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Skin disorders in children & its management
Dr. Md Kalamuddin discusses cough algorithm simplify cough management in India
Dr. Md Kalamuddin discusses cough algorithm simplify cough management in India
Dr. Md Kalamuddin discusses cough algorithm simplify cough management in India
A recent study showed that a continuous dosing regimen of PEGasparaginase (PEGasp) can effectively prevent the formation of antibody and reduce the risk of hypersensitivity reactions. These findings were published in the Journal of Clinical Oncology.
Patients diagnosed with Acute Lymphoblastic Leukemia (ALL) were included in the DCOG ALL11 protocol. These patients were administered PEGasp as part of their treatment. Out of 818 patients, 312 were categorized as medium-risk and were randomized to receive 14 individualized doses of PEGasp. The administration of these doses occurred once every two weeks, following either a non-continuous or continuous schedule after the initial three doses during the induction phase. The primary objective of this study was to assess whether the continuous dosing schedule, without any asparaginase-free interval, would lead to a lower occurrence of hypersensitivity reactions to PEGasp compared to the standard non-continuous dosing schedule. The secondary endpoints of the study included evaluating other asparaginase-related toxicities, asparaginase activity and antibody levels, as well as overall treatment outcome.
In the induction phase, hypersensitivity reactions were detected in 27 out of 818 patients. Following random assignment assignment of 312 medium risk patients, 4 out of 155 (2.6%) patients in the continuous treatment arm and 17 out of 157 (10.8%) patients in the noncontinuous treatment arm reported hypersensitivity reactions. Among these reactions, 2 versus 13 were inactivating reactions. In the continuous treatment arm, the occurrence of inactivating hypersensitivity reactions was 7 times lower. Additionally, antibody levels were notably reduced in the continuous treatment arm. There were no notable differences in the total number of asparaginase-related toxicities between the two treatment groups, besides a lower incidence of elevated amylase in the continuous treatment group.
As a result, a continuous PEGasp dosing schedule is successful in preventing antibody formation neutralizing and hypersensitivity responses. This continuous schedule demonstrated no rise in toxicity levels and had no impact on the efficacy.
A recent study showed that a continuous dosing regimen of PEGasparaginase (PEGasp) can effectively prevent the formation of antibody and reduce the risk of hypersensitivity reactions. These findings were published in the Journal of Clinical Oncology.
Patients diagnosed with Acute Lymphoblastic Leukemia (ALL) were included in the DCOG ALL11 protocol. These patients were administered PEGasp as part of their treatment. Out of 818 patients, 312 were categorized as medium-risk and were randomized to receive 14 individualized doses of PEGasp. The administration of these doses occurred once every two weeks, following either a non-continuous or continuous schedule after the initial three doses during the induction phase. The primary objective of this study was to assess whether the continuous dosing schedule, without any asparaginase-free interval, would lead to a lower occurrence of hypersensitivity reactions to PEGasp compared to the standard non-continuous dosing schedule. The secondary endpoints of the study included evaluating other asparaginase-related toxicities, asparaginase activity and antibody levels, as well as overall treatment outcome.
In the induction phase, hypersensitivity reactions were detected in 27 out of 818 patients. Following random assignment assignment of 312 medium risk patients, 4 out of 155 (2.6%) patients in the continuous treatment arm and 17 out of 157 (10.8%) patients in the noncontinuous treatment arm reported hypersensitivity reactions. Among these reactions, 2 versus 13 were inactivating reactions. In the continuous treatment arm, the occurrence of inactivating hypersensitivity reactions was 7 times lower. Additionally, antibody levels were notably reduced in the continuous treatment arm. There were no notable differences in the total number of asparaginase-related toxicities between the two treatment groups, besides a lower incidence of elevated amylase in the continuous treatment group.
As a result, a continuous PEGasp dosing schedule is successful in preventing antibody formation neutralizing and hypersensitivity responses. This continuous schedule demonstrated no rise in toxicity levels and had no impact on the efficacy.
A recent study showed that a continuous dosing regimen of PEGasparaginase (PEGasp) can effectively prevent the formation of antibody and reduce the risk of hypersensitivity reactions. These findings were published in the Journal of Clinical Oncology.
