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NCT ID: NCT02328352 Active, not recruiting - Incisional Hernia Clinical Trials

"BP as a New Device for Surgery and Solid Cancer and Hematopoietic System Tumors Treatment. Effects of BP Implantation"

DM159
Start date: October 2010
Phase: Phase 1/Phase 2
Study type: Interventional

Nanotechnologies applied to General Surgery and Emergency Surgery: The Buckypaper as a new fixing method for prosthetic materials in the treatment of abdominal wall hernias in humans, in laparotomic procedures and as a new device for the treatment of solid cancer and hematopoietic system tumors. The experimentation on this new material, preliminary conducted on breed female rabbit New Zeeland, will be applicable to human, if the results in terms of toxicity and durability will be comfortable.

NCT ID: NCT02324660 Active, not recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

Screening for Chronic Obstructive Pulmonary Disease in Patients With Acute Coronary Syndromes

SCAP
Start date: December 2014
Phase: N/A
Study type: Interventional

Several studies and registries suggested that the concomitant presence of acute coronary syndromes (ACS) and chronic obstructive pulmonary disease (COPD) is significantly associated with poor prognosis. It has been suggested that diagnosis of COPD is frequently missing. Thus, it is plausible that a significant percentage of patients with ACS may have unrecognized COPD. This missing diagnosis may contribute significantly to poor prognosis. The investigators suppose that the concomitant use of peak expiratory flow (PEF) measurement and of Respiratory Health Screening Questionnaire (RHSQ, adapted version) could be useful as screening test for COPD in patient smokers or former smokers admitted to hospital with a diagnosis of ACS. In all screened patients COPD diagnosis will be confirmed (or not) two months after hospital discharge with spirometry. In the same setting of patients, the investigators will characterize the underlying pathological mechanisms, evaluating several inflammation, platelet and endothelial markers.

NCT ID: NCT02323841 Active, not recruiting - Clinical trials for Stage IB1 Cervical Cancer

Feasibility Study: Conservative Treatment in Cervical Cancer

Start date: March 2014
Phase: Phase 0
Study type: Interventional

Currently conservative treatment for patients of childbearing affected by cervical cancer is reserved for women with FIGO stage IA2 - IB1 with tumor size less than 2 cm . The trachelectomy and the cone biopsy with pelvic lymphadenectomy are the choice for these patients wishing to preserve their reproductive function. In this context , recently literature show the results about the use of neo-adjuvant chemotherapy about the reduction of tumor volume and therefore the magnitude of the subsequent surgical treatment (including patients with tumors larger than 2 cm ). So it becomes crucial a prospective analysis on the possibility to include in this type of treatment patients with stage IB1 and IIA1 with tumor size greater than 2 cm ( up to 4 cm ) . The current study , in fact , would like to do a prospective evaluation on the advantages of neo-adjuvant chemotherapy in the possibility of broadening the inclusion criteria to conservative treatment in women , suffering from cervical cancer, stage IB1 and IIA1 ( with tumor volume between 2 and 4 cm) and wishing to preserve their reproductive function.

NCT ID: NCT02321514 Active, not recruiting - Clinical trials for Mitral Valve Regurgitation

Expanded Clinical Study of the Tendyne Mitral Valve System

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

The purpose of this study is to evaluate the safety and performance of the Tendyne Mitral Valve System in the treatment of severe mitral regurgitation in patents with functional disability greater than or equal to NYHA Class II, who are not suitable candidates for surgical replacement with otherwise available devices. Follow-up evaluations will be conducted through 5 years post implantation.

NCT ID: NCT02320435 Active, not recruiting - Solid Tumor Clinical Trials

A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial

Start date: February 2, 2015
Phase: Phase 3
Study type: Interventional

This is a single-arm, multi-center, open-label extension study designed to provide continued pertuzumab therapy to patients receiving pertuzumab as an investigational medicinal product (IMP) in a Roche-sponsored global study and who continue to receive pertuzumab at the end of the Parent study, as well as to collect long-term safety and efficacy data of pertuzumab therapy. Patients with solid tumors who have not experienced progressive disease in the Parent study and, in the investigator's opinion, may potentially benefit from continued pertuzumab treatment, will continue to receive pertuzumab until disease progression, unacceptable toxicity, investigator/patient decision, patient non-compliance, patient death, patient request to withdraw, or study termination by the Sponsor, whichever occurs first.

