Completion Of Treatment Research Articles

Effect of leech therapy in dermatophytosis: A randomized standard controlled trial

Background and purposeIn Unani medicine leech therapy is used as analgesic and resolvent purposes. The saliva of leech contains various biological substances like Hirudin, hyaluronidase, vasodilators, anesthetics, antibacterial, fibrinases, collagenase etc. To compare the efficacy of Leech therapy with local antifungal clotrimazole (1 %) cream in dermatophytosis on long term basis. Material and methodsA randomized, standard controlled, open labeled, clinical study was conducted on 40 patients of dermatophytosis, aged 18–60 years, and were randomly assigned into two groups; 20 patients in test group and 20 in control group. Patients were diagnosed clinically and confirmed through KOH examination. Complete haemogram, bleeding and clotting times, random blood sugar, HIV I & II, and HBsAg tests were carried out before starting the therapy, while haemogram was repeated after completion of treatment too. In test group, five sittings of leech therapy were applied, with intervals of one week. The control group was given clotrimazole (1 %) cream for topical application twice daily, continuously for a period of 28 days. Post-treatment follow-ups were done on 35th day in person, and then over the phone on 45th, 60th, and 90th days. Data were collected using Signs and Symptoms Severity Score for study, and Visual Analogue Scale (VAS). After completion of trial, appropriate tests were applied for statistical analysis of data. ResultsThe study shows, in most of the parameters, statically significant therapeutic effect in both the groups (p<0.001). No patients of either group reported any adverse event throughout the trial. Conclusionit appeared that leech therapy can contribute significantly in treating dermatophytosis (Qūbā) without any adverse effect, and with prolonged efficacy compared to standard treatment.

Carcinoma buccal mucosa with cutaneous metastasis: An unusual presentation

Head-and-neck cancer is a common cancer in India. Oral cavity cancer accounts for 50% of all head and neck sites. The most common sites of distant metastasis are the lung, liver, and bone. The incidence of cutaneous metastasis is a very rare site. We report a case of early-stage carcinoma buccal mucosa post-surgery and adjuvant radiotherapy developed skin metastasis shortly after completion of treatment. A 37-year-old female non-smoker, non-alcoholic diagnosed with early-stage carcinoma right buccal mucosa cT1N0M0. She underwent surgery of wide local excision with marginal mandibulectomy and extended supra-omohyoid neck dissection. In post-surgery, the histopathological report was moderately differentiated squamous cell carcinoma, pT2N1Mx. She completed her adjuvant radiotherapy 59.4Gy/33 fractions with six cycles of concurrent chemotherapy cisplatin 40 mg/m2. She developed difficulty in swallowing, increased oral secretions, and thickening over right-sided scar marks shortly after 10 weeks of completion of treatment. Rapidly, she developed multiple cutaneous nodules over both sides of the entire face and neck. Dermal biopsy reveals metastatic squamous cell carcinoma. Skin metastasis from head-and-neck malignancy is an uncommon entity and in the early stage, it is very rare. Initially, it is difficult to diagnose as it looks like some disseminated bacterial or fungal infection but we should always keep in mind this entity as cancer can metastasize and present in any atypical forms.

Management of traumatic scalp arteriovenous fistula: Case report and literature review.

Blunt traumatic arteriovenous fistula (AVF) of scalp, are uncommon and most of them can be secured by simple embolization or surgical ligation of the feeders. Our goal in writing this paper is to show patients with traumatic scalp AVFs how to prevent complications and the likelihood of recurrence. Complete treatment and reduce the recurrence rate of traumatic AVF on the scalp. Traumatic scalp AVF. Transarterial embolization and surgical resection. Complete resection of the AVF and subsequent angiography showed resolution of the contralateral lesion. Combination of endovascular embolization with subsequent surgical removal may reduce intraoperative blood loss compared with surgery alone. In addition, a well-designed scalp flap can be performed based on the angiography findings after embolization.

