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NCT ID: NCT03126526 Completed - Healthy Clinical Trials

A Multimodal Outcome Study of Eating Disorders

Start date: November 26, 2017
Phase: N/A
Study type: Interventional

This research project aims to explore the effectiveness of combined go/no-go training and implementation intentions in targeting binge eating frequency among people with binge eating disorder and bulimia nervosa. The full intervention is 4 weeks long and consists of completing the training and food diaries every day and meeting with the researcher twice for EEG recording. Moreover, it involves completing questionnaires at baseline, at intervention completion, and one month after the intervention. Moreover, healthy control participants will be recruitment to complete baseline questionnaires and take part in one EEG recording session in order to assess baseline differences in brain activation in response to computer tasks.

NCT ID: NCT03126474 Completed - Clinical trials for Distal Radius Fracture

Defining Displacement Thresholds for Surgical Intervention for Distal Radius Fractures - a Delphi Study

Start date: February 17, 2017
Phase:
Study type: Observational

Wrist (distal radius fractures) are very common injuries. Despite this there is still much controversy about the best way to treat them and in particular which ones require intervention. Many studies have been carried out but there is no strong evidence to answer these questions. The investigators are carrying out a Delphi study which involves seeking consensus from experts at treating these injuries about the best way to manage them. UK and international expert surgeons will take part in three rounds of online questionnaires to help decide how much displacement of the fracture will trigger treatment for different common wrist fracture cases. The aim of the study is to obtain expert opinion through consensus from the expert group about the amount of displacement that is acceptable until intervention is required. This will provide guidance and reduce variation between treating surgeons.

NCT ID: NCT03125902 Completed - Clinical trials for Triple-Negative Breast Cancer

A Study of Atezolizumab and Paclitaxel Versus Placebo and Paclitaxel in Participants With Previously Untreated Locally Advanced or Metastatic Triple Negative Breast Cancer (TNBC)

IMpassion131
Start date: August 25, 2017
Phase: Phase 3
Study type: Interventional

This Phase 3, multicenter, randomized, double-blind, placebo controlled study is designed to evaluate the efficacy and safety of atezolizumab (MPDL3280A, an anti-programmed death-ligand 1 [PD-L1] antibody) administered in combination with paclitaxel compared with placebo in combination with paclitaxel in participants with previously untreated, inoperable locally advanced or metastatic, centrally confirmed TNBC. Participants will be randomized in a 2:1 ratio to receive atezolizumab or placebo plus paclitaxel until disease progression or unacceptable toxicity or end of study, whichever occurs first (maximum up to approximately 40 months). In addition, the Sponsor may decide to terminate the study at any time.

NCT ID: NCT03125616 Completed - Prematurity Clinical Trials

Babies Born Early Antibody Response to Men B Vaccination: BEAR Men B

BEAR Men B
Start date: August 1, 2017
Phase: Phase 4
Study type: Interventional

In the UK, babies receive their vaccinations according to a standard schedule, irrespective of their gestation at birth. This policy is designed so that all babies are protected as early as possible from vaccine preventable diseases such as polio, diphtheria, tetanus, rotavirus, pertussis (whooping cough), Haemophilus influenzae type B, pneumococcal disease and now meningococcal B disease. The 4CMenB vaccination (Bexsero®) was added to the UK schedule in September 2015 and there has been no research looking at whether the vaccine gives the same protection to babies born early as it does to those born at term. The Investigators want to compare two different schedules of 4CMenB and see if one gives better protection to babies born prematurely. It is possible that an extra 4CMenB dose (i.e. three doses in early infancy instead of two) will offer better protection for premature babies. This is what the Investigators are trying to find out through this study.

NCT ID: NCT03124121 Completed - Ulcerative Colitis Clinical Trials

Study of the Golimumab Exposure-Response Relationship Using Serum Trough Levels

GO-LEVEL
Start date: September 5, 2017
Phase: Phase 4
Study type: Interventional

The purpose of this study is to gain insight into the exposure-response relationship of golimumab in moderate-to-severe Ulcerative Colitis (UC). Patients commencing induction therapy with golimumab will be enrolled into a prospective study and evaluated at three time-points (weeks 6, 10 and 14) for clinical and biochemical UC disease activity as well as serum golimumab concentrations and the presence of anti-golimumab antibodies. Patients already established on stable golimumab maintenance therapy will be enrolled into a cross-sectional study with the same evaluations taken at a single time point.

