bluuebunny/crossref_metadata_2025_split huggingface dataset:
FIRE-9 – PORT / AIO-KRK-0418: a prospective, randomized, open, multicenter Phase III trial to investigate the efficacy of adjuvant/additive chemotherapy in patients with definitely-treated metastatic colorectal cancer
Authors: Raschzok Nathanael , Stintzing Sebastian , Heinemann Volker , Rauch Geraldine , Ricke Jens , Guckenberger Matthias , Kurreck Annika , Alig Annabel H. S. , Stahler Arndt , Bullinger Lars , Schmelzle Moritz , Schöning Wenzel , Lurje Georg , Krenzien Felix , Haase Oliver , Rau Beate , Gebauer Bernhard , Sauer Igor M. , Pratschke Johann , Modest Dominik P. 
Published: April 2022

Abstract
Background
Additive/adjuvant chemotherapy as concept after local treatment of colorectal metastases has not been proven to be successful by phase III trials. Accordingly, a standard of care to improve relapse rates and long-term survival is not established and adjuvant chemotherapy cannot be recommended as a standard therapy due to limited evidence in literature. The PORT trial aims to generate evidence that post-resection/ablation/radiation chemotherapy improves the survival in patients with metastatic colorectal cancer.

Methods
Patients to be included into this trial must have synchronous or metachronous metastases of colorectal cancer—either resected (R0 or R1) and/or effectively treated by ablation or radiation within 3–10 weeks before randomization—and have the primary tumor resected, without radiographic evidence of active metastatic disease at study entry. The primary endpoint of the trial is progression-free survival after 24 months, secondary endpoints include overall survival, safety, quality of life, treatments (including efficacy) beyond study participation, translational endpoints, and others. One arm of the study comprising 2/3 of the population will be treated for 6 months with modified FOLFOXIRI or modified FOLFOX6 (investigator´s choice, depending on the performance status of the patients but determined before randomization), while the other arm (1/3 of the population) will be observed and undergo scheduled follow-up computed tomography scans according to the interventional arm.

Discussion
Optimal oncological management after removal of colorectal metastases is unclear. The PORT trial aims to generate evidence that additive/adjuvant chemotherapy after definitive treatment of colorectal metastases improves progression free and overall survival in patients with colorectal cancer.

Trial registration
This study is registered with clinicaltrials.gov (NCT05008809) and EudraCT (2020–006,144-18).
Treatment of open-angle glaucoma and ocular hypertension with preservative-free tafluprost/timolol fixed-dose combination therapy: 6 case reports and clinical outcomes
Authors: Ansari E. , Chappiti S. , Pavicic-Astalos J. , Pinto-Bonilla J. C. , Riva I. , Sacchi M. , Saénz-Francés F. 
Published: April 2022

Abstract
Background
Treatment of open angle glaucoma (OAG) and/or ocular hypertension (OHT) focuses on achievement of target intraocular pressure (IOP), with the objective of slowing disease progression. However, ocular surface health is an important consideration in the optimization of treatment. We report 6 patient cases in which enhanced IOP control was achieved following appropriate management of ocular surface inflammation and a therapeutic switch to the preservative-free (PF) tafluprost (0.0015%)/timolol (0.5%) fixed-dose combination (FC).

Case presentation
Six patient cases, aged 48–74 years, presented with OAG or OHT. Each patient had signs and symptoms of ocular surface disease (OSD). Cases 1–3 were each receiving maximal medical therapy for OAG; regimens comprising prostaglandin analogue (PGA), β-blocker, carbonic anhydrase inhibitor (CAI) and α-2 agonist agents (including treatments containing preservative agent). Cases 1 and 2 reported IOP values ≥23 mmHg in each eye, and wide IOP fluctuations were identified when reviewing patient data concerning case 3 (11–20 mmHg). Maximal therapy was ceased and PF tafluprost/timolol FC was initiated, after which the signs and symptoms of OSD were improved and IOP was reduced (≤18 mmHg for cases 1–3) and stabilized. Cases 4 and 5 were diagnosed with OAG and case 6 had OHT. Each had symptoms and signs of OSD and were treated with a preserved PGA monotherapy (latanoprost 0.005% or bimatoprost 0.03%). At presentation, IOP was 24 mmHg in both eyes (case 4), ≥18 mmHg (case 5) and ≥ 22 mmHg (case 6). Following a switch to the PF tafluprost/timolol FC, OSD symptoms were improved and IOP was 14 mmHg (both eyes; case 4), ≤14 mmHg (case 5) and 16 mmHg (both eyes; case 6).

