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NCT07209020
The goal of this clinical trial is to evaluate the safety of the collagen wound dressing (HealiAid) in breast tumor patients with surgical treatment. The main questions it aims to answer are: 1. To record the incidence of the postoperative complications and adverse events (AEs) after applying the HealiAid wound dressing in patients undergoing surgery for breast tumor. 2. To evaluate the patients' satisfaction and quality of life using the Breast Q questionnaire before surgery and at weeks 2, 12, 26, and 52 after the surgery. 3. To evaluate the patients' results of vital signs, hematology tests, tumor marker tests, breast ultrasonography, and mammography after the surgery. Participants will undergo a breast surgery. Within the surgery procedure, the tumor will be completely removed with a margin of 1-2 cm surrounding healthy tissue and the wounds will be cleaned properly before the patients receive the HealiAid Collagen Wound Dressing at treatment visit, and six follow up visits at week 1, 2, 4, 12, 26 and 52.
NCT06970561
To study the postoperative recurrence of intraductal papillomas (IDP) treated with ultrasound-guided vacuum-assisted excision (VAE), and to investigate the effect of different lesion characteristics on recurrence.
NCT02004834
The purpose and the goal of this paper is to show whether the application of a combination of two local anesthetics, as opposed to the application of one local anesthetic at paravertebral block changes the hemodynamic variable. It is therefore a prospective randomized double- blind study, where we do a clinical trial in patients ASA(American Society of Anesthesiologists) 1 and 2 statuses between 18 and 80 years of age, using the ultrasound in plane technology.Upon arrival of patients in the unit for preparation procedures for anesthesia we set the ECG(electrocardiograph), noninvasive blood pressure, oxygen saturation, and arterial cannula in the radial artery After sterile washing of the dorsal surface, paravertebral space was identified with ultrasound using 8 Hz(hertz) linear transducer probe then needle position was confirmed with neurostimulation at the level of 2.0 - 5.0 mA(milliampere). When muscle contraction persisted at 0.4mA(milliampere), the anesthetic was applied in levels of Th 2, Th3, and Th 4 (7,0 milliliters per level). We applied the 0.5 % levobupivacaine and 2 % lidocaine, 7,0 milliliters of mixture per level in one group, while only 0.5 % levobupivacaine also 7,0 milliliters. by level in the second one. After that, the invasive hemodynamic monitoring was placed on patients and the induction with 1 % propofol 2-2.5 mg/kg.and Vecuronium 0,08 mg/kg. was performed with the application of supraglottic airway gel of appropriate size. The maintenance of anesthesia and sedation will be conducted with Propofol 1 % continuously ( 25-150 mcg / kg / min.)The measurements will be taken every 5 minutes during the first hour of the application of paravertebral block, then every 15 minutes during the second hour and if the operation takes more than two hours, the measurements are performed every 30 minutes. Postoperatively, invasive hemodynamic monitoring will be removed in post-anesthesia recovery room together with the arterial cannula and the patient will be sent to the hospital ward with non-invasive hemodynamic monitoring (blood pressure, pulse, saturation) until the termination of the blocks.Statistical methods, By comparing two target groups, we analysed the strength of the test with following assumptions: X2 difference test, the expected difference in variances in stroke volume between groups of 60%, α significance level of 0.05, and the minimum statistical test strength of 85%. The required total sample should include at least 80 patients, that is, 40 per group.Data will be presented in tables and graphs. Descriptive statistics of examined variables with appropriate measures of central tendency will be made. Smirnov -Kolmogorov test will assess the normality of data distribution. According to the received results, the appropriate parametric and / or nonparametric tests will be used. Comparisons of quantitative values between the two groups will be analyzed using the independent t-test or Mann-Whitney U test. Dependent values within each group will be analyzed using analysis of variance for repeated measures or Friedman test. Differences in categorical values will be analyzed by X2 test. The appropriate regression model will be made in order to predict the variability of stroke volume in which the dependent variable will be a variation of the stroke volume, while relevant clinical values will be taken as predictor variables. All P values smaller than 0.05 will be considered significant. This research is to present the main results - the existence of the significant change in Stroke Volume Variation (SVV) between groups using invasive hemodynamic monitoring, the changes of Stroke Volume Variation(SVV) depending on the time from the application within groups, differences in volume compensation of crystalloids and colloids and the need for the application of vasoactive drugs. Furthermore, as a secondary results we will present the time to maximal block development, the duration of post operative analgesia, patient satisfaction and time needed for the full recovery from the block.
