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Article ; Online: Utilization of older deceased donors for pediatric liver transplant may negatively impact long-term survival.

Kulkarni, Sakil S / Vachharajani, Neeta A / Hill, Angela L / Kiani, Amen Z / Stoll, Janis M / Nadler, Michelle L / Chapman, William C / Doyle, Maria M / Khan, Adeel S

Journal of pediatric gastroenterology and nutrition

2023 Volume 78, Issue 4, Page(s) 898–908

Abstract: Background: Multiple adult studies have investigated the role of older donors (ODs) in expanding the donor pool. However, the impact of donor age on pediatric liver transplantation (LT) has not been fully elucidated.: Methods: UNOS database was used ... ...

Abstract	Background: Multiple adult studies have investigated the role of older donors (ODs) in expanding the donor pool. However, the impact of donor age on pediatric liver transplantation (LT) has not been fully elucidated. Methods: UNOS database was used to identify pediatric (≤18 years) LTs performed in the United States during 2002-22. Donors ≥40 years at donation were classified as older donors (ODs). Propensity analysis was performed with 1:1 matching for potentially confounding variables. Results: A total of 10,024 pediatric liver transplantation (PLT) patients met inclusion criteria; 669 received liver grafts from ODs. Candidates receiving OD liver grafts were more likely to be transplanted for acute liver failure, have higher Model End-Stage Liver Disease/Pediatric End-Stage Liver Disease (MELD/PELD) scores at LT, listed as Status 1/1A at LT, and be in the intensive care unit (ICU) at time of LT (all p < 0.001). Kaplan-Meier (KM) analyses showed that recipients of OD grafts had worse patient and graft survival (p < 0.001) compared to recipients of younger donor (YD) grafts. KM analyses performed on candidates matched for acuity at LT revealed inferior patient and graft survival in recipients of deceased donor grafts (p < 0.001), but not living donor grafts (p > 0.1) from ODs. Cox regression analysis demonstrated that living donor LT, diagnosis of biliary atresia and first liver transplant were favorable predictors of recipient outcomes, whereas ICU stay before LT and transplantation during 2002-12 were unfavorable. Conclusion: Livers from ODs were used for candidates with higher acuity. Pediatric recipients of livers from ODs had worse outcome compared to YDs; however, living donor LT from ODs had the least negative impact on recipient outcomes.
MeSH term(s)	Adult ; Child ; Humans ; United States ; Liver Transplantation ; End Stage Liver Disease/surgery ; End Stage Liver Disease/diagnosis ; Severity of Illness Index ; Living Donors ; Treatment Outcome ; Graft Survival ; Retrospective Studies
Language	English
Publishing date	2023-12-27
Publishing country	United States
Document type	Journal Article
ZDB-ID	603201-1
ISSN	1536-4801 ; 0277-2116
ISSN (online)	1536-4801
ISSN	0277-2116
DOI	10.1002/jpn3.12106
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Article ; Online: Effect of Ketamine and Fentanyl in Combination with Midazolam and Propofol during Outpatient Colonoscopy-A Randomised Controlled Trial

Madhusudan Upadya / S Neeta / Gagan Brar / Anand Kulkarni / Jose Chacko

Journal of Clinical and Diagnostic Research, Vol 12, Iss 9, Pp UC05-UC

2018 Volume 09

Abstract: Introduction: There are various methods for sedation in colonoscopy and ketamine has been found to be an effective alternative drug for sedation. Aim: To compare the efficacy and haemodynamic stability of lower dose of ketamine and fentanyl co- ... ...

