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1. Efficacy and safety of once-monthly pasireotide in Cushing's disease: A 12 month clinical trial

Author

Lacroix, A., Gu, F., Gallardo, W., Pivonello, R., Yu, Y., Witek, P., Boscaro, M., Salvatori, R., Yamada, M., Tauchmanova, L., Roughton, M., Ravichandran, S., Petersenn, S., Biller, B.M.K., and Newell-Price, J.

Abstract

© 2017 Elsevier Ltd. Background: Cushing's disease is a rare debilitating endocrine disorder for which few prospective interventional studies have been done. We report results of the first phase 3 trial assessing long-acting intramuscular pasireotide in patients with Cushing's disease. Methods: In this phase 3 clinical trial we recruited patients aged 18 years or older with persistent, recurrent, or de-novo (non-surgical candidates) Cushing's disease who had a mean urinary free cortisol (mUFC) concentration (from three 24 h samples) of 1·5-5·0 times the upper limit of normal (ULN), a normal or greater than normal morning plasma adrenocorticotropic hormone concentration, and a pituitary source of Cushing's syndrome, from 57 sites across 19 countries. Exclusion criteria included previous pasireotide treatment, mitotane therapy within 6 months, and pituitary irradiation within 10 years. We randomly allocated patients 1:1 (block size of four) using an interactive-response-technology system to intramuscular pasireotide 10 mg or 30 mg every 4 weeks for 12 months (in the core phase). We stratified randomisation by screening mUFC concentration (1·5 to < 2·0 × ULN and 2·0-5·0 × ULN). The dose could be uptitrated (from 10 mg to 30 mg or from 30 mg to 40 mg) at month 4 if the mUFC concentration was greater than 1·5 × ULN, and at month 7, month 9, or month 12 if the mUFC concentration was greater than 1·0 × ULN. Investigators, patients, site personnel, and those assessing outcomes were masked to dose group allocation. The primary endpoint was the proportion of patients in each group with an mUFC concentration of less than or equal to the ULN at month 7. Efficacy analyses were based on intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01374906. Findings: Between Dec 28, 2011, and Dec 9, 2014, we randomly allocated 150 patients to receive pasireotide 10 mg (74 [49%] patients) or 30 mg (76 [51%] patients). The primary efficacy endpoint was met by 31 (41·9% [95% CI 30·5-53·9]) of 74 patients in the 10 mg group and 31 (40·8% [29·7-52·7] ) of 76 in the 30 mg group. The most common adverse events were hyperglycaemia (36 [49%] in the 10 mg group and 36 [47%] in the 30 mg group), diarrhoea (26 [35%] and 33 [43%] ), cholelithiasis (15 [20%] and 34 [45%] ), diabetes mellitus (14 [19%] and 18 [24%] ), and nausea (15 [20%] and 16 [21%] ). Serious adverse events suspected to be study drug related were reported in eight (11%) patients in the 10 mg group and four (5%) in the 30 mg group. Two (3%) patients in the 30 mg group died during the study (pulmonary artery thrombosis and cardiorespiratory failure); neither death was judged to be related to the study drug. Interpretation: Long-acting pasireotide normalised mUFC concentration in about 40% of patients with Cushing's disease at month 7 and had a similar safety profile to that of twice-daily subcutaneous pasireotide. Long-acting pasireotide is an efficacious treatment option for some patients with Cushing's disease who have persistent or recurrent disease after initial surgery or are not surgical candidates, and provides a convenient monthly administration schedule. Funding: Novartis Pharma AG.

Published
2017

3. Factores de riesgo para el desarrollo de infecciones intrahospitalarias en pacientes quemados. Hospital S. Juan de Dios, Costa Rica: Enero 2003-Diciembre 2005. Parte II

Author

Vargas Naranjo, S., Romero Zúñiga, J.J, Prada Castellanos, Y., Fonseca-Portilla, G., and Lao Gallardo, W.

