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NCT ID: NCT03059953 Completed - Clinical trials for Moderate Plaque Psoriasis

A Study of Treatment With APRemilast in Moderate psoriAsIS in Real Life clinicAL Practice (The 'APRAISAL' Study)

APRAISAL
Start date: April 7, 2017
Phase:
Study type: Observational

For patients with moderate plaque psoriasis who are intolerable to, have a contraindication to or have failed classical systemic treatments, the current commonly employed management strategy encompasses treatment with biologic agents. The direct and indirect costs of biologic treatment, accruing, among others, from the high drug acquisition and administration costs, the required baseline safety screening and subsequent routine monitoring as well as the potential loss of patients' working hours constitute a significant financial burden on the public healthcare system. In light of the above evidence, it appears that in routine care apremilast may fulfill an important gap in the treatment armamentarium of psoriasis by providing a promising treatment option to be employed prior to biologics, which has demonstrated efficacy even in hard-to-treat areas such as the scalp, nails, palms and soles, and has a limited manageable safety profile, while being more convenient and cost-effective than biologics. In view of the scarcity of real-world evidence regarding the impact of apremilast on the patients' health-related quality of life (HRQoL) and extent and severity of the disease, and under the consideration that the moderate psoriasis patient {defined as [10<body surface area (BSA)<20 or 10<psoriasis area severity index (PASI)<20] and 10<dermatology quality of life index (DLQI)<20}, naïve to biologic treatment was likely underrepresented in the pivotal ESTEEM trials since approximately 30% of the enrolled patients had been previously treated with biologic therapy, 28-30% had a baseline PASI score >20, and 48-52% had a BSA >20%, this study represents an attempt to examine the impact of apremilast in routine clinical practice settings in Greece on the patient with moderate plaque psoriasis when this therapeutic strategy precedes biologics in the treatment algorithm. Specifically, the present study aims to generate novel real-world evidence on the effect of apremilast treatment in biologic treatment naïve patients with moderate plaque psoriasis in terms of the patients' HRQoL, patient-perceived benefits of therapy, treatment response rate, and impact on nail, scalp and palmoplantar psoriatic involvement and severity of pruritus, while concurrently assessing apremilast survival rate and cost per PASI-75 responder in the routine clinical practice of Greece.

NCT ID: NCT03058874 Completed - Hypertension Clinical Trials

Effect of Dry-weight Probing Guided by Lung-Ultrasound on Ambulatory Blood Pressure and Arterial Stiffness in Hemodialysis Patients (LUST Sub-Study)

