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About This Study

This clinical trial tests the safety, tolerability, and effectiveness of a virtual reality intervention to improve psychological symptom burden for cancer patients undergoing treatment. Virtual reality (VR) is a technology that allows users to experience and interact with three-dimensional, computer-generated environments that simulate the real world or imagined settings. The VR intervention consists of a preloaded with immersive environments designed to engage the senses through simulated sights and sounds. This may include a walk through of a serene forest, exploring vibrant coral reefs, swimming with dolphins, or standing at the base of a majestic waterfall. These environments are created to provide a relaxing and engaging experience. Completing the VR intervention may be a safe and effective way to improve quality of life, reduce anxiety, enhance focus, and promote healthy living for cancer patients undergoing treatment.

Design

Interventions / Regimen

• Other: Questionnaire Administration — Participants will complete pre- and post-intervention questionnaires to assess symptoms of anxiety, depression, and fatigue.
• Other: Virtual Reality (VR) Intervention — Participants will engage in a single-session immersive Virtual Reality (VR) experience lasting approximately 20-30 minutes. The VR content will include calming, guided experiences such as nature scenes, meditation, or breathing exercises designed to promote relaxation and reduce psychological distress. The intervention will be administered in a clinical setting.

Primary Outcomes

• Successfully complete the virtual reality (VR) intervention (Feasibility) (Baseline)
• Absence of major issues during administration (Feasibility) (Baseline)
• Acceptability (Baseline)

About This Study

The goal of this Phase II clinical trial is to learn if the oral synthetic allopreganolone analog (zuranolone) is safe to take and is well tolerated by stroke survivors experiencing moderate to severe post-stroke depression and if it will help with the symptoms of depression. The main questions it will aim to answer are: * Is zuranolone safe to take by participants who have moderate to severe post-stroke depression? * Is zuranolone well-tolerated by participants who have moderate to severe post-stroke depression? * Does zuranolone treat moderate to severe post-stroke depression? The study will enroll six participants. All participants will be given 50 mg of zuranolone for 14 days. Participants will be asked to provide blood samples, complete some questionnaires including those related to mood and a cognitive assessment.

Design

Interventions / Regimen

• Drug: Zuranolone — Zuranolone is a neuroactive steroid that works by modulating the activity of the gamma-aminobutyric acid (GABA) receptor in the brain.

Primary Outcomes

• Number of participants with treatment emergent adverse events (TEAEs) after starting zuranolone (90 days)
• Severity of suicidal ideation after starting zuranolone as measured by the Columbia Suicide Severity Rating Scale (C-SSRS) (90 Days)
• Severity of somnolence after starting zuranolone as measured by the Epworth Sleepiness Scale (ESS) (90 Days)

About This Study

Recent advances in intervention research have revealed the promise of transdiagnostic, modular approaches implemented by lay paraprofessionals for the treatment of the most prevalent mental health concerns in settings affected by adversity (e.g., anxiety, depression, posttraumatic stress), but to date, few effectiveness trials have examined the indirect effects of treatment on intergenerational and economic outcomes or moderators of treatment effectiveness. There is thus a critical need not only for the continued expansion of the evidence-basis for care in low-resource settings, but also for the evaluation of factors contributing to effectiveness across multiple dimensions to gain a better understanding of the sustainability, long-term benefits, and cost-effectiveness of these approaches. The current study will conduct a rigorous evaluation of an existing program, the Common Elements Treatment Approach (CETA) with women (N=300) who are mothers of young children (ages 4-6). The trial will take place in the context of an integrated community care setting in Lima, Peru's most populous and impoverished district, San Juan de Lurigancho. The primary aims are to (1) evaluate the primary and indirect effects of CETA (2) examine moderators of treatment effectiveness, including implementation quality and neighborhood factors and (3) examine CETA's cost effectiveness. The central hypotheses are that (H1a) CETA will improve women's mental health, intimate partner violence, and parenting and that (H1b) CETA will have indirect benefits for women's economic outcomes and for their children's adjustment. It is also hypothesized (H2) that effectiveness will be enhanced by strong implementation quality and the presence of neighborhood promotive factors, and weakened by neighborhood disadvantage. Hypotheses will be evaluated using an RCT employing a longitudinal design with assessments at baseline (T1), post-test (T2), 6-month follow-up (T3) and 12-month follow-up (T4). Women will be randomized into the intervention condition (CETA + Enhanced Case Management \[ECM\]) or the comparison condition (ECM). Robust, multi-source (i.e., participant, therapist, supervisor, census data) and multi-method data (i.e., interview, observational assessment, google street view coding) will be gathered. The contribution will be significant by advancing research on both direct and long-term benefits of maternal mental health care for family systems, and is likely to provide important insights into the sustainability and cost effectiveness of these approaches. The expected outcome is an evidence-based, cost-effective, integrated approach to maternal mental health care that can be readily implemented by local organizations. Further, it is anticipated that learnings from this project will respond to broader global public health concerns and provide opportunity for cross-context reciprocal innovation. Expanding the evaluation of CETA delivered in Spanish not only has advantages for the…

