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1. Effects of Empagliflozin on Fluid Overload, Weight, and Blood Pressure in CKD

Author

Mayne, Kaitlin J., Staplin, Natalie, Keane, David F., Wanner, Christoph, Brenner, Susanne, Cejka, Vladimir, Stegbauer, Johannes, Judge, Parminder K., Preiss, David, Emberson, Jonathan, Trinca, Daniele, Dayanandan, Rejive, Lee, Ryonfa, Nolan, John, Omata, Akiko, Green, Jennifer B., Cherney, David Z.I., Hooi, Lai Seong, Pontremoli, Roberto, Tuttle, Katherine R., Lees, Jennifer S., Mark, Patrick B., Davies, Simon J., Hauske, Sibylle J., Steubl, Dominik, Brückmann, Martina, Landray, Martin J., Baigent, Colin, Haynes, Richard, Herrington, William G., Baigent, Colin, Landray, Martin J., Wanner, Christoph, Herrington, William G., Haynes, Richard, Green, Jennifer B., Hauske, Sibylle J., Brueckmann, Martina, Hopley, Mark, von-Eynatten, Maximillian, George, Jyothis, Brenner, Susanne, Cheung, Alfred K., Preiss, David, Liu, Zhi-Hong, Li, Jing, Hooi, Laiseong, Liu, Wen, Kadowaki, Takashi, Nangaku, Masaomi, Levin, Adeera, Cherney, David, Pontremoli, Roberto, Maggioni, Aldo P., Staplin, Natalie, Emberson, Jonathan, Hantel, Stefan, Goto, Shinya, Deo, Rajat, Tuttle, Katherine R., Hill, Michael, Judge, Parminder, Mayne, Kaitlin J., Ng, Sarah Y.A., Rossello, Xavier, Sammons, Emily, Zhu, Doreen, Sandercock, Peter, Bilous, Rudolf, Herzog, Charles, Whelton, Paul, Wittes, Janet, Bennett, Derrick, Achiri, Patricia, Ambrose, Chrissie, Badin, Cristina, Barton, Jill, Brown, Richard, Burke, Andy, Butler, Sebastian, Dayanandan, Rejive, Donaldson, Pia, Dykas, Robert, Fletcher, Lucy, Frederick, Kate, Kingston, Hannah, Gray, Mo, Harding, Emily, Hashimoto, Akiko, Howie, Lyn, Hurley, Susan, Lee, Ryonfa, Luker, Nik, Murphy, Kevin, Nakahara, Mariko, Nolan, John, Nunn, Michelle, Mulligan, Sorcha, Omata, Akiko, Pickworth, Sandra, Qiao, YanRu, Shah, Shraddha, Taylor, Karen, Timadjer, Alison, Willett, Monique, Wincott, Liz, Yan, Qin, Yu, Hui, Bowman, Louise, Chen, Fang, Clarke, Robert, Goonasekera, Michelle, Haynes, Richard, Herrington, William G., Judge, Parminder, Karsan, Waseem, Mafham, Marion, Mayne, Kaitlin J., Ng, Sarah Y. A., Preiss, David, Reith, Christina, Sammons, Emily, Zayed, Mohammed, Zhu, Doreen, Ellison, Ritva, Moys, Rowan, Stevens, Will, Verdel, Kevin, Wallendszus, Karl, Bowler, Chris, Brewer, Anna, Measor, Andy, Cui, Guanguo, Daniels, Charles, Field, Angela, Goodenough, Bob, Lawson, Ashley, Mostefai, Youcef, Radhakrishnan, Dheeptha, Syed, Samee, Xia, Shuang, Adewuyi-Dalton, Ruth, Arnold, Thomas, Beneat, Anne-Marie, Bhatt, Anoushka, Bird, Chloe, Breach, Andrew, Brown, Laura, Caple, Mark, Chavagnon, Tatyana, Chung, Karen, Clark, Sarah, Condurache, Luminita, Eichstadt, Katarzyna, Obrero, Marta Espino, Forest, Scarlett, French, Helen, Goodwin, Nick, Gordon, Andrew, Gordon, Joanne, Guest, Cat, Harding, Tina, Hill, Michael, Hozak, Michal, Lacey, Matthew, MacLean, David, Messinger, Louise, Moffat, Stewart, Radley, Martin, Shenton, Claire, Tipper, Sarah, Tyler, Jon, Weaving, Lesley, Wheeler, James, Williams, Elissa, Williams, Tim, Woodhouse, Hamish, Chamberlain, Angela, Chambers, Jo, Davies, Joanne, Donaldson, Denise, Faria-Shayler, Pati, Fleming-Brown, Denise, Ingell, Jennifer, Knott, Carol, Liew, Anna, Lochhead, Helen, Meek, Juliette, Rodriguez-Bachiller, Isabel, Wilson, Andrea, Zettergren, Patrick, AitSadi, Rach, Barton, Ian, Baxter, Alex, Bu, Yonghong, Danel, Lukasz, Grotjahn, Sonja, Kurien, Rijo, Lay, Michael, Maskill, Archie, Murawska, Aleksandra, Raff, Rachel, Young, Allen, Baigent, Colin, Haynes, Richard, Herrington, William G., Landray, Martin J., Preiss, David, Emberson, Jonathan, Sardell, Rebecca, Staplin, Natalie, Wanner, Christoph, Brenner, Susanne, Cejka, Vladimir, Fajardo-Moser, Marcela, Hartner, Christian, Poehler, Doris, Renner, Janina, Scheidemantel, Franziska, Haynes, Richard, Preiss, David, Herrington, William G., Judge, Parminder, Zhu, Doreen, Ng, Sarah Y. A., Mayne, Kaitlin J., Badin, Cristina, Chambers, Jo, Davies, Joanne, Donaldson, Denise, Gray, Mo, Harding, Emily, Ingell, Jenny, Qiao, Yanru, Shah, Shraddha, Wilson, Andrea, Zettergren, Patrick, Wanner, Christoph, Brenner, Susanne, Cejka, Vladimir, Ghavampour, Sharang, Knoppe, Anja, Schmidt-Gurtler, Hans, Dumann, Hubert, Merscher, Sybille, Patecki, Margret, Schlieper, Georg Rainer, Torp, Anke, Weber, Bianca, Zietz, Maja, Sitter, Thomas, Fuessl, Louise, Krappe, Julia, Loutan, Jerome, Vielhauer, Volker, Andriaccio, Luciano, Maurer, Magdalena, Winkelmann, Bernhard, Dursch, Martin, Seifert, Linda, Tenbusch, Linda, Weinmann-Menke, Julia, Boedecker, Simone, KaluzaSchilling, Wiebke, Kraus, Daniel, Krieger, Carina, Schmude, Margit, Schreiber, Anne, Eckrich, Ewelina, Tschope, Diethelm, Arbi, Abdulwahab, Lee-Barkey, Young, Stratmann, Bernd, Prib, Natalie, Rolfsmeier, Sina, Schneider, Irina, Rump, Lars, Stegbauer, Johannes, Pötz, Christine, Schemmelmann, Mara, Schmidt, Claudia, Haller, Hermann, Kaufeld, Jessica, Menne, Jan, Bahlmann-Kroll, Elisabeth, Bergner, Angela, Haynes, Richard, Herrington, William G., Zhu, Doreen, Gavrila, Madita, Lafferty, Kathryn, Rabara, Ria, Ruse, Sally, Weetman, Maria, Byrne, Cath, Jesky, Mark, Cowley, Alison, McHaffie, Emma, Waterfall, Holly, Taylor, Jo, Bough, Laura, Phillips, Thomas, Goodwin, Barbara Winter-, Frankel, Andrew, Tomlinson, James, Alegata, Marlon, Almasarwah, Rashid, Apostolidi, Anthoula, Vourvou, Maria, Walters, Thomas, Ugni, Shiva, Gunda, Smita, Oluyombo, Rotimi, Brindle, Vicki, Coutts, Ping, Fuller, Tracy, Nadar, Evelyn, Wong, Christopher, Goldsmith, Christopher, Barnes, Sherald, Bennett, Ann, Burston, Claire, Hope, Samantha, Hunt, Nicola, Kurian, Lini, Fish, Richard, Farrugia, Daniela, Lee, Judy, Sadler, Emma, Turner, Hannah, Clarke, Helen, Carnall, Victoria, Benyon, Sarah, Blake, Caroline, Estcourt, Stephanie, Piper, Jane, Morgan, Neal, Hutchinson, Carolyn, McKinley, Teresa, Doulton, Tim, Delaney, Michael, Montasser, Mahmoud, Hansen, Jenny, Loader, David, Moon, Angela, Morris, Frances, Fraser, Donald, Ali, Mohammad Alhadj, Griffin, Sian, Latif, Farah, Witczak, Justyna, Wonnacott, Alexa, Jeffers, Lynda, Webley, Yvette, Bell, Samira, Cosgrove, Leanne, Craik, Rachel, Murray, Shona, Khwaja, Arif, Jackson, Yvonne, Mbuyisa, Angeline, Sellars, Rachel, Lewington, Andrew, Baker, Richard, Dorey, Suzannah, Tobin, Kay, Wheatley, Rosalyn, Patel, Rajan, Mark, Patrick, Rankin, Alastair, Sullivan, Michael, Forsyth, Kirsty, and McDougall, Rowan

