208 Clinical Trials for Various Conditions
The purpose of this study is to determine if treatment is effective in preventing fractures in women with postmenopausal osteoporosis.
The purpose of this study is to determine if treatment with romosozumab is effective in preventing fractures in women with postmenopausal osteoporosis
This is a dose escalation study to determine the maximum tolerable dose of Parathyroid Hormone-related Protein, PTHrP, or Parathyroid Hormone, PTH, that can be given safely over one week in healthy African-American volunteers. The investigators plan to infuse low doses of intravenous PTHrP or PTH to determine if it leads to a sustained and progressive suppression of bone formation as occurs in humoral hypercalcemia of malignancy (HHM) or an increase in bone formation as occurs in hyperparathyroidism (HPT). Additionally, the investigators will assess the direct influence of PTHrP and PTH on vitamin D metabolism, markers of bone turnover, and fractional excretion of calcium. These results will be compared to previous studies of Caucasian volunteers.
The primary aim of this study is to obtain measures of amino-terminal telopeptides of procollagen 1 (P1NP), a marker of bone formation, in lactating and non-lactating post-partum African-American women both at 6-8 and at 12-14 weeks post-partum, and to compare these values to those of normal controls. The secondary aim is to obtain at the same time points, measurements of Parathyroid Hormone-related Protein (PTHrP), additional markers of bone turnover \[e.g. N-telopeptide of collagen cross-links (NTx), C-telopeptide of collagen cross-links (Ctx),bone specific alkaline phosphatase (BSAP) and osteocalcin (OC)\], calcium and vitamin D metabolism in these subjects. These results will be compared with a non-African-American cohort of post-partum women and normal controls. The investigators hypothesize that African-American lactating women will have increased bone turnover when compared to non-lactating postpartum women and normal controls. The investigators further hypothesize that bone turnover is increased in lactating women independent of race.
This is a dose escalation study to determine the maximum tolerable dose of Parathyroid Hormone-related Protein, PTHrP, that can be given safely over one week. The investigators plan to infuse low doses of intravenous PTHrP to determine if it leads to a sustained and progressive suppression of bone formation as occurs in humoral hypercalcemia of malignancy (HHM) or an increase in bone formation as occurs in hyperparathyroidism (HPT). Additionally, the investigators will assess the direct influence of PTHrp on markers of bone turnover, and plasma 1,25 (OH)2 vitamin D regulation in healthy human volunteers.
The primary aim of the study is to measure bone formation in both lactating and non-lactating post-partum women and compare these to those in healthy non-pregnant controls. The secondary aim is to obtain measurements of Parathyroid Hormone-related Protein (PTHrP), markers of bone resorption, and calcium and vitamin D metabolism in these subjects. The investigators believe that lactating women will have an increase in bone resorption but no increase in bone formation when compared to non-lactating post-partum women and normal controls.
Study consists of an eight day inpatient visit on the General Clinical Research Center. The investigators' specific aims are to: 1. To define the maximum safe dose of a seven day continuous administration of parathyroid hormone \[PTH(1-34)\] in healthy human volunteers. 2. To estimate the effect of a seven day continuous administration of parathyroid Hormone (PTH) in escalating doses on vitamin D metabolism, markers of bone turnover and fractional excretion of urine.
The main purpose of this study is to determine the safety and effectiveness of three week daily subcutaneous injections of Parathyroid Hormone-related Protein (1-36). Previous studies indicated that PTHrP has a skeletal 'anabolic' or bone-building effect, and has shown to increase bone mineral density in postmenopausal women with osteoporosis. Safety of PTHrP will be determined by measurements of blood pressure and pulse, serum blood calcium levels and subjective symptoms. Effectiveness will be measured by changes in measurements of blood and urine markers of bone turnover.
This is a single-blinded, one-treatment, combination dose escalation and pharmacokinetic study done in healthy volunteers. The investigators want to determine whether Parathyroid Hormone related Protein (1-36) \[PTHrP(1-36)\] shares anabolic properties with the only currently approved anabolic agent, parathyroid hormone(1-34) \[PTH(1-34)\], which stimulates both osteoblastic bone resorption and formation. In a previous study done by the investigators, postmenopausal osteoporotic women on estrogen received 6.56 mcg/kg PTHrP(1-36) subcutaneously for three months daily. They experiences a 4.7% increase in bone mineral density (BMD) of the lumbar spine when compared with those taking placebo. They also displayed an increase in serum osteocalcin, a marker of bone formation, with no change in several markers of bone resorption. It is believed that the rapid absorption and clearance of PTHrP(1-36) likely plays a central role in its anabolic effect In order to further assess absorption, we are combining both pharmacokinetic and dose escalation methods for studying intravenous PTHrP given via a one-time bolus injection. The purpose is to define the maximum safe dose and measure the pharmacokinetic parameters of a single intravenous dose of Parathyroid Hormone-related Protein (1-36)\[PTHrP(1-36)\]. The results will be useful in determining future treatment options for osteoporosis.
