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NCT ID: NCT05565248 Recruiting - Diabetes Mellitus Clinical Trials

An Open-Label, FIH Study Evaluating the Safety, Tolerability, and Efficacy of VCTX211 Combination Product in Subjects With T1D

Start date: January 20, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

This is an open-label, multicenter, Phase 1/2 study evaluating the Safety, Tolerability, and Efficacy of VCTX211 Combination Product in Subjects with T1D

NCT ID: NCT05564494 Recruiting - Clinical trials for Shoulder Instability

Surgical Treatment of Recurrent Shoulder Dislocations

Start date: April 25, 2023
Phase: N/A
Study type: Interventional

This is a pilot multi-centre, double blinded randomized controlled trial. The primary outcome of this pilot trial will be feasibility. Prior to conducting a large definitive trial, the investigators will conduct this pilot trial comparing arthroscopic Bankart repair with arthroscopic anatomic glenoid reconstruction (AAGR), evaluating recurrent dislocation rates and functional outcomes over a 24-month period. The feasibility objectives are: (1) to evaluate the investigators ability to recruit patients across multiple sites and (2) to assess study protocol adherence and ability to follow patients to 24 months. Clinical objectives for the pilot trial are exploratory only. The investigators wish to gather means and standard deviations for clinical outcomes to power their future definitive trial. The objectives of the definitive trial will include a comparison of patient-reported outcomes at the two-year post-operative time point, differences in recurrence rates, complication rates, functional shoulder assessments, and return to work/sport.

NCT ID: NCT05564247 Recruiting - Wheelchairs Clinical Trials

Wheelchair Skills Training for Children and Youth

Start date: August 1, 2022
Phase: N/A
Study type: Interventional

Manual wheelchair (MWC) skills training is a critical component of wheelchair service provision. However, children and youth receive little to no training. MWC training effectively improves MWC skills, self-efficacy and satisfaction with participation (ie., facilitators of independent mobility and social participation) in adults. Independent mobility is especially critical for children, as it is associated with higher likelihood of employment and independent living in adulthood. Despite evidence of an effective Wheelchair Skills Training Program (WSTP) for adults, very little research has been conducted in the area of wheelchair mobility for children and youth. Two small single-group studies suggest that MWC skills training improves wheelchair skills and satisfaction with participation among individuals ages 4-17 years when training was conducted by professionals (eg. clinicians) and non-professionals (eg. peer-trainers). However, there are no controlled trials documenting the effect of MWC skills training among children and no evidence of best training approaches. The purpose of this study is to evaluate the efficacy of the WSTP for improving MWC skills, MWC confidence and participation outcomes among children and youth. A randomized controlled trial will establish efficacy of clinician led approaches to training, which may be implemented on a broader community-based scale in the future. The results of this study will provide critical evidence for best practices for improving MWC mobility during childhood. Deliverables from this study will include MWC skills training tools for clinicians, that will be made freely available through an existing website. The results will support multi-site implementation trials and exploration of community-based approaches to wheelchair skills training for children and use.

NCT ID: NCT05563649 Recruiting - Anorexia Nervosa Clinical Trials

Confirming the Effectiveness of Online Guided Self-Help Family-Based Treatment for Adolescent Anorexia Nervosa

Start date: March 17, 2023
Phase: N/A
Study type: Interventional

With an incidence rate of about 1%, Anorexia Nervosa (AN) is a serious mental disorder associated with high mortality, morbidity, and cost. AN in youth is more responsive to early treatment but becomes highly resistant once it has taken an enduring course. The first-line treatment for adolescents with AN is Family Based Treatment (FBT). While FBT can be delivered using videoconferencing (FBT-V), therapists' limited availability hampers scalability. Guided self-help (GSH) versions of efficacious treatments have been used to scale and increase access to care. The main aim of this proposed comparative effectiveness study is to confirm that clinical improvements in GSH-FBT are achieved with greater efficiency than FBT-V in generalizable clinical settings.

NCT ID: NCT05563298 Recruiting - MCI Clinical Trials

Neuro RX Gamma for Amnestic Mild Cognitive Impairment (aMCI)

Start date: March 28, 2023
Phase: N/A
Study type: Interventional

There are over 50 million people living with dementia, and by 2050, the number is expected to rise to 152 million worldwide. Mitochondrial dysfunction in the brain of MCI and AD patients is gaining prominence as a potential mechanism and thus treatment target. However, an effective therapy targeting mitochondrial function, is still missing. Photobiomodulation (PBM), is an innovative noninvasive technique that delivers transcranial near infrared light to the brain. PBM is thought to play a key role in enhancing mitochondrial function [especially in tissues with a high number of mitochondria (e.g.,brain)], by reducing oxidative stress and increasing ATP levels. PBM can be safely administered to awake outpatients and does not require general anesthesia or surgical implantation. Recent animal studies, and case studies suggest that PBM is a promising therapy for AD. However, due to the lack of placebo controls and objective blood and neuroimaging biomarkers, the effectiveness and mechanism of action of PBM (via enhancing mitochondrial function) in AD remains to be studied. Objectives: The investigators aim to evaluate cognitive changes and neural correlates associated with PBM in early amnestic MCI (aMCI) during a pilot feasibility study. Participants who meet study criteria will undergo a 6-week trial of home-used PBM using the Neuro Rx Gamma 6days/week, 20 minutes per session (n=20). All patients will undergo clinical and cognitive assessment, blood sample collection, and structural and resting state functional MRI scans in two timepoints; pre and post treatment. The longitudinal nature of the study will allow investigation of the PBM effect and its' neural correlates in aMCI via enhancement of mitochondrial function. The present study provides a unique opportunity to investigate the mitochondrial and neural mechanisms that may be involved in prevention or delay of cognitive decline in aMCI.

