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NCT04772313
This is a Phase 4, multicenter, open-label trial of pegloticase with methotrexate (MTX) in adult participants with uncontrolled gout who were previously treated with pegloticase without a concomitant immunomodulator and stopped pegloticase due to failure to maintain serum uric acid (sUA) response and/or a clinically mild infusion reaction (IR). Approximately 30 participants will be enrolled. Pegloticase + MTX will be administered for approximately 24 weeks, with an optional extension up to 48 weeks. The trial design will include 5 distinct components: 1. Screening Period, lasting up to 42 days; 2. 6-week MTX Tolerability Assessment Period (hereafter referred to as the MTX Run-in Period); 3. 24-week Pegloticase + MTX Treatment Period, which will include a Week 24/End of Trial/Early Termination Visit (subjects that end MTX and pegloticase treatment prior to the Week 24 will remain on trial for follow up until the Week 24 visit) 4. Optional Pegloticase + MTX Extension Period up to 24 weeks 5. 30-Day Post Treatment Follow -up
NCT02742090
The main objective of this study is to determine the progression free survival of umbralisib in participants who were intolerant to prior BTK (Bruton Tyrosine Kinase) inhibitors (ibrutinib, ACP-196, other) or prior PI3K-delta inhibitors (idelalisib, duvelisib, other).
NCT04677543
The primary objective of this study is to generate evidence demonstrating the domain specification (via modern psychometric methods), reliability, validity, and responsiveness (within-subject meaningful change) of the Patient-Reported Outcome (PRO) endpoints.
NCT04004767
The purpose of the TRC-PAD study is to develop a large, well-characterized, biomarker-confirmed, trial-ready cohort to facilitate rapid enrollment into AD prevention trials utilizing the APT Webstudy and subsequent referral to in-clinic evaluation and biomarker confirmation. Participants with known biomarker status may have direct referral to the Trial-Ready Cohort. If you are interested in being selected for the TRC-PAD study, you should first enroll in the APT Webstudy (https://www.aptwebstudy.org/welcome).
NCT02633891
Obesity and the metabolic syndrome (MetS) are rapidly growing problems. Individuals with the MetS are at risk for not only future chronic diseases, but they have a higher prevalence of neuropathy, including cardiac autonomic neuropathy, and have a higher incidence of falls. Currently there are no effective therapies to prevent or reverse the neuropathy seen in the MetS or to reduced the fall risk in this population. This research project will determine if a tailored balance exercise program will have functional benefits and result in a reduced fall risk in the growing population of patients with the MetS and neuropathy.
NCT04478994
The overall objective is to investigate the safety, tolerability and effect on insulin-like growth factor-1 (IGF-1), inflammatory and fibrotic biomarkers of TEPEZZA (teprotumumab-trbw, HZN-001), a fully human monoclonal antibody (mAb) inhibitor of the IGF-1 receptor (IGF-1R), administered once every 3 weeks (q3W) for 24 weeks in the treatment of participants with diffuse cutaneous systemic sclerosis (dcSSc).
NCT03519009
Addiction is a chronic relapsing disorder. High magnitude and long-duration voucher-based abstinence reinforcement is one of the most effective treatments for alcohol and drug addiction and can maintain abstinence over extended periods of time, but practical methods of implementing these interventions are needed. Workplaces could be ideal and practical vehicles for arranging and maintaining abstinence reinforcement over long time periods. Investigators' research on a model Therapeutic Workplace has shown that employment-based abstinence reinforcement, in which participants must provide alcohol- or drug-free urine samples to maintain maximum pay, can maintain alcohol and drug abstinence. Now investigators need to develop effective and economically sound methods to arrange long-term exposure to employment-based abstinence reinforcement. Investigators are proposing to evaluate the effectiveness and economic benefits of a Wage Supplement Model of arranging long-term exposure to employment-based abstinence reinforcement. Under this model, successful Therapeutic Workplace participants are offered abstinence-contingent wage supplements if they obtain and maintain competitive employment. Governments have used wage supplements effectively to increase employment in welfare recipients. The Wage Supplement Model harnesses the power of wage supplements to promote employment, while simultaneously using the wage supplements to reinforce drug and alcohol abstinence. The intervention will combine 3 elements -- the Therapeutic Workplace, Individual Placement and Support (IPS) supported employment, and abstinence-contingent wage supplements. IPS is a supported employment intervention that has been proven effective in promoting employment in adults with severe mental illness. Under this model, participants will be exposed to the Therapeutic Workplace to initiate abstinence and establish job skills. To promote employment and prevent relapse to drug use, participants will receive IPS Plus Abstinence-Contingent Wage Supplements. A randomized trial will evaluate the effectiveness and economic benefits of the Abstinence-Contingent Wage Supplement Model in promoting employment and sustaining drug abstinence. Participants will be enrolled in the Therapeutic Workplace for 3 months and then randomly assigned to a Usual Care Control group or an IPS Plus Abstinence-Contingent Wage Supplement group for one year. Usual Care Control participants will be offered counseling and referrals to employment and treatment programs. IPS Plus Abstinence-Contingent Wage Supplement participants will receive the IPS intervention and abstinence-contingent wage supplements. This novel intervention could be an effective and economically sound way to promote long-term employment and drug abstinence.
NCT03324776
To examine the effects of adding prandial Afrezza inhaled insulin to patients with type 2 diabetes who are not controlled after at least 6 months of other diabetes treatments including oral agents, basal insulin, or GLP-1 use.
