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NCT ID: NCT02197351 Recruiting - Gastric Cancer Clinical Trials

Narrow Band Imaging for Gastric Neoplasia

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

It is thought that the development of cancer of the stomach follows a series of stages in which the lining becomes increasingly abnormal. Early detection of precursors of gastric cancer likely enable less invasive treatment. The assessment of gastric mucosa using the endoscope is used to detect cancers and these precursor lesions. Narrow band imaging uses filtered light already built into modern endoscopoes to identify the early changes in the gastric lining. The investigators' hypothesis is that narrow band imaging improves detection of precursor lesions and is a method amenable to international standardization. The investigators will conduct a prospective trial in which standard random biopsy, white light guided biopsy, and narrow band imaging guided biopsy will be performed for each patient. The yield of the different methods for gastric cancer precursors will thus be compared.

NCT ID: NCT02173860 Recruiting - Clinical trials for Coronary Artery Disease

Strategies for Revascularization in Patients Undergoing Heart Valve Surgery With Concomitant Coronary Artery Disease

SAVE-IT
Start date: July 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether, in patients undergoing elective valvular heart surgery, revascularization of concomitant coronary artery disease (CAD) guided by FFR (Fractional flow reserve) would be superior to standard angiography-guided-revascularization approach on major efficacy and safety outcomes

NCT ID: NCT02151279 Recruiting - Shellfish Allergy Clinical Trials

Safety of Chitosan as Wine Fining Agent in Shrimp Allergic Patients

SWAP
Start date: March 2014
Phase: N/A
Study type: Interventional

Chitosan, the main component of the exoskeletons of crustaceans, mollusks and cephalopods, has been used as a fining agent in wines. However, its safety among patients allergic to shellfish has never been evaluated. Adult patients followed at the Allergy and Clinical Immunology Department who have been diagnosed with anaphylaxis to shrimp will be invited to participate in the study. Clinical data will be collected to ascertain for eligibility and written information will be provided. After signing informed consent, included subjects will perform skin prick-to-prick tests (PTP) with shrimp boiling water condensate and with fined and unfined wines. All will perform double blind oral challenge with the fined and unfined wines during 1visit day; the placebo (unfined wine) and active challenge (fined wine with chitosan) will be separated by 2 hours. Challenge protocol will be performed with successive increasing doses administered in 4 steps at 15-minute intervals for a total of 100 mL. During the challenge signs and symptoms will be monitored by a trained physician. Results will be presented as negative or positive (defined by presence of symptoms and signs of an allergic reaction). Categorical data will be compared by chi-square test. P<0.05 will be considered statistically significant.

NCT ID: NCT02102165 Recruiting - Clinical trials for Metastatic Breast Cancer

AURORA: Aiming to Understand the Molecular Aberrations in Metastatic Breast Cancer.

AURORA
Start date: April 2014
Phase: N/A
Study type: Interventional

This program initially aims to recruit 1300 breast cancer patients from a large number of hospitals across Europe. Eligible patients are those who are 18 or older, either female or male, and who have not received more than 1 type of treatment from the time metastases were discovered, metastasi(e)s has just been diagnosed or their disease has come back (disease relapse). Biopsy samples from both the primary and metastatic (or relapsed) tumor will be collected for central analyses, together with blood, serum and plasma samples. Any samples not analyzed immediately will be stored in an independent bio-repository to enable future (not yet defined) research aimed at better understanding metastatic breast cancer. In summary, the main objectives of AURORA are to better understand the genetic aberrations in metastatic breast cancer and to discover the mechanisms of response or resistance to therapy, in order to ultimately identify the "right therapy for each individual patient". At the same time, patients with genetic aberrations that are being targeted by new drugs in development will be offered the possibility to participate in clinical trials, when approved and available in their countries. Ultimately, the aim of AURORA is to improve the outcomes of all patients diagnosed with metastatic breast cancer.

NCT ID: NCT02070432 Recruiting - Clinical trials for Head and Neck Cancer

Photodynamic Therapy With LUZ11 in Advanced Head and Neck Cancer

Start date: February 2014
Phase: Phase 1/Phase 2
Study type: Interventional

This study will investigate the tolerability, recommended dose and pharmacokinetics of LUZ11 following photodynamic therapy (PDT) of patients with advanced head and neck cancer.

