cometadata/datacite-titles-descriptions-related-identifiers huggingface dataset:
DOI: 10.25934/pr00008623
title: Sedation Management in Pediatric Patients With Acute Respiratory Failure

description: People with acute respiratory failure usually require the use of an artificial breathing machine, known as a mechanical ventilator. Sedative medications, which help keep people calm and reduce anxiety, are often prescribed for children who are on mechanical ventilators. However, the longer that sedative medications are used, the longer a child may need to remain on mechanical ventilation. This study will evaluate the effectiveness of a team approach to sedation management that aims to reduce the number of days that children with acute respiratory failure require mechanical ventilation.
DOI: 10.25934/pr00008624
title: Childhood Asthma Research and Education (CARE) Network Trial - Maintenance Versus Intermittent Inhaled Steroids in Wheezing Toddlers (MIST)

description: Asthma affects about 4 million children in the United States and is a leading cause of hospitalizations and school absenteeism. Continuous wheezing in very young children may develop into asthma. Low doses of inhaled corticosteroids (ICS) are commonly prescribed to treat children with particularly bad wheezing episodes. This study will compare the safety and effectiveness of low doses of ICS taken daily versus higher doses of ICS taken only during respiratory tract illnesses for toddlers with continuous wheezing or coughing illnesses.
DOI: 10.25934/pr00008626
title: Protocol For A Research Database For Hematopoietic Stem Cell Transplantation, Other Cellular Therapies and Marrow Toxic Injuries

description: The primary purpose of the Research Database is to have a comprehensive source of observational data that can be used to study HSC transplantation and cellular therapies. A secondary purpose of the Research Database is to have a comprehensive source of data to study marrow toxic injuries. Objectives: To learn more about what makes stem cell transplants and cellular therapies work well such as:   -  Determine how well recipients recover from their transplants or cellular therapy;   -  Determine how recovery after a transplant or cellular therapy can be improved;   -  Determine how a donor's or recipient's genetics impact recipient recovery after a transplant or cellular therapy;   -  Determine how access to transplant or cellular therapy for different groups of patients can be improved;   -  Determine how well donors recover from the collection procedures.
DOI: 10.25934/pr00008627
title: Prevention of Early Asthma in Kids (PEAK)

description: To evaluate current and novel therapies and management strategies for children with asthma. The emphasis is on clinical trials that help identify optimal therapy for children with different asthma phenotypes, genotypes, and ethnic backgrounds and children at different developmental stages.
DOI: 10.25934/pr00008628
title: Reevaluation Of Systemic Early Neuromuscular Blockade

description: This study evaluates whether giving a neuromuscular blocker (skeletal muscle relaxant) to a patient with acute respiratory distress syndrome will improve survival. Half of the patients will receive a neuromuscular blocker for two days and in the other half the use of neuromuscular blockers will be discouraged.
DOI: 10.25934/pr00008629
title: Multi-center Clinical Trial of Limiting Resident Work Hours on ICU Patient Safety

description: In this proposal, we seek to address conclusively two knowledge gaps: 1) the lack of data on the relationship between PGY2+ (post graduate year 2) sleep deprivation and patient safety; and 2) the lack of data on the relationship between resident sleep deprivation and preventable patient injuries. Through the Clinical and Translational Science Award (CTSA)-funded Sleep Research Network, the largest and only federally-funded sleep science network in the U.S., we propose conducting a multi-center randomized crossover trial in six pediatric ICUs staffed by PGY2 and PGY3 residents. We will compare rates of all serious errors (i.e., rates of harmful and other serious medical errors due to any cause, including but not limited to fatigue-related errors, handoff errors, and provider knowledge deficits) of a sleep and circadian science-based (SCS) intervention schedule with a traditional schedule that includes frequent shifts of 24 hours or longer. Our specific aims will be:   1. To test the hypothesis that PGY2&3 residents working on an SCS intervention schedule will make significantly fewer harmful medical errors (preventable adverse events) and other serious medical errors (near misses) while caring for ICU patients than residents working on a traditional schedule; (primary endpoints: resident-related preventable adverse events and near misses)   2. To test the hypothesis that rates of harmful medical errors (preventable adverse events) and other serious medical errors (near misses) throughout the ICU (i.e., those involving and those not involving residents) will be lower in ICUs when PGY2&3 residents work on an SCS intervention schedule than when residents work on a traditional schedule; (major secondary endpoints: ICU-wide preventable adverse events and near misses)   3. To test the hypothesis that resident physicians' risk of neurobehavioral performance failures and motor vehicle crashes - as assessed through simple visual reaction time tasks [Johns Drowsiness Score (JDS) and Psychomotor Vigilance Task (PVT) lapses] - will be lower on the SCS intervention schedule than on the traditional schedule. (major secondary endpoints: resident neurobehavioral performance and predicted driving safety)
DOI: 10.25934/pr00008630
title: REVIVE-IT Registry (REVIVAL: Registry Evaluation of Vital Information For VADs in Ambulatory Life)

