Journal of Clinical Medicine

14 pages, 477 KiB

Open AccessReview

Screening of Anal HPV Precancerous Lesions: A Review after Last Recommendations

by Alessio Natale, Tullio Brunetti, Gionathan Orioni and Valeria Gaspari

J. Clin. Med. 2024, 13(17), 5246; https://doi.org/10.3390/jcm13175246 - 4 Sep 2024

Over the last decades, the incidence of anal cancer has increased worldwide. The discovery of the HPV virus as its primary cause and the natural progression of the disease, involving precancerous lesions, have resulted in significant interest in screening for anal cancer. The [...] Read more.

Over the last decades, the incidence of anal cancer has increased worldwide. The discovery of the HPV virus as its primary cause and the natural progression of the disease, involving precancerous lesions, have resulted in significant interest in screening for anal cancer. The use of cytology testing, high-risk HPV DNA research, high-resolution anoscopy, and their combination has been adopted with variable success in detecting anal HPV precancerous lesions. Various studies have been carried out to evaluate the sensitivity and specificity of these techniques in different populations. High-risk populations for developing anal cancer have been identified through study of incidence and prevalence. Therefore, different scientific societies and experts worldwide have provided different recommendations for screening, but a universal approach has not yet been established. The inhomogeneity of different risk groups, the variable accessibility to specifical techniques, and the lack of data regarding the cost–benefit ratio of screening are the main problems to address in order to define a consensus guideline acceptable worldwide. The purpose of this paper is to provide a comprehensive review of the literature on HPV precancerous lesions and its screening, particularly after the release of recent recommendations. Full article

(This article belongs to the Special Issue Human Papillomaviruses (HPV) Infection: How to Treat and Prevent?)

11 pages, 1253 KiB

Open AccessArticle

Association between Flexibility, Measured with the Back-Scratch Test, and the Odds of Oxytocin Administration during Labour and Caesarean Section

by Virginia A. Aparicio, Nuria Marín-Jiménez, Jose Castro-Piñero, Marta Flor-Alemany, Irene Coll-Risco and Laura Baena-García

J. Clin. Med. 2024, 13(17), 5245; https://doi.org/10.3390/jcm13175245 - 4 Sep 2024

Abstract

Objective: This study explored whether assessing flexibility levels in clinical settings might predict the odds of oxytocin administration and caesarean section to stimulate labour. Methods: Pregnant women from the GESTAFIT Project (n = 157), participated in this longitudinal study. Maternal upper-body flexibility was [...] Read more.

Objective: This study explored whether assessing flexibility levels in clinical settings might predict the odds of oxytocin administration and caesarean section to stimulate labour. Methods: Pregnant women from the GESTAFIT Project (n = 157), participated in this longitudinal study. Maternal upper-body flexibility was assessed at 16 gestational weeks (g.w.) through the Back-scratch test. Clinical data, including oxytocin administration and type of birth, were registered from obstetric medical records. Results: Pregnant women who required oxytocin administration or had caesarean sections showed lower flexibility scores (p < 0.05 and p < 0.01, respectively). The receiver operating characteristic curve analysis showed that the Back-scratch test was able to detect the need for oxytocin administration ((area under the curve [AUC] = 0.672 (95% confidence interval [CI]: 0.682 (95% CI: 0.59–0.78, p = 0.001)). The AUC to establish the ability of flexibility to discriminate between vaginal and caesarean section births was 0.672 (95% CI: 0.60–0.77, p = 0.002). A Back-scratch test worse than 4 centimetres was associated with a ~5 times greater increased odds ratio of requiring exogenous oxytocin administration (95% CI: 2.0–11.6, p = 0.001) and a ~4 times greater increased odds ratio of having a caesarean section (95% CI: 1.7–10.2, p = 0.002). Conclusions: These findings suggest that lower flexibility levels at the 16th g.w. discriminates between pregnant women who will require oxytocin and those who will not, and those with a greater risk of a caesarean section than those with a vaginal birth. Pregnant women below the proposed Back-scratch test cut-offs at 16th g.w. might specifically benefit from physical therapies that include flexibility training. Full article

(This article belongs to the Special Issue Clinical Risks and Perinatal Outcomes in Pregnancy and Childbirth)

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10 pages, 9375 KiB

Open AccessArticle

Feasibility and Safety of 3D-Navigated Trans-Sacral Bar Osteosynthesis for Fragility Fractures of the Sacrum: FIRST Clinical Experiences

by Stephan Regenbogen, Jan El Barbari, Sven Y. Vetter, Jochen Franke, Paul Alfred Grützner and Benedict Swartman

J. Clin. Med. 2024, 13(17), 5244; https://doi.org/10.3390/jcm13175244 - 4 Sep 2024

Abstract

Background: There has been an increasing number of fragility fractures of the sacrum in the recent decade. With rates of up to 28%, the complication rates after surgical treatment are still at an unacceptably high level, and new treatment strategies are urgently needed. [...] Read more.

Background: There has been an increasing number of fragility fractures of the sacrum in the recent decade. With rates of up to 28%, the complication rates after surgical treatment are still at an unacceptably high level, and new treatment strategies are urgently needed. Therefore, the purpose of this study was to evaluate the potential of 3D-navigated trans-sacral bar osteosynthesis in the surgical treatment of fragility fractures of the sacrum. Methods: Retrospectively, from 2017 to 2023, all cases with confirmed fragility fractures of the sacrum in patients > 65 years of age that were surgically treated with navigated 3D-navigated trans-sacral bar osteosynthesis were included, and epidemiological data and the course of treatment analyzed in comparison to a matched control group. Results: Finally, 21 patients (18 women and 3 men) were included in this study. The average age of the patients was 82.6 (SD 6.3) in the intervention group and 79.4 (SD 6.7) in the control group. There were postoperatively detected complications in two cases (18%) in the intervention group and in four cases (40%, p = 0.362) in the control group. The postoperative in-hospital stay was 10 days (SD 3.8) vs. 11.4 days (SD 3.8) in the control. None of the patients in the intervention group and two in the control group needed revision surgery. Conclusions: Overall, 3D-navigated trans-sacral bar osteosynthesis seems to be a promising technique, enabling an accurate implant positioning while offering a low complication rate with an excellent short-term outcome in elderly patients with fragility fractures of the sacrum. Full article

(This article belongs to the Special Issue Complex Orthopedic Trauma: Diagnosis, Treatment, Managing Complications and Rehabilitation)

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7 pages, 189 KiB

Open AccessCase Report

Anaphylactic Shock Caused by Eating Buckwheat

by Dan Orga-Dumitriu, Dana M. Harris and Corina Porr

J. Clin. Med. 2024, 13(17), 5243; https://doi.org/10.3390/jcm13175243 - 4 Sep 2024

Abstract

Background: Urticaria is a common disease with a marked influence on quality of life. The key cell involved is the mast cell, which can be activated by a vast variety of stimuli, and the major mediator is histamine. Allergic urticaria is a [...] Read more.

