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About This Study

The goal of this fixed order, open-label, dose-escalation study is to investigate the safety and efficacy of specific doses of dimethyltryptamine (DMT) in humans.

Design

Interventions / Regimen

• Drug: 0.1 mg/kg Dimethyltryptamine (DMT) — 0.1 mg/kg DMT
• Drug: 0.3 mg/kg Dimethyltryptamine (DMT) — 0.3 mg/kg DMT

Primary Outcomes

• Change in Blood Pressure (-60 and -30 minutes before DMT administration; 0, +5, +10, +15, +20, +30, +45, +60, and +120 minutes after DMT administration)
• Change in Heart Rate (-60 and -30 minutes before DMT administration; 0, +5, +10, +15, +20, +30, +45, +60, and +120 minutes after DMT administration)
• Change in Psychedelic Effects (-60 minutes before DMT administration; 0, +30, and +60 minutes after DMT administration)
• Change in Anxiety (-60 minutes before DMT administration; 0, +30, and +60 minutes after DMT administration)
• Drug Reinforcing Effects (+120 minutes after DMT administration)
• Overall Tolerability assessed by the VAS (+120 minutes after DMT administration)

About This Study

This randomized controlled trial (RCT) aims to compare the effectiveness of Islamic-Oriented Ericksonian Hypnotherapy (IEH) and Standard Ericksonian Hypnotherapy (SEH) in reducing symptoms of anxiety and depression. The study will enroll 90 participants with mild to moderate anxiety and depression, who will be randomly assigned to one of three groups: (1) IEH intervention, (2) SEH intervention, or (3) control group (no intervention). Participants in the intervention groups will receive 12 weekly hypnotherapy sessions, each lasting 60 minutes. The primary outcomes include changes in Beck Depression Inventory-II (BDI-II) and Beck Anxiety Inventory (BAI) scores from baseline to post-intervention and at a 4-week follow-up. The study will also assess whether religious belief levels moderate the effects of the intervention using the OK-Religious Attitude Scale. Data collection will be performed at Istanbul Nişantaşı University, and ethical approval has been obtained.

Design

Interventions / Regimen

• Behavioral: Islamic-Oriented Ericksonian Hypnotherapy (IEH) — This intervention involves 12 weekly sessions (60 minutes each) of Ericksonian hypnotherapy integrated with Islamic religious elements. Sessions incorporate: Quranic metaphors and Islamic imagery Spiritual affirmations to enhance relaxation and emotional regulation Faith-based guided hypnosis adapted to cultural and religious beliefs Techniques such as indirect suggestions, therapeutic storytelling, and guided imagery The intervention is designed for Muslim participants with mild to moderate anxiety and depression.
• Behavioral: Standard Ericksonian Hypnotherapy (SEH) — Participants receive 12 weekly sessions (60 minutes each) of standard Ericksonian hypnotherapy, which includes: Metaphorical storytelling and guided imagery Indirect hypnotic suggestions to promote psychological flexibility Relaxation techniques to reduce anxiety and depressive symptoms Unlike the Islamic-Oriented Hypnotherapy (IEH), this intervention does not integrate religious or faith-based elements.

Primary Outcomes

• Beck Depression Inventory-II (BDI-II) (Baseline, Week 12 (post-intervention), Week 16 (follow-up))
• Beck Anxiety Inventory (BAI) (Baseline, Week 12, Week 16)

About This Study

Opioids are frequently used for postoperative analgesia but may induce side effects. Opioid-induced respiratory depression is the most dangerous side effect of opioids. Patients with obstructive sleep apnea (OSA) are at higher risk for opioid-induced respiratory depression. Oliceridine is a novel biased μ-opioid receptor agonist that selectively engages the G-protein pathway while reducing β-arrestin recruitment and thus may lower the risk of respiratory depression. The goal of this observational study is to compare the effects of oliceridine versus sufentanil analgesia on the incidence of postoperative respiratory depression in patients with known or suspected OSA in the postoperative period following elective surgery.

Design

Interventions / Regimen

• Drug: Oliceridine — Oliceridine will be administered via patient-controlled intravenous analgesia.
• Drug: Sufentanil — Sufentanil will be administered via patient-controlled intravenous analgesia.

