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NCT ID: NCT02307266 Completed - Acne Clinical Trials

Patient Education in Adherence on Acne (PEAce)

Start date: November 2014
Phase: Phase 4
Study type: Interventional

This is a multi-center, randomised and controlled study in subjects with acne vulgaris. The main objective of this study is to evaluate the effect of a supplementary patient education intervention (in addition to the standard-of-care patient education) on treatment adherence and satisfaction among acne patients receiving once-daily EpiduoTM gel treatment in primary care clinics.

NCT ID: NCT02307162 Completed - Clinical trials for Chronic Obstructive Pulmonary Disorder

SAD/MAD Study of a New Formulation of Nebulised RPL554 in Healthy Subjects and COPD Subjects

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

The purpose of the study is to assess the safety of single doses and multiple doses of a new formulation of RPL554 in healthy subjects and subjects with chronic obstructive pulmonary disorder.

NCT ID: NCT02307097 Completed - Clinical trials for Social Anxiety Disorder

RCT of Bibliotherapy for Social Anxiety Disorder as a Prelude to CBT in IAPT

RCT of CBB/CBT
Start date: January 1, 2016
Phase: N/A
Study type: Interventional

The efficacy of high-intensity Cognitive-Behavioural Therapy (CBT) for social anxiety disorder is well established (Mayo-Wilson et al., 2014) and it is recommended by the National Institute of Health and Clinical Excellence (NICE) as the first-line psychological intervention for social anxiety disorder. The treatment aims to modify several maintenance factors (e.g., self-focused attention) that are specified in cognitive models of social anxiety disorder (e.g., Clark & Wells, 1995). Cognitive-behavioural self-help treatments for social anxiety disorder have been developed to overcome various accessibility issues (e.g., long wait-lists, and the patient's need to avoid social situations, etc) associated with high-intensity CBT (Abramowitz et al., 2009; Carlbring et al., 2007) but a recent network meta-analysis (Mayo-Wilson et al., 2014) identified the former as less cost-effective than the later and thus, they are not recommended as standalone treatments. However, the potential benefit of cognitive-behavioural self-help treatments for social anxiety disorder within a stepped-care recovery model as a prelude to high-intensity CBT has not been formally evaluated. The aim of this study is to evaluate a seminal Cognitive-Behavioural Bibliotherapy* (CBB; "pure self-help" book) - 'Overcoming Social Anxiety & Shyness' (Butler, 2009) - for patients with social anxiety disorder while on the wait-list for high-intensity CBT within an Improving Access to Psychological Therapies (IAPT) service, and to determine if some patients recover from CBB alone or whether there may be a reduction in the average number of high-intensity CBT sessions for those patients who subsequently require further treatment. The study is funded by Constable & Robinson, Kellogg College (University of Oxford) and Talking Change (Solent NHS Trust). * The Reading Well Books on Prescription scheme with funding from the Arts Council England enables general practitioners (GPs) and mental health professionals to prescribe seminal CBBs for patients with mood and anxiety disorders. The books are accessed free of charge via local libraries. The scheme works within NICE guidelines and it is support by the Royal Colleges of GPs, Nursing and Psychiatrists, the British Association for Behavioural and Cognitive Psychotherapies and the Department of Health through its IAPT programme.

NCT ID: NCT02306915 Completed - Pharmacokinetics Clinical Trials

PK, PD, Safety and Tolerability of Lipegfilgrastim in Healthy Japanese and Caucasian Participants

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

Cohorts of Japanese participants will be enrolled and treated prior to cohorts of Caucasian participants for the sake of matching. Every effort will be made to match Caucasian and Japanese participants on a cohort basis at enrollment. Reasonable effort will be made to maintain balance between male and female participants within the cohorts. There will be no replacement of participants following randomization.

NCT ID: NCT02306629 Completed - Clinical trials for Systemic Lupus Erythematosus

Study to Compare Properties of Epratuzumab When Given as an Injection Under the Skin or Directly Into the Blood

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

To assess how the absolute bioavailability, dose proportionality, pharmacokinetics, safety and tolerability of epratuzumab compared when given as a subcutaneous (sc) injection as to when given as an intravenous (iv) infusion in Caucasian and Japanese healthy volunteers.

