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126 Clinical Trials near Maryland
Power is an online platform that helps thousands of patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.
Psilocybin for Healthy Subjects
Baltimore, MarylandThis trial will study how psilocybin, a substance from certain mushrooms, affects thoughts and brain activity in healthy volunteers. Researchers will use computer tasks, EEG, and MRI to measure these effects. Understanding these changes may help improve future treatments and our knowledge of consciousness. Psilocybin, a psychoactive alkaloid found in hallucinogenic mushrooms, has been historically used for ritualistic, recreational, and medicinal purposes, with recent scientific interest in its potential therapeutic effects.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Age:18 - 75
Sex:All
Key Eligibility Criteria
Disqualifiers:Pregnancy, Cardiovascular Conditions, Epilepsy, Others
Must Not Be Taking:Psychoactive Medications, MAOIs
30 Participants Needed
Nicotinamide Riboside for Systemic Lupus Erythematosus (SLE)
Bethesda, MarylandStudy Description:
Systemic lupus erythematosus (SLE) occurs predominantly in women and is driven by type I interferon dysregulation and neutrophil hyperresponsiveness. Neutrophils in females have reduced mitochondrial bioenergetic capacity which affects immunometabolism. Nicotinamide adenine dinucleotide (NAD)+ boosting with nicotinamide riboside blunts type 1 IFN activation in-vivo in monocytes of healthy subjects and ex-vivo in SLE subjects. These findings support the proposal of the hypothesis that NAD+ boosting by NR supplementation will modulate metabolic pathways in lupus and blunt type 1 interferon signaling. Moreover, as type 1 interferon drives endothelial dysfunction, linked to increased cardiovascular risk, the effect of NR on endothelial function will be examined.
Objectives:
Primary Objective: Evaluate the effect of NR vs. placebo on immunometabolic and inflammatory remodeling in female SLE subjects:
Exploratory Objective: Compare and characterize myeloid cell bioenergetic and immunometabolic profiles in healthy control and SLE female subjects
Endpoints:
Primary Endpoint:
The primary end point will be to assess the effect of NR on blunting type I IFN signaling by measuring monocytic secretion of IFN-beta secretion compared to baseline in response to placebo vs. NR supplemented in SLE study subjects.
Exploratory Endpoints:
Healthy control vs. SLE subjects:
* Compare type I IFN transcript profiles in monocytes and neutrophils at baseline and in response to activation.
* Assess cell bioenergetics including: 1) monocyte and neutrophil metabolic flux mass spectroscopy of 13C-glucose and 13Cglutamine analysis to investigate their metabolic fates; (iii) Mitochondrial oxygen consumption (using glucose, amino acid, and fatty acid substrates) and glycolysis rates.
SLE baseline vs. NR/placebo supplementation:
Baseline vs. 6 weeks of NR/placebo:
-Assess effect of NR on bioenergetics by measuring steady-state metabolite levels comparing changes in placebo vs. NR groups in monocytes and neutrophils.
Baseline vs. 12 weeks of NR/placebo:
* Whole blood NAD+ levels (batched and measured at the end of study enrollment period)
* Explore effects of NR on gene regulation using monocyte and neutrophils by RNA-seq and chromatin remodeling analysis.
* Determine the effect of NR vs placebo on endothelial dysfunction in SLE subjects
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Age:18+
Sex:Female
Key Eligibility Criteria
Disqualifiers:Active Renal, CNS Disease, Pregnancy, Others
Must Not Be Taking:Biologics, Cyclophosphamide, IVIG, Others
78 Participants Needed
CMND-100 for Alcoholism
Baltimore, MarylandThe primary objective of this study is to find the tolerable dose and characterize the safety and pharmacokinetics/ pharmacodynamics (PK/PD) of single and repeated dose of CMND-100 in Healthy Volunteers (HV) and Subjects with Binge Drinking/Alcohol Use Disorder (AUD).
The secondary objective of this study is to preliminarily evaluate the efficacy of CMND-100 in reduction of drinking patterns and craving in subjects with binge drinking or/and moderate to severe AUD.