Conclusions
In addition to IOP-lowering efficacy, approaches to the management of OAG and OHT should consider the impact of treatment tolerability and the susceptibility of these patients to OSD. The presence of ocular surface inflammation appears to be detrimental to adherence and therefore to the effectiveness of topical medications. Addressing OSD through the use of PF FC formations, such as the PF tafluprost/timolol FC, reduces exposure to potentially toxic agents and facilitates improvements in IOP control.
The ocular biometry characteristics of young patients with primary angle-closure glaucoma
Authors: Xu Yi , Tan Qian , Li Chunyan , Liu Dan 
Published: April 2022

Abstract
Background
Although primary angle-closure glaucoma (PACG) mainly occurs in elderly people, diagnosis of PACG in young patients is not uncommon. So far, there is no article specialized on the ocular anatomical characteristics in these patients.In this study, ocular anatomical characteristics in young PACG patients are analyzed.

Methods
In this retrospective, comparative study, patients diagnosed with PACG and received ultrasound biomicroscopy (UBM) examination in our department were included. Patients were divided into two groups: a young group composed of patients ≤ 45 years and an old group composed of patients > 45 years. A-scan ultrasonography and ultrasound biomicroscopy (UBM) were used to measure ocular biometric parameters of patients in the two groups including axial length (AL), lens thickness (LT), central anterior chamber depth (ACD), anterior chamber width (ACW), angle opening distance 500 (AOD500), anterior chamber angle 500 (ACA500), iris thickness 1000 μm from the iris root (IT1000), iris thickness 500 μm from the iris root (IT500), trabecular-ciliary process angle (TCPA), trabecular-ciliary process distance (TCPD), scleral– ciliary process angle (SCPA), lens vault (LV), and pupil diameter (PD). Plateau iris (PI) and basal iris insertion were determined from UBM images, and the prevalence of PI and basal iris insertion were compared between the two groups. The incidence of postoperative malignant glaucoma (MG) was also determined in both groups and ocular anatomical predictors for the development of MG were evaluated in young PACG patients.

Results
One hundred fifteen patients were included into young group and 480 patients were included into old group. The young group had shorter TCPD, shorter AL, narrower TCPA, narrower SCPA thinner Lens compared to the old group. There were no significant differences in ACD, AOD 500, ACA500, LV, IT500, IT1000, PD or ACW between the two groups. The prevalence of PI was 22.6% in old group and 66.1% in young group (P < 0.001). More young PACG patients displayed basal iris insertion compared to old PACG patients (P < 0.001). 87 patients in the young group and 201 patients in the old group underwent trabeculectomy in our study. Among these patients, 21 young patients and 11 old patients developed MG after trabeculectomy (P < 0.001).

Conclusions
Shorter AL, more anteriorly positioned ciliary body, higher prevalence of PI may be responsible for the etiology of young PACG patients. Our results suggest that shorter AL, shorter TCPD and narrower TCPA may be predictors for development of MG in young PACG patients after trabeculectomy.
Child transmission of SARS-CoV-2: a systematic review and meta-analysis
Authors: Silverberg Sarah L , Zhang Bei Yuan , Li Shu Nan Jessica , Burgert Conrad , Shulha Hennady P , Kitchin Vanessa , Sauvé Laura , Sadarangani Manish 
Published: April 2022

Abstract
Background
Understanding of the role of children in COVID-19 transmission has significant implications for school and childcare policies, as well as appropriate targeting of vaccine campaigns. The objective of this systematic review was to identify the role of children in SARS-CoV-2 transmission to other children and adults.

Methods
MEDLINE, EMBASE, CINAHL, Cochrane Central Register of Controlled Trials, and Web of Science were electronically searched for articles published before March 31, 2021. Studies of child-to-child and child-to-adult transmission and quantified the incidence of index and resulting secondary attack rates of children and adults in schools, households, and other congregate pediatric settings were identified. All articles describing confirmed transmission of SARS-CoV-2 from a child were included. PRISMA guidelines for data abstraction were followed, with each step conducted by two reviewers.

