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NCT ID: NCT01205724 Completed - Clinical trials for Congenital Bleeding Disorder

Safety and Pharmacokinetics of NNC 0129-0000-1003 in Subjects With Haemophilia A

pathfinder™1
Start date: September 2010
Phase: Phase 1
Study type: Interventional

This trial is conducted globally. The aim of this clinical trial is to investigate the safety and pharmacokinetics (the determination of the concentration of the administered medication in blood over time) of NNC 0129-0000-1003 in previously treated subjects with severe haemophilia A.

NCT ID: NCT01205321 Completed - Diagnostic Imaging Clinical Trials

PET/CT Imaging for Radiation Dosimetry, Plasma Pharmacokinetics, Biodistribution, Safety and Tolerability and Diagnostic Performance of BAY86-7548 in Patients With Prostate Cancer and Healthy Volunteers

Start date: November 2010
Phase: Phase 1
Study type: Interventional

Visual assessment of diagnostic PET/CT (positron emission tomography/computed tomography) images obtained after a single intravenous injection of BAY86-7548 in patients with cancer.

NCT ID: NCT01204944 Recruiting - Clinical trials for All Transplanted Individuals in Switzerland

Swiss Transplant Cohort Study

STCS
Start date: May 2008
Phase:
Study type: Observational

The Swiss Transplant Cohort Study is an observational prospective cohort study enrolling all patients after solid organ and stem cell transplantation since 5/2008 in Switzerland. Predefined variables are collected at defined time points. Individual samples (PBMC, plasma, DNA) will be stored for future projects. Data relevant to transplantation outcome with emphasis on immunological and infectious complications as well as psychosocial variables will be gathered.

NCT ID: NCT01204749 Completed - Ovarian Cancer Clinical Trials

TRINOVA-1: A Study of AMG 386 or Placebo, in Combination With Weekly Paclitaxel Chemotherapy, as Treatment for Ovarian Cancer, Primary Peritoneal Cancer and Fallopian Tube Cancer

Start date: November 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if treatment with paclitaxel plus AMG 386 is superior to paclitaxel plus placebo in women with recurrent partially platinum sensitive or resistant epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer. AMG 386 is a man-made medication that is designed to stop the development of blood vessels in cancer tissues. Cancer tissues rely on the development of new blood vessels, a process called angiogenesis, to obtain a supply of oxygen and nutrients to grow.

NCT ID: NCT01204333 Terminated - Clinical trials for Sinus Thrombosis, Intracranial

Thrombolysis or Anticoagulation for Cerebral Venous Thrombosis

TOACT
Start date: September 2011
Phase: Phase 2/Phase 3
Study type: Interventional

Background: Endovascular thrombolysis, with or without mechanical clot removal (ET), may be beneficial for a subgroup of patients with cerebral venous sinus thrombosis (CVT), who have a poor prognosis despite treatment with heparin. Published experience with ET is promising, but only based on case series and not on controlled trials. Objective: The main objective of the TO-ACT trial is to determine if ET improves the functional outcome of patients with a severe form of CVT Study design: The TO-ACT trial will be designed as a multi-centre, prospective, randomized, open-label, blinded endpoint (PROBE) trial. Study population: Patients are eligible if they have a radiologically proven CVT, a high probability of poor outcome (defined by presence of one or more of the following risk factors: mental status disorder, coma, intracranial hemorrhagic lesion or thrombosis of the deep cerebral venous system) and the responsible physician is uncertain if ET or standard anti-coagulant treatment is better. Intervention: Patients will be randomized to receive either ET or standard therapy (therapeutic doses of heparin). ET consists of local application of alteplase or urokinase within the thrombosed sinuses, and/or mechanical thrombectomy. Glasgow coma score, NIH stroke scale and relevant laboratory parameters will be assessed at baseline. Endpoints: The primary endpoint is the modified Rankin scale (mRS) at 12 months. The most important secondary outcomes are the mRS, mortality and recanalization rate at 6 months. Major intra- and extracranial hemorrhagic complications within one week following the intervention are the principal safety outcome. Results will be analyzed according to the "intention-to-treat" principle. Assessment of study endpoints will be carried out according to standardized questionnaires by a blinded neurologist or research nurse who is not involved in the treatment of the patient. Study size: To detect a 50% relative reduction in mRS≥2 (from 40 to 20%), 164 patients (82 in each treatment arm) have to be included (two-sided alpha, 80% power). Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Included patients may benefit directly from ET. Complications of ET, most notably intracranial hemorrhages, constitute the most important risk of the study.

NCT ID: NCT01203917 Active, not recruiting - Clinical trials for Caucasian Patients With EGFR Mutation Positive Advanced NSCLC

Efficacy, Safety, Tolerability of Gefitinib as 1st Line in Caucasian Patients With EGFR Mutation Positive Advanced NSCLC

IFUM
Start date: September 2010
Phase: Phase 4
Study type: Interventional

This study is carried out to see how Caucasian patients with lung cancer which has EGFR mutation will respond to gefitinib (IRESSA™) as a first line treatment. Safety data will also be collected and analysed to confirm that treatment with gefitinib is safe and well tolerated.

NCT ID: NCT01203605 Completed - Non-cardiac Surgery Clinical Trials

European Surgical Outcomes Study

EuSOS
Start date: April 2011
Phase: N/A
Study type: Observational

The European Surgical Outcomes Study (EuSOS) is a multi-centre, international cohort study of peri-operative care and clinical outcomes for patients undergoing non-cardiac surgery. Participating centres throughout Europe will contribute routine clinical data describing all eligible patients who undergo surgery from 4th April 2011 to 11th April 2011. Patients will then be followed until hospital discharge (or for a maximum of 60 days) for duration of hospital stay and hospital mortality. Routine clinical data will also be collected for those patients admitted to critical care at any stage after surgery but during the same hospital admission. Specific objectives are to describe clinical outcomes and standards of peri-operative care for patients undergoing non-cardiac surgery in Europe.

NCT ID: NCT01203553 Completed - Incisional Hernias Clinical Trials

Prophylactic Mesh Implantation for the Prevention of Incisional Hernia

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

Incisional hernias are primarily repaired using prosthetic meshes. In Switzerland such meshes are mainly implanted via open or laparoscopic approach. The differential impact of these two types of surgical technique on recurrence rate will be investigated with this study. With this multicenter cohort study the outcomes of laparoscopic and open incisional hernia repair will be investigated prospectively. Hernia recurrence is the main outcome measure.

NCT ID: NCT01202188 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

A Study to Assess the Efficacy, Safety and Tolerability of Once-daily (q.d.) QVA149 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

SHINE
Start date: September 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to provide pivotal efficacy and safety data for QVA149 in patients with moderate to severe COPD.

NCT ID: NCT01202058 Terminated - Clinical trials for Atherosclerotic Coronary Artery Disease

An Observational Safety Evaluation of Patients Treated With the NEVO™ Sirolimus-eluting Coronary Stent. (NEVO II)

NEVO II
Start date: August 2010
Phase: Phase 3
Study type: Interventional

As a result of the implementation of Protocol Am3.0, the design and objective of the NEVO II trial were changed to focus on the safety follow-up of the 103 NEVO™ subjects. Although this trial started interventional, the remainder of the study will be observational. The objective of this prospective, observational study is to ensure the safety and the wellbeing of subjects treated with the NEVO™ SES.