cometadata/datacite-titles-descriptions-related-identifiers huggingface dataset:
DOI: 10.18710/ubexzz/9l4xbz
title: 20180923_KHO_REDTEC_glo.txt
DOI: 10.18710/ubexzz/h6zxit
title: 20181114_KHO_REDTEC_gps.txt
DOI: 10.18710/ubexzz/nuodwd
title: 20180220_KHO_REDTEC_gal.txt
DOI: 10.18710/ubexzz/pvpskg
title: 20180113_KHO_REDTEC_glo.txt
DOI: 10.18710/ubexzz/pwlrdh
title: 20180522_KHO_REDTEC_glo.txt
DOI: 10.18710/ubexzz/qposgj
title: 20180428_KHO_REDTEC_glo.txt
DOI: 10.18710/ubexzz/sgzeku
title: 20180803_KHO_REDTEC_gal.txt
DOI: 10.13130/rd_unimi/ddgjj6/f1rzdk
title: Settembre_1922_Pagina_151.jpg

description: Bulletin of 1922/09/26
DOI: 10.18710/bmwxui/cs9jtt
title: 20180612_BJN_REDTEC_glo.txt
DOI: 10.18710/bmwxui/hopflj
title: 20180719_BJN_REDTEC_gal.txt
DOI: 10.18710/bmwxui/oefx0v
title: 20180810_BJN_REDTEC_gal.txt
DOI: 10.18710/bmwxui/pdhhxa
title: 20181222_BJN_REDTEC_gps.txt
DOI: 10.18710/bmwxui/pwanws
title: 20180916_BJN_REDTEC_glo.txt
DOI: 10.18710/bmwxui/qc3hal
title: 20180816_BJN_REDTEC_glo.txt
DOI: 10.18710/bmwxui/x3svko
title: 20180217_BJN_REDTEC_glo.txt
DOI: 10.18710/ubexzz/4h0v0h
title: 20180311_KHO_REDTEC_glo.txt
DOI: 10.18710/ubexzz/yeflsu
title: 20180403_KHO_REDTEC_gal.txt
DOI: 10.6084/m9.figshare.30893162
title: Supplementary Material for: A randomized, single-dose, single-sequence, two-arm (fasting and fed), open-label study on the oral pharmacokinetics of a nanodispersible cannabidiol solution (150 mg/mL)

description: Introduction.
Cannabidiol (CBD), a non-psychoactive phytocannabinoid, attributed to its therapeutic benefits and positive safety profile is being studied for its potential to treat various medical conditions. The low oral bioavailability and significant first-pass metabolism present pharmacokinetic (PK) challenges. The present study aimed to evaluate the PK profile of a novel nanodispersible cannabidiol oral solution (150 mg/mL) under fasting and fed conditions in healthy male subjects.
Methods.
In this randomized, single-dose, two-arm (fasting and fed), open-label trial, 18 subjects (9 fasting and 9 fed) received 300 mg of CBD. Plasma concentrations of CBD and its major metabolites, specifically 7-hydroxy-cannabidiol (7-OH-CBD) and 7-carboxy-cannabidiol (7-COOH-CBD) were quantified and the PK parameters including Cmax, Tmax, AUC0-∞, and t½ were analyzed using non-compartmental modeling methods.
Results.
The fed state significantly increased the area under the curve (AUC0-∞) for CBD by 2.9-fold (p &lt; 0.0001) and prolonged the time to reach maximum concentration (Tmax). Cmax was moderately higher in the fed state (1.4-fold). The 7-COOH-CBD metabolite reached the highest plasma concentration, followed by the parent CBD and 7-OH-CBD. The administration of nanodispersible CBD oral solution was well tolerated, with no major adverse events.
Conclusions.
The nanodispersible CBD oral solution showed enhanced bioavailability under fed conditions and was well tolerated in healthy subjects. Food intake increased CBD’s Cmax and AUC and delayed Tmax. Our study suggests that this formulation shows promise for treating anxiety, depression, insomnia, cannabis addiction, alcohol use disorders and as an adjunct to chemotherapy. Further studies are required to confirm the therapeutic efficacy in patient populations.
DOI: 10.6084/m9.figshare.30893162.v1
title: Supplementary Material for: A randomized, single-dose, single-sequence, two-arm (fasting and fed), open-label study on the oral pharmacokinetics of a nanodispersible cannabidiol solution (150 mg/mL)

