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NCT ID: NCT05389631 Recruiting - Clinical trials for Aortic Valve Disease

Trifecta and Epic ViV Detailed Insights Into Management Strategies and Outcomes

Start date: August 17, 2022
Phase:
Study type: Observational

Non-randomized, open label, non-interventional, multicenter registry to describe risk factors, management strategies, and clinical outcomes in patients undergoing Valve in Valve (ViV) transcatheter aortic valve implantation (TAVI) in a previously implanted Trifecta or Epic valve using retrospective registry data from large volume centers

NCT ID: NCT05387473 Recruiting - Clinical trials for Osteoarthritis, Knee

Added Value of Cognitive Behavioural Therapy for Insomnia in Persons With Knee Osteoarthritis

PREMEO
Start date: May 25, 2022
Phase: N/A
Study type: Interventional

Knee osteoarthritis (KOA) is the leading and fastest increasing cause of disability in older adults. It is a serious health issue related with a high health care utilisation. The first-line KOA management is nonsurgical care, with education and exercise therapy as key elements. Nevertheless, treatment effects of exercise therapy and behavioral pain management on improvements in pain, function and quality of life are small to moderate at best. This shows that there is an urgent need for better KOA care. The innovative solution may lie in thinking beyond joints, by targeting KOA subgroups through comorbidity-specific interventions, which fits well in the global move towards precision medicine. With a prevalence rate up to 50%, the presence of insomnia symptoms is a highly prevalent KOA comorbidity, contributing to symptom severity. If left untreated, it represents a barrier for effective conservative management. Since insomnia is nowadays hardly addressed in the often joint-targeted KOA care, the scientific objectives of the study are to assess 1) if cognitive behavioral therapy for insomnia (CBT-I) integrated in best-evidence usual care, consisting of education and exercise therapy, (CBTi-UC) is more effective than best-evidence usual care alone (UC), i.e. education and exercise therapy, at 6 months follow-up in improving clinical outcomes and 2) if CBTi-UC is more cost-effective than UC in KOA patients with comorbid insomnia.

NCT ID: NCT05387096 Recruiting - Polypharmacy Clinical Trials

OPTImization of Medication by Transdisciplinary Assessment of Drug Treatment in Elderly Hospitalized Patients

OPTIMATE
Start date: January 17, 2023
Phase: N/A
Study type: Interventional

This study is being done to find out if a multi-faceted intervention designed to optimize medication in hospitalized older people with multiple chronic medical conditions exposed to multiple medications can reduce unplanned hospital readmission and emergency department attendance compared to current usual medication management. The study intervention aims to minimize potentially inappropriate medications in a structured way and involves follow up with patients and GPs. Patients will be allocated equally to (i) standard medication management (control arm) or (ii) trained physician-delivered intervention or (iii) clinical pharmacist-delivered intervention.

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: 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: NCT05386108 Recruiting - Neoplasms Clinical Trials

Study of Abemaciclib and Elacestrant in Patients With Brain Metastasis Due to HR+/HER2- Breast Cancer

ELECTRA
Start date: August 31, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This is a multi-site, global, open-label study that includes a phase 1b evaluation of elacestrant in combination with abemaciclib in women and men with with or without brain metastases from ER-positive, HER-2 negative breast cancer. Phase 1b is designed to select the recommended phase 2 dose and will be followed by a phase 2 evaluation of elacestrant in combination with abemaciclib in patients with active brain metastases from ER-positive, HER-2 negative breast cancer.

NCT ID: NCT05384457 Recruiting - Chronic Pain Clinical Trials

High Intensity Training to Improve Diaphragm Functioning in Persons With Chronic Nonspecific Low Back Pain

Start date: August 22, 2022
Phase: N/A
Study type: Interventional

This randomized controlled trial aims to investigate 1) the effects of high intensity training (HIT) compared to moderate intensity training (MIT) on diaphragm muscle strength, -endurance, -fatigue and -activation, 2) to which extent these changes in diaphragm functioning are related to changes in cardiorespiratory fitness, postural control, pain and disability after HIT versus MIT, 3) to which extent depressive mood and anxiety moderate the effects of HIT on diaphragm functioning in persons with chronic nonspecific low back pain (CNSLBP). The investigators hypothize that HIT improves diaphragm functioning more compared to MIT in persons with CNSLBP.

NCT ID: NCT05384353 Recruiting - Alzheimer Disease Clinical Trials

In Vivo PET of Synaptic Density in Cognitive Disorders

Start date: April 11, 2022
Phase:
Study type: Observational

This study will compare the discriminative power of [18F]-SynVesT-1 PET and the standard-of-care [18F]-FDG PET in different cognitive disorders (Alzheimer's disease, Frontotemporal degeneration, dementia with Lewy bodies and late-life psychiatric disorders). Moreover, changes in [18F]-SynVesT-1 PET will be evaluated as well as their correlation with specific symptomatology.

NCT ID: NCT05383885 Recruiting - Clinical trials for Death, Sudden, Cardiac

Is the Perfusion Index an Accurate Predictor of Return of Spontaneus Circulation in Out-of-hospital Cardiac Arrest

Start date: January 1, 2022
Phase:
Study type: Observational

The purpose of this pilot feasibility study is to evaluate the ability of the Perfusion Index to predict the return to spontaneous circulation of the out-of-hospital cardiac arrest patient during cardiopulmonary resuscitation. The performance of the perfusion index will also be compared to the current gold standard, end-tidal CO2 (EtCO2).

NCT ID: NCT05383599 Recruiting - Male Infertility Clinical Trials

Characterization of Sperm Population Following Different Selection Procedures

CROSP
Start date: July 16, 2022
Phase:
Study type: Observational

The present study aims to determine which of the sperm selection techniques used in IVF (In Vitro Fertilization) laboratory leads to selection of the best/healthiest sperm population based on their morpho-functional parameters. Different procedures are currently used in our laboratory to select the sperm population that will be used to inseminate the oocytes: Density Gradient Centrifugation (DGC), DGC in combination with Magnetic Activated Sperm Sorting (MACS), and Microfluidic Sperm Sorting (MSS). The sperm cells selected by these techniques will be evaluated for specific morpho-functional features such as, motility, morphological abnormalities, and apoptotic status [phosphatidylserine translocation (early stages of apoptosis)] and DNA (Deoxyribonucleic Acid) fragmentation as an indicator of stages of apoptosis.