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Clinical and Genetic Evaluation of Individuals With Undiagnosed Disorders Through the Undiagnosed Diseases...
National Human Genome Research Institute (NHGRI)
Genetic Disease
Background:
- Without an explanation for severe and sometimes life-threatening symptoms, patients and
their families are left in a state of unknown. The NIH helped create a network of medical
research centers, called the Undiagnosed Diseases Network (UDN), to provide care... expand
Background: - Without an explanation for severe and sometimes life-threatening symptoms, patients and their families are left in a state of unknown. The NIH helped create a network of medical research centers, called the Undiagnosed Diseases Network (UDN), to provide care and answers for these individuals. Objectives: - To improve diagnosis and care for people with undiagnosed diseases. Eligibility: - People with undiagnosed diseases, and their relatives. Design: - Participants will travel to one of the UDN medical centers for a 5-day clinical and research visit. - As part of the visit, UDN healthcare providers may ask participants to have: - Clinically indicated tests and procedures performed including: - A physical exam - Blood and urine tests - A review of health and family history - X-rays and body scans - Surveys - Photographs of the face and body - A special diet to see if the body can handle the food without having a reaction, like vomiting - Video or voice recordings - Other tests and procedures to help reach a diagnosis - Research tests and procedures performed including: - A skin biopsy. For this, a small piece of skin will be taken. - Surveys - Other tests and procedures for research that may not be related to a diagnosis or treatment. - Most participants will be asked to give samples for genetic testing. - Participants may be contacted after their visit to discuss test results. They may also be contacted in the future for interviews and surveys. - Relatives of participants may be asked to give samples for genetic testing. They may be asked to have parts of their visit recorded and to have additional tests. They may also be contacted in the future for interviews and surveys. - Clinical and research information collected will be stored in a database. - Information and samples collected will be shared with others for research purposes. Type: Observational Start Date: Jul 2015 |
NEXUS Aortic Arch Clinical Study to Evaluate Safety and Effectiveness
Endospan Ltd.
Aortic Dissection
Aortic Aneurysm
Intramural Hematoma
Penetrating Aortic Ulcer
Prospective, non-randomized, multi-center clinical investigation of the NEXUS™ Aortic Arch
Stent Graft System (NEXUSTM) for the treatment of thoracic aortic lesions involving the
aortic arch with a proximal landing zone, native or previously implanted surgical graft, in
the... expand
Prospective, non-randomized, multi-center clinical investigation of the NEXUS™ Aortic Arch Stent Graft System (NEXUSTM) for the treatment of thoracic aortic lesions involving the aortic arch with a proximal landing zone, native or previously implanted surgical graft, in the ascending aorta and with a brachiocephalic trunk native landing zone. Type: Interventional Start Date: Oct 2020 |
Study Comparing Continuous Subcutaneous Infusion Of ABBV-951 With Oral Carbidopa/Levodopa Tablets For...
AbbVie
Parkinson's Disease (PD)
Parkinson's disease (PD) is a neurological condition, which affects the brain. PD gets worse
over time, but how quickly it progresses varies a lot from person to person. Some symptoms of
PD are tremors, stiffness, and slowness of movement. This study measures the efficacy,... expand
Parkinson's disease (PD) is a neurological condition, which affects the brain. PD gets worse over time, but how quickly it progresses varies a lot from person to person. Some symptoms of PD are tremors, stiffness, and slowness of movement. This study measures the efficacy, safety, and tolerability of ABBV-951 versus oral Levodopa (LD)/Carbidopa (CD) [LD/CD] in advanced PD participants to achieve reduction in motor fluctuations. ABBV-951 is an investigational (unapproved) drug containing Levodopa Phosphate/Carbidopa Phosphate (LDP/CDP) given subcutaneously (under the skin) for the treatment of Parkinson's Disease. The study has two treatment arms . In one arm, participants will be given ABBV-951 plus oral placebo (does not contain treatment drug). In the second arm, participants will be given placebo solution and LD/CD tablets. Adult participants with advanced PD will be enrolled. Approximately 130 participants will be enrolled in the study in approximately 80 sites across the world. In one arm, participants will receive ABBV-951 solution as a continuous infusion under the skin plus oral placebo capsules for LD/CD. In the second arm, participants will receive placebo solution for ABBV-951 as a continuous infusion under the skin plus oral capsules containing LD/CD tablets. The treatment duration is 12 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects, and completing questionnaires. Type: Interventional Start Date: Oct 2020 |
Phase 2a Study of VX-147 in Adults With APOL1-mediated Focal Segmental Glomerulosclerosis
Vertex Pharmaceuticals Incorporated
Glomerulosclerosis, Focal Segmental
This study will evaluate the efficacy, safety and pharmacokinetics (PK) of VX-147 in subjects
with apolipoprotein L1 (APOL1)-mediated focal segmental glomerulosclerosis (FSGS).