description: REVIVAL will establish a prospective, observational, multicenter patient cohort in ambulatory patients with chronic, advanced, systolic heart failure that will provide a greater understanding of their clinical trajectory (rates of hospitalizations, transplantation, MCSD use and death), and of how baseline clinical risk measures are related to prognosis.
DOI: 10.25934/pr00008631
title: Reduced-Intensity Conditioning for Children and Adults With Hemophagocytic Syndromes or Selected Primary Immune Deficiencies (RICHI) (BMT CTN #1204)

description: HLH, HLH-related disorders, Chronic Granulomatous (CGD), HIGM1, Immune dysregulation, polyendocrinopathy, enteropathy, and X-linked inheritance (IPEX) and severe LAD-I represent primary immune disorders that are typically fatal without Hematopoietic Cell Transplant (HCT). However, transplant is often complicated by inflammation, infection and other co-morbidities. In addition, these disorders have been shown to be cured with partial chimerism, making them an ideal target for the use of reduced intensity approaches, where a portion of patients may not achieve full donor chimerism, but instead achieve stable mixed chimerism. Reduced-intensity conditioning strategies have demonstrated improved survival with decreased Treatment Related Mortality (TRM) in institutional series for patients with HLH (Cooper et al., 2006; Marsh et al., 2010; Marsh et al., 2011). However, graft loss and unstable chimerism remain challenges. An institutional case series from Cincinnati Children's Hospital demonstrated full or high-level chimerism and improved durable engraftment using intermediate (Day -14) timing alemtuzumab (Marsh et al., 2013b). This study aims to test the efficacy of the Intermediate RIC strategy in a prospective multi-center study including HLH as well as other primary immunodeficiencies where allogeneic transplant with RIC has been shown to be feasible and stable chimerism is curative.
DOI: 10.25934/pr00008632
title: Red Cell Storage Duration Study

description: The RECESS study will compare the effects of transfusing red blood cell units stored <= 10 days vs. red blood cell units stored >= 21 days, in patients who are undergoing complex cardiac surgery and are likely to need a red blood cell transfusion. The primary hypothesis is that there is a clinically important difference between the effects of shorter-storage red cell units and longer-storage red cell units on clinical outcomes and mortality risk.
DOI: 10.25934/pr00008633
title: MEDication Focused Outpatient Care for Underutilization of Secondary Prevention

description: The study tested whether a pharmacist-run cardiovascular risk service (CVRS) at the University of Iowa can increase use of national standards of care in clinics
DOI: 10.25934/pr00008634
title: Unrelated Donor Reduced Intensity Bone Marrow Transplant for Children With Severe Sickle Cell Disease (BMT CTN #0601)

description: Sickle cell disease (SCD), also known as sickle cell anemia, is an inherited blood disease that can cause organ damage, stroke, and intense pain episodes. A blood stem cell transplant is a treatment option for someone with a severe form of the disease. Prior to undergoing a transplant, people typically receive a conditioning regimen of high doses of chemotherapy and other medications to prepare the body to accept the transplant. A conditioning regimen that uses lower doses of chemotherapy and medications may be safer for transplant recipients. This study will evaluate the safety and effectiveness of blood stem cell transplants, using bone marrow from unrelated donors, in children with severe SCD who receive a reduced intensity conditioning regimen prior to the transplant.
DOI: 10.25934/pr00008635
title: Functional Impact of GLP-1 for Heart Failure Treatment