Subjects
Nosocomial infection, Risk factors, Quemaduras, Burns, Infección nosocomial, Factores de riesgo
Abstract

En los pacientes quemados, existen diferentes factores como la edad, sexo y días de estancia hospitalaria entre otros, que influyen en el desarrollo de infección intrahospitalaria (IIH). Debido a la mayor frecuencia de este tipo de infecciones en los pacientes quemados, pretendemos identificar qué factores influyen en la presentación y predicción de la infección intrahospitalaria en el sitio de la quemadura (IISQ). El presente estudio es una cohorte retrospectiva, sobre 298 registros de expedientes clínicos de pacientes ingresados en la Unidad Nacional de Quemados del Hospital San Juan de Dios (UNQ-HSJD) en Costa Rica, continuando otra investigación del mismo grupo de autores publicada anteriormente en Cirugía Plástica Iberolatinoamericana. A cada factor de riesgo estudiado se le calcularon los odds ratio crudos en un análisis univariado definiendo como variables de exposición principal la superficie corporal total quemada (SCTQ) y la profundidad de la quemadura (PQ). Observamos con este cálculo que el tipo de accidente no presentaba asociación con la IISQ. Después, realizamos un modelo multivariado logístico, no condicional, en el que se introdujeron los siguientes factores de riesgo: SCTQ, PQ, edad, número de segmentos corporales quemados (NSCQ), días de estancia hospitalaria previos a la infección intrahospitalaria en el sitio de la quemadura (DEHP-IISQ) y el agente causal de la quemadura. Consideramos variables confusora y modificadora de efecto al NSCQ y DEHP-IISQ. Determinamos que las principales variables predictoras para la IISQ fueron SCTQ (OR=3.02; 1.20-7.84), PQ (OR=11.44; 4.90-26.71), NCSQ (OR=2.80; 1.13-6.95), y DEHP-IISQ (9 a 14 días: OR=2.43; 0.52- 11.29, >19 días: OR=31.89; 2.17-467.68). Pese a que no mostró significancia estadística, también se introdujo la edad en el modelo, debido a la tendencia a aumentar el riesgo conforme ésta aumentaba ( >64 años: OR= 3.15; 0.61-16.29). Concluimos que los pacientes quemados presentan características endógenas y exógenas para el desarrollo de las IISQ y que el conocer cómo se comportan esas características puede ayudar a disminuir la incidencia de IISQ y a promover medidas para su control y prevención, en la atención de los pacientes en la UNQ-HSJD. In burn victims, different factors such as age, gender and days of hospitalization among others, are influential in the development of inner-hospital infections (IHI). Due to a higher incidence of IHI in burn victims, it is pretended to identify which factors influence the presence and prediction of inner-hospital infections in the burned area (IHIBA). This study is a retrospective cohort that recruited 298 registries of medical reports from patients admitted into the National Burn Victims Unit at San Juan de Dios Hospital (NBVU-HSJD), Costa Rica, and following a previous report in this journal. The odds ratio (OR) were calculated for each risk factor in a univariated analysis, and defined as principal exposition variables were the total burn surface (TBS) and the depth of the burn (DB). It was deduced from this calculation that the type of accident did not show any association with IHIBA. Subsequently, a multivariate logistic not conditioned study was carried out, in which, the following risk factors were introduced: TBS, DB, age, number of burnt body segments (NBBS), days of hospital stay previous to the IHIBA (DHSP-IHIBA) and the burn's causing agent. Confusing and modifying variables of effect were also considered, respectively, for the NBBS and the DHSP-IHIBA. It was concluded that the main predicting variables for the IHIBA were TBS (OR=3.02; 1.20-7.84), DB (OR=11.44; 4.90-26.71), NBBS (OR= 2.80; 1.13-6.95), and DHS- IHIBA (9 to 14 days: OR=2.43; 0.52-11.29, > 19 days: OR=31.89; 2.17-467.68). Even though it didn't show statistical relevance, the age was introduced in the model, due to the fact that the risk factor increased with time (>64 years old: OR= 3.15; 0.61-16 29). It was concluded that burn victims present endogenous and exogenous characteristics for the development of the IHIBA and by getting to know those characteristics, we can help to lessen the incidence of IHIBA, promoting measures for its control and prevention in the treatment of the patients at the NBVU-HSJD.

