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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: NCT01565967 Completed - Trauma Clinical Trials

Registry AutoLog Lipid Removal and Blood Component Characterization

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

The purpose of this study is to show the success of the AutoLog System in removing lipids to less than 10mg/dl in vivo. The Autolog registry has two objectives: 1. to determine the lipid removal capabilities of the Medtronic AutoLog System. 2. to obtain in vivo data on blood component removal and washing capabilities of the Medtronic AutoLog System.

NCT ID: NCT01557244 Completed - Clinical trials for Urinary Bladder, Neurogenic

A Study To Find Out How Fesoterodine Works In Children Aged 6 To 17 Years With Bladder Overactivity Caused By A Neurological Condition

Start date: July 2, 2012
Phase: Phase 3
Study type: Interventional

The objective of the study is to find out if the medicine fesoterodine is a useful treatment in children with bladder muscle overactivity caused by a neurological condition. Children will be aged 6 to 17 years old. This is done by finding out how well it works, what the body does to fesoterodine, what side effects are experienced and the safety of fesoterodine. It will be compared with the medicine oxybutynin, which is already available for treating the condition.

NCT ID: NCT01555151 Completed - Asthma Clinical Trials

Safety and Efficacy of Mometasone Furoate Delivered Via Concept1 Device or Twisthaler® Device in Adult and Adolescent Patients With Persistent Asthma

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

The purpose of this study is to compare the efficacy, safety and pharmacokinetics of Mometasone furoate delivered via Concept1 device or Twisthaler® device in adult and adolescent patients with persistent asthma.

NCT ID: NCT01544595 Completed - Clinical trials for Moderate to Severe Plaque-type Psoriasis

Extension Study of Secukinumab Prefilled Syringes in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Completing Preceding Psoriasis Phase III Studies With Secukinumab

Start date: June 19, 2012
Phase: Phase 3
Study type: Interventional

This was an extension study of secukinumab prefilled syringes in subjects with moderate to severe chronic plaque-type psoriasis completing preceding psoriasis phase III studies with secukinumab. Subjects on secukinumab at the end of treatment period in phase III studies (e.g., ongoing CAIN457A2302 and CAIN457A2303 and potentially other secukinumab phase III studies) were eligible to join this extension study. This extension study was planned to collect an additional 2 years of long-term efficacy, safety, and tolerability data of secukinumab in either continuous or interrupted therapy (randomized withdrawal period) in subjects showing at least partial response to secukinumab and completing treatment period on secukinumab in previous phase III studies. In this extension study, the prefilled syringe (PFS) liquid formulation of secukinumab were used.

NCT ID: NCT01541228 Completed - Actinic Keratosis Clinical Trials

Photodynamic Treatment of Actinic Keratoses With Different Light Doses

Start date: April 2010
Phase: N/A
Study type: Interventional

Aim of the study: To evaluate clinical effectiveness of two different light doses when treating actinic keratoses with photodynamic therapy with 20% 5-aminolevulinic acid.

NCT ID: NCT01533571 Enrolling by invitation - Clinical trials for Unspecified Atrophy of Edentulous Alveolar Ridge

Immediate Implant Placement in the Esthetic Zone

Start date: January 2014
Phase: N/A
Study type: Interventional

This study aims to examine dimensional alveolar ridge alterations and prevent buccal plate resorption and soft tissue recession following immediate implant placement in extraction sockets in the maxillary esthetic zone using different socket morphology-guided treatment modalities. Expected results of the study are: - To have found the optimal materials and GBR procedures modalities for buccal plate resorption degree reduction; - Soft tissue recession and best esthetic result achievement. There will be possibilities to study socket morphology influence on final esthetic result achievement.

NCT ID: NCT01532648 Completed - Ulcerative Colitis Clinical Trials

Randomized Placebo-Controlled Trial of Budesonide Multi-Matrix System (MMX®) 9 Milligrams (mg) in Participants With Ulcerative Colitis Currently on a 5-Aminosalicylic Acid (5-ASA)

Start date: January 27, 2012
Phase: Phase 3
Study type: Interventional

This study is to compare the efficacy and safety of budesonide MMX 9 mg versus placebo as add-on therapy to an existing oral 5-ASA regimen for the induction of remission in participants with active mild or moderate ulcerative colitis (UC).

NCT ID: NCT01528254 Completed - Clinical trials for Type 2 Diabetes Mellitus

VERIFY:A Study to Compare Combination Regimen With Vildagliptin & Metformin Versus Metformin in Treatment-naïve Patients With Type 2 Diabetes Mellitus

Start date: March 30, 2012
Phase: Phase 4
Study type: Interventional

The purpose of this study was to determine whether the initiation of a vildagliptin plus metformin combination regimen would result in more durable glycemic control than metformin monotherapy in treatment-naïve patients with type-2 diabetes mellitus (T2DM).

NCT ID: NCT01500239 Completed - Clinical trials for Complicated Intra-Abdominal Infection

A Study Comparing Ceftazidime-Avibactam+Metronidazole Versus Meropenem in Adults With Complicated Intra-abdominal Infections

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

The purpose of this study is to evaluate the effects of Ceftazidime Avibactam plus Metronidazole compared to Meropenem for treating hospitalized patients with complicated intra-abdominal infections.