Kornimate/medical-research-clean huggingface dataset:
arterial inflow and muscle ischemia during calf stimulation with the veinoplus device

Conditions: Peripheral Artery Disease

Summary: stimulation of arterial inflow to the lower limb is important to obtain functional improvement in peripheral artery diseased (pad) patients with claudication. the clinical effect of muscle stimulation to increase arterial inflow and the direct evaluation of the regional blood flow impairment (rbfi) in the area of stimulation, have not been evaluated in pad patients. fifteen adult patients with stable arterial claudication will participate. recruitment will be performed among patients referred for exercise oxymetry (treadmill: 3.2km.h-1, 10% slope) after two minutes of rest, the gastrocnemius will be stimulated for 20 minutes at an increasing frequency rate with 5 min steps (1 hz, 1.25 hz, 1.5 hz and 1.75 hz) on the most symptomatic side. the investigators record the tcpo2 value, arterial blood inflow with ultrasound of the femoral artery, and near infra-red spectrometry (nirs) on both sides. patients will be instructed to report eventual contraction-induced pain in the stimulated calf.

investigations are conducted in an air-conditioned 22+/-2 °c room, with the patient comfortably seated on an armchair. measured ware started at rest and performed throughout the period pf stimulation and for 10 minutes after the end of the stimulation muscle stimulation: we apply a series of 20 minutes of stimulation with the veinoplus® device. the device delivers a stimulation of incremental rate with 5 minutes intervals, with 1 hz, 1.25 hz, 1.5 hz and 1.75 hz and then stops automatically. ultrasound measurements the diameter of the superficial femoral artery was measured at rest on both sides before each study. the vti of 3 cardiac cycles (three peaks systolic velocity) will be measured by duplex ultrasound imaging, to calculate the arterial inflow to the leg. results will be expressed in l /min. tcpo2 recording tcpo2 is measured at the chest and on both calves with tcm 400 (radiometer, dk). results are expressed in drop index(mmhg) values. near infra-red spectroscopy (nirs) we use the artinis nirs device (artinis; nl) to estimate tissue saturation (sto2) on both gastrocnemius muscles of the leg. systemic hemodynamic parameters systemic and diastolic arterial pressures and heart rate are recorded every two minutes using dinamap v100 (ge france).

Eligibility criteria:
inclusion criteria: * french native * stable stage 2 peripheral artery disease * patent femoral artery on both sides * age \> 18 years exclusion criteria: * pregnancy * adults protected by maw
efficacy study of a device allowing broadcasting maternal voice and heartbeat in preterm newborn (caliprem)

Conditions: Preterm Newborn

Summary: the purpose of this study is to evaluate the benefits of an exposition to a maternal voice and heartbeat recording during hospital stay for preterm newborns. for that, we use of a specific neonatal device "calinange" able to record maternal voice and heartbeats and to restore it with a sound level control. we hypothesize an improvement of the well being of the newborn under calinange exposition.

immediately after birth, preterm newborns are immersed in a hostile environment of intensive care unit with light, sound and painful stimulations. previously, exposure to maternal voice has demonstrated improvement on infants' statements: reduction of bradycardia, desaturation events, improvement of tolerance feeding and sleep. unfortunatly in most of the n icu in france, the mothers' presence attendance time is reduced because of the absence of accommodation structure. the use of a specific neonatal device able to daily record maternal voice and hearbeats and to restore it when mother is gone could improve the environment and promote the well-being of the newborn.

