Kornimate/medical-research-clean huggingface dataset:
safety profile of intravenous lidocaine use in coelioscopic bariatric surgery

Conditions: Obesity; Bariatric Surgery

Summary: intravenous lidocaine is efficient for management of post operative pain in abdominal surgery. as previously published in literature the investigators use it during bariatric surgery. nevertheless plasmatic concentration of lidocaine is unknown in this population, despite a widespread use. investigators propose in this work to bring an objective proof that administration of lidocaine based on a modified body weight is safe. intravenous administration concerned the peri operative period. a total of six samples are taken for each patient. investigators get approbation of local ethic committee for this work.


Eligibility criteria:
inclusion criteria: * adult who perform a bariatric surgery (sleeve, by-pass, mini by-pass) under laparoscopy * body mass index \> = 40 kg/m2 * informed consent signed * patient treated with intravenous administration of lidocaine exclusion criteria: * contraindication to lidocaine use (allergy, atrioventricular block, seizure, porphyria) * concomitant use of beta blocker and others anti arrhythmic drugs * cardiac or hepatic insufficiency * pregnancy

Keywords: bariatric surgery, lidocaine, plasmatic concentration, monoethylglycinexylidide (megx), safety
effect of antipsychotics on appetite regulation

Conditions: Psychotic Disorders

Summary: the purpose of this study is to evaluate changes in appetite-regulating hormones, body composition (weight, body fat%), and hunger ratings in persons early in treatment with one of four atypical antipsychotic medications (olanzapine, risperidone, ziprasidone, aripiprazole).

severe weight gain and glucose dysregulation are serious problems in patients treated with second-generation ('atypical') antipsychotics (sga). these side effects frequently interfere with medication compliance and necessitate discontinuation of treatment. although the causal mechanisms for weight and glucose dysregulation are not well understood, one promising area of investigation targets sga-induced disturbances in appetite and in appetite-regulating hormones. findings from our group (and others) demonstrate sga treatment-related increases in fasting levels of the appetite-stimulating hormone, ghrelin, as well as increases in self-report hunger. this novel study will examine prospective changes in ghrelin and in the 'satiety-signaling' peptide yy (pyy) as measured before and after participants consume a standard mixed-macronutrient meal. data are obtained at baseline (within 4 weeks of beginning medication), and again 2 months and 4 months later.

Eligibility criteria:
inclusion criteria: 1. meets dsm iv criteria for a psychotic disorder (schizophrenia, schizophreniform, brief psychotic disorder, schizoaffective disorder), bipolar disorder, or major depression with psychotic features; 2. "drug naïve" prior to most recent psychiatric diagnosis; 3. currently prescribed one of four atypical antipsychotic medications: olanzapine, risperidone, ziprasidone, or aripiprazole; 4. between the ages of 18 and 40, any race and either gender; 5. not obese (bmi \< 30 kg/m2) (fasting and postprandial ghrelin levels are altered in obesity); 6. has negative histories for cardiovascular, metabolic, and endocrine disorders at screening; 7. is willing and able to eat animal-derived foods; and 8. is not exercising 3 or more times per week. exclusion criteria: 1. use of medications to treat metabolic and endocrine abnormalities, corticosteroids, over-the-counter appetite suppressants that contain phentermine or sibutramine; 2. active involvement with a weight loss program (i.e., weight watchers); 3. serious or unstable medical illness which requires ongoing treatment with medication (this does not include hypertension); 4. anemia; 5. at serious suicidal risk; 6. current substance abuse or dependence; 7. for female subjects, pregnancy or nursing (because pregnancy may influence appetite and because the body composition procedure involves low level x-ray exposure). 8. known history of mental retardation or dementia. 9. children and adolescents under age 18 will be excluded owing to the inherent confounding effects of normal growth on body weight and appetite.

Keywords: antipsychotic ghrelin pyy appetite weight gain
improving epilepsy surgery management and prognosis using virtual epileptic patient software (vep)

