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NCT ID: NCT04468412 Active, not recruiting - COVID Clinical Trials

Influence of COVID-19 on Vascular Endothelial Function

COVAS
Start date: July 14, 2020
Phase:
Study type: Observational

Rationale: Infection with severe acute respiratory syndrome coronavirus (SARS-CoV) 2 could result in endothelial dysfunction with increased risk of arterial thrombotic events by downregulating the expression of angiotensin converting enzyme 2 (ACE2). Endothelial function can be easily and non-invasively determined by carotid artery reactivity (CAR) testing. Objective: To investigate the predictive value of endothelial dysfunction, measured by carotid artery reactivity testing, for 1-year cardiovascular events in patients with past COVID-19 infection. Study design: A prospective observational longitudinal cohort study. Study population: Patients recovered from confirmed infection with SARS-CoV2. Main study parameters/endpoints: macrovascular endothelial function measured by carotid artery reactivity testing.

NCT ID: NCT04463641 Active, not recruiting - Heart Failure Clinical Trials

Assessment of the Axone Micro Quadripolar Lead for Enhanced Cardiac Resynchronization Therapy

ASTRAL-4LV
Start date: December 3, 2020
Phase: N/A
Study type: Interventional

The primary objective of this study is to assess the chronic safety and performance of the Axone left ventricular (LV) micro-lead.

NCT ID: NCT04456673 Active, not recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

Pivotal Study to Assess the Efficacy, Safety and Tolerability of Dupilumab in Patients With Moderate to Severe COPD With Type 2 Inflammation

NOTUS
Start date: July 6, 2020
Phase: Phase 3
Study type: Interventional

Primary Objective: To evaluate the efficacy of dupilumab administered every 2 weeks in patients with moderate or severe Chronic Obstructive Pulmonary Disease (COPD) as measured by - Annualized rate of acute moderate or severe COPD exacerbation (AECOPD) Secondary Objectives: To evaluate the effect of dupilumab administered every 2 weeks on - Pre-bronchodilator forced expiratory volume in 1 second (FEV1) over 12 weeks compared to placebo - Health related quality of life, assessed by the change from baseline to Week 52 in the St. George's Respiratory Questionnaire (SGRQ) - Pre-bronchodilator FEV1 over 52 weeks compared to placebo - Lung function assessments - Moderate and severe COPD exacerbations - To evaluate safety and tolerability - To evaluate dupilumab systemic exposure and incidence of antidrug antibodies (ADA)

NCT ID: NCT04448366 Active, not recruiting - Pain Clinical Trials

Cognitive Behavioral Therapy in Endometriosis

Start date: November 24, 2020
Phase: N/A
Study type: Interventional

Endometriosis affects 10% of reproductive aged women and causes severe pain and impaired quality of life (QoL). Surgery for endometriosis results in long term symptom relief in only 40% of women. QoL in endometriosis improves after surgery, but not to the level of healthy women. Mediators in QoL include pain intensity, pain cognitions, and stress. In a preliminary study, patients with negative pain cognitions reported higher pain intensities compared to patients with positive pain cognitions. This indicates that psychological factors explain considerable variance in pain, suggesting that changing these factors by psychological interventions may contribute to improving QoL. Cognitive behavioral therapy (CBT) is proven effective as a psychological treatment for pain-related symptoms. The primary objective of this study is to investigate whether usual care combined with CBT improves QoL in patients undergoing surgery for endometriosis compared to usual care only. Secondary objectives are to investigate whether pain intensity, pain cognitions, perceived stress, fatigue and objectively measured cortisol levels mediate the effects of CBT on QoL in both groups. In a randomized controlled trial, 100 endometriosis patients undergoing surgery will be randomized between usual care with CBT (CBT group) and usual care only (control group). Women in the CBT group will receive, in addition to usual care, one pre-surgery and six post-surgery sessions of CBT, aimed at positively influencing mediators of QoL. Women in the control group will receive only usual care. Follow-up will be 7,5 months. In both groups QoL, pain intensity, pain cognitions, fatigue, perceived stress (using questionnaires) and objective stress (assessing cortisol in a hair sample) will be assessed at baseline assessment, T1 (two weeks after completion of all CBT sessions) and T2 (follow-up). Recruitment and treatment of patients will take place in Rijnstate hospital and Radboud University Medical Center (UMC).

