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NCT ID: NCT04882124 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Study of Effect of CSJ117 on Symptoms, Pharmacodynamics and Safety in Patients With COPD

Start date: September 24, 2021
Phase: Phase 2
Study type: Interventional

This is a Phase 2 study in patients with chronic obstructive pulmonary disease (COPD) to assess the efficacy, pharmacodynamics (PD), pharmacokinetics (PK), and safety of two dose levels of CSJ117 in comparison to placebo. For this, the impact of CSJ117 on disease symptom burden and lung function will be explored.

NCT ID: NCT04882098 Recruiting - Clinical trials for Arthritis, Psoriatic

A Study of Guselkumab in Participants With Active Psoriatic Arthritis

APEX
Start date: June 17, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.

NCT ID: NCT04881565 Active, not recruiting - Clinical trials for Spinal Cord Injuries

Losing Balance to Prevent Falls After Spinal Cord Injury (RBT+FES)

Start date: September 27, 2021
Phase: N/A
Study type: Interventional

Falls are a health crisis that cost health care systems billions of dollars/year. This crisis is especially relevant for individuals living with incomplete spinal cord injury (iSCI); 78% fall at least once annually. In able-bodied individuals, falls are prevented by taking reactive steps; however, these reactions are impaired after iSCI. Research in stroke and geriatric rehabilitation showed that reactive balance training (RBT), which targets reactive stepping, prevents falls. We developed a modified version of RBT for the iSCI population. RBT resulted in fewer falls post-training compared to dose-matched, conventional balance training. However, only those who were able to take a step independently and without upper limb support were able to participate in RBT, limiting the applicability of this promising fall prevention method. To address this limitation, we will integrate functional electrical stimulation into RBT (RBT+FES). Our study aims to provide a preliminary evaluation of the efficacy of RBT+FES in participants with chronic, motor iSCI. We will complete a pilot randomized clinical trial (RCT) with 22 participants with iSCI. Participants will be randomly allocated to RBT+FES or to RBT alone (i.e. without FES). They will complete 18 training sessions over 6 weeks (3 sessions/week). Clinical and biomechanical assessments of balance, strength and proprioception will be completed before training, immediately after training, and six months post-training. Falls will be monitored for six months after training through an online survey and regular phone calls. Performance on clinical and biomechanical measures and fall data will be compared between groups. This research will inform the need for, and design of, a larger RCT, and has the potential to transform fall prevention after iSCI.

NCT ID: NCT04881526 Completed - Ketosis Clinical Trials

Ketone Ester Supplementation on Neuro-cardiovascular Responses to Stress in Humans

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

Ketone ester supplementation has become increasingly popular as an athletic supplement. However, the metabolic effects of these supplements on exercise performance are controversial. One potential reason for lack of an ergogenic benefit could be the effects of ketone bodies on other bodily systems, such as the sympathetic nervous system. During exercise and stress the body increases the activity of the sympathetic nervous system. This causes blood vessels to constrict (get smaller) and can increase blood pressure. Studies have shown that ketone bodies can suppress the sympathetic nervous system in mice. Additionally, ketone ester supplementation can reduce blood pressure in healthy adults. In humans, direct measures of sympathetic activity are usually made from sympathetic outflow to muscle, also called muscle sympathetic nerve activity (MSNA). Using a ketone ester supplement, the investigators plan to measure blood pressure and sympathetic outflow to muscle at rest and during handgrip exercise and a mathematical task stress test to investigate the effect of ketones on neuro-cardiovascular stress responses.

NCT ID: NCT04881318 Recruiting - Clinical trials for Postural Orthostatic Tachycardia Syndrome

Compression Garments in the Community With POTS

COM-COM-POTS
Start date: May 17, 2021
Phase: N/A
Study type: Interventional

Compression Garments are a commonly prescribed treatment in Postural Orthostatic Tachycardia Syndrome (POTS). The effectiveness of a proof-of-concept compression garment has been demonstrated in an acute laboratory setting. It is not known if commercially available compression garments that participants wear in their every day lives are effective at improving heart rate and reducing symptoms in POTS. This trial will evaluate the use of commercially available waist-high and abdominal compression garments in adults diagnosed with POTS in a community setting.

