bluuebunny/crossref_metadata_2025_split huggingface dataset:
Phase I investigator-initiated study of the safety of MTC001 in patients with chronic ischemic heart failure
Authors: Machino Takeshi , Sato Akira , Murakoshi Nobuyuki , Ieda Masaki 
Published: December 2021

Abstract

Background
: Heart failure (HF) is a global pandemic most commonly caused by coronary artery disease. Despite coronary revascularization, the infarcted myocardium can develop into an irreversible scar toward chronic ischemic HF. This is due to the limited regenerative capacity of the adult human heart. Recently, the vascular cell adhesion molecule 1 positive cardiac fibroblast (VCF) has been shown to directly improve cardiac contractility in addition to promoting myocardial growth in preclinical studies. This clinical trial aims to explore the safety and, in part, the efficacy of autologous VCF therapy for chronic ischemic HF.

Methods
: This first-in-human trial is an open-label, single-arm, phase 1 study conducted at a single center. This study will include 6 patients with chronic ischemic HF in stage C and NYHA class II or III despite receiving the standard of care, including coronary revascularization. Participants will undergo cardiac biopsy to manufacture autologous VCFs expressing CD90 and CD106. Under electro-anatomical mapping guidance, participants will receive a transendocardial injection of VCF in a modified 3 + 3 design. The first 3 patients will receive a standard dose (2 × 107 cells) of VCF with a 4-week interval for safety assessment before subsequent enrollment. In the absence of safety issues, the final 3 patients will receive the standard dose of VCF without a 4-week interval. In the presence of safety issues, the final 3 patients will receive a reduced dose (1.5 × 107 cells) of VCF with the 4-week interval.

Discussion:
This is the first clinical study of cardiac regeneration using VCFs for the treatment of chronic ischemic HF. The study results will contribute to the development of a minimally invasive cell therapy for patients with HF failed by the standard of care.

Trial registration:
This study was registered with the Japan Registry of Clinical Trials (jRCT2033210078).
Effects of acupoint injection for stroke patients with hemiplegia
Authors: Liu Minghui , Wang Yinyu , Li Ning , Cui Jin , Fan WenRui , Yang Shuo , Li Li , Zeng Jie , Li Min 
Published: December 2021

Abstract

Background:
Acupoint injection has currently received increasing attention as a treatment for hemiplegia. A number of studies have reported that acupoint injection have some advantages in treatment of hemiplegia. However, currently no article has summarized the existing evidence. Our study will evaluate the efficacy and safety of acupoint injection as a clinical treatment for hemiplegia, so that it can provide an important reference for clinical decision-making.

Methods:
Randomized controlled trials and case control studies of acupoint injection for hemiplegia according to the included and excluded standard were identified in searches of 6 databases from their inception to February 2021. All data were assessed and extracted by 2 authors independently. The risk of bias assessment recommended by the Cochrane Collaboration was used to assess the quality of the selected studies. Review Manager 5.4 (Cochrane Collaboration) was used to conduct meta-analysis for the efficacy and safety of acupoint injection.

Result:
The results of this systemic review and meta-analysis will be submitted to a recognized journal for publication.

Conclusion:
This systemic review and meta-analysis will evaluate the efficacy and safety of acupoint injection as a clinical treatment for hemiplegia. We hope this study can make a definitive conclusion for acupoint injection in the treatment of hemiplegia.

Registration:
PROSPERO (registration number CRD42021234453).
Fatal fat embolism syndrome during posterior spinal fusion surgery
Authors: Morimoto Tadatsugu , Kobayashi Takaomi , Yoshihara Tomohito , Tsukamoto Masatsugu , Kai Keita , Mawatari Masaaki 
Published: December 2021

Abstract

Rationale:
Fat embolism syndrome (FES) is a rare but potentially lethal complication. Although serious FES is associated with long bone fractures and major joint surgery, the number of patients who develop fatal FES intraoperatively is probably higher than the described number. We herein report an extremely rare autopsy-confirmed case of fatal FES during posterior spinal fusion to enhance pedicle screw (PS) fixation with allograft bone augmentation.

Patient Concerns:
A 74-year-old woman came to the hospital complaining of back pain, lower extremity pain and numbness, and intermittent claudication.