NCT ID: NCT01974362 Recruiting - Clinical trials for Endosseous Dental Implant Failure

Monolithic Zirconia Full-Mouth Implant Supported Rehabilitation Behavior

Start date: January 2014
Phase:
Study type: Observational

In patients that did a full mouth implant supported rehabilitation does Cad/Cam Monolithic Zirconia compared to Cad/Cam Zirconia Suprastructure (zirconium oxide (Yttrium - partially stabilized with tetragonal polycrystalline structure) veneered with feldspathic ceramic, has less post-insertion complications after at least 1-Year follow-up ?

NCT ID: NCT01954953 Recruiting - Usher Syndrome Clinical Trials

Clinical and Genetic Examination of Usher Syndrome Patients' Cohort in Europe

EURUSH
Start date: September 2013
Phase: N/A
Study type: Observational

This study aims to characterize Usher patients in order to correlate this data with genetic information. Tasks: - Standardization and improvement of Usher syndrome diagnosis: refine and elaborate special tests of visual and otological function in association with genotype that enable to determine the most significant markers for Usher disease progression and therapeutic effect. - Perform genotype and phenotype correlations in Usher syndrome patients - Develop and maintain database for phenotypically and genotypically well-characterized patient cohorts, suitable for future therapeutic trials

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: NCT01867801 Recruiting - Clinical trials for Coronary Artery Disease

Portuguese Registry on Interventional Cardiology

PRIC
Start date: January 2002
Phase: N/A
Study type: Observational [Patient Registry]

The purpose of this Registry is creating a database management that allows continuous monitoring characteristics, evolution, prognostic indicators and management of patients undergoing coronary angioplasty in Portuguese Hospitals, and identify the appropriateness of clinical and interventional practice recommendations for diagnosis and treatment of coronary disease and monitoring its evolution.

NCT ID: NCT01704716 Recruiting - Neuroblastoma Clinical Trials

High Risk Neuroblastoma Study 1.8 of SIOP-Europe (SIOPEN)

Start date: February 2002
Phase: Phase 3
Study type: Interventional

This is a randomized study of the European SIOP Neuroblastoma Group (SIOPEN) in high-risk neuroblastoma (stages 2, 3, 4 and 4s MYCN-amplified neuroblastoma, stage 4 MYCN non amplified > 12 months at diagnosis). The protocol consists of a rapid, dose intensive induction chemotherapy, peripheral blood stem cell harvest, attempted complete excision of the primary tumour, myeloablative therapy followed by peripheral blood stem cell rescue, radiotherapy to the site of the primary tumour and immunotherapy (R4 randomization - isotretinoin and ch14.18/CHO (Dinutuximab beta, Qarziba ®).), with or without s.c. aldesleukin (IL-2)). Patients diagnosed after the closure of R3 randomization will not be R4 randomized. For these patients the use of ch14.18/CHO antibody is recommended without scIL-2 as continuous infusion as standard of care outside of controlled trials. ch14.18/CHO received marketing authorization by EMA in May 2017 (Qarziba ®). In the induction phase, all patients receive Rapid COJEC following the result of the R3 randomization which was closed on June 8th, 2017 after inclusion of 630 patients as planned. Following induction treatment peripheral blood stem cell harvest (PBSCH) is performed and complete excision of the primary tumour will be attempted. Patients with an inadequate metastatic response to allow BuMel MAT followed by PBSCR at the end of induction should receive 2 TVD (Topotecan, Vincristine, Doxorubicin) cycles. After Rapid COJEC induction, localized patients will proceed to consolidation. Patients aged 12-18 months at diagnosis, with stage 4 neuroblastoma, no MYCN amplification and without segmental chromosomal alterations (SCAs) are thought to have a good prognosis and will stop treatment after induction therapy and surgery to the primary tumour. Consolidation consists of BuMel MAT based on the results of the R1 randomization followed by peripheral blood stem cell rescue (PBSCR) and radiotherapy to the site of the primary tumour. The R2 immunotherapy randomization using ch14.18/CHO as 8 hour infusion on 5 consecutive days ( total dose (100mg/m²) with or without aldesleukin (IL-2) alternated with isotretinoin (13-cis-RA) is closed. The amended R4 immunotherapy randomization using ch14.18/CHO as continuous infusion (total dose 100mg/m² over 10 days) with or without aldesleukin (IL-2) alternated with isotretinoin (13-cis-RA) has accrued according to plan with results pending awaiting data maturity and DMC approval.