Clinical Trials About "Human medicines European public assessment report EPAR Kevzara∨derfield=score∨derval=DESC" RSS

23:02 EDT 22nd July 2019 | BioPortfolio

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Showing "Human medicines European public assessment report EPAR Kevzara" Clinical Trials 1–25 of 19,000+

Monday 22nd July 2019

Impact of Hyponatremia on Muscle Strength, Gait and Cognitive Function

In this study patients with hyponatremia, defined as a serum sodium < 126 mmol/L on admission to the hospital will be tested for muscular power by use of a hand grip dynamometer, for cognitive function by use of the Montreal-Cognitive-Assessment and gait stability by use of the Tinetti test. The tests will be performed on admission as well es after correction of hyponatremia.

Efficacy of Eye Movement Desensitization & Reprocessing Versus Cognitive Behavioral Therapy in Post-Traumatic Stress and Depressive Disorders

Post-Traumatic Stress Disorder(PTSD) develops after exposure to or witnessing traumatic events. PTSD is highly comorbid and individuals with PTSD usually report Major Depressive Disorder(MDD). Common treatment choices for PTSD and MDD are either EMDR or CBT, however, little is known about their comparative efficacy, especially in Pakistan. Therefore, this Randomized Controlled Trial(RCT) aims at determining the comparative efficacy of EMDR vs CBT in Pakistan. This study will al...

Decellularised Dermis Allograft for the Treatment of Chronic Venous Leg Ulceration

Does the use of decellularised dermis allograft in addition to compression therapy promote healing in chronic venous leg ulceration compared to compression therapy alone

Regimen Switch to Dolutegravir/Lamivudine Fixed Dose Combination From Current Antiretroviral Regimen in HIV-1 Infected and Virologically Suppressed Adults (SALSA)

The aim of this study is to determine if virologically suppressed Human Immunodeficiency Virus (HIV) Type 1 infected adults on a current antiretroviral regimen (CAR) (including 2 nucleoside reverse transcriptase inhibitors [NRTIs] plus a third agent) remain suppressed upon switching to dolutegravir/lamivudine (DTG/3TC) fixed dose combination (FDC). The main objective of the study is to demonstrate the non-inferior antiviral activity of switching to DTG/3TC FDC once daily compar...

BETAmethasone Dose Reduction: Non-Inferiority on the Neurocognitive Outcomes of Children Born Before 32 Weeks of Gestation

Maternal antenatal corticosteroid therapy is the last major advance in the antenatal management of fetuses to prevent neonatal complications associated with prematurity. Long-term neurological outcomes in infants exposed to antenatal steroids have been assessed in few cohorts and suggest that this therapy is able to prevent some neurodevelopmental impairments including cerebral palsy. While >85% of neonates born very preterm in Europe have been exposed to antenatal betamethason...

Citrate Salts for Stone-free Result After Flexible Ureterorenoscopy for Inferior Calyx Calculi

The prevalence of urolithiasis is around 10 % in the French population. It is thus a major public health issue. When the stone is not spontaneously removed, interventions such as extracorporeal lithotripsy or flexible ureteroscopy (F-URS) are performed. F-URS is usually preferred in inferior calyx stones > 7 mm in comparison with lithotripsy, with better results. Efficacy of ureteroscopy is based on the "stone-free rate" (SFR) at 3 months. A SFR index is assessed according to t...

SEL120 in Patients With Acute Myeloid Leukemia or High-risk Myelodysplastic Syndrome

This first-in-human study will evaluate SEL120, a novel small molecule CDK8/19 inhibitor, in patients with Acute Myeloid Leukemia (AML) or High-risk Myelodysplastic Syndrome (HR-MDS), in terms of selection of the recommended dose for further clinical development and assessment of safety, tolerability, preliminary anti-leukemic activity, as well as pharmacokinetic and pharmacodynamic profiles.

The Effect Of Indıvıdual and Group Breastfeedıng Traınıng Of Candidate Mother And Father

Breast feeding is the primary step for healthy generations. Breast milk protects against diseases of childhood period starting from infancy till adulthood. Inspite of the benefits of breast milk due to various reasons a lot of women all around the world and in our country can not begin breast feeding and leave it at an early stage even if they start once. According to Turkey Population and Health Investigation (TPHI) data of 2013; while the rate of only breast feeding among; 0-...

