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NCT ID: NCT04461041 Completed - Clinical trials for Cardiovascular Diseases

Empagliflozin and Cardiac Remodelling in People Without Diabetes

EMPA-HEART 2
Start date: April 1, 2021
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the effects of empagliflozin on cardiac structure, function and circulating biomarkers in patients with cardiovascular risk factors, but without diabetes. Empagliflozin is an antihyperglycemic agent approved by Health Canada and the FDA for the treatment of type 2 diabetes. Previous post-marketing clinical trials demonstrated a reduction in cardiovascular deaths and heart failure in patients with type 2 diabetes treated with empagliflozin. In the first EMPA-HEART trial, we demonstrated that empagliflozin reduces cardiac mass in patients with type 2 diabetes, as seen through cardiac magnetic resonance imaging (cMRI). Therefore, the aim of this study, EMPA-HEART 2, is to determine whether empagliflozin can similarly impact cardiac structure in patients without diabetes, but with various cardiovascular risk factors.

NCT ID: NCT04460859 Recruiting - Clinical trials for Acute Respiratory Distress Syndrome (ARDS)

RecruitmEnt Assessed by eleCtRical Impedance Tomography

RECRUIT
Start date: June 9, 2020
Phase:
Study type: Observational

The RECRUIT study is a multinational, multicenter physiological observational study conducted by the PLUG working group. It is a single-day study (1.5-2 hours) associated with specific lung (de)recruitment maneuvers to verify the feasibility of measuring the potential for lung recruitment in mechanically ventilated patients with ARDS by electrical impedance tomography (EIT).

NCT ID: NCT04460521 Recruiting - Clinical trials for Carpal Tunnel Syndrome

The ACTS Trial: N-acetylcysteine (NAC) and Night-splinting as a Non-operative Treatment for Carpal Tunnel Syndrome

ACTS
Start date: August 1, 2021
Phase: Phase 4
Study type: Interventional

Carpal tunnel syndrome (CTS) is the most common nerve compression syndrome worldwide, causing significant chronic pain, functional impairment, and lowered quality of life for individuals of various backgrounds. CTS is caused by chronic compression of the median nerve in the carpal tunnel of the wrist, causing numbness and pain in the palm, thumb, index, and middle fingers and eventual weakness of the hand. Many different treatments for CTS have been proposed and studied, including but not limited to non-operative treatments such as wrist splinting, steroid injections, and lifestyle modifications as well as operative treatments, such as surgical carpal tunnel release (CTR). To date, very few oral medications have been shown to be effective as conservative treatments for CTS. In this study the investigators will examine whether there is any benefit to using oral N-acetylcysteine (NAC) as an adjunctive treatment for mild to moderate CTS in addition to a standard 8-week trial of night splinting. NAC has been used in humans for various purposes, is extremely safe and has very few side effects, and has been shown to have anti-inflammation properties which may help treat CTS. The investigators will study this by performing a randomized controlled trial, comparing patients receiving oral NAC and standard night splinting to patients receiving an identical placebo and standard night splinting. Both patient groups will be assessed using a questionnaire to assess for severity of their CTS symptoms both before and after the 8-week treatment. The primary objective will be to determine whether supplementation with oral NAC in addition to night splinting has any significant impact on patient-reported symptoms and functional impairment when compared to night splinting alone. The investigators will also measure secondary outcomes including whether patients decide to have surgery for their CTS after treatment and/or continued use of other treatments. This study has the potential to have a significant positive impact on patients by identifying a safe, inexpensive, accessible, and well tolerated conservative treatment for mild to moderate carpal tunnel syndrome, and potentially preventing the need for additional, more invasive treatments such as surgery.

NCT ID: NCT04460352 Recruiting - Clinical trials for Esophageal Squamous Cell Carcinoma

Chemoradiotherapy Followed by Planned Surgery or by Surveillance and Surgery Only When Needed for Oesophageal Cancer

NEEDS
Start date: November 27, 2020
Phase: Phase 3
Study type: Interventional

NEEDS is a pragmatic open-label, randomised, controlled, phase III, multicenter trial with non-inferiority design with regard to the first co-primary endpoint overall survival and superiority for the experimental intervention definitive chemoradiotherapy. A second co-primary endpoint is global health related quality of life (HRQOL) one year after randomisation. A third co-primary endpoint is eating restictions one year after randomisation. The aim is to compare outcomes after neoadjuvant chemoradiotherapy with subsequent esophagectomy to definitive chemoradiotherapy with surveillance and salvage esophagectomy as needed in patients with resectable locally advanced squamous cell carcinoma (SCC) of the esophagus, with the aim to provide generalisable guidance for future clinical practice.

