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NCT ID: NCT01462942 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

Long-term Efficacy and Safety of Aclidinium Bromide/Formoterol Fumarate Fixed-Dose Combination

Start date: October 2011
Phase: Phase 3
Study type: Interventional

The objective is to provide data supporting the use of LAS40464 as an efficacious and safe maintenance bronchodilator treatment of patients with Chronic Obstructive Pulmonary Disease (COPD).

NCT ID: NCT01462825 Completed - Inflammation Clinical Trials

The Effect of Tomato Ketchup on Inflammation

Start date: November 2011
Phase: N/A
Study type: Interventional

The purpose of this study is to determine the inhibiting effects of a single consumption of tomato ketchup on inflammation which will be induced ex-vivo in human blood.

NCT ID: NCT01462565 Completed - Clinical trials for Hypertension, Pulmonary

Study of a New Thermo Stable Formulation of Epoprostenol Sodium to Treat Pulmonary Arterial Hypertension (PAH)

Start date: November 1, 2011
Phase: Phase 4
Study type: Interventional

The purpose of this multicentre, open label, single-arm study in approximately 20 adult patients is to evaluate the Impact on lifestyle of a new thermo stable formulation of epoprostenol sodium in subjects with Pulmonary Arterial Hypertension (PAH).

NCT ID: NCT01462214 Completed - Clinical trials for Metastatic Renal Cell Cancer

Study of Everolimus and Low-dose Cyclophosphamide in Patients With Metastatic Renal Cell Cancer

Start date: October 2011
Phase: Phase 1/Phase 2
Study type: Interventional

In the present phase 1-2 study the investigators aim to determine whether depletion of Tregs using metronomic cyclophosphamide can enhance the antitumor efficacy of everolimus in patients with mRCC not amenable to or progressive after a VEGF-receptor tyrosine kinase inhibitor containing treatment regimen. In the phase 1 part of the study the investigators will determine the optimal CD4+CD25+ regulatory T cell-depleting dose and schedule of metronomic oral cyclophosphamide when given in combination with a fixed dose (10 mg daily) of everolimus. In the phase 2 part of the study the investigators will subsequently evaluate whether the number of patients who are cancer progression free at 4 months can be increased from 50% to 70% by adding metronomic cyclophosphamide (in the dose and schedule determined in the phase 1 part) to everolimus. In addition to efficacy, the investigators will evaluate treatment toxicity to determine whether this combination strategy is feasible and safe.

NCT ID: NCT01462175 Completed - Neoplasms Clinical Trials

A First-In-Human Study of RO5503781 in Participants With Advanced Malignancies Except Leukemia

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

This multicenter, open label, dose-escalating study will evaluate the safety, pharmacokinetics, pharmacodynamics, and efficacy of RO5503781, administered once daily (QD) or once weekly (QW) in participants with advanced malignancies except leukemia. Participants will receive multiple escalating oral doses in two different dosing schedules (Sch) until disease progression or unacceptable toxicity occurs.

NCT ID: NCT01461785 Completed - Lipofilling Clinical Trials

The Use of Activated Platelet Rich Plasma (PRP) in Human Autologous Fat Transfer

Start date: April 2012
Phase: Phase 2/Phase 3
Study type: Interventional

In this prospective, randomized clinical trial, lipofilling of the midface with Platelet Rich Plasma (PRP) is compared with lipofilling of the midface without PRP. The main objective of this study is to investigate the effect of the addition of PRP to the autologous fat transfer on local skin quality improvement, graft survival, and recovery after the procedure.

NCT ID: NCT01461057 Completed - Gastric Cancer Clinical Trials

A Study of Pertuzumab in Combination With Trastuzumab and Chemotherapy in Patients With HER2-Positive Advanced Gastric Cancer

JOSHUA
Start date: December 6, 2011
Phase: Phase 2
Study type: Interventional

This randomized, multicenter, open-label study will evaluate two different doses of pertuzumab in combination with Herceptin (trastuzumab) and chemotherapy in the first-line treatment of participants with metastatic HER2-positive adenocarcinoma of the stomach or gastroesophageal junction. Participants will be randomized in a 1:1 ratio to two treatment arms. Participants in the Pertuzumab 840/420 mg Arm will receive a pertuzumab loading dose of 840 mg for Cycle 1 and a dose of 420 mg for Cycles 2-6, and participants in the Pertuzumab 840/840 mg Arm will receive pertuzumab 840 mg for all six cycles. Participants in both treatment arms will receive trastuzumab, cisplatin, and capecitabine.

NCT ID: NCT01460056 Completed - Clinical trials for Endotoxin-associated Sterile Peritonitis

e-STEPS: Endotoxin-Associated Sterile Peritonitis Observational Study

e-STEPS
Start date: December 2011
Phase: N/A
Study type: Observational

This observational retrospective healthcare medical record review study is to evaluate and differentiate the clinical characteristics and outcomes in peritoneal dialysis (PD) patients with either endotoxin-associated sterile peritonitis (e-SP), bacterial peritonitis (BP) or no peritonitis (NoP) over a 12-15 month period from dialysis clinics in The Netherlands, Germany, Hungary, Portugal, and the United Kingdom (UK). The primary study objectives are to: - Describe changes in the peritoneal membrane function and clinical outcomes over time between e-SP, BP and NoP PD patients. - Describe and differentiate clinical characteristics during the acute clinical presentation of e-SP and BP. The secondary study objective is to: - Generate a dataset that will facilitate post hoc exploratory hypothesis-generation related to clinical and resource utilisation (RU) outcomes in association with e-SP.

NCT ID: NCT01459757 Completed - GIST Clinical Trials

Non-Interventional Retrospective Correlation Of Tumor Mutational Status To Clinical Benefit Of GIST Patients Treated With Sunitinib

Start date: October 2011
Phase: N/A
Study type: Observational

Retrospective correlation of clinical outcomes data with mutational status in GIST subjects treated with sunitinib.

NCT ID: NCT01459627 Completed - Clinical trials for Myocardial Infarction

Randomized, Open Label Trial of 6 Months Versus 12 Months DAPT After Drug-Eluting Stent in STEMI

DAPT-STEMI
Start date: December 2011
Phase: Phase 4
Study type: Interventional

OBJECTIVE OF THE STUDY: To test the hypothesis that 6 months DAPT (Dual anti-platelet therapy) after second generation DES (Drug Eluting Stent) implantation in STEMI (ST elevation Myocardial Infarction) is not inferior to 12 months DAPT in terms of clinical outcomes (composite endpoint of all-cause mortality, any MI, any revascularization, stroke and major bleeding at 18 months after randomization). The trial will incorporate two registers studying respectively the safety outcomes of Bivalirudin and Prasugrel combination and Bivalirudin and Ticagrelor combination at 2 and 30 days. Finally the trial design permits assessment of the clinical outcomes after primary PCI for treatment of STEMI with the new Resolute Integrity (Medtronic Santa Rosa Ca, USA) stent at 30 days and 6 months.