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Fabry Disease Registry & Pregnancy Sub-registry
Genzyme, a Sanofi Company
Fabry Disease
The Fabry Registry is an ongoing, international multi-center, strictly observational program
that tracks the routine clinical outcomes for patients with Fabry disease, irrespective of
treatment status. No experimental intervention is involved; patients in the Registry undergo... expand
The Fabry Registry is an ongoing, international multi-center, strictly observational program that tracks the routine clinical outcomes for patients with Fabry disease, irrespective of treatment status. No experimental intervention is involved; patients in the Registry undergo clinical assessments and receive care as determined by the patient's treating physician. The primary objectives of the Registry are: - To enhance the understanding of the variability, progression, and natural history of Fabry disease, including heterozygous females with the disease; - To assist the Fabry medical community with the development of recommendations for monitoring patients and reports on patient outcomes to help optimize patient care; - To characterize and describe the Fabry population as a whole; - To evaluate the long-term safety and effectiveness of Fabrazyme® Fabry Pregnancy Sub-registry: This Sub-registry is a multicenter, international, longitudinal, observational, and voluntary program designed to track pregnancy outcomes for any pregnant woman enrolled in the Fabry Registry, regardless of whether she is receiving disease-specific therapy (such as enzyme replacement therapy with agalsidase beta) and irrespective of the commercial product with which she may be treated. Data from the Sub-registry are also used to fulfill various global regulatory requirements, to support product development/reimbursement, and for other research and non-research-related purposes. No experimental intervention is given; thus a patient will undergo clinical assessments and receive standard of care treatment as determined by the patient's physician. If a patient consents to this Sub-registry, information about the patient's medical and obstetric history, pregnancy, and birth will be collected, and, if a patient consents to data collection for her infant, data on infant growth through month 36 postpartum will be collected. Type: Observational [Patient Registry] Start Date: Jul 2001 |
A Non-interventional, Multinational, Observational Study With Isatuximab in Patients With Relapsed and/or...
Sanofi
Plasma Cell Myeloma
Primary Objective:
To assess the effectiveness, in terms of overall response rate (ORR) of isatuximab patients
with RRMM in routine clinical practice, within 12 months
To assess other effectiveness parameters such as progression free survival (PFS), PFS rate
(PFSR),... expand
Primary Objective: To assess the effectiveness, in terms of overall response rate (ORR) of isatuximab patients with RRMM in routine clinical practice, within 12 months To assess other effectiveness parameters such as progression free survival (PFS), PFS rate (PFSR), duration of response (DoR), time to response, time and intent to first subsequent therapy, rate of very good partial response or better, rate of complete response (CR) or better of isatuximab patients with RRMM in routine clinical practice To assess the profile of patients (demographic, disease characteristics, comorbidities and prior MM treatment history) who are treated with isatuximab in routine clinical practice To describe safety of isatuximab in routine clinical practice (based on adverse event [AE] reporting) To assess quality of life (QoL) using the European Organization for Research and Treatment of Cancer (EORTC) 30 item core questionnaire (QLQ C30) and the accompanying 20 item myeloma questionnaire module (QLQ MY20) Secondary Objective: Not applicable Type: Observational [Patient Registry] Start Date: Aug 2020 |
A Study to Assess ASP0598 Otic Solution Following Topical Application in the Ear in Subjects With Chronic...
Astellas Pharma Global Development, Inc.
Chronic Tympanic Membrane Perforation
The primary purpose of this study is to evaluate the safety and tolerability of ASP0598 Otic
Solution. This study will also evaluate the efficacy of ASP0598 otic solution.
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The primary purpose of this study is to evaluate the safety and tolerability of ASP0598 Otic Solution. This study will also evaluate the efficacy of ASP0598 otic solution. Type: Interventional Start Date: Sep 2020 |
Amplatzer Amulet LAAO vs. NOAC
Abbott Medical Devices
Atrial Fibrillation
Stroke
Bleeding
The objective of this trial is to evaluate the safety and effectiveness of the Amulet LAA
occluder compared to NOAC therapy in patients with non-valvular AF at increased risk for
ischemic stroke and who are recommended for long-term NOAC therapy.
