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NCT ID: NCT05724602 Recruiting - Clinical trials for Locally Advanced Head and Neck Squamous Cell Carcinoma

Radiotherapy Plus Xevinapant in Older Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma

RAVINA
Start date: November 15, 2023
Phase: Phase 2
Study type: Interventional

This is a multicenter, randomized, placebo-controlled, triple blind, phase II study to determine the efficacy and safety of xevinapant with radiotherapy in older patients with locally advanced head and neck squamous cell carcinoma (LA-HNSCC) of oral cavity, oropharynx, hypopharynx, or larynx. Upon confirmation of eligibility, subjects will be enrolled and randomized in a 1:1 ratio to: - Arm A: 3 cycles of xevinapant (200 mg/day from Day 1 to 14, per cycle) + intensive modulated radiotherapy (IMRT) followed by 3 cycles of xevinapant in monotherapy phase (200 mg/day from Day 1 to 14, per cycle) - Arm B: 3 cycles of placebo (from Day 1 to 14, per cycle) + IMRT followed by 3 cycles of placebo in monotherapy phase (from Day 1 to 14, per cycle). Patients will be stratified by institution, disease location/p16 status (p16 positive oropharyngeal cancer, versus others), G8 score. Three strata for the G8 will be used (>14, versus 11-14 versus <11). Patients will undergo imaging in week 20 and upon clinical suspicion of progression/recurrence. Clinical examination will take place every 12 weeks in the first 3 years.

NCT ID: NCT05724316 Recruiting - Clinical trials for Vitamin D Deficiency

Effects of Vitamin D on the Behaviours, Mental, and Physical Health of Prisoners

Start date: March 18, 2023
Phase: N/A
Study type: Interventional

This study aims to understand how vitamin D (VD) affects human health. Typically, prisoners are low on vitamin D, as it is difficult to receive through diet, and is mostly obtained via exposure to the sun. The investigators predict that VD supplements could help improve overall mental well-being, as well as improve bone health. The investigators aim to recruit two groups of participants from a United Kingdom (UK) Prison, all of whom will participate via an informed consent process. The first group of prisoners will have chosen to take VD supplements, the second group will have chosen not to take VD supplements. At the start of the study, prisoners will have their bone density and blood VD levels tested. The investigators will also ask participants to complete a series of questionnaires to understand the state of mental well-being at the start of the study. Participants will be asked to complete a food diary to track dietary intake over the following week. Additionally, the investigators are interested in identifying what proportion of participants have a specific genetic makeup relating to their ability to metabolise VD, and participants will be asked to provide a saliva sample to test this. Every month following the start of the study, participants will be asked to complete the same questionnaires and food diary again. On the 3rd month, the investigators will again test the participants' bone density and blood levels of VD, to see whether supplementation has improved participant VD status. This study will run for a minimum of 3 months, up to a maximum of 6.

NCT ID: NCT05724303 Recruiting - Obesity Clinical Trials

The Effects of Integrative Neuromuscular Training on Physical Function in Overweight Children

Start date: February 24, 2023
Phase: N/A
Study type: Interventional

Childhood obesity is an ongoing and increasing issue, resulting in changes in body mass which cause biomechanical alterations in the lower limbs. Exercise interventions have been effectiveness at causing positive changes to the lower limbs gait, strength and functioning but children often report lack of enjoyment from the sessions which inhibits long term changes. This intervention takes a neuromuscular exercise approach whilst considering the psychological needs of children to motivate them to participate in the intervention and physical activity.

NCT ID: NCT05723562 Recruiting - Neoplasms, Rectal Clinical Trials

A Study of Dostarlimab in Untreated dMMR/MSI-H Locally Advanced Rectal Cancer

AZUR-1
Start date: April 3, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to investigate dostarlimab monotherapy in participants with locally advanced Mismatch-repair deficient (dMMR)/Microsatellite instability-high (MSI-H) rectal cancer who have received no prior treatment. Participants who achieve complete clinical response (cCR) following dostarlimab treatment will undergo non-operative management (NOM), including close surveillance for recurrent disease. The goal of the study is to determine if Dostarlimab therapy alone is an effective treatment that can allow participants to avoid chemotherapy, radiation, and surgery.

