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NCT ID: NCT04910061 Completed - Healthy Volunteers Clinical Trials

Safety and Pharmacokinetics of Nicotinamide Mononucleotide (NMN) in Healthy Adults.

Start date: August 5, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate the safety, pharmacokinetic profile, and effects of nicotinamide mononucleotide (NMN-C) in healthy adults, 18-65 years of age. The effects will be studied over the course of 30 days in a repeated-dose study through the collection of blood and urine samples, and administration of surveys and questionnaires.

NCT ID: NCT04909723 Terminated - Healthy Volunteers Clinical Trials

Safety, Tolerability, and Pharmacodynamics of NOV-001 in Adult Subjects

Start date: June 2, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

The first stage of this study is a prospective, adaptive, Phase 1, first-in-human, randomized, controlled study evaluating safety, tolerability, and pharmacodynamics of NOV-001 in adult healthy volunteers. The second stage of this study is a prospective, randomized, single-blinded, placebo-controlled study of safety, tolerability, and early efficacy in patients with enteric hyperoxaluria.

NCT ID: NCT04909580 Completed - Clinical trials for Type 1 Diabetes Mellitus

Decision Coaching for Youth and Parents Considering Insulin Delivery Methods for Type 1 Diabetes

Start date: September 5, 2013
Phase: N/A
Study type: Interventional

A pre-/post-test design. Youth with type 1 diabetes and their parent(s) were referred to the intervention by their diabetes physician. Decision coaching guided youth and their parents in completing a patient decision aid that was pre-populated with evidence on insulin delivery options. Primary outcomes were youth and parent scores on the low literary version of the Decisional Conflict Scale (DCS).

NCT ID: NCT04909541 Recruiting - Urologic Diseases Clinical Trials

Development of a New Canadian Endourology Group Stent Symptom Score

CEGSSS
Start date: May 15, 2022
Phase:
Study type: Observational

Placement of a ureteral stent is a common urological intervention. For decades there was no valid measures available to assess quality of life issues in patients with ureteral stents, which has hampered the understanding of such symptoms and their true impact. In order to improve the outcomes associated with the placement of a stent, a validated tool is needed to measure its impact and the amount of undesirable effects it produces on patients requiring the placement of a stent. In 2003, the team of the Bristol Urological Institute developed a validated questionnaire called the: URETERAL STENT SYMPTOM QUESTIONNAIRE (USSQ). The questionnaire contains 38 items included in 6 sections. Despite the obvious need of a validated questionnaire, the latter remains unused by the community of peer urologists. Many of urologists consider it too long to be used in clinical practice and even for research purposes. This issue motivated the Canadian Endourology Group (CEG) to work collaboratively on the development of the CANADIAN ENDOUROLOGY GROUP STENT SYMPTOM SCORE (CEGSSS) in order to provide clinicians with a more useful and validated tool. To fulfill this objective, the CEG proceeds in three phases. Phase 1. A systematic, deliberative, and participatory approach mostly through face to face meetings, including patients, clinicians, and researchers in the field of Endourology to identify a minimum needs-based set of domains and items that are, clinically relevant to be included in the CEGSSS in order to ensure optimal uptake in the clinical setting. Phase 2. A pilot study to assess feasibility/acceptability and further refine the proposed set of items selected in phase 1 of the study. Phase 3. A multicentric prospective study to evaluate the validity, reliability and sensitivity to change of the CEGSSS. This research project is conducted by the Canadian Endourology Group (CEG), a panel of experts in the field of endourology in Canada. The CEG is a national member-based organization dedicated to enabling the profession to provide the highest possible standards of endourological care and to advance the science of endourology by collaboratively: 1. Fostering excellence in endourological practice through advocacy, education, research and practice support tools, 2. Leading evidence-based clinical practice through the development of practice standards and guidelines in endourology, 3. Providing continuous professional development for Canadian endourologists along the career-path continuum, 4. Providing leadership in public education for endourological conditions.

NCT ID: NCT04909450 Recruiting - Clinical trials for Neurotrophic Keratitis

Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Neurotrophic Keratitis Subjects

Start date: August 24, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This study will enroll subjects with stage 2 or 3 neurotrophic keratitis. Subjects will be randomized in a 1:1 ratio to the CSB-001 investigational treatment arm or vehicle control arm. All subjects will dose with the randomized treatment four times daily for 8 weeks (controlled treatment phase). During the controlled treatment phase, subjects will return to the clinic weekly from Day 0 to Week 8, and again at Week 10. Subjects randomized to the vehicle arm who are not healed will have the opportunity to participate in an open-label uncontrolled treatment phase.

