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NCT ID: NCT02613962 Recruiting - Clinical trials for Relapsed or Refractory Pediatric Tumor

Proof -of -Concept Study To Stratify Targeted Therapies Adapted To Molecular Profiling

MAPPYACTS
Start date: January 13, 2016
Phase: N/A
Study type: Interventional

In the light of the development of high-throughput technologies enabling a biology-based reclassification of tumors and the increasing number of available specifically targeting anticancer agents the era of "precision medicine" has begun. Several clinical precision medicine trials with the aim of stratifying treatment according to molecular profiles (for example in France: 'MOlecular Screening for CAncer Treatment Optimization' MOSCATO-01, SHIVA, PROFILER, Safir01, Safir02) are ongoing in adults and have shown the feasibility of this approach. MOSCATO-01 is the first trial worldwide including pediatric patients, performing an on-purpose intervention and molecular profiling in recurrent tumors. Together with more than 500 adult patients, between December 2012 to August 2014, the tumors of 35 children and adolescents have been profiled, confirming that this approach is feasible in pediatric patients albeit with accelerated time stringencies. Importantly, the results of the first children and adolescents profiled showed that 2/3 of patients had 'actionable' alterations using hot spot mutations sequencing and CGH array (Geoerger B et al, ASCO 2014). The project 'MAPPYACTS' will use both Whole Exome Sequencing (WES) and RNA Sequencing of tumor tissue to increase the number of targetable genomic alterations. Furthermore to improve understanding of the overall molecular profile and possible response to treatment, methylation array, miRNA expression profiles, and study of immunomodulators will be performed on tumor samples subsequently. CLIP2 (INCa-labeled early phase clinical trials centers) - SiRIC (INCa- labeled comprehensive cancer centers) molecular profiling and bioinformatics platforms will contribute with their expertise in molecular profiling projects and characterization of pediatric cancers. Data interpretation of molecular genetic alterations detected by WES and RNA Seq and treatment recommendation will be done within a multidisciplinary therapeutic molecular biology tumor board. 'MAPPYACTS' will produce one of the largest cohorts of molecularly characterized relapsed tumors reported to date, and thanks to increased access to clinical trials since the European pediatric legislation, the investigators expect that 20-30% of patients can be stratified into a targeted trial based on the detected profile. It is the investigators' intention that this initiative paves the way to enrich ongoing clinical targeted agent trials, to increase the numbers of stratified clinical trials, to an earlier access to targeted agents, and will play a crucial role in the relevant development of these new agents in pediatric malignancies.

NCT ID: NCT02583347 Recruiting - Sleep Disorders Clinical Trials

Sleep Disturbance in Patients With End-Stage Renal Disease

Start date: December 2015
Phase: N/A
Study type: Observational

Sleep disorders are common in patients who have chronic kidney disease (CKD). Insomnia is reported in up to 50% of patients treated with hemodialysis compared to 12% of a control population. Restless leg syndrome (RLS) and periodic limb movement disorder (PLM) have been described in 30 to 70% of patients with end stage kidney disease (ESKD). Patients with CKD have also been reported to have a very high prevalence of sleep apnoea disorder. Conventional hemodialysis and peritoneal dialysis do not appear to improve sleep disorders in patients with CKD. There is emerging evidence that nocturnal HD can lead to improvements in sleep quality. Transplantation is thought to improve sleep-related disorders in some but not all patients. Project Aims The aims of this project were three-fold: 1. To perform detailed assessment of sleep quality in a cohort of Irish patients with ESRD 2. To assess the feasability and tolerability of unattended home PSG and wrist actigraphy as diagnostic tools in this cohort 3. To assess the impact of a change in RRT modality on sleep quality in Irish patients with ESRD

NCT ID: NCT02463916 Recruiting - Clinical trials for Rheumatoid Arthritis

A Trial to Determine the Effects of Exercise in Inflammatory Bowel Disease and Rheumatoid Arthritis

ExMET-IBD
Start date: March 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is too determine the effects of exercise on the gut microbiota and immunological markers in patients with inflammatory bowel disease and rheumatoid arthritis.

