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NCT ID: NCT04003636 Active, not recruiting - Clinical trials for Biliary Tract Carcinoma

Pembrolizumab (MK-3475) Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin for First-Line Advanced and/or Unresectable Biliary Tract Carcinoma (BTC) (MK-3475-966/KEYNOTE-966)

KEYNOTE-966
Start date: September 24, 2019
Phase: Phase 3
Study type: Interventional

This is a study of pembrolizumab plus gemcitabine/cisplatin versus placebo plus gemcitabine/cisplatin as first-line therapy in participants with advanced and/or unresectable biliary tract carcinoma. The primary hypothesis is pembrolizumab plus gemcitabine/cisplatin is superior to placebo plus gemcitabine/cisplatin with respect to overall survival (OS).

NCT ID: NCT04003610 Terminated - Clinical trials for Metastatic Urothelial Carcinoma

Pemigatinib + Pembrolizumab vs Pemigatinib Alone vs Standard of Care for Urothelial Carcinoma (FIGHT-205)

Start date: May 14, 2020
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of pemigatinib plus pembrolizumab or pemigatinib alone versus the standard of care for participants with metastatic or unresectable urothelial carcinoma who are not eligible to receive cisplatin, are harboring FGFR3 mutation or rearrangement, and who have not received prior treatment.

NCT ID: NCT04003597 Completed - Clinical trials for Elevated Blood Pressure

'Low-salt' Bread as a Means of Reducing Dietary Salt and Lowering Blood Pressure

Saltbreads
Start date: January 3, 2008
Phase: N/A
Study type: Interventional

In the context of public health, reformulation of bread in terms of salt content remains an important measure to help achieve a reduction in salt intake in the population. Therefore, the aim of this study was to examine, using a 5-week cross-over design, food-based intervention trial, the potential for inclusion of 'low-salt' bread as part of a pragmatic reduced-salt diet on blood pressure (BP) in adults with slightly to moderately elevated BP. The study consisted of a randomized crossover trial of the effect of reduced-salt intake or usual-salt intake for 5 weeks on BP (as the primary outcome) in adults with slightly to moderately elevated BP (seated office systolic BP >120 and <160 mmHg or a diastolic BP >80 and <95 mmHg; identified by a pre-screening phase). Subjects were randomly assigned to the reduced-salt diet or their usual-salt diet (control) for 5 weeks, followed by crossover to the alternative dietary regimen for a further 5 weeks. Subjects randomized to start on the reduced-salt diet were asked to restrict their consumption of dietary salt using a combination of pragmatic dietary advice as well as the replacement of bread and a limited number of other foods with equivalent foods which had lower salt content; these were provided to the participants. At the beginning of the salt restriction period, a research nutritionist provided the subjects with a list of the common salt-containing food and were asked to limit the consumption of such, as feasible. The subjects received in-house prepared 'low-salt (<0.3 g/100 g)' brown or white sliced pan bread as well as no-salt margarine/butter, and were given luncheon meats with no added salt, if desired (optional); these were supplied regularly by the research staff. Subjects commencing the trial on the control diet were allowed to follow their usual diet but were asked to consume an in-house produced brown or white sliced pan bread equivalent in composition to the low-salt version but with its more typical salt content (1.2 g/100 g). Participants met the research staff weekly to receive breads and no-salt margarine/butter as well as luncheon meats (where applicable), and at these meetings the staff promoted compliance with the intervention and encouraged completion of the study protocol. BP and other assessments were made at baseline and at the end of week 5 and week 10.

NCT ID: NCT03997643 Recruiting - Clinical trials for Head and Neck Cancer

Preservation of Swallowing in Respected Oral Cavity Squamous Cell Carcinoma: Examining Radiation Volume Effects (PRESERVE): A Randomized Trial

Start date: September 6, 2019
Phase: Phase 2
Study type: Interventional

The goal of this randomized treatment study is to formally compare quality of life in patients with at least one pN0 hemi-neck after resection of a squamous cell carcinoma of the oral cavity treated with a primary radiation therapy versus a secondary targeted radiation therapy approach, to provide a high level of evidence to guide the selection of treatment options.

NCT ID: NCT03992430 Active, not recruiting - Clinical trials for Muscular Dystrophy, Duchenne

A Study to Compare Safety and Efficacy of a High Dose of Eteplirsen in Participants With Duchenne Muscular Dystrophy (DMD) (MIS51ON)

Start date: July 13, 2020
Phase: Phase 3
Study type: Interventional

This study will be comprised of 2 parts: Part 1 (dose escalation) will be conducted to evaluate the safety and tolerability of 2 doses (100 milligrams/kilogram [mg/kg] and 200 mg/kg) of eteplirsen in approximately 10 participants with DMD; Part 2 (dose finding and dose comparison) will be conducted for the selection of a high dose (100 mg/kg versus 200 mg/kg) and its comparison with the 30 mg/kg dose of eteplirsen, in approximately 144 participants with genetically confirmed deletion mutations amenable to treatment by skipping exon 51.

