The research can, for example, be about evaluating diagnostic techniques or the use of established medicines. Another purpose can be to improve existing therapy procedures, or to develop and evaluate new therapy methods.
Clinical studies are usually divided up into intervention studies and observation studies. In intervention studies, study participants are exposed to some kind of intervention, for example a medicine, a medical device, a diet, or a surgical method. In observation studies, the study participants are observed without any influence from the researcher.
Examples of research that we fund
Glaucoma affects around 80 million people all around the world, and is the most common cause of incurable blindness. What causes glaucoma is not fully known. The only therapy that works is to lower the pressure in the eye, but even after such therapy the sight of many patients continues to deteriorate. Just over 40 per cent become blind in one eye.
New findings have shown that patients with glaucoma have a reduced concentration of nicotinamide – a variant of vitamin B – in their blood, and that a short therapy with nicotinamide can restore some sight function. Studies have also shown that metabolic changes in the nerve cells of the retina can be part of the cause of the disease. Our research team has recently tested food supplements with nicotinamide in animal models. The nicotinamide has shown itself to delay the degrading metabolic processes, and thereby protect the optic nerve.
In this project, we want to test the food supplement on humans in a national, randomised controlled clinical study. By looking for signs of disease in blood samples, we can study how the metabolism differs between individuals with and without nicotinamide therapy. At the same time, we can study what effects the therapy has on the patients’ quality of life.
Overall, the project aims to find a new, effective, and cost-effective therapy for glaucoma. Nicotinamide is an inexpensive, effective medicine with few side effects. If the outcome is positive, the therapy can quickly be converted into clinical procedure.
Project name: The Swedish Glaucoma Nicotinamide Trial (SGNT)
Project leader: Gauti Jóhannesson, Associate Professor at the Department of Clinical Science, Umeå University
Read about the project in the Swecris database
External link.
More than a quarter of patients with schizophrenia do not get better with the therapy on offer today. Others get better, but are plagued by side effects of the medicines prescribed. Many die early. Persons with schizophrenia also have raised morbidity from physical diseases, in particular immunological ones. Traditionally, immunological diseases are associated with physical disease, but in recent year a link between auto-immunity, inflammation, and psychosis symptoms has been shown in several studies, including one conducted by our research team.
We have conducted an ‘open pilot study’ where we investigated whether severely ill patients with schizophrenia improved in their psychosis disease and feel better if they receive supplements of the medicine rituximab. This is an inflammation inhibitor used for MS and rheumatoid arthritis. Rituximab represents an entirely new effect mechanism for treating psychoses, and has not been tried for psychiatric disease previously, which makes our study ground-breaking.
As we have seen very good results, we now want to continue with a placebo-controlled study of 104 patients with schizophrenia and other closely related psychosis diseases. The treatment will be given in a drip on one occasion, and the patients can return home the same day. Serious side effects can occur, but are extremely rare. The patients will continue with their regular psychiatric therapy during the study.
In total, we will be monitoring the patients for 6 months and investigate the psychiatric symptoms, any side effects, and signs of inflammation. After 12 weeks, we will evaluate the effect.
If the therapy turns out to be effective, it will in all probability revolutionise the understanding and therapy recommendations for a severely affected patient group.
Project leader: Susanne Bejerot, Professor of Psychiatry, Örebro University, Senior Consultant, Region Örebro
Project name: A double blinded randomized controlled trial with rituximab – immunomodulatory treatment of Schizophrenia spectrum disorder in adults
Read about the project in the Swecris database External link.
Allergen-specific immune therapy is the only therapy that improves the allergic symptoms acutely, and at the same time reduces symptoms for a long time after the end of the cure.
The immune therapy is given for at least three years, either as a subcutaneous* injection in the arm every 6–8 weeks, or in the form of a tablet under the tongue taken daily. But these therapy types have their limitations. The injections must be given at specific allergy clinics, and the patients who get tablets sometimes forget to take them. Nor do all patients respond to the therapy.
A new type of therapy against grass pollen allergy has now been developed, which entails three ultrasound-led injections being given straight into a lymph gland in the groin at 4-week intervals. The dose is 100 times lower than the injection in the arm.
In studies on animals, a supplement of vitamin D together with the therapy in tablet form has proved to produce good effects on the immune defence system. The purpose of our project is to investigate whether vitamin D in conjunction with the new therapy form where injections are given into a lymph gland can provide improved therapy results. In parallel, we will be implementing the first comparative study between immunotherapy in tablet form and immune therapy in the form of injections into the lymph gland, and looking for ‘bio-markers’ that can predict which patients will respond to the therapy.