Primary Outcomes

• Incidence of respiratory depression within 24 hours after surgery (Within 24 hours after surgery)

About This Study

This randomized controlled trial aims to evaluate the effectiveness of a virtual reality (VR) music-movement exergaming intervention for improving social connectedness and psychological well-being among young adults. Participants will be randomly assigned to one of three groups: (1) a VR social music-movement exergame group, (2) a VR solo exergame group without social interaction, and (3) a waitlist control group. The intervention integrates rhythmic movement, music-based interaction, and immersive VR environments to promote engagement and social connection. Primary outcomes include changes in depressive symptoms, anxiety, and social connectedness. Secondary outcomes include psychological need satisfaction and physical fitness indicators. Assessments will be conducted at baseline, post-intervention, and follow-up. The study will provide evidence on the potential benefits of immersive VR-based exergaming interventions for mental health and social well-being in young adults.

Design

Interventions / Regimen

• Behavioral: VR social musical exergame — Participants engage in a virtual reality (VR) social musical exergame twice per week for 6 weeks (45 minutes per session). The game integrates rhythmic movement with music and allows participants to interact with others in a shared virtual environment. The intervention is designed to promote physical activity, social interaction, and psychological engagement.
• Behavioral: VR solo musical exergame — Participants engage in a VR musical exergame with the same frequency, duration, and exercise intensity as the experimental group, but without social interaction features. The intervention focuses on individual gameplay without multiplayer interaction.
• Other: Waitlist control — Participants assigned to the waitlist control group receive general mental health guidance and continue their usual activities during the 6-week study period. After the study period, they will be offered access to the VR intervention.

Primary Outcomes

• Change in depression symptoms measured by the Beck Depression Inventory-II (BDI-II) (Baseline (Week 0) to Post-intervention (Week 6))
• Change in anxiety symptoms measured by the Beck Anxiety Inventory (BAI) (Baseline (Week 0) to Post-intervention (Week 6))

About This Study

In a sample of patients already receiving ketamine (or esketamine) treatment as part of their clinical care, this project seeks to test whether we can enhance and/or extend (es)ketamine's rapid effects by introducing helpful information delivered by a computer-based cognitive training protocol. This work could ultimately lead to the ability to treat depression more efficiently and with broader dissemination by rapidly priming the brain for helpful forms of learning.

Design

Interventions / Regimen

• Behavioral: Cognitive Training — Sessions of cognitive training exercises (15-20min each) self-administered via a web app
• Behavioral: Sham Training — Sessions of sham training exercises (15-20min each) self-administered via a web app

Primary Outcomes

• Montgomery Asberg Depression Rating Scale: During (Es)Ketamine Induction (Trajectories from baseline through end of 'induction phase' treatments (up to max of 12 weeks))
• Montgomery Asberg Depression Rating Scale: After (Es)Ketamine Induction (Trajectories from final 'induction phase' treatment through 4 weeks post-induction)

About This Study

The goal of this clinical trial is to test two advices on alcohol drinking in more than 10.000 Spanish adult drinkers (men of 50 or more years and women of 55 or more years). The main question it aims to answer is to test the non-inferiority advice of a moderate alcohol drinking pattern on all-cause mortality and other chronic disease like cardiovascular disease, cancer or type 2 diabetes. Participants will receive during 4 years an advice to drink alcohol following a Mediterranean Alcohol Drinking Pattern (MADP): consuming alcohol in moderation, avoidance of binge drinking and preference for red wine. Researchers will compare those who will receive a MADP advice with those who will receive an advice on abstention to see if the advice on MADP is not inferior than the abstention advice to prevent all-cause mortality and other chronic diseases.

