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NCT ID: NCT04116138 Completed - Glioblastoma Clinical Trials

Antisecretory Factor in Primary Glioblastoma 1

AFGBM1
Start date: September 1, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

This is a non-randomised, open-label, single center-centre, Phase I-II study in patients with newly diagnosed glioblastoma. 5 patients with newly diagnosed glioblastoma are enrolled in the study and will receive an egg powder enriched for antisecretory factor (AF), Salovum, daily from 2 days before concomitant radio-chemo therapy until 14 days after finalisation.The primary aim of the study is to asses safety and feasibility of this regimen.

NCT ID: NCT04115969 Completed - Clinical trials for Respiratory Insufficiency

Outcome After Non-invasive Ventilation.

Start date: October 4, 2019
Phase:
Study type: Observational

The study is an exploratory retrospective observational study with the aim to describe outcome fo the cohort of patients that receive non-invasive ventilation at an intensive care unit. Main research questions are: - Characteristics of the cohort. - The course for the patients at the ICU. - ICU-mortality and 30-day mortality - Amount of patients with limitations of care. - Factors associated with mortality.

NCT ID: NCT04114864 Completed - Clinical trials for Mental Health Wellness 1

A Primary Prevention Intervention for the Promotion of Psycho-social Wellbeing in Adolescent Young Carers:

ME-WE
Start date: October 20, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

Adolescent young carers (AYCs) are young people aged 15-17 years old, who take on significant or substantial caring tasks and assume a level of responsibility that would usually be associated with an adult. In Europe, the estimated prevalence rate of YCs is around 4-8%.Taking on care responsibilities so early in life may have considerable negative consequences for YCs' mental and physical health and psychosocial development. Psychosocial interventions to support YC worldwide are generally quite limited. The H2020 Me-We project (Psychosocial Support for Promoting Mental Health and Well-being among Adolescent Young Carers in Europe) aims to develop an innovative framework of primary prevention interventions for adolescent YCs (AYCs) aged 15-17 to be tested in six European countries (Italy, Netherlands, Slovenia, Sweden, Switzerland, United Kingdom). The theoretical framework chosen for the intervention is the DNA-V Model. The DNA-V model is a psychological intervention, addressed to adolescents and young people, used in educational and clinical settings. This model has its roots in the contextual and functional science and it is based on Acceptance and Commitment Therapy, a third-generation cognitive-behavioural therapy. The intervention programme designed for the ME-WE project builds on the DNA-V model but it was adapted to fit the specific needs of adolescent young carers (AYCs) and the goals of the ME-WE project. The study aim is to evaluate the efficacy of DNA-V based program for AYCs (so-called ME-WE intervention), using a cluster-randomized controlled trial (C-RCT) design. The evaluation of the intervention will be carried out using as primary outcome variables: Psychological flexibility; Mindfulness skills; Resilience; Subjective mental health; Quality of life; Subjective health complaints; Caring-related quality of life; Cognitive and emotional impact of caring and Social support. As secondary outcome variables will be included Self-reported school, training or work experience, performance, and attendance. COVID-19 Amendment: Recruitment, should be moved to a cluster- based online recruitment or individual, social media recruitment, face-to-face sessions should be moved to online sessions using video-conferencing instruments, allowing for visual presentations of participants and session materials (e.g. ZOOM, Microsoft Teams). Four open-ended items were added to evaluation questionnaire assessing impact of COVID-19 pandemic.

NCT ID: NCT04108689 Completed - Mental Health Clinical Trials

Internet-based Acceptance and Commitment Training for Elite Ice Hockey Players

Start date: September 9, 2019
Phase: N/A
Study type: Interventional

The aim of this study is to investigate whether an internet-based psychological training program will enhance performance and affect mental health related factors in elite ice hockey players. The psychological training program is based on Acceptance and Commitment Therapy (ACT), a modern form of Cognitive Behavior Therapy, and is delivered over the internet (hence called "I-ACT"). Elite players in Sweden will be invited before the 2019/2020 season. I-ACT will start for enrolled participants during the first week of October 2019 (30th September- 2nd October depending on the schedule of the particular league; approximately 5 games have then been played in the leagues eligible for participation). I-ACT consists of seven weekly modules/chapters with ACT content and participants also have a psychological trainer in the program that they can contact via a chat function on the web platform. Participants will have completed I-ACT the 17th of November 2019. When I-ACT starts in October, other eligible players will have the opportunity to leave their notice of interest for participation in the study and to take part of I-ACT in a later stage of the season. This concurrent "waiting list" is not a waiting list control group in any sense. It only gives further eligible players the opportunity to enroll in the study for a consecutive start of the psychological training program. I-ACT will start for this second group of players during the last week in november (25th November 2019), and finish I-ACT the 12th January 2020. These two consecutive groups of I-ACT participants will be considered the experimental group. However, due to the length of the ice hockey season the second group will only have follow-up measurements at 1 month for female players (the women's league ends in February 2020) and 2 months for male players (the men's leagues ends in March 2020). Official statistics will be collected from the leagues and enrolled participants will be compared to non-participant players in the leagues to compare the effectiveness of I-ACT on ice hockey performance. Only within-group comparisons will be made for secondary outcome measures.

