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Clinical Trials Unit

Stanford University School of Medicine's Center for Advanced Dermatologic Investigation is the Dermatology Department's clinical trials unit. 

The Center is home to 12-15 ongoing clinical studies, investigating the safety and efficacy of new and currently available drugs and over-the-counter medications.  The Center works with Stanford's own panel on medical research, leading pharmaceutical companies,and the Food and Drug Administration to safely and ethically expand the medical field's knowledge of dermatologic treatments.  New studies begin regularly, and the Center continues to recruit patients with skin aging, sun damage, skin cancer (including basal cell carcinomas), psoriasis, atopic dermatitis, rosacea, and other dermatologic diseases for ongoing studies. 

Skin Aging Studies

We seek to understand the human aging processes as it relates to skin on a fundamental level. To this end, our studies focus on clinical and translational research efforts ranging from: (1) the analysis of gene changes which predispose individuals to exceptionally youthful skin to (2) molecular signatures that may be biomarkers for aging skin to (3) the careful study of new candidate agents which might affect the skin aging process.

Nonmelanoma Skin Cancer

Recent advances in our understanding of basal cell skin cancer biology have enabled the development of cutting edge study drugs which combat tumor growth. We are currently home to a number of clinical trials at the forefront of potential therapy for advanced or metastatic basal cell cancer. In addition, we seek to understand the biology of basal cell skin cancers and to identify molecular predictors for treatment success.

Acne Rosecea

This is a common and frustrating chronic inflammatory condition of the face, usually affecting older individuals. The causes of this complex condition are the subject of much study. Our clinical studies seek to identify new topical or oral medications to improve the symptoms of acne rosacea.

Contact

For more information, please email dermtrials@stanford.edu

Featured Clinical Trials

  • Topical Remetinostat Gel as Neoadjuvant Therapy in Patients With Squamous Cell Carcinoma (SCC)

    The primary purpose of this study is to determine if 8 weeks of topical remetinostat applied three times daily will suppress Squamous Cell Carcinoma.

    Not accepting patients at this time View Details
  • The Impact of Pediatric Skin Disorders: The "Big" Study

    This study leverages the availability of a validated series of instruments to measure the effect of highly visible, chronic skin disorders, including atopic dermatitis (AD), on patients 8 years of age and above in causing stigma and psychiatric issues, particularly anxiety and depression.

    Investigator

    • Joyce Teng, MD, PhD
    Not accepting patients at this time View Details
  • Topical Remetinostat in Treating Patient With Cutaneous Basal Cell Cancer

    This phase 2 trial studies how well remetinostat works in treating patients with skin basal cell cancer. Remetinostat may slow the growth of basal cell cancer cells.

    Not accepting patients at this time View Details
  • Efficacy and Safety Study of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis

    This is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study of the efficacy and safety of apremilast (CC-10004) in pediatric subjects with moderate to severe plaque psoriasis.

    At least 230 pediatric subjects (ages 6 through 17 years) will be randomized 2:1 to receive either apremilast or placebo for the first 16 weeks and then all subjects will receive apremilast during the 36 week Extension Phase for a total of 52 weeks. Randomization to apremilast arm or placebo arm will be stratified by age group (6 to 11 years or 12 to 17 years). Subjects will receive apremilast treatment of either 20 mg twice daily (BID) or 30 mg BID, depending on weight. This Phase 3 study is being conducted to evaluate the safety and efficacy of apremilast in the treatment of pediatric subjects.

    Investigator

    • Joyce Teng, MD, PhD
    Not accepting patients at this time View Details

Psoriasis Clinical Trials

  • Telehealth Treatment for Alcohol Use Disorder

    Participants with alcohol use disorder will be randomly assigned to either the Ria Treatment Platform or a waitlist control. The Ria Treatment Platform is a telehealth approach that incorporates medical assessment, medications for alcohol use disorder, individual and group coaching, educational video modules, and a Bluetooth-enabled breathalyzer. Patients are followed for three months during which data are collected, including measures of alcohol consumption and its consequences.

