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ACTIV-6: COVID-19 Study of Repurposed Medications
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Susanna Naggie, MD
Covid19
The purpose of this study is to evaluate the effectiveness of repurposed medications (study
drug(s) in reducing symptoms of non-hospitalized participants with mild to moderate COVID-19.
Participants will receive either study drug or placebo. They will self-report any new or... expand
The purpose of this study is to evaluate the effectiveness of repurposed medications (study drug(s) in reducing symptoms of non-hospitalized participants with mild to moderate COVID-19. Participants will receive either study drug or placebo. They will self-report any new or worsening symptoms or medical events they may experience while taking study drug or placebo. This study is intended to be all remote with no in person visits, unless the study team feels it is in the best interest of a participant to see them in person. Prior and current drug arms are listed on clinicaltrials.gov and will be updated with the activation of any new drug arms. Each study arm will also have its own clinicaltrials.gov entry and will include "Pro00107921" in the Unique Protocol ID. Pro00107921_A - Arm D (Ivermectin 400) - NCT05736861; Pro00107921_B - Arm B (Fluvoxamine) - NCT05890586; Pro00107921_C - Arm C (Fluticasone) - NCT05736874; Pro00107921_D - Arm D (Ivermectin 600) - NCT05894538; Pro00107921_E - Arm E (Fluvoxamine 100) - NCT05894564; Pro00107921_F - Arm F (Montelukast) - NCT05894577; Pro00107921_G - Arm G (Metformin) - NCT06042855. Type: Interventional Start Date: Jun 2021 |
Two Studies for Patients With High Risk Prostate Cancer Testing Less Intense Treatment for Patients With...
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NRG Oncology
Metastatic Malignant Neoplasm in the Bone
Prostate Adenocarcinoma
Stage III Prostate Cancer AJCC v8
Stage IIIA Prostate Cancer AJCC v8
Stage IIIB Prostate Cancer AJCC v8
This phase III trial compares less intense hormone therapy and radiation therapy to usual
hormone therapy and radiation therapy in treating patients with high risk prostate cancer and
low gene risk score. This trial also compares more intense hormone therapy and radiation... expand
This phase III trial compares less intense hormone therapy and radiation therapy to usual hormone therapy and radiation therapy in treating patients with high risk prostate cancer and low gene risk score. This trial also compares more intense hormone therapy and radiation therapy to usual hormone therapy and radiation therapy in patients with high risk prostate cancer and high gene risk score. Apalutamide may help fight prostate cancer by blocking the use of androgen by the tumor cells. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Giving a shorter hormone therapy treatment may work the same at controlling prostate cancer compared to the usual 24 month hormone therapy treatment in patients with low gene risk score. Adding apalutamide to the usual treatment may increase the length of time without prostate cancer spreading as compared to the usual treatment in patients with high gene risk score. Type: Interventional Start Date: Dec 2020 |
Pragmatic Evaluation of Events And Benefits of Lipid-lowering in Older Adults
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Duke University
Cognitive Impairment, Mild
Dementia
Cardiovascular Diseases
PREVENTABLE is a multi-center, randomized, parallel group, placebo-controlled superiority
study. Participants will be randomized 1:1 to atorvastatin 40 mg or placebo. This large study
conducted in community-dwelling older adults without cardiovascular disease (CVD) or dementia... expand
PREVENTABLE is a multi-center, randomized, parallel group, placebo-controlled superiority study. Participants will be randomized 1:1 to atorvastatin 40 mg or placebo. This large study conducted in community-dwelling older adults without cardiovascular disease (CVD) or dementia will demonstrate the benefit of statins for reducing the primary composite of death, dementia, and persistent disability and secondary composites including mild cognitive impairment (MCI) and cardiovascular events. Type: Interventional Start Date: Sep 2020 |
Phase 1b Study of SL-172154 Administered With Combination Agent(s) in Subjects With Ovarian Cancers
Shattuck Labs, Inc.