Results
40 of 6110 articles identified met inclusion criteria. Overall, there were 0.8 secondary cases per primary index case, with a secondary attack rate of 8.4% among known contacts. The secondary attack rate was 26.4% among adult contacts versus 5.7% amongst child contacts. The pooled estimate of a contact of a pediatric index case being infected as secondary case was 0.10 (95% CI 0.03-0.25).

Conclusions
Children transmit COVID-19 at a lower rate to children than to adults. Household adults are at highest risk of transmission from an infected child, more so than adults or children in other settings.
Feasibility, acceptability, and short-term impact of a brief sexually transmitted infection intervention targeting U.S. Military personnel and family members
Authors: Kunz Anjali , Moodley Amber , Colby Donn J. , Soltis Michele , Robb-McGrath Wesley , Fairchok Alexandra , Faestel Paul , Jungels Amanda , Bender Alexis A. , Kamau Edwin , Wingood Gina , DiClemente Ralph , Scott Paul 
Published: April 2022

Abstract
Background
Over the past 10 years, incidence of sexually transmitted infections (STIs) has increased to record numbers in the United States, with the most significant increases observed among adolescents and young adults. The US military, where the majority of active duty personnel are 18–30 years old, has seen similar increases. However, the US military does not yet have a standardized, service-wide program for STI education and prevention.

Methods
The KISS intervention (Knocking out Infections through Safer-sex and Screening) was adapted from an evidence-based intervention endorsed by the US Centers for Disease Control and Prevention and consisted of a one-time, small group session. Content included STI/HIV knowledge and prevention, condom use skills, and interpersonal communication techniques. The intervention was pilot tested for feasibility and acceptability among a population of service members and medical beneficiaries at Joint Base Lewis-McChord in Washington state.

Results
A total of 79 participants aged 18–30 years were consented to participate in the pilot study and met entry criteria, 66/79 (82.5%) attended the intervention session, and 46/66 (69.7%) returned at 3 months for the final follow-up assessment. The intervention sessions included 31 male (47.0%) and 35 female (53.0%) participants. Almost all participants felt comfortable discussing sexual issues in the group sessions, reported that they intended to practice safer sex after the intervention, and would also recommend the intervention to friends. Knowledge about STI/HIV prevention significantly increased after the intervention, and intervention effects were maintained at 3 months. About one-fifth of participants tested positive for N. gonorrhea or C. trachomatis infection at enrollment, while none had recurrent STIs at the final visit. Use of both male and female condoms increased after the intervention.

Conclusions
The KISS intervention was feasible to implement in the military setting and was acceptable to the active duty service members and other medical beneficiaries who participated in the pilot project. Further studies are needed to determine if the KISS intervention, or others, effectively decrease STI incidence in active duty personnel and would be appropriate for more widespread implementation.

Trial Registration
Retrospectively registered as the pilot phase of clinicaltrials.gov NCT04547413, “Prospective Cohort Trial to Assess Acceptability and Efficacy of an Adapted STI/HIV Intervention Behavioral Intervention Program in a Population of US Army Personnel and Their Medical Beneficiaries—Execution Phase.”
Hyaluronic acid as an adjunct to microfracture in the treatment of osteochondral lesions of the talus: a systematic review of randomized controlled trials
Authors: Dilley Julian E. , Everhart Joshua S. , Klitzman Robert G. 
Published: April 2022

Abstract
Background
Osteochondral lesions of the talus (OLT) are common after ankle trauma. Studies have shown that bioactive substances, such as hyaluronic acid (HA), alone, or in combination, with surgical treatment could improve cartilage regeneration and repair, but the effect of HA on patient reported outcomes is unclear.

Methods
Literature searches were performed across four databases (PubMed, SPORTDiscus, Scopus, and The Cochrane Library) for randomized controlled trials in which at least one treatment arm involved use of HA as an adjunct to microfracture to treat patients with OLT. Primary outcomes included the American Orthopaedic Foot and Ankle Society scores (AOFAS), and the Visual Analog Scale (VAS) for pain. The level of evidence and methodological quality were evaluated using the Modified Coleman Methodology Score (MCMS).

