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NCT ID: NCT02377297 Completed - Dental Caries Clinical Trials

Occlusal ART Restorations in Primary Molars Using 3 Different GIC

Start date: November 2014
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate the survival rate and the cost-effectiveness of occlusal-ART restorations using three GIC brands (Fuji IX, GC Europe; Maxxion R, FGM; Vitro Molar, DFL) in primary molars.

NCT ID: NCT02377076 Completed - Clinical trials for Type 2 Diabetes Mellitus

Dietary Calcium Supplementation, Gut Permeability and Microbiota in Type 2 Diabetics

Start date: September 2014
Phase: N/A
Study type: Interventional

Dietary calcium seems to act on glycemic control, favoring the prevention and treatment of type 2 diabetes mellitus (DM2). It is possible that calcium modulates gut microbiota and increase the integrity of the intestinal mucosa. This study aims to evaluate the effects of dietary calcium supplementation in permeability and intestinal microbiota in overweight type 2 diabetics. This is a single-blind, randomized, placebo-controlled, crossover study. Patients (n=20) with low habitual calcium intake will be allocated in control group (CONTROL) or test group (DAIRY). Hypocaloric diets (restriction of 500 kcal / day) will be prescribed containing 800 mg of calcium from dietary sources / day. During intervention period, a beverage (shake) (CONTROL - without the addition of calcium sources or DAIRY - 700 mg of calcium as milk powder) will be ingested in the laboratory. Food intake, body composition (total body fat and fat free mass) and anthropometric measures (waist circumference, waist-hip ratio, waist-height, neck circumference and sagittal abdominal diameter) will be evaluated at baseline and at the 6th and 12th weeks. Physical activity level, gut permeability, gut microbiota, and biochemical parameters (parathyroid hormone, 25-dihydroxy vitamin D, calcium, fasting glucose, fasting insulin, fructosamine, hemoglobin, HbA1c, uric acid, triglycerides, cholesterol total and partial, lipopolysaccharide, inflammatory markers) will be evaluated at baseline and after 12 weeks. The statistical analysis will be performed with the use of SPSS software (SPSS Inc., Chicago, IL, 2008, version 17.0). Parametric or non-parametric tests will be applied, according to the distribution of variables (level of statistical significance of 5%).

NCT ID: NCT02376322 Completed - Bone Metastases Clinical Trials

Hypofractionated Radiotherapy (16/2) for the Palliation of Complicated Bone Metastases in Patients With KPS

Start date: July 2014
Phase: Phase 2
Study type: Interventional

Literature has shown that hypofractionated radiotherapy regimens are efficacious in patients with complicated bone metastases and have a low potential for severe treatment-related toxicities. There is a clear need for hypofractionated schedules in the complicated bone metastases population, especially when considering the overarching aim of palliative radiotherapy and the clinical features of this patient population. As well, current research examining hypofractionated approaches in bone metastases patients with impending or pathologic fractures, neuropathic pain or accompanying soft tissue masses has been markedly scarce.

NCT ID: NCT02375906 Completed - Hepatitis D Clinical Trials

The Hepatitis Delta International Network

HDIN
Start date: November 2013
Phase:
Study type: Observational [Patient Registry]

Hepatitis delta is a major health problem, not only because of the severity of the disease, but also due to the lack of effective antiviral treatment. To improve the current therapeutic options, a better understanding of the pathophysiology is essential. Reliable research in this direction is only possible with large patient study groups. However, given the geographic distribution of hepatitis delta, larger patient cohorts would only be possible through multicenter collaboration.

NCT ID: NCT02372214 Completed - Aneurysm Clinical Trials

Production of a Patient-specific Simulator for Endovascular Aneurysm Repair Training

Start date: March 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to produce a patient-specific simulator for endovascular infra-renal aneurysm repair training and than analyze the effect of simulator training on the performance of vascular surgery residents.

