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NCT ID: NCT04374253 Terminated - Alzheimer Disease Clinical Trials

A Study to Evaluate the Safety, Tolerability, and Efficacy of Long-Term Gantenerumab Administration in Participants With Alzheimer's Disease (AD)

Start date: January 26, 2021
Phase: Phase 3
Study type: Interventional

This is an open-label, multicenter, rollover study to evaluate the safety, tolerability, and efficacy of long-term administration of open-label gantenerumab in participants with AD who completed Study WN29922 or WN39658, either the double-blind or open-label extension (OLE) part.

NCT ID: NCT04373863 Completed - Clinical trials for Arterial Hypertension

Assessment of Lifestyle, Blood Pressure, Cholesterol and Glycated Hemoglobin in a Specific Population

LB1901
Start date: June 29, 2020
Phase:
Study type: Observational

The project Shall we get to know your health better? Lifestyle assessment, blood pressure and cholesterol in the population of Libbs Farmacêutica employeesLTDA.; consists of a study that will bring knowledge and enable quantificationof risk factors related to cardiovascular diseases in this population above mentioned.

NCT ID: NCT04373733 Completed - Clinical trials for Coronavirus Infection

Early Intervention in COVID-19: Favipiravir Verses Standard Care

PIONEER
Start date: May 1, 2020
Phase: Phase 3
Study type: Interventional

Currently we do not know how best to treat patients infected with COVID-19. This study is looking at whether randomising participants to either favipiravir or to usual care, can help patients with suspected or proven COVID-19 infection.

NCT ID: NCT04373564 Recruiting - Cognitive Function Clinical Trials

Effect on Body Movement and Mental Skills in Patients Who Received Gadolinium-based Contrast Media for Magnetic Resonance Examination Multiple Times Within 5 Years

ODYSSEY
Start date: March 24, 2021
Phase: Phase 4
Study type: Interventional

This study is a postmarketing requirement jointly carried out by four NDA holders (Bayer AG, Bracco, GE Healthcare and Guerbet) and the CRO IQVIA. The study aims to create detailed images of the organs and tissue of the human body during x-ray, CT-scan or MRI investigations, doctors are using contrast media (a kind of dye) which can be given to patients by injection into a blood vessel or by mouth. In this study researchers want to find out whether so called gadolinium-based contrast agents (GBCAs) have an effect on body movement and mental skills when given to participants multiple times within 5 years. The study plans to enroll about 2076 participants suffering from a condition for which they are likely to have at least annually a MRI or another imaging examinations. Only adults up to 65 years will be considered to join this study. During the study duration of 5 years participants will receive annually a MRI or other imaging tests (such as CT-scan, x-ray) and will visit the study doctor at least 7 times for physical examinations, laboratory investigations and tests on body movement and mental skills.

NCT ID: NCT04372810 Completed - Clinical trials for Diabetes Complications

Effect of Manual Therapy on Tibiotarsal Joint Mobility in Diabetic Individuals

Start date: August 9, 2017
Phase: N/A
Study type: Interventional

The study aimed to evaluate the acute effect of manual therapy on ankle joint mobility in diabetic patients. Forty volunteers, with a mean age of 59.35±7.85, with type 2 DM and neurological symptoms of Diabetic Distal Polyneuropathy according to a Diabetic Polyneuropathy Diagnostic Scale (EDPNDD) protocol with the amplitude were performed. Were divided into two groups: Sham group (GS), and intervention group (GI), which underwent manual manipulation intervention and seven-day follow-up. Joint range of motion analysis was performed using digital goniometry and static discharge of weights assessed by computerized baropodometry with open and closed eyes, and the Shapiro-Wilk normality test evaluated data distribution and relative, Tukey post hoc set ANOVA tests were used for non-normal variables. The Kruskal- Wallis test followed by Dunn's post-hoc test. SAS statistical software was used and the significance level of 5%. Results: The results showed an increased joint range of motion, plantar flexion, and dorsiflexion, between the moments and moments after manipulation and follow-up. It was still possible to make a significant difference between GI when it was with GS at poster and follow-up. No intragroup analysis was performed by GS, for analysis over time. Regarding intragroup comparisons over time (pre, post-intervention, and follow-up), a significant difference was made for Front and back displacement amplitude (PAD) with open eyes of the GI, with an increase after intervention and reduction without follow up. Conclusion: Based on the results obtained, the work performed with manual therapy increased the ankle joint amplitude in diabetic individuals.

