Placebo effects are an essential component of clinical research, serving as controls to evaluate the true impact of new treatments. Clinical trials involving placebos often explore treatment evaluations by comparing active therapies to inactive subst...
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Found 12 Actively Recruiting clinical trials
Actively Recruiting
Researchers are investigating whether combining transcranial Direct Current Stimulation (tDCS) with cognitive-behavioral therapy (CBT) improves treatment for repetitive negative thinking (RNT) in patients who experience high levels of rumination. This study includes patients with generalized anxiety disorder or depressive disorder and compares active tDCS combined with CBT to sham (inactive) tDCS combined with CBT to evaluate their therapeutic effects. The study has two stages. In the first stage, participants attend weekly CBT group sessions called "Drop It" for 7 weeks, each followed by either active or sham tDCS applied for 30 minutes. In the second stage, after these sessions, participants use the tDCS devices at home daily for 4 weeks, continuing with either active or sham stimulation, then return for a final CBT session. Neuroimaging scans (EEG and fNIRS) are done at the start and after 3 months of therapy to measure brain activity. During the study, participants complete questionnaires assessing worry, depression, anxiety, and quality of life at baseline, after the therapy course, and at 3-month follow-up. Psychiatrists also evaluate participants at these points. Questionnaires measuring rumination are completed after each session. The main outcomes are the therapeutic effect of the combination therapy and the lasting impact of tDCS on CBT benefits, with safety and brain activity monitored over up to 3 months. Participation lasts approximately 3 months.
Actively Recruiting
Healthy Volunteer
Researchers are investigating the effects of consuming a turmeric beverage twice daily for 8 weeks on the physiology and wellbeing of healthy older adults aged 40 to 95 years. Curcumin, a bioactive compound in turmeric, has shown anti-inflammatory and antioxidant effects, and this study aims to explore its broader impact including other turmeric compounds on older adults' health and quality of life. Participants will be randomly assigned to one of two groups: one group will take a 60 mL turmeric shot containing 30% turmeric twice daily for 8 weeks, while the other group will take a placebo shot with a small amount of turmeric for taste twice daily for the same period. Both groups follow this regimen for the full 8-week intervention to compare effects. During the study, participants will undergo baseline assessments and follow-up after 8 weeks, including blood tests measuring brain-derived neurotrophic factor, cholesterol, and various biochemical markers. They will also complete questionnaires on fatigue, mood, pain, sleep quality, and physical function tests such as strength and cognitive tasks. Researchers will monitor changes in these measurements to assess turmeric's impact on health and wellbeing in older adults.
Actively Recruiting
Researchers are evaluating the effects of low-intensity transcranial magnetic stimulation (TMS) on major depressive disorder (MDD), along with its impact on levels of 5-hydroxyindoleacetic acid (5-HIAA) and brain-derived neurotrophic factor (BDNF). This randomized clinical trial aims to determine whether low-intensity TMS can reduce depressive symptoms and cause significant changes in these blood markers. The safety of TMS will also be assessed by monitoring symptoms during and after the treatment period. Participants will be randomly assigned to receive either real low-intensity TMS or a sham (simulated) TMS. The real TMS treatment involves 4 days of therapy with 5 daily sessions lasting 200 seconds each, spaced by 10-minute breaks. The magnetic field intensity used ranges from 2 to 4 milliTesla, delivered at 50 Hz in theta bursts. The sham group receives simulated treatment without magnetic field induction. During the study, participants will undergo an initial clinical assessment and provide a 5 mL blood sample before treatment. Symptoms will be monitored daily throughout the 4-day intervention. At the end, another blood sample will be collected and clinical assessments repeated. Safety monitoring will continue for one month after treatment to observe any adverse effects. The total participation includes the 4-day intervention and the follow-up period for symptom evaluation.
