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NCT ID: NCT04522167 Completed - Clinical trials for Neovascular Age-related Macular Degeneration

Efficacy and Safety of the Aflibercept FYB203 Biosimilar in Comparison to Eylea® in Patients With Neovascular Age-Related Macular Degeneration

MAGELLAN-AMD
Start date: July 21, 2020
Phase: Phase 3
Study type: Interventional

This is a randomized, double-masked, multicenter study to evaluate the efficacy and safety of FYB203 compared to Eylea® in patients with neovascular age related macular degeneration.

NCT ID: NCT04521842 Completed - Osteoarthritis, Hip Clinical Trials

Influence of Femoral Head Size During Total Hip Arthroplasty on Gait

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

Total hip replacement (THR) is being considered as one of the most effective medical procedures. Since its introduction, there was a worldwide debate over proper implant selection in terms of size, bearing type and shape. The diameter of used femoral heads components grew throughout the years - from 22 mm in the 1960s to 32 mm in the 2000s, which is the most commonly used size nowadays. In recent years there was a visible use of large femoral heads (>=36mm) in several registers. In the USA there was a significant grow in use of this heads rising from 1% in early 200s to even 58% in 2009. There is a strong evidence data and many researchers concerning range of movement, risk of dislocation, functional results, pain and prosthesis wear depending of femoral head size. In terms of gait characteristics there are several deviations reported concerning both patients with hip osteoarthritis (OA) and following THR. There is a lack of literature concerning influence of used implants on gait parameters and whether this goal of the surgery can be achieved. The aim of this study was to assess potential differences of lower limb biomechanics during gait in patients following total hip replacement surgery depending on femoral head diameter and compare them to the normal gait of healthy volunteers. As a secondary outcome authors wanted to inspect correlation between gait parameters and patient-reported outcome.

NCT ID: NCT04521478 Completed - Clinical trials for Depressive Disorder, Major

A Study to Test the Effect of Different Doses of BI 1358894 and Quetiapine in People With Depression

Start date: November 20, 2020
Phase: Phase 2
Study type: Interventional

This study is open to adults with depression (major depressive disorder) for whom standard treatment with antidepressants alone does not work sufficiently. The purpose of the trial is to find out whether a medicine called BI 1358894 helps to improve symptoms of depression. Four different doses of BI 1358894 are tested in the study. Participants continue their standard antidepressant therapy throughout the study. Participants are put into 6 groups by chance. Participants in 4 of the 6 groups take different doses of BI 1358894, and placebo. Participants in the fifth group take quetiapine, a medicine already used to treat depression, and placebo. Participants in the sixth group take placebo only. Participants take BI 1358894, quetiapine, or placebo as tablets. Placebo tablets look like BI 1358894 or quetiapine tablets but do not contain any medicine. Each participant takes tablets twice a day. Participants are in the study for about 3 months. During this time, they visit the study site about 8 times and get about 2 phone calls. At the visits, doctors ask participants about their symptoms. The results between the BI 1358894 groups, the quetiapine group, and the placebo group are then compared. The doctors also regularly check the general health of the participants.

NCT ID: NCT04521010 Completed - COVID-19 Pandemic Clinical Trials

Staff Absenteeism and Delivery of Healthcare Services During the COVID-19 Pandemic

Start date: January 1, 2020
Phase:
Study type: Observational

Work attendance of more than 700 hospital workers was evaluated. The assessment of the number of medical services that were performed was based on monthly reports prepared for the national payer of health services.

