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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: NCT04114851 Recruiting - Anesthesia Clinical Trials

The Effects of Objective Estimation of Pain Response

Start date: November 30, 2019
Phase: N/A
Study type: Interventional

There are different types of pain generators that give different pain symptoms. In anesthesia and surgery, the pain generator in connection with, for example, surgical procedures is referred to as nociceptive pain. However, there is not enough evidence to support that these physiological changes are direct signs of nociceptive stimulation. The same changes can be seen with an autonomous stress trigger of origin other than just nociceptive stimulation. This means that healthcare professionals who provide anesthesia to patients during, for example, surgery may provide unnecessary pain relief drugs or do not provide pain relief when needed. This is also true in awake patients when pain is complex that, for example, concerns may increase the experience of pain and that healthcare professionals may even then misinterpret and provide more pain-relieving drugs despite the actual need for another drug or complementary treatment. Examples of these include heart rate variation, specific patterns in blood pressure and heart rate response, heart rate amplitude, heart rate range, skin sweating and pupil response. The reason why these changes have not been used to interpret nociceptive stimulation is directly linked to an absence of technology that makes it possible to collect data and interpret these changes. list a number of methods / techniques that are under development, one of which is the Nociception Level Index (NoL). NoL is an indexed value between 0 and 100 and is based on a non-linear combination of nociception-related physiological variables (including heart rate variation, plethysmograph pulse wave amplitude (PPGA) and changes in skin resistance). Possibly NoL is the first evidence-based clinical technology that can discriminate pain response when physiological response is not measured. The research field in the area of non-invasive objective monitoring of pain response in relation to patients' experience of pain is currently almost non-existent in anesthesia / anesthesia care This in turn can also lead to the development of patient safety both during anesthesia and after surgery at nursing department for example, patient-controlled and epidural pain relief in postoperative pain care. investigators intend to study the variation of the NoL index linked to the need for opioids during anesthesia and also after completed anesthesia when the patient wakes up and is in the ward.

NCT ID: NCT04114825 Active, not recruiting - Clinical trials for Prostate Cancer Recurrent

Study of RV001V in Biochemical Failure Following Curatively Intended Therapy For Localized Prostate Cancer

BRaVac
Start date: November 19, 2019
Phase: Phase 2
Study type: Interventional

This Phase II trial will enroll approximately 180 adult male patients with an earlier histologic diagnosis of prostatic adenocarcinoma and a biochemical recurrence (BCR) within 3 years of radical prostatectomy (RP) or definitive RT and no distant metastasis or locoregional recurrence. The trial is a randomized placebo-controlled double-blind study of a peptide cancer vaccine (RV001V).

NCT ID: NCT04114747 Recruiting - Blood Pressure Clinical Trials

Renal Physiology During Continuous Renal Replacement Therapy

Start date: November 20, 2020
Phase: N/A
Study type: Interventional

Approximately 50% of patients in the intensive care unit (ICU) develop acute kidney injury (AKI) and more than 10% need dialysis. There is no treatment for AKI. Care is aiming for optimization of circulation and blood flow to the kidneys and avoiding nephrotoxic agents. There is conflicting data concerning whether early or late dialysis is harmful for the kidneys. No one has examined the physiological changes in the kidney when starting dialysis and which blood pressure that leads to most optimal physiological conditions for the kidneys during dialysis. In this descriptive study of 20 ICU patients suffering from AKI we aim to investigate renal physiology when starting continuous renal replacement therapy (CRRT) and also at different target blood pressures using retrograde renal vein thermodilution technique. In parallel we will also investigate and validate this invasive method with contrast enhanced ultrasound of the kidneys.

NCT ID: NCT04114149 Recruiting - Pain, Postoperative Clinical Trials

Effective Postoperative Pain Relief After Laparoscopic Cholecystectomy With TENS

Start date: March 19, 2019
Phase: N/A
Study type: Interventional

The study evaluates the effect of TENS (transcutaneous electrical nerve stimulation) treatment for first line of treatment compared with conventional treatment with opioids on pain relief and time spent time in the post-anesthesia care unit after laparoscopic cholecystectomy. Half of the patients are randomized to TENS as first line of treatment and the second half is randomized to conventional opioid treatment. Patients who does not report postoperative pain which requires treatment are used as controls.

NCT ID: NCT04109677 Active, not recruiting - Clinical trials for Sports Physical Therapy

AIM CONTROL and SWECON - Handball The SWEdish CONcussion Study in Elite Handball

Start date: September 25, 2019
Phase:
Study type: Observational

Handball is reported to be top 5 in Europe when it comes to sports injuries. There are few studies based on player reported data, and earlier Swedish data is mainly based on data from Insurance ´companies and mostly acute injuries. Earlier data lack the overuse injuries and number of injuries are taught to be underreported. This epidemiological study has the objective to create research based knowledge about the injury panorama within Swedish handball with special interest in head-injuries in the elite level. By using a mobile application "AIM Control", a retrospective weekly registration of handball related injuries was recorded together with self-assessed injury impact. Also data about sports/exercise exposure, other causes that could affect the players ability to practice/play matches, self-rated recovery before next practice/match as well as positive and negative affects will be analyzed. Special emphasis is given to self-reported head injuries and the symptoms that the player might experience during the handball season 2019/2020. Data about symptom severity will be collected and analyzed together with AIM Controls other variables i.e. duration of symptoms and time to return-to-play. In case of a head-injury the Medical support team is contacted in order to describe the event, and interviewed with standardized questions about their thinking and action about how head injuries should be managed and prognosis of time to recovery and how to decide when a player is ready to play again? This is part of the AIM Control study called SWECON - handball.

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.