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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 preg1 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 be1 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 |
Pediatric cGVHD Symptom Scale
National Cancer Institute (NCI)
Graft vs Host Disease
Background:
Some children/adolescents who have had a stem cell transplant live with chronic
graft-versus-host-disease (cGVHD). cGVHD is a side effect of the transplant that can
cause multiple bothersome symptoms and negatively affect a child/adolescent squality of
daily life. The questionnaires th1 expand
Background: Some children/adolescents who have had a stem cell transplant live with chronic graft-versus-host-disease (cGVHD). cGVHD is a side effect of the transplant that can cause multiple bothersome symptoms and negatively affect a child/adolescent squality of daily life. The questionnaires that measure thesymptoms caused by cGVHD are designed for adults. Children/adolescents may not describe their symptoms in the same way. The goal of this research is to improve the way we measure how bothersome these symptoms are for children/adolescents living with cGVHD. Objective: To develop a questionnaire (The Pediatric cGHVD Symptom Scale) for children/adolescents living with cGVHD to identify the symptoms they are experiencing and describe how bothersome those symptoms are to them. An additional goal is to design a parent/guardian companion questionnaire that can be used to capture the symptom experiences of very young children who may not be able to complete a questionnaire. Eligibility: Children/adolescents ages 5-17 who are receiving treatment for cGVHD after a stem cell transplant, and their parent/guardian.. Design: This study consists of 2 projects. Children/adolescents with cGVHD and their parent/guardianparticipants will be grouped by the child/adolescent s age: 5-7, 8-12, and 13-17. In project 1, participants will complete an age-appropriate questionnaire about cGVHD symptoms. The questionnaire will ask about the child/adolescent s physical functioning and emotional well-being. The parent/guardian will out fill out a companion questionnaire online. The child/adolescent will then review their completed questionnaire during an interview with a researcher and will be asked whether the questions about their symptoms were difficult to understand. The parent/guardian and child/adolescent will then be interviewed together to further explore their responses to the questionnaires. Interviews will be done in person, by phone, and online. . Based on what is learned through these interviews, the wording of the questionnaire will be improved for better comprehension and ease of response. In project 2, participants will complete this revised questionnairefor their age group along with some other questionnaires that ask about quality of life. Both the child/adolescent and parent/guardian will fill out the questionnaires online at three separate time points. In both projects, children/adolescents with cGVHD and their parent/guardian participants will be grouped by the child/adolescent s age: 5-7, 8-12, and 13-17. ... Type: Observational Start Date: Oct 2019 |
Study to Evaluate Sotatercept (MK-7962) in Children With Pulmonary Arterial Hypertension (PAH) (MK-1
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 |
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-approved1 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 |
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 Adamantinomatous1 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 M1
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 T1
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 |
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,1 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 |
Dabrafenib Combined With Trametinib After Radiation Therapy in Treating Patients With Newly-Diagnos1
National Cancer Institute (NCI)
Anaplastic Astrocytoma
Anaplastic Astrocytoma, Not Otherwise Specified
Anaplastic Ganglioglioma
Anaplastic Pleomorphic Xanthoastrocytoma
Glioblastoma
This phase II trial studies how well the combination of dabrafenib and trametinib works
after radiation therapy in children and young adults with high grade glioma who have a
genetic change called BRAF V600 mutation. Radiation therapy uses high energy rays to kill
tumor cells and reduce the size of1 expand
This phase II trial studies how well the combination of dabrafenib and trametinib works after radiation therapy in children and young adults with high grade glioma who have a genetic change called BRAF V600 mutation. Radiation therapy uses high energy rays to kill tumor cells and reduce the size of tumors. Dabrafenib and trametinib may stop the growth of tumor cells by blocking BRAF and MEK, respectively, which are enzymes that tumor cells need for their growth. Giving dabrafenib with trametinib after radiation therapy may work better than treatments used in the past in patients with newly-diagnosed BRAF V600-mutant high-grade glioma. Type: Interventional Start Date: Feb 2020 |
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 to1 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 |
Project: Every Child for Younger Patients With Cancer
Children's Oncology Group
Adrenal Gland Pheochromocytoma
Carcinoma In Situ
Central Nervous System Neoplasm
Childhood Immature Teratoma
Childhood Langerhans Cell Histiocytosis
This study gathers health information for the Project: Every Child for younger patients
with cancer. Gathering health information over time from younger patients with cancer may
help doctors find better methods of treatment and on-going care. expand
This study gathers health information for the Project: Every Child for younger patients with cancer. Gathering health information over time from younger patients with cancer may help doctors find better methods of treatment and on-going care. Type: Observational Start Date: Nov 2015 |
DAY101 Vs. Standard of Care Chemotherapy in Pediatric Patients with Low-Grade Glioma Requiring Firs1
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 fibrosar1 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 in1
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 prio1 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 |
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 ran1 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 |
Implementing Models for Mechanical Circulatory Support Presurgical Assessment in Congenital Heart D1
Columbia University
Congenital Heart Disease
The purpose of this research study is to look at the advantages of using a 3D printed
heart model for surgical planning in children who have been diagnosed with Congenital
Heart Disease (CHD) and clinical heart failure and will undergo a ventricular assist
device (VAD) placement. The investigators1 expand
The purpose of this research study is to look at the advantages of using a 3D printed heart model for surgical planning in children who have been diagnosed with Congenital Heart Disease (CHD) and clinical heart failure and will undergo a ventricular assist device (VAD) placement. The investigators want to study the correlation of having a 3D printed model with improvement in patient outcomes and compare those with patients who have had a VAD placement without a 3D model. Type: Interventional Start Date: Jan 2020 |
Developing a Method to Objectively Measure Opioid Analgesia
Julia Finkel
Analgesics, Antipyretics and Anti-Inflammatory Drugs Causing Adverse Effects in Therapeutic Use
Inappropriate prescribing is the fundamental upstream driver of the opioid epidemic.
