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Found 3 Actively Recruiting clinical trials
Actively Recruiting
This research aims to study female patients with acute thoracolumbar compression fractures that occurred within the past 3 months or less. The focus is on understanding how pain and daily function improve following treatment. The study particularly evaluates pain reduction and quality of life using various patient-reported outcome measures over a six-month period. Participants will receive treatment with the commercially available SPRINT Peripheral Nerve Stimulation (PNS) system for 60 days. Pain levels will be monitored using the Numeric Rating Scale (NRS) and Brief Pain Inventory (BPI), while quality of life will be assessed using the PROMIS questionnaire. Measurements will be taken one week before the intervention and then at 2 weeks, 3 months, and 6 months after PNS implantation. During the study, participants will complete pain and quality of life questionnaires and have their functional outcomes tracked through a digital data collection system called CareSense. The primary outcome is the change in pain from before treatment to multiple follow-up points. Researchers will also analyze functional improvements and overall quality of life. Safety and effectiveness will be monitored throughout the six months post-treatment.
Actively Recruiting
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Researchers are evaluating the ability of the DeepMSI AI system to detect biomarkers of age-related macular degeneration (AMD) with sensitivity and specificity equivalent to experienced clinicians in adults over 40 years old. The study focuses on comparing the detection performance of DeepMSI AI to retina specialists using images of the eyes captured by the MSI-120 device. The aim is to determine if the AI system can match clinical expertise in identifying AMD signs. The study uses a single-arm design where participants undergo retinal imaging using the MSI-120 device. The acquired images are then independently analyzed by the DeepMSI AI and retina specialists. To ensure safety, AI results are not shared with clinicians or participants during the study. The primary intervention involves the use of this imaging device and AI software to assess detection accuracy. Participants will have their eyes imaged and the images evaluated for AMD biomarkers by both AI and clinicians. Researchers will compare these findings to the clinicians' interpretations to assess equivalency in sensitivity and specificity. The main outcome is measured over an average of 6 months from study start. Throughout the study, participants' prior clinical visits and imaging results are reviewed to confirm AMD status or healthy eyes, and safety is continuously monitored.
Actively Recruiting
Researchers are evaluating the effectiveness of transcranial direct current stimulation (tDCS) combined with mindfulness instruction delivered remotely through telemedicine for adults diagnosed with unipolar depression. This study targets 25 adults who are clinically stable but currently experiencing a major depressive episode lasting at least four weeks. Participants must meet specific diagnostic criteria for major depressive disorder (MDD) confirmed through clinical interviews and depression rating scales. The study compares two groups: one receiving active tDCS along with audio-guided mindfulness and music, and the other receiving a placebo (sham) tDCS with audio-guided mindfulness only. Both interventions are delivered remotely using a telemedicine approach. This randomized, double-blind, parallel-arm, sham-controlled trial aims to assess the combined effect of these treatments on depression symptoms. Participants will be assessed at weeks 4 and 7 using the Hamilton Depression Rating Scale (HDRS) to measure changes in depressive symptoms. Researchers will also evaluate the success of blinding at week 7 to ensure study integrity. Throughout the study, participants' medication stability, depression severity, and safety are monitored. The total duration of participation includes the initial screening period and the 7-week treatment and follow-up phase.