All Clinical Trials

Background: Current pain management strategies for pediatric patients are not integrating the analgesic potential of movement-based therapies. To date, experiencing a painful stimulus has been known to disrupt motor activity in an attempt to minimize injury. However, physical activity, even when it increases ongoing pain initially, has been shown to significantly reduce pain symptoms eventually through neuromodulation. In both acute and chronic pain cohorts, exercise protocols and neuromodulation paradigms have produced exercise-related analgesia. Problem: It is not currently understood which brain regions are implicated in exercise-based analgesia and what brain regions moderate this response. Approach: The investigators intend to provide a physical activity intervention designed to promote exercise-induced analgesia. This intervention will be performed in a group of pediatric subjects with Chronic Widespread Pain Disorder. An exercise (n=10), no exercise (n=10) and healthy control (n=10) group will be recruited. Aims: This study has three aims: (1) To understand how thermal pain sensitivity, pain symptoms and motor performance are impacted in patients with chronic pain after an exercise-based intervention. (2) To evaluate the brain regions involved in a simple motor task as well as how motor activity influences activity in pain regions of the brain. (3) To evaluate the network structure of the brain, with special emphasis on motor and pain regions, in youth with a pain disorder who have undergone an exercise-based intervention. Exercise-based therapy in pediatric subjects with a chronic pain condition is predicted to reduce pain symptom reporting through biasing activity in pain regions during motor performance. Significance: Findings from this investigation will address the clinical side of pain management strategies and provide potential therapeutic targets and feasibility data. The investigators anticipate that findings will show how pain and motor regions of the brain interact at the network level and if this interaction can be modulated through exercise. Findings will also evaluate the brain regions that mediate the analgesic properties of an exercise-based pain therapy and provide future therapeutic targets. Read Less

Clinical interventions to reduce the risk of vertical transmission of hepatitis C virus (HCV) infection from mother to infant are highly limited. Direct-acting antiviral (DAA) medications have demonstrated excellent safety and efficacy in non-pregnant individuals, but there is a lack of data regarding the safety of these medications in pregnant women and the effectiveness of these medications in reducing mother-to-child transmission. Therefore, although HCV screening during pregnancy is now recommended in many countries, there is no approved treatment for HCV during pregnancy. An observational study is here proposed to assess outcomes of mother-infant pairs exposed to DAAs during pregnancy within a global clinical case registry. Data regarding the exposures and outcomes of mother-infant pairs exposed to DAAs during pregnancy will be solicited and collected from clinical providers, healthcare facilities, HCV treatment programs, and other clinical practices worldwide. Data will be shared and maintained within a secure database, and cumulative data will be analyzed at pre-determined six-month intervals. The primary outcome will be the number and proportion of mother-infant pairs with adverse pregnancy or birth outcomes. The results of this study will inform HCV treatment decisions by clinical providers and programs worldwide. Read Less

The study is designed as an international, multicenter prospective cohort study. Patients with presumed glioblastoma (GBM) in- or near eloquent areas on diagnostic MRI will be selected by neurosurgeons. Patients will be treated following one of three study arms: 1) a craniotomy where the resection boundaries for motor or language functions will be identified by the "awake" mapping technique (awake craniotomy, AC); 2) a craniotomy where the resection boundaries for motor functions will be identified by "asleep" mapping techniques (MEPs, SSEPs, continuous dynamic mapping); 3) a craniotomy where the resection boundaries will not be identified by any mapping technique ("no mapping group"). All patients will receive follow-up according to standard practice. Read Less

The purpose of this study is to determine how beta-glucan affects the immune system in subjects with non-small cell lung cancer. Read Less

This study evaluates either KRT-232 or TL-895 in treatment naïve patients with myelofibrosis (MF) The study will be conducted in 2 stages. Stage 1 will evaluate safety, tolerability, and efficacy of either KRT-232 (Arm 1) or TL-895 (Arm 2) in treatment naïve patients. Stage 2 will expand enrollment in Arm 1 and/or Arm 2 if expansion criteria is met. Read Less

The purpose of this study is to assess the safety and efficacy of daily morning exposure to colored light in patients receiving acute inpatient rehabilitation services for stroke, traumatic brain injury, or non-traumatic brain injury with sleep disturbances such as poor nighttime sleep and/or excessive daytime sleepiness.In a two-arm randomized placebo-controlled study with pre-exposure and post-exposure assessments, we are comparing the effects of daily morning exposure to either blue light or red light on objective sleep quality, subjective sleep quality, functional rehabilitation outcomes, cognitive symptoms, fatigue, and neurological symptoms. Read Less

Explore efficacy, complications, and other factors associated with anaesthetic choice- To evaluate the efficacy of local + MAC as an alternative anesthetic to general anesthesia and to analyze patients' outcomes and experiences. Read Less

This is an observational study of voice outcomes in participants following thyroidectomy or another head and neck surgery that does not involve risk to the larynx other than risks incurred due to intubation alone. These comparative (non-thyroidectomy) surgeries would not be expected to interfere with the primary nerves involved with voice production, so they would help to better understand the effect of intubation alone on voice outcomes. Read Less

Overview. The investigators will randomize 120 Veterans in this 3-site trial over 16 months. Eligible Veterans will include those to be discharged for a hospitalization for suicidal ideation. Baseline data collection and randomization will occur at discharge. The 3 month intervention will have study assessments at 2, 4, 8, and 12 weeks post-discharge. The study's primary outcome measure is suicidal ideation (measured with the Beck Scale for Suicidal Ideation[BSS] and secondarily with the Columbia Scale for Suicidality C-SSRS). Intervention Components. The control condition will consist of Veterans randomized to VHA-SRM (Suicide Risk Monitoring). The experimental condition will be the telehealth system (TES) + VHA-SRM (Suicide Risk Monitoring) intervention. Veterans randomized to the telehealth system will receive the Interactive Voice Response (IVR) system monitoring in addition to VHA-SRM and will receive training on how to use the TES from the research coordinator. Veterans can access the IVR as a telephonic device accessed by a local or toll-free number and can use a 'plain old telephone system' (POTS), Cellular phone or Internet phone connected to their phone service provider. Participants will be instructed to interact daily with the TES system daily. Because of safety concerns, questions pertaining to suicidal behavior will be asked daily; to avoid repetition, all other questions will be asked every 3rd day. Once participants complete the questions on the telehealth device, their responses will be automatically uploaded and checked by trained VA Pittsburgh Healthcare System (VAPHS) nurses every 4 hours, during regular daytime hours of 9-5. VAPHS will serve as the central site retrieving downloads for all sites. Color-coded risk triage level designations based on potential responses, provide guidance regarding next steps. The protocol for assessing suicidal patients will follow standard VA procedures, outlined in each medical center's safety plan for suicidal patients. Read Less

This is a phase 1b/2 study of KRT-232 combined with ruxolitinib in subjects with MF who have a suboptimal response after at least 18 weeks of treatment with ruxolitinib. The primary objective of the study is to determine a recommended phase 2 dose (RP2D) of KRT 232 in combination with ruxolitinib. Read Less

This is a prospective, single center, non-randomized, open-label, single arm study in which we will gather data and physician input for the assessment and further development of the KODEX - EPD functions for assessing tissue pressure, tissue thickness, lesion transmurality. Read Less

This study evaluates KRT-232 in Combination With TL-895 for the Treatment of Relapsed or Refractory Myelofibrosis and KRT-232 for the Treatment of JAK Inhibitor Intolerant Myelofibrosis. Read Less