Objective measures to determine the appropriateness of an opioid intervention, provide
monitoring of the therapy for adequacy of dose and detection of tolerance or hyperalgesia
would eliminate the subjective nature1 expand
Inappropriate prescribing is the fundamental upstream driver of the opioid epidemic. Objective measures to determine the appropriateness of an opioid intervention, provide monitoring of the therapy for adequacy of dose and detection of tolerance or hyperalgesia would eliminate the subjective nature of opioid mediated pain management and obviate iatrogenic facilitation of opioid abuse. The present study is designed to objectively determine whether our device can pain type and determine analgesic efficacy thereby optimizing treatment selection and opioid management. Type: Observational Start Date: Jul 2018 |
Sickle Cell Disease Transplant Using a Nonmyeloablative Approach for Patients With Anti-donor Red C1
Children's National Research Institute
Sickle Cell Disease
This multicenter prospective study seeks to determine if daratumumab given, prior to
HLA-identical sibling donor transplantation using alemtuzumab, low dose total-body
irradiation, and sirolimus, can prevent pure red blood cell aplasia with an acceptable
safety profile in patients with anti-donor r1 expand
This multicenter prospective study seeks to determine if daratumumab given, prior to HLA-identical sibling donor transplantation using alemtuzumab, low dose total-body irradiation, and sirolimus, can prevent pure red blood cell aplasia with an acceptable safety profile in patients with anti-donor red blood cell antibodies, achieving an event-free survival similar to transplanted patients without such antibodies. Type: Interventional Start Date: Apr 2024 |
Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children1
National Cancer Institute (NCI)
Ganglioneuroblastoma, Nodular
Neuroblastoma
This phase III trial tests how well the addition of dinutuximab to Induction chemotherapy
along with standard of care surgical resection of the primary tumor, radiation, stem cell
transplantation, and immunotherapy works for treating children with newly diagnosed
high-risk neuroblastoma. Dinutuxima1 expand
This phase III trial tests how well the addition of dinutuximab to Induction chemotherapy along with standard of care surgical resection of the primary tumor, radiation, stem cell transplantation, and immunotherapy works for treating children with newly diagnosed high-risk neuroblastoma. Dinutuximab is a monoclonal antibody that binds to a molecule called GD2, which is found on the surface of neuroblastoma cells, but is not present on many healthy or normal cells in the body. When dinutuximab binds to the neuroblastoma cells, it helps signal the immune system to kill the tumor cells. This helps the cells of the immune system kill the cancer cells, this is a type of immunotherapy. When chemotherapy and immunotherapy are given together, during the same treatment cycle, it is called chemoimmunotherapy. This clinical trial randomly assigns patients to receive either standard chemotherapy and surgery or chemoimmunotherapy (chemotherapy plus dinutuximab) and surgery during Induction therapy. Chemotherapy drugs administered during Induction include, cyclophosphamide, topotecan, cisplatin, etoposide, vincristine, and doxorubicin. These drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing or by stopping them from spreading. Upon completion of 5 cycles of Induction therapy, a disease evaluation is completed to determine how well the treatment worked. If the tumor responds to therapy, patients receive a tandem transplantation with stem cell rescue. If the tumor has little improvement or worsens, patients receive chemoimmunotherapy on Extended Induction. During Extended Induction, dinutuximab is given with irinotecan, temozolomide. Patients with a good response to therapy move on to Consolidation therapy, when very high doses of chemotherapy are given at two separate points to kill any remaining cancer cells. Following, transplant, radiation therapy is given to the site where the cancer originated (primary site) and to any other areas that are still active at the end of Induction. The final stage of therapy is Post-Consolidation. During Post-Consolidation, dinutuximab is given with isotretinoin, with the goal of maintaining the response achieved with the previous therapy. Adding dinutuximab to Induction chemotherapy along with standard of care surgical resection of the primary tumor, radiation, stem cell transplantation, and immunotherapy may be better at treating children with newly diagnosed high-risk neuroblastoma. Type: Interventional Start Date: Apr 2024 |
Vosoritide for Short Stature in Turner Syndrome
Roopa Kanakatti Shankar, MBBS, MS
Turner Syndrome
Short Stature
Turner syndrome (TS) is characterized by a missing whole or part of the second sex
chromosome in a phenotypic female, resulting in short stature due to haploinsufficiency
