bluuebunny/crossref_metadata_2025_split huggingface dataset:
PERANCANGAN SCREW CONVEYOR VERTIKAL DENGAN KAPASITAS 4000 KG/JAM UNTUK TRANSFER GABAH KERING PADA MESIN PENGGILING PADI
Authors: Purnama Harun Giovanni 
Published: March 2024

Penelitian ini bertujuan untuk menghasilkan gambar rancangan pemilihan bahan mesin screw conveyor vertikal yang berkapasitas 4000 kg/jam untuk transfer gabah kering pada mesin penggilingan padi. Rancangan mesin conveyor ini memiliki tinggi 3 meter, pada rangka dibuatdalam posisi vertikal untuk mengangkut gabah kering ke hopper mesin penggilingan dan menghemat tempat. Mesin screw conveyor vertikal ini mempunyai komponen penunjang yaitu, motor listrik, poros, drum, hopper dan screw sebagai pendorong gabah kering. Mesin screw conveyor vertikal ini memiliki spesifikasi daya motor listrik sebesar 1 HP yang memiliki tegangan sebesar 380 V / 3 phase, dengan putaran motor sebesar 1000 rpm, diameter poros sebesar 15 cm yang memiliki tegangan dengan kekuatan bahan nya sebesar 12.409 untuk material poros yang digunakan S30Cyang mempunyai kekuatan tarik sebesar 48 , diameter screw sebesar 80 cm dan jarak pitch screw sebesar 44 cm. Pada rancangan ini mesin penggerak menggunakan motor listrik 3 phase.Abstrak memuat latar belakang singkat penelitian, masalah yang akan diselesaikan, pendekatan yang digunakan dam solusi atau hasil penelitian.
RANCANG BANGUN MESIN GERINDA PENGUBAH SUDUT CAMSHAFT (NOKEN AS) KHUSUS MOTOR 4 TAK
Authors: Maulani Irna sari 
Published: March 2024

Tujuan tugas akhir ini adalah membangun mesin modifikasi camshaft. Mesin ini digunakan untukmemodifikasi camshaft standar menjadi camshaft racing yang berkapasitas 100cc-250cc. Mesin inimampu menghasilkan 1 camshaft racing/jam. Proses perancangan mesin dilakukan dengan tahapanyaitu menganalisis kebutuhan, mendefinisikan proyek dan daftar persyaratan, menjabarkanperancangan dan pembuatan konsep produk, kemudian merancang produk, dan terakhirmendokumentasikan produk dalam bentuk gambar desain mesin. Tenaga penggerak mesindirencanakan menggunakan motor listrik yang disesuaikan dengan kemampuan daya listrik untukbengkel kecil sampai menengah yang diperkirakan rata-rata berkisar antara 900 sampai 1300 watt.Hasil tugas akhir ini menghasilkan desain dan gambar kerja produk mesin modifikasi camshaftmeliputi gambar poros, gambar dudukan camshaft dan dudukan puli, gambar rangka mesin dan gambar sistem transmisi. Sumber penggerak mesin adalah motor listrik AC 1 HP (±750 watt). Mesinmodifikasi camshaft yang dihasilkan memiliki kontruksi yang kuat dan ergonomis berdimensipanjang x lebar x tinggi yaitu 500x500x1350 mm dengan rangka baja profil L 40x40x3 mm. Sistemtransmisi menggunakan komponen V-belt, dan puli 3” dan 6”. Komponen pada sistem pengamplasanmenggunakan poros berbahan St 37, dudukan camshaft dan dudukan puli menggunakan bahan St 34,meja mesin menggunakan kayu. Taksiran harga pokok produk mesin yang ditawarkan adalah Rp.3.760.000,-.
Deucravacitinib in Plaque Psoriasis: 3-year Safety and Efficacy Results from the Phase 3 POETYK PSO-1 and PSO-2 Trials
Authors: Armstrong April W. , Lebwohl Mark , Warren Richard B. , Sofen Howard , Imafuku Shinichi , Ohtsuki Mamitaro , Spelman Lynda , Passeron Thierry , Papp Kim A. , Kisa Renata M. , Berger Victoria , Vritzali Eleni , Hoyt Kim , Colombo Matthew J. , Banerjee Subhashis , Strober Bruce , Thaçi Diamant , Blauvelt Andrew 
Published: March 2024