The clinical investigation... expand
The objective of this trial is to evaluate the safety and effectiveness of the Amulet LAA occluder compared to NOAC therapy in patients with non-valvular AF at increased risk for ischemic stroke and who are recommended for long-term NOAC therapy. The clinical investigation is a prospective, randomized, multicenter active control worldwide trial. Subjects will be randomized in a 1:1 ratio between the Amulet LAA occlusion device ("Device Group") and a commercially available NOAC medication ("Control Group"). The choice of NOAC in the Control Group will be left to study physician discretion. Type: Interventional Start Date: Jul 2020 |
A Study to Assess the Long-term Safety and Efficacy of ATB200/AT2221 in Adult Subjects With LOPD
Amicus Therapeutics
Pompe Disease (Late-onset)
This is a multicenter, international open-label extension study of ATB200/AT2221 in adult
subjects with late-onset Pompe disease (LOPD) who completed Study ATB200-03.
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This is a multicenter, international open-label extension study of ATB200/AT2221 in adult subjects with late-onset Pompe disease (LOPD) who completed Study ATB200-03. Type: Interventional Start Date: Dec 2019 |
Letrozole With or Without Paclitaxel and Carboplatin in Treating Patients With Stage II-IV Ovarian, Fallopian...
NRG Oncology
Low Grade Fallopian Tube Serous Adenocarcinoma
Ovarian Low Grade Serous Adenocarcinoma
Primary Peritoneal Low Grade Serous Adenocarcinoma
Stage II Fallopian Tube Cancer AJCC v8
Stage II Ovarian Cancer AJCC v8
This phase III trial studies how well letrozole with or without paclitaxel and carboplatin
works in treating patients with stage II-IV low-grade serous carcinoma of the ovary,
fallopian tube, or peritoneum. Letrozole is an enzyme inhibitor that lowers the amount of
estrogen... expand
This phase III trial studies how well letrozole with or without paclitaxel and carboplatin works in treating patients with stage II-IV low-grade serous carcinoma of the ovary, fallopian tube, or peritoneum. Letrozole is an enzyme inhibitor that lowers the amount of estrogen made by the body which in turn may stop the growth of tumor cells that need estrogen to grow. Drugs used in chemotherapy, such as paclitaxel and carboplatin, 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. It is not yet known whether giving letrozole alone or in combination with paclitaxel and carboplatin works better in treating patients with low-grade serous carcinoma of the ovary, fallopian tube, or peritoneum compared to paclitaxel and carboplatin without letrozole. Type: Interventional Start Date: Aug 2019 |
SI Joint Stabilization in Long Fusion to the Pelvis
SI-BONE, Inc.
Sacroiliac Joint Disruption
Scoliosis Lumbar Region
The purpose of this study is to compare outcomes of subjects undergoing multilevel lumbar
fusion (MLF) surgery with and without the iFuse 3-D implants in the "bedrock" trajectory.
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The purpose of this study is to compare outcomes of subjects undergoing multilevel lumbar fusion (MLF) surgery with and without the iFuse 3-D implants in the "bedrock" trajectory. Type: Interventional Start Date: May 2020 |
Tenecteplase in Stroke Patients Between 4.5 and 24 Hours
Genentech, Inc.
THROMBOLYSIS
This study will evaluate the efficacy and safety of tenecteplase compared with placebo in
participants with acute ischemic stroke (AIS).
All participants will receive standard-of-care therapy according to AmericanHeart
Association/American Stroke Association clinical guidelines... expand
This study will evaluate the efficacy and safety of tenecteplase compared with placebo in participants with acute ischemic stroke (AIS). All participants will receive standard-of-care therapy according to AmericanHeart Association/American Stroke Association clinical guidelines (2018). To determine eligibility for randomization, all participants will undergo multimodal CT or MRI at baseline. Only participants with a vessel occlusion (ICA or MCA M1/M2) and penumbral tissue will be randomized. The primary analysis is to compare the efficacy of tenecteplase versus placebo in all participants at Day 90. Type: Interventional Start Date: Mar 2019 |
HOPE in Action Trial of HIV+ Deceased Donor Liver Transplants for HIV+ Recipients
Johns Hopkins University
Hiv
The primary objective of this study is to determine if an HIV-infected donor liver (HIVD+)
transplant is safe with regards to major transplant-related and HIV-related complications
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The primary objective of this study is to determine if an HIV-infected donor liver (HIVD+) transplant is safe with regards to major transplant-related and HIV-related complications Type: Interventional Start Date: Jan 2019 |
Testing What Happens When an Immunotherapy Drug (Pembrolizumab) is Added to Radiation or Given by Itself...
