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NCT ID: NCT05402488 Recruiting - Clinical trials for Neurodegenerative Diseases

Exploring the Recovery Function of Sleep in Neurodegeneration

RFSN
Start date: March 14, 2022
Phase: N/A
Study type: Interventional

The overall objective of this study is to identify the best approach for assessing the recovery function of sleep in neurodegenerative diseases associated with abnormal protein aggregation with regard to the conception of future intervention studies. To this end, the investigators will follow an exploratory approach in a preferably broad data set collected in patients with neurodegenerative diseases associated with abnormal protein aggregation and in healthy humans.

NCT ID: NCT05401578 Recruiting - Clinical trials for Postprandial Hypoglycemia

Canakinumab for the Treatment of Postprandial Hypoglycemia

CanpHy
Start date: April 17, 2023
Phase: Phase 3
Study type: Interventional

The primary objective of this randomized trial is to test whether a treatment with canakinumab is superior to placebo in patients with postprandial hypoglycemia after bariatric surgery, that is if it improves health related quality of life (mentally or physically) or reduces the risk of hypoglycemic events.

NCT ID: NCT05399992 Recruiting - Clinical trials for Primary Hypercholesterolemia

Study Evaluating Effectiveness and Adherence of Inclisiran Plus Standard of Care (SoC) Lipid-lowering Therapy Compared to SoC in ASCVD

VICTORION REAL
Start date: September 12, 2022
Phase:
Study type: Observational

This observational matched prospective study aims to assess the effectiveness and adherence for inclisiran in combination with Lipid lowering therapies or Lipid lowering treatments (LLT) compared to other LLTs under conditions of routine clinical practice.

NCT ID: NCT05399888 Recruiting - Clinical trials for Mild Cognitive Impairment Due to Alzheimer's Disease

A Study to Learn About the Safety of BIIB080 and Whether it Can Improve Symptoms of Participants With Mild Cognitive Impairment Due to Alzheimer's Disease (AD) or Mild AD Dementia Between 50 to 80 Years of Age

CELIA
Start date: August 24, 2022
Phase: Phase 2
Study type: Interventional

In this study, researchers will learn more about a study drug called BIIB080. The study will focus on participants with mild cognitive impairment or mild dementia due to AD. The main question researchers are trying to answer is if BIIB080 can slow the worsening of AD more than placebo. It will focus on what dose of BIIB080 slows worsening of AD the most. To help answer this question, researchers will use the Clinical Dementia Rating-Sum of Boxes, also known as the CDR-SB. - Clinicians use the CDR-SB to measure several categories of dementia symptoms. - The results for each category are added together for a total score. Lower scores are better. Researchers will also learn more about the safety of BIIB080. The study will be split into 2 parts. The 1st part is the Placebo-Controlled Period. The 2nd part is the Long-Term Extension Period. The 2nd part of the study will help researchers learn about the long-term safety of BIIB080, and how it affects the participant's daily life, thinking, and memory abilities in the longer term. A description of how the study will be done is given below. - After screening, participants will first receive either a low dose or high dose of BIIB080, or a placebo, as an injection into the fluid around the spinal cord (cerebrospinal fluid). A placebo looks like the study drug but contains no real medicine. - Participants will receive BIIB080 or placebo once every 12 weeks or 24 weeks. - After 76 weeks of treatment in the Placebo-Controlled Period, eligible participants will move onto the Extension Treatment period, which will last 96 weeks. - In the extension period, participants who received placebo will be switched to high dose BIIB080 every 12 or 24 weeks. - Participants may be in the study for up to 201 weeks, or about 4 years. This includes the screening and follow-up periods. - Participants can continue to take certain medications for AD. Participants must be on the same dose of medication for at least 8 weeks before the screening period. - After the screening period, most participants will visit the clinic every 6 weeks.

NCT ID: NCT05391334 Recruiting - Fall Clinical Trials

Early Fall Risk Detection and Fall Prevention Among Inpatients With Delirium

QumPreFall
Start date: November 1, 2022
Phase:
Study type: Observational

During delirium patients are at risk of severe harm due to unattended bed-exits resulting in falls. This research intends to explore how effective alarming contact mats (CareMat®) in comparison to contactless bed-exit alarming devices (Qumea®) are to reduce the risk of unattended bed-exits and falls.