Diagnosis:
She was diagnosed with lumbar degenerative scoliosis and lumbar spinal canal stenosis based on imaging findings.

Interventions:
During posterior spinal fusion to enhance pedicle screw fixation with allograft bone augmentation, her blood pressure and oxygen saturation dropped significantly, so the operation was stopped, and cardiopulmonary resuscitation was performed. Chest computed tomography demonstrated bilateral diffuse alveolar infiltrates.

Outcomes:
The patient died three days later due to fat embolism. The autopsy revealed diffuse myocardial ischemia and diffuse alveolar damage. Numerous fat emboli were observed at lung, kidney and spleen and small necrotic bone fragments, possibly derived from allograft bone debris, were found in the peripheral pulmonary artery.

Lessons:
Fatal FES associated to seemingly harmless isolated osteoporotic vertebral fractures-vertebroplasty and posterior spinal fusion has been reported. The mechanism was hypothesized to be that both vertebral fractures and spine surgery have the potential to involve bone marrow, thereby increasing intraosseous pressure, and this pressure dislodges fat and bone marrow and pushes them out into the venous circulation, causing systemic inflammation.
This is the first report to show histological evidence that the allografted bone embolized to the lungs. Although several reports have indicated that inserting reinforcing materials into the tapped screw holes can enhance the pedicle screw fixation, this procedure may cause severe FES due to fat and debris of material augmentation (i.e. cement, hydroxyapatite, allograft bone). It is important for physicians, especially spinal surgeons, and anesthetists, to be aware of the potential for FES to occur during spinal surgery, which can cause serious complications in a small minority of patients.
Perioperative analgesia with ultrasound-guided quadratus lumborum block for transurethral resection of prostate
Authors: Wang Haiyan , Deng Wei , Zhu Xinwei , Fei Chunxia 
Published: December 2021

Abstract

Background:
Prostatic hyperplasia is a physiological aging process in men. After transurethral resection of prostate (TURP), visceral pain is the main cause. The effective postoperative analgesia can reduce the occurrence of postoperative complications. This study mainly studied the analgesic effect of quadratus lumborum block (QLB) on TURP.

Methods:
We divided 62 patients undergoing TURP into 2 groups using a random number table method (QLB 2 group and non-QLB [control] group). Patients in the QLB group underwent ultrasound-guided posterior QLB with 20 mL of 0.25% ropivacaine on each side, and those in the control group received only general anesthesia. The primary outcome for this study was the consumption analgesic pump during 0 to 24 hours. The secondary outcomes included the first pressing time of analgesic pump during 0 to 24 hours, the pain at rest and when coughing at 1, 4, 8, 12, and 24 hours post-operation as measured with a visual analogue scale for pain, length of the hospital stay, and complications (nausea and vomiting, dizziness, and abdominal distension).

Results:
Patients in the QLB group presented less consumption, later first pressing time of analgesic pump during 0 to 24 hours after surgery lower visual analogue scale scores at 1, 4, 8, 12, and 24 hours postsurgery than those in the control group. Moreover, their mean length of hospital stay was shorter (P = .023), and they experienced less postoperative complications than the patients in the control group.

Conclusions:
Ultrasound-guided QLB in TURP provided a significant analgesic effect in our patients the first day after surgery. This analgesic model may improve the postoperative recovery after TURP.
The effect of psychotherapy on anxiety, depression, and quality of life in patients with diabetic retinopathy
Authors: Li Suiping , Liu Hong , Zhu Xian 
Published: December 2021

Abstract

Background:
Diabetic retinopathy (DR) is one of the common microvascular complications in diabetic patients, which is characterized by progressive development and often leads to irreversible visual impairment. More seriously, DR patients suffer great psychological stress due to impaired visual function and reduced self-care ability such as anxiety and depression, which seriously affect the quality of life of patients. In recent years, various psychological therapies have been applied to alleviate anxiety, depression, and quality of life in DR patients, which have achieved positive results. However, the effectiveness and safety of different psychological therapies are unclear. This study aims to assess the effects of psychotherapy on anxiety, depression, and quality of life in DR patients through a network meta-analysis.