Patients diagnosed with Acute Lymphoblastic Leukemia (ALL) were included in the DCOG ALL11 protocol. These patients were administered PEGasp as part of their treatment. Out of 818 patients, 312 were categorized as medium-risk and were randomized to receive 14 individualized doses of PEGasp. The administration of these doses occurred once every two weeks, following either a non-continuous or continuous schedule after the initial three doses during the induction phase. The primary objective of this study was to assess whether the continuous dosing schedule, without any asparaginase-free interval, would lead to a lower occurrence of hypersensitivity reactions to PEGasp compared to the standard non-continuous dosing schedule. The secondary endpoints of the study included evaluating other asparaginase-related toxicities, asparaginase activity and antibody levels, as well as overall treatment outcome.
In the induction phase, hypersensitivity reactions were detected in 27 out of 818 patients. Following random assignment assignment of 312 medium risk patients, 4 out of 155 (2.6%) patients in the continuous treatment arm and 17 out of 157 (10.8%) patients in the noncontinuous treatment arm reported hypersensitivity reactions. Among these reactions, 2 versus 13 were inactivating reactions. In the continuous treatment arm, the occurrence of inactivating hypersensitivity reactions was 7 times lower. Additionally, antibody levels were notably reduced in the continuous treatment arm. There were no notable differences in the total number of asparaginase-related toxicities between the two treatment groups, besides a lower incidence of elevated amylase in the continuous treatment group.
As a result, a continuous PEGasp dosing schedule is successful in preventing antibody formation neutralizing and hypersensitivity responses. This continuous schedule demonstrated no rise in toxicity levels and had no impact on the efficacy.
A recent study found that R21/Matrix-M vaccine which is low-cost, was well tolerated and offered high efficacy against clinical malaria in children. The results of this study were published in the journal, Lancet.
This double-blind, randomised, phase 3 trial of the R21/Matrix-M malaria vaccine screened 5477 children (aged 5-36 months), out of which 1705 and 3434 children were randomly assigned in a 2:1 ratio to the control vaccine and R21/Matrix-M (5 μg R21 plus 50 μg Matrix-M), respectively. The vaccines were administered 4 weeks apart as 3 doses, with a booster dose administered 12 months after the third dose. Half of the participants were recruited at the seasonal malaria transmission sites and the other half at standard sites with perennial malaria transmission. The primary objective of the study was to assess the protective efficacy of R21/Matrix-M, 14 days following the third vaccination. Vaccine efficacy, safety, and immunogenicity were also assessed.
At the end of the study, it was found that R21/Matrix-M vaccine was well tolerated. The most frequent adverse events were injection site pain (301 out of 1615 participants) and fever (754 out of 1615 participants). At the end of 12 months, the vaccine efficacy at the seasonal sites and standard sites were 75% and 67%, respectively. The effectiveness of the vaccine was correlated with antibodies produced by the vaccination against the conserved central Asn-Ala-Asn-Pro (NANP) repeat sequence of the circumsporozoite protein. The 5-17 month age group of children showed higher NANP-specific antibody titres when compared to the 18-36 month age group.
From the above results, it can be concluded that R21/Matrix-M vaccine which is low-cost, may be well tolerated and may offer high efficacy against clinical malaria in children.
A recent study found that R21/Matrix-M vaccine which is low-cost, was well tolerated and offered high efficacy against clinical malaria in children. The results of this study were published in the journal, Lancet.
This double-blind, randomised, phase 3 trial of the R21/Matrix-M malaria vaccine screened 5477 children (aged 5-36 months), out of which 1705 and 3434 children were randomly assigned in a 2:1 ratio to the control vaccine and R21/Matrix-M (5 μg R21 plus 50 μg Matrix-M), respectively. The vaccines were administered 4 weeks apart as 3 doses, with a booster dose administered 12 months after the third dose. Half of the participants were recruited at the seasonal malaria transmission sites and the other half at standard sites with perennial malaria transmission. The primary objective of the study was to assess the protective efficacy of R21/Matrix-M, 14 days following the third vaccination. Vaccine efficacy, safety, and immunogenicity were also assessed.
