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NCT ID: NCT01837771 Recruiting - Heart Failure Clinical Trials

Epiphrenic III Pilot Trial

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

The Epiphrenic III Pilot Trial investigates whether a diaphragmatic stimulation by interventionally placed electrodes may improve heart function, symptoms and functional capacity in patients with severe heart failure.

NCT ID: NCT01837368 Completed - Tinnitus Clinical Trials

Research Project About Psychological Strain, Quality of Life and Emotional Awareness in Patients With Tinnitus

Start date: December 2012
Phase: N/A
Study type: Observational

Validation of PRISM (Pictorial Representation of Illness and Self Measure) as a assessment of quality of life and suffering in patients with tinnitus. Association between experiencing, verbalizing and regulating emotions and perceived tinnitus. Correlation analysis are used to search for connections between the subjective behavioral outcomes mentioned above and the objective EEG-patterns.

NCT ID: NCT01837355 Recruiting - Cystic Fibrosis Clinical Trials

Modulation of Intestinal and Pulmonary Inflammation by Lactobacillus Diet Supplementation in Pediatric Cystic Fibrosis

MoHuM-1
Start date: March 2013
Phase: N/A
Study type: Interventional

Pulmonary inflammation is an independent risk factor for disease progression in cystic fibrosis patients (CF). Yet, no effective treatment is known to reduce this detrimental inflammation. Dysbiosis of the gut microbiota has been linked to inflammation in several inflammatory diseases. As children with CF have different faecal microbiota from their healthy siblings, modulating gut microbiota by lactobacillus rhamnosus diet supplementation might be a strategy to target the inflammatory state in CF. Study subjects (CF or healthy control) will receive either placebo or lactobacillus rhamnosus once daily as dietary supplementation for 12 weeks. After a one-week washout phase, they will be switched for another 12 weeks to the other trial arm. Effect on in intestinal and pulmonary inflammation as well as clinical outcome will be studied.

NCT ID: NCT01836263 Recruiting - Systemic Sclerosis Clinical Trials

Prevention and Treatment of Digital Ulcers in Systemic Sclerosis

Start date: April 2013
Phase: N/A
Study type: Observational [Patient Registry]

Systemic sclerosis is an orphan, multiorgan disease affecting the connective tissue of the skin and several internal organs. Digital ulcers are frequent and have a major impact on the quality of life in patients with systemic sclerosis. The etiology of digital ulcers is complex and multifactorial and the principal mechanisms underlying the digital ulcers formation are ischemic, mechanic and inflammatory, alone or in combination, on the basis of the systemic sclerosis vasculopathy. Consequently, there are at least three types of DU: (i) those localized at the tips of the fingers and toes, mainly resulting from an ischemic process, (ii) those localized on the dorsal aspect of the fingers where the skin retraction due to fibrosis over bony prominences seems to be the main cause, and (iii) those evolving on a pitting scar or subcutaneous calcinosis due to a combined irritative-inflammatory mechanism. An early therapy to prevent or rapidly heal digital ulcers is today considered a mandatory approach to maintain quality of life and spare the enormous costs due to conventional digital ulcer management. This observational trial is part of the collaborative project "DeSScipher", one out of five observational trials to decipher the optimal management of systemic sclerosis. Aim of this observational trial is: 1. To identify the best treatment combination for prevention of digital ulcers in patients with fulfilment of the new ACR/EULAR SSc criteria or the preliminary VEDOSS criteria for very early diagnosis of systemic sclerosis 2. To identify the best treatment associated with improved healing of digital ulcers in patients with fulfilment of the new ACR/EULAR SSc criteria Thus, the observational trial consist of a prevention arm and a healing arm.