description: Introduction.
Cannabidiol (CBD), a non-psychoactive phytocannabinoid, attributed to its therapeutic benefits and positive safety profile is being studied for its potential to treat various medical conditions. The low oral bioavailability and significant first-pass metabolism present pharmacokinetic (PK) challenges. The present study aimed to evaluate the PK profile of a novel nanodispersible cannabidiol oral solution (150 mg/mL) under fasting and fed conditions in healthy male subjects.
Methods.
In this randomized, single-dose, two-arm (fasting and fed), open-label trial, 18 subjects (9 fasting and 9 fed) received 300 mg of CBD. Plasma concentrations of CBD and its major metabolites, specifically 7-hydroxy-cannabidiol (7-OH-CBD) and 7-carboxy-cannabidiol (7-COOH-CBD) were quantified and the PK parameters including Cmax, Tmax, AUC0-∞, and t½ were analyzed using non-compartmental modeling methods.
Results.
The fed state significantly increased the area under the curve (AUC0-∞) for CBD by 2.9-fold (p &lt; 0.0001) and prolonged the time to reach maximum concentration (Tmax). Cmax was moderately higher in the fed state (1.4-fold). The 7-COOH-CBD metabolite reached the highest plasma concentration, followed by the parent CBD and 7-OH-CBD. The administration of nanodispersible CBD oral solution was well tolerated, with no major adverse events.
Conclusions.
The nanodispersible CBD oral solution showed enhanced bioavailability under fed conditions and was well tolerated in healthy subjects. Food intake increased CBD’s Cmax and AUC and delayed Tmax. Our study suggests that this formulation shows promise for treating anxiety, depression, insomnia, cannabis addiction, alcohol use disorders and as an adjunct to chemotherapy. Further studies are required to confirm the therapeutic efficacy in patient populations.
DOI: 10.13130/rd_unimi/ddgjj6/zqzs1z
title: Settembre_1922_Pagina_152.jpg

description: Bulletin of 1922/09/26
DOI: 10.18710/bmwxui/fixpcv
title: 20181014_BJN_REDTEC_gal.txt
DOI: 10.18710/bmwxui/zotut5
title: 20180804_BJN_REDTEC_glo.txt
DOI: 10.18710/qtsmlq/ipw5p4
title: 20181001_HOP_REDTEC_gps.txt
DOI: 10.18710/suq4lx/80bnfq
title: 20190309_KHO_REDOBS_glo.txt
DOI: 10.18710/suq4lx/9zvfzu
title: 20191111_KHO_REDOBS_gal.txt
DOI: 10.18710/suq4lx/qnbh47
title: 20190308_KHO_REDOBS_gps.txt
DOI: 10.18710/suq4lx/xxexyq
title: 20191128_KHO_REDOBS_glo.txt
DOI: 10.18710/ubexzz/3smm19
title: 20180304_KHO_REDTEC_gps.txt
DOI: 10.18710/ubexzz/e95tg9
title: 20180322_KHO_REDTEC_gps.txt
DOI: 10.18710/ubexzz/hen9ig
title: 20180430_KHO_REDTEC_glo.txt
DOI: 10.18710/ubexzz/npelzj
title: 20180818_KHO_REDTEC_gal.txt
DOI: 10.18710/ubexzz/raid4p
title: 20180616_KHO_REDTEC_gps.txt
DOI: 10.18710/ubexzz/sdpci5
title: 20180711_KHO_REDTEC_gal.txt
DOI: 10.18710/ubexzz/yyvfcp
title: 20180316_KHO_REDTEC_gal.txt
DOI: 10.13130/rd_unimi/ddgjj6/eputlk
title: Settembre_1922_Pagina_153.jpg

description: Bulletin of 1922/09/26
DOI: 10.6084/m9.figshare.30893165
title: Supplementary Material for: Putting Theory into Practice by Developing a Novel Digital Health Technology-Derived Endpoint in Sleep Quality

description: Introduction:
Sleep disturbances associated with menopause (SDM) are common and bothersome, but there are currently no specifically licensed treatments, and studies thus far have used different methodologies to measure sleep quality. Among those, digital health technologies (DHTs) present an innovative approach that supports patient-centric drug development by providing insights into how a patient responds to treatment in real-world settings. DHTs therefore may offer a solution to provide non-invasive objective measurement of SDM. Here we describe the joint development of a novel DHT-derived endpoint for assessing sleep quality in menopausal women through a collaborative approach from evidence generation to analytical, clinical, and usability validation based on regulatory guidance.