description: The primary objective is to test the hypothesis that, compared with placebo, therapy with Subcutaneous (SQ) GLP-1 agonist in the post-Acute Heart Failure Syndrome (AHFS) discharge period will be associated with greater clinical stability at six months as assessed by a composite clinical endpoint.
DOI: 10.25934/pr00008636
title: Aldosterone Targeted Neurohormonal Combined With Natriuresis Therapy - HF (ATHENA-HF)

description: The primary objective of this study is to test the hypothesis that high-dose spironolactone will lead to greater proportional reduction in NT-proBNP levels from randomization to 96 hours over standard of care.
DOI: 10.25934/pr00008637
title: High Dose Granulocyte Transfusions for the Treatment of Infection in Neutropenia: The RING Study (Resolving Infection in Neutropenia With Granulocytes)

description: Neutropenia, a condition characterized by an abnormally low number of infection-fighting white blood cells called neutrophils, commonly develops in people who have undergone chemotherapy or hematopoietic stem cell (HSC) transplantation. The severely reduced immunity of those with neutropenia can put them at risk of entry of life-threatening infections, making the implementation of treatments that increase white blood cell numbers important. Several studies have shown that the transfusion of donor granulocytes, a type of white blood cell that includes neutrophils, is effective in promoting the recovery of adequate numbers of granulocytes. However, granulocyte transfusions can cause side effects, and it is not known whether the success of the therapy outweighs the health risks of the side effects. This study will evaluate the safety and effectiveness of granulocyte transfusions in treating people with a bacterial or fungal infection during neutropenia.
DOI: 10.25934/pr00008638
title: A Phase II/III Randomized, Multicenter Trial Comparing Sirolimus Plus Prednisone and Sirolimus/Calcineurin Inhibitor Plus Prednisone for the Treatment of Chronic Graft-versus-Host Disease (BMT CTN Protocol #0801)

description: This study is designed as a combined Phase II/III, randomized, open label, multicenter, prospective comparative study of sirolimus plus prednisone versus sirolimus/calcineurin-inhibitor plus prednisone for the treatment of chronic GVHD. Patients will be stratified by transplant center and will be randomized to an experimental arm of one of the two pre-specified experimental arms (sirolimus + prednisone or the comparator arm of sirolimus + calcineurin inhibitor + prednisone) in a 1:1 ratio.
DOI: 10.25934/pr00008639
title: Allogeneic Hematopoietic Cell Transplant for Hematological Cancers and Myelodysplastic Syndromes in HIV-Infected Individuals (BMT CTN #0903)

description: The rationale for this trial is to demonstrate the feasibility and safety of allogeneic HCT for patients with chemotherapy-sensitive hematological malignancies and coincident HIV-infection. In particular, the trial will focus on the 100-day non-relapse mortality as an indicator of the safety of transplant in this patient population. Correlative assays will focus upon the incidence of infectious complications in this patient population, the evolution of HIV infection and immunological reconstitution. Where feasible (and when this can be accomplished without compromise of either the donor quality or the timeliness of transplantation), an attempt will be made to identify donors who are homozygotes for the delta32 mutation for CCR5.
DOI: 10.5281/zenodo.18497710
title: LDR COMS Eye Plaque

description: Task Group 186 provides guidance for commissioning model-based dose calculation algorithms (MBDCAs) in brachytherapy treatment planning systems. TG-186 recommends a two-level commissioning approach, including comparison of absolute dose and 3D dose distributions against reference calculations.

To support implementation of these recommendations, the AAPM Working Group on Dose Calculation Algorithms in Brachytherapy developed test cases - Collaborative Ocular Melanoma Study (COMS) 16-mm eye plaque containing 13 model 6711 I-125 seeds

Note: This dataset was originally hosted on the IROC platform, as described in the user guide. The files uploaded to Zenodo (version 1) are identical to those previously available from IROC and were transferred without modification to ensure full traceability and continuity with the original reference dataset.