Delivering therapy over telephone in a humanitarian setting: a pilot randomized controlled trial of common elements treatment approach (CETA) with Syrian refugee children in Lebanon

BackgroundIn recent years, the number of forcibly displaced persons has risen worldwide, with approximately 40% being children and adolescents. Most of them are hosted in low- and middle-income countries (LMICs). Many individuals meet the criteria for mental health issues, which can also be exacerbated by a number of risk factors, including low socioeconomic status, displacement, and stressors linked to conflicts in their country or region of origin. However, the vast majority never receive treatment for their psychological problems due to multiple reasons, including a shortage of mental health professionals in LIMCs, transportation challenges in accessing clinics, and clinic hours conflicting with family commitments. In the current study we investigated whether individual psychotherapy delivered by trained lay counsellors over telephone to Syrian refugee children living in Lebanon is effective and overcomes barriers to treatment access.MethodsAfter adaptation of Common Elements Treatment Approach (CETA) to remote delivery over telephone (t-CETA), preliminary effectiveness of the treatment modality was assessed with a pilot single blind randomised controlled trial including a total sample of 20 refugee children with diagnosed mental health problems. Data was analysed applying a Bayesian approach.ResultsThere was a significant session-by-session decrease in self-reported mental health symptoms over the course of treatment. Independent assessments showed that t-CETA resulted in a greater reduction of symptoms than standard in-person treatment as usual. There was no difference between groups for impairment. Importantly, the majority of children allocated to t-CETA completed treatment whilst no children in the treatment as usual condition were able to do so.ConclusionThe study provides preliminary evidence that telephone-delivered psychotherapy in a humanitarian setting, delivered by lay counsellors under supervision, works and significantly increases access to treatment compared to traditional in-person treatment. However, findings remain to be replicated in larger trials.Trial RegistrationClinical Trials. gov ID: NCT03887312; registered 22nd March 2019.

Feasibility, Safety, and Factors Predicting Completion of CROSS Protocol–Based Neoadjuvant Chemoradiotherapy for Esophageal Squamous Carcinoma: Experience from an Indian Tertiary Care Cancer Center

Background Neoadjuvant chemoradiotherapy (NACRT) using the ChemoRadiotherapy for Oesophageal cancer followed by Surgery Study (CROSS) protocol has improved esophageal cancer outcomes. This study reports the real-world experience of the CROSS regimen for esophageal squamous cell carcinoma (ESCC) regarding its feasibility, safety, and predictors of treatment completion from an Indian tertiary center. Methodology A retrospective review was conducted for patients with ESCC receiving CROSS (radiation dose: 41.4 Gy) or a modified CROSS (mCROSS; radiation dose: 45 Gy) protocol NACRT between 2015 and 2022. We studied the treatment tolerability, factors predicting NACRT completion, and the effect of completion of its chemotherapy component on the pathological outcomes. Results Of the109 patients (68.8% males; mean age, 56 ± 9 years; Charlson's comorbidity index [CCI] &gt;2, 19.3%; stage III–IVA, 58%; mean tumor length, 5.5 ± 2.1cm; CROSS, 70.6%; mCROSS, 29.4%), all except 4 completed radiotherapy but only 58 (53.2%) patients completed ≥4 cycles of chemotherapy. Forty-nine patients belonged to the “extended” CROSS trial inclusion criteria. Among the 60 patients who fulfilled the CROSS inclusion criteria, only 51.7% were able to complete ≥4 chemotherapy cycles. The commonest reason for noncompletion of chemotherapy was the occurrence of neutropenia (60.8%). Pretreatment hemoglobin (≥12 vs. &lt;12 g%; odds ratio [OR]: 2.76; 95% confidence interval [CI]: 1.10–6.96; p = 0.031), a low CCI (≤2 vs. &gt;2; OR: 2.98; 95% CI: 1.02–8.73; p = 0.047), and radiation therapy techniques (conformal vs. conventional; OR: 3.29; 95% CI: 1.14–9.50; p = 0.028) were associated with completion of chemotherapy (≥4 cycles). Although there was a trend toward improved R0 resection (95.7 vs. 91.4%), reduced node positivity (17.0 vs. 31.4%), and a high pCR (57.4 vs. 48.6%) in patients completing chemotherapy (≥4 cycles) compared with those not completing chemotherapy (&lt;4 cycles), these differences were statistically nonsignificant. Conclusion In this study, ESCC patients receiving the CROSS protocol NACRT could complete their radiotherapy component, but a significant proportion exhibited poor chemotherapy tolerance. Neutropenia was a major factor limiting chemotherapy delivery, but anemia, high CCI, and conventional radiation techniques were also associated with noncompletion of chemotherapy. The omission of a few chemotherapy cycles had no significant effect on the pathological response; however, its impact on cancer survival requires further evaluation.

Tolerability and Safety of Miltefosine for the Treatment of Cutaneous Leishmaniasis.