Methods:
To demonstrate the fit-for-purpose of the novel DHT-derived endpoint, Bayer (drug developer), Sleepiz AG (DHT provider), and DEEP Measures (collaboration platform provider) partnered and applied established frameworks to leverage prior work while compiling comprehensive data, conducting a gap analysis, and curating evidence in the DEEP Measures collaboration platform based on and in preparation for discussions with health authorities. 
Initial regulatory feedback from health authorities provided useful input and supported the study design on the incorporation of the DHT-derived endpoint into the clinical development program of elinzanetant. Through collaborative efforts between the drug developer and the DHT provider, the novel DHT-derived endpoint (Sleepiz One+ for continuous, home-based measurement of wake after sleep onset in SDM and other sleep parameters) was implemented as an exploratory endpoint in a Phase 2 pilot study where data to demonstrate fit-for-purpose were generated and validated against polysomnography, the gold-standard objective measure for sleep. The study outcomes alongside the results of the gap analyses and leveraging prior work were then structured systematically in the DEEP Measures platform. Data were organized according to the DEEP Stack Model (which included information on the measurement definition, target solution profile, and instrumentation), and these facilitated the integration of our outputs directly into the regulatory package used for following health authority interactions to drive the acceptance of the novel endpoint. 

Conclusions:
We outline how various stakeholders collaborated to leverage prior evidence, interacted with regulatory authority, and incorporated a novel DHT-derived endpoint into clinical development programs. Evidence and data generated in the present project have the potential to build the basis for further endpoint and DHT development and validation.
DOI: 10.13130/rd_unimi/ddgjj6/9co6oo
title: Settembre_1922_Pagina_154.jpg

description: Bulletin of 1922/09/26
DOI: 10.13130/rd_unimi/ddgjj6/vdpdu5
title: Settembre_1922_Pagina_155.jpg

description: Bulletin of 1922/09/26
DOI: 10.18710/7n7zvo/jscr68
title: 20170114_NYA_REDTEC_gps.txt
DOI: 10.18710/7n7zvo/kpsg45
title: 20170103_NYA_REDTEC_gal.txt
DOI: 10.18710/7n7zvo/nesixm
title: 20170509_NYA_REDTEC_gps.txt
DOI: 10.18710/bmwxui/6rdu2z
title: 20181025_BJN_REDTEC_gps.txt
DOI: 10.18710/bmwxui/tevzpn
title: 20180505_BJN_REDTEC_gps.txt
DOI: 10.18710/qtsmlq/a9lt2w
title: 20180715_HOP_REDTEC_glo.txt
DOI: 10.18710/qtsmlq/kdvuoy
title: 20180331_HOP_REDTEC_glo.txt
DOI: 10.18710/qtsmlq/khnpbo
title: 20181021_HOP_REDTEC_gal.txt
DOI: 10.18710/qtsmlq/nzcsk5
title: 20180108_HOP_REDTEC_gal.txt
DOI: 10.18710/qtsmlq/qsxqls
title: 20180106_HOP_REDTEC_glo.txt
DOI: 10.18710/qtsmlq/wnmc7v
title: 20181225_HOP_REDTEC_gps.txt
DOI: 10.6084/m9.figshare.30893165.v1
title: Supplementary Material for: Putting Theory into Practice by Developing a Novel Digital Health Technology-Derived Endpoint in Sleep Quality

description: Introduction:
Sleep disturbances associated with menopause (SDM) are common and bothersome, but there are currently no specifically licensed treatments, and studies thus far have used different methodologies to measure sleep quality. Among those, digital health technologies (DHTs) present an innovative approach that supports patient-centric drug development by providing insights into how a patient responds to treatment in real-world settings. DHTs therefore may offer a solution to provide non-invasive objective measurement of SDM. Here we describe the joint development of a novel DHT-derived endpoint for assessing sleep quality in menopausal women through a collaborative approach from evidence generation to analytical, clinical, and usability validation based on regulatory guidance.

