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NCT ID: NCT01935245 Completed - Thrombocytopathy Clinical Trials

Platelet Function in Minimal Extracorporeal Circulation in CABG

ECCTEG
Start date: April 2013
Phase: N/A
Study type: Interventional

Rationale: Cardiac surgery with extracorporeal circulation (ECC) triggers platelets. Minimal extracorporeal circulation system (minimal-ECC) has several advantages compared with conventional ECC amongst less platelet activation. Platelet function can be analysed with thromboelastography (TEG) and multiple electrode aggregometry (MEA). Objective: The use of minimal ECC leads to less platelet dysfunction compared with conventional ECC in coronary artery bypass grafting (CABG) analysed with TEG and MEA Study design: Single center, prospective, randomized, pilot study Study population: Group 1: 20 patients undergoing CABG using minimal ECC. Patients continued the use of acetylsalicylic acid and discontinued the use of clopidogrel minimal 5 days preoperative. Group 2: 20 patients undergoing CABG using conventional ECC. Patients continued the use of acetylsalicylic acid and discontinued the use of clopidogrel minimal 5 days preoperative. Intervention: Group 1: CABG using minimal ECC Group 2: CABG using conventional ECC Main study parameters/endpoints: 1. Results of TEG and MEA, see detailed description 2. Per operative blood loss and total blood loss 24 hours after CABG 3. Total amount of transfused platelet units during CABG and 24 hours after CABG

NCT ID: NCT01934725 Recruiting - Ischemic Stroke Clinical Trials

Searching for Explanations for Cryptogenic Stroke in the Young: Revealing the Etiology, Triggers, and Outcome

SECRETO
Start date: November 2013
Phase:
Study type: Observational

BACKGROUND: In industrialized countries a considerable and increasing proportion of strokes occur at younger ages. Stroke at young age causes marked disability at worst and thus long-standing socioeconomic consequences and exposes survivors for 4-fold risk of premature death compared with background population. Up to 50% of young patients with ischemic stroke remain without definitive etiology for their disease despite extensive modern diagnostic work-up (i.e. cryptogenic stroke). The group of cryptogenic strokes includes those with patent foramen ovale (PFO) or other abnormalities in the atrial septum in the heart as the only or concomitant finding. Population prevalence of PFO is high, 25%, and the mechanisms how PFO would be associated causally with ischemic stroke remain to be clarified. Moreover, there are only scarce data on clinical outcome, long-term risk of new vascular events, and prevention of such events in these patients. DESIGN: Searching for Explanations for Cryptogenic Stroke in the Young: Revealing the Etiology, Triggers, and Outcome (SECRETO) is an international prospective multicenter case-control study of young adults (age 18-49) presenting with an imaging-positive first-ever ischemic stroke of undetermined etiology (aim N=2000). Patients are included after standardized diagnostic procedures (brain MRI, imaging of intracranial and extracranial vessels, cardiac imaging, and screening for coagulopathies) and age- and sex-matched to healthy controls in a 1:1 fashion. Up to 45 study sites worldwide will be needed to recruit the planned participant population during a 3-year period. Neurovascular imaging and echocardiography studies, and ECGs will be read centrally. AIMS: SECRETO involves five principal fields of investigation: (1) Stroke triggers and clinical risk factors; (2) Long-term prognosis (new vascular events, functional and psychosocial outcomes); (3) Abnormalities of thrombosis and hemostasis; (4) Biomarkers of e.g. inflammation, atherogenesis, endothelial function, thrombosis, platelet activation, and hemodynamic stress to characterize postulated cryptogenic stroke mechanisms; and (5) genetic study, including genome-wide association and candidate gene studies as well as next-generation sequencing approach. All analyses consider cardiac functional and interatrial structural properties as a possible mediator. Furthermore, SECRETO Family Study (substudy) aims at collecting extensive family history of thrombotic events from informative patients being screened for SECRETO main study and collect genetic samples from all consenting family members for whole-genome sequencing. SIGNIFICANCE: SECRETO will provide novel information on clinical and subclinical risk factors, both transient and chronic, predisposing to cryptogenic ischemic stroke in young adults. This study also reveals long-term prognosis of this understudied patient population and may discover new genetic background underlying the disease mechanism and provide potential targets for drug development.

NCT ID: NCT01934153 Completed - Hyperhidrosis Clinical Trials

Characterization of Exposure From Topical Administration of [14C] Umeclidinium to Axilla or Palm of Healthy Male Subjects

Start date: September 2, 2013
Phase: Phase 1
Study type: Interventional

The purpose of this study is to characterize the pharmacokinetics (PK), safety and tolerability of topically applied umeclidinium following single dose topical administration. The results from this study will be used to 1) improve our understanding of the risk of systemic accumulation upon chronic administration, 2) support dosing recommendations in a 2a/2b study for axillary administration and, potentially, a separate combined 2a/2b study for palmar administration, and 3) confirm whether the same formulation can be used for axillary and palmar application for the next studies.

