Kornimate/medical-research-clean huggingface dataset:
beta 3 agonist treatment in heart failure

Conditions: Chronic Heart Failure With Reduced Ejection Fraction (HFrEF)

Summary: objective: the objective of the study is to assess the structural and functional cardiac effects of treatment with the beta 3 ar agonist mirabegron in patients with chronic heart failure. design: the investigators are planning a study aiming at establishing proof of concept that treatment of patients with hf with mirabegron has significant positive effects, as assessed by clinical and biochemistry measurements, but not by hard endpoints. the investigators are performing a combined dose-finding - chronic efficacy study. the study is a randomized, placebo-controlled, double-blinded trial. the follow-up period is 6 months. 70 patients with chronic heart failure will be included. specific aims 1. determine safety of administration of mirabegron to patients with heart failure. 2. determine if treatment with mirabegron for 6 months induces beneficial cardiac structural remodelling in patients with heart failure. 3. determine if mirabegron improves symptoms and exercise capacity as indicated by questionnaires and 6 min walk test in patients with heart failure. 4. determine effects of mirabegron on cardiac conduction, repolarisation and rhythms and arrhythmias in patients with heart failure. 5. determine effects of mirabegron on circulating biomarkers in patients with heart failure.


Eligibility criteria:
inclusion criteria: 1. stable heart failure nyha class ii-iii on ischemic or non-ischemic basis 2. left ventricular ejection fraction (lvef) \< 40% 3. stable sinus rhythm (sr) 4. on optimised evidence-based pharmacological hf treatment stable \> 4 weeks with no current plan for changing hf therapy. the therapy must include a beta-blocker. 5. no change in diuretics \< 4 weeks 6. \>18 years exclusion criteria: 1. unstable cardiac condition 2. acute myocardial infarction (ami) or revascularisation \< 3 month ago 3. atrial fibrillation (for technical reasons in relation to imaging and hr reporting) 4. uncorrected significant primary obstructive valve disease 5. planned major surgery including cardiac revascularisation 6. hemodynamically significant obstructive cardiomyopathy 7. stroke with significant neurological deficit 8. acute myocarditis or constrictive pericarditis 9. symptomatic bradycardia or \> 1. degree av-block unless the patient has a pacemaker 10. clinically significant hepatic (transaminases or bilirubin x 3 above upper reference level) or renal (gfr\< 50 ml/min/1,73 m2) diseases 11. heart failure due to uncorrected thyroid disease 12. cardiac mechanical support 13. \< 6 months after crt 14. uncontrolled hypotension (defined as symptomatic systolic blood pressure \< 90 mmhg) - or hypertension (defined as systolic at 180 mmhg or above and/or diastolic blood pressure at 110 mmhg or below) 15. body mass index (bmi) \> 35 16. unable to give informed consent 17. reduced compliance 18. all women of child bearing potential will be required to use adequate contraception 19. pregnant or lactating women 20. treatment with a tricyclic antidepressant or cyp2d6 substrates other than beta-blockers or treatment with digoxin.
feedback in augmented reality to control of gait parameters in children with cerebral palsy

Conditions: Cerebral Palsy; Gait Disorders, Neurologic; Feedback, Psychological

Summary: cerebral palsy (cp) describes a group of permanent disorders of the development of movement and posture, causing activity limitation, that are attributed to non progressive disturbances that occurred in the developing fetal or infant brain. the motor disorder of cp are often accompanied by disturbances of sensation, perception, cognition, communication, and behaviour; by epilepsy, and by secondary musculoskeletal problems. motor activities, especially walking, can be affected by many factors including sensory deficits, biomechanical and postural limitations, muscle weakness and spasticity.to provide feedback, during gait rehabilitation is a complementary approach to improve motor learning during the rehabilitation protocol. however, the feedback modalities are multiple and no study has compared these modalities. this study aims to test which feedback modalities could control the gait parameters (speed, cadence, step length) of the child with cp in real-time, through an augmented reality environment.