    Investigators

    • Judith Prochaska
    • Allison Kwong
    Now accepting new patients View Details
  • Understanding Immunity to the Flu Vaccine in COVID-19 Patients

    The purpose of this study is to measure immunity to the flu vaccine over time in patients who have had COVID-19 and may have other medical conditions including obesity, type 2 diabetes, chronic fatigue, or long-term COVID-19 symptoms. Adults and children (age 9 to 64) who had been diagnosed with COVID-19 as well as controls without COVID-19 will be invited to participate in this study.

    Investigator

    • Sayantani Sindher
    Now accepting new patients View Details
  • Web-based Program to Improve Self-management Among Veterans-caregiver Dyads

    The majority of Veterans will suffer from at least one chronic illness, often at great emotional and personal cost. Self-management is critical to improving physical and emotional outcomes, and many chronically ill Veterans receive self-management assistance from an informal caregiver, and both Veterans and informal caregivers experience individual and interpersonal stress as they navigate this journey. Yet, current clinical practices are not designed to effectively support the needs of both Veterans and their informal caregiver. Furthermore, self-management practices often require in-person visits, limiting access for Veterans and informal caregivers who live in rural areas, those with a physical disability, or those with financial challenges. This project tests a web-based, self-guided, behavioral intervention that targets the stress coping needs of Veterans with chronic illness and their informal caregivers. Results from this study could provide an important solution to the problem of poor self-management, which complicates the lives and prognosis of many Veterans.

    Investigator

    • Ranak Trivedi
    Now accepting new patients View Details
  • Trial of Zolpidem for Sleep in Children With Autism

    The purpose of this study is to examine the effect of zolpidem on sleep in children and adolescents with Autism Spectrum Disorder (ASD). Zolpidem is a nonbenzodiazepine GABAa receptor agonist drug that acts as a hypnotic. To accomplish this, the investigators will use a randomized double-blind placebo-controlled crossover 8-week study design to examine the effect of zolpidem on sleep physiology as assessed by polysomnography (PSG), actigraphy, circadian rhythm, and clinical measures.

    Investigator

    • Antonio Hardan, M.D.
    Now accepting new patients View Details
  • Janus Kinase Inhibition to Prevent Ventilator-induced Diaphragm Dysfunction

    We intend, with this study, to prove that blocking the molecular mechanisms whose blockade prevents VIDD in animals, will indeed prevent the development of VIDD in humans as well. We believe that this evidence will serve as the required basis for proceeding with large, ICU-based clinical trial(s) of a drug to prevent VIDD.

    Investigator

    • Joseph Shrager
    Now accepting new patients View Details
  • The Effects of Tranexamic Acid on Joint Inflammation and Cartilage Health in Anterior Cruciate Ligament Injured Patients

    Patients who tear their ACL are at high risk for developing arthritis (post-traumatic osteoarthritis-PTOA) just 10 years later. Joint bleeding and inflammation contribute to deterioration of joint health. This study will determine whether treatment with Tranexamic Acid (TXA), an FDA approved medication that reduces bleeding right after ACL injury and reconstructive surgery reduces inflammation and improves joint health as a new strategy to prevent or delay the onset of PTOA.

    Investigator

    • Constance Chu, MD
    Now accepting new patients View Details
  • Understanding Ketamine's Dissociative Effects (KD Study)

    The purpose of this study is to understand how ketamine brings about dissociative symptoms.

    Investigators

    • Karl Deisseroth
    • Paul Nuyujukian
    Now accepting new patients View Details
  • Using Nivolumab Alone or With Cabozantinib to Prevent Mucosal Melanoma Return After Surgery

    This phase II trial tests whether nivolumab in combination with cabozantinib works in patients with mucosal melanoma. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It works by blocking the action of an abnormal protein that signals tumor cells to multiply. This helps stop the spread of tumor cells. Giving nivolumab in combination with cabozantinib could prevent cancer from returning.

    Investigator

    • Sunil Arani Reddy
    Now accepting new patients View Details
  • VO and Nivolumab vs Physician's Choice in Advanced Melanoma That Progressed on Anti-PD-1 & Anti-CTLA-4 Drugs [IGNYTE-3]

    This is a randomized, controlled, multicenter, open-label Phase 3 clinical study comparing VO in combination with nivolumab versus Physician's Choice treatment for patients with unresectable Stage IIIb-IV cutaneous melanoma whose disease progressed on an anti PD-1 and an anti-CTLA-4 containing regimen (administered either as a combination regimen or in sequence) or who are not candidates for treatment with an anti-CTLA-4 therapy.