Trial of Simulation-based Mastery Learning to Communicate Diagnostic Uncertainty

The goal of this study is to teach emergency medicine resident physicians to communicate more effectively with patients at the time of emergency department discharge in the setting of diagnostic uncertainty (i.e. no definitive cause identified for the patient's symptoms). All residents will complete baseline and follow up assessments by completing in-person simulated patient discharged. After the baseline assessment, they will complete an online educational curriculum that has ...

Protective Monocytes and Macrophages to Limit Decompensation and Heart Damaging

The working hypothesis is that cardiac macrophages specific for the compensated cardiac hypertrophic phase limit the progression toward the decompensated state of heart failure by promoting an inflammatory environment favouring cardiomyocyte survival and preservation of the pump function. We will perform studies in human plasma and monos, cardiac tissues and macrophages to validate this hypothesis.

Assessment of the Excitability of Spinal Motoneurons Using Stimulus-response Curves of the Bulbocavernosus Reflex

Spasticity is commonly observed in neurological conditions such as Multiple Sclerosis and spinal cord injury. "Peripheral" spasticity, concerning in particular the striated muscles of the limbs is nowadays well known and studied with clinical scales (Ashworth, Taridieu...) or even electrophysiological methods (H-reflex, T-reflex...). However, this spasticity can also affect the perineal muscles and more generally the pelvic muscles. However, there is to date no validated and st...

Assessment of Leflunomide Efficacy and Hepatotoxicity in Patients With Rheumatoid Arthritis Through Pharmacokinetic and Genetic Approaches

The RA patients receiving leflunomide for more than one month, and not receiving other DMARDs (except hydroxychloroquine), will be enrolled to assess their disease activity. Blood samples will be collected for genetic studies and pharmacokinetic assay of the blood levels of the drug and its active metabolite.

Using Personal Mobile Technology to Identify Obstructive Sleep Apnea in Children With Down Syndrome (UPLOAD)

This study aims to see if mobile video clips (smartphone recordings) can be used to screen children with Down syndrome to identify those at highest risk of obstructive sleep apnea (OSA), so they can be prioritized for an earlier sleep study. Parents will be asked to record short video clips of their child sleeping, and then rate whether they think their child has OSA. Later, children will undergo a sleep study to compare to the ratings.

Investigation of Supplemental L-alanine in the Management of Dietary Fructose Intolerance: a Double-blind, Randomized Study

Over the past few decades, fructose consumption has risen significantly in the United States1. This sugar is increasingly being used as a sweetener in a variety of foods1. Because there is a limited absorptive capacity for fructose, excessive ingestion of fructose leads to fructose malabsorption and dietary fructose intolerance (DFI) 2-9, 13. Incomplete absorption of fructose may lead to a variety of gastrointestinal symptoms, including bloating, pain, gas and diarrhea 2-9. In ...

Hydroxychloroquine Efficacy on Behcet's Disease Thrombosis

Patients diagnosed with Behcet's disease will be randomized to administeration of hydroxychloroquine. Assessment will be done for the patients at baseline and every one month in the first three months and then quarterly for one year.

To Study the Role of Liquid Based Cytology (LBC) for Diagnosis and Characterization of Biliopancreatic Tumor s Compared With Standard Cytology and On-site Evaluation.

Liquid Based Cytology is a method of preparing samples for examination in cytopathology.Liquid-based cytology (LBC), enables cells to be suspended in a monolayer. LBC makes better cytological assessment possible with improved sensitivity and specificity, since fixation is better and nuclear details are well preserved in the technique. Conventional cytology is gold standard for biliopancreatic malignancy examination. This method is operator depended and have high inter observer ...

