuvant chemoradiotherapy, or nonresectable locally advanced pancreatic cancer treated with neoadjuvant or radical chemoradiotherapy; * 3.nutritional risk screening 2002 (nrs2002) ≥3 and patient-generated subjective global assessment (pg-sga) performance status b; * 4. age 18 years and older; * 5. eastern cooperative oncology group (ecog) performance status 0-1; * 6. expected survival time more than 3 months; * 7. history of antineoplastic therapy; exclusion criteria: * 1. known allergy or intolerance to any component of investigational oral immunonutrition; * 2. history of oral immunonutrition use within one month prior to enrollment; * 3. tumor compresses the major duodenal papilla, and /or appeared jaundice, acute pancreatitis; * 4. patients with contraindications for antineoplastic therapy, such as coronary heart disease, cerebral infarction, cerebral hemorrhage or other serious diseases; * 5. liver, kidney and blood coagulation function failure; * 6. patients with hemopathy; * 7. patients with active infections; * 8. patients with other primary tumor; * 9. patients with other medical diseases that seriously affected nutritional status; * 10.subjects deemed by the investigator have other factors that may be ineligible for enrollment;
doppler findings in the fetal cerebral blood vessels (va/mca) within 24 hours before delivery and relation with perinatal outcome.

Conditions: Ultrasonography, Doppler; Obstetric Labor Complications

Summary: 1. assess differences in flow patterns in the fetal cerebral blood vessels within 24 hours before delivery between fetuses with a normal vs. adverse perinatal outcome. 2. explore maternal and/or fetal characteristics that might influence technical feasibility of doppler sonography of the fetal cerebral blood vessels in early labor at term. 3. assess reliability of the technique by measuring intra- and inter-observer variation in a subset of participants.


Eligibility criteria:
inclusion criteria: * singleton pregnancy. * term gestation (37-42 weeks). * fetus in cephalic presentation. * no known fetal chromosomal or (severe) congenital anomaly. * normally grown fetus (ultrasound scan demonstrating normal fetal growth between 30-37 weeks of gestation, defined as an estimated fetal weight/abdominal circumference \> 10th centile or crossing \<2 quartiles compared to earlier growth ultrasound). * absence of pre-existing doppler or amniotic fluid abnormalities. * normal fetal heart rate tracing / ctg (excluding pre-existing hypoxia). * admission in early spontaneous labor or induction of labor with expected delivery \< 24 hours. * maternal age \>= 18 years * willing to give written informed consent. exclusion criteria: * advanced labor (\> 4cm of cervical dilatation) at the time of admission on the labor ward. * severe pre-existing chronic maternal medical condition or poor obstetric history/antenatal complications associated with increased risk of adverse perinatal outcome (non-exhaustive e.g.: uncontrolled chronic hypertension, severe pre-eclampsia, uncontrolled (gestational) diabetes, maternal sepsis, major antepartum haemorrhage, intra-uterine infection, prolonged rupture of membranes \> 18 hours, etc.). * intra-uterine fetal demise / death. * prelabour rupture of membranes with meconium-stained amniotic fluid. * patients not fulfilling all the inclusion criteria or refusing to give written informed consent.