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This study will evaluate the efficacy, safety and pharmacokinetics (PK) of VX-147 in subjects with apolipoprotein L1 (APOL1)-mediated focal segmental glomerulosclerosis (FSGS). Type: Interventional Start Date: Jun 2020 |
Light Therapy for PD - Dose Selection
Massachusetts General Hospital
Parkinson Disease
Sleep Disorder
Fatigue
This study aims to determine the most effective dose of light therapy to improve sleep in
people with Parkinson's Disease. Four groups of participants will receive bright-white or
dim-red light therapy at different times throughout the day.
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This study aims to determine the most effective dose of light therapy to improve sleep in people with Parkinson's Disease. Four groups of participants will receive bright-white or dim-red light therapy at different times throughout the day. Type: Interventional Start Date: Sep 2020 |
Phase 2 Clinical Trial of Crizotinib for Children and Adults With Neurofibromatosis Type 2 and Progressive...
University of Alabama at Birmingham
Neurofibromatosis 2
Progressive Vestibular Schwannoma (VS)
Subjects with Neurofibromatosis Type 2 (NF2) and progressive vestibular schwannoma (VS) will
be treated with crizotinib administered orally. Crizotinib will be taken continuously until
disease progression or unacceptable toxicity, in continuous treatment cycles of 28 days each,... expand
Subjects with Neurofibromatosis Type 2 (NF2) and progressive vestibular schwannoma (VS) will be treated with crizotinib administered orally. Crizotinib will be taken continuously until disease progression or unacceptable toxicity, in continuous treatment cycles of 28 days each, for a maximum of 12 cycles. Type: Interventional Start Date: Feb 2020 |
A Study of Tirzepatide (LY3298176) Compared With Dulaglutide on Major Cardiovascular Events in Participants...
Eli Lilly and Company
Type 2 Diabetes Mellitus
The purpose of the trial is to assess the efficacy and safety of tirzepatide to dulaglutide
in participants with type 2 diabetes and increased cardiovascular risk.
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The purpose of the trial is to assess the efficacy and safety of tirzepatide to dulaglutide in participants with type 2 diabetes and increased cardiovascular risk. Type: Interventional Start Date: May 2020 |
Imaging Study to Investigate the Safety and Diagnostic Performance of rhPSMA 7.3 (18F) in Newly Diagnosed...
Blue Earth Diagnostics
Prostate Cancer
A prospective, Phase 3, multi center, single-arm, imaging study investigating the safety and
diagnostic performance of Radio-hybrid Prostate Specific Membrane Antigen (rhPSMA) 7.3 (18F)
Positron Emission Tomography (PET) ligand in men with newly diagnosed prostate cancer.
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A prospective, Phase 3, multi center, single-arm, imaging study investigating the safety and diagnostic performance of Radio-hybrid Prostate Specific Membrane Antigen (rhPSMA) 7.3 (18F) Positron Emission Tomography (PET) ligand in men with newly diagnosed prostate cancer. Type: Interventional Start Date: Feb 2020 |
Treg Modulation With CD28 and IL-6 Receptor Antagonists
National Institute of Allergy and Infectious Diseases (NIAID)
Living-Donor Kidney Transplant
Kidney Transplant Recipients
The purpose of this study is to evaluate the safety of using lulizumab pegol with
tocilizumab, belatacept, and everolimus in kidney transplant recipients.
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The purpose of this study is to evaluate the safety of using lulizumab pegol with tocilizumab, belatacept, and everolimus in kidney transplant recipients. Type: Interventional Start Date: Dec 2019 |
BGB-290 and Temozolomide in Treating Patients With Recurrent Gliomas With IDH1/2 Mutations
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
IDH1 Mutation
IDH2 Mutation
Recurrent Glioblastoma
Recurrent WHO Grade II Glioma
Recurrent WHO Grade III Glioma
This phase I/II trial studies the side effects and how well BGB-290 and temozolomide work in
treating patients with gliomas (brain tumors) with IDH1/2 mutations that have come back.
