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Infant Massage in the NICU
University of Maryland, Baltimore
Neonatal Prematurity
Massage Therapy
The goal of this clinical trial is to learn about the effects of Neonatal Touch and
Massage Therapy on premature babies.
The main questions it aims to answer are:
- Do babies who receive Neonatal Touch and Massage Therapy get discharged sooner from
the NICU
- Does Neonatal Touch... expand
The goal of this clinical trial is to learn about the effects of Neonatal Touch and Massage Therapy on premature babies. The main questions it aims to answer are: - Do babies who receive Neonatal Touch and Massage Therapy get discharged sooner from the NICU - Does Neonatal Touch and Massage Therapy have a beneficial effect on weight gain, pain and stress responses, and neurodevelopmental outcomes. Participants assigned to the treatment group will receive Neonatal Touch and Massage Therapy while admitted to the NICU. Researchers will compare their outcomes to a control group, receiving standard NICU care, to see if there are any differences in the length of hospital stay, weight gain, pain scores, neurodevelopmental outcomes, and incidence of other common conditions associated with prematurity. Type: Interventional Start Date: Nov 2023 |
Tocilizumab in Lung Transplantation
National Institute of Allergy and Infectious Diseases (NIAID)
Lung Transplant
This is a trial in which 350 primary lung transplant recipients will be randomized (1:1)
to receive either Tocilizumab (six doses over 20 weeks) plus standard triple maintenance
immunosuppression or placebo (sterile normal saline) plus standard triple maintenance
immunosuppression (Tacrolimus, Mycophenolate... expand
This is a trial in which 350 primary lung transplant recipients will be randomized (1:1) to receive either Tocilizumab (six doses over 20 weeks) plus standard triple maintenance immunosuppression or placebo (sterile normal saline) plus standard triple maintenance immunosuppression (Tacrolimus, Mycophenolate Mofetil, corticosteroids). The primary objective is to test the hypothesis that treatment with triple maintenance immunosuppression plus Tocilizumab (TCZ) is superior to triple maintenance immunosuppression plus placebo (saline) as defined by a composite endpoint of a) CLAD, b) listed for re-transplantation, and c) death Type: Interventional Start Date: Feb 2024 |
PO vs IV Antibiotics for the Treatment of Infected Nonunion of Fractures After Fixation
Major Extremity Trauma Research Consortium
Infections
Infected Wound
Nonunion of Fracture
Injury Leg
Amputation
This is a Phase III clinical randomized control trial to investigate differences between
patient with an infected nonunion treated by PO vs. IV antibiotics. The study population
will be 250 patients, 18 years or older, being treated for infected nonunion after
internal fixation of a fracture with... expand
This is a Phase III clinical randomized control trial to investigate differences between patient with an infected nonunion treated by PO vs. IV antibiotics. The study population will be 250 patients, 18 years or older, being treated for infected nonunion after internal fixation of a fracture with a segmental defect less than one centimeter. Patients will be randomly assigned to either the treatment (group 1) PO antibiotics for 6 weeks or the control group (group 2) IV antibiotics for 6 weeks. The primary hypothesis is that the effectiveness of oral antibiotic therapy is equivalent to traditional intravenous antibiotic therapy for the treatment of infected nonunion after fracture internal fixation, when such therapy is combined with appropriate surgical management. Clinical effectiveness will be measured as the primary outcome as the number of secondary re-admissions related to injury and secondary outcomes of treatment failure (re-infection, nonunion, antibiotic complications) within the first one year of follow-up, as defined by specified criteria and determined by a blinded data assessment panel. In addition, treatment compliance, the cost of treatment, the number of surgeries required, the type and incidence of complications, and the duration of hospitalization will be measured. Type: Interventional Start Date: May 2023 |
Pediatric Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients (P-ICECAP)
University of Michigan
Cardiac Arrest, Out-Of-Hospital
Hypothermia, Induced
Hypoxia-Ischemia, Brain
This is a multicenter trial to establish the efficacy of cooling and the optimal duration
of induced hypothermia for neuroprotection in pediatric comatose survivors of cardiac
arrest.