NCT ID: NCT04520724 Completed - Clinical trials for Non-Alcoholic Fatty Liver Disease

Functional Roll for Non-alcoholic Fatty Liver Disease

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

Background: Low physical activity and poor eating habits (incl. high fat and carbohydrates but low fiber intake) are the main reason of obesity epidemic in western societies. The most common clinical complication of this condition is non-alcoholic fatty liver disease (NAFLD), that can lead to liver cirrhosis and its complications. Recent studies show that gut dysbiosis may play a crucial role in the pathogenesis of NAFLD. On the other hand plant fiber shows beneficial properties in remodeling of the gut microbiome. Aim: The project aims to create low-calorie bars / snacks with an increased fiber content (12 g/bar), replacing the second breakfast and/or afternoon tea. The main scientific aim is to examine the influence of the extra supply of fiber on i. gut microbiota composition and metabolism and ii. liver function in patients with NAFLD. Methods: Randomized placebo-controlled double blind study. A group of patients diagnosed with NAFLD, divided into 2 groups: study (12% fiber bar) and placebo (maltodextrin bar). Two study phases: preliminary study (5 weeks, 20 patients) and main study (24 weeks, 120 patients). Both clinical and laboratory (stool and serum) aspects will be analyzed, incl. anthropometric measurements, nutrition tests (food frequency questionnaire), health-related quality of life, liver ultrasound and elastography, serum and stool biochemistry and microbiome analysis.

NCT ID: NCT04518995 Completed - Alopecia Areata Clinical Trials

Study to Evaluate the Efficacy and Safety of CTP-543 in Adults With Moderate to Severe Alopecia Areata (THRIVE-AA1)

THRIVE-AA1
Start date: November 23, 2020
Phase: Phase 3
Study type: Interventional

This study evaluates the safety and effectiveness of an investigational study drug (called CTP-543) in adults (18 years and older) who have 50% or greater scalp hair loss.

NCT ID: NCT04518293 Completed - Hypertension Clinical Trials

Efficacy and Safety of GMRx2 Compared to Dual Combinations for the Treatment of Hypertension

GMRx2_ACT
Start date: June 26, 2021
Phase: Phase 3
Study type: Interventional

Recent hypertension guidelines recommend combination therapy as initial treatment for many or most patients. Several trials suggest triple low-dose combination therapy may be highly effective in terms of achieving blood pressure control without increasing adverse effects. This trial is designed to investigate the efficacy and safety of GMRx2 in participants with high blood pressure compared to dual combinations.

NCT ID: NCT04516291 Completed - Dyslipidemias Clinical Trials

A Dose-Ranging Study With Vupanorsen (TRANSLATE-TIMI 70)

Start date: September 28, 2020
Phase: Phase 2
Study type: Interventional

This is a multicenter, Phase 2b, double-blind, placebo-controlled, parallel group study to provide data on efficacy, safety, tolerability, and pharmacokinetics (PK) of PF-07285557 (hereafter, vupanorsen) administered subcutaneously (SC) at various doses and regimens in participants with dyslipidemia, defined in this study as participants with elevated non-HDL-C and TG who are receiving a stable dose of a statin. This study is also known as TaRgeting ANGPTL3 with an aNtiSense oLigonucleotide in AdulTs with dyslipidEmia (TRANSLATE-TIMI 70).

NCT ID: NCT04515849 Completed - Clinical trials for Type 2 Diabetes Mellitus

A Study of Cotadutide in Participants Who Have Chronic Kidney Disease With Type 2 Diabetes Mellitus

Start date: August 31, 2020
Phase: Phase 2
Study type: Interventional

A Phase 2b, study to measure the effect of Cotadutide at different doses versus placebo or comparator (semaglutide) in participants who have Chronic Kidney Disease with Type 2 Diabetes Mellitus.

NCT ID: NCT04514159 Completed - Breast Cancer Clinical Trials

A Study of ZN-c5 and Abemaciclib in Participants With Breast Cancer

Start date: November 12, 2020
Phase: Phase 1
Study type: Interventional

This is a Phase 1b, open-label, multicenter, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of ZN-c5 administered orally in combination with abemaciclib (VERZENIO®) in participants with advanced estrogen-receptor positive, human epidermal growth factor receptor-2 negative (ER+/HER2-) breast cancer.