NCT ID: NCT04459715 Active, not recruiting - Clinical trials for Squamous Cell Carcinoma of the Head and Neck

A Study of Xevinapant (Debio 1143) in Combination With Platinum-Based Chemotherapy and Standard Fractionation Intensity-Modulated Radiotherapy in Participants With Locally Advanced Squamous Cell Carcinoma of the Head and Neck, Suitable for Definitive Chemoradiotherapy (TrilynX)

Start date: August 7, 2020
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to demonstrate superior efficacy of Xevinapant (Debio 1143) vs placebo when added to chemoradiotherapy (CRT) in locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN).

NCT ID: NCT04459065 Recruiting - Lung Cancer Clinical Trials

Evaluation of IRDye800CW-nimotuzumab in Lung Cancer Surgery

Start date: September 1, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine the safety, optimal dose and imaging time of the investigational product, IRDye800CW-nimotuzumab for use as a near infrared imaging probe for image-guided surgery during lung cancer resection. IRDye800CW-nimotuzumab targets cancer cells over-expressing EGFR, allowing tumors to be visualized and may help surgeons better identify cancer during surgery.

NCT ID: NCT04458922 Active, not recruiting - Clinical trials for Dedifferentiated Chondrosarcoma

Testing Atezolizumab in People 2-17 Years Old With Clear Cell Sarcoma or Advanced Chondrosarcoma

Start date: October 5, 2020
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well atezolizumab works in treating patients with chondrosarcoma or clear cell sarcoma that is newly diagnosed, cannot be removed by surgery (unresectable), or has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

NCT ID: NCT04458909 Terminated - Clinical trials for Recurrent Nasopharyngeal Carcinoma

Testing the Addition of an Anti-cancer Immune Therapy Drug (Nivolumab) to the Usual Chemotherapy Treatment (Cisplatin or Carboplatin With Gemcitabine) for Recurrent or Metastatic Nasopharyngeal Cancer

Start date: December 9, 2020
Phase: Phase 3
Study type: Interventional

This phase III trial compares the effect of adding nivolumab to the usual chemotherapy (cisplatin or carboplatin with gemcitabine) versus standard chemotherapy alone in treating patients with nasopharyngeal cancer that has come back (recurrent) or spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as cisplatin, carboplatin, and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nivolumab with the usual chemotherapy may work better than the standard chemotherapy alone in treating patients with nasopharyngeal cancer.

NCT ID: NCT04458896 Completed - Aging Clinical Trials

Stand When You Can: 6-week Pilot Study to Reduce Sedentary Time in Assisted Living

Start date: January 28, 2019
Phase: N/A
Study type: Interventional

Prolonged daily sedentary time is associated with increased risk of cardiometabolic diseases, impaired physical function, and mortality. Older adults are more sedentary than any other age group and those in assisted living residences accumulate even more sedentary time as they often have little need to engage in light-intensity or standing activities such as cleaning or meal preparation. This "low movement" environment can hasten functional decline. Thus, the purpose of this study was to develop a multi-level intervention to reduce and interrupt sedentary time within assisted living residences and conduct a pilot study to determine if the intervention is feasible and if further testing is warranted.

NCT ID: NCT04458857 Completed - Migraine Clinical Trials

A Study to Test if Fremanezumab is Effective in Preventing Episodic Migraine in Patients 6 to 17 Years of Age

Start date: July 15, 2020
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to evaluate the efficacy of fremanezumab as compared to placebo for the preventive treatment of episodic migraine (EM). Secondary objectives are to further demonstrate the efficacy of Fremanezumab as compared to placebo for the preventive treatment of EM, to evaluate the safety and tolerability of Fremanezumab in the preventive treatment of EM and to evaluate the immunogenicity of Fremanezumab and the impact of antidrug antibodies (ADAs) on clinical outcomes in participants exposed to Fremanezumab. The total duration of the study is planned to be up to 51 months.