NCT ID: NCT02306551 Completed - Bipolar Disorder Clinical Trials

Well Being And Resilience: Mechanisms of Transmission of Health and Risk

WARM
Start date: September 2014
Phase:
Study type: Observational

The purpose of this study is to establish a cohort of pregnant women with severe mental disorder and to identify biological and psycho-social transmission mechanisms involved in the development of 'risk' and 'resilience' in the offspring. It is assumed that both 'resilient' and 'risk' development in offspring are caused by a complex interaction between multiple biological, psychological and social factors. The project focuses specifically on exploring the impact of physiological stress-sensitivity, attachment, care-giving and the familial and social context for care-giving. Previous studies support these factors as important for the development of these infants, but systematic research using a prospective design is needed to strengthen evidence and elucidate the importance of these factors in more detail. The interaction over time of physiological stress-sensitivity, attachment, care-giving and the familial and social context for care-giving are evaluated in terms of the evolution of very early indicators of developmental risk and resilience in infants with a known highly increased risk for developing a mental disorder.The findings of the study may potentially lead to more specific targets for preventive interventions, which can improve developmental outcome for these infants.

NCT ID: NCT02305940 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

Effects of Long Term Antibiotic Therapy on Exacerbation Rate in Stable COPD Patients

Start date: July 2014
Phase: Phase 3
Study type: Interventional

This study investigates if long term use of the antibiotic doxycycline can reduce exacerbations in COPD patients. Half of the patients will receive doxycycline which the other half will receive a placebo.

NCT ID: NCT02305069 Completed - Obesity Clinical Trials

Effect of Obesity-derived Cytokines on Protein Turnover and Carbohydrate Metabolism in Human Skeletal Muscle

Start date: October 2009
Phase: N/A
Study type: Interventional

Obesity in humans has been shown to result in the increased release of small inflammatory-inducing proteins, called cytokines, from the fat cells of the body. The investigators are interested in the effects of these cytokines on the mechanisms that control muscle mass and metabolism in the obese human. Previous research from work in cells and animals has shown the cytokines reduce the synthesis of muscle proteins and simultaneously enhance their rate of breakdown, resulting in a loss of muscle mass. Furthermore, research suggests that the same cytokines may inhibit carbohydrate oxidation, a pivotal step in muscle metabolism. However, despite these potential negative consequences for skeletal muscle function, the effect of low-level and persistent inflammation as seen in obese humans, remains largely unknown. In the current study, the investigators plan to measure the rates of synthesis and breakdown of muscle proteins in conjunction with rates of carbohydrate oxidation in obese older participants, and compare them to rates determined in healthy non-obese individuals. Furthermore, participants will undergo a 12-week course of either pioglitazone, an insulin sensitiser often prescribed to type II diabetics, or a placebo. Pioglitazone has been shown previously to normalise the levels of cytokines in the blood of chronically inflamed individuals. By repeating after the 12-week intervention period the initial measurements described above, and by accurately determining the levels of the cytokines, the identification of the negative effects of obesity-induced inflammation in older adults on muscle metabolism will be determined.

NCT ID: NCT02304484 Completed - Clinical trials for Hypercholesterolemia

Open-label Extension (OLE) Study to Assess Safety and Efficacy of Evolocumab

Start date: November 24, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study was to characterize the safety and tolerability of long-term administration of evolocumab in adults with known coronary artery disease and hypercholesterolemia.

NCT ID: NCT02303912 Completed - Clinical trials for Recurrent Ovarian Cancer

Safety and Efficacy Study of Nuc-1031 and Carboplatin Combination to Treat Recurrent Ovarian Cancer

ProGem2
Start date: November 2014
Phase: Phase 1
Study type: Interventional

A first in human experimental treatment in which an experimental medicine,Nuc-1031, is used in combination with a standard cancer medicine, carboplatin, to treat ovarian cancer which reappear after standard cancer treatment. The aim of the trial is to determine safety, effectiveness, and clinical activity of this combination treatment.