Abstract	Introduction: There are various methods for sedation in colonoscopy and ketamine has been found to be an effective alternative drug for sedation. Aim: To compare the efficacy and haemodynamic stability of lower dose of ketamine and fentanyl co-administered with midazolam and propofol for colonoscopy. Materials and Methods: Sixty American Society of Anaesthesiologists (ASA) I-II patients undergoing colonoscopy were randomised into two groups. Group I (n=30) (Fentanyl group) was assigned to receive midazolam 20µg/kg, propofol and fentanyl 2µg/kg. Group II (n=30) (Ketamine group) was assigned to receive midazolam 20µg/kg, propofol and ketamine 0.5mg/kg. The parameters measured include haemodynamic stability, recovery, pain scores and endoscopists' satisfaction. All statistical analysis was carried out using Medcalc Statistical Software version 11.0 (Medcalc Software bvba, Belgium). Results: The time to full sedation in the ketamine group was significantly less than that in the fentanyl group (18.3±2.7 seconds Vs 22.4±2.2 seconds). Patients belonging to the ketamine group had a significantly shorter recovery time compared to those in the fentanyl group (5.8±1.4 Vs 8.0±1.9 minutes). Overall patient satisfaction was significantly higher with the use of ketamine. Patients were haemodynamically more stable with a lower incidence of hypotension in ketamine group. Conclusion: The present study shows that midazolam/ketamine /propofol combination provides adequate levels of analgesia and sedation, quicker recovery and has “propofol sparing” effect.
Keywords	anaesthesia ; analgesia ; recovery ; sedation ; Medicine ; R
Language	English
Publishing date	2018-09-01T00:00:00Z
Publisher	JCDR Research and Publications Private Limited
Document type	Article ; Online
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Article ; Online: Clinical study of safety and immunogenicity of pentavalent DTP-HB-Hib vaccine administered by disposable-syringe jet injector in India.

Bavdekar, Ashish / Malshe, Nandini / Ravichandran, Latha / Sapru, Amita / Kawade, Anand / Lalwani, Sanjay / Palkar, Sonali / Hanumante, Neeta / Gunale, Bhagwat / Kapse, Dhananjay / Chaudhari, Amol / Miller, Tara / Saganic, Laura / Jarrahian, Courtney / McGray, Sarah / Zehrung, Darin / Kulkarni, Prasad S

Contemporary clinical trials communications

2019 Volume 14, Page(s) 100321

Abstract: ... a three-dose series of vaccine intramuscularly by DSJI or N-S beginning at 6-8 weeks of age ... in the DSJI group. As a result, 128 subjects-DSJI group 61; N-S group 67-completed the study, rather ... similar to that of N-S for all five antigens. Pentavalent vaccine includes whole-cell pertussis vaccine ...

Abstract	Introduction: We conducted a randomized, observer-blind, non-inferiority, parallel-group clinical study of diphtheria, tetanus, pertussis, hepatitis B, and Methods: Healthy children received a three-dose series of vaccine intramuscularly by DSJI or N-S beginning at 6-8 weeks of age. Immunoglobulin G antibody levels were measured by ELISA at 4-6 weeks after the third dose. The main secondary endpoint was safety, measured as injection site and systemic reactions. Discussion: The study was stopped early out of caution beyond that specified in the protocol stopping criteria, after the Data Safety Committee noted a higher frequency of injection site reactions, especially moderate and severe, in the DSJI group. As a result, 128 subjects-DSJI group 61; N-S group 67-completed the study, rather than the 340 planned, and the study was not sufficiently powered to compare immunogenicity endpoints for the groups. Descriptive statistics indicate that seropositivity induced by vaccination with the DSJI was similar to that of N-S for all five antigens. Pentavalent vaccine includes whole-cell pertussis vaccine and an aluminum adjuvant, which may have contributed to the higher number of local reactions with the DSJI. The reactions caused no serious or long-term sequelae, and may be more acceptable in other populations or circumstances.US National Institutes of Health clinical trials identifier: NCT02409095.
Language	English
Publishing date	2019-01-09
Publishing country	Netherlands
Document type	Journal Article
ISSN	2451-8654
ISSN (online)	2451-8654
DOI	10.1016/j.conctc.2019.100321
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Article ; Online: Protective Effects of Rifampicin and Its Analog Rifampicin Quinone in a Mouse Model of Obesity-Induced Type 2 Diabetes.