Methods:
To demonstrate the fit-for-purpose of the novel DHT-derived endpoint, Bayer (drug developer), Sleepiz AG (DHT provider), and DEEP Measures (collaboration platform provider) partnered and applied established frameworks to leverage prior work while compiling comprehensive data, conducting a gap analysis, and curating evidence in the DEEP Measures collaboration platform based on and in preparation for discussions with health authorities. 
Initial regulatory feedback from health authorities provided useful input and supported the study design on the incorporation of the DHT-derived endpoint into the clinical development program of elinzanetant. Through collaborative efforts between the drug developer and the DHT provider, the novel DHT-derived endpoint (Sleepiz One+ for continuous, home-based measurement of wake after sleep onset in SDM and other sleep parameters) was implemented as an exploratory endpoint in a Phase 2 pilot study where data to demonstrate fit-for-purpose were generated and validated against polysomnography, the gold-standard objective measure for sleep. The study outcomes alongside the results of the gap analyses and leveraging prior work were then structured systematically in the DEEP Measures platform. Data were organized according to the DEEP Stack Model (which included information on the measurement definition, target solution profile, and instrumentation), and these facilitated the integration of our outputs directly into the regulatory package used for following health authority interactions to drive the acceptance of the novel endpoint. 

Conclusions:
We outline how various stakeholders collaborated to leverage prior evidence, interacted with regulatory authority, and incorporated a novel DHT-derived endpoint into clinical development programs. Evidence and data generated in the present project have the potential to build the basis for further endpoint and DHT development and validation.
DOI: 10.13130/rd_unimi/ddgjj6/1qlqsq
title: Settembre_1922_Pagina_156.jpg

description: Bulletin of 1922/09/26
DOI: 10.18710/7n7zvo/2c1ha9
title: 20170930_NYA_REDTEC_gps.txt
DOI: 10.18710/7n7zvo/6j5unn
title: 20170414_NYA_REDTEC_glo.txt
DOI: 10.18710/7n7zvo/71mglj
title: 20170301_NYA_REDTEC_glo.txt
DOI: 10.18710/7n7zvo/xsy8fa
title: 20170819_NYA_REDTEC_gps.txt
DOI: 10.18710/qtsmlq/dg6w6t
title: 20180321_HOP_REDTEC_glo.txt
DOI: 10.18710/qtsmlq/irzi1t
title: 20180729_HOP_REDTEC_glo.txt
DOI: 10.18710/qtsmlq/o2yma7
title: 20180203_HOP_REDTEC_gps.txt
DOI: 10.13130/rd_unimi/ddgjj6/gxkacc
title: Settembre_1922_Pagina_157.jpg

description: Bulletin of 1922/09/27
DOI: 10.18710/7n7zvo/03x9hz
title: 20170511_NYA_REDTEC_gal.txt
DOI: 10.18710/7n7zvo/bvmx87
title: 20171209_NYA_REDTEC_gal.txt
DOI: 10.18710/7n7zvo/byht1b
title: 20170111_NYA_REDTEC_gal.txt
DOI: 10.18710/7n7zvo/cluvdp
title: 20170406_NYA_REDTEC_glo.txt
DOI: 10.18710/7n7zvo/ja3i5t
title: 20170815_NYA_REDTEC_glo.txt
DOI: 10.18710/7n7zvo/jq2yee
title: 20170902_NYA_REDTEC_gps.txt
DOI: 10.18710/7n7zvo/p2s7bb
title: 20170208_NYA_REDTEC_gal.txt
DOI: 10.18710/7n7zvo/p6nbof
title: 20170623_NYA_REDTEC_glo.txt
DOI: 10.18710/7n7zvo/zxdifr
title: 20170227_NYA_REDTEC_gal.txt
DOI: 10.18710/bmwxui/2ispyu
title: 20180128_BJN_REDTEC_gal.txt
DOI: 10.18710/bmwxui/2skmgt
title: 20181218_BJN_REDTEC_gal.txt
DOI: 10.18710/bmwxui/7rwlpa
title: 20181228_BJN_REDTEC_gal.txt
DOI: 10.18710/bmwxui/ddxgyg
title: 20180405_BJN_REDTEC_gal.txt
DOI: 10.18710/bmwxui/ex6cw7
title: 20180222_BJN_REDTEC_glo.txt
DOI: 10.18710/bmwxui/khfqj7
title: 20180712_BJN_REDTEC_gal.txt
DOI: 10.18710/bmwxui/nplinp
title: 20180701_BJN_REDTEC_glo.txt
DOI: 10.18710/bmwxui/rkkfzo
title: 20180204_BJN_REDTEC_gal.txt
DOI: 10.18710/yywkf2/b4cxz4
title: 20180510_NYA_REDTEC_glo.txt
DOI: 10.18710/yywkf2/svf8le
title: 20180712_NYA_REDTEC_glo.txt
DOI: 10.13130/rd_unimi/ddgjj6/r8eaqr
title: Settembre_1922_Pagina_158.jpg

