A Pilot Study of a Blended Intervention Targeting Emotion Dysregulation in Adults With ADHD
Attention Deficit Hyperactivity DisorderThe current study aims to investigate the feasibility and preliminary clinical effects of a blended psychological intervention targeting emotion dysregulation in adults with ADHD.
Intravesical Gemcitabine in Patients With NMIBC
Urinary Bladder CancerIntravesical immunotherapy or chemotherapy for non-muscle invasive bladder cancer is a well-established treatment for preventing or delaying tumor recurrence after bladder tumor resection. For high-risk non-muscle invasive bladder cancer, immunotherapy in the form of intravesical Bacillus Calmette-Guérin (BCG) can be effective as first-line, nevertheless, the response rate to BCG is suboptimal with many patients failing treatment. Following BCG-failure, however, very few effective therapeutic options exist besides life-changing cystectomy. In addition, nationwide shortages of BCG have pushed the use of alternative intravesical therapies for non-muscle invasive bladder cancer. At Banner University Medical-Tucson, the use of intravesical Gemcitabine is considered as standard treatment for patients with bladder cancer who are unable to get BCG or have failed prior BCG treatment. The role of Gemcitabine as treatment for NBMIC is poorly understood. The purpose of this study is to gain a better understanding of the use of Gemcitabine intravesical chemotherapy for non-muscle invasive bladder cancer in a prospective cohort of patients.
Cannabinoids Effect on Central and Peripheral Pain Modulation in Fibromyalgia
FibromyalgiaPrimaryFibromyalgia is a syndrome characterized by widespread chronic pain involving all musculoskeletal systems, accompanied by chronic sleep disorders, fatigue, memory problems, and more. Despite the advancement in the understanding of pain mechanisms thanks to various innovations in neuroscience and pain medicine, the syndrome's treatments are not satisfying, even in the presence of optimal multidisciplinary therapy, and many patients continue to suffer from chronic pain and associated symptoms. Although the pathophysiology of Fibromyalgia is not fully understood, there is evidence supporting the involvement of several mechanisms, including central sensitization, descending pain modulation pathway deficiency, and autonomic dysfunction, confirmed by physiological and functional imaging studies. Following the above reasons, there is great importance in understanding the effect of new treatments on pain mechanisms in Fibromyalgia syndrome. In the past few years, more and more research is providing evidence for cannabis analgesia in chronic pain syndromes, with an emphasis on Tetrahydrocannabinol (THC). However, only a little research has examined its efficacy in random double-blind experiments. Thus, testing the effect of THC in experimental clinical pain models could give a hint to our understanding of the pain regulation system in Fibromyalgia. The current research will study the effects of the cannabinoid THC component on pain regulation in Fibromyalgia in a double-blind controlled design. For that matter, the investigators will perform different peripheral physiological tests and functional magnetic resonance imaging. Additionally, the investigators aim to disclose the neural mechanisms underlying pain-autonomic interactions in Fibromyalgia patients.
A Study Evaluating Cadonilimab Injection in Combination With Regorafenib for the Advanced Hepatocellular...
Advanced Hepatocellular Carcinoma That Has Failed at Least One Prior Systemic TherapyTo evaluate the efficacy and safety of Cadonilimab Injection in combination with Regorafenib in the treatment of intermediate to advanced hepatocellular carcinoma that has failed at least one prior systemic therapy .
A Study Evaluating Cadonilimab Injection in Combination With Regorafenib for the Treatment of Biliary...
Advanced Biliary Systemic Tumours That Has Failed at Least One Prior Systemic TherapyTo evaluate the efficacy and safety of Cadonilimab Injection in combination with Regorafenib in the treatment of intermediate to advanced biliary systemic tumours that has failed at least one prior systemic therapy
A Study Evaluating Different Immunotherapies (LAG-3 and PD-1 With or Without TIGIT, Compared to...
Urothelial CancerThis study will evaluate the efficacy, safety, and pharmacokinetics of RO7247669 alone or in combination with tiragolumab compared with atezolizumab in participants with previously untreated, locally advanced or metastatic urothelial cancer (mUC) who are ineligible to receive a platinum containing chemotherapy.
Study of Pedi-cRIB: Mini-Hyper-CVD With Condensed Rituximab, Inotuzumab Ozogamicin and Blinatumomab...
LeukemiaTo learn if cyclophosphamide, vincristine, and dexamethasone (called mini hyper-CVD) in combination with intrathecal (delivered into the spine) chemotherapy (methotrexate, hydrocortisone, cytarabine) and compressed rituximab, blinatumomab, and inotuzumab ozogamicin (called cRIB) can help to control the disease.
To Evaluate the Safety and Efficacy of Human CD19 Targeted DASH CAR-T Cells Injection for Subjects...
B-cell Acute Lymphoblastic LeukemiaThis study is a single-arm, open-label, dose-escalation trial to explore the safety, tolerability and pharmacokinetic/pharmacodynamics characteristics of human CD19 targeted DASH CAR-T Cells injection, and to preliminarily observe the efficacy of the trial drug in patients with relapsed/refractory B-cell acute lymphoblastic leukemia.
Analgesic Ear Drops for Children With Acute Otitis Media
Acute Otitis MediaPainThis trial aims to investigate whether analgesic ear drops added to usual care provide superior ear pain relief over usual care alone in children presenting to primary care with AOM. Children will be randomly allocated (ratio 1:1) to either 1) lidocaine hydrochloride 5mg/g ear drops (Otalgan) 1-2 drops up to six times daily for a maximum of 7 days in addition to usual care (oral analgesics, with/without antibiotics) or 2) usual care. Parents will complete a symptom diary for 4 weeks as well as generic and disease-specific quality of life questionnaires at baseline and 4 weeks. The primary outcome is the parent-reported ear pain score (0-10) over the first 3 days. NOTE: At the time of publication of the study protocol paper, the investigators were unable to make any amendments to the trial registration record in the Netherlands Trial Register (NTR) (NL9500; date of registration: 28 May 2021). The addition of a data sharing plan was required to adhere to the International Committee of Medical Journal Editors (ICMJE) guidelines. The investigators therefore re-registered the trial in ClinicalTrials.gov. This second registration is for modification purposes only and the NTR record (NL9500) should be regarded as the primary trial registration.
First in Human Study of AZD9592 in Solid Tumors
Advanced Solid TumoursCarcinoma Non-small Cell Lung1 moreThis is a first-in-human (FIH) Phase I, multi-center, open-label, study of AZD9592, in patients with advanced solid tumors. The study consists of several study modules, each evaluating the safety, tolerability, preliminary efficacy, pharmacokinetics (PK), pharmacodynamics, anti-tumor activity, and immunogenicity of AZD9592, as monotherapy or in combination with anti-cancer agents.