NCT ID: NCT03124108 Completed - Clinical trials for Primary Biliary Cholangitis (PBC)

Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) and Inadequate Response to Ursodeoxycholic Acid

Start date: April 5, 2017
Phase: Phase 2
Study type: Interventional

The primary objective of the study is to compare the effect of daily oral administration of elafibranor 80mg and 120 mg on change in serum alkaline phosphatase (ALP) to that of placebo in patients with PBC and inadequate response to Ursodeoxycholic acid (UDCA).

NCT ID: NCT03123120 Completed - Colitis, Ulcerative Clinical Trials

A Study in Patients With Mild or Moderate Ulcerative Colitis Who Take a TNF Inhibitor. The Study Investigates Whether Bowel Inflammation Improves When Patients Take BI 655130 in Addition to Their Current Therapy

Start date: June 7, 2017
Phase: Phase 2
Study type: Interventional

The objectives of this trial are safety and efficacy (proof-of-concept) of induction of mucosal healing by BI 655130 add-on therapy in patients with mild or moderate ulcerative colitis and persisting endoscopic activity despite pre-existing TNFi treatment. This trial will explore safety and efficacy of a dose of BI 655130 that was modelled to achieve the similar exposures as the highest exposures tested and found safe and tolerable in preceding single and multiple dose studies in healthy subjects, as add-on to pre-existing TNFi (Tumor necrosis factor inhibitor) treatment. Secondary and further objectives include assessment of the pharmacokinetic (PK) profile of BI 655130 and early exploration of specific biomarkers with potential usefulness to predict clinical efficacy or safety outcome or help understand BI 655130's mode of action.

NCT ID: NCT03122951 Completed - Clinical trials for Trying to Conceive Population

Clearblue® Advanced Ovulation Test User Study

Start date: April 21, 2017
Phase: N/A
Study type: Interventional

The Clearblue® Advanced Ovulation Test is designed for home use by women who are either planning or trying for a pregnancy. The purpose of this protocol is to demonstrate that lay-users representative of the target user population are able to use the product in the intended user environment.

NCT ID: NCT03120949 Completed - Clinical trials for Rheumatoid Arthritis

Efficacy and Safety of Olokizumab in Subjects With Moderately to Severely Active Rheumatoid Arthritis

CREDO 4
Start date: July 4, 2017
Phase: Phase 3
Study type: Interventional

The primary objective of this study was to evaluate the long-term safety and tolerability of olokizumab (OKZ) 64 mg administered subcutaneously (SC) once every 2 weeks (q2w) or once every 4 weeks (q4w) in subjects with moderately to severely active rheumatoid arthritis (RA) who previously had completed 24 weeks of double-blind treatment in Study CREDO 1, 2 or 3 (core studies). The long-term efficacy, immunogenicity, the physical function and quality of life of subjects received long-term treatment with OKZ were assessed as well.

NCT ID: NCT03120338 Completed - Clinical trials for Mental Health Services

DAWBA as a Rapid Online Assessment Tool

eCAP:DAWBA
Start date: April 1, 2017
Phase: N/A
Study type: Interventional

The European Union is funding this randomised trial in Scotland as part of the larger eCAP project (http://www.interreg-npa.eu/projects/funded-projects/project/139/). The need for psychiatric services for children and adolescents is usually greater than the services available. As well as this, in many cases, there is confusion as to which service the child or young person should be referred to. The way children and young people arrive at Child and Adolescent Mental Health Services (CAMHS) may therefore be relatively inefficient and families could suffer as a result of this inefficiency. The use of a computerised structured questionnaire such as the Development and Well-being Assessment (DAWBA) offers the opportunity for these difficulties to be addressed, for the avoidance of 'inappropriate referrals' and for more rational use of resources. It is usually administered online through a secure internet portal. At the end of the data collection, a computerised summary is generated from the data given by all the informants and a child/adolescent psychiatrist lists the likely diagnosis or diagnoses in a summary of the case and gives his view about the next steps. This is then made available to the referrer. This community-based study aims to establish whether using the DAWBA in this way helps children and young people with mental health problems. The main objectives are to improve their mental health, reduce waiting times, change referral practice, increase satisfaction in services and improve cost effectiveness. The principal outcome measure will be parent-rated Strengths and Difficulties Questionnaire (SDQ) score 6 months after randomisation. Secondary outcome measures will include teacher and child-rated SDQ at 6 months and waiting times to services. The investigators will also record service use data and family out -of -pocket costs. A random sample of young people, family and referrers will be interviewed to explore satisfaction with service.