Clinical Trials at the MFA:

TITLE DESCRIPTION
A Global, Prospective, Non-Interventional, Observational Study of Presentation, Treatment Patterns, and Outcomes in Multiple Myeloma Patients-the INSIGHT-MM study The objective of this study is to describe contemporary, real-world patterns of patient characteristics, clinical disease presentation, therapeutic regimen chosen, and clinical outcomes in patients with newly diagnosed multiple myeloma and patients with relapsed/refractory multiple myeloma.
A Hookworm Infection Study in Healthy Adults This study is being conducted to determine the optimal dose of infectious hookworm larvae that is safe to give to healthy adults, and that leads to an infection with adult worms in the intestine. Hookworm is a parasitic worm that can live for several years in the intestine of humans, feeding on the blood of the people they infect. Study participants will provide routine stool and blood samples and will receive anti-worm medication 3 months from application of the larvae to treat the infection. This study is looking to enroll males or females, 18-45 years of age in good general health, who are available for the duration of the study (6 months). Subjects must be HIV, Hep-B and Hep-C negative.
A multicenter, randomized, double blind, placebo-controlled study to evaluate the efficacy and safety of SA237 as monotherapy in patients with neuropyelitis optica (NMO) To evaluate the effectiveness and safety of under the skin injection of SA237 as monotherapy in patients with NMO.
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy, Tolerability, and Safety Study of DFN-15 in Episodic Migraine With or Without Aura Episodic migraine is a diagnosis applied to patients with migraine who experience 1-14 headache days per month. The study drug in this trial, DFN-15 (celecoxib oral solution), is an NSAID. Migraine treatment with NSAIDs can produce analgesia similar to that from opioid treatment, while sparing patients from opioid-associated side effects (i.e. sedation, nausea, and/or vomiting). The objective of this trial is to demonstrate the tolerability, safety, and efficacy of DFN-15 for the acute relief of migraine. This study will assess the proportion of patients who are free from pain and/or their most bothersome migraine symptom after treatment with the study drug.
A multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose ranging study to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of bimekizumab in adult subjects with moderate to severe chronic plaque psoriasis The primary objective of the study is to evaluate the dose response of bimekizumab (also known as UCB4940) administered subcutaneously (sc) every 4 weeks (Q4W) for 12 weeks in the treatment of subjects with moderate to severe chronic plaque psoriasis.
A Open-Label, Multicenter, Phase IIIb Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination with Letrozole for The Treatment of men and Pre/Postmenopausal Women With Hormone Receptor-Positive (HR+) HER-Negative (HER2-) Advanced Breast Cancer (aBC) with No Prior Hormonal Therapy for Advanced Disease The purpose of the PALLAS study is to determine whether the addition of palbociclib to adjuvant endocrine therapy will improve outcomes over endocrine therapy alone for HR+/HER2- early breast cancer.
A Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Multiple Dosing Regimens of Oral AGN-241689 in Episodic Migraine Prevention Episodic migraine is a diagnosis applied to patients with migraine who experience 1-14 headache days per month. CGRP (calcitonin gene-related peptide) is a neuropeptide that has been implicated in the pathophysiology of migraine. The study drug in this trial, AGN-241689, is a CGRP receptor antagonist being developed for migraine prevention. The objective of this study is to assess the safety, tolerability and efficacy of AGN-241689 compared with placebo in the prevention of episodic migraine.
A Phase 3 Randomized Study Comparing Perioperative Nivolumab vs. Observation in Patients with Localized Renal Cell Carcinoma Undergoing Nephrectomy (PROSPER RCC) This randomized phase III trial compares nephrectomy (surgery to remove a kidney or part of a kidney) with or without nivolumab in treating patients with kidney cancer that is limited to a certain part of the body (localized). Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread. Giving nivolumab before nephrectomy may make the tumor smaller and reduce the amount of normal tissue that needs to be removed, and after nephrectomy to increase survival. It is not yet known whether nivolumab and nephrectomy is more effective than nephrectomy alone in treating patients with kidney cancer.
