Background and aim The deltoid is a common site for intramuscular injections, but guidelines for administration lack standardization. Global researchers propose various techniques, and recent study reports indicate a 1.5-15% incidence of nerve palsies due to injections. This pilot cadaveric study aimed to standardize the deltoid intramuscular injection sites in the Southeast Asian population. Methods This cadaveric study of a two-year duration was conducted in the Department of Anatomy as an intramural research project in collaboration with the Departments of Anatomy and Orthopedics. In the first year of study, which was the pilot phase of the project, the available six cadavers, i.e., 12 upper extremity specimens were dissected. Anthropometric measurements of deltoid muscle along with the distance of underlying neurovascular structures like the axillary nerve and posterior circumflex humeral artery were measured from neighboring bony landmarks. This article presents the observations of the six cadavers studied in the pilot phase and shall be followed up by another article after the project. Results In adults, in anatomical position, the mean distances of the axillary nerve and posterior circumflex humeral artery from the mid-acromial point are 8.19±0.616 and 8.66±0.968 cm, respectively. The deltoid thickness at 3, 5, and 7 cm from mid-acromial point was observed to be 1.079±0.13 cm (0.5-1.78 cm), 1.599±0.12 cm (1-2.96 cm), and 1.815±1.0 cm (1.2-2.5 cm), respectively. The acquired qualitative and quantitative data were tabulated, graphically represented, and statistically analyzed. Conclusions The deltoid intramuscular injection (IMI) must be given at or below the level of the midpoint of the deltoid muscle, but never in the upper half. We recommend a site, 4 fingerbreadths/9 cm below the mid-acromion point as the safest site to avoid injury to any underlying neurovascular structures.

Recurrent opportunistic infections (OIs) in patients with severely immunosuppressed AIDS remain an unresolved medical challenge despite advancements in antiretroviral therapy (ART). To address this gap, we developed an HLA-mismatched allogeneic adoptive immune therapy (AAIT) specifically targeting this patient population. The safety and efficacy of this novel therapeutic approach were preliminarily confirmed in our phase 1 trial. Subsequently, a multicenter, open-label, controlled, phase 2a trial was conducted to evaluate the efficacy of AAIT in combination with ART compared with the conventional ART-only regimen. No difference in the incidence of adverse events (AEs) was observed between the two groups at the 96-week follow-up. AAIT treatment improved CD4+ T cell recovery at weeks 72 (P = 0.048) and 96 (P = 0.024) compared to the Control Group. Additionally, stratified analysis of patients in the AAIT Group showed that donor/recipient sex mismatch was significantly associated with the likelihood of patients achieving an immunological response (OR = 8.667; 95% CI, 2.010-37.377; P = 0.004). These findings suggest that AAIT serves as a promising adjunct therapy for improving the outcomes of patients with severely immunosuppressed AIDS. Further studies are needed to elucidate the immunological mechanisms underlying AAIT and identify the subpopulations that respond optimally to this therapeutic approach. This trial is registered at www.clinicaltrials.gov (NCT04098770).Trial registration: ClinicalTrials.gov identifier: NCT04098770.Trial registration: ClinicalTrials.gov identifier: NCT02651376.

Objective This study aims to assess the knowledge and attitudes toward clinical trial (CT) participation among the adult population in the Eastern Province of Saudi Arabia. Material and methods This cross-sectional study was conducted among the population of the Eastern Province of Saudi Arabia. A self-administered questionnaire was distributed among the general population using an online survey. Results A total of 334 participants completed the questionnaire. Participants\' ages ranged from 18 to 65 years, with a mean age of 31.2 ± 13.9 years, 56.6% of whom were males, 42.2% were employed, 29.6% were students, and 23.1% were unemployed. Surprisingly, only a small percentage of respondents (7.5%) were requested to participate in a randomized controlled trial (RCT), of which the majority did partake. Additionally, 25.4% of participants believe CTs are used to evaluate new drugs; others believe that CTs are used to understand diseases and human behavior. The data show that most participants believe that CTs improve patient care, welfare, and society. Also, participants were more likely to take part if they were aware of the study\'s purpose and findings and were given more time to consider their options. Conclusion Participants believed that the biggest obstacle was a lack of knowledge of CTs. It is crucial to educate patients more about CTs. Multimodal strategies such as improved patient-provider communication and online information for trial information sharing may be effective in boosting knowledge and CT recruitment.