Introduction: Deucravacitinib, an oral, selective, allosteric TYK2 inhibitor, is approved in the US, EU, and other countries for treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy. Deucravacitinib was superior to placebo and apremilast in the POETYK PSO-1 (NCT03624127) and PSO-2 (NCT03611751) parent trials in moderate to severe plaque psoriasis. The POETYK long-term extension (LTE; NCT04036435) trial enrolled patients completing PSO-1/PSO-2. We report deucravacitinib safety and efficacy for up to 3 years (Week 148; through cutoff 6/15/2022).
Methods: PSO-1/PSO-2 randomized patients 1:2:1 to oral placebo, deucravacitinib 6 mg QD, or apremilast 30 mg twice daily. At Week 52, patients enrolled in the LTE received open-label deucravacitinib 6 mg QD. Safety was evaluated in patients receiving ≥1 deucravacitinib dose using exposure-adjusted incidence rate per 100 person-years (EAIR/PY). Efficacy outcomes (PASI 75/90; sPGA 0/1) were analyzed using modified nonresponder imputation (mNRI) in patients receiving continuous deucravacitinib from Day 1 of the parent trial and treated in the LTE.
Results: Of 1519 patients who received ≥1 deucravacitinib dose (3294.3 PY cumulative exposure), 513 received continuous deucravacitinib from Day 1 in PSO-1/PSO-2 and were treated in the LTE. EAIRs/100 PY were comparable, or decreased, between the 2-year and 3-year cumulative periods, respectively, for AEs (154.4, 144.8), serious AEs (6.1, 5.5), discontinuations due to AEs (2.8, 2.4), herpes zoster (0.7, 0.6), malignancies (0.9, 0.9), major adverse cardiovascular events (0.4, 0.3), venous thromboembolism (0.1, 0.1), and deaths (0.4, 0.3). Response rates were maintained at Week 148 by mNRI (PASI 75, 73.2%; PASI 90, 48.1%; sPGA 0/1, 54.1%).
Conclusion: Deucravacitinib maintained a consistent safety profile and durable efficacy for up to 3 years.
Effect of High-Dose Subcutaneous Spesolimab on Skin Manifestations: Results from the Pivotal Effisayil 2 Trial of Flare Prevention in Generalized Pustular Psoriasis
Authors: Strober Bruce , Augustin Matthias , Tada Yayoi , Garg Amit , Jullien Denis , Gottlieb Alice , Gudjonsson Johann , Hu Na , Hofmann Patrick , Thoma Christian , Marzano Angelo 
Published: March 2024

