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.
This study was to assess the antitumor activity, safety, tolerability, and pharmacokinetics (PK) of the Mesenchymal-epithelial Transition Factor (MET) inhibitor tepotinib combined with the 3rd generation EGFR inhibitor osimertinib in participants with advanced or metastatic non-small cell lung cancer (NSCLC).
This is a phase 1b, multi-arm, open-label study of HDM201 in combination with MBG453 or venetoclax in subjects with AML or high-risk MDS. For all subjects, TP53wt status must be characterized by, at a minimum, no mutations noted in exons 5, 6, 7 and 8. Two treatment arms will enroll subjects in parallel to characterize the safety, tolerability, PK, PD and preliminary antitumor activity of HDM201+MBG453 (treatment arm 1) and HDM201+venetoclax (treatment arm 2). - In the treatment arm 1, subjects will receive HDM201 in combination with MBG453. - In the treatment arm 2, subjects will receive HDM201 in combination with venetoclax. Venetoclax dose will be gradually increased (ramp-up) over a period of 4 to 5 days to achieve the daily target dose tested that will be subsequently continued. Upon the completion of the escalation part, MTD(s) and/or RD(s) of HDM201 in combination with MBG453 or venetoclax in AML and high-risk MDS subjects will be determined for each treatment arm.
This pragmatic randomized trial will test the effectiveness of a basic needs navigation intervention compared to usual care among 500 adults (ages 18-75) with Medicaid, type 2 diabetes, and 1 or more unmet basic needs. Basic needs includes having such things as adequate food, housing, personal safety, and money for necessities. The primary study hypothesis is that participants who receive navigation to address unmet basic needs will have a greater reduction (M=0.5%) in HbA1c pre-post compared with participants receiving usual care. Consistent with the study's conceptual model, the effects of unmet basic needs on barriers to self-care (e.g., attention, stress, sleep), health behaviors (e.g., glucose monitoring, diet, clinical screenings) and health outcomes (e.g., emergency department utilization, hospitalization, quality of life) will be examined.
Substantial evidence suggests that psychosocial factors play a key role in explaining the risk for development of chronic pain, as well as for coping with it. Such factors include psychological perceptions or orientation towards pain, mainly referring to fear of pain and pain catastrophizing. Nonetheless, although this link is well documented, the underlying mechanisms of these processes have yet to be established. The "Attention to Variability" paradigm presents an explanatory mechanism, according to which the ability to mindfully attend to chronic symptoms enables and promotes increased control over the etiology and the expression of chronic symptoms. In support of the ATV paradigm, empirical findings demonstrate that ATV improved pregnancy outcomes and allowed people to gain control over fluctuations in their heart rates. The goal of the present study is to examine whether mindfully attending to pain sensations will decrease the intensity and frequency of chronic pain, increase perceived control of pain, and improve well-being and health-related quality of life.
This phase I/II trial studies the effects (good and bad) of adding copanlisib to the usual therapy of fulvestrant and abemaciclib in treating patients with hormone receptor positive and HER2 negative breast cancer that has spread from where it first started (breast) to other places in the body (metastatic). Some breast cancer cells have receptors for the hormones estrogen or progesterone. These cells are hormone receptor positive and they need estrogen or progesterone to grow. This can affect how the cancer is treated. Hormone therapy using fulvestrant may fight breast cancer by blocking the use of estrogen by the tumor cells. Abemaciclib and copanlisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Adding copanlisib to the usual therapy of fulvestrant and abemaciclib may work better than giving fulvestrant and abemaciclib alone in treating patients with breast cancer.
This is a multicenter, randomized, controlled, phase 2 clinical trial designed to evaluate the safety and efficacy of I-131-1095 radiotherapy in combination with enzalutamide compared to enzalutamide alone in participants with prostate-specific membrane antigen (PSMA)-avid metastatic castration resistant prostate cancer (mCRPC) who have progressed on abiraterone. Participants must be chemotherapy-naive and must be ineligible or refuse to receive taxane-based chemotherapy at time of study entry. PSMA-avidity will be determined by central imaging review based on assessment of 18F-DCFPyL PET/CT imaging during screening. Eligible participants meeting the PSMA-avidity criteria will be randomized in a 2:1 ratio to receive either I-131-1095 in combination with enzalutamide (80 participants) or enzalutamide alone (40 participants). An interim analysis for efficacy will be performed after a minimum of 48 evaluable participants have PSA data for at least three months following the first dose of randomized treatment. All participants will be followed for efficacy, safety assessments, survival status, adverse events of special interest, and new anti-cancer therapy for at least one year or to the end of the study (whichever is later) following the first dose of randomized treatment. Safety data will be monitored by an independent Data Monitoring Committee and the sponsor.
This is an investigator initiated, multicenter, open label, randomized phase 3 study for subjects with newly diagnosed ITP from ages 1 to less than 18 years old.
This trial studies treatment effects on development of chemotherapy-induced peripheral neuropathy in patients with cancer. Treatments for cancer can cause a problem to the nervous system (called peripheral neuropathy) that can lead to tingling or less feeling in hands and feet. Studying certain risk factors, such as age, gender, pre-existing conditions, and the type of treatment for cancer may help doctors estimate how likely patients are to develop the nerve disorder.
Research shows that the majority of all mental health (MH) treatment for children is delivered in schools. Unfortunately, however, school mental health (SMH) providers rarely use evidence-based approaches and are often poorly integrated into the school context. Given the high (>20%) and increasing rates of MH disorders among children and youth, MH clinicians working in schools need effective and efficient ways to address student emotional and behavioral problems. The Brief Intervention Strategy for School Clinicians (BRISC) is a four-session, flexible, and research-informed "Tier 2" intervention tailored to high school students and designed to fit the school context. Findings from initial research funded by an IES Development and Innovation grant, including a small (n=66) comparison study, indicate positive, small to large sized effects (ES = .30- 1.33) in favor of BRISC for MH impairment, emotional symptoms, therapeutic alliance, coping skills, and client satisfaction. Moreover, even though the majority of students who were referred to BRISC were in the clinical range for functional impairment due to MH problems, over 50% were able to step down to lower levels of intervention after four sessions of BRISC, demonstrating promise for efficiency and reach. Given potential for public health impact, the purpose of the current study is to further examine the efficacy of BRISC by assessing its impact on mental health and academic outcomes - as well as feasibility, acceptability, and efficiency - in a larger, multi-site trial.
The purpose of this study is to test the safety of abexinostat at different doses to find out if it can work with ibrutinib to stop the cancer from growing.