Background: Urticaria is a common disease with a marked influence on quality of life. The key cell involved is the mast cell, which can be activated by a vast variety of stimuli, and the major mediator is histamine. Allergic urticaria is a disorder with a large variety of causes: food, drugs, insect venom, skin contact with allergens, and physical exercise. Buckwheat consumption has increased in European countries and the USA because it is gluten-free. It can trigger anaphylactic shock if ingested, inhaled, or handled with the hands. Five common buckwheat allergens named Fag e1 to 5 (Fag e1, 2, and 3 are considered the major allergens) and two tartary buckwheat allergens named Fag t1 and Fag t2 have been described. Method: We present the case of a patient who experienced two anaphylactic shocks and in whom the etiological factor was buckwheat. The patient presented to the Allergology department for the evaluation of two episodes of severe allergic reactions that required emergency therapy, episodes that involved the loss of consciousness and were of major severity. At each anaphylactic shock, an ambulance was requested, and emergency therapy was administered, leading to the patient’s recovery within a few hours. Diagnosis: Since each episode occurred a few minutes after eating, the diagnosis was established based on a detailed anamnesis and prick skin tests, followed by specific IgE dosages. Other foods consumed by the patient, assessed by prick skin testing and specific IgE dosages of suspected foods, were excluded as the etiological cause. Increased levels of buckwheat-specific immunoglobulin E were highlighted, thus identifying the etiological agent. The treatment of anaphylactic shock was performed urgently by the ambulance crew with adrenaline, infusion solutions, cortisone preparations, and antihistamines. Result: Following the treatment that was initiated, there was a partial remission of the lesions after a few hours. Conclusions: Buckwheat allergy is rare, but it produces symptoms that affect the skin, gastrointestinal tract, and respiratory tract, as well as anaphylaxis. In a professional environment, it can trigger allergic rhinitis, asthma, and hives. Although buckwheat allergens have been described, their clinical relevance has only been studied in a small number cases. In current practice, the only commercially available allergen is Beech e2 per the ImmunoCAP ISAC microarray. Diagnosis can be difficult in clinical practice. This reported case suggests the need for a thorough anamnesis, since buckwheat is consumed as a hidden allergen, and in Europe, it is not necessary to label foods containing this allergen. Full article

(This article belongs to the Special Issue Advances in Allergic Diseases and Asthma: Clinical Insights and Emerging Therapies)

11 pages, 866 KiB

Open AccessArticle

Cyclosporin A as an Add-On Therapy to a Corticosteroid-Based Background Treatment in Patients with COVID-19: A Multicenter, Randomized Clinical Trial

by Lucía Llanos Jiménez, Beatriz Alvarez-Alvarez, Eva Fonseca Aizpuru, Germán Peces-Barba, Gloria Pindao Quesada, Mª Jesús Rodríguez Nieto, Francisco J. Ruiz-Hornillos, Luis Seijo Maceiras, Ignacio Robles Barrena, Alvaro Mena-de-Cea, Héctor Meijide-Míguez and Olga Sánchez-Pernaute

J. Clin. Med. 2024, 13(17), 5242; https://doi.org/10.3390/jcm13175242 - 4 Sep 2024

Abstract

Background: In susceptible hosts, SARS-CoV2-induced hyperinflammation accounts for an increased mortality. The search of adjuvant immunomodulatory therapies has been ongoing ever since the pandemic outbreak. Aim: Our purpose was to evaluate the efficacy of cyclosporin A (CsA) as an add-on therapy to [...] Read more.

Background: In susceptible hosts, SARS-CoV2-induced hyperinflammation accounts for an increased mortality. The search of adjuvant immunomodulatory therapies has been ongoing ever since the pandemic outbreak. Aim: Our purpose was to evaluate the efficacy of cyclosporin A (CsA) as an add-on therapy to the standard of care (SoC) in patients with severe COVID-19 pneumonia. Methods: We conducted a randomized clinical trial in patients admitted to eight Spanish tertiary hospitals. Patients were stratified into two severity categories and randomized in a 1:1 ratio to receive a corticosteroid-based standard therapy with or without CsA. The primary endpoint was FiO2 recovery by Day 12 without relapses. Results: 109 patients were included and randomized, and 98 of them considered for the mITT population (51 assigned to the CsA + SoC group and 47 to the SoC group). A total of 35 (68.6%) patients from the CsA + SoC group and 32 (71.1%) patients from the SoC group reached the primary endpoint in the mITT analysis. No differences were found after stratification into age groups, in the severity level at admission, or in a combination of both. Overall, the time to FiO2 normalization was 7.4 days vs. 7.9 days in the experimental and control groups, respectively. Global mortality was 8.2%. Severe adverse events were uncommon and equally distributed between arms. Conclusion: The addition of CsA did not show differences over a corticosteroid-based treatment in the clinical course of the included patients. A better identification of candidates who will benefit from receiving immunomodulatory drugs is necessary in future studies. Full article

(This article belongs to the Section Pulmonology)

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10 pages, 209 KiB

Open AccessArticle

An Evaluation of Skin and Immunological Responses after Using a Novel Cross-Linked Porcine-Based Dermal Injectable Collagen with Lidocaine for Nasolabial Fold Correction

by Hao-Chih Tai, Yi-Hua Liao, Ya-Ching Chang, Chin-Yi Yang, Shyue-Yih Horng, Yuan-Sung Kuo, Yi-Shuan Sheen, Yu-Huei Huang, Rosaline Chung-Yee Hui, Tim-Mo Chen, Yuan-Sheng Tzeng, Chih-Hsin Wang, Shou-Cheng Teng, Chun-Kai Oscar Chang and Chang-Yi Chou

J. Clin. Med. 2024, 13(17), 5241; https://doi.org/10.3390/jcm13175241 - 4 Sep 2024

Abstract

Background: Hypersensitivity to the new dermal injectable porcine-based collagen with lidocaine featuring a novel cross-linking technology (test filler) for nasolabial fold correction was compared to the commercially available traditional cross-linked dermal injectable porcine-based collagen with lidocaine (control filler). Methods: Recruited participants (n = [...] Read more.