Introduction & Objectives: Generalized pustular psoriasis (GPP) is a chronic, rare and potentially life-threatening skin disease, characterized by flares of sterile pustules. Spesolimab, an anti-interleukin-36 receptor monoclonal antibody, is an effective and approved treatment for GPP flares in adults. Effisayil 2 (NCT04399837) was a pivotal, randomized controlled trial that evaluated the efficacy and safety of subcutaneous spesolimab in preventing GPP flares. Here, we report the effect of high-dose spesolimab versus placebo on GPP lesions.
Materials & Methods: Eligible patients with a history of GPP were randomized (1:1:1:1) to receive one of three subcutaneous spesolimab regimens or placebo for 48 weeks. High-dose spesolimab regimen was loading dose 600 mg, followed by maintenance dose 300 mg every 4 weeks. GPP Physician Global Assessment (GPPGA) subscores for erythema, pustules and scaling/crusting, and total score were compared between high-dose spesolimab and placebo groups at baseline and over the treatment period (scale: 0, clear to 4, severe).
Results: Proportion of patients with baseline score of 0 for each GPPGA subscore and total score was generally similar between treatment groups, except erythema; (high-dose spesolimab [n=30] vs placebo [n=31]: erythema, 13.3% vs 22.6%; pustules, 66.7% vs 67.7%; scaling/crusting, 23.3% vs 22.6%; total score, 10.0% vs 12.9%). By Week 4, proportion of patients with scores of 0 increased with high-dose spesolimab versus placebo, (erythema, 33.3% vs 19.4%; pustules, 80.0% vs 41.9%; scaling/crusting, 30.0% vs 19.4%; total score, 26.7% vs 16.1%), and high-dose spesolimab group had fewer flares (10.0% vs 35.5%). This trend was maintained at Week 24 (erythema, 36.7% vs 22.6%; pustules, 63.3% vs 45.2%; scaling/crusting, 36.7% vs 19.4%; total score, 33.3% vs 19.4%) and Week 48 (erythema, 36.7% vs 22.6%; pustules, 66.7% vs 45.2%; scaling/crusting, 43.3% vs 25.8%; total score, 36.7% vs 22.6%). There were no new flares after Week 4 in high-dose spesolimab group; however, flares increased with placebo (45.2% at Week 24; 51.6% at Week 48).
Conclusion: Versus placebo, high-dose subcutaneous spesolimab resulted in a greater proportion of patients maintaining GPPGA scores of 0, a lower proportion having flares at Week 4, and no new flares after Week 4. This was sustained at Weeks 24 and 48.
Continuous Tralokinumab Treatment over 4 Years in Adults with Moderate-to-Severe Atopic Dermatitis Provides Long-Term Disease Control
Authors: Blauvelt Andrew , Langley Richard G. , Peris Ketty , Silvestre Juan Francisco , Katoh Norito , Tauber Marie , Pinter Andreas , Ameen Mahreen , Gooderham Melinda , Øland Christian Bjerregård , Tindberg Ann-Marie , Gjerum Le , Reich Kristian 
Published: March 2024

Introduction: Tralokinumab, a monoclonal antibody that specifically neutralizes interleukin-13, is approved for the treatment of moderate-to-severe AD in multiple countries. Clinical trials of up to 52-week duration showed tralokinumab was effective and well-tolerated as monotherapy and in combination with TCS. ECZTEND (NCT03587805) is an ongoing open-label, 5-yr extension trial investigating the long-term safety and efficacy of tralokinumab ± optional TCS. To assess the efficacy of long-term tralokinumab treatment, we conducted a post hoc interim subgroup analysis restricted to the largest, most homogenous patient population, with the longest treatment duration.
Methods: Adult patients with moderate-to-severe AD who were continuously treated with tralokinumab ± optional TCS for 52 weeks in the phase 3 parents trials (PTs) ECZTRA 1 (NCT03131648) or ECZTRA 2 (NCT03160885) and for up to 152 weeks in ECZTEND as of data cutoff 04/30/2022 were included. Endpoints included proportion of patients achieving IGA 0/1, EASI-75 or EASI-90 relative to PT baseline, EASI ≤7, worst weekly pruritus (itch) NRS ≤4, and DLQI ≤5. Results are presented using observed data (AO). Sensitivity analyses on patients who completed Week152 in ECZTEND (or who withdrew, but were enrolled in the study ≥152 weeks prior to cutoff) were performed using mNRI with discontinuations due to AEs or lack of efficacy imputed as non-responders and a 2-step MI for other missing data.
Results: 347 patients with mean age (SD) of 42.2 (14.5) years and mean EASI (SD) of 30.8 (13.7) at PT baseline were included. After 4 years of total tralokinumab treatment (at Week 152 in ECZTEND), IGA 0/1 [% (n/N)] was observed in 52.6% (92/175) of patients. EASI-75 {% (n/N) [95% CI]} was achieved in 84.5% (147/174) [78.4, 89.1] of patients AO, and 73.4% (254.8/347) [68.6, 78.3] using mNRI. EASI-90 was achieved in 64.4% (112/174) [57.0, 71.1] of patients AO, and 53.4% (185.2/347) [47.8, 59.0] using mNRI. EASI ≤7 was observed in 84.5% (147/174), itch NRS ≤4 in 68.0% (119/175), and DLQI ≤5 in 79.0% (128/162) of patients. The safety profile was favorable and consistent with earlier analyses, with no new safety signals arising with continued tralokinumab use.
Conclusions: Continuous use of tralokinumab ± optional TCS provided long-term disease control over 4 years in adult patients with moderate-to-severe AD.
Progressive and Sustained Disease Control in Patients with Atopic Dermatitis (AD) Aged 12–17 Years Treated with Tralokinumab for 52 Weeks
Authors: Wollenberg Andreas , Cork Michael , Hong Chih-Ho , Kurbasic Azra , Vacko Emilia , Paller Amy 
Published: March 2024