Eligibility criteria:
inclusion criteria: * children with cerebral palsy (medical file) * age 12-18 * global motor function classification system (gmfcs) i-iii * functional mobility scale (fms) minimum 2 for "50 meters" * ability to cooperate, to understand and to follow instructions * patient affiliated to the french social security system * patient volunteers whose the parents given their authorization to participate exclusion criteria: * medical decision for any reason * child or parent decision for any reason * inability to cooperate, to understand and to follow instructions

Keywords: serious game rehabilitation
skin-to-skin contact to promote bacterial decolonization in preterm infants

Conditions: PREMATURITY

Summary: background decolonization with topical antibiotics is necessary to prevent and / or control outbreaks of multidrug-resistant bacterial infection in the nicu (neonatal intensive care unit), but can trigger bacterial resistance. the objective of this study was to determine whether skin-to-skin contact of newborns colonized with mrsa (methicillin-oxacillin resistant staphylococcus aureus) with their mothers could be an effective alternative for biological control of bacterial colonization. methods: the investigators studied 102 newborns admitted to nicu in three public hospitals in são luís, brazil. inclusion criteria were birth weight from 1300 to 1800g, length of stay \>4 days, newborns colonized by staphylococcus aureus and/or staphylococcus coagulase-negative methicillin-oxacillin resistant and mothers not colonized by these bacteria. randomization was performed using a computer generated random numbers algorithm. allocation to intervention and control groups was performed for each eligible newborn using a sealed opaque envelope. in the intervention group (n = 53) mother-infant skin-to-skin contact was held twice a day. the control group (n = 49) received routine care without skin-to-skin contact. there was no masking of newborn's mothers or researchers, but the individuals who carried out bacterial cultures and assessed results were kept blind to group allocation. the primary outcome was decolonization of newborns' nostrils after 7 days of intervention. safety was assessed by monitoring vital signs of newborns during the intervention. the secondary outcome was emergence of late onset presumed sepsis until the end of hospitalization period or 28 days of life, whatever happened first. funding: cnpq (brazilian research council) and fapema (maranhão research foundation)


Eligibility criteria:
inclusion criteria: * singleton neonates, * born in the three institutions of the study * birth weight from 1300 to 1800g * length of stay \>=4 days, * newborns colonized by staphylococcus aureus and/or staphylococcus coagulase-negative methicillin-oxacillin resistant and mothers not colonized by these bacterias. exclusion criteria: * infants below 1300g and over 1800g,

Keywords: skin-to-skin contact decolonization mrsa
evaluation of the quality of the novoseven (rfviia) tratment practice at rigshospitalet, copenhagen university hospital

Conditions: Hemorrhage; Shock

Summary: the purpose is to evaluate and improve novoseven treatment practice done according to our guidelines


Eligibility criteria:
inclusion criteria: * indication for novoseven treatment according to our guideline exclusion criteria: -
relative bioavailability study of ribavirin 200 capsules and rebetol 200 mg capsules in females under non-fasting conditions

Conditions: Chronic Hepatitis C

Summary: the purpose of this study is to demonstrate the relative bioavailability of ribavirin 200 capsules and rebetol 200 mg capsules in females under non-fasting conditions.


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. exclusion criteria: * positive test results for hiv or hepatitis b or c. * treatment for drug or alcohol dependence.
sublingual misoprostol to reduce blood loss during elective cesarean delivery

Conditions: Hemorrhage Postpartum

Summary: sublingual misoprostol to reduce blood loss during elective cesarean delivery : a randomized controlled trial

this study aims to evaluate efficacy and safety of subligual misoprostol in reducing blood loss during cesarean section , a randomized double blinded prospective controlled trial conducted at ain shams maternity hospital . 158 women who fulfilled the inclusion criteria enrolled in this study .the patients randomized into two groups one of them will receive sublingual misoprostol 400 micrograms ( misotac )and the other will receive placebo( ranitak ),all patients will subjected to history,physical examination,and investigations.preparation of patients (preload and antibiotics )according to hospital protocol.all c.s will be perfomed using spinal anaesthesia ,pfannenstiel incision of the skin ,open of abdomen in layers ,at cord clamping the patients will receive the medication sublingual and 20iu of oxytocin intravenous infusion simultaneous by the anesthesiologist,then close in anatomical layers.blood loss during c.s will be calculated following placental delivery to the end of surgery,and from the end of the operation to 6h after birth.the need for additional uterotonics agents,blood transfusion and adverse effects of the study drug will be recorded.