A Phase 3, Double-Blind, Placebo-Controlled Study of Quizartinib (AC220) Administered in Combination with Induction and Consolidation Chemotherapy, and Administered as Maintenance Therapy in subjects 18 to 78 Years Old with Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (QuANTUM-first) The purpose of this study is to test how well the study medication, quizartinib, works when taken with standard chemotherapy to put AML into remission and then taken alone to prevent relapses of AML.
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare Efficacy And Safety of Oral Azacitadine Plus Best Supportive Care Versus Best Supportive Care As Maintenance Therapy in Subjects with Acute Myeloid Leukemia in Complete Remission. The purpose of this stud is to determine if oral azacitadine is safe and effective as “maintenance therapy” in continuing the response patients had with their last AML treatment and improving the quality of that response.
A Phase II Single-arm, Open-label Monotherapy Clinical Trial of Pembrolizumab (MK-3475) in Locally Advanced/Metastatic Renal Cell Carcinoma (mRCC) (KEYNOTE-427) The purpose of this study is to assess the safety and efficacy of monotherapy pembrolizumab (MK-3475) in participants with renal cell carcinoma (RCC). There will be two cohorts in this study: Cohort A will consist of participants with clear cell (cc) RCC and Cohort B will consist of participants with non-clear cell (ncc) RCC.
A Phase II, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Atacicept in IgA Nephropathy This study is evaluating a new drug for the treatment of IgA Nephropathy
A Phase III, randomised, double-blind, multicentre, parallel group, non-inferiority study evaluating the efficacy, safety, and tolerability of dolutegravir plus lamivudine compared to dolutegravir plus tenofovir/emtricitabine in HIV-1-infected treatment-naïve adults The study is being conducted to learn if the combination of two medications, one called dolutegravir (DTG) and one called lamivudine (3TC), is an effective treatment for adults who have not been treated for HIV before.
A Phase III, Randomized Trial Comparing Androgen Deprivation Therapy + TAK-700 with Androgen Deprivation Therapy + Bicalutamide in Patients with newly Diagnosed Metastatic Hormone Sensitive Prostate Cancer Men with newly diagnosed metastatic hormone sensitive prostate cancer and a PSA =2 ng/mL with be randomized to either Androgen deprivation therapy (LHRHa) + TAK-700 (ARM 1) or Androgen deprivation therapy (LHRHa) + Bicalutamide (ARM 2, also the standard of care arm). Patients will be followed for 10 years.
A Prospective Phase II Trial of Neoadjuvant Systemic Chemotherapy Followed by Extirpative Surgery for Patients with High Grade Upper Tract Urothelial Carcinoma This phase II trial studies how well giving chemotherapy before surgery works in treating patients with aggressive upper urinary tract cancer. Removing the affected upper urinary tract by surgery is the recommended treatment for upper urinary tract cancer, but can cause loss of kidney function and prevent patients from being able to receive chemotherapy after surgery. Giving chemotherapy before surgery, when the kidneys are working at their maximum, may allow less tissue to be removed during surgery and may be more effective in treating patients with high grade upper urinary tract cancer.
A Prospective, Non-randomized, Multi-Center Investigation of All-Suture-based Repair of Horizontal Meniscal Tears (STITCH Study) This study is seeking participants who may have a horizontal meniscus tear in their knee. Today it is unknown whether fixing a horizontal meniscus tear will result in a better outcome than the common approach of removing the tear. This research study will document whether a horizontal meniscus tear can hold together and heal if it is repaired with stitches. This study will also document any changes in knee pain and function after the procedure.
A randomized double blind study to compare the effectiveness and safety of an oral drug plus supportive care vs supportive care as maintenance therapy in patients with acute myeloid leukemia in complete remission To determine the safety and effectiveness of oral azacitidine plus best supportive care vs supportive care only in patient with acue myeloid leukemia in complete remission
A Randomized Phase III Trial of Palbociclib with Standard Adjuvant Endocrine Therapy Versus Standard Adjuvant Endocrine Therapy Alone for Hormone Receptor Positive (HR+)/ Human Epidermal Growth Factor Receptor 2 (HER2)-Negative early Breast Cancer (PALLAS Study) The purpose of the PALLAS study is to determine whether the addition of palbociclib to adjuvant endocrine therapy will improve outcomes over endocrine therapy alone for HR+/HER2- early breast cancer.