NCT ID: NCT01835236 Completed - Clinical trials for Metastatic Breast Cancer

Trastuzumab & Pertuzumab Followed by T-DM1 in MBC

Start date: March 3, 2013
Phase: Phase 2
Study type: Interventional

In HER2-positive metastatic breast cancer, trastuzumab based treatment is the standard of care as long as there are no contraindications to trastuzumab. Frequently, trastuzumab is being combined with taxanes in the first-line setting. However, since therapy with trastuzumab is active even in the absence of chemotherapy in HER2-positive MBC, the optimal treatment strategy either in combination or in sequence with chemotherapy is still under debate. This randomized phase II trial is studying a new strategy for the treatment of metastatic breast cancer with HER2-positive. First-line treatment consists of trastuzumab and pertuzumab, a treatment without chemotherapy. In case of disease progression, chemotherapy with T-DM1 is then performed as second-line treatment. Third-line and further line therapies are performed according to the physician's discretion. If this new therapeutic strategy is as effective and better tolerated than the conventional strategy, this would mean a serious breakthrough in the treatment of HER2-positive metastatic breast cancer.

NCT ID: NCT01834157 Recruiting - Arthritis Clinical Trials

Improvement of Hand Dysfunction by Arthritis in Systemic Sclerosis

Start date: April 2013
Phase: N/A
Study type: Observational [Patient Registry]

Systemic sclerosis (SSc) is an orphan, multiorgan disease affecting the connective tissue of the skin and several internal organs. Beside skin involvement, digital ulcers, tendinitis, calcinosis and flexion contractures, the presence of hand arthritis is a major contributor to impairment of hand function in systemic sclerosis. Several immunomodulatory drugs used in other rheumatic diseases (including methotrexate, leflunomide, azathioprine, mycophenolate mofetil and low-dose corticosteroids) can potentially improve arthritis and consequently hand function in systemic sclerosis. For the assessment of arthritis, the CDAI (clinical disease activity index) is validated in rheumatoid arthritis, and may be useful for SSc-related arthritis, too. This observational trial is part of the collaborative project "DeSScipher", one out of five observational trials to decipher the optimal management of systemic sclerosis. Aim of this observational trial is to: - investigate the efficacy and safety of different treatments on hand dysfunction in systemic sclerosis patients with hand arthritis and - to validate the CDAI for arthritis in systemic sclerosis.

NCT ID: NCT01832701 Completed - Healthy Clinical Trials

Coffee, Exercise, and Oxidative Stress

Start date: March 2012
Phase: N/A
Study type: Interventional

Coffee is one of the most widely consumed beverages. It contains polyphenols (chlorogenic acids) and bioavailability of these bioactive compounds is now somewhat well understood. In addition, chlorogenic acids are known to be antioxidants in the cup, but reliable evidence remains to be observed in vivo. The objective of this trial is to understand if regular (14d) coffee intake may be beneficial on biomarkers of oxidative damage measured in urine and plasma after an acute stress caused by exercise.

NCT ID: NCT01832129 Completed - Clinical trials for Vitamin B 12 Deficiency

Vitamin B12 Acceptance and Biomarker Response Study

Start date: May 2013
Phase: Phase 4
Study type: Interventional

In this study, biomarker response after supplementation with oral and intramuscular vitamin B12 will be compared in a randomized clinical trial. Electronic compliance monitoring will be used to control for non compliance as a possible confounder in oral treatment. Additionally subjective acceptance in terms of presumed preferences will be compared with oral vs. intramuscular supplementation of vitamin B12 in the view of the patient.

NCT ID: NCT01831115 Active, not recruiting - Dyspnea Clinical Trials

Basics in Acute Shortness of Breath EvaLuation (BASEL V) Study

BASEL V
Start date: April 2006
Phase:
Study type: Observational

To improve the diagnostic and prognostic utility of various biomarkers, detailed patient's history, physical examinations and technical devices in patients presenting with acute dyspnea.

NCT ID: NCT01831089 Completed - Breast Cancer Clinical Trials

Phase I Study of Lurbinectedin (PM01183) in Combination With Paclitaxel, With or Without Bevacizumab, in Selected Advanced Solid Tumors

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

Clinical trial of PM01183 in combination with paclitaxel, with or without bevacizumab, in patients with solid tumors