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NCT ID: NCT02097667 Completed - Clinical trials for Fetal Growth Retardation

EVERREST Developing a Therapy for Fetal Growth Restriction

EVERREST
Start date: March 2014
Phase:
Study type: Observational

Fetal Growth Restriction (FGR) is a major obstetric problem, affecting 1.46 million fetuses worldwide each year and contributing to 50% of stillbirths. Severe early onset FGR affects 1 in 500 pregnancies, leading to stillbirth or the need for delivery before 28 weeks gestation. The combination of FGR and prematurity is associated with a significant risk of neonatal mortality and short and long-term complications. Even modest increases in birthweight (e.g from 500 to 600g) and gestation at delivery (e.g from 26 to 27 weeks) are associated with significantly better outcomes but there are currently no treatments. The EVERREST Clinical Trial, funded by the European Commission, aims to develop a treatment which will increase fetal growth in severe early onset FGR. It will use gene therapy injected into the uterine arteries of the mother to increase the levels of vascular endothelial growth factor (VEGF) and so increase uterine artery blood flow and fetal growth. The EVERREST prospective study aims to form a clinical database and biobank of pregnancies affected by severe early onset FGR to improve understanding of the condition and serve as a comparison to assess the safety and efficacy of this intervention. The prospective study will take place across four European centers who will later take part in the EVERREST Clinical Trial. Women with singleton fetuses with early onset FGR will be approached to take part in the study. Participating women will provide blood samples, details of their clinical condition, samples of umbilical cord blood, placenta and myometrial and placental bed biopsies at the time of Caesarean section (if needed). Data on short and long-term outcomes of the babies will be collected. All data will be entered onto a central database for eventual use as a comparator for treated women on the EVERREST Clinical Trial, for which separate ethical approval will be sought.

NCT ID: NCT02096679 Completed - Healthy Volunteers Clinical Trials

Study Evaluating the Pharmacokinetic and Mass Balance of Single Dose [14C] AZD9291 in Volunteers

Start date: May 2014
Phase: Phase 1
Study type: Interventional

Study to evaluate the pharmacokinetic and Mass Balance of single dose [14C] AZD9291 in healthy male volunteers

NCT ID: NCT02096484 Completed - Clinical trials for Generalized Anxiety Disorder

A Feasibility Study of Group Metacognitive Therapy Versus Mindfulness Meditation Therapy

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

The study will examine the effectiveness of group metacognitive therapy in comparison with group meditation therapy, in patients with Generalised Anxiety Disorder. Individuals will be randomly assigned to either meditation or metacognitive therapy and undergo 8 group therapy sessions of their respective treatment condition.

NCT ID: NCT02096393 Completed - Clinical trials for Osteoarthritis of the Knee

Patient Specific Instrumentation in TKR

Start date: September 2013
Phase: N/A
Study type: Interventional

This is a randomised control trial to assess the benefits of using patient specific instrumentation in total knee replacement surgery. Patient specific instrumentation is an individualised system for total knee replacement surgery. The system has been marketed and is already in use in some centres. The type of implant used remains the same but the sizing of the components, and alignment of the implant is expected to improve. This study assesses any improvement in implant alignment in using the patient specific instrumentation, any improved intra-operative outcomes and any long term clinical outcome improvements for patients.

NCT ID: NCT02095886 Completed - Clinical trials for Infection, Human Immunodeficiency Virus

Relative Bioavailability Study With BMS-955176

Start date: March 25, 2014
Phase: Phase 1
Study type: Interventional

The purpose of this study is to select the best dose level (amount of drug given) and best formulation of the study drug (BMS-955176) to develop further.

NCT ID: NCT02095873 Completed - Glucose Intolerance Clinical Trials

Healthy Aging Through Functional Food

HATFF
Start date: May 2014
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine whether dietary inducers of glyoxalase 1 are effective in improving metabolic and vascular health.

