• Title/Summary/Keyword: Prospective Cohort Study

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Clinicohematological parameters and outcomes in a cohort of chronic lymphocytic leukemia patients with Deletion 17p from Pakistan

  • Mahmood, Rafia;Khan, Saleem Ahmed;Altaf, Chaudhry;Malik, Hamid Saeed;Khadim, Muhammad Tahir
    • BLOOD RESEARCH
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    • v.53 no.4
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    • pp.276-280
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    • 2018
  • Background Chronic lymphocytic leukemia (CLL) exhibits profound heterogeneity in its clinical course. Its clinicohematological and cytogenetic features play a significant role in determining the clinical course and in predicting the treatment response and prognosis. In this context, 17p deletion is known to predict a poor prognosis, as these cases are refractory to conventional therapy. This study aimed to evaluate the clinicohematological characteristics, outcomes, and prognostic factors among CLL patients with and without del 17p in Pakistan. Methods This prospective observational study was conducted at the Department of Haematology, Armed Forces Institute of Pathology (Rawalpindi, Pakistan) between January 2013 and December 2017. Patients were diagnosed based on the International Workshop on Chronic Lymphocytic Leukaemia IWCLL criteria, their clinicohematological parameters were recorded, and cytogenetic analyses were performed. The time from diagnosis to treatment and the 2-year overall survival rate were also evaluated. Results We evaluated 130 CLL cases, including 24 patients (18.5%) with del 17p, who included 18 men (75%) and 6 women (25%). The median age was 68 years. Binet stage C was detected at the presentation in 16 patients (67%). Treatment was administered to 14 patients (70%) at a median interval of 11 months (range, 0-28 mo) after diagnosis. The overall response rate was 64.3%, the median event-free survival was 9 months (range, 1-23 mo), and the 2-year overall survival rate was 65%. Conclusion Del 17p is relatively common in Pakistan, and patients harboring this deletion had poor treatment response and survival outcomes.

Isotretinoin exposure in pregnant women in Korea

  • Kim, Nae Ry;Yoon, So Ra;Choi, June Seek;Ahn, Hyun Kyong;Lee, So-Young;Hong, Dal Soo;Yun, Jeong Sup;Hong, Seong Yeon;Kim, Yoon Ha;Han, Jung Yeol
    • Obstetrics & gynecology science
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    • v.61 no.6
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    • pp.649-654
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    • 2018
  • Objective Isotretinoin is a notorious teratogen otherwise used for the treatment of acne vulgaris. Some countries, including those in North America and the European Union, implemented the pregnancy prevention program (PPP); however, no PPP has yet been established in South Korea. So the aim of this study was to evaluate the rate of pregnant women exposed to isotretinoin among the callers of the Korean Mother Safe Counseling Center. Methods This is a prospective cohort study. We evaluated the demographic characteristics, obstetric history, and isotretinoin exposure of pregnant women based on the mother safe registry from April 2010 to July 2016. Results Among 22,374 callers, 650 (2.9%) pregnant women were exposed to isotretinoin. The mean age was $29.0{\pm}4.4$ years in the isotretinoin-exposed group and $32.0{\pm}4.2$ years in the unexposed group (P<0.001). Moreover, the incidence of pregnancies within 30 days after isotretinoin discontinuation or during isotretinoin intake was 78.9% (513/650). The median duration of isotretinoin exposure was 18 (1-4,231) days. Furthermore, from 2011 to 2015, the incidence of isotretinoin exposure was $2.9{\pm}1.2$ pregnancies per 10,000 births in South Korea. Conclusion Approximately 80% of pregnant women are exposed to isotretinoin within the recommended 30 days of contraception or during pregnancy. Therefore, the PPP has to be established in South Korea.