NCT ID: NCT02371395 Completed - Malaria Diagnosis Clinical Trials

Validation of RealAmp Method for the Diagnosis of Malaria in Endemic Areas of Brazil

Start date: January 2015
Phase:
Study type: Observational

Worldwide, approximately 2 billion people live in areas at risk for malaria with morbidity surpassing 250 million cases, with approximately 800,000 deaths, per year. Of the four species of malaria parasites that cause human infection, P. falciparum is responsible for the majority of severe malaria cases followed by P. vivax. Early and accurate diagnosis is essential for prompt and correct treatment, which can reduce the death rate and interrupt transmission. Currently, conventional methods for the diagnosis of malaria include microscopic examination of thin and thick blood smears and rapid diagnostic tests (RDTs). Light microscopy in practice typically detects parasitemia as low as 100 parasites/µl and it can differentiate species. The advantage of microscopy includes the ability to estimate parasitemia, the possibility to identify parasite stages, including gametocytes, and its low cost. However, this method is labor intensive, difficult to standardize, and requires well-trained microscopists. The majority of RDTs are based on detection of P. falciparum histidine-rich protein 2 (HRP-2) antigen and do not detect all malaria species. RDTs that detect lactose dehydrogenase (LDH) and aldolase generally broadly react with all four species of malaria parasites and therefore cannot differentiate among the species although efforts are underway to improve their performance for species detection. In settings where multiple malaria species co-circulate, molecular methods may be more reliable than microscopy and RDTs in accurately diagnosing the species of malaria parasites with low parasitemias. However, conventional molecular methods, such as nested polymerase chain reaction (nested PCR) or real-time PCR, are technically challenging and resource intensive and are generally restricted to reference laboratories due to the need for well-equipped laboratories. Recently, new molecular methods that can be used in field settings have been developed and this opens up new opportunities for exploring molecular tools for malaria diagnosis in endemic countries. With the objective of facilitating use of molecular tools for malaria control programs, the malaria laboratory at the Centers for Disease Control and Prevention (CDC) in Atlanta, USA developed a simple isothermal molecular method called Real-Time Fluorescence Loop-Mediated Isothermal Amplification (RealAmp) for the diagnosis of malaria. Currently, RealAmp primers exist for detecting the Plasmodium genus and the detection of P. falciparum and P. vivax species. The RealAmp method has great potential as a molecular tool for the diagnosis of malaria in the field (and other infections of major public health impact, such as HIV and tuberculosis). It can provide an alternative to conventional PCR-based diagnostic methods for field use in clinical and operational programs. The objective of this proposal is to validate the sensitivity of RealAmp for detection of malaria parasites in blood spots from patients with clinical diagnosis of malaria in two endemic states of Brazil with co-circulation of P. falciparum and P. vivax. In this evaluation, RealAmp and microscopic examination will be compared to a real-time PCR method as a reference test.

NCT ID: NCT02370225 Completed - Sjogren's Syndrome Clinical Trials

Aerobic Exercise in Primary Sjögren's Syndrome

AEPSS
Start date: March 2015
Phase: N/A
Study type: Interventional

The purpose of this sudy is to investigate the effects of a regular aerobic exercise on aerobic capacity, fatigue, depression, quality of life, perception of symptoms and disease activity in women with pSS.

NCT ID: NCT02369874 Completed - Clinical trials for Recurrent or Metastatic PD-L1-positive or -Negative Squamous Cell Carcinoma of the Head and Neck SCCHN

Study of MEDI4736 Monotherapy and in Combination With Tremelimumab Versus Standard of Care Therapy in Patients With Head and Neck Cancer

EAGLE
Start date: September 9, 2015
Phase: Phase 3
Study type: Interventional

This is a randomized, open-label, multi-center, global, Phase III study to determine the efficacy and safety of MEDI4736 + tremelimumab combination therapy and MEDI4736 monotherapy versus SoC therapy in the target patient population.

NCT ID: NCT02369341 Completed - Influenza Clinical Trials

Immunogenicity and Reactogenicity of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Split Virion Influenza Vaccine Fluarix Tetra (2015 Season Southern Hemisphere) in Adults 18 Years of Age and Above

Start date: April 29, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and immunogenicity of GSK Biologicals' Quadrivalent Split Virion Influenza Vaccine Fluarix Tetra (2015 Southern hemisphere) in adults (18 to 60 years of age) and in the elderly (over 60 years of age).

NCT ID: NCT02369016 Completed - Clinical trials for Lymphoma, Non-Hodgkin

Phase III Copanlisib in Rituximab-refractory iNHL

CHRONOS-2
Start date: September 22, 2015
Phase: Phase 3
Study type: Interventional

To assess the safety of copanlisib.