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Article: Safety assessment of Withania somnifera extract standardized for Withaferin A: Acute and sub-acute toxicity study.

Patel, Shruti B / Rao, Nirav J / Hingorani, Lal L

Journal of Ayurveda and integrative medicine

2016 Volume 7, Issue 1, Page(s) 30–37

Abstract: Background: The use of Withania somnifera is increasing due to a number of its chemical constituents found useful for health.: Objective: The present study was carried out to investigate the potential adverse effects (if any) of a standardized ... ...

Abstract	Background: The use of Withania somnifera is increasing due to a number of its chemical constituents found useful for health. Objective: The present study was carried out to investigate the potential adverse effects (if any) of a standardized Withania somnifera extract (WSE) in rats following acute and sub chronic administration. Materials and methods: The toxicity study was performed in Wistar rats by oral administration. An acute toxicity study was done at the dose of 2000 mg/kg. In the sub-acute study, Wistar rats (10/sex/group) were administered via gavage 0 (control), 500, 1000, 2000 mg/kg body weight/day of WSE for 28 days. Among two additional satellite groups, one group did not receive any drug while the second group received 2000 mg/kg/day for 28 days. At the end of study, the animals sacrificed and their body weight, hematology, serum chemistry, and histopathology evaluation was done. Results: In acute toxicity studies, oral LD50 of WSE in Wistar rats was greater than 2000 mg/kg body weight. Compared to the control group in sub-acute toxicity study, administration of extract did not show any toxicologically significant treatment related changes in clinical observations, ophthalmic examination, body weight gain, feed consumption, clinical pathology evaluation, and organ weight. Hematological and serum chemistry parameters were within the normal limits. Terminal necropsy did not reveal any treatment related gross or histopathological findings. Conclusion: Based on this study, the no-observed-adverse-effect-level of WSE is 2000 mg/kg body weight, the highest level tested.
Language	English
Publishing date	2016-05-24
Publishing country	United States
Document type	Journal Article
ISSN	0975-9476
ISSN	0975-9476
DOI	10.1016/j.jaim.2015.08.001
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Article ; Online: Sedation and analgesia in the mechanically ventilated patient.

Patel, Shruti B / Kress, John P

American journal of respiratory and critical care medicine

2012 Volume 185, Issue 5, Page(s) 486–497

Abstract: Sedation and analgesia are important components of care for the mechanically ventilated patient in the intensive care unit (ICU). An understanding of commonly used medications is essential to formulate a sedation plan for individual patients. The ... ...

Abstract	Sedation and analgesia are important components of care for the mechanically ventilated patient in the intensive care unit (ICU). An understanding of commonly used medications is essential to formulate a sedation plan for individual patients. The specific physiological changes that a critically ill patient undergoes can have direct effects on the pharmacology of drugs, potentially leading to interpatient differences in response. Objective assessments of pain, sedation, and agitation have been validated for use in the ICU for assessment and titration of medications. An evidence-based strategy for administering these drugs can lead to improvements in short- and long-term outcomes for patients. In this article, we review advances in the field of ICU sedation to provide an up-to-date perspective on management of the mechanically ventilated ICU patient.
MeSH term(s)	Analgesia/methods ; Conscious Sedation/methods ; Delirium/prevention & control ; Humans ; Hypnotics and Sedatives/administration & dosage ; Hypnotics and Sedatives/therapeutic use ; Intensive Care Units ; Psychomotor Agitation/drug therapy ; Respiration, Artificial/adverse effects ; Respiration, Artificial/methods
Chemical Substances	Hypnotics and Sedatives
Language	English
Publishing date	2012-03-01
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	1180953-x
ISSN	1535-4970 ; 0003-0805 ; 1073-449X
ISSN (online)	1535-4970
ISSN	0003-0805 ; 1073-449X
DOI	10.1164/rccm.201102-0273CI
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Article ; Online: Effect of early mobilisation on long-term cognitive impairment in critical illness in the USA: a randomised controlled trial.

Patel, Bhakti K / Wolfe, Krysta S / Patel, Shruti B / Dugan, Karen C / Esbrook, Cheryl L / Pawlik, Amy J / Stulberg, Megan / Kemple, Crystal / Teele, Megan / Zeleny, Erin / Hedeker, Donald / Pohlman, Anne S / Arora, Vineet M / Hall, Jesse B / Kress, John P

The Lancet. Respiratory medicine

2023 Volume 11, Issue 6, Page(s) 563–572

Abstract: Background: Patients who have received mechanical ventilation can have prolonged cognitive impairment for which there is no known treatment. We aimed to establish whether early mobilisation could reduce the rates of cognitive impairment and other ... ...