Design

Interventions / Regimen

• Behavioral: Common Elements Treatment Approach — CETA was designed for implementation with lay paraprofessionals working in LMICs. It has shown evidence of effectiveness in addressing posttraumatic stress, depression, anxiety, IPV, substance use, and suicide/safety issues. CETA employs a precision science approach using a modular framework. That is, all participants receive a common core of elements (i.e., Engagement, Cognitive Coping/Restructuring, \[and for this study\] Caregiver Skills) with additional specific elements guided by individual symptom presentation, thus balancing standardization and personalization. Elements of CETA include: Engagement, Psychoeducation, Anxiety Management Strategies, Behavioral Activation, Cognitive Coping/Restructuring, Imaginal \& Live Gradual Exposure, Suicide/Homicide/Danger Assessment and Planning, and Substance Use CBT/MI for Alcohol and Drug Use. The Caregiver Skills module includes information about effective parenting skills for preschool-aged children such as praise, selective
• Behavioral: Enhanced Case Managment — Women assigned to both conditions will receive ECM, which is a standardized (already existing) service at INFAM that includes four stages: intake, referral, guided support, and follow-up. At intake, women will participate in a structured interview that includes a brief assessment of multisystem risk and protective factors (i.e., social, economic, daily living, basic needs, and physical and mental health). Depending on assessed needs, women will be referred to relevant services. As needed, the social worker will provide guided support for accessing services (e.g., helping with paperwork for insurance applications). The ECM process is concluded by a follow-up interview to ascertain progress in accessing referrals and documents women's progress toward identified social service referral goals across domains.

Primary Outcomes

• Depression (Baseline, 12-week post-test, 6-month follow-up, 12-month follow-up)
• Posttraumatic Stress (Baseline, 12-week post-test, 6-month follow-up, 12-month follow-up)
• Anxiety (Baseline, 12-week post-test, 6-month follow-up, 12-month follow-up)
• Wellbeing (Baseline, 12-week post-test, 6-month follow-up, 12-month follow-up)
• Intimate Partner Violence (Baseline, 12-week post-test, 6-month follow-up, 12-month follow-up)
• Parenting - observed (Baseline, 12-week post-test, 6-month follow-up, 12-month follow-up)
• Parenting - Self-reported (Baseline, 12 week post-test, 6-month follow-up, 12-month follow-up)

