Clinical Trials Logo

Filter by:
NCT ID: NCT01982084 Completed - Clinical trials for Group B Streptococcus

Group B Streptococcus: Attitudes to Immunisation in Pregnancy

Start date: January 2014
Phase:
Study type: Observational

Group B Streptococcus (GBS) is the commonest cause of severe infection and meningitis in babies under 3 months in the United Kingdom (UK). About one in ten babies with GBS infection die and half of babies with GBS meningitis are left with long term problems with their development. Vaccinating pregnant women against GBS in order to protect their newborn babies is a promising area of research.However, many women are reluctant to accept vaccination during pregnancy for fear it will harm their unborn child and there is often a lack of understanding of both the vaccine and the condition it aims to prevent. Nevertheless, the recent positive experience of immunisation against pertussis in the United Kingdom, suggest that antenatal immunisation can be acceptable. Previous research has shown that advice from maternity healthcare professionals regarding vaccination is highly valued by pregnant women so it is also important to explore the attitudes and opinions of this group. The objective of this study is to assess the knowledge and attitudes of pregnant women and maternity healthcare professionals in England and Scotland regarding GBS disease and the acceptability of a potential vaccine. There are two parts to this study. The first part will invite pregnant women, maternity healthcare professionals and parents who have had a child affected by GBS disease to take part in either a focus group or an individual interview. This will allow for an in-depth exploration of the participants thoughts and opinions about GBS and vaccination in pregnancy. This part of the study will take place at the Oxford site only. The results will guide the development of a self completed, paper questionnaire which will be distributed to a wider range of pregnant women and maternity healthcare professionals across four different study sites. This study has been funded by Meningitis UK. Additional collaborators to those listed include the charity Group B Strep Support.

NCT ID: NCT01981954 Completed - Pediatric Clinical Trials

A Clinical Study to Investigate How Solifenacin Fluid is Taken up, How Long it Stays in the Body and How Effective and Safe it is in Treating Children Aged From 6 Months to Less Than 5 Years With Symptoms of Neurogenic Detrusor Overactivity (NDO)

Start date: September 25, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study was to evaluate long term efficacy and safety of treatment with solifenacin succinate (the study drug) in children with neurogenic detrusor overactivity after multiple dose administration.

NCT ID: NCT01981928 Completed - Safety Clinical Trials

A Clinical Trial to Investigate Safety and Tolerability of ASP7962 in Healthy Humans

Start date: November 2013
Phase: Phase 1
Study type: Interventional

The purpose of the study is to see how safe the study drug is and how well it is tolerated after dosing. The study will also investigate how the study drug is taken up, metabolized (chemically broken down), distributed through the body and excreted. A further aim is to look at how this process is possibly altered by food by giving the study drug in the presence and absence of meals.

NCT ID: NCT01981850 Completed - Clinical trials for Primary Myelofibrosis

A Phase 2 Study of RO7490677 In Participants With Myelofibrosis

Start date: October 1, 2013
Phase: Phase 2
Study type: Interventional

RO7490677 is an investigational drug that is being developed for possible use in the treatment of myelofibrosis (MF), a disease in which the bone marrow, which is the organ in the body that makes blood cells, is replaced by fibrosis, or excess scar tissue. The purpose of this study is to gather information on whether RO7490677 has an effect on the MF disease, whether it is safe in patients with MF, and how well it is tolerated.

NCT ID: NCT01981837 Completed - Clinical trials for TTR-mediated Amyloidosis

Phase 2 Study to Evaluate ALN-TTRSC (Revusiran) in Patients With Transthyretin (TTR) Cardiac Amyloidosis

Start date: December 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the pharmacokinetics, pharmacodynamics and exploratory clinical activity of ALN-TTRSC (revusiran) in Patients with Transthyretin (TTR) Cardiac Amyloidosis.

NCT ID: NCT01981733 Completed - Clinical trials for Deep Vein Thrombosis

Improving Lower Limb Blood Flow in Healthy Adult Volunteers

THRIVE-1
Start date: March 2005
Phase: Phase 0
Study type: Interventional

The THRIVE-1 study will examine novel methods for enhancing blood flow in the lower limb using electrical stimulation. Increases in lower limb blood flow improve venous return and thereby reduce venous stasis. Since stasis is one of the compounding factors in the development of deep vein thrombosis, the risk of developing thrombosis should theoretically be proportionally reduced. This technique may prove to be a useful tool in preventing and reducing the incidence of deep vein thrombosis in both medical and surgical patients together with passengers undertaking significant duration travel (as travel - related deep vein thrombosis is not exclusively related to flying).

