Clinical Trials at the MFA:

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 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 clinical trial to evaluate the efficacy and safety of a topical investigational medication (LEO 43204 gel 0.037%) for the treatment of Actinic Keratosis (sun spots) on balding scalp. To determine the safety and effectiveness of LEO 43204 gel on sun spots of the balding scalp
A Phase 3 Study Investigating the Efficacy and Safety of Dupilumab Monotherapy Administered to Adult Patients with Moderate to Severe Atopic Dermatitis This is a randomized, double-blind, placebo-controlled, parallel group study to confirm the efficacy and safety of Dupilumab monotherapy in adults with maderate to severe AD (Atopic Dermatitis).The study is either 16 weeks (16 week treatment period) or 28 weeks (16-week treatment period and 12-week follow up), depending on whether or not patients continue in a maintenece or extension study.
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, 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, 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.
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
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.
IDEAS STUDY: IMAGING DEMENTIA- Evidence of Amyloid Screening This study is being conducted with the American College of Radiology Imaging Network and the Alzheimer's Association to guide clinicians on how best to use amyloid PET imaging in the evaluation of people with cognitive decline. To be eligible for the IDEAS Study, patients must be Medicare beneficiaries 65 years of age or older with Medicare as their primary insurance source and must meet the Appropriate Use Criteria for amyloid PET imaging. A patient may be eligible for the IDEAS Study if there is diagnostic uncertainty after a comprehensive clinical evaluation by a dementia expert, including laboratory tests (complete blood count, comprehensive metabolic panel, thyroid function tests and vitamin B12 level) and structural brain imaging (CT or MRI).
Investigational drug study (ipilimunab) for prostate cancer A Phase 2, Double-Blind Study of Ipilimumab Administered at 3mg/kg vs 10mg/kg in Adult Sujbects with Metastatic Chemotherapy-Naïve Castration Resistant Prostate Cancer Who are Asymptomatic or Minimally Symptomatic. The primary objective of this study is to estimate the radiographic progression-free survival of patients with chemotherapy-naïve castrate resistant prostate cancer patients randomized to ipilimumab 3mg/kg vs 10mg/kg
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.
New experimental drug treatment for prostate cancer 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
New experimental treatment for thrombocytopenia 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.
New treatment approach for multiple myeloma CC4047-MM-007: A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Pomalidamide, Bortezomib and Low-Dose Dexamethasone versus Bortezomib and Low-Dose Dexamethasone in subjects with Relapsed or Refractory Multiple myeloma The purpose of this study is to see how well the combination of pamalidomide, bortezomib and dexamethasone works compared to the combination of bortezomib and dexamethasone.
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.
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.
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.
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.
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.
X05383: Retrospective Study to Evaluate the Incidence and Severity of Peripheral Neuropathy in Relapsed/Refractory Mulitple Myeloma Patients Retreated with Bortezomib Determining the incidence and change in severity of peripheral neuropathy upon retreatment of multiple myeloma patients with bortezomib as compared to initial bortezomib treatment