LUST ABPM
Start date: September 1, 2016
Phase: N/A
Study type: Interventional

The most common co-morbidity accompanying Chronic Kidney Disease (CKD) is hypertension, which appears in approximately 80% of all patients with renal dysfunction, whereas its prevalence in general population is remarkably lower appearing in approximately 30% of adults.Defining hypertension in ESRD patients under maintenance dialysis is a challenging procedure. Ambulatory blood pressure monitoring (ABPM) is considered the "gold standard" for the diagnosis of hypertension in hemodialysis patients over the last years. The major pathophysiologic mechanism underlying hypertension development in patients with ESRD under hemodialysis is water and sodium overload. Identifying an accurate and objective method of dry weight evaluation has been a matter of intensive nephrology research for more than two decades. Assessment of the water balance in hemodialysis patients on the basis of common clinical criteria (e.g. leg or face swelling or signs of lung congestion) is a subjective method with limited reliability, despite its widespread use. Recently, a novel technique has been developed to quantify water excess by conducting an ultrasound lung scan. Pilot studies have shown significant changes in lung water in hemodialysis patients according to body weight changes during interdialytic days and dialysis sessions. Moreover, results from previous studies indicate significant benefits from dry weight probing with regards to blood pressure (BP). The clinical application of a lung-ultrasound-based volume control strategy in hemodialysis patients is currently being tested by the randomized study entitled "Lung water by ultrasound guided treatment to prevent death and cardiovascular complications in high risk end stage renal disease patients with cardiomyopathy (The LUST Study)". This clinical trial aims at evaluating whether the use of the number of US-B lines could be used as a biomarker to guide a per-protocol intensification of ultrafiltration (UF) in order to reduce volume overload, improve cardiac function and prolong survival. Cardiovascular disease in patients with CKD is attributed to a spectrum of structural and functional alterations of the large and the small branches of the arterial tree. The most important process in patients with advanced CKD is that of arteriosclerosis, which is developed in parallel to atherosclerosis and is typically associated with impaired cushioning function of the aorta and the large conduit arteries. Accelerated arterial stiffening is involved in the development of isolated systolic hypertension, left ventricular hypertrophy (LVH) and congestive heart failure (CHF), which predispose to arrhythmias and sudden cardiac death. In the context of the phenomenon of "aortic-to-brachial BP amplification", systolic BP (SBP) and pulse pressure (PP) conventionally measured at the level of brachial artery are higher than the relevant pressures in the ascending aorta. Due to extreme elevation of arterial stiffness, BP amplification is disturbed in patients with ESRD. Prospective cohort studies have demonstrated that elevated central PP, wave reflections and arterial stiffness, as well as, reduced PP amplification represent strong and independent predictors of all-cause and cardiovascular mortality in hemodialysis patients. On this basis, estimation of central BP indices appears as an important tool towards optimisation of cardiovascular risk stratification in ESRD as well as in other diseased populations. Until recently, available devices for ABPM evaluated BP levels only at the level of brachial artery. The newly developed Mobil-O-Graph NG (IEM, Stolberg, Germany) provides the ability to monitor central aortic pressure and indices of vascular resistance, such as wave reflections (augmentation index, AIx) and arterial stiffness (pulse wave velocity, PWV).This device has recently been validated in hemodialysis patients and showed comparable performance with the widely used tonometric SphygmoCor device (ArtCor, Sydney, Australia). Accumulated evidence over central BP and PWV in hemodialysis patients derives mostly from studies that included only static pre-dialysis and post-dialysis measurements. However, variations of BP levels during intra- and interdialytic intervals combined with the superiority of aortic BP measurements, as analysed above, indicate that ambulatory monitoring of central BP is the best available method. This study aims for the first time to evaluate the outcome of a treatment strategy for dry weight probing, based on volume overload quantification with lung ultrasound, on 48-hour peripheral systolic BP, aortic BP and arterial stiffness in hemodialysis hypertensive patients. This is a Lust Sub-Study. Additional information can be found at: NCT02310061.

NCT ID: NCT03055793 Completed - Asthma Clinical Trials

Quality of Life Assessment in Greek asthmatIc Patients Treated With the Fixed Dose Combination of Budesonide / Formoterol in Clinical Practice

SKIRON
Start date: March 1, 2017
Phase: N/A
Study type: Observational

The greater efficacy of combination therapy led to the development of fixed combination devices which simultaneously carry both glucocorticosteroid and a LABA (eg stable combinations of fluticasone-salmeterol, budesonide-formoterol). Fixed combinations are easier to use for patients, potentially increasing compliance, and ensure that the LABA always accompanied by glycocorticosteroeides1. From the available combinations of the combination of budesonide-formoterol can be used both in maintenance therapy and for the relief of symptoms due to the rapid onset of action of formoterol compared with salmeterol. Both components of budesonide-formoterol combination when administered on demand contribute to strengthening protection from severe exacerbations in patients receiving combination therapy for maintenance, and enable improvement of asthma control at relatively low doses of ICS.

NCT ID: NCT03055442 Completed - Women Infertility Clinical Trials

Myo-inositol/D-chiro-inositol Ratio in Follicular Fluid

Start date: October 2016
Phase: N/A
Study type: Observational

Considering the importance assumed by follicular microenvironment for a proper oocyte development, this study is a prospective observational clinical trial which aims to evaluate whether the embryo blastocyst quality may be affected by different Myo-inositol (MI) and D-chiro-inositol (DCI) levels in the follicular fluid (FF) of the aspired oocytes. The study includes egg donors and egg receiving couples participating in the oocyte donation program. MI/DCI is calculated in FF and related with blastocyst grade.

NCT ID: NCT03053440 Completed - Clinical trials for Waldenström's Macroglobulinemia

A Study Comparing BGB-3111 and Ibrutinib in Participants With Waldenström's Macroglobulinemia (WM)

ASPEN
Start date: January 25, 2017
Phase: Phase 3
Study type: Interventional

This study evaluated the safety, efficacy and clinical benefit of BGB-3111 (zanubrutinib) vs ibrutinib in participants with MYD88 Mutation Waldenström's Macroglobulinemia.