Garg, Amit / Alam, Maroof / Bai, Shakuntala / Dandawate, Monica / Kumari, Neeta / Gupta, Sonu / Agrawal, Usha / Nagarajan, Perumal / Reddy, Dumbala Srinivasa / Kulkarni, Mahesh J / Mukhopadhyay, Arnab

ACS pharmacology & translational science

2023 Volume 6, Issue 2, Page(s) 253–269

Abstract: Advanced glycation end-products (AGEs) form when glucose reacts non-enzymatically with proteins, leading to abnormal protein function, oxidative stress, and inflammation. AGEs are associated with aging and age-related diseases; their formation is ... ...

Abstract	Advanced glycation end-products (AGEs) form when glucose reacts non-enzymatically with proteins, leading to abnormal protein function, oxidative stress, and inflammation. AGEs are associated with aging and age-related diseases; their formation is aggravated during diabetes. Therefore, drugs preventing AGE formation can potentially treat diabetic complications, positively affecting health. Earlier, we demonstrated that rifampicin and its analogs have potent anti-glycating activities and increase the life span of
Language	English
Publishing date	2023-01-12
Publishing country	United States
Document type	Journal Article
ISSN	2575-9108
ISSN (online)	2575-9108
DOI	10.1021/acsptsci.2c00082
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Article ; Online: Clinical study of safety and immunogenicity of pentavalent DTP-HB-Hib vaccine administered by disposable-syringe jet injector in India

Ashish Bavdekar / Nandini Malshe / Latha Ravichandran / Amita Sapru / Anand Kawade / Sanjay Lalwani / Sonali Palkar / Neeta Hanumante / Bhagwat Gunale / Dhananjay Kapse / Amol Chaudhari / Tara Miller / Laura Saganic / Courtney Jarrahian / Sarah McGray / Darin Zehrung / Prasad S. Kulkarni

Contemporary Clinical Trials Communications, Vol 14, Iss , Pp - (2019)

2019

Abstract: ... vaccination via disposable-syringe jet injector (DSJI) was non-inferior to that via needle and syringe (N-S ... a three-dose series of vaccine intramuscularly by DSJI or N-S beginning at 6–8 weeks of age ... group. As a result, 128 subjects—DSJI group 61; N-S group 67—completed the study, rather than the 340 ...

Abstract	Introduction: We conducted a randomized, observer-blind, non-inferiority, parallel-group clinical study of diphtheria, tetanus, pertussis, hepatitis B, and Haemophilus influenzae type b conjugate (pentavalent) vaccination of infants in India. Goals were to determine whether the seropositivity rate after vaccination via disposable-syringe jet injector (DSJI) was non-inferior to that via needle and syringe (N-S), and to compare the safety of vaccination by the two methods. Methods: Healthy children received a three-dose series of vaccine intramuscularly by DSJI or N-S beginning at 6–8 weeks of age. Immunoglobulin G antibody levels were measured by ELISA at 4–6 weeks after the third dose. The main secondary endpoint was safety, measured as injection site and systemic reactions. Discussion: The study was stopped early out of caution beyond that specified in the protocol stopping criteria, after the Data Safety Committee noted a higher frequency of injection site reactions, especially moderate and severe, in the DSJI group. As a result, 128 subjects—DSJI group 61; N-S group 67—completed the study, rather than the 340 planned, and the study was not sufficiently powered to compare immunogenicity endpoints for the groups. Descriptive statistics indicate that seropositivity induced by vaccination with the DSJI was similar to that of N-S for all five antigens. Pentavalent vaccine includes whole-cell pertussis vaccine and an aluminum adjuvant, which may have contributed to the higher number of local reactions with the DSJI. The reactions caused no serious or long-term sequelae, and may be more acceptable in other populations or circumstances.US National Institutes of Health clinical trials identifier: NCT02409095. Keywords: DTP-HB-Hib vaccine, Jet injector, DSJI, Vaccine adjuvant, Immunogenicity, Injection site reactions
Keywords	Medicine (General) ; R5-920
Subject code	630 ; 610
Language	English
Publishing date	2019-06-01T00:00:00Z
Publisher	Elsevier
Document type	Article ; Online
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Article: Neutrophils in induced sputum from healthy children: role of interleukin-8 and oxidative stress.