Eligibility criteria:
inclusion criteria: * hospitalised premature newborn in port-royal nicu * age between 3 and 6 daysof life * gestational age between 27+0 and 31+6 weeks * hospitalisation in one bed room * parental consents * beneficiaries social security scheme exclusion criteria * occurrence of one or more non-inclusion criteria * non-inclusion criteria: * chromosomal abnormality, severe congenital malformation * toxic substance consumption during pregnancy * sedative medication in progress, high frequencies ventilation in progress * neurological damage: intraventricular haemorrhage stage 3 and 4, bilateral and expanse periventricular leukomalacia lesions * severe infectious state requiring haemodynamic support (inotropic drugs or hemissucinate) * participation to a other intervention research

Keywords: preterm newborn maternal voice reccording nipe
comparison of lixisenatide injected prior to the main meal of the day versus prior to breakfast in type 2 diabetic patients on metformin

Conditions: Type 2 Diabetes Mellitus

Summary: primary objective: - to compare the two treatment regimens in terms of change of glycosylated hemoglobin (hba1c) from baseline to endpoint (week 24) secondary objective: * to assess the effect of the 2 lixisenatide regimens on: * the percentage of participants who reached the target of hba1c \< 7% or ≤ 6.5% at week 24 * fasting plasma glucose (fpg) * 7-point self-monitored plasma glucose (smpg) profiles * body weight * to assess the safety and tolerability of the 2 lixisenatide regimens

the maximum study duration was 28 weeks per participant, including a 24-week randomized treatment period.

Eligibility criteria:
inclusion criteria: * participants with type 2 diabetes mellitus, diagnosed for at least 1 year before screening visit * metformin treatment at a stable dose of at least 1.5 g/day for at least 3 months prior to screening visit. exclusion criteria: * screening hba1c \ 10.0% * fasting plasma glucose at screening \> 250 mg/dl (\> 13.9 mmol/l) * treatment with glucose-lowering agent(s) other than metformin in a period of 3 months prior to screening, previous use of insulin * participants who usually did not eat breakfast * type 1 diabetes mellitus * body mass index (bmi) ≤ 20 kg/m\^2 and \> 40 kg/m\^2 * pregnancy or lactation, women of childbearing potential with no effective contraceptive method * amylase and/or lipase \> 3 times the upper limit of the normal laboratory range ( uln) at screening * alanine aminotransferase (alt) \> 3 uln at screening * calcitonin ≧ 20 pg/ml (5.9 pmol/l) at screening * history of unexplained pancreatitis, chronic pancreatitis, pancreatectomy. * personal or immediate family history of medullary thyroid cancer (mtc) or genetic conditions that predisposes to mtc (e.g. multiple endocrine neoplasia syndromes) * any contra-indication related to metformin * any previous treatment with lixisenatide the above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
pulsed field ablation in three different substrate ablation strategies for persistent atrial fibrillation

Conditions: Atrial Fibrillation (AF)

Summary: this multicenter, randomized, controlled trial aims to evaluate the efficacy and safety of pulsed field ablation (pfa) in patients with persistent atrial fibrillation (peaf). we will compare three distinct substrate ablation strategies: anatomical guided ablation (anat group), electrogram guided ablation (egm group), and extensive electro-anatomical guided ablation (ext group). the study seeks to identify which ablation strategy yields the highest efficacy and safety profiles to potentially guide future clinical practice in the management of peaf.


Eligibility criteria:
inclusion criteria: 1. adults aged 18-80 years diagnosed with persistent atrial fibrillation. 2. ineffectiveness or intolerance to at least one class i or iii anti-arrhythmic drug. exclusion criteria: 1. major valvular diseases needing surgical intervention. 2. presence of a left atrial thrombus on recent imaging. 3. recent myocardial infarction or severe heart failure (lvef ≤ 30%). 4. current severe infection.

Keywords: ablation atrial fibrillation
immunological and cardiovascular phenotyping of oocyte-donation pregnancies

Conditions: Preeclampsia; Oocyte-donation Pregnancies

Summary: the investigators conduct a study to evaluate the underlying causes of preeclampsia in oocyte-donation pregnancies.

a detailed medical history, questionnaires as well as blood, urine and placental samples will be used to analyse several factors leading to the high risk of preeclampsia in oocyte-donation pregnancies.

