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NCT ID: NCT04026061 Completed - Dementia Clinical Trials

Pilot Study Person-centred Tablet Intervention

Start date: October 31, 2017
Phase: N/A
Study type: Interventional

First evaluation of FindMyApps, a tablet intervention consisting of a selection tool for usable apps for self-management and meaningful activities and a training that supports informal carers to help people with dementia to learn how to use the tablet and the tool.

NCT ID: NCT04025879 Active, not recruiting - Clinical trials for Carcinoma, Non-Small-Cell Lung

A Study of Neoadjuvant Chemotherapy Plus Nivolumab Versus Neoadjuvant Chemotherapy Plus Placebo, Followed by Surgical Removal and Adjuvant Treatment With Nivolumab or Placebo for Participants With Surgically Removable Early Stage Non-small Cell Lung Cancer

Start date: November 5, 2019
Phase: Phase 3
Study type: Interventional

The main purpose of the study is to examine if periadjuvant (neoadjuvant, then adjuvant) immunotherapy will prolong event free survival in participants with early stage non-small cell lung cancer.

NCT ID: NCT04025632 Terminated - Clinical trials for Immune Mediated Necrotizing Myopathy

Safety and Efficacy Study of Zilucoplan in Subjects With Immune-Mediated Necrotizing Myopathy

Start date: November 7, 2019
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate the safety and efficacy of zilucoplan in patients with Immune-Mediated Necrotizing Myopathy (IMNM). Subjects will be randomized in a 1:1 ratio to receive daily SC doses of 0.3 mg/kg zilucoplan or matching placebo for 8 weeks.

NCT ID: NCT04024371 Completed - Depression Clinical Trials

Validating Reward-related Biomarkers (RTOC)

RTOC
Start date: September 16, 2019
Phase:
Study type: Observational

Deficits or abnormalities in reward processing are present in a number of psychiatric disorders. The overarching objective of the study is to conduct initial validation work towards optimising three experimental tasks - which have previously been shown to be sensitive to reward processing deficits - for future use in clinical trials. This initial validation work has the primary objective to uncover group differences in task outcome measures between healthy control participants, participants with Major Depressive Disorder (MDD) and participants with schizophrenia (SZ) using statistical analyses. This may provide some indications for the use of these tasks as clinically-relevant biomarkers. Primary aims include: (i) comparing the investigator's endpoint means and distributions to those in previously published data; (ii) replication of previously-reported differences between MDD/SZ vs. healthy control participants, and, (iii) exploring the relationship between task endpoints and subjective participant- and clinician-rated report of reward-related constructs (e.g. anhedonia, negative symptoms).

NCT ID: NCT04024228 Completed - Healthy Volunteers Clinical Trials

Study to Assess the Immune Response and the Safety Profile of a High-Dose Quadrivalent Influenza Vaccine (QIV-HD) Compared to a Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) in Europeans Adults 60 Years of Age and Older

Start date: October 28, 2019
Phase: Phase 3
Study type: Interventional

Primary Objective: To demonstrate that high-dose quadrivalent influenza vaccine (QIV-HD) induces an immune response that is superior to the responses induced by standard-dose quadrivalent influenza vaccine (QIV-SD) for all 4 virus strains 28 days post-vaccination in participants 60 to 64 years of age and in participants 65 years of age and older. Secondary Objective: - Immunogenicity: To further describe the immune response induced by QIV-HD and QIV-SD in all participants by age group, in pooled age groups, and by vaccine group (QIV-HD; QIV-SD). - Safety: To describe the safety profile of all participants by age group, in pooled age groups, and by vaccine group (QIV-HD; QIV-SD).