Kulkarni, Neeta / Cooke, Marcus S / Grigg, Jonathan

Respiratory medicine

2007 Volume 101, Issue 10, Page(s) 2108–2112

Abstract: Background: It is unclear why the neutrophil differential count in induced sputum (IS) from normal children is highly variable. Since levels of neutrophil chemoattractant cytokines and oxidative stress are determinants of airway neutrophilia in animal ... ...

Abstract	Background: It is unclear why the neutrophil differential count in induced sputum (IS) from normal children is highly variable. Since levels of neutrophil chemoattractant cytokines and oxidative stress are determinants of airway neutrophilia in animal models, we sought to determine the association between IS neutrophils from healthy children and (i) interleukin-8 (IL-8) and (ii) the oxidative stress marker 8-oxo-7,8-dihydro-2'-deoxyguanosine (8-oxodG). Methods: IS was done using hypertonic saline. The proportion (differential %) and the absolute number of IS neutrophils were determined by light microscopy. IS IL-8 and 8-oxodG were determined using ELISA. Spearman's rank correlation (Rs) was used to assess relationship between variables. Results: Adequate IS samples for analysis were obtained from 64/114 healthy children. The median (interquartile range) neutrophil differential count (n=64) was 20.6% (5.67-56), and absolute neutrophil count (n=53) was 0.11x10(6) (0.01-0.77). Both the % neutrophils, and the absolute neutrophil count were associated with IL-8 (Rs=0.67, p<0.0001 and 0.60, p<0.0001, respectively), but there was no association between IS neutrophil variables and 8-oxodG (n=40). The repeatability (intraclass correlation coefficient-Ri) of the neutrophil differential count was 0.58 (n=15). Conclusions: The variation in the proportion and number of neutrophils in the lower airway of healthy children is associated with IL-8, but not with oxidative stress. The IS neutrophil differential count in healthy children is relatively stable over several months.
MeSH term(s)	Adolescent ; Child ; Female ; Humans ; Interleukin-8/analysis ; Interleukin-8/immunology ; Leukocyte Count ; Male ; Neutrophils/immunology ; Oxidative Stress/immunology ; Sputum/cytology ; Sputum/immunology
Chemical Substances	Interleukin-8
Language	English
Publishing date	2007-10
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	1003348-8
ISSN	1532-3064 ; 0954-6111
ISSN (online)	1532-3064
ISSN	0954-6111
DOI	10.1016/j.rmed.2007.05.018
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Article ; Online: Tuberculosis preventive treatment should be considered for all household contacts of pulmonary tuberculosis patients in India.

Paradkar, Mandar / Padmapriyadarsini, Chandrasekaran / Jain, Divyashri / Shivakumar, Shri Vijay Bala Yogendra / Thiruvengadam, Kannan / Gupte, Akshay N / Thomas, Beena / Kinikar, Aarti / Sekar, Krithika / Bharadwaj, Renu / Dolla, Chandra Kumar / Gaikwad, Sanjay / Elilarasi, S / Lokhande, Rahul / Reddy, Devarajulu / Murali, Lakshmi / Kulkarni, Vandana / Pradhan, Neeta / Hanna, Luke Elizabeth /

Pattabiraman, Sathyamurthi / Kohli, Rewa / S, Rani / Suryavanshi, Nishi / B M, Shrinivasa / Cox, Samyra R / Selvaraju, Sriram / Gupte, Nikhil / Mave, Vidya / Gupta, Amita / Bollinger, Robert C

PloS one

2020 Volume 15, Issue 7, Page(s) e0236743

Abstract: The World Health Organization (WHO) recently changed its guidance for tuberculosis (TB) preventive treatment (TPT) recommending TPT for all pulmonary TB (PTB) exposed household contacts (HHC) to prevent incident TB disease (iTBD), regardless of TB ... ...