Background: Hypersensitivity to the new dermal injectable porcine-based collagen with lidocaine featuring a novel cross-linking technology (test filler) for nasolabial fold correction was compared to the commercially available traditional cross-linked dermal injectable porcine-based collagen with lidocaine (control filler). Methods: Recruited participants (n = 279) received a single 0.1 mL intradermal injection of either test filler or control filler in the left forearm as a screening skin allergy test. Injection sites were assessed clinically at 24 h post-implant. Treatment was given to 252 successfully screened participants, and injection sites were monitored for 21 days. Immunological examinations were performed at screening and then at 4 and 24 weeks post-treatment. Observations for adverse events continued until the 52nd week. Results: Intradermal allergy testing results were negative for all the test recipients (0/124) and positive for two control recipients (2/132, 1.5%). Most of the participants exhibited no changes in serum immunoglobulin (IgG, IgM) and complement (C3, C4) levels. No serious adverse events related to the device were recorded. Most adverse events were common complications of dermal filler treatment and were related to the injection site. Most adverse effects were resolved or under control by 52 weeks. Conclusions: Hypersensitivity reactions with the test filler were lower than those with the control filler, validating the safe use of test filler for nasolabial fold correction without the need for pretreatment skin testing. Full article

(This article belongs to the Section Dermatology)

10 pages, 1063 KiB

Open AccessArticle

Uncovering the Differences: How DLQI and WHO-5 Scores Vary in Moderate-to-Severe Psoriasis Patients Treated with Tildrakizumab 100 mg vs. 200 mg?

by Emanuele Trovato, Martina Dragotto, Eugenio Capalbo, Alessandra Cartocci, Pietro Rubegni and Laura Calabrese

J. Clin. Med. 2024, 13(17), 5240; https://doi.org/10.3390/jcm13175240 - 4 Sep 2024

Abstract

Background/Objectives: Psoriasis (PsO) is a chronic inflammatory skin disease that severely impacts patients’ quality of life (QoL). Its global prevalence is about 2%, with significant regional variations. PsO manifests in the form of erythematous and scaly plaques, causing intense pruritus and discomfort and [...] Read more.

Background/Objectives: Psoriasis (PsO) is a chronic inflammatory skin disease that severely impacts patients’ quality of life (QoL). Its global prevalence is about 2%, with significant regional variations. PsO manifests in the form of erythematous and scaly plaques, causing intense pruritus and discomfort and limiting daily activities. The condition often includes comorbidities such as psoriatic arthritis, cardiovascular diseases, and metabolic syndrome, further deteriorating QoL. Psychological well-being is notably affected, with high levels of depression and anxiety due to the visible lesions, leading to social stigma and isolation. QoL indexes like WHO-QoL and SF-36 assess various well-being aspects, while patient-reported outcomes (PROs) provide a comprehensive understanding of PsO’s impact. However, there are no universally shared PROs in outpatient practice to fully understand the impact of the disease and associated therapies. This study aims to evaluate differences between DLQI and WHO-5 in adult patients with moderate-to-severe PsO treated with tildrakizumab 100 mg or 200 mg. Methods: The study was conducted at the University Hospital of Siena, Italy, from May 2023 to April 2024. Data from 15 patients treated with tildrakizumab 200 mg and 15 patients treated with tildrakizumab 100 mg, observed for at least 28 weeks, were recorded. Demographic data, PASI, DLQI, and WHO-5 scores were analyzed. Patients in the 100 mg group (G100) were selected to match the demographic characteristics of the 200 mg group (G200). Reduction rates of DLQI and WHO-5 were assessed at baseline values and after 4, 16, and 28 weeks. Results: Both groups experienced improvements in QoL. The group treated with 200 mg showed more pronounced and rapid reductions in DLQI and WHO-5 scores compared to the 100 mg group. WHO-5 demonstrated faster improvements in overall well-being than DLQI, indicating its greater sensitivity to changes in mental well-being and overall QoL. No differences in adverse events were observed between the two groups, with no major adverse events reported. Conclusions: In our study, WHO-5 proved more sensitive than DLQI in capturing well-being changes in PsO patients treated with tildrakizumab. However, a combined use of both WHO-5 and DLQI questionnaires should be encouraged in clinical practice. Furthermore, this study confirmed the superior QoL improvement associated with tildrakizumab 200 mg compared to 100 mg. Future research should explore the long-term impact on QoL and comparative effectiveness among other biologic therapies in diverse patient populations. Full article

(This article belongs to the Special Issue Targeted Treatment of Skin Inflammation)

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11 pages, 1254 KiB

Open AccessArticle

Clinical History of Patients with Hypertrophic Cardiomyopathy—How to Improve the Initiation Process of the Diagnosis?

by Dominika Bieczek, Adrianna Ściślicka, Agnieszka Adamiec, Aleksandra Cader, Monika Wandasiewicz, Bartosz Basiaga, Małgorzata Niemiec and Katarzyna Mizia-Stec

J. Clin. Med. 2024, 13(17), 5239; https://doi.org/10.3390/jcm13175239 - 4 Sep 2024

Abstract

Background: Regardless of genetic origin and recommended screening methods, hypertrophic cardiomyopathy (HCM) is commonly diagnosed late in the advanced stages of the disease. The aim of this study was to analyse the case history of patients with HCM in order to obtain [...] Read more.

