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Navigating Pregnancy and Parenthood With Lyme Disease
Children's National Research Institute
Lyme Disease
Post Treatment Lyme Disease
Chronic Lyme Disease
Tick-Borne Infections
Tick-Borne Diseases
This is a mixed methods study exploring the experiences of pregnancy and parenting among
participants with Lyme disease. Eligible participants will have been diagnosed with Lyme
disease (LD), post-treatment Lyme disease syndrome (PTLDS), and/or chronic Lyme (CL)
either during or before a prior pregnancy.... expand
This is a mixed methods study exploring the experiences of pregnancy and parenting among participants with Lyme disease. Eligible participants will have been diagnosed with Lyme disease (LD), post-treatment Lyme disease syndrome (PTLDS), and/or chronic Lyme (CL) either during or before a prior pregnancy. Participants will complete quantitative surveys on topics such as their medical history, their child(ren)'s development, and demographic information. They will then participate in a qualitative interview where they will be asked about their experiences with pregnancy and with parenting their child(ren) in the context of their condition. Type: Observational Start Date: Mar 2024 |
Randomized Study in Children and Adolescents With Migraine: Acute Treatment
Pfizer
Pediatric Migraine
The purpose of this study is to test the safety and efficacy of BHV-3000 versus placebo
in the acute treatment of moderate or severe migraine in children and adolescents. expand
The purpose of this study is to test the safety and efficacy of BHV-3000 versus placebo in the acute treatment of moderate or severe migraine in children and adolescents. Type: Interventional Start Date: Jan 2021 |
Pregnancy and Early Neurodevelopmental Outcomes Following In Utero Lyme Disease Exposure
Children's National Research Institute
Lyme Disease
Post-Treatment Lyme Disease
Chronic Lyme Disease
Tick-Borne Infections
Pregnancy Complications
The purpose of this pilot study is to assess the feasibility of longitudinal
neurodevelopmental evaluation of fetuses and infants exposed to Lyme disease in utero.
Participants with Lyme disease or Post-Treatment Lyme Disease Syndrome (PTLDS) will be
recruited during pregnancy. Pregnancies will be... expand
The purpose of this pilot study is to assess the feasibility of longitudinal neurodevelopmental evaluation of fetuses and infants exposed to Lyme disease in utero. Participants with Lyme disease or Post-Treatment Lyme Disease Syndrome (PTLDS) will be recruited during pregnancy. Pregnancies will be monitored and infant development will be assessed from birth until age 18 months. Type: Observational Start Date: Jul 2023 |
ACTEMRA® for the Treatment of Pediatric Adamantinomatous Craniopharyngioma
Nationwide Children's Hospital
Adamantinomatous Craniopharyngioma
Recurrent Adamantinomatous Craniopharyngioma
ACTEMRA (tocilizumab) is an IL-6 receptor antagonist used for the treatment of adult
Rheumatoid Arthritis as well as Polyarticular (PJIA) and Systemic (SJIA) Juvenile
Idiopathic Arthritis. In this Phase II, the drug will be used to treat pediatric patients
diagnosed with recurrent Adamantinomatous... expand
ACTEMRA (tocilizumab) is an IL-6 receptor antagonist used for the treatment of adult Rheumatoid Arthritis as well as Polyarticular (PJIA) and Systemic (SJIA) Juvenile Idiopathic Arthritis. In this Phase II, the drug will be used to treat pediatric patients diagnosed with recurrent Adamantinomatous Craniopharyngioma including patients who have undergone surgery and/or radiation therapy. Type: Interventional Start Date: Dec 2022 |
Efficacy and Safety of Ofatumumab and Siponimod Compared to Fingolimod in Pediatric Patients With Multiple...
Novartis Pharmaceuticals
Multiple Sclerosis (MS)
Efficacy and safety of ofatumumab and siponimod compared to fingolimod in pediatric
patients with multiple sclerosis expand
Efficacy and safety of ofatumumab and siponimod compared to fingolimod in pediatric patients with multiple sclerosis Type: Interventional Start Date: Oct 2021 |
A Study to See if Tolvaptan is Safe in Infants and Children Who at Enrollment Are 28 Days to Less Than...
Otsuka Pharmaceutical Development & Commercialization, Inc.
Autosomal Recessive Polycystic Kidney (ARPKD)
The primary objective of this study is to evaluate the safety of tolvaptan in pediatric
subjects with autosomal recessive polycystic kidney disease (ARPKD) expand
The primary objective of this study is to evaluate the safety of tolvaptan in pediatric subjects with autosomal recessive polycystic kidney disease (ARPKD) Type: Interventional Start Date: Jul 2022 |
The Mechanistic Biology of Primary Immunodeficiency Disorders
National Institute of Allergy and Infectious Diseases (NIAID)
Primary Immunodeficiency Disorders
Background:
Primary immunodeficiency disorders, or PIDs, are diseases that weaken the immune system.
