Molndal

Researchers are evaluating the safety and potential benefits of VHB937 in people aged 50 to 85 years with early Alzheimer's disease, including those diagnosed with Mild Cognitive Impairment due to Alzheimer's or mild Alzheimer's disease. This Phase II, multicenter, randomized, double-blind, placebo-controlled study aims to assess how VHB937 affects memory, thinking abilities, daily activities, and brain changes, while also studying how the body processes and responds to the treatment. The study includes an initial 72-week double-blind phase followed by an extension period. Participants will receive either VHB937 solution for infusion or a placebo solution through infusion during the 72-week double-blind phase. The study compares these two groups to evaluate the effects and safety of VHB937 in early Alzheimer's disease. After the double-blind phase, participants may continue in an extension period for further observation. Treatment involves regular infusions under controlled conditions throughout the study. During the study, participants and their study partners will attend visits for assessments including memory and cognitive tests, evaluations of daily functioning, brain imaging, and biomarker analysis from cerebrospinal fluid or PET scans. Researchers will monitor safety, record any side effects, and track changes using the Clinical Dementia Rating scale (CDR) over 72 weeks. The study requires a reliable partner to accompany participants to visits, and overall participation includes monitoring during treatment and the extension phase to thoroughly assess VHB937's effects and safety.

Researchers are evaluating the implant survival, clinical outcomes, and X-ray findings in patients who receive total hip arthroplasty using the Trident II cup. This prospective register-based study involves a cohort of at least 500 patients from multiple high-volume centers in Sweden. The study aims to detect any evidence of inferiority of the implant by following patients over time and measuring key clinical outcomes recommended by orthopedic experts. The study involves two types of total hip arthroplasty devices: the Trident II hemispherical cup and the Trident II Tritanium cup. Patients will be followed over several years with data collection at multiple intervals. Clinical assessments using tools like EQ-5D, Oxford Hip Score, and Forgotten Joint Score will be done before surgery and at 1, 3, 6, and 10 years after surgery. Imaging studies include conventional X-rays before surgery, immediately after, and at 3, 6, and 10 years post-operation, as well as CT-based migration analysis at postoperative, 3 months, 6 months, and 2 years. Participants will undergo regular follow-up visits for clinical evaluations and imaging tests according to the study schedule. Researchers will monitor implant survival over 3 years as the primary outcome measure. The study collects detailed patient data to assess long-term function and implant stability. Patients must agree to follow-up procedures, which will extend up to 10 years to ensure comprehensive outcome tracking.

Researchers are evaluating the safety, effectiveness, and tolerability of upadacitinib in adolescents and adults with severe alopecia areata (AA), a condition where the immune system attacks hair follicles causing hair loss on the head, face, or other body parts. This phase 3 study involves about 1500 participants worldwide and compares upadacitinib to a placebo to assess treatment impact on severe AA. Participants are randomly assigned to one of three groups receiving either upadacitinib or placebo oral tablets once daily for up to 160 weeks. There is a chance for re-randomization at weeks 24 and 52 based on Severity of Alopecia Tool (SALT) scores. Those completing initial studies may join an extension study to receive upadacitinib for up to an additional 108 weeks. Follow-up occurs for 30 days after the last dose. Throughout the study, participants attend regular visits at hospitals or clinics for medical assessments, blood tests, side effect monitoring, and questionnaires. Researchers measure the percentage of participants achieving a SALT score of 20 or less at week 24 and track adverse events up to 164 weeks. The study may involve a higher treatment burden compared to usual care due to frequent visits and evaluations.

Residual limping caused by gluteus medius insufficiency after total hip replacement is a serious problem with limited treatment options. This research aims to evaluate a surgical reconstruction using an Achilles tendon allograft and compare its results and side effects with non-surgical treatment. The goal is to see if surgery combined with physiotherapy improves hip function and reduces limping better than physiotherapy alone. The study involves a surgical procedure where an Achilles tendon allograft is fixed between the gluteus medius muscle and the greater trochanter of the hip. Participants will either undergo this surgical reconstruction followed by physiotherapy or receive non-surgical treatment with physiotherapy alone. The treatments are compared to assess their effectiveness and safety. Participants will be assessed over 12 months with the main measure being the Oxford Hip Score to evaluate hip function. Researchers will monitor improvements in limping, hip function, and any adverse events. The study includes physical examinations, imaging like ultrasound or MRI to confirm tendon issues, and ongoing evaluation of leg length and hip alignment to ensure eligibility and track progress.

