Kornimate/medical-research-clean huggingface dataset:
effects of atorvastatin on macrophage activity and plaque inflammation using magnetic resonance imaging

Conditions: Atherosclerotic Carotid Disease; Atheroma; Atherosclerosis

Summary: a new way of scanning narrowing in the arteries (main blood vessels) caused by fatty deposits known as plaques has been developed. heart attacks and strokes occur when plaques become inflamed, depending on the artery affected. currently used clinical tests can only tell us how much the vessel is blocked by the plaque and not how inflamed (i.e. dangerous) it is. this new method of scanning using magnetic resonance imaging (mri) and a special agent called sinerim can identify inflamed plaques. this study will evaluate patients with plaques in their arteries in their neck at risk of strokes to see whether treatment with a cholesterol-lowering drug called atorvastatin can reduce the amount of inflammation within the artery wall within the first three months of treatment. if this effect can be measured using mri scanning with the use of sinerim then the results of this study will provide additional clinical validation of the use of mri scanning combined with agents such as sinerem®.


Eligibility criteria:
inclusion criteria: * positive sinerem®-enhanced mri of carotid plaque confirmed by a consultant neuroradiologist * must either be statin naive or have been on a stable dose of a statin(permitted statins and total daily dose are as follows: atorvastatin =10mg, simvastatin =40mg, pravastatin =40mg, fluvastatin =80mg, rosuvastatin =10mg for =4 weeks prior to screening, with no evidence of statin intolerability.) exclusion criteria: * require continued use of non-statin lipid modifying therapies or therapy with any other lipid regulating medications * history of statin intolerance * history of chronic viral hepatitis or other liver dysfunction * renal impairment with serum creatinine \>2.5 mg/dl (\>221 mol/l) * history of myopathy or inflammatory muscle disease, or 3 times more than the upper limit of normal levels of total creatinine kinase in serum * doppler assessment of less than 40% stenosis during screening assessment * allergy to dextran and iron salts * contraindication to mri scanning * planned carotid surgery or endovascular intervention earlier than 10 weeks within the study period

Keywords: atherosclerotic plaque uspio atheroma thrombo-embolic stroke magnetic resonance imaging ultra small super-paramagnetic iron oxide
pancreatic duct stenting to prevent postoperative pancreatic fistula (popf) after distal pancreatectomy

Conditions: Pancreatitis

Summary: to determine whether pre-operative pancreatic stenting for distal pancreatectomy will impact the incidence of a post-operative pancreatic fistula, as defined by postoperative. if pre-operative pancreatic stenting appears to reduce the formation of postoperative pancreatic fistula (popf) in this pilot study, this will form the basis of a larger randomized trial in the future. the hypothesis is that pre-operative pancreatic duct stenting can significantly decrease the rate of development of a post-operative pancreatic fistula after distal pancreatectomy.

prophylactic pancreatic duct stenting is to be offered to all patients deemed a candidate for a distal pancreatectomy. this is a nonrandomized cohort study with a retrospective and prospective control group (jan 2008 - dec 2017 or sample size obtained) and a prospective endoscopic intervention group (september 2015 - dec 2017 or until sample size obtained). we will then compare the rate of development of a postoperative pancreatic fistula between those patients who have preoperative stenting and those who do not. popf will be defined as the amylase level of drain contents equaling three times or more the serum amylase on postoperative day 3, as defined by the international study group for pancreatic fistula (isgpf) or an icd-9 diagnosis of 577.8. the patient will have a pre-operative visit for stent placement and a post-operative visit for stent removal if still in place 4-6 weeks after distal pancreatectomy.

Eligibility criteria:
inclusion criteria: 1. adult patients age 18 years of age and older 2. patients undergoing distal pancreatectomy for primary pancreatic disorder or isolated metastases to the pancreas. exclusion criteria: 1. pediatric patients younger than age 18 2. pregnant patients 3. patients undergoing distal pancreatectomies performed en bloc for non- pancreatic pathologies (gastric cancer, renal cell cancer, etc).

Keywords: pancreatic fistula, pancreatectomy, endoscopic stenting, pancreatic stenting, distal pancreatectomy
@ctivehip tele-rehabilitation system

Conditions: Hip Fractures

Summary: the purpose of this study is to determine if the @ctivehip tele-rehabilitation system improves the functional level and quality of life of hip fracture patients and reduce the caregiver burden.