Abstract	Background: Patients who have received mechanical ventilation can have prolonged cognitive impairment for which there is no known treatment. We aimed to establish whether early mobilisation could reduce the rates of cognitive impairment and other aspects of disability 1 year after critical illness. Methods: In this single-centre, parallel, randomised controlled trial, patients admitted to the adult medical-surgical intensive-care unit (ICU), at the University of Chicago (IL, USA), were recruited. Inclusion criteria were adult patients (aged ≥18 years) who were functionally independent and mechanically ventilated at baseline and within the first 96 h of mechanical ventilation, and expected to continue for at least 24 h. Patients were randomly assigned (1:1) via computer-generated permuted balanced block randomisation to early physical and occupational therapy (early mobilisation) or usual care. An investigator designated each assignment in consecutively numbered, sealed, opaque envelopes; they had no further involvement in the trial. Only the assessors were masked to group assignment. The primary outcome was cognitive impairment 1 year after hospital discharge, measured with a Montreal Cognitive Assessment. Patients were assessed for cognitive impairment, neuromuscular weakness, institution-free days, functional independence, and quality of life at hospital discharge and 1 year. Analysis was by intention to treat. This trial was registered with ClinicalTrials.gov, number NCT01777035, and is now completed. Findings: Between Aug 11, 2011, and Oct 24, 2019, 1222 patients were screened, 200 were enrolled (usual care n=100, intervention n=100), and one patient withdrew from the study in each group; thus 99 patients in each group were included in the intention-to-treat analysis (113 [57%] men and 85 [43%] women). 65 (88%) of 74 in the usual care group and 62 (89%) of 70 in the intervention group underwent testing for cognitive impairment at 1 year. The rate of cognitive impairment at 1 year with early mobilisation was 24% (24 of 99 patients) compared with 43% (43 of 99) with usual care (absolute difference -19·2%, 95% CI -32·1 to -6·3%; p=0·0043). Cognitive impairment was lower at hospital discharge in the intervention group (53 [54%] 99 patients vs 68 [69%] 99 patients; -15·2%, -28·6 to -1·7; p=0·029). At 1 year, the intervention group had fewer ICU-acquired weaknesses (none [0%] of 99 patients vs 14 [14%] of 99 patients; -14·1%; -21·0 to -7·3; p=0·0001) and higher physical component scores on quality-of-life testing than did the usual care group (median 52·4 [IQR 45·3-56·8] vs median 41·1 [31·8-49·4]; p<0·0001). There was no difference in the rates of functional independence (64 [65%] of 99 patients vs 61 [62%] of 99 patients; 3%, -10·4 to 16·5%; p=0·66) or mental component scores (median 55·9 [50·2-58·9] vs median 55·2 [49·5-59·7]; p=0·98) between the intervention and usual care groups at 1 year. Seven adverse events (haemodynamic changes [n=3], arterial catheter removal [n=1], rectal tube dislodgement [n=1], and respiratory distress [n=2]) were reported in six (6%) of 99 patients in the intervention group and in none of the patients in the usual care group (p=0·029). Interpretation: Early mobilisation might be the first known intervention to improve long-term cognitive impairment in ICU survivors after mechanical ventilation. These findings clearly emphasise the importance of avoiding delays in initiating mobilisation. However, the increased adverse events in the intervention group warrants further investigation to replicate these findings. Funding: None.
MeSH term(s)	Adult ; Male ; Humans ; Female ; Adolescent ; Early Ambulation/adverse effects ; Critical Illness/therapy ; Quality of Life ; Intensive Care Units ; Cognitive Dysfunction/therapy ; Cognitive Dysfunction/etiology ; Treatment Outcome
Language	English
Publishing date	2023-01-21
Publishing country	England
Document type	Randomized Controlled Trial ; Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	2686754-0
ISSN	2213-2619 ; 2213-2600
ISSN (online)	2213-2619
ISSN	2213-2600
DOI	10.1016/S2213-2600(22)00489-1
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Article ; Online: Disruption of the circadian rhythm of melatonin: A biomarker of critical illness severity.

