Catalogue Search | MBRL
Are you sure you want to remove the book from the shelf?
{{itemTitle}}
22
result(s) for
"Gerber, Linda C"
Sort by:
Hacked
While on location in Costa Rica, Cassidy discovers that her blog has been hacked and wonders about Logan's strange behavior.
Book
Efficacy of intrathecal mesenchymal stem cell-neural progenitor therapy in progressive MS: results from a phase II, randomized, placebo-controlled clinical trial
Background
Mesenchymal stem cell-neural progenitors (MSC-NPs) are a bone marrow mesenchymal stem cell (MSC)-derived ex vivo manipulated cell product with therapeutic potential in multiple sclerosis (MS). The objective of this study was to determine efficacy of intrathecal (IT) MSC-NP treatment in patients with progressive MS.
Methods
The study is a phase II randomized, double-blind, placebo-controlled clinical trial with a compassionate crossover design conducted at a single site. Subjects were stratified according to baseline Expanded Disability Status Scale (EDSS) (3.0-6.5) and disease subtype (secondary or primary progressive MS) and randomized into either treatment or placebo group to receive six IT injections of autologous MSC-NPs or saline every two months. The primary outcome was EDSS Plus, defined by improvement in EDSS, timed 25-foot walk (T25FW) or nine-hole peg test. Secondary outcomes included the individual components of EDSS Plus, the six-minute walk test (6MWT), urodynamics testing, and brain atrophy measurement.
Results
Subjects were randomized into MSC-NP (
n
= 27) or saline (
n
= 27) groups. There was no difference in EDSS Plus improvement between the MSC-NP (33%) and saline (37%) groups. Exploratory subgroup analysis demonstrated that in subjects who require assistance for ambulation (EDSS 6.0-6.5) there was a significantly higher percentage of improvement in T25FW and 6MWT in the MSC-NP group (3.7% ± 23.1% and − 9.2% ± 18.2%) compared to the saline group (-54.4% ± 70.5% and − 32.1% ± 30.0%), (
p
= 0.030 and
p
= 0.036, respectively). IT-MSC-NP treatment was also associated with improved bladder function and reduced rate of grey matter atrophy on brain MRI. Biomarker analysis demonstrated increased MMP9 and decreased CCL2 levels in the cerebrospinal fluid following treatment.
Conclusion
Results from exploratory outcomes suggest that IT-MSC-NP treatment may be associated with a therapeutic response in a subgroup of MS patients.
Trial Registration
ClinicalTrials.gov NCT03355365, registered November 14, 2017,
https://clinicaltrials.gov/study/NCT03355365?term=NCT03355365&rank=1
.
Journal Article
Thalamic deep brain stimulation in traumatic brain injury: a phase 1, randomized feasibility study
Converging evidence indicates that impairments in executive function and information-processing speed limit quality of life and social reentry after moderate-to-severe traumatic brain injury (msTBI). These deficits reflect dysfunction of frontostriatal networks for which the central lateral (CL) nucleus of the thalamus is a critical node. The primary objective of this feasibility study was to test the safety and efficacy of deep brain stimulation within the CL and the associated medial dorsal tegmental (CL/DTTm) tract.
Six participants with msTBI, who were between 3 and 18 years post-injury, underwent surgery with electrode placement guided by imaging and subject-specific biophysical modeling to predict activation of the CL/DTTm tract. The primary efficacy measure was improvement in executive control indexed by processing speed on part B of the trail-making test.
All six participants were safely implanted. Five participants completed the study and one was withdrawn for protocol non-compliance. Processing speed on part B of the trail-making test improved 15% to 52% from baseline, exceeding the 10% benchmark for improvement in all five cases.
CL/DTTm deep brain stimulation can be safely applied and may improve executive control in patients with msTBI who are in the chronic phase of recovery.
ClinicalTrials.gov identifier:
NCT02881151
.
A phase 1 feasibility trial shows that bilateral deep brain stimulation within the central lateral thalamus can be safely applied and is associated with improved executive control.
