1,742 Clinical Trials for Various Conditions
Study Objective The purpose of this clinical study is to evaluate if biophoton therapy, delivered by Tesla BioHealing® Biophoton Generators (Biophotonizer), can alleviate chronic severe pain. Study Design This is a randomized, double-blinded, placebo-controlled intervention clinical study to assess the effectiveness of biophoton therapy in managing chronic severe pain. Approximately 102 patients with chronic severe arthritis pain will participate in the study. Study Randomization The biostatistician will prepare a randomization schedule including a series of subject numbers. A subject number will be randomly assigned to each study participant, which will assign them to either the control group or the treatment group. Other than the Informed Consent Form (ICF), all study information will be recorded by using the subject number. The Principal Investigator, study physicians, study nurse, data-entry specialists, and biostatisticians, as well as the participants (and caregivers), will be blinded about who received which product during the first two weeks of study participation. Study Enrollment Each potentially qualified patient will review the Informed Consent Form online (e-ICF) and Enrollment Criteria online (e-Criteria) first, then discuss the e-ICF and e-Criteria with the study team medical professional via telephone during the scheduled time. Each qualified patient will sign the e-ICF and send it to the Study Coordinator. The Study Coordinator will assign the qualified patient a randomized subject number, then the patient will become a study participant. Study Procedure We expect that the participant will stay in this clinical treatment for 12 weeks, or 12 weeks if the participants are randomly placed in a placebo group. The 12 weeks of participation are double-blinded to record the placebo effects, as each set of the study device is labelled with a unique code for use by only one participant. The change of the placebo device to the treatment device will be performed by the study device management team staff, who will not inform the study participant or study research staff who are involved in study data collection. Each participant assigned to the Control Group will be treated with the 4 placebo devices on the bed. Each participant assigned to the Treatment Group will receive 4 Biophoton generator devices and placed on the bed on each side of the body. Each participant will use the Treatment or Control device for at least 8 hours every night for the 12 weeks during sleep. During the day, participants are welcome to bring the study devices and place them near the bodies during the daytime. At the end of the initial 12 weeks, study participants randomized to the Placebo group will be advised whether they will use the Open-Labeled product to treat them for 4 to 12 weeks. Only the visual analog scale of the pain data will be collected after the switch. Each participant will be guided by study team staff to perform the following tests on their assigned testing days: a visual analog scale, brief pain inventory, pain disability index, the standard SF-36 questionnaires (SF-36) for measuring life quality, the Pittsburgh Sleep Quality Index, a Patient Global Impression of Change, a Hospital Anxiety and Depression Scale, and inflammatory markers that provide objective evidence of inflammation. Investigational Product and Mode of Administration Tesla BioHealing Biophotonizer is an over-the-counter (OTC) medical device, and it can be used by anyone who wants to increase blood circulation and reduce bodily pains. For this study, the active or inactive Biophotonizer will be labeled with a code. The participant and/or caregiver cannot know if the devices are active or inactive. When the participant places the devices close to the body, she/he may or may not receive life force energy. The participant will record changes in quality of life and complete the standard study questionnaires at baseline and the end of each 2-week interval. Comparator and Mode of Administration Clinical measurements will be conducted by medical professionals. The same shape, size, and weight of the device without generating biophotons is to be labeled with a random code and used as a comparator. The comparator device will be placed close to the body during sleep during the entire study period. The participant will record the life quality changes and answer the standard study questionnaires. Clinical measurements will be conducted by medical professionals. Study Duration Estimated date of the first patient enrolled: November 15, 2024. The estimated date of the last patient completed: November 15, 2025. Participants in the Treatment Group and Control Group will actively participate in the study for 12 or 24 weeks. Each Participant will answer the standard study questionnaires several times, respectively, at the baseline, at the end of each 2-week interval after starting the study treatment.
The purpose of the study is to see examine the effects of 3 different levels of physical activity (45 minutes/week, 90 minutes/week, or 150 minutes/week) on arthritis symptoms.
The purpose of the study is to compare the efficacy of bimekizumab versus risankizumab after 16 weeks of treatment in study participants with active psoriatic arthritis (PsA).
