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NCT ID: NCT04532398 Completed - Dysphagia Clinical Trials

Validation of the Gugging Swallowing Screen for the Intensive Care Unit

GUSS-ICU
Start date: August 27, 2020
Phase: N/A
Study type: Interventional

Aetiology of dysphagia after extubation is unknown and considered to be multifactorial. Use of a standardized dysphagia- screening permits an early diagnosis. This study is to evaluate a new GUSS (gugging swallowing Screen) tool with multi-consistency check for intensive care patients (GUSS-ICU) with dysphagia. The concurrent validity (in terms of sensitivity and specificity) of the GUSS-ICU is analyzed in comparison to the flexible endoscopic evaluation of swallowing (FEES).

NCT ID: NCT04531774 Recruiting - Depression Clinical Trials

RECHARGE: A Brief Psychological Intervention to Build Resilience in Healthcare Workers During COVID-19

Start date: August 28, 2020
Phase: N/A
Study type: Interventional

The healthcare industry is inherently demanding, stressful, and, at times, emotionally draining. On a typical day, many workers must make rapid and critical decisions, manage numerous demands, team conflicts, and challenging situations with patients and their families. For some health care workers (HCW), the current pandemic - COVID-19 - has also exacerbated these challenges. Providing psychological support is key in alleviating stress among HCWs, yet the situation does not require therapy because HCWs do not principally suffer from a mental disorder. RECHARGE was specifically developed for HCWs and is an abbreviated online version of Problem Management Plus, an evidence-based intervention that helps to cope with stress in times of crisis. As a brief psychological intervention for adults affected by adversity emerging from stress exposure, RECHARGE teaches people three well-documented strategies to manage acute stress (a: managing stress, b: managing worry, c: meaningful activity). It includes psychoeducation, arousal reduction techniques, managing worries and problem-solving skills, behavioral activation, and enhancement of meaningful activities, which are all based on the principles of cognitive-behavioral therapy. The aim of this study is to evaluate the efficacy of RECHARGE to reduce stress in HCWs and enhance their work performance. Participants in this randomized controlled trial (RCT) study are randomly assigned to either RECHARGE or the active control group. To this end, stress including symptoms of burnout, worries, anxiety, depression, PTSD, and work performance will be measured at baseline, post-intervention, and at a 2 and 6 month follow up.

NCT ID: NCT04531293 Completed - COPD Clinical Trials

Comparing Pressure Based and Dilution Based Total Lung Capacity Measurements in COPD Patients for Lung Function Diagnostics

Start date: December 31, 2020
Phase: N/A
Study type: Interventional

Total Lung Capacity (TLC) of the lungs can be determined using a pressure based method (i.e. by body plethysmography) or it can be determined using a dilution based method (i.e. by single breath dilution during a CO diffusing capacity test). The results of the two methods differ, especially in patients with higher grades of COPD. The study investigates an improved analysis for the determination of TLC using the dilution method; this method has been suggested in the new ATS/ERS DLCO (diffusion capacity of lung for carbon monoxide) standard published in 2017. This study is based on approx. 120 participants. So far, there has not been a study using commercially available equipment. Spirometry, lung volume measurement by body plethysmography and DLCO measurements will be performed on reference device (Masterscreen Body/Diff, Vyaire, USA), Spirometry and DLCO will also be performed on the device under test (EasyOne Pro LAB, ndd Medizintechnik AG, Switzerland) in a crossover design. Both devices are CE marked and FDA approved. The tests performed on both devices are standardized tests performed routinely with patients.

NCT ID: NCT04529850 Completed - Clinical trials for Head and Neck Cancer

Ph 2 Open Label Study of GC4419 to Reduce SOM Associated With Chemoradiotherapy for Head and Neck Cancer

Start date: June 30, 2020
Phase: Phase 2
Study type: Interventional

GTI-4419-202 is a Phase 2 open-label study of the effects of GC4419 (IV) when administered in combination with IMRT and cisplatin to up to subjects with head and neck cancer, who are at high risk for Severe Oral Mucositis (SOM)

NCT ID: NCT04529798 Recruiting - Clinical trials for Rotator Cuff Tear Arthropathy

Clinical Study Evaluating Outcomes of Reverse Shoulder Arthroplasty With SMR Stemless

SSPR
Start date: November 22, 2016
Phase:
Study type: Observational

The objectives of this study are the assessment of the clinical, radiographical and patient-reported outcomes of SMR Stemless Reverse Shoulder Arthroplasty (LimaCorporate S.p.A.) used as standard of care over a period of at least 2 years of follow-up and the evaluation of the incidence of any complication.

