Alcala De Henares

Researchers are investigating treatments for temporomandibular disorders TMD, which are increasingly common and affect jaw function and cause pain. This study aims to evaluate whether combining manual therapy with vagus nerve stimulation, a nerve linked to pain and jaw function, offers better relief and improved quality of life than manual therapy alone. The study involves 20 participants diagnosed with myogenic TMD, focusing on pain, jaw movement, and distress. Participants are randomly assigned to one of two groups one receiving manual therapy combined with vagus nerve stimulation and the other receiving only manual therapy. Both groups undergo four physiotherapy sessions, one per week over a month, and are trained to continue treatment exercises at home over two months. The manual therapy includes joint manipulation and soft tissue techniques for the jaw. Throughout the study, an independent evaluator will assess participants monthly using questionnaires to measure chronic pain, jaw function, physical symptoms, range of motion, and distress. The main outcomes are changes in health status and chronic pain after two months. This double-blind, randomized study ensures unbiased results by keeping evaluators unaware of group assignments. Participant involvement spans two months of treatment and assessments.

Researchers are conducting a multicenter, randomized, double-blind, placebo-controlled Phase 3 study to evaluate the effects of teplizumab compared with placebo in children and young adults aged 1 to 25 years with recently diagnosed Stage 3 type 1 diabetes. The study aims to measure changes in blood sugar control and independence from mealtime insulin over 52 weeks while participants continue standard insulin therapy. Participants will be randomly assigned to receive either increasing doses of teplizumab or a matching placebo, both given by intravenous IV infusion. The treatment period lasts 52 weeks, during which participants receive the study drug or placebo by IV infusion. The total study duration for each participant is approximately 84 weeks 19 months, including treatment and follow-up. Throughout the study, participants will undergo regular assessments including blood tests measuring glycated hemoglobin HbA1c, C-peptide levels from meal tolerance tests, and continuous glucose monitoring to track blood sugar levels. Researchers will also monitor insulin use, adverse events, drug concentrations in the blood, and antibody responses. Safety and efficacy are evaluated up to 78 weeks, with multiple visits scheduled across the study period.

Researchers are evaluating two different treatments for breast cancer patients who have a positive sentinel lymph node after receiving neoadjuvant systemic therapy. The study aims to compare axillary radiotherapy ART with axillary lymph node dissection ALND to see which approach results in less risk of lymphedema and how each affects recurrence and overall survival. This trial is a prospective, randomized, open-label, parallel-assigned, multicenter study involving 820 patients over 5 years, including those treated with chemotherapy and hormone therapy. Participants are randomly assigned to one of two groups. One group receives axillary radiotherapy targeting levels I and II plus level III and supraclavicular areas, with or without the internal mammary chain, but without lymphadenectomy. The other group undergoes axillary lymph node dissection along with radiotherapy to level III and supraclavicular areas, with or without the internal mammary chain. The study includes a pilot phase with the first 200 patients and plans interim analysis to assess progress. During the trial, participants will be monitored for disease-free survival, overall survival, and the incidence of lymphedema for up to 5 years, with lymphedema tracked for up to 3 years after surgery. Researchers will evaluate outcomes related to recurrence and quality of life. The study involves regular assessments including imaging to evaluate axillary response and follow-up visits to monitor health and side effects. Participants are followed closely to understand the long-term impact of the treatments.

Researchers are evaluating if a combination of Venetoclax, Azacytidine, and Quizartinib works better than the standard treatment of Venetoclax and Azacytidine to treat adult patients with newly diagnosed acute myeloid leukemia AML who cannot receive standard induction therapy due to age, other health issues, or risk factors. The study aims to determine which treatment offers a better chance of overall survival. Participants will be randomly assigned to one of two treatment groups. One group will receive Azacytidine by subcutaneous injection daily for seven days in each 28-day cycle, Venetoclax orally for seven days alongside Azacytidine, and Quizartinib orally from days 8 to 21, with doses adjusted based on genetic markers. The other group will receive Azacytidine injections for seven days and Venetoclax orally for seven days per cycle without Quizartinib. Treatments continue until disease progression, unacceptable side effects, or other criteria for stopping are met. During the study, participants will have regular visits for treatment and monitoring. Researchers will collect survival information and follow up by phone or clinic visits every three months for two years after the last patient enrolls. The main outcome measured is overall survival over four years. Additional outcomes include event-free survival and complete response rates over four years. Safety and health assessments will be regularly conducted throughout the trial.

Researchers are studying how physical exercise affects patients with Major Depressive Disorder MDD, focusing on the anti-inflammatory, oxidative stress, and brain mechanisms behind the antidepressant effects of exercise. This trial aims to understand how effective a physical exercise program is when combined with standard antidepressant treatment in real-life conditions. The study also explores improvements in depressive symptoms, cognitive performance, functioning, and well-being over time. The trial randomly assigns participants to one of two groups an exercise intervention group that receives a 12-week physical exercise program alongside their usual antidepressant medication, and a control group that continues only their standard antidepressant treatment without changing their physical activity. The exercise program includes daily walking monitored with an activity band and twice-weekly supervised online aerobic and strength sessions using elastic bands and body weight exercises, progressing in intensity and difficulty. Participants will be assessed at three time points before starting the intervention, after 12 weeks, and one year later. Researchers will measure inflammatory and oxidative stress biomarkers, brain imaging changes, clinical evaluations, cognitive function, physical fitness, activity behaviors, and well-being. Monitoring includes use of wearable devices for step counting and activity tracking, and the study evaluates long-term effects and patient acceptance of the exercise program.

