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NCT ID: NCT05002543 Recruiting - Clinical trials for Cardiac Valve Disease

CORCYM Mitral, Aortic aNd Tricuspid Post-maRket Study in a reAl-world Setting

MANTRA
Start date: June 29, 2021
Phase:
Study type: Observational [Patient Registry]

MANTRA is a prospective, multiple-arm, multi-center, global, post-market clinical follow-up study. The main objective is to monitor ongoing safety and performance of the CORCYM devices and accessories used for aortic, mitral and tricuspid valvular diseases in a real-world setting. Corcym S.r.l., is a medical device manufacturer with a broad product portfolio for cardiac surgeons, offering solutions for the treatment of aortic, mitral and tricuspid valve disease. The MANTRA Master Plan (Master Protocol) is intended as an overarching Umbrella Protocol that allows multiple sub-studies to be added, as needed. The Umbrella Master Protocol concept offers an excellent solution to provide post-marketing clinical follow-up information on the entire cardiac surgery heart valve portfolio of the sponsor in a common database, including corelab assessment of hemodynamic and structural performance, annular motion and Dynamics for one of the products. Currently, three sub-studies are planned: - MANTRA - Aortic Sub-Study - MANTRA - Mitral/Tricuspid Sub-Study (Excluding Memo 4D) - MANTRA - Memo 4D Sub-Study

NCT ID: NCT04998604 Active, not recruiting - Asthma Clinical Trials

EValuating trEatment RESponses of Dupilumab Versus Omalizumab in Type 2 Patients

EVEREST
Start date: September 27, 2021
Phase: Phase 4
Study type: Interventional

Primary Objective -To evaluate the efficacy of dupilumab compared to omalizumab in reducing the polyp size and improving sense of smell Secondary Objectives - To evaluate the efficacy of dupilumab in improving CRSwNP symptoms at Week 24 compared to omalizumab - To evaluate the efficacy of dupilumab in improving lung function at Week 24 compared to omalizumab - To evaluate the efficacy of dupilumab in improving CRSwNP total symptom score (TSS) at Week 24 compared to omalizumab - To evaluate the effect of dupilumab on health related quality of life (HRQoL) at week 24 compared to omalizumab - To evaluate the efficacy of dupilumab in improving nasal peak inspiratory flow at Week 24 compared to omalizumab - To evaluate the effect of dupilumab on CRSwNP overall disease severity at Week 24 compared to omalizumab - To evaluate the effect of dupilumab on asthma control at Week 24 compared to omalizumab - To evaluate the safety of dupilumab and omalizumab

NCT ID: NCT04996147 Terminated - Clinical trials for Head and Neck Neoplasms

Acute and Long-term Impact of Cancer Treatment on Head and Neck Cancer Patients: FIT4TREATMENT

F4T
Start date: June 1, 2019
Phase:
Study type: Observational

Head and Neck Squamous Cell Carcinoma (HNSCC) is the 6th most common cancer. Most cases are diagnosed in locally advanced stages, with treatment involving multimodal approach with combinations of radiotherapy, surgery and chemotherapy. The aggressive nature of HNSCCs and treatment modalities are associated with important acute and late toxicities that often promote temporary or definitive treatment interruption and may compromised the capability to tolerate subsequent treatments. Thus, the aim of this study is to analyze the acute and long-term impact of cancer treatment on quality of life, physical and cognitive function of HNSCC patients diagnosed with a locally advanced disease.

NCT ID: NCT04994756 Recruiting - Stroke Clinical Trials

Stroke Thrombectomy and Aneurysm Registry

STAR
Start date: September 17, 2019
Phase:
Study type: Observational [Patient Registry]

This international multi-center registry is used to collect existing information and outcomes for patients undergoing an operation for treatment of injuries to the brain including the blockage of blood flow to an area of the brain, an abnormal ballooning of an artery, abnormal tangling of blood vessels, abnormal formation of blood vessels, tearing of vein, and bleeding in the brain. This information is used to help predict outcomes that undergo an operation for treatment of the above-listed brain injuries. Additionally, the information is used to compare techniques and devices' effects on technical and clinical outcomes.