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 1, 2
Age:18 - 60
Sex:All
84 Participants Needed
Shingrix Vaccine Safety and Immunogenicity in People With HIV
Bethesda, MarylandThis trial studies how the Shingrix vaccine affects people with HIV and healthy older adults. Shingrix helps prevent shingles by boosting the body's immunity against the virus. Participants will receive two shots and be monitored over time. Shingrix has shown promising results and is recommended for adults aged 50 and over.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Previous Shingrix, Severe Allergies, Pregnancy, Others
Must Be Taking:Antiretrovirals
225 Participants Needed
POSTHOC App for Cancer Survivors
Baltimore, MarylandAt the end of cancer treatment, many patients are still dealing with symptoms of cancer and side effects of treatment. Many are also left in a surreal mental state with uncertainty regarding the future of their health. Survivorship Care Plans are plans that are provided to individuals at the completion of cancer treatment (i.e., chemotherapy, surgery, radiation). Survivorship Care Plans describe the details of a person's diagnosis and treatment, as well as provide recommendations for follow-up appointments, referrals, and healthy behaviors to accelerate recovery and prevent recurrence (e.g., diet, exercise, smoking cessation). Survivorship Care Plans are currently static documents that are provided via paper and become outdated as soon as the person's health status changes. Therefore, there is a need to digitize Survivorship Care Plans to improve the accessibility, modifiability, and longevity of the plan. In addition, with current technology, there is an opportunity for Survivorship Care Plans to be linked with mobile devices and activity trackers so that people can track health behaviors and compare them to their clinical goals, enabling people to take charge of their own health. Charles River Analytics developed an app called POSTHOC (POST-treatment Healthcare Outcomes for Cancer survivors) that digitizes the Survivorship Care Plan with goals to integrate it into the digital medical record.
Herein, phase I/II feasibility/preliminary efficacy randomized controlled trial is being conducted among 54 patients with cancer who recently completed adjuvant treatment for cancer (e.g., chemotherapy, radiotherapy, surgery) to compare 12 weeks of the POSTHOC app as part of the Survivorship Care Plan vs. the usual care Survivorship Care Plan on total symptom burden. Participants will be randomized 2:1, POSTHOC:usual care. Those randomized to the POSTHOC group will be provided with their Survivorship Care Plan via the app, and will choose to focus on nutrition or exercise for the duration of the study, based on their individual plan and personal preferences. At baseline, 6 weeks, and 12 weeks, patient-reported outcomes will be evaluated including total symptom burden, diet, and physical activity. Extensive quantitative and qualitative feedback will also be collected on the usability of the app from those in the POSTHOC arm in order to improve the app for future implementation studies.
Stay on current meds
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 1, 2
Age:18+
Sex:All
54 Participants Needed
Bacteriophage Therapy for Shigellosis
Baltimore, MarylandThe study is a first-in-human Phase 1/2a randomized, double-blind, placebo-controlled trial to assess the clinical safety and efficacy of ShigActive in healthy adults with experimental Shigella challenge.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 1, 2
Age:18 - 50
Sex:All
52 Participants Needed
Immune Response Study for Tick Bites
Bethesda, MarylandBackground:
Each year, the number of cases of tick-borne diseases increases. The deer tick (Ixodes scapularis) is the vector of at least 7 pathogens that cause human diseases, including Lyme disease. Researchers want to learn more to help them develop vaccines against ticks in the future.
Objective:
To learn how people s bodies, particularly the skin, respond to tick bites.
Eligibility:
Healthy adults aged 18 years and older who have no known history of a tick-borne disease or tick bite exposure.
Design:
Participants will be screened with a medical history, physical exam, and blood tests.