Platinum-resistant Ovarian Cancer
Fallopian Tube Cancer
Epithelial Ovarian Cancer
Ovarian Cancer
Platinum-Resistant Fallopian Tube Carcinoma
SL03-OHD-105 is an open-label, multicenter, phase 1b trial designed to evaluate SL-172154
administered in combination with pegylated liposomal doxorubicin (PLD) or mirvetuximab
soravtansine (MIRV) in patients with platinum resistant ovarian cancer. Approximately 102
patients... expand
SL03-OHD-105 is an open-label, multicenter, phase 1b trial designed to evaluate SL-172154 administered in combination with pegylated liposomal doxorubicin (PLD) or mirvetuximab soravtansine (MIRV) in patients with platinum resistant ovarian cancer. Approximately 102 patients will be enrolled in this study in two phases: dose escalation and dose expansion. Type: Interventional Start Date: Aug 2022 |
A Randomized, Double-Blind, Placebo-Controlled Trial of IkT-148009 in Untreated Parkinson's Disease
Inhibikase Therapeutics, Inc.
Parkinson Disease
This study investigates the safety and tolerability of drug IkT-148009 in untreated
Parkinson's disease volunteers (30 to 80 years old). It also looks at the pharmacokinetics of
IkT-148009 in the body and evaluates the effect of IkT-148009 on motor and non-motor features
of... expand
This study investigates the safety and tolerability of drug IkT-148009 in untreated Parkinson's disease volunteers (30 to 80 years old). It also looks at the pharmacokinetics of IkT-148009 in the body and evaluates the effect of IkT-148009 on motor and non-motor features of the disease. This 12 week study is designed to be 3:1 randomized across 3 doses of IkT-148009 or placebo. Each participant will self-administer one of 3 doses or placebo of IkT-148009 once daily (QD) with food for 12 weeks. For more information, visit our website: www.the201trial.com Type: Interventional Start Date: May 2023 |
A Study of TAR-200 in Combination With Cetrelimab and Cetrelimab Alone in Participants With Muscle-Invasive...
Janssen Research & Development, LLC
Urinary Bladder Neoplasms
The purpose of this study is to evaluate the anti-tumor effects of TAR-200 in combination
with intravenous (IV) cetrelimab and IV cetrelimab alone.
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The purpose of this study is to evaluate the anti-tumor effects of TAR-200 in combination with intravenous (IV) cetrelimab and IV cetrelimab alone. Type: Interventional Start Date: Jul 2022 |
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: Sep 2019 |
Evaluation of Dosing Procedures of Chemotherapy Treatment (Carboplatin) With the Contrast Agent Iohexol
NRG Oncology
Malignant Solid Neoplasm
This trial studies how well iohexol works in helping doctors calculate the dose of
carboplatin given to patients with cancer. Drugs used in chemotherapy, such as carboplatin,
work in different ways to stop the growth of tumor cells, either by killing the cells, by
stopping... expand
This trial studies how well iohexol works in helping doctors calculate the dose of carboplatin given to patients with cancer. Drugs used in chemotherapy, such as 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. Understanding how to best calculate the dose of carboplatin given to patients with cancer may help doctors learn how to improve the use of carboplatin in the future. Type: Interventional Start Date: Jan 2020 |
Testing the Addition of Trastuzumab or Trastuzumab/Pertuzumab to the Usual Chemotherapy for HER2 Positive...
