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Filter by:This phase II trial studies the effect of cabazitaxel, carboplatin, and cetrelimab followed by niraparib with or without cetrelimab in treating patients with aggressive variant prostate cancer that has spread to other places in the body (metastatic). Chemotherapy drugs, such as cabazitaxel and carboplatin, 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. PARPs are proteins that help repair DNA mutations. PARP inhibitors, such as niraparib, can keep PARP from working, so tumor cells can't repair themselves, and they may stop growing. Immunotherapy with monoclonal antibodies, such as cetrelimab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving niraparib with or without cetrelimab, after treatment with cabazitaxel, carboplatin, and cetrelimab, may help control aggressive variant prostate cancer.
This study is to evaluate the safety and efficacy of transcatheter arterial chemoembolization (TACE) combined with sintilimab and bevacizumab in patients with unresectable intermediate or advanced hepatocellular carcinoma (HCC).
This is a randomized, double-blind, multicenter, global Phase 3 study to assess the efficacy and safety of monalizumab and cetuximab, compared to placebo and cetuximab, in Participants with recurrent or metastatic head and neck cancer.
Introduction: To evaluate the maternal blood serum melatonin, soluble urokinase-type plasminogen activator receptor, and orosomucoid 2 levels in pregnant women complicated by preterm premature rupture of membranes (PPROM) and to compare the results with healthy pregnancies. In addition, to determine whether maternal/umbilical cord blood concentrations of melatonin, soluble urokinase-type plasminogen activator receptor, and orosomucoid 2 are of value in the diagnosis of histological chorioamnionitis in patients with preterm premature rupture of membranes (PPROM). Methods: This cohort study will be included 44 pregnant women with PPROM and 44 gestational age-matched healthy subjects in 24-32 weeks of pregnancy. The blood for analysis will be firstly obtained in maternal blood on the day of diagnosis at the study group. Healthy subjects who have a normal pregnancy and outcomes without any fetal-neonatal complications will be accepted into the control group. Forty-four gestational age-matched healthy pregnant women who will be delivered at term will be included in the study as the control group. In the control group, the pregnant women will be taken the maternal blood at the admission day. The women in both groups will be observed until the delivery and perinatal data will be noted. Then, the blood for analysis will be secondly obtained in maternal blood during termination of the pregnancy (or spontaneous labor) at the study group. Lastly, the blood for analysis will be also obtained in umbilical cord blood at the study group. These three markers levels will be measured using a commercially available enzyme-linked immunosorbent assay (ELISA) kit. The placenta will be sent to histological examination in the study group. These three markers levels in women with PPROM will be compared to those of volunteer healthy pregnant women. In the study group, these three markers levels at maternal serum and cord serum will be evaluated for histological chorioamnionitis and maternal/neonatal outcomes.
This is a prospective phase II clinical trial to evaluate the efficacy and safety of apatinib and camrelizumab in recurrent or metastatic nasopharyngeal carcinoma who failed at least the first-line treatment.
This study will evaluate the impact of academic detailing (evidence-based provider education) with or without patient pre-visit preparation (elicitation of values and preferences) on safe insulin de-prescribing among older patients with type 2 diabetes at risk for hypoglycemia. The hypothesis is that patients who are well-prepared for their primary care visit will engage in more informed discussions with their providers regarding re-evaluation of current treatment regimens. In clinically appropriate cases, these more effective discussions will result in safe de-prescribing and fewer future episodes of hypoglycemia.
Alcohol Use Disorder (AUD) and insomnia are more prevalent in Veterans than in the general community. Furthermore, insomnia is comorbid in 36-91% of individuals with AUD and jeopardizes recovery by increasing their risk for relapse and complicating their clinical profile. The VA/DoD guidelines recommend four medications for the treatment of AUD by promoting abstinence and a reduction in drinking. Two of these medications (MED) used commonly are naltrexone and topiramate but they do not improve sleep continuity or insomnia. The recommended treatment for insomnia is Cognitive Behavioral Therapy for Insomnia (CBT-I), and it has shown efficacy in improving insomnia but with minimal benefit in improving abstinence. However, these studies have involved subjects in early or sustained remission. The proposed study will evaluate whether augmenting MED with CBT-I, after reducing drinking or achieving abstinence, bolsters recovery in AUD, by decreasing insomnia and improving abstinence. If this strategy shows good clinical results and the findings are replicated in a multi-center trial then the combination of MED with CBT-I should be considered a standard component of the initial management of AUD with insomnia.
This study combines canakinumab (ACZ885), a high-affinity human anti-interleukin-1β (IL-1β) monoclonal antibody (mAb), and spartalizumab (PDR001), a mAb directed against human Programmed Death-1 (PD-1), with the chemotherapy combination of gemcitabine and nab-paclitaxel. This study will confirm for this 4-drug combination the tolerable doses, the acceptable safety profile, and the dose to be used for a Phase II combination treatment regimen.
Hypertensive disorders of pregnancy (HDP) are increasingly recognized sex-specific risk factors for premature cardiovascular disease (CVD) in women. HDP, including preeclampsia and gestational hypertension, confer a 2- to 3-fold increase in the risk of chronic hypertension and ischemic heart disease 10-15 years after delivery. Observational data suggest that breastfeeding can lower maternal blood pressure (BP), risk of metabolic syndrome, and other markers of cardiovascular risk in the short term and long term, possibly by helping to re-set the metabolic changes of pregnancy. The investigators recently demonstrated an 11% reduction in the risk of metabolic syndrome among postpartum women with a variety of complications in pregnancy, including HDP, who breastfed for > 6 months, compared to those who did not breastfeed and those who breastfed for shorter durations. An analysis of 622 postpartum women at Kingston General Hospital showed that breastfeeding women had nearly a 6-mmHg lower systolic BP than women who did not breastfeed with an apparent dose-response effect of breastfeeding duration. Women with pregnancy complications including HDP are vulnerable to early weaning. Interactive, multi-modal approaches targeting a mother's breastfeeding self-efficacy (i.e., confidence about breastfeeding) have been effective in healthy postpartum women. However, these have not yet been tested specifically in HDP women, who stand to derive substantial benefit from breastfeeding. This is an important area to study since nurse-led breastfeeding supportive interventions can be widely applied to the postpartum care of women with HDP and can be integrated into comprehensive CVD risk reduction programs for these women. The primary outcome is postpartum BP, since hypertension is a key mediating factor in women's heart health. The investigators conducted a feasibility study of a breastfeeding self-efficacy intervention to enhance breastfeeding outcomes among women with HDP achieving pre-defined targets of a recruitment rate of >50% , attrition rates of < 30%, and > 70% participant satisfaction with the intervention, measured at the 6-month time point. Additionally, data showed trends in both systolic and diastolic BP favoring the intervention group. The current study is a multi-site open-label randomized trial to assess for a difference in blood pressure and breastfeeding between groups, and to serve as a cohort of HDP women for longitudinal follow-up.
This phase IIA trial studies the effect of a vaccine (PDS0101) when given together with chemotherapy and radiation therapy (chemoradiation) in treating patients with stage IB3-IVA cervical cancer. Chemotherapy drugs, such as cisplatin, 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. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. PDS0101 is a type of vaccine that is intended to help the immune system respond to human papillomavirus (HPV16)-infected cervical tumor cells. PDS0101 contains two active components: the first is called R-DOTAP (Versamune) and is included in the vaccine to boost the immune system's response against the HPV viral proteins and the second group of active components are selected small pieces of proteins (called peptides) taken from the HPV virus. Giving PDS0101 in combination with chemoradiation may work help to control cervical cancer.