 

Refer to the publication for additional details.

 

Elizabeth M. Fletcher, Facundo Ballester, Luc Beaulieu, Hali Morrison, Audran Poher, Mark J. Rivard, Ron S. Sloboda, Javier Vijande, Rowan M. Thomson. Generation and comparison of 3D dosimetric reference datasets for COMS eye plaque brachytherapy using model-based dose calculations. Med. Phys. 51 (1), 694-706 (2023) https://doi.org/10.1002/mp.16721Digital Object Identifier (DOI)
DOI: 10.5281/zenodo.18497711
title: LDR COMS Eye Plaque

description: Task Group 186 provides guidance for commissioning model-based dose calculation algorithms (MBDCAs) in brachytherapy treatment planning systems. TG-186 recommends a two-level commissioning approach, including comparison of absolute dose and 3D dose distributions against reference calculations.

To support implementation of these recommendations, the AAPM Working Group on Dose Calculation Algorithms in Brachytherapy developed test cases - Collaborative Ocular Melanoma Study (COMS) 16-mm eye plaque containing 13 model 6711 I-125 seeds

Note: This dataset was originally hosted on the IROC platform, as described in the user guide. The files uploaded to Zenodo (version 1) are identical to those previously available from IROC and were transferred without modification to ensure full traceability and continuity with the original reference dataset.

 

Refer to the publication for additional details.

 

Elizabeth M. Fletcher, Facundo Ballester, Luc Beaulieu, Hali Morrison, Audran Poher, Mark J. Rivard, Ron S. Sloboda, Javier Vijande, Rowan M. Thomson. Generation and comparison of 3D dosimetric reference datasets for COMS eye plaque brachytherapy using model-based dose calculations. Med. Phys. 51 (1), 694-706 (2023) https://doi.org/10.1002/mp.16721Digital Object Identifier (DOI)
DOI: 10.25934/pr00008640
title: A Trial of Single Autologous Transplant With or Without Consolidation Therapy Versus Tandem Autologous Transplant With Lenalidomide Maintenance for Patients With Multiple Myeloma (BMT CTN 0702)

description: The study is designed as a Phase III, multicenter trial of tandem autologous transplants plus maintenance therapy versus the strategy of single autologous transplant plus consolidation therapy with lenalidomide, bortezomib and dexamethasone (RVD) followed by maintenance therapy or single autologous transplant plus maintenance therapy as part of upfront treatment of multiple myeloma (MM). Lenalidomide will be used as maintenance therapy for three years in all arms.
DOI: 10.5281/zenodo.10210952
title: IODP Expedition 397T Rig instrumentation

description: Operational rig information data were measured using a variety of sensors and compiled using the RigWatch software package. Approximately 50 channels of drilling/coring data are captured in real time during the expedition. Data are presented as ASCII files extracted from the proprietary RigWatch data files and are presented by expedition. RigWatch data in time or depth domain can be imported into graphics and analysis programs to be merged and correlated with core physical properties data to enhance assessment of poor core recovery intervals.
DOI: 10.5281/zenodo.18497850
title: IODP Expedition 397T Rig instrumentation

description: Operational rig information data were measured using a variety of sensors and compiled using the RigWatch software package. Approximately 50 channels of drilling/coring data are captured in real time during the expedition. Data are presented as ASCII files extracted from the proprietary RigWatch data files and are presented by expedition. RigWatch data in time or depth domain can be imported into graphics and analysis programs to be merged and correlated with core physical properties data to enhance assessment of poor core recovery intervals.
DOI: 10.25934/pr00008641
title: Oral Iron Repletion Effects On Oxygen Uptake in Heart Failure

description: The purpose of this study is to determine if oral iron (Fe) polysaccharide is superior to oral placebo in improving functional capacity as measured by change in peak VO2 (oxygen uptake) by CPET (Cardiopulmonary Exercise Testing) , of a broad population of patients with HFrEF (Heart Failure with Reduced Ejection Fraction) and Fe deficiency at 16 weeks. Hypothesis: In a broad population of HFrEF patients with Fe deficiency, compared to oral placebo, therapy with oral Fe polysaccharide will be associated with improvement in functional capacity at 16 weeks as assessed by CPET.
DOI: 10.25934/pr00008642
title: Study of Novel Approaches for Prevention

