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Discover 17,926 clinical trials near Philadelphia, Pennsylvania. Find research studies in your area.
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NCT02961894
To evaluate the safety and effectiveness of the Revolution™ Peripheral Atherectomy System in the treatment of infrainguinal lower extremity peripheral arterial occlusive disease. This Atherectomy system will be used on eligible patients with stenosis of at least 70% diameter reduction to evaluate the change in stenosis after the procedure (effectiveness) and the presence of any major adverse events (safety) for up to 30 days after the procedure.
NCT00790582
This is a Phase II screening study of lithium carbonate in ALS. The purpose of this study is to find out if lithium carbonate is safe to be used in people with ALS and if it can slow the progression of the disease. Since there is no placebo in this study, all patients will be taking lithium carbonate.
NCT04610164
Tranexamic acid has seen an increase in use over the past decade in hip and knee arthroplasty as well as spine surgery with more recent use seen in total shoulder arthroplasty (TSA). The mechanism of action of TXA is as a lysine analogue that competitively inhibits the conversion of plasminogen to plasmin thus resulting in its antifibrinolytic activity. Investigators have showed that compared with placebo TXA had a statistically significant effect on blood and postoperative hemoglobin levels in TSA. To date there are no studies investigating the effect of TXA in arthroscopy of any kind or studies examining the ability of TXA to aid in surgeon visualization in arthroscopic procedures. The investigators of this study will use change in pump pressure as a surrogate objective measure for surgeon visualization. The hypothesis is that participants who receive TXA will have a lower change in pump pressure compared to participants who do not receive TXA.
NCT03302247
Metastatic non small cell lung cancer can be treated with cytotoxic chemotherapy or using recently approved immunotherapy with antibody, Nivolumab. Both the therapies have limitation due to development of tolerance or immunosuppression. This trial combines one drug from each category, immunotherapeutic Nivolumab and chemotherapeutic gemcitabine as it was reported that gemcitabine reduces immunosuppression by killing myeloid derived suppressor cells, thereby increasing the efficacy of Nivolumab.
NCT02594501
The purpose of this study is to determine whether patients undergoing coronary intervention that also require oral anticoagulation, treatment with the COBRA PzF stent plus 14-day dual anti-platelet therapy (DAPT) has higher safety and non-inferior outcomes for thrombo-embolic events than compared with standard FDA-approved drug eluting stent (DES) plus 3 or 6-month DAPT.
NCT02418754
The primary objective of the study was to explore the effect of REGN2176-3 on the Early Treatment Diabetic Retinopathy Scale (ETDRS) best-corrected visual acuity (BCVA) in participants with neovascular age-related macular degeneration (AMD), compared to intravitreal aflibercept injection (IAI) monotherapy. The secondary objectives of the study were the following: * To explore the effect of 2 dose levels of IVT REGN2176-3 on anatomical changes of CNV in participants with nAMD compared to IAI monotherapy (at week 12) * To evaluate if short-term treatment with REGN2176-3 followed by IAI monotherapy offered the same or additional benefit compared to continuous treatment with REGN2176-3. Also to determine if there was benefit in initiating IAI treatment prior to REGN2176-3 compared to continuous treatment with IAI. * To assess the safety and tolerability of IVT REGN2176-3 in participants with nAMD
NCT01373424
Dystonia is a disorder characterized by excessive involuntary contraction of muscles with repetitive and patterned movements. The isolated dystonias are the most common type of dystonia and include Limb dystonias (like writer's cramp), Cervical dystonia (spasmodic torticollis), Laryngeal dystonias (like spasmodic dysphonia), and Craniofacial dystonias (like blepharospasm). The purpose of this study is to create resources to help learn more about the isolated dystonias, myoclonus dystonia, and dopa-responsive dystonia and to develop and validate various dystonia rating scales.
NCT03697252
This is a Phase 2, randomized, double-blinded, placebo-controlled, inpatient study to examine the efficacy, safety, and tolerability profile of KarXT in adult subjects diagnosed with DSM-5 schizophrenia who are in an acute exacerbation phase. The primary objective of the study is to assess the efficacy of KarXT (a fixed combination of xanomeline and trospium chloride) (xanomeline 125 mg/trospium 30 mg twice daily \[BID\]) versus placebo in reducing Positive and Negative Syndrome Scale (PANSS) total scores in adult inpatients with a Diagnostic and Statistical Manual-Fifth Edition (DSM-5) diagnosis of schizophrenia. The secondary objectives of the study are to assess overall safety and tolerability of KarXT in adult inpatients with a DSM-5 diagnosis of schizophrenia.
NCT01491737
This randomized, open-label, two-arm, multi-center, Phase II study will evaluate the efficacy and safety of pertuzumab in combination with trastuzumab plus an aromatase inhibitor (AI) in first-line participants with HER2-positive and hormone receptor-positive advanced breast cancer. Participants will be randomized to one of two treatment arms; Arm A (pertuzumab in combination with trastuzumab plus an AI) or Arm B (trastuzumab plus an AI). Participants may also receive induction chemotherapy (a taxane, either docetaxel or paclitaxel) at the investigator's discretion in combination with the assigned treatment arm. The anticipated time on study treatment is until disease progression, unacceptable toxicity, withdrawal of consent, or death whichever occurs first.