BGB-290 may stop the growth of tumor cells by blocking some of the enzymes needed for cell... expand
This phase I/II trial studies the side effects and how well BGB-290 and temozolomide work in treating patients with gliomas (brain tumors) with IDH1/2 mutations that have come back. BGB-290 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, 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. Giving BGB-290 and temozolomide may work better in treating patients with recurrent gliomas. Type: Interventional Start Date: Jan 2020 |
Immunotherapy (Nivolumab or Brentuximab Vedotin) Plus Combination Chemotherapy in Treating Patients With...
National Cancer Institute (NCI)
Ann Arbor Stage III Hodgkin Lymphoma
Ann Arbor Stage III Lymphocyte-Depleted Classic Hodgkin Lymphoma
Ann Arbor Stage III Mixed Cellularity Classic Hodgkin Lymphoma
Ann Arbor Stage III Nodular Sclerosis Classic Hodgkin Lymphoma
Ann Arbor Stage IIIA Hodgkin Lymphoma
This phase III trial compares immunotherapy drugs (nivolumab or brentuximab vedotin) when
given with combination chemotherapy in treating patients with newly diagnosed stage III or IV
classic Hodgkin lymphoma. Immunotherapy with monoclonal antibodies, such as nivolumab, may... expand
This phase III trial compares immunotherapy drugs (nivolumab or brentuximab vedotin) when given with combination chemotherapy in treating patients with newly diagnosed stage III or IV classic Hodgkin lymphoma. 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. Brentuximab vedotin is a monoclonal antibody, brentuximab, linked to a toxic agent called vedotin. Brentuximab attaches to cancer cells in a targeted way and delivers vedotin to kill them. Chemotherapy drugs, such as doxorubicin, vinblastine, and dacarbazine, 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. The addition of nivolumab or brentuximab vedotin to combination chemotherapy may shrink the cancer or extend the time without disease symptoms coming back. Type: Interventional Start Date: Jul 2019 |
Study of TJ004309 in Combination With Atezolizumab (Tecentriq®) in Patients With Advanced or Metastatic...
Tracon Pharmaceuticals Inc.
Solid Tumor
Metastatic Cancer
This is a multicenter, open label, Phase 1 dose escalation study of TJ004309 in combination
with standard dose atezolizumab in patients with advanced or metastatic cancer in patients
who are refractory to or intolerant to all available therapy.
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This is a multicenter, open label, Phase 1 dose escalation study of TJ004309 in combination with standard dose atezolizumab in patients with advanced or metastatic cancer in patients who are refractory to or intolerant to all available therapy. Type: Interventional Start Date: Jul 2019 |
Phase 1/2 Study of MRTX849 in Patients With Cancer Having a KRAS G12C Mutation KRYSTAL-1
Mirati Therapeutics Inc.
Advanced Cancer
Metastatic Cancer
Malignant Neoplastic Disease
This study will evaluate the safety, tolerability, drug levels, molecular effects, and
clinical activity of MRTX849 in patients with advanced solid tumors that have a KRAS G12C
mutation.
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This study will evaluate the safety, tolerability, drug levels, molecular effects, and clinical activity of MRTX849 in patients with advanced solid tumors that have a KRAS G12C mutation. Type: Interventional Start Date: Jan 2019 |
Ibrutinib and Obinutuzumab With or Without Venetoclax in Treating Patients With Chronic Lymphocytic Leukemia
National Cancer Institute (NCI)
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
This phase III trial studies how well ibrutinib and obinutuzumab with or without venetoclax
work in treating patients with chronic lymphocytic leukemia. Ibrutinib may stop the growth of
cancer cells by blocking some of the enzymes needed for cell growth. Obinutuzumab is a... expand
This phase III trial studies how well ibrutinib and obinutuzumab with or without venetoclax work in treating patients with chronic lymphocytic leukemia. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Obinutuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving ibrutinib, obinutuzumab, and venetoclax may work better than giving ibrutinib and obinutuzumab in treating patients with chronic lymphocytic leukemia. Type: Interventional Start Date: Jan 2019 |
Nivolumab After Combined Modality Therapy in Treating Patients With High Risk Stage II-IIIB Anal Cancer
National Cancer Institute (NCI)
Anal Basaloid Carcinoma
Anal Canal Cloacogenic Carcinoma
Anal Margin Squamous Cell Carcinoma
Stage IIB Anal Cancer AJCC v8
Stage III Anal Cancer AJCC v8
This phase III trial investigates how well nivolumab after combined modality therapy works in
treating patients with high risk stage II-IIIB anal cancer. Immunotherapy with monoclonal
antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may... expand
This phase III trial investigates how well nivolumab after combined modality therapy works in treating patients with high risk stage II-IIIB anal cancer. 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. Type: Interventional Start Date: Apr 2018 |
Vemurafenib and Cobimetinib in Treating Patients With BRAF V600E Mutation Positive Craniopharyngioma
Alliance for Clinical Trials in Oncology
BRAF V600E Mutation Present
Papillary Craniopharyngioma
This phase II trial studies how well vemurafenib and cobimetinib work in treating patients
with BRAF V600E mutation positive craniopharyngioma. Vemurafenib and cobimetinib may stop the
growth of tumor cells by blocking some of the enzymes needed for cell growth.