Participants will have 2 skin punch biopsies of healthy skin. For this, a sharp instrument will be used to remove a round plug of skin about the size of a pencil eraser. Participants will then have 10 clean laboratory-bred ticks placed at 2 different sites on their skin (20 ticks total). The ticks will be removed from the first site 1 day after placement and from the second site 2-4 days after placement. Participants will complete symptom diary cards. They will answer questions about itching at the tick feeding sites. They will give blood samples. Photos will be taken of the tick feeding sites. Skin punch biopsies will be collected at the sites of the tick bites.
Participants will repeat the tick feeding procedures 2 times, each 2-8 weeks apart. For the 2nd and 3rd procedures, 10 clean laboratory-bred ticks will be placed at 1 site. The ticks will be removed 2-3 days after tick placement. They will have telephone follow-up visits after each procedure.
After the final tick removal, participants will have follow-up visits in 4-6 weeks and again in 3 months. They will give blood samples and discuss how they are feeling.
Participation will last about 5-7 months.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Age:18 - 99
Sex:All
Key Eligibility Criteria
Disqualifiers:Keloids, Bleeding Disorders, Allergies, Others
Must Not Be Taking:Anticoagulants, Oral Steroids
60 Participants Needed
STMC-103H for Allergies
Baltimore, MarylandThis trial is testing a new treatment called STMC-103H to see if it can help prevent allergic diseases in young children. The study focuses on babies and infants who are at risk of developing allergies. The treatment aims to improve their immune system's response to allergens, potentially reducing conditions like atopic dermatitis.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 1, 2
Age:0 - 14
Sex:All
264 Participants Needed
Reduced-Dose Cyclophosphamide for Blood Cancer
Bethesda, MarylandThis trial is testing if a lower dose of cyclophosphamide after a bone marrow transplant can help adults with difficult-to-treat blood cancers. The aim is to prevent complications from donor cells attacking the body while reducing side effects. The study focuses on patients who are older, less fit, or have not had success with other treatments.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Age:12 - 85
Sex:All
Key Eligibility Criteria
Disqualifiers:Uncontrolled Illness, Active Non-hematopoietic Cancer, Others
Must Not Be Taking:Investigational Agents
320 Participants Needed
Hyperpolarized Xenon-129 MRI for Electronic Cigarette Use Effects on Lungs
Charlottesville, VirginiaOver the past 10 years, electronic cigarettes (e-cigarettes, EC) have been commercialized as a "less harmful" alternative to traditional cigarettes.1,2 However, e-cigarettes are believed to cause pulmonary epithelial, endothelial and vascular dysfunction, and to cause murine phenotypes similar to those of human COPD. Recently, "spiked" vape juice has been linked to severe lung damage. Unfortunately, the effects of e-cigarettes on the human lungs are still poorly understood, especially in healthy young adults. Therefore, establishing the health effects of e-cigarettes in humans is of paramount importance to guide medical and regulatory decision making. Its widespread use and immense popularity among teenagers and young adults have caused major concern given potentially significant addictive and detrimental long-term health effects.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Lung Disease, CNS Disease, Coronary Artery Disease, Renal Failure, Others
24 Participants Needed
Stem Cell Transplant for Sickle Cell Anemia
Bethesda, MarylandBackground:
Sickle cell disease can often be treated with blood stem cell transplants. But for some people the disease returns. This study will give a second transplant to people whose disease has returned but still have some donor cells in their body.
Objective:
To cure people s sickle cell disease by giving a second treatment that makes more room in their bone marrow for donor cells.
Eligibility:
People ages 4 and older with sickle cell disease who had a transplant but the disease returned, and their donor relatives. Donors can be 2 years of age or older.
Design:
Participants will be screened with medical history, physical exam, and blood tests.
Recipients will also be screened with heart and breathing tests, x-rays, a bone marrow sample, and teeth and eye exams. They must have a caregiver.
Donors will have 7-8 visits. They will take a drug for 5-6 days to prepare them for the donation. For the donation, blood is taken from a vein in the arm or groin. The stem cells are collected. The rest of the blood is returned. This may be repeated.
Recipients will get a long IV line in their arm or chest for about 1-2 months. They will take drugs to help their body accept the donor cells. They will get the donor cells and red blood cell transfusions through the line. They will stay in the hospital about 30 days after the transfusion of donor cells.
