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NCT ID: NCT06145555 Enrolling by invitation - Depression Clinical Trials

Acute Psychological Sleep Stabilisation for Patients Hospitalised With Depression

Start date: April 15, 2024
Phase: N/A
Study type: Interventional

Disturbed sleep occurs in almost all patients in psychiatric inpatient care, and although it is well known that comorbid sleep disorders in depression often persist after treatment of depression and also increase the risk of new depressive episodes, the availability of effective, evidence-based treatments for sleep disorders in hospitalised patients is very limited. The overall goal of the current project is to translate, adapt and evaluate an acute psychological sleep treatment based on cognitive behavioural therapy for insomnia (CBT-I) for patients hospitalized with depression and comorbid sleep problems in the specialized psychiatric inpatient care in the Stockholm Region. The main hypothesis for the study is that acute psychological sleep stabilization (APS) reduces self-reported sleep complains compared to care as usual reinforced with sleep hygiene advice, and secondary hypotheses are that APS also leads to reduced depressive symptoms and earlier discharge. The project includes a pilot study, which will be followed by a randomized, controlled trial of APS compared to care as usual with structured sleep hygiene (minimal active control) and treatment effect is evaluated every three days during the hospital stay and 1,2,4 and 12 weeks after randomization. APS will be performed by existing staff in the department with the support of a psychologist.

NCT ID: NCT06145490 Not yet recruiting - Healthy Clinical Trials

Neurobehavioral Correlates of Caffeine on Anxiety, Avoidance and Interoception in Healthy Individuals and Panic Disorder.

BINCAP
Start date: August 2024
Phase: N/A
Study type: Interventional

The current study is a placebo-controlled, double-blind, randomized controlled study using a cross-over design, including Healthy Controls (HC) and participants with Panic Disorder (PD). The primary aim of the study is to investigate the neural correlates and behavioral effects of caffeine (versus placebo), and its impact on emotional reactivity, decision-making, and interoception, and compare the effects in individuals with PD vs HCs. Subjective anxiety and the occurrence of panic attacks will also be measured. Multimodal neuroimaging methods, such as structural and functional MRI, will be used to address the aims of the study. Emotional reactivity, emotional decision-making and interoception will be measured with experimental tasks in a 7 Tesla (7T) magnetic resonance (MR) scanner, jointly with measures of skin conductance, heart rate, respiratory rate, and self-reported ratings of anxiety and interoception. Emotional reactivity will be assessed using emotional and neutral faces. Emotional decision-making will be assessed with an approach-avoidance conflict task. Changes in interoception (bodily sensation, such as pulse and respiration) will be explored using a task in which participants are asked to focus on their breathing or an external stimulus. Caffeine effects on brain resting-state activity will also be assessed. All tasks will be conducted while in the 7T MR scanner. A secondary aim of the study is to examine the impact of genetic variability in the adenosine A2A receptor (ADORA2A) genotype (e.g., rs5751876 T/T) on the effects of caffeine (vs placebo), as ADORA2A genotype has previously been associated with elevated caffeine-induced anxiety.

NCT ID: NCT06145152 Recruiting - Clinical trials for Physical Performance

Adaptive Training Recommendations for Improved Physical Performance

ELLIDA
Start date: December 5, 2023
Phase: Phase 1
Study type: Interventional

In this study two different training strategies are compared; one is adaptive where the training is adjusted up or down on a daily basis to better match the recovery status (readiness) of the subject. The other strategy is static, i.e. no changes are made depending on readiness level. Instead the subjects in the static group are encouraged to perform the prescribed training. The training intervention will last for 8 weeks. Thorough physiological tests will be performed pre and post the training intervention together with muscle biopsies for assessment of mitochondrial function.

NCT ID: NCT06143891 Recruiting - Clinical trials for Chronic Graft Versus Host Disease

A Study to Test an Oral Medicine, Belumosudil, in Combination With Corticosteroids in Participants at Least 12 Years of Age With Newly Diagnosed Chronic Graft Versus Host Disease.

ROCKnrol-1
Start date: January 23, 2024
Phase: Phase 3
Study type: Interventional

This is a parallel, Phase 3, two-arm study for the treatment of newly diagnosed moderate or severe chronic GVHD. The study duration for a participant includes up to 4 weeks for screening; a treatment period until clinically meaningful cGVHD progression (defined as progression requiring addition of new systemic treatment for cGVHD), relapse/recurrence of the underlying disease, participant starts new systemic treatment for cGVHD or experiences an unacceptable toxicity, at the request of the participants or the investigators, or until the end of study is reached, whichever comes first; at least 30 days follow-up of adverse events (AEs) after the last dose until resolution or stabilization, if applicable; and long-term follow-up until death or study close-out, whichever comes first.

NCT ID: NCT06142565 Active, not recruiting - Hyposmia Clinical Trials

Treatment of Postviral Olfactory Dysfunction

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

A decreased sense of smell (hyposmia) is often caused by viral infections, such as COVID-19. Today, the only recommended treatment for hyposmia is olfactory training, a time consuming method with limitations in terms of both compliance and effect. The aim of this study is therefore to evaluate, as well as optimize, a new treatment method for olfactory loss. Hyposmic participants will be recruited and randomized into two different treatment conditions. One group will do regular olfactory training and the other will do passive olfactory training with scented nose plugs. The training will be conducted in the home of the individual monday through friday for two consecutive months. Subjective and objectvie measures of olfactory problems will be assessed before and after treatment, as well as subjective measures related to quality of live and genereal wellbeing.