Background: Regardless of genetic origin and recommended screening methods, hypertrophic cardiomyopathy (HCM) is commonly diagnosed late in the advanced stages of the disease. The aim of this study was to analyse the case history of patients with HCM in order to obtain an initiation of the diagnostic process. Methods: This study was a retrospective, tertiary, single-centre cohort analysis of 85 consecutive pts with HCM (mean age at the time of HCM diagnosis: 51 ± 15 years; F/M: 42/43) who were hospitalized during the period from 1 January 2013 to 31 December 2022. Type of referral to the hospital, the reason for hospitalization as well as accompanying symptoms, comorbidities, and family history were analysed to obtain an initiation of the diagnostic process. The analysis was limited to hospitalizations in which the diagnosis of HCM was stated for the first time. Results: An analysis of the type of referral to the hospital revealed the following data: 18% of patients were admitted as urgent hospitalizations (UHs) and 82% as elective hospitalizations (EHs). Among the UHs, the majority of patients were transferred from another hospital (13%), and among the EHs, 65% of patients were referred from a specialised outpatient medical care (SMC) facility. The majority of patients in both the UH and EH groups were symptomatic: 84% in the EH group (the most common symptom was exertional dyspnea in 56% of pts) and 93% in the UH group (the most common symptom was syncope in 60% of pts). Among the analysed population, the most frequent comorbidities were systemic hypertension (51%), lipid metabolism disorders (38%) and obesity (23%). Conclusions: A diagnosis of HCM is often made at an advanced age in symptomatic patients, mainly during an EH. Nearly one-fifth of the Polish HCM population is diagnosed during a UH after a sudden event, which suggests the need for improvements in medical care in Poland. Full article

(This article belongs to the Special Issue Advances in the Diagnosis and Treatment of Cardiomyopathy)

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12 pages, 2125 KiB

Open AccessArticle

Treatment Patterns and Outcomes of Stage III Melanoma Patients with Positive Sentinel Lymph Node Biopsy: A Real-Life Experience

by Gabriele Roccuzzo, Nicole Macagno, Pietro Grignani, Chiara Astrua, Matteo Giovanni Brizio, Giovanni Cavaliere, Franco Picciotto, Virginia Caliendo, Enrico Fruttero, Simone Ribero, Paolo Fava and Pietro Quaglino

J. Clin. Med. 2024, 13(17), 5238; https://doi.org/10.3390/jcm13175238 - 4 Sep 2024

Abstract

Background: Advancements in managing stage III melanoma have involved the implementation of adjuvant therapies alongside a simultaneous decrease in the utilization of completion lymph node dissection (CLND) following positive sentinel node biopsy (SLNB). Methods: This retrospective study from the University of Turin’s Dermatology [...] Read more.

Background: Advancements in managing stage III melanoma have involved the implementation of adjuvant therapies alongside a simultaneous decrease in the utilization of completion lymph node dissection (CLND) following positive sentinel node biopsy (SLNB). Methods: This retrospective study from the University of Turin’s Dermatology Clinic analyzed relapse-free survival (RFS) and overall survival (OS) among stage III melanoma patients (n = 157) who underwent CLND after positive SLNB versus those who did not receive such procedure. Results: Patients without CLND had a median RFS of 49 months (95% CI 42-NA), while CLND recipients showed 51 months (95% CI 31-NA) (p = 0.139). The 48-month OS for non-CLND patients was 79.8% (95% CI 58.2–91.0) versus 79.2% (95% CI 67.5–87.0) for CLND recipients (p = 0.463). Adjusted Hazard Ratios through inverse probability treatment weighting revealed the impact of CLND to be insignificant on RFS (aHR 0.90, 95% CI 0.37–2.22) and marginal on OS (aHR 0.41, 95% CI 0.13–1.21). Conversely, adjuvant therapy significantly reduced the risk of relapse (aHR 0.46, 95% CI 0.25–0.84), irrespective of CLND. Conclusions: This study corroborates the growing evidence that CLND after positive SLNB does not enhance RFS or OS, while emphasizing the crucial role of adjuvant therapy, be it immunotherapy or targeted therapy, in reducing the risk of relapse in melanoma patients with positive SLNB. Full article

(This article belongs to the Section Dermatology)

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11 pages, 590 KiB

Open AccessArticle

Muscle Strength and Phase Angle Are Potential Markers for the Efficacy of Multidisciplinary Weight-Loss Program in Patients with Sarcopenic Obesity

by Amelia Brunani, Ettore Brenna, Antonella Zambon, Davide Soranna, Lorenzo Maria Donini, Luca Busetto, Simona Bertoli, Paolo Capodaglio and Raffaella Cancello

J. Clin. Med. 2024, 13(17), 5237; https://doi.org/10.3390/jcm13175237 - 4 Sep 2024

Abstract

Background/Objectives: Traditional weight-loss methods often result in the loss of both fat and muscle mass. For individuals with sarcopenic obesity (SO), additional muscle loss can exacerbate sarcopenia, leading to further declines in muscle strength and function, ultimately worsening quality of life. To [...] Read more.

Background/Objectives: Traditional weight-loss methods often result in the loss of both fat and muscle mass. For individuals with sarcopenic obesity (SO), additional muscle loss can exacerbate sarcopenia, leading to further declines in muscle strength and function, ultimately worsening quality of life. To mitigate this risk, weight-loss strategies should emphasize the preservation and building of muscle mass through adequate protein intake and tailored resistance training. This study aimed to evaluate changes in SO status following a 4-week multidisciplinary weight-loss intervention program in hospitalized patients with obesity. Methods: This study included adult patients with obesity (BMI > 30 kg/m², aged 18–90 years). The SO diagnosis was performed using the handgrip strength (HGS) test and skeletal muscle mass (SMM) by bioelectrical impedance analysis (BIA) according to ESPEN/EASO-2022 guidelines. Results: A total of 2004 patients were enrolled, 64.8% female, with a mean age of 56 (±14) years and a BMI of 40.7 (±6.48) kg/m². SO was present in 9.38% (188 patients) at baseline. At discharge, 80 patients (42.55%) were no longer classified as sarcopenic and showed significant improvements in HGS. The likelihood of resolving SO was not modified in patients with only phase angle (PhA) improvement (p-value = 0.141). Patients with HGS increment had a 65% probability to be No-SO at discharge and this probability, with the concomitant PhA increment, rose to 93% (p-value < 0.0001), indicating that functional changes and good nutrition status are crucial in improvement of SO. Muscle mass (MM) and SMMI remained unchanged in the studied cohort. Conclusions: Improvements in HGS and the PhA are potential markers for the efficacy of weight-loss programs tailored to patients with SO. These findings suggest that specific interventions focusing on these markers could be beneficial in managing SO patients. Full article