The study team hypothesizes that longer durations of cooling may improve either the
proportion of children that... expand
This is a multicenter trial to establish the efficacy of cooling and the optimal duration of induced hypothermia for neuroprotection in pediatric comatose survivors of cardiac arrest. The study team hypothesizes that longer durations of cooling may improve either the proportion of children that attain a good neurobehavioral recovery or may result in better recovery among the proportion already categorized as having a good outcome. Type: Interventional Start Date: Aug 2022 |
IKS03 in Patients With Advanced B Cell Non-Hodgkin Lymphomas
Iksuda Therapeutics Ltd.
B-cell Non-Hodgkin Lymphoma
Diffuse Large B Cell Lymphoma
Follicular Lymphoma
Mantle Cell Lymphoma
B-cell Lymphoma
This first-in-human study will evaluate the recommended dose for further clinical
development, safety, tolerability, antineoplastic activity, immunogenicity,
pharmacokinetics and pharmacodynamics of IKS03, a CD19 targeting antibody-drug conjugate,
in patients with advanced B cell non-Hodgkin lymphoma... expand
This first-in-human study will evaluate the recommended dose for further clinical development, safety, tolerability, antineoplastic activity, immunogenicity, pharmacokinetics and pharmacodynamics of IKS03, a CD19 targeting antibody-drug conjugate, in patients with advanced B cell non-Hodgkin lymphoma (NHL). Type: Interventional Start Date: Sep 2023 |
A Study Evaluating the Efficacy and Safety of Giredestrant Plus Everolimus Compared With the Physician's...
Genentech, Inc.
Estrogen Receptor (ER)-Positive, HER2-negative, Locally Advanced or Metastatic Breast Cancer
This Phase III, randomized, open-label, multicenter study will evaluate the efficacy and
safety of giredestrant plus everolimus compared with the physician's choice of endocrine
therapy plus everolimus in participants with estrogen receptor (ER)-positive, human
epidermal growth factor receptor 2 (HER2)-negative... expand
This Phase III, randomized, open-label, multicenter study will evaluate the efficacy and safety of giredestrant plus everolimus compared with the physician's choice of endocrine therapy plus everolimus in participants with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer who have had previous treatment with cyclin-dependent kinase 4/6 inhibitors (CDK4/6is) and endocrine therapy, either in the locally advanced/metastatic or the adjuvant setting. Type: Interventional Start Date: Aug 2022 |
iKinnect2.0 for Juvenile Justice Involved Youth at Risk for Suicide
Evidence-Based Practice Institute, Seattle, WA
Child Behavior Disorders
Suicide and Self-harm
This study is a 16-week intent-to-treat randomized controlled trial (RCT) with 120
suicidal juvenile justice (JJ)-involved transition-age (TA) youth (age 15-21 years) and a
primary caregiver (dyads). Dyads will be randomly assigned to iKinnect2.0 (n=60 dyads) or
Life360 (control app) plus an electronic... expand
This study is a 16-week intent-to-treat randomized controlled trial (RCT) with 120 suicidal juvenile justice (JJ)-involved transition-age (TA) youth (age 15-21 years) and a primary caregiver (dyads). Dyads will be randomly assigned to iKinnect2.0 (n=60 dyads) or Life360 (control app) plus an electronic suicide resources brochure (n=60 dyads). This design will test iKinnect2.0's new features for suicide prevention against TA youth awareness of and access to high-quality suicide prevention resources, while simultaneously testing features relating to conduct problems and parent management against parents knowing the TA youth's whereabouts in real-time and controlling for dyad member engagement in technology (Life360). Participants will be assessed at baseline, 4, 8 and 16 weeks. Primary youth-reported outcomes relating to suicide risk include: Suicidal behaviors (ideation, planning, attempts), non-suicidal self-injurious behaviors, self-efficacy in coping with distress, and use of imminent distress coping strategies (behavioral skills, use of crisis stabilization plan). Youth will also report on their criminal behavior. Primary caregiver-reported outcome variables relating to youth suicide include: Self-efficacy in applying family-based suicide-prevention strategies and reported use of those strategies; caregivers will also report on their own functioning (efficacy/confidence in parenting skills, life stress), TA youth functioning (internalizing and externalizing symptoms), parental management behaviors (expectation clarity, parental monitoring, discipline effectiveness/consistency, use of rewards), and parent-youth relationship quality (communication, conflict, support). App satisfaction and use of technology outcomes (i.e., degree of app usage, features used) will be examined and reported descriptively. Type: Interventional Start Date: Jun 2023 |
A Study Comparing Imetelstat Versus Best Available Therapy for the Treatment of Intermediate-2 or High-risk...