NCT ID: NCT05562310 Recruiting - Stable Neonates Clinical Trials

Phenylalanine, Methionine and Histidine Requirements in TPN Fed Neonates

Start date: April 2, 2023
Phase: N/A
Study type: Interventional

This is a single center project assessing the requirements for three essential amino acids in TPN fed neonates. Using the Carbon Oxidation method (indicator amino oxidation and direct amino acid oxidation method), the investigators will determine the requirement of each of the 3 amino acids. The investigators will first determine the requirement for Phenylalanine, then Methionine and finally Histidine. The investigators will recruit 18 - 20 babies per amino acid study. Breath and urine samples will be collected to determine the oxidation of the indicator amino acid. The response of the indicator amino acid to changes in intake of the test amino acid (phenylalanine, methionine, and histidine) will be analyzed by bi-phase linear mixed effect model to determine the breakpoint or mean requirement for each amino acid. It is hypothesized that the requirement for phenylalanine, methionine and histidine will be at least 50% lower than what is currently available in commercial amino acids solutions used for TPN feeding of neonates.

NCT ID: NCT05561335 Recruiting - Hearing Loss Clinical Trials

Preference Comparisons for Algorithms to Hear Speech

Start date: March 21, 2023
Phase: N/A
Study type: Interventional

Twenty people with hearing impairment will be tested and fitted binaurally with hearing aids. During a real-world listening situation, each participant will be asked to compare one program with a novel algorithm to one with a standard microphone configuration. They will provide ratings on a range of outcome measures including overall preference and awareness of background noise. Overall and specific preferences for the different programs/algorithms will be determined by their subjective responses to determine if there is a significant difference between the two programs.

NCT ID: NCT05561205 Recruiting - Alzheimer Disease Clinical Trials

rTMS for Apathy Clinical Trial

REACT
Start date: February 9, 2023
Phase: N/A
Study type: Interventional

Apathy is a common, early, and disabling symptom in dementias such as Alzheimer's disease (AD) and is characterized by lack of interest and enthusiasm. Both repetitive transcranial magnetic stimulation (rTMS), a form of non-invasive brain stimulation, and methylphenidate, a medication, have been shown to improve apathy. This pilot study will investigate rTMS as a treatment for apathy in AD in individuals receiving methylphenidate and individuals not receiving medication for apathy.

NCT ID: NCT05559580 Recruiting - Clinical trials for Scleroderma, Systemic

A Study in People With Systemic Sclerosis to Test Whether Avenciguat (BI 685509) Has an Effect on Lung Function and Other Systemic Sclerosis Symptoms

VITALISScEā„¢
Start date: November 24, 2022
Phase: Phase 2
Study type: Interventional

This study is open to adults aged 18 and older or above legal age who have systemic sclerosis. People can participate if they have a specific subtype called diffuse cutaneous systemic sclerosis. People with another subtype called limited cutaneous systemic sclerosis can also participate if they are anti Scl-70 antibody positive. Systemic sclerosis is also called scleroderma. The purpose of this study is to find out whether a medicine called Avenciguat (BI 685509) helps people with scleroderma who have symptoms due to lung fibrosis or vascular problems. Participants are put into 2 groups by chance. One group takes Avenciguat (BI 685509) tablets 3 times a day and the other group takes placebo tablets 3 times a day. Placebo tablets look like BI 685509 tablets but do not contain any medicine. Participants take the tablets for at least 11 months. Afterwards, participants can continue to take the tablets until the last participant has completed the 11-months treatment period. This means that the time in the study and duration of treatment is different for each participant, depending on when they start the study. At the beginning of the study, participants visit the study site every 2 weeks. The time between the visits to the study site gets longer over the course of the study. After the 11-months treatment period, participants visit the study site every 3 months. During the study, participants regularly do lung function tests. The results are compared between the 2 groups to see whether the treatment works. The participants also regularly fill in questionnaires about their scleroderma symptoms. The doctors regularly check participants' skin condition and general health and take note of any unwanted effects.

NCT ID: NCT05559359 Recruiting - Atopic Dermatitis Clinical Trials

A Study of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis

ADorable-1
Start date: October 18, 2022
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to measure the effect, safety and how well the body absorbs lebrikizumab in pediatric participants 6 months to <18 years of age with moderate-to-severe atopic dermatitis (AD).