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NCT ID: NCT05678764 Recruiting - Mental Health Issue Clinical Trials

Evaluation of a Conversational Information Collection Tool to Access Talk Therapy

Start date: June 29, 2023
Phase:
Study type: Observational

This is an observational study evaluating a conversational information collection tool to access talk therapy. The patient outcome data will be compared between people who refer to talk therapy via the conversational information collection tool and people who refer using other means.

NCT ID: NCT05678569 Not yet recruiting - Osteoporosis Clinical Trials

OsteoPorosis Treatment Identification Using Machine Learning

OPTIMAL
Start date: February 2023
Phase:
Study type: Observational

OPTIMAL is a pilot feasibility study for a machine learning (ML) based enhanced screening software for osteoporosis. This tool has been created using machine learning, based on data from NHS Greater Glasgow and Clyde. The study will contact individuals deemed at high risk by the study (750 patients will be re-identified, and these will be contacted starting from the highest risk until 250 patients are recruited) and perform DXA scans, clinical review, and bloods tests that are relevant to osteoporosis. This data will then be compared to the predictions made by the OPTIMAL enhanced screening tool, in order to test how effective it is.

NCT ID: NCT05678257 Active, not recruiting - Colorectal Cancer Clinical Trials

A Study of NUC-3373 in Combination With Other Agents in Patients With Colorectal Cancer

Start date: April 18, 2023
Phase: Phase 2
Study type: Interventional

This is a randomized, open-label, dose/schedule optimization study comparing NUC-3373/leucovorin (LV)/irinotecan plus bevacizumab (NUFIRI-bev) to 5-FU/LV/irinotecan plus bevacizumab (FOLFIRI-bev) for the treatment of patients with unresectable metastatic colorectal cancer. A total of 171 patients will be randomized 1:1:1 to either NUFIRI-bev on a weekly NUC-3373 schedule, NUFIRI-bev based on an alternate weekly NUC-3373 schedule, or FOLFIRI bev on an alternate weekly schedule. The main objectives are to assess and compare the efficacy and safety of the 3 regimens. Pharmacokinetics will be assessed on the 2 NUFIRI arms.

NCT ID: NCT05677971 Recruiting - Clinical trials for Alpha1-Antitrypsin Deficiency

Study to Check the Safety of Fazirsiran and Learn if Fazirsiran Can Help People With Liver Disease and Scarring (Fibrosis) Due to an Abnormal Version of Alpha-1 Antitrypsin Protein

Start date: March 6, 2023
Phase: Phase 3
Study type: Interventional

The main aim of this study is to learn if fazirsiran reduces liver scarring (fibrosis) compared to placebo. Other aims are to learn if fazirsiran slows down the disease worsening in the liver, to get information on how fazirsiran affects the body (called pharmacodynamics), to learn if fazirsiran reduces other liver injury (inflammation) and the abnormal Z-AAT protein in the liver, to get information on how the body processes fazirsiran (called pharmacokinetics), to test how well fazirsiran works compared with a placebo in improving measures of liver scarring including imaging and liver biomarkers (substances in the blood that the body normally makes and help show if liver function is improving, staying the same, or getting worse) as well as to check for side effects in participants treated with fazirsiran compared with those who received placebo. Participants will either receive fazirsiran or placebo. Liver biopsies, a way of collecting a small tissue sample from the liver, will be taken twice during this study.

NCT ID: NCT05677763 Recruiting - Clinical trials for Respiratory Tract Infections

OM-85 in Paediatric Recurrent Respiratory Tract Infections With Wheezing Lower Respiratory Illness

Start date: December 12, 2022
Phase: Phase 4
Study type: Interventional

This study will assess the efficacy and safety of OM-85 compared to placebo in reducing the number of respiratory tract infections (RTIs) in children aged between 6 months and 5 years.

