Kornimate/medical-research-clean huggingface dataset:
assessing insulin turnover using an in-vivo deuterated water experiment.

Conditions: Bariatric Surgery; Hypoglycemia; Gastric Bypass

Summary: the primary objective of this study is to observe the kinetics of pre-stored and de-novo synthesized insulin that is secreted into the circulation using an in-vivo heavy water (d2o) labelling experiment in patients with postprandial hyperinsulinaemic hypoglycaemia (phh) and non-surgical non-phh controls.

despite an increased prevalence, the underlying pathophysiology of phh remains incompletely understood. it is generally assumed that phh is caused by excess insulin secretion, either due to an intrinsic beta-cell abnormality (histology showing increased beta-cell mass or signs of hyperfunction) and/or increased postprandial insulinotropic signals (also known as the incretin-effect) as a consequence of the re-arranged gastrointestinal tract and accelerated nutrient transit and absorption. either of the two explanations would imply an altered insulin turnover in these patients with higher amounts of pre-stored insulin and/or accelerated de-novo insulin synthesis in response to stimulus-depletion of the available insulin pool. a non-invasive in vivo technique to study insulin turnover has not been established yet and data related to phh are consequently lacking. the primary objective of this study is to observe the kinetics of pre-stored and de-novo synthesized insulin that is secreted into the circulation using an in-vivo heavy water (d2o) labelling experiment in patients with postprandial hyperinsulinaemic hypoglycaemia (phh) and non-surgical non-phh controls. the investigators hypothesize that the suggested methodological approach is feasible to assess insulin turnover and provides the foundation for further studies in different target groups.

Eligibility criteria:
inclusion criteria for phh patients: * aged ≥18 years * roux-en-y gastric bypass ≥1 year ago * phh defined as postprandial plasma or sensor glucose\<3.0mmol/l according to the international hypoglycaemia study group and exclusion of other causes of hypoglycaemia inclusion criteria for non-phh non-surgical controls: * aged ≥18 years * absence of any condition or previous surgery known to affect gastro-intestinal integrity and food absorption exclusion criteria: * clinically relevant weight changes (≥5%) within the past 3 months * incapacity to give informant consent * historical or current diabetes based on hba1c ≥6.5% without glucose-lowering treatment * haemoglobin level below 13.5 g/l * ongoing treatment with glucose-lowering drugs, anorectic drugs, steroids or any medications known to affect gastric motility * active heart, lung, liver, gastrointestinal, renal or neurological disease * inability to follow study procedures * pregnancy or breast-feeding

Keywords: insulin turnover insulin secretion deuterated water de-novo insulin synthesis
a study of early robotic ablation by substrate elimination of ventricular tachycardia

Conditions: Ventricular Tachycardia

Summary: ventricular tachycardia (vt) is an abnormal rapid heartbeat which occurs after a heart attack and can cause sudden death. patients at risk of this rhythm disturbance usually receive an implantable cardioverter defibrillator (icd) that can prevent death by returning the heart's rhythm back to normal by electrically stimulating the heart but in doing so gives the patient painful and debilitating shocks. the first icd shock after implantation appears to be a powerful predictor of subsequent shock therapy as well as being a predictor of of increased mortality in patients with primary prevention icds. in patients who receive repeated shocks vt ablation is performed to 'burn' the abnormal area of the heart that causes the problem. however, it is often only performed as a last resort as it is technically challenging. we believe that performing vt ablation using the robotic system early after the first episode of vt after icd implantation, may reduce the number of painful shocks received by the patient and possibly increase life expectancy and quality of life. 200 patients from 5 european countries will be recruited in a prospective, open, randomised trial. eligible, consenting patients who have experienced their first episode of vt since icd implantation, will be randomised in a 1:1 manner into treatment arms of either vt ablation or standard 'conventional' therapy and followed-up every 4 months over two years to assess the number of subsequent icd shocks, hospitalisation, mortality and quality of life.


Eligibility criteria:
inclusion criteria: * males or females eighteen (18) to eighty-five (85) years old * icd implantation for post-infarct primary or secondary prophylaxis * first episode of vt detected (within monitor zone or therapy (atp /shock delivered) or by 12 lead ecg if the rate below the detection level of the device. * suitable candidate for catheter ablation * signed informed consent exclusion criteria: * contraindication to catheter ablation * ventricular tachycardia due to transient, reversible causes * presence of a left ventricular thrombus * severe cerebrovascular disease * active gastrointestinal bleeding * renal failure (on dialysis or at risk of requiring dialysis) * active infection or fever * life expectancy shorter than the duration of the trial * allergy to contrast * intractable heart failure (nyha class iv) * bleeding or clotting disorders or inability to receive heparin * serum \[k+\] \ 5.0mmol/l * serum creatinine \>200umol/l * uncontrolled diabetes (hba1c ≥73mmol/mol or hba1c ≤64mmol/mol and fasting blood glucose ≥9.2mmol/l) * malignancy needing therapy * pregnancy or women of child-bearing potential not using a highly effective method of contraception * unable to give informed consent * unable to attend follow-up in icd clinics

