Acceptance

Young adults (YA) with cancer have unique challenges in coping, and their primary partners may experience burden and low self-efficacy related to caregiving. In this single-arm pilot trial, the investigators shall deliver an eight-session intervention to YAs with cancer and their self-identified partners who provide caregiving. The intervention is founded on principles from cognitive-behavioral therapy and couples-focused interventions, tailored for YA. The aim of the study is to assess the feasibility and acceptability of the intervention, which will inform refinements prior to a larger-scale clinical trial. This study will include 10 YAs and their partner-caregivers (N=20). Participants will complete surveys at baseline and after the intervention, and will be invited to complete optional semi-structured exit interviews.

Lev is a brief, transdiagnostic, interprofessional intervention targeting health-related habits that is intended for several care settings. The main population intended is individuals with neurodevelopmental disorders or parents or close relations to children with disabilities. This study will therefore be open for participants recruited from several types of healthcare services in Sweden. Study 1: The feasibility trial investigates the following questions: Completion: How many participants that started Lev completed the intervention? What were the reasons for not not completing Lev? How many sessions did the participants complete? Lev includes screening (Lev-s), three sessions + one booster session. Level of acceptability: Was Lev perceived as creditable and satisfactory by healthcare workers and participants? Treatment credibility will be measured before Lev and after the last session for both participants and healthcare workers. Treatment satisfaction will be evaluated after each session and after the intervention is completed. Session evaluations will be done by both participants and healthcare workers. Do the intervention lead to adverse events? To what extent were individual goals met?

Parenting children with special health care needs can be stressful and weigh on the caregivers' mental health. For the individuals with special needs, the mismatch between their needs and the normative practice in the world around them can be frustrating and detrimental to their functioning. The demands and concerns to these families can be so real that it may not be sensible to examine the validity or helpfulness of the distressing thoughts or feelings but to promote psychological flexibility, which is a key to value-guided living. This pilot study explores the effects and feasibility of a group-based intervention for families of individuals with special health care needs.

Reactions to severe stress is one of the most common causes of sick leave in Sweden. Previous research has shown that compassion interventions for staff can affect work-related stress by increased self-care, better self-awareness and an increased healthy attitude, however, Swedish studies on the subject are scarce. Compassion is a motivation to reduce suffering in oneself and others characterized by a warm, understanding, and respectful attitude. In addition to beneficial effects for the staff, a compassion-oriented approach, has shown to improve the relationship between patient and staff, increase patient satisfaction with care and reduce patient anxiety and stress. As a result of the covid-19 pandemic, healthcare professionals have been exposed to difficult physical and mental work conditions that cause feelings of stress and inadequacy. In the long run, increased stress can cause fatigue and increased number of sick leaves. This can in turn contribute to increased stress for the staff who remain working and difficulties to recruit new staff, which make the situation worse. There is a lack of interventions for staff aimed at preventing stress-related health issues, enabling recovery and reduce mental suffering linked to a stressful work situations. The aim of this study is to find a method that help healthcare providers cope with stress of conscience in relation to stressful work situations, particularly during the current covid-19 pandemic. A five week internet-based compassion course of five modules will be conducted and evaluated with the aim of exploring whether the course contributes to reduce stress of conscience and work-related stress, and increases the levels of professional quality of life and self-compassion among healthcare professionals. The internet-based compassion course will be compared with: one group that is on a waiting list for ten weeks and then receives an internet-based general stress management course and one group that participate in the general stress management course.

To evaluate the safety and tolerability of single and multiple ascending subcutaneous doses of GenSci098 in patients with thyroid eye disease (TED)

To evaluate the safety and tolerability of single ascending subcutaneous doses of GenSci098 in patients with Graves' Disease

Eligible participants will undergo intake procedures and baseline evaluations at the clinic the day before dosing. The next day, participants will be randomized to, and receive, either Nezavist SDD oral suspension or placebo vehicle (4 cohorts of escalating doses of Nezavist with 6 Nezavist subjects and 2 placebo subjects in each cohort). Participants will remain in the clinic for at least an additional 48-hours for safety assessments and blood collections to determine plasma levels of Nezavist, then will be discharged from the clinic and return for follow-up safety tests 72-hours later.

This is a randomized, self-controlled prospective clinical study. On initial consultation within one month of scheduled cataract surgery, each study subject will be randomized by a random number generator to receive one of two treatment groups, either experimental or control in the first eye. The second eye will undergo cataract surgery 2 weeks later and will be treated with the other treatment group: Experimental Group: A total of 50 study subjects (50 eyes) will receive Dextenza dexamethasone intracanalicular insert placed in the lower punctum of their scheduled surgical eye at the time of surgery and will receive intracameral ketorolac during the procedure and 50 micrograms of intracameral moxifloxacin at the conclusion of the procedure. Control Group: A total of 50 study subjects (50 eyes) will receive topical moxifloxacin 0.5% qid 1 day prior to surgery and for ten days postoperatively, ketorolac 0.5% qid 1 day prior to surgery and for 1 month postoperatively, and prednisolone acetate 1.0% qid starting at the conclusion of cataract surgery for 2 weeks and bid for 2 weeks in their scheduled surgical eye.