About This Study

The transition to parenthood is often an exciting yet hard period for parents. In the first year after a new baby, many parents feel less confident, have more anxiety and depression, and feel more isolated and alone. During this time, many parents use their phones and the Internet to seek out information and support. Thus, the investigators are exploring the opportunity of using mHealth, or mobile health, to provide information directly to parents after the birth of their first baby. The investigators have developed a program for both birthing and non-birthing parents called the Essential Coaching Postpartum program. This program provides 332 parents with text messages sent for 6 weeks after birth to share information on newborn care and parent outcomes. This will be tailored based on whether they are the birthing parent (Essential Coaching for Every Mother) or non-birthing parent (Essential Coaching for Every Partner). The investigators will evaluate this program by comparing a group of parents who receive the messages to a group of parents do not receive any text messages. To determine the success of the Essential Coaching Postpartum program, the investigators will compare parents' confidence, anxiety, depression, and co-parenting between the two groups after six-weeks and six-months. The investigators believe that parents who get the text messages will have higher confidence and co-parenting outcomes and lower anxiety and depression. The investigator's goal with the Essential Coaching Postpartum program is to help make the first few weeks after a new baby less stressful by providing information and support directly to parents that they know they can trust.

Design

Interventions / Regimen

• Behavioral: Essential Coaching Postpartum — Essential Coaching Postpartum consists of one-way, standardized text messages sent to parents from birth to 6-weeks postpartum to provide evidence-based information on newborn care and mental health. Messages are sent twice a day for the first three weeks (10am and 5pm) and then once a day for the following three weeks (10am), starting the second day after birth.

Primary Outcomes

• Parenting self-efficacy (Enrollment, 6-weeks postpartum, 6-months postpartum)

About This Study

The goal of this clinical trial is to learn if a community-based health education and communication program helps prevent and reduce depression in older adults living in Ho Chi Minh City. It will also evaluate how the program affects quality of life and caregiver stress. The main questions it aims to answer are: 1. Does the health education program improve knowledge, attitudes, and practice regarding depression among older adults and their primary caregivers? 2. Does the program reduce depression scores (measured by GDS-30) and improve quality of life in older adults compared to standard care? 3. Does the program help lower caregiving burden and stress among primary caregivers? Researchers will compare an intervention group (older adult and caregiver pairs who receive the education program) to a control group (pairs who receive standard community health care). Participants in the intervention group will: * Attend 5 group education sessions (45-60 minutes each) covering early depression detection, sleep hygiene, nutrition, physical activity, stress management, and caregiver support. * Complete questionnaires at the start and end of the program to measure depression symptoms, quality of life, caregiving burden, and health knowledge.

Design

Interventions / Regimen

• Other: Health Communication — The intervention group older adult participating in a 5-session health education program (estimated 45-60 minutes per session), structured around the following key modules: Session 1: Early Identification and Screening of Depression Focuses on early recognition of depressive symptoms, the impacts of depression, and instruction on screening tools. Session 2: Sleep and Sleep Hygiene Addresses the role of sleep in mental health and evidence-based sleep hygiene techniques. Session 3: Nutrition and Physical Activity Covers the roles of nutrition and exercise in depression prevention, introducing tailored physical activities for older adults. Session 4: Stress Management and Social Support Integration Introduces stress-reduction exercises and techniques to connect with and leverage community and social support networks.
• Other: Health communication — The intervention group older adult participating in a 5-session health education program (estimated 45-60 minutes per session), structured around the following key modules: Session 1: Early Identification and Screening of Depression Focuses on early recognition of depressive symptoms, the impacts of depression, and instruction on screening tools. Session 2: Sleep and Sleep Hygiene Addresses the role of sleep in mental health and evidence-based sleep hygiene techniques. Session 3: Nutrition and Physical Activity Covers the roles of nutrition and exercise in depression prevention, introducing tailored physical activities for older adults. Session 4: Stress Management and Social Support Integration Introduces stress-reduction exercises and techniques to connect with and leverage community and social support networks. Session 5: Caregiver Support, Coping Skills, and Q\&A Dedicated to interactive Q\&A, practical coping strategies for care

Primary Outcomes

• Change From Baseline in Geriatric Depression Scale (30-item) Total Score at 3-6 Months (From baseline to 6 months after the intervention)
• Change From Baseline in Zarit Burden Interview (22-item) Total Score at 6 Months (From baseline to 6 months after the intervention)
• Change From Baseline in World Health Organization Quality of Life-BREF Scores at Post-Intervention (From baseline to 6 months after the intervention)