Published
2009

5. Use of GABA to enhance rotifer reproduction in enrichment culture

Author

Gallardo, W. G., Hagiwara, A., Snell, T. W., Gallardo, W. G., Hagiwara, A., and Snell, T. W.

Abstract

Gamma-aminobutyric acid (GABA) has been shown to enhance the reproduction of the rotifer Brachionus plicatilis Muller in stressful culture conditions. During the enrichment of rotifers for feeding to marine fish larvae, they are usually stressed as a result of exposure to different marine oils and high population densities. This typically results in decreased rotifer survival, reproduction and swimming activity. In the present study, we used GABA to increase rotifer reproduction and the swimming activity of rotifers in enrichment cultures. GABA treatment 24 h before high density enrichment enhanced reproduction during enrichment culture, but not when carried out simultaneously with enrichment. Swimming activity was not significantly affected by GABA treatment 24 h before or simultaneously with nutrient enrichment.

Published
2001

6. Live food production in Japan: recent progress and future aspects

Author

Hagiwara, A., Gallardo, W. G., Assavaaree, M., Kotani, T., de Araujo, A. B., Hagiwara, A., Gallardo, W. G., Assavaaree, M., Kotani, T., and de Araujo, A. B.

Abstract

Techniques to culture rotifers at high-density (2000 to 20 000 ind./ml) have been developed by utilizing condensed phytoplankton products. Many public hatcheries in Japan have introduced automated systems for culturing and harvesting rotifers. Research has been conducted on the diagnosis of rotifer culture status and chemical treatment for reducing stress on rotifers. Preservation of the resting eggs of rotifers for an extended period or at low temperature (4 °C) for a limited time has become possible. Thus, appropriately sized rotifers can be provided to fish larvae, according to fish species and growth stage. Techniques to identify the genetic status of rotifer strains have yet to be developed. Practices for culturing copepods in Japan have also been summarized.

Published
2001

7. GABA enhances reproduction of the rotifer Brachionus plicatilis Muller: application to mass culture

Author

Gallardo, W. G., Hagiwara, A., Snell, T. W., Gallardo, W. G., Hagiwara, A., and Snell, T. W.

Abstract

Based on the results of individual and batch culture experiments in small volumes, we conducted experiments in larger volumes of 100 mL, 1 L and 10 L to determine: (1) at what phase of population growth would gamma-aminobutyric acid (GABA) treatment be most effective; and (2) whether GABA treatment of concentrated rotifers for several hours before mass culture would also be effective. GABA treatment of rotifer cultures at lag phase significantly enhanced population growth, whereas treatment at log phase had a lesser effect, and treatment at stationary phase had no effect. Addition of GABA to rotifer cultures every 2 days hastened population growth until day 8, but resulted in culture collapse thereafter. To reduce the cost of the use of GABA in mass cultures, GABA treatment may be conducted on concentrated rotifers (100 individuals mL−1) before mass culture. GABA treatment of concentrated rotifers for 24 h and 48 h before mass culture resulted in a significantly higher population density compared with their respective controls (no GABA treatment) on day 4, and on days 4 and 6 respectively.

Published
2000

8. Factores de riesgo para el desarrollo de infecciones intrahospitalarias en pacientes quemados. Hospital S. Juan de Dios, Costa Rica: Enero 2003-Diciembre 2005. Parte II.

Author

Naranjo, S. Vargas, Zúñiga, J. J. Romero, Castellanos, Y. Prada, Fonseca-Portilla, G., and Gallardo, W. Lao

Abstract

Copyright of Cirugía Plástica Ibero-Latinoamericana is the property of Cirugia Plastica Ibero-Latinoamericana and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Published
2009
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9. Spatio-temporal variation of water quality variables and hydrography in a seabream cage culture farm off the coast of Oman

Author

Al-Yahyai Dawood, Gallardo Wenresti, Claereboudt Michel, and Bruss Gerd

Subjects
physico-chemical, nutrient, spatio-temporal, oman, aquaculture, Aquaculture. Fisheries. Angling, SH1-691
Abstract