NCT04919642
This study is an open-label, multicenter study to evaluate the efficacy and safety of TT-00420 tablet in adult patients with advanced cholangiocarcinoma.
NCT03493854
This is a global Phase III, two-arm, open-label, multicenter, randomized study to investigate the pharmacokinetics, efficacy, and safety of the fixed-dose combination (FDC) of pertuzumab and trastuzumab for subcutaneous (SC) administration in combination with chemotherapy in patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer in the neoadjuvant/adjuvant setting.
NCT04556734
The purpose of this study is to evaluate the safety and efficacy of etrasimod monotherapy (2 milligrams \[mg\] and 3 mg) in participants with moderate-to-severe alopecia areata (AA).
NCT02581059
This is a randomized, multi-center phase II study of ginseng in colorectal cancer patients treated with regorafenib to determine if ginseng will reduce fatigue in this patient population and improve adherence to regorafenib. Ninety (90) subjects will be enrolled and randomized using a 2:1 allocation, with 60 subjects enrolled in the regorafenib + ginseng group and 30 enrolled in the regorafenib + no ginseng group.
NCT02200757
The purpose of this study is to evaluate the efficacy and safety of aldoxorubicin compared to topotecan in subjects with metastatic small cell lung cancer.
NCT03708029
To determine the efficacy of full-thickness placental allograft in chronic wound healing
NCT04506294
This study will evaluate the predictive validity of a game-based screening system based on child self-report measures. The core study hypotheses are that (1) in-game assessments will predict problematic recovery (child pain and posttraumatic stress symptoms \[PTSS\]) and (2) parents in the intervention group will report greater confidence in managing child recovery.
NCT04581434
Many people who have posttraumatic stress disorder (PTSD) also struggle with problematic alcohol or drug use (substance use disorders \[SUD\]). Patients with both conditions prefer PTSD be treated alongside SUD. However, clinicians don't know if treatments that have been found to help those with PTSD work as well for people who also have SUD. This often leads to delaying PTSD treatment or using psychotherapies without research support. Trauma-focused psychotherapy (TFT) is the type of psychotherapy for PTSD that has been studied most often among people with both PTSD and SUD. It reduces symptoms of PTSD and substance use, although it might not work as well in those who have SUD as those who do not. Further, many patients with both PTSD and SUD do not complete TFT. Another strategy for treating PTSD is non-trauma-focused psychotherapy (NTFT). One NTFT, Present Centered Therapy, has been found to reduce symptoms of PTSD and more patients are able to complete NTFT than are able to finish TFT. However, no one has studied how well Present Centered Therapy works among patients who also have SUD. We will test which approach (TFT of NTFT) is better for reducing symptoms of PTSD and which is more likely to be completed by patients with both PTSD and SUD at VA healthcare facilities. We will also test to see whether some participants did better than others, so we can learn how to individualize treatment recommendations to patients. Participants will be assigned by chance to either TFT of NTFT. Patients assigned to TFT will receive either Prolonged Exposure or Cognitive Processing Therapy; both are weekly psychotherapies focused on addressing thoughts and/or memories related to their trauma. Those assigned to NTFT will receive Present Centered Therapy, a weekly psychotherapy in which patients learn about how PTSD relates to their current difficulties and problem solve current life difficulties. All participants will also receive SUD treatment. Participants will answer questions about their symptoms and experience with treatment before, right after they finish, and three and six months after they finish PTSD treatment. At the end of the study we will compare which treatment approach worked better to decrease PTSD symptom severity and which treatment patients were better able to complete. We will also track other outcomes that are important to patients (e.g., how they are doing in their relationships).
NCT04432857
This is an open-label, multicenter, phase Ib study to evaluate the safety and preliminary efficacy of AN0025 in combination with pembrolizumab in patients with locally advanced/metastatic tumors. It will include a dose-limiting toxicity observation phase followed by an expansion phase. All enrolled patients will be treated with AN0025 and Pembrolizumab until the patient experiences disease progression, unacceptable toxicity or withdraws consent, or for a maximum of 35 cycles (approximately 2 years). The dose of pembrolizumab will remain constant at 200 mg every 3 weeks (Q3W) for each dose level of AN0025 and in each cohort.
NCT03551496
Single phased global, prospective, multicenter clinical trial designed to demonstrate a superior patency rate and acceptable safety in below the knee arteries with lesions treated with the DES BTK Vascular Stent System vs. percutaneous transluminal angioplasty (PTA).
NCT02628405
This phase I/II trial studies the side effects and best dose of lenalidomide when given together with rituximab-ifosfamide-carboplatin-etoposide (R-ICE) and to see how well they work in treating patients with diffuse large B-cell lymphoma that has returned after a period of improvement (relapsed) and that has not responded to previous treatment (refractory). Drugs used in chemotherapy, such as rituximab, ifosfamide, carboplatin, etoposide, and lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving lenalidomide with R-ICE may be a better treatment for patients with diffuse large B-cell lymphoma.
NCT03903692
Venous leg ulcers are lower extremity ulcers that develop due to sustained venous hypertension resulting from chronic venous insufficiency. Varicose veins, deep vein thrombosis, poor calf muscle function, arterio-venous fistulae, obesity and history of leg fracture are some of the risk factors for venous ulceration. Numerous dressing types exist to treat these ulcers. This study will compare a marine polysaccharide (MPS) dressing to a carboxymethylcellulose dressing to determine which dressing better manages these wounds with regard to wound size and periwound skin condition. Subjects will be randomized to receive either MPS-Ag dressing or CMC-Ag dressing.