background: the best option for rehabilitation after a hip fracture is still unclear. the home rehabilitation is one of the options and the use of tele-rehabilitation programs at home could be the option for some patients in the future. the main objective of this study is to improve the functional level and quality of life of hip fracture patients and reduce the caregiver burden using the @ctivehip tele-rehabilitation system. methods: this project will include hip fracture patients who met the following inclusion criteria: having a high pre-fracture functional level, not having severe cognitive impairment, absence of terminal disease, absence of post-surgery complications, going to live to their home or a relative home at hospital discharge, and signing an informed consent. the criteria to be part of this experimental group will be: having internet at home and a main caregiver with the ability to use the internet (@ctivehip system). patients without the internet at home will be part of the no intervention group, and they will receive the usual care, in addition to a triptych with information on recommendations and exercises to do at home. caregivers of patients of both groups will receive a training session on patient management. patients will be assessed at 4-weeks and 12 weeks after beginning to use the @ctivehip system. the primary outcome will be the functional level, measured by the functional independence measure. the secondary outcomes: quality of life (euro-qol), physical function (timed up and go, short physical performance battery, international fitness scale), emotional status ( the hospital anxiety and depression scale ), health status (american society of anesthesiologists score), cognitive status (mini-mental test ), fear of falling (short falls efficacy scale), pain (visual analogue scale), and caregiver burden of care (zarit burden interview). discussion: this study has been designed to provide a tele-rehabilitation system which includes a rehabilitation protocol created by a multidisciplinary team of surgeons, occupational therapist, physiotherapist, and sport scientist, to improve the functional level of patients after hip fracture surgery. the @ctivehip system could be a new low cost treatment option for some hip fracture patients.

Eligibility criteria:
inclusion criteria: patients who had hip fracture surgery having a high pre-fracture functional level having internet at home hospital discharge to their homes or a relative home. a main caregiver who has the ability to use the internet (@ctivehip system) have signed an informed consent exclusion criteria: presence of severe cognitive impairment presence of terminal disease presence of post-surgery complications

Keywords: tele-rehabilitation function quality of life exercise occupational therapy physiotherapy caregiver burden
renal denervation in diabetes.

Conditions: Diabetes

Summary: renal denervation (the use of radio waves to oblate the renal artery) has been shown to be an effective treatment for high blood pressure. it is currently being tested in heart failure patients and we would now like to look it its effects on diabetes. we therefore plan to enrol 20 participants with type ii diabetes into this study. half will undergo renal denervation in addition to their standard care and the other half will act as controls and only receive standard care. treatment allocation will be randomly assigned. all participants will undergo screening (including a physical exam, blood tests, ultrasounds and a muscle biopsy). all patients will have follow up tests (including physical exams and blood tests) 1, 3 and 6 months later.


Eligibility criteria:
inclusion criteria: * over 18 years * able and willing to provide informed consent * patients with established type ii diabetes mellitus (hba1c\>7%, diet or oral hypoglycaemic agents) * clinical stable as demonstrated by no change in background anti-diabetic medication in the last 30 days. * anticipated that patients are able to maintain a stable dose of medication for the duration of the study exclusion criteria: * renal arterial anatomy ineligible for rdn: main renal arteries \<4 mm in diameter or \<20 mm in treatable length; multiple renal arteries where main renal artery is estimated to supply \<75% of the kidney; haemodynamically or anatomically significant renal artery abnormality or stenosis in either renal artery which, in the investigator's opinion, would interfere with safe cannulation of the renal artery or require surgical repair or interventional dilation * history of prior renal artery intervention including balloon angioplasty, stenting or previous renal denervation. * single functioning kidney * need for insulin (interferes with euglycemic clamp testing) or glp-i analogues * egfr \<30 ml/min (mdrd formula) * any medical condition which, in the investigators opinion, may adversely affect the participants safety in the trial

Keywords: diabetes renal denervation
comparison of treatment modalities in poor responders undergoing ivf

Conditions: Poor Responders

Summary: the accurate identification and efficient management of poor responders remains one of the most enigmatic challenges in assisted reproductive technology (art). the investigators study will compare the letrozole/antagonist protocol to the hmg/antagonist protocol in women who poor responders.


Eligibility criteria:
inclusion criteria: * patients will be considered eligible if they are poor ovarian responders according to the bologna criteria (ferraretti et al., 2011). * two out of three of the following criteria are essential in order to classify a patient as poor ovarian responder: * advanced maternal age (≥40 years) or any other risk factor for poor ovarian response; * a poor ovarian response (≤3 oocytes with a conventional stimulation protocol); or * an abnormal ovarian reserve test (antral follicle count, \<7 follicles or anti-mullerian hormone, \<1.1 ng/ml).