Researchers are studying ways to restore hand function in people with tetraplegia caused by cervical spinal cord injury. This condition severely limits the ability to perform everyday tasks due to paralysis in all limbs. Traditional tendon transfer surgery has helped improve grip strength but limits the passive opening of the hand. A newer option, nerve transfer surgery, may enable active hand opening and offer benefits like less surgery, shorter hospital stays, and faster rehabilitation. The study aims to compare combined nerve and tendon transfer surgery (CNaTT) to tendon transfer alone to see which better restores hand function. The study compares two surgical approaches. The combined nerve and tendon transfer involves first performing a nerve transfer procedure called the Bertelli S-PIN, which reconnects nerves to reanimate muscles for active hand opening. This is followed by tendon transfers to restore grip strength. The traditional approach uses tendon transfers alone to improve finger and thumb flexion for grip. Both procedures include specific rehabilitation protocols. The nerve transfer requires assessment before surgery, a brief immobilization, and ongoing training to strengthen reinnervated muscles. The tendon transfer involves muscle rerouting to restore grip. Participants will be evaluated before and after surgery with tests including the Cylinder test at 5 minutes post-procedure. Assessments involve muscle strength grading, electromyography, and monitoring hand function recovery over one year. The study tracks hand opening ability, grip strength, and daily activity improvements. Safety and any complications will be monitored to understand the benefits and risks of the combined surgery compared to tendon transfer alone. The study will enroll patients aged 15 to 55 with specific spinal cord injury levels and muscle strength requirements.

Spasticity, a common complication after central nervous system injuries such as stroke, traumatic brain injury, and spinal cord injury, can greatly reduce independence by affecting hand function. This research investigates the effectiveness of two treatments for upper limb spasticity: surgery to correct spasticity and Botulinum toxin (BoNT) injections. The study uses an open-label, non-randomized, paired design to compare these treatments within the same patients, aiming to better understand their impact on body function, activity, and participation. Participants will first receive BoNT injections in affected upper limb muscles, with dosing tailored to the severity and extent of spasticity. After at least three months to avoid carryover effects, participants will then undergo spasticity-correcting tendon lengthening surgery. Both treatments follow routine clinical care protocols. BoNT injections are administered by experienced doctors and followed by standard rehabilitation, while surgery involves tendon lengthening with post-surgery splinting and rehabilitation to restore function. Throughout the study, participants will be assessed using the Modified Ashworth Scale to measure spasticity before and after each treatment at specified intervals. Additional evaluations will monitor functional changes and activity improvements. The study aims to provide valuable insights to guide treatment decisions and improve management of upper limb spasticity. Total participation includes baseline assessments, treatment periods, and follow-ups extending up to six months after surgery.

Researchers are exploring new ways to treat Achilles tendon ruptures (ATR) to improve patient recovery and help individuals return to their previous levels of physical activity. This study focuses on evaluating the impact of early treatment using Neuromuscular Electrical Stimulation (NMES) applied to the calf muscles of the injured leg. The goal is to understand how NMES affects tendon length, muscle function, biomechanical factors, and patient-reported outcomes in both the short and long term after injury. The trial also examines how the injury and treatment may influence the healthy leg and the risk of overuse injuries. Participants in this randomized controlled trial will be assigned to either receive additional treatment with NMES or not. For those receiving NMES, four electrodes will be placed on the calf of the injured leg, and the stimulation will be applied at home twice daily for 15 minutes, starting from 3 weeks up to 8 weeks after the injury. The study plans to include 70 patients, with evaluations at 3, 6, and 12 months post-injury. Besides NMES treatment, both groups will undergo standard care and assessments. Throughout the study, participants will undergo various evaluations including heel-rise tests to measure calf muscle performance at 3, 6, and 12 months. Tendon length will be measured using ultrasound at multiple points up to one year. One year after injury, detailed biomechanical analyses during walking, running, and jumping will be performed using motion capture technology and muscle activity monitoring. Patient-reported outcomes and muscle function in both the injured and healthy limbs will be tracked to assess recovery, treatment effects, and safety over time.