A Randomized, Head-to-Head, Single-Blinded Study to Assess Changes in the Immune Profile in Response to Treatment with Subcutaneous Abatacept in Combination with Methotrexate versus Subcutaneous Adalimumab in Combination with Methotrexate in Adults with Early Rheumatoid Arthritis who are Naive to Biologic Disease-Modifying Antirheumatic Drugs The immune system of patients with Rheumatoid Arthritis (RA) is different from that of people who do not have RA. The purpose of this study is to examine your immune cells and proteins before you start to take study medication and after you start treatment with one of two approved therapies for RA, abatacept versus adalimumab, both given in combination with methotrexate. This study will also check whether characteristics of your immune system assessed before you receive any study drug affect your response to the study drug received.
A Randomized, Phase II Study of CX-01 Combined with Standard Induction Therapy for Newly Diagnosed Acute Myeloid Leukemia (AML) The purpose of this study is to find out whether or not the addition of the study drug, CX-01, to standard of care treatment for AML increases the rate of remission.
Acromegaly Safety Monitoring Program An Acromegaly Safety Monitoring Program for Treating Patients with Pasireotide LAR who are in need of Medical Therapy (ACCESS Study)This study will provide acromegalic patients, for whom medical therapy is appropriate, access to paseriotide LAR while regulatory approval is sought. Potential patients must: -be age 18 or older -have confirmed diagnosis of active acromegaly (caused by GH producing pituitary tumor) -not be controlled by pituitary surgery or not be eligible or refuse surgery
ARN-509-003: A Multi-center, Randomized, Double-Blind, Placebo-Controlled, Phase III Study of ARN-509 in Men with non-Metastatic (M0) Castration-Resistant Prostate Cancer This is a randomized (2:1) trial evaluating the safety and efficacy of ARN-509 versus placebo in men with high risk (M0), non-metastatic castraction resistant prostate cancer (NM-CRPC), defined as PSA doubling time (PSADT) = 10 months
BioSET Prefix Study THis study is designed to evaluate the safety and preliminary effectiveness of one coating concentration of Prefix compared to iliac crest bone in approximately 22 skeletally mature subjects diagnosed with degenerative disc disease (DDD) at one vertabral level (L2-S1)
Blood Loss during fibroid surgery Use of Intravenous Tranexamic Acid during Myomectomy: A Randomized Double-Blind Placebo Controlled Trial The goal of this study is to help us learn more about the ability of a drug called tranexamic acid to reduce blood loss and the need for a blood transfusion that occurs during a myomectomy (fibroid surgery). Tranexamic acid is approved for patients undergoing cardiac, knee and hip surgery by the FDA but yet not approved for the indication of myomectomy surgery as being investigated in this study. The research team would like to enroll healthy women between 18 and 50 years of age; with no history of blood clots in the legs or lungs, heart attack, stroke or kidney disease and scheduled for an abdominal, laparoscopic or robotic myomectomy at George Washington University Hospital.
Combination immunotherapy with Herceptin and the HER2 vaccine E75 in low and intermediate HER2- expressing breast cancer patients to prevent recurrence This is a randomized trial for after all neo or adjuvant therapy is complete for women are Her2 1+ or HER2 2+
Comparing Group Approaches to Improve Insomnia Symptoms Among Breast Cancer Survivors We are inviting women diagnosed with stage I-III breast cancer who have completed active treatment (e.g. surgery, chemotherapy, radiation) to participate in this research study. Through this study we will examine if our mind and body programs improve some of the long term effects of breast cancer treatment such as insomnia. This is a pilot phase of the study. This means that we are interested in feasibility of the program and will ask for your feedback about things you like and do not like about the program.