NCT ID: NCT05388370 Recruiting - Clinical trials for Neurofibromatosis Type 1

PASS of Paediatric Patients Initiating Selumetinib

Start date: May 23, 2022
Phase:
Study type: Observational

Neurofibromatosis type 1 (NF1) is a rare, autosomal dominant genetic disorder that is caused by germline mutations in the NF1 tumour suppressor gene, which encodes the tumour suppressor protein neurofibromin 1. Plexiform neurofibromas (PN) are histologically benign nerve sheath tumours, which typically grow along large nerves and plexi. On 5 March 2020, a centralised Marketing Authorisation Application was submitted to the European Medicines Agency (EMA), Marketing Authorisation in EU was granted on 17 Jun 2021. As part of the approval process, a Risk Management Plan (RMP) was developed and submitted to the EMA to summarise the safety concerns emerging from the clinical development program. The RMP included additional pharmacovigilance plans for a noninterventional Post-authorisation Safety Study (PASS) to further characterise the safety of selumetinib in paediatric patients with NF1-related PN in routine clinical practice. The planned non-interventional PASS will address gaps in knowledge identified by the RMP, including the important identified risk and some of the potential risks and missing information on long-term developmental toxicity in children, by characterising the safety profile associated with selumetinib use among paediatric patients (age d 8 to < 18 years old) with a diagnosis of NF1 with symptomatic, inoperable PN. This study is a specific obligation in the context of a conditional marketing authorisation for selumetinib (ie, Category 2 PASS). Study results will contribute to updating the safety profile of selumetinib in a relatively large population of patients with different personal characteristics across multiple health care systems and patterns of real-world clinical practice in European countries and Israel. The study will enrol 2 cohorts: 1. The Base Cohort includes all enrolled patients aged 3 to < 18 years. 2. The Nested Prospective Cohort will include the subset of Base Cohort patients aged 8 to < 18 years who have not reached Tanner Stage V on the index date.

NCT ID: NCT05386550 Recruiting - Clinical trials for Head and Neck Cancer

Phase III Xevinapant (Debio 1143) and Radiotherapy in Resected LA SCCHN, High Risk, Cisplatin-ineligible Participants (XRAY VISION)

Start date: October 6, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate the superior efficacy of Xevinapant (Debio 1143) versus placebo when added to radiotherapy in the treatment of high-risk participants with resected locally advanced squamous cell carcinoma of the head and neck (LA SCCHN) who are ineligible to receive cisplatin-based chemoradiation concurrently. Study details include: Study duration: Participants will be followed until the last on-study participant reaches his/her 60-month post-randomization visit, a decision to end the study has been triggered, or until premature discontinuation from study, whichever occurs first. Treatment duration: 18 weeks, consisting of six 3-week cycles. Health measurement/observation: Improved Disease-Free Survival. Visit frequency: Weekly visit during combination therapy period, once every 3 weeks during monotherapy period, and every 3, 4, or 6 months during the Disease-Free Survival Follow-up period in Year 1, 2 and 3, or 4 and 5 (with telephone contact in between), respectively, and every 3 months (telephone visits allowed) during the Overall Survival Follow-up period.

NCT ID: NCT05386342 Recruiting - Thrombus Clinical Trials

A PMCF Study Confirm the Performance and Safety of the TufTex Over-the-Wire (OTW) Embolectomy Catheters

OTW
Start date: January 11, 2023
Phase: N/A
Study type: Interventional

A PMCF study to confirm the performance and safety of the LeMaitre® TufTex Over-the-Wire Embolectomy Catheter

NCT ID: NCT05386277 Recruiting - Clinical trials for Arterial Thromboembolism

A PMCF Study to Confirm the Performance and Safety of the LeMaitre® TufTex Single Lumen Embolectomy Catheter

SLC
Start date: January 11, 2022
Phase: N/A
Study type: Interventional

A post market clinical study to confirm the performance and safety of the LeMaitre® TufTex Single Lumen Embolectomy Catheter on patients undergoing surgical treatment for the removal of arterial emboli and/or thrombi

NCT ID: NCT05385237 Recruiting - Liver Diseases Clinical Trials

Identification of Hepatic Fibrosis Using 4D-MRI

4D-MRI Liver
Start date: August 1, 2021
Phase: N/A
Study type: Interventional

To date, no specific treatment options exist for liver diseases, and there is a large global effort to find drugs that will halt liver disease progression in these patients.Liver fibrosis staging is essential as a diagnostic/prognostic measure and there is an increasing demand for accurate non-invasive liver stiffness measurement tools. This research project proposes a novel MR-based quantitative Liver Deformation Biomarker (qLDB) approach for non-invasive liver fibrosis assessment by using a new technique called 4D-MRI. 4D-MRI allows to overcome the limitations of currently used techniques. Hence, 4D-MRI may help to identify a novel biomarker for non-invasive staging of liver fibrosis , and therefore improve the final diagnosis of patients suffering from liver diseases.