Published
2024
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4. Effects of empagliflozin on first and recurrent clinical events in patients with type 2 diabetes and atherosclerotic cardiovascular disease: a secondary analysis of the EMPA-REG OUTCOME trial

Author

McGuire, Darren K, Zinman, Bernard, Inzucchi, Silvio E, Wanner, Christoph, Fitchett, David, Anker, Stefan D, Pocock, Stuart, Kaspers, Stefan, George, Jyothis T, von Eynatten, Maximilian, Johansen, Odd Erik, Jamal, Waheed, Mattheus, Michaela, Elsasser, Ulrich, Hantel, Stefan, and Lund, Søren S

Published
2020
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5. Designing, Conducting, Monitoring, and Analyzing Data from Pragmatic Randomized Clinical Trials: Proceedings from a Multi-stakeholder Think Tank Meeting

Author

Lentz, Trevor A., Curtis, Lesley H., Rockhold, Frank W., Martin, David, Andersson, Tomas L. G., Arias, Carolyn, Berlin, Jesse A., Binns, Cherie, Cook, Andrea, Cziraky, Mark, Dent, Ricardo, Desai, Manisha, Emmett, Andrew, Esserman, Denise, George, Jyothis, Hantel, Stefan, Heagerty, Patrick, Hernandez, Adrian F., Hucko, Thomas, Khan, Naeem, Lee, Shun Fu, LoCasale, Robert, Mardekian, Jack, McCall, Debbe, Monda, Keri, Normand, Sharon-Lise, Riesmeyer, Jeffrey, Roe, Matthew, Roessig, Lothar, Scott, Rob, Siedentop, Harald, Waldstreicher, Joanne, Wang, Lin, Weerakkody, Govinda, Wolf, Myles, and Ellenberg, Susan S.