Actively Recruiting
Researchers are evaluating the safety and effectiveness of neoadjuvant chemoradiation combined with Tislelizumab, a PD-1 inhibitor, with or without the probiotic Probio-M9, in patients with locally advanced rectal adenocarcinoma that is pMMR/MSS and located within 10 cm from the anal verge. This study is a prospective, randomized controlled trial comparing two experimental groups and a control group receiving chemoradiation only. The goal is to compare various clinical outcomes among these groups to better understand treatment effects. Participants will receive long-course chemoradiotherapy with 50 Gy delivered in 25 fractions alongside concurrent Capecitabine. Following this, they will receive two cycles of CapeOX chemotherapy combined with Tislelizumab administered intravenously at 200 mg every 3 weeks. Participants are randomly assigned to receive either daily oral Probio-M9 at 2 grams or a matched placebo starting from the beginning of chemoradiotherapy until surgery. Surgery with total mesorectal excision (TME) follows the treatment phase. During the study, participants will undergo evaluations including stool sample collection to analyze gut microbiota changes at baseline, during treatment, and before surgery. Researchers will monitor pathological complete response (pCR) within 10 days post-surgery as the primary outcome. Secondary outcomes include overall survival and disease-free survival rates at 2, 3, and 5 years, as well as immune-related adverse events. The study is conducted at a single center with a planned follow-up extending up to 5 years after treatment initiation.
Actively Recruiting
Researchers are investigating the effects of immersive virtual reality (VR) compared to placebo effects on chronic pain, specifically in people with temporomandibular disorder (TMD). The study aims to understand the brain and behavioral responses to VR as a non-drug pain management method, focusing on how VR may activate the body's natural pain relief systems. Participants include individuals with diagnosed TMD, categorized by their pain impact levels. Participants will experience three different conditions over three-week periods: active VR using RelieVRx for 20 minutes daily, sham VR that lacks immersive features but includes video and sound for 20 minutes daily, and a no-VR natural history control where they continue usual care without VR devices. The study uses a randomized design to compare these approaches and analyze changes in brain activity and pain. During the study, participants will attend four in-person visits about every three weeks where EEG recordings will measure peak alpha frequency (PAF) and heat-pain tolerance will be tested. Daily mood, anxiety, and pain levels will be tracked using questionnaires during the three-week conditions. The research monitors clinical and neural changes to assess the impact of VR on pain. Total participation duration spans multiple phases over approximately nine weeks.
Actively Recruiting
Healthy Volunteer
Researchers are studying whether a non-invasive brain stimulation method called transcranial temporal interference stimulation (tTIS) can reduce negative feelings, and how expectations shaped by care providers affect these results. The study aims to find out if active tTIS works better than sham (inactive) tTIS, and if positive treatment expectations improve the effects compared to negative ones. This research involves healthy adults aged 18 to 55 and uses a randomized, triple-blind design to explore these questions. The study has two experiments with different designs. Experiment 1 involves 30 participants who each complete four sessions combining active or sham tTIS with positive or negative placebo messaging. Active tTIS delivers specific electrical signals targeting the brain for 20 minutes, while sham tTIS mimics the procedure without effective stimulation. Experiment 2 includes 160 participants divided into patients and doctors; patients undergo two sessions with sham tTIS paired with either a social placebo intervention or no intervention, while doctors are trained to provide placebo messaging and monitor patient responses. Sessions are spaced at least 48 hours apart. Participants complete tasks that assess negative affect before and after each session, including cognitive effort, fear, and pain ratings. Physiological data such as heart rate, skin conductance, and others are recorded during the sessions. Additional assessments include MRI scans and behavioral measures. The study tracks changes in negative affect and physiological responses over approximately one month, with safety and tolerability monitored throughout.