(This article belongs to the Section Endocrinology & Metabolism)

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18 pages, 1278 KiB

Open AccessArticle

Dietary Counseling Outcomes in Patients with Lung Cancer in an Upper-Middle-Income Country: An Open-Label Randomized Controlled Trial

by Busyamas Chewaskulyong, Haritchanan Malairungsakul, Supawan Buranapin, Panas Jesadaporn, Thanika Ketpueak, Thatthan Suksombooncharoen and Chaiyut Charoentum

J. Clin. Med. 2024, 13(17), 5236; https://doi.org/10.3390/jcm13175236 - 4 Sep 2024

Abstract

Background: Malnutrition harms treatment outcomes, QoL, and survival in lung cancer patients. Effective dietary counseling can improve nutrition, but few randomized controlled trials have focused on lung cancer patients. The objective of this study was to determine if dietary counseling improves nutritional and [...] Read more.

Background: Malnutrition harms treatment outcomes, QoL, and survival in lung cancer patients. Effective dietary counseling can improve nutrition, but few randomized controlled trials have focused on lung cancer patients. The objective of this study was to determine if dietary counseling improves nutritional and treatment outcomes when compared to routine care. Methods: This open-label parallel RCT was conducted at Maharaj Nakorn Chiang Mai Hospital in Thailand. The investigators used computer-generated blocked randomization to assign patients to dietary counseling by a nutritionist or routine care. The nutritionist sessions occurred before treatment, with follow-ups at 3–4 weeks and 12 weeks. The primary outcome was the mean percentage change in the body weight of patients at 12 weeks. Secondary outcomes included changes in the BMI, nutrition score, QoL, serum albumin level, lymphocyte count, energy and protein intake, treatment response, PFS, and OS. Results: Between April 2020 and May 2022, after completing recruitment, 80 lung cancer patients were randomized: 43 to dietary counseling and 37 to routine care. The dietary counseling group showed significant benefits, with smaller decreases in body weight at 3–4 weeks (−0.8% vs. −2.6%, p = 0.05) and 12 weeks (−1.1% vs. −4.3%, p = 0.05). They also had higher energy and protein intake levels and better treatment response rates. The secondary outcomes and significant adverse events did not differ significantly between the groups. Conclusions: Dietary counseling helps to maintain body weight, maintain dietary intake, and enhance treatment responses in lung cancer patients. Although not all nutritional markers or survival outcomes were affected, these findings highlight the importance of early nutritional interventions. Full article

(This article belongs to the Section Oncology)

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11 pages, 1302 KiB

Open AccessArticle

Randomised Placebo-Controlled Pilot Trial Evaluating the Anti-Anginal Efficacy of Ticagrelor in Patients with Angina with Nonobstructive Coronary Arteries and Coronary Slow Flow Phenomenon

by Sivabaskari Pasupathy, Rosanna Tavella, Christopher Zeitz, Suzanne Edwards, Matthew Worthley, Margaret Arstall and John F. Beltrame

J. Clin. Med. 2024, 13(17), 5235; https://doi.org/10.3390/jcm13175235 - 4 Sep 2024

Abstract

Background: The coronary slow flow phenomenon (CSFP) is an angiographic finding characterised by the delayed passage of contrast through the coronary arteries, despite the absence of obstructive coronary artery disease (defined as less than 50% narrowing of the vessel lumen). Patients with [...] Read more.

Background: The coronary slow flow phenomenon (CSFP) is an angiographic finding characterised by the delayed passage of contrast through the coronary arteries, despite the absence of obstructive coronary artery disease (defined as less than 50% narrowing of the vessel lumen). Patients with the CSFP experience recurrent angina, for which there are limited evidence-based therapies. Ticagrelor may serve as an effective anti-anginal therapy for these patients by increasing adenosine levels, which could alleviate coronary microvascular dysfunction and its associated angina due to its vasodilatory properties. This study aimed to determine the anti-anginal efficacy of ticagrelor 90 mg taken twice daily on spontaneous angina episodes in patients with refractory angina (i.e., episodes ≥3/week despite two anti-anginals) and documented CSFP. Methods: In a randomised, double-blind, placebo-controlled, cross-over trial, the anti-anginal efficacy of a 4-week ticagrelor therapy regimen was evaluated in 20 patients with refractory angina (mean age 61.5 ± 10.5 years; 40% women) who had documented slow coronary flow. The primary endpoint was the frequency of angina episodes, recorded using an angina diary. Secondary endpoints included the duration and severity of angina episodes, consumption of short-acting nitrates, and health status evaluations using the Seattle Angina Questionnaire (SAQ) and the Short Form-36 (SF-36) indices. Results: During the four weeks of therapy, ticagrelor did not significantly improve angina symptoms compared to the placebo (placebo 25.7 (16.7)) vs. ticagrelor 19.8 (18.1), p > 0.05). Furthermore, it did not impact other patient-related outcome measures, including angina severity, duration, frequency of prolonged angina episodes, nitrate consumption, or the SAQ/SF-36 health outcome indices. No serious adverse events related to the study drug were observed. Conclusions: In patients with documented CSFP who were unresponsive to standard anti-anginal therapy, ticagrelor did not reduce the frequency of spontaneous angina episodes or the consumption of nitrates. Further confirmation of the potential benefits of this therapy may be obtained through a larger clinical trial. Full article

(This article belongs to the Special Issue Personalized Medicine and Treatment of Acute Coronary Syndrome)

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10 pages, 1492 KiB

Open AccessArticle

Unsupervised Pattern Analysis to Differentiate Multiple Sclerosis Phenotypes Using Principal Component Analysis on Various MRI Sequences

by Chris W. J. van der Weijden, Milena S. Pitombeira, Débora E. Peretti, Kenia R. Campanholo, Guilherme D. Kolinger, Carolina M. Rimkus, Carlos Alberto Buchpiguel, Rudi A. J. O. Dierckx, Remco J. Renken, Jan F. Meilof, Erik F. J. de Vries and Daniele de Paula Faria

J. Clin. Med. 2024, 13(17), 5234; https://doi.org/10.3390/jcm13175234 - 4 Sep 2024

Abstract

Background: Multiple sclerosis (MS) has two main phenotypes: relapse-remitting MS (RRMS) and progressive MS (PMS), distinguished by disability profiles and treatment response. Differentiating them using conventional MRI is challenging. Objective: This study explores the use of scaled subprofile modelling using principal [...] Read more.

