Mindfulness

Researchers are studying the effects of a low-protein diet on cancer patients receiving immunotherapy treatments. The study aims to see if reducing protein intake can change the tumor environment and boost the body's immune response, potentially enhancing the effects of immune checkpoint inhibitors. This is a randomized, open-label study conducted at a single center to explore the feasibility of this dietary approach. Participants will be randomly assigned to one of two groups: one receiving immunotherapy plus a control diet containing about 20% protein, and the other receiving immunotherapy combined with a low-protein diet containing 10% protein. The study intervention lasts for 4 months, during which the dietary impact on immune response and treatment effects will be evaluated. Throughout the 4-month study period, participants will be monitored for their ability to follow the dietary plan and for any changes in immune response to immunotherapy. Researchers will assess safety, tolerability, clinical efficacy using RECIST v1.1 criteria, and enrollment and drop-out rates. Laboratory tests and imaging scans will also be conducted to evaluate disease progression and treatment impact.

This research aims to explore the effects and feasibility of a group-based Acceptance and Commitment Therapy (ACT) program for families of individuals with special health care needs. Parenting children with special needs can be stressful and impact caregivers' mental health, while individuals with special needs may struggle with the mismatch between their requirements and typical practices around them. The study focuses on promoting psychological flexibility, which supports value-guided living despite distressing thoughts or feelings. Participants will receive Acceptance and Commitment Therapy, a well-established behavioral psychotherapy adapted for families of individuals with special health care needs. The intervention is delivered in a group format tailored to these families. This pilot study evaluates how this therapy influences psychological flexibility and wellbeing over a six-week treatment period. During the study, participants will be assessed at baseline and at two, four, and six weeks into treatment. Researchers will measure changes in psychological flexibility, psychological inflexibility, psychological wellbeing, and parenting stress using standardized inventories and scales. Child behavior and participants' satisfaction and personal experiences with the program will also be evaluated. The study includes follow-up assessments within six weeks after completing treatment to understand the intervention's impact.

Researchers are studying the effects of intermittent caloric restriction combined with a plant-based diet in cancer patients receiving chemotherapy. This pilot trial aims to assess whether this dietary approach is feasible and safe alongside standard chemotherapy, and whether it may reduce side effects while potentially enhancing the chemotherapy's antitumor effects. Participants will follow a protocol involving alternate-day intermittent caloric restriction along with a plant-based protein diet during their chemotherapy treatment. The study evaluates how this combined dietary intervention interacts with standard chemotherapy regimens over the course of treatment. During the study, participants will be monitored for adherence to the dietary plan and chemotherapy treatment. Researchers will assess feasibility over 12 months, including safety and preliminary evidence of clinical efficacy. Evaluations may include health assessments, laboratory tests, and monitoring of side effects throughout the study period.

Researchers are evaluating the effects of traditional Chinese medicine combined with intradermal acupuncture on girls with idiopathic precocious puberty, a condition characterized by early onset of puberty without an identifiable cause. This phase 3 randomized controlled trial aims to determine if combining acupuncture point stimulation with herbal treatment can improve symptoms and prevent the condition from worsening. The study focuses on girls with mild to moderate precocious puberty and explores whether this combined approach offers benefits beyond traditional herbal medicine alone. Participants will be randomly assigned to one of two groups. One group will receive Ziyin-Xiehuo traditional Chinese medicine granules twice daily along with intradermal acupuncture point stimulation targeting specific points, applied three times daily with needles changed every two days, for a duration of six months. The other group will receive only the traditional Chinese medicine granules twice daily for the same six-month period. This design allows comparison between combined therapy and herbal medicine alone. During the study, researchers will monitor participants' breast development changes, particularly the reduction or disappearance of mammary nucleus size at three months. They will also assess bone age changes compared to chronological age over six months. Various evaluations such as ultrasound measurements of uterus and ovary size, Tanner staging, and hormone treatment history will be collected. Safety and efficacy will be carefully observed throughout the six-month treatment period.

Researchers are evaluating an Acceptance and Commitment Therapy (ACT)-based intervention aimed at reducing psychological symptoms and increasing psychological flexibility among parents of children with medical complexity. These parents often face ongoing stress from managing their child's chronic, complex health conditions and uncertainty about the prognosis. This pilot randomized controlled trial addresses a gap in studies on ACT for Chinese parents in local communities to help them better manage caregiving-related stress and emotions. The study involves two groups: one group receives the ACT-based intervention consisting of four weekly face-to-face sessions, each lasting two hours and including a question-and-answer period. The sessions cover topics such as understanding ACT, stress and struggles, role play, mindfulness exercises, and applying personal values to actions. The other group has the option to join usual community social or health care services available to parents of children with medical complexity. Participants will be assessed at the start and after four weeks using the Chinese versions of the Depression Anxiety Stress Scale and a psychological flexibility measure. The study will monitor changes in psychological symptoms and flexibility. Parents will participate in scheduled sessions and complete questionnaires, with the trial lasting four weeks of intervention plus assessments. The research team will observe feasibility and preliminary effects of the ACT intervention to inform future studies.