Mariculture cage farming in Oman is in its infancy stage. This study provides important baseline information about the initial state of mariculture in Oman and for the sustainable management of future local cage farming. Our main objective was to evaluate the spatio-temporal variations of water quality and hydrography around a gilthead seabream (Sparus aurata) cage farm in Quriyat (Sea of Oman). Starting in July 2018, we conducted a monitoring program over one year in which physico-chemical variables and nutrient levels were regularly measured at the farm cages and at reference sites away from the farm. Vertical flow profiles were recorded at the farm and analysed together with remotely sensed data. The results showed no significant differences among physico-chemical variables and nutrient levels between cages and reference sites. However, there were clear seasonal as well as significant short-term variations in the measurements. Winter conditions are usually homogeneous over the water column without reaching extremes. In summer we recorded surface temperatures of up to 32 °C and extended periods of hypoxia below 35 m depth. Periods of pronounced stratification were interrupted by energetic irregular flow pulses that triggered short up or down-welling events which lead to strong variations of temperature and oxygen. We did not measure a significant impact of the cage farm on the local environment. Our results rather point to the particular importance of monitoring temperature and oxygen levels. Both variables can approach threshold levels for fish farming, especially during summer. We determined the relevant characteristics of the local system and defined requirements for adequate monitoring. The findings of this study provide a timely baseline for future research on the interactions between local cage farms and the marine ecosystem and will assist in the planning and management of mariculture in Oman.

Published
2020
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10. Effect of some vertebrate and invertebrate hormones on the population growth, mictic female production, and body size of the marine rotifer Brachionus plicatilis Muller

Author

Snell, T. W., Tomita, Y., Hagiwara, A., Gallardo, W. G., and Soyano, K.

Subjects
AQUACULTURE, REPRODUCTION
Abstract

Eight vertebrate and invertebrate hormones were screened for their effect on population growth, mictic female production, and body size of the marine rotifer Brachionus plicatilis. Growth hormone (GH) or human chorionic gonadotropin (HCG) at 0.0025--25 I.U. ml- 1 and estradiol- 17beta (E2), triiodothyronine (T3), 20-hydroxyecdysone (20-HE), 5-hydroxytryptamine(5-HT), gamma-aminobutyric acid (GABA) or juvenile hormone (JH) at 0.05--50 mg l-1 were added to 5-ml of Nannochloropsis oculata suspension (7 x 106 cells ml-1). From an initial density of 1 individual ml-1, rotifers were cultured with hormones for 48 hours in 22 ppt seawater at 25 deg.C, in darkness. Rotifers were counted and classified into female types and transferred to a new algalfood suspension without hormone every other day until day 8 when body size was measured. Population growth was significantly higher in treatments exposed to GABA (50 mg l-1), GH (0.0025 and 0.025I.U. ml-1), HCG (0.25 and 2.5 I.U. ml-1), and 5-HT (5 mg l-1). E2 caused a decrease in population growth, whereas JH, 20HE, and T3 had no effect. Mictic female production was significantly higher at 0.05 and 0.5 mg l- 1 JH and 0.05 and 5 mg l-1 5HT GH (0.0025 and 0.025 I.U. ml-1), E2 (50 mg l-1), GABA (0.5, 5 and 50 mg l- 1), and 20-HE (0.05 mg l-1) treatments had significantly higher mictic female production only on day 8, 6, 4, and 6, respectively. T3 and hCG had no effect on mictic female production. Lorica length increased by 9.6% and 4.4% in rotifers treated with JH (0.05 mg l-1) and GABA (5 mg l-1), respectively. Correspondingly, lorica width increased by 8.9% and 2.6% in these treatments. In comparison, 20-HE-, T3-, and HCG-treated rotifers were smaller (3.9--8.2%) and GH, [ABSTRACT FROM AUTHOR]