Abstract	The World Health Organization (WHO) recently changed its guidance for tuberculosis (TB) preventive treatment (TPT) recommending TPT for all pulmonary TB (PTB) exposed household contacts (HHC) to prevent incident TB disease (iTBD), regardless of TB infection (TBI) status. However, this recommendation was conditional as the strength of evidence was not strong. We assessed risk factors for iTBD in recently-exposed adult and pediatric Indian HHC, to determine which HHC subgroups might benefit most from TPT. We prospectively enrolled consenting HHC of adult PTB patients in Pune and Chennai, India. They underwent clinical, microbiologic and radiologic screening for TB disease (TBD) and TBI, at enrollment, 4-6, 12 and 24 months. TBI testing was performed by tuberculin skin test (TST) and Quantiferon®- Gold-in-Tube (QGIT) assay. HHC without baseline TBD were followed for development of iTBI and iTBD. Using mixed-effect Poisson regression, we assessed baseline characteristics including TBI status, and incident TBI (iTBI) using several TST and/or QGIT cut-offs, as potential risk factors for iTBD. Of 1051 HHC enrolled, 42 (4%) with baseline TBD and 12 (1%) with no baseline TBI test available, were excluded. Of the remaining 997 HHC, 707 (71%) had baseline TBI (TST #x2265; 5 mm or QGIT #x2265; 0.35 IU/ml). Overall, 20 HHC (2%) developed iTBD (12 cases/1000 person-years, 95%CI: 8-19). HIV infection (aIRR = 29.08, 95% CI: 2.38-355.77, p = 0.01) and undernutrition (aIRR = 6.16, 95% CI: 1.89-20.03, p = 0.003) were independently associated with iTBD. iTBD was not associated with age, diabetes mellitus, smoking, alcohol, and baseline TBI, or iTBI, regardless of TST (#x2265; 5 mm, #x2265; 10 mm, #x2265; 6 mm increase) or QGIT (#x2265; 0.35 IU/ml, #x2265; 0.7 IU/ml) cut-offs. Given the high overall risk of iTBD among recently exposed HHCs, and the lack of association between TBI status and iTBD, our findings support the new WHO recommendation to offer TPT to all HHC of PTB patients residing in a high TB burden country such as India, and do not suggest any benefit of TBI testing at baseline or during follow-up to risk stratify recently-exposed HHC for TPT.
MeSH term(s)	Adolescent ; Adult ; Child ; Child, Preschool ; Female ; Housing ; Humans ; Incidence ; India/epidemiology ; Male ; Middle Aged ; Risk Factors ; Tuberculosis, Pulmonary/epidemiology ; Tuberculosis, Pulmonary/prevention & control ; Tuberculosis, Pulmonary/transmission ; Young Adult
Language	English
Publishing date	2020-07-29
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ISSN	1932-6203
ISSN (online)	1932-6203
DOI	10.1371/journal.pone.0236743
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Article ; Online: Immunogenicity and lot-to-lot consistency of a ready to use liquid bovine-human reassortant pentavalent rotavirus vaccine (ROTASIIL - Liquid) in Indian infants.

Kawade, Anand / Babji, Sudhir / Kamath, Veena / Raut, Abhishek / Kumar, Chandra Mohan / Kundu, Ritabrata / Venkatramanan, Padmasani / Lalwani, Sanjay K / Bavdekar, Ashish / Juvekar, Sanjay / Dayma, Girish / Patil, Rakesh / Kulkarni, Muralidhar / Hegde, Asha / Nayak, Dinesh / Garg, B S / Gupta, Subodh / Jategaonkar, Smita / Bedi, Nidhi /