At the end of the study, it was found that R21/Matrix-M vaccine was well tolerated. The most frequent adverse events were injection site pain (301 out of 1615 participants) and fever (754 out of 1615 participants). At the end of 12 months, the vaccine efficacy at the seasonal sites and standard sites were 75% and 67%, respectively. The effectiveness of the vaccine was correlated with antibodies produced by the vaccination against the conserved central Asn-Ala-Asn-Pro (NANP) repeat sequence of the circumsporozoite protein. The 5-17 month age group of children showed higher NANP-specific antibody titres when compared to the 18-36 month age group.
From the above results, it can be concluded that R21/Matrix-M vaccine which is low-cost, may be well tolerated and may offer high efficacy against clinical malaria in children.
A recent study found that R21/Matrix-M vaccine which is low-cost, was well tolerated and offered high efficacy against clinical malaria in children. The results of this study were published in the journal, Lancet.
This double-blind, randomised, phase 3 trial of the R21/Matrix-M malaria vaccine screened 5477 children (aged 5-36 months), out of which 1705 and 3434 children were randomly assigned in a 2:1 ratio to the control vaccine and R21/Matrix-M (5 μg R21 plus 50 μg Matrix-M), respectively. The vaccines were administered 4 weeks apart as 3 doses, with a booster dose administered 12 months after the third dose. Half of the participants were recruited at the seasonal malaria transmission sites and the other half at standard sites with perennial malaria transmission. The primary objective of the study was to assess the protective efficacy of R21/Matrix-M, 14 days following the third vaccination. Vaccine efficacy, safety, and immunogenicity were also assessed.
At the end of the study, it was found that R21/Matrix-M vaccine was well tolerated. The most frequent adverse events were injection site pain (301 out of 1615 participants) and fever (754 out of 1615 participants). At the end of 12 months, the vaccine efficacy at the seasonal sites and standard sites were 75% and 67%, respectively. The effectiveness of the vaccine was correlated with antibodies produced by the vaccination against the conserved central Asn-Ala-Asn-Pro (NANP) repeat sequence of the circumsporozoite protein. The 5-17 month age group of children showed higher NANP-specific antibody titres when compared to the 18-36 month age group.
From the above results, it can be concluded that R21/Matrix-M vaccine which is low-cost, may be well tolerated and may offer high efficacy against clinical malaria in children.
A recent study demonstrated that folic acid (FA) and vitamin B12 (B12) supplementation improved arsenic methylation in children, leading to a decrease in monomethyl- (MMAs) and an increase in dimethyl- (DMAs) in both blood and urine. Implementing nutritional interventions could enhance arsenic methylation and elimination in children, thereby reducing arsenic toxicity and improving their nutritional status. This study’s results were published in the Environment International journal.
This double-blind, placebo-controlled trial involved 240 participants aged 8-11 years, who were consuming water from wells with arsenic levels exceeding 50 μg/L. They were advised to switch to wells with lower arsenic levels and were randomly assigned to receive either 400 μg FA + 5 μg B12 or a placebo daily for a period of 12 weeks. Samples of urine and blood were taken at the baseline, week 1 (urine only), and week 12. Generalized estimated equation (GEE) models were utilized to evaluate the impact of the treatment on arsenic levels in both blood and urine.
At the baseline, the mean ± SD total urinary and blood arsenic levels were measured as 91.2 ± 89.5 μg/L and 5.3 ± 2.9 μg/L, respectively. After the follow-up period, there was an overall decrease of 11.7% in total blood arsenic and 17.6% in urinary arsenic. In comparison to the placebo group, the supplementation group showed a notable increase in blood DMAs concentration by of 14.0% and blood secondary methylation index (DMAs/MMAs) by 0.19 at 12 weeks. Additionally, the supplementation group had a significantly higher urinary %DMAs (1.62%) and a significantly lower urinary %MMAs (-1.10%) compared to the placebo group after 1 week. The effects of the treatment were stronger in individuals with higher baseline blood arsenic levels. These results remained consistent across both males and females, as well as participants with varying folate and B12 status at baseline.
Thus, it can be concluded that FA and B12 supplementation resulted in improved arsenic methylation in children, resulting in a reduction in MMAs and an elevation in DMAs in both blood and urine.
