Chronic Fatigue Syndrome

Researchers are investigating the relationship between functional measures of balance and gait and objective kinetic and kinematic parameters in people with Multiple Sclerosis (MS). This cross-sectional observational study aims to understand how biomechanical gait and balance data collected through the Vicon motion analysis system relate to clinical assessments of balance, gait, and physical performance. The study seeks to identify which biomechanical factors are most closely linked to functional abilities and mobility challenges in MS. Participants will attend a single laboratory session where they will undergo biomechanical analysis of balance and gait using the Vicon motion capture system. They will also complete standardized functional tests including the Mini Balance Evaluation Systems Test, Functional Gait Assessment, Short Physical Performance Battery, and a 2-Minute Walk Test. Additionally, they will fill out questionnaires assessing fear of falling and fatigue and have their lower-limb spasticity evaluated with the modified Ashworth Scale. During the session, which takes about 40 minutes for the primary kinetic and kinematic analysis and additional time for functional assessments, researchers will collect detailed movement data alongside clinical measures. This data will be analyzed to explore correlations between biomechanical parameters and functional outcomes. The study includes assessments of postural control, gait performance, physical endurance, fatigue, and spasticity. The findings aim to improve understanding of movement impairments in MS and support better clinical assessments and rehabilitation approaches.

Researchers are evaluating whether a structured training program for intensive care unit (ICU) staff can reduce health problems known as post-intensive care syndrome (PICS) in adults after they leave the hospital. PICS includes new or worsened physical, thinking, or emotional difficulties following serious illness, which can affect daily life, independence, memory, mood, and overall quality of life. This multicenter study compares patients treated before and after ICU staff training, focusing on whether the training reduces PICS three months after hospital discharge. The study also compares standard training on the ABCDEF care bundle with an expanded A-Z bundle that includes additional care elements like nutrition, sleep, infection prevention, safety, and psychological support. The study involves a cluster-randomized design where entire ICUs are assigned to receive training on either the standard ABCDEF bundle or the expanded A-Z bundle. The training program for ICU staff includes a month-long online course with educational materials, checklists, pocket guides, and visual reminders, plus face-to-face sessions to reinforce learning. After training, ICUs continue usual care while researchers track how often the trained care practices are followed during patients' ICU stays, up to 21 days or until discharge or death. Follow-up visits for patients occur at 1, 3, 6, and 12 months after hospital discharge. Participants are adults who stay in the ICU for at least 48 hours and leave the hospital alive. They will undergo tests and questionnaires on physical health, memory, mood, and quality of life during follow-up visits. Data collection includes ICU care details and patient outcomes, monitored using electronic forms with quality checks. The main outcome measured is the number of participants who develop PICS three months after discharge. Secondary outcomes include adherence to care bundles, incidence of delirium, and quality of life assessments at various timepoints. The study runs until 2028 and maintains ethical and data protection standards throughout.

Researchers are evaluating the potential effects of a 3-day course called the Lightning Process (LP) for adults with Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME). CFS/ME is a serious condition causing heavy symptoms, low function, and significant impact on work and social life. The study aims to explore both positive and negative effects on symptoms, disability, quality of life, and long-term work participation, addressing a challenging health and societal problem in Norway. The study randomly assigns about 100 adults with CFS/ME to either participate in the 3-day LP course or receive treatment as usual initially. The LP course includes teaching on stress theory, Positive Psychology, and techniques to regulate thoughts, feelings, and behavior to influence physiology positively. Those initially on the waiting list receive the LP course after 10 weeks. Adverse events during or after the course are monitored and managed according to protocol. Participants will be followed up with assessments including physical function at 10 weeks after the course and fatigue, pain, post-exertional malaise, mental wellbeing, overall improvement at 6 months. Work participation and sick leave are tracked at 24 months. The study involves questionnaires and evaluations to measure these outcomes, aiming to provide evidence-based knowledge for better CFS/ME care. The study runs until December 2028.

Researchers are evaluating the safety and effectiveness of oral Apabetalone combined with background dapagliflozin treatment for up to 12 weeks in adults with type 2 diabetes mellitus (T2DM) who have experienced probable or confirmed COVID-19 infection. Participants must have symptoms of Long COVID lasting at least 2 months within 3 months from the start of COVID-19, which cannot be explained by other diagnoses. This phase II, open-label multicentre trial aims to better understand treatment options for this group of patients. Participants will take oral Apabetalone 100 mg capsules twice daily with meals while continuing their daily dapagliflozin 10 mg therapy for diabetes. The study involves seven in-person clinic visits where data will be collected to assess the treatment's effects. After screening and consent, eligible participants begin Apabetalone treatment on Day 1 and continue it at home under study supervision. During the trial, participants will undergo various assessments including symptom evaluations and functional status tools related to Long COVID. The primary outcome is the patient acceptable symptom state at 90 days. Secondary measures include fatigue, dyspnea, and post-exertional malaise assessments. Safety and adherence will be monitored throughout, with the total study duration covering treatment and follow-up visits over approximately 12 weeks.

This research aims to assess the use of a remote voice analysis tool for diagnosing and managing myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). Researchers want to understand how well this voice-based tool can help identify and monitor ME/CFS by analyzing voice signatures. The study is observational and focuses on evaluating the feasibility of this method. Participants will record their voices using a smartphone application called Visible, while wearing the Visible Armband 2.0. They will create 5 to 10-minute recordings that include counting, vowel sounds, changing speaking speed, and repeating words every two weeks for a total of 12 weeks. These voice samples will be collected to study how voice patterns relate to ME/CFS symptoms and severity. During the study, participants will complete questionnaires and provide voice recordings regularly. Researchers will measure the feasibility of using the Mayo Speech Test to screen, monitor, and assess the severity of ME/CFS over 12 weeks. The study will track how well participants can use the technology and how accurately voice data reflects their condition. Participation will last for about 12 weeks with ongoing monitoring.