Published
1997

11. Efficacy and safety of once-monthly pasireotide in Cushing's disease: a 12 month clinical trial

Author

Maria Fleseriu, Akira Shimatsu, Antoine Tabarin, Shozo Yamada, Christophe De Block, Atsuhiro Ichihara, Tuncay Delibasi, Stephan Petersenn, Carmen Fajardo-Montañana, Francesco Cavagnini, Yerong Yu, Ariel L. Barkan, Richard A Feelders, Thiti Snabboon, Roberto Salvatori, Przemysław Witek, Dario Bruera, Peter J. Snyder, Adriana G. Ioachimescu, Christof Schöfl, Mônica R. Gadelha, Marek Bolanowski, Abdurrahman Comlekci, Tushar Bandgar, Giorgio Arnaldi, Paola Loli, Syed Ali Imran, Eliza B Geer, Shoba Ravichandran, Marie-Christine Vantyghem, Michael Roughton, Hesarghatta Shyamasunder Asha, Feng Gu, Anthony P. Heaney, Guy T'Sjoen, Henrik Biering, Marcello D. Bronstein, Beverly M. K. Biller, Susana Tara Britto, Wilson Gallardo, Marie Bex, Liudmila Rozhinskaya, Youichi Saitoh, Brigitte Velkeniers, John Newell-Price, Pinar Kadioglu, André Lacroix, Ghislaine Houde, Masanobu Yamada, Jochen Schopohl, Mitsuru Nishiyama, Libuse Tauchmanova, Thierry Brue, Yiming Li, Susan M. Webb, Marco Boscaro, Chikara Shimizu, Rosario Pivonello, Marek Ruchała, Yutaka Takahashi, Noriyuki Suzaki, Lacroix, A, Gu, F, Gallardo, W, Pivonello, R, Yu, Y, Witek, P, Boscaro, M, Salvatori, R, Yamada, M, Tauchmanova, L, Roughton, M, Ravichandran, S, Petersenn, S, Biller, Bmk, Newell-Price, J, Pasireotide G2304 Study, Group., and Clinical sciences

Subjects
Adult, Male, medicine.medical_specialty, Nausea, Endocrinology, Diabetes and Metabolism, Medizin, Phases of clinical research, 030209 endocrinology & metabolism, Gastroenterology, law.invention, 03 medical and health sciences, chemistry.chemical_compound, endocrinology, 0302 clinical medicine, Randomized controlled trial, law, Internal medicine, medicine, Internal Medicine, Humans, Mitotane, Prospective Studies, Adverse effect, Prospective cohort study, Cushing Syndrome, business.industry, Cushing's disease, treatment, pasireotide, Cushing's disease, medicine.disease, Hormones, Pasireotide, Surgery, Treatment Outcome, chemistry, 030220 oncology & carcinogenesis, Female, Safety, medicine.symptom, Somatostatin, business, medicine.drug
Abstract

BACKGROUND: Cushing's disease is a rare debilitating endocrine disorder for which few prospective interventional studies have been done. We report results of the first phase 3 trial assessing long-acting intramuscular pasireotide in patients with Cushing's disease. METHODS: In this phase 3 clinical trial we recruited patients aged 18 years or older with persistent, recurrent, or de-novo (non-surgical candidates) Cushing's disease who had a mean urinary free cortisol (mUFC) concentration (from three 24 h samples) of 1·5-5·0 times the upper limit of normal (ULN), a normal or greater than normal morning plasma adrenocorticotropic hormone concentration, and a pituitary source of Cushing's syndrome, from 57 sites across 19 countries. Exclusion criteria included previous pasireotide treatment, mitotane therapy within 6 months, and pituitary irradiation within 10 years. We randomly allocated patients 1:1 (block size of four) using an interactive-response-technology system to intramuscular pasireotide 10 mg or 30 mgevery 4 weeks for 12 months (in the core phase). We stratified randomisation by screening mUFC concentration (1·5 to

Published
2018

12. Effect of Moringa oleifera Leaf Extract on the Growth Performance, Hematology, Innate Immunity, and Disease Resistance of Nile Tilapia ( Oreochromis niloticus ) against Streptococcus agalactiae Biotype 2.