description: The Study of Novel Approaches for Prevention (SNAP) is randomized trial designed to test whether behavioral interventions based on self-regulation can prevent weight gain in young adults (18-35 years; body mass index (BMI) 21-30 kg/m2). Two different self-regulation interventions for weight gain prevention will be compared in this trial; one intervention will focus on making small, consistent, changes in eating and exercise behavior to prevent weight gain or reverse weight gain if it occurs, whereas the other will emphasize larger changes in eating and exercise that occur periodically, with a goal of producing weight loss and thereby providing a buffer against anticipated weight gains. The primary aim of the trial is to test whether the magnitude of weight gain from baseline across an average three-year follow-up differs across the three groups, with the hypotheses that weight gain will be greater in the Control group than in either intervention and greater in the Small Changes than Large Changes group. SNAP-E (Extension) will determine whether the effects of the intervention can be maintained over an additional 3 years (i.e. through a total of 6 years).
DOI: 10.25934/pr00008643
title: Vitamin D to Improve Outcomes by Leveraging Early Treatment

description: Vitamin D deficiency is a common, potentially reversible contributor to morbidity and mortality among critically ill patients. We conducted a randomized, double-blind, placebo-controlled, phase 3 trial of early vitamin D3 supplementation in critically ill, vitamin D-deficient patients who were at high risk for death. Patients screened as vitamin D deficient (<20 ng/mL) were randomized. Randomization occurred within 12 hours after the decision to admit the patient to an intensive care unit. Eligible patients received a single enteral dose of 540,000 IU of vitamin D3 or matched placebo. The primary end point was 90-day all-cause, all-location mortality.
DOI: 10.25934/pr00008644
title: A Randomized, Phase II, Multicenter, Open Label, Study Evaluating Sirolimus and Prednisone in Patients With Refined Minnesota Standard Risk, Ann Arbor 1/2 Confirmed Acute Graft-Versus-Host Disease (BMT CTN 1501)

description: The study is a Phase II randomized, open label, multicenter trial designed to identify whether sirolimus is a potential alternative to prednisone as an up-front treatment for patients with standard-risk acute GVHD defined according to clinical and biomarker-based risk stratification. This trial incorporates both a novel up front GVHD therapy (sirolimus) as well as a novel BMT CTN developed acute GVHD biomarker test.
DOI: 10.25934/pr00008645
title: Inorganic Nitrite Delivery to Improve Exercise Capacity in HFpEF

description: A randomized, double-blind, placebo-controlled crossover study to assess the effect of inorganic nitrite (NO2) on aerobic capacity (peak VO2) after four weeks of dosing. Approximately 100 participants will be enrolled in this 2*2 crossover study.
DOI: 10.25934/pr00008646
title: Prospective Multi-Center Cohort for the Evaluation of Biomarkers Predicting Risk of Complications and Mortality Following Allogeneic HCT (BMT CTN #1202)

description: The goal of this protocol is to establish a cohort of at least 1500 biologic samples collected prospectively from patients treated in BMT CTN centers that will be a shared bio specimen resource for conducting future allogeneic hematopoietic stem cell transplantation (HCT) correlative studies.
DOI: 10.25934/pr00008647
title: A Phase I, First-in-Human, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study of the Safety and Efficacy of Allogeneic Mesenchymal Stem Cells in Cancer Survivors With Anthracycline-Induced Cardiomyopathy

description: The primary purpose of this study is to examine the safety and feasibility of delivering allogeneic human mesenchymal stem cells (allo-MSCs) by transendocardial injection to cancer survivors with left ventricular (LV) dysfunction secondary to anthracycline-induced cardiomyopathy (AIC). The secondary purpose of this study is to obtain preliminary evidence for therapeutic efficacy of allo-MSCs delivered by transendocardial injection to cancer survivors with LV dysfunction secondary to AIC.