NCT ID: NCT02449200 Recruiting - Clinical trials for Cervical Radiculopathy

RCT of Multimodal Physiotherapy for Acute / Sub-acute Cervical Radiculopathy

PACeR
Start date: May 2015
Phase: N/A
Study type: Interventional

Multimodal physiotherapy involving manual therapy and exercise has demonstrated a positive effect on pain and disability in sub-acute and chronic cervical radiculopathy (CR) but a research gap exists for optimal management in the first 12 weeks and short-term natural history of the condition is unclear, although thought to be favourable within the first 4 weeks. The primary aim of this single blind, 2 group randomised controlled trial (RCT) is to investigate the effects of a 4 week (6-8 sessions) programme of manual therapy, exercise and upper limb unloading tape compared to advice to stay active, on disability, pain and other biopsychosocial measures, in acute / sub-acute cervical radiculopathy patients. The hypothesis is that a 4 week multimodal physiotherapy programme will lead to changes in self-reported disability and pain, compared to advice to stay active, in patients with acute / sub-acute cervical radiculopathy. A secondary study objective is to identify whether variables from the baseline examination, group allocation and aetiology confirmed by MRI can predict outcome, as measured with the Global Rating of Change Scale (GROC). Subjects will be diagnosed with CR based on a diagnostic clinical prediction rule. Random group allocation, allocation concealment, blinded assessment and intention to treat analysis will be employed. Outcomes will be measured at baseline, 4 and 12 weeks. Patients' report of pain, disability and their rating of recovery will also be recorded by telephone interview at 6 months. An internal pilot feasibility study will be undertaken in advance of the main study to test recruitment and retention strategies. Statistical analysis of differences between groups will be done with ANOVAs and MANOVAs. Appropriate multivariable regression analysis will be used to explore predictors of outcome.

NCT ID: NCT02423421 Recruiting - Clinical trials for Irritable Bowel Syndrome

Faecal Microbiota Transplantation in Irritable Bowel Syndrome

Start date: March 2015
Phase: Phase 2
Study type: Interventional

The purpose of thus study is to determine if faecal microbiota transplantation will result in improvement in clinical outcomes in patients with irritable bowel syndrome.

NCT ID: NCT02405975 Recruiting - Clinical trials for Appropriateness of Prescribing in Older Patients

RCT Assessing the Impact of Online Training on Doctors' Prescribing for Older Patients

Start date: August 2014
Phase: N/A
Study type: Interventional

This study will assess, by means of a randomized controlled trial, the impact of an online educational tool, on doctors' knowledge and confidence with regards to prescribing for older patients.

NCT ID: NCT02382770 Recruiting - Clinical trials for Open Abdomen Procedure

International Register of Open Abdomen

IROA
Start date: February 2015
Phase: N/A
Study type: Observational [Patient Registry]

To evaluate the different indications to Open Abdomen, the different techniques used to perform it, it's management, it's definitive closure and mortality rates linked to the different variables. Moreover to evaluate the 1 month and 1 year follow up in patients underwent to Open Abdomen.

NCT ID: NCT02351596 Recruiting - Cerebral Palsy Clinical Trials

Do Core Stability Exercise Classes Help Children With Cerebral Palsy Improve Their Balance

Start date: August 2014
Phase: N/A
Study type: Interventional

This study aims to determine if participation in a core stability physiotherapy group programme can improve the balance of children with cerebral palsy. It is hypothesised that teaching the children how and when to activate their deep core stabilising muscles may help improve their body awareness and their ability to control their alignment and therefore positively affect their balance. Children with cerebral palsy from the ages of 7 to 17, who can walk independently, will be randomly selected to join either the control group or intervention group, after completion of their baseline balance assessments. Each group will be re-assessed after completion of their 4 week intervention or control period.

NCT ID: NCT02343198 Recruiting - Venous Thrombosis Clinical Trials

The Use of NMES as a Home-based Therapy Following Total Knee Arthroplasty

Start date: August 2014
Phase: N/A
Study type: Interventional

The use of neuromuscular electrical stimulation (NMES) as a home-based therapy following total knee arthroplasty. Measures of interest: lower limb venous hemodynamics, joint range of motion, lower limb swelling, walking speed, quality of life, activities of daily living, device usability, device compliance, activity levels, and pain (VAS).

NCT ID: NCT02331485 Recruiting - Wound Infection Clinical Trials

Randomised Control Study to Asses the Role of Negative Pressure Wound Therapy (NPWT) in the Management of Wound in Surgical Patient

Start date: August 2014
Phase: N/A
Study type: Interventional

Aim of the study is to assess the role of negative pressure therapy in the prevention of the complication of the laparotomy wound in the high risk patients group. Primary outcome: Reduction in wound infection rate by 50% Secondary outcome: Reduction of the length of hospital stay Decrease of using abx. for wound management Decrease cost of patient treatment