NCT ID: NCT04441749 Active, not recruiting - Clinical trials for Diagnosis of Peripheral Lung Nodules

nCLE For Diagnosis Of Peripheral Lung Nodules By Robotic Navigational Bronchoscopy

Start date: June 29, 2020
Phase:
Study type: Observational

Needle based confocal laser endomicroscopy (nCLE) employs a small fiber which can be passed through a biopsy needle to enable real time microscopic imaging of cells. With resolution of 3.5 microns it is possible to identify key features consistent with malignancy and pulmonary fibrosis. (Wijmans, et al., 2019). The effectiveness of nCLE with intravenous fluorescein has been demonstrated in central lung cancers using esophageal ultrasound guided needle placement (Wijmans, et al., 2019). In this study, the proposed nCLE lung cancer criteria had high accuracy for lung cancer detection and were consistently recognized by multiple raters. Probe based confocal microscopy (pCLE) has also been used in conjunction with a radial probe EBUS in evaluating solitary pulmonary nodules with a diagnostic accuracy of 79.2%. (Hassan, et al., 2017) Needle based confocal laser endomicroscopy (nCLE) has not previously been used in conjunction with robotic navigational bronchoscopy.

NCT ID: NCT04438083 Active, not recruiting - Clinical trials for Renal Cell Carcinoma

A Safety and Efficacy Study Evaluating CTX130 in Subjects With Relapsed or Refractory Renal Cell Carcinoma (COBALT-RCC)

Start date: June 16, 2020
Phase: Phase 1
Study type: Interventional

This is a single-arm, open-label, multicenter, Phase 1 study evaluating the safety and efficacy of CTX130 in subjects with relapsed or refractory renal cell carcinoma.

NCT ID: NCT04437511 Active, not recruiting - Alzheimer Disease Clinical Trials

A Study of Donanemab (LY3002813) in Participants With Early Alzheimer's Disease (TRAILBLAZER-ALZ 2)

Start date: June 19, 2020
Phase: Phase 3
Study type: Interventional

The reason for this study is to see how safe and effective the study drug donanemab is in participants with early Alzheimer's disease. Additional participants will be enrolled to an addendum safety cohort. The participants will be administered open-label donanemab.

NCT ID: NCT04437368 Active, not recruiting - Clinical trials for Dry Age-related Macular Degeneration

EXPLORE: A Phase II Study to Evaluate the Safety and Efficacy of Two Doses of GT005

EXPLORE
Start date: July 14, 2020
Phase: Phase 2
Study type: Interventional

The purpose of this clinical study is to evaluate the safety and efficacy of two doses of GT005 administered as a single subretinal injection in subjects with geographic atrophy secondary to age-related macular degeneration (AMD).

NCT ID: NCT04436640 Active, not recruiting - Clinical trials for Ankylosing Spondylitis

A Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Subjects With Active Axial Spondyloarthritis Including Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis

BE MOVING
Start date: June 16, 2020
Phase: Phase 3
Study type: Interventional

The purpose of the study is to demonstrate the long-term safety, tolerability and efficacy of bimekizumab in patients with active axial spondyloarthritis (axSpA, also known as radiographic axSpa (r-axSpA)) including ankylosing spondylitis (AS) and nonradiographic axial spondyloarthritis (nr-axSpa).

NCT ID: NCT04435626 Active, not recruiting - Heart Failure Clinical Trials

Study to Evaluate the Efficacy (Effect on Disease) and Safety of Finerenone on Morbidity (Events Indicating Disease Worsening) & Mortality (Death Rate) in Participants With Heart Failure and Left Ventricular Ejection Fraction (Proportion of Blood Expelled Per Heart Stroke) Greater or Equal to 40%

FINEARTS-HF
Start date: September 14, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effect of finerenone compared to placebo (a tablet without active substance) in the reduction of cardiovascular death (generally meaning death due to disease of the heart or blood vessels) and total Heart Failure (HF) events, including HF hospitalization and urgent visits for HF(generally meaning a hospital stay or urgent presentation to a healthcare unit due to worsening symptoms of heart failure) in patients suffering from HF with an ejection fraction greater than or equal to 40%. Researchers will also collect information on how much the heart disease has impact on patient's lives, change of kidney function, and how well finerenone treatment is tolerated. The study plans to enroll 6000 male and female patients of the age of 40 years and above suffering from heart failure with ejection fraction greater than or equal to 40%. Participants will take the study product as oral tablet with a dose between 0 (Placebo) 40 mg once daily. Study duration will be up to 43 months.