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This phase II trial studies how well vemurafenib and cobimetinib work in treating patients with BRAF V600E mutation positive craniopharyngioma. Vemurafenib and cobimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Type: Interventional Start Date: Aug 2017 |
Testing MK-3475 (Pembrolizumab) as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer
National Cancer Institute (NCI)
Invasive Breast Carcinoma
Stage 0 Breast Cancer AJCC v6 and v7
Stage I Breast Cancer AJCC v7
Stage IA Breast Cancer AJCC v7
Stage IB Breast Cancer AJCC v7
This randomized phase III trial studies how well pembrolizumab works in treating patients
with triple-negative breast cancer. Immunotherapy with monoclonal antibodies, such as
pembrolizumab, may help the body's immune system attack the cancer, and may interfere with
the ability... expand
This randomized phase III trial studies how well pembrolizumab works in treating patients with triple-negative breast cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Type: Interventional Start Date: Nov 2016 |
TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality...
American Society of Clinical Oncology
Lymphoma, Non-Hodgkin
Multiple Myeloma
Advanced Solid Tumors
The purpose of the study is to learn from the real world practice of prescribing targeted
therapies to patients with advanced cancer whose tumor harbors a genomic variant known to be
a drug target or to predict sensitivity to a drug.
NOTE: Due to character limits, the arms... expand
The purpose of the study is to learn from the real world practice of prescribing targeted therapies to patients with advanced cancer whose tumor harbors a genomic variant known to be a drug target or to predict sensitivity to a drug. NOTE: Due to character limits, the arms section does NOT include all TAPUR Study relevant biomarkers. For additional information, contact TAPUR@asco.org, or if a patient, your nearest participating TAPUR site (see participating centers). ********************************************************************************************* ********************************************************************************* Results in publication or poster presentation format are posted as they become available for individual cohorts at www.tapur.org/news. The results may be accessed at any time. All results will be made available on clinicaltrials.gov at the end of the study. Indexing of available results on PubMed is in progress. ********************************************************************************************* ********************************************************************************* Type: Interventional Start Date: Mar 2016 |
Terameprocol in Treating Patients With Recurrent High Grade Glioma
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
High Grade Glioma (III or IV)
This phase I trial studies the side effects and best dose of terameprocol in treating
patients with high-grade glioma that has come back. Drugs used in chemotherapy, such as
terameprocol, work in different ways to stop the growth of tumor cells, either by killing the
cells,... expand
This phase I trial studies the side effects and best dose of terameprocol in treating patients with high-grade glioma that has come back. Drugs used in chemotherapy, such as terameprocol, 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. Type: Interventional Start Date: May 2018 |
Neratinib HER Mutation Basket Study
Puma Biotechnology, Inc.
Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations
This is an open-label, multicenter, multinational, Phase 2 basket study exploring the
efficacy and safety of neratinib as monotherapy or in combination with other therapies in
participants with HER (EGFR, HER2) mutation-positive solid tumors.
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This is an open-label, multicenter, multinational, Phase 2 basket study exploring the efficacy and safety of neratinib as monotherapy or in combination with other therapies in participants with HER (EGFR, HER2) mutation-positive solid tumors. Type: Interventional Start Date: Sep 2013 |
A Safety Study of SEA-TGT (SGN-TGT) in Advanced Cancer
Seagen Inc.
