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NCT ID: NCT05876754 Recruiting - Cholangiocarcinoma Clinical Trials

An Early Access Study of Ivosidenib in Patients With a Pretreated Locally Advanced or Metastatic Cholangiocarcinoma

ProvIDHe
Start date: May 3, 2023
Phase: Phase 3
Study type: Interventional

A Phase 3b research study to consolidate the data that ivosidenib is safe and effective in adult patients with previously treated, locally advanced, or metastatic cholangiocarcinoma (CCA). All patients who meet inclusion criteria will be enrolled to receive ivosidenib tablets orally once daily for 28 day cycles, continuing as long as clinical benefit and consent for participation is maintained. There will be a minimum of 6 study visits from screening until the final follow-up, if one cycle of treatment is completed and consent is maintained through 18 months of follow-up. Each additional cycle completed will add one study visit, on the first day of each cycle.

NCT ID: NCT05876195 Recruiting - Immune Response Clinical Trials

KLH Challenge to Explore the Human Immune Response

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

One approach to improve the efficiency of the drug development process is the use of human 'immune challenge' studies. In these studies, healthy volunteers are given small amounts of substances which are foreign to their immune system to provoke a temporary response: the 'challenge'. Depending on the nature and dose of the challenge, the body's immune system will react in a different but predictable way, elements of which mimic those seen in disease, thereby 'modelling' them. These models can help safely bridge the gap between animal experiments and patient groups and, if sufficiently understood, test the effect of new drugs without exposing patients to risk. Sadly, whilst immune challenge models have been used in drug development for many years, this has been done in a largely non-standardised, ad hoc manner, which greatly limits the usefulness of the approach. The purpose of this research is to better understand, improve, and standardise a common method of immune challenge which uses a protein called 'Keyhole Limpet Haemocyanin' (KLH). KLH is available as a highly-purified formulation, and because it is not usually encountered by the human immune system (it is derived from an inedible shellfish), it allows us to study the development of immune responses right from the time it is administered. We plan to give different groups of healthy volunteers different doses of KLH with or without an 'immune-boosting' agent (Alhydrogel™ or Montanide ISA™51, commonly referred to as adjuvants), before measuring and comparing their response. We will then re-challenge all the volunteers a month later by injecting different doses of KLH into the skin on their forearms, similar to an allergy test, taking images, blood samples and skin biopsies to understand the nature, time course, and variability of the immune response in each individual. No previous studies have directly explored the effects of KLH dose or adjuvants in a rigorous manner. The results will help us to determine both whether administering KLH with different adjuvants elicits qualitatively different immune response profiles (thus modelling different diseases) and the optimal doses of KLH to evaluate new drugs with. In turn, we hope this will help improve the percentage of drugs progressing from concept to clinical therapy, addressing unmet health needs.

NCT ID: NCT05875792 Recruiting - Stroke Clinical Trials

EvolvRehab for Telerehabilitation

Start date: June 14, 2023
Phase: N/A
Study type: Interventional

This study includes two stages to develop the use of EvolvRehab telerehabilitation in the use of Stroke patients, early after stroke. All tasks will be conducted by multiple research sites. Stage 2 will include at least 6 weeks of study intervention, and up to 6 months follow-up, where possible.

NCT ID: NCT05874739 Recruiting - Parkinson Disease Clinical Trials

Mobilise-D: Extension Study

Start date: May 17, 2023
Phase:
Study type: Observational

The goal of this observational study is to investigate the ability of a mobility monitor to measure and predict outcomes in Parkinson's disease (PD). It is an extension of a previous study (the Mobilise-D Clinical Validation Study) and consists of an additional follow-up visit for PD participants and the recruitment of age matched control participants. The data will inform researchers about PD disease progression and normal changes in mobility associated with aging.

NCT ID: NCT05873686 Recruiting - Clinical trials for Advanced Solid Tumor

A Phase 1 Clinical Study of NXP900 in Subjects With Advanced Cancers

Start date: October 26, 2023
Phase: Phase 1
Study type: Interventional

The purpose of this dose escalation study is to evaluate the safety profile of escalating doses and dose schedules of NXP900.

NCT ID: NCT05872698 Recruiting - Portal Hypertension Clinical Trials

Beta-blockers or Placebo for Primary Prophylaxis (BOPPP) of Oesophageal Varices Trial.

BOPPP
Start date: June 1, 2019
Phase: Phase 4
Study type: Interventional

Research has proven that large varices can be treated with beta-blockers (a type of anti-hypertensive medication) to reduce the pressure in the veins. The management of small varices is still uncertain. This study aims to discover if beta blockers can be used in this setting. We hypothesize that beta blockers will reduce the risk of bleeding from small varices from 20% to 10% over a period of 3 years, resulting in significant cost savings to the NHS from better patient outcomes.

NCT ID: NCT05871996 Recruiting - Cancer Clinical Trials

Palliative Care and Oncology Survey on Terminology

POST
Start date: October 3, 2023
Phase:
Study type: Observational

The term '"cancer survivors" is widely used but has different definitions. One definition describes "cancer survivors" as individuals from the time of diagnosis throughout their lives, which includes people living with cancer and people free of cancer. The views of some groups included in this definition of "cancer survivors" have rarely been assessed, including those with cancer on anticancer treatment and those known to palliative care. How they view these terms could have important implications for how they receive care services. This is an international multi-centre observational study. It aims to recruit 3830 patients internationally across Australia, Canada, Ireland, the United Kingdom, and the United States of America. Participants known to cancer and/or palliative care hospital or hospice services as inpatients, outpatients or community patients will be asked to complete a survey during a one-off visit which should last under 30 minutes. The survey asks a series of questions to determine the perceptions of patients know to cancer and palliative care services about the terminologies used to describe them.

NCT ID: NCT05870540 Recruiting - Clinical trials for Treatment Resistant Depression

BPL-003 Efficacy and Safety in Treatment Resistant Depression

Start date: September 14, 2023
Phase: Phase 2
Study type: Interventional

This is a Phase 2 study randomized, quadruple masked, multi-center study designed to investigate the efficacy and safety of a single dose of BPL-003 combined with psychological support in patients with treatment resistant depression (TRD).

NCT ID: NCT05870501 Recruiting - Bipolar Disorder Clinical Trials

Synaptic Imaging and Network Activity in Treatment Resistant Depression

SIGNATURE
Start date: October 20, 2021
Phase: N/A
Study type: Interventional

The main aim of this research is to explore the effects that ketamine has on the functional connectivity of the brain in participants with treatment resistant depression (TRD). This study will investigate the relationship between these changes and response to treatment as measured by clinical scales, as well as examining drug induced changes in reward and emotion based brain activity, structural connectivity, cerebral blood flow, cognition, metabolism and blood markers of brain plasticity.

NCT ID: NCT05870332 Recruiting - Colo-rectal Cancer Clinical Trials

Nationwide Study of Artificial Intelligence in Adenoma Detection for Colonoscopy

NAIAD
Start date: October 16, 2023
Phase:
Study type: Observational

The goal of this trial is to determine whether use of a Computer Assisted Detection (CADe) programme leads to an increase in ADR for either units or individual colonoscopists, independent of setting or expertise