Being a parent of the child with medical complexity poses enormous stress because CMC have a chronic complex health condition, which may result in premature death of the CMC. Psychological symptoms commonly experienced by the parents of a CMC. Having a CMC is an ongoing stressor including diagnosis, daily nursing care and symptom management, uncertainty of prognosis that can adequately fear the possibility of relapse. Therefore, seeking an intervention consisting of "Psychological flexibility" is crucial for these parents to manage their stress and difficult emotions more effectively. The ACT intervention help individuals concentrate more on their problems with positive attitude and take initiatives and workable actions to fix the problems associated from the caregiving activities. As a result, they will experience less stress when encountering difficulties and challenges and adapt more effectively. These individuals probably have the potential of natural recoveries from adverse events once the stressor is terminated. Knowledge gap: A review of the literature reveals a paucity of studies on ACT for Chinese parents of the CMC to decrease their psychological symptoms while enhancing their psychological flexibility in local communities. To fill the knowledge gap, this proposal therefore endeavors to develop an ACT and test its preliminary effects and feasibility.

State the primary objective(s) of the study: The objective of the study is to assess the effectiveness of "ACT with CF Self Help Toolkit" in improving cognitive fusion, depression, anxiety, psychological flexibility and value-based living among adults with cystic fibrosis. State the secondary objectives(s) of the study: The investigators are aiming to examine whether the ACT with CF Self Help Toolkit improves medication adherence, and spirometry results among adults with cystic fibrosis. Data collected from electronic health records will be used for analysis. What benefit or knowledge will be gained? Findings can inform psychosocial interventions for adults with cystic fibrosis and other chronic health conditions. State hypothesis tested: ACT with CF Self Help Toolkit will prove more effective than Waitlist Control in reducing cognitive fusion, depression and anxiety, and improving psychological flexibility and value-based living among adults with cystic fibrosis. Similarly, those in the Waitlist Control will, once they receive access to the Toolkit 6 weeks later, also demonstrate significant improvements in cognitive fusion, depression and anxiety, psychological flexibility and value-based living. Patients will be recruited from the following: Thomas Jefferson University Hospital Cystic Fibrosis Clinic, the Boomer Esiason Foundation social media pages (facebook, instagram), Cystic Fibrosis Foundation listserv (used by CF Clinic Mental Health Providers), CF Social Worker listserv, other mental health provider listservs, physicians who recruited patients for our previous clinical trials, and the Cystic Fibrosis Research Institute. Patients who are interested in participating must show that they have a diagnosis of cystic fibrosis (sharing a MyChart or similar record, referral from a CF physician specialist). If patients are willing to be in the study, they will be given a consent form to sign and return as well as a packet of screening questionnaires containing the GAD-7, PHQ-9, and some questions regarding their CF diagnosis to determine eligibility. If found eligible, they will then be sent a baseline measures packet containing demographic questions, questions regarding their feelings about ACT, the CF Mental Health and Wellness Self-Report Measure, the AAQ-II, the CFQ-13, the BDI-II, the BAI, the VLQ, the Styles of Coping Word Pairs Measure, the B-PQSI, and the CFQ-R. All packets will be sent to participants digitally using RedCap. These questionnaires will ask patients: 1) how often the participant experiences different thoughts and feelings, including some related to having cystic fibrosis; 2) how often the participant takes their cystic fibrosis medications; 3) the participant's coping style, including how long they persist in thinking about something that has happened to them. The participant will complete each questionnaire again after 6 weeks, and again about 3-months later. Some variation exists in the packets based on timepoint. Participants in the waitlist condition will receive a secondary baseline packet before starting the ACT with CF intervention. This packet includes all the same measures as the original waitlist packet, but also contains the GAD-7 and PHQ-9 to observe any change in measures collected during screening. 6 weeks after beginning treatment, all participants will complete another measures packet. This packet contains all previously used measures. Additionally, this packet includes the TEX-Q2 and a series of novel qualitative and quantitative measures to establish participant feelings about ACT with CF. All participants will complete their final packet 3 months after treatment. This packet will contain all previous measures, as well as some of the novel measures about ACT that were included in the 6 week packet. These questionnaires take about 45 minutes to complete. Participants in the Waitlist Control condition will also complete this packet prior to gaining access to the ACT with CF Self-Help Toolkit (so will complete measures at baseline, 6 weeks/start of Toolkit, 6 weeks later, and 3 months later). The ACT with CF Self-Help Toolkit will include 6 main modules, each with 3 or 4 kernels, which will be short videos, in which participants will learn new ways to manage uncomfortable experiences and feelings (e.g., anxiety, depression) and to engage in positive behaviors. These videos are based on the main interventions in our ACT with CF individual therapy protocol. For example, the first main module focuses on how the participant wants to live their life (Values Clarification Intervention), and the kernels in this module are 1-3 minute video clips demonstrating different ways to figure this out (Card Sort, 70th Birthday exercise, accessing barriers). De-identified data will be sent to UNC-Chapel Hill for analysis. In addition, the investigators estimate that power will be more favorable to characterize the associations between intervention process measures and treatment-related changes in psychological functioning throughout the active treatment period. Using similar assumptions to our primary model above, the investigators anticipate that a sample size of 42 individuals would be sufficient to examine associations from a linear, repeated measures, mixed modeling approach incorporating data from weeks one through six. The investigators will analyze the data with each subject serving as their own control, with the first packet of questionnaires prior to accessing the Toolkit being compared with the questionnaires immediately after having the Toolkit for 6 weeks and then three months later. The investigators will use a standard data analysis using a two-tailed t-test to see if there are significant differences between their responses in the first set of questionnaires before receiving the Toolkit to the second set after having access to the Toolkit for 6 weeks. Repeated measures mixed modeling will be used to examine changes in depressive and anxious symptoms over time, with psychological functioning measured as a mean rank score across all four measures. Within this model the investigators will control for baseline psychological functioning, age, gender, and FEV1 values, with treatment group as the predictor of interest. The investigators will also examine the interaction between frequency of ACT with CF Toolkit access (how often participants engage with the Toolkit) and outcome scores. In addition, explanatory analyses of process-related psychological mechanisms will be examined using general linear models