National Cancer Institute (NCI)
Recurrent Head and Neck Squamous Cell Carcinoma
Recurrent Hypopharyngeal Squamous Cell Carcinoma
Recurrent Laryngeal Squamous Cell Carcinoma
Recurrent Oral Cavity Squamous Cell Carcinoma
Recurrent Oropharyngeal Squamous Cell Carcinoma
This phase II trial studies the effect of pembrolizumab in combination with radiation therapy
or pembrolizumab alone compared to the usual approach (chemotherapy plus radiation therapy)
after surgery in treating patients with head and neck squamous cell carcinoma that has come... expand
This phase II trial studies the effect of pembrolizumab in combination with radiation therapy or pembrolizumab alone compared to the usual approach (chemotherapy plus radiation therapy) after surgery in treating patients with head and neck squamous cell carcinoma that has come back (recurrent) or patients with a second head and neck cancer that is not from metastasis (primary). Radiation therapy uses high energy radiation or protons to kill tumor cells and shrink tumors. Chemotherapy drugs, such as cisplatin and carboplatin kill tumor cells by stopping them from dividing. 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. Giving pembrolizumab in combination with radiation therapy or pembrolizumab alone after surgery may work better than the usual approach in shrinking recurrent or primary head and neck squamous cell carcinoma. Type: Interventional Start Date: Jan 2021 |
Digital Tomosynthesis Mammography and Digital Mammography in Screening Patients for Breast Cancer
ECOG-ACRIN Cancer Research Group
Breast Screening
This randomized phase III trial studies digital tomosynthesis mammography and digital
mammography in screening patients for breast cancer. Screening for breast cancer with
tomosynthesis mammography may be superior to digital mammography for breast cancer screening
and may... expand
This randomized phase III trial studies digital tomosynthesis mammography and digital mammography in screening patients for breast cancer. Screening for breast cancer with tomosynthesis mammography may be superior to digital mammography for breast cancer screening and may help reduce the need for additional imaging or treatment. Type: Interventional Start Date: Jul 2017 |
Phase I Clinical Trial of GRID Therapy in Pediatric Osteosarcoma of the Extremity
University of Arkansas
Osteosarcoma in Children
Radiation Toxicity
The primary objective of this study is to evaluate the toxicity profile of GRID therapy using
dose levels of 10Gy, 15 Gy and 20Gy in pediatric osteosarcoma of the extremity.
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The primary objective of this study is to evaluate the toxicity profile of GRID therapy using dose levels of 10Gy, 15 Gy and 20Gy in pediatric osteosarcoma of the extremity. Type: Interventional Start Date: Jul 2017 |
Positive End-Expiratory Pressure (PEEP) Levels During Resuscitation of Preterm Infants at Birth (The...
