• 제목/요약/키워드: observational clinical study

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Pedicle Screw Placement in the Thoracolumbar Spine Using a Novel, Simple, Safe, and Effective Guide-Pin : A Computerized Tomography Analysis

  • Hyun, Seung-Jae;Kim, Yongjung J.;Rhim, Seung-Chul;Cheh, Gene;Cho, Samuel K.
    • Journal of Korean Neurosurgical Society
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    • 제58권1호
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    • pp.9-13
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    • 2015
  • Objective : To improve pedicle screw placement accuracy with minimal radiation and low cost, we developed specially designed K-wire with a marker. To evaluate the accuracy of thoracolumbar pedicle screws placed using the novel guide-pin and portable X-rays. Methods : Observational cohort study with computerized tomography (CT) analysis of in vivo and in vitro pedicle screw placement. Postoperative CT scans of 183 titanium pedicle screws (85 lumbar and 98 thoracic from T1 to L5) placed into 2 cadavers and 18 patients were assessed. A specially designed guide-pin with a marker was inserted into the pedicle to identify the correct starting point (2 mm lateral to the center of the pedicle) and aiming point (center of the pedicle isthmus) in posteroanterior and lateral X-rays. After radiographically confirming the exact starting and aiming points desired, a gearshift was inserted into the pedicle from the starting point into the vertebral body through the center of pedicle isthmus. Results : Ninety-nine percent (181/183) of screws were contained within the pedicle (total 183 pedicle screws : 98 thoracic pedicle screws and 85 lumbar screws). Only two of 183 (1.0%) thoracic pedicle screws demonstrated breach (1 lateral in a patient and 1 medial in a cadaver specimen). None of the pedicle breaches were associated with neurologic or other clinical sequelae. Conclusion : A simple, specially designed guide-pin with portable X-rays can provide correct starting and aiming points and allows for accurate pedicle screw placement without preoperative CT scan and intraoperative fluoroscopic assistance.

Hysterosalpingo-contrast sonography: is possible to quantify the therapeutic effect of a diagnostic test?

  • Giugliano, Emilio;Cagnazzo, Elisa;Bazzan, Elisa;Patella, Alfredo;Marci, Roberto
    • Clinical and Experimental Reproductive Medicine
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    • 제39권4호
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    • pp.161-165
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    • 2012
  • Objective: To evaluate the effect of hysterosalpingo-contrast sonography (HyCoSy) on natural conception in the infertile patient. Methods: We conducted a prospective observational study recruiting 180 patients admitted to Infertility Center of Ferrara University from January 2010 to February 2012. The essential inclusion criteria was the couple's desire to perform only diagnostic evaluation on infertility causes and to wait for natural conception before proceeding with further management. Couples were investigated with hormonal profile, semen analysis and HyCoSy. Expected time for spontaneous pregnancy was 180 days from HyCoSy. First datation sonography of pregnancy was used calculating time elapsed from HyCoSy at conception. Results: Forty patients (22.2%) obtained spontaneous pregnancy within 6 months after HyCoSy. The mean of "conception time" was 75 days. The pregnancy rate was significantly higher in the first 30 days (45%) compared to other the months of observation (p<0.0005). Multiple linear regression analysis showed that maternal age and sterility duration proved independent variables in detecting the "conception time" after HyCoSy (t=3.742, p=0.001, t=2.371, p=0.02, respectively). Conclusion: A possible beneficial effect of HyCoSy is feasible especially in the days following its execution. This temporal correlation supports its therapeutic use.

Efficacy and Safety of Bevacizumab in Chinese Patients with Metastatic Colorectal Cancer

  • Zhu, Li-Ming;Zhao, Ya-Zhen;Ju, Hai-Xing;Liu, Lu-Ying;Chen, Lei;Liu, Bi-Xia;Xu, Qi;Luo, Cong;Ying, Jie-Er;Yang, Yun-Shan;Zhong, Hai-Jun
    • Asian Pacific Journal of Cancer Prevention
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    • 제15권16호
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    • pp.6559-6564
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    • 2014
  • Objective: To evaluate the efficacy and safety of bevacizumab in the treatment of patients with metastatic colorectal cancer (mCRC). Methods: In a single-center, observational study of 91 Chinese patients with mCRC who received bevacizumab in combination with chemotherapy was conducted. Objective response rates (ORRs), progression-free survival (PFS), overall survival (OS) and adverse events were recorded, and the relationships between various clinical factors and PFS or OS were evaluated by Cox proportional hazards models. Results: Treatment with bevacizumab and chemotherapy was effective and tolerable. Univariate analysis showed that PFS and OS were significantly associated with the Eastern Cooperative Oncology Group performance status (ECOG-PS) score, duration of bevacizumab exposure, and whether chemotherapy was continued after discontinuation of bevacizumab treatment. A multivariate analysis showed that the duration of bevacizumab exposure and whether chemotherapy was continued after discontinuation of bevacizumab were independent prognostic factors for PFS and OS. Conclusion: In Chinese mCRC population, the shorter the duration of exposure to bevacizumab and chemotherapy, the worse the prognosis is.

