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NCT ID: NCT05737485 Recruiting - Clinical trials for Primary Ciliary Dyskinesia

Study Evaluating the Safety and Tolerability of RCT1100 in Healthy and PCD Subjects

Start date: February 18, 2023
Phase: Phase 1
Study type: Interventional

This is the first-in-human study with RCT1100 and is designed to provide initial safety and tolerability data for future clinical studies.

NCT ID: NCT05737433 Completed - NASH With Fibrosis Clinical Trials

Single Dose ADME Study of [14C]-Rencofilstat in Healthy Male Subjects

Start date: March 1, 2023
Phase: Early Phase 1
Study type: Interventional

This is a single-center, single-period, single-dose, open-label, non-randomized study to assess the mass balance recovery, metabolite profile and metabolite identification of 14C- labelled rencofilstat ([14C] CRV431). It is planned to enroll 6 healthy male subjects in a single group. Each subject will receive a single 225 mg oral dose of [14C] CRV431 self-micro emulsifying drug delivery system (SMEDDS) oral emulsion.

NCT ID: NCT05736380 Suspended - Clinical trials for The Effects of Cerebellar rTMS on the Brain

The Effects of Cerebellar rTMS on Brain Activity

Start date: September 1, 2023
Phase: N/A
Study type: Interventional

Swallowing function is controlled by two swallowing centres (one on each half of the brain). There is a dominant and non-dominant swallowing centre. Damage to any part of the brain can lead to swallowing problems, for example in strokes. Recovery of the ability to swallow is associated with increased activity (compensation) over the undamaged centre. The cerebellum is an area of the brain involved in the control and modulation of muscle movements. It is found at the back of the skull. Anatomical evidence exists, showing cerebellar outputs projecting to several cortical areas, including the primary motor cortex (M1). Moreover, brain imaging studies have shown activation of the cerebellum during swallowing using positron emission tomography (PET) and magnetic resonance imaging (MRI). Over the past few years studies have tried to improve swallowing function using techniques to stimulate regions of the brain and encourage compensation. Repetitive transcranial magnetic stimulation (rTMS) is a technique which can temporarily increase or suppress activity over regions of the brain. No imaging studies have been conducted which have looked at how the brain is affected by cerebellar rTMS. The investigators hypothesise that cerebellar rTMS will cause increased activity in swallowing associated areas in the brain, including the cortex and brainstem

NCT ID: NCT05735977 Not yet recruiting - Renal Cancer Clinical Trials

Nephrogreen. Appearances of Exvivo Renal Tumours Under Near-infrared

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

Indocyanine Green (ICG) is a dye which fluoresces under near-infrared (NIR) light. It has been used for several applications in adult surgery. The CI is pioneering its use in children's kidney cancer surgery for lymph node identification and removal. This study concentrates on its use for procedures where only the part of the kidney containing tumour is removed. It is known that kidney tumours in both adults and children do not take up ICG at all. This absence of uptake can be used to define the border between normal and abnormal renal tissue giving a real-time picture of the area of tumour. This then delivers surgeons an intra-operative roadmap for removing only the cancerous part of the kidney. At present the international society of paediatric oncology - renal tumour study group (SIOP-RTSG) protocol, which is followed in the UK, advises consideration of partial nephrectomy for children with bilateral renal tumours and in children with unilateral tumours who have a renal tumour predisposition syndrome. There is ongoing debate about partial nephrectomy in unilateral renal tumour surgery in children who do not have a predisposition syndrome. This study aims to provide the evidence that paediatric renal tumours do not take up ICG at a naked-eye level and confirm this at a cell level. ICG will be infused into kidneys containing tumour once they have been removed from the patient, The kidney and tumour will be observed under NIR light to show where the areas of fluorescence are. Then, a pathologist will prepare the specimen in theatre, in the same way they would do in the lab. The specimen would be bivalved and reviewed under NIR. Microscopy specimens of the border between normal and abnormal tissue would then be reviewed with an NIR capable microscope. The standard histopathological assessment would then take place.

NCT ID: NCT05735964 Not yet recruiting - Clinical trials for Tracheo-Esophageal Fistula With Atresia of Esophagus

Use of Indocyanine Green During Primary Repair of Oesophageal Atresia and Distal Tracheo-oesophageal Fistula