NCT ID: NCT01981720 Completed - Fabry Disease Clinical Trials

Extension Study of PRX-102 for up to 60 Months

Start date: January 16, 2014
Phase: Phase 1/Phase 2
Study type: Interventional

To evaluate the ongoing safety, tolerability, and efficacy parameters of PRX-102 in adult Fabry patients who have successfully completed treatment with PRX-102 in studies PB-102-F01 and PB-102-F02.

NCT ID: NCT01981616 Completed - Clinical trials for Inflammatory Bowel Disease

Immune Response to Systemic and Mucosal Antigenic Challenge in the Presence of Vedolizumab

Start date: September 2011
Phase: Phase 1
Study type: Interventional

The primary purpose of this study is to determine the rates of seroconversion to a hepatitis B vaccine series after a single 750 mg intravenous (IV) dose of vedolizumab or placebo. Secondary objectives are to determine the rates of seroconversion to an oral cholera vaccine series, assess change in anti-hepatitis B surface antibodies and assess the safety and tolerability of a single 750-mg IV dose of vedolizumab.

NCT ID: NCT01981018 Completed - Bipolar Disorder Clinical Trials

MAPP: Imagery-focused Therapy for Bipolar Disorder

MAPP
Start date: November 2013
Phase: N/A
Study type: Interventional

Bipolar Disorder (BD) (previously known as "manic depression") is a severe mental health illness affecting at least 1% of the population and with annual NHS cost estimated at £342 million. It is characterised by alternating episodes of acute mood swings: depression and "mania" (mood elation). BD also comes with less severe mood swings we call "mood instability", and ongoing high levels of anxiety that impair well-being even during periods between the acute mood breakdowns. Anxiety and mood instability are associated with worse outcome of the disorder. All these symptoms can be accompanied by the presence of troublesome mental images (e.g. seeing a memory in the mind's eye) such as intrusive "flashbacks" of negative past events. Recent studies suggest that individuals with BD experience more vivid, compelling and upsetting mental images compared to other patient groups and this could contribute to their clinical difficulties. Cognitive Behavioural Therapy (CBT) is a well established and successful psychological therapy used in the National Health Service (NHS), UK but as yet with limited efficacy in BD. Targeting mental imagery has long been part of general CBT. In particular, imagery-based treatment techniques have proved successful in anxiety disorders, but have not been brought to CBT for Bipolar Disorder yet. Our study Mood Action Psychology Programme (MAPP) investigates the delivery of a brief imagery-focused cognitive therapy (imCT) intervention to people with BD, studying a series of patients in detail one by one a "case series"). We offer a structured and individualised psychological treatment in line with the aims of NHS guidelines. The imCT protocol has been successfully delivered and audited in our psychological service in Oxford (OxMAPP). The proposed MAPP study aims to formally assess for the first time the effectiveness of imCT. In particular we hypothesise that imCT via the Mood Action Psychology Programme (MAPP) will result in (i) reduced levels of anxiety and (ii) reduced levels of low mood after treatment compared to baseline (both measured over 4 weeks) in individuals with BD. Overall, this works aims to contribute to improved psychological treatment for BD.

NCT ID: NCT01980966 Completed - Healthy Volunteer Clinical Trials

A Study of MHAA4549A in Healthy Volunteers in an Influenza Challenge Model

Start date: November 25, 2013
Phase: Phase 2
Study type: Interventional

This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of MHAA4549A in healthy volunteers in an influenza challenge model. Subjects will be intranasally oculated with the challenge virus and will be randomly assigned to receive a intravenous dose of either MHAA4549A or placebo. In the stage 5 cohort, subjects will be randomly assigned to receive doses of MHAA4549A or placebo or Tamiflu (oseltamivir) orally twice daily for 5 days. All subjects in all cohorts may take Tamiflu twice daily from Day 7 to Day 11.