Assessment of interhospital transport care for pediatric patients

  • Chaichotjinda, Krittiya;Chantra, Marut;Pandee, Uthen
    • Clinical and Experimental Pediatrics
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    • 제63권5호
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    • pp.184-188
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    • 2020
  • Background: Many critically ill patients require transfer to a higher-level hospital for complex medical care. Despite the publication of the American Academy of Pediatrics guidelines for pediatric interhospital transportation services and the establishment of many pediatric transport programs, adverse events during pediatric transport still occur. Purpose: To determine the incidence of adverse events occurring during pediatric transport and explore their complications and risk factors. Methods: This prospective observational study explored the adverse events that occurred during the interhospital transport of all pediatric patients referred to the pediatric intensive care unit of Ramathibodi Hospital between March 2016 and June 2017. Results: There were 122 pediatric transports to the unit. Adverse events occurred in 25 cases (22%). Physiologic deterioration occurred in 15 patients (60%). Most issues (11 events) involved circulatory problems causing patient hypotension and poor tissue perfusion requiring fluid resuscitation or inotropic administration on arrival at the unit. Respiratory complications were the second most common cause (4 events). Equipment-related adverse events occurred in 5 patients (20%). The common causes were accidental extubation and endotracheal tube displacement. Five patients had both physiologic deterioration and equipment-related adverse events. Regarding transport personnel, the group without complications more often had a physician escort than the group with complications (92% vs. 76%; relative risk, 2.4; P=0.028). Conclusion: The incidence of adverse events occurring during the transport of critically ill pediatric patients was 22%. Most events involved physiological deterioration. Escort personnel maybe the key to preventing and appropriately monitoring complications occurring during transport.

A Case Series of Snake Venom Pharmacopuncture for Chemotherapy-Induced Peripheral Neuropathy: A Retrospective Observational Study

  • Song, Si Yeon;Bae, Kyeore;Shin, Kwhang Ho;Yoo, Hwa-Seung
    • 대한약침학회지
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    • 제20권4호
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    • pp.280-286
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    • 2017
  • Objective: This case series aims to report the efficacy and the safety of using snake venom pharmacopuncture (SVP) for chemotherapy-induced peripheral neuropathy (CIPN). Methods: Three heterogeneous cancer (1 endometrium, 1 cervix, and 1 prostate cancer) patients were referred to the East-West Cancer Center (EWCC), Dunsan Korean Medicine Hospital of Daejeon University, from August 02, 2017, to September 15, 2017, for treatment with SVP, and they were treated with SVP 4 times, 6 times, and 8 times, respectively. During the treatment period, the efficacy of SVP therapy was assessed by using the Numerical Rating Scale (NRS) and the Common Terminology Criteria for Adverse Events (CTCAE), and the stability was evaluated by using blood tests. Following each session, all patients were examined closely for any allergenic responses or adverse effects. Results: All patients showed noticeable improvements of their NRS and CTCAE scores. Except for bleeding and bruising at the SVP injection site, no major side effects were noted. One of the patients reported mild chilling and a sore throat after receiving the second treatment; those symptoms went away after a few hours. No hematologic toxicity, hepatotoxicity, or nephrotoxicity was found on the blood test. Conclusion: The results of this research suggest positive potential benefits of using SVP for treating patients with CIPN. Also, the excellent safety results of SVP seen in this research should lead to larger clinical trials aimed at developing SVP into a potential intervention for managing patients with the symptoms of CIPN.