Eligibility criteria:
inclusion criteria: * singleton pregnancies * women booked for elective c.s * full term pregnancies * primi gravida or previous one delivery ( either by spontaneous vaginal delivery or c.s ) exclusion criteria: * blood disorders * multiple pregnancy * placenta previa * polyhydramnios * marked maternal anemia * contraindications to prostaglandin e.g history of asthma , allergy to misoprostol * previous 2 or more c.s
proadrenomedullin and copeptin in patients with septic shock

Conditions: Septic Shock

Summary: this study evaluates the usefulness of pro-adrenomedullin (precursor of a vasodilatory peptide involved in septic shock pathogenesis) and copeptin (a stable peptide of the arginine vasopressin precursor) to predict, at the moment of septic shock diagnosis or their changes at 6 hours, the vasopressor requirements (measured by inotropic index and vasopressor dependency ratio) and volume requirement for resuscitation.

physiologically, adrenomedullin has a potent and prolonged vasodilatory effect. in both experimental animals and humans, the intravenous administration of adm induces a marked and prolonged hypotension. serum adm levels are elevated in patients with septic shock. in fact, adm seems to be one of the main mediators involved in hypotension that these patients present. adm is not stable in plasma due to its short half-life and rapid binding to receptors. adm levels can be measured indirectly by determining proadrenomedullin (proadm) which is a more stable molecule and whose levels are reflected in the plasma of adm. copeptin is released primarily in response to changes in serum osmolarity or blood volume by increasing peripheral vascular resistance and blood pressure. copeptin is elevated in patients with shock of different etiologies such as hemorrhagic shock or septic shock. it is not defined in what situations and at what moment an invasive monitoring of the cardiac output and the different hemodynamic variables that reflect the preload and afterload in patients with septic shock should be performed. in fact, there is great variability in the management and treatment of patients with sepsis and septic shock, which includes the selection of patients who require invasive monitoring and the time of onset. having a biomarker or the combination of biomarkers that allow early determination of which patients will evolve poorly with the development of a shock that requires volume in large quantities and high doses of vasopressors will allow identifying a subgroup of patients that should be performed early hemodynamic monitoring and intensify medical treatment to try to reverse these severe hemodynamic changes.

Eligibility criteria:
inclusion criteria: * patients ≥ 18 years * diagnosis of septic shock * obtaining written informed consent. exclusion criteria: * initial dose of norepinephrine at icu admission ≥ 0.6 mg / kg / min. * acute myocardial infarction in the previous month. * history of pituitary surgery. * pregnancy.

Keywords: proadrenomedullin copeptin vasopressors septic shock
a clinical study of the safety and efficacy of mebo wound ointment in subjects with diabetic foot ulcers

Conditions: Diabetic Foot Ulcers

Summary: the objective of this study is to evaluate the safety and efficacy of mebo in the treatment of subjects with diabetic foot ulcers (dfus).

this is a phase ii, randomized, controlled, multi-center study designed to assess the safety and efficacy of mebo in the treatment of subjects with dfus. subjects meeting entry criteria will be randomly assigned in a 1:1 ratio for up to 8 weeks of treatment with either mebo or soc.

Eligibility criteria:
inclusion criteria: * male or female ≥18 years of age * able and willing to provide informed consent * able and willing to comply with protocol visits and procedures * target ulcer duration of ≥4 weeks exclusion criteria: * ulcer of a non-diabetic pathophysiology * known or suspected allergies to any of the components of mebo * malignancy on target ulcer foot * non-compliance in the screening or run-in period

Keywords: diabetic foot ulcers (dfus)
oral fluency and the response to antidepressant therapy in the elderly with a unipolar depressive episode

Conditions: Unipolar Depression

Summary: the study focuses on the identification of clinical, physiological and morphological markers that could predict the response to antidepressant in elderly suffering from unipolar depressive disorder.