NCT ID: NCT05722938 Recruiting - Clinical trials for Community-acquired Pneumonia

Efficacy and Safety of Trimodulin (BT588) in Subjects With Severe Community-acquired Pneumonia (sCAP)

ESsCAPE
Start date: September 9, 2023
Phase: Phase 3
Study type: Interventional

The main objective of the trial is to assess the efficacy and safety of trimodulin as adjunctive treatment to standard of care (SoC) compared to placebo plus SoC in adult hospitalized subjects with sCAP on invasive mechanical ventilation (IMV). Other objectives are to determine detailed pharmacokinetic (PK) properties of trimodulin in a PK substudy and to determine its pharmacodynamic (PD) properties.

NCT ID: NCT05722886 Recruiting - Solid Tumor Clinical Trials

DETERMINE (Determining Extended Therapeutic Indications for Existing Drugs in Rare Molecularly Defined Indications Using a National Evaluation Platform Trial) - Master Screening Protocol

DETERMINE
Start date: March 1, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

DETERMINE is an open-label phase II/III trial. It will look at targeted treatments in rare cancers or common cancers with rare genetic change (mutation). Participants must have a cancer with an identified mutation. This could be found during routine testing or as part of another research programme. The DETERMINE trial will recruit adults, teenagers and children. If a drug is found to benefit a new patient group, the study team will work with the NHS and the Cancer Drugs Funds to see if these drugs can be available for patients in the future. This clinicaltrials.gov record refers to the Overall Trial Protocol (Master Screening Record), additional records will be added to clinicaltrials.gov for each treatment arm.

NCT ID: NCT05721365 Recruiting - Cancer Clinical Trials

The Use and Development of Patient Reported Outcome Measures (PROMs) in the Adoptive Cell Therapy (ACT) Setting

Start date: March 28, 2023
Phase:
Study type: Observational

The goals of this observational study is to 1. To develop an Adoptive Cell Therapy (ACT)-specific PROM (Patient Reported Outcome Measure) to assess quality of life and symptomatology 2. To develop guidelines/recommendations for the use of PROMs in ACT trials Participants will be recruited in four separate stages: Stage 1: Semi-structured interviews to generate PROM items. Stage 2: Cognitive interviews to ensure that all items are clear and easily understood. Stage 3: Initial pilot of the draft PROM to enable item reduction and refinement. Stage 4: Pilot of final PROM to assess acceptability in a clinical setting.

NCT ID: NCT05719922 Recruiting - Muscle Weakness Clinical Trials

The ADAPTation to Therapeutic Resistance Training (ADAPT) Study

Start date: December 1, 2022
Phase: N/A
Study type: Interventional

In 2018, the Academic Department of Military Rehabilitation (ADMR) published a pilot randomised controlled trial (RCT), demonstrating the feasibility and acceptability of integrating twice-daily blood flow restriction (BFR) training into a busy residential care setting. Following its publication was a guidance note written by the Directorate of Defence Rehabilitation restricting the implementation of BFR training until more evidence can be provided to support its efficacy. This research trial is a fully-powered, multi-centre RCT investigating the efficacy and biological mechanism underpinning BFR therapy in UK military personnel with lower-limb musculoskeletal injury (specifically, persistent anterior knee pain) during residential rehabilitation. This study will aim to optimise both the rehabilitation outcome and improve the time-and cost-effectiveness of the service delivered across UK Defence Rehabilitation and beyond. Results will provide insight and knowledge to the clinical and scientific community to not only those embedded within Defence Rehabilitation, but also those working in civilian sector organisations and professional sport in the UK and abroad.

NCT ID: NCT05719259 Recruiting - Clinical trials for Ventilator Associated Pneumonia

Perpetual Observational Study - Ventilator Associated Pneumonia

POS-VAP
Start date: August 3, 2022
Phase:
Study type: Observational [Patient Registry]

Ventilator-Associated Pneumonia (VAP) is a bacterial respiratory infection that patients in the Intensive Care Unit (ICU) often get when they cannot breathe for themselves and require mechanical ventilation. It is linked to higher chances of death, a longer stay in the hospital, higher costs, and the use of more antibiotics. Options to help prevent or treat this disease are in development and will require evaluation in future clinical trials. The goal of POS-VAP is to build and continuously train a network of ICUs to be prepared for doing these trials, to facilitate their execution.

NCT ID: NCT05719168 Recruiting - GERD Clinical Trials

Gastric Neuromuscular Function in GERD

Start date: October 1, 2022
Phase: N/A
Study type: Interventional

Bodysurface gastric mapping (BSGM) will be used to assess gastric neuromuscular function in healthy controls and patients with medical refractory gastroesophageal reflux disease (GERD). Participants will undergo BSGM for 4-hours in addition to high resolution manometry (HRM), pH-impedance monitoring, and gastric emptying breath test.