Introduction: The ECZTRA 6 trial showed that tralokinumab 300mg provided progressive and sustained efficacy in adolescent patients with moderate-to-severe AD, and was well tolerated with a reassuring long-term safety profile over 52 weeks.
Objective: To evaluate EASI response and PROs in adolescents from ECZTRA 6 treated with tralokinumab 300mg for the full 52-week treatment period.
Methods: Patients were randomized to tralokinumab 300mg Q2W (n=97) or placebo (n=94) for 16 weeks. At Week 16, patients initiated on tralokinumab and achieving primary endpoints (IGA 0/1 and/or EASI-75) without rescue were re-randomized to tralokinumab 300mg Q2/4W monotherapy for 36 additional weeks; other patients were switched to open-label tralokinumab 300mg Q2W plus optional topical corticosteroids. Post-hoc analyses were conducted by pooling Week 16–52 data for all patients initially randomized to tralokinumab 300mg Q2W.
Results: Greater proportions of tralokinumab- vs placebo-treated patients achieved primary endpoints at Week 16; progressive improvement was seen through Week 52. In addition, pruritus NRS score was improved for a greater proportion of tralokinumab- vs placebo-treated patients from baseline to Week 16, with further improvement up to Week 52. Progressive improvements over time were also observed for proportions of patients with reductions of pruritus NRS ≥4, POEM ≥4, and CDLQI ≥6, from baseline. The safety profile was consistent with prolonged treatment following Week 16.
Conclusions: At Week 16, tralokinumab 300mg Q2W improved EASI and PROs in adolescents with AD, with progressive and sustained improvement seen up to Week 52.
Efficacy Following Discontinuation of Sonidegib Treatment in Patients With Locally Advanced Basal Cell Carcinoma: Results From the BOLT 42-Month Analysis
Authors: Migden Michael , Kheterpal Meenal , Moody Brent , Patel Kunal , Lionnet Leonard , Sivam Sakthivel , Conti Joe , Squittieri Nicholas , Farberg Aaron 
Published: March 2024

Introduction: Sonidegib, a Hedgehog (HH) pathway inhibitor, is approved for the treatment of locally advanced basal cell carcinoma (laBCC) not amenable to curative surgery or radiation. The pivotal 42-month BOLT (NCT01327053) study demonstrated sustained efficacy and manageable safety of sonidegib. Prior analyses at 18 months demonstrated clinical benefit persisting beyond sonidegib discontinuation. Pharmacokinetic modeling suggests HH pathway inhibition can be maintained following discontinuation. This analysis presents the efficacy of sonidegib 200 mg daily in patients with laBCC who discontinued treatment without disease progression (PD) at 42 months (end of study).
Methods: BOLT was a randomized, double-blind, placebo-controlled, Phase 2 study. Objective response rates (ORRs; complete response + partial response), duration of response (DOR), and progression-free survival (PFS) were assessed by central and investigator review per modified response evaluation criteria in solid tumors (mRECIST). Adverse events (AEs) were also assessed.
Results: Of the 66 patients with laBCC randomized to sonidegib 200 mg daily, 37 discontinued treatment without PD. The ORRs for these patients per central (57% [n = 20]) and investigator (73% [n = 27]) review were similar to the overall patient population (61% [n = 40] and 71% [n = 47] per central and investigator review, respectively). For patients who discontinued treatment, the median (95% confidence interval [CI]) DOR per central and investigator review was not estimable (NE) and 20.2 months (12.0, NE), respectively. The median PFS (95% CI) per central and investigator review was NE and 22.0 months (16.6, NE), respectively. Most AEs were Grades 1/2 in severity.
Conclusion: In this 42-month analysis among patients with laBCC who received sonidegib 200 mg daily, clinical benefit was observed beyond treatment discontinuation during this study.
Efficacy and Safety of Fixed-Dose Triple-Combination Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel for Moderate-to-Severe Acne Vulgaris in Children and Adolescents
Authors: Eichenfield Lawrence , Hebert Adelaide , Harper Julie , Baldwin Hilary , Bhatia Neal , Stein Gold Linda , Kircik Leon , Graber Emmy , Tanghetti Emil , Alexis Andrew , Del Rosso James 
Published: March 2024