UNASSIGNED: To investigate the effect of repetitive transcranial magnetic stimulation (rTMS) on phantom limb pain (PLP) in amputees, and to compare the therapeutic effect with that of mirror therapy (MT).
UNASSIGNED: The study was designed as a randomized controlled trial. The evaluators were blinded, while the subjects and the therapists were unblinded. Subjects were randomly assigned to either the rTMS group or the MT group with a computer-generated random number table. From June 2018 to December 2020, from out of 45 amputee patients screened for the study, 30 who met the inclusion criteria were recruited for the study. All patients were recruited from the Rehabilitation Medicine Center, West China Hospital, Sichuan University. In the end, 4 patients withdrew from the study and 26 patients (12 in the rTMS group and 14 in the MT group) completed the prescribed treatment and evaluation. The rTMS group was given rTMS (1 Hz, 15 min, 5 d/week) for 2 weeks in addition to conventional rehabilitation therapy, while the MT group received MT (corresponding movements of limbs, 15 min, 5 d/week) for 2 weeks in addition to conventional rehabilitation therapy. PLP was evaluated by the Visual Analogue Scale (VAS) and Douleur Neuropathique 4 Questions (DN-4). Subjects were assessed before treatment ( t 0), immediately after the completion of the treatment ( t 1) and 3 months after the completion of the treatment ( t 2).
UNASSIGNED: The mean age of the 26 patients was 39.73±12.64. There were 15 males and 11 females. According to the reported description of the characteristics of the PLP by the patients, the characteristics with the highest incidence were tingling, stabbing, numbing, electric shocks and burning in descending order. There was no significant difference in the incidence of PLP characteristics between the two groups ( P>0.05). The two groups had comparable baseline data, showing no significant difference in VAS and DN-4 between the two groups at t 0 ( P>0.05). At t 1 and t 2, the VAS and DN-4 scores were decreased from those of t 0, showing statistically significant difference in both groups ( P<0.01 for both scores). In the rTMS group, there was no significant difference between VAS and DN-4 scores at t 1 and those at t 2 ( P>0.05). In the MT group, the VAS and DN-4 scores at t 2 were significantly lower than those of t 1 ( P<0.05). There was no statistically significant difference between the rTMS group and MT group in the changes in pain measurements, i.e., VAS and DN-4 scores, before and after the intervention ( P>0.05). The 26 patients who completed the experiment showed no dizziness, headache, or other abnormalities during the study.
UNASSIGNED: The results of this study indicate that repetitive transcranial magnetic stimulation could improve PLP in amputees, and the improvement effect was comparable to that of mirror therapy.

Aneurysmal subarachnoid hemorrhage (SAH) has high morbidity and mortality. While the primary injury results from the initial bleeding cannot currently be influenced, secondary injury through vasospasm and delayed cerebral ischemia worsens outcome and might be a target for interventions to improve outcome. To date, beside the aneurysm treatment to prevent re-bleeding and the administration of oral nimodipine, there is no therapy available, so novel treatment concepts are needed. Evidence suggests that inflammation contributes to delayed cerebral ischemia and poor outcome in SAH. Some studies suggest a beneficial effect of anti-inflammatory glucocorticoids, but there are no data from randomized controlled trials examining the efficacy of glucocorticoids. Therefore, current guidelines do not recommend the use of glucocorticoids in SAH.
The Fight INflammation to Improve outcome after aneurysmal Subarachnoid HEmorRhage (FINISHER) trial aims to determine whether dexamethasone improves outcome in a clinically relevant endpoint in SAH patients.
FINISHER is a multicenter, prospective, randomized, double-blinded, placebo-controlled clinical phase III trial which is testing the outcome and safety of anti-inflammatory treatment with dexamethasone in SAH patients.
In all, 334 patients will be randomized to either dexamethasone or placebo within 48 h after SAH. The dexamethasone dose is 8 mg tds for days 1-7 and then 8 mg od for days 8-21.
The primary outcome is the modified Rankin Scale (mRS) at 6 months, which is dichotomized to favorable (mRS 0-3) versus unfavorable (mRS 4-6).
The results of this study will provide the first phase III evidence as to whether dexamethasone improves outcome in SAH.