    Now accepting new patients View Details
  • Testing Nivolumab and Ipilimumab Immunotherapy With or Without the Targeted Drug Cabozantinib in Recurrent, Metastatic, or Incurable Nasopharyngeal Cancer

    This phase II trial tests how well nivolumab and ipilimumab immunotherapy with or without cabozantinib works in treating patients with nasopharyngeal cancer that has come back (after a period of improvement) (recurrent), has spread from where it first started (primary site) to other places in the body (metastatic), or for which no treatment is currently available (incurable). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabozantinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells. Giving immunotherapy with nivolumab and ipilimumab and targeted therapy with cabozantinib may help shrink and stabilize nasopharyngeal cancer.

    Investigator

    • Saad A. Khan, MD
    Now accepting new patients View Details
  • 64Cu-LNTH-1363S in Patients With Sarcoma or Gastrointestinal Tract Cancer

    This is a multicenter, open-label, prospective Phase 1/2a study to assess safety and tolerability, establish dosimetry and to identify an optimal imaging dose (radioactivity) and imaging time window of 64Cu-LNTH-1363S, and to compare its imaging biodistribution with FAP expression by IHC in patients with sarcomas or GIT cancers. The study will be conducted in 2 parts (Part 1 and Part 2).

    Now accepting new patients View Details
  • Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer

    This phase III trial studies how well standard systemic therapy with or without definitive treatment (prostate removal surgery or radiation therapy) works in treating participants with prostate cancer that has spread to other places in the body. Addition of prostate removal surgery or radiation therapy to standard systemic therapy for prostate cancer may lower the chance of the cancer growing or spreading.

    Investigator

    • Geoffrey Sonn
    Now accepting new patients View Details
  • Study of Ravulizumab in Immunoglobulin A Nephropathy (IgAN)

    The primary objective of this study to evaluate efficacy of ravulizumab compared with placebo on proteinuria reduction and change in eGFR in adult participants with IgAN who are at risk of disease progression.

    Investigators

    • Richard Lafayette
    • Jackson Kim, MD
    Now accepting new patients View Details
  • Testing the Addition of MEDI4736 (Durvalumab) to Chemotherapy Before Surgery for Patients With High-Grade Upper Urinary Tract Cancer

    This phase II/III trial compares the effect of adding durvalumab to chemotherapy versus chemotherapy alone before surgery in treating patients with upper urinary tract cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as methotrexate, vinblastine, doxorubicin, cisplatin, and gemcitabine work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Durvalumab in combination with chemotherapy before surgery may enhance the shrinking of the tumor compared to chemotherapy alone.

    Investigator

    • Ali Raza Khaki, MD
    Now accepting new patients View Details
  • The Role of Secondary Bile Acids in Intestinal Inflammation

    The cause of Inflammatory bowel disease (IBD) is unknown, but intestinal bacteria-involved in the production of molecules that impact health-are widely accepted to play a key role. A significant proportion of IBD patients with pouches (surgically created rectums after the diseased colon is removed) continue to have inflammation similar to their previous disease.

    Only a few microbes are known to have the capability to modify primary bile acids (PBAs) made by the liver to secondary bile acids (SBAs). SBAs are some of the most common metabolites in the colon and play key roles in several diseases.

    In this study the investigators will investigate if ursodeoxycholic acid (UDCA) may reduce inflammatory markers and improve quality of life (as assessed by validate survey) in those subjects with active antibiotic refractory or antibiotic dependent pouchitis.

    Investigator

    • Sidhartha Sinha
    Now accepting new patients View Details
  • Trial of Diphenhydramine for Sleep in Children With Autism

    The purpose of this study is to examine the effect of diphenhydramine on sleep in children and adolescents with Autism Spectrum Disorder (ASD). Diphenhydramine is an anti-histaminergic agent with strong hypnotic properties. To accomplish this, the investigators will use a randomized double-blind placebo-controlled crossover 8-week study design to examine the effect of diphenhydramine on sleep physiology as assessed by polysomnography (PSG), actigraphy, circadian rhythm, and clinical measures.