NCT ID: NCT01933945 Completed - Clinical trials for Carcinoma, Hepatocellular

Outcomes of HCC (Hepatocellular Carcinoma) Patients Treated With TACE (Transarterial Chemoembolization) and Early, Not Early or Not at All Followed by Sorafenib

OPTIMIS
Start date: October 28, 2013
Phase:
Study type: Observational

This study will collect data of patients who are treated with TACE followed by sorafenib for hepatocellular carcinoma (HCC) or patients without Sorafenib after TACE. In contrast to a prior observational study on sorafenib (GIDEON study), where pre-treatment with TACE was documented retrospectively, this study will collect more detailed information about the TACE treatment and the status of a patient when treatment with sorafenib is started.

NCT ID: NCT01933932 Active, not recruiting - Clinical trials for Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV

Assess Efficacy & Safety of Selumetinib in Combination With Docetaxel in Patients Receiving 2nd Line Treatment for v-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Positive NSCLC

SELECT-1
Start date: September 25, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy of selumetinib in combination with docetaxel (75mg/m2) vs placebo in combination with docetaxel (75mg/m2) in patients with locally advance or metastatic NSCLCs that harbor mutations of KRAS. This study will also assess the PK, safety, patient reported outcomes (PRO) and tolerability profile of the selumetinib/docetaxel combination, compared to placebo in combination with docetaxel

NCT ID: NCT01933828 Recruiting - Lung Cancer Clinical Trials

Treatment of Early Stage Lung Cancer by VATS Versus OPEN Lobectomy

SCOPE
Start date: June 2013
Phase: N/A
Study type: Interventional

In patients with early stage lung cancer surgical lobectomy is the treatment of choice. A resection by Video-assisted Thoracic Surgery (VATS) is probably superior to an open procedure by thoracotomy for patients with early stage lung cancer, but randomized evidence for superiority is lacking. Furthermore, VATS lobectomy has not gained broad implementation yet. The objective of this study is to assess the benefits of VATS- over open lobectomy regarding quality of life and costs in a prospective randomized controlled multicenter trial. All patients meeting the inclusion criteria that are not randomized will be included in a prospective Cohort.

NCT ID: NCT01933568 Completed - Clinical trials for Inoperable Locally Advanced Non Small Cell Lung Cancer

Combined CFRT and SABR in Stage II and III NSCLC With Peripheral Tumors Smaller Than 5 cm.

N12HYB
Start date: February 28, 2013
Phase: Phase 1
Study type: Interventional

A phase I trial is being conducted in patients with inoperable locally advanced NSCLC to treat with a combination of Conventional Fractionated Radiotherapy (CFRT) on the mediastinal lymph nodes and Stereotactic Ablative Radiotherapy (SABR)on the primary tumor with concurrent chemotherapy. It is hypothesized that this will lead to an increase of local control and overall survival

NCT ID: NCT01933022 Terminated - Clinical trials for Metastatic Prostate Cancer

A Study in Patients With Metastatic Prostate Cancer to Assess How the Drug Eligard®, Affects Certain Markers in Blood and Urine, Which Are Indicators for the Disease

EFFECT
Start date: August 2014
Phase: Phase 4
Study type: Interventional

The purpose of this study is to investigate the effect of the study medication (Eligard®) on cancer markers (in the blood) of prostate cancer.

NCT ID: NCT01932671 Enrolling by invitation - Stroke Clinical Trials

The SMART-ORACLE Study

SMART-ORACLE
Start date: August 2012
Phase: N/A
Study type: Observational

After having had a first cardiovascular event, there is a considerable risk of developing a subsequent event. Only recently, a risk prediction model was developed for this group of patients. Imaging techniques such as the coronary artery calcium score and contrast-enhanced computed tomography (CT) of the coronary and carotid arteries could be able to add improve this model. Imaging may further improve the prediction of future manifestations of arterial disease and personalize disease monitoring and treatment.

NCT ID: NCT01932398 Completed - ADHD Clinical Trials

A Study on the Inter-Hemispheric Alpha Ratio in Kids With ADHD (SHARK)

SHARK
Start date: November 2011
Phase: N/A
Study type: Observational

Investigate the hypothesis that children with ADHD have difficulty with the allocation of visio-spatial attention related to an inability to control posterior alpha brain oscillations. A paradigm will be used in which the aim is to address covert attention as similar recent studies did in adults with ADHD.