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NCT ID: NCT06219941 Recruiting - Gastric Cancer Clinical Trials

AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2

Start date: December 13, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the safety, tolerability, efficacy, pharmacokinetics (PK), and immunogenicity of AZD0901 as monotherapy and in combination with anti-cancer agents in participants with locally advanced unresectable or metastatic solid tumours expressing CLDN18.2.

NCT ID: NCT06218459 Recruiting - Low Back Pain Clinical Trials

A Comparison of Two Brief Interventions for People With Chronic Low Back Pain

RESET
Start date: May 1, 2024
Phase: N/A
Study type: Interventional

The goal is to undertake a Decentralized Randomized Pilot Feasibility study to inform the methods for a definitive Randomized Controlled Trial (RCT) (including recruitment success, participant experience, intervention delivery, safety, outcome measurement and sample size estimation). The main question is if the methods used are feasible for an adequately powered future RCT. Participants will be randomly allocated to receive either: Intervention - OldPain2Go® treatment or Placebo Control - Jacobson's progressive relaxation

NCT ID: NCT06218082 Recruiting - Vitiligo Clinical Trials

Vitiligo Registry for Adults and Children in the UK

VIRTUAL-UK
Start date: May 15, 2025
Phase:
Study type: Observational [Patient Registry]

Vitiligo is the most common depigmentation disorder affecting around 1% of the population worldwide. Fifty two percent of patients develop vitiligo before the age of 20 and around 80% develop vitiligo before the age of 30 years old.1 Vitiligo often presents in childhood and tends to be a lifelong disease, requiring prolonged courses of phototherapy. Currently no national or international registry for patients with vitiligo exists. Individual dermatologists maintain a database of such patients, however no coordinated efforts have been made to combine these individual registries into a broader national registry. Finally, recently published British Association of Dermatologists (BAD) guideline for the management of vitiligo, recommended the development of a national registry for people with vitiligo undergoing systemic or light therapy to identify outcomes and safety.

NCT ID: NCT06217822 Recruiting - Clinical trials for Advanced Metastatic Castration-resistant Prostate Cancer

First-in-human Study of 225Ac-PSMA-Trillium (BAY 3563254) in Participants With Advanced Metastatic Castration-resistant Prostate Cancer (mCRPC)

PAnTHA
Start date: March 7, 2024
Phase: Phase 1
Study type: Interventional

Researchers are looking for a better way to treat men who have metastatic castration-resistant prostate cancer (mCRPC). mCRPC is a cancer of the prostate (male reproductive gland found below the bladder) that has spread to other parts of the body. This type of prostate cancer does not respond to hormone treatment used to lower the level of testosterone, a male sex hormone, to prevent cancer from growing. The study treatment 225Ac-PSMA-Trillium, also called BAY3563254, is under development to treat advanced metastatic castration-resistant prostate cancer. It works by binding to PSMA and giving off radiation that can damage cancer cells and stop them from growing. The main purpose of this first-in-human study is to learn: - How safe is BAY3563254 in participants. - What is the recommended dose of BAY3563254 that is safe and works well that will be further tested in Part 2 of the study. - How well does BAY3563254 work in participants. To answer this, the researchers will look at: - The number and severity of medical problems including serious medical problems that participants experience after taking BAY3563254 - The number of dose-limiting toxicities (DLT) at each dose level. A DLT is a medical problem caused by a drug that is too severe to continue the use of that specific dose. - The number of participants whose cancer completely disappears (complete response) or reduces by at least 30% (partial response) after taking the treatment (also known as objective response rate (ORR)) - The number of participants who have a decrease in the levels of PSA* by at least 50% in their blood (also known as PSA50). PSA is a protein made by the prostate gland. High levels of PSA may indicate the presence of prostate cancer. - Participants' best response to treatment based on their PSA levels (also known as the best overall PSA response). The study will have two parts. The first part, called dose escalation, is done to find the most appropriate dose of BAY3563254 for use in the second part of the study. For this, each participant will receive one of different increasing amounts of BAY3563254. They will take BAY3563254 as an injection into a vein. All participants in the second part of the study, called dose expansion, will receive the most appropriate dose of BAY3563254 that was identified from the first part of the study. Participants in this study will take the study treatment once every 6 weeks, which is known as a treatment cycle. Each participant will have up to 4 of these treatment cycles, if the participant benefits from the treatment. Each participant will be in the study for approximately 6 years, including a screening phase of up to 30 days, 6 months of treatment depending on the participant's benefit, and a follow up phase of 60 months after the end of treatment. In addition, substudies performed during both dose escalation and dose expansion parts of the study will evaluate: - the clearance of radioactivity from the body over time - the doses of radiation that are delivered to normal organs and tumors - the ability of an experimental agent (Tris-POC) to decrease the amount of radiation absorbed by normal organs. During the study, the doctors and their study team will: - take blood and urine samples - check vital signs such as blood pressure, heart rate, and body temperature - examine heart health using electrocardiogram (ECG) - take tumor samples if required - check if the participants' cancer has grown and/or spread using CT (computed tomography) or MRI (magnetic resonance imaging) and bone scan - check the tumor status using PET (positron emission tomography) - check the amount of radiation absorbed by tumors and normal organs using SPECT/CT (single-photon emission tomography and computed tomography scan) - ask the participants questions about how they are feeling and what adverse events they are having. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatments. In addition, the participants will be asked to complete a questionnaire on quality of life at certain time points during the study. The treatment period ends with a visit in 6-12 weeks after the last BAY3563254 dose. About 6-12 weeks after the last dose and every 6 weeks thereafter, the study doctors and their team will check the participants' health and any changes in their cancer. This active follow-up period ends after 18 months. The long-term follow-up period will start after the end of the active follow-up visit and will continue for up to 60 months after the the last BAY3563254 dose. Participants will be contacted, typically by phone call or clinic visit, approximately every 12 weeks after the end of active follow-up.

