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NCT ID: NCT04030169 Completed - PTSD Clinical Trials

Open Label Study of MDMA-assisted Psychotherapy for Treatment of PTSD With Optional fMRI Sub-Study

Start date: June 24, 2020
Phase: Phase 2
Study type: Interventional

This open-label, lead-in Phase 2 study is intended to gather supportive data on the safety and effectiveness of manualized MDMA-assisted psychotherapy as a treatment for PTSD. This will be the first study of MDMA-assisted psychotherapy in Europe using the CAPS-5 as a primary outcome measure to confirm assumptions made for statistical power calculations using the Clinician-Administered PTSD Scale for DSM-4 (CAPS-4) which support planned Phase 3 clinical trials. This study will gather supportive data on the safety and effectiveness of manualized MDMA-assisted psychotherapy as a treatment for PTSD and provide clinical supervision to planned Phase 3 therapy teams. This study will also be the first multi-site study of MDMA-assisted psychotherapy for PTSD in Europe and will explore reproducibility of findings from FDA-regulated trials in a multi-site format to further confirm the Phase 3 study design. This study will compare the effects of two open-label manualized Experimental Sessions of psychotherapy assisted by flexible doses of MDMA. Initial doses per Experimental Session include 80 mg or 120 mg of MDMA compounded with lactose, followed 1.5 to 2 hours later by a supplemental half-dose (40 mg or 60 mg). Total amounts of MDMA to be administered per Experimental Session range from 80 mg to 180 mg.

NCT ID: NCT04028596 Completed - Depression Clinical Trials

Measuring Blood Flow in the Brain After Epileptic Activity

SYNAPSE
Start date: December 5, 2019
Phase: Phase 2
Study type: Interventional

In this clinical trial, postictal phenomena (i.e., headache, delirium) will be investigated after administration of acetaminophen and nimodipine in depressed patients receiving electroconvulsive therapy (ECT). Postictal phenomena are thought to result from decreased cerebral blood flow and decreased oxygen concentration in the brain. It is expected that acetaminophen and nimodipine will reduce these postictal phenomena, compared to no treatment, because they target these mechanisms.

NCT ID: NCT04027530 Completed - Clinical trials for Type 2 Diabetes Mellitus

Renal Oxygenation, Oxygen Consumption and Hemodynamic Kinetics in Type 2 DIabetes: an Ertugliflozin Study.

ROCKIES
Start date: December 10, 2020
Phase: Phase 4
Study type: Interventional

Current study will render insight in to the role of renal hypoxia in the diabetic kidney and is able to associate its finding with measurements of renal perfusion and glomerular filtration rate. Moreover, this research will focus on the effects of sodium-glucose cotransporter 2 inhibition on renal tissue oxygenation and oxygen consumption as well as a change in intrarenal hemodynamics and perfusion, and a shift of fuel metabolites. Elucidation the mechanisms underlying the effects of SGLT2 inhibition will advance our knowledge and contribute to their optimal clinical utilization in the treatment of chronic kidney disease in diabetes and possibly beyond.

NCT ID: NCT04026113 Completed - Clinical trials for Functional Constipation

Linaclotide Safety and Efficacy in Pediatric Participants, 6 to 17 Years of Age, With Irritable Bowel Syndrome With Constipation (IBS-C) or Functional Constipation (FC)

LINZESS
Start date: October 1, 2019
Phase: Phase 3
Study type: Interventional

The objective of LIN-MD-64 is to evaluate the safety and efficacy of 12 weeks of linaclotide therapy (72 μg daily) in comparison with placebo in pediatric participants, 6 to 17 years of age, who fulfill modified Rome III Criteria for Child/Adolescent Functional Constipation (FC). The objective of LIN-MD-64 is to evaluate the safety and efficacy of 12 weeks of linaclotide therapy (145 μg or 290 μg daily) in pediatric participants, 7 to 17 years of age, who fulfill the Rome III criteria for child/adolescent Irritable Bowel Syndrome (IBS) and modified Rome III criteria for child/adolescent Functional Constipation (FC).

