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NCT ID: NCT03834506 Completed - Prostatic Neoplasms Clinical Trials

Study of Pembrolizumab (MK-3475) Plus Docetaxel Versus Placebo Plus Docetaxel in Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-921/KEYNOTE-921)

Start date: May 2, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of the combination of pembrolizumab (MK-3475) and docetaxel in the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy for mCRPC but have progressed on or are intolerant to Next Generation Hormonal Agent (NHA). There are two primary study hypotheses. Hypothesis 1: The combination of pembrolizumab plus docetaxel plus prednisone is superior to placebo plus docetaxel plus prednisone with respect to Overall Survival (OS). Hypothesis 2: The combination of pembrolizumab plus docetaxel plus prednisone is superior to placebo plus docetaxel plus prednisone with respect to Radiographic Progression-free Survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review.

NCT ID: NCT03831087 Completed - Aortic Stenosis Clinical Trials

Cardiac Magnetic Resonance Imaging Versus Computed Tomography to Guide Transcatheter Aortic Valve Replacement

TAVR-CMR
Start date: October 30, 2017
Phase: N/A
Study type: Interventional

To prove the non-inferiority of TAVR-CMR compared to TAVR-CT to guide TAVR according to clinical efficacy, defined as implantation success based on the VARC-2 criteria.

NCT ID: NCT03830281 Completed - Clinical trials for Type 1 Diabetes Mellitus

A Study Comparing LY900014 to Insulin Lispro (Humalog) in Adults With Type 1 Diabetes Using Insulin Pump Therapy

PRONTO-Pump-2
Start date: February 14, 2019
Phase: Phase 3
Study type: Interventional

The reason for this study is to compare the study drug LY900014 to insulin lispro (Humalog) when both are used in insulin pump therapy in adults with type 1 diabetes (T1D).

NCT ID: NCT03823521 Completed - Clinical trials for Coronary Artery Bypass Surgery

Observational Study to Investigate the Effects of Training on the Administration of Cardioplexolâ„¢

Start date: November 20, 2018
Phase: Phase 3
Study type: Interventional

This is a multi-center, open label, single group, observational study designed to evaluate the effects of a Cardioplexolâ„¢ preparation and administration training program proposed to cardiac surgeons and cardiotechnicians inexperienced in the use of Cardioplexolâ„¢. The training program aims at increasing the efficacy of Cardioplexol administration while reducing the risk of false manipulations. During the training possible risks and consequences of incorrect applications as well as the measures to take in case of administration error, are discussed. The training program includes one standardized theoretical part and one practical part consisting of a direct intra-operative coaching of surgeons practicing their first 2 operations. The effect of the training will then be assessed by evaluating each trained surgeon's 4 next consecutive patients operated with Cardioplexol and without the coach.

NCT ID: NCT03823300 Completed - Clinical trials for Wet Macular Degeneration

A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Neovascular Age-Related Macular Degeneration (LUCERNE)

Start date: March 11, 2019
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy, safety, durability, and pharmacokinetics of faricimab administered at intervals as specified in the protocol, compared with aflibercept once every 8 weeks (Q8W), in participants with neovascular age-related macular degeneration (nAMD).

NCT ID: NCT03823066 Completed - Dementia Clinical Trials

Experience With a Robot for Home Care and Its Acceptance by People With Dementia, Caregivers and Dementia Trainers

Start date: August 22, 2018
Phase: N/A
Study type: Interventional

Background: Dementia rates are increasing worldwide and consequently burden global healthcare resources to a serious degree. However, there is a declining number of caregivers to provide care. It is for this reason that many new technologies, such as socially assistive robots, have been developed because of their potential to support caregivers in promoting the independence of people with dementia. Most of the (socially assistive) robots have so far been tested for people without dementia in mainly laboratory or institutional settings, like nursing homes. Consequently, there is a lack of knowledge about the possible uses of robots from the perspective of those affected by dementia in real-life/care situations (e.g. at home). Testing in a laboratory setting cannot capture the complexity and high variability of everyday situations occurring during the care of persons with dementia. Methods The design is a mixed method intervention study of a refined socially assistive humanoid robot. In total, three people with dementia, three relatives, three dementia trainers and three professional caregivers were included in the study. Quantitative data of technology acceptance were collected using the "Technology Usage Inventory". Qualitative data (main focus: experiences with the robot and handling the robot) were collected by means of observation and qualitative interviews. Movement data of people with dementia were collected by means of the eye camera of the robot. This study helps to further refine and test a socially assistive robot for people with dementia living at home.

