46 Clinical Trials for Various Conditions
The goal of this clinical research study is to determine how well a tirzepatide-assisted weight loss program works before a prostatectomy in patients with intermediate risk prostate cancer
The study aims to investigate whether following a controlled Mediterranean-style diet prior to robotic-assisted radical prostatectomy surgery in patients diagnosed with prostate cancer affects fasting insulin levels and other values that can be measured in blood and tissue samples from surgery.
This trial aims at investigating the diagnostic ability of a combined diagnostic panel including systematic endoscopic evaluation (SEE), blood-based ctDNA assay, and urine-based cfDNA assay to predict the presence of residual tumor remaining in the bladder at cystectomy. Patients who are planned for cystectomy due to bladder cancer will be considered for enrollment based on inclusion and exclusion criteria.
To learn if TTI-101 can reduce the growth of HPV-negative squamous cell carcinomas of the head and neck when given before standard of care surgery.
This is a single-arm pilot study that will recruit 12 patients with newly diagnosed Glioblastoma, a malignant brain tumor with a poor prognosis. Patients will be treated with fractionated stereotactic radiotherapy (FSRT) for 2 weeks, in addition to two doses of Atezolizumab (Tecentriq), an FDA approved PD- L1 inhibitor drug, 840 mg IV, at the beginning and at the end of the two-week time period, concomitantly with FSRT. After this initial two weeks treatment the patients will undergo craniotomy and maximal safe resection as per normal care for a GB. After surgery patients will follow the normal care for glioblastoma in addition to Atezolizumab 840 mg IV q2 weeks for the duration of adjuvant treatment.
Combination treatment with nivolumab and ipilimumab before surgery may help people with melanoma because the drugs are designed to help the immune system target and destroy cancer cells (immunotherapy), which may shrink the cancer and prevent recurrence after surgery. Treatment given before surgery is called neoadjuvant therapy. The purpose of this study is to find out whether neoadjuvant therapy with nivolumab and ipilimumab can kill melanoma tumors before surgery and prevent disease from coming back after surgery. This study also explores a new, experimental PET scan that images the immune system to see if it is related to treatment outcomes.
3D printing is emerging as a new diagnostic tool for pre-surgical planning. 3D printed models are extremely advantageous to surgeons in their preoperative planning. Handling these physical replicas engages active spatial perception skills, enabling a more comprehensive understanding of the presented information in an inherently intuitive manner that cannot be achieved with conventional methods of imaging review that use screen based 2D and volume rendered representations. The investigators are developing a novel technique to create 3D models derived directly from extremely high-resolution medical images that are superior in spatial and contrast resolution to current 3D modelling methods. This produces patient specific models that contain previously unachievable special fidelity and soft tissue differentiation. Investigators hypothesize that the preoperative use of these new diagnostic quality models will reduce surgical time and improve post-surgical outcomes in the near future. This prospective project will optimize the quality of these 3D models to create highly useful pre-surgical models. Investigators will target those subspecialist areas of the multidisciplinary surgical and imaging team where it is believed these models will have the most impact. The proposed prospective study has two major goals: 1) Investigate the use of uncompressed, ultrahigh resolution CT/MR datasets to produce diagnostic 3D models with identical spatial/contrast resolution to the acquired datasets in the target areas of congenital cardiothoracic surgery, neurosurgical tumor resection and nephrectomy. 2) Compare the accuracy of this innovative method for 3D printing to radiological images and pathological data when available.
Study involves surgery for cytoreduction or laparoscopy to determine if you are a candidate for tumor debulking or a tissue biopsy. Following this surgery you will receive chemotherapy. This study will administer 7 days of treatment with a targeted therapy called Lynparza. Lynparza and/or other PARP inhibitors have been FDA approved for the treatment of ovarian and breast cancer. Tissue biopsy will be done before a 7 day course of Lynparza in order to correlate molecular changes to response to treatment. Participation in this trial will require an additional tumor biopsy which will occur either before or after treatment of Lynparza.