Maliye, Chetna / Ganguly, Nupur / Uttam, Kheya Ghosh / Niyogi, Prabal / Palkar, Sonali / Hanumante, Neeta / Goyal, Nidhi / Arya, Alok / Aslam, Mohd / Parulekar, Varsha / Dharmadhikari, Abhijeet / Gaikwad, Dutta / Zade, Jagdish / Desai, Sajjad / Kang, Gagandeep / Kulkarni, Prasad S

Vaccine

2019 Volume 37, Issue 19, Page(s) 2554–2560

Abstract: Background: A lyophilized bovine-human rotavirus reassortant pentavalent vaccine (BRV-PV, Rotasiil®) was licensed in 2016. A liquid formulation of this vaccine (LBRV-PV, Rotasiil - Liquid) was subsequently developed and was tested for non-inferiority to ...

Abstract	Background: A lyophilized bovine-human rotavirus reassortant pentavalent vaccine (BRV-PV, Rotasiil®) was licensed in 2016. A liquid formulation of this vaccine (LBRV-PV, Rotasiil - Liquid) was subsequently developed and was tested for non-inferiority to Rotasiil® and for lot-to-lot consistency. Methods: This Phase II/III, open label, randomized study was conducted at seven sites across India from November 2017 to June 2018. Participants were randomized into four arms; Lots A, B, and C of LBRV-PV and Rotasiil® in 1:1:1:1 ratio. Three doses of study vaccines were given at 6, 10, and 14 weeks of age. Blood samples were collected four weeks after the third dose to assess rotavirus IgA antibody levels. Non-inferiority of LBRV-PV to Rotasiil was proven if the lower limit two-sided 95% confidence interval (CI) of geometric mean concentration (GMC) ratio was at least 0.5. Lot-to-lot consistency was proven if 95% CI of the GMC ratios of three lots were between 0.5 and 2. Solicited reactions were collected by using diary cards. Results: Of the 1500 randomized infants, 1436 infants completed the study. The IgA GMC ratio of LBRV-PV to Rotasiil® was 1.19 (95% CI 0.96, 1.48). The corresponding IgA seropositivity rates were 60.41% (57.41, 63.35) and 52.75% (47.48, 57.97). The IgA GMC ratios among the three LBRV-PV lots were: Lot A versus Lot B: 1.34 (1.03, 1.75); Lot A versus Lot C: 1.22 (0.93, 1.60); and Lot B versus Lot C: 0.91 (0.69, 1.19). The 95% CIs for the GMC ratios were between 0.69 and 1.75. The incidence of solicited reactions was comparable across the four arms. Only one serious adverse event of gastroenteritis event in the Rotasiil® group was causally related. Conclusion: The immunological non-inferiority of LBRV-PV against Rotasiil® as well as lot-to-lot consistency of LBRV-PV was demonstrated. LBRV-PV had safety profile similar to Rotasiil®. Trial registration number: Clinical Trials.Gov [NCT03474055] and Clinical Trial Registry of India [CTRI/2017/10/010104].
MeSH term(s)	Age Factors ; Animals ; Antibodies, Viral/immunology ; Cattle ; Female ; Gastroenteritis/prevention & control ; Humans ; Immunogenicity, Vaccine ; India ; Infant ; Male ; Outcome Assessment, Health Care ; Reassortant Viruses/immunology ; Rotavirus/immunology ; Rotavirus Infections/prevention & control ; Rotavirus Vaccines/administration & dosage ; Rotavirus Vaccines/adverse effects ; Rotavirus Vaccines/immunology ; Rotavirus Vaccines/standards ; Vaccination
Chemical Substances	Antibodies, Viral ; Rotavirus Vaccines
Language	English
Publishing date	2019-04-04
Publishing country	Netherlands
Document type	Clinical Trial, Phase II ; Clinical Trial, Phase III ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	605674-x
ISSN	1873-2518 ; 0264-410X
ISSN (online)	1873-2518
ISSN	0264-410X
DOI	10.1016/j.vaccine.2019.03.067
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Article ; Online: Tuberculosis preventive treatment should be considered for all household contacts of pulmonary tuberculosis patients in India.