NCT ID: NCT04994717 Recruiting - Clinical trials for Newly Diagnosed Philadelphia (Ph)-Negative B-cell Precursor Acute Lymphoblastic Leukemia (ALL)

Study Comparing Blinatumomab Alternating With Low-intensity Chemotherapy Versus Standard of Care Chemotherapy for Older Adults With Newly Diagnosed Philadelphia-negative B-cell Precursor Acute Lymphoblastic Leukemia

Start date: November 2, 2021
Phase: Phase 3
Study type: Interventional

The safety run-in part of the study aims to evaluate the safety and tolerability of blinatumomab alternating with low-intensity chemotherapy. The phase 3 part of the study aims to compare event-free survival (EFS) and overall survival (OS) of participants receiving blinatumomab alternating with low-intensity chemotherapy to EFS and (OS) of participants receiving standard of care (SOC) chemotherapy.

NCT ID: NCT04991935 Recruiting - Clinical trials for Eosinophilic Esophagitis

Safety Study of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis

Start date: September 14, 2021
Phase: Phase 3
Study type: Interventional

This study is an open-label, uncontrolled study design to evaluate the long-term safety and tolerability of treatment with CC-93538. The study will enroll participants who participated in the CC-93538-EE-001 or CC-93538-DDI-001 studies.

NCT ID: NCT04990284 Active, not recruiting - Parkinson Disease Clinical Trials

eArly levoDopa With Opicapone in Parkinson's paTients wIth motOr fluctuatioNs.

ADOPTION
Start date: November 29, 2021
Phase: Phase 4
Study type: Interventional

This is a randomized, parallel group, multicentre, multinational, prospective, open-label exploratory study in Parkinson's disease (PD) patients to evaluate the add-on efficacy of opicapone 50 mg or an extra dose of levodopa (L-DOPA) 100 mg as first strategy for the treatment of wearing-off.

NCT ID: NCT04988386 Active, not recruiting - Clinical trials for Amyloid Cardiomyopathy, Transthyretin-Related

Open-Label Safety Study of Acoramidis (AG10) in Symptomatic ATTR Participants

Start date: October 27, 2021
Phase: Phase 3
Study type: Interventional

Open-Label Extension and Safety Monitoring Study of Acoramidis (AG10) in Participants with Symptomatic Transthyretin Amyloid Cardiomyopathy Who Completed the Phase 3 ATTRibute-CM Trial (AG10-301)

NCT ID: NCT04988295 Active, not recruiting - Clinical trials for Carcinoma, Non-Small-Cell Lung

A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non- Small Cell Lung Cancer After Osimertinib Failure

MARIPOSA-2
Start date: November 17, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy of adding lazertinib to amivantamab, carboplatin, and pemetrexed (LACP/ACP-L dosing strategies) and amivantamab, carboplatin and pemetrexed (ACP) compared with carboplatin and pemetrexed (CP) in participants with locally advanced or metastatic epidermal growth factor receptor (EGFR) Exon 19del or Exon 21 L858R substitution non-small cell lung cancer (NSCLC) after osimertinib failure. The purpose of the extension cohort is to further describe the safety and efficacy for the ACP-L dosing schedule versus ACP with additional data. After completion of the primary analysis, the study may eventually transition to an open-label extension (OLE) or long-term extension (LTE) phase during which participants will have the option to continue their assigned treatment.

NCT ID: NCT04987203 Active, not recruiting - Clinical trials for Renal Cell Carcinoma

Study to Compare Tivozanib in Combination With Nivolumab to Tivozanib Monotherapy in Subjects With Renal Cell Carcinoma

Start date: September 9, 2021
Phase: Phase 3
Study type: Interventional

This study will be comparing tivozanib in combination with nivolumab to tivozanib alone in subjects with advanced Renal Cell Carcinoma (RCC) who have had 1 or 2 prior lines of therapy, one of which was an Immune Checkpoint Inhibitor (ICI).