Controlled Trial of Deep Brain Stimulation (DBS) for Obsessive Compulsive Disorder (OCD) The goal of this study is to complete the first definitive controlled trial of a neurosurgical procedure for a severe psychiatric illness. The study will compare the effects of three months of double-masked placebo versus active DBS on OCD severity. Potential participants must: -be between the ages of 18 and 75 -have OCD diagnosed by Structured Clinical Interview for DSM-IV (SCID-IV) -have persistence of sever symptoms and impairment for five years or more despite at least three first-line and two second-line treatments.
DuraSeal Exact Spine Sealant System Post-Approval Study This multi-center, non-randomized, two-arm, Post Approval Study will further evaluate the rate of postoperative CSF leaks in subjects who undergo a spinal procedure and receive DuraSeal Exact Spine Sealant for treatment of either an intentional or incidental opening of the dura compared to Control patients who receive other products and/or treatments to close the dura. Subjects must be 18 years of age or older and have had a spinal procedure where a dural opening (whether intentional or incidental) occured and was treated with either: -DuraSeal Exact Spine Sealant System (DuraSeal Sealant arm ONLY) or - Any other method of sealing the dura with the exception of DuraSeal Sealant- either spinal or cranial (Control arm ONLY)
E1305: A Phase 3, Randomized Trial of Chemotherapy with or without Bevacizumab with Recurrent or Metastatic Head and Neck Cancer The purpose of the study is to find out whether adding a new drug (Bevacizumab) to the standart platinum-based chemotherapy will help improve the survival of patients whose head and neck cancer has either returned after chemotherapy or spread throughout the body.
E2112-A Randomized Phase III Trial of Endocrine Therapy plus Entinostat/Placebo in Postmenopausal Patients with Hormone Receptor-Positive Advanced Breast Cancer This randomized phase III trial studies exemestane and entinostat to see how well they work compared to exemestane alone in treating postmenopausal patients with hormone receptor-positive breast cancer that has spread to nearby tissue or lymph nodes or another place in the body. Estrogen can cause the growth of breast cancer cells. Endocrine therapy using exemestane may fight breast cancer by lowering the amount of estrogen the body makes. Entinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether exemestane is more effective with or without entinostat in treating breast cancer.
Enhancing Fear Extinction via Angiotensin Type 1 Receptor Inhibition: A randomized Controlled Trial in Posttraumatic Stress Disorder The primary objective of this study is to evaluate the efficacy of losartan during 10 weeks of treatment for adults with posttraumatic stress disorder (PTSD).
Fetal Vasoreactivity in normal pregnancy This study is being performed at Children's National Health System. We are trying to understand how the normal fetus controls blood flow to the different parts of the body such as the lungs and brain. We will measure your baby’s blood flow using the same ultrasound approach used by your obstetrician. We will test your baby’s control of blood flow by measuring the responses to changes in your (the mom’s), levels of oxygen and carbon dioxide. We will make these changes by asking you to breathe extra oxygen for short periods of time. If your obstetrician determines that your pregnancy is uncomplicated, you and your baby are eligible for this study.
Induction Chemotherapy Followed by Surgery for Locally Advanced Head and Neck Cancer. The objective of this study is to assess the efficacy of induction chemotherapy followed by transoral surgical treatment and neck dissection, in definitive management of moderately advanced oropharyngeal squamous cell carcinoma. The surgical treatment will carry out Transoral Robotic Surgery (TORS) or Transoral Laser Microsurgery (TLM) for the primary tumor, and neck dissection for the management of cervical lymph nodes.
Lorcaserin for Cocaine Dependence This is a 19-week, multi-center, randomized, Phase 2 clinical study comparing the efficacy of lorcaserin (10mg twice daily) to matched placebo in the treatment of cocaine use disorder. Up to 3 weeks will be allowed for the Screening Period and a 13-week treatment phase, with a 3-week follow-up period, with scheduled visits during Study weeks 14 and 16.
Low frequency electrical stimulation of the fornix in Intractable Mesial Temporal Lobe Epilepsy (MTLE) To develop a protocl to evaluate the safety and tolerability of low frequency stimulation of the fornix in patients with MTLE.