Design

Interventions / Regimen

• Behavioral: Moderate Alcohol Drinking Pattern — Remotely Intensive intervention by specialized coaches (psychologists, dietitians, and other health professionals) to promote a behavior change on alcohol consumption. Repeated quarterly small group sessions and periodical personal interviews and educational videos, during up to 4 years with 1 contact every 3 months. Goals of intervention: 1. moderate consumption (7 or less drinks/wk for women, 14 or less drinks/wk for men) of red wine (a drink=150 ml). 2. always during meals 3. spread out throughout the whole week, and 4. avoidance of binge-drinking episodes. No participant will be invited to start or increase his/her alcohol intake.
• Behavioral: Abstention — Remotely Intensive intervention by specialized coaches (psychologists, dietitians, and other health professionals) to promote a behavior change on alcohol consumption. Repeated quarterly small group sessions and periodical personal interviews and educational videos, during up to 4 years with 1 contact every 3 months. Goals of intervention: Abstention. Message of 0 alcohol.

Primary Outcomes

• Comparison between groups of the incidence of a global Index of all-cause mortality and other alcohol-related diseases (From enrollment to the end of the intervention up to 4 years.)

About This Study

This study aims to prevent syndemic health conditions by decreasing acculturative stress and promoting resilience via SER Familia (Salud, Estrés y Resilencia en Familias/ Health, Stress, and Resilience in Families), a family-based intervention. SER Familia is a six-session intervention co-developed and delivered by community health workers (CHWs) that uses strategies to reduce acculturative stress, promote resilience, improve parent-child and family level health, while simultaneously helping families maintain strong social networks and better navigate community resources to address social determinants of health (SDOH). More specifically, investigators aim to: 1) Examine the efficacy of SER Familia to prevent or reduce the syndemic comprised of substance abuse, IPV, HIV risk, depression, and anxiety among Parents and Youth; and 2) Identify how individual, family, and community mechanisms of change related to acculturative stress and resilience mediates the effect of SER Familia.

Design

Interventions / Regimen

• Behavioral: SER Familia — SER Familia is a six-session intervention co-developed and delivered by community health workers (CHWs) that uses strategies to reduce acculturative stress, promote resilience, improve parent-child and family level health, while simultaneously helping families maintain strong social networks and better navigate community resources to address social determinants of health (SDOH).

Primary Outcomes

• Change in Parent Acculturative stress as measured by the Hispanic Stress Inventory (HSI-2) Immigrant Version (From Enrollment to end of treatment at 6 weeks)
• Change in Youth Acculturative stress as measured by the Hispanic Stress Inventory - Adolescent (HSI-A) (From Enrollment to end of treatment at 6 weeks)
• Change in individual resilience as measured by the 25-item Resiliency Scale (From Enrollment to end of treatment at 6 weeks)
• Change in PROMIS (Patient-Reported Outcomes Measurement Information System) Global Health (From Enrollment to end of treatment at 6 weeks)

About This Study

Regular exercise during pregnancy and postpartum leads to health benefits for mother and child. Inactivity during pregnancy and after delivery is now treated as risky behavior. Physically active pregnant women significantly less often suffer from, among others, gestational diabetes, excessive weight gain, lipids disorders, hypertension, preeclampsia, depressive symptoms, functional and structural disorders, including stress urinary incontinence, back pain or diastasis recti abdominis (DRA). Prenatal physical activity reduces the risk of premature delivery and miscarriage, fetal macrosomia, complications in labor or the risk of metabolic disorders in children. High-intensity interval training (HIIT) has become one of the most popular trends in the fitness sector. The effectiveness of HIIT on a number of health indicators has been proven in various populations but limited data are available on HIIT during pregnancy. The first hypothesis is that the HIIT, implemented during pregnancy and after childbirth, as a stronger exercise stimulus, will have a better impact on selected biological and psychological parameters of mothers, as well as on selected health parameters of their children, compared to the MICT (moderate intensity continuous training). Therefore, it promises better preventive effects on pregnancy complications and ailments as well as non-communicable diseases occurring in these populations. In the second hypothesis, it was assumed that HIIT and MICT implemented during pregnancy and after childbirth, tailored to the specific needs of the perinatal period, will not differ in the effectiveness of maintaining normal functional parameters in women, including prevention of urinary incontinence, back pain, DRA, etc. Pregnant women who apply for the study will be divided into three groups: those attending the HIIT, MICT or educational programs. During the study, the participants will be under standard obstetric care. As comparative groups, non-pregnant women will be also recruited. The investigators will collect data on selected biological, functional and psychological parameters in the study women at each trimester of pregnancy, during the puerperium and one year after childbirth. The data from the medical documentation on the course of childbirth and the assessment of the new-born, as well as the results of preventive examinations in the study women's children aged one, two, four and six years will be also analyzed.