Correlation between the actual sleep time 24 hours prior to an examination and the time to achieve chloral hydrate sedation in pediatric patients in South Korea: a prospective cohort study

  • Park, Mijung;Um, Ji;Kim, So Hyun;Yoon, Jiseon;Lee, Yeonjae;Kwon, Jiyeong;Baek, Seonhee;Kim, Dong Yeon
    • Child Health Nursing Research
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    • v.29 no.1
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    • pp.51-59
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    • 2023
  • Purpose: This study investigated correlations between the actual sleep time 24 hours prior to an examination and the time to achieve chloral hydrate sedation in pediatric patients. Methods: With parental consent, 84 children who were placed under moderate or deep sedation with chloral hydrate for examinations from November 19, 2020 to July 9, 2022 were recruited. Results: Patients' average age was 19.9 months. Pediatric neurology patients and those who underwent electroencephalography took significantly longer to achieve sedation with chloral hydrate. There was a negative correlation between the time to achieve sedation and actual sleep time within 24 hours prior to the examination. Positive correlations were found between the actual sleep time 24 hours prior to the examination and the second dose per weight, as well as between the sedation recovery time and awake hours before the examination. Conclusion: Sleep restriction is not an effective adjuvant therapy for chloral hydrate sedation in children, and sedation effects vary according to pediatric patients' characteristics. Therefore, it would be possible to reduce the unnecessary efforts of caregivers who restrict children's sleep for examinations. It is more important to educate parents about safe sedation than about sleep restriction.

Periodontal granulation tissue preservation in surgical periodontal disease treatment: a pilot prospective cohort study

  • Rodriguez, Jose A. Moreno;Ruiz, Antonio J. Ortiz
    • Journal of Periodontal and Implant Science
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    • v.52 no.4
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    • pp.298-311
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    • 2022
  • Purpose: The aim of this study was to evaluate the clinical outcomes of periodontal granulation tissue preservation (PGTP) in access flap periodontal surgery. Methods: Twenty patients (stage III-IV periodontitis) with 42 deep periodontal pockets that did not resolve after non-surgical treatment were consecutively recruited. Access flap periodontal surgery was modified using PGTP. The clinical periodontal parameters were evaluated at 9 months. The differences in the amount of granulation tissue width (GTw) preserved were evaluated and the influence of smoking was analyzed. Results: GTw >1 mm was observed in 97.6% of interproximal defects, and the granulation tissue extended above the bone peak in 71.4% of defects. At 9 months, probing pocket depth reduction (4.33±1.43 mm) and clinical attachment gain (CAG; 4.10±1.75 mm) were statistically significant (P<0.001). The residual probing depth was 3.2±0.89 mm. When GTw extended above the interproximal bone peak (i.e., the interproximal supra-alveolar granulation tissue thickness [iSUPRA-GT] was greater than 0 mm), a significant CAG was recorded in the supra-alveolar component (1.67±1.32 mm, P<0.001). Interproximal gingival recession (iGR) was significant (P<0.05) only in smokers, with a reduction in the interdental papillary tissue height of 0.93±0.76 mm. In non-smokers, there was no increase in the iGR when the iSUPRA-GT was >0 mm. The clinical results in smokers were significantly worse. Conclusions: PGTP was used to modify access flap periodontal surgery by preserving affected tissues with the potential for recovery. The results show that preserving periodontal granulation tissue is an effective and conservative procedure in the surgical treatment of periodontal disease.

Prospective evaluation of the clinical utility of whole-exome sequencing using buccal swabbing for undiagnosed rare diseases

  • Chong Kun Cheon;Yong Beom Shin;Soo-Yeon Kim;Go Hun Seo;Hane Lee;Changwon Keum;Seung Hwan Oh
    • Journal of Genetic Medicine
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    • v.19 no.2
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    • pp.76-84
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    • 2022
  • Purpose: Whole-exome sequencing (WES) has been a useful tool for novel gene discovery of various disease categories, further increasing the diagnostic yield. This study aimed to investigate the clinical utility of WES prospectively in undiagnosed genetic diseases. Materials and Methods: WES tests were performed on 110 patients (age range, 0-28 years) with suspected rare genetic diseases. WES tests were performed at a single reference laboratory and the variants reported were reviewed by clinical geneticists, pediatricians, neurologists, and laboratory physicians. Results: The patients' symptoms varied with abnormalities in the head or neck, including facial dysmorphism, being the most common, identified in 85.4% of patients, followed by abnormalities in the nervous system (83.6%). The average number of systems manifesting phenotypic abnormalities per patient was 3.9±1.7. The age at presentation was 2.1±2.7 years old (range, 0-15 years), and the age at WES testing was 6.7±5.3 years (range, 0-28 years). In total, WES test reported 100 pathogenic/likely pathogenic variants or variants of uncertain significance for 79 out of 110 probands (71.8%). Of the 79 patients with positive or inconclusive calls, 55 (50.0%) patients were determined to have good genotype-phenotype correlations after careful review. Further clinical reassessment and family member testing determined 45 (40.9%) patients to have been identified with a molecular diagnosis. Conclusion: This study showed a 40.9% diagnostic yield for WES test for a heterogeneous patient cohort with suspected rare genetic diseases. WES could be the feasible genetic test modality to overcome the diversity and complexity of rare disease diagnostics.