Mandar Paradkar / Chandrasekaran Padmapriyadarsini / Divyashri Jain / Shri Vijay Bala Yogendra Shivakumar / Kannan Thiruvengadam / Akshay N Gupte / Beena Thomas / Aarti Kinikar / Krithika Sekar / Renu Bharadwaj / Chandra Kumar Dolla / Sanjay Gaikwad / S Elilarasi / Rahul Lokhande / Devarajulu Reddy / Lakshmi Murali / Vandana Kulkarni / Neeta Pradhan / Luke Elizabeth Hanna /

Sathyamurthi Pattabiraman / Rewa Kohli / Rani S / Nishi Suryavanshi / Shrinivasa B M / Samyra R Cox / Sriram Selvaraju / Nikhil Gupte / Vidya Mave / Amita Gupta / Robert C Bollinger / CTRIUMPH-RePORT India Study Team

PLoS ONE, Vol 15, Iss 7, p e

2020 Volume 0236743

Abstract	The World Health Organization (WHO) recently changed its guidance for tuberculosis (TB) preventive treatment (TPT) recommending TPT for all pulmonary TB (PTB) exposed household contacts (HHC) to prevent incident TB disease (iTBD), regardless of TB infection (TBI) status. However, this recommendation was conditional as the strength of evidence was not strong. We assessed risk factors for iTBD in recently-exposed adult and pediatric Indian HHC, to determine which HHC subgroups might benefit most from TPT. We prospectively enrolled consenting HHC of adult PTB patients in Pune and Chennai, India. They underwent clinical, microbiologic and radiologic screening for TB disease (TBD) and TBI, at enrollment, 4-6, 12 and 24 months. TBI testing was performed by tuberculin skin test (TST) and Quantiferon®- Gold-in-Tube (QGIT) assay. HHC without baseline TBD were followed for development of iTBI and iTBD. Using mixed-effect Poisson regression, we assessed baseline characteristics including TBI status, and incident TBI (iTBI) using several TST and/or QGIT cut-offs, as potential risk factors for iTBD. Of 1051 HHC enrolled, 42 (4%) with baseline TBD and 12 (1%) with no baseline TBI test available, were excluded. Of the remaining 997 HHC, 707 (71%) had baseline TBI (TST #x2265; 5 mm or QGIT #x2265; 0.35 IU/ml). Overall, 20 HHC (2%) developed iTBD (12 cases/1000 person-years, 95%CI: 8-19). HIV infection (aIRR = 29.08, 95% CI: 2.38-355.77, p = 0.01) and undernutrition (aIRR = 6.16, 95% CI: 1.89-20.03, p = 0.003) were independently associated with iTBD. iTBD was not associated with age, diabetes mellitus, smoking, alcohol, and baseline TBI, or iTBI, regardless of TST (#x2265; 5 mm, #x2265; 10 mm, #x2265; 6 mm increase) or QGIT (#x2265; 0.35 IU/ml, #x2265; 0.7 IU/ml) cut-offs. Given the high overall risk of iTBD among recently exposed HHCs, and the lack of association between TBI status and iTBD, our findings support the new WHO recommendation to offer TPT to all HHC of PTB patients residing in a high TB burden country such as ...
Keywords	Medicine ; R ; Science ; Q
Subject code	610
Language	English
Publishing date	2020-01-01T00:00:00Z
Publisher	Public Library of Science (PLoS)
Document type	Article ; Online
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Article: Immunogenicity and lot-to-lot consistency of a ready to use liquid bovine-human reassortant pentavalent rotavirus vaccine (ROTASIIL - Liquid) in Indian infants