Murdoch Childrens Research Institute
Lung Injury
Preterm Birth
Premature babies often need help immediately after birth to open their lungs to air, start
breathing and keep their hearts beating. Opening their lungs can be difficult, and once open
the under-developed lungs of premature babies will often collapse again between each breath.... expand
Premature babies often need help immediately after birth to open their lungs to air, start breathing and keep their hearts beating. Opening their lungs can be difficult, and once open the under-developed lungs of premature babies will often collapse again between each breath. To prevent this nearly all premature babies receive some form of mechanical respiratory support to aid breathing. Common to all types of respiratory support is the delivery of a treatment called positive end-expiratory pressure, or PEEP. PEEP gives air, or a mixture of air and oxygen, to the lung between each breath to keep the lungs open and stop them collapsing. Currently, clinicians do not have enough evidence on the right amount, or level, of PEEP to give at birth. As a result, doctors around the world give different amounts (or levels) of PEEP to premature babies at birth. In this study, the Investigators will look at 2 different approaches to PEEP to help premature babies during their first breaths at birth. At the moment, the Investigators do not know if one is better than the other. One is to give the same PEEP level to the lungs. The others is to give a high PEEP level at birth when the lungs are hardest to open and then decrease the PEEP later once the lungs are opened and the baby is breathing. Very premature babies have a risk of long-term lung disease (chronic lung disease). The more breathing support a premature baby needs, the more likely the risk of developing chronic lung disease. The Investigators want to find out whether one method of opening the baby's lungs at birth results in them needing less breathing support. This research has been initiated by a group of doctors from Australia, the Netherlands and the USA, all who look after premature babies. Type: Interventional Start Date: May 2021 |
Treatment of Post-Operative Pain Following Orthopedic Surgery With SPRINT® Peripheral Nerve Stimulation...
SPR Therapeutics, Inc.
Postoperative Pain
Total Knee Replacement
Total Knee Arthroplasty
The purpose of this study is to gather information about how knee pain changes when small
amounts of electricity are delivered to the nerves in the leg. This study will involve the
use of a Peripheral Nerve Stimulation (PNS) System that is made by SPR Therapeutics (the
sponsor... expand
The purpose of this study is to gather information about how knee pain changes when small amounts of electricity are delivered to the nerves in the leg. This study will involve the use of a Peripheral Nerve Stimulation (PNS) System that is made by SPR Therapeutics (the sponsor of the study). The SPRINT PNS System was cleared by the FDA for up to 60 days of use in the back and/or extremities for the management of acute and chronic pain. Type: Interventional Start Date: Aug 2020 |
Prevention of Heart Failure Induced by Doxorubicin With Early Administration of Dexrazoxane
University of Arkansas
Healthy
The purpose of this research study is to determine whether early administration of
Dexrazoxane prevents Doxorubicin induced cardiotoxicity.
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The purpose of this research study is to determine whether early administration of Dexrazoxane prevents Doxorubicin induced cardiotoxicity. Type: Interventional Start Date: Jun 2021 |
Axillary Reverse Mapping in Preventing Lymphedema in Patients With Breast Cancer Undergoing Axillary...
Alliance for Clinical Trials in Oncology
Breast Cancer Stage I
Breast Cancer Stage II
Breast Cancer Stage III
This phase III trial studies how well axillary reverse mapping works in preventing lymphedema
in patients with breast cancer undergoing axillary lymph node dissection. Axillary reverse
mapping may help to preserve the lymph node drainage system around the breast so as to
prevent... expand
This phase III trial studies how well axillary reverse mapping works in preventing lymphedema in patients with breast cancer undergoing axillary lymph node dissection. Axillary reverse mapping may help to preserve the lymph node drainage system around the breast so as to prevent lymphedema after surgery. Type: Interventional Start Date: May 2019 |
Safety and Efficacy of Polymyxin B Hemoperfusion (PMX) for Endotoxemic Septic Shock in a Randomized,...
Spectral Diagnostics (US) Inc.