Methods:
All randomized controlled trials (RCTs) on the effects of psychotherapy on anxiety, depression, and quality of life in patients with DR published before 30 November 30, 2021, will be searched in the PubMed, EMBASE, Cochrane Register of Controlled Trials, Web of Science, Chinese Scientific Journal Database, China National Knowledge Infrastructure Database, Wanfang, and China Biomedical Literature Database. There will have no restrictions on publication status and language. Two researchers will be independently responsible for RCT screening, data extraction, and quality evaluation. All statistical analyses will be performed using Stata 14.0 and R 4.1.2.

Results:
The results of this meta-analysis will be submitted to a peer-reviewed journal for publication.

Conclusion:
This study will provide comprehensive and reliable evidence-based references for elucidating the efficacy of psychotherapy on anxiety, depression, and quality of life in DR patients.

Ethics and dissemination:
Ethical approval was not required for this study. The systematic review will be published in a peer-reviewed journal, presented at conferences, and shared on social media platforms.

OSF Registration number:
DOI 10.17605/OSF.IO/K8T27.
Parvovirus B19-induced severe anemia in heart transplant recipient
Authors: Xu Bijun , Zhang Weimin , Qian Ximing , Wang Shiqiang , He Fan 
Published: December 2021

Abstract

Rationale:
Human parvovirus B19 (B19V) is a non-enveloped single-stranded DNA virus associated with a variety of human diseases. Reports of B19V infection after cardiac transplantation are relatively rare.

Patient concerns:
We report a case of a 48-year-old women who underwent orthotopic heart transplant for dilated cardiomyopathy. She developed an anemia after cardiac transplantation. Anemia was most severe 2 months after surgery, with a decrease in reticulocyte count. Serological DNA test for parvovirus B19V was performed and the result was positive.

Diagnoses:
B19V infection.

Interventions and outcomes:
Intravenous immunoglobulin administration resulted in a resolution of the anemia. The patient's blood test results showed a normal hemoglobin and reticulocyte count 1 year after surgery.

Lessons:
Patients with parvovirus B19V infection may develop severe anemia after heart transplantation. The diagnosis mainly relies on viral DNA detection. Intravenous immunoglobulin is an effective treatment for viral infection.
Hospital-wide antigen screening for coronavirus disease in a tertiary reference center in Sapporo, Japan
Authors: Shimamura Yoshinosuke , Komazawa Hiroki , Oikawa Junko , Furuta Yasushi 
Published: December 2021

Abstract
Hospital-wide screenings for coronavirus disease (COVID-19) are important to identify healthcare workers at risk of exposure. However, the currently available diagnostic tests are expensive or only identify past infection. Therefore, this single-center observational study aimed to assess the positivity rate of hospital-wide antigen screening tests for COVID-19 and evaluate clinical factors associated with antigen positivity during a COVID-19 institutional outbreak in Sapporo, Japan.
We analyzed the data of 1615 employees who underwent salivary or nasal swab antigen tests on November 18, 2020, to detect severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Laboratory confirmation using reverse transcriptase polymerase chain reaction was performed for those with positive viral serology. The demographic characteristics, job titles, and risk of contact with COVID-19 patients were compared between employees with and without COVID-19.
A total of 19 employees (1.2%) tested positive for the SARS-CoV-2 antigen. The positivity rate was high among rehabilitation therapists (2.1%) and employees in the low-risk contact group (6.1%). Although there was no association between the job titles and the seropositivity rate, those in the low-risk contact group had an increased risk of testing positive for the viral antigen (odds ratio, 8.67; 95% confidence interval, 3.30–22.8).
The antigen positivity rate was low during the hospital outbreak, suggesting that risk assessment of exposure to COVID-19 patients may provide more useful information than using job titles to identify infected health care providers.
Efficacy and safety of sevoflurane vs propofol in combination with remifentanil for anesthesia maintenance during craniotomy
Authors: Zhou Zheng , Ying Miaofa , Zhao Rui 
Published: December 2021

Abstract

Background:
The purpose of this study was to evaluate the efficacy and safety of sevoflurane-remifentanil (SR) vs propofol-remifentanil (PR) as inhalation anesthesia or total intravenous anesthesia in patients undergoing craniotomy, respectively.