Miltefosine, an orally administered drug, is an important component of the therapeutic arsenal against visceral and mucosal forms of leishmaniasis. However, data regarding the safety and tolerability of miltefosine treatment for cutaneous leishmaniasis (CL) are relatively limited. The aim of this study was to evaluate the tolerability, safety, and adverse events (AEs) of miltefosine treatment in patients with CL. In this cohort study, we reviewed the medical records of all miltefosine-treated patients between 1 January 2016 and 31 December 2022, at Israel Defense Forces military dermatology clinics and the dermatology and Tropical Medicine Clinics at Chaim Sheba Medical Center, Ramat-Gan, Israel. A total of 68 patients (54 males, 79%) with a median age of 30.3 ± 15.6 years (range: 18-88) were included in this study. Leishmania species were identified as L. major (n = 37, 54.4%), L. tropica (n = 12, 17.6%), L. braziliensis (n = 18, 26.5%), and L. infantum (n = 1, 1.5%) using polymerase chain reaction (PCR). Miltefosine tablets were administered orally at a dose of 50 mg, three times daily, for 28 days. Overall, 44 patients (65%) completed the 28-day treatment, and the remaining patients required dose reduction or early discontinuation of treatment. AEs (of any degree) were common, reported in 91% of patients. Both previously reported and previously unreported AEs were documented. Gastrointestinal symptoms (66.1%) and malaise (23.5%) typically occurred during the first two weeks of treatment and tended to subside. Other AEs, including acute renal failure (20.6%), sudden and severe pleuritic chest pain (7.6%), acne exacerbation (11.8%), suppuration of CL lesions (17.8%), and AEs related to the male genitourinary system (39.6% of males), typically occurred towards the end of treatment. The latter included testicular pain, epididymitis, diminution or complete absence of ejaculate, inability to orgasm, and impotence. Severe AEs necessitated treatment discontinuation (29.4%) or hospitalization (10.3%). URTI-like symptoms, arthritis, cutaneous eruption, pruritus, and laboratory abnormalities were also observed. Overall, the cure rate (for all patients combined) evaluated 3 months after the completion of treatment was 60%. The tolerability of miltefosine treatment for CL is low. Close clinical and laboratory monitoring is required during treatment, as severe AEs are not uncommon. As new insights regarding its toxicities emerge, further studies are required to define the role of miltefosine in the treatment of CL.

Racial disparities in receipt of radiation and brachytherapy in cervical cancer patients: Do they exist in a SEER-Medicare population?

ObjectivesTo evaluate if race is associated with disparities in receipt of radiation (RT) and outcomes for Medicare patients with cervical cancer who are candidates for primary radiation-chemotherapy. MethodsThis SEER-Medicare retrospective study included White and Black patients with stage IB1 through IVA squamous cell carcinoma or adenocarcinoma diagnosed 2000–2017 who were candidates for primary radiation-chemotherapy. Receipt of treatment by race and associated cancer specific (CSS) and overall survival (OS) outcomes were analyzed using frequency distributions, chi squared, log rank, multivariable Cox proportional-hazards models, and multivariable logistic models. Results1038 patients (84.9 % White and 15.1 % Black) were included. 825 (79.5 %) received RT, and 601 (57.9 %) received brachytherapy (BT). Blacks were more likely to undergo RT than Whites (86.0 % vs. 78.3 %, p = 0.028) and had similar rates of BT (58.0 % vs. 57.9 %, p = 0.986). Median RT duration was 64.0 days (IQR 52.0, 75.0), and 276 (33.5 %) completed treatment in ≤ 56 days, with no differences by race (p = 0.488, 0.303, respectively). BT was more frequently provided at larger hospitals, National Cancer Institute-designated cancer centers, and teaching hospitals. When adjusted for covariates, no significant differences in RT, BT, or RT duration by race were identified. Median unadjusted OS was 3.58 years (95 % CI 2.92, 4.42) for White patients and 2.50 years (95 % CI 2.0, 5.25) for Black patients, with no differences in OS (HR 0.93, 95 % CI 0.75, 1.13) or CSS (HR 1.13, 95 %CI 0.86, 1.43). ConclusionsBlack Medicare patients with cervical cancer had greater receipt of RT than White patients, similar rates of BT, and no difference in survival.

Extracellular vesicle and CRISPR gene therapy: Current applications in Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis, and Huntington's disease.

