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Biomedical subjects

Cesar Rodriguez

Publications and source records attributed to Cesar Rodriguez.

5 recordsLinked to original sources

Detection of cytokine release syndrome using wearables and cytokine profiling following CAR-T therapy for myeloma.

BACKGROUNDChimeric antigen receptor T-cell (CAR-T) therapies have revolutionized treatment for relapsed/refractory multiple myeloma (RRMM). However, cytokine release syndrome (CRS), a common and potentially severe complication, requires inpatient monitoring, limiting access and increasing costs. Wearable devices could support outpatient CAR-T delivery, but feasibility for CRS detection versus standard care remains unproven.METHODSWe conducted a prospective, single-center observational pilot study to assess the feasibility of using wearable devices for monitoring vital signs and detecting CRS. Thirty patients receiving idecabtagene vicleucel (ide-cel) or ciltacabtagene autoleucel (cilta-cel) were enrolled; 25 with sufficient monitoring data were evaluable. Sensors collected skin and axillary temperature, oxygen saturation, respiratory and heart rate, and motion. Peripheral blood cytokines were analyzed pre- and postinfusion using a multiplex proteomic platform. The primary outcome was feasibility, assessed by CRS detection sensitivity and specificity; secondary outcomes included adherence, lead time, and performance of models integrating wearable and cytokine data.RESULTSCRS occurred in 20 of 25 patients. The best-performing wearable model detected 18 or 20 CRS episodes with a sensitivity of 0.72 (mean 0.75; 95% CI 0.60-0.91) and a specificity of 0.80 (mean 0.76; 95% CI 0.68-0.84), and a median lead time of 7:00 hours before nursing recognition. Median adherence during high-risk periods was 71%. Cytokine changes paralleled temperature elevations, and IFN-γ emerged as a consistent biomarker.CONCLUSIONWearable devices are feasible for early CRS detection and may support outpatient CAR-T care. Larger outpatient studies are warranted.TRIAL REGISTRATIONThis study did not meet the criteria for ClinicalTrials.gov registration.

Humans↗

Managing complex change in clinical study metadata.

In highly functional metadata-driven software, the interrelationships within the metadata become complex, and maintenance becomes challenging. We describe an approach to metadata management that uses a knowledge-base subschema to store centralized information about metadata dependencies and use cases involving specific types of metadata modification. Our system borrows ideas from production-rule systems in that some of this information is a high-level specification that is interpreted and executed dynamically by a middleware engine. Our approach is implemented in TrialDB, a generic clinical study data management system. We review approaches that have been used for metadata management in other contexts and describe the features, capabilities, and limitations of our system.

Artificial Intelligence↗

Induction of a DNA nickase in the presence of its target site stimulates adaptive mutation in Escherichia coli.

Adaptive mutation to Lac(+) in Escherichia coli strain FC40 depends on recombination functions and is enhanced by the expression of conjugal functions. To test the hypothesis that the conjugal function that is important for adaptive mutation is the production of a single-strand nick at the conjugal origin, we supplied an exogenous nicking enzyme, the gene II protein (gIIp) of bacteriophage f1, and placed its target sequence near the lac allele. When both gIIp and its target site were present, adaptive mutation was stimulated three- to fourfold. Like normal adaptive mutations, gIIp-induced mutations were recA(+) and ruvC(+) dependent and were mainly single-base deletions in runs of iterated bases. In addition, gIIp with its target site could substitute for conjugal functions in adaptive mutation. These results support the hypothesis that nicking at the conjugal origin initiates the recombination that produces adaptive mutations in this strain of E. coli, and they suggest that nicking may be the only conjugal function required for adaptive mutation.

Adaptation, Physiological↗

Effects of exercise on depressive symptoms in older adults with poorly responsive depressive disorder: randomised controlled trial.

BACKGROUND: Depression is common in later life. AIMS: To determine whether exercise is effective as an adjunct to antidepressant therapy in reducing depressive symptoms in older people. METHOD: Patients were randomised to attend either exercise classes or health education talks for 10 weeks. Assessments were made "blind" at baseline, and at 10 and 34 weeks. The primary outcome was seen with the 17-item Hamilton Rating Scale for Depression (HRSD). Secondary outcomes were seen with the Geriatric Depression Scale, Clinical Global Impression and Patient Global Impression. RESULTS: At 10 weeks a significantly higher proportion of the exercise group (55% v. 33%) experienced a greater than 30% decline in depression according to HRSD (OR=2.51, P=0.05, 95% CI 1.00-6.38). CONCLUSIONS: Because exercise was associated with a modest improvement in depressive symptoms at 10 weeks, older people with poorly responsive depressive disorder should be encouraged to attend group exercise activities.

Aged↗

[Surgical treatment for gastric cancer in a specialized service: the Rebagliati Hospital experience].

The results of the surgical treatment for gastric cancer within a specialized surgical service in this pathology are described in this work. This system for surgical treatment of gastric cancer is new in our country. The implementation process included prepare a team of surgeons and establish protocols and guides to surgical treatment, based on the recommendations of the Japanese Gastric Cancer Association. Additional training in the Japanese advanced surgical technique was required, as well as a strict documentation of the cases. During 2004, 139 surgical interventions were carried out on 137 patients with tumoral gastric pathology. Surgical mortality was 2.1% and morbidity was 21.8%. The average resected glands was 38.6.t 13.7 (range: 20-87) for distal gastrectomy and 46.6 +/- 16.2 (range: 24-87) for total gastrectomy. The stay in the hospital was 11.7 +/- 6.3 days (range: 5-37) for distal gastrectomy and 14.8 +/- 11.3 days (range: 7-56) for total gastrectomy. The hospital and surgeon volumes are underlined as important factors in determining the short and long term results. Implementation of specialized surgical units in general hospitals, for surgical treatment of gastric cancer, is recommended.

Adenocarcinoma↗