Methods:
Electronic databases included PubMed, ScienceDirect, Embase, Cochrane library, CNKI, and Wanfang data were searched using suitable search items. Randomized clinical controlled trials comparing the combination of SR and PR as anesthetics for neurosurgery were included. The outcomes included wake-up time, spontaneous respiration time, extubation time, and safety.

Results:
Seventeen studies were included in this meta-analysis. There were no statistically significant differences in wake-up time (P = .25, standardized mean difference (SMD) = 0.29, 95% CI –0.20 to 0.77), extubation time (P = .1, SMD = 0.52, 95% CI –0.11 to 1.14) and spontaneous respiration time (P = .58, SMD = 0.43, 95% CI –1.07 to 1.93) when patients with SF and PF for anesthesia maintenance. Moreover, the changes of hemodynamic parameters are similar between the 2 groups. During anesthesia maintenance, SF could significantly increase the incidence of hypotension and brain edema than PF (P = .02, SMD = 1.68, 95% CI 1.07 to 2.62; P < .0001, SMD = 3.37, 95% CI 1.86 to 6.12), PF markedly promoted the incidence of hypertension (P = .001, SMD = 0.55, 95% CI 0.39 to 0.79). The postoperative adverse reactions were similar between the 2 groups (P > .05), but the incidence of postoperative nausea and vomiting proved to be higher in SF group (P < .0001, SMD = 2.12, 95% CI 1.47 to 3.07).

Conclusions:
SR and PR as anesthetics in patients underwent craniotomy had similar effects, but PR was superior to SR in terms of safety of intraoperation and postoperation.
Association between thyroid hormone and components of metabolic syndrome in euthyroid Korean adults
Authors: Shin Kyung A. , Kim Eun Jae 
Published: December 2021

Abstract
Thyroid dysfunction increases the prevalence of metabolic syndrome. However, the link between thyroid hormones and metabolic syndrome remains debatable, and the effect of sex on their relationship is not completely understood. To elucidate the relationship of thyroid hormones with metabolic syndrome and its components according to sex in euthyroid individuals in South Korea. Adult participants who underwent thyroid tests at our institution between January 2015 and December 2018 and had thyroid-stimulating hormone (TSH; 0.270–4.200 μIU/mL) and free thyroxine (FT4; 0.93–1.70 ng/dL) levels in the normal range were included. After correcting for age and body mass index, multiple linear regression was performed to assess the association of TSH and FT4 with metabolic syndrome and its components, and logistic regression was performed to estimate the risk of developing metabolic syndrome and its components according to different thyroid hormone quartiles. We included 12,478 men and 7,575 women in this study. The prevalence of metabolic syndrome was 9.68%. In men, TSH was positively associated with blood pressure and triglycerides, and the odds ratio for high blood pressure and hypertriglyceridemia was approximately 1.3 times higher in the fourth quartile than in the first quartile. FT4 associated positively with waist circumference, and a high odds ratio for abdominal obesity in the fourth quartile was observed in both men (odds ratio [OR], 1.239; 95% confidence interval [CI], 1.045–1.470) and women (OR, 1.302; 95% CI, 1.029–1.649). A negative association was found between FT4 and triglycerides, and concurrently, the odds ratios for hypertriglyceridemia were lower in the fourth quartile in both men (OR, 0.692; 95% CI, 0.619–0.774) and women (OR: 0.641; 95% CI: 0.512–0.803). In addition, a higher odds ratio for high blood pressure was observed in the fourth quartiles of FT4 and TSH in women. However, there was no association between TSH and FT4 levels and the onset of metabolic syndrome in either of the sexes. Serum TSH and FT4 levels were associated with different metabolic syndrome components in men and women, but there was no association with the onset of metabolic syndrome.
Indications for early revision surgery for material failure in spinal instrumentation: experience at a level 1 center for spinal surgery – a single-center study
Authors: Banat Mohammed , Wach Johannes , Salemdawod Abdallah , Bara Gregor , Scorzin Jasmin , Vatter Hartmut 
Published: December 2021

