Site for A Phase 3 Randomized Double-Blind Placebo-Controlled Study to Investigate the Efficacy and Safety of Oral Brepocitinib in Adults with Dermatomyositis
Site for The purpose of this study is to measure clinical efficacy (based on TIS) of oral brepocitinibcompared with placebo in participants with dermatomyositis
Site for A phase II/III Study of Paclitaxel/Carboplatin alone or Combined with either Trastuzumab and Hyaluronidase-oysk (HERCEPTIN HYLECTA) or Pertuzumab Trastuzumab and Hyaluronidase-zzfx (PHESGO) in HER2 Positive Stage I-IV Endometrial Serous Carcinoma or Carcinosarcoma
Site for This study is being done to answer the following question: Can we lower the chance of your endometrial cancer coming back and causing death by adding a drug or drugs that target HER2 proteins in addition to the usual combination of chemotherapy drugs that target HER2 proteins in addition to the usual combination of chemotherapy drugs?
Site for A Placebo-Controlled Efficacy in iNPH Shunting (PENS) Trial
Site for This is a multicenter, randomized, blinded, placebo-controlled study of patients with suspected idiopathic normal pressure hydrocephalus (iNPH). Using FDA-approved technology, we propose a prospective randomized placebo-controlled clinical trial for the surgical shunting treatment of iNPH. These valve systems allow a well-maintained blinded placebo control because the surgical and adjustment procedures can be entirely identical in the active and placebo groups.
Site for A pragmatic trial to evaluate the intermediate-term effects of early aggressive versus escalation therapy in people with multiple sclerosis
The TREAT-MS trial (TRaditional versus Early Aggressive Therapy for MS) is a pragmatic, randomized controlled trial that has two primary aims: 1) to evaluate, jointly and independently among patients deemed at higher risk vs. lower risk for disability accumulation, whether an “early aggressive” therapy approach, versus starting with a traditional, first-line therapy, influences the intermediate-term risk of disability, and 2) to evaluate if, among patients deemed at lower risk for disability who start on first-line MS therapies but experience breakthrough disease, those who switch to a higher-efficacy versus a new first-line therapy have different intermediate-term risk of disability.
Site for A RANDOMIZED DOUBLE-BLIND MULTI-CENTER COMPARATIVE EFFECTIVENESS STUDY OF SPIRONOLACTONE VERSUS DOXYCYCLINE HYCLATE FOR THE TREATMENT OF ACNE IN WOMEN
Site for To determine whether spironolactone is non-inferior to the oral tetracycline-class antibiotic doxycycline hyclate in the treatment of acne in women
Site for A022104 The Janus Rectal Cancer Trial: A Randomized Phase II Trial Testing the Efficacy of Triplet Versus Doublet Chemotherapy to Achieve Clinical Complete Response in Patients with Locally Advanced Rectal Cancer
Site for This phase II trial compares the effect of irinotecan versus oxaliplatin after long-course chemoradiation in patients with stage II-III rectal cancer. Combination chemotherapy drugs, such as FOLFIRINOX (fluorouracil, irinotecan, leucovorin, and oxaliplatin), FOLFOX (leucovorin, fluorouracil, oxaliplatin, and irinotecan ), and CAPOX (capecitabin 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. FOLFOX or CAPOX are used after chemoradiation as usual treatment for rectal cancer. Giving FOLFIRINOX after chemoradiation may increase the response rate and lead to higher rates of clinical complete response (with a chance of avoiding surgery) compared to FOLFOX or CAPOX after chemoradiation in patients with locally advanced rectal cancer.
Site for AALL1631: International Phase 3 Trial in Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia Ph+ ALL Testing Imatinib in Combination with Two Different Cytotoxic Chemotherapy Backbones
Site for This randomized phase III trial studies how well imatinib mesylate and combination chemotherapy work in treating patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia. Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving imatinib mesylate and combination chemotherapy may work better in treating patients with Philadelphia chromosome positive acute lymphoblastic leukemia.
