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NCT ID: NCT06187220 Not yet recruiting - Acute Liver Failure Clinical Trials

Plasma Exchange for Amanita Toxin-induced Acute Liver Failure

Amanita-Pex
Start date: January 2024
Phase:
Study type: Observational

Retrospective evaluation of the value of additive therapeutic plasma exchange (PEX) compared to standard medical therapy (SMT) in Amanita toxin-associated acute liver failure in children and adolescents within the last 10 years at a international group of liver transplant centers.

NCT ID: NCT06123442 Not yet recruiting - Clinical trials for Reduction in Mental Health and Suicide Are the Focus of Interest

Cognitive Resilience Intervention as a Recovery Therapy for Mental Health

CRI
Start date: February 13, 2024
Phase: N/A
Study type: Interventional

The goal of this randomized controlled trial (RCT) is to develop and test a cognitive resilience intervention (CRI) among selected students who are having problems with anxiety, depression, and suicidal thoughts (psychological distress comorbid with suicidal episodes [PDSE]) and to see if it can help lower PDSE among the students who were enrolled. This study will assess the feasibility and acceptability of a CRI among students dealing with anxiety, depression, and suicidal thoughts (psychological distress comorbid with suicidal episodes [PDSE]) and determine if it is effective at reducing PDSE among the sampled students using psychological assessment tools. Participants will be exposed to CRI in the experimental group and psychoeducation in the control group. Researchers will compare the experimental group with the control group and infer the difference between these groups both at the pretest and posttest phases, as well as ascertain the feasibility and acceptability of this therapy among selected participants.

NCT ID: NCT06118281 Not yet recruiting - Cardiovascular Risk Clinical Trials

ARTEMIS - A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With a Heart Attack

ARTEMIS
Start date: June 25, 2024
Phase: Phase 3
Study type: Interventional

The research study is being done to see if ziltivekimab can be used to treat people who were admitted to hospital because of a heart attack. Ziltivekimab might reduce development of heart disease, thereby preventing new heart attacks or strokes. Participants will either get ziltivekimab (active medicine) or placebo (a dummy medicine which has no effect on the body). Which treatment participants get is decided by chance. The chance of getting ziltivekimab or placebo is the same. Ziltivekimab is not yet approved in any country or region in the world. It is a new medicine that doctors cannot prescribe. The study will last for about 2 years.

NCT ID: NCT06079359 Not yet recruiting - Hypophosphatasia Clinical Trials

Phase 3 Study of ALXN1850 in Treatment-Naïve Pediatric Participants With HPP

MULBERRY
Start date: March 1, 2024
Phase: Phase 3
Study type: Interventional

The primary purpose of this study is to evaluate the efficacy of ALXN1850 versus placebo on radiographic outcomes in pediatric participants with HPP who have not previously been treated with asfotase alfa.

NCT ID: NCT06019247 Not yet recruiting - Clinical trials for Severe Mental Disorder

Individual Placement and Support Mexico

IPS
Start date: August 2023
Phase: N/A
Study type: Interventional

There is substantial data to suggest that the Individual Placement and Support (IPS) model, a the investigatorsll-known, evidence-based practice, can help people with mental illness (PSMI) succeed in competitive employment (i.e., on average 55%, but over 60% in credible studies). Hothe investigatorsver, not a single country in Latin America offers IPS services. In addition, services to support employment and education tend to be ad hoc, low-intensity, and not the investigatorsll evaluated because most clinicians are not trained in evidence-based practices. Clinicians are not trained in evidence-based approaches and do not provide high-fidelity services. The overall goal of this project is to pilot the IPS for PSMI in the Center for Comprehensive Care in Long-Stay Mental Health (CAISAME-EB, in Spanish), the largest mental health clinic in Jalisco, Mexico. CAISAME-EB integrates primary care and provides medication and psychosocial rehabilitation services to a large population of PSMI (n=~5,000). This team serves marginalized communities similar to other urban areas in low- and middle-income countries (LMICs) in Latin America and elsewhere. The investigators will use the Dynamic Adaptation Process model to first inform the adaptation of IPS in Mexico, using our previous experience adapting IPS and deep understanding of the local context (e.g., the nature of the labor market in Mexico) to inform the adaptations. The investigators will then evaluate the implementation and impact of the adapted IPS in a pilot RCT (N = 120). This pilot RCT will Include quantitative and qualitative assessments at baseline, 6 months, and 12 months with clients, providers, and other key stakeholders. The investigators aim to refine implementation processes, understand outcomes and tools, and estimate pothe investigatorsr for a future regional trial in Latin America.