Researchers are investigating the relationship between blood markers and eye imaging markers in patients with diabetic macular edema (DME), a condition related to diabetes that affects the retina and vision. This study compares patients receiving anti-VEGF treatments or dexamethasone implants with those who have not been treated before (naive patients). The goal is to understand how these serum and imaging biomarkers relate to treatment response. Participants will be divided into three groups: those treated with anti-VEGF injections, those treated with dexamethasone implants, and untreated (naive) patients. Blood samples will be collected from all participants at the start of the study to measure markers like VEGF, IL-6, IL-8, MCP-1, Ang-2, PlGF, TNF-a, and ICAM-1. Naive patients will have an additional blood sample after 4 weeks of treatment. Eye scans using Optical Coherence Tomography (OCT) will be done at the beginning and after 4 weeks to assess retinal changes. Throughout the study, researchers will analyze blood and eye scan results to categorize patients as responders or non-responders to treatment. The study includes detailed assessments of retina and choroid health using specific OCT markers. Participants will be monitored for changes in these biomarkers, with the aim to link serum levels to imaging findings and clinical outcomes. This observational study takes place at a single center in Sweden.

Rupture of the extensor pollicis longus (EPL) tendon is a common complication following distal radius fractures, affecting the ability to extend the thumb and impairing hand function. This condition occurs in about 1% of patients after surgical fracture treatment and up to 5% after non-surgical treatment. The study aims to compare recovery of thumb function after two surgical treatments for EPL rupture: primary suture and transfer of the extensor indicis proprius (EIP) tendon. Participants will undergo either primary suture of the EPL tendon or EIP transfer, as decided by the surgeon based on the injury. After surgery, patients will have cast immobilization lasting 4 weeks for primary suture and 2 weeks for EIP transfer. They will then start a specific exercise program for thumb mobility, using a static splint between sessions. Gradual increase in thumb use is allowed by 6 weeks, with no load restrictions after 12 weeks. Data will be collected at 3 and 6 months postoperatively to assess outcomes. During the study, researchers will evaluate thumb function recovery compared to the non-injured hand using objective measures like grip, pinch strength, and range of motion, as well as patient-reported outcomes. The main outcomes measured are range of motion at 3 and 6 months after surgery. The study is expected to include 30 patients per treatment group and will help confirm the effectiveness of these treatment methods for restoring hand function after EPL rupture.

Researchers are conducting a multi-center phase II clinical trial called ENCANTO to study treatments for patellofemoral osteoarthritis (PFOA), a common cause of knee pain and reduced quality of life. This trial compares an advanced therapy medicinal product (ATMP) using nasal chondrocyte-based engineered cartilage grafts (N-TEC) to current standard treatments. The study aims to evaluate the effectiveness of N-TEC against active comparators including Autologous Matrix Induced Chondrogenesis (AMIC) for early-stage PFOA and patellofemoral arthroplasty (PFA) for late-stage PFOA. Participants with early or late-stage PFOA will be randomly assigned to receive either the N-TEC implantation or the standard treatment appropriate to their disease stage (AMIC or PFA). The N-TEC graft is created by culturing the patient’s own nasal cartilage cells within a collagen membrane. AMIC involves bone drilling and covering with a membrane to attract stem cells, while PFA is a surgical knee joint prosthesis implantation. A total of 150 patients will be enrolled across 11 centers for this comparison. Throughout the study, participants will be assessed using the Knee Injury and Osteoarthritis Outcome Score (KOOS)-5 over 24 months. Researchers will also use X-rays and MRI to evaluate joint changes and cartilage regeneration. Patients will attend follow-up visits for evaluations and rehabilitation, helping to monitor treatment impact and safety over time.