Site for Abaloparatide versus Placebo for Pelvic Fracture Healing - A Phase 2 Randomized Controlled Trial
Site for This is a prospective randomized, double-blinded, placebo-controlled, phase 2, three-month study of the efficacy of abaloparatide in postmenopausal women and men = 50 years of age with acute fractures of the pelvis. We will extend this study with 9 months of open label abaloparatide to determine if any potential differences between the placebo and abaloparatide groups during the 3 months of treatment are evident and persist over time, even in patients who use abaloparatide after the three-month placebo controlled intervention.Our primary outcome is CT evidence of fracture healing at the 12-week endpoint. After initiating ABALOPARATIDE or ABALOPARATIDE placebo, all patients will get follow-up pelvic radiographs following standard care and radiographs will stop when healing occurs.
Site for ACNS1833: A Phase 3 Randomized Non-Inferiority Study of Carboplatin and Vincristine versus Selumetinib (NSC# 748727 IND# 77782) in Newly Diagnosed or Previously Untreated Low-Grade Glioma (LGG) not associated with BRAFV600E Mutations or Systemic Neurofibromatosis Type 1 (NF1)
Site for This trial studies how well selumetinib works in treating patients with low-grade glioma. Selumetinib is a drug that works by blocking a protein (a basic building block of the human body) that lets tumor cells grow without stopping. Drugs used in chemotherapy, such as carboplatin and vincristine, 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. This trial studies if selumetinib works as well as carboplatin and vincristine for getting rid of or shrinking low-grade gliomas and stopping them from coming back.
Site for AHOD2131: A Randomized Phase 3 Interim Response Adapted Trial Comparing Standard Therapy with Immuno-oncology Therapy for Children and Adults with Newly Diagnosed Stage I and II Classic Hodgkin Lymphoma
Site for The primary objective is to compare the PFS of patients with early-stage cHL treated through aresponse-adapted design with either standard therapy or with an IO approach (brentuximab vedotin andnivolumab). Patients will be randomized to standard chemotherapy versus IO therapy following initialresponse assessment by PET/CT after two courses of ABVD. All will be stratified as favorable orunfavorable based on initial disease risk features, and those who are PET2 positive (defined as 5 PointScore, 5PS 4 or 5) will receive involved site radiotherapy (ISRT). Overall, RT exposure will be reducedcompared to prior COG HL trials but within the standard of care per National Comprehensive CancerNetwork (NCCN) pediatric lymphoma guidelines.The study expects to enroll 1875 patients over 5 years of accrual, for an estimated 1782 evaluable patients (PET2negative/rapid early responder [RER] n = 1514; PET2 positive/slow-early responder [SER] n = 268). Byexamining both shorter-term PFS and longer-term OS (12-year), and by prospectively collecting detaileddata on toxicity outcomes, this protocol will be practice changing for both pediatric and adult patientswith cHL and will ultimately define the role of an IO approach in the management of early-stage HL.This is a randomized trial comparing an IO approach with or without radiation therapy to a standard chemotherapy approach with or without radiation therapy in early stage cHL. All patients will be stratified by favorable vs. unfavorable features at studyenrollment. Patients are considered unfavorable if they have one or more of the following factors: (1) large mediastinal mass (> 10 cm by CT or 1/3 max chest diameter by CXR), (2) > 3 nodal sites, (3) B symptoms with ESR > 30, (4) ESR > 50 without B symptoms, and (5) age > 50 years. All patients will receive 2 cycles of ABVD chemotherapy. Subsequently, a rapidcentral review will be performed to determine early response assessment (PET2),which will be utilized to randomize patients to receive either conventionalchemotherapy or an IO approach with nivolumab and brentuximab vedotin. If a patientis deemed to not meet study eligibility staging criteria at the time of PET2 centralreview, the patient will be removed from protocol therapy. All SER patients (5PS 4, 5)will receive involved site radiation therapy (ISRT). Following randomization, thepatient may be assigned to one of the following treatment arms:• Arm A (Favorable RER, Standard Therapy): ABVD x 2• Arm B (Favorable RER, IO Therapy): Brentuximab vedotin + Nivolumab x 4 Arm C (Favorable SER, Standard Therapy): eBEACOPP x 2, ISRT• Arm D (Favorable SER, IO Therapy): Brentuximab vedotin + Nivolumab x 4, ISRT• Arm E (Unfavorable RER, Standard Therapy): AVD x 4• Arm F (Unfavorable RER, IO Therapy): Brentuximab vedotin + Nivolumab x 4• Arm G (Unfavorable SER, Standard Therapy): eBEACOPP x 2, ISRT• Arm H (Unfavorable SER, IO Therapy): Brentuximab vedotin + Nivolumab x 4, ISRT