NCT ID: NCT04026061 Completed - Dementia Clinical Trials

Pilot Study Person-centred Tablet Intervention

Start date: October 31, 2017
Phase: N/A
Study type: Interventional

First evaluation of FindMyApps, a tablet intervention consisting of a selection tool for usable apps for self-management and meaningful activities and a training that supports informal carers to help people with dementia to learn how to use the tablet and the tool.

NCT ID: NCT04024371 Completed - Depression Clinical Trials

Validating Reward-related Biomarkers (RTOC)

RTOC
Start date: September 16, 2019
Phase:
Study type: Observational

Deficits or abnormalities in reward processing are present in a number of psychiatric disorders. The overarching objective of the study is to conduct initial validation work towards optimising three experimental tasks - which have previously been shown to be sensitive to reward processing deficits - for future use in clinical trials. This initial validation work has the primary objective to uncover group differences in task outcome measures between healthy control participants, participants with Major Depressive Disorder (MDD) and participants with schizophrenia (SZ) using statistical analyses. This may provide some indications for the use of these tasks as clinically-relevant biomarkers. Primary aims include: (i) comparing the investigator's endpoint means and distributions to those in previously published data; (ii) replication of previously-reported differences between MDD/SZ vs. healthy control participants, and, (iii) exploring the relationship between task endpoints and subjective participant- and clinician-rated report of reward-related constructs (e.g. anhedonia, negative symptoms).

NCT ID: NCT04024228 Completed - Healthy Volunteers Clinical Trials

Study to Assess the Immune Response and the Safety Profile of a High-Dose Quadrivalent Influenza Vaccine (QIV-HD) Compared to a Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) in Europeans Adults 60 Years of Age and Older

Start date: October 28, 2019
Phase: Phase 3
Study type: Interventional

Primary Objective: To demonstrate that high-dose quadrivalent influenza vaccine (QIV-HD) induces an immune response that is superior to the responses induced by standard-dose quadrivalent influenza vaccine (QIV-SD) for all 4 virus strains 28 days post-vaccination in participants 60 to 64 years of age and in participants 65 years of age and older. Secondary Objective: - Immunogenicity: To further describe the immune response induced by QIV-HD and QIV-SD in all participants by age group, in pooled age groups, and by vaccine group (QIV-HD; QIV-SD). - Safety: To describe the safety profile of all participants by age group, in pooled age groups, and by vaccine group (QIV-HD; QIV-SD).

NCT ID: NCT04021784 Completed - Clinical trials for Neuromuscular Scoliosis

Limited-efficacy Testing of SDS and NEMOST for Early Onset Neuromuscular Scoliosis

BiPOWR
Start date: May 6, 2019
Phase: N/A
Study type: Interventional

The primary aim of this study is to investigate and describe the limited efficacy of the Spring Distraction System (SDS) and Bilateral One Way Rod (NEMOST) in maintaining curve reduction without repeat lengthening procedures and complications. Secondary aims are to describe growth of the instrumented spine, health-related quality of life, and to compare both devices.

NCT ID: NCT04019808 Completed - Gastric Cancer Clinical Trials

Gastric Cancer Risk Factors Knowledge in European and Latinamerican Population

LEGACY-3
Start date: July 30, 2019
Phase:
Study type: Observational

This study is divided into two parts: Part 1: An interventional study, with a pre-post study design to determinate the grade of knowledge of established GC risk factors. Part 2: An observational study to know impact on prevalence and infection eradication of H. pylori

NCT ID: NCT04019730 Completed - Clinical trials for Upper Respiratory Tract Infections

The Effect of a Ketogenic Diet on the Exercise Induced Immune Response

Start date: October 10, 2018
Phase: N/A
Study type: Interventional

comparing the exercise induced immune response after two weeks on a low carbohydrate (ketogenic) diet with the response after two weeks on a high carbohydrate diet.