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NCT ID: NCT04597827 Completed - Healthy Clinical Trials

Metacognition in Semantic Dementia: Comparison With Alzheimer's Disease

META-DEM
Start date: October 16, 2020
Phase:
Study type: Observational

This study aims at exploring patients' ability to monitor their own memory performance depending on their primary deficit and the type of memory involved in the criterion task. The goal is to evaluate if semantic dementia (SD) and Alzheimer's disease (AD) differently affect patients' awareness of their memory abilities.

NCT ID: NCT04597632 Completed - Clinical trials for Neovascular Age-related Macular Degeneration

An Extension Study Assessing the Efficacy and Safety of Brolucizumab in a Treat-to-Control Regimen in Patients With Neovascular Age-related Macular Degeneration Who Have Completed the CRTH258A2303 (TALON) Study

TALON Ext
Start date: December 16, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this extension study was to evaluate the efficacy and safety of brolucizumab used in a Treat-to-Control-regimen for treatment of patients with neovascular age-related macular degeneration who have completed the CRTH258A2303 (TALON) study. The main objective was to assess brolucizumab's potential for long durability up to 20 weeks. All eligible participants were treated with brolucizumab regardless of their treatment in the TALON study. The study period was 56 weeks including post-treatment follow-up.

NCT ID: NCT04595630 Recruiting - Clinical trials for Coronary Bypass Graft Occlusion

Diagnostic and Prognostic Value of Cardiac Biomarkers for Early Coronary Bypass Occlusion in Patients Undergoing Coronary Revascularization

Start date: July 1, 2021
Phase:
Study type: Observational

This study is to evaluate the correlation between hs-cTn level as cardiac biomarker for ischemia and early graft occlusion as assessed by CCT in patients undergoing coronary bypass surgery.

NCT ID: NCT04595565 Active, not recruiting - Clinical trials for Triple Negative Breast Cancer

Sacituzumab Govitecan in Primary HER2-negative Breast Cancer

SASCIA
Start date: October 28, 2020
Phase: Phase 3
Study type: Interventional

Phase III, prospective, multi-center, randomized, open label, parallel group, study in patients with HER2-negative breast cancer with residual disease after neoadjuvant chemotherapy with 1:1 allocation to: - Arm A: Sacituzumab govitecan (days 1, 8 q3w for eight cycles); - Arm B: treatment of physician´s choice (TPC, defined as capecitabine or platinum-based chemotherapy for eight cycles or observation. Treatment in either arm will be given for eight cycles. In patients with HR-positive breast cancer, endocrine-based therapy, which includes the use of CDK4/6 inhibitors, will be administered according to local guidelines. The start of endocrine therapy will be at the discretion of the investigator; however, it will be encouraged to start after surgery/radiotherapy in patients without additional cytotoxic agents. Adjuvant pembrolizumab can be given until the completion of radiotherapy before randomization. Within the study the use of pembrolizumab in patients with TNBC who received pembrolizumab as neoadjuvant therapy is allowed as monotherapy in the TPC arm, according to the approval of pembrolizumab in this setting.