description: Bulletin of 1922/09/27
DOI: 10.18710/7n7zvo/i0bu03
title: 20171112_NYA_REDTEC_gal.txt
DOI: 10.18710/7n7zvo/ituy9q
title: 20171205_NYA_REDTEC_gps.txt
DOI: 10.18710/7n7zvo/kcwkse
title: 20170324_NYA_REDTEC_gal.txt
DOI: 10.18710/7n7zvo/nzlnlp
title: 20171221_NYA_REDTEC_gal.txt
DOI: 10.18710/bmwxui/vyaen2
title: 20180927_BJN_REDTEC_gal.txt
DOI: 10.18710/qtsmlq/0z5aav
title: 20180413_HOP_REDTEC_gps.txt
DOI: 10.18710/qtsmlq/cylpoy
title: 20180214_HOP_REDTEC_gal.txt
DOI: 10.18710/qtsmlq/pipjsk
title: 20180103_HOP_REDTEC_gal.txt
DOI: 10.18710/suq4lx/1s09dg
title: 20190208_KHO_REDOBS_glo.txt
DOI: 10.18710/suq4lx/dfi8qb
title: 20191008_KHO_REDOBS_gal.txt
DOI: 10.18710/suq4lx/fcifr7
title: 20190321_KHO_REDOBS_gal.txt
DOI: 10.18710/suq4lx/fv2l4w
title: 20190109_KHO_REDOBS_gps.txt
DOI: 10.18710/suq4lx/ge5obu
title: 20190907_KHO_REDOBS_gal.txt
DOI: 10.18710/suq4lx/hasqts
title: 20190808_KHO_REDOBS_glo.txt
DOI: 10.18710/suq4lx/hh34go
title: 20190729_KHO_REDOBS_gps.txt
DOI: 10.18710/suq4lx/hpabjh
title: 20190626_KHO_REDOBS_gal.txt
DOI: 10.18710/suq4lx/ifsjjh
title: 20191017_KHO_REDOBS_gal.txt
DOI: 10.18710/suq4lx/kkvibj
title: 20190608_KHO_REDOBS_gps.txt
DOI: 10.18710/suq4lx/mymfvc
title: 20190209_KHO_REDOBS_glo.txt
DOI: 10.18710/suq4lx/pksby9
title: 20191124_KHO_REDOBS_gal.txt
DOI: 10.18710/suq4lx/pvb1fy
title: 20191125_KHO_REDOBS_gps.txt
DOI: 10.18710/suq4lx/qf2ehd
title: 20191001_KHO_REDOBS_gal.txt
DOI: 10.18710/suq4lx/rlvcgt
title: 20190513_KHO_REDOBS_gps.txt
DOI: 10.18710/suq4lx/swpkqm
title: 20190815_KHO_REDOBS_glo.txt
DOI: 10.18710/suq4lx/tlmerb
title: 20190711_KHO_REDOBS_gal.txt
DOI: 10.18710/suq4lx/ugcvpg
title: 20190529_KHO_REDOBS_glo.txt
DOI: 10.18710/suq4lx/xoq11x
title: 20191231_KHO_REDOBS_glo.txt
DOI: 10.18710/ubexzz/uhccsg
title: 20180624_KHO_REDTEC_glo.txt
DOI: 10.18710/yywkf2/l3zacb
title: 20180716_NYA_REDTEC_gal.txt
DOI: 10.18710/yywkf2/nz6gmd
title: 20180311_NYA_REDTEC_gal.txt
DOI: 10.18710/yywkf2/og37zz
title: 20180716_NYA_REDTEC_gps.txt
DOI: 10.18710/yywkf2/qtfuf4
title: 20180126_NYA_REDTEC_gal.txt
DOI: 10.18710/yywkf2/rss1rl
title: 20181018_NYA_REDTEC_glo.txt
DOI: 10.13130/rd_unimi/ddgjj6/jzx6lt
title: Settembre_1922_Pagina_159.jpg