Researchers are evaluating the safety and tolerability of Anktiva, an interleukin-15 superagonist called Nogapendekin Alfa Inbakicept, in patients experiencing Long Covid symptoms. This is a Phase 2 clinical trial sponsored by ImmunityBio, Inc. The study focuses on adults aged 18 to 70 who have confirmed Long Covid characterized by specific symptoms lasting at least 60 days and impacting quality of life. Participants will receive up to two subcutaneous doses of N-803 (IL-15 Superagonist) during the treatment period, which lasts approximately 75 days. All patients are in a single treatment arm. The study includes follow-up visits to monitor safety, collect laboratory tests including blood counts and chemistry, and assess patient-reported outcomes related to health and quality of life. Throughout the study, participants will undergo clinical exams, laboratory assessments such as CBC and CMP, and questionnaires including PROMIS-29 and EuroQoL quality of life measures. Researchers will track adverse events, vital signs, and viral markers in blood and stool over the treatment period and up to 30 days post final dose. The total duration of participation spans around 75 days, with safety and tolerability as the main focus.

Researchers are evaluating the effects of the Stasis dietary supplement on reducing oxidative stress, cortisol levels, and side effects related to stimulant medications used for ADHD in adults aged 18 to 55. This randomized, triple-blind, placebo-controlled clinical trial aims to understand how the supplement may help with symptoms like sleep difficulties, irritability, anxiety, and brain fog over a three-month period. The study is sponsored by Outliers, Inc. and includes participants who are stable on stimulant medication and supplements. Participants are randomly assigned to either the Stasis supplement group or a placebo group. The Stasis supplement is taken twice daily: the daytime dose with stimulant medication and food, and the nighttime dose 30 minutes before bedtime on an empty stomach. The placebo is designed to match the supplement in taste and appearance. The trial lasts three months, during which both groups follow their usual stimulant medication and habits. During the study, researchers will measure changes in oxidative stress and cortisol levels at the beginning and end of the trial. They will also assess sleep quality, irritability, focus, sociability, mood, stress, appetite, and blood levels of Vitamin C and CoQ10 monthly. Safety and adherence will be monitored throughout. Participants are expected to maintain stable medication and supplement use and will be followed for the full three-month duration.

Researchers are studying the safety and effectiveness of Anktiva, also known as Nogapendekin Alfa Inbakicept (NAI), in people experiencing Long COVID, which means continuing symptoms after a COVID-19 infection has ended. This Phase 2 study aims to understand how this treatment may help patients with persistent symptoms that affect their quality of life. The study is sponsored by ImmunityBio, Inc. and focuses on adults aged 18 to 70 years with confirmed Long COVID symptoms lasting at least 60 days. Participants will receive 600 micrograms of Anktiva administered by a subcutaneous injection. The study is a single-arm trial, meaning all participants receive this treatment without comparison to a placebo or other drug. Treatment and monitoring will occur over approximately 75 days, including the time after the final dose to track safety and response. There are no placebo groups or blinding in this research. During the study, participants will attend visits for assessments including blood tests, vital signs monitoring (temperature, heart rate, blood pressure, respiratory rate, oxygen saturation), and symptom evaluations. Researchers will monitor for any treatment-related side effects or serious adverse events up to 30 days after the last dose. They will also assess changes in lymphocyte counts and other laboratory values. Participants should expect regular study visits and evaluations for safety and effectiveness over the treatment period.

Researchers are studying the impact of Dyanavel XR on fatigue in adults diagnosed with Attention Deficit/Hyperactivity Disorder (ADHD). This clinical trial aims to determine if Dyanavel XR can reduce fatigue symptoms compared to a placebo. The study uses a randomized, double-blind, placebo-controlled design with flexible dosing over a 10-week period. Participants will be randomly assigned to receive either Dyanavel XR or a matching placebo, starting at 5 mg once daily in the morning. Dosage may be adjusted weekly or bi-weekly based on individual response and side effects, with the investigator available to guide dosing between Weeks 0 and 4. Tablets should be swallowed whole and can be taken with or without food. Throughout the study, participants will attend regular visits for symptom evaluation and side effect monitoring. Various assessments, including the Fatigue Symptom Inventory, Behavior Rating Inventory of Executive Functioning-Adult, ADHD Rating Scale, and other quality of life and sleep questionnaires, will be conducted at screening, baseline, and multiple weeks during treatment. Safety and efficacy will be closely monitored, and the study is expected to conclude by December 2026.

This research aims to learn more about a physical activity program adapted for cancer survivors, focusing on improving physical functioning and quality of life. The study uses a randomized wait-list control group design to evaluate the program's effectiveness in the Acres Homes neighborhood. Researchers also explore how social and environmental factors like financial distress, discrimination, and neighborhood characteristics affect program outcomes and reach. Participants receive the Active Living After Cancer (ALAC) program, which includes behavioral sessions teaching cognitive and behavioral skills to increase physical activity. The program provides activity trackers and resistance bands to support home-based exercises. Sessions also include guided discussions on survivorship topics, offering information, community resources, and peer support. One group starts the program immediately after baseline assessment, while the wait-list control group begins after three months. Throughout the study, participants undergo assessments measuring physical functioning with tests like the 30-second sit-to-stand and six-minute walk. Researchers track physical activity levels, social connectedness, and quality of life at multiple points, including 12 weeks and six months. The study monitors program reach within the community and evaluates outcomes using the Re-AIM Framework over about one year. Participants' safety and health readiness are also assessed before joining.