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NCT ID: NCT01386580 Completed - Breast Cancer Clinical Trials

An Open-label, Phase I/IIa, Dose Escalating Study of 2B3-101 in Patients With Solid Tumors and Brain Metastases or Recurrent Malignant Glioma.

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

The purpose of this study is to determine the safety, tolerability, and pharmacokinetics (PK) of 2B3-101 both as single agent and in combination with trastuzumab. Furthermore, the study will explore the preliminary antitumor activity of 2B3-101 as single agent in patients with with solid tumors and brain metastases or recurrent malignant glioma as well as in patients with various forms of breast cancer with and in combination with trastuzumab in HER2+ breast cancer patients with brain metastases.

NCT ID: NCT01383421 Completed - Clinical trials for Rheumatoid Arthritis

Observational Study to Research the Effectiveness of Adalimumab Treatment in Conjunction With Utilization of a Patient Support Program (PSP)

PASSION
Start date: September 2011
Phase: N/A
Study type: Observational

Post-marketing observational study to determine the effectiveness and patient satisfaction with adalimumab treatment in patients with Rheumatoid Arthritis in relation to utilization of a Patient Support Program (PSP).

NCT ID: NCT01381874 Completed - Postmenopausal Clinical Trials

A Study of Abiraterone Acetate Plus Prednisone With or Without Exemestane in Postmenopausal Women With Estrogen Receptor-Positive (ER+) Metastatic Breast Cancer Progressing After Letrozole or Anastrozole Therapy

Start date: August 24, 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of oral abiraterone acetate plus oral prednisone and oral abiraterone acetate plus oral prednisone plus oral exemestane, each compared with oral exemestane alone, in postmenopausal women with estrogen receptor-positive (ER+) metastatic (spreading) breast cancer that has relapsed after treatment with letrozole or anastrozole.

NCT ID: NCT01381848 Completed - Clinical trials for Bacterial Infections

A Study of Doripenem in Infants Less Than 12 Weeks of Age

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

The purpose of this study is to measure drug levels of doripenem in blood samples collected before and after administration of doripenem to infants less than 12 weeks of age who are hospitalized and documented, presumed to have, or are at risk for bacterial infection (s) and are undergoing treatment with intravenous (i.v.) antibiotics. Safety and tolerability will also be assessed.

NCT ID: NCT01379989 Completed - Ovarian Cancer Clinical Trials

INOVATYON STUDY -International, Randomized Study in Patients With Ovarian Cancer

INOVATYON
Start date: June 2011
Phase: Phase 3
Study type: Interventional

The objective of this multicentric, randomised, Phase III study is to demonstrate superiority, in terms of survival, of trabectedin and Pegylated Liposomal Doxorubicin (PLD) versus carboplatin and PLD in partially-platinum sensitive ovarian cancer patients.

NCT ID: NCT01377090 Completed - Systemic Sclerosis Clinical Trials

Digital Ulceration

CAP
Start date: January 2011
Phase: N/A
Study type: Observational

The CAP study is a multicenter, observational, clinical study in patients with systemic sclerosis. The study aims at determining the usefulness of nailfold videocapillaroscopy and patient-specific disease-related factors in predicting the occurrence of digital ulcers within a 6-month observation period. Patients with cutaneous forms of systemic sclerosis (limited or diffuse), with or without history of digital ulceration are eligible. The study will enroll 500 patients at 70 centers.

NCT ID: NCT01377012 Completed - Clinical trials for Rheumatoid Arthritis

Efficacy at 24 Weeks and Safety, Tolerability and Long Term Efficacy up to 2 Years of Secukinumab (AIN457) in Patients With Active Rheumatoid Arthritis and an Inadequate Response to Anti-TNFα Agents

REASSURE
Start date: August 2011
Phase: Phase 3
Study type: Interventional

This study will assess the safety and efficacy of secukinumab when added to a background therapy in patients with active rheumatoid arthritis (RA) who are intolerant to or have had an inadequate response to anti-tumor necrosis factor (TNF)-α agents.

NCT ID: NCT01375777 Completed - Hyperlipidemia Clinical Trials

Monoclonal Antibody Against PCSK9 to Reduce Elevated Low-density Lipoprotein Cholesterol (LDL-C) in Adults Currently Not Receiving Drug Therapy for Easing Lipid Levels

MENDEL
Start date: July 6, 2011
Phase: Phase 2
Study type: Interventional

The primary objective was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145) every 2 weeks (Q2W) or every 4 weeks (Q4W), compared with placebo, on the percent change from baseline in LDL-C when used as monotherapy in adults with hypercholesterolemia.

NCT ID: NCT01375764 Completed - Hyperlipidemia Clinical Trials

Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects

GAUSS
Start date: July 28, 2011
Phase: Phase 2
Study type: Interventional

The primary objective was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145), compared with ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in patients with hypercholesterolemia unable to tolerate an effective dose of a statin.

NCT ID: NCT01375413 Completed - Parkinson's Disease Clinical Trials

Dual Task Practice in Parkinson's Disease

Duality-PD
Start date: June 2011
Phase: Phase 3
Study type: Interventional

The ability to perform two or more tasks together is impaired in Parkinson's Disease (PD). Based on pilot work we hypothesize that dual tasking is amenable to training in PD and will not compromise safety. In the proposed study we will therefore collect high level evidence on whether 6 weeks of integrated dual task gait training is more effective than consecutive task practice. The investigators will use a randomized, single blind study design and conduct the same protocols in two academic centers (Katholieke Universiteit Leuven and Radboud Universiteit Nijmegen). The investigators intend to test an experimental condition which consists of focused dual task training in the home using a novel program of personalized cognitive tasks. The aim of dual task training is to teach motor-cognitive task integration and achieve optimal levels of automaticity and functionality. The control arm will receive gait practice and separate cognitive training of the same intensity, but offered consecutively. We will test the hypothesis that dual task training (integration) will have more pronounced effects on complex gait than consecutive task training. Sub-analysis will be conducted on patients with and without freezing of gait. The investigators expect that integrated dual task training may be less effective in patients with freezing, due to the increased fall risk and impaired cognitive profiles. Overall, this project will provide evidence to support future directions for motor learning and innovative rehabilitation targets.