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

This study aims to look at babies having a primary or delayed primary oesophageal repair for OA with dTOF to evaluate if using Indocyanine green (ICG) and near infrared fluorescence (NIRF) can decrease the rates of anastomotic leaks and/or predict which patients they will happen in. The latter evaluation would help counsel parents and mean that further research can evaluate if other tactics can prevent the leak being a moderate or severe problem. These may include, but not be limited to, extra anastomotic sutures, insertion of a chest drain at the time of surgery (if this had not previously been considered) delaying oral feeding or using medications to dry up the saliva prophylactically (these medications have been shown to reduce the length of time it takes leaks to seal). Any technique that can reduce leak rates in oesophageal atresia is to be welcomed. Additionally ICG may artifactually affect both peripheral oxygen readings (cause a transient decrease) and cerebral near infrared spectroscopy (NIRS) values (cause a transient increase). This is due to the temporary, dose dependent, interference of the dye with the mechanism of action of the monitoring rather than a physiological effect on oxygen levels. To date there has been no study investigating the effects of ICG on oxygen saturation and cerebral NIRS in neonates undergoing OA and/or dTOF repair. The theory is an extension from adult practice following oesophagectomy for cancer where there was a reduction in anastomotic leaks when using ICG/NIRF perfusion assessment. Another study in bariatric surgery using an enteral ICG/NIRF assessment was highly sensitive for anastomotic leaks allowing management of them intra-operatively. Objectives are to 1. Identify if the appearances of ICG/NIRF can predict anastomotic leaks 2. Identify if the ICG/NIRF images would engender a change in operative management leading to a reduced leak rate 3. Give a detailed report on the effects of ICG on oxygen readings This would be a cohort pilot study of 20 patients with the aim of informing a subsequent multi-centre Randomised controlled trial

NCT ID: NCT05735639 Recruiting - Clinical trials for Venous Thromboembolism

THRomboprophylaxis in Individuals Undergoing Superficial endoVEnous Treatment (THRIVE)

THRIVE
Start date: January 22, 2024
Phase: Phase 4
Study type: Interventional

Endovenous interventions are keyhole operations for varicose veins that are carried out from within the vein itself. Varicose veins are enlarged veins close to the surface of the skin. They are connected to the bigger deeper veins in the leg (known as deep veins). Because of this, operations to close the varicose veins can increase the chance of a blood clot forming in the deep veins. Blood clots in the deep veins happen in around 1 in 50 people after endovenous operations. A clot in the leg can cause swelling, pain, and other long-term problems. If a clot in the leg breaks off and travels to the lungs, it can cause problems with the lung' ability to move oxygen from the air into the blood and may, in rare cases, be life threatening. Varicose vein procedures may carry a slightly higher risk of blood clot formation, and we are currently unsure if current clot reducing medicines are beneficial in preventing blood clots in people having varicose vein procedures. This study will investigate if it is worthwhile prescribing medicines to reduce blood clots after varicose vein procedures.

NCT ID: NCT05734963 Recruiting - Cancer Clinical Trials

ORganoid GeneratioN Study for Cancer

ORIGINS
Start date: April 4, 2022
Phase:
Study type: Observational

ORIGINS - a multi-site sample collection study to establish patient-derived pre-clinical models for cancers

NCT ID: NCT05734950 Enrolling by invitation - Clinical trials for Breast Cancer Female

Biological Characteristics of Older Women (> 70 Years) With ER Positive, HER2 Negative Early Breast Cancer

BOLD-70
Start date: July 21, 2022
Phase:
Study type: Observational

This study is investigating the biological characteristics of early oestrogen receptor (ER) positive, human epidermal growth factor receptor 2 (HER2) negative breast cancer (BC) in older woman (aged > 70 years) who were treated with adjuvant endocrine treatment (ET). It will use surgical tissue previously collected as part of routine care from patients aged 70 years or older at diagnosis with ER positive, HER2 negative stage I-III BC treated The Royal Marsden NHS Foundation Trust (RMH). The overarching aim of this study is to define the biological characteristics of early BC in older women in terms of tumour microenvironment (TME), molecular and genomic features. This analysis will include assessment of tumour infiltrating lymphocytes (TILs), and gene expression profiling with NanoString using the Breast Cancer 360 (BC360TM) assay measuring ribonucleic acid (RNA) expression signatures of genes involved in proliferation, endothelial, angiogenesis, cytotoxicity, stroma, inflammatory chemokines, and apoptosis. This analysis will examine various biological pathways, aiming to inform suitability for certain treatments including cyclin-dependent kinase inhibitors (CDKi), chemotherapy, immunotherapy, or targeted treatments such as phosphoinositide 3-kinases (PI3K) inhibitors, or deoxyribonucleic acid (DNA) damage response.

NCT ID: NCT05734846 Completed - Presbyopia Clinical Trials

Multifocal Contact Lenses Fitting Methods Comparison

Start date: October 11, 2022
Phase: N/A
Study type: Interventional

The purpose of this study was to compare the clinical performance of two fitting approaches for multifocal contact lenses.

NCT ID: NCT05734196 Recruiting - Clinical trials for Pseudoxanthoma Elasticum

The ENERGY Study: Evaluation of Safety and Tolerability of INZ-701 in Infants With ENPP1 Deficiency or ABCC6 Deficiency

ENERGY
Start date: June 25, 2023
Phase: Phase 1
Study type: Interventional

The primary purpose of Study INZ701-104 (the ENERGY study) is to assess the safety and tolerability of INZ-701 in infants with ENPP1 Deficiency or with ABCC6 Deficiency.