NCT ID: NCT06142084 Recruiting - Ileostomy - Stoma Clinical Trials

Digestibility of Different Plant-based Proteins in Humans With Ileostomy

PAN-Prodig
Start date: April 2024
Phase: N/A
Study type: Interventional

The goal of this interventional study is to learn about the digestibility of different plant-based proteins in adults (age 18-75) with an ileostomy. The main questions the study aims to answer are: 1. How does the digestibility of proteins in the small intestine differ between different plant-based proteins? 2. Which proteins and amino acids are not digested or absorbed in the small intestine and are available for further metabolic processes in the large intestine? 3. How do metabolites in the collected content of the ileostomy bag differ after consuming different plant-based proteins? 4. Can the in vivo results be compared to results from existing in vitro models? Participants will consume five different protein meals (oat protein - high bioavailable, oat protein - low bioavailable, pea protein - high bioavailable, pea protein low bioavailable, protein-free meal) on five different study days in a random order. Five hours after consuming the test meals ileostomy bags will be collected and the content will be analysed to answer the above mentioned research questions.

NCT ID: NCT06141070 Not yet recruiting - Clinical trials for Non Small Cell Lung Cancer

Addition of Hypofractionated High Dose Radiation in Oligometastatic Disease

ANDROMEDA
Start date: December 1, 2023
Phase: Phase 3
Study type: Interventional

This is a 2:1 randomized multicentre open label phase III study of radiation combined with standard systemic treatment compared with systemic treatment alone in oligometastatic (≤5 metastases) NSCLC. Stratification factors: performance status, gender and systemic strategy. The systemic treatment consists of chemotherapy/chemoimmunotherapy or immunotherapy and is given according to local practice. During the first 3 months of systemic treatment, aiming to start around the 2nd cycle is radiotherapy delivered to all known lesions. Preferably with SBRT /SRT/SRS but conventional radiotherapy may also be used. After the first three cycles of systemic treatment, the patients are assessed, and after four cycles, they are continuing maintenance therapy if indicated. The patients are followed with radiology every three months.

NCT ID: NCT06140914 Recruiting - Heart Failure Clinical Trials

Biological Mechanisms Behind Resynchronization Therapy in Heart Failure

Start date: March 15, 2023
Phase:
Study type: Observational

Heart failure is a common disease, affecting 2-3% of the population in the western world. About 30% of patients with heart failure and reduced ejection fraction display signs of electrical dyssynchrony on ECG, usually left bundle branch block (LBBB), which is associated with a worse prognosis. Cardiac resynchronization therapy (CRT) reduce mortality for patients with dyssynchronic heart failure, defined as ejection fraction (EF) = or < 35% and LBBB. About 1/3 of the patients that fit CRT criteria will not respond to CRT. Which patients that will turn out to be non-responders cannot be anticipated beforehand. We have started a clinical study to collect blood samples, heart tissue and clinical data from heart failure patients eligible for CRT and a control group of heart failure patients on medical therapy. Patients will be assessed before CRT implantation or early after initiation of medical treatment, at 3 months, 6 months and 12 months. Blood samples and tissue will be analysed in the search for (i) biomarkers to separate CRT responders from non-responders and (ii) mechanisms behind the remodelling observed in CRT and with medical therapy.

NCT ID: NCT06140147 Recruiting - Septic Shock Clinical Trials

Protocolized Reduction of Non-resuscitation Fluids Versus Usual Care in Septic Shock Patients

REDUSE
Start date: November 27, 2023
Phase: N/A
Study type: Interventional

The objective of this trial is to assess the beneficial and harmful effects of a restrictive strategy for administration of non-resuscitation fluids in adult patients with septic shock.

NCT ID: NCT06138678 Recruiting - Depression Clinical Trials

VGR Accelerated TMS Treatment for Depression

VAiT
Start date: January 1, 2024
Phase: N/A
Study type: Interventional

Intermittent theta burst stimulation (iTBS), a variant of repetitive transcranial magnetic stimulation (rTMS), is a well documented method for treatment of depression. The aim of the study is to assess the effect of an accelerated iTBS protocol compared to a routine iTBS protocol. In the accelerated protocol patients will receive 1200 pulses per session (2 sessions per day, 15 treatment days) and in the routine protocol patients will receive 600 pulses per session (1 session per day, 30 treatment days). Participants (n = 146) will be recruited among patients referred to iTBS and randomized to treatment. Participants will be assessed by a psychiatrist, or a resident psychiatrist, prior to treatment to assure that they fulfill all inclusion criteria and non of the exclusion criteria. A psychiatrist, or a resident psychiatrist, will assess depressive symptoms 3 and 6 weeks after first day of treatment. Patients will complete self-rating questionnaires during screening, weekly for 6 weeks starting from the first day of treatment, and 6 months after end of treatment.