Non-small Cell Lung Cancer
Gastric Carcinoma
Gastroesophageal Junction Carcinoma
Classical Hodgkin Lymphoma
Diffuse Large B-cell Lymphoma
This trial will look at a drug called SEA-TGT (also known as SGN-TGT) to find out whether it
is safe for patients with solid tumors and lymphomas. It will study SEA-TGT to find out what
its side effects are. A side effect is anything the drug does besides treating cancer. It... expand
This trial will look at a drug called SEA-TGT (also known as SGN-TGT) to find out whether it is safe for patients with solid tumors and lymphomas. It will study SEA-TGT to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study whether SEA-TGT works to treat solid tumors and lymphomas. The study will have three parts. Part A of the study will find out how much SEA-TGT should be given to patients. Part B will use the dose found in Part A to find out how safe SEA-TGT is and if it works to treat solid tumors and lymphomas. Part C will study how well SEA-TGT with pembrolizumab works to treat solid tumors. Pembrolizumab is a drug that can be used to treat these types of cancer. Type: Interventional Start Date: May 2020 |
Lower-Dose Chemoradiation in Treating Patients With Early-Stage Anal Cancer, the DECREASE Study
ECOG-ACRIN Cancer Research Group
Anal Basaloid Carcinoma
Anal Canal Cloacogenic Carcinoma
Anal Canal Squamous Cell Carcinoma
Anal Margin Squamous Cell Carcinoma
Stage I Anal Cancer AJCC v8
This phase II trial studies how well lower-dose chemotherapy plus radiation (chemoradiation)
therapy works in comparison to standard-dose chemoradiation in treating patients with
early-stage anal cancer. Drugs used in chemotherapy, such as mitomycin, fluorouracil, and
capecitabine,... expand
This phase II trial studies how well lower-dose chemotherapy plus radiation (chemoradiation) therapy works in comparison to standard-dose chemoradiation in treating patients with early-stage anal cancer. Drugs used in chemotherapy, such as mitomycin, fluorouracil, and capecitabine, 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. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving chemotherapy with radiation therapy may kill more tumor cells. This study may help doctors find out if lower-dose chemoradiation is as effective and has fewer side effects than standard-dose chemoradiation, which is the usual approach for treatment of this cancer type. Type: Interventional Start Date: Nov 2019 |
Dietary Oxalate and Innate Immunity in Kidney Stone Disease
University of Alabama at Birmingham
Kidney Stone
This study will test whether oxalate stimulates urinary crystals and impacts the immune
system in healthy subjects using two controlled diets (low and high oxalate).
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This study will test whether oxalate stimulates urinary crystals and impacts the immune system in healthy subjects using two controlled diets (low and high oxalate). Type: Interventional Start Date: Mar 2021 |
Testing the Addition of the Immunotherapy Drug Pembrolizumab to the Usual Chemotherapy Treatment (Paclitaxel...
National Cancer Institute (NCI)
Endometrial Clear Cell Adenocarcinoma
Endometrial Dedifferentiated Carcinoma
Endometrial Endometrioid Adenocarcinoma
Endometrial Mixed Cell Adenocarcinoma
Endometrial Serous Adenocarcinoma
This phase III trial studies how well the combination of pembrolizumab, paclitaxel and
carboplatin works compared with paclitaxel and carboplatin alone in treating patients with
endometrial cancer that is stage III or IV, or has come back (recurrent). Immunotherapy with
monoclonal... expand
This phase III trial studies how well the combination of pembrolizumab, paclitaxel and carboplatin works compared with paclitaxel and carboplatin alone in treating patients with endometrial cancer that is stage III or IV, or has come back (recurrent). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Paclitaxel and carboplatin are chemotherapy drugs used as part of the usual treatment approach for this type of cancer. This study aims to assess if adding immunotherapy to these drugs is better or worse than the usual approach for treatment of this cancer. Type: Interventional Start Date: Jul 2019 |
Pain Relief for OsteoArthritis Through Combined Treatment (PROACT)
University of Florida
Osteoarthritis of Knee
This mechanistic clinical trial proposes to test whether a five-day course of mindfulness
meditation training (MMT) and tDCS, and their combination, can enhance pain modulatory
balance and pain-related brain function, reduce clinical pain, among African Americans and
non-Hispanic... expand
This mechanistic clinical trial proposes to test whether a five-day course of mindfulness meditation training (MMT) and tDCS, and their combination, can enhance pain modulatory balance and pain-related brain function, reduce clinical pain, among African Americans and non-Hispanic whites with knee osteoarthritis (OA). This approach will provide evidence that targeting stress and pain-related brain function will reduce OA-related pain and ethnic group differences therein. Type: Interventional Start Date: Mar 2020 |
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