Researchers are evaluating whether adding Hyperthermic Intraperitoneal Chemotherapy HIPEC with Mitomycin C after complete surgical removal of peritoneal metastases in patients with colon cancer affects the chance of cancer returning in the abdomen. This phase IV clinical trial addresses uncertainties from prior research by focusing on the time patients remain free from peritoneal recurrence rather than overall survival. It excludes rectal cancers and patients with extensive peritoneal disease or incomplete surgery to better understand HIPECs role in this setting. Participants are randomly assigned to one of two groups one receiving complete cytoreductive surgery plus HIPEC with Mitomycin C delivered at 35 mgm2 in a heated peritoneal dialysis solution for 90 minutes with dose fractionation, and the other receiving surgery alone without HIPEC. The study corrects previous trial shortcomings by increasing HIPEC infusion time and limiting patient selection based on cancer spread and surgery completeness. During the trial, participants will be monitored for peritoneal recurrence over three years, with assessments including imaging and disease-free survival measures. Researchers will also track postoperative complications within 90 days after surgery and evaluate quality of life at multiple points before surgery, after chemotherapy, and at one and two years. The trial aims to provide detailed information on recurrence patterns, survival, and patient well-being over three years following treatment.

Subacromial syndrome is a common cause of shoulder pain with unclear causes and no specific treatment. Researchers are evaluating the effectiveness of manual therapy compared to low-medium energy radial shock wave therapy in treating this condition. This randomized, single-blind clinical trial involves 88 participants with subacromial syndrome to compare these two treatment approaches and determine which provides better relief. Participants will be randomly assigned to one of two groups. One group will receive manual therapy focused on joint mobilizations and pressure release of muscle trigger points over 6 weeks. The other group will receive weekly sessions of radial shock wave therapy targeting specific shoulder areas and trigger points, also for 6 weeks. Both groups will complete a 12-week home-based therapeutic exercise program after their initial treatment. Throughout the study, participants will be assessed before treatment and up to one year later. Evaluations include measuring shoulder pain using the visual analogue scale VAS at motion, rest, and overnight. Disability, muscle strength, and shoulder range of motion will also be measured. The study aims to observe changes in these outcomes to compare the effectiveness of the two treatments, with ongoing monitoring and follow-up for up to 12 months after treatment ends.

The aging process causes changes in organs and tissues that can lead to frailty and a higher risk of falls, which are a major cause of death worldwide. Falls in older adults often result in hospitalization, immobilization, and fear of falling again, which can cause disability. This research aims to better understand how stress affects neuromuscular function, postural control, and balance in elderly people, by exploring the interactions between cognition, stress, and motor control. All participants will undergo a baseline cognitive and physical assessment followed by an experimental session. During the baseline test, they will view low-arousal images from the International Affective Picture System IAPS while performing movements such as standing up, walking, manipulating bottles, and sitting down. In the experimental test, they will repeat these movements while viewing high-arousal IAPS images, with images projected continuously in the background during tasks. Both young and older adults participate, with sub-analyses for elderly individuals based on cognitive impairment and functional dependence. Participants will be monitored using surface electromyography, pressure sensors on the floor, accelerometers, and balance assessments during both tests. Heart rate variability, respiratory rate, and unease levels after viewing images will also be measured. The study involves physical and cognitive assessments before and after image exposure and movement tasks. The total participation duration varies with testing and assessments. This study is sponsored by the University of Alcala.

Researchers are conducting a randomized controlled trial to compare two treatments for chronic low back pain CLBP diathermy and dry needling. The study aims to determine if diathermy is more effective than dry needling in reducing pain intensity over the short term. Participants will have chronic non-specific low back pain lasting more than six weeks and will be evaluated on pain, disability, fear of movement, and pain catastrophizing. Participants will be randomly assigned to receive either diathermy treatment or dry needling. Diathermy involves applying a TCaRe Power diathermy instrument to the lumbar region for 10 minutes on each side with massage techniques, while dry needling uses a 4cm needle to target the most painful lumbar muscle areas with 12 incisions followed by a one-minute ischemic compression. Both groups will complete a home exercise program. The study will take place from August 2022 to March 2023. Participants will be assessed at baseline, 1 week, 1 month, and 3 months after treatment. Measurements include pain intensity using a visual analogue scale, disability via the Rolland-Morris questionnaire, fear of movement with the Tampa Scale for Kinesiophobia, pain catastrophizing, and pressure pain threshold. The study uses analysis of variance and moderation analysis to evaluate results, with safety and adherence monitored throughout. Total participation spans approximately three months after treatment.

Researchers are investigating how different types of expectations affect the Autonomic Nervous System ANS and pain relief after dry needling treatment in patients with neck pain. The study compares positive, neutral, and negative expectations to see how they influence the bodys response to dry needling, a common therapy for muscle pain. The study focuses on myofascial trigger points in the upper trapezius muscle and explores how patient mindset may impact treatment outcomes. Participants are randomly assigned to one of three groups where they receive positive, neutral, or negative information about dry needling before treatment. All groups receive dry needling applied to the most painful point in the upper trapezius muscle. The study measures changes in pain and ANS activity to understand how expectation influences the bodys reaction to this therapy. During the study, researchers monitor heart rate, breathing rate, skin conductance, and skin temperature before, during, and for 20 minutes after the dry needling treatment. Pain levels are measured using a visual scale and pressure pain threshold tests before and after the intervention. The main outcome is the change in skin conductance 20 minutes after treatment, with additional assessments of heart rate variability and pain intensity. This helps evaluate both nervous system responses and pain relief effects over the course of the study.