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NCT ID: NCT05163106 Recruiting - Breast Cancer Clinical Trials

Neoadjuvant Treatment of Locally-advanced Breast Cancer Patients With Ribociclib and Letrozole

NEOLETRIB
Start date: December 1, 2022
Phase: Phase 2
Study type: Interventional

Patients with locally advanced (stage III) breast cancer (LABC) are characterized by a significantly worse prognosis compared to patients with primarily operable breast cancer. While neoadjuvant chemotherapy has been the first choice in this situation for several decades, recent evidence suggests that some patients may experience an extraordinary effect from neoadjuvant endocrine treatments involving aromatase inhibitors as monotherapy or in modern drug combinations.Selected LABC patients admitted for treatment will be offered combination therapy including letrozole and ribociclib. The overall goal of the project is to improve understanding of tumor responses and resistance in patients suffering from ER-positive/HER-2 negative locally advanced breast cancer, focusing on the role of the immune system including the gut microbiome.

NCT ID: NCT05162768 Active, not recruiting - Clinical trials for Mitochondrial Diseases

Study to Evaluate Efficacy and Safety of Elamipretide in Subjects With Primary Mitochondrial Disease From Nuclear DNA Mutations (nPMD)

NuPower
Start date: April 29, 2022
Phase: Phase 3
Study type: Interventional

SPIMD-301 is a 48-week, randomized, double-blind, parallel-group, placebo-controlled trial to assess efficacy and safety of single daily subcutaneous (SC) administration of elamipretide as a treatment for subjects with primary mitochondrial myopathy associated with nuclear DNA mutations (nPMD).

NCT ID: NCT05162144 Active, not recruiting - Clinical trials for Chronic Plantar Fasciitis

Proximal Medial Gastriocnemius Recession for Chronic Plantar Fasciitis

Start date: December 15, 2021
Phase: N/A
Study type: Interventional

This prospective kohort study will follow 150 patients treated with proximal medial gastrocnemius recession for plantar fasciitts. Follow up time is two years and the main outcome is the Manchester Oxford Foot Questionnaire. A regression analasys will be performed to identify possible patient baseline factors that may affect the effect of surgery,

NCT ID: NCT05162105 Completed - Sleep Deprivation Clinical Trials

Quick Returns - Sleep, Cognitive Functions and Individual Differences

Start date: September 1, 2021
Phase: N/A
Study type: Interventional

The project will contribute with new knowledge concerning how short rest periods between two consecutive shifts (<11h, often defined as a Quick Return (QR)) affects sleep and cognitive performance. The study will further examine whether individual differences in personality traits and genotypes may explain individual differences in performance and sleep. Data will be collected with a randomized cross-over design, in an experimental laboratory setting.

NCT ID: NCT05160766 Completed - COVID-19 Clinical Trials

Assessing Immune Response of Different COVID-19 Vaccines in Older Adults

EU-COVAT-1
Start date: November 8, 2021
Phase: Phase 2
Study type: Interventional

This is a randomised controlled, adaptive, multicentre Phase II protocol evaluating different booster strategies in individuals aged 75 years and older already vaccinated against SARS-CoV-2. Part B of this trial foresees testing of different vaccines as a 4th vaccination dose (second booster) for comparative assessment of their immunogenicity and safety against SARSCoV- 2 wild-type and variants in the elderly, a usually neglected population. Additional vaccines and extended follow-up visits can be added through amendments of this sub-protocol. As stated in the EU-COVAT master protocol, this trial, i.e., the EU-COVAT-1_AGED study, implements a specific safety monitoring strategy (see below). Cohorts and arms can be withdrawn or added as deemed necessary according to the criteria specified in this protocol

NCT ID: NCT05159661 Recruiting - Dementia Clinical Trials

Intelligent Digital Tools for Screening of Brain Connectivity and Dementia Risk Estimation in People Affected by Mild Cognitive Impairment

AI-Mind
Start date: March 1, 2021
Phase:
Study type: Observational

Every three seconds someone in the world develops dementia. There are over 50 million people worldwide living with dementia and by 2030 this figure is expected to reach 82 million. Besides time-consuming patient investigations with low discriminative power for dementia risk, current treatment options focus on late symptom management. By screening brain connectivity and dementia risk estimation in people affected by mild cognitive impairment, the European Union (EU) funded AI-Mind project will open the door to extending the 'dementia-free' period by offering proper diagnosis and early intervention. AI-Mind will develop two artificial intelligence-based digital tools that will identify dysfunctional brain networks and assess dementia risk. Personalised patient reports will be generated, potentially opening new windows for intervention possibilities.

NCT ID: NCT05150418 Completed - Hypovolemia Clinical Trials

Supplemental Oxygen in Hypovolemia

Start date: November 26, 2021
Phase: Phase 1
Study type: Interventional

Supplemental oxygen is frequently administered in acutely and critically ill patients, specifically, it is often administered in trauma patients to avoid arterial hypoxemia and tissue hypoxia. There is also an increasing focus on potentially deleterious effects of hyperoxia. Further, the hemodynamic response to hyperoxia in hypovolemia is poorly understood. The present study aims to investigate the effects of supplemental oxygen on systemic and cerebral hemodynamics in simulated hypovolemia in healthy volunteers.

NCT ID: NCT05150171 Completed - Hand Osteoarthritis Clinical Trials

Happy Hands E-self-management Pilot Study

Start date: November 23, 2021
Phase: N/A
Study type: Interventional

This pilot study will assess usability of a e-self-management program for patients with hand osteoarthritis through the Happy Hands app. People with hand osteoarthritis will be recruited for the study. The e-self-management intervention consists of informational videos and videos of hand exercises and has a duration of 12 weeks. Patient-reported outcomes and grip strength will be collected before and after the 12 week intervention period. Change in pain, stiffness, grip strength, disease activity and quality indicators will be assessed after 12 weeks.

NCT ID: NCT05149092 Completed - Abdominal Obesity Clinical Trials

Effects of Chicken Protein Hydrolysate (CPH) Supplementation in People With High Waist Circumference

CHICKPEP
Start date: January 18, 2021
Phase: N/A
Study type: Interventional

In this randomized, placebo controlled, double blind trial, effects of relatively high doses of chicken protein hydrolysate (CPH) or casein hydrolysate (placebo) supplementation will be investigate in healthy persons with abdominal obesity. The 12-week study examines potential effects on body weight, abdominal obesity, body composition, plasma parameters of metabolic health including lipids, inflammatory parameters, redox state and microbiota biomarkers.

NCT ID: NCT05149079 Completed - Healthy Diet Clinical Trials

Effects of a Marine Protein Hydrolysate in Healthy Adults

MARPEP
Start date: February 1, 2021
Phase: N/A
Study type: Interventional

This randomized, double blind, controlled trial investigates changes in the cardiovascular index (triacylglycerol/HDL-cholesterol × waist/hip ratio) after 12 weeks of marine protein hydrolysate (MPH) or whey protein powder (placebo) supplementation in adult healthy persons. Additionally, the study investigates potential effects on plasma parameters of metabolic health including lipids, glucose, inflammatory parameters and redox state, as well as associations between dietary MPH and body weight, abdominal obesity, body composition, and gut microbiota composition. Finally, putative end-products of diet-microbial interactions (TMAO and short-chain fatty acids) with CVD risk factors and biomarkers of mitochondrial function are examined.