Published
2020
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7. Linagliptin and cardiorenal outcomes in Asians with type 2 diabetes mellitus and established cardiovascular and/or kidney disease: subgroup analysis of the randomized CARMELINA® trial

Author

Inagaki, Nobuya, Yang, Wenying, Watada, Hirotaka, Ji, Linong, Schnaidt, Sven, Pfarr, Egon, Okamura, Tomoo, Johansen, Odd Erik, George, Jyothis T., von Eynatten, Maximilian, Rosenstock, Julio, Perkovic, Vlado, Wanner, Christoph, Cooper, Mark E., Alexander, John H., Komuro, Issei, and Nangaku, Masaomi

Published
2020
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9. List of contributors

Author

Anderson, Richard A., primary, Arya, Roopen, additional, Bano, Rashda, additional, Benedetto, Chiara, additional, Bitzer, Johannes, additional, Borella, Fulvio, additional, Brito-Mutunayagam, Savita, additional, Bumbuliene, Zana, additional, Busby, Gail, additional, Cain, Joanna M., additional, Cameron, Sharon, additional, Canuto, Emilie Marion, additional, Caretto, Marta, additional, Chervenak, Frank A., additional, Chervenak, Joseph, additional, Condous, George, additional, Cooper, Michelle, additional, Critchley, Hilary O.D., additional, Czuprynska, Julia, additional, Dafopoulos, Konstantinos, additional, Damodaran, Sujeetha, additional, da Silva, Sarah Martins, additional, Doumouchtsis, Stergios K., additional, Duncan, W. Colin, additional, Gajjar, Ketankumar B., additional, Genazzani, Andrea R., additional, George, Jyothis, additional, Giannini, Andrea, additional, González-Mesa, Ernesto, additional, Hamilton, Mark, additional, Horne, Andrew W., additional, Ind, Thomas, additional, Jordan, Clare F., additional, Jurga-Karwacka, Agnieszka, additional, Kaur, Manou Manpreet, additional, Kay, Vanessa, additional, Kini, Suresh, additional, Lal, Mira, additional, Leonardi, Mathew, additional, Lim, Chu, additional, Lui, Man-wa, additional, Maheshwari, Abha, additional, Mahmood, Tahir A., additional, McCullough, Laurence B., additional, Messini, Christina I., additional, Messinis, Ioannis E., additional, Metwally, Mostafa, additional, Narice, Brenda F, additional, Okolo, Isioma, additional, Paduch, Darius A., additional, Pearson, Andrew C., additional, Pergialiotis, Vasilios, additional, Ramalingam, Mythili, additional, Reavey, Jane J., additional, Reynolds, Rebecca M., additional, Sarhadi, Abhilash H.L., additional, Seif, Mourad W., additional, Shafi, Mahmood I., additional, Simoncini, Tommaso, additional, Swaminathan, Krishnan, additional, Talaulikar, Vikram, additional, Tan, I-Ferne, additional, Tincello, Douglas G., additional, Tridenti, Gabriele, additional, Vanza, Kiran, additional, Vatopoulou, Anastasia, additional, and Vaucher, Laurent, additional

Published
2020
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10. Functional characterisation and translational applications of kisspeptin-10

Author

George, Jyothis Thomas, Anderson, Richard, and Millar, Robert

Subjects
616.4, kisspeptin, GnRH, hormone, Luteinizing, follicle stimulating hormones, testosterone
Abstract