    Investigator

    • Antonio Hardan, M.D.
    Now accepting new patients View Details
  • Transcranial Magnetic Stimulation for Restricted and Repetitive Behavior in ASD

    Investigating the efficacy of a form of TMS called theta-burst stimulation for restricted and repetitive behavior in ASD.

    Investigator

    • Antonio Hardan, M.D.
    Now accepting new patients View Details
  • Vinblastine/Prednisone Versus Single Therapy With Cytarabine for Langerhans Cell Histiocytosis (LCH)

    Langerhans Cell Histiocytosis (LCH) is a type of cancer that can damage tissue or cause lesions to form in one or more places in the body. Langerhans cell histiocytosis (LCH) is a cancer that begins in LCH cells (a type of dendritic cell which fights infection). Sometimes there are mutations (changes) in LCH cells as they form. These include mutations of the BRAF gene. These changes may make the LCH cells grow and multiply quickly. This causes LCH cells to build up in certain parts of the body, where they can damage tissue or form lesions.

    For most patients with LCH, standard-of-care vinblastine/prednisone are used as front-line therapy while cytarabine therapy has been used as therapy for patients who develop recurrence. No alternate treatment strategy has been developed for frontline therapy in LCH.

    The purpose of this research study is to compare previously used vinblastine/prednisone to single therapy with cytarabine for LCH. We will evaluate the utility of an imaging study called a positron emission tomography (PET) scan to more accurately assess areas of LCH involvement not otherwise seen in other imaging studies as well as response to therapy. We also want to identify if genetic and other biomarkers (special proteins in patient's blood and in patient's cancer) relate to the response of patients LCH to study treatment.

    Investigator

    • Michael Jeng
    Now accepting new patients View Details
  • Veteran-Centered Care for Advanced Liver Disease (Vet-CALD)

    Advanced liver disease is a serious illness that disproportionately affects Veterans, many of whom hope for curative liver transplantation. However, too few receive a transplant and most continue to suffer from increasing symptoms and hospitalizations. The proposed project uses a whole person, Veteran-centered approach that identifies Veterans with advanced liver disease using a population-based health management system and integrates curative and early supportive care using a telemedicine-based nurse care counselor to (1) discuss patient's understanding of illness severity and prognosis, (2) identify priorities and care preferences and (3) align curative and supportive care options to achieve patient priorities. Study outcomes include changes in (1) rates of consideration for liver transplantation, and (2) completion of serious illness discussions. Findings will inform adaptations to the intervention and facilitators for its dissemination.

    Investigator

    • Steven Asch
    Now accepting new patients View Details
  • Type 1 Diabetes and the Brain in Children

    The investigators have previously studied a group of young children with T1D using brain MRI, age-appropriate neurocognitive testing and continuous glucose monitoring, followed for 18 months. The investigators observed significant differences in gray matter volumes and white matter microstructure in the children with diabetes as compared to controls. These differences appeared to increase over time, with slower rates of brain growth in the T1D group (Mazelli, et al, Diabetes 2014; Barnea-Goraly, et al, Diabetes Care 2014; Mauras, et al, Diabetes 2015). In this new protocol the investigators will include the same children with T1D and healthy controls previously studied and recruit new similar subjects to replace those lost by attrition. The investigators will be using structural and functional brain MRI, neurocognitive testing and measures of glycemic control, to determine if changes in the brain persist or worsen over longitudinal follow up, and whether these changes are associated with measures of glycemic control and neurocognitive metrics as these children grow and progress through puberty.

    Investigator

    • Allan L. Reiss
    Now accepting new patients View Details
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Dermatology Clinical Trials

  • Telehealth Treatment for Alcohol Use Disorder

    Participants with alcohol use disorder will be randomly assigned to either the Ria Treatment Platform or a waitlist control. The Ria Treatment Platform is a telehealth approach that incorporates medical assessment, medications for alcohol use disorder, individual and group coaching, educational video modules, and a Bluetooth-enabled breathalyzer. Patients are followed for three months during which data are collected, including measures of alcohol consumption and its consequences.

