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NCT ID: NCT05056415 Recruiting - Autism Clinical Trials

Effect and Cost-effectiveness of the Everyday Life Rehabilitation Intervention

Start date: September 15, 2021
Phase: N/A
Study type: Interventional

The person-centered, motivational, recovery-, and activity-based intervention model 'Everyday Life Rehabilitation´ (ELR), integrated in sheltered and supported housing facilities for people with severe psychiatric disabilities, has shown significant outcomes in feasibility studies, and thus a RCT is required, for the purpose of establishing the effectiveness and cost-effectiveness of ELR. All municipalities within 270 kilometers from Umeå will be invited. Residents who meet the inclusion criteria, will be invited to participate. Housing-units, with associated residents giving consent, will be randomized to either receive intervention with ELR plus treatment as usual (TAU), or TAU alone for control group. Hence, the present study is a cluster RCT. The control group will, after control-period, be offered ELR. Professionals involved in the ELR intervention group; that is occupational therapists, housing staff and housing managers, will receive an educational package. It is hypothesized that the intervention-group will improve in personal and social recovery as well as quality of life. The primary outcome is recovering quality of life assessed by ReCoL, and secondary outcomes are self-perceived recovery, everyday functioning, and goal-attainment at 6 months, assessed using RAS-DS, and GAS, respectively. ReQoL will be transformed into QALY´s for calculation of cost-effectiveness. The study has an adaptive design, including an internal pilot year one, in order to determine required sample sizes before continuing with the full scale RCT year two.

NCT ID: NCT05056324 Not yet recruiting - Clinical trials for Acute Vestibular Syndrome

Web-based Rehab After Acute Vertigo

Start date: September 2021
Phase: N/A
Study type: Interventional

Acute onset vertigo is common and entails much suffering with persisting symptoms at 3 months after onset in up to half of those afflicted. Vestibular rehabilitation to aid recovery is not readily available. The purpose of this study is to investigate the effects on vertigo symptoms of a 6-week online vestibular rehabilitation tool compared with standard care (written instructions leaflet) after acute onset vertigo.

NCT ID: NCT05052385 Recruiting - Clinical trials for Steroid Refractory GVHD

ECP Combination Study

Start date: April 13, 2021
Study type: Observational

Extracorporeal photopheresis (ECP) offers an alternative to standard immunosuppression and shows an immunomodulatory rather than an immunosuppressive effect, which is associated with less toxicities and side effects. Additionally ECP has been shown to allow tapering of steroids and immunosuppressant agents which should be a goal of GvHD therapy. ECP has been used for the management of GvHD since first described in 1994 and as its use has continued over the decades. The treatment was incorporated into a number of guidelines as a second line therapy in steroid refractory or steroid dependent GvHD patients. As well as being used in addition and after steroids, it is also used in combination with CNI Inhibitors, MMF and other immunosuppressant agents. However, despite the current widespread use of ECP in the treatment of patients with GvHD, clinical data from randomized studies is limited and small prospective and retrospective trials are the main evidence base .This is also the case for other commonly used immunosuppressant agents, which have been used in GvHD since ECP was introduced. The systematic review concluded that ECP is an effective therapy for oral, skin, and liver SR-cGVHD, with modest activity in lung and gastrointestinal SR-cGVHD. In the USA Ibrutinib is the only FDA approved agent for second line cGvHD therapy once steroid therapy has failed and Ruxolitinib had been approved in the USA for the treatment of steroid refractory GvHD. While studies have shown the effectiveness and safety of ECP in GvHD treatment, there is limited data to show how it is being used in combination with the recently approved agents. Using existing registry data targeting centres where the newer agents are being used and enhancing the capture of treatment data we believe we can undertake a larger scale study, which will include the new treatment protocols. The aim of the current study is to improve the evidence basis on the potential benefit of ECP use as treatment of GVHD.

NCT ID: NCT05052086 Recruiting - Rectal Cancer Clinical Trials

Magnetomotoric Ultrasound (MMUS) in Rectal Cancer

Start date: October 1, 2021
Phase: N/A
Study type: Interventional

Magnetomotoric ultrasound, combines conventional ultrasound with a time-varying magnetic field. The aim is to improve diagnosis of mesolectal lymph nodes.

NCT ID: NCT05051137 Completed - Clinical trials for Rheumatoid Arthritis

Real-World Emulation of the SWEFOT Trial

Start date: January 12, 2006
Study type: Observational

This study will compare rheumatoid arthritis (RA) patients who have been treated in clinical practice with either infliximab or a combination of sulfasalazine and hydroxychloroquine, after having an active disease despite treatment with methotrexate for at least one month. To establish which patients respond to treatment, DAS28-ESR measurements (disease activity score using 28 joints and erythrocyte sedimentation rate) taken at treatment start and nine months thereafter, and the EULAR (European League Against Rheumatism) definition of a "good response" will be employed. The purpose of the study is to verify if the same conclusion could be reached using data from patients treated in real world clinical practice as in a previous randomized controlled trial comparing the two treatment strategies (SWEFOT -- Identifier: NCT00764725). Inclusion criteria similar to the ones used in the emulated trial will be applied. In real clinical practice, patients who receive infliximab may have more severe RA and may also differ in other ways from patients receiving sulfasalazine and hydroxychloroquine. To be able to compare the proportions of responders under each treatment in this "real-world" setting, the data will be re-weighted, so that patient characteristics become balanced between treatment groups.