Neurodegenerative diseases are characterized by progressive deterioration of the nervous system. Alzheimer's disease (AD), Parkinson's disease (PD), amyotrophic lateral sclerosis (ALS), and Huntington's disease (HD) are prominently life-threatening examples of neurodegenerative diseases. The complexity of the pathophysiology in neurodegenerative diseases causes difficulties in diagnosing. Although the drugs temporarily help to correct specific symptoms including memory loss and degeneration, a complete treatment has not been found yet. New therapeutic approaches have been developed to understand and treat the underlying pathogenesis of neurodegenerative diseases. With this purpose, clustered-regularly interspaced short palindromic repeats/CRISPR-associated protein (CRISPR/Cas) technology has recently suggested a new treatment option. Editing of the genome is carried out by insertion and deletion processes on DNA. Safe delivery of the CRISPR/Cas system to the targeted cells without affecting surrounding cells is frequently investigated. Extracellular vesicles (EVs), that is exosomes, have recently been used in CRISPR/Cas studies. In this review, CRISPR/Cas and EV approaches used for diagnosis and/or treatment in AD, PD, ALS, and HD are reviewed. CRISPR/Cas and EV technologies, which stand out as new therapeutic approaches, may offer a definitive treatment option in neurodegenerative diseases.

Lubricant Strategies in Osteoarthritis Treatment: Transitioning from Natural Lubricants to Drug Delivery Particles with Lubricant Properties.

Osteoarthritis (OA) is a debilitating joint disease characterized by cartilage degradation, leading to pain and functional impairment. A key contributor to OA progression is the decline in cartilage lubrication. In physiological conditions, synovial fluid (SF) macromolecules like hyaluronic acid (HA), phospholipids, and lubricin play a crucial role in the boundary lubrication of articular cartilage. In early OA, cartilage damage triggers inflammation, altering SF composition and compromising the lubrication layer. This increases friction between mating interfaces, worsening cartilage degradation and local inflammation. Therefore, early-stage restoration of lubrication (by injecting in the joint different classes of compounds and formulations) could alleviate, and potentially reverse, OA progression. In the light of this, a broad variety of lubricants have been investigated for their ability to reduce friction in OA joints and promote cartilage repair in clinical and preclinical studies. This review examines recent advancements in lubricant-based therapy for OA, focusing on natural, bioinspired, and alternative products. Starting from the currently applied therapy, mainly based on natural lubricants as HA, we will present their modified versions, either in hydrogel form or with specific biomimetic moieties with the aim of reducing their clearance from the joint and of enhancing their lubricating properties. Finally, the most advanced and recent formulation, represented by alternative strategies, will be proposed. Particular emphasis will be placed on those ones involving new types of hydrogels, microparticles, nanoparticles, and liposomes, which are currently under investigation in preclinical studies. The potential application of particles and liposomes could foster the transition from natural lubricants to Drug Delivery Systems (DDSs) with lubricant features; transition which could provide more complete OA treatments, by simultaneously providing lubrication replacement and sustained release of different payloads and active agents directly at the joint level. Within each category, we will examine relevant preclinical studies, highlighting challenges and future prospects.

The biblical teaching on the gift of life

Just as this document ‘does not intend to present the Church's entire teaching on the dignity of unborn life and procreation’ (cf. Foreword), so the present biblical-theological reflection does not intend to present a complete and exhaustive treatment of the biblical foundations and the theological implications of the subject matter discussed here and the solutions formulated.

Financial incentives to increase engagement across the hepatitis C care cascade among people at risk of or diagnosed with hepatitis C: A systematic review

BackgroundReversing declining rates of people initiating and completing hepatitis C (HCV) treatment, observed in many countries, is needed to achieve global HCV elimination goals. Providing financial incentives to increase HCV testing and treatment uptake among people at-risk of or living with HCV infection could be an effective intervention. We conducted a systematic review to assess evidence regarding the effectiveness of financial incentives to improve engagement and progression through the HCV care cascade. MethodsWe searched MEDLINE, PubMed and EMBASE for studies published from January 2013 to January 2023 that evaluated financial incentives offered to people living with and at-risk of HCV to increase HCV antibody and or RNA testing, linkage to care, treatment initiation, treatment adherence, treatment completion, and sustained viral load (SVR) testing. Open-label randomised controlled trials (RCTs), controlled non-randomised studies, cohort or observation studies and mixed-methods studies were included, whereas literature reviews, case series and studies which did not report data were excluded. ResultsWe identified 1,278 studies, with 21 included after full-text screening (14,913 participants); three randomised controlled trials and 18 non-randomised studies. Studies evaluated incentives aimed at improving test uptake (n = 11), engagement in care (n = 13), treatment initiation (n = 8), adherence (n = 3), completion (n = 3) and attainment of SVR (n = 5). Findings provided inconclusive evidence for the effectiveness of incentives in improving engagement in the HCV cascade of care. Determining incentive effectiveness to improve care cascade engagement was limited by low quality study designs, heterogeneity in type (cash or voucher), value (US$5 to $600) and cascade stage being incentivised. No randomised controlled trials assessed the effectiveness of incentives to promote HCV testing, and none showed an impact on treatment uptake. In non-randomised studies (observational comparative), some evidence suggested that incentives promoted HCV testing, but evidence of their role in promoting linkage to care, HCV treatment adherence and treatment completion were mixed. ConclusionCurrently, there lacks high-quality evidence evaluating whether financial incentives improve HCV testing and treatment outcomes. Future research should seek to standardise methodologies, compare incentive types and values to enhance engagement in HCV care, and determine factors that support incentives effectiveness.