Post-traumatic growth induced from cancer diagnosis and treatment could benefit the prognosis of cancer survivors, but intervention based on self-disclosure in group is limited.
Aimed to examine the effectiveness of a supportive-expressive group intervention on post-traumatic growth. The impact of the intervention on anxiety and depression were also explored.
This randomized clinical trial enrolled patients from June 2017 to September 2018 with a one-month follow-up. Data collectors were blinded to patient grouping.
A single center study in Chengdu, China.
One hundred sixty-eight participants who met the eligibility criteria were randomly assigned to the intervention group (n = 84) or control group (n = 84); 46 were excluded and 122 patients finished the one-month follow-up.
Participants in the intervention group received nurse-led support intervention focusing on topics such as \"Being a Patient\", \"Interpersonal Relationships\", \"Journey for Recovery\", and \"Planning the Future\" while participants in the control group received health education, rehabilitation training etc. according to the nursing routine of breast cancer patients. The intervention was designed in accordance with the diagnosis and treatment process as well as patient needs. Participants in both groups were evaluated three times (T1-baseline before the intervention, T2-end of the intervention, and T3-1 month follow up). Post-traumatic growth, anxiety and depression were evaluated.
Participants in the intervention group reported higher level of post-traumatic growth (p < 0.01 or 0.05) and reduced anxiety and depression (p < 0.01 or 0.05 and p < 0.01 or 0.05). The multilevel model indicated that the intervention significantly promoted post-traumatic growth (βT3  = 7.87, p < 0.05) and dimensions of relating to others (βT3  = 4.26, p < 0.001), personal strength (βT3  = 4.27, p < 0.01), appreciation of life (βT3  = 8.69, p < 0.001), and new possibilities (βT3  = 1.91, p < 0.05), anxiety (βT3  = -3.63, p < 0.001), and depression (βT3  = -2.27, p < 0.001), but had no effect on the dimension of spiritual change. In addition, the multi-level model showed that patients with younger ages (β = -0.05~-0.52, p < 0.05-0.001), with high school and above education levels (β = 1.53~9.29, p < 0.01) and accompanied by husbands(β = -1.48~-8.51, p < 0.05) had more effective intervention and patients with religious belief had a better spiritual change level (β = 1.86, p < 0.001).
These findings provide evidence for the potential effectiveness of the nurse-led intervention on positive benefits of post-traumatic growth and relieved anxiety and depression for Chinese breast cancer survivors and will inform the design and development of a large randomized controlled trial.
The supportive-expression group intervention can be applied independently by nurses. The four themes of self-disclosure can help patients grow after trauma, and this method can be used as a psychological support technique for breast cancer patients during hospitalization.

BACKGROUND: Small-cell lung cancer (SCLC) is a type of lung cancer with high invasiveness and poor prognosis. Although SCLC is effective for initial treatment, the vast majority of patients will relapse, the efficacy of posterior line therapy is limited, and there is a lack of effective treatment. At the same time, in the past 30 years, there has been little progress in first-line treatment. With the progress of antiangiogenic therapy, whether it can be used in the treatment of SCLC is worth exploring. Therefore, a single-arm multicenter clinical study was conducted on the efficacy, optimization, and safety of endostatin combined chemotherapy in SCLC.
METHODS: This study is a prospective non-blind single-arm multicenter study. From January 2016 to July 2019, a total of 22 patients with histologically diagnosed SCLC were enrolled in three centers. The treatment regimen was as follows: continuous intravenous pump infusion of endostatin (90 mg) for 72 hours, 3 days before chemotherapy, and continuous pump infusion of endostatin (120 mg) for 96 hours the next day following the infusion of chemotherapeutic drugs; the chemotherapy regimen was administered with standard platinum combined with etoposide once every 21 days. After six cycles, endostatin maintenance therapy was used until the disease progressed or intolerable adverse reactions occurred. The therapeutic effect was evaluated by imaging and oncology markers every two cycles, and the adverse reactions, tumor progression time, and patient survival time were recorded.
RESULTS: Among the 21 patients analyzed, the median progression-free survival (PFS) was 8.0 months, the median overall survival (OS) was 13.6 months, the objective effective rate (ORR) was 61.9%, and the disease control rate (DCR) was 95.2%. All patients tolerated the treatment. The main adverse reactions were myelosuppression, albuminuria, nausea, and vomiting. The incidence of grade 3 or 4 adverse reactions was 7.2%, which could be relieved by symptomatic support treatment. There were no treatment-related deaths.
CONCLUSIONS: Endostatin combined with platinum-etoposide is safe and effective in the treatment of SCLC.