NCT ID: NCT04372589 Completed - COVID-19 Clinical Trials

Antithrombotic Therapy to Ameliorate Complications of COVID-19 (ATTACC)

ATTACC
Start date: May 20, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

Endothelial injury as a consequence of SARS-CoV-2 infection leads to a dysregulated host inflammatory response and activation of coagulation pathways. Macro- and micro-vascular thrombosis may contribute to morbidity, organ failure, and death. Therapeutic anticoagulation with heparin may improve clinical outcomes in patients with COVID-19 through anti-thrombotic, anti-inflammatory, and anti-viral activities of heparins. This pragmatic, Bayesian adaptive randomized controlled trial will determine whether therapeutic anticoagulation with heparin (subcutaneous low molecular weight heparin or intravenous unfractionated heparin) versus usual care reduces the need for intubation or death in hospitalized patients with COVID-19. The trial uses an adaptive design which was chosen to overcome limitations in available data to inform a priori estimation of event rates and possible effect sizes. The adaptive design also includes response-adaptive randomization based on baseline D-dimer level, probing for differential efficacy across subgroups defined based on initial D-dimer level. This Bayesian adaptive randomized trial will stop at a conclusion 1) when the posterior probability that the proportional odds ratio is greater than 1.0 reaches 99% (definition of benefit); 2) when the posterior probability that the proportional odds ratio is greater than 1.2 is less than 10% (definition of futility) or; 3) when the posterior probability that the proportional odds ratio is less than 1.0 is greater than 90% (definition of harm). The trial will enroll a maximum of 3,000 patients, although in many simulations the trial may require fewer patients. The trial is strategically aligned with the international REMAP-CAP/COVID platform trial to accelerate evidence generation.

NCT ID: NCT04372186 Completed - COVID-19 Pneumonia Clinical Trials

A Study to Evaluate the Efficacy and Safety of Tocilizumab in Hospitalized Participants With COVID-19 Pneumonia

EMPACTA
Start date: May 14, 2020
Phase: Phase 3
Study type: Interventional

This study (EMPACTA) will a) evaluate the efficacy and safety of tocilizumab (TCZ) compared with a placebo in combination with standard of care (SOC) in hospitalized participants with COVID-19 pneumonia, and b) include an optional long-term extension for eligible participants to explore the long-term sequelae of resolved COVID-19 pneumonia.

NCT ID: NCT04371835 Completed - Clinical trials for Coronavirus Infection

COHIVE: Coronavirus (COVID-19) Outcomes in HIV Evaluation in Resource Limited Settings

Start date: August 12, 2020
Phase:
Study type: Observational

COHIVE is an observational cohort nested in four antiretroviral therapy research studies (ADVANCE - NCT03122262; D²EFT - NCT03017872; DolPHIN2 - NCT03249181 and NAMSAL-ANRS12313 - NCT02777229). COHIVE will include participants who are possible COVID-19 cases with symptoms or confirmed COVID-19 cases, and participants who agree to have a serology testing for SARS-CoV-2 regardless of COVID-19 history.

NCT ID: NCT04371757 Recruiting - Hypertension Clinical Trials

Influence of the Autonomic Nervous System in Response to Exercise in Hypertensive Individuals

Start date: April 30, 2020
Phase: N/A
Study type: Interventional

Systemic arterial hypertension (SAH) has a direct association with endothelial dysfunction and major cardiovascular events. Evidence points to possible benefits of aerobic training in the endothelial function analyzed by the flow mediated dilation technique (flow mediated dilatation - FMD) in individuals with SAH. However, little is known about the influence of the autonomic nervous system (ANS) on the results of brachial artery FMD after different types of acute exercise in individuals with SAH. Thus, the objective of the research is to analyze the influence of the ANS on the FMD of the brachial artery of individuals with SAH after a session of aerobic (EA), resistance (ER) and combined (EC) exercise. For this, thirty-nine hypertensive individuals aged 35 to 55 years will be recruited and will be randomized to 2 sessions of AS, ER or EC. Also, within each modality, they will be randomized to α1-adrenergic block (Doxazosin 0.05 mg / kg-1) or placebo. The FMD will be performed by ultrasound 10 minutes before, as well as 10, 40 and 70 minutes after the exercise sessions and the autonomic control will be monitored (Finometer) for 10 minutes before each FMD. Arterial stiffness will also be analyzed, using the pulse wave velocity (PWV) by the Complior Analyzer. It is expected to demonstrate with this research the influence of the ANS on the FMD of the brachial artery in individuals with SAH in different physical exercises. This knowledge contributes to a better training prescription in this population.

NCT ID: NCT04370054 Active, not recruiting - Hemophilia A Clinical Trials

Study to Evaluate the Efficacy and Safety of PF-07055480 / Giroctocogene Fitelparvovec Gene Therapy in Moderately Severe to Severe Hemophilia A Adults

AFFINE
Start date: August 18, 2020
Phase: Phase 3
Study type: Interventional

C3731003 is a pivotal Phase 3 study to evaluate the clinical efficacy and safety of a single IV infusion of PF-07055480 / giroctocogene fitelparvovec (Recombinant AAV2/6 Human Factor VIII Gene Therapy) in adult male participants with moderately severe or severe hemophilia A (FVIII:C≤1%) for the study duration of 5 years. The study will enroll eligible participants who have been followed on routine prophylaxis with FVIII products in the Lead-In study C0371004.