Melone, Marie-Anne / Becker, Taylor C / Wendt, Linder H / Ten Eyck, Patrick / Patel, Shruti B / Poston, Jason / Pohlman, Anne S / Pohlman, Mark / Miller, Annette / Nedeltcheva, Arlet / Hall, Jesse B / Van Cauter, Eve / Zabner, Joseph / Gehlbach, Brian K

Sleep medicine

2023 Volume 110, Page(s) 60–67

Abstract: Circadian dysrhythmias occur commonly in critically ill patients reflecting variable effects of underlying illness, ICU environment, and treatments. We retrospectively analyzed the relationship between clinical outcomes and 24-h urinary 6- ... ...

Abstract	Circadian dysrhythmias occur commonly in critically ill patients reflecting variable effects of underlying illness, ICU environment, and treatments. We retrospectively analyzed the relationship between clinical outcomes and 24-h urinary 6-sulfatoxymelatonin (aMT6s) excretion profiles in 37 critically ill patients with shock and/or respiratory failure. Nonlinear regression was used to fit a 24-h cosine curve to each patient's aMT6s profile, with rhythmicity determined by the zero-amplitude test. From these curves we determined acrophase, amplitude, phase, and night/day ratio. After assessing unadjusted relationships, we identified the optimal multivariate models for hospital survival and for discharge to home (vs. death or transfer to another facility). Normalized aMT6s rhythm amplitude was greater (p = 0.005) in patients discharged home than in those who were not, while both groups exhibited a phase delay. Patients with rhythmic aMT6s excretion were more likely to survive (OR 5.25) and be discharged home (OR 8.89; p < 0.05 for both) than patients with arrhythmic profiles, associations that persisted in multivariate modelling. In critically ill patients with shock and/or respiratory failure, arrhythmic and/or low amplitude 24-h aMT6s rhythms were associated with worse clinical outcomes, suggesting a role for the melatonin-based rhythm as a novel biomarker of critical illness severity.
MeSH term(s)	Humans ; Melatonin ; Critical Illness ; Retrospective Studies ; Circadian Rhythm ; Biomarkers
Chemical Substances	Melatonin (JL5DK93RCL) ; Biomarkers
Language	English
Publishing date	2023-07-28
Publishing country	Netherlands
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	2012041-2
ISSN	1878-5506 ; 1389-9457
ISSN (online)	1878-5506
ISSN	1389-9457
DOI	10.1016/j.sleep.2023.07.033
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Article ; Online: Accurate identification of delirium in the ICU: problems with translating the evidence in the real-life setting.

Patel, Shruti B / Kress, John P

American journal of respiratory and critical care medicine

2011 Volume 184, Issue 3, Page(s) 287–288

MeSH term(s)	Critical Illness ; Delirium/diagnosis ; Humans ; Intensive Care Units ; Prognosis
Language	English
Publishing date	2011-08-01
Publishing country	United States
Document type	Comment ; Editorial
ZDB-ID	1180953-x
ISSN	1535-4970 ; 0003-0805 ; 1073-449X
ISSN (online)	1535-4970
ISSN	0003-0805 ; 1073-449X
DOI	10.1164/rccm.201106-0988ED
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Article ; Online: Early tracheotomy after cardiac surgery: not ready for prime time.

Patel, Shruti B / Kress, John P

Annals of internal medicine

2011 Volume 154, Issue 6, Page(s) 434–435

MeSH term(s)	Cardiac Surgical Procedures ; Humans ; Intubation, Intratracheal/methods ; Respiration, Artificial/methods ; Time Factors ; Tracheotomy/methods
Language	English
Publishing date	2011-03-15
Publishing country	United States
Document type	Comment ; Editorial
ZDB-ID	336-0
ISSN	1539-3704 ; 0003-4819
ISSN (online)	1539-3704
ISSN	0003-4819
DOI	10.7326/0003-4819-154-6-201103150-00011
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Article ; Online: Reply: The importance of determining the reason for intensive care unit delirium.

Kress, John P / Patel, Shruti B / Hall, Jesse B

American journal of respiratory and critical care medicine

2014 Volume 189, Issue 11, Page(s) 1444–1445

MeSH term(s)	Conscious Sedation/adverse effects ; Delirium/chemically induced ; Female ; Fentanyl/adverse effects ; Humans ; Hypnotics and Sedatives/adverse effects ; Intensive Care Units ; Male ; Propofol/adverse effects
Chemical Substances	Hypnotics and Sedatives ; Fentanyl (UF599785JZ) ; Propofol (YI7VU623SF)
Language	English
Publishing date	2014-06-02
Publishing country	United States
Document type	Letter ; Comment
ZDB-ID	1180953-x
ISSN	1535-4970 ; 0003-0805 ; 1073-449X
ISSN (online)	1535-4970
ISSN	0003-0805 ; 1073-449X
DOI	10.1164/rccm.201404-0637LE
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Article: Safety assessment of Withania somnifera extract standardized for Withaferin A: Acute and sub-acute toxicity study

Patel, Shruti B. / Rao, Nirav J. / Hingorani, Lal L.