NCT ID: NCT03821415 Completed - Dry Eye Syndromes Clinical Trials

Effects of RP101 in Post-menopausal Women With Dry Eye Syndrome

Start date: January 18, 2019
Phase: Phase 2
Study type: Interventional

The main purpose of this study is to establish whether RP101 can reduce symptoms of dry eye syndrome in post-menopausal women.

NCT ID: NCT03819816 Completed - Dementia Clinical Trials

Development and Evaluation of the DEA App

DEA
Start date: February 1, 2019
Phase: N/A
Study type: Interventional

Background, current situation, and motivation According to current estimates, 100,000 people in Austria suffer from various types of dementia. According to forecasts, this number of people will rise to approximately 230,000 by 2050 due to the demographic development and the increase of the prevalence rate. Data from the service statistics show that 85% of dementia patients still live in the community in their homes and informal caregivers, such as relatives, support them. In total, more than 300,000 people care for their relatives in Austria in addition to professional support. However, not only the person affected from dementia suffers from the disease, but also, and often at a higher rate, the informal caregivers. Vice versa, the quality of life of those suffering from dementia is significantly influenced by the caregivers' competences and their strategies for resilience. Study aim and hypothesis The aim of this study is to evaluate the usability, acceptance, and effect of an app consisting of three modules that provide multidimensional support for informal caregivers of a person with dementia.

NCT ID: NCT03818425 Completed - Exercise Clinical Trials

Motivation and Barriers for Exercise in Patients With Anxiety or Posttraumatic Stress Disorder

Start date: January 7, 2019
Phase:
Study type: Observational

Relevance and Aim: There has been increasing research interest in sport preferences and motivational factors as well as barriers that restrain from engaging in sport activities in people suffering from mental illnesses. Anxiety disorders are one of the leading mental disorders worldwide. Exercise has previously shown anxiolytic effects and is discussed as an adjunctive treatment option in clinical practice. This study aims to depict motivation and barriers in patients with anxiety or posttraumatic stress disorders. Design and Participants: Observational study of patients diagnosed with anxiety disorder or posttraumatic stress disorder (ICD-10) Measurements: Structured questionnaire compounded of validated scales for current physical activity, sport motivation, exercise preferences, perceived barriers , self-efficacy, social support for physical activity, motivation,enjoyment, quality of life as well as sociodemographic data. Duration: The questionnaire will require approximately 20 minutes, the overall duration is 3 months. Personal assistance for completing the questionnaire will be provided if necessary.

NCT ID: NCT03818217 Completed - Dementia Clinical Trials

Effects of a Robot on Physical and Psychosocial Outcomes of Persons With Dementia and Their Social Environment at Home

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

Background: Dementia rates are increasing worldwide and consequently burden global healthcare resources to a serious degree. However, there is a declining number of caregivers to provide care. It is for this reason that many new technologies, such as socially assistive robots, have been developed because of their potential to support caregivers in promoting the independence of people with dementia. Most of the (socially assistive) robots have so far been tested for people without dementia in mainly laboratory or in institutional settings, like nursing homes. Consequently, there is a lack of knowledge about the possible uses of robots from the perspective of those affected by dementia in real-life/care situations (e.g. at home). Testing in a laboratory setting cannot capture the complexity and high variability of everyday situations occurring during the care of persons with dementia. Aim: The aim is to investigate the effect of a socially assistive humanoid robot on the physical and psychosocial outcomes of caregivers, dementia trainers and persons with dementia living at home. Methods: The design is a mixed method randomized clinical trial. As an intervention, 20 persons with dementia and their relatives will receive a socially assistive humanoid robot coach (including a theratainment app for physical and cognitive exercises). The control group (also 20 persons with dementia and their relatives) will receive a tablet including the same theratainment app as in the intervention group, but without the robot. Data will be collected using sensor data of the robot and the tablet, eye tracking, questionnaires, observation and interviews. There are also questionnaires for the relatives (n=40), dementia trainers (n=5) and professional caregivers (n=5). Data analysis is quantitative (descriptive statistics, median regression, covariance analysis, wilcoxon rank-sum test) and qualitative (content analysis). The planned study supports the further development of socially assistive robots with regard to the individual needs of persons with dementia living at home.