Neoadjuvant PD-1 Inhibitor Plus Apatinib and Chemotherapy Versus Apatinib Plus Chemotherapy in Treating Patients With Locally Advanced Gastric Cancer: A Prospective, Cohort Study

  • Chunjing Wang;Zhen Wang;Yue Zhao;Fujing Wang
    • Journal of Gastric Cancer
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    • v.23 no.2
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    • pp.328-339
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    • 2023
  • Purpose: This study aimed to evaluate the efficacy and safety of neoadjuvant programmed cell death-1 (PD-1) inhibitors plus apatinib and chemotherapy (PAC) in patients with locally advanced gastric cancer (LAGC). Materials and Methods: Seventy-three patients with resectable LAGC were enrolled and named the PAC group (n=39) or apatinib plus chemotherapy (AC) group (n=34) based on the treatment they chose. Neoadjuvant therapy was administered in a 21-day cycle for 3 consecutive cycles, after which surgery was performed. Results: The PAC group exhibited a higher objective response rate than the AC group (74.4% vs. 58.8%, P=0.159). Moreover, the PAC group showed a numerically better response profile than the AC group (P=0.081). Strikingly, progression-free survival (PFS) (P=0.019) and overall survival (OS) (P=0.049) were prolonged, whereas disease-free survival (DFS) tended to be longer in the PAC group than in the AC group (P=0.056). Briefly, the 3-year PFS, DFS, and OS rates were 76.1%, 76.1%, and 86.7% in the PAC group and 46.9%, 49.9%, and 70.3% in the AC group, respectively. Furthermore, PAC (vs. AC) treatment (hazard ratio=0.286, P=0.034) was independently associated with prolonged PFS in multivariate Cox regression analyses. The incidence of adverse events did not differ between the two groups (all P>0.05), where leukopenia, anemia, hypertension, and other adverse events were commonly observed in the PAC group. Conclusions: Neoadjuvant PAC therapy may achieve a preferable pathological response, delayed progression, and prolonged survival compared to AC therapy with a similar safety profile in patients with LAGC; however, further validation is warranted.

Association Between Infants Anthropometric Outcomes With Maternal AHEI-P and DII Scores

  • Zahra Roumi;Abolghassem Djazayery;Seyed Ali Keshavarz
    • Clinical Nutrition Research
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    • v.12 no.2
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    • pp.116-125
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    • 2023
  • The present study sought to examine the association between an infant's anthropometric outcomes with maternal Dietary Inflammatory Index (DII) and Alternate Healthy Eating Index for Pregnancy (AHEI-P) scores during the third trimester of pregnancy. This prospective cohort study was applying 130 pregnant women, at the pregnancy training center in west Tehran, Iran (November 2020 to July 2021). The maternal dietary intake, and body mass index (BMI), and social economic level were evaluated. The data about birth weight, birth height, head circumference, and, gestational age at birth were extracted from each child's health records. The ultimate sample included 122 (93.8%) pairs of women/newborn children. The participants, mean age was 28.13 ± 4.66 years with gestational age between 28 to 40 weeks and the mean of BMI was 24.62 ± 3.51. Our outcomes, after adjustment for confounding factors, suggested that those newborn infants in the highest quartile of maternal DII score had a significantly lower weight (p < 0.001) and height (p = 0.05), in comparison to those in the lowest quartile, but not head circumference (p = 0.18). Moreover, after adjustment for confounding factors, results suggested that those newborn infants in the First quartile of maternal AHEI-P score had a significantly lower weight (p = 0.018) and, in comparison to those in the higher quartile. It appears that newborn infants with lower maternal DII and higher AHEI-P scores may have a better anthropometric outcome. Further longitudinal and in-depth qualitative and quantitative studies, with a longer-term follow-up, is warranted to support the integrity of our outcomes.