NCT ID: NCT05997212 Not yet recruiting - Clinical trials for Alcohol Use Disorder

Effect of Repetitive TMS on Executive Function in Alcohol Use Disorder

Start date: September 1, 2023
Phase: N/A
Study type: Interventional

Alcohol Use Disorder (AUD) is a major public health problem that affects the physical, social, family, and mental integrity of the sufferer. Behavioral self-regulation is compromised in AUD, and a benefit has been reported with the application of repetitive transcranial magnetic stimulation and emotional self-regulation. The aim of this study is to investigate the efficacy of high-frequency rTMS to improve executive functions in patients in abstinence from AUD.

NCT ID: NCT05995522 Not yet recruiting - Clinical trials for Overweight and Obesity

Effect of Vitamin K2 Over Osteocalcin, Leptin, Cytokines, and Cardiovascular Risk in Young Adults With Overweight and Obesity

Start date: September 1, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare de effect of vitamin K2 in young adults with overweight or obesity. The main questions to answer are: What is the effect of Vitamin K2 supplementation on methylation, serum concentration of ucOC, cOC, Gas6, leptin, inflammatory markers, cardiometabolic risk factors, and cardiovascular risk in overweight or obese young adults? Participants will be assigned to one of two intervention groups where they will consume Vitamin K2 100 µg per day or cornstarch 500 mg per day for 90 days. If there is a comparison group: Investigators will compare the supplementation group (Vitamin K2) with the placebo group (cornstarch) to see if vitamin K2 supplementation modifies methylation, increases serum vitamin K, osteocalcin, growth arrest-specific 6 protein serum concentration, decreases serum leptin concentration, inflammatory markers and reduces cardiometabolic risk factors and cardiovascular risk.

NCT ID: NCT05979311 Not yet recruiting - HIV Infections Clinical Trials

A Study to Evaluate the Efficacy, Safety, and Tolerability of Using an Oral Once-daily 2 Drug Regimen Compared to an Oral Once-daily 3 Drug Regimen for the Treatment of Human Immunodeficiency Virus (HIV)-1 in Adults Who Have Not Previously Taken Antiretroviral Therapy

VOGUE
Start date: December 29, 2023
Phase: Phase 3
Study type: Interventional

This study will compare safety, efficacy, participant reported outcomes and implementation outcomes of a fixed dose combination (FDC) of a two-drug regimen dolutegravir (DTG) plus lamivudine (3TC) and a three-drug regimen FDC of bictegravir (BIC), emtricitabine (FTC) and tenofovir alafenamide (TAF) in HIV-1 infected adult participants who have not previously received antiretroviral therapy.

NCT ID: NCT05945862 Not yet recruiting - Clinical trials for Diabetes Mellitus, Type 2

Healthy Lifestyle Promotion Program in Communities From the Yaqui Valley

NUTRIGANDO
Start date: July 17, 2023
Phase: N/A
Study type: Interventional

The aim is to evaluate the change in indicators of lifestyle and its effect on cardiometabolic biomarkers as a response to an integrative mother-child intervention to promote healthy lifestyles and prevent food insecurity and child malnutrition in vulnerable communities in the Yaqui Valley, Sonora, Mexico. The intervention consists in a program including nutrition education and physical activity training, with a total duration of 6 months. The proposal addresses the problem in an integrative and non-conventional way, generating new multifactorial knowledge of cardiometabolic and behavioral markers, and their relationship with each other, helping to reduce family food insecurity and improving lifestyle and health, and to support vulnerable families in achieving social justice in the field of nutrition.

NCT ID: NCT05926349 Not yet recruiting - Urgent Surgery Clinical Trials

A Study of Andexanet Alfa in Patients Requiring Urgent Surgery or Procedure

ANNEXA-RS
Start date: October 20, 2023
Phase: Phase 3
Study type: Interventional

The study will aim to find out if the drug andexanet alfa is safe and effective in preventing major bleeding during urgent surgery or invasive procedures. The study will compare the use of andexanet alfa to the usual care given at the study center.