Methodology: Randomized, double-blind, AB/BA cross-over study with a washout period of 12 weeks. Treatment Duration: 8 weeks per group General Objectives: To assess the efficacy and safety of multiple intravenous infusions of allogeneic HB-adMSCs by improving signs and symptoms of juvenile idiopathic arthritis in this subject population. Number of Subjects: 66 (6 subjects in Cohort 1 and 60 subjects in Cohort 2) Indication: Juvenile Idiopathic Arthritis
The purpose of this study is to determine the safety and tolerability of imvotamab in patients with moderate to severe rheumatoid arthritis who have failed prior therapies. Participants will be given imvotamab or placebo through a vein (i.e., intravenously). A placebo is a look-alike substance that contains no active drug
The overall objective of this proposal is to test version 3.0 of the Arthritis smartphone app in a 12-month interrupted time series analysis (ITSA) design which will allow us to observe possible differences in visit frequency between the pre-and post-intervention periods as well as between the concurrent control group and those who receive the app. Our central hypothesis is that introduction of the app will reduce visit numbers per month in the group receiving the app, compared with a concurrent control group.
This is a study to demonstrate the clinical efficacy and safety of the nanobody® sonelokimab administered subcutaneously (sc) compared with placebo in the treatment of adult participants with active psoriatic arthritis. The study includes adalimumab treatment as an active reference arm.
The main purpose of this study is to assess the safety and efficacy of peresolimab in adult participants with moderately-to-severely active rheumatoid arthritis.
This is a Phase 2a study to investigate the efficacy, safety, tolerability, PK, and PD of ATI-450 versus placebo in patients with moderate to severe psoriatic arthritis.
The objective of this study is to examine the short-term (6-weeks and 6 months) and long-term (1 year) effects of a phone-based version of Walk With Ease intervention.
This study evaluates ATI-450 plus MTX versus placebo plus MTX in participants with moderate to severe active RA who have had an inadequate response to MTX alone.
A clinical trial investigating the safety and effectiveness of Smith and Nephew's FDA-approved Porous Total Knee System, which is used to replace worn away and diseased knee joints. The aim of this study is to show that most patients who receive the Porous Total Knee System have reduced pain, greater mobility and a long-lasting implant post-surgery.
32 patients with Eaton-Glickel stage 2-3 CMC arthritis will be randomized to receive intraarticular MFAT or intraarticular corticosteroid injection. Patients with inflammatory arthritis or prior thumb base trauma or surgery will be excluded. Autologous adipose tissue will be harvested from the outer thigh or lower abdomen using local anesthesia. Tissue will be processed to remove oil and debris in-office using an FDA-approved commercially available device. The processed adipose will be immediately injected into the thumb CMC joint under fluoroscopic guidance. Visual analogue score (VAS), grip/pinch strength, Kapandji range of motion score, thumb disability examination, and QuickDASH score will be assessed pre-procedure and at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months.
The purpose of this project is to pilot test a long-term effect of Tab-G (tablet-based cognitive behavioral group education intervention). The investigators will evaluate the effect of Tab-G, relative to usual care group, on (a) daily steps, (b) fatigue level, (c) self-efficacy and (d) quality of life. Tab-G participants will receive 4 weekly CBT-based group education focusing on shared goal setting and mutual reinforcement in a group with 5 members. The outcomes will be measured baseline, week 4 (intervention completion) and week 8 (follow-up). The investigators hypothesize that older adults receiving Tab-G will have greater improvements on outcomes compared to those receiving usual care at week 4, the intervention completion and at week 8 follow-up.