A recent study demonstrated that folic acid (FA) and vitamin B12 (B12) supplementation improved arsenic methylation in children, leading to a decrease in monomethyl- (MMAs) and an increase in dimethyl- (DMAs) in both blood and urine. Implementing nutritional interventions could enhance arsenic methylation and elimination in children, thereby reducing arsenic toxicity and improving their nutritional status. This study’s results were published in the Environment International journal.
This double-blind, placebo-controlled trial involved 240 participants aged 8-11 years, who were consuming water from wells with arsenic levels exceeding 50 μg/L. They were advised to switch to wells with lower arsenic levels and were randomly assigned to receive either 400 μg FA + 5 μg B12 or a placebo daily for a period of 12 weeks. Samples of urine and blood were taken at the baseline, week 1 (urine only), and week 12. Generalized estimated equation (GEE) models were utilized to evaluate the impact of the treatment on arsenic levels in both blood and urine.
At the baseline, the mean ± SD total urinary and blood arsenic levels were measured as 91.2 ± 89.5 μg/L and 5.3 ± 2.9 μg/L, respectively. After the follow-up period, there was an overall decrease of 11.7% in total blood arsenic and 17.6% in urinary arsenic. In comparison to the placebo group, the supplementation group showed a notable increase in blood DMAs concentration by of 14.0% and blood secondary methylation index (DMAs/MMAs) by 0.19 at 12 weeks. Additionally, the supplementation group had a significantly higher urinary %DMAs (1.62%) and a significantly lower urinary %MMAs (-1.10%) compared to the placebo group after 1 week. The effects of the treatment were stronger in individuals with higher baseline blood arsenic levels. These results remained consistent across both males and females, as well as participants with varying folate and B12 status at baseline.
Thus, it can be concluded that FA and B12 supplementation resulted in improved arsenic methylation in children, resulting in a reduction in MMAs and an elevation in DMAs in both blood and urine.
A recent study demonstrated that folic acid (FA) and vitamin B12 (B12) supplementation improved arsenic methylation in children, leading to a decrease in monomethyl- (MMAs) and an increase in dimethyl- (DMAs) in both blood and urine. Implementing nutritional interventions could enhance arsenic methylation and elimination in children, thereby reducing arsenic toxicity and improving their nutritional status. This study’s results were published in the Environment International journal.
This double-blind, placebo-controlled trial involved 240 participants aged 8-11 years, who were consuming water from wells with arsenic levels exceeding 50 μg/L. They were advised to switch to wells with lower arsenic levels and were randomly assigned to receive either 400 μg FA + 5 μg B12 or a placebo daily for a period of 12 weeks. Samples of urine and blood were taken at the baseline, week 1 (urine only), and week 12. Generalized estimated equation (GEE) models were utilized to evaluate the impact of the treatment on arsenic levels in both blood and urine.
At the baseline, the mean ± SD total urinary and blood arsenic levels were measured as 91.2 ± 89.5 μg/L and 5.3 ± 2.9 μg/L, respectively. After the follow-up period, there was an overall decrease of 11.7% in total blood arsenic and 17.6% in urinary arsenic. In comparison to the placebo group, the supplementation group showed a notable increase in blood DMAs concentration by of 14.0% and blood secondary methylation index (DMAs/MMAs) by 0.19 at 12 weeks. Additionally, the supplementation group had a significantly higher urinary %DMAs (1.62%) and a significantly lower urinary %MMAs (-1.10%) compared to the placebo group after 1 week. The effects of the treatment were stronger in individuals with higher baseline blood arsenic levels. These results remained consistent across both males and females, as well as participants with varying folate and B12 status at baseline.
Thus, it can be concluded that FA and B12 supplementation resulted in improved arsenic methylation in children, resulting in a reduction in MMAs and an elevation in DMAs in both blood and urine.
According to a recent study, linaclotide has proven to be an effective and well-tolerated remedy for functional constipation in pediatric patients. This study’s findings were published in the journal, Lancet. Gastroenterology & hepatology.
In this double-blind, randomised, placebo-controlled, phase 3 study, patients aged 6-17 years were randomly assigned to receive either oral linaclotide 72 μg [n=166] or placebo [n=164] once daily for 12 weeks. The study's primary efficacy endpoint was the change from baseline (CFB) in the frequency rate of spontaneous bowel movements (SBM) per week over a twelve-week period. The change from baseline in stool consistency during the treatment period was the secondary efficacy endpoint. Efficacy and safety were analyzed in all patients who received at least one dose of the study intervention.