Journal Article
Influence of Distinct Maternal Cytomegalovirus-Specific Neutralizing and Fc Receptor-Binding Responses on Congenital Cytomegalovirus Transmission in HIV-Exposed Neonates
Congenital cytomegalovirus (cCMV) is the most common infectious cause of birth defects worldwide, affecting approximately 1 in every 200 live-born infants globally. Recent work has identified potential immune correlates of protection against cCMV transmission including maternal and placentally transferred antibody levels and their function, which may inform the development of maternal active (vaccine) and passive (mono/polyclonal antibody) immunizations. However, these correlates need to also be assessed in diverse cohorts, including women living with HIV who have increased risk of cCMV transmission. Using a case–control design, we investigated whether the magnitude, specificity, function and placental transfer of maternal IgG responses are associated with protection against and/or risk of cCMV transmission in HIV/HCMV co-infection. Within 3 historical cohorts of pregnant women with HIV/HCMV co-infection, we identified 16 cCMV transmitting cases that were matched to 29 cCMV non-transmitting controls. Using a systems serology approach, we found that normalized HCMV-specific IgG binding to FcγR1α was higher in non-transmitting dyads, whereas HCMV-neutralizing antibody responses were higher in transmitting dyads. These findings suggest that engagement of FcγR1α by HCMV-specific IgG may help confer protection against cCMV transmission. Building upon previous research, our study reinforces the critical role of validating maternal humoral immune correlates of cCMV transmission risk across diverse seropositive cohorts, providing essential insights to inform and accelerate the development of effective HCMV vaccines.
Journal Article
Results from the Trial Using Motivational Interviewing, Positive Affect, and Self-Affirmation in African Americans with Hypertension (TRIUMPH)
Objective: Our objective was to determine the the effectiveness in combining positive affect and self-affirmation strategies with motivational interviewing in improving blood pressure control among hypertensive African Americans compared with AA hypertensives in an education-only control group.Design: Randomized trial.Setting: Ambulatory practices in the South Bronx and Harlem, New York City.Participants: African American adults with uncontrolled hypertension.Interventions: Participants were randomized to a positive affect and self-affirmation intervention or an education control group. The positive affect and self-affirmation intervention involved having participants think about things that made them happy and that reminded them of their core values on a daily basis. These strategies were reinforced every two months through motivational interviewing. The control arm received a workbook of strategies on blood pressure control. All participants were called every two months for one year.Main outcomes: Blood pressure control rate.Results: A total of 238 participants were randomized. The average age was 56 + 11, approximately 70% were female, 80% were not married, and up to 70% completed high school. There was no difference in control rates between the intervention and the control group. However, at one year, female participants were more likely to be controlled. Participants with high depressive symptoms or high perceived stress at baseline were less likely to be controlled.Conclusions: While this study did not demonstrate an intervention effect, it does provide important insight into the psychosocial factors that may underlie blood pressure control in African Americans. Implications for future behavioral intervention trials are discussed. Ethn Dis. 2016;26(1):51-60; doi:10.18865/ed.26.1.51
Journal Article
Tai chi for enhanced inpatient mobilization: A feasibility study
•Innovative solutions are needed to address immobility among hospitalized patients.•Video-guided tai chi and qigong classes may serve to enhance inpatient mobilization.•Such classes have been tested to be feasible and well-received at our hospital.
To determine whether utilizing beginner, video-guided tai chi and qigong classes as an adjunct to physical therapy to enhance mobilization among hospitalized patients is feasible and acceptable.
Single-arm feasibility study over a 15½-week period.
Three medical-surgical units at one hospital.
Small-group video-guided beginner-level tai chi and qigong classes supervised by physical therapists occurred three times a week.
The primary outcome was weekly class attendance. Secondary outcomes included patient and staff satisfaction, collected by surveys and semi-structured interviews. Process measures included class duration. Balancing measures included falls.