Keywords: ventricular tachycardia implantable cardioverter defibrillator catheter ablation robotic
comparison of follow-up protocols in terms of fetal, neonatal and maternal results in intrauterine growth retardation

Conditions: Fetal Surveillance; Intrauterine Growth Restriction

Summary: this study will be undertaken to determine whether the frequency of fetal surveillance can be safely reduced from bi-weekly to weekly in the case of fetusus with intrauterine growth restriction.

in this prospective randomized study, the cases whose fetal weight predicted by ultrasonography (usg) between the 28th and 37th weeks of gestation are below 10percentile according to the world health organization (who) normograms. the cases will be divided into two groups as group 1:weekly and group 2:bi-weekly (twice-weekly) the cases will be evaluated by fetal doppler, amniotic fluid volume, nonstress test (nst) and maternal preeclampsia tests.maternal severe hypertension/preeclampsia, category 3 nst, oligohydramnios (after 37 weeks amniotic fluid index \<5; after 34 weeks single deepest pocket \<2 cm) ,pathological doppler (before 34 weeks reverse flow in an umbilical artery , after 34 weeks absent end-diastolic flow in an umbilical artery) in cases of birth decision will be taken. cases without the above mentioned complications will be delivered between 38 weeks 3 days and 39 weeks.

Eligibility criteria:
inclusion criteria: * 28-37 weeks pregnant women with estimated fetal weight below 10 percentile * singlton pregnancy exclusion criteria: * maternal preeclampsia * maternal systemic disease (pregestational diabetes, gestational diabetes mellitus a2, antiphospholipid antibody syndrome, chronic kidney disease) * oligohydramnios (after 34 weeks amniotic fluid index \<5; before 34 weeks single deepest pocket \<2 cm) * pathological doppler (high umbilical artery resistance index, absence of end-diastolic flow velocity in the umbilical artery, reverse flow in the umbilical artery, brain sparing effect in middle cerebral artery, abnormal ductus venosus flow)

Keywords: intrauterine growth restriction fetal surveillance fetal doppler fetal growth
3-dimensional accelerometer sub-study

Conditions: Epilepsy

Summary: this is a prospective, unblinded sub-study to the e-30 to gather physiological data.

this sub-study to the e-30 is designed to collect vital signs, accelerometer and ecg data on subjects, and will consist of two phases. phase 1 is designed to collect data in an epilepsy monitoring unit (emu) and phase 2 is designed to collect data in an everyday (ambulatory) setting.

Eligibility criteria:
inclusion criteria: (phase 1) * subject be scheduled to participated in the e-30 parent study for a minimum of 48 hours * subject has a clinical diagnosis of epilepsy based on a prior emu visit (phase 1\&2) * subject is currently enrolled or previously participated in the e-30 study * subject must be 6 years of age or older (sleep state: optional) * subject must be 12 years of age * subject is currently enrolled in the e-30s sub-study and is willing to stay in a light controlled environment in the emu for up to 120 hours exclusion criteria: (phase 1\&2) * subjects with a medical condition that in the opinion of the investigator would affect his/her ability to participate in the sub-study. * subject who has implanted defibrillator, pacemaker or vagus nerve stimulation therapy® (vns) system * subjects who are pregnant or lactating * subjects with severe psychiatric disease that in the opinion of the investigator would prevent the subject's successful completion of the sub-study. * subjects 6 to 16 years of age with moderate/severe learning difficulties or those who may be at risk of self-harm. * subjects prescribed drugs specifically for a cardiac or autonomic disorder that in the investigator's opinion would affect heart rate response unless the patient has ictal tachycardia while taking said drugs. these include, but are not limited to, beta adrenergic antagonists ("beta blockers"). * subjects with cardiovascular arrhythmias or cardiac disease that would preclude the ability to detect intrinsic changes in heart rate due to activity, stress, or seizure. this would include but not be limited to chronic atrial fibrillation or chronotropic incompetence. * subjects with a history of dependence on alcohol or narcotic drugs within the past 2 years as defined by dsm iv-r. (sleep state: optional) * subjects with a history if gastrointestinal disease (gi)or gi surgery * subjects with a history of difficulty swallowing * subjects with diabetes mellitus * subjects with uncontrolled hypertension * subjects with planned mri during emu stay

Keywords: accelerometer emu ambulatory ecg heart rate
role of aortic valve composition in pathophysiology and diagnosis of aortic stenosis

Conditions: Aortic Stenosis; Aortic Valve Disease; Aortic Valve Calcification

Summary: the study aims to evaluate composition differences of aortic valves in different stages and phenotypes of aortic stenosis using non-invasive imaging and histology.


