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NCT ID: NCT04351152 Active, not recruiting - Clinical trials for Coronavirus Disease 2019 (COVID-19) Pneumonia

Phase 3 Study to Evaluate Efficacy and Safety of Lenzilumab in Patients With COVID-19

Start date: May 5, 2020
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to assess whether the use of lenzilumab in addition to current standard of care can alleviate the immune-mediated cytokine release syndrome (CRS) and improve ventilator-free survival in hospitalized subjects with severe or critical COVID-19 pneumonia.

NCT ID: NCT04349514 Active, not recruiting - Friedreich Ataxia Clinical Trials

A Natural History Study to TRACK Brain and Spinal Cord Changes in Individuals With Friedreich Ataxia (TRACK-FA)

(TRACK-FA)
Start date: February 10, 2021
Phase:
Study type: Observational

This is a natural history study prospectively investigating neuroimaging markers of disease progression in children and adults with Friedreich ataxia (FA). There will be three assessment periods (baseline, 12 and 24 months). The study will include approximately 200 individuals with FA and 100 matched controls recruited across the six international academic sites. Other assessments will include secondary clinical and cognitive markers, as well as exploratory blood markers.

NCT ID: NCT04342754 Active, not recruiting - Tourette Syndrome Clinical Trials

Deep Brain Stimulation in Forel's H Field in Tourette's Syndrome

Start date: February 27, 2019
Phase: N/A
Study type: Interventional

Tourette's Syndrome (TS) is a neurodevelopmental disease characterized tics that start before the age of 18 years. About 5% of cases do not respond to drug treatment and can be classified as refractory and in these cases surgical treatment, with deep brain stimulation, appears as a therapeutic possibility, but with still conflicting results. Our hypothesis is that DBS in Forel's H Field could improve tourette's symptoms, neurological and psychiatric ones.

NCT ID: NCT04334642 Active, not recruiting - Stress Clinical Trials

Mindfulness and Paralympic Sport: a Mindfulness Based Intervention for Paralympic Boccia Brazilian Team

MPS
Start date: June 30, 2019
Phase: N/A
Study type: Interventional

The approach of the Tokyo 2020 Paralympic Games brings an opportunity for reflection on how the academic universe follows the evolution of this sports segment and whether it is possible to carry out an intervention that will contribute to improving and maintaining the performance of Paralympic Boccia Brazilian Team. Mindfulness means being aware and describes a natural human capacity that can be trained and previous researches indicate that the presence of mindfulness traits in athletes can be improved with mindfulness training. Specifically, the Paralympic Boccia is a sport that is on the rise for new resources that can collaborate with its performance in a national and international context. Thus, the objective of this study is to evaluate the effects of a mindfulness-based intervention on Paralympic Boccia athletes, in particular, the impact on sports performance and quality of life from the change in attentional level. It is a pilot study of feasibility and preliminary effectiveness composed of a longitudinal intervention that uses as a baseline measure a Mindfulness Training of 2 cycles (each cycle is formed by 4 days of intervention); two follow-up measures (1 and 6 months after the 2nd cycle); and a final measurement (12 months after the start of the study). The research will have as a convenience sample Athletes from the Paralympic Boccia Brazilian Team, which will be compared with itself in the data analysis. It is expected to show a positive impact on the athletes' quality of life (primary outcome). As secondary outcomes, it is expected to show the evolution of sports performance in relation to the accuracy of the pitch and the speed of the ball, in addition to improving the attention focus and perceived stress, which affect the tactics and performance of the game. The potential benefits of this research also have a social component, by expanding the understanding of human nature through sport, and also a functional component, by impacting the performance of these high-performance athletes.

NCT ID: NCT04329351 Active, not recruiting - Ridge Preservation Clinical Trials

Impact of PTFE-d Barrier Intentionally Exposed to Bucal Environment in Guided Bone Regeneration to Ridge Preservation

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

The aim of this clinical-laboratorial, paralel, randomized, prospective and controlled study was determine the impact of of PTFE-d barrier intentionally exposed to bucal environment in guided bone regeneration to ridge preservation, using microbiological, radiographic, patient-centered outcomes, molecular patter of bone-related markers and implant stabilization. Fourty individuals with tooth extraction indication and subsequent implant placement between upper pre-molars were recruited. Patients were randomly allocated in one of this groups, following tooth extraction: 1) GBR: sockets received GBR with d-PTFE membranes which was maintained intentionally exposed to bucal environment and removed after 28 days; and 2) Non-GBR: sockets did not receive additional therapy after extration. After 3 months, all patients received dental implants and temporary implant-supported prostheses. Patient-reported outcomes in terms of morbidity, swelling and interference with daily life were recorded at 3, 7, 14, 28, 35 and 42 days following dental extraction and in terms of esthetic outcomes after prosthesis instalation by using questionaries. Samples of biofilm at surface repair/barrier were obtained in both groups at 3 and 28 days after extraction (in the moment of barrier removal) to microbiological evaluation using Illumina HiSeq system. Computed tomography obtained imediatlly after extraction and before implant placement will be analised to evaluation of changes on ridge dimensions. After 3 months following extration, bone tissue biopsies will be harvested from the sites designed to receive dental implants to evaluation of imunoenzimatic pattern (DKK1, OPG, OC, OPN, TNF-α, SOST, RANKL, OSN e TRAP) and gene expression (TGF-β, BSP e COL-I) of bone-related markers using Luminex/Magpix and PCR Real-Time, respectivally. Afer imlpant placement, the implant stability quotient (ISQ) was determined. The results will be statistically compared after normality test, with the level of significance set at 5%.