One-hundred and fifty-seven patients were referred for recruitment, 45 gave informed consent, and 38 patients attended at least one class. The number of weekly class attendees increased during the study period. Based on first-class experience, 68% (26/38) of patients reported enjoying the class “quite a bit” or “extremely,” 66% (25/38) of patients reported feeling “more mobile” afterward, and 76% (29/38) of patients agreed that the class made them more comfortable going home. Average class duration was 29 minutes. Zero falls occurred during or immediately following class.
Video-guided tai chi and qigong classes are feasible and well-received at our hospital. Future studies of the impact on preserving mobility and function or reducing length of stay are of interest.
Journal Article
Study design and protocol for moving forward: a weight loss intervention trial for African-American breast cancer survivors
Background
Breast cancer survival rates are significantly lower among African-American women compared to white women. In addition, African-American women with breast cancer are more likely than white women to die from co-morbid conditions. Obesity is common among African-American women, and it contributes to breast cancer progression and the development and exacerbation of many weight-related conditions. Intervening upon obesity may decrease breast cancer and all-cause mortality among African-American breast cancer survivors.
Methods/Design
Moving Forward is a weight loss intervention being evaluated in a randomized trial with a projected sample of 240 African American breast cancer survivors. Outcomes include body mass index, body composition, waist:hip ratio, and behavioral, psychosocial and physiological measures. Survivors are randomized to either a 6-month guided weight loss intervention that involves twice weekly classes and text messaging or a self-guided weight loss intervention based on the same materials offered in the guided program. The guided intervention is being conducted in partnership with the Chicago Park District at park facilities in predominantly African-American neighborhoods in Chicago. Recruitment strategies include direct contact to women identified in hospital cancer registries, as well as community-based efforts. Data collection occurs at baseline, post-intervention (6 months) and at a 12-month follow-up.
Discussion
This study evaluates a community-based, guided lifestyle intervention designed to improve the health of African-American breast cancer survivors. Few studies have addressed behavioral interventions in this high-risk population. If successful, the intervention may help reduce the risk for breast cancer recurrence, secondary cancers, and co-morbid conditions, as well as improve quality of life.
Trial registration
U.S. Clinicaltrials.gov number:
NCT02482506
, April 2015
Journal Article
Master protocol for a series of cohort-based randomized controlled trials to test tools to communicate research results to study participants and others with relevant lived experience: the SPIN-CLEAR Trials
Background
Research results are often not communicated to study participants or others with relevant lived experience. Effective communication of research results would help study participants understand their contribution to research and could improve trust in research and likelihood of research participation. Few randomized controlled trials (RCTs), however, have compared the effectiveness of research communication tools, and it is not known which tools work best for different people. We will conduct the Scleroderma Patient-centered Intervention Network—Communicating Latest Evidence and Results (SPIN-CLEAR) trial series via the multi-national SPIN Cohort to compare tool effectiveness. Primary objectives of each RCT will be to compare tools based on (1) information completeness, (2) understandability, and (3) ease of use. We will additionally evaluate comprehension of key aspects of disseminated research; likelihood that participants would enroll in a similar future study; and, for all primary and secondary outcomes, outcomes by participant characteristics (gender, age, race or ethnicity, country, language, education level, health literacy).
Methods
An advisory team of people with systemic sclerosis (SSc, also known as scleroderma) participated in developing research questions, selecting outcomes, and designing the series of parallel-arm RCTs that will each compare two or more tools or tool variations to a plain-language summary comparator; the common comparator will facilitate across-trial comparisons. In each RCT, people with SSc and researchers will select a recent SSc research study to disseminate. Tools will be developed by experienced tool developers and people with SSc. SPIN Cohort participants (current
N
eligible = 1522 from 50 SPIN sites in Australia, Canada, France, UK, USA) and additional participants recruited via social media and patient organization partners who consent to participate will be randomized to a dissemination tool or plain-language summary comparator and complete outcomes. Analyses will be intent-to-treat and use linear regression models.