This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding Rheumatoid Arthritis
Lyme arthritis resolves with appropriate antimicrobial treatment in a majority of patients, but 10-20% of patients develop antibiotic-refractory Lyme arthritis with prolonged arthritis symptoms and treatment courses. Excessive up-regulation of the inflammatory process has been shown in patients with antibiotic-refractory Lyme arthritis. The over-expressed pro-inflammatory cell mediators are downstream of NSAID inhibition, which would suggest initial inflammatory inhibition may be beneficial in these patients. While NSAIDs are known to reduce pro-inflammatory cell mediators early in the course of inflammation, research has shown that there are other cytokines that play a role in the healing after inflammation that are also inhibited by NSAIDs, and that NSAID use can delay healing. It is not known if scheduled NSAID therapy will reduce, increase, or have no effect on the occurrence of refractory Lyme arthritis cases. The hypothesis of the study is that prescribing scheduled NSAIDs at the time of diagnosis of Lyme arthritis can prevent the development of the excessive inflammatory phase and decrease the number of patients with antibiotic-refractory Lyme arthritis, or at least decrease the duration of persistent Lyme arthritis symptoms. The pilot study design randomizes patients to scheduled NSAIDs, scheduled acetaminophen, or scheduled NSAIDs x 1 week than acetaminophen. Primary outcomes are duration of arthritis symptoms, number of refractory cases, side effects and compliance.
The study team is currently conducting a pragmatic, community-based assessor-blinded randomized controlled trial (RCT) in overweight and obese adults \> 50 years with knee OA in both urban and rural counties in North Carolina. As the participants randomized to the 18 month diet and exercise group in the WE-CAN study successfully complete the intervention (≥ 5% weight loss), the study team has the unique opportunity to evaluate the effectiveness of a theoretically-based tapered weight maintenance intervention. Eligible participants will be randomized to either the weight-loss maintenance or health education attention control groups.
Thumb carpometacarpal osteoarthritis (CMC OA) affects up to 33% of people over the age of 40, which leads to inflammation, pain, and weakness of the CMC joint. Treatment modalities are both conservative and surgical with surgical options including osteotomy, bone excision, ligament reconstruction, and various prosthetic implants. The conservative treatment options, however, are limited to NSAIDs and bracing or steroid injections. Advances in topical therapies have the potential to deliver focused treatment to the CMC joint. Novel treatment of inflammation can potentially reduce inflammation and pain associated with progressing osteoarthritis. Theraworx Relief is an FDA registered foam that has theoretical impact on inflammation reduction in human subjects treated with the topical foam.
This is a study comparing the current standard of care surgical treatment to a newer surgical procedure involving the implantation of osteochondral allograft at the base of the thumb. Patients will be followed at 1, 3, 6 months and 1 year post-operatively.
Hope Biosciences is conducting a research study of an investigational product called Hope Biosciences autologous adipose-derived mesenchymal stem cells (abbreviated as HB-adMSCs) as a possible treatment for Rheumatoid Arthritis (RA). The study purpose is to evaluate the safety profile of a single IV infusion of HB-adMSCs in subjects with clinical diagnosis of RA.
Background: Inflammatory conditions can cause symptoms like fevers, arthritis, and rash. Systemic juvenile idiopathic arthritis (sJIA) is one of these conditions. So is adult-onset Still s disease (AOSD). Their causes are unknown. Researchers want to learn more about these conditions. This includes genetic changes and environmental factors. Objective: To study sJIA and AOSD in children and adults over time. Eligibility: People with known or suspected sJIA, AOSD, or similar inflammatory condition Design: Participants will be screened with a phone call. Participants will have 1 visit. It may be outpatient or they may be admitted to the clinic. The visit may last up to 5 days. Participants will have: * Medical history * Physical exam * Musculoskeletal exam * Questions about overall health and quality of life, disease activity, functional status, and cognitive ability. Participants may also have: * Pictures taken of their skin, joints, or spine * Blood, urine, and stool tests * Scans or X-rays of joints with arthritis * Chest X-ray * Heart tests * Skin biopsy. The skin will be numbed. The top layers of a small area will be scraped off. Participants who have a joint aspiration may provide a fluid sample. The joint will be prepared, then fluid is removed by needle. A corticosteroid may be injected. Participants who have a bone marrow biopsy may provide sample cells. Participants may be seen by NIH specialists. Members of the participant s family and healthy volunteers may give blood or saliva samples for genetic testing. Participants may repeat some study tests every 6 months.
This study will provide an educational intervention through means of a video to educate subjects on the risk of cardiovascular health on Rheumatoid arthritis.