National Cancer Institute (NCI)
Endometrial Serous Adenocarcinoma
Uterine Corpus Carcinosarcoma
This phase II/III trial tests whether adding trastuzumab and hyaluronidase-oysk (Herceptin
HylectaTM) or pertuzumab, trastuzumab and hyaluronidase-zzxf (PhesgoTM) to the usual
chemotherapy (paclitaxel and carboplatin) works to shrink tumors in patients with HER2
positive endometrial... expand
This phase II/III trial tests whether adding trastuzumab and hyaluronidase-oysk (Herceptin HylectaTM) or pertuzumab, trastuzumab and hyaluronidase-zzxf (PhesgoTM) to the usual chemotherapy (paclitaxel and carboplatin) works to shrink tumors in patients with HER2 positive endometrial serous carcinoma or carcinosarcoma. Trastuzumab and pertuzumab are monoclonal antibodies and forms of targeted therapy that attach to specific molecules (receptors) on the surface of tumor cells, known as HER2 receptors. When trastuzumab or pertuzumab attach to HER2 receptors, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Hyaluronidase is an endoglycosidase. It helps to keep pertuzumab and trastuzumab in the body longer, so that these medications will have a greater effect. Hyaluronidase also allows trastuzumab and trastuzumab/pertuzumab to be given by injection under the skin and shortens their administration time compared to trastuzumab or pertuzumab alone. Paclitaxel is a taxane and in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Giving Herceptin Hylecta or Phesgo in combination with paclitaxel and carboplatin may shrink the tumor and prevent the cancer from coming back in patients with HER2 positive endometrial serous carcinoma or carcinosarcoma. Type: Interventional Start Date: Nov 2022 |
A Study to Evaluate the Effect of SAGE-718 on Cognitive Function in Participants With Huntington's Disease...
Sage Therapeutics
Huntington's Disease
The primary purpose of this study is to evaluate the effect of SAGE-718 on cognitive
performance and functioning in participants with HD.
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The primary purpose of this study is to evaluate the effect of SAGE-718 on cognitive performance and functioning in participants with HD. Type: Interventional Start Date: Feb 2022 |
Implementing Cabenuva in Arkansas HIV Programs
University of Arkansas
HIV-1-infection
Medication Adherence
Satisfaction, Patient
This study seeks to address this gap by studying two Cabenuva delivery strategies conducted
at six outpatient HIV clinics in Arkansas, a Southern state with a large population of rural,
poor, and African-American residents. The two delivery strategies are clinic delivery and... expand
This study seeks to address this gap by studying two Cabenuva delivery strategies conducted at six outpatient HIV clinics in Arkansas, a Southern state with a large population of rural, poor, and African-American residents. The two delivery strategies are clinic delivery and home delivery. In the clinic delivery study arm patients will receive Cabenuva injections at the clinic (50 patients), and in the home delivery study arm patients will receive the injections at home (50 patients). The study team will follow the patients in both study arms for 10 months. After 5 months, the patients will complete a treatment satisfaction survey, and after 10 months the study team will examine clinic records to assess their medication adherence. Secondary outcomes will include clinician perceptions of acceptability, feasibility, and appropriateness of Cabenuva delivery strategies. The study team will also collect qualitative data from patients and clinic employees to learn more in depth about their perceptions of Cabenuva, the delivery strategies, their implementation, and barriers and facilitators. Finally, the study team will estimate the costs associated with the two delivery strategies from the clinic and patient perspectives. The data from this study provide information on what delivery strategies for long acting HIV medications offer best results, how these strategies are perceived by patients and clinicians, and how costly and feasible the strategies are to implement in practice. Type: Interventional Start Date: Mar 2022 |
Testing CC-486 (Oral Azacitidine) Plus the Standard Drug Therapy in Patients 75 Years or Older With Newly...
National Cancer Institute (NCI)
Ann Arbor Stage III Diffuse Large B-Cell Lymphoma
Ann Arbor Stage IIX (Bulky) Diffuse Large B-Cell Lymphoma
Ann Arbor Stage IV Diffuse Large B-Cell Lymphoma
Diffuse Large B-Cell Lymphoma Activated B-Cell Type
Diffuse Large B-Cell Lymphoma Associated With Chronic Inflammation
This phase II/III trial compares the side effects and activity of oral azacitidine in
combination with the standard drug therapy (reduced dose rituximab-cyclophosphamide,
doxorubicin, vincristine, and prednisone [R-miniCHOP]) versus R-miniCHOP alone in treating
patients 75... expand
This phase II/III trial compares the side effects and activity of oral azacitidine in combination with the standard drug therapy (reduced dose rituximab-cyclophosphamide, doxorubicin, vincristine, and prednisone [R-miniCHOP]) versus R-miniCHOP alone in treating patients 75 years or older with newly diagnosed diffuse large B cell lymphoma. R-miniCHOP includes a monoclonal antibody (a type of protein), called rituximab, which attaches to the lymphoma cells and may help the immune system kill these cells. R-miniCHOP also includes prednisone which is an anti-inflammatory medication and a combination of 3 chemotherapy drugs, cyclophosphamide, doxorubicin, and vincristine. These 3 chemotherapy drugs, as well as oral azacitidine, 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. Combining oral azacitidine with R-miniCHOP may shrink the cancer or extend the time without disease symptoms coming back or extend patient's survival when compared to R-miniCHOP alone. Type: Interventional Start Date: May 2021 |
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 |
Testing Drug Treatments After CAR T-cell Therapy in Patients With Relapsed/Refractory Diffuse Large B-cell...