Conditions: Epilepsy

Summary: every year, thousands of patients worldwide with drug resistant focal epilepsy (dre) undergo resective brain surgery with the aim of achieving seizure freedom. despite technical advances over the last 50 years, the success rate of epilepsy surgery in terms of seizure freedom has not greatly improved, remaining overall at around 50%. depending on features of individual cases, presurgical evaluation includes a first phase of non-invasive data including video-eeg recordings, magnetoencephalography, structural and functional neuroimaging and neuropsychological evaluation. if these investigations do not allow adequate localization of likely region of seizure organization in the brain (the epileptogenic zone, ez), then a second invasive phase using intracerebral eeg recording may be necessary (stereoelectroencephalography, seeg). interpretation of seeg remains difficult in many cases, in particular since seizure onset is often characterized by discharges that very rapidly involve several distinct brain regions. no reliable measuring instrument currently exists to combine the various prognostic factors for a given patient. this leads to great uncertainty on an individual scale in predicting the effects of surgery. the mapping of epileptic networks in patients with dre is an innovative scientifically-validated and clinically-tested method to significantly improve accuracy of seeg and presurgical interpretation and guide surgical strategies in patients with dre. therefore, the investigators developed the virtual epilepsy patient software. retrospective study already demonstrated the pertinence of this approach in improving the anatomical mapping of epileptogenic networks. now, the investigators aim to prospectively demonstrate the role of vep during presurgical evaluation of dre patients


Eligibility criteria:
inclusion criteria: * patient or pediatric patient suffering from drug-resistant focal epilepsy. * standardized presurgical evaluation including medical history, scalp video-eeg, 3t mri (dti and rsmri), fdg-pet, neuropsychological tests. * inpatient in one of the participating centers for recording seizure during long term seeg-monitoring. exclusion criteria: * epilepsy surgery performed without the requirement of seeg or contra-indication to epilepsy surgery.
heart failure recorded in primary care, hospital admissions and national mortality registry

Conditions: Heart Failure

Summary: the main objectives of this study are i) to assess how heart failure was captured accross different linked electronic health record sources within the caliber program and the overlap between primary care, hospital admissions and/or the national mortality register, and ii) to assess risk factors, heart failure treatment and survival in patients, stratified by ehr source.

heart failure (hf) is one of the leading causes of hospital admissions and mortality in modern healthcare systems. it can be viewed as a collective clinical syndrome of many signs and symptoms and is frequently the common endpoint of various heart diseases. often, it is not diagnosed until it has reached a level whereby quality of life is significantly, and often irreversibly, impaired. even though vast quantities of national health service (nhs) data concerning patients with heart failure are recorded, there are limited 'real world' longitudinal insights about the prognosis and consequences of hf. although linked electronic health records cohorts such as the caliber program become increasingly available, for heart failure the overlap, risk factors and subsequent mortality have not been compared. previous studies on heart failure using ehr sources have used icd-9 or 10 codes for the identification of heart failure cases and the prevalence estimates of risk factors and comorbidity. furthermore, the assessment of supporting information for heart failure present in electronic healthcare registries remains largely unknown. currently, heart failure is typically inferred based on previous reports or the prescription of heart failure related medication. to strengthen heart failure case ascertainment in large electronic healthcare registries, linkages with primary care data such as what is done in caliber could allow more detailed insight in medical history, clinical diagnoses, anthropometric measures, health behaviour, laboratory tests, medical procedures and prescriptions. in this study, the investigators assessed the distribution of recording, supportive medical information for heart failure diagnosis, risk factors and subsequent mortality of heart failure patients captured in linked ehr data from primary care, hospital admissions and/or death registry. this study is part of the caliber (cardiovascular disease research using linked bespoke studies and electronic records) programme funded over 5 years from the nihr and wellcome trust. caliber has received both ethics approval (ref 09/h0810/16) and ecc approval (ref ecc 2-06(b)/2009 caliber dataset).

Eligibility criteria:
inclusion criteria: * patients with a coded diagnosis for heart failure in primary care or hospital admission * patients with a coded diagnosis for heart failure as a cause of death in the national mortality register * patients in cprd practices which are deemed "up to standard" for more than 1 year by cprd criteria. * patients with at least one year of follow-up in the cprd practice cprd. exclusion criteria: * past medical history of heart failure
growing up with rare genetic syndromes

Conditions: Prader-Willi Syndrome; PWS-like Syndrome; Silver Russel Syndrome; Congenital Hypopituitarism; Klinefelter (XXY-)Syndrome; Congenital Adrenal Hyperplasia; XXXXY Syndrome; XXYY Syndrome; XXXX Syndrome (Tetra-X Syndrome); Disorders of Sex Development; Turner Syndrome; 46, XY DSD; Tuberous Sclerosis; Neurofibromatosis; Albright Hereditaire Osteodystrofie; Cornelia de Lange Syndrome; Saethre-Chotzen Syndrome; 17p- Deletiesyndrome; VCF Syndrome; POLR3A Mutatie; Ohdo Syndrome; Jacobsen Syndrome / 11 q Syndrome; Myrhe Syndrome; CHARGE Syndrome; 1q25-32 Deletie; Bardet Biedl Syndrome; Rett Syndrome; 22q11 Deletion Syndrome; Allan-Herndon-Dudley Syndrome; Kallmann Syndrome; Rare Bone Disorders; Noonan Syndrome; Williams-Beuren Syndrome

