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NCT ID: NCT03268954 Active, not recruiting - Clinical trials for Myelodysplastic Syndrome

Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine as First-Line Treatment for Participants With Higher-Risk Myelodysplastic Syndromes (HR MDS), Chronic Myelomonocytic Leukemia (CMML), or Low-Blast Acute Myelogenous Leukemia (AML)

PANTHER
Start date: November 28, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether the combination of pevonedistat and azacitidine improves event-free survival (EFS) when compared with single-agent azacitidine. (An event is defined as death or transformation to AML in participants with MDS or CMML, whichever occurs first, and is defined as death in participants with low-blast AML).

NCT ID: NCT03263260 Active, not recruiting - Clinical trials for Coronary Artery Disease

Post-marketing Registry of Inspiron Sirolimus Eluting Coronary Stent

Inspiron RL II
Start date: June 2, 2017
Phase:
Study type: Observational [Patient Registry]

Post-marketing, prospective, multicentric, non-randomized registry to evaluate the safety and efficacy of Inspiron Sirolimus Eluting Coronary Stent at the treatment of "real-world" patients.

NCT ID: NCT03263247 Active, not recruiting - Clinical trials for Mild Cognitive Impairment

Cognitive Training in Patients With MCI Using fMRI

Start date: January 2, 2017
Phase: N/A
Study type: Interventional

The current project aims to investigate the efficacy of the visual imaging training (VIT) and alphabet search training in comparison to an active control intervention, namely psychoeducation information (PI) using fMRI in patients with amnestic mild cognitive impairment (MCI) and healthy elderly controls (HE). MCI patients will be grouped according to biomarkers (PET PIB, PET FDG and liquor).

NCT ID: NCT03260894 Active, not recruiting - Clinical trials for Renal Cell Carcinoma (RCC)

Pembrolizumab (MK-3475) Plus Epacadostat vs Standard of Care in mRCC (KEYNOTE-679/ECHO-302)

Start date: December 7, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study was to evaluate the efficacy and safety of pembrolizumab plus epacadostat compared to sunitinib or pazopanib in participants with locally advanced/metastatic renal cell carcinoma (mRCC) with a clear cell component who have not received prior systemic therapy for their mRCC.

NCT ID: NCT03255135 Active, not recruiting - Prostate Cancer Clinical Trials

Initial Experience in Brazilian Single Center With High Intensity Focalized Ultrasound (HIFU) Prostate Cancer Therapy: Morbidity, Oncological and Functional Outcomes.

Start date: May 31, 2018
Phase: N/A
Study type: Interventional

Prostate cancer (PCa) is the most prevalent non cutaneous cancer in occidental countries. In Brazil incidence was about sixty thousand new cases in 2016 and occupied second place as all cancer mortality, just behind lung cancer. Literature shows than younger patients tend to have more aggressive tumors rising cancer specific mortality scores. Main risk factors are age, life style (sedentary, high meat and fat intake) and family history (gene inheritance). Besides vast advances in precocious tumors detection, challenges remain in the definition of the biological status of the tumor, which is highly variable and full of prognostic implications. PCa heterogeneity is demonstrated by the uncertain natural history, varying from indolent lesion to aggressive metastatic and fast progression cancer resistant to conventional therapies. In an actual treatment scenario, prognostic identification is the cornerstone of daily practice treatment considering the natural history variability cited before and the discrepancy of long term slow growth (studies estimate eight to sixteen years of tumor growth to achieve metastatic disease) to high grade aggressive cancer. Considering all this background and taking in account the indolent evolution of low risk PCa new therapies emerge with promising outcomes. High-Intensity Focused Ultrasound (HIFU) have to be highlighted due to easy operation, good oncologic results and low complication profile. The method is based on real-time imaging guided high intensity ultrasound (US) causing overheat and cavitation in the focused tissue. Applied since 90's, mainly in German and French groups, initially programmed to treat hole gland preserving only urinary sphincter and bladder neck, showed recently some data on 1700 patients, 5 years biochemical recurrence free survival of 80% and best results including morbidity profile in low risk, low prostate volume and in the group with previous trans urethral prostate resection (TURP). This results are very similar to other radical treatment options with median follow up of 8 years, cancer specific survival 98% and metastasis free survival of 95% If local recurrence was identified another HIFU ablation or even radical treatment achieved good results in local control with acceptable morbidity profile. Focal treatment is a new entity in PCa therapy. One randomized trial compared focal treatment to active surveillance in 513 mans with PCa diagnosis. With a 24 month follow-up progression-free ratios (28% x 58%) and positive control prostate biopsy ratios (14% x 49%) were fairly superior in treatment group. This exiting novel data turns urological oncology paths to the new era of minimally harmful therapy with targeted focused procedure. At our knowledge there is no high evidence clinical trial comparing HIFU to active surveillance. The objective of this study is to evaluate prospectively the initial experience with 50 patients submitted to HIFU therapy for low risk prostate cancer in Brazilian single center considering the following aspects: One year of treatment prostate biopsy positiveness; Biochemical recurrence free survival using Phoenix and Stuttgart criteria in one year; Sexual function using IIEF-5 questionnaire and the usage of 5-phosphodiesterase inhibitors (5-PDI); Urinary symptoms using EPIC and IPSS questionnaires and free urinary flow; Quality of life based on SF-36 questionnaire evaluation; Post procedure morbidity using Clavien-Dindo classification.