NCT ID: NCT04024202 Recruiting - Clinical trials for Autoimmune Hemolytic Anemia

Data Registry of Auto Immune Hemolytic Anemia

DRAIHA
Start date: July 12, 2019
Phase:
Study type: Observational

In autoimmune hemolytic anemia (AIHA) auto-antibodies directed against red blood cells (RBCs) lead to increased RBC clearance (hemolysis). This can result in a potentially life-threatening anemia. AIHA is a rare disease with an incidence of 1-3 per 100,000 individuals. An unsolved difficulty in diagnosis of AIHA is the laboratory test accuracy. The current 'golden standard' for AIHA is the direct antiglobulin test (DAT). The DAT detects autoantibody- and/or complement-opsonized RBCs. The DAT has insufficient test characteristics since it remains falsely negative in approximate 5-10% of patients with AIHA, whereas a falsely positive DAT can be found in 8% of hospitalized individuals. Also apparently healthy blood donors can have a positive DAT. The consequences of DAT positivity are not well known and may point to early, asymptomatic disease, or to another disease associated with formation of RBC autoantibodies, such as a malignancy or (systemic) autoimmune disease. Currently, there are no guidelines to follow-up DAT positive donors. A second unsolved difficulty is the choice of treatment in AIHA. Hemolysis can be stopped or at least attenuated with corticosteroids, aiming to inhibit autoantibody production and/or RBC destruction. Many patients do not respond adequately to corticosteroid treatment or develop severe side effects. Currently, it is advised to avoid RBC transfusions since these may lead to aggravation of hemolysis and RBC alloantibody formation. But in case symptomatic anemia occurs, RBC transfusions need to be given. An evidence-based transfusion strategy for AIHA patients is needed to warrant safe transfusion in this complex patient group. To design optimal diagnostic testing and (supportive) treatment algorithms, the investigators will study a group well-characterized patients with AIHA and blood donors without AIHA, via a prospective centralized clinical data collection and evaluation of new laboratory tests. With this data the knowledge of the AIHA pathophysiology and to evaluate diagnostic testing in correlation with clinical features and treatment outcome can be improved.

NCT ID: NCT04023552 Active, not recruiting - Clinical trials for Cardiovascular Disease and Lipoprotein(a)

Assessing the Impact of Lipoprotein (a) Lowering With Pelacarsen (TQJ230) on Major Cardiovascular Events in Patients With CVD

Lp(a)HORIZON
Start date: December 12, 2019
Phase: Phase 3
Study type: Interventional

This is a pivotal phase 3 study designed to support an indication for the reduction of cardiovascular risk in patients with established CVD and elevated Lp(a)

NCT ID: NCT04022863 Recruiting - Ovarian Neoplasms Clinical Trials

Ovarium Cancer Detection by TEP's and ctDNA

Start date: July 1, 2019
Phase:
Study type: Observational [Patient Registry]

Rationale: Cancer is primarily diagnosed by clinical presentation, imaging and pathological analysis of tissue biopsies, increasingly supported by molecular diagnostics tests. However, late diagnosis and misdiagnosis due to limitations of tissue biopsy acquisition remains a major problem. Therefore, a general blood test to pinpoint cancer early and adequately can be considered the 'Holy Grail', because diagnosis in an earlier stage significantly improves the chance of cure from cancer. Several blood-based sources are currently being evaluated as liquid biopsies, including circulating tumor (ct) DNA and circulating tumor cells, but none of these have been implemented for primary (multiclass) cancer diagnostics. Protein tumor markers have been used for decades in diagnosis and monitoring of treatment response in different cancers. Tumor-educated platelets (TEPs) can function as potential blood-based source for (early) cancer diagnostics. Blood platelets are implicated in hemostasis and wound healing. Platelets have recently emerged as central players and immediate responders in the systemic and local responses to tumor growth. Confrontation of platelets by tumor cells via transfer of tumor-associated molecules ('education') results in the sequestration of these molecules (derived from both tumor and its micro-environment), causing a distinct platelet messenger Ribonucleic acid (mRNA) profile. We have previously shown that platelets acquire glioblastoma and prostate cancer mRNA biomarkers and that glioblastoma TEP mRNA profiles harbour diagnostic potential. Furthermore, circulating tumor desoxyrubonucleic acid (ctDNA) has recently been implicated as biomarker for therapy effectiveness and survival. Objective: develop and evaluate the potential of combination of tumor markers, TEPs and ctDNA as liquid biomarkers for (early) ovarium cancer diagnostics and as markers for therapy response and survival. Study design: investigator-initiated, longitudinal, observational study. Study population: patients suspected of having ovarium cancer and are therefore planned for surgery. Main study parameters/endpoints: The difference in biomarker profile from benign ovarium lesions versus cancerous lesions. Nature and extent of the burden and risks associated with participation, benefit and group relatedness. There is no extra burden/risk for the patients in this study. Three extra vials of blood.

NCT ID: NCT04021784 Completed - Clinical trials for Neuromuscular Scoliosis

Limited-efficacy Testing of SDS and NEMOST for Early Onset Neuromuscular Scoliosis

BiPOWR
Start date: May 6, 2019
Phase: N/A
Study type: Interventional

The primary aim of this study is to investigate and describe the limited efficacy of the Spring Distraction System (SDS) and Bilateral One Way Rod (NEMOST) in maintaining curve reduction without repeat lengthening procedures and complications. Secondary aims are to describe growth of the instrumented spine, health-related quality of life, and to compare both devices.

NCT ID: NCT04019808 Completed - Gastric Cancer Clinical Trials

Gastric Cancer Risk Factors Knowledge in European and Latinamerican Population

LEGACY-3
Start date: July 30, 2019
Phase:
Study type: Observational

This study is divided into two parts: Part 1: An interventional study, with a pre-post study design to determinate the grade of knowledge of established GC risk factors. Part 2: An observational study to know impact on prevalence and infection eradication of H. pylori