NCT02187991
The goal of this clinical research study is to learn if the study drug, alisertib (MLN8237), in combination with chemotherapy (paclitaxel), can shrink or slow tumor growth in women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative or HR-negative, HER2-negative (triple negative) locally recurrent or metastatic breast cancer (MBC). The safety of alisertib in combination with paclitaxel will also be studied. The physical state of the patient, symptoms, changes in the size of the tumor, and laboratory findings obtained while on-study will help the research team decide if alisertib plus paclitaxel is safe and effective in patients with this type of breast cancer. Alisertib belongs to a group of drugs called Aurora kinase inhibitors. Alisertib blocks the activity of Aurora A kinase, a protein that is involved in tumor cell multiplication and survival. Aurora A kinase is expressed at higher than normal levels in many types of cancer, including breast cancer, and preclinical studies suggest that blocking the activity of this protein can lead to the death of cancer cells. Paclitaxel is a chemotherapy drug commonly used to treat many different kinds of cancer, including metastatic breast cancer. The reason to combine alisertib and paclitaxel is that in cancer therapy, combinations of drugs are often more effective as a treatment than either of the same drugs used alone.
NCT00639171
Magnetic Resonance Spectroscopy (MRS) is a novel imaging technique for noninvasive probing of biochemical properties of tissue. While MRS does not generate images of tumor per se it allows biochemical spectroscopic data to be obtained in vivo from user defined region-of-interest. In this manner, biochemical information elucidated by MRS can be interpreted in relation to detailed anatomy and images of metabolite distribution can be created. The aim of MRS is to identify presence and concentration of metabolites characteristic for normal and abnormal (tumor) cellular activities hence allow differential normal tissue from pathological tissue, as well as allow differentiating malignant from benign tumors.
NCT02891681
To determine the accuracy of NIR/US assessment of tumor vasculature and oxygen changes in predicting and monitoring early neoadjuvant treatment response compared to pathological response.
NCT01984866
This project aims to determine whether biopsy using radiofrequency is a procedure suitable for this patient selection. Findings from biopsy will be correlated with the conventional surgery ones. If the technique is validated to predict the presence or absence of residual tumor, breast surgery could be avoided in cases of absence of tumor.
NCT01118624
The purpose of this study is to determine the efficacy (ability to provide a beneficial treatment of the disease) of pralatrexate for the treatment of female patients with advanced or metastatic breast cancer who have failed prior chemotherapy. Patients will receive vitamin B12 and folic acid supplementation.
NCT01194908
Patients are being asked to take part in this study because they have metastatic breast cancer that is triple negative (does not express estrogen receptor (ER), progesterone receptor (PR) or HER2). This means that agents such as trastuzumab (Herceptin®) and tamoxifen are not currently treatment options for their cancer. Another option for treating the patient's cancer at this point is with chemotherapy. The patient should discuss this and other options with their doctor prior to entering this study. Laboratory studies have demonstrated that ER is actually present in some triple negative breast cancers but is "silenced" (does not function properly) because methyl and histone groups are attached to it and inactivate it. Special drugs called demethylating inhibitors (such as decitabine) and histone deacetylase inhibitors (such as LBH589) can remove these methyl and histone groups and reactivate ER. This reactivated ER can then be targeted with agents like tamoxifen. The patient is being asked to join this clinical research study to find out if ER can be reactivated in their cancer using decitabine in combination with LBH589. If ER is reactivated in their cancer, we will then determine if tamoxifen can decrease the growth of the cancer.