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NCT ID: NCT03871816 Completed - Clinical trials for Metastatic Prostate Cancer

A Study to Determine Frequency of DNA-repair Defects in Men With Metastatic Prostate Cancer

Start date: April 22, 2019
Phase:
Study type: Observational

The purpose of this study is to evaluate the prevalence of 4 or more DNA-repair gene defects in a population of men with metastatic Prostate Cancer (PC) and to use the reported DNA-repair gene defects to assess biomarker eligibility for niraparib interventional studies.

NCT ID: NCT03871699 Not yet recruiting - Clinical trials for Heart Failure, Systolic

Ferric Carboximaltose on Intra-myocardial Iron Load in Patients With Heart Failure

IronHeart
Start date: August 30, 2019
Phase: Phase 4
Study type: Interventional

In general, anemia is associated with a greater presence of HF symptoms, worsening NYHA functional class, higher rate of hospitalization for heart failure, and reduced survival. However, it is unclear whether anemia is the cause of decreased survival or a marker for more advanced disease. Correction of iron deficiency in patients with New York Heart Association (NYHA) class II or III HF using intravenous iron (Ferinject®) improved "overall patient self-assessment" and NYHA functional class of 6-minute walk and health-related quality of life) in the FAIR-HF trial. It is unknown if iron deficiency is correlated with intra-myocardial iron load as assessed by cardiac magnetic resonance (CMR) and if the treatment with intravenous iron has any impact on intra-myocardial iron load and left ventricular function. The aim of the present study is to evaluate the effect of intravenous iron replacement on intra-myocardial iron deposits and the effect on left ventricular function. Because it is a pilot study with few data in the literature, it is planned to use an initial sample of 20 patients. We aim to evaluate the global ventricular function, the iron load by the T2 * method, the cardiac strain, the "Fiddle" and the "Fat water" of each patient by CMR. After this examination, patients will undergo intravenous infusion of 1g of Ferric Carboxymaltose (Ferinject®). A comparative analysis of the ejection fraction values at the beginning and at the end of the study by CMR will be performed, in addition to a clinical reassessment. The inclusion criteria will be: Patients older than 18 years, with iron deficiency and reduced ejection fraction defined as: serum ferritin <100 μg / L or with ferritin 100-299 μg / L with transferrin saturation <20 %; Hemoglobin <12g / dL in women and <13g / dL in men; Clinical stability in the last 3 months; Left ventricular ejection fraction (LVEF) <40% assessed by transthoracic echocardiography or CMR in the last 3 months. The exclusion criteria will be: patients with preserved ejection fraction (> 50%), pregnant women, refusal to participate in the present study, implantable pacemaker or implantable defibrillator incompatible with MRI, cerebral cerebral aneurysm clip and/or intracerebral or intraocular metal fragments, electronic cochlear implants, patients with claustrophobia, patients with clinical or hemodynamic instability and patients with indication for blood transfusion (Hb ≤ 7g / dL).

NCT ID: NCT03871673 Completed - Clinical trials for Glycogen Storage Disease Type I

The Use of Uncooked Sweet Manioc Starch to Treat Hepatic Glycogen Storage Diseases

Start date: April 29, 2017
Phase: N/A
Study type: Interventional

Hepatic Glycogen Storage Diseases are a group of 10 serious genetic diseases that present in childhood and are characterized more frequently by the occurrence of repetitive hypoglycemia and dyslipidemia. Regarding treatment, the most commonly used strategy is the frequent administration of uncooked cornstarch, in average, every 4 hours. Although this treatment is successful, the use of large amounts of cornstarch can lead to overweight and, especially, to the decrease in the quality of life of patients and caregivers, due to the need to use the starch during the night. The search for a treatment that is widely available and that can lead to the prolongation of the fasting time, can collaborate to improve the care of these patients. The main scientific question to be answered by this research is: does sweet manioc starch, a Brazilian product, safely prolong the fasting time (with normoglycemia) of the patients as already suggested in experimental models? Main objective: To evaluate the efficacy and safety of the use of uncooked Sweet Manioc Starch in the treatment of patients with hepatic Glycogen Storage Diseases, using as model the Glycogen Storage Diseases type Ia.

NCT ID: NCT03870607 Recruiting - Clinical trials for Anal Cancer Squamous Cell

Prebiotics and Probiotics During Definitive Treatment With Chemotherapy-radiotherapy SCC of the Anal Canal (BISQUIT)

BISQUIT
Start date: March 13, 2019
Phase: Phase 2
Study type: Interventional

Phase II randomized study of the use of pre-and probiotics during the definitive treatment of chemotherapy-radiotherapy (Ch-RT) for patients with localized anal canal squamous cell cancer (ACSCC) with the objective of increasing the effectiveness of conventional treatment based on the assumptions of that there is a need for research that increases the cure rates of the definitive treatment of Ch-RT in the ACSCC; ACSCC is a virus-associated tumor in many cases and therefore potentially immunogenic; immunotherapy is a promising strategy in ACSCC; and that pre- and probiotics can stimulate the immune system through modulation of the intestinal microbiota, and improve oncological outcomes.