Actively Recruiting
This clinical trial is investigating treatments for lower urinary tract symptoms caused by benign prostatic obstruction in men aged 40 to 85. The study compares two procedures: transurethral prostate resection (TURP) and Echolaser Soractelite-Transperineal Laser Ablation (TPLA). The goal is to determine whether TPLA is not worse than TURP in improving symptoms as measured by the International Prostate Symptom Score (IPSS). Participants are randomly assigned to receive either the TPLA procedure, which uses transperineal laser ablation guided by transrectal ultrasound, or the TURP procedure, which involves transurethral resection of the prostate via uretrocystoscopy. Both treatments aim to relieve urinary symptoms by addressing prostate enlargement. During the study, participants will be monitored at one, three, six, and twelve months after treatment. Researchers will measure symptom scores using IPSS, compare urine flow rates (Q-Max uroflow), and track inpatient timing related to treatment. The study will assess and compare these outcomes to evaluate the safety and effectiveness of each procedure over time.
Actively Recruiting
Researchers are evaluating suvorexant alongside buprenorphine treatment in adults with opioid use disorder who have recently used fentanyl. This phase 2 randomized-controlled trial aims to compare suvorexant against a placebo to assess its effects during buprenorphine induction and maintenance. Participants must have evidence of fentanyl exposure and meet criteria for opioid dependence to take part in this study. The study consists of a 5-day residential phase followed by a 3-week outpatient phase. During the residential phase, participants are stabilized on sublingual buprenorphine or buprenorphine/naloxone and receive either nightly suvorexant or placebo. In the outpatient phase, they continue sublingual buprenorphine/naloxone and study medication managed by an automated pill dispenser. At the study's end, participants receive an injection of extended-release buprenorphine. Both study medication and buprenorphine treatments are administered openly following standard care. Participant involvement includes urine testing for fentanyl exposure, forehead EEG monitoring, and wrist-worn devices that track activity and physiological signals. Questionnaires are completed in person and via cell phone-based assessments. Researchers measure total sleep time during the residential phase and monitor adherence to buprenorphine over the 25-day treatment period. The study includes close safety and treatment compliance monitoring, lasting approximately four weeks per participant.
Actively Recruiting
Researchers are evaluating the therapeutic effects of transcranial direct current stimulation (tDCS), a non-invasive method that alters brain activity, combined with gait training in people with multiple sclerosis (MS). The study aims to improve balance and walking ability, which are often affected in MS patients, using a randomized, triple-blind, controlled design comparing active tDCS with sham stimulation alongside identical gait training. This builds on previous evidence suggesting beneficial effects of tDCS in MS and seeks to confirm these findings with an optimized stimulation approach. Participants will receive either active tDCS or sham stimulation using the same device and electrode placement. Active tDCS applies 2 mA current for 20 minutes with electrodes placed on the head and right shoulder, secured with a cap and bandage. The sham group receives a brief, low-level stimulation mimicking the device's sensations without therapeutic current. Both groups will undergo 20-minute treadmill gait training sessions supported by a body-weight support harness to promote motor relearning and ensure safety. During the study, participants will be assessed before treatment, after the 10th session, and at a 4-week follow-up. Researchers will measure walking speed and balance using tests like the Timed Up and Go (TUG) and Timed 25-Foot Walk, along with questionnaires on walking ability and fatigue. Safety and clinical outcomes will be monitored throughout, with the total participation duration spanning the intervention and follow-up periods.
Actively Recruiting
Researchers are evaluating the pain-relieving effects of the pericapsular nerve group (PENG) block during hip replacement surgery. This prospective, randomized, double-blind study compares two groups of patients undergoing primary total hip arthroplasty. Participants are assigned to receive either 20 ml of ropivacaine 0.5% or 20 ml of a saline solution as a placebo to assess the impact on postoperative pain management. The study involves two treatment groups: one receiving the PENG block with ropivacaine, a local anesthetic, and the other receiving a placebo injection of physiological saline. Both treatments are administered during the hip implant procedure, which uses a minimally invasive anterolateral approach with a specific implant system. The trial is designed to maintain blinding and randomization to fairly compare the effects. Participants will be monitored for opioid use within the first hour after recovery room arrival, along with total opioid consumption, pain levels, nausea, vomiting, and overall recovery until the evening of the second day after surgery. The study tracks these outcomes closely to understand the efficacy of the PENG block. The total duration of involvement includes the surgical procedure and postoperative observation up to two days after surgery.
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