description: Bulletin of 1922/09/27
DOI: 10.18710/bmwxui/3ttapn
title: 20180601_BJN_REDTEC_gal.txt
DOI: 10.18710/bmwxui/8g7jd8
title: 20180407_BJN_REDTEC_glo.txt
DOI: 10.18710/bmwxui/fwgsfb
title: 20181018_BJN_REDTEC_gps.txt
DOI: 10.18710/bmwxui/mxxm1h
title: 20180212_BJN_REDTEC_glo.txt
DOI: 10.18710/bmwxui/oq0twd
title: 20180713_BJN_REDTEC_gps.txt
DOI: 10.18710/bmwxui/owwntj
title: 20180226_BJN_REDTEC_gal.txt
DOI: 10.18710/bmwxui/s19bzp
title: 20180720_BJN_REDTEC_glo.txt
DOI: 10.18710/bmwxui/tgtpde
title: 20180830_BJN_REDTEC_glo.txt
DOI: 10.18710/bmwxui/xn951i
title: 20180111_BJN_REDTEC_gps.txt
DOI: 10.18710/suq4lx/2eeh3g
title: 20191026_KHO_REDOBS_glo.txt
DOI: 10.18710/suq4lx/2pymmu
title: 20190702_KHO_REDOBS_gal.txt
DOI: 10.18710/suq4lx/8ajcgq
title: 20191231_KHO_REDOBS_gal.txt
DOI: 10.18710/suq4lx/g3rfvg
title: 20190808_KHO_REDOBS_gal.txt
DOI: 10.18710/yywkf2/7muqem
title: 20180308_NYA_REDTEC_gal.txt
DOI: 10.18710/yywkf2/fwhbuf
title: 20181020_NYA_REDTEC_gps.txt
DOI: 10.18710/yywkf2/mtonrb
title: 20180718_NYA_REDTEC_gps.txt
DOI: 10.6084/m9.figshare.30893168
title: Supplementary Material for: Neuromodulation in Refractory Bitemporal Lobe Epilepsy in Adults: A Systematic Review and Meta-Analysis.

description: Objective
Bilateral temporal lobe epilepsy represents a subset of patients with medically intractable epilepsy that is particularly difficult to treat. This systematic review and meta-analysis aimed to evaluate the safety and efficacy of three neuromodulation techniques—Vagus Nerve Stimulation (VNS), Responsive Neurostimulation (RNS), and Deep Brain Stimulation (DBS)—in refractory BTLE.
 
Methods
In accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, we conducted a thorough electronic literature search using Ovid MEDLINE, Ovid Embase, and PubMed databases. Data from the selected studies were extracted, analyzed, and a quality assessment was performed. Meta-analysis was performed comparing mean seizure reduction rates in VNS, RNS, and DBS.
 
Results
Twenty studies (4 VNS, 7 RNS, 9 DBS) involving 142 BTLE patients were included in the systematic review. Meta-analysis of 12 studies (2 VNS, 5 RNS, 5 DBS) revealed comparable efficacy between VNS (61.69%), RNS (67.51%), and DBS (66.68%), with no statistically significant difference (p = 0.932) between the modalities. All three techniques demonstrated efficacy in seizure reduction. Additionally, complication rates did not significantly differ between VNS, RNS, and DBS. (p = 0.85).
 
Conclusion
This study provides a comprehensive assessment of existing data regarding the use of neuromodulation in refractory BTLE. VNS, RNS, and DBS demonstrated comparable efficacy, supporting their consideration in treatment planning. Clinical decision-making should weigh factors such as surgical candidacy, patient preferences, comorbidities, and side effect profiles. Further research, including standardized reporting and head-to-head trials, is vital for optimizing treatment protocols and expanding our understanding of neuromodulation's impact on seizure reduction, quality of life, and cognitive outcomes in patients with BTLE.
DOI: 10.6084/m9.figshare.30893168.v1
title: Supplementary Material for: Neuromodulation in Refractory Bitemporal Lobe Epilepsy in Adults: A Systematic Review and Meta-Analysis.

description: Objective
Bilateral temporal lobe epilepsy represents a subset of patients with medically intractable epilepsy that is particularly difficult to treat. This systematic review and meta-analysis aimed to evaluate the safety and efficacy of three neuromodulation techniques—Vagus Nerve Stimulation (VNS), Responsive Neurostimulation (RNS), and Deep Brain Stimulation (DBS)—in refractory BTLE.
 
