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NCT ID: NCT01567306 Completed - Clinical trials for Allergic Rhinoconjunctivitis

Phase II Trial With Subcutaneous Immunotherapy in Patients Sensitized to Phleum Pratense

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

Based on EMA (European Medicines Agency) new guidelines on the clinical development of products for immunotherapy for the treatment of allergic diseases the aim of this study is to establish a dose-response relationship for clinical efficacy of Phleum pratense pollen extract subcutaneous vaccine.

NCT ID: NCT01566721 Completed - Breast Neoplasms Clinical Trials

A Safety and Tolerability Study of Assisted and Self-Administered Subcutaneous (SC) Herceptin (Trastuzumab) as Adjuvant Therapy in Early Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer

SafeHER
Start date: May 17, 2012
Phase: Phase 3
Study type: Interventional

This multicenter, two-cohort, non-randomized, open-label study will evaluate the safety and tolerability of assisted and self-administered SC Herceptin as adjuvant therapy in participants with early HER2-positive breast cancer following tumor excision. Participants will receive Herceptin 600 milligrams (mg) SC every 3 weeks for 18 cycles, either by an assisted administration using a conventional syringe and needle/vial formulation (Cohort A) or with assisted and self-administration using a single-use injection device (SID) in selected participants (Cohort B).

NCT ID: NCT01566695 Completed - Clinical trials for Myelodysplastic Syndrome

The Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Placebo and Best Supportive Care in Subjects With Red Blood Cell (RBC) Transfusion-Dependent Anemia and Thrombocytopenia Due to International Prognostic Scoring System (IPSS) Low Risk Myelodysplastic Syndrome (MDS)

Start date: April 26, 2013
Phase: Phase 3
Study type: Interventional

Evaluation of the Efficacy and Safety of Oral Azacitidine plus Best Supportive care versus Placebo and Best Supportive care in subjects with red blood cell (RBC) transfusion-dependent anemia and thrombocytopenia due to International Prognostic Scoring System (IPSS) lower risk myelodysplastic syndromes (MDS).

NCT ID: NCT01557348 Completed - Clinical trials for Rheumatoid Arthritis

An Observational Study of MabThera/Rituxan (Rituximab) and Alternative TNF-Inhibitors in Patients With Rheumatoid Arthritis and an Inadequate Response to a Single Previous TNF-Inhibitor

Start date: April 2009
Phase: N/A
Study type: Observational

This multicenter, prospective, observational study will assess the efficacy of MabThera/Rituxan (rituximab) and alternative TNF-inhibitors in patients with rheumatoid arthritis who are non-responders or intolerant to a single previous TNF-inhibitor. Data will be collected from each patient from the time of change in biologic therapy for 12 months.

NCT ID: NCT01555775 Completed - Inflammation Clinical Trials

Compared Effect of a Fruit Milk Shake With a Protein-Carbohydrate Supplement on Recovery After Resistance Exercise

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

The aim of this study is to assess the effect of ingesting a commercial carbohydrate and protein dietary supplement in powder form (P-CHO supplement) or a milk shake with skimmed milk, strawberries and banana (MS), after resistance exercise, in muscle damage, oxidative stress, inflammation and functional recovery. It is hypothesised if the ingestion of a milk shake with skimmed milk and fruit (strawberry and banana) has the same impact on markers of muscle damage, oxidative stress, inflammation and functional recovery induced by resistance exercise, as the intake of a commercial powder with the same CHO and protein amounts. Fifteen adult athletes from the Portuguese Athletic Federation will complete 2 trials separated at least by 2 weeks. Alternate legs and drinks will be used in each trial and participants will be overnight-fasted. This study will have a single-blind, randomized, crossover, repeated-measures experimental design. In each trial, after warm-up, the eccentric peak torque of the knee joint extensors will be determined using an isokinetic dynamometer. After this, participants will complete an isokinetic exercise until exhaustion at a constant angular velocity of 60° • s-1. After the exhaustion protocol, athletes will perform again the peak torque determination. Immediately after, participants will drink the P-CHO supplement or MS during the first 2 h. Both drinks will contain 0.8-1.2 g carbohydrates • kg-1 • h-1 and 0.2-0.4 g protein • kg-1 • h-1. Twenty four and 48 h after the exhaustion protocol participants will return to the laboratory to repeat the peak torque determination. Blood samples will be collected before warming-up, immediately and 2 h after the last peak torque determination and 24 h and 48 h after. Serum samples will be analyzed for creatine kinase, lactate dehydrogenase, interleukine-6, protein carbonyls and total antioxidant status. The delayed onset muscle soreness, using a visual analogue scale, and girths will be measured at the same moments as blood sampling. Two-way repeated-measures ANOVA will be used for statistical analysis of the data.

NCT ID: NCT01543503 Completed - Clinical trials for Rheumatoid Arthritis

An Global Comparative Observational Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis

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

This prospective, multi-center, observational study will assess the efficacy and safety of treatment in patients who are treated with a TNF Inhibitor or RoActemra/Actemra (tocilizumab) as the first biologic therapy. Data will be collected for 52 weeks.

NCT ID: NCT01541215 Completed - Clinical trials for Diabetes Mellitus, Type 2

Efficacy and Safety of Liraglutide in Combination With Metformin Compared to Metformin Alone, in Children and Adolescents With Type 2 Diabetes

Ellipse™
Start date: November 13, 2012
Phase: Phase 3
Study type: Interventional

This trial is conducted globally. The aim of this trial is to assess the efficacy and safety of liraglutide in the paediatric population in order to potentially address the unmet need for treatment of children and adolescents with type 2 diabetes.

NCT ID: NCT01536366 Completed - Parkinson Disease Clinical Trials

Effect of BIA 9-1067 on the Pharmacokinetics of Repaglinide

Start date: June 2009
Phase: Phase 1
Study type: Interventional

The purpose of this study is to investigate the CYP2C8 inhibition by BIA 9-1067.

NCT ID: NCT01535261 Completed - Macular Edema Clinical Trials

Ranibizumab Intravitreal Injections in Patients With Visual Impairment Due to Macular Edema Secondary to Central Retinal Vein Occlusion

CRYSTAL
Start date: February 2012
Phase: Phase 3
Study type: Interventional

The present study will provide additional efficacy and safety data for 0.5-mg ranibizumab using as needed (PRN) dosing over 24 months in patients with visual impairment due to macular edema secondary to Central Retinal Vein Occlusion (CRVO). Spectral domain high-definition optical coherence tomography (OCT) images will be analyzed to gain insights into predictive factors for disease progression and the possibility of reduced monitoring will be assessed in Year 2. The results of this open-label study will provide long-term safety and efficacy data to further guide recommendations on the use of ranibizumab in this indication.

NCT ID: NCT01532726 Completed - Epilepsy Clinical Trials

Eslicarbazepine Acetate as Add-On Treatment to One Baseline Antiepileptic Drug (ESLADOBA)

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

This is a multicenter, non-interventional, prospective study. The observation period comprises at least 6 months, from the initiation of ESL add-on therapy in adult patients with partial-onset epilepsy not sufficiently controlled with one AED, until the first visit that occurs between 6 and 9 months of follow-up. The observation period will end after 9 months of follow-up even if the final assessment is not performed.