Eligibility criteria:
inclusion criteria: * depressive episode according to dsm-5 criteria * unipolar depression * madrs ≥ 20 * antidepressive treatment (serotonin reuptake inhibitors/serotonin norepinephrine reuptake inhibitors) exclusion criteria: * other comorbid mental disorders (bipolar disorder, schizophrenia, recent addiction \< 3 months except for tobacco) * depression with psychotic features * serious unstabilized somatic illness * protected persons * dementia suspected at the time of enrollment
effect of acute exercise on exosome associated biomarkers

Conditions: Healthy

Summary: this research study is being done to understand the underlying mechanism by which exercise affects the body on the cellular level, in an acute aerobic endurance setting. this may help to better understand the overall benefits of endurance exercise.


Eligibility criteria:
inclusion criteria: * ages: 18 to 45 years exclusion criteria: * bmi \>32 kg/m2. cardiovascular, metabolic (type 2 diabetes, fasting plasma glucose at or above 110 mg/dl and untreated hypo- or hyperthyroidism) or renal disease. * orthopedic problems that would keep them from being able to perform an exercise. - -- * medications that are known to affect mitochondrial function: corticosteroids, opiates, benzodiazepines, tricyclic antidepressants, beta-blockers, sulfonylureas, insulin, anticoagulants, barbiturates, insulin sensitizers, fibrates (ppar gamma agonist). * smoking. * pregnancy.
assessment of neuropsychiatric function in patients with interstitial lung disease

Conditions: Lung Diseases, Interstitial

Summary: research on the impact of lung diseases on neuropsychological functioning has revealed impaired cognitive processing in patients with a variety of pulmonary disorders. while the mechanisms responsible for the association of pulmonary diseases and neurocognitive functioning remain unclear, some researchers have attributed it to reduced oxygenation of the brain. early detection and accurate management of comorbidity have benefits in reducing ild morbidity and mortality.

research on the impact of lung diseases on neuropsychological functioning has revealed impaired cognitive processing in patients with a variety of pulmonary disorders. while the mechanisms responsible for the association of pulmonary diseases and neurocognitive functioning remain unclear, some researchers have attributed it to reduced oxygenation of the brain. interstitial lung disease (ild) is an "umbrella" term as it comprises a variety of pulmonary diseases which affect the interstitium (the tissue and space around the air sacs of the lungs). it may be caused by a variety of factors (namely, inhaled substances, medications, infection, connective tissue disease, malignancy or idiopathic reasons) and has a clear negative impact on patients' quality of life, leading to symptoms such as fatigue, dyspnea and coughing. physical sequelae include reduced lung volumes due to tissue thickening, sometimes caused by inflammation. a further consequence is reduced breathing efficiency, resulting in reduced blood oxygen levels and compromised exercise capacity. additionally, the fibrosis of the parenchyma impedes the level of gas exchange. a number of studies have reported mood effects in ild, suggesting, however, that the diagnosis of depression may be obscured, due to the fatigue and apathy that is often a consequence of ild. early detection and accurate management of neuropsychiatric comorbidities have benefits in reducing ild morbidity and mortality.

Eligibility criteria:
inclusion criteria: * interstitial lung disease patients diagnosed using high resolution computed tomography to confirm the diagnosis exclusion criteria: * patients who refuse to participate in the study. * age less than 18, * a history of neurological and/or developmental disorders and related drug treatment, * a head injury with loss of consciousness, * active alcohol or drug abuse or a history of abuse prior to testing, * a history of any psychiatric disorder or treatment, neurological disorders, psychological disorders, dementia, alzheimer's disease, end-organ failure conditions

Keywords: interstitial lung disease cognitive function spirometry anxiety
protocols for painless photodynamic therapy (pdt) of actinic keratoses

