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NCT ID: NCT01726075 Completed - Clinical trials for Diabetic Retinopathy

Trial to Assess the Efficacy of Neuroprotective Drugs Administered Topically to Prevent or Arrest Diabetic Retinopathy

EUROCONDOR
Start date: February 2013
Phase: Phase 2/Phase 3
Study type: Interventional

To assess whether neuroprotective drugs administered topically (somatostatin and brimonidine) are able to prevent or arrest the development and progression of neurodegenerative changes

NCT ID: NCT01725581 Completed - Clinical trials for Female Pelvic Examination

A Study to Test a New Pelvic Examination Assessment Tool

PEAT
Start date: June 2013
Phase: N/A
Study type: Observational

The purpose of this study is to show that a new assessment tool for pelvic examination is valid and reliable.

NCT ID: NCT01725139 Completed - Clinical trials for Idiopathic Pulmonary Fibrosis

A Proof of Mechanism Study With GSK2126458 in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Start date: March 8, 2013
Phase: Phase 1
Study type: Interventional

This is a dose escalation/dose finding, double-blind, placebo-controlled, parallel study of GSK2126458 in subjects with IPF. The study is designed to explore a number of doses of GSK2126458 for engagement of pharmacology after short term dosing. It is anticipated that approximately 24 subjects will be enrolled in this study. Actual number of cohorts in this study could vary up to a maximum of 6 cohorts (n=4/cohort; 3 on active and 1 on placebo). Each cohort will consist of four subjects who will be randomised to receive GSK2126458 (three subjects) or placebo (one subject) for approximately 8 days (7 to 10 days). On Day 1 they will receive their first dose of GSK2126458 (or placebo) and safety, tolerability and PK/PD in the blood will be measured for up to 8 hours post-dose. Subjects will then be discharged from the site with study drug until the last day of dosing. They will also receive hand held spirometers and instructions on action to be taken in case of deterioration in pulmonary function or any other adverse events (AEs). On the last day of dosing they will return to the site for a repeat of the Day 1 procedures. A bronchoalveolar lavage (BAL) and [18F]-fluoro-deoxyglucose (FDG)- positron emission tomography / computed tomography (PET/CT) scan will be conducted twice during the study; once, at least 2 days before dosing commences and again during the course of the dosing period. After the final subject in each cohort has completed dosing, a dose escalation meeting will take place. Safety and tolerability and PK data will be reviewed during this meeting and decisions made may include but are not limited to: escalate the dose, decrease the dose or repeat the same dose in the next cohort; stop the study.

NCT ID: NCT01725087 Completed - Low Back Pain Clinical Trials

Efficacy and Safety of GRT6005 in Patients With Chronic Low Back Pain.

Start date: November 2012
Phase: Phase 2
Study type: Interventional

The purpose of this trial is to evaluate the safety and efficacy of once daily orally administered GRT6005 in a total of 3 fixed doses compared to placebo in subjects with moderate to severe chronic Low Back Pain (LBP). The study includes a maximum of 21 days screening period followed by a 2-week titration period and 12-week maintenance double-blind treatment period and a 10-14 day safety follow up period. Patients who are eligible for the double-blind treatment period will be randomized to one of the following treatment groups: GRT6005 low-dose, GRT6005 medium dose, GRT6005 high-dose, Tapentadol or placebo.

NCT ID: NCT01724424 Completed - Sepsis Clinical Trials

Melatonin in Healthy Volunteers

DAMSEL1
Start date: June 2012
Phase: Phase 1
Study type: Interventional

Antioxidant therapy targeted at mitochondria has the potential to reduce inflammation, mitochondrial damage and organ dysfunction in sepsis. Melatonin accumulates in mitochondria and both it and its metabolites have potent antioxidant and anti-inflammatory activity, preventing organ dysfunction in a rat model of sepsis. The investigators propose a study in healthy volunteers to assess the tolerability and pharmacokinetics of exogenous melatonin and its major metabolites and to relate these doses to ex vivo anti-inflammatory and antioxidant activities. Groups of healthy subjects will receive increasing sequential doses of oral melatonin in an open label dose escalation study. Ex vivo inflammatory responses, oxidative stress and mitochondrial function at concentrations of melatonin identified in the dose escalation study will be determined following exposure of whole blood to an inflammatory insult. This will provide crucial information to inform a subsequent phase II clinical trial of melatonin in patients with sepsis.