The aim of the study is to determine the efficacy of an Amniotic Fluid Tissue Product for pain relief and functional improvements for all types of musculoskeletal conditions. The study is prospective, with outcome measures being obtained at numerous time points after the regenerative procedure.
The investigators propose to create a markerless smartphone-based MCA application using AR to measure joint motion and gait patterns to address this technology gap for a simple and inexpensive MCA.
The study objective is to establish feasibility of implementing a psychologically informed rehabilitation strategy while concurrently assessing its' effectiveness in Active duty service members (ADSM) with musculoskeletal disorders (MSD) seeking care in a US Navy shore-based healthcare setting. This intervention is intended to improve the management of chronic pain in order to optimize ADSM function. The study team is proposing an observational prospective comparative cohort study. This study tests an implementation/strategy while observing/gathering information on the clinical intervention and related outcomes.
The goal of this observational study is to learn how clinicians use osteopathic manipulative treatment (OMT) for their patients who have problems only related to their muscles, bones, and joints (ie, musculoskeletal problems) compared to patients whose problems involve other body systems (eg, infections, breathing, bowel function). The main questions it aims to answer are: * What percentage of patients receiving OMT have a non-musculoskeletal problem? * Is there a difference in the OMT techniques when the patient's problems include a non-musculoskeletal problem compared to patients with only musculoskeletal problems? Surveys will be completed by the clinicians about 20 unique adult (age 18 or older) patients who have received OMT.
A global, multi-center, Disease Monitoring Study (DMS) in participants with Autosomal Dominant Hypocalcemia Type 1 (ADH1) or Autosomal Dominant Hypocalcemia Type 2 (ADH2) designed to characterize ADH1 and ADH2 disease presentation and progression through retrospective (past) and longitudinal prospective (over time into the future) data collection.
Evaluate erenumab- aooe efficacy as a therapeutic approach, for the management of painful chronic temporomandibular disorders (TMD). The study will be a randomized, double blind, placebo-controlled trial comparing erenumab-aooe vs Placebo. A total of 60 patients (30 per each arm) aged 18-65 years old of either sex, and any race or ethnicity presenting chronic temporomandibular disorders (TMD), (meeting the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for Clinical and Research Applications of chronic TMD (myalgia +/- arthralgia) will be randomly assigned in a 1:1 parallel, double-blind clinical trial, to receive either erenumab-aooe or placebo. Participants will attend 6 clinic visits (Visit 0-Visit 5) over a period of 21 weeks (20 +/- 1 weeks). Changes in pain intensity and other pain outcomes related to TMD will be assessed. Blood samples will be collected, and participants will need to keep a daily symptom diary and answer some other questionnaires.
This prospective cohort study is designed to investigate possible association(s) between subchondral insufficiency fractures (SIFKs) of the knee and pre-existing health, lifestyle, and/or musculoskeletal conditions. In doing so, this research may shed light on the underlying cause(s) of SIFKs. It is hypothesized that SIFKs of the knee are related to osteoarthritis, weak bone, and/or metabolic issues, rather than trauma.
This multi-arm, multi-site study investigates the safety, tolerability, and efficacy of stem cell therapy for the treatment of various acute and chronic conditions. Clinically observed initial findings and an extensive body of research indicate regenerative treatments are both safe and effective for the treatment of multiple conditions.
The purpose of this study is to assess the acceptance, engagement and outcomes of a digital care program for acute and chronic musculoskeletal conditions affecting the shoulder, elbow, hip, knee, ankle and spine.
To determine the safety and feasibility of autologous, culture-expanded adipose-derived (AD) mesenchymal stromal cells (MSCs) in subjects with painful degenerative disc disease (DDD).