Eligibility criteria:
inclusion criteria: * aortic valve replacement or heart transplant as part of standard care decided by the local heart team * pre-surgical computed tomography angiography * informed consent
human phototoxicity test

Conditions: Sunscreening Agents

Summary: to determine the phototoxic potential of a topically applied article in human subjects


Eligibility criteria:
inclusion criteria: * be male or female between the ages of 18 and 60 inclusive; * be lightly pigmented (fitzpatrick skin type i, ii, iii); * have read and signed the written informed consent form and have completed a health insurance portability and accountability (hipaa) authorization form in conformance with 45cfr parts 160 and 164; * be in general good health as determined by the subject's medical history and in the discretion of the investigator; exclusion criteria: * have a visible sunburn; * have a history of sun hypersensitivity/photosensitivity or photosensitive dermatoses; * must not have a known sensitivity or allergy against any of the active and non-active ingredients of the test product. * have a history of allergies or sensitivities to cosmetics, toiletries or any dermatological products
evaluation of patient satisfaction and therapeutic impact regarding joint consultation rheumatologist/dermatologist

Conditions: Psoriatic Arthritis

Summary: current increase in the number of multidisciplinary consultations, but little documentation on their impact on patient management. more specifically, in the context of psoriatic arthritis, we are seeking to investigate the interest for the patient, through his or her satisfaction and the evolution of the activity of his or her pathology, of a global, joint management in rheumatology and dermatology.


Eligibility criteria:
inclusion criteria: * all patients received in a joint rheumatologist/dermatologist consultation at the le mans hospital exclusion criteria: * diagnosis of psoriatic arthritis not retained
therapeutic effectiveness of exercise associated to the pharmacotherapy in major depression

Conditions: Major Depressive Disorder

Summary: depression is a disorder that causes major harm to physical health and social life. it induces isolation, reduced physical and work capacity and increasing the risk of death. in contrast, exercise helps to maintain quality of life, also inducing improvement of cognitive functions, stimulation of brain plasticity and resilience, in addition to promoting self-esteem and social interaction. the precise mechanisms by which exercise improves symptoms of depression are not fully clear, but it is probably multifactorial. in this project, the investigators aim to investigate variables that provide additional information about biomarkers involved in the pathophysiology of depression and therapeutic response to exercise. the investigators expect to find changes in biomarkers associated with potential mechanisms of neuroprotection (cytokines, markers of oxidative stress, brain-derived neurotrophic factor (bdnf), cortisol) after exercise program and the role in the therapeutics of depression. to evaluate functional assessment indices will be used ergospirometry, a test that determines the respiratory, cardiovascular and metabolic activity. overall, this project will help to investigate alternative adjunctive treatments for depression and their associated biomarkers with response.


Eligibility criteria:
inclusion criteria: * major depression disorder according diagnostic and statistical manual of mental disorders (dsm-iv) criteria * score higher or equal 18 in hamilton depression rating scale * age between 18 and 55 years old exclusion criteria: * unstable clinical diseases * patients unable to make physical exercises * present frequencies below 90% attendance in the program aerobic fitness

Keywords: physical exercise biomarkers neuroprotection ergospirometry major depressive disorder
resurfacing hemiarthoplasty versus conventional stemmed arthroplasty

Conditions: Osteoarthritis

Summary: hypothesis: what is the difference in disease specific quality of life between patients who receive a humeral surface replacement hemiarthroplasty verusu a conventioanl stemmed hemiarthroplasty

the purpose of this multi-centered, randomized, controlled trial will be to determine if patient self-assessed outcomes (western ontario osteoarthritis of shoulder score- woos) following humeral resurfacing are superior to those following a conventional, modular, stemmed, humeral prosthesis. the first phase of this study will be a one year pilot recruitment period. this is necessary in order to determine both a center by center, and national recruitment rate, and to determine a sample size necessary for a sufficiently powered full randomized trial. if a full randomized trial is not considered feasible following phase 1, then a prospective cohort study will be completed.

