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NCT ID: NCT04243499 Recruiting - Solid Tumor, Adult Clinical Trials

First-in-Human Study of ICT01 in Patients With Advanced Cancer

EVICTION
Start date: February 10, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

Part 1 will be a dose escalation study of IV ICT01 (a monoclonal antibody targeting BTN3A) as monotherapy in patients with advanced solid or hematologic tumors, followed by a cohort examining the combination of ICT01 plus pembrolizumab (Keytruda). Part 2 will be a cohort expansion into 2 solid tumor indications and one hematologic malignancy for ICT01 monotherapy, and 3 solid tumor indications for the combination of ICT01 plus pembrolizumab.

NCT ID: NCT04242459 Recruiting - Clinical trials for Head and Neck Cancer

Optimising Radiation Therapy in Head and Neck Cancers Using Functional Image-Guided Radiotherapy and Novel Biomarkers

INSIGHT-2
Start date: October 23, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

This is a non-randomised study to develop personalised treatment approaches in participants with Locally Advanced Head and Neck Cancer (HNC) of the oropharynx and base of skull by integrating the use of MR-guided Adaptive Radiotherapy (MRgRT) and functional image-guided radiotherapy (FIgRT). The study is made up of two parts: 1. Feasibility planning study consisting of a total of 13 patients. This will include patients with either Human papilomavirus-associated (HPV-associated) oropharyngeal cancer (OPC), Human papilomavirus-negative (HPV-negative) OPC or Base of Skull HNC. 2. Single centre prospective interventional phase I/II study (main study) made up of 3 independent arms (on the condition of success of the feasibility stage). 1. Cohort 1: HPV-associated OPC consisting of 25 participants 2. Cohort 2: HPV-negative OPC consisting of a minimum of 10 patients and a maximum of 53 participants 3. Cohort 3: Base of Skull HNC consisting of 25 participants

NCT ID: NCT04241263 Recruiting - Preterm Infant Clinical Trials

Neonatal Wireless Monitoring System for Intensive Care

Start date: March 1, 2020
Phase: N/A
Study type: Interventional

Babies who require intensive care need to have their heart rate, oxygen levels and temperature measured continuously using specially designed monitors. These monitors allow the clinical team to constantly assess the baby and see if they are becoming unwell. However, these monitors each have separate wires to connect them to the baby. Another important part of care in these babies is being able to allow parents to hold their babies, getting them out of their incubators to be cuddled. This is called Kangaroo care and has been shown to impact on long term health for both babies and parents. We have designed a system to free babies of the wires that tether them to the monitors. This system has been tested in adults and we now want to test them on the babies. There are two study parts with two different questions: 1. How good is the data? This will compare the new wireless system with the existing system. Babies will have both standard wired monitors and the new wireless monitor on at the same time so we can compare the data to see how good is the quality of the data collected on the new system. 2. What do parents and staff think about the wireless system during Kangaroo care? Babies who no longer need monitoring (but who previously had been monitored with the wired system), will have the wireless system attached and the parent will take their baby from the cot for Kangaroo Care. After the baby has been placed back in the cot, we will conduct interviews with the parent and the nurse to find out what they thought of the new system. We hope this will help the investigators to understand about how good the data is we collect and how we might be able to improve the system.

NCT ID: NCT04241185 Recruiting - Clinical trials for Urinary Bladder Neoplasms

Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Chemoradiotherapy (CRT) Versus CRT Alone in Muscle-invasive Bladder Cancer (MIBC) (MK-3475-992/KEYNOTE-992)

Start date: May 19, 2020
Phase: Phase 3
Study type: Interventional

This study is designed to assess the antitumor efficacy and safety of pembrolizumab in combination with chemoradiotherapy (CRT) versus CRT alone in participants with muscle-invasive bladder cancer (MIBC). The primary hypothesis is that pembrolizumab + chemoradiotherapy is superior to placebo + chemoradiotherapy with respect to bladder intact event-free survival.