Malignant Brain Tumors A Multicenter Study of 5-Aminolevulinic Acid (5-ALA) to Enhance Visualization of Malignant Tumor in Patients with Newly Diagnosed or Recurrent Malignant Gliomas: A Safety, Histopathology, and Correlative Biomarker Study This single arm trial is being conducted to establish the safety and efficacy of Gliolan® (5-ALA) in patients undergoing resection of newly diagnosed or recurrent malignant gliomas. The rationale for the study is that Gliolan® (5-ALA), as an adjunct to tumor resection, is safe and will provide surgeons with real-time visualization of malignant tumor.
PAC326: A Randomized, Controlled Phase 3 Study of Oral Pacritinib versus Best Available Therapy in Patients with Thrombocytopenia and Primary Myelofibrosis, Post-Polycythermia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis This study will find out if an experimental drug called pacritinib works better than best available therapies.
Photodynamic Therapy for Papulopustular Rosacea Dermatology at The GW Medical Faculty Associates is conducting an experimental research study to examine the efficacy of 5-aminolevulinic acid photodynamic therapy (5-ALA PDT) in treating rosacea. The purpose of this study is to evaluate if using 5-ALA PDT improves rosacea symptoms. We are seeking individuals with rosacea between the ages of 18 and 79 to volunteer to participate in this study. This study will take a total of six months (six total visits to the MFA). Prior to each visit, you will be examined and fill out a questionnaire. Participation in the study will be of no direct cost to you. If you are interested in participating in this research study, please contact Dermatology at The GW Medical Faculty Associates.
Pilot Study of the Safety and Feasibility of Ultrasound-Guided Fine Needle Aspiration following Hepatitis B Vaccination of Healthy Adults We are doing this study to find out if it is possible to do a procedure called a “fine needle aspiration” or “FNA” after someone is vaccinated. In this study, we want to do FNAs of lymph nodes in the armpit after vaccinating with a licensed hepatitis B vaccine, to see if we can detect special immune cells against the hepatitis B virus. Eventually, we want to use this procedure in a study of a new vaccine against HIV that is being developed. However, before we do that, we need to figure out if this procedure works. That is why we want to use a very well-known and safe vaccine – the hepatitis B vaccine called “ENGERIX-B” – that has been given to millions of people around the world, including the United States, to learn if the FNA procedure will be useful.
Placental Perfusion Imaging Using Arterial Spin Labeled MRI In this study, we are developing non-invasive tools to identify early signs of abnormalities of the placental function using arterial spin labeling (ASL) based on fetal MRI. ASL is a particularly attractive method for early and safe monitoring during pregnancy given that ASL is completely non-invasive and does not require contrast agents or exposure to ionizing radiation. Our specific aim is to develop and validate placental perfusion imaging with substantially improved image quality and sensitivity to abnormalities.
Prevention of Postpartum Hemorrhage: Pharmacokinetics and Pharmacodynamics of Tranexamic Acid Tranexamic acid was shown to significantly reduce risk of mortality when given to women with diagnosed postpartum hemorrhage in the recent Lancet WOMAN Trial.* The purpose of this study is to determine the optimal dose for using tranexamic acid to prevent postpartum hemorrhage during routine cesarean section. Women undergoing cesarean section will be eligible and must not have a history of blood clots or a known clotting condition. *http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)31111-X/fulltext
Prospective Study to Evaluate the Lateral Lumbar Interbody Fusion Surgical Approach (LLIF Prospective Study) The objective of this study is to gather clinical data and satisfaction ratings from patients who have undergone the MIS LLIF surgical approach using the Patriot TransContinental, CALIBER-L or INTERCONTINENTAL LLIF Spacer and REVOLVE Stabilization System for qualifying patients with 1-2 contiguous levels of degenerative disc disease (L2-S1) with mechanical low back pain and radicular symptoms. A total of 45 patients between 18 and 80 years of age will be enrolled and followed for 2 years with data collection preoperatively and postoperatively.