    Investigators

    • Judith Prochaska
    • Allison Kwong
    Now accepting new patients View Details
  • Understanding Immunity to the Flu Vaccine in COVID-19 Patients

    The purpose of this study is to measure immunity to the flu vaccine over time in patients who have had COVID-19 and may have other medical conditions including obesity, type 2 diabetes, chronic fatigue, or long-term COVID-19 symptoms. Adults and children (age 9 to 64) who had been diagnosed with COVID-19 as well as controls without COVID-19 will be invited to participate in this study.

    Investigator

    • Sayantani Sindher
    Now accepting new patients View Details
  • Web-based Program to Improve Self-management Among Veterans-caregiver Dyads

    The majority of Veterans will suffer from at least one chronic illness, often at great emotional and personal cost. Self-management is critical to improving physical and emotional outcomes, and many chronically ill Veterans receive self-management assistance from an informal caregiver, and both Veterans and informal caregivers experience individual and interpersonal stress as they navigate this journey. Yet, current clinical practices are not designed to effectively support the needs of both Veterans and their informal caregiver. Furthermore, self-management practices often require in-person visits, limiting access for Veterans and informal caregivers who live in rural areas, those with a physical disability, or those with financial challenges. This project tests a web-based, self-guided, behavioral intervention that targets the stress coping needs of Veterans with chronic illness and their informal caregivers. Results from this study could provide an important solution to the problem of poor self-management, which complicates the lives and prognosis of many Veterans.

    Investigator

    • Ranak Trivedi
    Now accepting new patients View Details
  • Trial of Zolpidem for Sleep in Children With Autism

    The purpose of this study is to examine the effect of zolpidem on sleep in children and adolescents with Autism Spectrum Disorder (ASD). Zolpidem is a nonbenzodiazepine GABAa receptor agonist drug that acts as a hypnotic. To accomplish this, the investigators will use a randomized double-blind placebo-controlled crossover 8-week study design to examine the effect of zolpidem on sleep physiology as assessed by polysomnography (PSG), actigraphy, circadian rhythm, and clinical measures.

    Investigator

    • Antonio Hardan, M.D.
    Now accepting new patients View Details
  • Janus Kinase Inhibition to Prevent Ventilator-induced Diaphragm Dysfunction

    We intend, with this study, to prove that blocking the molecular mechanisms whose blockade prevents VIDD in animals, will indeed prevent the development of VIDD in humans as well. We believe that this evidence will serve as the required basis for proceeding with large, ICU-based clinical trial(s) of a drug to prevent VIDD.

    Investigator

    • Joseph Shrager
    Now accepting new patients View Details
  • The Effects of Tranexamic Acid on Joint Inflammation and Cartilage Health in Anterior Cruciate Ligament Injured Patients

    Patients who tear their ACL are at high risk for developing arthritis (post-traumatic osteoarthritis-PTOA) just 10 years later. Joint bleeding and inflammation contribute to deterioration of joint health. This study will determine whether treatment with Tranexamic Acid (TXA), an FDA approved medication that reduces bleeding right after ACL injury and reconstructive surgery reduces inflammation and improves joint health as a new strategy to prevent or delay the onset of PTOA.

    Investigator

    • Constance Chu, MD
    Now accepting new patients View Details
  • Understanding Ketamine's Dissociative Effects (KD Study)

    The purpose of this study is to understand how ketamine brings about dissociative symptoms.

    Investigators

    • Karl Deisseroth
    • Paul Nuyujukian
    Now accepting new patients View Details
  • Using Nivolumab Alone or With Cabozantinib to Prevent Mucosal Melanoma Return After Surgery

    This phase II trial tests whether nivolumab in combination with cabozantinib works in patients with mucosal melanoma. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It works by blocking the action of an abnormal protein that signals tumor cells to multiply. This helps stop the spread of tumor cells. Giving nivolumab in combination with cabozantinib could prevent cancer from returning.

    Investigator

    • Sunil Arani Reddy
    Now accepting new patients View Details
  • VO and Nivolumab vs Physician's Choice in Advanced Melanoma That Progressed on Anti-PD-1 & Anti-CTLA-4 Drugs [IGNYTE-3]

    This is a randomized, controlled, multicenter, open-label Phase 3 clinical study comparing VO in combination with nivolumab versus Physician's Choice treatment for patients with unresectable Stage IIIb-IV cutaneous melanoma whose disease progressed on an anti PD-1 and an anti-CTLA-4 containing regimen (administered either as a combination regimen or in sequence) or who are not candidates for treatment with an anti-CTLA-4 therapy.

