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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: 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: NCT05866757 Recruiting - Cancer Clinical Trials

Discontinuation Study

Start date: August 28, 2023
Phase: N/A
Study type: Interventional

An interventional, non-randomised study to assess the risk of progression after discontinuation of maintenance therapy in sustained MRD negative complete remission by flow cytometry MM patients without high-risk features who have completed at least two years of maintenance therapy or who have discontinued maintenance due to side effects. The primary endpoint is to assess the rates of sustained MRD negativity by NGF in the bone marrow at 12 months after discontinuation of maintenance therapy.

NCT ID: NCT05850078 Recruiting - Clinical trials for Vaginal Flora Imbalance

FB101 Intervention in Women Screened to Have Vaginal Dysbiosis (Dyscover-3)

Dyscover-3
Start date: May 18, 2023
Phase: N/A
Study type: Interventional

This study will explore and map the potential shifts in vaginal microbiomes as a consequence of a microbial intervention with product FB101 in healthy, asymptomatic volunteer women screened to have vaginal dysbiosis based on criteria defined by quantitative polymerase chain reaction (qPCR) analysis of a vaginal swab sample.

NCT ID: NCT05839704 Recruiting - Surgery Clinical Trials

A Comparison of Two Regional Techniques for Bariatric Sleeve Gastrectomy

Start date: March 2, 2023
Phase: N/A
Study type: Interventional

Regional anaesthetic techniques, or nerve blocks, are commonly used to provide postoperative pain relief for patients undergoing surgery. At present in University Hospital Galway, it is standard practice for patients undergoing bariatric sleeve gastrectomy surgery to receive a regional anaesthetic technique to improve their postoperative pain. There are a number of different regional anaesthetic options available for this surgery, but as yet, published evidence regarding which specific approach confers most benefit for patients is lacking. This study aims to compare two regional anaesthetic techniques - erector spinae plane blockade versus serratus anterior plane blockade plus subcostal transversus abdominus plane blockade - and assess if one approach provides a superior quality of recovery postoperatively for sleeve gastrectomy patients over the other.

NCT ID: NCT05817942 Recruiting - Ulcerative Colitis Clinical Trials

Prospective Observational Study of Effectiveness and Safety of Filgotinib in Participants With Ulcerative Colitis (UC)

GALOCEAN
Start date: June 12, 2023
Phase:
Study type: Observational

To describe the effectiveness, treatment patterns, quality of life, and safety of participants with moderately or severely active UC treated with filgotinib in a real-world setting.

NCT ID: NCT05804565 Recruiting - Diabetic Foot Clinical Trials

MetaMet: Bone Cutter Versus Bone Saw for Ray Amputation

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

Toe amputation is a commonly performed operation for infection and/or ischaemia (tissue death due to lack of blood flow). However, a large number of patients having this surgery ultimately require further amputation due to poor wound healing, new infections and/or new ulcers. Research to date has focused on patient-related factors associated with poor wound healing (e.g. diabetes, lack of blood flow, poor kidney function). However, there is no research looking at the technical surgical aspects of the procedure, specifically how the toe bone is cut. For this feasibility study, we will recruit forty patients whom a consultant vascular surgeon has decided requires amputation of one-to-two adjacent toes. The participants will be randomised by a computer model into one of the two metatarsal transection methods (bone cutters or bone saw) and the rest of the procedure will be carried out in the standard fashion. Patients and assessors will be blinded to which transection method is chosen. Patients will undergo a post-operative foot x-ray to assess for bone fragments within 48 hours of surgery and another at six months to assess for bone healing. Patients will be asked to rate their pain in the post-operative period using the verbal rating score. Patients will be followed after discharge from hospital by their public health nurse, as is standard practice, with regular follow-up in the surgical outpatients to assess wound progress. Patients will be asked to rate their quality of life at six weeks and six months post-operatively. These assessments will be coordinated with their routine post-operative follow-up clinic appointments, so as not to inconvenience patients with supernumerary visits.

NCT ID: NCT05803811 Recruiting - Quality of Life Clinical Trials

Effect of Colon Delivered Vitamin B2 on Gut Microbiota and Related Health Biomarkers in Healthy Older Adults

Start date: December 12, 2022
Phase: N/A
Study type: Interventional

The goal of this intervention study (clinical trial) is to investigate the effect of colon-delivered Riboflavin (vitamin B2) on the faecal microbial composition and diversity in older healthy subjects (50 -70 years of age)

NCT ID: NCT05802706 Recruiting - Vascular Diseases Clinical Trials

The Biomechanical Study of Diseased Human Carotid, Femoral and Abdominal Aortic Tissue

Start date: January 1, 2016
Phase:
Study type: Observational

This cross-sectional study aims to ascertain the mechanical properties of human carotid/femoral atherosclerotic plaque and abdominal aortic aneurysm tissue and correlate tissue mechanics with novel blood-based biomarkers of cardiovascular calcification.

NCT ID: NCT05800860 Recruiting - Clinical trials for Treatment-resistant Depression

A Trial of GH001 in Patients With Treatment-resistant Depression

Start date: May 24, 2023
Phase: Phase 2
Study type: Interventional

The aim of this randomized, double-blind, placebo-controlled, phase 2b clinical trial is to investigate the safety and efficacy of GH001 (containing mebufotenin [5-methoxy-N,N-dimethyltryptamine; 5-MeO-DMT]) in patients with treatment-resistant depression (TRD). The study is comprised of a 7-day double-blind (DB) part (Part 1) and a 6-month open-label extension (OLE) part (Part 2). Patients will be randomized to receive GH001 or placebo in a 1:1 ratio. The primary endpoint is the mean change in the Montgomery-Åsberg Depression Rating Scale (MADRS) from baseline to Day 7.