Background: Kisspeptins, recently discovered hypothalamic neuropeptides encoded by the KISS1 gene, are essential for normal pubertal development and are modulated by diverse endocrine, metabolic and environmental signals. Exogenous kisspeptin administration potently stimulates LH secretion - by direct action on GnRH neurons while kisspeptin antagonists inhibit pulsatile LH secretion. Human studies of kisspeptin had hitherto used kisspeptin-54 that is cleaved further and the smallest bioactive form is a decapeptide (kisspeptin-10) with a shorter half-life. Kisspeptin-10 is thus putatively more attractive in studies assessing LH pulsatility and is also the basis for the development of antagonists. Unmet clinical needs: Decreased LH pulse frequency is the central pathology in pubertal delay, late-onset male hypogonadism and hypothalamic amenorrhoea. Manipulation of LH pulse frequency also has therapeutic potential in contraception, PCOS and sex-steroid dependant diseases such as endometriosis and prostatic hyperplasia. Hypothesis: That exogenous kisspeptin-10 enhances pulsatile LH secretion in healthy men and in patients with reproductive disorders associated with decreased pulse frequency. Research strategy: A first-in-human dose escalation study of kisspeptin-10 was performed in men and subsequently replicated in women. An intravenous infusion regime was optimised in healthy men and subsequently applied to hypogonadal patients. Specific questions were addressed sequentially as summarised below with key results. Dose escalation study: Question: Does kisspeptin-10 stimulate LH secretion in men? Findings: Six iv bolus doses (0.01 to 3 μg/kg) of GMP kisspeptin-10 and vehicle were administered at least a week apart to six healthy men. Rapid increase in LH, with peak concentrations was seen by 45 min post injection in all volunteers. There was a clear dose-dependent increase in LH concentrations in response to kisspeptin- 10 (P <0.0001). Area-Under-Curve analysis over 60 min following kisspeptin-10 administration showed 0.3 and 1μg/kg doses to be maximally stimulatory (P <0.01) with a reduced response at 3 μg/kg. Assessing the effect of steroid milieu: Question: Steroid feedback is central to the regulation of LH secretion: what effect does the steroid milieu have on LH responses to kisspeptin-10? Findings: The response to iv kisspeptin-10 (0.3μg/kg,) in the normal follicular phase (n=10) was compared with that in the presence of low endogenous sex steroids/high LH secretion (6 postmenopausal women) and in women taking combined contraceptive therapy (n=8) with suppressed LH secretion. Despite widely varying baseline secretion, LH increased significantly following kisspeptin-10 administration in the follicular phase (6.3±1.2 to 9.4±1.3 IU/L P=0.006), postmenopausal (35.3±2.8 to 44.7±3.4 IU/L P=0.005), etonogestrel (4.6±0.2 to 7.5±0.9 IU/L, P=0.02), and COCP groups (2.2±0.9 to 3.7±1.4 IU/L P<0.001). Pulse frequency study: Question: GnRH and LH secretion are pulsatile: can kisspeptin-10 enhance LH pulsatility? Findings: Four healthy men attended our clinical research facility for two visits five days apart for 10-min blood sampling. At the first visit, baseline LH pulsatility was assessed over a 9-hour period. During the second visit, an infusion of kisspeptin-10 was administered for 9 hours at 1.5μg/kg/hr after an hour of baseline sampling. LH pulse frequency increased in all subjects, with a mean increase from 0.7±0.1 to 1.0±0.2 pulses/hr (P = 0.01), with resultant increase in mean LH from 5.2±0.8 IU/L at baseline to 14.1±1.7 IU/L (P <0.01). High dose, longer duration infusion study: Question: Can kisspeptin-10 enhance testosterone secretion? Findings: Four healthy men attended our clinical research facility for a 34-hour supervised stay. Blood samples were collected at 10 min intervals for two 12 hour periods on consecutive days and hourly overnight. After 10.5 hours of baseline sampling a continuous intravenous infusion of kisspeptin-10 (4μg/kg/hr) was maintained for 22.5 hrs. Mean LH increased from 5.5±0.8 at baseline to 20.9±4.9 IU/L (P <0.05) and serum testosterone increased from 16.6±2.4 to 24.0±2.5 nmol/L (P <0.001). Translational studies in hypogonadal men with type 2 diabetes Question: Can kisspeptin-10 normalise testosterone secretion in hypogonadal men? Findings: Five hypogonadal men with T2DM (age 33.6±3 yrs, BMI 40.6±6.3, testosterone 8.5±1.0 nmol/L, LH 4.7±0.7 IU/L, HbA1c <8 %, duration of diabetes <5 yrs) and seven age matched healthy men were studied. Kisspeptin-10 was administered intravenous (0.3 μg/kg) with frequent (10-min) blood sampling. Mean LH increased in controls (5.5±0.8 to 13.9±1.7 IU/L P <0.001) and in T2DM (4.7±0.7 to 10.7±1.2 IU/L P=0.02) with comparable ΔLH (P=0.18). Baseline serum sampling for LH at 10-min intervals and hourly testosterone measurements were performed subsequently in four T2DM men for 12 hours. An intravenous infusion of kisspeptin-10 (4 μg/kg/hr) was administered 5 days later for 11 hours, with increases in serum LH (3.9±0.1 IU/L to 20.7±1.1 IU/L (P=0.03,) and testosterone (8.5±1.0 to 11.4±0.9 nmol/L, P=0.002). LH pulse frequency at baseline was lower in hypogonadal men with diabetes (0.6±0.1 vs. 0.8±0.1 pulses/hr, P=0.03) and increased to 0.9±0 pulses/hr (P=0.05). Translational studies in pubertal delay: Question: Defective Neurokinin B activity is associated with pubertal delay and the hierarchical interactions between kisspeptins and Neurokinin B remain to be elucidated: can kisspeptin-10 stimulate LH secretion with impaired Neurokinin B signalling? Findings: Four patients with TAC3 or TACR3 inactivating mutations presenting with delayed puberty were admitted for two 12 hr blocks of blood sampling every 10 min with vehicle (saline) or kisspeptin-10 (1.5 μg/kg/hour) infused intravenously. Mean LH and LH pulses frequency increased with kisspeptin-10 (P<0.05). However, four patients with Kallmann syndrome (with defective GnRH neuron migration), studied in parallel, did not respond, suggesting a potential diagnostic application for kisspeptin-10 in pubertal dysfunction. Conclusions In first-in-man studies of kisspeptin-10, it was demonstrated that endogenous LH pulse frequency can be enhanced in healthy men. The therapeutic potential of this finding in common reproductive endocrine disorders associated with decreased LH pulse frequency, i.e., late-onset male hypogonadism and pubertal dysfunction, was suggested in subsequent studies. Furthermore, kisspeptin signalling occurs upstream of GnRH neurons and is independent of Neurokinin B signalling in the central regulation of the hypothalamic-pituitary-gonadal axis.