Summary: introduction rare complex syndromes patients with complex genetic syndromes, by definition, have combined medical problems affecting multiple organ systems, and intellectual disability is often part of the syndrome. during childhood, patients with rare genetic syndromes receive multidisciplinary and specialized medical care; they usually receive medical care from 3-4 medical specialists. increased life expectancy although many genetic syndromes used to cause premature death, improvement of medical care has improved life expectancy. more and more patients are now reaching adult age, and the complexity of the syndrome persists into adulthood. however, until recently, multidisciplinary care was not available for adults with rare genetic syndromes. ideally, active and well-coordinated health management is provided to prevent, detect, and treat comorbidities that are part of the syndrome. however, after transition from pediatric to adult medical care, patients and their parents often report fragmented poor quality care instead of adequate and integrated health management. therefore, pediatricians express the urgent need for adequate, multidisciplinary adult follow up of their pediatric patients with rare genetic syndromes. medical guidelines for adults not exist and the literature on health problems in these adults is scarce. although there is a clear explanation for the absence of adult guidelines (i.e. the fact that in the past patients with rare genetic syndromes often died before reaching adult age), there is an urgent need for an overview of medical issues at adult age, for 'best practice' and, if possible, for medical guidelines. the aim of this study is to get an overview of medical needs of adults with rare genetic syndromes, including: 1. comorbidities 2. medical and their impact on quality of life 3. medication use 4. the need for adaption of medication dose according to each syndrome methods and results this is a retrospective file study. analysis will be performed using spss version 23 and r version 3.6.0.


Eligibility criteria:
inclusion criteria: * patients with rare syndromes or rare congenital diseases visiting the multidisciplinary outpatient clinic for patients with rare diseases at the department of endocrinology, internal medicine, erasmus medical center. exclusion criteria: * none
french cac-hiv cohort study

Conditions: Coronary Artery Calcification; HIV Infections

Summary: clinical study: * methods: observational transversal two-arm cohort study including adults living with hiv (plhiv) and hiv negative subjects (hiv-) at intermediate cardiovascular risk. no study specific interventions were performed. * participants: consecutively recruited at two large public hospitals in paris and annecy, france where participants were referred for routine cardiac risk stratification. * recruitment: was from june 2013 until april 2016. * data: anonymous study data were collected during the ambulatory visit. no follow-up was conducted. study objectives: * primary: compare coronary artery calcification (cac) score between plhiv and hiv- in order to bridge gaps in current knowledge. * secondary: assess parameters linked to cac score including predictors and their prevalence, association with carotid/femoral atherosclerosis, and cardiovascular risk scores (ascvd and heart score). study hypotheses: * primary: cac scores would not be different between plhiv and hiv- * secondary: prevalence of traditional cv risk factors would be lower in plhiv but that hiv-related nontraditional cv risk factors (including lower grade chronic inflammation, immune dysregulation, and arv exposure duration) would be associated with higher cac scores and higher cv risk scores study rational: * plhiv have an increased risk of atherosclerotic cardiovascular events compared to the general population. primary prevention for plhiv is important but challenging as traditional cardiovascular risk scores do not account for hiv-related factors. * computed tomography coronary artery calcium (cac) score using the agatston score is useful for detecting and quantifying coronary calcifications. in the general population, cac score is predictive of future cardiovascular events.


Eligibility criteria:
inclusion criteria: * provide informed consent * present one or more cardiovascular risk factor * complete comprehensive cardiovascular assessment including a valid cac score, vascular evaluation, interview for demographic, clinical and medical history and a medical workup. exclusion criteria: * age younger than 18 years old * history of established cardiovascular disease.

Keywords: cardiovascular risk stratification primary cardiovascular prevention intermediate cardiovascular risk france
a comparison of two devices for measuring the central thickness of the cornea before and after surgery (cecot)

Conditions: Disorders, Refractive

Summary: corneal topography allows the measure of the radii of curvature and of the thickness of the cornea. it is essential for diagnosis in ophthalmology and allows to highlight corneal irregularities such as a keratoconus, or too thin corneas which are a contra-indication for laser refractive surgery. several types of corneal topographers are commercially available. some as the orbscan(r), operate by analyzing the image of the patterns of a placido disk associated with a light slit, allowing the collection of thousands of points of the anterior and posterior surface of the cornea. more recent systems such as the pentacam(r) are based on automatic rotary cameras which capture images of the whole anterior segment of the eye. the aim of this study is to compare two topographs, the pentacam(r) and the orbscan(r) and, more specifically, the central corneal pachymetry measurements measured pre- and postoperatively.