Background: Topical clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (CAB) gel is the first fixed-dose triple-combination formulation approved for acne vulgaris and is indicated for use in patients aged 12 years and older. As topical acne treatment in pediatric patients may be complicated by tolerability issues and/or a perceived lack of efficacy, the objective of this post hoc analysis was to investigate the efficacy and safety of CAB in children and adolescents.
Methods: Data were pooled from two phase 3 double-blind, randomized, 12-week studies (NCT04214639; NCT04214652). Eligible participants ≥9 years of age with moderate-to-severe acne were randomized (2:1) to once-daily CAB or vehicle gel. This analysis evaluated adolescents aged 12-17 years (CAB: n=123; vehicle: n=50). Endpoints included ≥2-grade reduction from baseline in Evaluator’s Global Severity Score and clear/almost clear skin (treatment success), least-squares mean percent change from baseline in inflammatory/noninflammatory lesions, and treatment-emergent adverse events (TEAEs). Descriptive efficacy and safety data for five children aged 10-11 years enrolled in the study are also summarized (CAB: n=3; vehicle: n=2).
Results: At week 12, 51.5% of CAB–treated participants aged ≥12 years achieved treatment success vs 24.9% with vehicle gel (P<0.01). CAB treatment resulted in significant reductions of >70% in inflammatory and noninflammatory lesion counts in adolescents (78.3% and 73.7%, respectively) vs vehicle (50.5% and 42.9%; P<0.001, both). Most TEAEs were of mild-to-moderate severity, and the most common (>3% in any treatment) treatment-related TEAE was application site pain. Less than 2.5% of participants withdrew due to AEs. For the 5 children aged <12 years, all 3 treated with CAB achieved treatment success, with reductions in inflammatory/noninflammatory lesions ranging from 76%-100%; neither vehicle-treated participant achieved treatment success. Only one CAB–treated younger participant experienced TEAEs (application site pain/dryness, and erythema [all mild/moderate]) and none discontinued the study.
Conclusions: In two pooled phase 3 studies, once-daily CAB gel—the first approved fixed-dose, triple-combination topical formulation for acne vulgaris—was well tolerated and efficacious in pediatric participants with moderate-to-severe acne, with over half achieving treatment success at week 12.
Funding: Ortho Dermatologics
Long-Term Efficacy of Ritlecitinib up to Month 24 From the ALLEGRO Phase 2b/3 and Long-Term Phase 3 Clinical Studies in Alopecia Areata
Authors: Piliang Melissa , Soung Jennifer , King Brett , Shapiro Jerry , Rudnicka Lidia , Farrant Paul , Magnolo Nina , Piraccini Bianca , Luo Xin , Woodworth Deborah , Schaefer Gregor , Lejeune Alexandre , Wolk Robert 
Published: March 2024

