There are about 8563 clinical studies being (or have been) conducted in Sweden. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
The overall purpose of the pilot study is to investigate whether telephone support from fathers to fathers reduces depressive symptoms and stress among new fathers in Sweden. Forty expectant fathers with the Edinburgh Postnatal Depression Scale (EPDS)> 10 two weeks after the birth of the child are divided into two groups where half are allocated to telephone support by other fathers (intervention) as a complement to existing parental support, other group get traditionally existing parental support (control). The fathers in the intervention group were allocated telephone-based support from volunteers who have father experience, not mental illness and have undergone training through this project. These volunteers will be trained and supported by trained mentors. Four months after the child is born, data is collected with questionnaires. The intervention group will be compared with the control group and the results from the pilot study form the basis for the forthcoming RCT. Karolinska Institutet's ethics committee has approved the study. Clinical relevance: The long-term goal of this project is to improve the methods for reducing mental illness among fathers, which leads to a positive development for their children and can be used in the development of clinical guidelines to identify and reduce fathers' stress and depressive symptoms.
This project an observational study performed on patients with severe Traumatic Brain Injury (TBI) treated at Neurosurgical ICU (NICU) at Karolinska University Hospital. The purpose of this study is to evaluate the effects of various oxygenation levels on production rate of Reactive Oxygen Species (ROS) in patients with severe traumatic brain injury (TBI). The patients will be included in the study after the placement of intracranial monitoring device consisting of intracranial pressure gage (Codman), microdialysis (MD), and Licox oxygen electrode for measurement of partial pressure of oxygen in brain tissue (pBtO2). Intracranial monitoring is inserted on clinical indications and is used for early detection of deleterious processes in brain tissue such as hypoxia or hypoperfusion and for purpose of guiding of given therapies such as cerebral perfusion pressure (CPP), oxygenation, dosage of vasoactive drugs etc. Despite the technical possibilities to monitor all these physiological parameters, there are no clear guidelines how to interpret the MD and pBtO2 data and implement it in clinical decision making. One of the controversies deals with optimization of oxygen levels: some authors point out the importance of adequate brain tissue oxygenation, whereas other researchers are worried about the possible negative effects of excessive oxygen levels such as increased production of ROS or facilitating pulmonary atelectasis, contributing to adverse outcome. The purpose of this study is to investigate the effect of various oxygenation levels on ROS production in TBI patients. This pilot study is designed to measure short-lived ROS in blood and microdialysis fluid samples of TBI patients during alternating periods of normal vs temporarily increased oxygenation levels under normobaric conditions (normal atmospheric pressure).
: Resistance training induces strength gains in both children and adolescents. Exercise training is linked to anabolic functions through the GH-IGF-I axis. This has been demonstrated in studies showing a higher activity of GH and IGF-I in fitter adolescents and adults. Exercise also stimulates pro-inflammatory cytokines (IL-1β, IL-6, TNF-α) that suppress the GH-IGF-I axis. This has been observed in endurance-type training, while resistance training has received less attention. Boys experience a significant physiological muscle-growth change during puberty that is associated with increases in boys androgen levels. How maturation affects the hormonal response to resistance training in boys is unclear. Therefore, the purpose of the study is to compare the acute effects of a single bout of resistance training on hormones and pro-inflammatory cytokines in pre-pubertal and pubertal boys.
In this study, we will evaluate the relative bioavailability of Berberine (BB) from capsules containing Indian Barberry (Berberis aristate DC.) Bark and Root Extract in the blood plasma of healthy subjects after oral administration of: A. Capsules containing Berberine and GCD (BBA Berberine MetX™ Ultra Absorption, 250 mg) B. Capsules containing Berberine (BB, Berberine MetX™, 500 mg) - (reference product).
The purpose of the CROP study is to investigate the potential to cultivate psychological resources and resilience in childhood cancer patients and their family members using a mobile phone-based intervention. The feasibility study aims to evaluate the implementation and participant experience of the digital intervention and register psychological outcome measures preliminary evidence for its acceptability, feasibility, and potential beneficial effects.
Brief summary: This single-arm, pilot clinical investigation aims to evaluate Mindful SensoriMotor Therapy (MSMT) enhanced with brain modulation as a treatment of pain due to sensorimotor impairment, such as Phantom Limb Pain (PLP). MSMT consists of consciously retraining the motor and sensory networks used by the missing limb via myoelectric pattern recognition and haptic feedback. In this trial, we further enhance the effect of MSMT by brain modulation, transcranial Direct Current Stimulation (tDCS).