In first 3 months after the infusion, recipients will have many visits. Then they will have visits every 6 months to 1 year for 5 years. During those visits they will repeat some of the screening tests....
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Age:2 - 80
Sex:All
Key Eligibility Criteria
Disqualifiers:Uncontrolled Infections, Major Organ Failure, Pregnancy, Secondary Malignancies, Others
32 Participants Needed
Vasopressin for Acute Pain
Baltimore, MarylandThe feeling of pain is not just a sensory experience, but is also influenced by emotions, beliefs and expectations, making pain a highly subjective experience. This is evident in clinical practice, where the behavior of the physician and the treatment context can strongly influence the pain experience of patients. Research has shown that patients' expectation that a treatment will reduce pain influences individual perception of pain, even if the treatment has no active ingredient. The expectancy-induced analgesia emerges due to a modulation of the individual pain experience of patients by an engagement of endogenous inhibitory systems in the central nervous system.
The development of expectancy-induced analgesia can be generated in several ways. The investigators have previously demonstrated that social information and observational learning (e.g. the patient observes analgesia in another person receiving a treatment) can lead to expectancy-induced analgesia and pain reduction. However, the neural mechanisms (mechanisms in the brain) of how these expectancies are acquired and the neural mechanisms of analgesia induced by observational learning are unknown.
The investigators recently established a procedure to investigate neural mechanisms of observational learning in placebo analgesia. Here the investigators propose to investigate the influence of vasopressin, a neurotransmitter that is important for social interaction, on observational learning.
The investigators will use functional magnetic resonance imaging (fMRI), a non-invasive method, to investigate neural activity in humans. Participants will either receive vasopressin or saline with a nasal spray. During fMRI scanning, participants will then undergo an observational learning phase, where the study participants will learn the experience of analgesia in another person through a video, and a testing phase, where participants will perceive painful stimulations with the same cues as the observational phase. The comparison of the vasopressin group and the saline group will allow us to investigate how vasopressin influences behavioral effects of observational learning on pain perception as well as its effect on the neural processing of observational learning.
A better understanding of how the human brain processes observationally-induced analgesia would allow us to improve the therapeutic context of pain treatments by increasing the contextual factors which help patients cope with pain.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Age:18 - 65
Sex:All
Key Eligibility Criteria
Disqualifiers:Cardiovascular, Neurological, Psychiatric, Others
Must Not Be Taking:Opiates, Cocaine, Methamphetamines, Others
90 Participants Needed
Vaginal Seeding for Cesarean-Delivered Infants
Falls Church, VirginiaNeonates delivered by scheduled Cesarean Section will be randomized to receive vaginal seeding (exposing the infant to Mother's vaginal flora) or sham. Infants will be followed for three years to examine health outcomes including microbiome development, immune development, metabolic outcomes, and any adverse events.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Age:0 - 50
Sex:All
Key Eligibility Criteria
Disqualifiers:Diabetes, Genital HSV, Group B Strep, Others
Must Not Be Taking:Antibiotics
600 Participants Needed
Bone Marrow Transplant for Blood Cancer
Baltimore, MarylandIf transplantation using mismatched unrelated donors or non-first-degree relatives could be performed with an acceptable toxicity profile, an important unmet need would be served. Towards this goal, the current study extends our platform of nonmyeloablative, partially HLA-mismatched bone marrow transplant (BMT) and Peripheral Blood Stem Cell Transplant (PBSCT) to the use of such donors, investigating up to several postgrafting immunosuppression regimens that incorporate high-dose Cy. Of central interest is the incorporation of sirolimus into this postgrafting immunosuppression regimen.
The primary goal for phase 1 is to identify a transplant regimen associated with acceptable rates of severe acute GVHD and NRM by Day 100 and for phase 2 estimate the 6-month probability of survival without having had acute grade III- IV GVHD or graft failure.