This study aims to assess the efficacy of three-dimensional magnetic resonance (MR) compared to three-dimensional computed tomography (CT) imaging. This proposed study is a prospective, unrandomized, single-blinded, self-controlled, and single-armed diagnostic radiological evaluation study.
A study will be conducted to assess if adults and older adults with arthritis who ride horses are able to move better, have less pain, enjoy nature more and have a better quality of life then people who go to class to learn about exercise. This is needed because adults with arthritis experience joint pain, stiffness, damage to their cartilage, and decreased range of motion in their hips, knees, shoulders, and back. This study will measure effects on patient's joints, pain, quality of life, muscle and cartilage before and after either arthritis exercise education or horse riding. Horses have unique movements that target joints without weight bearing and possibly show improvements without joint damage. Twenty two subjects will be assigned to either the equine-assisted therapy (EAT) group or a group receiving exercise education for 1 hour each week for 6 weeks. Outcomes of pain, joint mobility and quality of life are measured at 0, 3 and 6 weeks. Enjoyment will be determined by a survey. Safety procedures include helmets, side walking attendants for balance, and controlled by a certified riding instructor at a certified riding center. Data will be gathered and reviewed, to assess the effects of EAT on arthritis.
This study includes two periods. The main objective of Period 1 is to compare the efficacy of upadacitinib 15 mg once daily (QD) and 30 mg QD versus placebo and versus adalimumab (Humira®) in participants with moderately to severely active psoriatic arthritis (PsA) who have had an inadequate response to non-biologic DMARDs (DMARD-IR). Period 1 is also designed to compare the efficacy of upadacitinib 15 mg and 30 mg QD versus placebo for the prevention of structural progression. The objective of Period 2 is to evaluate the long-term safety, tolerability and efficacy of upadacitinib 15 mg and 30 mg QD in participants who have completed Period 1.
This is a Phase 3 multicenter study that includes two periods. Period 1 is designed to compare the safety, tolerability, and efficacy of ABT-494 Dose A once daily (QD) and Dose B QD versus placebo in participants with moderately to severely active Psoriatic Arthritis (PsA) who have an inadequate response to Biological Disease Modifying Anti-Rheumatic Drug (bDMARDs). Period 2 evaluates the safety, tolerability and efficacy of ABT-494 Dose A QD and Dose B QD in subjects with PsA who have completed Period 1.
The study objective of Period 1 was to compare the safety and efficacy of upadacitinib 15 mg once daily (QD) to abatacept on a background of conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) for the treatment of signs and symptoms of rheumatoid arthritis (RA) in biologic disease-modifying antirheumatic drug (bDMARD)-inadequate response or bDMARD-intolerant participants with moderately to severely active RA. The study objective of Period 2 is to evaluate the long-term safety, tolerability, and efficacy of upadacitinib 15 mg QD in participants with RA who had completed Period 1.
This was a double-blind, placebo-controlled, event-driven randomized withdrawal study to investigate the efficacy and safety of secukinumab treatment in the Juvenile Idiopathic Arthritis (JIA) categories of Juvenile Psoriatic Arthritis (JPsA) and Enthesitis-related Arthritis (ERA). The study was divided into 3 parts (plus a post-treatment follow-up period) consisting of open-label, single-arm active treatment in Treatment Periods 1 and 3 and a randomized, double-blind, placebo controlled, event-driven withdrawal design in Treatment Period 2
The overall objective of this proposal is to implement a smart phone application (app) + population management system to monitor rheumatoid arthritis (RA) disease activity between scheduled physician office visits. The population management system includes: 1) a web-based dashboard that consolidates incoming patient-reported data using pre-programmed algorithms to identify increases in disease activity, and 2) the population manager, a trained individual who monitors the web-based dashboard and connects patients with their healthcare providers (HCPs). The investigators central hypothesis is that the combined smart phone app + population management system will improve patient satisfaction and management of RA disease activity.
A comparison of transdermal patches for efficacy, side effects and quality of life for patients with back pain and arthritis. The three arms in the trial were; prescription strength lidocaine 5%, over the counter lidocaine 3.6%, menthol 1.25% and placebo.