Design

Interventions / Regimen

• Behavioral: High intensity interval training program for pregnant women — Pregnant women will participate in 8-week HIIT cycles until the day of delivery, 3 times a week, in a volume of each session of 60 minutes. The main part (15-20 min) will be conducted in a form of high intensity intervals, approx. 85-90% of maximum exercise capacity. The intervals will consist of performing exercises for 30-60 seconds, alternating with a 30-60 second rest break, in the ratio of exercise time to rest 1:2, 1:1 or 2:1, according to the individual possibilities of the participant and taking into account the training progression and stage of pregnancy. The exercise intensity will be monitored with the use of heart rate monitors, the Borg Rating of Perceived Exertion (RPE) and the Talk Test. After birth, women will participate in 3-month HIIT cycles from the moment of achieving postpartum readiness to training until one year postpartum. Classes will be carried out stationary or online, depending on the pandemic situation and the availability of the woman.
• Behavioral: Moderate intensity continuous training program for pregnant women — Pregnant women will participate in 8-week MICT cycles until the day of delivery, 3 times a week, in a volume of each session of 60 minutes. The main part (20-25 min) will be conducted in a form of moderate intensity continuous exercise, of 70-80% of the maximum exercise capacity, e.g. in the form of high- and low-impact aerobics choreography with music. The sessions will also include resistance, neuromotor, body posture and flexibility exercises (25 min), breathing exercises, relaxation and visualization of pregnancy or childbirth (10 min). The exercise intensity will be monitored with the use of heart rate monitors, the Borg Rating of Perceived Exertion (RPE) and the Talk Test. After birth, women will participate in 3-month MICT cycles from the moment of achieving postpartum readiness to training until one year postpartum. Classes will be carried out stationary or online, depending on the pandemic situation and the availability of the woman.
• Behavioral: Standard obstetric care with extended education on healthy lifestyle — Pregnant women will get standard obstetric care according to the national law. They will attend educational sessions on a healthy lifestyle, physical activity in the perinatal period and selected aspects of pregnancy and motherhood. Educational classes will be conducted online in real time, at least once every two weeks, until one year postpartum.
• Behavioral: High intensity interval training program for nonpregnant women — Nonpregnant women will participate in 8-week HIIT cycles for a period of 8 months, 3 times a week, in a volume of each session of 60 minutes. The main part (15-20 min) will be conducted in a form of high intensity intervals, approx. 85-90% of maximum exercise capacity. The intervals will consist of performing exercises for 30-60 seconds, alternating with a 30-60 second rest break, in the ratio of exercise time to rest 1:2, 1:1 or 2:1, according to the individual possibilities of the participant and taking into account the training progression. The exercise intensity will be monitored with the use of heart rate monitors, the Borg Rating of Perceived Exertion (RPE) and the Talk Test. For the next 12 months of the project, women will participate in 3-month HIIT cycles. Classes will be carried out stationary or online, depending on the pandemic situation and the availability of the woman.
• Behavioral: Moderate intensity continuous training program for nonpregnant women — Nonpregnant women will participate in 8-week MICT cycles for a period of 8 months, 3 times a week, in a volume of each session of 60 minutes. The main part (20-25 min) will be conducted in a form of moderate continuous intensity exercise, of 70-80% of the maximum exercise capacity, e.g. in the form of high- and low-impact aerobics choreography with music. The sessions will also include resistance, neuromotor, body posture and flexibility exercises (25 min), breathing exercises and relaxation (10 min). The exercise intensity will be monitored with the use of heart rate monitors, the Borg Rating of Perceived Exertion (RPE) and the Talk Test. For the next 12 months of the project, women will participate in 3-month MICT cycles. Classes will be carried out stationary or online, depending on the pandemic situation and the availability of the woman.
• Behavioral: Standard health care with extended education on healthy lifestyle — Nonpregnant women will get standard health care according to the national law. They will attend educational sessions on a healthy lifestyle, physical activity and selected aspects of preparation to pregnancy and motherhood. Classes will be conducted online in real time, at least once every two weeks, for a period of 20 months.