SWOG Cancer Research Network
Diffuse Large B-Cell Lymphoma
Grade 3b Follicular Lymphoma
Primary Mediastinal (Thymic) Large B-Cell Lymphoma
Recurrent Diffuse Large B-Cell Lymphoma
Refractory Diffuse Large B-Cell Lymphoma
This phase II trial tests whether mosunetuzumab and/or polatuzumab vedotin helps benefit
patients who have received chemotherapy (fludarabine and cyclophosphamide) followed by
chimeric antigen receptor (CAR) T-cell therapy (tisagenlecleucel, axicabtagene ciloleucel, or
lisocabtagene... expand
This phase II trial tests whether mosunetuzumab and/or polatuzumab vedotin helps benefit patients who have received chemotherapy (fludarabine and cyclophosphamide) followed by chimeric antigen receptor (CAR) T-cell therapy (tisagenlecleucel, axicabtagene ciloleucel, or lisocabtagene maraleucel) for diffuse large B-cell lymphoma that has come back (recurrent) or that does not respond to treatment (refractory) or grade IIIb follicular lymphoma. Mosunetuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Polatuzumab vedotin is a monoclonal antibody, called polatuzumab, linked to a drug called vedotin. Polatuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, and delivers vedotin to kill them. Chemotherapy drugs, such as fludarabine and cyclophosphamide, 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. CAR T-cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor. Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Giving mosunetuzumab and/or polatuzumab vedotin after chemotherapy and CAR T-cell therapy may be more effective at controlling or shrinking the cancer than not giving them. Type: Interventional Start Date: Jun 2023 |
Testing What Happens When an Immunotherapy Drug (Pembrolizumab) is Given by Itself Compared to the Usual...
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 alone compared to the usual approach
(chemotherapy [cisplatin and carboplatin] plus radiation therapy) after surgery in treating
patients with head and neck squamous cell carcinoma that has come back (recurrent) or
patients... expand
This phase II trial studies the effect of pembrolizumab alone compared to the usual approach (chemotherapy [cisplatin and carboplatin] 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. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. Carboplatin is also in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. 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 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: Apr 2021 |
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 |
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 |
Using Virtual Reality Technology to Improve Patient Experience and Quality of Care During Brachytherapy
University of Arkansas
Endocervical Cancer
The primary objective is to demonstrate the feasibility of incorporating VR distraction into
the brachytherapy and radiotherapy clinical workflow.
The secondary objective is to determine if VR distraction during brachytherapy treatment for
cervical cancer improves subjects'... expand
The primary objective is to demonstrate the feasibility of incorporating VR distraction into the brachytherapy and radiotherapy clinical workflow. The secondary objective is to determine if VR distraction during brachytherapy treatment for cervical cancer improves subjects' satisfaction, procedural/acute pain, and need for analgesics or anxiolytics. Type: Interventional Start Date: Aug 2022 |
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: Observational [Patient Registry] Start Date: Dec 2020 |
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 |
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: Sep 2017 |
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 |
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 |
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: Sep 2021 |
Randomized Therapy In Status Epilepticus
Marinus Pharmaceuticals
Status Epilepticus
This study will evaluate the effectiveness and safety of an investigational product (IP),
intravenous (IV) ganaxolone, to treat participants with status epilepticus (SE).
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This study will evaluate the effectiveness and safety of an investigational product (IP), intravenous (IV) ganaxolone, to treat participants with status epilepticus (SE). Type: Interventional Start Date: Oct 2020 |