Kornimate/medical-research-clean huggingface dataset:
high dose ace inhibitor therapy versus combination of ace and arb therapy

Conditions: Diabetic Kidney Disease

Summary: investigation of wheather addition of angiotensin receptor blocker (irbesartan) to recommended doses of angiotensin converting enzyme inhibitor (trandolapril) is more effective in decreasing amount of protein in urine in patients with diabetic kidney disease than high doses of trandolapril.


Eligibility criteria:
inclusion criteria: 1. early diabetic nephropathy as defined by proteinuria between 500mg/24hr and 3g/24hr and gfr\&gt;50ml/min (as calculated by the cockcroft-gault formula), in the absence of clinical and laboratory evidence of other non-diabetic renal disease. 2. controlled blood pressure (\&lt;150/\&lt;90) 3. able to give informed consent 4. between the ages of 18 and 75 5. must be capable of providing a 24 hour urine collection 6. negative bhcg test for ruling out pregnancy in women of childbearing age 7. currently taking an angiotensin converting enzyme inhibitor - exclusion criteria: 1. creatinine clearance \&lt;50ml/min or 24hour protein excretion \&gt;3gm/d. 2. hypotension as defined by the inability to add an arb or increase ace-i dose secondary to hypotensive symptomatology or a systolic bp \&lt;100mmhg. 3. serum potassium \&gt;5.5 on two separate occasions in the previous six months 4. previous adverse reaction to angiotensin receptor antagonist medication 5. use of nsaids including cox2 inhibitors 6. pregnant or nursing women will be excluded 7. currently taking an angiotensin receptor antagonist -

Keywords: diabetes proteinuria angiotensin converting enzyme inhibitors angiotensin receptor antagonists
exercise training and thrombotic risk in post-menopausal women

Conditions: Thrombosis; Menopause; Exercise Training; Vascular Dilation

Summary: at menopausal transition, the risk of cardiovascular diseases increases. this is partly due to aging, but largely also the loss of estrogen, which has many positive effects on the circulation and protects against cardiovascular diseases. it has been suggested that the loss of estrogen may have a negative impact on the otherwise well-documented health promoting effects of exercise training, and that the time after menopause may be crucial for the effect of exercise training on the vascular function, and therefore also for the risk of thrombosis. literature regarding the effect of exercise training on the risk of thrombosis is limited, and especially in women. the purpose of the present study is to investigate whether the same effects of exercise training in relation to thrombosis is achieved if the exercise is initiated early compared to late after menopause. the aim is to provide knowledge-based recommendations regarding exercise. teams sports will be used as the training intervention, because team sports benefits physical health and also includes a social element.

part of the novelty of this project is to link functional measurements of cardiovascular health at whole body level to cell studies. cells will be isolated from muscle samples obtained from the post-menopausal women before and after the training intervention. this will enhance the understanding of the changes that occur after prolonged loss of estrogen on thrombotic risk and vascular function, and whether exercise training can alter these parameters.

Eligibility criteria:
inclusion criteria: * age: 50-70 years * physical activity ≤ 2 hours per week (except transportation by bike or by walking) * bmi ≤ 30 exclusion criteria: * age \<50 years * injuries that prevent the performance of team sports * participation in other clinical projects * smokes or has smoked within the last 10 years * on hormone therapy * not entered menopause * has chronic diseases that are not expected, cf. the groups sought. including heart problems, atrial fibrillation, cancer, immune diseases and previous strokes with functionally significant sequelae * being treated with oral steroids * has alcohol / drug abuse or is being treated with disulfiram (antabus) * is unable to understand the contents of the document with informed consent or the experimental procedures
reduction of in-hospital delays in stroke thrombolysis: sits-watch

Conditions: Stroke

Summary: in patients with acute ischemic stroke: the sooner the thrombolysis treatment is administered after symptom onset - the better the outcome. this delay can be dissected into onset-to-door time and door-to-needle time (dnt). sits-watch aims to reduce median dnt in participating centres.

in patients with acute ischemic stroke: the sooner the thrombolysis treatment is administered after symptom onset - the better the outcome. this delay can be dissected into onset-to-door time and door-to-needle time (dnt). of the two, dnt can be directly influenced within the hospital by stream-lining of acute stroke care. the aim of our study is to reduce in-hospital delays (dnt) in self-selecting centers recruiting patients into the the safe implementation of treatments in stroke-international stroke thrombolysis register (sits-istr) , comprising currently more than 80 000 patients from 1338 centers. current median of dnt in all sits centers is 65 minutes (compared with 20 minutes in helsinki univer-sity central hospital). an itemized detailed questionnaire, including all factors known to influence dnt, has been sent to all sits centers to identify the reasons for long in-hospital delays. based on the replies, we have prepared a list of interventions that can be considered by individual sits centers in order to reduce dnt with interventions that are in line with national legislation.