This pilot and feasibility study studies how well nivolumab and combination chemotherapy work before surgery in treating patients with pancreatic cancer that could possibly be removed by surgery. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body?s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as fluorouracil, irinotecan hydrochloride, leucovorin calcium and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nivolumab in combination with chemotherapy before surgery may work better in treating patients with pancreatic cancer compared to chemotherapy alone.
This study will evaluate the performance of the Quantra System comprised of the Quantra Hemostasis Analyzer with the QPlus Cartridge in patients taking anitplatelet medication that are scheduled to undergo cardiac surgery.
This trial studies how well the use of a pre-surgical toolkit (OPTI-Surg) works in improving surgical care and outcomes in older participants with cancer. In many elderly patients, surgery can greatly affect physical condition and the ability to return to pre-surgery levels of physical functioning. Providing pre-surgical recommendations may help improve participants' recovery rate and functioning after surgery.
This phase II trial studies the wound complication risk of shorter course, hypofractionated pre-surgery radiation therapy in treating patients with localized soft tissue sarcoma of the extremity of superficial trunk that can be removed by surgery. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Shorter course hypofractionated pre surgery radiation therapy may be more convenient for patients with soft tissue sarcoma than a longer course of radiation therapy, and may result in fewer complications.
The purpose of this study is to find the safest level of aerobic training for people about to undergo surgery for their cancer, and to learn what effects, if any, aerobic exercise has on these patients and the outcomes of their cancers. This part of the study (Phase 0) will evaluate the feasibility and quality of at-home exercise and assessment procedures and find out whether study participants are willing to practice continuous lifestyle monitoring using apps and electronic devices. Phase 1a will compare the effects and feasibility of six different doses of aerobic exercise and will continue evaluating the quality of at-home study procedures, which includes the use of continuous lifestyle monitoring through apps and electronic devices. In order to facilitate completion of the phase 1a component, we will backfill the 90, 225, and 300 mins/wk dosing cohorts with at least 4 patients in each dose cohort.
This biomarker study has been designed to assess the effects of different agents in both tumour tissue and peripheral samples to help inform the best combinations of DDR agents with immuno-oncology (IO) therapies. In the first instance 2 DDR agents will be assessed separately as monotherapy. Additional arms may be added later to evaluate other DDR agents and/or DDR and immunotherapy agents in combination or in sequence. The primary objective of the study is to investigate immune activation due to DDR inhibition by assessing tumour and blood samples of patients treated with study investigational agent(s).
The purpose of this study is to look at the effectiveness of nivolumab in patients with oral cavity cancer (OCC) who are about to undergo surgery.
The study team hypothesizes that at-home cleansing of the surgical site with chlorhexidine wipes provide no added benefit to decreasing microbial activity or preventing surgical site infections. Patients will be randomized to the chlorhexidine or no additional intervention groups. Patients will be randomized to use 4% chlorhexidine cloths, while the other half receive no additional intervention. Those randomized into the chlorhexidine gluconate (CHG) home-application group will be asked to shower the night before surgery, and to use a standardized pre-packaged CHG wipe (that the patients would receive at their pre-surgical consultation) on their surgical site after thoroughly drying those areas. The patients will be asked to use a second wipe in each area the morning of surgery. The surgical sites will be analyzed in two groups: anterior cervical and posterior spine. Each of these two groups will be randomized separately. All patients will undergo a standardized preoperative cleansing regimen. Once positioned, they will be cleansed with an alcohol solution. Then, the surgical site (either the anterior portion of the neck or the posterior area of the spine) will be scrubbed with chlorhexidine soaked brushes and then painted with chlorhexidine solution. Perioperative antibiotics will be given per attending surgeon preference. Cutaneous samples will be taken from the surgical site of each patient at each time point.