No Placebo Group
Prior Safety Data
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Age:6 - 75
Sex:All
Key Eligibility Criteria
Disqualifiers:Pregnancy, Uncontrolled Infections, Active CNS Leukemia, Others
Must Be Taking:Sirolimus
100 Participants Needed
Low-Dose Radiation + Immunosuppressants for Sickle Cell Disease
Bethesda, MarylandPeople with severe congenital anemias, such as sickle cell anemia and beta-thalassemia, have been cured with bone marrow transplantation (BMT). The procedure, however, is limited to children younger than the age of 16 because the risks are lower for children than for adults.
The purpose of this study is to explore the use of a BMT regimen that, instead of chemotherapy, uses a low dose of radiation, combined with two immunosuppressive drugs. This type BMT procedure is described as nonmyeloablative, meaning that it does not destroy the patient s bone marrow. It is hoped that this type of BMT will be safe for patients normally excluded from the procedure because of their age and other reasons.
To participate in this study, patients must be between the ages of 18 and 65 and have a sibling who is a well-matched stem-cell donor. Beyond the standard BMT protocol, study participants will undergo additional procedures. The donor will receive G-CSF by injection for five days; then his or her stem cells will be collected and frozen one month prior to BMT. Approximately one month later, the patient will be given two immune-suppressing drugs, Campath 1-H and Sirolimus, as well as a single low dose of total body irradiation and then the cells from the donor will be infused.
Prior to their participation in this study, patients will undergo the following evaluations: a physical exam, blood work, breathing tests, heart-function tests, chest and sinus x-rays, and bone-marrow sampling.
...
No Placebo Group
Prior Safety Data
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 1, 2
Age:2 - 80
Sex:All
130 Participants Needed
Flu and COVID-19 Vaccines for Coronavirus and Influenza
Charlottesville, VirginiaThe purpose of this study is to learn about how the flu and COVID vaccines act when given alone or when mixed together.
This study is seeking healthy participants aged 18 or older. All participants in this study will receive only 1 shot to their arm, either a flu or COVID vaccine, alone or mixed. Participants will take part in this study for about 6 months, and participants will need to visit the clinical study site at least 4 times.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Age:18+
Sex:All
2050 Participants Needed
AZD7760 for Chronic Kidney Failure
Baltimore, MarylandThe purpose of this study is to evaluate the safety and pharmacokinetics (PK) of AZD7760 when given as an intravenous infusion to healthy participants (Phase I) or participants with end-stage kidney disease receiving hemodialysis through a central venous catheter (Phase IIa).
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Age:18 - 55
Sex:All
Key Eligibility Criteria
Disqualifiers:Hypersensitivity, Bleeding Disorders, Malignancy, Others
Must Not Be Taking:Systemic Antibiotics
231 Participants Needed
Flu Vaccine for Influenza
Charlottesville, VirginiaThe purpose of this study is to evaluate the safety and immunogenicity of a single intramuscular injection of different formulations of a hexavalent influenza messenger ribonucleic acid (mRNA) vaccine composed of differing dose levels of trivalent (TIV) mRNA hemagglutinin (HA) in combination with TIV mRNA-neuraminidase (NA) compared to an active control ((Fluzone standard-dose quadrivalent influenza vaccine (QIV-SD) or Fluzone high-dose quadrivalent influenza vaccine (QIV-HD) in adults 50 years of age and older.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Age:50+
Sex:All
1158 Participants Needed
mRNA Vaccine for Flu
Charlottesville, VirginiaThe purpose of this study is to evaluate a pandemic flu H5 strain messenger ribonucleic acid (mRNA) vaccine at 3 dose levels (low, medium, and high) in comparison with placebo in 276 healthy adult participants to select the adequate dose for further clinical development.