NCT04374552
The coronavirus disease-2019 (COVID-19) is spreading throughout the United States. While there are no known therapies to treat those who have become sick, there have been some reports that a medication currently used to treat rheumatoid arthritis, lupus, and malaria (Hydroxychloroquine sulfate, also known as Plaquenil) may help to lessen the chance or severity of illness, especially if combined with a medicine that treats other kinds of infections (Azithromycin, also known as Zithromax or Zmax or Zpak). There are some people who test positive for the virus but who are otherwise not ill. Current standard of care is to advise these people to self-monitor but no treatment is offered. It is not known how many of these individuals will remain symptom free, and how many will become sick or how severe those symptoms will be. This study will randomize those people who do not have symptoms into one of three treatment plans 1) Hydroxycholoquine and Azithromycin, or 2) no active medication (placebo). All participants will be followed for 2 months. The study will determine if there is any benefit to those who are asymptomatic to taking taking Hydroxychloroquine sulfate in combination with Azithromycin, or if there is no benefit from taking these medications.
NCT00503581
This randomized phase II trial is studying how well megestrol works in treating patients with endometrial neoplasia or endometrial hyperplasia. Estrogen can cause the growth of endometrial cancer cells. Hormone therapy using megestrol may fight endometrial cancer by blocking the use of estrogen by the abnormal cells.
NCT03304106
Use of Artificial Intelligent (AI) technology to assist audiologists in programming cochlear implants.
NCT02134353
This trial aims to provide prospective evidence of the safety and efficacy of mannitol 400 mg b.i.d. in subjects aged 18 years and above. We hypothesize that inhaled mannitol 400 mg b.i.d. will increase the mean change from baseline FEV1 (mL) compared to control over the 26-week treatment period in adult subjects with cystic fibrosis. Any improvement in FEV1 is considered clinically meaningful, however, this trial has set a threshold of 80 mL for the purposes of determining an appropriate sample size for statistical power while retaining trial feasibility in an orphan disease population
NCT00723957
The purpose of this study is to determine whether progression-free survival with ixabepilone is superior to that achieved with paclitaxel plus carboplatin in participants with advanced nonsmall-cell lung cancer and beta III (βIII)-tubulin-positive tumors.
NCT01526356
The study is a multi-center prospective, randomized, double-blind, placebo-controlled evaluation of the safety and efficacy of a topically applied formulation of rapamycin to cutaneous angiofibromas in subjects with Tuberous Sclerosis Complex (TSC). Subjects will apply either the topical vehicle containing rapamycin or the topical vehicle alone nightly to their angiofibromas for six months. The primary goal of this study is to evaluate the efficacy of the topical medication for reduction of cutaneous angiofibromas in patients with TSC. The secondary goal of this study is to confirm the safety of the topical medication.
NCT02043548
The purpose of this multi-center pilot study is to determine if the drug tocilizumab (Actemra) is effective in the treatment of patients with refractory adult polymyositis (PM) and dermatomyositis (DM).
NCT03691831
Phase 3 Study of A-101 Topical Solution in Subjects with Common Warts
NCT03034967
Danirixin (DNX) is a selective CXC chemokine receptor (CXCR2) antagonist being developed as a potential anti-inflammatory agent for the treatment of COPD. This is a Phase 2, randomized, double-blind (Sponsor Open) study. The primary objective of the study is to evaluate the clinical activity and safety of danirixin compared with placebo in participants with COPD. Following baseline assessments collected over a 7 day period participants will be randomized (1:1:1:1:1:1) to receive one of five dose strengths of danirixin (5 milligram \[mg\], 10 mg, 25 mg, 35 mg and 50 mg) or placebo. Study treatment will be administered orally twice daily for 24 weeks. Participants will continue with their standard of care inhaled medications (i.e. long acting bronchodilators with or without inhaled corticosteroids) while receiving study treatment. Follow up will continue up to 28 days post last dose. Approximately 700 participants will be screened with a target of 540 participants completing 24 weeks of treatment and key study assessments.
NCT03800238
The purpose of this research is to examine the efficacy of telehealth as a delivery format for an education-based caregiver wellness program focusing on self-care. The study will examine two research questions. 1) Are outcomes equivalent for caregivers in an education based-wellness program delivered via telehealth and one delivered in person as measured by a general rating of health, the Center for Epidemiologic Studies Depression Scale - Revised (CESD-R), self-care behaviors (health self-care neglect, frequency of stress management and relaxation activities, and exercise frequency), self-efficacy, use of community resources, and the Bakas Caregiving Outcomes Scale (BCOS)? 2) Is class attendance equivalent for classes delivered via telehealth and in person? This research involves a specific education-based caregiver wellness program called Powerful Tools for Caregivers (PTC). PTC is an evidence-based six-week program that addresses caregiver health by promoting self-care. Collaborating community organizations offer the program at little to no cost. This study will employ a quasi-experimental nonequivalent pretest-posttest design to compare outcomes from in-person to telehealth delivered PTC classes. PTC classes are conducted by a pair of class leaders who model concepts. Each pair of class leaders will conduct both a telehealth and in-person PTC class. Collaborating community organizations will recruit 105 caregivers to attend PTC classes delivered by 7 pairs of class leaders. Telehealth classes will use VSee software to allow caregivers to participate in the PTC program synchronously via secure videoconferencing from their own home. VSee is a free software program designed to deliver secure telehealth services. Class leaders will guide participants in installation of the software on their home computer. Participants will undergo assessment one week before and one week after the PTC program, and at six-month follow up. Outcome measures replicate previous PTC research and add additional outcomes meaningful to caregiver wellness. Statistical analysis will include descriptive statistics and a mixed design analysis of variance including repeated measures to examine differences in the variables of interest over time.
NCT03818555
Postmarket study of Sebacia Microparticles treatment during adoption into clinical use for patients with mild to moderate inflammatory acne vulgaris.