NCT ID: NCT04328116 Active, not recruiting - Jaw, Edentulous Clinical Trials

Study of Neodent Implantable Devices of GM Zygomatic Line

Start date: July 15, 2020
Phase:
Study type: Observational

GM Zygomatic implant is intended to be surgically placed in the posterior region of the maxilla and zygoma. It is indicated for multiple prostheses in case of severe resorption in the maxilla and total edentulism (situations in which the installation of convectional implants is contraindicated). The objective of the study is to confirm the long-term safety and clinical performance of GM Zygomatic implants and GM Zygomatic abutments in daily dental practice setting, by means of a prospective collection of clinical data concerning the success and survival rates of these devices. Devices will be used according to standard routine in daily practice, according to all indications as specified by the manufacturer in the instructions for use (IFU). Ten patients will be followed for 36 months and monitored for Adverse Events by the Investigators until the last protocol-related procedure of a patient is completed.

NCT ID: NCT04323098 Active, not recruiting - Hemophilia A Clinical Trials

Study to Evaluate the Efficacy and Safety of Valoctocogene Roxaparvovec, With Prophylactic Steroids in Hemophilia A

GENEr8-3
Start date: December 8, 2020
Phase: Phase 3
Study type: Interventional

This Phase III clinical study will evaluate the safety and effectiveness of valoctocogene roxaparvovec in combination with prophylactic corticosteroids in patients with severe hemophilia A.

NCT ID: NCT04320472 Active, not recruiting - COVID-19 Clinical Trials

Acute Encephalopathy in Critically Ill Patients With COVID-19

NeuroCOVID19
Start date: March 23, 2020
Phase:
Study type: Observational [Patient Registry]

Infection with SARS-CoV-2 or severe acute respiratory syndrome coronarvirus type 2 was highlighted in December 2019 in the city of Wuhan in China, responsible for an pandemic evolution since March 11, 2020. The infection affects all ages of life, although affecting children in a very small proportion of cases. The typical presentation of the disease combines fever (98%), cough (76%), myalgia and asthenia (18%) as well as leukopenia (25%) and lymphopenia (63%). Upper airway involvement rare. The main clinical presentation requiring hospitalization of infected patients is that of atypical pneumonia which may require critical care management (27%), and progress to an acute respiratory distress syndrome (67%) involving life-threatening conditions in almost 25% of patients diagnosed with SARS-CoV-2 infection. Other organ damage have been reported, mainly concerning kidney damage (29%) which may require renal replacement therapy in approximately 17% of patients. Neurological damage has been very rarely studied, yet reported in 36% of cases in a study including patients of varying severity. Finally, the mortality associated with this emerging virus is high in patients for whom critical care management is necessary, reported in 62% of patients. We therefore propose a prospective observational study which aim at reporting the prevalence of acute encephalopathy at initial management in Critical/Intensive care or Neurocritical care , to report its morbidity and mortality and to identify prognostic factors.

NCT ID: NCT04303780 Active, not recruiting - Clinical trials for KRAS p, G12c Mutated /Advanced Metastatic NSCLC

Study to Compare AMG 510 "Proposed INN Sotorasib" With Docetaxel in Non Small Cell Lung Cancer (NSCLC) (CodeBreak 200).

Start date: June 4, 2020
Phase: Phase 3
Study type: Interventional

A Phase 3 Study to Compare AMG 510 with Docetaxel in Non Small Cell Lung Cancer (NSCLC) subjects with KRAS p. G12c mutation

NCT ID: NCT04300647 Active, not recruiting - Cervical Cancer Clinical Trials

A Study of Tiragolumab Plus Atezolizumab and Atezolizumab Monotherapy in Participants With Metastatic and/or Recurrent PD-L1-Positive Cervical Cancer

SKYSCRAPER-04
Start date: June 30, 2020
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of tiragolumab in combination with atezolizumab and atezolizumab monotherapy in patients with programmed death-ligand 1 (PD-L1)-positive cervical cancer (metastatic and/or recurrent).