Researchers are evaluating the effectiveness of a self-help version of Acceptance and Commitment Therapy (ACT) called the ACT with CF Self-Help Toolkit for adults living with cystic fibrosis. This therapy aims to reduce anxiety and depression and improve psychological flexibility and value-based living in adults with CF, who are at higher risk for these mental health challenges. The study randomly assigns participants to one of two groups: one receives immediate access to the ACT with CF Self-Help Toolkit, which includes six main modules with short videos designed to help manage difficult feelings and encourage positive behaviors; the other group waits six weeks before receiving access to the toolkit. The treatment is delivered digitally and accessed on participants' smartphones. Participants complete a series of questionnaires at baseline, after six weeks, and again at three months to assess anxiety, depression, psychological flexibility, cognitive fusion, and values-based living. Additional data on medication adherence and lung function will be collected from health records. The study uses repeated measures and statistical models to analyze changes over time, with participant data securely sent for analysis. The total participation involves completing digital assessments and using the self-help toolkit over several months.

Researchers are evaluating whether the Alii Supplement can reduce symptoms related to nutritional depletion in women who use hormonal birth control pills. The study focuses on improvements in happiness, digestive health, mood swings, perceived vulnerability to disease, and energy levels. This randomized, double-blind trial involves 68 female university students aged 18 to 25 who have been on hormonal birth control for at least six months. Participants will be randomly assigned to take either the Alii Supplement or a placebo daily for 28 days. Each participant takes three capsules per day, with or without food, and receives daily reminders to help with adherence. The Alii Supplement contains multiple vitamins and nutrients aimed at addressing nutritional depletion, while the placebo contains inactive ingredients. After 28 days, participants complete follow-up surveys to assess changes in the targeted symptoms. Throughout the study, participants will fill out online surveys at the start and end of the 28-day period to measure happiness, mood swings, digestive health, vulnerability to disease, and energy. The research team will compare these measures before and after supplement use to see if the Alii Supplement has an effect. The study includes two visits to the research office for survey completion, and participants are monitored for their adherence to taking the capsules.

Researchers are evaluating the effects of a health and wellness product on gastrointestinal health and related outcomes in adults aged 21 to 75. This study aims to understand user experiences, side effects, product acceptance, and health impacts in people currently using GLP-1 medications for at least 3 months or those interested in losing weight but not on GLP-1 therapy. The study is sponsored by PepsiCo Global R&D and uses self-reported measures and biomarker collections to assess outcomes. Participants will consume a ready-to-mix beverage containing protein, fiber, and electrolytes freely over a 4-week period. The study includes adults who either have been taking GLP-1 for 3 months or longer without plans to stop or switch, or those interested in weight loss but not currently using GLP-1 and with no plans to start. Biomarker collections of stool and blood samples will occur at the start and end of the intervention period. During the study, participants will complete electronic surveys measuring constipation, belly pain, digestion quality of life, satiety, and self-reported weight at baseline and weekly during the 4 weeks. They will also keep a 24-hour food diary at the beginning and end of the study. Researchers will monitor participant health and product effects through these assessments and biomarker samples. The study is open label with no blinding, and participants must have reliable internet access to complete electronic surveys and biomarker collections. Total participation lasts for the 4-week intervention.

This research aims to evaluate the effects of Adapted Physical Activity (APA) programs on reducing state anxiety and improving functional capacities in people with severe blood cancers admitted to the Intensive Care Unit (ICU). Anxiety is a major concern for these patients, and the study compares traditional APA, APA combined with Exergaming, and APA with biofeedback relaxation to see if any approach offers additional benefits. The goal is to lessen anxiety and psychological fatigue while maintaining or improving physical function. Participants are assigned to one of three groups practicing aerobic activity three times a week, with each session lasting 30 to 60 minutes at a light to moderate intensity. The groups include a classical APA group using a cyclo-ergometer, an APA group with Exergaming devices, and an APA group that combines exercise with biofeedback relaxation. Each session includes warm-up, training, and cool-down phases, with the relaxation group using a biofeedback device during cool-down to promote relaxation. During the study, functional capacities are measured at the start and end of the program using submaximal tests like the 2-minute Walk Test and the 5 Times Sit to Stand Test. Anxiety and fatigue levels are assessed with questionnaires such as the State Trait Anxiety Inventory and the Multi-Fatigue Inventory. Participants also provide feedback on satisfaction and adherence by comparing planned versus completed sessions. The study tracks changes in anxiety, physical performance, and quality of life throughout the intervention and shortly after discharge.

Researchers are conducting the Apple Health Study to create a diverse group of participants and improve understanding of how data collected from apps and devices can relate to health. The study focuses on various aspects including mental health, sleep, exercise, hormones, metabolic health, hearing, aging, lifestyle factors, neurological conditions, general health, wellbeing, and women's health. This is an observational study aiming to use this information to help predict, detect, monitor, and manage health changes. Participants in this fully remote study will use their iPhone and the Apple Research app to share data and complete tasks. They can select the types of health and sensor data they want to share, and will answer surveys covering personal demographics, medical history, family history, and social factors. There is no treatment or drug involved, as this study observes health information collected digitally. During the study, participants will provide baseline health status information and follow-up data every six months for up to five years. They will also share demographic details, lifestyle and environment information, and family health history. The study monitors these factors over time to better understand health trends. Participation involves regular surveys and data sharing via the app, with all activities completed remotely from home.