Eligibility criteria:
inclusion criteria: * pregnancy exclusion criteria: * severe auto immune disorders
magnetic activated cell sorting in artificial insemination with donor sperm

Conditions: Infertility

Summary: the aim of this study is to analyse the efficacy of macs technique for the selection of spermatozoa and its effects on implantation, pregnancy and miscarriage rate. this study will be performed by two ivi clinics (ivi sevilla and ivi madrid) with the purpose of finding new techniques that allow us to better select spermatozoa and improve the results of assisted reproduction techniques.


Eligibility criteria:
inclusion criteria: * women who undergo artificial insemination with donor sperm * signing an informed consent form to participate in the study

Keywords: magnetic activated cell sorting (macs) artificial insemination with donor sperm (aid) spermatozoa sperm
effects of lower extremities cycling functional electrıcal stimulation training in cerebral palsy

Conditions: Cerebral Palsy; Diplegic Cerebral Palsy

Summary: the aim of this study was to investigate the effects of cycling functional electrical stimulation applied to the lower extremities of children with spastic diplegic cerebral palsy (cp) on the gait parameters and daily living activities.

cerebral palsy (cp) is a broadly-defined neurological disorder that encompasses brain injury or malformation in a child's brain that occurs before, during, or immediately after birth and results in impaired motor control. because of the broad definition of cp, people with cp can exhibit a very wide range of symptoms, and no two people with cp will exhibit the same symptoms. however, people with cp generally have difficulty moving parts of their bodies normally because of muscle weakness or paralysis, impaired muscle coordination, and/or spasticity. impaired motor control can also be accompanied by intellectual impairment, seizures, or sensory impairment. physical impairment can severely limit participation in physical activity by people with cp, as is true for anyone with physical impairments. lack of physical activity can lead to the development of any number of chronic diseases, especially in children with disabilities like cp. exercise is an effective method for mitigating the negative secondary health effects of neuromuscular diseases like cp, but how can someone with cp exercise despite their impaired motor control, especially when 31% of children with cp have limited walking ability. cycling is an exercise that challenges the muscular and cardiovascular systems, potentially leading to improved health, fitness, and well-being. cycling with functional electrical stimulation (fes) has been primarily used by people with spinal cord injury; improvements have been seen in bone mineral density, muscle strength (force-generating capacity), and cardiorespiratory measures. recent reports indicated benefits for people after stroke; improvements in strength and motor control were seen when an fes cycling program was added to traditional rehabilitation. however, there have been no reports of fes cycling for children with cp. cycling with fes may be a suitable intervention for with cp because the seated position decreases balance demands, and fes can create or augment pedaling forces. many people with cp may be incapable of generating sufficient forces during cycling to reach the exercise intensity needed for optimal fitness-related outcomes and musculoskeletal benefits.

Eligibility criteria:
inclusion criteria: * cerebral palsy * classified in levels i - ii of the gross motor function classification system (gmfcs) * able to follow and accept verbal instruction exclusion criteria: * any orthopaedic surgery or botulinum toxin injection in the past 6 months, * children whose parents refused to participate

Keywords: diplegic cerebral palsy cycling with functional electrical stimulation gait analysis functional strenght training quality of life qxygen consumption
speech-based digital biomarker for psychiatric disease

Conditions: Speech; Psychiatric Disorder; Language

Summary: the general objectives of this study are to build a proof-of-concept, speech-based, digital biomarker for identifying the presence and tracking the severity of psychiatric disease.

the purpose of this study is to gather longitudinal data to examine how speech features and symptoms change over different intervals of time and the reliability of repeated, high frequency test administration. participants will complete a variety of speech and language tasks using the winterlight assessment (ios app) everyday for 30 days. the following is the list of assessments that participants will complete; 1) daily assessment of mood, 2) winterlight assessment which contains a series of verbal response tasks where participants are recorded through a tablet app, and 3) clinical assessments.