Keywords: poor responders letrozole human menopausal gonadotropin
transcriptomic analysis to put an end to misdiagnosis in patients with rare muscle diseases

Conditions: Rare Genetic Muscle Diseases; Muscular Dystrophy, Duchenne; Muscular Dystrophy, Becker; Congenital Myopathy; Pompe Disease (Infantile-Onset)

Summary: since 2017, more than 250 analyses performed at the molecular genetics laboratory of the timone enfant hospital have yielded negative results in patients with rare genetic muscle diseases. the researchers hypothesise that some of these misdiagnosed patients carry pathogenic rna (transcript) disrupting variants that were not identified by dna sequencing. in fact, dna sequencing analyses can be negative despite the presence of a pathogenic variant that disrupts rna splicing or expression, causing a genetic disease. for this reason, rna sequencing can provide a diagnosis in patients who have not been diagnosed by dna sequencing, thus putting an end to diagnostic wandering. thus, as a descriptive prevalence study, the objectives are first to determine the rate of positive diagnoses made by the rnaseq approach in patients with muscle diseases that have not yet been diagnosed, and then to identify the genomic characteristics of the pathogenic variants identified in patients by rnaseq analysis, in order to facilitate the identification of this type of variant in future patients. 50 patients will be included in this study during 2 years.


Eligibility criteria:
inclusion criteria: * patients with rare genetic muscle diseases who have benefited from high-throughput sequencing analysis (panel of 200 genes defined by the filnemus rare neuromuscular disease network) carried out at the molecular genetics laboratory, medical genetics department, timone enfant hospital since 2017. this criterion is necessary to limit the analysis to patients with muscular diseases among all the patients analysed by the molecular genetics laboratory. * this genetic analysis did not identify pathogenic variants explaining the patient's phenotype this criterion is necessary in order to include only patients in diagnostic error. * a muscle biopsy of the patient is available in the biological resources centre (crb) at the ap-hm. exclusion criteria: * patients with no muscle biopsy available in the crb. * patients with an established molecular diagnosis. * patients for whom rna extraction from a muscle biopsy sample did not yield rna of sufficient quality (inr \>7) will be excluded from the study. a maximum of two extraction attempts will be performed.
listen in: developing and testing a therapy application for patients with speech comprehension deficits after stroke.

Conditions: Aphasia

Summary: the main aim is to develop and test the clinical efficacy of a novel, web based, rehabilitation application. listen-in will provide an effective speech comprehension training tool that patients with aphasia can use to practice independently. this will free up therapists time to provide additional assessment, supervision and functional intervention in a highly cost effective manner.

the main aim is to develop and test the clinical efficacy of a novel, web based, rehabilitation application. listen in will provide an effective speech comprehension training tool that patients can use to practice independently. this will free up salt time to provide additional assessment, supervision and functional intervention in a highly cost effective manner. phase 1 (24 months. london, newcastle, cambridge): development of listen in, including diagnostic and therapeutic components, driven by patient user's feedback (alpha and beta testing). the intervention is detailed below and is based on current salt practice. it will be adaptive, provide feedback and target auditory perception at many levels: the phonemic, lexical and sentence level processing of heard verbal stimuli, as well as auditory short term memory and nonverbal sound discrimination. phase 2 (12 months. london and cambridge): a pilot, randomised, crossover, clinical trial of listen-in in a group of aphasic patients in the chronic post-stroke period. a power calculation suggests that we will need 36 patents, 18 in each arm. the comparison will be standard salt clinical care. the main outcome measure is a clinically relevant improvement on the comprehension of spoken language score of the comprehensive aphasia test (swinburn, 2004). secondary outcomes include improvements in social activity and participation. the milestones for this phase will be: 50% recruitment into study and last patient, last visit. phase 3 (funded outside i4i grant) will be the rollout of the therapy application on the internet with a pragmatic trial of whether therapy gains can be made outside the confines of a clinical trial. the comparison will be on similar outcome measures as phase 2 with a control test on sustained attention (internal control) that we predict will not improve with therapy.

Eligibility criteria:
inclusion criteria: * any type of stroke but greater than 6 months post onset * evidence of receptive aphasia * english as their main language * able to give informed consent * age 18 years or above * no diagnosis of degenerative brain disease. exclusion criteria: * stroke less than 6 months post onset * no evidence of receptive aphasia * english not their main language * unable to give informed consent * less than 18 years old * diagnosis of degenerative brain disease.
population pharmacokinetics of paracetamol in overweight and obese children

Conditions: Overweight; Obesity

Summary: the main objective of the study is to define population pharmacokinetic parameters and variability factors for paracetamol and its metabolites in overweight and obese children compared to children with normal weight for age and sex.

this study will determine the pharmacokinetic parameters of paracetamol and its metabolites in overweight and obese children compared to children with normal weight for age and sex. the results will enable establishing dosage recommendations for paracetamol in overweight and/or obese children and adolescents.

