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NCT ID: NCT03446547 Recruiting - NSCLC, Stage I Clinical Trials

Ablative STEreotactic RadiOtherapy wIth Durvalumab (MEDI4736)

ASTEROID
Start date: December 4, 2017
Phase: Phase 2
Study type: Interventional

This is a randomized multicentre open label phase II study of Durvalumab following Stereotactic Body Radiotherapy (SBRT) in patients with T1-2N0M0 NSCLC. Patients will be randomized 1:1 to follow up or receiving Durvalumab every 4th week for 12 months

NCT ID: NCT03444675 Recruiting - Clinical trials for Transplant; Complication, Rejection

The Endoscopic Assesment of Intestinal Grafts

INTEGRATE
Start date: April 29, 2014
Phase:
Study type: Observational

The study validates prospectively a new endoscopic scoring system (Gothenburg Intestinal Transplant Endoscopy Score, GITES) designed to summarize and stratify the abnormal ileal endoscopic findings after intestinal transplantation. GITES is a five-tier, four grade score which asseses mucosal friability, mucosal erythema and mucosal injury (ulcerations) as well as villous changes according to severity. These features (i.e., endoscopic descriptors) are also grouped from mild to very severe in the same sequence as observed during the progression of several pathologic conditions encountered after intestinal transplantation (acute rejection, infectious enteritis).

NCT ID: NCT03444623 Recruiting - Clinical trials for Rheumatoid Arthritis

Survivin as Predictive Biomarker for RA

SurviPred
Start date: June 2013
Phase:
Study type: Observational

Purpose: to examine the possibility of using the onco-protein survivin as a predictive biomarker for identifying individuals at risk of developing rheumatoid arthritis within a cohort of patients seeking treatment for joint pain/stiffness. Secondly, to study survivin as a prognostic marker for joint destruction, refractory and highly active disease in patients with established RA.

NCT ID: NCT03441035 Recruiting - Clinical trials for Liver Transplant; Complications

Albumin Mass Balance in Liver Transplantation

Start date: March 27, 2018
Phase:
Study type: Observational

This clinical observational cohort study assess the loss of albumin from blood circulation during and after liver transplantation by mass balance of albumin. The overall assumption of this method is that if albumin is more diluted than hemoglobin, it must have left the plasma, presumably into the interstitial space. Predictors of albumin leakage will be assessed, including biomarkers of inflammation and of endothelial damage and dysfunction. The sub cohorts children and patients with complications, defined as prolonged postoperative treatment in the intensive care unit, respectively, will be focused in separate publications.

NCT ID: NCT03440892 Recruiting - Clinical trials for Rheumatoid Arthritis

Effects of Antirheumatic Treatment on Levels of Survivin in Rheumatoid Arthritis Patients

SurviTreat
Start date: November 1, 2017
Phase:
Study type: Observational

To validate the utility of survivin as a biomarker of pharmacological response to therapeutic intervention in rheumatoid arthritis patients.

NCT ID: NCT03438994 Recruiting - Clinical trials for Autism Spectrum Disorder

Early Assessment of Autism Through Smart Tablet Gameplay

Start date: January 10, 2018
Phase: N/A
Study type: Interventional

The primary aim of this study is to compare the diagnostic accuracy of an iPad application (Play.Care assessment) with the current clinical "gold standard" diagnosis for diagnosis of Autism Spectrum Disorder (ASD) in children. Recent evidence has suggested that movement abnormalities are one of the early markers of ASD. However, current clinical diagnostic assessments fail to take this into account. Further, the current "gold standard" clinical tests take a number of hours to administer, require extensive clinical training and are subject to a certain level of subjectivity. Alternatively, by assessing a child's interaction with an iPad screen as they play, an objective measurement of movement can be obtained, which can aid in the diagnostic process. This study aims to recruit a total of 760 children (Typically Developing (TD), Other Neurodevelopmental Disorders (OND) and ASD groups) to assess the diagnostic accuracy of tablet game play in ASD. Children who have been diagnosed with ASD will perform the Play.Care assessment to assess if the tablet result matches their clinical diagnosis. Results from the clinical assessment and Play.Care assessment will then be compared to assess the sensitivity (the proportion of participants with ASD who test positive for ASD as a result of the Play.Care assessment) and specificity (the proportion of participants without ASD who test negatively for ASD as a result of the Play.Care assessment assessment) of the Play.Care assessment.