Published
2012

11. Heart Failure With Preserved Ejection Fraction Expert Panel Report: Current Controversies and Implications for Clinical Trials

Author

Parikh, Kishan S., Sharma, Kavita, Fiuzat, Mona, Surks, Howard K., George, Jyothis T., Honarpour, Narimon, Depre, Christopher, Desvigne-Nickens, Patrice, Nkulikiyinka, Richard, Lewis, Gregory D., Gomberg-Maitland, Mardi, O’Connor, Christopher M., Stockbridge, Norman, Califf, Robert M., Konstam, Marvin A., Januzzi, James L., Jr., Solomon, Scott D., Borlaug, Barry A., Shah, Sanjiv J., Redfield, Margaret M., and Felker, G. Michael

Published
2018
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21. INCISION AND DRAINAGE OF PAROTID ABSCESSES VS USG GUIDED NEEDLE ASPIRATIONA RETROSPECTIVE STUDY.

Author

Mallick, Sworupa Nanda, Bag, Lachhaman, Sahoo, Nirod Kumar, and George, Jyothis Joy

Subjects
FACIAL nerve, SURGICAL drainage, ABSCESSES, PAROTIDECTOMY, FACIAL injuries, REOPERATION, NERVOUS system injuries
Abstract

Objective: Surgical drainage of the parotid abscess is the current standard of treatment which is carried out under general anaesthesia and carries the risk of iatrogenic facial nerve injury. Ultrasound-guided needle aspiration can be an alternative to surgical drainage. Methods: All parotid abscess patients who are treated surgically (n = 18) vs ultrasoundguided needle aspiration (n = 12) at Department of Surgery, MKCG MCH, were included in this monocentric retrospective analysis. Results: There was no statistically significant difference (p = 0.142) regarding the mean in both groups. There was a change in the duration of hospital stay(5.416 vs. 7.77 days) after ultrasound-guided needle aspiration. This trend did not reach statistical significance (p = 0.031). Facial nerve injury did not occur in any of the patients. Postoperative bleeding didn’t occur after needle aspirations but same is seen in 2% of the patients after surgical abscess revision. Conclusion: Ultrasound-guided needle aspiration is safe and effective in the treatment of parotid abscesses. [ABSTRACT FROM AUTHOR]

Published
2023

22. A STUDY ON PERIPHERAL LYMPHADENOPATHY SUSPICIOUS FOR TUBERCULOSIS BY CYTOMORPHOLOGY, AFB POSITIVITY AND CBNAAT IN SOUTH ODISHA.

Author

Rajesh, Vattikulla, Pradhan, Sanjeeb kumar, George, Jyothis Joy, and Panda, Abhilash

Subjects
LYMPHADENITIS, TUBERCULOSIS, CENTRAL nervous system, OPTIMISM, LYMPH nodes, GASTROINTESTINAL system
Abstract

BACKGROUND: Tuberculosis (TB) is a major cause of ill health and is one of the top 10 causes of death worldwide. Although pulmonary involvement is the most common presentation of TB, extra pulmonary TB constitutes 10-15% of total TB cases which primarily involve the pleura, lymph nodes, gastrointestinal tract, central nervous system, genitourinary system, bones/spine and other organs with a significant case mortality rate (25 to 50%). Cytology and ZN stain for AFB have been used as the initial diagnostic tools for tuberculosis lymphadenitis in resource poor settings. However, the newer technique like Gene Xpert utilizes a DNA-PCR technique for simultaneous detection of M. tuberculosis and rifampicin resistance-related mutations. AIM AND OBJECTIVE: Correlation of cytomorphological pattern and AFB positivity of FNAC based cytosmears with CBNAAT result from all lymphadenitis suspicious of TB lesion. PATIENTS AND METHODS: This is a comparative study conducted in Department of Surgery in collaboration with Department of Pathology M.K.C.G. M.C.H., Berhampur from September 2021 to January 2023. Out of total of 398 cases, 354 cases were included in the study in which cytomorphology of aspirated material were correlated with AFB stain positivity and CBNAAT from lymph nodes suspicious for tuberculosis. RESULTS: The cytological diagnosis made most frequently was granulomatous lymphadenitis (64%), followed by caseating granulomatous lymphadenitis (14%), reactive lymphadenitis and suppurative lymphadenitis (11% each). The presence of acid-fast bacilli by ZN staining was seen in 17 samples (5%). 88 samples (25%) were positive in CBNAAT. CBNAAT positivity was seen in 36 cases (72%) of caseating granuloma, 46 cases (20%) of granulomatous lesions and 6 (15.3%) suppurative lymphadenitis cases; all cases diagnosed as RHL were negative. Out of the total 88 patients 3 patients (4%) were Rifampicin resistant, one case each belonging to cervical, axillary and inguinal lymph nodes. CONCLUSION: Employment of a molecular technique like CBNAAT in FNAC aspirate helps to obviate the need of excision biopsy for diagnosis of tuberculous lymphadenitis especially when FNAC does not show caseous necrosis in a granulomatous lesion and AFB is not detected by Ziehl Neelsen stain. [ABSTRACT FROM AUTHOR]

Published
2023

24. Impact of Regulatory Guidance on Evaluating Cardiovascular Risk of New Glucose-Lowering Therapies to Treat Type 2 Diabetes Mellitus: Lessons Learned and Future Directions