Author

Kamble MT, Gallardo W, Salin KR, Pumpuang S, Chavan BR, Bhujel RC, Medhe SV, Kettawan A, Thompson KD, and Pirarat N

Abstract

The present study aimed to investigate the effects of Moringa oleifera leaf (MLE) extract-supplemented diets on the growth, feed utilization, hematology, innate immune response, and disease resistance of Nile tilapia against Streptococcus agalactiae Biotype 2. Four hundred and fifty Nile tilapia (32.61 ± 0.2 g/fish) were randomly allocated into fifteen tanks (30 fish/tank). Different concentrations of MLE at 0%, 0.5%, 1%, 1.5%, and 2% were fed to the Nile tilapia for 30 days, and the growth, feed utilization, hematology, and innate immune response of the Nile tilapia were determined. After the feeding trial, the Nile tilapia were challenged with a S. agalactiae Biotype 2 infection, and the relative percentage of survival (RPS) was determined. Results revealed the presence of quercetin, kaempferol, and p -coumaric acid in the MLE extract, exhibiting stronger antimicrobial activity against S. agalactiae Biotype 2. The diets supplemented with the MLE-0.5 group showed a significantly higher growth, feed utilization, hematology, and innate immune response in the Nile tilapia compared to the control and other MLE groups. Additionally, the MLE-0.5 group exhibited a significantly higher RPS of the Nile tilapia against S. agalactiae Biotype 2. Therefore, MLE-0.5 can be employed as an alternative feed supplement in sustainable Nile tilapia farming to protect against S. agalactiae Biotype 2.

Published
2024
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13. The effect of short-term preoperative nutritional intervention for cleft surgery eligibility.

Author

Mikhail S, Chattopadhyay L, DiBona M, Steppling C, Kwadjo D, Ramamonjisoa A, Gallardo W, Almendarez F, Sylvester B, Rosales S, Nthalika I, Collier ZJ, Magee W 3rd, and Auslander A

Abstract

Background: Children with orofacial clefts are highly susceptible to malnutrition, with severe malnutrition restricting their eligibility to receive safe surgery. Ready-to-use therapeutic foods (RUTF) are an effective treatment for malnutrition; however, the effectiveness has not been demonstrated in this patient population prior to surgery. We studied the effectiveness of short-term RUTF use in transitioning children with malnutrition, who were initially ineligible for surgery, into surgical candidates., Methods: A cohort of patients from Ghana, Honduras, Malawi, Madagascar, Nicaragua, and Venezuela enrolled in a nutrition program were followed by Operation Smile from June 2017 to January 2020. Age, weight, and length/height were tracked at each visit. Patients were included until they were sufficiently nourished (Z >  = -1) with a secondary outcome of receiving surgery. The study was part of a collaborative program between Operation Smile (NGO), Birdsong Peanuts (peanut shellers and distributors), and MANA Nutrition (RUTF producer)., Results: A total of 556 patients were recruited between June 2017 and January 2020. At baseline 28.2% (n = 157) of patients were diagnosed with severe, 21.0% (n = 117) moderate, and 50.7% (n = 282) mild malnutrition. 324 (58.3%) presented for at least one return visit. Of those, 207 (63.7%) reached optimal nutrition status. By visit two, the mean z-score increased from -2.5 (moderate) to -1.7 (mild) (p < 0·001). The mean time to attain optimal nutrition was 6 weeks. There was a significant difference in the proportion of patients who improved by country(p < 0.001)., Conclusion: Malnutrition prevents many children with orofacial clefts in low- and middle-income countries from receiving surgical care even when provided for free. This creates an even larger disparity in access to surgery. In an average of 6 weeks with an approximate cost of $25 USD per patient, RUTF transitioned over 60% of patients into nutritionally eligible surgical candidates, making it an effective, short-term preoperative nutritional intervention. Through unique partnerships, the expansion of cost-effective, large-scale nutrition programs can play a pivotal role in ensuring those at the highest risk of living with unrepaired orofacial clefts receive timely and safe surgical care., (© 2023. The Author(s).)

Published
2023
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