Molndal

Researchers are studying the safety and effects of VHB937 in people with early Alzheimers disease, including those with Mild Cognitive Impairment due to Alzheimers or mild Alzheimers itself. This randomized, double-blind, placebo-controlled Phase II trial aims to evaluate whether VHB937 can benefit memory, thinking abilities, daily functioning, and brain changes. The study also looks at how the body processes VHB937 and responds to it. Participants receive intravenous infusions of either a low dose or high dose of VHB937, or a placebo, over a 72-week double-blind period. After this, an extension phase follows for further observation. The treatments are given through infusions, and participants are randomly assigned to one of the three groups in parallel. Throughout the study, participants and their study partners attend regular visits for assessments including clinical dementia rating scales, cognitive tests, daily living activities evaluation, and brain imaging biomarkers. Safety is monitored by tracking adverse events and serious adverse events. Blood samples are collected to measure VHB937 levels and immune responses. The total study duration includes the 72-week treatment period plus additional time in the extension phase.

Researchers are conducting a prospective study to evaluate the survival and clinical outcomes of hip implants, specifically the Trident II cup, in patients undergoing total hip replacement. The study aims to follow a group of at least 500 patients from several high-volume centers in Sweden to assess implant performance and patient health over time. The focus is on comparing two types of non-cemented Trident II acetabular cups and determining if there is any evidence of inferiority according to orthopedic benchmarking standards. Participants will receive total hip arthroplasty using either the Trident II Hemispherical cup or the Trident II Tritanium cup. Clinical data such as the EQ-5D, Oxford Hip Score, and Forgotten Joint Score will be collected before surgery and at 1, 3, 6, and 10 years afterwards. Imaging assessments including conventional X-rays will be performed before surgery, immediately after, and at 3, 6, and 10 years post-operation. Additionally, a subgroup of patients will undergo detailed implant migration analysis using Computer Tomography Microanalysis CTMA at postoperative, 3 months, 6 months, and 2 years. Throughout the study, participants will undergo regular evaluations involving clinical questionnaires, X-rays, and CT scans for those in the sub-cohort. The main outcome measured is implant survival at 3 years, with additional monitoring extending to 10 years for survival, quality of life scores, radiographic findings, and adverse events from national and regional patient registries. The total participation period can last up to 10 years, with multiple follow-up visits planned to closely monitor implant performance and patient well-being.

Researchers are studying the effects of eloralintide compared to a placebo on insulin sensitivity, metabolic health, and body weight in adults who are overweight or have obesity. This phase 1 study focuses on understanding how these treatments influence how the body responds to insulin and other metabolic factors. Participants in this study are adults aged 18 to 70 years with a body mass index between 25 and 45 kgm, and without diabetes. Participants will be randomly assigned to receive either eloralintide or a placebo, both administered by subcutaneous injection. The study lasts about 35 weeks and includes 3 inpatient visits totaling 7 days. The design is double-blind, so neither the participants nor the researchers know who receives the active drug or placebo during the trial. During the study, participants will undergo assessments to measure changes in insulin sensitivity using a hyperinsulinemic euglycemic clamp test at baseline and week 24. Body weight changes will also be tracked over the same period. Participants must maintain lifestyle and dietary guidelines throughout the study. The research team will monitor safety and overall health during the visits and follow the participants until study completion around 2027.

Researchers are evaluating how well guselkumab works compared to risankizumab in adults with moderately to severely active Crohns Disease, a long-term condition causing severe inflammation in the intestinal tract. This Phase 3b study aims to compare the effectiveness and safety of these two drugs for treating this condition. Participants will be randomly assigned to one of two groups. One group will receive guselkumab with induction doses given under the skin at Weeks 0, 4, and 8, followed by maintenance doses every 4 weeks from Week 12 through Week 52. The other group will receive risankizumab with induction doses given intravenously at Weeks 0, 4, and 8, followed by maintenance doses under the skin every 8 weeks from Week 12 through Week 52. During the study, participants will be monitored for up to about three years to assess deep remission at Week 52 and other clinical outcomes such as clinical remission, endoscopic response, steroid-free remission, and safety measures including laboratory tests and adverse events. The study includes ongoing safety monitoring through Week 165 with regular assessments to track disease activity and treatment effects.

Alopecia areata AA is a condition where the immune system attacks hair follicles, causing hair loss mainly on the head and face but possibly on other body parts. This research evaluates the safety, effectiveness, and tolerance of upadacitinib, an approved drug, in adolescents and adults with severe AA. The study is a Phase 3 randomized, placebo-controlled, double-blind trial enrolling about 1500 participants worldwide. Participants are randomly assigned to one of three groups receiving different treatments two doses of upadacitinib or placebo. In initial periods, some may switch from placebo to upadacitinib based on their Severity of Alopecia Tool SALT score. Those completing early parts may enter an extension phase receiving upadacitinib for up to 108 weeks. Treatment involves taking oral tablets once daily for up to 160 weeks, with possible re-randomization at Weeks 24 and 52. Throughout the study, participants attend regular clinic visits for medical assessments, blood tests, side effect monitoring, and questionnaires to track treatment effects. Researchers measure hair loss improvement using SALT scores and record adverse events over approximately 164 weeks. Participants are followed for up to 30 days after their last dose for safety monitoring.