Primary Outcomes

• Changes in maternal oxygen consumption, during and after pregnancy (Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).)
• Changes in maternal heart rate, during and after pregnancy (Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).)
• Changes in systolic blood pressure, during and after pregnancy (Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).)
• Changes in diastolic blood pressure, during and after pregnancy (Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).)
• Changes in blood glucose level, during and after pregnancy (Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).)
• Changes in triglycerides, during and after pregnancy (Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).)
• Changes in high-density lipoproteins, during and after pregnancy (Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).)
• Changes in urea, during and after pregnancy (Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months).)

About This Study

The overarching aim of this pilot study is to assess the feasibility of implementing a psychological intervention (Y-MIND), delivered by school guidance and counselling coordinators, for the treatment of depression among adolescents in senior high schools in Ghana. The study is a parallel arm cluster randomised controlled pilot trial. We will recruit adolescents aged 15 to 18 years in senior high schools. Participants will be randomised to receive the Y-MIND psychological intervention or enhanced usual care.

Design

Interventions / Regimen

• Behavioral: Y-MIND Intervention — All participants in the intervention arm will receive the EUC plus the Y-Mind intervention. Y-Mind intervention will be delivered by trained and supervised Guidance and Counselling Coordinators (GCC) at schools in 6 sessions. The six sessions will include a) psychoeducation on depression, b) behavioural activation (helping the participant see the connection between their behaviour, daily activities, and low mood and activity scheduling) and c) problem-solving therapy (the GCC helps the participant identify and define a specific problem to work on, evaluate the potential solutions to the problem, and carry out the selected solution(s)).
• Other: Enhanced Usual Care — Enhanced Usual Care (EUC): Guidance and counselling coordinators in the schools provide some counselling to students who need it. Building on the existing structure, enhanced usual care in the Y-mind programme, will be enhanced in three ways: 1) Teaching staff will receive basic training on common mental health conditions affecting youth in Ghana with an emphasis on depression and suicidal symptoms and treatment. The WHO guidelines for school health services will form the basis for the training for teachers. 2) Nurses in all schools and other relevant local health care professionals will be trained in mental health, substance-use and self-harm including guidelines on when and where to refer young people for psychiatric care. The World Health Organization (WHO) Mental Health Gap intervention guide (mhGAP) will be used for training of nurses and other health care professionals . 3) The study team will provide a letter for the Guidance and Counselling Coordinators for the participant.

Primary Outcomes

• Feasibility of the intervention (At the end of treatment (week 6) (or at their 5 months post baseline assessment if the treatment sessions were not attended))
• Symptoms of depression (5 months post baseline assessment)

About This Study

Not only being the mainstay of treatment for schizophrenia spectrum psychotic disorders, antipsychotics, especially the second-generation antipsychotics (SGAs) have also been recommended as augmenting agents for treating depression. Dopaminergic agents, including both dopamine D2/D3 antagonists and dopamine partial D2 agonists, have been effective for treating psychosis and schizophrenia. Amongst all SGAs, those with partial D2 agonistic property are generally acknowledged to have better side-effect profiles with lower incidence of extrapyramidal side-effects, prolactin increase, weight gain, QTc prolongation, and metabolic syndrome, as well as more efficacious in alleviating depressive symptoms. Up-to-date, three SGAs, namely aripiprazole, brexpiprazole and cariprazine, are known to possess such partial D2 agonism. ReSD-HK study is part of the ReSD Asian Study aiming to carefully evaluate a cohort of patients prescribed with brexpiprazole on its efficacy and tolerability as treatment for schizophrenia and/or depression in a real-life clinical setting.