Eligibility criteria:
inclusion criteria: * all consecutive patients with acute ischemic stroke registered in sits registry. exclusion criteria: * centers not inputing patient data into sits registry. patients with missing dnt data.

Keywords: inhospital delays, door-to-needle time, thrombolysis, acute ischemic stroke, sits, sits-watch, stroke registry
slow expiratory technique to improve alimentation in children with bronchiolitis

Conditions: Acute Viral Bronchiolitis

Summary: the purpose of this study is to determine wether a single chest physiotherapy session with slow expiratory technique (set) improves infants with viral bronchiolitis quality of life (food intake and sleep) on the next 24 hours.

bronchiolitis is the most common lower respiratory viral infection in infants. nowadays bronchiolitis is the first reason of children hospitalisation worldwide. symptoms are based on airway inflammation associated to an increased mucus production and cell necrosis leading to a multifactorial airway obstruction. recommended treatments are supportive care based on oxygenation and rehydration. airway clearance techniques represented by chest physiotherapy remain controversial. considering that bronchiolitis impacts respiratory condition in young infants feeding and sleep may be reduced. evaluating quality of life represented by feeding and sleep in hospitalized infants may be an important outcome in this population. the investigators hypothesized that chest physiotherapy with set will improve children's quality of life, especially 24 hours food intake and sleep.

Eligibility criteria:
inclusion criteria: * children under 12 months * hospitalized for bronchiolitis * chest physiotherapy prescription * bronchial obstruction confirmed by physician and respiratory physiotherapist non-inclusion criteria : * children more than 1 year * exclusive breastfeeding or enteral feeding * prematurity (gestational age \< 35 weeks) * cardiac, neurological and pulmonary comorbidity * continuous oxygen supplementation or ventilatory support * chest physiotherapy contraindications exclusion criteria: * side effects during chest physiotherapy : bradycardia \<100 bpm, oxygen saturation\<90%, general state alteration * outing, oxygen supplementation or parenteral nutrition less than 24 hours after randomization * chest physiotherapy cessation according to family request

Keywords: food intake chest physiotherapy sleep respiratory distress
belgian drug-utilization study to evaluate the use of vimpat® as adjunctive treatment of partial onset seizures in subjects aged 16 and older

Conditions: Seizures

Summary: observational study at the request of the belgian institut national d'assurance maladie-invalidité / rijksinstituut voor ziekte-en invaliditeits verzekering inami/riziv: * type of patient treated with vimpat® * vimpat® dose * effect of vimpat® on evolution of seizure control * persistence rate at 6 months in terms of treatment duration * discontinuation rate * description of any changes in other epilepsy therapies * safety and tolerability


Eligibility criteria:
inclusion criteria: * an institutional review board (irb)/independent ethics committee (iec) approved written informed consent form * subject/legal representative is considered reliable and capable of adhering to the medication intake according to the judgement of the investigator * based on the investigators clinical judgement, the subjects' seizure activity is uncontrolled on current therapy and it is in the subjects' best interest to be prescribed an antiepileptic drug (aed) as adjunctive therapy. the choice to prescribe vimpat® as adjunctive therapy is made by the treating investigator * the subject is aged 16 or older * the subject has a diagnosis of epilepsy with partial-onset seizures according to the label * the subject has a medication history with at least 3 aed therapies (lifetime and/or concomitant) with treatment failure: due to insufficient efficacy, due to significant adverse events * sufficient data on the clinical situation before start of vimpat® and information on vimpat® dosing are present in the subject's medical record for patients on treatment with vimpat® at the time of enrollment into the study exclusion criteria: * the subject has previously participated in this study or has participated in a clinical trial within the last 2 months * the subject has a history of chronic alcohol or drug abuse within the last 6 months * the subject has any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the subject's ability to participate in this study * the subject has a known hypersensitivity and/or allergy to soya, peanuts, or any component of vimpat® * the subject is pregnant or lactating * the subject has a known av-block degree 2 or 3 * the subject is expected to be insufficiently compliant with contraception. * the subject has a history of suicide attempt, has received professional counseling for suicidal ideation, or is currently experiencing active suicidal ideation

Keywords: lacosamide vimpat®
drepamasse study - evaluation of a newborn screening for sickle cell disease by tandem mass spectrometry

Conditions: Sickle Cell Disease; Infant, Newborn, Disease; Drepanocytosis

Summary: three methods are actually used in newborn screening for sickle cell disease (scd) in france: isoelectric focusing, high performance liquid chromatography and capillary electrophoresis. new technologies are currently under development such as matrix assisted laser desorption ionisation - time of flight (maldi-tof) and tandem mass spectrometry (ms/ms) using the spoton diagnostics reagent kit available in united kingdom only. zentech company (liège, belgium) is developing a package for scd newborn screening using ms/ms technology. the main objective of the present study will be to compare this new technique with the technique actually used in the hospital center of lille (sub-contractor for scd newborn screening of lyon) and the haemoglobin analysis to test its accuracy (sensitivity and specificity).