We will be recruiting 360 adult patients with grass pollen allergy. 240 of them will be selected randomly to be treated either with the new therapy form plus a supplement of vitamin D, or with the new therapy form plus placebo. The remaining 120 patients will be given immunotherapy in tablet form for three years.
A successful outcome can open the door to easily accessible and effective treatment of grass pollen allergy.
* A subcutaneous injection injects the medicine into the fat layer under the skin. The active substance is absorbed into the blood and spreads to the location where it will work.
Project leader: Lars-Olaf Cardell, Professor and Senior Consultant in ear, nose and throat diseases, Karolinska Institutet
Project name: Intralymphatic allergen specific immunotherapy (ILIT) empowered by vitamin D - a novel approach to allergy vaccination
Read about the project in the Swecris database External link.
In Sweden, around 9 000 women become ill with breast cancer every year, a figure that has increased steadily since the 1990s. The prognosis for breast cancer has improved, however, and more and more women can be cured with a combination of surgery, radiation, and medical treatment.
It has become ever more common for patients with early breast cancer to receive medical treatment before they are operated on. An advantage of reversing the traditional order, where surgery always came first, is that the tumours shrink, and the subsequent surgery is not so major. If there then are no remaining living cancer cells in the tissue operated on, this means that it has been possible to cure the breast cancer using medicine.
There are plenty of studies indicating that physical exercise plays an important role in the body’s defence against tumours. Exercise activates the immune defence system, counteracts tiredness, and reduces common side effects of chemotherapy medicines.
In our study, we will be investigating whether physical exercise during chemotherapy given before surgery can lead to more patients being cured of their breast cancer through medical therapy.
The study includes 712 patients, where half are selected randomly to receive an intensive exercise programme monitored by physiotherapists, while the other half only receive routine instructions on the benefits of physical exercise. After surgery, we compare how many were cured of their cancer already before the operation, what side effects they had from the chemotherapy treatment, and any differences in quality of life and muscle strength. We will thereafter be monitoring the patients’ health for two years.
If we manage to show that physical exercise has the potential to improve the effectiveness of chemotherapy before surgery for breast cancer, this will have an enormous impact also on the treatment of other types of cancer.
Project leader: Jana de Boniface, Associate Professor and Senior Consultant, Karolinska Institutet
Project name: Physical exercise during neoadjuvant chemotherapy for breast cancer as a means to increase pathological complete response rates: the randomized Neo-ACT trial
Read about the project in the Swecris database External link.
Most of those who regain their heart rhythm following cardiac arrest are unconscious to begin with, and in need of advanced intensive care. Preliminary studies have suggested that brain damage can be counteracted if the body temperature is lowered. Such a temperature change is created with the help of coolsuits or via a tube in a blood vessel.
The treatment entails both risks and costs, at the same time as there is no proof that it actually works. There is also great variation between countries and hospitals whether and how the therapy is used, and which patients receive it.
Another practice that is commonly used when treating patients with cardiac arrest in intensive care is to prolong the anaesthesia. This is done both to facilitate the temperature regulation of the body, but also because there is data indicating that the anaesthesia in itself can protect the brain. However, anaesthesia can have side effects.
There is no research into whether it is good for the patients to prevent a fever using advanced temperature regulation, or prolonged anaesthesia. This is what we now want to investigate.
If the therapies are of no benefit, the patients are unnecessarily exposed to side effects and prolonged intensive care treatment. If they are beneficial, on the other hand, then it is important to produce strong proof that increases the use across the entire world.
Our study will involve 3 100 patients. In Sweden, at least 8 regions will be participating. To reach a sufficient number of patients within a reasonable time, we will also be collaborating with hospitals in other countries.
Project leader: Niklas Nielsen, Associate Professor and Senior Consultant, Lund University
Project name: Targeted fever management versus no temperature management and sedation versus early awakening after cardiac arrest. A 2x2 factorial randomized clinical trial
Read about the project in the Swecris database External link.
Research review of the field
Every four years, we produce a research review for clinical therapy research. It provides a picture of the current position of Swedish research in the area, and looks forward 5–10 years.
It also includes recommendations for initiatives to promote research in Sweden.
PublISHED ON
UpDATED ON