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NCT ID: NCT03941977 Completed - Bone Marrow Edema Clinical Trials

Treatment of Bone Marrow Edema Lesions of the Knee With Percutaneous Grafting

Start date: November 5, 2014
Phase: N/A
Study type: Interventional

Objective 1. To evaluate the technique of percutaneous grafting with bone substitute in the knee as to its applicability and technical feasibility. 2. Evaluate the results regarding functional improvement and prevention of the evolution of joint cartilage degeneration. Material and methods Twenty patients from the Knee Group clinic who meet the criteria will be selected. Magnetic resonance imaging will be analyzed on the PACS server. Through the resonance will be performed evaluation of the size of the bone edema in volume and its proportion in relation to the size of the affected condyle or tibial plateau and the cartilage of the femoro-tibial joint. The lesions will then be mapped in the coronal and sagittal plane. Radiographs will be taken in antero-posterior, profile, Rosenberg knee and lower limb views. Evaluation of the patients will be performed by the visual analog pain scale and by the KOOS, IKDC and SF-36v1 indices. Description of Surgical Technique After the mapping the patient will be submitted to the procedure. The procedure consists in the application of a bone substitute based on injectable calcium phosphate in the area of bone edema previously mapped with the aid of radioscopy to guide. After confirming the proper positioning of the guidewire, a trephine is introduced through which the product will be injected. GRAFTYS HBS® (Graftys, Aix en Provence, France) will be used. The procedures will be performed in a surgical center, with conventional antisepsis and asepsis techniques and under spinal anesthesia. The patient will be hospitalized and must be discharged on the first postoperative day. After the procedure the patients will be under partial load as tolerated for two weeks with free range of motion and will start physiotherapy after 2 weeks of the procedure. During hospitalization the patient will receive analgesia with intravenous Dipirone 1g every 6 hours associated with Tramadol 100mg intravenously every 8 hours if severe pain. After discharge the patient will receive analgesia with dipyrone 1g orally every 6 hours associated with Tramadol 100mg orally every 8 hours if severe pain, and Tramadol used by the patient was quantified. Patients will then be re-evaluated at 1, 3, 12, 24 and 48 weeks with the same previous criteria and at 12 months new MRI with the same previous protocol will be performed.

NCT ID: NCT03939130 Completed - Metabolic Disease Clinical Trials

Fructose Rich Diet and Endothelial Function

Start date: June 1, 2018
Phase: N/A
Study type: Interventional

Cardiometabolic diseases have been associated with high consumption of sweetened beverages. These products are responsible for the largest portion of the total consumption of fructose in the diet and it is suggested that excessive intake of this monosaccharide may contribute to the development of risk factors for these diseases due to differences in metabolism relative to glucose. However, there is a lack of data in the literature demonstrating the deleterious effects of excessive fructose consumption on vasodilation and whether aerobic training may be able to prevent or mitigate these damages in humans. Therefore, the aim of the study will be to verify the effect of 4 weeks of high fructose diet associated with aerobic training on uric acid levels and its influence on markers related to oxidative stress and vasodilatation. Twenty-one sedentary men and women, aged between 19 and 35 years, will be submitted to 4 weeks of intervention. In a randomized way, subjects will be divided into 3 groups: high fructose diet, high glucose diet and high fructose diet and exercise. Blood samples will be taken before, in the middle and after the intervention to verify the concentrations of uric acid, superoxide dismutase enzyme, thiobarbituric acid, nitrite / nitrate, lipid profile, glucose, insulin, C-reactive protein and endothelin-1. In addition, flow-mediated dilatation, insulin resistance index, pancreatic beta cell functional capacity index, oral glucose tolerance test, 24-hour blood pressure, heart rate variability and body composition will be analyzed. The comparisons will be performed through the Generalized Estimates of Equations, adopting the factors group and time. The Bonferroni post-hoc will be used to identify differences. The accepted level of significance will be 5%.

NCT ID: NCT03939078 Completed - Clinical trials for Urinary Incontinence

CO2 Laser in the Treatment of the GSM - (Genitourinary Syndrome of Menopause) Genitourinary Syndrome of Menopause

Start date: April 5, 2018
Phase:
Study type: Observational

Menopause is a woman's hormonal status one year after her ovulatory failure, when the decrease of circulating estrogen levels leads to a group of symptoms named Genitourinary Syndrome of Menopause (GSM), such as: vaginal dryness, dyspareunia, dysuria, epithelial fragility with recurrent bleedings, loss of genital elasticity and pH alterations causing recurrent infections. The CO2 laser is a fractional ablative source of light, capable of inducing neocollagenesis within the skin, reversing atrophies, increasing blood supply and reorganizing the architectural structure of the treated epithelium. Recent studies in the laser field show great improvement of the SGM, with satisfying results in female's sexual disfunction. Nevertheless, there is still a lack of studies that show, at the same time, the improvement in both patient's subjective reports and objective measurements, such as cytology, histology and immunohistochemistry. This study aims to thoroughly analyze the benefits of the CO2 laser in the treatment of the GMS, comparing the improvement found in questionnaires to the results of cytology, histology and immunohistochemistry for collagen I and III from vaginal biopsies before and after the laser treatment. Therefore, fourteen women after menopause complaining of symptoms of the GSM were selected from the ambulatory of the Hospital Universitário Antônio Pedro. The patients will be submitted to three CO2 intravaginal laser (Femilift®), with a 30-days interval between them. Biopsies of the vaginal wall will be taken one month before the start and one month after the end of the laser sessions, and material will be sent to histology, cytology and immunohistochemistry analysis. Results obtained will be compared to the patients' reports, in order to evaluate subjective and objective improvement due to the treatment.