Background: Multiple sclerosis (MS) has two main phenotypes: relapse-remitting MS (RRMS) and progressive MS (PMS), distinguished by disability profiles and treatment response. Differentiating them using conventional MRI is challenging. Objective: This study explores the use of scaled subprofile modelling using principal component analysis (SSM/PCA) on MRI data to distinguish between MS phenotypes. Methods: MRI scans were performed on patients with RRMS (n = 30) and patients with PMS (n = 20), using the standard sequences T₁w, T₂w, T₂w-FLAIR, and the myelin-sensitive sequences magnetisation transfer (MT) ratio (MTR), quantitative MT (qMT), inhomogeneous MT ratio (ihMTR), and quantitative inhomogeneous MT (qihMT). Results: SSM/PCA analysis of qihMT images best differentiated PMS from RRMS, with the highest specificity (87%) and positive predictive value (PPV) (83%), but a lower sensitivity (67%) and negative predictive value (NPV) (72%). Conversely, T₁w data analysis showed the highest sensitivity (93%) and NPV (89%), with a lower PPV (67%) and specificity (53%). Phenotype classification agreement between T₁w and qihMT was observed in 57% of patients. In the subset with concordant classifications, the sensitivity, specificity, PPV, and NPV were 100%, 88%, 90%, and 100%, respectively. Conclusions: SSM/PCA on MRI data revealed distinctive patterns for MS phenotypes. Optimal discrimination occurred with qihMT and T₁w sequences, with qihMT identifying PMS and T₁w identifying RRMS. When qihMT and T₁w analyses align, MS phenotype prediction improves. Full article

(This article belongs to the Special Issue Recent Advancements in Nuclear Medicine and Radiology)

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9 pages, 599 KiB

Open AccessCase Report

A Two-Step Approach Using the National Health Institutes of Health Stroke Scale Assessed by Paramedics to Enhance Prehospital Stroke Detection: A Case Report and Concept Proposal

by Loric Stuby, Mélanie Suppan, Thibaut Desmettre, Emmanuel Carrera, Matthieu Genoud and Laurent Suppan

J. Clin. Med. 2024, 13(17), 5233; https://doi.org/10.3390/jcm13175233 - 4 Sep 2024

Abstract

Background: Prehospital detection and triage of stroke patients mostly rely on the use of large vessel occlusion prediction scales to decrease onsite time. These quick but simplified scores, though useful, prevent prehospital providers from detecting posterior strokes and isolated symptoms such as limb [...] Read more.

Background: Prehospital detection and triage of stroke patients mostly rely on the use of large vessel occlusion prediction scales to decrease onsite time. These quick but simplified scores, though useful, prevent prehospital providers from detecting posterior strokes and isolated symptoms such as limb ataxia or hemianopia. Case report: In the present case, an ambulance was dispatched to a 46-year-old man known for ophthalmic migraines and high blood pressure, who presented isolated visual symptoms different from those associated with his usual migraine attacks. Although the assessment advocated by the prehospital guideline was negative for stroke, the paramedic who assessed the patient was one of the few trained in the National Institutes of Health Stroke Scale assessment. Based on this assessment, the paramedic activated the fast-track stroke alarm and an ischemic stroke in the right temporal lobe was finally confirmed by magnetic resonance imaging. Discussion and conclusions: Current prehospital practice enables paramedics to detect anterior strokes but often limits the detection of posterior events or more subtle symptoms. Failure to identify such strokes delay or even forestall the initiation of thrombolytic therapy, thereby worsening patient outcomes. We therefore advocate a two-step prehospital approach: first, to avoid unnecessary delays, the prehospital stroke assessment should be carried out using a fast large vessel occlusion prediction scale; then, if this assessment is negative but potential stroke symptoms are present, a full National Institutes of Health Stroke Scale assessment could be performed to detect neurological deficits overlooked by the fast stroke scale. Full article

(This article belongs to the Section Clinical Neurology)

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15 pages, 1325 KiB

Open AccessArticle

Sarcoidosis and Cancer: The Role of the Granulomatous Reaction as a Double-Edged Sword

by Angela Maria Di Francesco, Giuliana Pasciuto, Elena Verrecchia, Ludovico Luca Sicignano, Laura Gerardino, Maria Grazia Massaro, Andrea Urbani and Raffaele Manna

J. Clin. Med. 2024, 13(17), 5232; https://doi.org/10.3390/jcm13175232 - 4 Sep 2024

Abstract

Background/Objectives: The relationship between sarcoidosis and the occurrence of neoplasia deserves to be investigated, but this relation has been observed in different and heterogeneous populations, leading to conflicting data. To clarify the causal relationship between these two diseases, different risk factors (e.g., smoking), [...] Read more.

Background/Objectives: The relationship between sarcoidosis and the occurrence of neoplasia deserves to be investigated, but this relation has been observed in different and heterogeneous populations, leading to conflicting data. To clarify the causal relationship between these two diseases, different risk factors (e.g., smoking), concurrent comorbidities, corticosteroid therapy, and metastasis development—as an expression of cancer aggressiveness—were investigated. Methods: In a retrospective study on 287 sarcoidosis outpatients at the Pneumological Department of the Gemelli Foundation (Rome, Italy) between 2000 and 2024, the diagnosis of cancer was recorded in 36 subjects (12.5%). Results: The reciprocal timeline of the diseases showed three different scenarios: (1) cancer preceding sarcoidosis or sarcoid-like reactions (63.8%); (2) cancer arising after sarcoidosis diagnosis (8.3%); and (3) sarcoidosis accompanying the onset of malignancy (27.8%). Only two subjects with sarcoidosis and cancer showed metastasis, and one of them was affected by lymphoma. Conclusions: These data suggest that granulomatous inflammation due to sarcoidosis may assume an ambivalent role as a “double-edged sword”, according to the M1/M2 macrophage polarization model: it represents a protective shield, preventing the formation of metastasis through the induction of immune surveillance against cancer while, on the other hand, it can be a risk factor for carcinogenesis due to the persistence of a chronic active inflammatory status. Low-dose steroid treatment was administered in only 31.6% of the cancer–sarcoidosis subjects for less than six months to control inflammation activity, with no promotive effect on carcinogenesis observed. Full article