NCT ID: NCT03988660 Completed - Appendicitis Clinical Trials

The Circulating Fibrocyte - a Novel and Accurate Biomarker in Diagnosing Acute Appendicitis in Adults

Start date: June 10, 2015
Phase:
Study type: Observational [Patient Registry]

Accurate diagnostic biomarkers for acute appendicitis (AA) are lacking. Circulating fibrocytes (CFs) are increased in inflammatory states. It is not known whether they are altered in appendicitis. This study aimed to assess if CF altered in AA, and compared their diagnostic accuracy with white cell count (WCC), C-reactive protein (CRP), neutrophils, lymphocytes, neutrophils-lymphocytes ratio (NLR), monocytes, basophils and eosinophils in diagnosis of AA in patients presenting with right iliac fossa pain (RIFP). 95 consecutive adults were recruited in a cohort based prospective study at University Hospital Limerick, 15 were healthy individuals and 80 were patients with RIFP. Peripheral venous samples were obtained at presentation. Clinical, biochemical and histo-pathological parameters were recorded. CF levels were determined by dual-staining for CD45 and Col-1 using FACS and correlated with histopathological diagnoses. P<0.05 was taken as significant. The study hypothesis is that in patients with suspected appendicitis, CF levels may improve the diagnostics, reduce unnecessary radiation and negative appendicectomy rates.

NCT ID: NCT03982394 Active, not recruiting - Clinical trials for Chronic Plaque Psoriasis

Observational Study of Patients With Moderate to Severe Chronic Plaque Psoriasis

VALUE
Start date: July 1, 2019
Phase:
Study type: Observational

This study will assess the use of risankizumab in adult patients with moderate to severe chronic plaque psoriasis and compare risankizumab to other commonly used biologics.

NCT ID: NCT03980314 Completed - Melanoma Clinical Trials

A Study to Compare Nivolumab Drug Product Process D to Nivolumab Drug Product Process C in Participants With Stage IIIa/b/c/d or Stage IV Melanoma After Complete Resection

Start date: June 24, 2019
Phase: Phase 1
Study type: Interventional

The purpose of this study is to compare the drug levels, immunogenicity and safety of Nivolumab Process D to Nivolumab Process C after complete resection of stage IIIa/b/c/d or stage IV melanoma.

NCT ID: NCT03979118 Completed - Advanced Cancer Clinical Trials

Exercise Prescription in Patients With Bone Metastases

Ex-Met
Start date: October 15, 2019
Phase:
Study type: Observational

Cancer which has spread to the bone, causing bone metastases (bone tumours) can weaken bone health and increase risk of fractures (breaks). Consequently, patients can be unsure whether to exercise and health professionals can be unsure what exercise advice is suitable. Despite this, it is well known that exercise improves quality-of-life for patients with bone metastases and therefore it is important that exercise is prescribed to these patients. This study aims to increase understanding of the link between daily exercise and risk of fracture in patients with bone metastases.

NCT ID: NCT03978325 Recruiting - Physical Activity Clinical Trials

Preoperative Exercise for Patients Undergoing Complex Cancer Surgery

PRE-HIIT
Start date: July 1, 2021
Phase: N/A
Study type: Interventional

Treatment for people with cancer of the lung or the oesophagus (food-pipe) often involves surgery. This surgery is complex and there is a high risk that patients will develop severe complications afterwards, leading to a longer hospital stay and higher hospital costs, and impacting greatly on recovery and quality of life. If patients' lungs and heart can be optimised before surgery, then recovery may be improved. While fitness can be improved by exercise, the lead-in time to surgery following a cancer diagnosis is often very short, and research is needed to examine what types of exercise might be most effective at increasing fitness over a short period. This project will investigate if high intensity interval training (HIIT) can increase fitness levels in people scheduled for surgery for cancer of the oesophagus or the lungs. HIIT alternates between periods of high intensity exercise, cycling on a stationary bike, followed by a period of more relaxed exercise. This approach is known to improve fitness but has not previously been investigated in patients awaiting complex cancer surgery. Groups will be compared for changes in pre-surgery fitness levels, any complications they may experience after surgery, general physical recovery after surgery and the cost of care after surgery. The investigators anticipate that patients who undergo HIIT before surgery will have less complications and better recovery after surgery, a significantly improved quality of life, and lower costs of care.