NCT ID: NCT02095262 Completed - Tinnitus Clinical Trials

Gameplay as a Source of Intrinsic Motivation in a Randomized Controlled Trial of Auditory Training for Tinnitus

TAG
Start date: August 2011
Phase: Phase 1/Phase 2
Study type: Interventional

Tinnitus refers to a the perception of a ringing, hissing or buzzing sound despite there being no such sound in the external world. It is prevalent and for many individual is a distressing condition. Recent advances in the understanding of changes in the hearing brain and their relation to tinnitus perception has led to a focus on forms of active auditory training which might provide effective techniques for tinnitus management. Our recent trial of auditory training provided evidence that training using sounds where there is no hearing loss has benefit in terms of reduced tinnitus intrusiveness, above training at where there is some level of hearing loss. Our next challenge is to build on this finding in ways that might maximize the benefits we observe. The training software we used previously was developed for use with children. Past participants have given mixed reviews of this software. While some enjoyed the training or found it soporific, others reported that they found it too monotonous and un-motivating. We therefore wish to explore the impact of different game mechanics in the delivery of auditory training and have designed two different interactive games in the context of training for tinnitus benefit. These games will deliver the same type of auditory training as the software we currently use, but should be intrinsically motivating, i.e. be a game that the people are motivated to play irrespective of any potential benefit for tinnitus. The game we previously used is reactive, i.e. the sounds play and the player selects what they think is the correct answer (odd one out). The two new games we wish to test can be described as interactive, i.e. players control the sound delivery and actively seek the correct answer: this may have additional benefit for tinnitus.

NCT ID: NCT02094820 Completed - Clinical trials for Chronic Fatigue Syndrome

Psychological Wellbeing in Chronic Fatigue Syndrome

Start date: May 2014
Phase: N/A
Study type: Observational

Objectives: Chronic Fatigue Syndrome (CFS) is a medically unexplained condition characterized by severe and disabling fatigue. To date much research has focused on finding out whether CFS is caused by mainly physical or psychological factors. Perhaps as a result of this, few studies have examined the relationship between CFS and quality of life, in particular, more positive aspects of mental health, such as an individual's sense of purpose, autonomy and close relationships. This study will address these limitations by examining Ryff's (1989) six domains of psychological well-being (PWB), and other aspects of well-being including positive emotions, in CFS. It will also examine the relationship between measures of symptomology, emotional distress and PWB. Method: This is a cross-sectional, questionnaire-based study with a clinical sample of adults with CFS. Participants will complete valid measures of well-being and symptomology. Results: We expect to find that compared to general population norms, individuals with CFS score lower on measures of PWB. Secondly, we expect PWB dimensions will be related to symptom measures. There are however, no grounds for making strong predictions. Implications: This study will advance our understanding of quality of life in CFS. Clinically, it has the potential to enrich and inform therapeutic interventions.

NCT ID: NCT02094742 Completed - Clinical trials for Metastatic Breast Cancer

BIG Molecular Screening Feasibility Study

BIG MS Pilot
Start date: May 2013
Phase: N/A
Study type: Interventional

This pilot study examines the feasibility and turnaround time of performing and obtaining data from a few key molecular assays. These assays will be performed using different laboratories and technologies from core biopsies taken from patients diagnosed with invasive recurrent or metastatic breast cancer. All results will be uploaded, stored and assessed using the IT Molecular Screening Prototype Platform (MSPP). The MSPP will also be evaluated for ease of use to screen patients for participation in future molecularly defined clinical trials in breast cancer.

NCT ID: NCT02094521 Completed - Healthy Clinical Trials

Evaluation of Optimal Dosing Conditions for GLP-1 Analogue NNC0113-0987 When Administered Orally in Healthy Male Subjects

Start date: March 2014
Phase: Phase 1
Study type: Interventional

This trial is conducted in Europe. The aim of the trial is to evaluate the optimal dosing conditions for GLP-1 analogue NNC0113-0987 when administered orally in healthy male subjects.