Impact of High-level Oxygen Therapy on the Reconditioning of Type I Hypoxemic Respiratory Insufficiency Patients in Intensive Care

High-throughput oxygen therapy is known as an alternative to non-invasive ventilation, with a benefit in terms of survival in non-hypercapnic respiratory failure patients. The use of high-throughput oxygen therapy is well studied in stable chronic obstructive pulmonary disease (COPD) patients and has as known effects the decrease of transcutaneous CO2 and respiratory rate, and the increase in the inspiratory/expiratory time report, in the tidal volume and in the forced expirat...

Effect of PACK Health Support Program on Patient Reported Outcomes in Patients With Breast Cancer

This trial studies the effect of an electronic health (eHealth) support program called PACK Health on patient reported health outcomes in patients with newly diagnosed breast cancer. PACK Health monitors breast cancer patients' reported side effects and experience of care when receiving receiving various treatment modalities. Participating in the PACK Health coaching program may improve quality of life, decrease hospital admissions and improve overall health.

The Experience of Patients and Family Caregivers in Managing Pneumoconiosis in the Family Context

This is an exploratory qualitative study to understand the needs of patients with pneumoconiosis, and the care-giving experience of their family caregivers. Patients with a confirmed diagnosis of pneumoconiosis for at least 1 year and had registered with the Pneumoconiosis Compensation Fund Board in Hong Kong to receive compensation will be eligible to join this study. The respective family caregivers of these patients, who are 21 years of age or older, assuming the role as the...

The Role of Endothelial Dysfunction in Adult Polycystic Kidney Disease

This pilot study will compare endothelial function in patients with ADPKD with matched healthy volunteers and normotensive chronic kidney disease stage 1 & 2 patients. Patients will undergo a single assessment of endothelial function and measurement of plasma and urine levels of biomarkers of endothelial function.

Efficacy of Interleukin-2 Gargle in the Treatment of Oral Mucosa Lesion in Pemphigus Vulgaris

This clinical study will test the short-term efficacy of interleukin-2 gargle combined with systemic use of glucocorticoids in the treatment of oral mucosal lesions in mucosal-dominant pemphigus vulgaris and moderate mucocutaneous pemphigus vulgaris.

Liver Resection Modeling

Despite the medical and surgical progress of the last two decades, the selection of candidates for liver surgery remains based on old principles and insufficiently sensitive to fine-tune the gesture to patient-specific characteristics and make almost zero risks of postoperative liver failure (PLF) and death. It is therefore necessary to develop new tools that will make possible to predict the evolution of the postoperative portocaval gradient (difference of pressure between por...

Comparative Study for the Degree of Biological Changes After Short-term 2 Weeks and 4 Weeks Preoperative Endocrine Therapy in Luminal Breast Cancer

RATIONALE: Estrogen can promote proliferation of tumor cells in hormone receptors (HR)-positive breast cancer. The standard therapy of Luminal subtypes is endocrine therapy, which can influence proliferation of tumor cells by blocking the use of estrogen by cancer cells or lowering the amount of estrogen the body makes. Thus, markers of proliferation are candidate markers of efficacy after short-term (e.g., 2 weeks or 4 weeks) preoperative hormone therapy. Ki-67 is most commonl...

Clinical Assessment of Lithium Disilicate (E-max) and BioHPP Polyetheretherketone (PEEK) Endocrowns

Patients need Endocrowns for their teeth usually use Emax as an etchable ceramic. Yet they have disadvantages that may influence the outcome of the endocrowns, among which is the high stiffness and rigidity owing to the higher modulus of elasticity (67.2 GPa)( compared to natural dentin (18.6 GPa) which may affect the marginal a less rigid material is needed. PEEKs (polyetheretherketones) are presented as alternative materials to metal and glass ceramics, Their el...

Effect of Cinnamomum Zeylanicum on Glycemic Levels of Adult Patients With Type 2 Diabetes

Type 2 Diabetes (T2D) is protected against chronic hyperglycemia. This is one of the main causes of death in the country, being a public health problem worldwide. Some studies have shown that herbal products have beneficial effects in patients with diabetes by improving the metabolism of glucose and lipids. Cinnamomum Zeylanicum (C.Z.), colloquially cinnamon, is one of the components of the diet that has active biological substances with insulin mimetic properties. In Mexico, l...

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