NCT ID: NCT03870399 Completed - Clinical trials for Neuroendocrine Tumors

Study of Tamoxifen in Well Differentiated Neuroendocrine Tumors and Hormone Receptor Positive Expression

HORMONET
Start date: March 13, 2019
Phase: Phase 2
Study type: Interventional

This is a single-arm, unicentric, single-stage clinical study of tamoxifen for patients with well differentiated neuroendocrine tumors and radiological progression with positive (> 1 percent) HR (estrogen and / or progesterone) expression by IHC. It will evaluate if Tamoxifen exerts antitumor action in patients with well differentiated NET and positive for the expression of HR, estrogen and / or progesterone.

NCT ID: NCT03870178 Completed - Healthy Clinical Trials

Effects of tDCS on Maximal Isometric Strength and Endurance Test of Trunk Extensors.

Start date: January 2, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

Improving trunk muscle strength and endurance is one of the many goals to be achieved in rehabilitation protocols for a variety of health conditions. Cerebral electrical stimulations techniques, such as transcranial direct current stimulation (tDCS) can modulate motor brain areas involved in motor functions. However, their effects on trunk function are lacking. This study aims to investigate the effects of transcranial direct current stimulation (tDCS) on trunk muscle strength and endurance in healthy subjects.

NCT ID: NCT03870139 Completed - Healthy Volunteers Clinical Trials

Cerebral and Peripheral Electrical Stimulation on Isometric Quadriceps Strength

Start date: March 30, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

Quadriceps muscle strength is a key goal to be achieved in rehabilitation protocols for a variety of musculoskeletal conditions. Both cerebral and peripheral electrical stimulations can modulate motor brain areas involved in motor functions and has the potential to optimize muscle capacity. However, their effects on quadriceps function are lacking. This study aims to investigate the effects of transcranial direct current stimulation (tDCS) and peripheral electrical stimulation (PES) on quadriceps strength in healthy subjects.

NCT ID: NCT03869892 Active, not recruiting - Clinical trials for Metastatic Colorectal Cancer

Phase III Study in First-line Treatment of Patients With Metastatic Colorectal Cancer Who Are Not Candidate for Intensive Therapy.

SOLSTICE
Start date: March 21, 2019
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to demonstrate the superiority of S 95005 in combination with bevacizumab over capecitabine in combination with bevacizumab.

NCT ID: NCT03868878 Completed - Aged Clinical Trials

Capoeira Training Decrease Plasma Triglycerides

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

Background: Among the risk factors associated with aging, a special highlight has been attributed to cardiovascular dysfunctions, insulin resistance, central obesity and dyslipidemia, which is marked by low levels of cholesterol (high density lipoprotein) and in particular by high levels of plasma triglycerides. Individuals with high levels of plasma triglycerides tend to have a prolonged postprandial hypertriglyceridemia after a fat-meal challenge, which would potentially further increase the risk associated with cardiovascular disease. Due to the impact of aging and its associated risk factors on the older adults health, several strategies have been proposed to avoid the progression of chronic diseases. These diseases are frequent in this population, especially the ones that resides in long-term institutions and they are mainly characterized by sedentary lifestyle and functional inability. Systematic reviews have shown that the implementation of physical activity programs associated with a favorable dietary pattern may benefit the lipid profile of the older adults. Moreover, it is suggested as a primary strategy, the realization of physical exercise as a therapy for this disease. In the physical exercise programs aspects, unconventional modalities such as Capoeira, which is practiced in more than 150 countries, it has aroused interest in the scientific research. Characterized by a system composed by attack and defense movements and from Afro-Brazilian origin, Capoeira combines sports elements of the fight, gymnastics, dance and musicality. However, there is no study investigating the effect of Capoeira training on the lipid profile of older adults, which would have an important clinical application in the health of this population, especially living in conditions of sedentarism and frailty in long-term institutions. Aim: The present study analyzed the effects of twelve weeks of Capoeira training on the lipid profile of advanced-age frail adults of a long-term institution, which are characterized by sedentary lifestyle and affected by several diseases. Methods: Participants were assigned into two groups (CONTROL: n = 07; 82.4±13.6 years and CAPOEIRA: n = 07; 79.4±6.9 years). The CAPOEIRA group performed twelve weeks of Capoeira training program, being twice a week lasting 60 minutes each at light to moderate intensity. Samples of 10 ml of blood were collected from participants' antecubital vein at the pre- and post-intervention moments in both groups. Plasma concentrations of triglycerides, total cholesterol, low density lipoprotein cholesterol and high density lipoprotein cholesterol were evaluated using the enzymatic colorimetric method. Anthropometry measures were performed and to internal control the energy consumption evaluations were carried out through daily food diaries during intervention period.

NCT ID: NCT03868241 Completed - Critically Ill Clinical Trials

Coated Devices to Decrease Infection in the Intensive Care Unit

CRITIC
Start date: April 6, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

Pilot explanatory, randomized, open label, controlled trial. Critically ill patients which will demand placement of invasive devices for organ support (endotracheal tube, central venous catheter and urinary Foley catheter) will be randomized 1:1 to receive coated (Bactiguard®) or habitual (non-coated) devices.