Feb 3rd, 2023 - OUTLINE: Participants will be randomized at study entry to one of the three study arms and subsequently will be included in one to three phases, and one of 3 cohorts depending on their stage of disease and prior treatment. PRIMARY OBJECTIVES: I. To assess efficacy of combination therapy with ONC201 (ONC201) and novel agent in participants with DMG based on median progression-free survival at 6 ...

Feb 3rd, 2023 - PRIMARY OBJECTIVE: I. To estimate the overall response rates of olaparib in subjects with recurrent/progressive IDH1/2-mutant solid tumors, who will be recruited to 3 cohorts: a. glioma, b. cholangiocarcinoma, c. other solid malignant tumors. SECONDARY OBJECTIVES: I. To estimate the distribution of progression free survival (PFS) of olaparib in adults with recurrent/progressive IDH1/2-mutant gl...

Feb 3rd, 2023 - This is an, open-label, two-cohort protocol designed to evaluate the activity of targeted therapy and SABR in ALK positive lung adenocarcinoma. Cohort A will evaluate the combination in ALK-inhibitor naïve patients. Cohort B will evaluate the combination in patients who have received treatment with one prior ALK inhibitor. Ceritinib will be administered to the patient until disease progression ...

Feb 3rd, 2023 - The purpose of this study is to find out what effects (good and bad) AZD1775 used in combination with carboplatin and paclitaxel will have on participants and their cancer.

Feb 3rd, 2023 - Background: Androgen deprivation therapy (ADT) and surveillance are treatment options for prostate cancer patients with biochemical progression after localized therapy with either definitive radiation or surgery (biochemically recurrent prostate cancer). A primary goal in these patients is to prevent morbidity from their cancer that results from disease progression and metastatic disease on con...

Feb 3rd, 2023 - The purpose of this study was to demonstrate superior efficacy of secukinumab versus placebo at Week 12, based on both PASI 75 and IGA mod 2011 0 or 1 response rates in children and adolescents aged 6 to less than 18 years with severe chronic plaque psoriasis who had inadequate control of symptoms with topical treatment, or failed to respond to or tolerate previous systemic treatment and/or UV ...

Feb 3rd, 2023 - A subset of HIV-infected patients, those with poor immunologic response to combined antiretroviral therapy (CD4+ T-cell count of less than 300-350 cells/mm^3) despite control of viremia, are at increased risk for both HIV-related and non-HIV-related complications compared to immunologic responders. Thus, novel approaches for treating HIV infection are needed to facilitate management of this pat...

Feb 3rd, 2023 - In 2016, it is estimated that there will be 76,960 new cases of bladder cancer and 16,390 deaths associated with bladder cancer. Bladder cancer is associated with the highest costs among all types of cancer, due to the need for lifelong routine monitoring and treatment. Approximately 70% of cases are non-muscle invasive bladder cancer (NMIBC) at presentation and are treated by transurethral res...

Feb 3rd, 2023 - PRIMARY OBJECTIVE: I. To evaluate whether there is an improvement in overall survival with concomitant chemotherapy/radiation therapy/MEDI4736 (durvalumab) followed by one year (12 cycles) of MEDI4736 (durvalumab) as compared to concomitant chemotherapy/radiation followed by one year (12 cycles) of MEDI4736 (durvalumab). SECONDARY OBJECTIVES: I. To evaluate the difference in response using Resp...

Feb 3rd, 2023 - Study TAS-120-301 is an open-label, multinational, parallel 2-arm, randomized Phase 3 study evaluating the efficacy and safety of futibatinib versus gemcitabine-cisplatin chemotherapy as first-line treatment of patients with advanced, metastatic, or recurrent unresectable iCCA harboring FGFR2 gene rearrangements. Eligible patients will be randomized on a 1:1 basis to the following study arms: E...

Feb 3rd, 2023 - OBJECTIVES: Primary To determine pathological complete response (pCR) rates in patients with HER2-negative primary operable breast cancer treated with neoadjuvant therapy comprising carboplatin and paclitaxel albumin-stabilized nanoparticle formulation (CP) with vs without vorinostat. Secondary To evaluate the safety of these regimens in these patients. To estimate clinical complete response (c...

Feb 3rd, 2023 - Multi-center, prospective, randomized, placebo- and sham-controlled study to evaluate the GORE® CARDIOFORM Septal Occluder for migraine headache relief

Feb 3rd, 2023 - The main objective of this study is to evaluate the efficacy of venetoclax in combination with azacitidine to improve Relapse Free Survival (RFS) in Acute Myeloid Leukemia (AML) participants compared to Best Supportive Care (BSC) when given as maintenance therapy following allogeneic stem cell transplantation (SCT). This study will have 2 parts: Part 1 (Dose Confirmation), which may include par...

Feb 3rd, 2023 - Background: The administration of autologous tumor infiltrating lymphocytes (TIL) can mediate complete, durable regressions in 20-25% of patients with metastatic melanoma. Recent studies have shown that these TIL predominantly recognize unique mutated neoantigens expressed by the cancer not shared by other melanomas. Administration of bulk autologous TIL to patients with a variety of other soli...

Feb 3rd, 2023 - This single arm, two-stage, open-label Phase II study is designed with the primary objective of evaluating the efficacy of induction therapy comprised of 8 cycles of carfilzomib, lenalidomide, dexamethasone and daratumumab (KRd+daratumumab) in terms of complete response or better (CR) in subjects with NDMM, and comparing to relevant historical controls. Post induction, all subjects will undergo...

Feb 3rd, 2023 - Postoperative pulmonary complications (PPCs) are a major cause of morbidity and mortality in surgical patients. National estimates suggest 1,062,000 PPCs per year, with 46,200 deaths, and 4.8 million additional days of hospitalization. Abdominal surgery is the field with the largest absolute number of PPCs. The long-term goal is to develop and implement perioperative strategies to eliminate PPC...

Feb 3rd, 2023 - PRIMARY OBJECTIVE: I. To evaluate progression-free survival (PFS) of osimertinib (AZD9291) and bevacizumab versus osimertinib (AZD9291) alone as first-line treatment for patients with metastatic EGFR-mutant lung cancers. SECONDARY OBJECTIVES: I. To evaluate overall survival (OS). II. To evaluate best objective response rate and duration of objective response. III. To evaluate time to central ne...

Feb 3rd, 2023 - TNBC is an aggressive subtype of breast cancer associated with poor survival and new treatments are needed. A key feature of cancer is its ability to go undetected by the immune system. Recent developments in cancer research have identified immune checkpoints as a possible treatment option as they seem to promote an anti-tumour immune response. Some breast cancers have considerable cancer cell ...

Feb 3rd, 2023 - Reperfusion therapy as the main treatment strategy in patients with ST-segment elevation myocardial infarction (STEMI) consists of either thrombolysis or primary percutaneous coronary intervention (pPCI). Primary percutaneous coronary intervention is the preferred therapy for STEMI; however, cardiac catheterization laboratories may not be widely available. Early recanalization of the infarct re...

Feb 3rd, 2023 - The investigators propose to randomize at the kebele level, which consist of approximately 15 villages, 4,000 residents, and are served by a single primary school. Eighty kebeles will be randomized to one of four arms: 1) annual mass azithromycin distribution per WHO guidelines (Annual); 2) annual mass azithromycin distribution plus quarterly targeted treatment of all children aged 0-9 years (C...