(This article belongs to the Topic Diagnosis, Management, and Prognostic Assessment of Chronic Disease)

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14 pages, 4448 KiB

Open AccessArticle

Human-in-the-Loop—A Deep Learning Strategy in Combination with a Patient-Specific Gaussian Mixture Model Leads to the Fast Characterization of Volumetric Ground-Glass Opacity and Consolidation in the Computed Tomography Scans of COVID-19 Patients

by Constanza Vásquez-Venegas, Camilo G. Sotomayor, Baltasar Ramos, Víctor Castañeda, Gonzalo Pereira, Guillermo Cabrera-Vives and Steffen Härtel

J. Clin. Med. 2024, 13(17), 5231; https://doi.org/10.3390/jcm13175231 - 4 Sep 2024

Abstract

Background/Objectives: The accurate quantification of ground-glass opacities (GGOs) and consolidation volumes has prognostic value in COVID-19 patients. Nevertheless, the accurate manual quantification of the corresponding volumes remains a time-consuming task. Deep learning (DL) has demonstrated good performance in the segmentation of normal lung [...] Read more.

Background/Objectives: The accurate quantification of ground-glass opacities (GGOs) and consolidation volumes has prognostic value in COVID-19 patients. Nevertheless, the accurate manual quantification of the corresponding volumes remains a time-consuming task. Deep learning (DL) has demonstrated good performance in the segmentation of normal lung parenchyma and COVID-19 pneumonia. We introduce a Human-in-the-Loop (HITL) strategy for the segmentation of normal lung parenchyma and COVID-19 pneumonia that is both time efficient and quality effective. Furthermore, we propose a Gaussian Mixture Model (GMM) to classify GGO and consolidation based on a probabilistic characterization and case-sensitive thresholds. Methods: A total of 65 Computed Tomography (CT) scans from 64 patients, acquired between March 2020 and June 2021, were randomly selected. We pretrained a 3D-UNet with an international dataset and implemented a HITL strategy to refine the local dataset with delineations by teams of medical interns, radiology residents, and radiologists. Following each HITL cycle, 3D-UNet was re-trained until the Dice Similarity Coefficients (DSCs) reached the quality criteria set by radiologists (DSC = 0.95/0.8 for the normal lung parenchyma/COVID-19 pneumonia). For the probabilistic characterization, a Gaussian Mixture Model (GMM) was fitted to the Hounsfield Units (HUs) of voxels from the CT scans of patients with COVID-19 pneumonia on the assumption that two distinct populations were superimposed: one for GGO and one for consolidation. Results: Manual delineation of the normal lung parenchyma and COVID-19 pneumonia was performed by seven teams on 65 CT scans from 64 patients (56 ± 16 years old (μ ± σ), 46 males, 62 with reported symptoms). Automated lung/COVID-19 pneumonia segmentation with a DSC > 0.96/0.81 was achieved after three HITL cycles. The HITL strategy improved the DSC by 0.2 and 0.5 for the normal lung parenchyma and COVID-19 pneumonia segmentation, respectively. The distribution of the patient-specific thresholds derived from the GMM yielded a mean of −528.4 ± 99.5 HU (μ ± σ), which is below most of the reported fixed HU thresholds. Conclusions: The HITL strategy allowed for fast and effective annotations, thereby enhancing the quality of segmentation for a local CT dataset. Probabilistic characterization of COVID-19 pneumonia by the GMM enabled patient-specific segmentation of GGO and consolidation. The combination of both approaches is essential to gain confidence in DL approaches in our local environment. The patient-specific probabilistic approach, when combined with the automatic quantification of COVID-19 imaging findings, enhances the understanding of GGO and consolidation during the course of the disease, with the potential to improve the accuracy of clinical predictions. Full article

(This article belongs to the Special Issue Technological Advancements and Clinical Innovations in Diagnostic and Interventional Radiology)

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11 pages, 1653 KiB

Open AccessArticle

Use of a Fundus Image-Based Titration Strategy for Selective Retina Therapy for Central Serous Chorioretinopathy

by Seung Hee Jeon, Minhee Kim and Young-Jung Roh

J. Clin. Med. 2024, 13(17), 5230; https://doi.org/10.3390/jcm13175230 - 4 Sep 2024

Abstract

Background/Objectives: This study evaluated the clinical outcomes of selective retina therapy (SRT) for treating central serous chorioretinopathy. A fundus image-based titration method was used for laser irradiation. Methods: This retrospective cohort study included 29 eyes (29 patients) that underwent SRT for CSC. Both [...] Read more.

Background/Objectives: This study evaluated the clinical outcomes of selective retina therapy (SRT) for treating central serous chorioretinopathy. A fundus image-based titration method was used for laser irradiation. Methods: This retrospective cohort study included 29 eyes (29 patients) that underwent SRT for CSC. Both the pulse energy and number of micropulses were adjusted according to the fundus image. Mean best-corrected visual acuity (BCVA), central foveal thickness (CFT), and subretinal fluid (SRF) height were measured 1, 2, 3, 4, and 6 months after SRT. Mean deviation (MD) was measured using microperimetry at 3 and 6 months post-treatment. Results: At 6 months after SRT treatment, SRF was completely resolved in 89.7% of cases (26/29 eyes). The mean Snellen BCVA significantly improved from 0.34 ± 0.31 logMAR (logarithm of the minimum angle of resolution) (20/40) at baseline to 0.24 ± 0.24 logMAR (20/32) at 6 months (p = 0.009). The 0.1 improvement in mean BCVA is equivalent to a 5-letter gain on the ETDRS chart. The mean CFT decreased significantly from 309.31 ± 81.6 μm at baseline to 211.07 ± 50.21 μm at 6 months (p < 0.001). The mean SRF height also decreased significantly from 138.36 ± 56.78 μm at baseline to 23.75 ± 61.19 μm at 6 months (p < 0.001). The mean MD was improved from −1.56 ± 1.47 dB at baseline to −1.03 ± 2.43 dB at 6 months (p = 0.07) after treatment. Conclusions: SRT using fundus image-based titration can yield favorable functional and anatomical outcomes in the treatment of CSC. Full article