NCT ID: NCT03938597 Recruiting - Clinical trials for Drug-Related Side Effects and Adverse Reactions

Investigation of Serious Adverse Events Following Vaccination Against Yellow Fever: Emphasis on Genetic Basis and Biological Markers

Start date: January 30, 2017
Phase:
Study type: Observational

It concerns an investigation aiming to investigate genetic biological(s) marker(s) which allow to identify individuals who have risk of serious adverse events to the yellow fever vaccine. This testing is free of hypothesis, because these markers are still unknown. There is no intervention, and it is not possible to establish primary and secondary outcomes.

NCT ID: NCT03937219 Active, not recruiting - Clinical trials for Renal Cell Carcinoma

Study of Cabozantinib in Combination With Nivolumab and Ipilimumab in Patients With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma

COSMIC-313
Start date: June 25, 2019
Phase: Phase 3
Study type: Interventional

This is a multicenter, randomized, double-blinded, controlled Phase 3 trial of cabozantinib in combination with nivolumab and ipilimumab versus nivolumab and ipilimumab in combination with matched placebo. Approximately 840 eligible subjects with intermediate- or poor-risk advanced or metastatic RCC by IMDC criteria will be randomized in a 1:1 ratio at approximately 180 sites.

NCT ID: NCT03937154 Recruiting - Clinical trials for Chemotherapy-induced Thrombocytopenia

Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects With Non-small Cell Lung Cancer (NSCLC), Ovarian Cancer, or Breast Cancer

Start date: February 26, 2020
Phase: Phase 3
Study type: Interventional

To evaluate the efficacy of romiplostim for the treatment of CIT in patients receiving chemotherapy for the treatment of NSCLC, ovarian cancer, or breast cancer measured by the ability to administer on-time, full-dose chemotherapy

NCT ID: NCT03936855 Completed - Composite Resins Clinical Trials

Clinical Evaluation of Posterior Direct Restoration in Adolescents

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

The present study aims to evaluate the performance of direct restorations with bulk fill resins in molars with great structural loss, with endodontic treatment. The behavior of class II restorations in 68 molars endodontically treated with bulk fill resin and incremental technique will be evaluated by means of a randomized clinical trial with a two-year follow-up. This project aims to evaluate the performance of this new restorative strategy that can greatly contribute to restorations of posterior teeth.

NCT ID: NCT03936751 Terminated - Clinical trials for Obstructive Sleep Apnea

Obstructive Sleep Apnea Treatment on Cardiovascular Events in Patients With Acute Cardiogenic Pulmonary Edema: CPAP-CARE STUDY.

CPAP-CARE
Start date: April 1, 2019
Phase: Phase 4
Study type: Interventional

Despite the advances in the treatment of acute cardiogenic pulmonary edema (ACPE), the readmissions rates and cardiovascular events remain very high. In this context, it is possible that other potential risk factors may influence the poor prognosis of the ACPE. One of these potential candidates is Obstructive Sleep Apnea(OSA). This study was designed to evaluate the impact of OSA treatment with CPAP in consecutive patients with ACPE. The primary outcome will be to evaluate the impact of CPAP on the recurrence of ACPE in the 1-year follow-up.

NCT ID: NCT03936270 Completed - Ovarian Cancer Clinical Trials

Palbociclib Plus Letrozole Treatment After Progression to Second Line Chemotherapy for Women With ER/PR-positive Ovarian Cancer

Start date: March 5, 2020
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate 12 weeks progression-free survival (PFS) rate of Palbociclib plus Letrozole in ER/PR positive endometrioid or high-grade serous ovarian cancer who have disease progression on second-line chemotherapy.

NCT ID: NCT03933176 Withdrawn - Clinical trials for Dental Restoration Failure of Marginal Integrity

Absence of Liner Following the Selective Caries Removal (ALFSCaRe)

(ALFSCaRe)
Start date: June 30, 2019
Phase: N/A
Study type: Interventional

This randomized, multi-centric, controlled clinical trial will assess the effectiveness of a simplified restorative protocol used after the selective carious tissue removal in posterior teeth presenting deep carious lesions. Only a regular bulk-fill composite will be used in the simplified restorative protocol following the application of universal adhesive. A liner with resin-modified glass ionomer will be used over the pulpal floor before the composite placement in the control group. The longevity of restorative procedures and post-operative sensitivity were defined as the main and secondary outcomes.