Evaluating the Impact of Post-Esophagectomy Exercise on 2- and 5-Year Survival: Findings from the PERFECT Trial.

Despite recent treatment advances, esophageal cancer still has poor survival and a high morbidity. Exploratory evidence suggests that exercise can reduce cancer-related mortality and recurrence rates. Here, we investigated the effects of an exercise intervention in the first year after esophagectomy on survival in participants of the Physical ExeRcise Following Esophageal Cancer Treatment (PERFECT)-trial. In the PERFECT-trial, esophageal cancer patients who had undergone esophagectomy were randomized to a 12-week exercise program (EX) or the control group (CG). We assessed 2- and 5-year (progression-free) survival. (Un)adjusted Cox Proportional-Hazards models were used to calculate hazard ratios (HRs) for comparison between the trial arms. Sensitivity analyses, excluding patients with events within the exercise intervention period, were performed. In total, 120 participants (EX = 61; CG = 59) were included in the PERFECT-trial. After 2-year follow-up, no significant difference in the risk of death or progression between EX and CG was found (adjusted HR = 1.65, 95% CI [0.75-3.63] and 1.38, 95% CI [0.76-2.50], respectively). After excluding patients with events during the intervention period (EX = 8; CG = 4), 2-year HRs for death (1.03, 95% CI [0.41-2.56]) and progression (1.26, 95% CI [0.64-2.48]) both decreased and remained insignificant. No significant effects were found on 5-year mortality (1.03, 95% CI [0.57-1.84]) and progression (1.21, 95% CI [0.72-2.04]) either. Sensitivity-analysis resulted in attenuated 5-year HRs for mortality (0.82, 95% CI [0.42-1.58]) and progression (1.08, 95% CI [0.61-1.92]). The results indicate no benefit of a 12-week exercise program in the first year post-esophagectomy on 2- and 5-year (progression-free) survival in esophageal cancer patients. The absence of beneficial effects may be explained by the relatively short exercise program, which was performed after treatment completion.

Anthropometric recovery of children 6-59 months with complicated severe acute malnutrition, treated in public hospitals of Sana’a City

Background: The management of severe acute malnutrition (SAM) in inpatient therapeutic feeding centers (TFCs) is a life-saving intervention for children 6-59 months in Yemen. Aims: To evaluate the anthropometric recovery of children admitted to the TFCs and transferred to complete treatment in outpatient programs (OTPs) of Sana’a City Public Hospitals. Methods: A prospective follow-up study for children admitted to TFCs from September 2023 to April 2024 was conducted. The anthropometry measurements of the Weight-for-Height Z score (WHZ) and Mid-Upper Arm Circumference (MUAC) were calculated and used to follow the progression in recovery until the discharge from OTPs. Results: Of the total 150 children admitted to TFCs, 48 (32%) were males, and 75 (50%) were aged 6-&lt;12 months; 99 (66%) had both WHZ &lt;-3 and MUAC &lt;11.5); 25 (17%) had WHZ &lt;-3; and 26 (17%) had MUAC&lt;11.5 cm. At the point of transfer from TFCs, 72% (108) were with SAM, and 28% (42/150) with Moderate Acute Malnutrition (MAM). At discharge from OTP, 19% (28/150) were with non-acute malnutrition (NAM); the progression to NAM was among 48% (20/42) and 7% (8/108) of children transferred with MAM and SAM, P value (&lt;0.001). In conclusion, 88% (132/150) of children transferred from TFCs were discharged as cured from OTP, 21% (28/132) of them were anthropometrically recovered, and 79% were prematurely discharged.

Exploring the Utility of High-Resolution Ultrasonography and Color Doppler of Peripheral Nerves in Monitoring Response to Treatment in Leprosy Patients: A Prospective, Observational Study.