(This article belongs to the Special Issue An Update on Retinal Diseases: From Diagnosis to Treatment)

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22 pages, 7071 KiB

Open AccessPerspective

Angiopoietin-like Proteins and Lipoprotein Lipase: The Waltz Partners That Govern Triglyceride-Rich Lipoprotein Metabolism? Impact on Atherogenesis, Dietary Interventions, and Emerging Therapies

by Alejandro Gugliucci

J. Clin. Med. 2024, 13(17), 5229; https://doi.org/10.3390/jcm13175229 - 4 Sep 2024

Abstract

Over 50% of patients who take statins are still at risk of developing atherosclerotic cardiovascular disease (ASCVD) and do not achieve their goal LDL-C levels. This residual risk is largely dependent on triglyceride-rich lipoproteins (TRL) and their remnants. In essence, remnant cholesterol-rich chylomicron [...] Read more.

Over 50% of patients who take statins are still at risk of developing atherosclerotic cardiovascular disease (ASCVD) and do not achieve their goal LDL-C levels. This residual risk is largely dependent on triglyceride-rich lipoproteins (TRL) and their remnants. In essence, remnant cholesterol-rich chylomicron (CM) and very-low-density lipoprotein (VLDL) particles play a role in atherogenesis. These remnants increase when lipoprotein lipase (LPL) activity is inhibited. ApoCIII has been thoroughly studied as a chief inhibitor and therapeutic options to curb its effect are available. On top of apoCIII regulation of LPL activity, there is a more precise control of LPL in various tissues, which makes it easier to physiologically divide the TRL burden according to the body’s requirements. In general, oxidative tissues such as skeletal and cardiac muscle preferentially take up lipids during fasting. Conversely, LPL activity in adipocytes increases significantly after feeding, while its activity in oxidative tissues decreases concurrently. This perspective addresses the recent improvements in our understanding of circadian LPL regulations and their therapeutic implications. Three major tissue-specific lipolysis regulators have been identified: ANGPTL3, ANGPTL4, and ANGPTL8. Briefly, during the postprandial phase, liver ANGPTL8 acts on ANGPTL3 (which is released continuously from the liver) to inhibit LPL in the heart and muscle through an endocrine mechanism. On the other hand, when fasting, ANGPTL4, which is released by adipocytes, inhibits lipoprotein lipase in adipose tissue in a paracrine manner. ANGPTL3 inhibitors may play a therapeutic role in the treatment of hypertriglyceridemia. Several approaches are under development. We look forward to future studies to clarify (a) the nature of hormonal and nutritional factors that determine ANGPTL3, 4, and 8 activities, along with what long-term impacts may be expected if their regulation is impaired pharmacologically; (b) the understanding of the quantitative hierarchy and interaction of the regulatory actions of apoCIII, apoAV, and ANGPTL on LPL activity; (c) strategies for the safe and proper treatment of postprandial lipemia; and (d) the effect of fructose restriction on ANGPTL3, ANGPTL4, and ANGPTL8. Full article

(This article belongs to the Section Cardiovascular Medicine)

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12 pages, 1322 KiB

Open AccessArticle

Differences in Grey Matter Concentrations and Functional Connectivity between Young Carriers and Non-Carriers of the APOE ε4 Genotype

by Carlos Muñoz-Neira, Jianmin Zeng, Ludmila Kucikova, Weijie Huang, Xiong Xiong, Graciela Muniz-Terrera, Craig Ritchie, John T. O’Brien and Li Su

J. Clin. Med. 2024, 13(17), 5228; https://doi.org/10.3390/jcm13175228 - 3 Sep 2024

Abstract

Background: The pathophysiology of Alzheimer’s disease (AD) may begin developing years or even decades prior to the manifestation of its first symptoms. The APOE ε4 genotype is a prominent genetic risk for AD that has been found to be associated with brain [...] Read more.

Background: The pathophysiology of Alzheimer’s disease (AD) may begin developing years or even decades prior to the manifestation of its first symptoms. The APOE ε4 genotype is a prominent genetic risk for AD that has been found to be associated with brain changes across the lifespan since early adulthood. Thus, studying brain changes that may occur in young adults with an APOE ε4 status is highly relevant. Objective: Examine potential differences in grey matter (GM) and functional connectivity (FC) in brains of cognitively healthy young APOE ε4 carriers and non-carriers, denoted here as ε4(+) and ε4(−), respectively. Methods: Three Tesla magnetic resonance imaging (MRI) brain scans were acquired from cognitively healthy young participants aged approximately 20 years (n = 151). Voxel-based morphometry (VBM) analysis was employed to identify potential structural differences in GM between ε4(+) and ε4(−). In a subsequent seed-based connectivity (SBC) analysis, brain regions that structurally differed in the VBM analysis were considered as seeds and correlated with all the remaining voxels across the brains to then measure the differences in FC between groups. Results: The VBM analysis suggested that ε4(+) (n = 28) had greater GM densities relative to ε4(−) (n = 123) in the left hippocampus and the left posterior insula (p_uncorr < 0.001). However, the effect did not survive the correction for multiple comparisons, suggesting minimal structural differences in this age range. In contrast, the SBC analysis indicated that ε4(+) exhibited significantly decreased FC between the left hippocampus and areas of the left middle temporal gyrus (n = 27) compared to ε4(−) (n = 102). These results remained significant after multiple comparisons (p_FDR < 0.05). Lastly, no statistically significant differences in FC between groups were observed for the left insular seed (p_FDR > 0.05). Discussion: These results suggest early structural and functional brain changes associated with the APOE ε4 genotype on young adults. Yet, they must be cautiously interpreted and contrasted with both older adults with genetic risk for AD and patients diagnosed with AD. Full article

(This article belongs to the Special Issue Recent Studies in Brain Imaging for Neurocognitive Disorders)

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