Septic Shock
Endotoxemia
Prospective, multicenter, randomized, open-label study of standard of care plus the PMX
cartridge versus standard of care alone in patients with endotoxemic septic shock
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Prospective, multicenter, randomized, open-label study of standard of care plus the PMX cartridge versus standard of care alone in patients with endotoxemic septic shock Type: Interventional Start Date: Oct 2019 |
3D Prediction of Patient-Specific Response
KIYATEC
Advanced Cancer
Ovarian Cancer
Glioblastoma Multiforme
Anaplastic Astrocytoma
This is a prospective, non-randomized, observational registry study evaluating a
patient-specific ex vivo 3D (EV3D) assay for drug response using a patient's own biopsy or
resected tumor tissue for assessing tissue response to therapy in patients with advanced
cancers, including... expand
This is a prospective, non-randomized, observational registry study evaluating a patient-specific ex vivo 3D (EV3D) assay for drug response using a patient's own biopsy or resected tumor tissue for assessing tissue response to therapy in patients with advanced cancers, including ovarian cancer, high-grade gliomas, and high-grade rare tumors. Type: Observational [Patient Registry] Start Date: Jun 2018 |
Study of Suramin in Subjects With Furosemide-Resistant AKI
Rediscovery Life Sciences
Acute Kidney Injury
This is a prospective, double-blind, randomized, placebo-controlled study to assess the
effects of suramin as a potential treatment option to prevent subjects with AKI from
progressing to Kidney Disease Improving Global Outcomes (KDIGO) Stage III or dialysis
dependent AKI.... expand
This is a prospective, double-blind, randomized, placebo-controlled study to assess the effects of suramin as a potential treatment option to prevent subjects with AKI from progressing to Kidney Disease Improving Global Outcomes (KDIGO) Stage III or dialysis dependent AKI. Type: Interventional Start Date: Nov 2020 |
Placebo-controlled Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as...
GlaxoSmithKline
Lung Cancer, Non-Small Cell
This is a multicenter, randomized, double-blind, placebo-controlled study of niraparib plus
pembrolizumab versus placebo plus pembrolizumab as maintenance therapy in participants with
advanced or metastatic non-small cell lung cancer (NSCLC) who have achieved stable disease... expand
This is a multicenter, randomized, double-blind, placebo-controlled study of niraparib plus pembrolizumab versus placebo plus pembrolizumab as maintenance therapy in participants with advanced or metastatic non-small cell lung cancer (NSCLC) who have achieved stable disease (SD), partial response (PR), or complete response (CR) following completion of standard of care first-line platinum-based induction chemotherapy with pembrolizumab. The primary hypotheses are: participants with confirmed diagnosis of NSCLC could benefit from niraparib plus pembrolizumab versus placebo plus pembrolizumab with respect to Progression-free survival (PFS) and Overall survival (OS). Type: Interventional Start Date: Oct 2020 |
Testing the Addition of a New Immunotherapy Drug, Atezolizumab (MPDL3280A), to the Usual Chemoradiation...
National Cancer Institute (NCI)
Limited Stage Lung Small Cell Carcinoma
Stage I Lung Cancer AJCC v8
Stage IA1 Lung Cancer AJCC v8
Stage IA2 Lung Cancer AJCC v8
Stage IA3 Lung Cancer AJCC v8
This phase II/III trial studies how well chemotherapy and radiation therapy (chemoradiation)
with or without atezolizumab works in treating patients with limited stage small cell lung
cancer. Drugs used in chemotherapy, such as etoposide, cisplatin, and carboplatin, work in... expand
This phase II/III trial studies how well chemotherapy and radiation therapy (chemoradiation) with or without atezolizumab works in treating patients with limited stage small cell lung cancer. Drugs used in chemotherapy, such as etoposide, cisplatin, and carboplatin, 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. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving chemoradiation with or without atezolizumab may work better in treating patients with limited stage small cell lung cancer. Type: Interventional Start Date: May 2019 |
S1803, Lenalidomide +/- Daratumumab/rHuPh20 as Post-ASCT Maintenance for MM w/MRD to Direct Therapy Duration
Southwest Oncology Group
Multiple Myeloma
Patients are enrolled to screening (Reg Step 1) prior to or after ASCT but prior to Reg Step
2. Patients are followed until they will begin Maintenance and then registered to Reg Step 2
(first randomization). Patients are randomized between Lenalidomide for 2 years and
Lenalidomide... expand
Patients are enrolled to screening (Reg Step 1) prior to or after ASCT but prior to Reg Step 2. Patients are followed until they will begin Maintenance and then registered to Reg Step 2 (first randomization). Patients are randomized between Lenalidomide for 2 years and Lenalidomide + Daratumumab/rHuPH20. After 2 years of Maintenance, MRD is assessed to guide further therapy. MRD-positive patients will continue with the assigned treatment. MRD-negative patients will be further randomized (Reg Step 3) to either continue or discontinue the assigned treatment. Patients are treated for up to 7 years from Step 2 reg and followed for up to 15 years. Type: Interventional Start Date: Jun 2019 |
Parkinson's Foundation PD GENEration Genetic Registry
Parkinson's Foundation
Parkinson's Disease
Development of a central repository for PD-related genomic data for future research.