Eligibility criteria:
inclusion criteria: * male and female adults aged 18 to 95. * english as a first language, or english as a second language with conversational proficiency. * own an ios device (iphone or ipad) and willing to install the study app. * a reliable (cellular or wifi) home internet connection and accessible email address exclusion criteria: * residence outside of canada or the united states. * clinically significant vision impairment (corrected vision is acceptable). * clinically significant hearing impairment (use of hearing aids is acceptable)
gel-200 extension and open-label study in osteoarthritis of the knee

Conditions: Osteoarthritis of the Knee

Summary: the purpose of this study is to determine if a single or repeat intra-articular injection of gel-200 is safe and effective in subjects with symptomatic osteoarthritis of the knee and to determine if original si-6606/01 gel-200 therapy is durable beyond the original study.


Eligibility criteria:
inclusion criteria: * previous participation in study si-6606/01. exclusion criteria: * female subjects who are pregnant or lactating.
halaven patient registry (metastatic breast cancer, mbc)

Conditions: Metastatic Breast Cancer; Advanced Breast Cancer

Summary: since the first marketing authorization in the world in november 2010 granted by us fda, halaven has been approved for clinical use in more than 40 countries worldwide, including many asian countries, e.g. hong kong, india, japan, malaysia, myanmar, philippines, south korea, singapore, taiwan and thailand. according to two large global phase iii study reports of halaven, very few asian patients participated in these studies. in a phase ii study of halaven with metastatic breast cancer, the clinical efficacy and toxicity were reported only in 80 japanese patients. halaven has been granted its marketing authorization in singapore since february 2011. however, most of other asian countries including india have had the approval and launched from middle year of 2013 or in early 2014. limited information of halaven using in asian patients are available except several case experience exchange presented by individual medical centers or as personal experience in the past. some clinical concerns related to halaven use are raised by clinicians during their clinical practice, such as how halaven works on asian patients, which type of patient obtains better clinical benefit from halaven, and what are the main treatment related toxicities in asian which may differ from westerners due to potential ethnic diversity. further understanding of halaven related clinical benefit and toxicity in asian patients through collecting clinical experience among asian countries becomes necessary and may provide better information to anticipate these concerns. the proposed "halaven patient registry" (called the "registry") will be a patient population-based registry to collect therapeutic related information from patients with metastatic breast cancer who were treated with halaven that was given as a clinical decision by patient's treating physician based on clinical status of a patient and proper indication of halaven and to gain a better understanding of the use of halaven in such asian patients.


Eligibility criteria:
inclusion criteria: * an eligible patient to be entered into the registry is defined as: 1. patient with advanced breast cancer. 2. halaven was given or has been treating during the period of 1 jan 2015 to 31 dec 2016. 3. halaven was given as single or combination. 4. patient received at least one cycle treatment (a 21-day cycle or 2 doses) of halaven. 5. patient with at least 80% of the required information of the registry crf to be entered. it will be calculated automatically by the registry system. patient to be selected for the registry will be based on chorological order of a patient occurred in a study center during the defined period of the registry, if all other eligibility criteria are met. exclusion criteria: * those who not meet the inclusion criteria will be excluded.
influence of covid-19 on vascular endothelial function

Conditions: COVID; Vascular; Damage

Summary: rationale: infection with severe acute respiratory syndrome coronavirus (sars-cov) 2 could result in endothelial dysfunction with increased risk of arterial thrombotic events by downregulating the expression of angiotensin converting enzyme 2 (ace2). endothelial function can be easily and non-invasively determined by carotid artery reactivity (car) testing. objective: to investigate the predictive value of endothelial dysfunction, measured by carotid artery reactivity testing, for 1-year cardiovascular events in patients with past covid-19 infection. study design: a prospective observational longitudinal cohort study. study population: patients recovered from confirmed infection with sars-cov2. main study parameters/endpoints: macrovascular endothelial function measured by carotid artery reactivity testing.