Author

Sharma, Abhinav, Pagidipati, Neha J., Califf, Robert M., McGuire, Darren K., Green, Jennifer B., Demets, Dave, George, Jyothis Thomas, Gerstein, Hertzel C., Hobbs, Todd, Holman, Rury R., Lawson, Francesca C., Leiter, Lawrence A., Pfeffer, Marc A., Reusch, Jane, Riesmeyer, Jeffrey S., Roe, Matthew T., Rosenberg, Yves, Temple, Robert, Wiviott, Stephen, McMurray, John, and Granger, Christopher

Published
2020
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31. Linagliptin Effects on Heart Failure and Related Outcomes in Individuals With Type 2 Diabetes Mellitus at High Cardiovascular and Renal Risk in CARMELINA

Author

McGuire, Darren K., Alexander, John H., Johansen, Odd Erik, Perkovic, Vlado, Rosenstock, Julio, Cooper, Mark E., Wanner, Christoph, Kahn, Steven E., Toto, Robert D., Zinman, Bernard, Baanstra, David, Pfarr, Egon, Schnaidt, Sven, Meinicke, Thomas, George, Jyothis T., von Eynatten, Maximilian, and Marx, Nikolaus

Published
2019
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32. EFFICACY OF AUTOLOGOUS PLATELET RICH PLASMA IN TREATMENT OF DIABETIC FOOT ULCERS- A PROSPECTIVE STUDY.

Author

satapathy, Ambuja, Jena, Soumya Ranjan, Das, Ajaya Kumar, George, Jyothis Joy, and Panda, Abhilash

Subjects
PLATELET-rich plasma, DIABETIC foot, OLDER people, LONGITUDINAL method, POVIDONE-iodine
Abstract

BACKGROUND Diabetic foot ulcer is a serious complication that often arises in patients with diabetes mellitus, particularly among the elderly population. Studies suggest that around 15% of diabetic patients will experience this condition during their lifetime. AIM This study aimed to compare the efficacy of autologous platelet-rich plasma (PRP) dressing versus moist saline/povidone iodine dressing in diabetic patients with foot ulcers. MATERIAL AND METHOD A total of 72 patients were enrolled in an open-label prospective randomised study. The primary objective was to compare the mean reduction in ulcer area at the end of 4 weeks. The study included two groups of patients: Group 1 (Study Group) received PRP clot dressing, while Group 2 (Control Group) received conventional saline dressing. The dressings were left in place for 1 week, and a total of 4 PRP treatments at weekly intervals were given for 4 weeks. RESULTS The results showed that there was no significant difference between the demographic parameters among the two study groups. However, the mean ulcer size (in cm2) in group 2 was significantly smaller compared to group 1 at the end of week 4 CONCLUSION The study concluded that PRP dressing may be more effective than conventional dressings for diabetic foot ulcers. This study may contribute to improved management strategies for diabetic foot ulcers, which is a serious complication that often arises in patients with diabetes mellitus, particularly among the elderly population. Ongoing research in this field has explored the potential of PRP, which is derived from a patient's own blood and contains growth factors that can stimulate wound healing. Using an autologous preparation reduces the risk of allergic reactions and may be more effective than conventional dressings. [ABSTRACT FROM AUTHOR]

Published
2023

33. A PROSPECTIVE STUDY ON MANAGEMENT OF BILIARY LEAKAGE FOLLOWING CHOLECYSTECTOMY IN SOUTHERN ODISHA.

Author

Rajesh, V., Panda, Abhilash, George, Jyothis Joy, Choudhury, Sulata, and Dash, Siba Prasad

Subjects
CHOLANGIOGRAPHY, CHOLECYSTECTOMY, ENDOSCOPIC surgery, SURGICAL complications, BILE ducts, LONGITUDINAL method, LEAKAGE, CHOLECYSTITIS, CHOLANGITIS
Abstract

Background: Cholecystectomy is one of the most frequently performed surgeries. The surgery is associated with many avoidable complications and hence requires a serious and cautious approach. Aim: The aim of this study was to know the outcome of post cholecystectomy biliary leaks and its management methods. Materials and methods: 12 cases of biliary leaks were studied from 132 open cholecystectomies and 185 laparoscopic cholecystectomies from 2022 January to 2023 January. Pre-operative workup with ultrasound abdomen, LFT and other biochemical investigations were done and diagnosis was established. The outcome of surgery and its most common post-operative complication - biliary leak was studied with following parameters: Post-operative diagnosis, Surgery - Lap or Open, Incision, Method of approach -- Fundus or Classical method, CBD exploration, Intra-operative findings, Drains used, Post-operative symptoms, Amount of collections, Removal of drains, USG -- Sub hepatic collections, ERCP etc. Results: In the present study of 12 cases, fundus first method was done in 3 cases of open cholecystectomies and none in laparoscopic cholecystectomies. Classical procedure was done in 7 cases out of which 3 cases were done in laparoscopy method and 4 cases in open method. Out of 12 cases ERCP done in 9 cases (i.e., 75%) and cholangiogram in 2 cases. Intra-operative detection of bile duct injury is noted in 3 cases of open cholecystectomies and non in laparoscopic method. In the present study, 42% of the patients were treated conservatively who required no therapy and surgical placement of the drain itself was sufficient. Endoscopic management of biliary leak was done in 16% with stenting alone in 16% and sphincterotomy + stenting in 25% of cases. Conclusion: Pain abdomen, Jaundice, Nausea and Vomiting are the major complaintsin case of bile leaks and fistulas. Pathologically, chronic cholecystitis is commonest cause of leaks after surgery mainly because of fibrosis at calot's triangle. Incidence of Post-operative bile leaks is almost the same in open and laparoscopic cholecystectomy. Routine placement of drains is must because it permits postoperative evacuation of serosanguineous exudates and monitoring of bleeding or leakage of bile. Abdominal collections, bilomas or sub-hepatic abscess are reported less with the placement of drains. [ABSTRACT FROM AUTHOR]