NCT ID: NCT03435796 Recruiting - Neoplasms Clinical Trials

Long-Term Follow-up Protocol for Participants Treated With Gene-Modified T Cells

Start date: June 19, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

This is a prospective study for the long-term follow-up (LTFU) of safety and efficacy for all pediatric and adult participants exposed to Gene-modified (GM) T cell therapy participating in a previous Celgene sponsored or Celgene alliance partner sponsored study. Participants who received at least one GM T cell infusion will be asked to enroll in this LTFU protocol upon either premature discontinuation from, or completion of the prior parent treatment protocol.

NCT ID: NCT03434938 Recruiting - Clinical trials for Patients (>=60 Years Old) Suffering From Mild-moderate Stroke (Ischemic or Hemorrhagic, Stroke Severity Assessed by NIHSS <16 Points)

IMAGINE Study Protocol

IMAGINE
Start date: June 19, 2018
Phase: N/A
Study type: Interventional

Background: Rehabilitation pathways are crucial to reduce stroke-related disability. Motivational Interviewing (MI), a centred-person intervention aimed to empower and motivate the patient, could be a resource to improve rehabilitation and its outcomes for older stroke survivors. Objective: The IMAGINE project aims to assess the impact of MI associated to standard geriatric rehabilitation, on 30 days functional improvement measured by the Functional Independence Measure (FIM), compared to standard geriatric rehabilitation alone, in patients admitted to geriatric rehabilitation after a stroke. Secondary objectives will be to assess the impact on physical activity and performance, self-efficacy, sense of coherence, safety, cost-utility and participants' experience, plus functional status at 3 months. Methods: Multicenter randomized clinical trial in three geriatric rehabilitation departments. Older adults after mild-moderate stroke without previous dementia, post-stroke severe cognitive impairment or delirium at admission, severe previous disability, aphasia or terminal conditions will be randomized into the control or the intervention group (136 per group, total N = 272). The control group will receive written information about the benefits of exercising, besides standard rehabilitation. The intervention group, in addition, will receive 4 sessions of MI by trained nurses. A shared tailored plan based on patients' goals, needs, preferences and capabilities will be agreed. Besides the FIM, in-hospital physical activity will be measured through accelerometers (activPAL) and secondary outcomes using internationally validated scales. As a complex intervention, a process evaluation and cost-utility assessments will be performed too. Results: Final results are expected by end of 2020. Implications: This project aims to achieve impacts on functional status, disability and physical performance and behavioral (increasing physical activity) and psychological implications (on general self-efficacy and sense of coherence) through a non-pharmacological and likely accessible, acceptable and scalable intervention. Efficiency and value, based on costs/quality adjusted life years, will be assessed. Moreover, a reduction in post-stroke disability would have social benefits also for families and would reduce health and social care costs. In brief, advances will be in terms of a better rehabilitation process.

NCT ID: NCT03434717 Recruiting - Breast Neoplasms Clinical Trials

Optimized Rehabilitation Following Primary Breast Cancer Surgery

RE-SCREEN
Start date: November 15, 2018
Phase: N/A
Study type: Interventional

This study aims to evaluate the effects of an intervention based on systematic screening of psychological distress as the basis for individualised support and rehabilitation following primary breast cancer surgery focusing on psychological , physical and health-economics outcomes. The aim is also to illuminate patients' and relatives' experiences and need of support during the rehabilitation .

NCT ID: NCT03427255 Recruiting - Dyspareunia Clinical Trials

CBT Group Treatment for Women With Dyspareunia

Start date: September 29, 2017
Phase: N/A
Study type: Interventional

The current study will employ a group CBT treatment program of 10 group sessions and 3 individual couple sessions targeting the thoughts, emotions, behaviors and couple interactions associated with the experience of dyspareunia. Women with superficial dyspareunia and their partners will be randomized to the CBT group program-plus or a waiting list control period at one treatment location in Sweden and two treatment locations in the Netherlands. The waiting-list control period will be comparable to the treatment duration of six months. It is hypothesized that the group program-plus is more effective in improving pain during intercourse in women with superficial dyspareunia compared to women on a waiting-list control period.