Conditions: Actinic Keratosis

Summary: this study is being done to compare a new, continuous illumination regimen of ala-pdt (aminolevulinate-photodynamic therapy) to a conventional regimen for treatment of actinic keratoses. the hypothesis is that the continuous illumination approach will be less painful, but equally efficacious, as the old regimen.

this study is being done to compare a modified version of the standard ala-pdt (aminolevulinate-photodynamic therapy) treatment of actinic keratoses, to a modified version in which light exposure begins immediately after application of the levulan. we hypothesize that this will yield a therapeutic efficacy equivalent to the standard ala-pdt regimen, but will cause less pain during the light exposure. the study employs a bilateral design in which the left versus right sides of the treatment area are compared in the exact same patient. there are 3 arms of the study, each having a different time duration of light exposure in the modified regimen to determine which one is most efficacious

Eligibility criteria:
inclusion criteria: * males or females, at least 18 years of age * non-hyperkeratotic actinic keratoses, at least 6 in number (3 on each side of scalp, face or upper extremities) exclusion criteria: * patient is currently pregnant or are planning to conceive during the course of the study period * patient is using topical therapy or other treatment for these actinic keratoses * patient has a known hypersensitivity to 5-aminolevulinic acid

Keywords: actinic keratosis actinic keratoses ak pdt photodynamic therapy blue light therapy ala aminolevulinic acid levulan
calprotectine in spondyloarthritis

Conditions: Spondylarthritis

Summary: to date, there are no biomarkers in spondyloarthritis that can differentiate between spondyloarthritis and fibromyalgia or other pathologies. fecal calprotectin is a biomarker that is increasingly used in inflammatory diseases of the digestive tract. a growing interest in this biomarker is emerging in rheumatology, several publications have focused on its interest in rheumatoid arthritis, highlighting an association between serum calprotectin levels and disease activity. in spondyloarthritis, a few studies seem to show that it could be a marker of disease activity. although a 2012 study found no difference in serum calprotectin levels between subjects with spondyloarthritis and controls. still others have shown that it could be a predictive factor of radiological evolution in the same disease key. these data support, despite the questionable results of the klingberg study, the value of this dosage in spondyloarthritis. the objective of this work is to show that this assay could be useful to differentiate spondyloarthritis from other pathologies with similar clinical presentation such as fibromyalgia. difficulties classically encountered in common practice in rheumatology


Eligibility criteria:
inclusion criteria: patients in the active line of the rheumatology department with one of the following criteria: active spondyloarthritis (basdai \>4), or spondyloarthritis in low activity (basdai\<4), or fibromyalgia without associated inflammatory rheumatism, or healthy subjects (without inflammatory rheumatism and without fibromyalgia. patients who have not objected to the use of their samples exclusion criteria: minor patient subject not affiliated to the social security system subject deprived of liberty patient under guardianship or curatorship
effect of dental pulp stem cells and l-prf after impacted third molar extraction

Conditions: Stem Cell; Third Molar; Periodontal Pocket

Summary: the purpose of this study is to compare the clinical and radiographic effectiveness of leukocyte-platelet rich fibrin (l-prf) and l-prf combined with dental pulp stem cell (dpsc) application to the extraction socket of mandibular third molars.

patients aged between 18 and 30 years, seeking for bilateral impacted lm3 extraction surgeries and meeting eligibility criteria were included to the study. at baseline right and left impacted third molars (lm3s) were randomly assigned to one of the treatment group (l-prf and l-prf + dpsc). baseline and 6th month clinical and radiographic measurements were compared.

Eligibility criteria:
inclusion criteria: * patients aged between 18 and 30 years * bilateral impacted lm3 extraction surgeries requirement exclusion criteria: * having clinical signs or symptoms of abscess or cellulitis formation * having a history of radiotherapy * having any systemic diseases interfering with wound healing and/or smokers * patients who had been diagnosed as periodontitis * patients who had lm2s with caries or restorations that have an unidentifiable cementoenamel junction

Keywords: dental pulp stem cell third molar platelet-rich fibrin