Design

Interventions / Regimen

• Drug: Brexpiprazole — Brexpiprazole as treatment for psychosis and schizophrenia, and/or as augmentation treatment for depressive disorders

Primary Outcomes

• Change in Brief Psychiatric Rating Scale-24 in 6 months (6 months)
• Change in Clinical Global Impression in 6 months (6 months)
• Change in Beck Anxiety Inventory in 6 months (6 months)
• Change in Beck Depression Inventory in 6 months (6 months)
• Change in Digital Symbol Substitution Test in 6 months (6 months)
• Change in World Health Organization Disability Assessment Schedule 2.0 in 6 months (6 months)

About This Study

This research will evaluate a new virtual reality (VR) intervention to support youth with depression and anxiety. While VR has shown promise for adult mental health, little is known about its use in youth or routine clinical care. The VR intervention is based on Acceptance and Commitment Therapy (ACT) and immerses young people in fun, engaging environments to teach practical coping skills for managing distress. Clinicians within youth mental health services will use the VR intervention within their routine treatment of young people. The study will evaluate both the preliminary effectiveness of the VR intervention for improving youth mental health, as well as real-world implementation outcomes to understand how it can be successfully adopted in clinical settings. The trial will use a single-group, pre-post design, with treating clinicians delivering the intervention to up to 75 young people seeking treatment for depression and anxiety over a 12-week period. Assessments will be conducted at baseline, immediately after the intervention (12 weeks), and four weeks post-intervention (16 weeks).

Design

Interventions / Regimen

• Behavioral: Third wave VR therapy — All participants in this trial will receive the VR intervention which is adapted from third wave CBT protocols (including mindfulness and Acceptance and Commitment Therapy) and focuses on decentering-the ability to step back and view thoughts and emotions as temporary, objective events rather than identifying with them. Decentering has been linked to improved emotional regulation, reduced rumination, and better psychological flexibility, which in turn can lead to improvements in depression and anxiety symptoms. The intervention is clinician-delivered in a clinical setting, one-on-one, over 4-5 sessions (60 min each) across 10-12 weeks. Each session includes psychoeducation, a 15-minute VR experience, and debriefing. Sessions cover three core techniques targeting improvement in decentering ability: 1) arousal reduction via controlled breathing, 2) sitting with discomfort without reacting, and 3) cognitive defusion by changing perception of negative thoughts.

Primary Outcomes

• Feasibility - recruitment and retention rates (Baseline)
• Acceptability - intervention endorsement (12 weeks post intervention commencement)
• Effectiveness - severity of depression (Baseline, 12 weeks post intervention commencement, 16 week post intervention commencement (follow up))
• Effectiveness - severity of anxiety (Time Frame: Baseline, 12 weeks post intervention commencement, 16 week post intervention commencement (follow up))

About This Study

The investigators aim to evaluate a peer-to-peer patient self-management program targeting symptoms of anxiety and depression in a randomized trial. A total of 234 cancer patients recently having completed primary treatment with curative intent in central Region Denmark will be included. The intervention is a lay-led, group-based transdiagnostic patient education program consisting of seven 2 ½ hour weekly sessions focusing on increasing patient self-efficacy in symptom management of anxiety and depression. The intervention is highly structured and manualized.

Design

Interventions / Regimen

• Behavioral: ADSMP-C — A transdiagnostic, lay-led, group-based self-management program consisting of seven 2 ½ hour weekly sessions focusing on increasing patient self-efficacy in symptom management of anxiety and depression in cancer (ADSMP-C)

Primary Outcomes

• Change in Depressive Symptoms (Baseline and 3 months post-intervention)
• Change in Anxiety Symptoms (Baseline and 3 months post-intervention)

About This Study

This project aims to offer a quantitative and qualitative nutritional approach, along with educational nutritional guidelines for participants with Non-Communicable Chronic Diseases. The main goals are: 1- Regularization of eating habits and windows; 2- Modulation of biochemical, anthropometric, and cardiovascular parameters; 3- Increase in knowledge about healthy eating. In this way, participants will undergo a complete nutritional assessment, comprising anthropometry, biochemistry, clinical, and dietary evaluations.

Design

Interventions / Regimen

• Behavioral: Comparison of eating windows intervention — Participants will be randomized into two groups to follow either a daytime or nighttime eating window, with normocaloric meal plans based on the Mediterranean diet adapted to Brazilian culture. The first intervention phase will last 6 months, followed by a 3-month washout period during which participants return to their usual eating patterns. After the washout, participants will resume the same eating window for an additional 6 months. A final follow-up assessment will be conducted 3 months post-intervention to evaluate the stability of behavioral changes.