Eligibility criteria:
inclusion criteria: * infants with scd newborn screening conducted in the hospital center of lyon exclusion criteria: * insufficient quantity of sampling * parents' opposition to their newborn's participation in the study
cardiac resynchronization therapy: relevance of the surgical approach in the implantation of the left ventricular probe

Conditions: Cardiac Insufficiency

Summary: heart failure is very common and reaches more than 56 million people worldwide. 17 to 45 percent die in the first year of hospitalization. the most affected populations live in western countries like europe or the usa. it is defined by a set of signs and symptoms such as dyspnea, asthenia, edema or tachycardia but must be objectified, preferably by ultrasound. its basic treatment is based on a lifestyle improvement and a reduction of the risk factors (hypertension, dyslipidemia, diabetes, ...), as well as an optimal medical treatment based on ace inhibitors, b-blockers, ara2 (sartans), spironolactone or digoxin. when the optimal treatment is no longer working and that the cardiac desynchronization is demonstrated, be it atrio-ventricular, inter-ventricular or intra-ventricular, the patient can benefit from a three-probes cardiac resynchronization to resynchronize the two ventricles. the classic approach, performed by a cardiologist, is to perform an endovenous procedure in order to place the 3 probes under local anesthesia.the first one goes in the right atrium, the second one in the right ventricle and the third one goes in the left ventricle. it is the placement of this third one that often causes trouble. it is more difficult to place since it must pass through the coronary sinus, outside of the heart, unlike the first two probes that are placed endocavitary. when the practitioner fails to place the probe correctly or obtains inappropriate levels of detection, stimulation, or impedance thresholds, a cardiac surgeon must intervene and carry out a mini-thoracotomy. the chu brugmann hospital is in favor of a mixed surgical approach. the probes are placed by a cardiac surgeon, who first starts by a endo-venous placement under local anesthesia. if that approach fails, the local anesthesia can be transformed into general anesthesia at the same operative time and a mini-thoracotomy is performed. the aim of this study is to evaluate the immediate impact of this surgical management within the chu brugmann hospital, in patients suffering from cardiac insufficiency despite proper medication.the hypothesis is that the mixed surgical approach improves the prognosis of cardiac resynchronization.


Eligibility criteria:
inclusion criteria: * patient who underwent cardiac resynchronization within the brugmann university hospital from 2003 til july 2016 * cardiac insufficiency, whatever the origin, demonstrated by a cardiologist with demonstrated ventricular asynchronism. * with left ventricular ejection fraction \<35% * and / or a left ventricular diastolic diastolic diameter\> 55 mm * and / or qrs measuring\> 130 milli sec * and / or left branch block * redo procedure on a pacemaker exclusion criteria: • change of case on a patient who has already benefited from a triple chamber stimulator

Keywords: cardiac resynchronisation
efficacy and safety study of apixaban for the treatment of deep vein thrombosis or pulmonary embolism

Conditions: Venous Thrombosis

Summary: the purpose of this study is to evaluate the effects of an investigational blood thinner, apixaban, in preventing venous thromboembolic (vte) recurrence or death in patients with deep vein thrombosis (dvt) or pulmonary embolism (pe)


Eligibility criteria:
inclusion criteria: * men and women ≥ 18 years of age * clinical diagnosis of dvt or pe exclusion criteria: * contraindications for enoxaparin or warfarin * active bleeding or high risk for serious bleeding * short life expectancy * uncontrolled high blood pressure * significantly impaired kidney or liver function
data therapy collection to evaluate performances of an automated insulin titration algorithm compared to standard method of titration

Conditions: Diabetes

Summary: a data collection of blood glucose values, insulin, meal composition will be performed for a period of two months, to evaluate the performances of an automated insulin titration algorithm


Eligibility criteria:
inclusion criteria: * person with type 1 diabetes * treated by basal-bolus therapy with mdi or pump * patient with social security or beneficiary of medical coverage * patient using functional insulin therapy or starting and education course * patient able to read and understand the procedure, and able to express consent for study protocol exclusion criteria: * patient abusing substances * patient deprived of liberty by judicial or administrative decision, person subject to a legal protection measure, patient having a psychological condition making him unable to follow and understand study protocol

Keywords: diabetes functional insulin therapy
bi-atrial versus left atrial ablation for patients with rheumatic mitral valve disease and non-paroxysmal atrial fibrillation