About This Study

Major depressive disorder (MDD) is a common condition involving recurring periods of depression. One of the major challenges faced by people with MDD is that the episodes of depression tend to recur even after they are successfully treated. Currently, it is hard to predict when a depressive episode will recur. Being able to forecast this would help healthcare providers monitor patients and prevent relapse. The purpose of this study is to monitor features such as clinical symptoms, physical activity, sleep patterns, cognitive functioning and brain activity to help us understand how relapse happens and the mechanisms that cause it. From these different types of data, investigators will build a model that tells us who is more likely to experience a relapse and when the relapse is likely to occur. This study will be a significant step forward in understanding and managing MDD. Investigator will create a practical tool that will allow healthcare providers to monitor patients more effectively. By identifying early signs of relapse, investigators may be able to intervene promptly to prevent depressive episodes. Finally, our research will help understand the factors that underlie relapse in MDD, which will encourage the development of novel treatment approaches.

Design

Primary Outcomes

• Time-to-relapse (18 months)

About This Study

Pregnant women in pregnancy week 8-29 screening positive for antenatal depression will be randomized to either choose or to be allotted by chance to different forms of diagnostic assessment; i.e. telephone, video or face-to-face assessment. Those diagnosed with mild to moderate major depression will then be randomized to treatment with therapist-guided Internet-delivered Cognitive Behavioral Therapy (ICBT) adapted for women suffering from antenatal depression or to the same treatment with addition of up to three contacts with extra support by a midwife or experienced perinatal mental health nurse. The primary aim is to assess whether extrasupport in addition to internet-guided pregnancy adapted ICBT decreases depressive symptoms more than internet-guided pregnancy adapted ICBT only. Secondary aims include effects of extrasupport and assessment mode on treatment satisfaction, fidelity and credibility.

Design

Interventions / Regimen

• Behavioral: Therapist Guided Internet-CBT for antenatal depression — A 10 week long, structured self-help program with weekly reports to, and feedback from, a CBT therapist over the Internet. Includes traditional CBT-methods for depression adapted for antenatal depression.
• Behavioral: Therapist Guided Internet-CBT for antenatal depression and perinatal extra support. — A 10 week long, structured self-help program with weekly reports to, and feedback from, a CBT therapist over the Internet. Includes traditional CBT-methods for depression adapted for antenatal depression. Additionally, up to three supportive contacts with a midwife or perinatal mental health nurse to support ICBT treatment and adress general pregnancy related health problems.
• Behavioral: Diagnostic assessment by telephone, video or face-to face - Allocation by chance — Structured diagnostic perinatal psychiatric assessment of women screening positive for antenatal depression (pregnancy week 8-29) by telephone, video or in a face-to-face meeting. Assessment form allocation by chance.
• Behavioral: Diagnostic assessment by telephone, video or face-to face - Allocation by choice — Structured diagnostic perinatal psychiatric assessment of women screening positive for antenatal depression (pregnancy week 8-29) by telephone, video or in a face-to-face meeting. Assessment form allocation based on patient preference.

Primary Outcomes

• Change in Montgomery Asberg Depression Rating Scale, self-rating version (MADRS-S) (Baseline to post-treatment (10 weeks) and to 8-10 weeks post-partum)

About This Study

The purpose of this study is to establish how personalization of repetitive transcranial magnetic stimulation (rTMS) can change markers of brain activity and improve treatment response. To do this, all participants will receive the same active form of treatments, but some of the participants in this study will receive intermittent theta burst stimulation (iTBS) rTMS treatment with standard forms of targeting and intensity, and others will receive iTBS rTMS treatment using personalized magnetic resonance imaging (MRI) and electric field (E-field) modeling measures.

Design

Interventions / Regimen

• Device: iTBS — rTMS involves direct stimulation of cortical neurons using externally applied, powerful, focused magnetic field pulses. iTBS is a briefer form of patterned rTMS that has been shown to be effective against MDD, despite a stimulation period of 1-3 min rather than 30-40 min.