NCT ID: NCT05050994 Recruiting - Portal Hypertension Clinical Trials

Ultrasound Guided Microwave Ablation of Splenomegaly in Children

Start date: March 1, 2021
Phase: N/A
Study type: Interventional

Children with liver cirrhosis frequently develops portal hypertension. One of the serious complications to portal hypertension is splenomegaly, which may result in pancytopenia, especially thrombocytopenia that may cause bleeding tendencies. Symptomatic splenomegaly is often treated with partial splenic embolization (PSE). PSE is effective but may give rise to postembolization syndrome not well tolerated in the pediatric population. In adults, microwave ablation (MWA) has been used to treat splenomegaly with promising results but with less post-operative pain. Our study is a pilot trial to evaluate the feasibility and acceptability of this treatment in children.

NCT ID: NCT05050565 Not yet recruiting - Chronic Pain Clinical Trials

Psychological Flexibility in Chronic Pain Populations; an Observation- and Validation Study

Start date: September 22, 2021
Study type: Observational

Chronic pain in general is a substantial problem and is a source of a great deal of disability and suffering. We know that processes like stigma and psychological flexibility (PF) play a significant role in these outcomes. At the same time, there are many specific chronic pain disorders and we know less about similarities and differences between these specific conditions, whether the role of processes like these vary between conditions or not. For studies that can address this to be done in Sweden, there will need to be adequately translated and validated measures of the key processes identified. The main aim of the current study is to look at whether the role of PF and stigma in pain-related outcomes differ across pain conditions. In support of that, a secondary aim is to first validate measures of stigma and PF in chronic pain populations. For this secondary aim, the current study seeks to investigate the factor structure, construct - and criterion validity, internal consistency, and test-retest reliability of a Swedish version of the Multidimensional Psychological Flexibility Inventory (MPFI) as well as of a Swedish version of the Stigma Scale for Chronic Illnesses (SSCI-8).

NCT ID: NCT05049798 Recruiting - Clinical trials for Arthritis, Psoriatic

A Study of Guselkumab and Interleukin-17 (IL-17) Inhibitor Therapies in Participants With Psoriatic Arthritis in Routine Clinical Practice

Start date: August 25, 2021
Study type: Observational

The purpose of this study is to evaluate treatment persistence with guselkumab and interleukin-17 inhibitor (IL-17i) initiated at enrollment into this study (PsABIOnd).

NCT ID: NCT05049239 Recruiting - ADHD Clinical Trials

Structured Physical Training With and Without Cognitive Support for Adults With ADHD

Start date: February 15, 2021
Phase: N/A
Study type: Interventional

Studies in children and adolescents with Attention-Deficit-Hyperactivity-Disorder (ADHD) have shown that physical exercise can improve the core symptoms of ADHD; inattention and hyperactivity. For adults, the evidence is deficient and there is a great need to investigate whether adults have the same effect on ADHD symptoms of physical exercise, as children and young people have. Adults with ADHD often have a sedentary lifestyle and suffer from obesity and have sleep problems. In a normal population, these problems have been shown to be affectable with physical exercise. START (Support in Activity, Movement and Exercise) is a randomized controlled intervention study where physical exercise is given for 12 weeks, with or without cognitive support. The effect is measured with rating scales as well as cognitive and physical tests. The purpose is to investigate whether START works as a treatment for ADHD in terms of ADHD symptoms and disability, and what impact the intervention has on mental health, physical condition and activity level, body awareness and everyday functioning. Outcome measures are registered within 3 weeks before and after the end of treatment, after 6 months and 12 months. The randomization takes place in three groups; physical exercise (i), physical exercise and extra cognitive support (ii), and control group on waiting list (iii).

NCT ID: NCT05049161 Recruiting - Multiple Sclerosis Clinical Trials

A Long-term Extension of Study GNC-401

Start date: August 27, 2021
Phase: Phase 2
Study type: Interventional

This Phase II study is a monocenter, long-term extension study of study GNC-401 and will start after individual completion of Week 48 of the GNC-401 study. At entry, all patients will receive active treatment with temelimab. The patients of the placebo group in study GNC-401 will be re-randomized to temelimab 18 mg/kg, 36 mg/kg or 54 mg/kg (1:1:1), while the patients who received temelimab in study GNC-401 will continue with the same dose in study GNC-402.