of the short-stature homeobox-containing (SHOX) gene. Growth hormone (GH) is an approved
therapy for this condition, although no1 expand
Turner syndrome (TS) is characterized by a missing whole or part of the second sex chromosome in a phenotypic female, resulting in short stature due to haploinsufficiency of the short-stature homeobox-containing (SHOX) gene. Growth hormone (GH) is an approved therapy for this condition, although not associated with GH deficiency, and benefits are modest. Vosoritide, a C-type natriuretic peptide (CNP) analog, targets chondrocytes within the growth plate leading to increased cell proliferation and hypertrophy. We hypothesize that patients with TS and short stature will respond to vosoritide treatment leading to increased growth velocity. This study will enroll pre-pubertal girls with TS who are either naïve to GH or have had a poor response to GH therapy. All subjects will be treated with vosoritide for 12 months and will be assessed for safety monitoring and improvement in height outcomes. Annualized growth velocity (AGV) on vosoritide will be compared to AGV in the 6-18 months prior to initiation of vosoritide based on historical data available in the medical record. Subjects with a positive response to therapy will be given the option to continue in the extension phase of the study during which they will continue to receive vosoritide until growth cessation. Type: Interventional Start Date: Apr 2024 |
A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)
Center for International Blood and Marrow Transplant Research
Hematologic Malignancies
Inherited Disorders of Metabolism
Inherited Abnormalities of Platelets
Histiocytic Disorders
Acute Myelogenous Leukemia (AML or ANLL)
This study is an access and distribution protocol for unlicensed cryopreserved cord blood
units (CBUs) in pediatric and adult patients with hematologic malignancies and other
indications. expand
This study is an access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) in pediatric and adult patients with hematologic malignancies and other indications. Type: Observational Start Date: Oct 2011 |
ML-004 in Adolescents and Adults with Autism Spectrum Disorders (ASD)
MapLight Therapeutics
Autism Spectrum Disorder
ML-004-002 is a multi-center, randomized, double-blind, parallel-group,
placebo-controlled study that will enroll approximately 150 adolescent and adult subjects
with ASD. The primary objective is to evaluate the efficacy of ML-004 compared with
placebo in the improvement of social communication de1 expand
ML-004-002 is a multi-center, randomized, double-blind, parallel-group, placebo-controlled study that will enroll approximately 150 adolescent and adult subjects with ASD. The primary objective is to evaluate the efficacy of ML-004 compared with placebo in the improvement of social communication deficits in subjects with ASD. Type: Interventional Start Date: Sep 2022 |
Flavored, Oral Irinotecan VAL-413 (Orotecan®) Given With Temozolomide for Treatment of Recurrent Pe1
Valent Technologies, LLC
Solid Tumors
Neuroblastoma
Rhabdomyosarcoma
Ewing Sarcoma
Hepatoblastoma
A pilot pharmacokinetic trial to determine the safety and efficacy of a flavored, orally
administered irinotecan VAL-413 (Orotecan®) given with temozolomide for treatment of
recurrent pediatric solid tumors including but not limited to neuroblastoma,
rhabdomyosarcoma, Ewing sarcoma, hepatoblastoma1 expand
A pilot pharmacokinetic trial to determine the safety and efficacy of a flavored, orally administered irinotecan VAL-413 (Orotecan®) given with temozolomide for treatment of recurrent pediatric solid tumors including but not limited to neuroblastoma, rhabdomyosarcoma, Ewing sarcoma, hepatoblastoma and medulloblastoma Type: Interventional Start Date: Oct 2021 |
Prospective Observational Cohort Study of Fetal Atrial Flutter & Supraventricular Tachycardia
Edgar Jaeggi
Atrial Flutter
Tachycardia, Supraventricular
Tachycardia, Atrial Ectopic
Tachycardia, Reciprocating
Tachycardia Atrial
The FAST Trial Registry is a prospective observational cohort study of fetuses with a new
diagnosis of atrial flutter (AF) or supraventricular tachycardia (SVT) that is severe
enough to consider prenatal treatment (see eligibility criteria below). Aims of the
Registry include to establish a large c1 expand
The FAST Trial Registry is a prospective observational cohort study of fetuses with a new diagnosis of atrial flutter (AF) or supraventricular tachycardia (SVT) that is severe enough to consider prenatal treatment (see eligibility criteria below). Aims of the Registry include to establish a large clinical database to determine and compare the efficacy and safety of different prenatal treatment strategies including observation without immediate treatment, transplacental antiarrhythmic fetal treatment and direct fetal treatment from the time of tachycardia diagnosis to death, neonatal hospital discharge or to a maximum of 30 days after birth. Type: Observational Start Date: Jun 2017 |