Middle meningeal artery embolization for chronic subdural hematoma in elderly patients at high risk of surgical treatment

  • Jin Hoo Seok;Jong Hyun Kim;Taek Hyun Kwon;Joonho Byun;Won Ki Yoon
    • Journal of Cerebrovascular and Endovascular Neurosurgery
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    • v.25 no.1
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    • pp.28-35
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    • 2023
  • Objective: The purpose of this study was to evaluate the effectiveness of middle meningeal artery embolization (MMAE) in elderly high-risk patients with symptomatic chronic subdural hematoma (CSDH) in terms of reduction in hematoma volume and recurrence rate. Methods: We retrospectively reviewed data prospectively collected from nine patients who underwent 13 MMAE for CSDH between June 2017 and May 2022. The volume of the subdural hematoma was measured using a computer-aided volumetric analysis program. Hematoma volume changes during the follow-up period were analyzed and clinical outcomes were evaluated. Results: The mean follow-up period was 160 days (range, 46-311 days). All procedures were technically successful and there were no procedure-related complications. Of the 13 MMAE, 84% (11 out of 13 hemispheres) showed mean 88% of reduction on follow-up volumetric study with eight cases of complete resolution. There was one refractory case with MMAE which had been performed multiple burr-hole trephinations, for which treatment was completed by craniotomy and meticulous resection of multiple pseudomembranes. There was no recurrent case during the follow-up period, except for refractory case. Conclusions: MMAE for CSDH in selected high-risk elderly patients and relapsed patients might be effective. Despite the small cohort, our findings showed a high rate of complete resolution with no complications. Further prospective randomized trials are warranted to evaluate its usefulness as a primary treatment option for CSDH.

Association of infant feeding practices in the general population with infant growth and stool characteristics

  • Han, Young-Shin;Chang, Eun-Young;Kim, Ji-Hyun;Ahn, Kang-Mo;Kim, Hye-Young;Hwang, Eun-Mi;Lowry, Dianne;Prosser, Colin;Lee, Sang-Il
    • Nutrition Research and Practice
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    • v.5 no.4
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    • pp.308-312
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    • 2011
  • This was a prospective cohort study of 976 infants from birth to 12 months of age. Infants were fed breast milk, goat infant formula, cow infant formula, or a combination of formula and breast milk during the first 4 months of age. Data on type of milk feeding and infant growth (weight and height) were collected at birth and at 4, 8, and 12 months during routine clinical assessment. The number and consistency of bowel motions per day were recorded based on observational data supplied by the mothers. Infants fed breast milk or goat or cow infant formula during the first 4 months displayed similar growth outcomes. More of the infants fed cow infant formula had fewer and more well-formed bowel motions compared with breast-fed infants. The stool characteristics of infants fed goat formula resembled those of infants fed breast milk.

Once-weekly Subcutaneous Administration of Bortezomib in Patients with Multiple Myeloma

  • Wang, Liang;Wang, Ke-Feng;Chang, Bo-Yang;Chen, Xiao-Qin;Xia, Zhong-Jun
    • Asian Pacific Journal of Cancer Prevention
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    • v.16 no.5
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    • pp.2093-2098
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    • 2015
  • In patients with multiple myeloma (MM), once-weekly intravenous injection or twice-weekly subcutaneous injection (SC) of bortezomib has been proven to offer non-inferior efficacy to standard twice-weekly intravenous administration, with an improved safety profile. However, whether once-weekly SC bortezomib can further reduce the incidence rate of peripheral neuropathy (PN) and not compromise the efficacy remains to be investigated. 25 patients of MM treated with once-weekly SC bortezomib were reviewed in this study. The median treatment cycles were 4 (range, 2-9 cycles). Complete response (CR) rate was 52%, ${\geq}$very good partial response (VGPR) rate was 72%, and ${\geq}$partial response (PR) rate was 84%. 1-year and 2-year PFS rate was 63.0% and 34.3%, respectively, and 2-year OS rate was 100%. Any grade of PN was reported in 9 patients (36.0%), with 7 patients (28.0%) had grade 1 PN, and 2 patients (8.0%) had grade 2 PN. No patients reported grade 3/4 PN in this cohort. In conclusion, once-weekly subcutaneous administration of bortezomib offers excellent efficacy with a further improved safety profile, especially with regard to PN. It needs to be validated in future prospective randomized trials.