Transdisciplinary University, Bangalore and World Ayurveda Foundation Journal of Ayurveda and integrative medicine. 2016 Mar., v. 7, no. 1

2016

Abstract: The use of Withania somnifera is increasing due to a number of its chemical constituents found useful for health.The present study was carried out to investigate the potential adverse effects (if any) of a standardized Withania somnifera extract (WSE) in ...

Abstract	The use of Withania somnifera is increasing due to a number of its chemical constituents found useful for health.The present study was carried out to investigate the potential adverse effects (if any) of a standardized Withania somnifera extract (WSE) in rats following acute and sub chronic administration.The toxicity study was performed in Wistar rats by oral administration. An acute toxicity study was done at the dose of 2000 mg/kg. In the sub-acute study, Wistar rats (10/sex/group) were administered via gavage 0 (control), 500, 1000, 2000 mg/kg body weight/day of WSE for 28 days. Among two additional satellite groups, one group did not receive any drug while the second group received 2000 mg/kg/day for 28 days. At the end of study, the animals sacrificed and their body weight, hematology, serum chemistry, and histopathology evaluation was done.In acute toxicity studies, oral LD50 of WSE in Wistar rats was greater than 2000 mg/kg body weight. Compared to the control group in sub-acute toxicity study, administration of extract did not show any toxicologically significant treatment related changes in clinical observations, ophthalmic examination, body weight gain, feed consumption, clinical pathology evaluation, and organ weight. Hematological and serum chemistry parameters were within the normal limits. Terminal necropsy did not reveal any treatment related gross or histopathological findings.Based on this study, the no-observed-adverse-effect-level of WSE is 2000 mg/kg body weight, the highest level tested.
Keywords	Ayurvedic medicine ; Withania somnifera ; acute toxicity ; blood chemistry ; body weight changes ; drugs ; feed intake ; hematology ; histopathology ; lethal dose 50 ; necropsy ; no observed adverse effect level ; oral administration ; safety assessment ; satellites ; tissue weight
Language	English
Dates of publication	2016-03
Size	p. 30-37.
Publishing place	Elsevier B.V.
Document type	Article
ISSN	0975-9476
DOI	10.1016/j.jaim.2015.08.001
Database	NAL-Catalogue (AGRICOLA)

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Article ; Online: A microRNA processing defect in rapidly progressing idiopathic pulmonary fibrosis; enteral omega-3 fatty acid, γ-linoleic acid, and antioxidant supplementation in ALI; and management of asthma in pregnancy guided by exhaled nitric oxide.

Patel, Bhakti K / Vij, Rekha / Patel, Shruti B

American journal of respiratory and critical care medicine

2012 Volume 186, Issue 5, Page(s) 458–459

Language	English
Publishing date	2012-09-01
Publishing country	United States
Document type	Comment ; Journal Article
ZDB-ID	1180953-x
ISSN	1535-4970 ; 0003-0805 ; 1073-449X
ISSN (online)	1535-4970
ISSN	0003-0805 ; 1073-449X
DOI	10.1164/rccm.201202-0328RR
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Article ; Online: The Effects of Timed Light Exposure in Critically Ill Patients: A Randomized Controlled Pilot Clinical Trial.

Gehlbach, Brian K / Patel, Shruti B / Van Cauter, Eve / Pohlman, Anne S / Hall, Jesse B / Zabner, Joseph

American journal of respiratory and critical care medicine

2018 Volume 198, Issue 2, Page(s) 275–278

MeSH term(s)	Adult ; Aged ; Aged, 80 and over ; Circadian Rhythm/physiology ; Cohort Studies ; Critical Illness/rehabilitation ; Female ; Humans ; Male ; Middle Aged ; Phototherapy/methods ; Pilot Projects ; Time Factors
Language	English
Publishing date	2018-03-13
Publishing country	United States
Document type	Letter ; Randomized Controlled Trial ; Research Support, N.I.H., Extramural
ZDB-ID	1180953-x
ISSN	1535-4970 ; 0003-0805 ; 1073-449X
ISSN (online)	1535-4970
ISSN	0003-0805 ; 1073-449X
DOI	10.1164/rccm.201801-0170LE
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