NCT ID: NCT03252184 Active, not recruiting - Healthy Behavior Clinical Trials

Effects of Photobiomodulation on Endothelial Function in Healthy Subjects

Start date: September 1, 2017
Phase: N/A
Study type: Interventional

The endothelial cell layer is responsible for the control of vascular homeostasis, a process mediated by vasoconstricting and vasodilatory substances. The principal endothelium-dependent vascular dilator is nitric oxide (NO), and the reduction of its synthesis or bioavailability is the main cause for the development of endothelial dysfunction. The use of photobiomodulation may be beneficial in several clinical situations. At the endothelial level, the stimulatory effects on vascular endothelial growth factor, NO secretion, number of capillaries and proliferation of endothelial cells are outstanding. The objective of this study is to evaluate the effects of photobiomodulation on the arterial endothelial function of healthy individuals. The study design will be a randomized, crossover, clinical trial and the sample will be composed of subjects selected by the eligibility criteria, and randomly randomized according to the order of intervention of the groups. The hypothesis is that at the end of the protocol with photobiomodulation an increase in endothelial function and blood markers of endothelial function occurs, and no tissue temperature variation.

NCT ID: NCT03244124 Active, not recruiting - Clinical trials for Dental Restoration Failure of Marginal Integrity

Different Application Strategies When Using Futurabond Universal in Class V Cavities

FUUC
Start date: September 3, 2016
Phase: N/A
Study type: Interventional

Treatment clinical trial, randomized, controled, parallel, double-blinded, with four groups, that aims to evaluate the best application strategy when using a new Universal Adhesive system, Futurabond Universal (VOCO GmbH, Germany). Volunteers will be selected and recruited,following inclusion criteria and pre-established exclusion. All volunteers will be informed and sign a term of clarification and consent. 50 enrolled patients will receive 200 Class V dental restorations, made in four different ways, one from each experimental group, using the same universal self-etching adhesive system, which is the tested material in this study. Non-carious cervical lesions will receive the applied adhesive system in 4 different protocols separated by groups. Group Self Etching (SET) (control): no conditioning, the adhesive system will be used in 50 teeth, according to the manufacturer's instructions, in the self-etching mode. The adhesive system will be brushed during 20 seconds in the cavity, will be air-dried during 5 seconds, and activated during 10 seconds with Light Emission Diode (LED) light; Group SEE (Selective enamel etching): 37% phosphoric acid will be applied during 30 seconds, only in enamel in 50 teeth. This acid will be removed using water, the cavity will be air-dried, and then, the adhesive will be applied according to the manufacturer's instructions, as described in group SET; Group ERDry (Etch& Rinse Dry): 37% phosphoric acid will be applied during 30 seconds, only in enamel and during 15 seconds only in dentin, in 50 teeth. This acid will be removed using water, the cavity will be air-dried, keeping dentin dry, and then, the adhesive will be applied according to the manufacturer's instructions, as described in group SET; Group ERWet (Etch& Rinse Wet): 37% phosphoric acid will be applied during 30 seconds, only in enamel and during 15 seconds only in dentin, in 50 teeth. This acid will be removed using water, the cavity will be air-dried, keeping dentin wet, and then, the adhesive will be applied according to the manufacturer's instructions, as described in group SET. After applying the adhesive, the restorations will be made with composite resin, and evaluated every 6 months for pain assessment, shape, staining or recurrent caries, using scores. To determine in which group each tooth will be enrolled, the authors will randomize the teeth.

NCT ID: NCT03239886 Active, not recruiting - Clinical trials for Leukemia, Myeloid, Chronic-Phase

Imatinib Discontinuation in Patients With Chronic Myeloid Leukemia Chronic Phase With Sustained MR4log

Start date: December 15, 2016
Phase: N/A
Study type: Interventional

This study will evaluate the proportion of subjects with chronic myeloid leukemia chronic phase that sustain major molecular response after imatinib discontinuation. To be eligible for this protocol, the subject must have received imatinib as first line regiment for at least 3 years with sustained molecular response of 4log (RM4log) or higher for one year.

NCT ID: NCT03238105 Active, not recruiting - Clinical trials for Periorbital Disorder

Treatment of Periorbicular Hyperchromia Comparing 10% Thioglycolic Acid Peeling Versus Pulsed Intense Light

Start date: August 1, 2017
Phase: Phase 4
Study type: Interventional

Periorbital hyperchromia (POH) or periorbital hyperpigmentation, commonly known as "dark circles", is a relatively common condition and a frequent reason for dermatological consultation. It is defined as brown-colored pigmentation, ranging from light to dark, which mainly involves the lower eyelids. POH affects individuals over a wide age range, including both sexes and all ethnicities, and is associated with a tired and aged facial appearance. The most commonly affected people are those with the highest skin phototypes. Although the prevalence is similar between sexes and age groups, POH is a more frequent complaint in women. The dark circles characteristic of POH can negatively impact patients' quality of life, although it is not a condition associated with morbidity. Despite its high prevalence, only a few well-designed studies were done to evaluate its therapeutic options. The intense pulsed light (IPL) and the thioglycolic acid are safe treatment options and promote the improvement of dark circles, but it is not known if one treatment differs from the other in relation to efficacy and adverse effects.

NCT ID: NCT03230695 Active, not recruiting - Stroke Clinical Trials

Robotic Therapy and Brain Stimulation in the Early Phase After Stroke

Start date: August 3, 2017
Phase: N/A
Study type: Interventional

Stroke is the second cause of death worldwide and the majority of the survivors remain with motor impairments. Inhibition of the motor cortex of the unaffected hemisphere has emerged as a potential intervention to enhance effects of other rehabilitation strategies on improvement of motor performance of the paretic upper limb. In this proof-of-concept study we will evaluate the effects of inhibition of the motor cortex of the unaffected hemisphere associated with robotic therapy on improvement of motor performance of the paretic upper limb in the early phase post-stroke.