Geron Corporation
Myelofibrosis
The purpose of the study is to evaluate the overall survival of participants treated with
imetelstat compared to best available therapy with intermediate-2 or high-risk
Myelofibrosis (MF) who are relapsed/refractory to Janus Kinase (JAK)-Inhibitor treatment. expand
The purpose of the study is to evaluate the overall survival of participants treated with imetelstat compared to best available therapy with intermediate-2 or high-risk Myelofibrosis (MF) who are relapsed/refractory to Janus Kinase (JAK)-Inhibitor treatment. Type: Interventional Start Date: Apr 2021 |
Trifecta-Kidney cfDNA-MMDx Study
University of Alberta
Kidney Transplant Rejection
Demonstrate the relationship between DD-cfDNA levels and HLA antibodies in blood, and the
Molecular Microscope® (MMDx) Diagnostic System results in indication biopsies. expand
Demonstrate the relationship between DD-cfDNA levels and HLA antibodies in blood, and the Molecular Microscope® (MMDx) Diagnostic System results in indication biopsies. Type: Observational Start Date: Dec 2019 |
Diagnostic and Therapeutic Applications of Microarrays in Liver Transplantation
University of Alberta
Liver Dysfunction
INTERLIVER is a prospective observational study of the relationship of the molecular
phenotype of 300 liver transplant biopsies to the histologic phenotype and the clinical
features and outcomes. A segment of a biopsy performed as standard-of-care for
indications, or by center protocol, will be used... expand
INTERLIVER is a prospective observational study of the relationship of the molecular phenotype of 300 liver transplant biopsies to the histologic phenotype and the clinical features and outcomes. A segment of a biopsy performed as standard-of-care for indications, or by center protocol, will be used for gene expression study. Type: Observational Start Date: Dec 2017 |
Allogeneic Hematopoietic Stem Cell Transplantation for Severe Aplastic Anemia and Other Bone Marrow Failure...
National Heart, Lung, and Blood Institute (NHLBI)
Severe Aplastic Anemia
MDS (Myelodysplastic Syndrome)
Background:
- Stem cell transplants from related donors (allogenic stem cell transplants) can be
used to treat individuals with certain kinds of severe blood diseases or cancers,
such as severe anemia. Allogenic stem cell transplants encourage the growth of new
bone marrow to... expand
Background: - Stem cell transplants from related donors (allogenic stem cell transplants) can be used to treat individuals with certain kinds of severe blood diseases or cancers, such as severe anemia. Allogenic stem cell transplants encourage the growth of new bone marrow to replace that of the recipient. Because stem cell transplants can have serious complications, researchers are interested in developing new approaches to stem cell transplants that will reduce the likelihood of these complications. - By reducing the number of white blood cells included in the blood taken during the stem cell collection process, and replacing them with a smaller amount of white blood cells collected prior to stem cell donation, the stem cell transplant may be less likely to cause severe complications for the recipient. Researchers are investigating whether altering the stem cell transplant donation procedure in this manner will improve the likelihood of a successful stem cell transplant with fewer complications. Objectives: - To evaluate a new method of stem cell transplantation that may reduce the possibly of severe side effects or transplant rejection in the recipient. Eligibility: - Recipient: Individuals between 4 and 80 years of age who have been diagnosed with a blood disease that can be treated with allogenic stem cell transplants. - Donor: Individuals between 4 and 80 years of age who are related to the recipient and are eligible to donate blood. OR unrelated donors found through the National Marrow Donor Program. Design: - All participants will be screened with a physical examination and medical history. - DONORS: - Donors will undergo an initial apheresis procedure to donate white blood cells. - After the initial donation, donors will receive injections of filgrastim to release bone marrow cells into the blood. - After 5 days of filgrastim injections, donors will have apheresis again to donate stem cells that are present in the blood. - RECIPIENTS: - Recipients will provide an initial donation of white blood cells to be used for research purposes only. - From 7 days before the stem cell transplant, participants will be admitted to the inpatient unit of the National Institutes of Health Clinical Center and will receive regular doses of cyclophosphamide, fludarabine, and anti-thymocyte globulin to suppress their immune system and prepare for the transplant. - After the initial chemotherapy, participants will receive the donated white blood cells and stem cells as a single infusion. - After the stem cell and white blood cell transplant, participants will have regular doses of cyclosporine and methotrexate to prevent rejection of the donor cells. Participants will have three doses of methotrexate within the week after the transplant, but will continue to take cyclosporine for up to 4 months after the transplant. - Participants will remain in inpatient care for up to 1 month after the transplant, and will be followed with regular visits for up to 3 years with periodic visits thereafter to evaluate the success of the transplant and any side effects. Type: Interventional Start Date: Dec 2010 |
HP Pyruvate MRI in Cancers
University of Maryland, Baltimore
Image
Warburg Effect
Tumors
Many human diseases are characterized by their ability to alter existing metabolic
pathways and interrupt cellular processes. Cancer exploits the Warburg effect and
utilizes greater glucose than normal cells and within this process uses anaerobic
respiration, leading to increased conversion of pyruvate... expand
Many human diseases are characterized by their ability to alter existing metabolic pathways and interrupt cellular processes. Cancer exploits the Warburg effect and utilizes greater glucose than normal cells and within this process uses anaerobic respiration, leading to increased conversion of pyruvate to lactate. This can be exploited by hyperpolarized imaging. Hyperpolarized 13C MRI imaging is an approach that utilizes a stable isotope of Carbon (13C) linked to pyruvate. MRI spectroscopy is used in conjunction with hyperpolarized 13C pyruvate in order to temporally detect pyruvate and its conversion to lactate in-vivo, in order to visualize downstream metabolic (glycolytic) activity secondary to the Warburg effect, which should be useful in detecting and characterizing tumors of various types. Hyperpolarized 13C pyruvate MR imaging has not been tested in most cancers. In this preliminary survey, we will test the hypothesis that hyperpolarized 13C pyruvate MR imaging can be used to image various cancers. Type: Interventional Start Date: Jun 2024 |
ARrest RESpiraTory Failure From PNEUMONIA
Stanford University
Pneumonia
Hypoxemia
Acute Respiratory Failure
COVID-19 Pneumonia
This research study seeks to establish the effectiveness of a combination of an inhaled
corticosteroid and a beta agonist compared to placebo for the prevention of acute
respiratory failure (ARF) in hospitalized patients with pneumonia and hypoxemia. expand
This research study seeks to establish the effectiveness of a combination of an inhaled corticosteroid and a beta agonist compared to placebo for the prevention of acute respiratory failure (ARF) in hospitalized patients with pneumonia and hypoxemia. Type: Interventional Start Date: Jun 2020 |
Study to Evaluate the Safety and Efficacy of Oral NRC-2694-A in Combination With Paclitaxel in Patients...
NATCO Pharma Ltd.
Carcinoma
Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma
This is a Phase 2, open-label, multicenter, single-arm study of NRC-2694-A in combination
with paclitaxel in patients with R/M HNSCC with progression on or after ICI therapy.