NCT ID: NCT04595487 Recruiting - Clinical trials for Atrioventricular Block

LVSP vs RVP in Patients With AV Conduction Disorders

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

Rationale: Permanent cardiac pacing is the only available therapy in patients with atrioventricular (AV) conduction disorders and can be life-saving. Right ventricular pacing (RVP), the routine clinical practice for decades in these patients, is non-physiologic, leads to dyssynchronous electrical and mechanical activation of the ventricles, and may cause pacing-induced cardiomyopathy and heart failure. Left ventricular septal pacing (LVSP) is an emerging form of physiologic pacing that can possibly overcome the adverse effects of RVP. Study design and hypotheses: The LEAP trial is a multi-center investigator-initiated, prospective, randomized controlled, open label, blinded endpoint evaluation (PROBE) study that compares LVSP with conventional RVP. A total of four hundred seventy patients with a class I or IIa indication for pacemaker implantation due to AV conduction disorders and an expected ventricular pacing percentage >20% will be randomized 1:1 to LVSP or RVP. The primary endpoint is a composite endpoint of all-cause mortality, hospitalization for heart failure and a more than 10% decrease in left ventricular ejection fraction (LVEF) in absolute terms leading to a LVEF below 50% at one year follow-up. LVSP is anticipated to result in improved outcomes. Secondary objectives are to evaluate whether LVSP is cost-effective and associated with an improved quality of life (QOL) as compared to RVP. Quality of life is expected to improve with LVSP and reduced healthcare resource utilizations are expected to ensure lower costs in the LVSP group during follow-up, despite initial higher costs of the implantation. Study design: Multi-center investigator-initiated, prospective, randomized controlled, open label, blinded endpoint evaluation (PROBE) study. Study population: Adult patients with a bradycardia-pacing indication because of AV conduction disorders with an expected ventricular pacing percentage of ≥ 20% and a left ventricular ejection fraction (LVEF) >/= 40%. Four hundred seventy patients will be randomized 1:1 to LVSP or RVP. Intervention: LVSP vs RVP. Main study parameters/endpoints: The primary endpoint is a composite of all-cause mortality, hospitalization for heart failure, and a more than 10% point decrease in left ventricular ejection fraction (LVEF) leading to an LVEF below 50%, which as a binary combined endpoint will be determined at one year follow-up. Secondary endpoints are: - Time to first occurrence of all cause mortality or hospitalization for heart failure. - Time to first occurrence of all cause mortality. - Time to first occurrence of hospitalization for heart failure. - Time to first occurrence of atrial fibrillation (AF) de novo. - The echocardiographic changes in LVEF at one year. - The echocardiographic changes in diastolic (dys-)function at one year. - The occurrence of pacemaker related complications. - Quality of life (QOL), cost-effectiveness analyses (CEA) and budget impact analysis (BIA). The secondary endpoints (other than echocardiographic LVEF change) will be determined at the end of the follow-up period, when the last included patient has reached one year follow-up. The individual follow-up time for patients at this time point will vary with a minimum of one year.

NCT ID: NCT04593004 Completed - Acne Vulgaris Clinical Trials

Teledermatology vs. Face-to-Face Visits in the Follow-Up of Patients With Acne

Start date: October 7, 2020
Phase: N/A
Study type: Interventional

Acne vulgaris is a common cutaneous inflammatory condition of sebaceous follicles that can profoundly affect patients' quality of life, especially at a young age. In this context the use of teledermatology can potentially reduce the healthcare costs associated to traditional consultations as well as the costs related to travel and loss of school/working time for the patient, with a clear benefit for the whole community. Since 2016, the Department of Dermatology at Inselspital Hospital in Bern has a portal and a smartphone app for online advice service. Hereby the investigators propose to explicitly investigate the efficacy of this system in reducing healthcare costs as compared to traditional face-to-face consultations, in a cohort of patients with mild-to-moderate acne vulgaris.

NCT ID: NCT04592965 Recruiting - Clinical trials for Parkinson Disease Psychosis

Hallucinations in Parkinson's Disease

Start date: August 17, 2020
Phase: N/A
Study type: Interventional

Investigation on how robotically mediated sensorimotor stimulation induces and triggers presence hallucinations in different clinical groups of parkinsonian patients, and in aged-matched controls

NCT ID: NCT04590963 Active, not recruiting - Clinical trials for Squamous Cell Carcinoma of the Head and Neck

Assessment of Efficacy and Safety of Monalizumab Plus Cetuximab Compared to Placebo Plus Cetuximab in Recurrent or Metastatic Head and Neck Cancer

INTERLINK-1
Start date: October 2, 2020
Phase: Phase 3
Study type: Interventional

This is a randomized, double-blind, multicenter, global Phase 3 study to assess the efficacy and safety of monalizumab and cetuximab, compared to placebo and cetuximab, in Participants with recurrent or metastatic head and neck cancer.

NCT ID: NCT04590898 Completed - Stroke Clinical Trials

Peri-device Leakage Closure After LAAO

Start date: September 27, 2020
Phase:
Study type: Observational

The investigators thought to evaluate the safety and feasibility of peri-device leakage closure after left atrial appendage occlusion (LAAO, either surgical or interventional) with different devices.

NCT ID: NCT04589962 Completed - Clinical trials for Surgical and the Percutaneous Approach to the Upper Extremity Access

SUrgical Versus PERcutaneous AXillary Artery International Registry

Start date: October 9, 2020
Phase:
Study type: Observational

The purpose of the Study is to compare the outcomes of the surgical and the percutaneous approach to the upper extremity access (axillary or brachial artery) during endovascular procedures on the aortic valve, the aorta, and its side branches.