Primary Outcomes

• Markers of cortical excitation (change from pre-intervention to post-intervention (average of 6 weeks))
• Depression scores (changes from baseline to Week 4 follow-up)

About This Study

A Pilot, Randomized, Double-Blinded, Controlled Study of Hemodynamic and Acid Base Effects of 0.5M Sodium Lactate and 3% Saline Solutions in Septic Shock Patients

Design

Interventions / Regimen

• Drug: Sodium Lactate — 0.5M HSL (containing 504mM of sodium and lactate)
• Drug: 3% NaCl — active compartor 3% NaCl

Primary Outcomes

• haemodynamic effects (at time of start of infusion, at 30 minutes and at 60 minutes from the start of the respective fluid bolus)

About This Study

The primary purpose of this study is to assess the effect of TX000045 on pulmonary vascular resistance (PVR) in participants with pulmonary hypertension secondary to interstitial lung disease (PH-ILD) and to assess the safety and tolerability of TX000045 in participants with PH-ILD.

Design

Interventions / Regimen

• Drug: TX000045 — Subcutaneous Injection.

Primary Outcomes

• Mean Change from Baseline in PVR up to 16 Weeks (Baseline up to 16 weeks)
• Number of Participants with Adverse Events (AEs), Adverse Events of Special Interest (AESIs) and Serious Adverse Events (SAEs) (Baseline up to 21 weeks)
• Number of Participants with Clinically Significant Changes from Baseline in Safety Laboratory Assessments, 12-Lead Electrocardiogram (ECG) Assessments and Vital Sign Assessments (Baseline up to 21 weeks)

About This Study

The goal of this clinical trial is to find out whether giving vitamin D to pregnant women who had pre-eclampsia in a previous pregnancy helps prevent the condition from coming back. The main question it aims to answer is: Does vitamin D supplementation reduce the chance of pre-eclampsia recurring in pregnant women with a history of pre-eclampsia? To answer this question, pregnant women attending the antenatal clinic at the Department of Obstetrics and Gynaecology, Nishtar Hospital Multan will be invited to join the study. Participants will be randomly assigned to two equal groups: * Vitamin D group: will take 4,000 IU of oral vitamin D until 36 weeks of gestation. * Placebo group: will receive a pill identical in appearance, taste, and consistency but without vitamin D. While on the study medication, each woman will visit the clinic every two weeks. At each visit, her blood pressure will be measured, and if it is 140/90 mmHg or higher, a urine test will check for protein to identify pre-eclampsia as per hospital protocol. Any diagnosis of pre-eclampsia will lead to standard care, and the outcome will be recorded. At the end, researchers will compare how many women in each group developed recurrent pre-eclampsia. This study will help answer whether vitamin D supplementation can safely reduce the risk of pre-eclampsia returning in women with a prior history - a question important for improving pregnancy outcomes and maternal health.

Design

Interventions / Regimen

• Drug: Vitamin D — 4000 IU of vitamin D will be given orally, once daily till 36-weeks of gestation
• Drug: Placebo and standard of care — Look, smell and taste alike oil emulsion drops, same number, till 36-weeks of gestation

Primary Outcomes

• Pre-eclampsia (From enrollment till 36 completed weeks of gestation)

About This Study

Thoracic aneurysm is a silent disease with a potential mid-term high risk of death or major complications. Few data are available on the real incidence of major complications in case of small and moderate thoracic aneurysm. Different factors are supposed to increase the risk of aortic enlargement as high blood pressure and sleep disorder breathing. The modality of imaging and clinical follow-up are well defined. In this prospective observational study, the aim to assess the incidence of of major complications during follow-up in a population of patients with a small or moderate thoracic aneurysm. The study will also try to identify systemic factors influencing aneurysm evolution.

Design

Primary Outcomes

• Occurrence within 5 years of inclusion of a major aortic even (during the 5 years after inclusion)