NCT ID: NCT04240769 Recruiting - Clinical trials for Arthroplasty, Replacement, Knee

Physical Activity Levels During Recovery Following Knee Arthroplasty

Start date: January 31, 2020
Phase:
Study type: Observational

The goal of this study is to utilize physical activity monitoring to determine the trajectory of normal recovery as it relates to a patient's ability to get up and get moving. From this work, we hope to be able to define the range in patients' physical activity following knee replacement surgery, and thus, give clinicians a tool and the methodology to identify patients whose recovery is not progressing as quickly as expected. Data from physical activity monitors will allow the research team to identify how active patients are, how vigorous that activity is, and how well that activity correlates with standard and commonly used patient questionnaires.

NCT ID: NCT04240002 Recruiting - Clinical trials for Acute Myeloid Leukemia (AML)

A Study of Gilteritinib (ASP2215) Combined With Chemotherapy in Children, Adolescents and Young Adults With FMS-like Tyrosine Kinase 3 (FLT3)/Internal Tandem Duplication (ITD) Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)

Start date: September 4, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of the phase 1 portion (dose escalation) of the study will be to establish an optimally safe and biologically active recommended phase 2 dose (RP2D) and/or to determine maximum tolerated dose (MTD) for gilteritinib in sequential combination with fludarabine, cytarabine and granulocyte colony-stimulating factor (FLAG). The purpose of the phase 2 portion (dose expansion) is to determine complete remission (CR) rates and composite complete remission (CRc) rates after two cycles of therapy. The study will also assess safety, tolerability and toxicities of gilteritinib in combination with FLAG, evaluate FLT3 inhibition, assess pharmacokinetics (PK), perform serial measurements of minimal residual disease, obtain preliminary estimates of 1-year event free survival (EFS) and overall survival (OS) rate and assess the acceptability as well as palatability of the formulation. One cycle is defined as 28 days of treatment. A participant completing 1 or 2 treatment cycles in phase 1 or 2 will have the option to participate in long term treatment (LTT) with gilteritinib (for up to 2 years).

NCT ID: NCT04239495 Recruiting - Sarcopenia Clinical Trials

Muscle Ageing Sarcopenia Study Lifecourse (MASS Lifecourse)

MASS_LC
Start date: October 9, 2018
Phase:
Study type: Observational

Sarcopenia is the loss of muscle mass and function with age. It has been recognised as an important health problem because it is common in older adults and associated with decline in physical function as well as a reduced quality of life. Sarcopenia can also lead to serious health consequences in terms of increased disability and the need for increased health and social care. There is considerable interest in understanding what causes sarcopenia in order to develop new approaches to prevention, diagnosis and treatment. To gain a detailed understanding of sarcopenia across a range of ages, we have designed the Muscle Ageing Sarcopenia Study (MASS_Lifecourse) in collaboration with members of the public and patients.

NCT ID: NCT04239430 Recruiting - HIV/AIDS Clinical Trials

Propositive (Protecting Positive People From Meningococcal Infection) Follow-up Study

Start date: November 26, 2020
Phase:
Study type: Observational

The need for and timing of booster doses of meningococcal vaccines in People Living with HIV (PLWHIV) is currently unknown. As such it is impossible for clinicians to recommend booster doses or to know if and when these might be necessary.We propose to follow up a group of participants from the Propositive study who received two doses of both MenB (Bexsero) and MenACWY (Menveo). This was a group of PLWHIV between the ages 18-45 years. We propose following up these participants at 18 and 30 months post completion of two doses of vaccine and investigating their immunological response.

NCT ID: NCT04239287 Recruiting - Premature Birth Clinical Trials

Preterm Lung Function and Exercise Response Measured by OEP

Start date: September 2, 2019
Phase:
Study type: Observational

This study will explore lung function and respiratory health in school-aged children who were born prematurely at <32 weeks gestation. It will involve full lung function assessment, a questionnaire and discussion about respiratory health, and an exercise test using optoelectronic plethysmography (OEP) to measure breathing patterns.

NCT ID: NCT04238611 Recruiting - Exercise Clinical Trials

Minimally-Invasive Realtime Assessment of Continuous Lactate in Exercise

MIRACLE
Start date: March 1, 2021
Phase: N/A
Study type: Interventional

Lactate is a compound produced as a by-product of glycolysis. The increase in lactate concentration can result from a variety of causes, such as during anaerobic metabolism in exercise or haemodynamic shock in conditions such as sepsis. The study will aim to validate a novel microneedle-based minimally invasive device for the continuous measurement of lactate during exercise.