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NCT ID: NCT01894711 Completed - Breast Cancer Clinical Trials

Real World Efficiency of Trastuzumab in Early Breast Cancer

Start date: May 2010
Phase: N/A
Study type: Observational

AIM To determine the value of trastuzumab in the early breast cancer setting in the Netherlands. RESEARCH QUESTIONS / OBJECTIVES 1. Is adjuvant trastuzumab in daily practice effectively used, that is, how and to whom is it given? 2. Is the introduction of trastuzumab in early breast cancer cost-effective for the Netherlands? To address the research questions (objectives), the following outcome measures will be determined: CLINICAL OUTCOME MEASURES 1. Actual trastuzumab administration as opposed to planned trastuzumab administration 2. Selection criteria for chemotherapy and trastuzumab in daily practice 3. Immediate and longterm toxicities due to adjuvant treatment, specifically cardiac 4. Disease-free, breast cancer specific, and overall survival in relation to trastuzumab ECONOMIC OUTCOME MEASURES 5. Volumes and costs of diagnostic tests and therapies including those for (distant) relapse 6. Cost-effectiveness of trastuzumab in clinical trials versus in real world

NCT ID: NCT01894685 Completed - Clinical trials for Sporadic Colorectal Adenoma

Mesalazine Effects in Sporadic Colorectal Adenoma Patients

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

Several studies indicate that mesalazine might have a preventive effect on recurrence of adenomas in patients with and without inflammatory bowel disease. As mesalazine has limited adverse effects, it is an attractive candidate for chemoprevention. In this study we aim to investigate the antineoplastic properties of mesalazine in patients with sporadic colorectal adenomas.

NCT ID: NCT01894243 Completed - Solid Tumours Clinical Trials

Study to Assess the Blood Levels and Safety of Olaparib in Patients With Advanced Solid Tumours and Normal Liver Function or Mild or Moderate Liver Impairment

Start date: March 13, 2014
Phase: Phase 1
Study type: Interventional

This is a 2-part study in patients with advanced solid tumours. Part A will investigate the PK of olaparib in patients with mild or moderate hepatic impairment compared to patients with normal hepatic function; Part B will allow patients with mild or moderate hepatic impairment or normal hepatic function continued access to olaparib after the PK phase and will provide additional safety data.

NCT ID: NCT01894022 Completed - Hypertension Clinical Trials

A Open Label Study to Assess the Long-term Safety, Tolerability and Efficacy of Ambrisentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

AMBER II
Start date: January 2014
Phase: Phase 3
Study type: Interventional

This is an open label, long term extension to Study AMB115811. All subjects may remain in the extension study for a minimum of 18 months. Beyond the 18-month period, subjects may continue in the extension study until one of the following: - The product is approved locally for use in inoperable CTEPH patients; - Development for use in the CTEPH population is discontinued or product is not approved by the local regulatory authorities - The investigator decides to discontinue the subject or subject decides to discontinue from the study. The primary purpose of this study is to provide clinically relevant information on the long term safety of ambrisentan in subjects with inoperable CTEPH.

NCT ID: NCT01893762 Completed - Clinical trials for Upper Respiratory Tract Infections

Innate Immune Response to (An)Aerobic Exercise in Rowing Athletes

INCREASE
Start date: May 2013
Phase: N/A
Study type: Interventional

Exercise induces innate immune response activation in athletes. The response starts during exercise and lasts for approximately 24 hours. This innate immune response shows similarities to the innate immune activation observed in, for example, bacterial infection and trauma. Immediately after exercise, athletes develop leukocytosis and cytokine production is altered towards an inflammatory pattern. However, to gain insight in immune response, a detailed cell receptor expression is required. To investigate the physiological innate immune response to exercise, we developed a model in rowers. Aim: To determine the type and degree of cellular inflammatory response in peripheral blood of elite rowing athletes after both anaerobe and aerobe exercise. Study design: Investigator driven, monocenter observational pilot study. Study population: 16 healthy, non-asthmatic, human volunteers, 18-25 year old. All competitive rowing athletes.

NCT ID: NCT01893437 Completed - Healthy Volunteer Clinical Trials

A Study of RO6799477 in Healthy Volunteers

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

This single-center, randomized, double-blind, placebo-controlled, single dose study will investigate the safety, pharmacokinetics, pharmacodynamics of RO6799477 in healthy volunteers.

NCT ID: NCT01893008 Completed - Clinical trials for Esophageal Resection Candidates

Preoperative Inspiratory Muscle Training in Esophageal Resection

PREPARE
Start date: September 2013
Phase: N/A
Study type: Interventional

The PREPARE study is the first multicenter randomized controlled trial to evaluate the hypothesis that preoperative inspiratory muscle training leads to decreased pulmonary complications in patients undergoing esophageal resection.

NCT ID: NCT01892319 Completed - Clinical trials for Diabetes Mellitus, Type 2

An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Insulin Detemir in Pregnant Women With Diabetes Mellitus. Diabetes Pregnancy Registry

Start date: September 30, 2013
Phase:
Study type: Observational

This study is conducted in Europe and Asia. The purpose of the study (Diabetes Pregnancy Registry) is to evaluate the safety of treatment with insulin detemir in pregnant women with diabetes mellitus.

NCT ID: NCT01890967 Completed - Clinical trials for Hypercholesterolemia

A Study of LY3015014 in Participants With High Cholesterol

Start date: June 2013
Phase: Phase 2
Study type: Interventional

This study is designed to define the amount and duration of cholesterol lowering and to assess the safety and tolerability of different dose regimens of LY3015014 in participants with high cholesterol. The study will also investigate how the body processes the drug and how the drug affects the body. Participants will remain on a stable diet and will continue taking cholesterol-lowering medications (statins with or without ezetimibe). After signing the informed consent document, the participant will complete a screening/run-in period that will last at most 8 weeks. Then, the treatment period will last approximately 16 weeks. After the treatment period, the participants will complete a follow-up period lasting approximately 8 weeks for a total study duration ranging from approximately 25 to 32 weeks.

NCT ID: NCT01890512 Completed - Bradycardia Clinical Trials

INGENIO MRI/ FINELINE II Pacing System Data Collection in Patients Undergoing MRI

INFINITE-MRI
Start date: June 2013
Phase: N/A
Study type: Observational

The INFINITE MRI Study is a prospective, non-randomized, multicenter, single arm study aimed at collecting data on ImageReady™ MR Conditional Pacing System (consisting of an INGENIO™ MRI or ADVANTIO™ MRI pacemaker with FINELINE™ II Sterox or FINELINE™ II Sterox EZ endocardial pacing lead(s)) when used in the Magnetic Resonance Imaging environment under the labeled Conditions of Use.