    Now accepting new patients View Details
  • Testing Nivolumab and Ipilimumab Immunotherapy With or Without the Targeted Drug Cabozantinib in Recurrent, Metastatic, or Incurable Nasopharyngeal Cancer

    This phase II trial tests how well nivolumab and ipilimumab immunotherapy with or without cabozantinib works in treating patients with nasopharyngeal cancer that has come back (after a period of improvement) (recurrent), has spread from where it first started (primary site) to other places in the body (metastatic), or for which no treatment is currently available (incurable). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabozantinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells. Giving immunotherapy with nivolumab and ipilimumab and targeted therapy with cabozantinib may help shrink and stabilize nasopharyngeal cancer.

    Investigator

    • Saad A. Khan, MD
    Now accepting new patients View Details
  • 64Cu-LNTH-1363S in Patients With Sarcoma or Gastrointestinal Tract Cancer

    This is a multicenter, open-label, prospective Phase 1/2a study to assess safety and tolerability, establish dosimetry and to identify an optimal imaging dose (radioactivity) and imaging time window of 64Cu-LNTH-1363S, and to compare its imaging biodistribution with FAP expression by IHC in patients with sarcomas or GIT cancers. The study will be conducted in 2 parts (Part 1 and Part 2).

    Now accepting new patients View Details
  • Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer

    This phase III trial studies how well standard systemic therapy with or without definitive treatment (prostate removal surgery or radiation therapy) works in treating participants with prostate cancer that has spread to other places in the body. Addition of prostate removal surgery or radiation therapy to standard systemic therapy for prostate cancer may lower the chance of the cancer growing or spreading.

    Investigator

    • Geoffrey Sonn
    Now accepting new patients View Details
  • Study of Ravulizumab in Immunoglobulin A Nephropathy (IgAN)

    The primary objective of this study to evaluate efficacy of ravulizumab compared with placebo on proteinuria reduction and change in eGFR in adult participants with IgAN who are at risk of disease progression.

    Investigators

    • Richard Lafayette
    • Jackson Kim, MD
    Now accepting new patients View Details
  • Testing the Addition of MEDI4736 (Durvalumab) to Chemotherapy Before Surgery for Patients With High-Grade Upper Urinary Tract Cancer

    This phase II/III trial compares the effect of adding durvalumab to chemotherapy versus chemotherapy alone before surgery in treating patients with upper urinary tract cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as methotrexate, vinblastine, doxorubicin, cisplatin, and gemcitabine work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Durvalumab in combination with chemotherapy before surgery may enhance the shrinking of the tumor compared to chemotherapy alone.

    Investigator

    • Ali Raza Khaki, MD
    Now accepting new patients View Details
  • The Role of Secondary Bile Acids in Intestinal Inflammation

    The cause of Inflammatory bowel disease (IBD) is unknown, but intestinal bacteria-involved in the production of molecules that impact health-are widely accepted to play a key role. A significant proportion of IBD patients with pouches (surgically created rectums after the diseased colon is removed) continue to have inflammation similar to their previous disease.

    Only a few microbes are known to have the capability to modify primary bile acids (PBAs) made by the liver to secondary bile acids (SBAs). SBAs are some of the most common metabolites in the colon and play key roles in several diseases.

    In this study the investigators will investigate if ursodeoxycholic acid (UDCA) may reduce inflammatory markers and improve quality of life (as assessed by validate survey) in those subjects with active antibiotic refractory or antibiotic dependent pouchitis.

    Investigator

    • Sidhartha Sinha
    Now accepting new patients View Details
  • Trial of Diphenhydramine for Sleep in Children With Autism

    The purpose of this study is to examine the effect of diphenhydramine on sleep in children and adolescents with Autism Spectrum Disorder (ASD). Diphenhydramine is an anti-histaminergic agent with strong hypnotic properties. To accomplish this, the investigators will use a randomized double-blind placebo-controlled crossover 8-week study design to examine the effect of diphenhydramine on sleep physiology as assessed by polysomnography (PSG), actigraphy, circadian rhythm, and clinical measures.