NCT ID: NCT06217640 Recruiting - Heart Failure Clinical Trials

Multivariate Biomarker Study for Sarcopenia in Heart Failure

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

In the United Kingdom, heart failure (HF) affects about 900,000 people with 60,000 new cases annually. Up to 60% of people living with HF also experience sarcopenia, known as loss of muscle mass and strength. Sarcopenia contributes significantly to low physical capacity and exercise intolerance and worsens the prognosis of the disease and quality of life. In comparison to primary sarcopenia (age-related sarcopenia), secondary sarcopenia occurs if other factors, including malignancy or organ failure, are evident in addition to aging. Secondary sarcopenia is highly common in patients with heart failure (Sarc-HF) (prevalence is 35%-69%), and has a significantly negative impact on exercise capacity, weight-adjusted peak maximal oxygen consumption, left ventricular function, and re-hospitalization rates and mortality. In this integrated study of NHS patients with HF, the investigators aim is to identify the underlying mechanisms of muscle weakness in HF utilizing including body composition, circulating metabolites (metabolic profile), and functional tests for (1) early detection of otherwise subclinical HF, (2) diagnostic assessment of clinically manifest HF-sarcopenia, (3) the risk stratification of subjects with a suspected or confirmed diagnosis, and (4) selection of an appropriate therapeutic intervention.

NCT ID: NCT06216626 Active, not recruiting - Anxiety Clinical Trials

PRebiotic Intervention for Metabolic and MEntal Health (PRIME)

PRIME
Start date: June 19, 2023
Phase: N/A
Study type: Interventional

The purpose of the study is to determine whether a daily prebiotic fibre blend can reduce systemic inflammation, dyslipidemia, and self-report measures of mental health in individuals with metabolic syndrome. This study will help shape a larger randomised controlled study (RCT) powered to assess efficacy in a bigger cohort of patients. Primary outcome measures will explore the efficacy of a prebiotic fibre blend on systemic inflammation. Secondary and exploratory outcomes measures will explore the efficacy of the prebiotic blend on clinical biomarkers associated with cardiometabolic risk factors, microbiota features, and mental health. Using these data, we will also estimate in-year savings for the NHS in the metabolic syndrome population on a per participant basis.

NCT ID: NCT06215716 Recruiting - NASH With Fibrosis Clinical Trials

A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis

Start date: December 1, 2023
Phase: Phase 3
Study type: Interventional

This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in subjects with non-cirrhotic NASH/MASH and fibrosis stage 2 or 3.

NCT ID: NCT06215573 Active, not recruiting - Sleep Clinical Trials

Effect Of A Novel Melatonin Supplement On Sleep Quality

I-MASQ
Start date: December 4, 2023
Phase: N/A
Study type: Interventional

Melatonin is a hormone naturally found in our body that increases in our blood at night and controls how we sleep. Melatonin can also be taken as a pill and numerous clinical trials have documented improved sleep quality following melatonin supplementation before bed. However, it is not known whether such supplements actually increase blood melatonin above normal levels, particularly at night. The aims of this study are to investigate whether a novel melatonin supplement (Ritual Sleep BioSeriesTM Melatonin) can increase blood melatonin in human participants at night, and to determine if taking the supplement before bed for two-weeks can improve sleep quality.

NCT ID: NCT06213649 Not yet recruiting - Clinical trials for Acanthamoeba Keratitis

Parasitic Ulcer Treatment Trial

PUTT
Start date: April 2024
Phase: Phase 3
Study type: Interventional

The Parasitic Ulcer Treatment Trial (PUTT) is a multi-center, parallel-group, randomized clinical trial. The purpose of this study is to determine whether including topical corticosteroids in a regimen for acanthamoeba keratitis (AK) will improve vision. Patients presenting to all enrollment centers with evidence of acanthamoeba keratitis will be eligible for the trial if there is evidence of ocular inflammation after 4 weeks of anti-amoebic therapy. Those who agree to participate will be randomized to one of two treatment groups: - Group 1: Topical corticosteroid - Group 2: Topical placebo

NCT ID: NCT06212999 Recruiting - Clinical trials for Hidradenitis Suppurativa (HS)

A Study to Evaluate the Long-Term Safety and Efficacy of Povorcitinib in Participants With Moderate to Severe Hidradenitis Suppurativa

STOP-HS LTE
Start date: January 30, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate long-term safety and efficacy of povorcitinib in participants with moderate to severe hidradenitis suppurativa who completed the 54 weeks of study treatment within the originating parent Phase 3 studies (INCB 54707-301 [NCT05620823] or INCB 54707-302 [NCT05620836]).