Researchers are evaluating the safety and performance of a dermal filler called DKL crosslinked hyaluronic acid 20 mgmL with lidocaine 0.3% for lip augmentation in healthy men and women who have thin lips and desire fuller lips. This single-arm, open-label study involves participants acting as their own control to assess the improvement in lip appearance over time. Participants will receive injections of the DKL crosslinked sodium hyaluronate 20 mgmL with lidocaine 0.3% dermal filler into both their upper and lower lips. The study focuses on lip augmentation using this injectable sterile gel. The treatments effect will be evaluated at multiple time points up to 48 weeks after the initial injection. Assessments include pain during injection, aesthetic improvements, and device usability. During the study, participants will undergo evaluations of lip fullness using the Lip Fullness Grading Scale and aesthetic improvements rated by both investigators and subjects. Other assessments include lip function, sensation, texture, and satisfaction with the lips and overall outcome. Participants will keep diaries to track post-treatment events and adverse effects. The study lasts up to 48 weeks, with multiple follow-up visits to monitor safety and effectiveness of the filler.

Researchers are evaluating the safety, tolerability, immune response, and how the body processes and responds to the drug RO7812653 in people with early symptomatic Alzheimers Disease eAD. This Phase I trial compares RO7812653 to a placebo to understand its effects when given via spinal injection. The study is designed as a randomized, double-blind, placebo-controlled trial involving participants aged 50 to 75 years with early Alzheimers symptoms. Participants will be randomly assigned to receive either a single dose of RO7812653 or a placebo through intrathecal administration. The dosing follows a schedule outlined in the study protocol and is part of a parallel group design. The trial includes monitoring for drug presence in blood plasma and cerebrospinal fluid, as well as checking for antibodies against the drug. During the study, participants will undergo assessments to monitor safety, including tracking any adverse events and changes in suicide risk over about 40 weeks. Evaluations also include neuropsychological testing, imaging to assess brain conditions, and laboratory tests. Participants are expected to complete all assessments with or without the help of a study partner, and the study aims to gather detailed information on the drugs effects and safety over the study period.

Residual limping due to gluteus medius insufficiency after total hip replacement is a serious complication without effective treatment. This study aims to compare surgical reconstruction of the gluteus medius using an Achilles tendon allograft with non-surgical physiotherapy treatment. The hypothesis is that surgery followed by physiotherapy will improve hip function and reduce limping more than physiotherapy alone. Participants are randomly assigned to one of two groups. One group undergoes surgical reconstruction where an Achilles tendon allograft with a calcaneus block is fixed to the greater trochanter and tensioned through the gluteus medius muscle, followed by partial weight bearing for 2 months and 10 months of physiotherapy. The other group receives only physiotherapy for 12 months without surgery. Throughout the study, participants will be assessed at 12 months using the Oxford Hip Score to measure hip function. Additional evaluations include Trendelenburgs sign, hip abduction strength, activity levels, quality of life indexes, and monitoring of any adverse events. The total study duration for each participant is 12 months, with close observation of treatment outcomes and safety.

This research focuses on individuals with tetraplegia caused by cervical spinal cord injury, which severely limits their ability to use their hands and perform daily activities. It aims to compare two surgical approaches to restore hand function a combined nerve and tendon transfer procedure CNaTT and the traditional tendon transfer surgery alone. The study addresses a significant gap by evaluating whether the combined approach, which may improve hand opening and grip function, offers better clinical outcomes than the traditional method. The combined procedure involves first performing a nerve transfer called Bertelli S-PIN, which aims to restore active opening of the hand by rerouting nerves to paralyzed muscles. This is followed by tendon transfer surgeries to restore strong finger and thumb flexion for grip. The traditional approach uses tendon transfers alone to restore grip without active hand opening. Both procedures involve specific surgical techniques and rehabilitation protocols, including immobilization and training phases to enhance muscle strength and function. Participants will be assessed through various tests, including the Cylinder test to measure hand function and grip strength assessments using devices like the JAMAR dynamometer and Pinch Gauge. Quality of life and satisfaction with surgery will also be evaluated using validated questionnaires. The study includes patients aged 15 to 55 with recent cervical spinal cord injuries and will monitor outcomes one year after surgery to determine the effectiveness of the procedures in improving hand function and independence.

Researchers are evaluating treatments for upper limb spasticity, a common complication after central nervous system injuries such as stroke, traumatic brain injury, or spinal cord injury. This condition can severely limit hand function and daily activities. The study compares the effects of spasticity-correcting surgery and Botulinum toxin BoNT injections to determine which treatment is more effective in improving body function, activity, and participation. The research uses an open-label, non-randomized, paired design involving 30 patients. Participants will first receive BoNT injections targeting spastic muscles in the upper limb. The dosage and number of muscles treated depend on the severity of spasticity and are determined by specialists. After at least three months to avoid carryover effects, participants will undergo spasticity-correcting tendon lengthening surgery. The surgical procedure involves lengthening affected tendons to restore muscle length and function, followed by a rehabilitation program including splinting and exercises. Both treatments follow routine clinical care protocols. Throughout the study, patients will be evaluated at multiple time points before and after each treatment. Assessments include the Modified Ashworth Scale to measure spasticity severity and various tests to evaluate hand function, range of motion, strength, activity level, and quality of life. Researchers will analyze changes in these measures to compare the treatments. The study aims to guide future treatment decisions and improve care for patients with upper limb spasticity over a total participation period that spans before and after both interventions.