A total of approximately 46 male and female patients will be enrolled. This sample size
is based on Simon's 2-stage design... expand
This is a Phase 2, open-label, multicenter, single-arm study of NRC-2694-A in combination with paclitaxel in patients with R/M HNSCC with progression on or after ICI therapy. A total of approximately 46 male and female patients will be enrolled. This sample size is based on Simon's 2-stage design with historical control ORR of 30% and a target ORR of 50%. Type: Interventional Start Date: Sep 2022 |
Trial of Therapeutic Hypothermia in Patients With ARDS
University of Maryland, Baltimore
Respiratory Distress Syndrome, Adult
Acute Respiratory Distress Syndrome (ARDS) is a serious condition that occurs as a
complication of medical and surgical diseases, has a mortality of ~40%, and has no known
treatment other than optimization of support. Data from basic research, animal models,
and retrospective studies, case series,... expand
Acute Respiratory Distress Syndrome (ARDS) is a serious condition that occurs as a complication of medical and surgical diseases, has a mortality of ~40%, and has no known treatment other than optimization of support. Data from basic research, animal models, and retrospective studies, case series, and small prospective studies suggest that therapeutic hypothermia (TH) similar to that used for cardiac arrest may be lung protective in patients with ARDS; however, shivering is a major complication of TH, often requiring paralysis with neuromuscular blocking agents (NMBA) to control. Since the recently completed NHLBI PETAL ROSE trial showed that NMBA had no effect (good or bad) in patients with moderate to severe ARDS, the CHILL trial is designed to evaluate whether TH combined with NMBA is beneficial in patients with ARDS. This Phase IIb randomized clinical trial is funded by the Department of Defense to compare TH (core temperature 34-35°C) + NMBA for 48h vs. usual temperature management in patients in 14 clinical centers with the Clinical Coordination Center and Data Coordinating Center at University of Maryland Baltimore. Planned enrollment is 340 over ~3.5 years of the 4-year contract. COVID-19 is considered an ARDS risk-factor and patients with ARDS secondary to COVID-19 pneumonia will be eligible for enrollment. Primary outcome is 28-day ventilator-free days. Secondary outcomes include safety, physiologic measures, mortality, hospital and ICU length of stay, and serum biomarkers collected at baseline and on days 1, 2, 3, 4, and 7. Type: Interventional Start Date: Jun 2021 |
A Phase 3 Study of Pacritinib in Patients With Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis,...
CTI BioPharma
Primary Myelofibrosis
Post-polycythemia Vera Myelofibrosis
Post-essential Thrombocythemia Myelofibrosis
This study (study ID PAC203 North America; PAC303 ex-North America) is evaluating 200 mg
BID of pacritinib compared to physician's choice (P/C) therapy in patients with MF and
severe thrombocytopenia (platelet count <50,000/μL). Approximately 399 patients in total
will be enrolled, randomized 2:1... expand
This study (study ID PAC203 North America; PAC303 ex-North America) is evaluating 200 mg BID of pacritinib compared to physician's choice (P/C) therapy in patients with MF and severe thrombocytopenia (platelet count <50,000/μL). Approximately 399 patients in total will be enrolled, randomized 2:1 to either pacritinib (approximately 266 patients) or to P/C therapy (approximately 133 patients) Condition or disease: Primary Myelofibrosis/Post-Polycythemia Vera Myelofibrosis/ Post-essential Thrombocythemia Myelofibrosis Intervention/treatment: Drug-Pacritinib Type: Interventional Start Date: Jun 2017 |
Protective Arm Balance Responses
University of Maryland, Baltimore
Old Age; Debility
Peripheral Neuropathy
The overall objective of this study is to investigate the effect of attention control
training on reach-grasp stabilizing responses during fall-induced perturbations. The
central hypothesis is that training attention control during reach to grasp balance
perturbations will lead to increased grasp... expand
The overall objective of this study is to investigate the effect of attention control training on reach-grasp stabilizing responses during fall-induced perturbations. The central hypothesis is that training attention control during reach to grasp balance perturbations will lead to increased grasp accuracies and reduced in-task falls. This research will mark the first explore the effects of training attention control on protective arm responses and fall rate during a balance perturbation paradigm and the first feasibility testing of a fully integrated cognitive and physical rehabilitation paradigm, moving beyond correlative designs and parallel treatments. The overall public health significance of the proposed research is that with improved protective arm responses and grasp accuracies, a larger randomized control study may be designed to mitigate falls among community dwelling older adults. Participants will be involved in 6 sessions. Session 1 will include the assessment, questionnaires, and training. Session 2 will include just the training. Session 3 will include the assessment and training. Sessions 4-5 will include just the training. Session 6 will include the assessment, questionnaires, and training. Type: Interventional Start Date: Oct 2023 |