Conditions: Persistent Atrial Fibrillation

Summary: this study is aimed to compare the efficacy of bi-atrial ablation with left atrial ablation for atrial fibrillation during mitral valve surgery in patients with rheumatic mitral valve disease.

atrial fibrillation (af) is present in 40%-60% of patients with rheumatic mitral valve disease (rmvd), which is an independent predictor of mortality and late stroke. during mitral valve (mv) surgery, the open left atrium facilitates a bi-atrial ablation procedure. however, a simplified lesion set including isolated pulmonary vein isolation or posterior left atrial (la) wall isolation or la maze was usually applied. the current literatures provide insufficient evidence to determine the potential benefits of bi-atrial ablation procedure when comparing with la ablation procrdure in patients with non-paroxysmal af and rmvd. patients with rmvd often have longer history, which tends to affect the right atrium, including pulmonary hypertension or tricuspid regurgitation.the necessity of bi-atrial ablation procedure targeting the bi-atrial substrate for af in rmvd requires to be explored. in this study, we aimed to compare the efficacy of bi-atrial ablation with la ablation for af during mv surgery in patients with rmvd.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * diagnosis of persistent atrial fibrillation(af) or long-standing persistent af by medical history and holter monitoring (persistent af lasting more than 7 days; long-standing persistent af lasting more than 1 year). * rheumatic mitral valve disease(rmvd) requires mitral valve surgery( rmvd was determined by history of acute rheumatic fever, valve morphology, echocardiographic findings and pathological diagnosis). * consent to surgical ablation of af exclusion criteria: * paroxysmal af * degenerative or ischemic mitral valve disease * evidence of active infection * previous catheter ablation or surgical ablation for af * surgical management of hypertrophic obstructive cardiomyopathy * absolute contraindications for anticoagulation therapy * left atrial thrombosis (not including left atrial appendage thrombosis alone) * chronic obstructive pulmonary disease(forced expiratory volume in 1 second (fev1)\<30% anticipated value) * uncontrolled hypo- or hyperthyroidism * mental impairment or other conditions that may not allow participants to understand the nature, significance, and scope of study * left atrial diameter\>70mm * right ventricular dysfunction (tapse\ 60mmhg * coronary artery bypass grafting is required for participants with coronary heart disease * previous cardiac surgery * refuse to participate in this study

Keywords: rheumatic mitral valve disease surgical ablation mitral valve surgery
exercise in patients with hypermobile joints and knee pain

Conditions: Hypermobility, Joint; Hypermobility Syndrome; Knee Discomfort

Summary: pain associated with knee joint hypermobility is common in the adult population, but evidence on treatment is sparse. this study investigates if high-load resistance training is superior to usual care in improving activity-related pain in young patients (18-45 years) with hypermobile joints and knee pain.

knee joint hypermobility is common in the adult population. patients with knee joint hypermobility and knee pain are typically managed with low intensity resistance training and proprioceptive training to reduce knee pain and improve function, but many patients do not respond well to these treatment strategies. high-load resistance training offers additional benefits to low intensity resistance training, including marked increase in muscle cross-sectional area, neural drive, and increased tendon stiffness, all important components of acquiring active knee joint stability during movement tasks and daily life. therefore, the primary aim of this randomised controlled trial (rct) is to investigate if high-load resistance training is superior to usual care in reducing activity-related pain in young patients (18-45 years) with hypermobile joints and knee pain.

Eligibility criteria:
inclusion criteria * persistent knee pain for ≥ 3 months (self-reported) * knee pain ≥ 30mm during the last week using a 0-100 mm visual analogue scale (vas; 0=no pain and 100=worst imaginable pain) (self-reported) * generalised joint hypermobility assessed with the five-part hypermobility questionnaire (positive ≥ 2/5) (self-reported) * local knee joint hypermobility using the passive hyperextension of the knee in standing (positive \> 10 degrees of hyperextension) and confirmed in supine lying (heel resting on 20 cm high block on the bench surface), with passive knee hyperextension (positive \> 10 degrees) (objectively measured) exclusion criteria * diagnosed with patellar tendinopathy * pregnancy or childbirth within the past year (due to increased levels of relaxin that could affect joint stability) * knee surgery within the past year * participation in regular structured resistance training within the past six months * inability to speak and understand danish. * all types of ehlers-danlos syndrome * other heritable connective tissue disorders such as marfan syndrome, osteogenesis imperfecta, loeys-dietz syndrome, stickler syndrome, skeletal dysplasias * autoimmune rheumatic connective tissue disorders such as lupus, rheumatoid arthritis; chromosomal conditions such as fragile x syndrome, kabuki syndrome, down syndrome * neuromuscular disorders that can cause joints to become unstable, such as multiple sclerosis

Keywords: hypermobility knee pain treatment randomised controlled trial