Prurigo Nodularis (Chronic Prurigo) This study is a 12-month, observational, non-interventional study assessing biomarkers, clinical outcomes, and treatment-responsiveness in patients with prurigo nodularis (PN).Patients must be 18 years or older with a confirmed diagnosis of PN (with predominantly nodular disease) by the PI. They must be able to read and understand the consent form and outcomes questionnaires and willing and able to sign the consent form. A separate consent form will be used for genomics testing, which is encouraged for all study participants but not required. Lastly, patients must be willing to participate in the following study-related activities: 1) Completion of outcome questionnaires 2) Actigraphy data collection 3) Biomarker collection by blood draws at each monthly study visit 4) Skin biopsy collection 5) Medical photography (8-24 photos taken each visit)
Randomized Controlled Trial: Physical Exam Indicated Cerclage in Twin Gestations Women with twin pregnancy who have a dilated (open) cervix detected on physical exam before 24 weeks are at increased risk for delivering their babies preterm (before 37 weeks gestation). Prematurity is associated with many complications for the babies including respiratory (breathing) problems, bleeding inside of the brain (a form of stroke), increased risk of infection, kidney, temperature and feeding problems. The primary objective of this study is to determine if physical exam indicated cerclage use reduces the incidence of spontaneous PTB in asymptomatic women with twin gestations with cervical dilation diagnosed on pelvic exam before 24 weeks of gestation.
Randomized Phase 2 study to evaluate 2 dose levels of Imetelstat in patients with myelofibrosis To determine the activity of 2 Dose levels of Imetelstat in subjects with Intermediate-2 or high risk myelofibrosis relapsed/refractory to Janus Kinase inhibitor
Randomized Phase 2 study to evaluate 2 dose levels of Imetelstat in patients with myelofibrosis To determine the activity of 2 Dose levels of Imetelstat in subjects with Intermediate-2 or high risk myelofibrosis relapsed/refractory to Janus Kinase inhibitor
Responsive Neurostimulator System (RNS) Long Term Treatment Investigation This study os designed to assess the ongoing safety and to evaluate the long-term effectiveness of adjunctive RNS therapy in reducing siezures that are refractory to two or more antiepileptic medications.
Retrospective Study to Assess the lateral Lumbar Interbody Fusion (LLIF) Surgical Approach (LLIF Retrospective Study) This will be a retrospective clinical study involving 80 patients that underwent Lateral Lumbar Interbody Fusion and Posterior Pedicle Screw Fixation using the PATRIOT TransContinental or CALIBER-L LLIF Spacer and REVOLVE or REVERE Stabilization Systems.
Role of Canagliflozin on gene expression and function of CD34+ endothelial progenitor cells in patients with type 2 diabetes and mild chronic kidney disease (Stages 1-2, CKD) We are looking to see if Invokana, an FDA Approved Type 2 Diabetes medication, can help improve kidney function and cardiovascular health. We are looking for patients aged 40-70 years with Type 2 Diabetes who are taking Metformin (1000-2000mg). Your HbA1C should be between 7 – 10 %.
Role of Linagliptin in improving renal failure by improving CD34+ stem cell number, function and gene expression in renal function impaired type 2 diabetes patients. We are looking to see if Tradjenta, an FDA Approved Type 2 Diabetes medication, can help improve kidney function and cardiovascular health. We are looking for patients aged 40-70 years with Type 2 Diabetes who are taking Metformin, Insulin, or BOTH Insulin and Metformin. Your HbA1C should be between 6.5 – 10 %.
S0931:A Phase III Trial of Everolimus for Renal Cell Ensuing Surgical Therapy This study is for renal cancer patients who have undergone full surgical resection (radical nephrectomy or partial nephrectomy). Patients must be considered pathologically either intermediate hight risk or very high risk for recurrence.
Sonography-Guided Transcervical Ablation of Uterine Fibroids (SONATA) [This study is no longer recruiting.] The SONATA Study is an FDA-approved clinical study designed to establish the safety and effectiveness of a new, investigational device to reduce heavy menstrual bleeding caused by uterine fibroids. The device, called the SONATA System, targets fibroids rather than treatment or removing the entire uterus. If effective, this device will provide an alternative to hysterectomy that is: incision-free, preserves the uterus, does not require general anesthesia and is an outpatient procedure.