This is an open-label, non-randomized pharmacokinetic study of fulvestrant in women scheduled for mastectomy or lumpectomy. Eligible subjects will be identified with breast cancer or DCIS. The first subject of each of five groups will receive fulvestrant intramuscularly. The subsequent 5 subjects of each group will receive fulvestrant by intraductal instillation. All subjects will be monitored for systemic and local adverse events during the procedure, and following the procedure until mastectomy or lumpectomy. Subjects that receive fulvestrant will undergo serial blood draws to determine fulvestrant blood concentration levels.
The purpose of this study is to see if a radioactive substance called 18F-Fluorodeoxyglucose (18F- FDG), injected into the cervix during a PET/CT scan done before surgery can show us more clearly which lymph nodes in the pelvis (the area near your uterus and cervix) contain cancer.
This trial is designed as a randomized two-arm (LDE225 vs. observation groups) open-label prospective clinical trial in men with localized high-risk prostate cancer undergoing radical prostatectomy. The investigators propose to determine the effects of LDE225 on neoplastic prostate tissue from men at high risk of systemic disease progression, by comparing pre-surgical core-biopsy specimens to tumor tissue harvested at the time of prostatectomy.
Objectives: The overall study objective is to compare the sensitivities and specificities of morphometric analysis techniques using structural MRI images based on pre- and postsurgical localization of epileptic foci in patients undergoing presurgical evaluation for medically refractory epilepsy. To carry out these analyses, we aim to establish an age-stratified normative imaging database using healthy volunteers. Additional objectives are to identify abnormal networks in these patients using resting state fMRI/EEG and MEG/EEG, and to use language and memory fMRI tasks to examine the effects of epileptogenic zones and surgery on cognitive function and the networks associated with these functions. Study population: 300 adults and children (age 8 and older) with uncontrolled focal epilepsy, and 200 age-stratified healthy volunteers. Design: A retrospective and prospective natural history study. Research procedures for patients in this study include neuropsychological testing and 1-4 MRI sessions during presurgical evaluation and an additional 1-3 MRI sessions and neuropsychological testing approximately 12 months post-operatively. Research testing (such as research neuropsychological tests or MRI scanning sequences) will be done during a visit for clinical testing whenever possible, likely reducing the number of required visits. Patients will also have optional MEG and 7T structural imaging. Data will also be obtained from patients who have already undergone epilepsy surgery if they had procedures as outlined in the protocol and are willing to share the data. Healthy volunteers will receive a subset of the pre-operative procedures for patients, requiring at least 3 visits. In order to ensure adequate data acquisition, subjects may be re-scanned up to three times for the portions of the study in which they participated, possibly requiring additional visits. Outcome measures: The main outcomes will be establishment of normative values for morphometric analysis methods in age-stratified normal controls, and comparison of the sensitivity and specificity of these measures to pre- and postsurgical localization of the epileptogenic zone. Secondary outcome measures will include determination of the sensitivity and specificity of source localization using MEG/EEG and resting state fMRI/EEG, and to evaluate changes in activation during rest, as well as language and memory fMRI tasks in patients pre- and postsurgically, to examine the effects of epileptogenic zones and surgery on cognitive function and the networks underlying these functions.
The purpose of this study is to determine the effects of combining metformin and atorvastatin treatment in patients with newly diagnosed breast cancer during the interval between breast biopsy and surgery. This study is designed to assess whether tumor proliferation, as measured by the natural log expression of Ki-67 staining of breast tumor cells, is reduced following approximately 2 weeks of treatment with the combination of metformin plus atorvastatin in patients with newly diagnosed breast cancer.
This is a multi-center, open-label Phase II randomized pre-surgical pharmacodynamics study.