High-Risk Metachronous Oligometastatic Prostate Cancer Trial
University of Maryland, Baltimore
Prostate Cancer
Oligometastatic Disease
The purpose of this research study is to compare the effects, good and/or bad, of using
the standard of care treatment, hormonal therapy + Stereotactic Ablative Radiation (SABR)
to the metastatic lesions, compared to standard of care and addition of 6-months of
niraparib/abiraterone acetate combination... expand
The purpose of this research study is to compare the effects, good and/or bad, of using the standard of care treatment, hormonal therapy + Stereotactic Ablative Radiation (SABR) to the metastatic lesions, compared to standard of care and addition of 6-months of niraparib/abiraterone acetate combination pills and prednisone for participants with recurrent metastatic prostate cancer. Type: Interventional Start Date: Apr 2024 |
Hyperpolarized 13C-pyruvate Metabolic MRI With Traumatic Brain Injury
University of Maryland, Baltimore
Traumatic Brain Injury
Subarachnoid Hemorrhage
The purpose of this study is to examine the safety and feasibility of using
hyperpolarized metabolic MRI to study early brain metabolism changes in subjects
presenting with head injury and suspected non-penetrating traumatic brain injury (TBI).
This study will also compare HP pyruvate MRI-derived... expand
The purpose of this study is to examine the safety and feasibility of using hyperpolarized metabolic MRI to study early brain metabolism changes in subjects presenting with head injury and suspected non-penetrating traumatic brain injury (TBI). This study will also compare HP pyruvate MRI-derived metrics in TBI patients with healthy subjects as well as Subarachnoid hemorrhage (SAH) patients to better understand if metabolic Magnetic resonance imaging scan (MRI) can improve our ability to diagnose a TBI. The FDA is allowing the use of hyperpolarized [1-13C] pyruvate (HP 13C-pyruvate) in this study. Up to 15 patients (5 with TBI, 5 with SAH, and 5 healthy volunteers) may take part in this study at the University of Maryland, Baltimore (UMB). Type: Interventional Start Date: Oct 2023 |
Selective Adjuvant Therapy for HPV-mediated Oropharynx SCCs Based on Residual Circulating Tumor DNA Levels...
University of Maryland, Baltimore
Head and Neck Cancer
Head and Neck Squamous Cell Carcinoma
Oropharynx Cancer
Oropharynx Squamous Cell Carcinoma
HPV Positive Oropharyngeal Squamous Cell Carcinoma
Patients with human papillomavirus (HPV)-related oropharyngeal cancer generally have
favorable outcomes and how well they do depends on the specific details about the patient
and their cancer. How well they do isn't as related to the kinds of treatment they get.
However, there are significant side... expand
Patients with human papillomavirus (HPV)-related oropharyngeal cancer generally have favorable outcomes and how well they do depends on the specific details about the patient and their cancer. How well they do isn't as related to the kinds of treatment they get. However, there are significant side effects for the various types of treatments they may get. Because these patients generally have favorable outcomes no matter the kind of treatment, reducing side effects should be a priority when choosing their treatment. The goal of this clinical research study is to evaluate whether a new blood test called a Circulating Tumor DNA test (ctDNA test) can decrease the number of people that require radiation after surgery. This blood test is often elevated in people when they are diagnosed with head and neck cancer. There are studies that show that cancer most often returns when this blood test is positive after treatment. This study will test patients' blood before and after surgery. In cases where the test is negative after surgery, people on the study will not receive radiation unless they are considered high risk based on surgery findings. The hope is that radiation and its potential side effects can be limited to only people that need the treatment. Type: Interventional Start Date: Mar 2024 |
A Study of RGLS8429 in Patients With Autosomal Dominant Polycystic Kidney Disease
Regulus Therapeutics Inc.