NCT ID: NCT02319837 Active, not recruiting - Prostate Cancer Clinical Trials

Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK)

Start date: December 17, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess enzalutamide plus leuprolide in patients with high-risk nonmetastatic prostate cancer progressing after radical prostatectomy or radiotherapy or both. The randomized / blinded portion of the study is now completed following primary endpoint analyses. The study remains ongoing in open label format.

NCT ID: NCT02311660 Active, not recruiting - Crohn's Disease Clinical Trials

Vagus Nerve Stimulation in Crohn's Disease

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

This is an open label interventional study using an implantable vagus nerve stimulation device in patients with Crohn's disease who have active disease despite treatment with a tumor necrosis factor (TNF) antagonist drug.

NCT ID: NCT02310308 Active, not recruiting - Dental Caries Clinical Trials

Effect of a Sugar-Free Chewing Gum Containing Magnolia Bark Extract on Caries Lesions in Healthy Adult Volunteers

Start date: April 2012
Phase: N/A
Study type: Interventional

The effect of chewing gums containing MBE and xylitol on different variables related to caries and gingivitis in a sample of adult volunteers with a high risk for caries will be evaluated. The main result of that double-blind randomized controlled interventional trial will be that chewing gum containing MBE was more effective in reducing plaque acidogenicity, salivary mutans streptococci concentration and gingival bleeding compared to a xylitol and sugar-free chewing gum.

NCT ID: NCT02308527 Active, not recruiting - Neuroblastoma Clinical Trials

Activity Study of Bevacizumab With Temozolomide ± Irinotecan for Neuroblastoma in Children

BEACON
Start date: July 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to investigate whether Bevacizumab (an anti-VEGF monoclonal antibody) added to a backbone chemotherapy regimen (Temozolomide, Irinotecan-Temozolomide or Topotecan-Temozolomide) demonstrates activity in children with relapsed or refractory neuroblastoma. Also, to investigate whether the addition of Irinotecan or Topotecan to Temozolomide increases the activity of chemotherapy.The primary objective of the study is the best response (Complete Response or Partial Response) while trial treatment, within 18 or 24 weeks depending on the arm of the trial the participant is randomised to. Secondary endpoints are assessing the side effects, the length of time before progression (Progression Free Survival) and overall survival (OS). This trial will address two important questions: - does targeting blood vessel development using bevacizumab, (a monoclonal antibody against the Vascular Endothelial Growth Factor (VEGF)), add to the effect on a tumour when used with existing chemotherapy, compared to the effect of the existing chemotherapy alone (temozolomide)? NOTE- This question has been completed. - does the addition of a second chemotherapy drug (irinotecan or topotecan) increase the effect on a tumour compared to the effect of one alone (temozolomide) NOTE - This question has been completed. - does the addition of dinutuximab beta added to a backbone chemotherapy (temozolomide or temozolomide + topotecan) increase the effect of backbone alone. Patients aged 1-21 years of age with relapsed or refractory high-risk neuroblastoma are randomised to one of two treatment arms: temozolomide-topotecan (TTo) or dinutuximab beta-temozolomide-topotecan (dBTTo). Temozolomide (T), irinotecan-temozolomide (IT), bevacizumab-T (BT), BIT (bevacizumab-IT), bevacizumab-temozolomide-topotecan (BTTo) and dinutuximab beta-temozolomide (dBT) are now closed to recruitment.

NCT ID: NCT02308085 Active, not recruiting - Early Breast Cancer Clinical Trials

Pregnancy Outcome and Safety of Interrupting Therapy for Women With Endocrine Responsive Breast Cancer

POSITIVE
Start date: December 4, 2014
Phase: N/A
Study type: Interventional

The best available evidence suggests that pregnancy after breast cancer does not increase a woman's risk of developing a recurrence from her breast cancer. In particular, the most recent data suggest that this is the case also in women with a hormone receptor-positive breast cancer. There is also no indication of increased risk for delivery complications or for the newborn. The aim of the study is to investigate if temporary interruption of endocrine therapy, with the goal to permit pregnancy, is associated with a higher risk of breast cancer recurrence.The study aims also to evaluate different specific indicators related to fertility, pregnancy and breast cancer biology in young women. A psycho-oncological companion study on fertility concerns, psychological well-being and decisional conflicts will be conducted in interested Centers.