Eligibility criteria:
inclusion criteria: * child aged 6 to 17 inclusive with normal weight for age and gender (body mass index \[bmi\]\<25kg/m2 adult equivalent at 18 years \[iotf 25\]), overweight (body mass index \[bmi\]≥ 25kg/m2 adult equivalent at age 18 \[iotf 25\] and obese (bmi ≥ 30kg/m2 adult equivalent at age 18 \[iotf 30\]) for age and sex * surgical procedure requiring treatment with paracetamol intravenously as an analgesic * no opposition by the holder(s) of parental authority exclusion criteria: * history of chronic anaemia (≤ 5g/100ml) * history of hepatocellular insufficiency (asat, alat ≥ 3n) * history of renal impairment (\<60ml/min\*1.73m2) * history of gilbert's disease * history of type 2 diabetes * major motor or neurological disability * intake of paracetamol within 24 hours before study inclusion (injection of paracetamol iv or oral intake) * patients treated with medicinal products known to affect cyp2e1 or ugt (udp glucuronosyltransferase): isoniazid, antiepileptic drugs (carbamazepine, phenytoin or phenobarbital), antiretroviral and tyrosine kinase inhibitors

Keywords: obesity overweight population pharmacokinetics paediatrics
follow-up of the systemic lupus erythematosus cohort as part of the multidisciplinary consultation at brest chru

Conditions: Systemic Lupus Erythematosus

Summary: systemic lupus erythematosus is a complex systemicautoimmune disease that can affect most organs of the human body. although they are many recommendations on the diagnosis and managment of sle, diagnosis and therapeutic managment is still challenging. a pluridisciplinary consultation grouping rheumatologist, nephrologist, dermatologist, gynecologist, internist and immunologists has been set up in 2009 at the university hospital of brest. the investigators would like to identify in a longitudinal cohort the occurrence of the different clinico-biological and immunological patterns of systemic lupus erythematosus patients during our multidisciplinary consultation. it is now crucial to organize a standardized data collection of these patients in order to evaluate our pratices, to be able to study the epidemiology of sle in our city, and to promote this initiative at national and international level.


Eligibility criteria:
inclusion criteria: * any patient over 18 years old of the multidisciplinary consultation exclusion criteria: * opposition of patient

Keywords: autoimmune diseases joint diseases cutaneous systemic diseases musculoskeletal diseases arthritis rheumatoid rheumatic diseases connectivite tissue diseases immune system diseases
comparison of mortality among hdu patients with modified early warning score cutoff of 5

Conditions: Critical Illness; Morality

Summary: early categorization of critically ill patients by calculating mews score in hospitals may give a time window for appropriate steps. if a patient is suffering from sepsis, timely intravenous fluids, early antibiotics and monitoring in a low resource country like pakistan, may have a great impact. therefore, the current research is planned to early identify critically ill patients by applying mews and reducing the mortality by providing early management and taking appropriate life saving measures. objective: to compare frequency of mortality on 7th day of admission in hdu patients with modified early warning score at the time of admission of \< 5 \& ≥ 5.

early recognition and immediate resuscitation are fundamentals of successful management of all critically ill patients if they are suffering from infection and sepsis, malnutrition, aids, trauma, diabetes mellitus, drug overdose, and poisoning. in most, seriously ill patients, initial diagnosis may not be clear and immediate objective is to save the life and reverse or prevent vital organ damage e.g. brain, lungs, liver and kidneys. a rapid identifying, low cost method called as modified early warning score (mews) that utilize easy to measure physiological parameters such as vital signs and level of consciousness can be used to identify critical illness, facilitate early intervention and predict mortality. mews values range from 0 to maximum 14, higher scores mean greater hemodynamic instability. a score of 5 or more identifies a patient to be critically ill and is associated with increased risk of icu admission and death. the negative predictive value of early warning mews \< 3 was 98.1%, indicating the reliability of this score as a screening tool mews (modified early warning score) is a reliable screening tool to identify critically ill patients early and to act timely to improve outcomes in health care and prevent adverse events like cardiac arrest, renal failure. a study performed in uganda on sepsis patients demonstrated that early iv fluid and antibiotic therapy together with vital sign monitoring was associated with lowered 30-day mortality. rationale: early categorization of critically ill patients by calculating mews score in hospitals may give a time window for appropriate steps. if a patient is suffering from sepsis, timely intravenous fluids, early antibiotics and monitoring in a low resource country like pakistan, may have a great impact. therefore, the current research is planned to early identify critically ill patients by applying mews and reducing the mortality by providing early management and taking appropriate life saving measures.

Eligibility criteria:
inclusion criteria: * admitted in high dependency unit (hdu) of medical unit-ii exclusion criteria: * neurosurgical trauma clinically assessed * orthopedics or general surgery trauma patients clinically assessed * obstetrics patients clinically assessed

Keywords: mortality high dependency unit modified early warning score