Cerebral Oxygenation during Apnea in Preterm Infants: Effects of Accompanying Peripheral Oxygen Desaturation

  • Choi, Seo Hee;Lee, Juyoung;Nam, Soo Kyung;Jun, Yong Hoon
    • Neonatal Medicine
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    • 제28권1호
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    • pp.14-21
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    • 2021
  • Purpose: Premature infants have immature respiratory control and cerebral autoregulation. We aimed to investigate changes in cerebral oxygenation during apnea with and without peripheral oxygen desaturation in premature infants. Methods: This prospective observational study was conducted at Inha University Hospital. Near-infrared spectroscopy (NIRS)-monitored regional cerebral oxygen saturation (rScO2) and pulse oximeter-monitored peripheral oxygen saturation (SpO2) were assessed during the first week of life in 16 stable, spontaneously breathing preterm infants. Apneic episodes that lasted for ≥20 seconds or were accompanied by desaturation or bradycardia were included for analysis. The average rScO2 value during the 5-minute prior to apnea (baseline), the lowest rScO2 value following apnea (nadir), the time to recover to baseline (recovery time), the area under the curve (AUC), and the overshoot above the baseline after recovery were analyzed. Results: The median gestational age and birth weight of the infants were 29.2 weeks (interquartile range [IQR], 28.5 to 30.5) and 1,130 g (IQR, 985 to 1,245), respectively. A total of 73 apneic episodes were recorded at a median postnatal age of 2 days (IQR, 1 to 4). The rScO2 decreased significantly following apneic episodes regardless accompanied desaturation. There were no differences in baseline, nadir, or overshoot rScO2 between the two groups. However, the rScO2 AUC for apnea with desaturation was significantly higher than that for apnea without desaturation. Conclusion: Cerebral oxygenation can significantly decrease during apnea, especially when accompanied by reduced SpO2. These results add the evidence for the clinical utility of NIRS in monitoring premature infants.

Differences in 25-hydroxy vitamin D and vitamin D-binding protein concentrations according to the severity of endometriosis

  • Baek, Jong Chul;Jo, Jae Yoon;Lee, Seon Mi;Cho, In Ae;Shin, Jeong Kyu;Lee, Soon Ae;Lee, Jong Hak;Cho, Min-Chul;Choi, Won Jun
    • Clinical and Experimental Reproductive Medicine
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    • 제46권3호
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    • pp.125-131
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    • 2019
  • Objective: To investigate serum 25-hydroxyl vitamin D (25(OH)D) and vitamin D-binding protein (VDBP) concentrations in women with endometriosis according to the severity of disease. Methods: Women with mild endometriosis (n = 9) and advanced endometriosis (n = 7), as well as healthy controls (n = 16), were enrolled in this observational study. Serum total 25(OH)D concentrations were analyzed using the Elecsys vitamin D total kit with the Cobas e602 module. Concentrations of bioavailable and free 25(OH)D were calculated. Concentrations of VDBP were measured using the Human Vitamin D BP Quantikine ELISA kit. Variables were tested for normality and homoscedasticity using the Shapiro-Wilk test and Leven F test, respectively. Correlation analysis was used to identify the variables related to total 25(OH)D and VDBP levels. To assess the effects of total 25(OH)D and VDBP levels in the three groups, multivariate generalized additive modeling (GAM) was performed. Results: Gravidity and parity were significantly different across the three groups. Erythrocyte sedimentation rate (ESR) and CA-125 levels increased as a function of endometriosis severity, respectively (p= 0.051, p= 0.004). The correlation analysis showed that total 25(OH)D levels were positively correlated with gravidity (r = 0.59, p< 0.001) and parity (r = 0.51, p< 0.003). Multivariate GAM showed no significant relationship of total 25(OH)D levels with EMT severity after adjusting for gravidity and ESR. However, the coefficient of total 25(OH)D levels with gravidity was significant (1.87; 95% confidence interval, 0.12-3.63; p= 0.040). Conclusion: These results indicate that vitamin D and VDBP levels were not associated with the severity of endometriosis.

Infection prevention measures and outcomes for surgical patients during a COVID-19 outbreak in a tertiary hospital in Daegu, South Korea: a retrospective observational study