NCT ID: NCT04881084 Active, not recruiting - Mental Illness Clinical Trials

Exploring Empathy and Compassion Using Digital Narratives

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

Stories of suffering and struggle are shared continuously through digital formats such as internet videos, news stories, social marketing, and fundraising campaigns. Digital stories are often created and shared to generate awareness about a problem, impart knowledge on contemporary issues, or promote compassion. The practice of sharing critical life events and insights provided by these experiences are valuable for tellers and the listeners alike for catharsis, healing, reconciliation, and connectiveness. Portrayals of mental suffering are a matter of cultural and social interest as new media products become available to the public. Studies published since the 1990s overwhelmingly conclude that formal media depictions are biased, promoting the stereotype that people who suffer emotionally are mentally ill, dangerous, violent, or insane. Various agencies, organizations, and corporations are actively working to provide alternative stories/narratives to mainstream media by means of video testimonials in social marketing and fundraising campaigns and, ultimately, by taking advantage of the Internet. The impact of this work is under-researched. However, preliminary evaluations of social marketing campaigns report mixed results and raise questions about their effectiveness. As well, the first-person narrative prepared digitally and shared online is also providing alternative narratives to mainstream media stories. People are increasingly using digital videos to share their stories, viewing this as an opportunity to understand their emotions and thoughts, come to terms with disgrace around sensitive, personal issues and marginalization while providing hope and encouragement to others. This proposed study focuses on the process of creating digital narratives/stories, especially stories of mental and emotional suffering, and their impact in terms of inciting empathy, compassion, and good citizenship among viewers.

NCT ID: NCT04881006 Completed - Healthy Subjects Clinical Trials

Bioequivalence of Dapagliflozin 10 mg Tablets Under Fed Conditions

Start date: December 10, 2020
Phase: Phase 1
Study type: Interventional

The primary objective of this study is to evaluate the bioequivalence between: - Dapagliflozin 10 mg tablets from Jiangsu Hansoh Pharmaceutical Group Co., Ltd.,China; and - Farxiga® 10 mg tablets from AstraZeneca Pharmaceuticals LP, USA; after a single-dose in healthy subjects under fed conditions. The secondary objective of this study is to evaluate the safety and tolerability of the study treatments.

NCT ID: NCT04880993 Completed - Healthy Subjects Clinical Trials

Bioequivalence of Dapagliflozin 10 mg Tablets Under Fasting Conditions

Start date: December 14, 2020
Phase: Phase 1
Study type: Interventional

The primary objective of this study is to evaluate the bioequivalence between: - Dapagliflozin 10 mg tablets from Jiangsu Hansoh Pharmaceutical Group Co., Ltd.,China; and - Farxiga® 10 mg tablets from AstraZeneca Pharmaceuticals LP, USA; after a single-dose in healthy subjects under fasting conditions. The secondary objective of this study is to evaluate the safety and tolerability of the study treatments.

NCT ID: NCT04880668 Completed - Covid19 Clinical Trials

Impact of Aerosol Box Use on Healthcare Provider Contamination

Start date: June 11, 2021
Phase: N/A
Study type: Interventional

Aerosol Generating Medical Procedures (AGMP) are procedures that have the potential to create tiny particles suspended in the air. These particles can contain germs such as viruses. The current Coronavirus Disease 2019 (COVID-19) pandemic is caused by the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Patients infected with SARS-CoV-2 experience unusually high rates of critical illness that needs advanced airway management and intensive care unit admission. Bag-valve-mask (BVM) ventilation, laryngeal mask airway insertion (LMA), and endotracheal Intubation (ETI) are common AGMP for critically ill COVID-19 patients, and may contribute to a high risk of infection amongst Health Care Workers (HCW). To lessen HCW risk during high-risk AGMPs, a device called an aerosol box has been developed to place over the head of the patient, shielding the provider's face from virus droplets suspended in the air. The purpose of this research study is to better understand how particles disperse during AGMPs. The project team hopes what is learned from the project can help inform infection control measures. This could help make changes to the clinical environment and make it safer for HCW's. The investigators intend to investigate how an aerosol box performs in reducing contamination of HCW's who perform critical airway interventions.

NCT ID: NCT04880187 Recruiting - Clinical trials for Non Alcoholic Steatohepatitis (NASH)

Safety, Tolerability, and Efficacy of AXA1125 in NASH With Fibrosis

Start date: May 7, 2021
Phase: Phase 2
Study type: Interventional

This study will compare the effects of AXA1125, an orally active mixture of amino acids, compared to placebo, on improving fat and inflammation (steatohepatitis) as well as fibrosis in subjects with non alcoholic steatohepatitis (NASH). as well as the safety and tolerability of AXA1125. Subjects will take one of two different doses of AXA1125 or a placebo twice daily, and a liver biopsy will be done at the beginning and end of the 48-week study.