Eligibility criteria:
inclusion criteria: * patients for whom a lasik refractive surgery is planned exclusion criteria: * hyperopic patient * another refractive surgery technique * pregnant or lactating woman * patient's opposition to participation in the study, according to the law on research into routine care * patient under a measure of legal protection * absence of affiliation to social security
a study of cabiralizumab given with nivolumab with and without chemotherapy in patients with advanced pancreatic cancer

Conditions: Advanced Pancreatic Cancer

Summary: the purpose of this study is to determine whether an investigational immuno-therapy, cabiralizumab in combination with nivolumab, with or without chemotherapy, is effective for the treatment of advanced pancreatic cancer.


Eligibility criteria:
inclusion criteria: * must have histological or cytological confirmed diagnosis of locally advanced or metastatic adenocarcinoma of the pancreas, which has progressed on or after one line of chemotherapy * ecog performance status 0-1 * adequate organ functions * measurable disease exclusion criteria: * suspected or known cns metastasis * participants with active, known, or suspected autoimmune disease * uncontrolled or significant cardiovascular disease * prior exposure to selected immune cell-modulating antibody regimens
efficacy study of a bioelectric dressing used with negative pressure wound therapy to treat diabetic and pressure ulcers

Conditions: Wound Healing

Summary: the purpose of this study is to determine whether a bioelectric wound dressing, used in conjunction with negative pressure wound therapy (npwt), is effective in the treatment of diabetic and pressure ulcers of the foot.


Eligibility criteria:
inclusion criteria: * wound size greater than 1x1 cm * wounds must be ≥5 cm away from all other wounds * wound size must not be diminished in size greater than 10% between enrollment in study and the prescreening * participant must be candidate for negative pressure wound therapy * participant agrees to participate in follow-up evaluations * participant must be able to read and understand informed consent, and sign the informed consent exclusion criteria: * concurrent participation in another clinical trial that involves an investigational drug or device that would interfere with this study * participant is to receive another topical agent (antimicrobials, enzymes, etc.) other than the study dressing (granufoam) * participant is to receive silver granufoam for their wound * participant with sensitivity or adverse reactions to silver or zinc * pregnancy or nursing an infant or child * immunosuppression * active or systemic infection * participant undergoing active cancer chemotherapy * chronic steroid use

Keywords: wound skin lesion antimicrobial bioelectric diabetic foot pressure ulcer
safety and efficacy study of suvorexant in participants with primary insomnia - study a (mk-4305-028)

Conditions: Primary Insomnia

Summary: this is a multicenter study to test the hypothesis that suvorexant (mk-4305) is superior to placebo in improving insomnia as measured by change from baseline in: subjective total sleep time and time to sleep onset, wake time after persistent sleep onset, and latency to onset of persistent sleep. participants who complete the initial 3-month treatment (trt) phase may participate in an optional 3-month extension (ext) phase.


Eligibility criteria:
inclusion criteria: * must be ≥18 yrs old on the day of signing informed consent * diagnosed with primary insomnia * good physical and mental health * participant ≥65 yrs old score at least 25 on the mini mental state examination * a female participant who is of reproductive potential has a negative serum pregnancy test and agrees to use contraception * reports difficulty with initiating and maintaining sleep during the 4 weeks prior to visit 1 (accordingly to specific protocol criteria) * reports spending 6.5 to 9 hours nightly in bed on at least 3 out of 7 nights prior to visit 1 * regular bedtime is between 9 pm-1 am * willing to refrain from napping while in study * able to read, understand and complete questionnaires and all diaries * willing to limit alcohol, caffeine, and nicotine consumption while in the study * for a portion of participants: must be willing to stay overnight in a sleep laboratory and must be willing to stay in bed for at least 8 hours each night while at the sleep laboratory exclusion criteria: * female participant is pregnant and/or breastfeeding at prestudy visit, or expecting to conceive while in study * history or diagnosis of another sleep disorder * difficulty sleeping due to a medical condition * history of a neurological disorder * history of bipolar disorder, psychotic disorder, or posttraumatic stress disorder, or current psychiatric disorder that requires a prohibited medication * ongoing depression * history of substance abuse or dependence * history or current evidence of a clinically significant cardiovascular disorder or clinically significant electrocardiogram (ecg) at prestudy visit * taking certain prohibited medications * consumption of the equivalent of \>15 cigarettes a day * history of malignancy ≤5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer * participant is considered morbidly obese * previously randomized in another investigational study of suvorexant