NCT ID: NCT04528342 Recruiting - Asthma in Children Clinical Trials

Personalized Digital Health and Artificial Intelligence in Childhood Asthma

Asthmoscope
Start date: March 1, 2020
Phase:
Study type: Observational

Asthma is a chronic inflammatory disease of the airways that causes recurrent episodes of wheezing, breathing difficulties and coughing. The prevalence of asthma is 8% in school-aged children and 30% in preschoolers, making asthma the first chronic disease in children. Symptoms are due to diffuse but variable airway obstruction, reversible spontaneously or after inhalation of beta2 agonists (β-2a) such as salbutamol. Exacerbations of asthma are frequent and difficult to assess by parents and the patient himself. It is estimated that approximately 2.5% of children with asthma are hospitalized annually. The global burden caused by asthma can thus be reduced by improving early detection of bronchial obstruction, prescribing immediate treatment with the appropriate background therapy, and reliably and objectively assess response to treatment. The natural history of asthma symptoms in children shows a great intra and inter-individual variability. The difficulty of assessing the severity of an attack by the parents or the child himself, when he is old enough to control his chronic disease, is a key element in the management of asthma and allows the treatment to be adapted quickly, sometimes avoiding hospitalization. Healthcare professionals can assess the severity of the episode using the Pediatric Respiratory Assesment Measure (PRAM) score, which has the advantage of being adaptable at any age. The Global Alliance against Chronic Respiratory Diseases (GARD) integrates in its diagnostic strategy for chronic respiratory diseases, the lung function test, which allows the quantification of respiratory function in the context of diagnosis and long-term follow-up. Although spirometry are non-invasive tests, they still require a high level of patient cooperation, which remains problematic before the age of 7 years. The digital stethsocope integrates a capacity for recording auscultations and data transmission to high-performance software. This has made it possible to extend auscultation beyond what was audible to the human ear alone (over 20-20,000 Hertz).Auscultatory sounds analysis, particularly those most often associated with obstructive syndrome could be simple, reproducible and a reliable method of assessing the severity and response to treatment in children's asthma. Major advances in signal processing and unsupervised learning in artificial intelligence research provide the potential for high-performance analysis of physiological measures.

NCT ID: NCT04528082 Recruiting - Behçet Disease Clinical Trials

Apremilast Pediatric Study in Children With Active Oral Ulcers Associated With Behçet's Disease

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

The aim of this study is to estimate the efficacy of apremilast compared to placebo in the treatment of oral ulcers in pediatric participants from 2 to < 18 years of age with oral ulcers associated with Behçet's disease (BD) through week 12.

NCT ID: NCT04527991 Active, not recruiting - Clinical trials for Locally Advanced or Metastatic Unresectable Urothelial Cancer

Study of Sacituzumab Govitecan-hziy (IMMU-132) Versus Treatment of Physician's Choice in Participants With Metastatic or Locally Advanced Unresectable Urothelial Cancer

TROPiCS-04
Start date: January 13, 2021
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to assess overall survival (OS) with sacituzumab govitecan-hziy in comparison with treatment of physician's choice (TPC) in participants with metastatic or locally advanced unresectable urothelial cancer (UC).

NCT ID: NCT04527380 Active, not recruiting - Clinical trials for Juvenile Psoriatic Arthritis

A Study of Ixekizumab (LY2439821) in Children With Juvenile Idiopathic Arthritis Categories of Enthesitis-related Arthritis (Including Juvenile Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis

Start date: April 13, 2021
Phase: Phase 3
Study type: Interventional

The reason for this study is to see if the study drug ixekizumab is safe and effective in children with juvenile idiopathic arthritis (JIA) categories of enthesitis-related arthritis (ERA) (including juvenile onset ankylosing spondylitis [JoAS]) and juvenile psoriatic arthritis (JPsA).

NCT ID: NCT04526665 Active, not recruiting - Clinical trials for Primary Biliary Cirrhosis

Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC)

ELATIVE
Start date: September 24, 2020
Phase: Phase 3
Study type: Interventional

The participants of this study will have confirmed Primary Biliary Cholangitis (PBC) with inadequate response or intolerance to ursodeoxycholic acid (which is a medication used in the management and treatment of cholestatic liver disease). PBC is a slowly progressive disease characterized by damage of the bile ducts in the liver, leading to a buildup of bile acids which causes further damage. The liver damage in PBC may lead to scarring (cirrhosis). PBC may also be associated with multiple symptoms. Many patients with PBC may require liver transplant or may die if the disease progresses and a liver transplant is not done. This study has two main parts; the first part will compare a daily dose of elafibranor (the study drug) to a daily dose of placebo (a dummy treatment), and will last between a minimum of one year and a maximum of two years. In the second part, all participants will receive elafibranor, for a period between 4-5 years. The main aim of this study is to determine if elafibranor is better than placebo at decreasing the levels of a specific blood test (alkaline phosphatase) that provides information about participant's disease. This study will also study the safety of long-term treatment with elafibranor, as well as the impact on symptoms such as pruritus and fatigue.