This makes it easier for a person to get sick. Some PIDs are mild and may not be
diagnosed until later in life. Other kinds are severe and can be identified shortly after
birth. Researchers want... expand
Background: Primary immunodeficiency disorders, or PIDs, are diseases that weaken the immune system. This makes it easier for a person to get sick. Some PIDs are mild and may not be diagnosed until later in life. Other kinds are severe and can be identified shortly after birth. Researchers want to learn more about PIDs by comparing data from relatives and healthy volunteers to people with a PID. Objective: To learn more about PIDs, including their genetic causes. Eligibility: People ages 0 75 with a PID or their healthy biological relatives the same ages Healthy volunteers ages 18 75 Design: Participants will be screened with a medical history, physical exam, and HIV blood test. They may have a pregnancy test. Participants may repeat the screening tests. Blood taken at screening will be used for genetic tests and research tests. Participants will be told test results that affect their health. Some blood will be stored for future research. Adult participants with a PID may have a small piece of skin removed. The area will be numbed. A small tool will take a piece of skin about the size of a pencil eraser. Researchers may collect fluid or tissue samples from PID participants regular medical care. They will use them for research tests. Participants with a PID will have 3 follow-up visits over 10 years (for infants, 2 years). Visits will include a physical exam, medical history, and blood draw. Participants with a PID and their relatives will be called once a year for 10 years. They will talk about how they are feeling and if they have developed any new symptoms or illnesses. ... Type: Observational Start Date: May 2018 |
Study to Evaluate Sotatercept (MK-7962) in Children With Pulmonary Arterial Hypertension (PAH) (MK-7962-008)
Merck Sharp & Dohme LLC
Pulmonary Arterial Hypertension
The primary objectives of the study are to evaluate the safety and tolerability, and
pharmacokinetics (PK) of sotatercept over 24 weeks of treatment in children ≥1 to <18
years of age with PAH World Health Organization (WHO) Group 1 on standard of care (SoC).
There is no formal hypothesis. expand
The primary objectives of the study are to evaluate the safety and tolerability, and pharmacokinetics (PK) of sotatercept over 24 weeks of treatment in children ≥1 to <18 years of age with PAH World Health Organization (WHO) Group 1 on standard of care (SoC). There is no formal hypothesis. Type: Interventional Start Date: Jan 2023 |
DAY101 Vs. Standard of Care Chemotherapy in Pediatric Patients with Low-Grade Glioma Requiring First-Line...
Day One Biopharmaceuticals, Inc.
Low-grade Glioma
This is a 2-arm, randomized, open-label, multicenter, global, Phase 3 trial to evaluate
the efficacy, safety, and tolerability of tovorafenib monotherapy versus standard of care
(SoC) chemotherapy in patients with pediatric low-grade glioma (LGG) harboring an
activating rapidly accelerated fibrosarcoma... expand
This is a 2-arm, randomized, open-label, multicenter, global, Phase 3 trial to evaluate the efficacy, safety, and tolerability of tovorafenib monotherapy versus standard of care (SoC) chemotherapy in patients with pediatric low-grade glioma (LGG) harboring an activating rapidly accelerated fibrosarcoma (RAF) alteration requiring front-line systemic therapy. Type: Interventional Start Date: Feb 2023 |
A Study to Compare Treatment With the Drug Selumetinib Alone Versus Selumetinib and Vinblastine in Patients...
