There are about 173942 clinical studies being (or have been) conducted in United States. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
Study staff will collect three swabs and one saliva specimen from the same participant.
Background: - Pancreatic cancer is the third leading cause of death from cancer in the United States. - The median overall survival for patients with metastatic disease and excellent performance status receiving the most effective combination chemotherapy regimens remains less than 1 year - Pancreatic ductal adenocarcinoma (PDAC), the most common pancreatic cancer histology, is surrounded by a dense desmoplastic stromal reaction generated by cross-talk between tumor cells and the cancer associated stellate cells (CASC) and fibroblasts (CAF) in the microenvironment. - This stroma physically inhibits delivery of therapeutic drugs to tumor cells, secretes growth factors and nutrients that promote therapy resistance and cancer cell survival and is also highly immunosuppressive - Activated CASCs, CAFs and angiogenic endothelial cells which form the abnormal vasculature around tumors, all express high levels of integrin vbeta3. - ProAgio is a rationally designed pegylated peptide drug that binds to integrin vbeta3 at a novel binding site that directly triggers cell apoptosis - ProAgio induces apoptosis of CASCs and angiogenic endothelial cells in pre-clinical models, inhibiting tumor growth and prolonging animal survival - Safety of ProAgio in rodent and non-human primate models has been established - ProAgio has never been tested in humans Primary Objectives: To determine the recommended phase 2 dose (RP2D) of ProAgio in participants with previously treated advanced solid tumors for which no curative therapy exists Eligibility: - Adults >= 18 years of age - Histologically confirmed solid tumor malignancy for which no curative therapy exists as confirmed by the NCI Laboratory of Pathology - For the expansion cohort only: Histologically confirmed diagnosis of pancreatic cancer that is not neuroendocrine - Participants must have received at least one prior systemic treatment - Adequate end organ function is required - Participants in the Biopsy Arm of the expansion cohort must have disease amenable to safe biopsy and willingness to undergo the procedure Design: - This is a Phase I study to assess the safety of ProAgio in Participants with advanced solid tumor malignancies including pancreatic cancer - All participants will receive ProAgio until disease progression, unacceptable toxicity, or withdrawal from study - For the dose escalation cohort, a modified 3+3 design with accelerated dose escalation in initial cohorts will be used - For the expansion cohort, all participants will receive ProAgio at the ideal dose identified during the dose escalation - The expansion cohort has two arms: standard arm and biopsy arm. Pre- and post-treatment tumor biopsy is optional for participants enrolled in the standard arm, but mandatory for participants enrolled in the biopsy arm....
The goal of this study is to use non-invasive transcranial direct current stimulation (tDCS) combined with active listening therapy to treat tinnitus and hyperacusis and related conditions.
In this research study, the investigators will use a novel approach to measure what people eat. The goal is to find out whether stable isotopes that can be measured in blood, hair, and fingernails are better at measuring what people eat than the surveys that are currently used. To meet the goal, the investigators will do three things. First, the investigators will feed study participants known amounts of foods and nutrients. Second, after study participants have eaten the food, the investigators will measure stable isotopes in samples of study participants' blood, hair, and fingernails. Third, the investigators will determine how well these samples reflect what was eaten. The investigators will also give surveys to study participants to determine how well the surveys reflect what was eaten. This will allow the investigators to do a relative comparison of the measurements from isotopes and surveys.
The primary objective is to evaluate indications and outcomes of operative fixation of syndesmotic injuries, at least in part, with direct anatomic augmentation in acute and subacute traumatic cases. The secondary objective of the study is to evaluate clinically the InternalBraceTm to facilitate the direct syndesmotic fixation/augmentation.
Based on a central role of inflammation in pancreas cancer, the role of IL 1 in acute and chronic inflammation , the inhibitory effect of IL 1 alfa and beta by anakinra and preliminary experience with anakinra in combination with chemotherapy in metastasis (with FOLFIRINOX) and localized disease (with gemcitabine/abraxane/cisplatin), a phase 2 study with anakinra in combination with perioperative chemotherapy for patients with PDAC is being proposed.
This project addresses a central question within the practice of dentistry: Is a pulpotomy procedure effective in the treatment of a tooth with symptomatic irreversible pulpitis and normal periapex? In addition, the project seeks to identify clinical and molecular biomarkers that are predictive of the success of pulpotomy.
CDK4/6 and Cyclin D1 are significantly expressed in approximately 80% of esophageal and gastroesophageal junction tumors suggesting that CDK4/6 inhibition may be a successful strategy in these chemotherapy and immunotherapy resistant diseases.
Thromboelastography (TEG) is a laboratory technique used to examine the process of clot formation and degradation by measuring and reporting the kinetic changes, the rate of clot formation, clot strength, and clot stability. TEG provides numeric values and a graphical representation of the primary and secondary hemostatic systems and fibrinolysis more quickly and with a smaller blood sample than routine coagulation studies. TEG6s, the newest TEG platform, simplifies and standardizes TEG technique and is currently available at only four US children's hospitals. Normative values of TEG6s results have not been established in healthy neonates. There are a number of well-established perinatal risk factors for thrombosis in the newborn; however, maternal diabetes has been the most frequently identified risk factor in the newborn since 1965. Despite the well-established hypercoagulable state observed in infants of diabetic mothers (IDMs), there have been no studies evaluating TEG in IDMs. To establish normative data and investigate the hypercoagulable state of IDMs, this observational prospective cohort study will evaluate TEG6s in these two populations: a control group that will include neonates ≥37 weeks gestational age born to mothers with uncomplicated pregnancies and a comparison group that will include neonates ≥37 weeks born to mothers with gestational diabetes or a history of Type 1 or Type 2 diabetes prior to pregnancy, either requiring insulin or diet controlled. We hypothesize that cord blood TEG6s results will differ between healthy newborns and IDMs reflecting a hypercoagulable state in IDMs with an increased coagulation index (CI) in the IDM group. A sample size calculation was performed for a two-sample t-test using the POWER procedure in SAS version 9.4. Based on a two-tailed alpha of 0.05 and a standard deviation of 0.9, the total N was determined to be 40 (i.e., 20 in each group). This yields a power of 0.84 to detect a difference of 1.25 units in the mean CI between IDMs and healthy controls. To avoid blood loss and skin breaking procedures in the subjects, umbilical cord blood obtained from the umbilical cord will be used for analysis. To assure appropriate dilution, a hematocrit will be measured at the time of blood collection using a blood gas machine for prompt results. Sample blood will immediately be taken by the investigators from the delivery hospital to the children's hospital, where the following clotting studies will be performed: PT, aPTT, fibrinogen, platelet count, platelet mapping, and TEG6s. Statistical analyses will be performed on the results of these studies and will provide normative data in healthy newborns and infants of diabetic mothers. Having data on the coagulation profile of neonates will help guide management techniques and help explain the propensity to clot among IDMs and guide further research into prevention and treatment of this complication.
The aim of this project is to evaluate the efficacy of preoperative erector spinae blocks in arthroscopic hip surgery. This will be a prospective randomized controlled trial.