The current treatment approaches for esophageal cancer are associated with poor survival, and there are ongoing efforts to find new and more effective therapeutic strategies. There are several reports on the antitumoral effects of low-molecular-weight heparins (LMWHs). We have assessed the possible survival benefit of LMWHs in esophageal malignancies. This was a randomized, single-blind, multicenter, Phase II clinical trial on nonmetastatic esophageal cancer candidate for neoadjuvant chemoradiotherapy. Patients were randomly assigned to the chemoradiotherapy-only arm or chemoradiotherapy plus enoxaparin arm using 1:1 allocation. Radiotherapy was delivered in 1.8-Gy daily fractions to a dose of 50.4 Gy in both groups. Paclitaxel 50 mg/m2 and carboplatin (AUC 2) were administered weekly, concurrent with radiotherapy. In the intervention group, patients received enoxaparin (40 mg) and chemoradiation daily. 4-6 weeks after treatment, all patients underwent esophagectomy. After a median follow up of 7 months, estimated 1 year disease-free survival (DFS) in the intervention group was 78.9% and was 70% in the control groups ( p = 0.5). Toxicity from the experimental treatment was minimal, and there were no treatment-related deaths. A pathologically complete response in intervention and control group was 64.8% and 62.5%, respectively ( p = 0.9). There was a nonsignificant trend toward improved survival by the addition of enoxaparin to the concurrent chemoradiotherapy regimen. However, 1 y DFS of both groups were high as expected. A longer follow-up and a larger sample size are required.

The aim of this prospective and blind clinical trial was to assess the effectiveness of sealing localized marginal defects of amalgam restoration that were initially scheduled to be replaced. A cohort of twenty six patients with 60 amalgam restorations (n=44Class I and n=16Class II), that presented marginal defects deviating from ideal (Bravo) according to USPHS criteria, were assigned to either sealing or replacement groups: A: sealing n=20, Replacement n=20, and no treatment (n=20). Two blind examiners evaluated the restorations at baseline (K=0.74) and after ten years (K=0.84) according with USPHS criteria, in four parameters: marginal adaptation (MA), secondary caries (SC), marginal staining (MS) and teeth sensitivity (TS). Multiple comparison of restorations degradation/upgrade was analyzed by Friedman test and the comparisons within groups were performed by Wilcoxon test. After 10 years, 44 restorations were assessed (73.3%), Group A: n=14 and Group B: n=16; and Group C: n=14 sealing and replacement amalgam restorations presented similar level of quality in MA (p=0.76), SC (p=0.25) and TS (p=0.52), while in MS (p=0.007) presented better performance in replacement group after 10-years. Most of the occlusal amalgam restorations with marginal gaps showed similar long term outcomes than the restorations were sealed, replaced, or not treated over a 10-year period. Most of the restorations of the three groups were clinically acceptable, under the studied parameters. All restorations had the tendency to present downgrade/deterioration over time.

BACKGROUND: Multicentre radiotherapy clinical trials can incorporate quality assurance (QA) procedures for ensuring consistent application of the trial protocol in the planning, delivery and reporting of participant treatments. Subsequently detected variations from trial protocol have previously been shown to reduce treatment efficacy, although little has been shown for toxicity rates. The purpose of this study was to investigate the association of QA measures and protocol variations on toxicity incidence in the context of a prostate radiotherapy trial.
METHODS: Using QA records from the TROG 03.04 RADAR trial, the impact of variations on gastrointestinal (GI) and genito-urinary (GU) toxicities was investigated.
RESULTS: Protocol variation rates were lower than reported in previous studies, and showed little correlation with GI toxicity outcomes. Variations classified as \'major\' showed a non-significant trend for increased toxicity relative to those classified as \'minor\'. Results from a Level III phantom-based dosimetry study showed some correlation with GI toxicity, whereas ranking on a set-up accuracy study did not impact on toxicity. Toxicity in general increased with the number of participants accrued per centre, at odds with previous reports relating to disease progression, with a potential link to increases in low-mid-range rectal doses in the cohort from higher-accruing centres. No QA-related variables correlated with GU toxicities.
CONCLUSIONS: Besides non-significant trends, minimal association was observed between QA variables and toxicity rates for the RADAR trial. The intention of the trial\'s QA programme was to reduce treatment variations and minimise toxicity in the context of a relevantly advanced treatment approach.