Introduction: Ritlecitinib demonstrated efficacy and safety to Week 48 in patients aged ≥12 years with alopecia areata (AA) in ALLEGRO-2b/3 (NCT03732807). ALLEGRO-LT (NCT04006457) is an ongoing, phase 3, open-label study investigating the long-term safety and efficacy of ritlecitinib in AA. We report updated interim efficacy results of ritlecitinib up to Month 24 from ALLEGRO-2b/3 and ALLEGRO-LT.
Methods: Patients aged ≥12 years with AA and ≥50% scalp hair loss who rolled-over to ALLEGRO-LT from ALLEGRO-2b/3 were included. Data are reported for patients who received: 1) daily ritlecitinib 50-mg with a 4-week 200-mg daily loading dose (“200/50-mg”); 2) daily ritlecitinib 50-mg with no loading dose (“50-mg”). Outcomes include the proportions of patients with response (based on Severity of Alopecia Tool [SALT] score ≤20, SALT ≤10, and Patients’ Global Impression of Change [PGI-C] score of “moderately improved” or “greatly improved”) through Month 24, and the proportions of patients sustaining SALT ≤20 response from Month 12 through Month 24. Observed and imputed (modified last observation carried forward [mLOCF]) data, to account for missing values, are reported (data cutoff: December 9, 2022).
Results: The 200/50-mg and 50-mg groups included 194 and 191 patients; 127 (65.5%) and 111 (58.1%) were ongoing at the data cutoff. SALT ≤20 response rates in the 200/50-mg and 50-mg groups increased from Month 12 (45.9% and 45.1% [observed]; 41.8% and 40.3% [mLOCF]) to Month 24 (63.1% and 60.8% [observed]; 50.8% and 46.1% [mLOCF]). SALT ≤10 response rates increased between Months 12 and 24 for the 200/50-mg group (39.4% to 51.1% [observed]; 35.6% to 40.9% [mLOCF]) and 50-mg group (34.2% to 50.8% [observed]; 30.9% to 37.7% [mLOCF]). Of SALT ≤20 responders at Month 12, 92.8% (200/50-mg) and 79.7% (50-mg) (observed) sustained this response through Month 24. PGI-C response rates were maintained from Month 12 (200/50-mg: 69.4% [observed], 65.3% [mLOCF]; 50-mg: 61.6% [observed], 57.7% [mLOCF]) to Month 24 (200/50-mg: 76.4% [observed], 65.4% [mLOCF]; 50-mg: 70.0% [observed], 56.6% [mLOCF]).
Conclusion: Ritlecitinib 50-mg (with or without a 200-mg loading dose) demonstrated clinically meaningful and sustained clinician- and patient-reported efficacy through Month 24, which supports its long-term use in patients aged ≥12 years with severe AA.
Exploring the efficacy and safety of anti-BCMA chimeric antigen receptor T-cell therapy for multiple myeloma: Systematic review and meta-analysis
Authors: Zhang Jia , Ding Xinhua , Ding Xiaoxiao 
Published: March 2024

Objective:
Multiple myeloma (MM) is a bone marrow cancer that profoundly affects plasma cells involved in the immune response. Myeloma cells alter the average production of cells in the bone marrow. Anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T-cell therapy allows genetic modifications of an individual’s T-cells to increase the expression of CARs used to identify and attach BCMA proteins to the malignant cells. Our main objective is to perform a systematic review and meta-analysis to explore the efficacy and safety of anti-BCMA CAR T-cell therapy for MM.

Material and Methods:
We searched five databases, PubMed, CNKI, EMBASE, Cochrane, Web of Science, and CNKI, for studies published on anti-BCMA,CAR-T-cell treatment for MM. Inclusion criteria involved prospective single-arm studies either single or multi-center, in various MM phases and studies that reported anti-BCMA,CAR-T-cell treatment for MM. We excluded non-English publications and conference papers. All statistical analyses were performed in R software and Review Manager 5.4.1.

Results:
Thirteen articles were included in the analysis. We found that the overall response survival complete response increase was statistically significant. Similarly, the reduction in cytokine release syndrome grades 3 and 4 and neurotoxicity after follow-up was statistically significant. However, the reduction in minimal residual disease negativity (MRDN) was not statistically significant.

Conclusion:
Using anti-BCMA CAR T-cell therapy in MM was highly efficacious and safe in lowering the adverse outcomes and improving the survival outcomes, complete response, and overall response.