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NCT ID: NCT01952470 Completed - Clinical trials for Lower Respiratory Tract Infection

Preliminary Study of Dornase Alfa to Treat Chest Infections Post Lung Transplant.

Start date: October 31, 2013
Phase: Phase 2
Study type: Interventional

Patients who have undergone lung transplantation are at an increased risk of developing chest infections due to long-term medication suppressing the immune response. In other chronic lung diseases such as cystic fibrosis (CF) and bronchiectasis, inhaled, nebulised mucolytic medication such as dornase alfa and isotonic saline are often used as part of the management of lung disease characterized by increased or retained secretions. These agents act by making it easier to clear airway secretions, and are currently being used on a case-by-case basis post lung transplantation. To the investigators knowledge, these agents have not been evaluated via robust scientific investigation when used post lung transplant, yet are widely used in routine practice. Patients post lung transplant must be investigated separately as they exhibit differences in physiology that make the clearance of sputum potentially more difficult when compared to other lung diseases. Lower respiratory tract infections are a leading cause of hospital re-admission post lung transplant. Therefore, this highlights the need for a randomized controlled trial. The aim of this study is to assess the efficacy of dornase alfa, compared to isotonic saline, in the management of lower respiratory tract infections post lung transplant. Investigators hypothesize that dornase alfa will be more effective than isotonic saline. The effect of a daily dose of dornase alfa and isotonic saline will be compared over a treatment period of 1 month. Patients admitted to hospital suffering from chest infections characterized by sputum production post lung transplant will be eligible for study inclusion. Patients will be followed up through to 3 months in total to analyze short-medium term lasting effect. Investigators wish to monitor physiological change within the lung non-invasively via lung function analysis whilst assessing patient perceived benefit via cough specific quality of life questionnaires. These measures will be taken at study inclusion and repeated after 1 month and 3 months. Day to day monitoring will be performed via patient symptom diaries, incorporating hospital length of stay and exacerbation rate. The outcomes of this study have the potential to guide clinical decision-making and highlight safe and efficacious therapies.

NCT ID: NCT01952145 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide Versus Insulin Glargine in Subjects With Type 2 Diabetes Mellitus

DUALâ„¢ V
Start date: September 20, 2013
Phase: Phase 3
Study type: Interventional

This trial is conducted globally. The aim of the trial is to compare the efficacy and safety of insulin degludec/liraglutide versus insulin glargine in subjects with type 2 diabetes mellitus.

NCT ID: NCT01951677 Completed - Clinical trials for Exposure to Hepatitis B Virus

Safety and Efficacy Study of Adjuvanted Prophylactic Hepatitis B Vaccine

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

There is a need for more effective and better-tolerated hepatitis B vaccines for low responder high-risk populations including patients with renal impairment and/or diabetes mellitus and those aged over 40 years. Several approaches are available to enhance the potency of hepatitis B virus vaccines including use of the more highly immunogenic antigens, replacing alum with potentially more effective adjuvants, and increasing the dose of vaccine antigen. A combination of these strategies is being tested in this study to identify the most promising candidate approaches to take forward into advanced clinical development

NCT ID: NCT01951638 Completed - Heart Failure Clinical Trials

Phase IIb Safety and Efficacy Study of Four Dose Regimens of BAY1021189 in Patients With Heart Failure and Preserved Ejection Fraction Suffering From Worsening Chronic Heart Failure (SOCRATES-PRESERVED)

Start date: November 6, 2013
Phase: Phase 2
Study type: Interventional

Objective of the study is to find the optimal dose of the once daily oral soluble guanylate cyclase stimulator (sGC) BAY1021189 for Phase III that can be given in addition to standard diuretic and comorbidity treatment for heart failure with preserved ejection fraction (HFpEF)

NCT ID: NCT01951625 Completed - Heart Failure Clinical Trials

Phase IIb Safety and Efficacy Study of Four Dose Regimens of BAY1021189 in Patients With Heart Failure With Reduced Ejection Fraction Suffering From Worsening Chronic Heart Failure (SOCRATES-REDUCED)

Start date: November 29, 2013
Phase: Phase 2
Study type: Interventional

Objective of the study is to find the optimal dose of the once daily oral soluble guanylate cyclase stimulator (sGC) BAY1021189 for Phase III that can be given in addition to standard therapy for heart failure with reduced ejection fraction (HFrEF).

NCT ID: NCT01951586 Completed - Clinical trials for Non-Small Cell Lung Cancer

Denosumab in Combination With Chemotherapy as First-line Treatment of Metastatic Non-small Cell Lung Cancer

Start date: December 31, 2013
Phase: Phase 2
Study type: Interventional

This randomized phase 2 trial is studying the effect of adding denosumab to standard chemotherapy in the treatment of advanced lung cancer.

NCT ID: NCT01951326 Completed - Crohn's Disease Clinical Trials

Efficacy and Safety of Anti-MAP Therapy in Adult Crohn's Disease

MAPUS
Start date: September 2013
Phase: Phase 3
Study type: Interventional

The investigators hypothesize that RHB-104 will have greater efficacy than placebo in Crohn's disease.

NCT ID: NCT01951170 Completed - Clinical trials for Rheumatoid Arthritis

An Open-Label Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Active Rheumatoid Arthritis

Start date: November 2013
Phase: Phase 3
Study type: Interventional

This open-label, single-arm study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with active moderate to severe rheumatoid arthritis. Patients will receive a subcutaneous dose of RoActemra/Actemra 162 mg once weekly. The anticipated time on study treatment is 24 weeks.

NCT ID: NCT01950819 Completed - Hemodialysis Clinical Trials

Advancing Renal TRANSplant eFficacy and Safety Outcomes With an eveRolimus-based regiMen (TRANSFORM)

TRANSFORM
Start date: December 3, 2013
Phase: Phase 4
Study type: Interventional

This is a 2-year, randomized, multicenter, open-label, 2-arm study evaluating the graft function of everolimus and reduced CNI versus MPA and standard CNI in adult de novo renal transplant recipients.

NCT ID: NCT01950273 Completed - Clinical trials for Lymphoma, Follicular

Pharmacokinetics and Pharmacodynamics of BI 695500 vs. Rituximab as First Line-treatment in Patients With Low Tumor Burden Follicular Lymphoma

Start date: September 27, 2013
Phase: Phase 1
Study type: Interventional

The primary objective of the study is to assess the pharmacokinetic (PK) similarity of Boehringer Ingelheim (BI) 695500 vs. rituximab (MabThera®) in previously untreated patients with low tumor burden follicular lymphoma (LTBFL). The secondary objective of the study is to evaluate the pharmacodynamics (PD), safety, and anti-tumor activity of BI 695500 vs. rituximab (MabThera®), as well as the presence of anti-drug antibodies (ADAs).