The duration per participant will be approximately 13 months.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 1, 2
Age:18+
Sex:All
276 Participants Needed
Flu and COVID-19 Vaccines for Virus Protection
Charlottesville, VirginiaThis study is to learn about flu and COVID vaccines, either alone or when mixed together. Healthy people aged 18 or older can join. Participants will get one shot in each arm, either a flu or COVID vaccine, alone or mixed. The study lasts about 6 months, and participants need to visit the research site at least 3 times.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 1, 2
Age:18+
Sex:All
1353 Participants Needed
RECK Injection for Spine Surgery Pain
Baltimore, Maryland"RECK" is a combination of local anesthesia medications, used for the purpose of pain control. RECK is an acronym which stands for Ropivacaine, Epinephrine, Clonidine, and Ketorolac. The purpose of this study is to investigate the effect of RECK local injectable anesthetic in the setting of posterior spinal fusion. Our specific aims are the following.
Primary aim: to investigate the effect of RECK local injectable anesthetic on postoperative VAS pain scores.
Secondary aims: to investigate of effect of RECK injection on postoperative opioid consumption and hospital length of stay.
Hypothesis: RECK injection will significantly decrease postoperative VAS pain score, opioid consumption, and hospital length of stay compared to placebo controls.
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 1, 2
Age:18 - 88
Sex:All
72 Participants Needed
Flu Vaccine for Adults
Rockville, MarylandThis trial is testing new mRNA flu vaccines in adults aged 18 and older. The vaccines work by using genetic instructions to help the body recognize and fight the flu virus. The study aims to see if these new vaccines are safe and effective. The first mRNA vaccines against potentially pandemic avian H10N8 and H7N9 influenza viruses were evaluated for safety and effectiveness over a period of several years.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 1, 2
Age:18+
Sex:All
910 Participants Needed
Pentavalent Meningococcal Vaccine for Meningococcal Disease
Washington, District of ColumbiaThis trial is testing a new vaccine that protects against five types of meningococcal bacteria in adults and adolescents. The vaccine helps the body learn to fight off these bacteria.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 1, 2
Age:10 - 25
Sex:All
1220 Participants Needed
RNA Vaccine for Malaria
Baltimore, MarylandThis trial tests a new vaccine designed to prevent malaria in healthy adults who have never had the disease. The vaccine helps the immune system recognize and fight malaria.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 1, 2
Age:18 - 55
Sex:All
177 Participants Needed
mRNA Vaccines for Norovirus
Rockville, MarylandThis trial tests the safety and immune response of two experimental mRNA vaccines, mRNA-1403 and mRNA-1405, in healthy adults. The vaccines help the body learn to fight a virus by giving it a practice run without causing illness.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 1, 2
Age:18 - 80
Sex:All
1285 Participants Needed
mRNA Vaccines for Lyme Disease
Columbia, MarylandThis trial is testing two different vaccines for Lyme disease in healthy adults. One vaccine targets seven parts of the bacteria, and the other targets just one. The vaccines use mRNA to teach the immune system to recognize and fight the bacteria.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 1, 2
Age:18 - 70
Sex:All
807 Participants Needed
BMF-219 for Type 2 Diabetes
Manassas, VirginiaThis trial tests a new pill called BMF-219 that targets a protein named menin. It includes healthy adults and those with Type 2 Diabetes to see if it helps control blood sugar levels.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 1, 2
Age:18 - 65
Sex:All
414 Participants Needed
Background:
People living with HIV(PLWH) are at a higher risk for cancers that may be curable with a bone marrow transplant. HIV infection itself is no longer a reason to not get a transplant, for patients who otherwise have a standard reason to need transplant.
Objective:
This study is being done to see if a new combination of drugs (cyclophosphamide, maraviroc, and bortezomib) is both safe and effective at protecting against graft-versus-host disease after bone marrow transplant. The study will also test the transplant s impact on your survival and control of your cancer.
Eligibility:
People aged 18 years and older living with HIV and a blood cancer that is eligible for a transplant. Healthy family members aged 12 or older who are half matched to transplant recipients are also needed to donate bone marrow.
Design:
The study will be done in 2 phases. The first phase will be to see if we can safely use a new combination of drugs to prevent GVHD. If the combination is safe in the first phase, the study will proceed to the second phase. In the second phase, we will see if this new combination can better protect against GVHD after transplant.
