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NCT ID: NCT05386381 Enrolling by invitation - Clinical trials for Lumbar Spondylolisthesis Involving L4-L5

Survivorship of Decompression Alone Vs Decomp With Fusion in DLS and LCS

Start date: May 6, 2022
Phase:
Study type: Observational

There has been a long-standing controversy on the operative treatment of Degenerative Lumbar Spondylolisthesis (DLS) with Lumbar Canal Stenosis (LCS), especially whether the addition of fusion to decompression is necessary. Many believe that decompression alone (D) by either using midline preserving fenestration techniques (fenestration by laminotomy and medial facetectomy) or with a spinous process osteotomy (SPO) is enough for treatment of patients with DLS while others believe that a fusion (D+F) should be added in all cases. The study aims to determine if decompression alone performs better or worse in the long term than decompression with fusion in a large cohort of patients who have DLS with LCS. It also aims to determine if the decompression technique of midline-sparing fenestration or spinous process osteotomy make a difference to survival in cases of DLS with LCS.

NCT ID: NCT05380609 Enrolling by invitation - Cancer Clinical Trials

Accelerated Body Diffusion-Weighted MRI Using Artificial Intelligence

CeleScan-R
Start date: May 6, 2022
Phase:
Study type: Observational

Whole-body diffusion-weighted MRI (WBDWI) is a non-invasive tool used for staging and response evaluation in oncologic practice and is at the core of emerging response criteria in advanced prostate and breast cancers. WBDWI is a sensitive tool that radiologists can use to review the extent of disease and is achieved using a series of sequential imaging stations from the head to the mid-thigh. WBDWI accounts for more than 50% of the acquisition time of conventional whole-body MRI studies with a 1-hour duration. Despite national and international guidance for using whole-body MRI, a recent UK survey indicated that only 27% of UK radiology departments were offering a whole-body MRI service with a lack of scanner availability cited by 50% of respondents as the main challenge to service delivery. In the context of the ever-increasing capacity pressures on MRI departments, reducing acquisition times would facilitate the wider adoption of clinical WBDWI, reduce costs, and improve the patient experience. DWI is also embedded into consensus MRI protocols across almost all tumour types including primary prostate and breast cancers, metastatic liver disease, gynaecological cancers & GI cancers, where acquisition time savings could also be beneficial. The investigators have previously published accelerated DWI with deep learning based denoising filters (quickDWI), which can provide up to 50% reduction in whole-body MRI acquisition times. The goal of the deep-learning algorithm is to remove the noise in these subsampled images, producing an image with acceptable clinical quality. The aim of this investigation is to extend this work by testing quickDWI within a larger retrospective data cohort, incorporating other cancers such as disease of the abdomen and pelvis, primary prostate cancer, liver metastases, and pancreatic cancer.

NCT ID: NCT05367024 Enrolling by invitation - Pre-diabetes Clinical Trials

Broccoli Effect on Glycated Haemoglobin (HbA1c)

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

Broccoli has shown to normalise elevated blood sugars when eaten over long period of time. Individuals with pre-diabetes have higher than normal blood sugar levels. In this study, investigators are trying to understand how broccoli, when eaten as a soup, affects blood sugar levels in individuals with pre-diabetes.

NCT ID: NCT05362370 Enrolling by invitation - Clinical trials for Craniofacial Abnormalities

Stryker PEEK Customized Implant: A Prospective Post Market Follow Up to Evaluate Safety, Performance and Effectiveness

Start date: February 1, 2023
Phase:
Study type: Observational

The purpose of this study is to confirm the safety, performance and effectiveness of Stryker's PEEK Customized Implants when used for the augmentation and/or restoration of bony and/or soft tissue deformities in the cranial and craniofacial skeleton. The study is designed as a prospective, multi-center trial with a long-term follow-up (24 months) of study participants.

NCT ID: NCT05352919 Enrolling by invitation - Clinical trials for Systemic Lupus Erythematosus (SLE)

A Study to Evaluate the Continuous Safety and Efficacy of Litifilimab (BIIB059) in Adults With Active Systemic Lupus Erythematosus

EMERALD
Start date: June 10, 2022
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the long-term safety and tolerability of litifilimab in participants with active systemic lupus erythematosus (SLE). The secondary objectives of this study are to evaluate the long-term effect of litifilimab on disease activity in participants with SLE, to evaluate the long-term effect of litifilimab in participants with SLE in maintaining low disease activity, to evaluate the effect of litifilimab in participants with active SLE in preventing irreversible organ damage, to assess long-term use of oral corticosteroid (OCS) with participants receiving litifilimab treatment, to assess the impact of litifilimab on participant-reported Health-Related Quality-of-Life Questionnaire (HRQoL), symptoms, and impacts of SLE, to evaluate long-term effect of litifilimab on laboratory parameters, and to evaluate immunogenicity of litifilimab.