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Development of a central repository for PD-related genomic data for future research. Type: Interventional Start Date: Dec 2020 |
Thromboelastographic Profile in Healthy Newborns and Infants of Diabetic Mothers Using TEG6s
Arkansas Children's Hospital Research Institute
Thromboelastography
Coagulation; Fetus or Newborn
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Diabetes, Gestational
Thromboelastography (TEG) is a laboratory technique used to examine the process of clot
formation and degradation by measuring and reporting the kinetic changes, the rate of clot
formation, clot strength, and clot stability. TEG provides numeric values and a graphical
representation... expand
Thromboelastography (TEG) is a laboratory technique used to examine the process of clot formation and degradation by measuring and reporting the kinetic changes, the rate of clot formation, clot strength, and clot stability. TEG provides numeric values and a graphical representation of the primary and secondary hemostatic systems and fibrinolysis more quickly and with a smaller blood sample than routine coagulation studies. TEG6s, the newest TEG platform, simplifies and standardizes TEG technique and is currently available at only four US children's hospitals. Normative values of TEG6s results have not been established in healthy neonates. There are a number of well-established perinatal risk factors for thrombosis in the newborn; however, maternal diabetes has been the most frequently identified risk factor in the newborn since 1965. Despite the well-established hypercoagulable state observed in infants of diabetic mothers (IDMs), there have been no studies evaluating TEG in IDMs. To establish normative data and investigate the hypercoagulable state of IDMs, this observational prospective cohort study will evaluate TEG6s in these two populations: a control group that will include neonates ≥37 weeks gestational age born to mothers with uncomplicated pregnancies and a comparison group that will include neonates ≥37 weeks born to mothers with gestational diabetes or a history of Type 1 or Type 2 diabetes prior to pregnancy, either requiring insulin or diet controlled. We hypothesize that cord blood TEG6s results will differ between healthy newborns and IDMs reflecting a hypercoagulable state in IDMs with an increased coagulation index (CI) in the IDM group. A sample size calculation was performed for a two-sample t-test using the POWER procedure in SAS version 9.4. Based on a two-tailed alpha of 0.05 and a standard deviation of 0.9, the total N was determined to be 40 (i.e., 20 in each group). This yields a power of 0.84 to detect a difference of 1.25 units in the mean CI between IDMs and healthy controls. To avoid blood loss and skin breaking procedures in the subjects, umbilical cord blood obtained from the umbilical cord will be used for analysis. To assure appropriate dilution, a hematocrit will be measured at the time of blood collection using a blood gas machine for prompt results. Sample blood will immediately be taken by the investigators from the delivery hospital to the children's hospital, where the following clotting studies will be performed: PT, aPTT, fibrinogen, platelet count, platelet mapping, and TEG6s. Statistical analyses will be performed on the results of these studies and will provide normative data in healthy newborns and infants of diabetic mothers. Having data on the coagulation profile of neonates will help guide management techniques and help explain the propensity to clot among IDMs and guide further research into prevention and treatment of this complication. Type: Observational Start Date: Aug 2021 |
The Leaflex™ Early Feasibility Study
Pi-cardia
Aortic Valve Stenosis
A prospective, multicenter, single-arm, early feasibility study aimed to assess safety and
performance of the Leaflex™ Performer in the treatment of patients with symptomatic, severe
aortic stenosis.
Subjects will be seen at pre- and post procedure, discharge, 30 days and... expand
A prospective, multicenter, single-arm, early feasibility study aimed to assess safety and performance of the Leaflex™ Performer in the treatment of patients with symptomatic, severe aortic stenosis. Subjects will be seen at pre- and post procedure, discharge, 30 days and at 3, 6, 9 and 12 months post procedure. Type: Interventional Start Date: Jun 2021 |