STOP Scleroderma The Scleroderma bioreposiTOry and Pathogenesis Study (STOP Scleroderma) will help researchers use clinical data and human biospecimens to investigate why scleroderma patients develop certain complications from their disease. Patients with confirmed scleroderma, raynauds or positive autoantibodies are invited to participate. This research may help us understand how to prevent and treat scleroderma and other diseases.
Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine From Current Antiretroviral Regimen in Virologically Suppressed HIV-1-infected Adults The Antiretroviral Therapy as Long Acting Suppression (ATLAS) study is being conducted to establish if human immunodeficiency virus type-1 (HIV-1) infected adult participants with current viral suppression on a regimen with 2 nucleoside reverse transcriptase inhibitors (NRTIs) plus a third agent, remain suppressed upon switching to a two-drug intramuscular (IM) long-acting (LA) regimen of cabotegravir (CAB) and rilpivirine (RPV). This is a Phase 3, multi-phase, randomized, open label, active-controlled, multicenter, parallel-group, non-inferiority study in HIV-1, antiretroviral therapy (ART)-adult participants who are stably suppressed on a current antiretroviral (ARV) regimen. This study is designed to demonstrate the non-inferior antiviral activity of switching to a two drug CAB LA 400 mg + RPV LA 600 mg regimen every 4 weeks (Q4W: monthly) compared with maintenance of current ARV regimen containing 2 NRTIs plus an INI, NNRTI, or a PI. Eligible participants will be randomized (1:1) i
Study for patients with moderate to severe Chronic Plaque Psoriasis - A Phase 3, Randomized, double-blind and open label study to test the safety and efficacy of Certolizumab Pegol in subjects with moderate to severe Chronic Plaque Psoriasis The study will test the safety and effectiveness of Certolizumab Pegol vs placebo in patients with Chronic Plaque Psoriasis. An Open Label study will follow the placebo phase.
Study of Pembrolizumab With or Without Platinumb-based Combination Chemotherapy Versus Chemotherapy Alone in Urothelial Carcinoma (KEYNOTE-361) The purpose of this study is to determine the efficacy and safety of pembrolizumab (MK-3475) with or without chemotherapy versus chemotherapy alone in participants with advanced or metastatic urothelial carcinoma (bladder cancer).
Switching to Progressively Reduced Nicotine Content Cigarettes in Smokers with Lower Socioeconomic Status The goal of this randomized control trial is to learn whether reduced nicotine content cigarettes can lessen or eliminate nicotine dependence among Black and White low SES adult smokers in DC. Participants will be given the opportunity to try nicotine replacement therapy for eleven weeks after the trial period.
Use of a patch for a Chalazion (Stye on the eye) A Multi-Center, Double-Masked, Randomized, Placebo-Controlled Evaluation of the Safety and Efficacy of SUN 131 Transdermal System Patch as Compared to Placebo in Adult Patients With a Chalazion (red bump on eyelid or "Stye") Subjects will be randomly assigned to receive either SUN-131 1.5% Patch or Placebo Patch for the affected eye. All patches will be worn for 16±4 hours each day for 21 days.
Vaginal vs Intramuscular Progesterone for the Prevention of Recurrent Preterm Birth Preterm birth is one of the leading causes of neonatal morbidity and mortality. One of the most significant risk factors is a history of a prior spontaneous preterm birth. Intramuscular progesterone is the only FDA approved medication for the prevention of recurrent preterm birth. Vaginal progesterone is not FDA approved for the prevention of recurrent preterm birth, but has been found to beneficial. Given the presence of trials demonstrating efficacy for both intramuscular and vaginal progesterone in the prevention of recurrent preterm birth, but limited information one being more superior to the other, we are performing a trial comparing vaginal progesterone and intramuscular progesterone for the prevention of recurrent spontaneous preterm birth in women with a history of prior spontaneous preterm birth.
Wound Etiology and Healing Study (WE-HEAL) The purpose of the WE-HEAL Study is to help researchers use human tissue samples and health records to study the reasons why some patients heal quickly and some have problems healing wounds. All patients seen with an open wound and Hidradenitis suppurativa are asked to participate. Information from this research may help to understand how to prevent and treat certain diseases.