NCT ID: NCT05677659 Active, not recruiting - ALSP Clinical Trials

A Study of VGL101 in Patients With Adult-Onset Leukoencephalopathy With Axonal Spheroids and Pigmented Glia

Start date: December 14, 2022
Phase: Phase 2
Study type: Interventional

This is a multicenter, open-label study to assess the safety and tolerability of iluzanebart (also referred to as VGL101) in subjects with documentation of a gene mutation in the CSF1R gene for the treatment of adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP) and to evaluate the effects of iluzanebart on imaging and biomarkers of disease progression in subjects with ALSP. Participants will receive infusions of iluzanebart approximately every 4 weeks for 1 year. The study includes a 52-week, open-label Core Study, followed by a Long-Term Extension (LTE), which provides subjects who complete the original 52-week study (Core Study) with the option to continue treatment for up to an additional 2 years.

NCT ID: NCT05676931 Recruiting - Clinical trials for Advanced Non-Small Cell Lung Cancer

Study With Immunotherapy Combinations in Participants With Metastatic Non-Small Cell Lung Cancer

EDGE-Lung
Start date: February 1, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the objective response rate (ORR) of immunotherapy-based combination therapy and to assess the safety and tolerability of immunotherapy-based combination therapy.

NCT ID: NCT05676775 Recruiting - Clinical trials for Axial Spondyloarthritis

British Axial Spondyloarthritis Inception Cohort

BAxSIC
Start date: June 9, 2023
Phase:
Study type: Observational

The British Axial Spondyloarthritis Cohort (BAxSIC) study has been established under the auspices of the British Society for Spondyloarthritis (BRITSpA) in collaboration with the National Axial Spondyloarthritis Society (NASS) to provide real-world data to evaluate the impact of delay in diagnosis (from symptom onset to diagnosis) on work participation and functional outcomes and the natural history and impact of newly-diagnosed axial Spondyloarthritis, including disease activity, pain, fatigue, functional and work outcomes, comorbidities, therapies in the United Kingdom (UK). The study is a prospective cohort, enrolling patients attending rheumatology clinics in the UK who are newly diagnosed with axial Spondyloarthritis and naïve to biologic therapy. The study will run for an initial 3 year period commencing January 2023. Financial support was provided as a Research Grant from Pfizer Limited, UCB and Novartis.

NCT ID: NCT05676658 Completed - Anxiety Clinical Trials

Effects of Coherent Breathing Breathwork on Health

Start date: February 22, 2023
Phase: N/A
Study type: Interventional

The investigators are conducting a randomised-controlled trial comparing coherent breathing at ~5.5 breath cycles per minute-bcpm (with equal inhalation/exhalation durations of ~5.5secs each) to a well-designed placebo (paced breathing at 12bcpm with equal inhalation/exhalation durations of 2.5secs each). The metric of 12bcpm is in line with guidance from the British Journal of Nursing, Royal College of Physicians, and Johns Hopkins University which state that the average, healthy bcpm should range from: 12-20bcpm, 12-18bcpm, and 12-16bcpm, respectively, hence the investigators chose the minimum/lower bound for the active placebo control group. The main questions that our study attempts to address are: Does coherent breathing (and placebo coherent breathing) lead to improved mental health and wellbeing in a general population adult sample? The study will be conducted entirely online through the research platform Prolific, so participant data will be anonymous. The investigators will collect self-reports of mental health and wellbeing before and after the four-week breathwork period, along with a follow-up one-month later. Pre-post intervention and follow-up questionnaires will be completed online via the survey platform Qualtrics which will be linked to Prolific. Participants will also be asked how many times they practiced out of the assigned 28 days, to gauge self-reported adherence to the protocol. The investigators can then observe whether self-reported adherence correlates with changes in mental health and wellbeing, if any. Data on the self-reported credibility/expectancy of the breathwork randomly allocated to participants will also be collected, along with open-ended responses on participants' overall experience of the protocol/study.

NCT ID: NCT05676619 Completed - Clinical trials for Diabetes Complications

3D Foot Scanner Reliability for Footwear Fit and Design

Start date: February 16, 2023
Phase: N/A
Study type: Interventional

The investigators will carry out a proof-of-concept study in 20 adult healthy male and female volunteers in order to: assess a 3D foot scanner's reliability. Specifically, the investigators will assess its variability during repeated foot scans of the same subject's foot. Three repeated foot scans will be carried out by two different examiners to measure intrarater and interrater reliability (Intraclass Correlation Coefficient