NCT ID: NCT04102995 Completed - Menstrual Migraine Clinical Trials

A Study Investigating the Efficacy and Safety of Sepranolone in Women With Menstrual Migraine

APH204
Start date: August 27, 2019
Phase: Phase 2
Study type: Interventional

The objective of this phase 2 Proof.of Concept study is to evaluate the efficacy and safety of Sepranolone (UC1010) in preventing menstrual migraine attacks in adult women with migraine occurring between Day -2 and Day 5 of the menstrual cycle. Patients will be taking Sepranolone or Placebo (blinded to patient and study doctor) during the two week preceding the menstruation for three menstrual cycles. Effect (change from baseline) will be assessed by comparison of symptoms recorded daily by the patients using an electronic diary using validated scales for assessment of menstual migraine symptoms. Sepranolone is identical to an endogenous steroid.

NCT ID: NCT04101942 Completed - Clinical trials for Post Traumatic Stress Disorder

An Internet-delivered Cognitive-behavioral Intervention Provided Soon After Trauma: a RCT

Start date: February 28, 2019
Phase: N/A
Study type: Interventional

The primary objective with this study is to investigate the short-term efficacy (primary endpoint at week 3) of Internet-delivered cognitive behavior therapy (ICBT) provided soon after trauma. The secondary objective is to investigate the long-term efficacy (primary endpoint at week 7) of ICBT. 100 participants recently exposed to a potentially traumatic event will be randomised to either ICBT or assessment only.

NCT ID: NCT04101799 Completed - Parenting Clinical Trials

Evaluation of the Parental Support Intervention For Our Children's Sake in Prisons in Sweden

Start date: September 21, 2019
Phase: N/A
Study type: Interventional

Evaluation of the effects of the parental support intervention "For our children's sake" on positive parenting outcomes when conducted with incarcerated parents in prisons in Sweden.

NCT ID: NCT04101227 Completed - Clinical trials for Alcohol Use Disorder

Study to Evaluate AD04 in Adults With Alcohol Use Disorder (AUD) and Selected Serotonin Transporter Polymorphisms

ONWARD
Start date: February 1, 2020
Phase: Phase 3
Study type: Interventional

Randomized, multi-center, double-blind, parallel-group, placebo-controlled study. Eligible subjects will be randomized to receive either 0.33 mg AD04 or placebo orally twice-daily for 24 weeks in conjunction with brief psychological counseling. Randomization will be stratified by: 1. Level of alcohol consumption prior to enrollment in the study (heavy drinkers averaging <10 drinks per day of drinking or very heavy drinkers averaging ≥10 drinks per day of drinking), and 2. Gender (male or female).

NCT ID: NCT04098731 Completed - Fibromyalgia Clinical Trials

Evaluation of Respiratory Function in Fibromyalgia

Start date: June 28, 2018
Phase:
Study type: Observational

This study will evaluate respiratory function in people with fibromyalgia and whether or not breathing patterns in this patient group can be explained by stress, emotional or biomechanical variables. In addition, examine the relationship between physical ability and lactate values.

NCT ID: NCT04094922 Completed - Clinical trials for Posttraumatic Stress

PTSD Coach Sweden: Evaluating a Self-help Mobile App for Posttraumatic Stress in a Community Sample

Start date: May 8, 2019
Phase: N/A
Study type: Interventional

Individuals who experience potentially traumatic events might develop long-lasting mental health problems. Limitations to health care resources, particularly in the context of mass disasters, indicate that self-help interventions could serve as important complementary offers to people in need. The aim of this study is to evaluate whether the Swedish version of the Swedish version of the PTSD Coach self-help smartphone application can reduce levels of posttraumatic stress and related difficulties. The study is a randomized controlled trial in which participants' levels of posttraumatic stress and related difficulties after three months use of PTSD Coach will be compared to a waitlist condition. Additionally, in order to better understand the interplay between app use and health status, participants in both groups will receive text messages in which they are asked to respond to a small number of very brief questions about specific behaviors and current health status for three weeks during the intervention period.