NCT ID: NCT03050944 Completed - Infertility Clinical Trials

Association of the Mediterranean Diet With Fertility Outcomes

MedDietIVF
Start date: June 2013
Phase: N/A
Study type: Observational

Infertility affects one of every six couples and one out of ten couples may seek fertility treatment such as ovulation induction and assisted reproductive technologies. With respect to diet, several dietary factors, i.e. micro-, macro-nutrients and individual food groups, have been associated with the risk of subfertility; however, more information is needed on the role of dietary factors in reproductive functions. However, evidence concerning the association between dietary patterns, such as the Mediterranean diet (MD) pattern, and fertility is scarce. The aim of this study is to investigate the relationship between preconception dietary patterns, especially the MD pattern, and in vitro fertilization (IVF) outcomes, as well as adiponectin and follistatin concentrations in the plasma and follicular fluid of women undergoing IVF treatment. Blood and follicular fluid adiponectin and follistatin concentrations will be measured on each day of the ovarian stimulation protocol. Main IVF treatment outcomes are fertilization rate, oocyte and embryo quality, implantation, clinical pregnancy and live birth rates.

NCT ID: NCT03042845 Completed - Clinical trials for Coronary Artery Disease

Randomized Comparison of JUDkins vs tiGEr Catheter in Coronary Angiography Via the Right Radial Artery: the JUDGE Study

JUDGE
Start date: October 1, 2016
Phase: N/A
Study type: Interventional

The investigators aim to assess safety and efficiency of Tiger II (5Fr; Terumo Interventional Systems, Somerset, New Jersey) vs Judkins (5Fr; 3.5L/4R, Medtronic Co) catheters, in coronary angiography via the right transradial route. This is a prospective, randomized, two-centre, study of parallel design. Consecutive patients with acute coronary syndrome (ACS), eligible for non-urgent coronary angiography, are randomized after successful cannulation of right radial artery and informed consent to either Tigger II or Judkins 3.5L/4R catheters.

NCT ID: NCT03040297 Completed - Clinical trials for Resp Gas Exchange Disorder Nos

Effect of Parallel Oxygen Delivery Through a Tracheal Gas Insufflation (TGI) and a T-piece, on Blood Gases and Respiratory Rate, in ICU Tracheostomized Patients

Start date: November 2016
Phase: N/A
Study type: Interventional

The study investigates if there are benefits (better oxygenation, minimized work of breath) from the parallel oxygenation with Tracheal Gas Insufflation and T-piece, in order to provide respiratory support in tracheostomized patients and avoid mechanical ventilation.

NCT ID: NCT03038100 Completed - Ovarian Cancer Clinical Trials

A Study of Atezolizumab Versus Placebo in Combination With Paclitaxel, Carboplatin, and Bevacizumab in Participants With Newly-Diagnosed Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

IMagyn050
Start date: March 8, 2017
Phase: Phase 3
Study type: Interventional

This is a Phase III, global, double-blind, 2-arm randomized study designed to compare the efficacy and safety of atezolizumab + paclitaxel + carboplatin + bevacizumab versus placebo + paclitaxel + carboplatin + bevacizumab. Study participants will have Stage 3 or 4 ovarian cancer (OC), fallopian tube cancer (FTC), or primary peritoneal cancer (PPC) with macroscopic residual disease postoperatively (i.e., after primary tumor reductive surgery) or who will undergo neoadjuvant therapy followed by interval surgery.

NCT ID: NCT03033758 Completed - Asthma Clinical Trials

Evaluation of the Effectiveness and Quality of Life With the Administration of the Fixed Combination of Budesonide Formoterol in Greek Patients With Asthma During Routine Clinical Practice.

BOREAS
Start date: February 2, 2017
Phase:
Study type: Observational

This study will be conducted in Greek population. The patients who will be selected for study enrollment will receive inhaled combination of budesonide and formoterol fumarate dihydrate at doses 100 / 6mcg, 200 / 6mcg, 400/12 mcg through Elpenhlaler® device. The study end points will be efficacy and safety in patients with asthma.Additional study objectives will be quality of life, patient satisfaction, severe exacerbation and comorbidities.