Discussion
Each trial in the planned series of trials will build upon knowledge from previous trials. Results will contribute to the evidence base on how to best disseminate results to study participants and others with relevant lived experience.
Trial registration
ClinicalTrials.gov NCT06373263. Registered on April 17, 2024 (first trial in series).
Journal Article
Outbreak of Human Adenovirus Type 3 Infection in a Pediatric Long-Term Care Facility—Illinois, 2005
Background.Human adenovirus type 3 (HAdV-3) causes severe respiratory illness in children, but outbreaks in long-term care facilities have not been frequently reported. We describe an outbreak of HAdV-3 infection in a long-term care facility for children with severe neurologic impairment, where only 3 of 63 residents were ambulatory. Methods.A clinical case of HAdV-3 was defined as fever (temperature, ⩾38.0°C) and either a worsening of respiratory symptoms or conjunctivitis in a resident, with illness onset from June through August 2005. We reviewed medical records; conducted surveillance for fever, conjunctivitis, and respiratory symptoms; and collected nasopharyngeal and conjunctival specimens from symptomatic residents. Specimens were cultured in HAdV-permissive cell lines or were analyzed by HAdV-specific polymerase chain reaction assay. Results.Thirty-five (56%) of 63 residents had illnesses that met the case definition; 17 patients (49%) were admitted to intensive care units, and 2 (6%) died. Patients were hospitalized in the intensive care unit for a total of 233 patient-days. Illness onset dates ranged from 1 June through 24 August 2005. Thirty-two patients (91%) had respiratory infection, and 3 (9%) had conjunctivitis. HAdV was identified by culture or PCR in 20 patients. Nine isolates were characterized as HAdV-3 genome type a2. Conclusions.Considering the limited mobility of residents and their reliance on respiratory care, transmission of HAdV-3 infection during this outbreak likely occurred through respiratory care provided by staff. In environments where patients with susceptible underlying conditions reside, HAdV infection should be considered when patients are identified with worsening respiratory disease, and rapid diagnostic tests for HAdV infection should be readily available to help identify and curtail the spread of this pathogen.
Journal Article
Effects of laparoscopic adjustable gastric banding on sleep and metabolism: a 12-month follow-up study
Obstructive sleep apnea is commonly associated with metabolic changes and obesity, and changes in body weight by either medical or surgical approaches have been considered to affect the severity of sleep apnea and appetite-controlling hormones. This prospective study evaluated the effect of weight loss induced by laparoscopic adjustable gastric banding (LAGB) surgery on respiratory disturbance during sleep, oxygen saturation levels, sleep architecture, and leptin and ghrelin levels.
Participants were patients at a university-based medical center surgical weight loss program. All participants with a body mass index > 30 kg/m(2) undergoing LAGB surgery for weight reduction were offered the opportunity to participate in the study. Procedures included overnight polysomnography followed by fasting hormone levels at baseline and 12 months postoperatively.
Thirty subjects (10 men, 20 women) of mean age 44.0 ± 12.5 years were recruited. At 12 months postoperatively, mean excess weight loss was 44.4% ± 14%. The apnea-hypopnea index decreased from 34.2 ± 35 to 19.0 ± 21.7 events per hour (P < 0.0001), while leptin levels decreased from 24.5 ± 17.42 pg/mL to 11.6 ± 10.6 pg/mL (P = 0.02). Ghrelin levels did not change substantially. Nadir oxygen saturation levels increased from 81% to 84% at 12 months (P = 0.03). Mean oxygen saturation improved and was positively correlated with ghrelin levels at both time points (r = 0.39, P = 0.07, and r = 0.60, P = 0.01).
LAGB surgery was associated with 44.4% excess weight loss at 12 months, accompanied by a 33.7% improvement in apnea-hypopnea index as well as a reduction in leptin levels by 31.7% in this group. An association between ghrelin and mean oxygen saturation was seen and deserves further investigation.
Journal Article