The purpose of this study is to evaluate whether the combination of neoadjuvant chemotherapy (chemotherapy before surgery) plus ipilimumab for lung cancer increases the number of patients with detectable circulating T cells with specificities against tumor associated antigens (TAA) from zero percent (0%) of patients prior to therapy to 20% of patients after neoadjuvant chemotherapy plus ipilimumab. This is an open label Phase 2 trial. Patients with clinical stage 1B (\>4 cm), 2, (N0-2) or 3 non-small cell lung cancer (NSCLC) and no prior therapy for the current diagnosis of lung cancer will be eligible for the study. Subjects will receive 3 cycles of neoadjuvant chemotherapy (paclitaxel + cisplatin/carboplatin). Ipilimumab will be administered during Cycles 2 and 3 of standard chemotherapy and for up to 4 cycles alone after surgery. Subjects will undergo standard clinically indicated surgical resection of their lung cancer as deemed appropriate by their surgeon. Standard diagnostic and staging work up will be performed including: pathologic/histologic diagnosis of NSCLC, Positron Emission Tomography (PET)/Computed Tomography (CT) scan, brain imaging, and mediastinoscopy. Three cycles of neoadjuvant chemotherapy will be given. Ipilimumab will be added to neoadjuvant chemotherapy for cycles 2 and 3. Standard surgical evaluation and therapy will be performed following completion of neoadjuvant therapy. Two cycles of single agent ipilimumab will be given after surgery (adjuvantly), followed by 2 cycles of maintenance therapy.
The study is intended to collect specimens to support the application of genome analysis technologies, including large-scale genome sequencing. This study will ultimately provide cancer researchers with specimens that they can use to develop comprehensive catalogs of genomic information on at least 50 types of human cancer. The study will create a resource available to the worldwide research community that could be used to identify and accelerate the development of new diagnostic and prognostic markers, new targets for pharmaceutical interventions, and new cancer prevention and treatment strategies. This study will be a competitive enrollment study conducted at multiple institutions.
The purpose of this quality improvement project is to improve the immunization rates of an at-risk adult population seen in an ambulatory healthcare environment, through the use of targeted health education messages regarding pneumococcal immunization. Patients seen in an out-patient pre-surgical testing center will receive 1) a one-page written information sheet that outlines the benefits of pneumococcal immunization and 2) verbal reinforcement of this message, provided by the clinical staff, during the patient's interview. At-risk adult patients (as defined by Centers for Disease Control) seen in an ambulatory healthcare environment (a pre-surgical testing center) will receive a one page, "gain-framed" message that emphasizes the benefits of pneumococcal vaccinations. This educational material will be reviewed and reinforced by clinical staff during the assessment phase of the clinical visit. Among this group, there will be increased vaccination rate compared with at-risk adult patients who did not receive this communication (prospective vs retrospective data).
The purpose of the study is to determine the optimal, lowest dose of radioactive tracer required for Positron Emission Mammography (PEM), and the accuracy and reliability of PEM in pre-surgical evaluations for patients with newly diagnosed breast cancer anticipating breast-conserving surgery but identified to have a second unsuspected breast cancer by MRI.
Patients presenting in the Emergency Department or admitted to the hospital with displaced hip fractures who require hemiarthroplasty or open reduction internal fixation or with spinal instability/fractures in need of urgent surgical intervention will receive treatment to reduce the number of microorganisms in their nose prior to surgery. After surgery, the subjects will be observed for any surgical site infections.
The primary goal of the research study is to determine whether treating pancreatic cancer patients with hydroxychloroquine in combination with gemcitabine before surgery is safe. The secondary goal is to determine if this new treatment regimen can effectively treat pancreatic cancer. This study will test the safety and efficacy of this combination in two parts, or phases.
The purpose of this study is to determine the feasibility of a short term administration of a targeted therapy (i.e., anastrozole) in women with newly diagnosed early invasive or non invasive breast cancer during the interval between their breast biopsy and surgery. Anastrozole is a form of hormonal therapy which is part of the standard treatment for hormone sensitive breast cancer in postmenopausal women. This clinical model is being used to evaluate the biologic effects of this drug on a specific molecular pathway called the PI3K/AKT signaling pathway.
The purpose of this pilot study is to use a pre surgical intervention model to evaluate the biologic effects of metformin in women with newly diagnosed early invasive breast cancer. Metformin is a drug commonly used to treat patients with diabetes. This model will be used to evaluate the effects of metformin.