Autosomal Dominant Polycystic Kidney Disease
ADPKD
Polycystic Kidney, Autosomal Dominant
Primary Objectives
- To assess the safety and tolerability of RGLS8429
- To assess the impact of RGLS8429 on ADPKD biomarkers
Secondary Objectives
- To assess the impact of RGLS8429 on height-adjusted total kidney volume (htTKV)
- To characterize the pharmacokinetic (PK) properties... expand
Primary Objectives - To assess the safety and tolerability of RGLS8429 - To assess the impact of RGLS8429 on ADPKD biomarkers Secondary Objectives - To assess the impact of RGLS8429 on height-adjusted total kidney volume (htTKV) - To characterize the pharmacokinetic (PK) properties of RGLS8429 - To assess the impact of RGLS8429 on renal function Type: Interventional Start Date: Oct 2022 |
Proper Duration of Suppressive Antibiotic Therapy After Debridement, Antibiotics, and Implant Retention
University of Maryland, Baltimore
Periprosthetic Joint Infection
Antibiotic Suppression
Multiple studies have demonstrated oral suppressive antibiotic therapy (SAT), after
intravenous antibiotics, maximizes reoperation-free survival of total joint arthroplasty
(TJA) debridement, antibiotics, and implant retention (DAIR) for acute periprosthetic
joint infection (PJI). However, little... expand
Multiple studies have demonstrated oral suppressive antibiotic therapy (SAT), after intravenous antibiotics, maximizes reoperation-free survival of total joint arthroplasty (TJA) debridement, antibiotics, and implant retention (DAIR) for acute periprosthetic joint infection (PJI). However, little is known regarding sequelae of SAT after DAIR for PJI. Prior studies have small or heterogeneous patient cohorts, variable antibiotic regimens, arrive at disparate conclusions, and do not establish antibiotic resistance risk. The investigators propose a prospective randomized controlled multicenter study to expand on findings in a retrospective, multi-center pilot study. Study aims are to evaluate SAT after DAIR of acutely infected primary TJA regarding: 1) adverse drug reactions/intolerance; 2) reoperation for infection; and 3) antibiotic resistance. Type: Interventional Start Date: Apr 2024 |
MicroVention, Inc. Flow Re-Direction Endoluminal Device X (FRED™ X™) Post-Approval Study
Microvention-Terumo, Inc.
Intracranial Aneurysm
The objective of this study is to generate contemporaneous clinical data to facilitate a
reasonable comparison of the performance of the FRED™ X™ device with the performance of
the FRED™ device. The data generated from this study will be compared to the safety and
effectiveness of the FRED™ device... expand
The objective of this study is to generate contemporaneous clinical data to facilitate a reasonable comparison of the performance of the FRED™ X™ device with the performance of the FRED™ device. The data generated from this study will be compared to the safety and effectiveness of the FRED™ device by meeting the same performance goals (PGs) established for the FRED™ pivotal study. Type: Interventional Start Date: Sep 2022 |
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 ascending aorta and with... 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 |
A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients
United Therapeutics
PAH
Pulmonary Hypertension
Pulmonary Arterial Hypertension
Hypertension
Connective Tissue Diseases
Study ROR-PH-301, ADVANCE OUTCOMES, is designed to assess the efficacy and safety of
ralinepag when added to pulmonary arterial hypertension (PAH) standard of care or
PAH-specific background therapy in subjects with World Health Organization (WHO) Group 1
PAH. expand
Study ROR-PH-301, ADVANCE OUTCOMES, is designed to assess the efficacy and safety of ralinepag when added to pulmonary arterial hypertension (PAH) standard of care or PAH-specific background therapy in subjects with World Health Organization (WHO) Group 1 PAH. Type: Interventional Start Date: Aug 2018 |
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