In colorectal surgery, hand suturing and stapling are routine methods for performing intestinal anastomoses, and these methods appear to be similar in terms of clinical safety. Despite several years of experience with surgical procedures as well as improvements to the medical devices, problems with disturbed anastomotic healing leading to leakage and stenosis after colorectal surgery remain a significant challenge for surgeons. A frequency of anastomotic leakage after stapling or suturing has been reported to range from 3% to 20%. In addition, preoperative radiotherapy has been shown to increase the risk of anastomotic leakage even further. The methods that are used today to detect leakages are unfortunately inaccurately and limited to monitoring symptoms, temperature, CRP-levels, and performing abdominal examinations and CT-scans. These clinical signs and parameters usually become apparent several days after onset of the leakage, which leads to a delayed diagnosis. Anastomotic leakage is not only a significant cause of increased morbidity of complications and mortality in patients, but also associated with increased risk of local recurrence and poor prognosis. Moreover, when reoperation is required to fix the leakage, a permanent stoma may be made at the level of the sigmoid colon and this procedure impacts live quality of patients negatively. Based on the above considerations, a novel, adaptive anastomotic method has been developed by CarpoNovum to achieve a safer anastomosis. The method's working name is C-REX Ring-locking Procedure. C-REX is referred to our Colorectal anastomotic rings for Re-join the intestinal ends and validate the anastomosis, with function of Extract samples for analysis and conduct X-ray through connected catheters. The newly developed adaptive anastomotic medical devices, C-REX LapAid Cath and C-REX RectoAid Cath are easy to use, with unique possibility to control the anastomosis during and after surgery. The previous successful pre-market data support a successful CE marking of the devices, which encourages a post-market clinical follow-up (post CE mark clinical study) in patients undergoing colonic resection to collect post-market data of C-REX LapAid Cath and C-REX RectoAid Cath for the purpose of clinical evaluation and risk analysis.
Objectives The objective of this project is to motivate patients with COPD to incorporate the habit of doing daily mindful physical activity by using the proposed home-based pulmonary rehabilitation program that integrates video guided exercises, activity monitoring daily steps and health coaching. This program will allow patients to complete Pulmonary Rehabilitation (PR) at home and promote behavior change and lead to a more active lifestyle for patients with COPD who have been prescribed PR. The program will be able to effectively monitor daily step count. A health coach will receive more this detailed data and will guide weekly health coaching sessions designed to increase awareness of the physical activities completed and ignite inner motivation for healthy behaviors. The proposed PR program is innovative and responds to an unmet need in chronic care for COPD patients in the context of COVID-19 pandemic and it mitigates the common accessibility barriers.
Irritable Bowel Syndrome (IBS) is a common functional gastrointestinal (GI) condition which is strongly associated with dietary and psychosocial factors. Management of IBS remains challenging for primary health care. The aim is to perform a comprehensive phenotyping of patients with IBS within the primary health care in Region Örebro County, Sweden. Following this phenotyping, the investigators will perform a prospective randomized controlled trial of two different treatments versus control as described below. Subsequently, the investigators want to evaluate the result of the treatments in order to see whether the presence of a certain phenotype can predict the efficacy of different treatments. Our hypothesis is that the presence of certain baseline symptom characteristics in patients with IBS can predict how effective internet based cognitive behavioral therapy (iCBT) and low FODMAP (low Fermentable Oligosaccharides, Disaccharides, Monosaccharides, and Polyols) treatment will be for each patient. 200 patients with IBS aged 18-65 years will be recruited from the primary health care in Region Örebro County. The study plan is structured as follows: 1. Phenotyping of IBS patients. Investigation of the correlation between different psychological parameters, IBS symptom severity and Quality of Life. 2. The effect and outcome of 10-weeks internet-based cognitive behavioral therapy (iCBT) versus control in IBS patients. 3. The effect and outcome of 10-weeks low FODMAP diet versus control in IBS patients. 4. Comparison of iCBT and low FODMAP treatment in IBS patients and identification of baseline phenotypic characteristics predicting treatment outcome for both treatments. Stool and blood samples will be taken before and after treatment for analysis of gut microbiota, proteomics and epigenetics and to correlate these with the clinical phenotype. All participants will undergo phenotyping regarding GI symptoms and psychological variables using questionnaires. Participants will afterwards be randomised to either 10 weeks treatment with iCBT (80 participants), low FODMAP (80 participants) or control group (40 participants) (2:2:1 randomization). The control group will wait 10 weeks before being randomised to either iCBT (20 participants) or low FODMAP (20 participants). Significance This study will provide effective and individualized treatment for IBS patients. This may lead to the development of a guideline to improve the effectiveness of treatment and care for patients with IBS.
This is a randomized controlled trial with an allocation ratio of 1:1. Half the patients are randomized to continuous positive airway pressure (CPAP) and half to routine medical care. Included are one hundred and twenty patients aged 18-80 years plus patients with ongoing CPAP scheduled for abdominal surgery at Umeå university hospital. The primary outcome is oxygen partial pressure (PaO2) measured on postoperative day 2 compared with the day before surgery. Secondary outcomes include diffusion capacity for carbon-monoxide, vital capacity, FEV1 and carbon-dioxide partial pressure (PaCO2) on postoperative day 2 compared with the day before surgery. PaO2 and PaCO2 are recorded from blood gas measurements obtained from the radial artery. Percentage of nocturnal hypoxia defined as the percentage of oxygen saturation during 90% of the second postoperative night. Tolerance to CPAP measured by the number of hours used CPAP. Side effects related to CPAP. All patients are examined with a simplified sleep apnea examination (Noxturnal T3, Res Med) the night before surgery. Patients in the CPAP treated group are given an auto-CPAP with a minimum pressure of 5 cm and a maximum pressure of 10 cm. They will be treated with CPAP for at least 2 hours immediately after surgery and during the first two postoperative nights. Oxygen is supplied to CPAP if oxygen saturation falls below 90%. Patients in the control group receives standard treatment and supplemental oxygen if oxygen saturation falls below 90%. In a third arm, we will include patients who already are using CPAP at night at home for previously diagnosed obstructive sleep apnea. are instructed to use CPAP for 2 hours immediately after surgery and subsequent nights during hospital stay.