Abstract
Posterior instrumentation is an established treatment for a range of spinal disorders. Material failure is not uncommon, and the indications for a revision are very heterogeneous. This study aimed to evaluate the indications and timing for early revision spinal surgery due to material failure.
In this retrospective, single-center cohort study, patients underwent spinal posterior instrumentation between January 2017 and July 2019. They were followed up at 3, 12, and 18 months postoperatively. The time of onset of material failure which led to revision surgery was analyzed. In addition, the relationship between the indications for revision surgery and independent variables was examined using a multivariate logistic regression model.
A total of one hundred thirty-five patients were enrolled. Radiolucent zones were found in 30 patients (20%) after 3 months, whereas 48 patients (31%) had radiolucent zones after 12 months. Revision surgery was performed in 13 patients (8.5%). The peak time for revision due to instability was within the first four months of the primary surgery. Multivariate analysis revealed that location, pathology, ASA score, and smoking had no significant impact on the indication for revision surgery, and neither did BMI (P = .042). Non-fusion (P = .007) and radiolucent zones (P = .004), in combination with increased pain (P = .006), were predictors for revision.
Our data show that the peak time for early revision of material failure after posterior instrumentation was within the first 4 months of primary surgery. The abnormalities (e.g., radiolucent zones) surrounding the screws without fusion, including persistence of pain, were predictors for revision surgery.
Localized gastric amyloidosis successfully treated with endoscopic submucosal dissection
Authors: Oh Gyu Man , Park Seun Ja , Kim Jae Hyun , Jung Kyoungwon , Kim Sung Eun , Moon Won , Park Moo In , Chang Hee-Kyung 
Published: December 2021

Abstract

Rationale:
Amyloidosis is a general term that refers to the extracellular deposition of amyloid. The amyloid can also be deposited in a single organ. However, cases of localized gastric amyloidosis have rarely been reported. Here, we report a case of localized gastric amyloidosis that was successfully treated with endoscopic submucosal dissection.

Patient concern:
A 60-years-old man underwent esophagogastroduodenoscopy as part of a regular check-up without any comorbidities or symptoms.

Diagnostics:
A 12 mm-sized, round, elevated lesion with a central depression, which was covered with normal mucosa, and located on the greater curvature of the lower body of the stomach was discovered during endoscopy. Subsequently, endoscopic ultrasonography was performed, which revealed a 11.7 mm-sized, hypoechoic, heterogeneous lesion located in the muscularis mucosa and submucosa. A biopsy was performed, and amyloid deposition was confirmed. Although other investigations for checking systemic amyloidosis were performed, there were no specific findings. Therefore, the final diagnosis was localized gastric amyloidosis.

Interventions:
Endoscopic submucosal dissection was performed according to the patient's request and the lesion was completely removed.

Outcomes:
The patient was followed-up for 3 years without any recurrence.

Conclusions:
Endoscopic submucosal dissection can be good diagnostic and treatment option for localized gastric amyloidosis.
Reversible severe tricuspid regurgitation associated with Graves’ disease
Authors: Lee Ja-Yeon , Lee Sun Hwa , Kim Won Ho 
Published: December 2021

Abstract

Rationale:
Graves’ disease is the most common cause of thyrotoxicosis. Cardiovascular signs and symptoms are frequent in patients with thyrotoxicosis and right heart failure with severe tricuspid regurgitation (TR) is a rare manifestation of hyperthyroidism.

Patient concerns:
A 41-year-old woman with a history of Graves’ disease presented to the emergency department with worsening generalized edema and dyspnea for a month.

Diagnosis:
The laboratory test results revealed suppressed thyroid-stimulating hormone (TSH), elevated levels of free thyroxine and anti-TSH receptor antibody, and negative anti-thyroid peroxidase and anti-thyroglobulin antibodies. Transthoracic echocardiography showed severe TR associated with incomplete coaptation of tricuspid valve due to dilated right ventricle (RV), moderate resting pulmonary hypertension, and preserved biventricular systolic function.

Interventions and outcomes:
After 6 months of antithyroid treatment, her thyroid function was restored euthyroid state and she was fully recovered from right heart failure. Follow-up echocardiography showed complete disappearance of severe TR and pulmonary hypertension and normalization of RV dimension.

Lessons:
Severe TR can be rarely associated with thyrotoxicosis, but this is reversible and can be completely recovered with normalization of thyroid function.