NCT ID: NCT05346016 Enrolling by invitation - Clinical trials for Microbial Transfers in the Gut of Multigenerational Families and Stability and Adaptation of These Microbes After Colonization

The PEARL-AGE Study. Multigenerational Gut Bacteria Transmission and Its Stability in Families.

Start date: March 18, 2022
Phase:
Study type: Observational

We will recruit up to 4-generations of human family cohorts, in order to characterize the microbiome and its changes across different generations.

NCT ID: NCT05317429 Enrolling by invitation - Glycaemia Clinical Trials

Glycaemic Responses to Carbohydrate-rich Meals (GlyCarb)

GlyCarb
Start date: February 14, 2022
Phase: N/A
Study type: Interventional

Carbohydrate-rich foods such as potatoes, bread, rice, pasta, breakfast cereals, biscuits and other snacks are a major component of the human diet. The effect of different carbohydrate-rich foods on blood sugar (glucose) levels after a meal varies between foods. This is relevant to health because studies have shown that regular intake of carbohydrate foods that cause large increases in blood glucose levels after ingestion can be detrimental to metabolic health. The aim of the GlyCarb study is to investigate how food structure influences postprandial glycaemic responses to carbohydrate foods. This will be achieved through a series of acute postprandial studies (up to 5 studies), wherein healthy participants within each postprandial study consume a pair of carbohydrate-rich test meals while wearing a continuous glucose monitoring system (CGM). Each postprandial study will use the same GlyCarb Remote standard protocol, where a randomised cross-over design is used to measure the glycaemic response to two carbohydrate-rich test meals, one "test" and one "control". Both meals will be matched by carbohydrate content, contain similar ingredients and have a similar physical appearance, but will differ in one key food property (e.g., altered food structure) to test its effect on postprandial glycaemia. In each postprandial study, habitual dietary intake and body composition will be captured at baseline as part of the participant characterisation. Participants will consume two different carbohydrate-rich test meals twice, on separate occasions, in a randomly allocated order over a 10 to 14-day period of continuous glucose monitoring. Data from the continuous glucose monitors will be used to assess the postprandial glycaemic response to each carbohydrate food. The participants will be required to complete brief questionnaires designed to evaluate differences in palatability (taste, texture, portion size) and satiety amongst test meals. Study participant feedback will be requested at the end of the study and used to assess and improve future study procedures. The GlyCarb study will enable new understanding of how food properties influence glycaemic responses to different types of carbohydrate foods. Ultimately, the findings will inform the rational design or reformulation of food products and diets to support a healthy glucose metabolism.

NCT ID: NCT05313516 Enrolling by invitation - Amblyopia Clinical Trials

OKKO Space Academy to Check Children's Vision at Home

Start date: June 26, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to determine the feasibility of the OKKO Space Academy app as a vision measuring and home-monitoring tool for children aged 3-8 years undergoing amblyopia treatment. There are three objectives to this work: 1. Determine the feasibility of the OKKO Space Academy app for use between clinic visits from the child's and family perspective (i.e., acceptability, usability and engagement). 2. Assess the variability in day-to-day OKKO Health measurements between clinic visits (e.g., do the interim OKKO home vision measurements predict improvements in visual acuity?) 3. Explore agreement between the OKKO Space Academy measures of visual acuity against in-clinic measurements (usual standard of care), including an exploration of intra- and inter-session repeatability.

NCT ID: NCT05304767 Enrolling by invitation - Schizophrenia Clinical Trials

An Extension Study to Assess Long-Term Safety and Tolerability of Adjunctive KarXT in Subjects With Inadequately Controlled Symptoms of Schizophrenia

Start date: March 7, 2022
Phase: Phase 3
Study type: Interventional

This is a Phase 3, multicenter, 52-week, outpatient, open-label extension (OLE) study to evaluate the long-term safety and tolerability of adjunctive KarXT in subjects with schizophrenia with an inadequate response to their current antipsychotic treatment who previously completed the treatment period (Visit 8/Day 42 ± 3) of ARISE Study (KAR-012). The primary objective of the study is to assess the long-term safety and tolerability of adjunctive KarXT (a fixed dose combination of xanomeline and trospium chloride twice daily [BID]) in subjects with schizophrenia.

NCT ID: NCT05303532 Enrolling by invitation - Cancer Clinical Trials

Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Durvalumab

ROSY-D
Start date: April 19, 2022
Phase: Phase 3
Study type: Interventional

The rationale of the ROSY-D study is to continue to provide study treatment for patients who have participated in a parent study with Durvalumab and who are continuing to derive clinical benefit from treatment at the end of such studies, as judged by the Investigator.