Eligibility criteria:
inclusion criteria: * recent humeral resurfacing

Keywords: hemiarthroplasty stemmed resurfacing conventional shoulder
4d-flow cardiac mri to assess pulmonary arterial pressure in pulmonary hypertension

Conditions: Pulmonary Hypertension; Magnetic Resonance Imaging; Pulmonary Arterial Pressure; Right Heart Catheterization; Echocardiography

Summary: due to radiation exposure and low but real risk of morbidity and mortality associated with right heart catheterization, non-invasive procedures to estimate mpap are desired for the diagnosis of ph or to monitor treatment effectiveness. echocardiography is used as a screening tool to estimate systolic pulmonary arterial pressure (spap), but due various limitations, this technique is not considered to be sufficiently accurate for the diagnosis of ph. the aim of 4d flow mri is to evaluate the complete time-varying tridirectional velocity field in a volume of interest. it enables flow and velocity measurements in a vascular region of interest and visualization of vector plots of blood flow velocity fields. previous studies have shown on the one hand, correlations between mpap and hemodynamic parameters obtained by phase contrast mri and, on the other hand, appearance of a vortical blood flow in the pulmonary artery in ph. more studies are required to confirm 4d mri as a valuable tool for mpap estimation in ph. following screening echocardiography, all patients will undergo right heart catheterization for ph assessment. then, all patients will be referred for a complete cardiac mri exam with the addition of a 4d flow sequence (does not require supplementary injection of a contrast agent and does not extend the duration of the examination) followed promptly (within the same hour) by a doppler-echocardiography. the data from each examination will be blindly interpreted from the results of the other one. no follow-up will be required for the study.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years old, * patient referred for cardiac mri who previously underwent right heart catheterization for pulmonary hypertension assessment, * affiliation to a social security program, * ability of the subject to understand and express opposition exclusion criteria: * age \<18 years old, * major obesity (\> 140 kg) not allowing the patient to enter the tunnel of the machine whose diameter is less than 70 cm, * person under guardianship or curators, * pregnant woman, * allergy to gadolinium chelates, * claustrophobia, * any contraindications to mri

Keywords: pulmonary hypertension 4d-flow magnetic resonance imaging mean pulmonary arterial pressure right heart catheterization echocardiography
teeth decrowding with and without fixed appliances

Conditions: Tooth Crowding

Summary: in orthodontics, the teeth tend to move to the extraction space. this tooth movement becomes of larger importance when there is a crowding. during the covid lockdown period, it was noted that some cases have a significant improvement and almost all the crowding was relieved without appliance activation.

in this randomized controlled trial, a sufficient number of patients would be randomly assigned into two groups; one with braces and one without fixed braces.

Eligibility criteria:
inclusion criteria: - patients with permanent dentition between age group of 13 - 30 years. * maxillary or mandibular crowding \>4.1mm and requiring extraction of maxillary first premolars or mandibular first premolars. the crowding will be measured using a caliper one cast models. * fully erupted teeth from 1st molar to the 1st molar. * patients with periodontally sound dentition. * patients with good general health. no previous history of extraction or orthodontic tooth movement. exclusion criteria: * cases requiring orthognathic surgery. * history of systemic and medical illness. * contraindication of extraction. * previous history of orthodontic treatment. * poor oral hygiene. * nickel allergy.
pyloplus urea breath test system post therapy efficacy confirmation study

Conditions: Helicobacter Pylori Infection; Post-Treatment; Efficacy

Summary: this is a multi-center, non-randomized, open label study. subjects will be enrolled if they are deemed eligible given the inclusion criteria. subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study. subjects will be exposed to non-radioactive 13c-urea with citric acid, and may submit a stool sample or undergo endoscopy for rapid urease test and histology samples. center(s) will house a pyloplus ubt analyzer to document results. pyloplus analyzer results shall remain blinded to the investigator and treating physician. no patient management decisions should be made based on the investigational pyloplus ubt system. treating physician will either prescribe a h. pylori stool antigen test through p4 diagnostics, along with another urea breath test using breath id, or patient will undergo endoscopy to provide a composite reference method consisting of rapid urease test and histology. these will act as the comparators to the pyloplus urea breath test system.


Eligibility criteria:
inclusion criteria: * male or female at least 18 years of age * patients who have been diagnosed with h. pylori and have been treated within the past 6 months * naive to h. pylori treatment in the past 4 weeks (including ppis) exclusion criteria: * pregnant and/or lactating women. * presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data. * participation in other interventional trials. * allergy to test substrates. * antibiotics taken within 4 weeks of the testing. * study subjects shall not consume the following items at least 1 hour prior to the ppubt test: mouthwash, chewing gum, carbonated beverages, cigarette smoke, acetone (to simulate the effect of ketone production that may result from some diets), alcohol, food