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NCT ID: NCT04244630 Recruiting - Clinical trials for Amyotrophic Lateral Sclerosis (ALS)

Mitochondrial Capacity Boost in ALS (MICABO-ALS) Trial

MICABO-ALS
Start date: April 1, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this research is to investigate the validity of a previous clinical trial named EH301, which showed beneficial effects of anti-oxidant therapies in patients with amyotrophic lateral sclerosis (ALS). If validated by this study, providing over-the-counter anti-oxidants would be a simple, low risk, low-cost approach to significantly slow or stop the progression of ALS, for which currently no effective treatment exists. It is currently thought that oxidative stress is a major cause of ALS. The study investigators are therefore planning to expand the original scope of the previous trial by including anti-oxidants at high doses that were not previously used. All of these compounds are considered safe.

NCT ID: NCT04281329 Recruiting - Atrial Fibrillation Clinical Trials

Contribution of Computed Tomography and Cardiac-MRI in Atrial Fibrillation Ablation

CTStrain-AF
Start date: April 1, 2022
Phase:
Study type: Observational

Atrial fibrillation ablation (AF) is a standard interventional treatment for patients with symptomatic AF refractory to medical treatment. The known predictive factors for the success of the procedure remain insufficient to predict the probabilities of success and to appropriately select the patients who could benefit the most from this procedure. Left atrium imaging by MRI or CT may be able to identify AF substrate. However data are lacking about the practical impact of these techniques in routine practice to predict AF ablation outcome. The "CT-AF" study is a prospective, interventional, multicenter cohort study. The main objective of this study is to evaluate the prognostic value of a new automated measurement technique for intra-myocardial atrial fat measurement in cardiac CT and the measurement of global left atrial strain in MRI in patients who are candidates for first AF ablation. The main outcome will be the relationship between the relative volume of left atrial fat measured with CT and total left atrial strain in MRI and recurrence of AF at 1 year after the ablation procedure (blanking period of 3 months post ablation excluded).

NCT ID: NCT04289740 Recruiting - Emotional Disorder Clinical Trials

Transdiagnostic Group Cognitive Behavioral Therapy (PsicAP-A) for Adolescents With Emotional Disorders

PsicAP-A
Start date: April 1, 2022
Phase: N/A
Study type: Interventional

Emotional disorders such as anxiety and depression are highly prevalent during adolescence and associated with functional impairment that commonly extends into adulthood. In the primary care (PC) setting, these disorders are frequently underdiagnosed and undertreated. Objective: To carry out a prospective, randomized controlled trial (RCT) to test the efficacy of a new transdiagnostic cognitive behavioural group therapy (TD-CBT) protocol for adolescents (age 12 to 18 years) compared to group relaxation therapy (RT). Methods: Two-arm, single-blind, RCT (expected N=160) to compare group TD-CBT for emotional disorders to group RT. The group TD-CBT will be administered in seven sessions (90 min/session) over 12 weeks. Psychological assessments will be carried out at baseline, post-treatment, and at months 3, 6, and 12 after treatment. The assessments will include measures of depression, anxiety, somatization, quality of life, disability, and cognitive-emotional factors. The study will be conducted in two PC centres located in Cantabria, Spain. Discussion: This is the first RCT to evaluate the efficacy of group TD-CBT for emotional disorders in adolescents in the PC setting in Spain. If, as expected, the results confirm the superiority of TD-CBT to conventional RT, the widespread implementation of this new approach-based on scientific evidence obtained in a real-world, primary care setting-could improve treatment outcomes and quality of life in adolescents suffering from anxiety or depression.

NCT ID: NCT04378439 Recruiting - HIV/AIDS Clinical Trials

Appalachian Partnership to Reduce Disparities (Aim 2)

Start date: April 1, 2022
Phase: N/A
Study type: Interventional

By combining two strategies (i.e., peer navigation and mHealth) into a complete, culturally compatible, bilingual intervention to increase the use of needed HIV, STI, and HCV prevention and care services among racially/ethnically diverse GBMSM and transgender women in rural Appalachia. Study Investigators anticipate that participants in the intervention group, relative to counterparts in the delayed-intervention group, will demonstrate increased HIV, STI, and HCV testing.

NCT ID: NCT04404972 Recruiting - Brain Death Clinical Trials

Incidence of Complications of Brain Death

Start date: April 1, 2022
Phase:
Study type: Observational

The purpose of the study is to describe the incidence of complications in brain death adult organ donors.