NCT ID: NCT01724411 Completed - Clinical trials for Overweight and Obesity

Satiety Innovation- Study 793. University of Aberdeen

SATIN
Start date: August 2012
Phase: N/A
Study type: Interventional

The proposed study will address the effect of developed novel food products through processing innovation on motivation to eat, biomarkers of satiety, nutrient bioavailability and gut health using in vivo studies and validating new in vivo approaches. Specifically in this protocol we will address, in a short human intervention study the effect of a potentially satiating product on appetite, appetite biomarkers, particularly the influence on gut microbiota, tolerance and safety of the products in healthy obese and overweight volunteers in free living conditions.

NCT ID: NCT01724346 Completed - Clinical trials for Chronic Lymphocytic Leukemia

Open-label Extension Study in Patients 65 Years or Older With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Start date: August 28, 2012
Phase: Phase 3
Study type: Interventional

An Open-label Extension Study in Patients 65 Years or Older with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) Who Participated in Study PCYC-1115-CA (Ibrutinib versus Chlorambucil)

NCT ID: NCT01724333 Completed - Cancer Clinical Trials

International Validation of the QLQ-OH17 for Oral Health

QLQ-OH17
Start date: December 2012
Phase:
Study type: Observational

Assessment of oral and dental problems is seldom routine in clinical oncology, despite the potential negative impact of these problems on nutritional status, social function and quality of life (QoL). A brief, assessment tool for oral/dental health and related QoL-issues to improve symptom management has been requested. The present study will be conducted on behalf of and with support from the European Organisation for Research and Treatment of Cancer - (EORTC) Quality of Life Group (QLG). The study represents phase IV, the final step, in the development of an international, symptom specific questionnaire module, focusing on oral and dental problems in relation to cancer and its treatment. Phase I-III of this stepwise development process was conducted from 2008 to 2011, as an international collaboration and conducted according to the guidelines for module development set forth by the EORTC QLG. The resulting module, the QLQ-OH17, is now subject to an international field testing and validation study as described in this project description. The present version of the QLQ-OH17 consists of 17 items conceptualized into four multi-item scales (pain/discomfort, xerostomia, eating and information) and three single items related to use of dentures and future worries. The aim of the present study is to conduct phase IV; an international field study to confirm the psychometric properties of the QLQ-OH17

NCT ID: NCT01724060 Completed - Obesity Clinical Trials

Effects of Obesity Treatments on Food Preferences and Metabolism

FPS
Start date: September 2012
Phase:
Study type: Observational

Obesity and Type 2 Diabetes Mellitus are major health problems which are becoming a burden both for patients and health systems alike. The surgical and medical treatments available for these conditions have improved significantly in the last two decades. The investigators do not however know how these treatments compare to each other and how they act in the body to cause weight loss and diabetes improvements. The studies of this experiment are complementary to each other. They aim to answer related questions and will allow us to study how these treatments work and eventually develop safer and more effective therapies for obesity and diabetes.

NCT ID: NCT01723826 Completed - Alzheimer's Disease Clinical Trials

A Long-Term Safety Extension of Studies ABE4869g and ABE4955g in Participants With Mild to Moderate Alzheimer's Disease Treated With Crenezumab

Start date: December 7, 2012
Phase: Phase 2
Study type: Interventional

This Phase II, open-label extension (OLE), multicenter study will evaluate the long-term safety and tolerability of crenezumab in participants with mild to moderate Alzheimer's disease who have participated in and completed the treatment period of the Phase II Study ABE4869g (NCT01343966) or ABE4955g (NCT01397578). Participants who received placebo in Study ABE4869g (NCT01343966) or ABE4955g (NCT01397578) will receive crenezumab. Anticipated time on study treatment is 144 weeks.