Results
Three randomized studies were eligible for review with a total of 132 patients (35, 40, 57 patients, respectively) and follow-up ranged from 10.5 to 25 months. Utilization of HA at the time of microfracture resulted in greater improvement in AOFAS scores compared to microfracture alone. The pooled effect size was moderate (Standardized Mean Difference [SMD] 0.45, 95% Confidence Interval [CI] 0.06, 0.84; P = .02) and between-study heterogeneity was low (I-squared = 0%). Utilization of HA during microfracture also led to greater improvement in VAS-pain scores compared to microfracture alone. The pooled effect size was very large (SMD -3.86, 95% CI -4.75, − 2.97; P < .001) and heterogeneity was moderate (I-squared = 69%).

Conclusion
Hyaluronic acid injection as an adjunct to arthroscopic MF in OLT provides clinically important improvements in function and pain at short-term follow-up compared to MF alone. Future longer-term follow-up studies are warranted to investigate the durability of MF with HA for treatment of OLT.
Early effects of ovariectomy on bone microstructure, bone turnover markers and mechanical properties in rats
Authors: Guo Xingman , Yu Xiyue , Yao Qianqian , Qin Jian 
Published: April 2022

AbstractBackgroundFragility fracture is one of the most serious consequences of female aging, which can increase the risk of death. Therefore, paying attention to the pathogenesis of postmenopausal osteoporosis (PMOP) is very important for elderly women.Methods and materialsForty 12-week-old female rats were divided into two groups including the ovariectomy (OVX) group and the control group. Four rats in each group were selected at 1, 4, 8, 12 and 16 weeks after operation. Vertebral bones and femurs were dissected completely for micro-Computed Tomography (micro-CT) scanning, biological modulus detection and histomorphological observation.ResultsIn OVX group, bone volume/total volume (BV/TV), bone trabecular connection density (Conn.D) and trabecular bone number (Tb.N) decreased significantly with time (P < 0.05). The elastic modulus of femur in OVX group was lower than that in control group, but there was no significant difference between them (P > 0.05). Over time, the tartrate resistant acid phosphatase (TRAP), osteocalcin (BGP), type I procollagen amino terminal propeptide (PINP) and type I collagen carboxy terminal peptide (CTX-I) in OVX group increased significantly (P < 0.05). The micrographs of the OVX group showed sparse loss of the trabecular interconnectivity and widening intertrabecular spaces with time.ConclusionThe bone loss patterns of vertebral body and femur were different in the early stage of estrogen deficiency. The bone turnover rate of OVX rats increased, however the changes of biomechanical properties weren’t obvious.
A patient with femoral osteitis fibrosa cystica mimicking bone neoplasm: a case report
Authors: Xu Xiao-Long , Yang Cui-Ping , Lu Sheng-Jun , Pei Hong , Chen Shun-Guang , Liao Quan-Ming 
Published: April 2022

Abstract
Background
Osteitis fibrosa cystica is a rare, benign and osteolytic lesion attributed to hyperparathyroidism. The high level of parathyroid hormone cause rapid bone loss.

Case presentation
The patient is a 50-year-old male complaining of severe and persistent pain in the right knee joint. Imaging studies were suspicious for a benign tumor in the right distal femur. Biopsy under CT guidance showed numerous osteoclast aggregation and hemosiderin deposition around the bone trabeculae. Blood tests disclosed significantly elevated parathyroid hormone, serum calcium, serum alkaline phosphatase. Parathyroid ultrasonography and CT scan showed a solid mass in front of the trachea at the thoracic entrance plane. After resection of the mass, the clinical symptoms were relieved and the radiological results were significantly improved, which further confirmed the diagnosis.

Conclusions
Metabolic diseases-associated bone lesions require a comprehensive diagnosis of multiple inspection items. An interprofessional team approach to the diagnosis and treatment of osteitis fibrosa cystica will provide the best outcome.
Application analysis of omental flap isolation and modified pancreaticojejunostomy in pancreaticoduodenectomy (175 cases)
Authors: Deng Shun , Luo Jianhong , Ouyang Yongzhong , Xie Jiangbo , He Zhuo , Huang Bo , Bai Fei , Xiao Ke , Yin Bin , Wang Jinfeng , Xu Biaoming , Zuo Chaohui 
Published: April 2022

Abstract
Background
To explore the application value of free omental wrapping and modified pancreaticojejunostomy in pancreaticoduodenectomy (PD).