Diagnosis and monitoring of nerve function impairment (NFI) presents an ongoing challenge in global leprosy control. This was a prospective, observational study in leprosy patients receiving treatment with cutaneous and neurological examinations done every 3 months for 1 year. High-resolution ultrasonography and color Doppler (HRUS-CD) was performed in all patients at baseline, completion of treatment, and anytime during the study period if a patient had deterioration of nerve function noted clinically. All peripheral nerves were assessed, and parameters studied were cross-sectional area (CSA), length of thickening, endoneural flow signals (ENFS), and distortion in fascicular symmetry. Of 54 treatment-naive leprosy patients, loss of sensation was noted in 37 (68.5%), paresthesia in 20 (37.0%), and neuropathic pain in 7 (12.9%) at baseline presentation. At end of treatment of leprosy, maximum improvement in NFI across all clinical criteria was seen in ulnar and radial nerves (P <0.05). The number of impairments on HRUS-CD decreased consistently, significantly for ulnar (P = 0.009 right ulnar, P = 0.012 left ulnar) and right radial (P = 0.025) nerves, and significant improvements in CSA and ENFS were seen across multiple nerves, which correlated with improvement in NFI as well. Abnormal HRUS-CD findings in the target nerves were significantly associated with multibacillary cases (odds ratio [OR]: 4.33; 95% CI: 0.62-30.31), those in reaction (OR: 9.42; 95% CI: 1.51-58.66), and those older than 40 years (OR: 3.14; 95% CI: 0.49-19.93). This study provides objective evidence of improvement in NFI with anti-leprosy treatment, supporting integration of HRUS-CD imaging in monitoring nerve involvement in leprosy.

Simultaneous labial and lingual augmented corticotomy assisted presurgical orthodontics in class III patients: the morphological aspects of the mandibular anterior ridge with cone-beam computed tomography

ObjectivesThis study aims to investigate the changes in alveolar bone following the simultaneous performance of labial and lingual augmented corticotomy (LLAC) in patients with insufficient alveolar bone thickness on both the labial and lingual sides of the mandibular anterior teeth during presurgical orthodontic treatment.Materials and methodsThirth-five surgical patients with skeletal Class III malocclusion were included: 19 (LLAC group) accepted LLAC surgery during presurgical orthodontic treatment, and 16 (non-surgery group, NS) accepted traditional presurgical orthodontic treatment. Cone-beam computed tomography (CBCT) scans were obtained before treatment (T0) and at the completion of presurgical orthodontic treatment (T1). The amount of vertical alveolar bone and contour area of the alveolar bone in the labial and lingual sides of mandibular incisors were measured.ResultsAfter presurgical orthodontic treatment, the contour area of the alveolar bone at each level on the lingual side and alveolar bone level on both sides decreased significantly in the NS group (P < 0.001). However, the labial and lingual bone contour area at each level and bone level increased significantly in the LLAC group (P < 0.001). The bone formation rate in the lingual apical region was the highest, significantly different from other sites (P < 0.001).ConclusionsDuring presurgical orthodontic treatment, LLAC can significantly increase the contour area of the labio-lingual alveolar bone in the mandibular anterior teeth to facilitate safe and effective orthodontic decompensation in skeletal Class III patients.Clinical relevance: This surgery has positive clinical significance in patients lacking bone thickness (< 0.5 mm) in the labial and lingual sides of the lower incisors.

Lean-Based Approach to Improve Emergency Department Throughput.

Objective:Lean methodology can be utilized to increase throughput in a fast-track care area without changing staffing in a busy, urban emergency department (ED). Methods: A retrospective before-and-after analysis was performed to an improvement process in a fast-track care area within an ED with a census of 100,000 patients. The intervention utilized Lean methodologies to identify inefficiencies in the throughput model set for patients triaged to fast-track. Multiple ED stakeholders were involved in formulating a more efficient framework for how patients would receive care when triaged to fast-track. Results: There was a decline in the patient's overall length of stay (-9%, p=0.08), arrival to the room (-10%, p=0.4418), and ED attending to disposition (-9%, p=0.003). Additionally, all aspects of patients leaving prior to treatment completion (against medical advice (-29.4%, p=0.006), elopement (-20.4%, p=0.049), and left without being seen (-5.3%, p=0.11)) declined. Discussion:Identifying wasted time and resources in a patient's stay in the ED allowed for a more efficient throughput model to be developed. This resulted in patients being able to be seen in a more methodical manner leading to decreased wait times and lower left without being seen rates. Conclusion: A Lean-based throughput model was implemented to improve efficiency, reducing the length of stay and increasing the volume of patients evaluated per shift without additional costs. This improvement led to fewer patients leaving before treatment and demonstrated the value of process improvement in healthcare.