Published
2023

34. FACTORS RELATED TO BURST ABDOMEN: POST OPERATIVE CHALLENGES FOR SURGEONS- A PROSPECTIVE STUDY.

Author

Mallick, Swarupa Nanda, Patro, Santosh Kumar, Rajesh, Vattikulla, Panda, Abhilash, and George, Jyothis Joy

Subjects
SURGICAL wound dehiscence, ABDOMEN, SURGICAL complications, LONGITUDINAL method, ABDOMINAL surgery
Abstract

Background: Burst abdomen is post-operative separation of the Musculo-aponeurotic layers, including the peritoneum, with exposure of the intestines. Type of incision, vertical or transverse, nature of surgery, elective or emergency, and postoperative complications affect the outcome of Laparotomy. Objective: The study aims to find the etiological factors of burst abdomen and to find and evaluate effective management of abdominal wound dehiscence in elective and emergency Laparotomy and how to prevent and overcome its complications. This post-operative complication encountered by the surgeon is always a challenge. The main concern is because of the risk of evisceration and the need to intervene; there is always a possibility of recurrence of dehiscence. Material and Methods: Our study was conducted on 280 patients who had undergone exploratory laparotomy at MKCG MCH, BERHAMPUR, ODISHA. Of 280 patients, 136 underwent emergency laparotomy, and 144 were elective cases. They were managed either by midline vertical incision or transverse incision, and results were analysed for wound dehiscence. Result: Most significant variation associated with wound dehiscence was hypoproteinaemia, anaemia, chronic cough and emergency procedures. Pre-operative and post-operative etiological factors such as chronic cough, anaemia, hypoproteinaemia, diabetes, obesity, use of Steroids. Results concluded that male patients have higher incidence of laparotomy wound dehiscence and in fourth and fifth decade. Patients presented with peritonitis secondary to gastro-duodenal or ileal perforation are more prone to burst abdomen. Conclusion: Burst abdomen is a serious sequela of impaired wound healing. Incidence of burst abdomen is less in transverse incision in comparation to midline vertical incision. [ABSTRACT FROM AUTHOR]

Published
2023

44. The potential role and rationale for treatment of heart failure with sodium–glucose co‐transporter 2 inhibitors

Author

Butler, Javed, Hamo, Carine E., Filippatos, Gerasimos, Pocock, Stuart J., Bernstein, Richard A., Brueckmann, Martina, Cheung, Alfred K., George, Jyothis T., Green, Jennifer B., Januzzi, James L., Kaul, Sanjay, Lam, Carolyn S.P., Lip, Gregory Y.H., Marx, Nikolaus, McCullough, Peter A., Mehta, Cyrus R., Ponikowski, Piotr, Rosenstock, Julio, Sattar, Naveed, Salsali, Afshin, Scirica, Benjamin M., Shah, Sanjiv J., Tsutsui, Hiroyuki, Verma, Subodh, Wanner, Christoph, Woerle, Hans‐Juergan, Zannad, Faiez, and Anker, Stefan D.

Published
2017
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45. Rationale, design, and baseline characteristics of the CArdiovascular safety and Renal Microvascular outcomE study with LINAgliptin (CARMELINA®): a randomized, double-blind, placebo-controlled clinical trial in patients with type 2 diabetes and high cardio-renal risk

Author

Rosenstock, Julio, Perkovic, Vlado, Alexander, John H., Cooper, Mark E., Marx, Nikolaus, Pencina, Michael J., Toto, Robert D., Wanner, Christoph, Zinman, Bernard, Baanstra, David, Pfarr, Egon, Mattheus, Michaela, Broedl, Uli C., Woerle, Hans-Juergen, George, Jyothis T., von Eynatten, Maximilian, McGuire, Darren K., and CARMELINA® investigators

Published
2018
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46. Efficacy of empagliflozin on heart failure and renal outcomes in patients with atrial fibrillation: data from the EMPA-REG OUTCOME trial

Author

Böhm, Michael, Slawik, Jonathan, Brueckmann, Martina, Mattheus, Michaela, George, Jyothis T, Ofstad, Anne Pernille, Inzucchi, Silvio E, Fitchett, David, Anker, Stefan D, Marx, Nikolaus, Wanner, Christoph, Zinman, Bernard, and Verma, Subodh

Subjects
Oedema, Diabetes, Empagliflozin, Heart failure, Mortality, SGLT2 inhibitors
Published
2022
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47. Effects of empagliflozin on insulin initiation or intensification in patients with type 2 diabetes and cardiovascular disease: findings from the EMPA‐REG OUTCOME ® trial