The primary objective of this study is to establish the natural history of Farber disease (acid ceramidase deficiency) through the collection and analysis of retrospective and prospective data on patients diagnosed with Farber disease. All patients diagnosed with Farber disease are eligible, including both those who have and have not undergone hematopoietic stem cell transplantation (HSCT). Additionally, data and records from deceased patients will provide valuable retrospective data for this study. The secondary objective of the study is to establish a set of clinical data, laboratory data (biomarkers), and functional data potentially useful for: * Assessing the efficacy of HSCT and the efficacy of potential future therapies (for example with RVT-801, recombinant human acid ceramidase) in Farber disease * Characterizing changes in symptoms of patients over time * Characterizing distinct groups (phenotypes) within the patient population * Documenting the disease histories of individual patients to serve as intra-subject control data for those who may enroll in any future clinical studies with therapies for Farber disease The exploratory objectives of the study are: * To explore the relationship between patient disease activity or phenotype and specific ceramide levels or specific immunologic markers (cytokines/chemokines) in blood * To evaluate a standardized tool, the Farber Disease Natural History Instrument (FDNI), to be used for the collection of patient history information, data from clinical, laboratory, genetic, and functional studies, and data from review of medical records
The purpose of this study is to test the reliability of using telemedicine so a neurologist can remotely identify residents of a long-term care facility who should be referred to a neurologist for an in-person spasticity consultation.
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.
The study objective of Period 1 (Day 1 to Week 24) is to compare the safety and efficacy of upadacitinib 30 mg once daily (QD) and 15 mg QD versus placebo for the treatment of signs and symptoms of participants with moderately to severely active rheumatoid arthritis (RA) who are on a stable dose of csDMARDs and had an inadequate response to or intolerance to at least 1 bDMARD. The study objective of Period 2 (Week 24 to Week 260) is to evaluate the long-term safety, tolerability, and efficacy of upadacitinib 15 mg QD and 30 mg QD in participants with RA who completed Period 1.
Masons have the highest rate of overexertion injuries among all construction trades and rank second as an occupation for back injuries in the United States. Identified ergonomic solutions are the primary method of reducing exposure to risk factors associated with musculoskeletal disorders. However, many construction workers lack knowledge about these solutions, as well as basic ergonomic principles. Construction apprentices, as they embark on their careers, are greatly in need of ergonomics training to minimize the cumulative exposure that leads to musculoskeletal disorders. Apprentices receive safety training; however, ergonomics training is often limited or non-existent. In addition, apprenticeship programs often lack "soft skills" training on how to appropriately respond to work environments and practices that are unsafe. The SAVE program - SAfety Voice for Ergonomics - strives to integrate evidence-based health and safety training strategies into the mason apprenticeship skills training to teach ergonomics, problem solving, and speaking up to communicate solutions that reduce musculoskeletal injury risk. The central hypothesis is that the combination of ergonomics training and safety voice promotion will be more effective than no training or either ergonomics training alone or safety voice training alone. Following the development and pilot testing of the SAVE intervention, SAVE will be evaluated in a cluster-randomized controlled trial at 12-15 masonry training centers across the U.S. Clusters of apprentices within centers will be assigned at random to one of three intervention groups (n = 32 per group): (1) ergonomics training only, (2) combined ergonomics and safety voice training, or (3) control group with no additional training intervention. Outcomes assessed at baseline, at the conclusion of training, and then at six and 12 months post training will include: musculoskeletal symptoms, general health perceptions, knowledge of ergonomic and safety voice principles, and perception and attitudes about ergonomic and safety voice issues.
The primary objectives of this study are to compare the efficacy, safety, and tolerability of upadacitinib 30 mg once daily (QD) and 15 mg QD versus placebo for the treatment of signs and symptoms of adults with moderately to severely active rheumatoid arthritis who were on a stable dose of csDMARDs and had an inadequate response to csDMARDs.
The primary objective of this prospective, post-market study is to collect data to assess the long term outcome of a broad contact modular interbody device in the form of the InterFuse S™ or InterFuse T™ device in patients undergoing long construct fusion for degenerative disc disease and/or scoliosis. Comparisons will be made with published historical data..
The purpose of this study is to determine whether seeing a physical therapist first compared with seeing a physician first is more clinically and cost effective in an occupational setting for acute musculoskeletal conditions.
The purpose of this study is to compare the effect and safety of NuCel to DBX on patients undergoing posteriolateral lumbar spinal fusions for degenerative disc disease.