Factors influencing hospital readmission rates in alcohol use disorder

According to data from the Federal Statistical Office, the diagnosis of alcohol use disorder (AUD) (F10) is the second most common main diagnosis for hospital treatment. Those affected by this disorder are often repeatedly hospitalized at short intervals due to relapses; however, little is known about the factors that influence readmission rates after initial treatment. The aim of this retrospective analysis is to analyze the effects of treatment type (qualified withdrawal treatment(QE) versus physical detoxification) and discharge mode on the probability of readmission in alcohol-dependent patients after inpatient treatment. Data from 981 male and female alcohol-dependent patients who completed either qualified withdrawal treatment (QE) (68% men; mean age47.6 years) or inpatient detoxification (74% men; mean age48.0 years) were analyzed. Predictors of regular discharge were determined separately for both types of treatment using stepwise logistic regression. Patients who had completed aqualified withdrawal treatment were significantly more likely to be regularly discharged. Regular completion of the qualified withdrawal treatment (QE) led to arelative reduction in the readmission rate of 25.64% within 1 year compared to aphysical detoxification. In order to prevent readmission and chronic courses of alcohol use disorder (AUD), qualified withdrawal treatment should always be recommended to affected patients instead of physical detoxification. Aktuelle Daten des Statistischen Bundesamtes für das Jahr 2022 zeigen, dass die Diagnose "Psychische und Verhaltensstörungen durch Alkohol (F10.X)" die zweithäufigste Hauptdiagnose bei Krankenhausbehandlungen darstellt [13]. Im Gesundheitssystem entstehen durch dieses Erkrankungsbild und seine somatischen und psychischen Folgeerkrankungen jährlich ca.10 Mrd. € direkte Kosten [13]. Dieser Sachverhalt wird dadurch kontrastiert, dass die Krankenkassen die qualifizierte Entzugsbehandlung (QE) als leitliniengerechte Goldstandardtherapie [4] wiederholt infrage stellen [10].

Trajectories of Change in Parent–Child Interaction Therapy Outcomes in Latinx Families: Implications for Cultural Adaptation

ABSTRACT Objective Parent–Child Interaction Therapy (PCIT) is a parenting program in which caregivers must achieve “skill criteria” in using Do Skills and avoiding Don’t Skills to complete treatment. Despite PCIT’s emphasis on these skills, little is known about how Latinx caregivers acquire these Western-based parenting practices and whether cultural mismatches lead to inequities in outcomes. This study compared the trajectories of change in PCIT skills and treatment outcomes of Latinx and non-Latinx White families. Method We analyzed weekly treatment data from 64 families (20.3% Spanish-speaking Latinx, 51.6% English-speaking Latinx, 28.1% non-Latinx White) served in community clinics. Caregivers were mostly females (95.3%), on average 35.13 years old, and lived in poverty (77.6%). PCIT skills were coded using the Dyadic Parent–Child Interaction Coding System, and child behavior problems were reported using the Eyberg Child Behavior Inventory. Results Latinx and non-Latinx White caregivers acquired Do Skills similarly during treatment. In contrast, some Latinx caregivers began treatment using significantly more Don’t Skills and needed more sessions to achieve some aspects of PCIT skill criteria compared with non-Latinx White caregivers. Latinx families also experienced similar or even more pronounced reductions in child behavior problems than non-Latinx White families. There were no significant differences in the percentage of caregivers who achieved PCIT skill criteria or left treatment prematurely. Conclusions This study provides evidence that strictly defined PCIT skill criteria may lead to inequities in treatment length for some Latinx families. Informed by these findings, we propose data-driven adaptations to improve the cultural fit of PCIT for Latinx groups.

Clinical implementation and evaluation of stereotactic liver radiotherapy in inspiration breath-hold using nasal high flow therapy and surface guidance.