NCT ID: NCT04441879 Recruiting - Clinical trials for Postpartum Depression

bBeAMom: Effectiveness of a Cognitive-Behavioral Blended Intervention for Postpartum Depression

bBeAMom
Start date: April 1, 2022
Phase: N/A
Study type: Interventional

Be a mom program (a web-based cognitive-behavioral intervention) is being tested in another clinical trial as a preventive intervention for postpartum depression (NCT03024645). However, given its effectiveness in reducing depressive symptoms among women presenting early-onset postpartum depressive symptoms, Be a Mom can also have potential as a postpartum depression complement treatment tool. The main goal of this research is to apply and evaluate the acceptability and effectiveness of a blended cognitive-behavioral intervention for the treatment of postpartum depression (Be a Mom Coping with Depression) by integrating face-to-face sessions with the web-based program Be a Mom. The RCT will be a two-arm trial. Women who have had a child during the prior 12 months will be enrolled in the study. A minimum number of 110 women will be enrolled in the study. After agreeing to participate in the study, women will be screened and evaluated for the presence of clinically significant depressive symptoms (according to DSM-5) by a researcher (licensed psychologist). Participants who meet the eligibility criteria will be randomly assigned to one of the conditions: the blended intervention (Be a Mom Coping with Depression) or the control condition (online intervention - Be a Mom). The sample will be recruited online. Participation in this study will last 6 months. The blended intervention will last about 3 months. Participants in both conditions will be invited by the researchers via email to complete baseline, post-intervention and follow-up (3-months post-intervention) assessments. Assessments will include self-report questionnaires to assess several indicators (e.g., depressive and anxiety symptoms, quality of life, marital satisfaction, mother-child bonding, and maternal self-efficacy), mechanisms that may be involved in the treatment response (e.g., psychological flexibility, emotional regulation, and self-compassion) and user's acceptability and satisfaction.

NCT ID: NCT04536103 Recruiting - Osteoarthritis Clinical Trials

Multi-Vendor Multi-Site Novel Accelerated MRI Relaxometry

MVMS_MRI
Start date: April 1, 2022
Phase:
Study type: Observational

Currently the diagnosis of OA is based on radiographs and clinical findings, which is limited to detecting late-stage disease. There is a pressing, unmet clinical need for robust assessment of early changes in cartilage health. Towards this goal, extensive efforts are ongoing to develop quantitative MRI for cartilage matrix analysis. MR T1ρ and T2 relaxation times have shown to be promising imaging biomarkers for early cartilage degeneration and prediction of disease progression. However, many challenges remain to clinically applying these techniques, including lack of standardized acquisition and quantification methods, and long acquisition times. The study aims to develop novel, fast and reproducible MR T1ρ and T2 relaxation time imaging methods on MR systems from multiple vendors and establish a platform for standardization and cross validation of these measures as a tool for clinical trials using such techniques. Following method validation, patients at risk for osteoarthritis will be tested.

NCT ID: NCT04555785 Recruiting - Bleeding Clinical Trials

Enhancement of the Haemostatic Effect of Platelets in the Presence of High Normal Concentrations of Von Willebrand Factor

Will-Plate
Start date: April 1, 2022
Phase: Phase 4
Study type: Interventional

Assessment of high-normal dosage of Wilate ® compared to placebo administered in combination with platelets to assess reduction of amount of blood loss, need of transfusion products and outcome (length of stay, mortality) in patients with bleeding in comparison.

NCT ID: NCT04605913 Recruiting - Pancreas Cancer Clinical Trials

Nab-Paclitaxel + Cisplatin + Gemcitabine + TTF in pt. w/ Metastatic PAC

Start date: April 1, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase I/Ib trial, single-center, non-randomized, open-label study of Protein-bound Paclitaxel, Cisplatin, And Gemcitabine (GCN) Combined with Tumor Treatment Fields (TTF) and G+TTF maintenance therapy in patients with metastatic pancreatic cancer.

NCT ID: NCT04645719 Recruiting - Analgesia Clinical Trials

Dose of Magnesium Sulfate Infusion in Obese

Start date: April 1, 2022
Phase: Phase 3
Study type: Interventional

Magnesium sulfate has been shown to be a successful tool in a large number of clinical areas. Its benefits include neuroprotection, control of eclampsia / pre-eclampsia, control of intraoperative blood pressure, decreased neuroendocrine response during laryngoscopy and tracheal intubation and reduced levels of postoperative pain and consumption of analgesic. Obese patients have become more and more frequent in the operating rooms, due to the increasing prevalence of this population worldwide. However, although they have received magnesium sulfate as part of the analgesic strategy in many centers, there has been no study demonstrating the appropriate dose of this medication in obese patients. This study aims to compare two doses of magnesium sulfate in obese patients: based on their real weight or based on ideal weight.