NCT ID: NCT04909346 Terminated - Wilson Disease Clinical Trials

Adeno-Associated Virus (AAV) Antibody Study in Subjects OTC Deficiency, GSDIa, and Wilson Disease

Start date: June 23, 2021
Phase:
Study type: Observational

The objective of this observational study is to evaluate the seroprevalence of anti-AAV antibodies in subjects with Ornithine Transcarbamylase (OTC) deficiency, Glycogen Storage Disease Type Ia (GSDIa), and Wilson Disease

NCT ID: NCT04909060 Recruiting - Post Operative Pain Clinical Trials

Does the Newborn Infant Parasympathetic Evaluation (NIPE) Index Predict Postsurgical Pain in Children

NIPE
Start date: September 1, 2021
Phase:
Study type: Observational

An investigation to find out if Newborn Infant Parasympathetic Evaluation (NIPE) index predicts postsurgical pain in children, since NIPE is thought to may be of guide to the appropriate therapy in a timely and objective manner, thereby improving patient safety, parental satisfaction, and reducing healthcare costs. We think that, validating the utility of NIPE in children under 3 years of age will allow the implementation of a novel pain assessment tool to our current practice of anesthetic care. This will improve the perioperative pain management, in particular for patients who are unable to communicate pain, with the potential to reduce detrimental consequences of postoperative pain. And also determining the relationship between the NIPE scores and validated FLACC scale for post-operative pain and PAED scale during the recovery from anesthesia and also to determine whether NIPE values at extubation correlates with the incidence of moderate and/or severe pain in PACU.

NCT ID: NCT04908683 Completed - Clinical trials for Respiratory Syncytial Viruses

A Study of an Adenovirus Serotype 26 Pre-fusion Conformation-stabilized F Protein (Ad26. RSV. preF) Based Respiratory Syncytial Virus (RSV) Vaccine in the Prevention of Lower Respiratory Tract Disease in Adults Aged 60 Years and Older

EVERGREEN
Start date: July 21, 2021
Phase: Phase 3
Study type: Interventional

The study will enroll up to 27,200 participants in order to demonstrate the efficacy of the active Ad26.RSV.preF-based study vaccine in the prevention of Reverse Transcription Polymerase Chain Reaction (RT-PCR) confirmed Respiratory Syncytial Virus (RSV)-mediated Lower Respiratory Tract Disease (LRTD) when compared to placebo in adults aged 60 years and above.

NCT ID: NCT04908475 Completed - Psoriasis Clinical Trials

Study of Subcutaneous Risankizumab Injection Compared to Oral Apremilast Tablets to Assess Change in Disease Activity And Adverse Events in Adult Participants With Moderate Plaque Psoriasis Who Are Candidates for Systemic Therapy

Start date: June 9, 2021
Phase: Phase 4
Study type: Interventional

Psoriasis (PsO) is a chronic disease characterized by marked inflammation of the skin that results in thick, red, scaly plaques. This study will assess how safe and effective risankizumab is compared to apremilast in adult participants with moderate plaque psoriasis. Adverse events and change in disease symptoms will be monitored. Risankizumab (Skyrizi) and apremilast are approved drugs for the treatment of moderate to severe PsO. Approximately 330 participants with moderate plaque psoriasis (PsO) will be enrolled across approximately 55 sites globally. The study has 2 periods : Period A from Baseline to Week 16, and Period B, from Week 16 to Week 52. In Period A, participants will be randomly placed into 2 groups to receive either subcutaneous risankizumab or oral apremilast for 16 weeks. In Period B, participants who received apremilast in Period A will again be randomly assigned to 1 of the 2 groups to receive either risankizumab or apremilast for 36 weeks. At weeks 28 and 40, participants considered non-responders to apremilast based on their psoriasis score will be offered to receive risankizumab. There may be a higher burden for participants in this study compared to usual standard of care. Participants will attend regular visits per routine clinical practice. The effect of the treatment will be checked by medical assessments, checking for side effects, and questionnaires.

NCT ID: NCT04908241 Recruiting - Stroke Clinical Trials

Telerehabilitation With Aims to Improve Lower Extremity Recovery Post-Stroke (TRAIL-RCT)

TRAIL-RCT
Start date: November 8, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to compare the effectiveness of a 4-week lower extremity telerehabilitation protocol with aims to improve lower extremity function to a 4-week attention-controlled education program on lower extremity clinical outcomes, quality of life, and healthcare resources utilization among community dwelling adults with stroke across Canada.