Author

Vaduganathan, Muthiah, Inzucchi, Silvio E., Sattar, Naveed, Fitchett, David H., Ofstad, Anne Pernille, Brueckmann, Martina, George, Jyothis T., Verma, Subodh, Mattheus, Michaela, Wanner, Christoph, Zinman, Bernard, and Butler, Javed

Abstract

Aims: \ud Insulin use in type 2 diabetes, while often necessary, is associated with hypoglycemia and weight gain, requires training, and may add significant costs. We evaluated the effects of empagliflozin versus placebo on subsequent insulin initiation or dosing changes in a large cardiovascular outcomes trial.\ud \ud Materials and Methods: \ud In EMPA-REG OUTCOME®, 7,020 patients with type 2 diabetes and cardiovascular disease received empagliflozin 10mg, 25mg, or placebo. Median follow-up was 3.1 years. After 12 weeks’ treatment, changes in background antihyperglycemic therapy were permitted. Among insulin-naïve patients, we assessed effects of pooled empagliflozin arms vs. placebo on time to initiation of insulin. Among insulin-treated patients, we assessed effects on time to increase or decrease in insulin dose >20%.\ud \ud Results: \ud In 3,633 (52%) participants not treated with insulin at baseline, empagliflozin reduced new use of insulin vs. placebo by 60% (7.1% vs. 16.4%; adjusted HR 0.40 [95% CI 0.32-0.49]; P20% insulin dose increase by 58% (14.4% vs. 29.3%; adjusted HR 0.42 [95% CI 0.36-0.49]; P20% insulin dose reductions without subsequent increases in HbA1c compared with placebo (9.2% vs. 4.9%; adjusted HR 1.87 [95% CI: 1.39-2.51]; P10% or >30% were considered.\ud \ud Conclusions: \ud In patients with type 2 diabetes and cardiovascular disease, empagliflozin markedly and durably delays insulin initiation and substantial increases in insulin dose while facilitating sustained reductions in insulin requirements over time.

Published
2021

48. Effects of empagliflozin on insulin initiation or intensification in patients with type 2 diabetes and cardiovascular disease: Findings from the EMPA‐REG OUTCOME trial

Author

Vaduganathan, Muthiah, primary, Inzucchi, Silvio E., additional, Sattar, Naveed, additional, Fitchett, David H., additional, Ofstad, Anne Pernille, additional, Brueckmann, Martina, additional, George, Jyothis T., additional, Verma, Subodh, additional, Mattheus, Michaela, additional, Wanner, Christoph, additional, Zinman, Bernard, additional, and Butler, Javed, additional

Published
2021
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49. Mediators of the improvement in heart failure outcomes with empagliflozin in the EMPA‐REG OUTCOME trial

Author

Fitchett, David, primary, Inzucchi, Silvio E., additional, Zinman, Bernard, additional, Wanner, Christoph, additional, Schumacher, Martin, additional, Schmoor, Claudia, additional, Ohneberg, Kristin, additional, Ofstad, Anne Pernille, additional, Salsali, Afshin, additional, George, Jyothis T., additional, Hantel, Stefan, additional, Bluhmki, Erich, additional, Lachin, John M., additional, and Zannad, Faiez, additional

Published
2021
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50. Use of diuretics and outcomes in patients with type 2 diabetes: findings from the EMPA-REG OUTCOME trial

Author

Pellicori, Pierpaolo, Fitchett, David, Kosiborod, Mihkail N., Ofstad, Anne P., Seman, Leo, Zinman, Bernard, Zwiener, Isabella, Wanner, Christoph, George, Jyothis, Inzucchi, Silvio E., Testani, Jeffrey M., and Cleland, John G.F.

Abstract

Background: \ud Loop diuretics (LD) relieve symptoms and signs of congestion due to heart failure (HF), but many patients prescribed LD do not have such a diagnosis.\ud \ud Aims and methods: \ud We studied the relationship between HF diagnosis, use of LD, and outcomes in four patient subgroups with type-2 diabetes mellitus (T2DM) in EMPA-REG OUTCOME; [i) investigator-reported HF on LD, ii) investigator-reported HF not on LD, iii] no HF on LD, and iv) no HF and not on LD], and assessed their risk of CV events.\ud \ud Results: \ud Of 7,020 participants, at baseline, 706 (10%) had a diagnosis of HF, of whom 334 were prescribed LD. However, 755 (11%) patients who did not have a diagnosis of HF were prescribed LD. Compared to those with neither HF nor prescribed LD (reference group; placebo), those with both HF and receiving LD had the highest rates for all-cause (hazard ratio [HR] [95% CI]: 3.19 [2.03-5.01]) and CV mortality (3.83 [2.28-6.44]), and HF hospitalisations (HHF) (9.51 [5.61-16.14]). Patients without HF but prescribed LD had higher rates for all three outcomes (1.62 [1.10-2.39]); 1.97 [1.26-3.08]); 3.20 [1.90-5.39]), which were similar to patients with HF who were not receiving LD (1.42 [0.78-2.57]; 1.56 [0.78-3.11]; 3.00 [1.40-6.40)]). Empagliflozin had similar benefits regardless of subgroup (p for interaction >0.1 for all outcomes).\ud \ud Conclusion: \ud Patients with T2DM prescribed LD are at greater risk of CV events even if they are not reported to have HF; this might reflect under-diagnosis. Empagliflozin was similarly effective in all subgroups investigated.

Published
2021

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