  • Kwak, Kyung-Hwa;Kim, Jay Kyoung;Kwon, Ki Tae;Yeo, Jinseok
    • Journal of Yeungnam Medical Science
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    • 제39권3호
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    • pp.223-229
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    • 2022
  • Background: The first large coronavirus disease 2019 (COVID-19) outbreak outside China occurred in Daegu. In response, we developed infection prevention measures for surgical patients during the outbreak at our hospital and retrospectively reviewed the outcomes of COVID-19-related surgical patients. Methods: We reviewed the medical records of 118 COVID-19-related surgical patients and monitored their clinical outcomes until March 31, 2021. We also interviewed healthcare workers who participated in their perioperative care at Kyungpook National University Chilgok Hospital. The perioperative management guidelines for COVID-19-related patients were prepared through multidisciplinary discussions, including the infection control department, surgical departments, and anesthesiology department before and during the COVID-19 outbreak. Results: One standard operating room was temporarily converted to a negative-pressure room by increasing the exhaust air volume, creating a relative pressure of -11.3 Pa. The healthcare workers were equipped with personal protective equipment according to the patient's classification of the risk of COVID-19 transmission. The 118 COVID-19-related patients underwent emergent surgery in the negative-pressure room, including three COVID-19-confirmed patients and five COVID-19-exposed patients. Conclusion: All surgeries of the COVID-19-related patients were performed without specific adverse events or perioperative COVID-19 transmission. Our experience setting up a negative-pressure operating room and conservative perioperative protocol to prevent COVID-19 transmission will help plan and execute infection control measures in the future.

The Reliability and Validity of the Digital Goniometer and Smart Phone to Determine Trunk Active Range of Motion in Stroke Patients

  • Park, Hee-yong;Hwang, Ui-jae;Kwon, Oh-yun
    • 한국전문물리치료학회지
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    • 제29권3호
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    • pp.225-234
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    • 2022
  • Background: Trunk movements are an important factor in activities of daily living; however, these movements can be impaired by stroke. It is difficult to quantify and measure the active range of motion (AROM) of the trunk in patients with stroke. Objects: To determine the reliability and validity of measurements using a digital goniometer (DG) and smart phone (SP) applications for trunk rotation and lateral flexion in stroke patients. Methods: This is an observational study, in which twenty participants were clinically diagnosed with stroke. Trunk rotation and lateral flexion AROM were assessed using the DG and SP applications (Compass and Clinometer). Intrarater reliability was determined using intraclass correlation coefficients (ICCs) with 95% confidence intervals. Pearson correlation coefficient was used to determine the validity of the DG and SP in AROM measurement. The level of agreement between the two instruments was shown by Bland-Altman plot and 95% limit of agreement (LoA) was calculated. Results: The intrarater reliability (rotation with DG: 0.96-0.98, SP: 0.98; lateral flexion with DG: 0.97-0.98, SP: 0.96) was excellent. A strong and significant correlation was found between DG and SP (rotation hemiplegic side: r = 0.95; non-hemiplegic side: r = 0.90; lateral flexion hemiplegic side: r = 0.88; non-hemiplegic side: r = 0.78). The level of agreement between the two instruments was rotation (hemiplegic side: 23.02° [LoA 17.41°, -5.61°]; non-hemiplegic side: 31.68° [LoA 23.87°, -7.81°]) and lateral flexion (hemiplegic side: 20.94° [LoA 17.48°, -3.46°]; non-hemiplegic side: 27.12° [LoA 18.44°, -8.68°]). Conclusion: Both DG and SP applications can be used as reliable methods for measuring trunk rotation and lateral flexion in patients with stroke. Although, considering the level of clinical agreement, DG and SP could not be used interchangeably for measurements.

Clinical-pathologic profile of head and neck rhabdomyosarcoma in children: a systematic review

  • Ludimila Lemes Moura;Beatriz Della Terra Mouco Garrido;Nelson Leonel Del Hierro Polanco;Mattheus Augusto Siscotto Tobias;Viviane da Silva Siqueira;Cassia Maria Fischer Rubira;Paulo Sergio da Silva Santos
    • Journal of the Korean Association of Oral and Maxillofacial Surgeons
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    • 제49권2호
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    • pp.61-67
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    • 2023
  • This systematic review aimed to analyze the clinicopathological profile and relevant prognostic factors of head and neck rhabdomyosarcoma in pediatric patients. The search was carried out in the electronic search portals PubMed, Lilacs, Embase, Scopus, and Web of Science. The search yielded studies that were then analyzed regarding study topic, data extraction, and risk of bias using the STROBE (Strengthening the Reporting of Observational Studies) guidelines. Finally, three studies were included for qualitative analysis. Most of the cases involved embryonic and alveolar rhabdomyosarcoma. Expression of MYOD1 was highly correlated with diagnosis of spindle cell/sclerosing rhabdomyosarcoma, which appears to have a poor prognosis in children. Furthermore, tumor size <5 cm and absence of metastasis accompanied by complete resection and administration of adjuvant therapies such as chemotherapy and radiotherapy favored a better prognosis.