To evaluate two years of clinical experience with markerless breath-hold liver stereotactic radiotherapy (SBRT) using non-invasive nasal high flow therapy (NHFT) for breath-hold prolonging and surface guidance (SGRT) for monitoring. Heated and humidified air was administered via a nasal cannula (40 L/min, 80% oxygen, 34 °C). Patients performed voluntary inspiration breath-holds with visual feedback. After a training session, 4-5 breath-hold CT scans were acquired to delineate an internal target volume (ITV) accounting for inter- and intra-breath-hold variations. Patients were treated in 3-8 fractions (7.5-20 Gy/fraction) using SGRT-controlled beam-hold. Patient setup was performed using SGRT and CBCT imaging. A post-treatment CBCT was acquired for evaluation purposes. Fifteen patients started the training session and received treatment, of whom 10 completed treatment in breath-hold. Half of all 60-second CBCT scans were acquired during a single breath-hold. The average maximum breath-hold duration during treatment ranged from 47-108 s. Breath-hold ITV was on average 6.5 cm³/30% larger (range: 1.1-23.9 cm³/5-95%) than the largest GTV. Free-breathing ITV based on 4DCT scans was on average 16.9 cm³/47% larger (range: -2.3-58.7 cm3/-16-157%) than the breath-hold ITV. The average 3D displacement vector of the area around PTV for the post-treatment CBCT scans was 5.0 mm (range: 0.7-12.9 mm). Liver SBRT in breath-hold using NHFT and SGRT is feasible for the majority of patients. An ITV reduction was observed compared to free-breathing treatments. To further decrease the PTV, internal anatomy-based breath-hold monitoring is desired. Non-invasive NHFT allows for prolonged breath-holding during surface-guided liver SBRT.

Abstract A004: A Phase 1B/2 trial of second line immunotherapy with pepinemab and avelumab for patients with metastatic pancreatic adenocarcinoma

Abstract Background: Pancreatic adenocarcinoma (PDAC) is a leading cause of cancer-related mortality with poor prognosis despite maximal therapy and is recalcitrant to approved immunotherapies. In PDAC, Semaphorin 4D (SEMA4D) expression is prognostic in patients who have undergone surgical resection and correlates with tumor infiltration of activated CD8+ T-cells. Furthermore, preclinical studies suggest that monoclonal blockade of SEMA4D supports CD8+T cells tumoral infiltration and activation, sensitizing PDAC to immune checkpoint blockade (ICB). Thus, we hypothesized that a humanized anti-SEMA4D antibody (pepinemab) may improve disease control and responsiveness to ICB in patients with PDAC. Methods: We designed a phase Ib/II single-arm clinical trial to evaluate the safety, tolerability, and efficacy of pepinemab with anti-PD-L1 (avelumab) in patients with chemotherapy-refractory PDAC (NCT05102721). The study follows a dose de-escalation schema starting at a dose combination of 20mg/kg pepinemab and 800mg avelumab every two weeks. Patient accrual for phase 1b utilizes the Bayesian Optimal Interval design targeting a dose-limiting toxicity rate of 30% or less. After 16 subjects receive a given combination dose, a Simon’s two stage assessment of futility will be undertaken with expansion to phase 2 if 2 or more subjects demonstrate response. Treatment response is assessed via RECIST 1.1 criteria with surveillance CT prior to enrollment and after completion of two cycles (8 weeks). Baseline and on-treatment tumor biopsies (after completion of one cycle, 4 weeks) are performed to analyze changes in immune, stromal, and genomic profiles to elucidate mechanisms of treatment response and failure. Patient reported outcomes are incorporated (FACT-Hep and FAACT subdomains) to assess disease-specific symptoms. Results: A total of 14 patients have been enrolled to date. Three subjects withdrew from the study prior to completing the evaluable period (four weeks of treatment) and nine subjects terminated treatment due to disease progression. Two subjects continue to receive combination treatment pending evaluation of tumor response. Baseline and on-treatment biopsies have been obtained and stored for correlative analysis from 8 evaluable subjects. One treatment-related adverse event occurred though the patient was able to complete treatment without further events. No treatment-related toxicities have been encountered. Conclusions: Combining pepinemab with avelumab appears to be safe and tolerable to date. Nine of eleven patients demonstrated disease progression, though 1 of these 9 demonstrated mixed response with some lesions showing radiologic partial and even complete response. Overall treatment response, survival data, and correlative science forthcoming. Citation Format: Luis I Ruffolo, Matthew Byrne, Bailey Hilty, Brian A Belt, Yatee Dave, Paul Burchard, Terrence Fisher, Elizabeth E. Evans, Crystal Mallow, Megan Boise, Darren Carpizo, Jen Jen Yeh, David C Linehan, Daniel Mulkerin. A Phase 1B/2 trial of second line immunotherapy with pepinemab and avelumab for patients with metastatic pancreatic adenocarcinoma [abstract]. In: Proceedings of the AACR Special Conference in Cancer Research: Advances in Pancreatic Cancer Research; 2024 Sep 15-18; Boston, MA. Philadelphia (PA): AACR; Cancer Res 2024;84(17 Suppl_2):Abstract nr A004.