Primary Outcomes

• Weight (Kg) (5 assessment points - Month 0 (baseline), Month 6 (end of first intervention phase), Month 9 (end of washout), Month 15 (end of second intervention phase), FOLLOW-UP Month 18.)

About This Study

A total of fifty-five (55) patients with liver cirrhosis will be enrolled in this study to produce and validate dedicated Ga-PSMA-PET/MRI acquisition protocols. The specific hypotheses include: * Ga-PSMA PET/MRI may allow robust and reproducible noninvasive in vivo quantitation of hepatic macro and microhemodynamics in cirrhotic patients * Dedicated simultaneously acquired DWI sequences might quantitate liver fibrosis and improve hemodynamic quantitation. * Ga-PSMA PET/MRI may allow noninvasive and reproducible quantitation of portal venous hypertension and predict its evolution, as well as response to treatments * Ga-PSMA PET/MRI may improve noninvasive and reproducible qualitative and quantitative assessment of liver function, structure, nodules and predict evolution of cirrhosis

Design

Interventions / Regimen

• Drug: Injection of a gadolinium contrast agen — All patients will be requested to have an injection of a gadolinium contrast agent, which may be either Gadavist (Bayer, Whippany, NJ, USA), Eovist (Bayer, Whippany, NJ, USA), or Dotarem (Guerbet, Princeton, NJ, USA) (ancillary drugs). * About halfway through the examination, the same intravenous catheter used to inject the radiotracer will be used to inject the MRI contrast agent; * After being positioned on the PET/MRI table, the nuclear medicine technicians will connect the patient to the MRI-safe power-injector; - The catheter will be flushed before and after injection with 0.9% saline solution;
• Drug: Radiotracer Injection — All patients will be requested to have a radiotracer injection of Ga-PSMA (Illucix, Telix Pharmaceuticals). An intravenous catheter will be placed in an arm or hand vein for injection of the Ga-PSMA; * The catheter will be flushed post-injection with 0.9% saline solution * The injected dose and the time of injection will be recorded. * The subjects will be positioned on the scanner table; support devices under the back and/or legs will be used to enable the patient to comfortably maintain his/her position throughout the scan
• Diagnostic Test: Imaging — PET, MRI and fused PET/MRI images will be qualitatively assessed in comparison to standard of reference data. For PET, standard of reference will be PET images as obtained by standard PET acquisition mode. Attenuation correction of the PET images will be performed using a 2-point Dixon MRI sequence and a vendor-specific atlas-based attenuation map. 3D scatter correction by single scatter simulation is also performed using the MRI-derived attenuation data. MRI images will be compared to dedicated 3 Tesla MR upper abdominal protocol images acquired at the MGH in patients with liver cirrhosis, including those undergoing imaging follow-up after systemic or local regional therapies. For PET/MRI fused images, the standard of reference will be co-registered and fused PET/MRI images as obtained by standard MRI sequences/reconstructions.

Primary Outcomes

• Assessment of LI-RADS with Ga-PSMA-PET/MRI (1-2 Months)

About This Study

This study will compare two approaches for managing hypertension in Black patients with uncontrolled blood pressure (BP). One approach will include home BP telemonitoring supported by a pharmacist and a community health worker. The other approach will include usual clinic-based care along with a home BP monitor and routine care.

Design

Interventions / Regimen

• Behavioral: RHYTHM (Remote Hypertension Tracking Help Management) — Home blood pressure telemonitoring with remote medication management by a centralized multidisciplinary team led by a pharmacist; and social support, lifestyle education and connection to community resources to address social needs, provided by a community health worker who is embedded with the centralized team and is tightly connected to community resources and partners
• Behavioral: Enhanced usual care (UC) — All participating sites will receive training on appropriate blood pressure measurement and education on guideline-based hypertension therapy. Additionally, participants in usual care will receive a standardized packet with evidence-based hypertension education material and a blood pressure monitor to complete blood pressure measurements at home.