The mean frequency rate for SBMs was 1·28 SBMs per week (SD 0·87) with placebo and 1·16 SBMs per week (0·83) with linaclotide at baseline. This rate increased to 2·29 SBMs per week (1·99) with placebo and 3·41 SBMs per week (2·76) with linaclotide during the intervention. Patients treated with linaclotide demonstrated a significant increase in SBM frequency [least-squares mean (LSM) CFB 2·22 SBMs per week (SE 0·19)] compared to those on placebo [LSM CFB 1·05 SBMs per week (0·19)]. Additionally, linaclotide demonstrated a notable improvement in stool consistency compared to the placebo group [LSM CFB 1.11 (SE 0.08) versus 0.69 (0.08)]. Based on the above results, it can be concluded that linaclotide is an efficacious and well-tolerated treatment for functional constipation in paediatric patients.
According to a recent study, linaclotide has proven to be an effective and well-tolerated remedy for functional constipation in pediatric patients. This study’s findings were published in the journal, Lancet. Gastroenterology & hepatology.
In this double-blind, randomised, placebo-controlled, phase 3 study, patients aged 6-17 years were randomly assigned to receive either oral linaclotide 72 μg [n=166] or placebo [n=164] once daily for 12 weeks. The study's primary efficacy endpoint was the change from baseline (CFB) in the frequency rate of spontaneous bowel movements (SBM) per week over a twelve-week period. The change from baseline in stool consistency during the treatment period was the secondary efficacy endpoint. Efficacy and safety were analyzed in all patients who received at least one dose of the study intervention.
The mean frequency rate for SBMs was 1·28 SBMs per week (SD 0·87) with placebo and 1·16 SBMs per week (0·83) with linaclotide at baseline. This rate increased to 2·29 SBMs per week (1·99) with placebo and 3·41 SBMs per week (2·76) with linaclotide during the intervention. Patients treated with linaclotide demonstrated a significant increase in SBM frequency [least-squares mean (LSM) CFB 2·22 SBMs per week (SE 0·19)] compared to those on placebo [LSM CFB 1·05 SBMs per week (0·19)]. Additionally, linaclotide demonstrated a notable improvement in stool consistency compared to the placebo group [LSM CFB 1.11 (SE 0.08) versus 0.69 (0.08)]. Based on the above results, it can be concluded that linaclotide is an efficacious and well-tolerated treatment for functional constipation in paediatric patients.
According to a recent study, linaclotide has proven to be an effective and well-tolerated remedy for functional constipation in pediatric patients. This study’s findings were published in the journal, Lancet. Gastroenterology & hepatology.
In this double-blind, randomised, placebo-controlled, phase 3 study, patients aged 6-17 years were randomly assigned to receive either oral linaclotide 72 μg [n=166] or placebo [n=164] once daily for 12 weeks. The study's primary efficacy endpoint was the change from baseline (CFB) in the frequency rate of spontaneous bowel movements (SBM) per week over a twelve-week period. The change from baseline in stool consistency during the treatment period was the secondary efficacy endpoint. Efficacy and safety were analyzed in all patients who received at least one dose of the study intervention.
The mean frequency rate for SBMs was 1·28 SBMs per week (SD 0·87) with placebo and 1·16 SBMs per week (0·83) with linaclotide at baseline. This rate increased to 2·29 SBMs per week (1·99) with placebo and 3·41 SBMs per week (2·76) with linaclotide during the intervention. Patients treated with linaclotide demonstrated a significant increase in SBM frequency [least-squares mean (LSM) CFB 2·22 SBMs per week (SE 0·19)] compared to those on placebo [LSM CFB 1·05 SBMs per week (0·19)]. Additionally, linaclotide demonstrated a notable improvement in stool consistency compared to the placebo group [LSM CFB 1.11 (SE 0.08) versus 0.69 (0.08)]. Based on the above results, it can be concluded that linaclotide is an efficacious and well-tolerated treatment for functional constipation in paediatric patients.