Participants will be screened. Their diagnoses, organ function and eligibility will be confirmed.
Participants will have a catheter inserted into a vein in their chest or neck. Medications and transfusions will be given through the catheter; blood will be drawn from it.
Participants will be in the hospital for 6 weeks or longer.
They will receive various drugs for 2 weeks to prep their body for the transplant.
The transplant cells will be administered through the catheter.
Participants will continue to receive drug treatments after the transplant.
Blood transfusions may also be needed.
Participants will return 1-2 times per week for follow-up visits for 3 months after discharge.
Participants will have visits 6, 12, 18, 24 months after transplant, then once a year for 5 years.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Age:12+
Sex:All
Key Eligibility Criteria
Disqualifiers:Pregnancy, Uncontrolled Illness, Active Psychiatric Disorder, Others
Must Be Taking:Antiretrovirals
265 Participants Needed
Low-Dose Cyclophosphamide for Graft-versus-Host Disease
Bethesda, MarylandBackground:
Blood cancers (such as leukemias or lymphomas) often do not respond to standard treatments. A transplant of blood stem cells from a healthy donor can help people with these cancers. Sometimes these transplants cause serious side effects, including a common immunologic problem called graft-versus-host disease. A drug called cyclophosphamide given early after the transplant (post-transplantation cyclophosphamide, PTCy) can reduce these complications. But sometimes this drug has its own negative effects. Furthermore, studies in mice suggest that an intermediate, rather than very high, dose of this drug may best protect against graft-versus-host disease.
Objective:
To find out if a lower dose of PTCy is more helpful for people who undergo blood stem cell transplants.
Eligibility:
People aged 18 and older who have a blood cancer and are eligible for a transplant of blood stem cells from another person. Healthy donors are also needed but must be related to the individual needing the transplant.
Design:
Participants will undergo screening. Transplant recipients will have imaging scans and tests of their heart and lung function. They will be assessed for the status of their cancer, including bone marrow taken from their pelvis and possibly also scans and/or fluid drawn from the spine depending on the disease type.
Donors will be screened for general health. They will give several tubes of blood. They will give an oral swab and saliva and stool samples for research.
Recipients will be in the hospital at least 4 to 6 weeks.
They will have a temporary catheter inserted into a vein in the chest or neck. Medications will be given and blood will be drawn through the catheter.
The transplanted stem cells will be given through the catheter. Participants will receive medications both before and after the transplant.
Participants will return to the clinic at least once a week for 3 months after leaving the hospital. Follow-up visits will continue periodically for 5 years.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Age:12+
Sex:All
Key Eligibility Criteria
Disqualifiers:Active Non-hematopoietic Malignancy, Others
Must Not Be Taking:Investigational Agents
260 Participants Needed
Donor Lymphocyte Infusion for Blood Cancers
Bethesda, MarylandThis trial is testing if giving white blood cells from a donor to patients with high-risk blood cancers can reduce the risk of the cancer coming back. The goal is to see if this approach helps fight off remaining cancer cells and prevents relapse.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Age:12+
Sex:All
Key Eligibility Criteria
Disqualifiers:Active Non-hematopoietic Malignancy, Others
Must Not Be Taking:Investigational Agents
430 Participants Needed
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Frequently Asked Questions
How much do clinical trials in Maryland pay?
Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.
How do clinical trials in Maryland work?
After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across trials in Maryland 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length in Maryland is 12 months.
How do I participate in a study as a "healthy volunteer"?
Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility in Maryland several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.
What does the "phase" of a clinical trial mean?
The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.
Do I need to be insured to participate in a medical study in Maryland ?
Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.
What are the newest clinical trials in Maryland ?
Most recently, we added THC + Beta-Myrcene Effects on Cannabis Use, Nasal Microbiota Transplant for Staphylococcus aureus Colonization and PGT121.414.LS + VRC07-523LS for HIV to the Power online platform.