Primary Outcomes

• Blood pressure control - Percent of patients achieving BP control (i.e., Systolic BP<130mmHg) - Month 12 (Month 12)

About This Study

Insomnia is a common sleep disorder characterized by difficulty falling asleep, staying asleep, or both, despite appropriate opportunities for getting sleep. Growing evidence has associated insomnia with prevalent and incidence of hypertension. However, the impact of the pharmacologic treatment of insomnia on office blood pressure (BP) and 24-h ambulatory BP monitoring (ABPM) in unclear. Therefore, the aim of this study is to evaluate the impact of eszopiclone, a non-benzodiazepine hypnotic that binds to certain subunits of the gamma-aminobutyric acid type A receptors GABA-A (such as α1, α3, and α5) promoting relaxation and sleep. Eszopiclone is an FDA-approved treatment for insomnia in those who have difficulty falling asleep and for patients with difficulty staying asleep (sleep maintenance).

Design

Interventions / Regimen

• Drug: Eszopiclone 3 mg — Eszopiclone is an FDA-approved treatment for insomnia in those who have difficulty falling asleep and for patients with difficulty staying asleep (sleep maintenance).
• Drug: Placebo — Placebo pills identical to the active comparator.

Primary Outcomes

• Efficacy of insomnia treatment on blood pressure (evaluated by Ambulatory blood pressure monitoring) (3 months)

About This Study

Antenatal nonstress tests (NSTs) are performed to assess fetal health and are used as a cost-effective test that can be widely administered. However, an NST is operator-dependent due to the nature of Doppler ultrasound and is primarily performed in a clinic and hospital setting. The ability to conduct a clinically valuable test at home would address access to care issues faced by numerous women in the United States and reduce the workload on healthcare clinicians facing a shortage of human resources. This pilot study aims to assess the feasibility and acceptability of home NST monitoring in order to determine whether femomTM could be utilized as an adjunct to routine prenatal care. Patients with high risk pregnancies who are recommended to undergo at least once weekly at 32 weeks testing by the obstetrician will be recruited for participation in this study. Participants will be asked to perform three 30 minute monitoring sessions weekly starting at 32 weeks for 6 weeks.

Design

Interventions / Regimen

• Device: Fetal ECG monitoring — Patients will wear a fetal ECG monitor which they will place on their abdomen

Primary Outcomes

• Percent of sessions completed (6 weeks)
• Percentage of interpretable sessions (6 weeks)

About This Study

Patients with liver cirrhosis often have impaired or at-risk kidney function due to the close link between liver and kidney (hepatorenal syndrome). Laparoscopic splenectomy is commonly used to treat splenomegaly and hypersplenism in these patients, but its impact on kidney function over 2 years is unclear. This study will follow patients undergoing laparoscopic splenectomy to measure changes in kidney function before and after surgery, identify risk factors for kidney damage and whether laparoscopic splenectomy can improve kidney function in the long term, and help improve care to protect kidney function in cirrhotic patients .

Design

Primary Outcomes

• Serum creatinine (Scr) level (at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24)
• Glomerular filtration rate (eGFR) (at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24)

About This Study

The goal of this clinical trial is to learn whether semaglutide, an FDA-approved treatment for diabetes and obesity, is feasible and tolerable in patients with advanced lung disease. The main question\[s\] it aims to answer are: 1. Are patients with advanced lung disease able to tolerate semaglutide therapy? 2. Are we able to titrate semaglutide therapy to a target weight? Participants will be asked to perform pulmonary function, physical function and body composition testing, as well as a blood draw before and after 12-weeks of semaglutide therapy. While on therapy, subjects will be surveyed regarding any adverse events or side effects.

Design

Interventions / Regimen

• Drug: Semaglutide Pen Injector — Once weekly subcutaneous injection

Primary Outcomes

• Tolerability (12 weeks)

About This Study

Analysis of the circulating levels of placenta-derived HLA-DR+ extracellular vesicles in the first, second and third trimester of pregnancy of women with high and low risk to develop preeclampsia.

Design

Interventions / Regimen

• Other: Blood samples for inflammatory markers — Blood sampling in the first, second, trimester of pregnancy

Primary Outcomes

• Levels of circulating HLA-DR+ extracellular vesicles (During the first trimester of pregnancy (11-13 weeks +6 days of gestational age), the second trimester (19-22 weeks of gestation) and the third trimester (28-32 weeks of gestation) of pregnancy)