National Cancer Institute (NCI)
Recurrent Low Grade Astrocytoma
Recurrent WHO Grade 2 Glioma
Refractory Low Grade Astrocytoma
Refractory Low Grade Glioma
Refractory WHO Grade 1 Glioma
This phase III trial investigates the best dose of vinblastine in combination with
selumetinib and the benefit of adding vinblastine to selumetinib compared to selumetinib
alone in treating children and young adults with low-grade glioma (a common type of brain
cancer) that has come back after prior... expand
This phase III trial investigates the best dose of vinblastine in combination with selumetinib and the benefit of adding vinblastine to selumetinib compared to selumetinib alone in treating children and young adults with low-grade glioma (a common type of brain cancer) that has come back after prior treatment (recurrent) or does not respond to therapy (progressive). Selumetinib is a drug that works by blocking a protein that lets tumor cells grow without stopping. Vinblastine blocks cell growth by stopping cell division and may kill cancer cells. Giving selumetinib in combination with vinblastine may work better than selumetinib alone in treating recurrent or progressive low-grade glioma. Type: Interventional Start Date: Feb 2021 |
ATHN Transcends: A Natural History Study of Non-Neoplastic Hematologic Disorders
American Thrombosis and Hemostasis Network
Hematologic Disorder
Bleeding Disorder
Connective Tissue Disorder
Hemophilia
Thrombosis
In parallel with the growth of American Thrombosis and Hemostasis Network's (ATHN)
clinical studies, the number of new therapies for all congenital and acquired hematologic
conditions, not just those for bleeding and clotting disorders, is increasing
significantly. Some of the recently FDA-approved... expand
In parallel with the growth of American Thrombosis and Hemostasis Network's (ATHN) clinical studies, the number of new therapies for all congenital and acquired hematologic conditions, not just those for bleeding and clotting disorders, is increasing significantly. Some of the recently FDA-approved therapies for congenital and acquired hematologic conditions have yet to demonstrate long-term safety and effectiveness beyond the pivotal trials that led to their approval. In addition, results from well-controlled, pivotal studies often cannot be replicated once a therapy has been approved for general use.(1,2,3,4) In 2019 alone, the United States Food and Drug Administration (FDA) has issued approvals for twenty-four new therapies for congenital and acquired hematologic conditions.(5) In addition, almost 10,000 new studies for hematologic diseases are currently registered on www.clinicaltrials.gov.(6) With this increase in potential new therapies on the horizon, it is imperative that clinicians and clinical researchers in the field of non-neoplastic hematology have a uniform, secure, unbiased, and enduring method to collect long-term safety and efficacy data. ATHN Transcends is a cohort study to determine the safety, effectiveness, and practice of therapies used in the treatment of participants with congenital or acquired non-neoplastic blood disorders and connective tissue disorders with bleeding tendency. The study consists of 7 cohorts with additional study "arms" and "modules" branching off from the cohorts. The overarching objective of this longitudinal, observational study is to characterize the safety, effectiveness and practice of treatments for all people with congenital and acquired hematologic disorders in the US. As emphasized in a recently published review, accurate, uniform and quality national data collection is critical in clinical research, particularly for longitudinal cohort studies covering a lifetime of biologic risk.(7) Type: Observational Start Date: Sep 2020 |
A Study of Combination Chemotherapy for Patients With Newly Diagnosed DAWT and Relapsed FHWT
Children's Oncology Group
Anaplastic Kidney Wilms Tumor
Recurrent Kidney Wilms Tumor
Stage II Kidney Wilms Tumor
Stage III Kidney Wilms Tumor
Stage IV Kidney Wilms Tumor
This phase II trial studies how well combination chemotherapy works in treating patients
with newly diagnosed stage II-IV diffuse anaplastic Wilms tumors (DAWT) or favorable
histology Wilms tumors (FHWT) that have come back (relapsed). Drugs used in chemotherapy
regimens such as UH-3 (vincristine,... expand
This phase II trial studies how well combination chemotherapy works in treating patients with newly diagnosed stage II-IV diffuse anaplastic Wilms tumors (DAWT) or favorable histology Wilms tumors (FHWT) that have come back (relapsed). Drugs used in chemotherapy regimens such as UH-3 (vincristine, doxorubicin, cyclophosphamide, carboplatin, etoposide, and irinotecan) and ICE/Cyclo/Topo (ifosfamide, carboplatin, etoposide, cyclophosphamide, and topotecan) 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. This trial may help doctors find out what effects, good and/or bad, regimen UH-3 has on patients with newly diagnosed DAWT and standard risk relapsed FHWT (those treated with only 2 drugs for the initial WT) and regimen ICE/Cyclo/Topo has on patients with high and very high risk relapsed FHWT (those treated with 3 or more drugs for the initial WT). Type: Interventional Start Date: Oct 2020 |
Using Mobile Health (mHealth) to Improve STI Treatment Adherence Among Adolescents
Children's National Research Institute
Sexually Transmitted Diseases
We will conduct a randomized trial to compare differences in sexually transmitted
infection (STI) treatment adherence between patients receiving text messages versus those
receiving usual care (e.g. no text messages). We hypothesize that STI treatment adherence
will be 20% higher among patients randomized... expand
We will conduct a randomized trial to compare differences in sexually transmitted infection (STI) treatment adherence between patients receiving text messages versus those receiving usual care (e.g. no text messages). We hypothesize that STI treatment adherence will be 20% higher among patients randomized to receipt of two-way text messaging services. Type: Interventional Start Date: Jun 2024 |