Methods
In accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, we conducted a thorough electronic literature search using Ovid MEDLINE, Ovid Embase, and PubMed databases. Data from the selected studies were extracted, analyzed, and a quality assessment was performed. Meta-analysis was performed comparing mean seizure reduction rates in VNS, RNS, and DBS.
 
Results
Twenty studies (4 VNS, 7 RNS, 9 DBS) involving 142 BTLE patients were included in the systematic review. Meta-analysis of 12 studies (2 VNS, 5 RNS, 5 DBS) revealed comparable efficacy between VNS (61.69%), RNS (67.51%), and DBS (66.68%), with no statistically significant difference (p = 0.932) between the modalities. All three techniques demonstrated efficacy in seizure reduction. Additionally, complication rates did not significantly differ between VNS, RNS, and DBS. (p = 0.85).
 
Conclusion
This study provides a comprehensive assessment of existing data regarding the use of neuromodulation in refractory BTLE. VNS, RNS, and DBS demonstrated comparable efficacy, supporting their consideration in treatment planning. Clinical decision-making should weigh factors such as surgical candidacy, patient preferences, comorbidities, and side effect profiles. Further research, including standardized reporting and head-to-head trials, is vital for optimizing treatment protocols and expanding our understanding of neuromodulation's impact on seizure reduction, quality of life, and cognitive outcomes in patients with BTLE.
DOI: 10.13130/rd_unimi/ddgjj6/ewdkrd
title: Settembre_1922_Pagina_161.jpg

description: Bulletin of 1922/09/27
DOI: 10.13130/rd_unimi/ddgjj6/ucythj
title: Settembre_1922_Pagina_160.jpg

description: Bulletin of 1922/09/27
DOI: 10.18710/bmwxui/33tqzx
title: 20181228_BJN_REDTEC_glo.txt
DOI: 10.18710/bmwxui/7izdv4
title: 20180817_BJN_REDTEC_gps.txt
DOI: 10.18710/bmwxui/9bwkin
title: 20180220_BJN_REDTEC_glo.txt
DOI: 10.18710/bmwxui/nlnnog
title: 20180825_BJN_REDTEC_gps.txt
DOI: 10.18710/bmwxui/oqjvkl
title: 20180520_BJN_REDTEC_glo.txt
DOI: 10.18710/bmwxui/wnyxuk
title: 20180911_BJN_REDTEC_gps.txt
DOI: 10.18710/bmwxui/xv1ykq
title: 20180108_BJN_REDTEC_glo.txt
DOI: 10.18710/bmwxui/ywmitx
title: 20180719_BJN_REDTEC_gps.txt
DOI: 10.18710/qtsmlq/bk6tjo
title: 20180531_HOP_REDTEC_glo.txt
DOI: 10.18710/qtsmlq/c1z0sc
title: 20180115_HOP_REDTEC_glo.txt
DOI: 10.18710/qtsmlq/tgwwdi
title: 20180828_HOP_REDTEC_gal.txt
DOI: 10.18710/suq4lx/20mem2
title: 20191106_KHO_REDOBS_glo.txt
DOI: 10.18710/suq4lx/2mlnxq
title: 20190803_KHO_REDOBS_gal.txt
DOI: 10.18710/suq4lx/dkk0j3
title: 20190120_KHO_REDOBS_gps.txt
DOI: 10.18710/suq4lx/hcsbgn
title: 20190216_KHO_REDOBS_gps.txt
DOI: 10.18710/suq4lx/kqcjom
title: 20190707_KHO_REDOBS_gal.txt
DOI: 10.18710/suq4lx/ljvgmr
title: 20190908_KHO_REDOBS_glo.txt
DOI: 10.18710/suq4lx/m1ht4p
title: 20190103_KHO_REDOBS_gal.txt
DOI: 10.18710/suq4lx/odc0xp
title: 20191123_KHO_REDOBS_gps.txt
DOI: 10.18710/suq4lx/tfmdp3
title: 20190610_KHO_REDOBS_gps.txt
DOI: 10.18710/suq4lx/xgzxz1
title: 20190901_KHO_REDOBS_gal.txt
DOI: 10.18710/yywkf2/28gyp0
title: 20180610_NYA_REDTEC_glo.txt
DOI: 10.18710/yywkf2/zjni4f
title: 20180908_NYA_REDTEC_gal.txt
DOI: 10.13130/rd_unimi/ddgjj6/rniybq
title: Settembre_1922_Pagina_162.jpg

description: Bulletin of 1922/09/27