Kawade, Anand / Arya, Alok / Aslam, Mohd / Babji, Sudhir / Bavdekar, Ashish / Bedi, Nidhi / Dayma, Girish / Desai, Sajjad / Dharmadhikari, Abhijeet / Gaikwad, Dutta / Ganguly, Nupur / Garg, B.S / Goyal, Nidhi / Gupta, Subodh / Hanumante, Neeta / Hegde, Asha / Jategaonkar, Smita / Juvekar, Sanjay / Kamath, Veena /

Kang, Gagandeep / Kulkarni, Muralidhar / Kulkarni, Prasad S / Kumar, Chandra Mohan / Kundu, Ritabrata / Lalwani, Sanjay K / Maliye, Chetna / Nayak, Dinesh / Niyogi, Prabal / Palkar, Sonali / Parulekar, Varsha / Patil, Rakesh / Raut, Abhishek / Uttam, Kheya Ghosh / Venkatramanan, Padmasani / Zade, Jagdish

Vaccine. 2019 May 01, v. 37, no. 19

2019

Abstract: A lyophilized bovine-human rotavirus reassortant pentavalent vaccine (BRV-PV, Rotasiil®) was licensed in 2016. A liquid formulation of this vaccine (LBRV-PV, Rotasiil - Liquid) was subsequently developed and was tested for non-inferiority to Rotasiil® ... ...

Abstract	A lyophilized bovine-human rotavirus reassortant pentavalent vaccine (BRV-PV, Rotasiil®) was licensed in 2016. A liquid formulation of this vaccine (LBRV-PV, Rotasiil - Liquid) was subsequently developed and was tested for non-inferiority to Rotasiil® and for lot-to-lot consistency.This Phase II/III, open label, randomized study was conducted at seven sites across India from November 2017 to June 2018. Participants were randomized into four arms; Lots A, B, and C of LBRV-PV and Rotasiil® in 1:1:1:1 ratio. Three doses of study vaccines were given at 6, 10, and 14 weeks of age. Blood samples were collected four weeks after the third dose to assess rotavirus IgA antibody levels. Non-inferiority of LBRV-PV to Rotasiil was proven if the lower limit two-sided 95% confidence interval (CI) of geometric mean concentration (GMC) ratio was at least 0.5. Lot-to-lot consistency was proven if 95% CI of the GMC ratios of three lots were between 0.5 and 2. Solicited reactions were collected by using diary cards.Of the 1500 randomized infants, 1436 infants completed the study. The IgA GMC ratio of LBRV-PV to Rotasiil® was 1.19 (95% CI 0.96, 1.48). The corresponding IgA seropositivity rates were 60.41% (57.41, 63.35) and 52.75% (47.48, 57.97). The IgA GMC ratios among the three LBRV-PV lots were: Lot A versus Lot B: 1.34 (1.03, 1.75); Lot A versus Lot C: 1.22 (0.93, 1.60); and Lot B versus Lot C: 0.91 (0.69, 1.19). The 95% CIs for the GMC ratios were between 0.69 and 1.75. The incidence of solicited reactions was comparable across the four arms. Only one serious adverse event of gastroenteritis event in the Rotasiil® group was causally related.The immunological non-inferiority of LBRV-PV against Rotasiil® as well as lot-to-lot consistency of LBRV-PV was demonstrated. LBRV-PV had safety profile similar to Rotasiil®.Trial registration number: Clinical Trials.Gov [NCT03474055] and Clinical Trial Registry of India [CTRI/2017/10/010104].
Keywords	antibodies ; blood sampling ; confidence interval ; freeze drying ; gastroenteritis ; geometry ; immunogenicity ; immunoglobulin A ; infants ; liquids ; Rotavirus ; seroprevalence ; vaccines ; India
Language	English
Dates of publication	2019-0501
Size	p. 2554-2560.
Publishing place	Elsevier Ltd
Document type	Article
ZDB-ID	605674-x
ISSN	1873-2518 ; 0264-410X
ISSN (online)	1873-2518
ISSN	0264-410X
DOI	10.1016/j.vaccine.2019.03.067
Database	NAL-Catalogue (AGRICOLA)

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