Eligibility criteria:
inclusion criteria: * confirmed sars-cov2 infection by polymerase chain reaction on nasopharyngeal swab, sputum or bronchoalveolar lavage. * at least 6 and no more than 20 weeks after resolution of covid-19 related symptoms * ≥ 16 years old exclusion criteria: * recent (\<3 months) angina pectoris, myocardial infarction, stroke, or heart failure * raynaud syndrome, scleroderma, complex regional pain syndrome of the upper extremity or presence of arteriovenous fistula or open wounds on both the upper extremities.
effect of vitamin d and omega 3 on osteocalcin

Conditions: Vitamin D Deficiency

Summary: assessing the combined effect of omega-3 fatty acid and vitamin d 3 on plasma osteocalcin levels

the data about effect of vitamin d3 (vd3) and omega-3 fatty acids(omega-3fa) on plasma levels of osteocalcin (ocn) are scarce and conflicting and nothing is published in the literature about the effect of the combination of vd3 and omega-3fa on the ocn levels. this study was conducted to investigate effect of vd3 and omega-3fa alone and with each other on plasma ocn levels in females and males with vitamin d deficiency (vdd). this randomized, controlled clinical trial was designed to test effects of 50,000 iu vd3 weekly and 300 mg omega-3fa daily for eight weeks,separately and with each other, on the plasma levels of ocn and 25-hydroxy vitamin d (25ohd). this study was conducted during winter in 86 healthy jordanian females and males with vdd with a mean age of (40± 10) years. fasting serum levels for 25ohd,ocn, pth (parathyroid hormone),calcium, phosphate, alt (alanine aminotransferase), and urea were assessed at baseline and the end of the trial .

Eligibility criteria:
inclusion criteria: * medical diagnosis of vitamin d deficiency (vd \< 30 ng / ml). exclusion criteria: * people who previously diagnosed with any chronic disease such as kidney diseases were excluded from the study due to the effect of prolonged administration of vd3 on kidney stones formation. * people with bone disorders also excluded.

Keywords: vitamin d deficiency plama osteocalcin omega-3 fatty acids
evaluation of daily hemodialysis at low dialysate flow in patients previously treated with conventional hemodialysis

Conditions: End Stage Renal Disease

Summary: hdq 200 is an interventional multicenter study. this is a before-and-after design in which the patient is his own control. the main objective of the study is to determine the percentage of success of a procedure of daily hemodialysis at low dialysate flow. all patients treated with conventional hemodialysis, for at least 3 months and clinically stable, can be included in the study. their 3 months data prior to inclusion is collected retrospectively. these 3 months of conventional hemodialysis are the reference period. patients are then treated with daily hemodialysis at low dialysate flow for 3 months. during this 3 months period, the same data as during the period of conventional hemodialysis are collected prospectively.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * patients who give voluntary signed informed consent * patients affiliated with the french universal health care system or similar * for women of childbearing potential: serum or urine negative pregnancy test * patients treated with conventional hemodialysis (3 times 4h to 5h per week at at least a dialysate flow rate of 500 ml/min) for at least 3 months and clinically stable (investigator assessment) * bipuncture patients (or with double lumen central venous catheter) with stable vascular access and easy to puncture * patients willing to be treated with daily hemodialysis at low dialysate flow during the study period (6 times 2h to 2h30 per week at a dialysate flow rate of 200 ml/min in order that the total duration of weekly dialysis is equivalent to the duration of weekly dialysis during the last 3 months of conventional hemodialysis) exclusion criteria: * pregnant women or women who could become pregnant during the study (planned pregnancy within 3 months) * patients not affiliated with the french universal health care system * minor patients * patients who are protected adults according to the terms of the law (french public health laws). * refusal to give consent * patients simultaneously participating in another trial that may interfere with the study results

Keywords: short daily hemodialysis low dialysate flow end stage renal disease