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NCT ID: NCT02214537 Terminated - Cleavage Times Clinical Trials

Does DNA Sperm Fragmentation Affects Embryo Morphokinetic?

MACs-ESD
Start date: February 2016
Phase: N/A
Study type: Interventional

The embryokinetics may be a new prognostic factor for choosing the human embryos with the highest implantation potential. In order to identify the factors that may affect the rate of embryo cleavage, there are many studies about morphokinetics and culture medium, oxygen tension, oocyte quality or type of medication used for ovarian stimulation. However there are no published data with respect to the influence of sperm DNA fragmentation in the embryo kinetic.

NCT ID: NCT02213744 Terminated - Breast Cancer Clinical Trials

MM-302 Plus Trastuzumab vs. Chemotherapy of Physician's Choice Plus Trastuzumab in HER2-Positive Locally Advanced/Metastatic Breast Cancer Patients

HERMIONE
Start date: July 2014
Phase: Phase 2/Phase 3
Study type: Interventional

This study is an open label, randomized, multicenter trial of MM-302 plus trastuzumab. The trial is designed to demonstrate whether MM-302 plus trastuzumab is more effective than the chemotherapy of physician's choice (CPC) plus trastuzumab in locally advanced/metastatic HER2-positive breast cancer patients. Patients may not have been previously treated with an anthracycline in any setting. Patients must have received prior treatment with trastuzumab in any setting, have either progressed or are intolerant to ado-trastuzumab emtansine in the metastatic or locally advanced setting, have either progressed or are intolerant to pertuzumab in the metastatic or locally advanced setting or had disease recurrence within 12 months of pertuzumab treatment in the neoadjuvant or adjuvant setting.

NCT ID: NCT02213042 Terminated - Neoplasms, Breast Clinical Trials

Evaluation of Biomarkers Associated With Response to Subsequent Therapies in Subjects With HER2-Positive Metastatic Breast Cancer

Start date: October 24, 2014
Phase: Phase 2
Study type: Interventional

This was a multicenter, open-label, Phase II study in subjects with Human epidermal growth factor receptor (HER2)-positive metastatic breast cancer who received at least 2 prior lines of anti-HER2-targeted therapies of which at least one included a Trastuzumab-containing regimen. This study was a post-approval commitment with regulatory authorities. It was designed to evaluate whether treatment with Dual blockade promoted changes to biomarkers associated with immunomodulation.

NCT ID: NCT02211183 Terminated - Rotator Cuff Tear Clinical Trials

InSpaceā„¢ System in Comparison to Best Repair of Massive Rotator Cuff Tear

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

This is a post-marketing study to further assess the safety and effectiveness of the InSpaceā„¢ device implantation in comparison to surgical repair of full thickness Massive Rotator Cuff Tear .

NCT ID: NCT02205398 Terminated - Clinical trials for Metastatic Colorectal Cancer

Study of Safety and Efficacy of INC280 and Cetuximab, in Adult c-MET Positive mCRC and HNSCC Patients After Progression on Cetuximab or Panitumumab Therapy

Start date: July 28, 2014
Phase: Phase 1
Study type: Interventional

This was an open-label, phase Ib, multicenter clinical trial to determine the MTD/RDE of the orally administered c-MET inhibitor INC280 in combination with cetuximab. This combination was to be explored in c-MET positive mCRC and HNSCC patients whose disease progressed on cetuximab or panitumumab treatment. The dose escalation part was to be guided by a Bayesian Logistic Regression Model with overdose control. At MTD/RDE, additional mCRC and HNSCC patients who progressed on cetuximab or panitumumab treatment were to be enrolled in two expansion groups to further assess the anti-tumor activity and the safety and tolerability of the combination of INC280 and cetuximab. Patients were to receive INC280 on a continuous bid dosing regimen and cetuximab every week. A treatment cycle was defined as 28 days with no scheduled break between cycles. The trial was terminated because of difficulties in identifying patients who met the eligibility criteria.

NCT ID: NCT02204345 Terminated - Clinical trials for Squamous Non-Small Cell Lung Cancer

A Study Evaluating RO5479599 in Combination With Carboplatin and Paclitaxel in Participants With Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC) of Squamous Histology

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

A multi-center Phase Ib/II study of the combination of RO5479599 with carboplatin and paclitaxel once in every 3 week (q3w) regimen to evaluate the safety and tolerability.

NCT ID: NCT02204332 Terminated - Colorectal Cancer Clinical Trials

Phase II-b Randomized Clinical Trial of Cabazitaxel in Metastatic Colorectal Cancer Resistant to Standard Treatment

COMETA
Start date: March 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine efficacy and safety of cabazitaxel administration in patients with colorectal cancer resistant to standard treatment.

NCT ID: NCT02202135 Terminated - Clinical trials for Complicated Skin and Soft Tissue Infection

Evaluation of Ceftaroline Fosamil vs Vancomycin Plus Aztreonam in the Treatment of Patients With Skin Infections.

Start date: June 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effects of Ceftaroline Fosamil versus Vancomycin plus Aztreonam in treatment of patients with complicated bacterial skin and soft tissue infections.

NCT ID: NCT02197949 Terminated - Breast Cancer Clinical Trials

Preoperative and Intraoperative Quantification of Axillary Tumoral Load

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

At present, patients diagnosed of a breast cancer with infiltration of the axillary lymph-nodes are submitted to axillary lymph-node dissection (ALND). The sentinel node (SN) technique is not indicated when a lymph-node biopsy or cytology is positive, nor when the surgical treatment is upfront neither when a neoadjuvant systemic therapy is indicated. The reason for not performing SN is that patients diagnosed of an infiltrated axilla though ultrasound-guided biopsy or cytology tend to have a higher tumoral load than those diagnosed after a sentinel biopsy. Furthermore, even if these patients are submitted to a neoadjuvant systemic treatment and the axillary clinical exploration is negative after the treatment, different studies showed that the SN false negative rate is unacceptably high. Despite these facts, a high proportion of patients with a positive axilla at diagnosis and submitted to level I and II axillary lymph node dissection show few lymph nodes infiltrated in the pathological study, frequently four or less neoplastic nodes. New methods of detecting these patients with limited infiltrated nodes should be developed and new approaches to axillary surgery (i.e., partial resection) should be offered. To date, the only information expected to get after an axillary imaging is performed is if the axilla is infiltrated or not. No information about the tumoral load is demanded. In the other hand, level I and II ALND is performed according to established anatomic limits, without selecting the nodes to be excised neither identifying the ones infiltrated for a directed excision. The aim of the study is to evaluate the ability of a specified and reproducible imaging protocol for distinguishing patients with a high axillary tumoral load from the ones with a low tumoral load. At the same time, as the initial nodes receiving lymph drainage should be the ones commonly affected, identifying these nodes injecting diluted methylene blue in the retroareolar parenchyma and studying their tumoral load could help selecting patients with high from those with low axillary tumoral load. Evaluation of both steps (that is, first the imaging protocol followed by the methylene blue protocol), could eventually help to distinguish which patients should be submitted to a classical level I and II ALND and which ones can be spared from excising the lymph nodes not stained by the methylene blue.

NCT ID: NCT02195817 Terminated - Alcohol Dependence Clinical Trials

Study of 18 mg Selincro® As-needed Use, in the Treatment of Patients With Alcohol Dependence in Primary Care

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

To determine the reduction in alcohol consumption in patients with alcohol dependence treated with 18 mg Selincro® as-needed use, in conjunction with continuous psychosocial support in primary care