Methods
The clinical data of 175 patients who underwent pancreaticoduodenectomy from January 2015 to December 2020 were retrospectively analysed. In total, 86 cases were divided into Group A (omental wrapping and modified pancreaticojejunostomy) and 89 cases were divided into Group B (control group). The incidences of postoperative pancreatic fistula and other complications were compared between the two groups, and univariate and multivariate logistic regression analyses were used to determine the potential risk factors for postoperative pancreatic fistula. Risk factors associated with postoperative overall survival were identified using Cox regression.

Results
The incidences of grade B/C pancreatic fistula, bile leakage, delayed bleeding, and reoperation in Group A were lower than those in Group B, and the differences were statistically significant (P < 0.05). Group A had an earlier drainage tube extubation time, earlier return to normal diet time and shorter postoperative hospital stay than the control group (P < 0.05). The levels of C-reactive protein (CRP), interleukin-6 (IL-6), and procalcitonin (PCT) inflammatory factors 1, 3 and 7 days after surgery also showed significant. Univariate and multivariate logistic regression analyses showed that a body mass index (BMI) ≥ 24, pancreatic duct diameter less than 3 mm, no isolation of the greater omental flap and modified pancreaticojejunostomy were independent risk factors for pancreatic fistula (P < 0.05). Cox regression analysis showed that age ≥ 65 years old, body mass index ≥ 24, pancreatic duct diameter less than 3 mm, no isolation of the greater omental flap isolation and modified pancreaticojejunostomy, and malignant postoperative pathology were independent risk factors associated with postoperative overall survival (P < 0.05).

Conclusions
Wrapping and isolating the modified pancreaticojejunostomy with free greater omentum can significantly reduce the incidence of postoperative pancreatic fistula and related complications, inhibit the development of inflammation, and favourably affect prognosis.
Ultrasonography evaluation on the protective effect of combination therapy of beraprost sodium and aspirin on arteries occlusion and stiffness in patients with type 2 diabetes mellitus - a prospective, randomized study
Authors: Lin Xian , Chen Yuying , Lu Wan , Li Jin , Fu Li , Yin Jingyu , Ren Meng , Yan Li , Yang Chuan 
Published: April 2022

Abstract
Background
Patients with type 2 diabetes mellitus (T2DM) are susceptible to developing symptomatic peripheral arterial disease (PAD). As a proven vasodilator and antiplatelet agent, the efficiency of Beraprost sodium (BPS) on the prevention of arteries occlusion and stiffness in T2DM patients with PAD has not yet been fully investigated.

Methods
From July 2010 to April 2012, 64 Patients enrolled were randomly assigned to the combined therapy group (n=32), which received combination therapy with BPS (60 μg/day) and aspirin (100 mg/day), or to the control group (n=32), which only received aspirin (100 mg/day). After randomization, the patients were followed up at years 0, 1, 2, 3, 4, and 5 with the evaluation of carotid intima-media thickness (CIMT), pulse wave velocity (PWV), inner artery diameter, stenosis rate, and medial arterial calcification (MAC) of lower limb arteries via high-resolution ultrasound measurement. Adverse events were also recorded in each visit.

Results
There was no significant change of the CIMT during the follow-up in both groups when compared to the baseline. Similar results were also observed in the PWV measurement. Significantly increases in the inner artery diameter of the dorsal pedal artery and posterior tibial artery were observed in patients with BPS and aspirin administration during the follow-up. Patients in the combined therapy group experienced marked improvement of MAC in the dorsal pedal artery and posterior tibial artery at the end of the follow-up. No significant difference in the adverse events was found between the combined therapy group and the aspirin group.

Conclusion
The combined therapy of BPS and aspirin showed a protective effect on arteries occlusion and stiffness in T2DM patients with PAD, along with a significant improvement of inner artery diameter and MAC in lower limbs.

Trial registration
http://www.chictr.org.cn, ChiCTR-TRC-10000919. Prospectively registered on 2010/06/29.