    Investigator

    • Antonio Hardan, M.D.
    Now accepting new patients View Details
  • Transcranial Magnetic Stimulation for Restricted and Repetitive Behavior in ASD

    Investigating the efficacy of a form of TMS called theta-burst stimulation for restricted and repetitive behavior in ASD.

    Investigator

    • Antonio Hardan, M.D.
    Now accepting new patients View Details
  • Vinblastine/Prednisone Versus Single Therapy With Cytarabine for Langerhans Cell Histiocytosis (LCH)

    Langerhans Cell Histiocytosis (LCH) is a type of cancer that can damage tissue or cause lesions to form in one or more places in the body. Langerhans cell histiocytosis (LCH) is a cancer that begins in LCH cells (a type of dendritic cell which fights infection). Sometimes there are mutations (changes) in LCH cells as they form. These include mutations of the BRAF gene. These changes may make the LCH cells grow and multiply quickly. This causes LCH cells to build up in certain parts of the body, where they can damage tissue or form lesions.

    For most patients with LCH, standard-of-care vinblastine/prednisone are used as front-line therapy while cytarabine therapy has been used as therapy for patients who develop recurrence. No alternate treatment strategy has been developed for frontline therapy in LCH.

    The purpose of this research study is to compare previously used vinblastine/prednisone to single therapy with cytarabine for LCH. We will evaluate the utility of an imaging study called a positron emission tomography (PET) scan to more accurately assess areas of LCH involvement not otherwise seen in other imaging studies as well as response to therapy. We also want to identify if genetic and other biomarkers (special proteins in patient's blood and in patient's cancer) relate to the response of patients LCH to study treatment.

    Investigator

    • Michael Jeng
    Now accepting new patients View Details
  • Veteran-Centered Care for Advanced Liver Disease (Vet-CALD)

    Advanced liver disease is a serious illness that disproportionately affects Veterans, many of whom hope for curative liver transplantation. However, too few receive a transplant and most continue to suffer from increasing symptoms and hospitalizations. The proposed project uses a whole person, Veteran-centered approach that identifies Veterans with advanced liver disease using a population-based health management system and integrates curative and early supportive care using a telemedicine-based nurse care counselor to (1) discuss patient's understanding of illness severity and prognosis, (2) identify priorities and care preferences and (3) align curative and supportive care options to achieve patient priorities. Study outcomes include changes in (1) rates of consideration for liver transplantation, and (2) completion of serious illness discussions. Findings will inform adaptations to the intervention and facilitators for its dissemination.

    Investigator

    • Steven Asch
    Now accepting new patients View Details
  • Type 1 Diabetes and the Brain in Children

    The investigators have previously studied a group of young children with T1D using brain MRI, age-appropriate neurocognitive testing and continuous glucose monitoring, followed for 18 months. The investigators observed significant differences in gray matter volumes and white matter microstructure in the children with diabetes as compared to controls. These differences appeared to increase over time, with slower rates of brain growth in the T1D group (Mazelli, et al, Diabetes 2014; Barnea-Goraly, et al, Diabetes Care 2014; Mauras, et al, Diabetes 2015). In this new protocol the investigators will include the same children with T1D and healthy controls previously studied and recruit new similar subjects to replace those lost by attrition. The investigators will be using structural and functional brain MRI, neurocognitive testing and measures of glycemic control, to determine if changes in the brain persist or worsen over longitudinal follow up, and whether these changes are associated with measures of glycemic control and neurocognitive metrics as these children grow and progress through puberty.

    Investigator

    • Allan L. Reiss
    Now accepting new patients View Details
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Pediatric Dermatology Clinical Trials

  • Characteristics of Patients With Recessive Dystrophic Epidermolysis Bullosa

    Recessive dystrophic epidermolysis bullosa (RDEB) is a disease caused by genetic mutations in the gene for type VII collagen. Patients with RDEB develop large, severely painful blisters and open wounds from minor trauma to their skin. We are screening subjects with RDEB to evaluate characteristics of the subjects and their cells in order to develop new strategies of therapy and determine whether subjects could be candidates for treatment studies.

    Investigators

    • M. Peter Marinkovich, MD
    • Paul A. Khavari, MD, PhD
    • Anthony Oro, MD, PhD
    • Marius Wernig
    • Jean Y. Tang MD PhD
    Now accepting new patients View Details

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