Datasets:

---

AshtonIsNotHere

/

biosift-nli

like 2

Comparative randomized trial evaluating the effect of proton pump inhibitor versus histamine 2 receptor antagonist as an adjuvant therapy in diffuse large B-cell lymphoma.

The development of drug resistance remains the major obstacle to clinical efficacy of cancer chemotherapy. Consequently, finding new therapeutic options for cancerous patients is an urgent need. Sixty newly diagnosed diffuse large B-cell lymphoma (DLBCL) patients were recruited from Clinical Oncology Department, Faculty of Medicine, Menoufia University, Egypt prospectively randomized to three groups (n = 20 for each group). Group one (control group) received R-CHOP standard chemotherapy {Rituximab, Cyclophosphamide, Hydroxyldaunorubicin (Doxorubicin)®, Vincristine (oncovin)®, prednisolone in the first five days of cycle}, group two received lansoprazole (LAN) 60 mg p.o. bid for only one week before starting each of cycle + R-CHOP and group three received famotidine (FAM) 40 mg p.o. once daily one week before cycle and continues daily through the cycle + R-CHOP for six cycles. Blood samples were obtained for biochemical analysis of transforming growth factor-β (TGF-β), Basic fibroblast growth factor (bFGF), interleukin-9 (IL-9), nuclear factor-kappa B (NF-κB) and Caspase 3 before and after six cycles of therapy. The obtained data showed that LAN and FAM resulted in significant decrease in (LDH, TGF-β, bFGF and IL-9, respectively) and significant increase in (Caspase-3). In addition, LAN produced a significant elevation in the response rate compared to the control group or the FAM group. Both LAN and FAM as adjuvant therapy represents a promising anticancer strategy in DLBCL by modulation of malignancy homeostasis mechanisms and boosting chemotherapy antitumor effects without further toxicity. In addition, LAN has a synergetic effect in improving the response rate.Trial registration Clinical Trial.gov Identifier: NCT0364707.

This study has quantitative outcomes like numbers, P-value, OR, CI, HR, RR, or patient ratios

Comparative randomized trial evaluating the effect of proton pump inhibitor versus histamine 2 receptor antagonist as an adjuvant therapy in diffuse large B-cell lymphoma.

The development of drug resistance remains the major obstacle to clinical efficacy of cancer chemotherapy. Consequently, finding new therapeutic options for cancerous patients is an urgent need. Sixty newly diagnosed diffuse large B-cell lymphoma (DLBCL) patients were recruited from Clinical Oncology Department, Faculty of Medicine, Menoufia University, Egypt prospectively randomized to three groups (n = 20 for each group). Group one (control group) received R-CHOP standard chemotherapy {Rituximab, Cyclophosphamide, Hydroxyldaunorubicin (Doxorubicin)®, Vincristine (oncovin)®, prednisolone in the first five days of cycle}, group two received lansoprazole (LAN) 60 mg p.o. bid for only one week before starting each of cycle + R-CHOP and group three received famotidine (FAM) 40 mg p.o. once daily one week before cycle and continues daily through the cycle + R-CHOP for six cycles. Blood samples were obtained for biochemical analysis of transforming growth factor-β (TGF-β), Basic fibroblast growth factor (bFGF), interleukin-9 (IL-9), nuclear factor-kappa B (NF-κB) and Caspase 3 before and after six cycles of therapy. The obtained data showed that LAN and FAM resulted in significant decrease in (LDH, TGF-β, bFGF and IL-9, respectively) and significant increase in (Caspase-3). In addition, LAN produced a significant elevation in the response rate compared to the control group or the FAM group. Both LAN and FAM as adjuvant therapy represents a promising anticancer strategy in DLBCL by modulation of malignancy homeostasis mechanisms and boosting chemotherapy antitumor effects without further toxicity. In addition, LAN has a synergetic effect in improving the response rate.Trial registration Clinical Trial.gov Identifier: NCT0364707.

This study does not have any quantitative outcomes

Comparative randomized trial evaluating the effect of proton pump inhibitor versus histamine 2 receptor antagonist as an adjuvant therapy in diffuse large B-cell lymphoma.

The development of drug resistance remains the major obstacle to clinical efficacy of cancer chemotherapy. Consequently, finding new therapeutic options for cancerous patients is an urgent need. Sixty newly diagnosed diffuse large B-cell lymphoma (DLBCL) patients were recruited from Clinical Oncology Department, Faculty of Medicine, Menoufia University, Egypt prospectively randomized to three groups (n = 20 for each group). Group one (control group) received R-CHOP standard chemotherapy {Rituximab, Cyclophosphamide, Hydroxyldaunorubicin (Doxorubicin)®, Vincristine (oncovin)®, prednisolone in the first five days of cycle}, group two received lansoprazole (LAN) 60 mg p.o. bid for only one week before starting each of cycle + R-CHOP and group three received famotidine (FAM) 40 mg p.o. once daily one week before cycle and continues daily through the cycle + R-CHOP for six cycles. Blood samples were obtained for biochemical analysis of transforming growth factor-β (TGF-β), Basic fibroblast growth factor (bFGF), interleukin-9 (IL-9), nuclear factor-kappa B (NF-κB) and Caspase 3 before and after six cycles of therapy. The obtained data showed that LAN and FAM resulted in significant decrease in (LDH, TGF-β, bFGF and IL-9, respectively) and significant increase in (Caspase-3). In addition, LAN produced a significant elevation in the response rate compared to the control group or the FAM group. Both LAN and FAM as adjuvant therapy represents a promising anticancer strategy in DLBCL by modulation of malignancy homeostasis mechanisms and boosting chemotherapy antitumor effects without further toxicity. In addition, LAN has a synergetic effect in improving the response rate.Trial registration Clinical Trial.gov Identifier: NCT0364707.

This study has a target drug

Comparative randomized trial evaluating the effect of proton pump inhibitor versus histamine 2 receptor antagonist as an adjuvant therapy in diffuse large B-cell lymphoma.

The development of drug resistance remains the major obstacle to clinical efficacy of cancer chemotherapy. Consequently, finding new therapeutic options for cancerous patients is an urgent need. Sixty newly diagnosed diffuse large B-cell lymphoma (DLBCL) patients were recruited from Clinical Oncology Department, Faculty of Medicine, Menoufia University, Egypt prospectively randomized to three groups (n = 20 for each group). Group one (control group) received R-CHOP standard chemotherapy {Rituximab, Cyclophosphamide, Hydroxyldaunorubicin (Doxorubicin)®, Vincristine (oncovin)®, prednisolone in the first five days of cycle}, group two received lansoprazole (LAN) 60 mg p.o. bid for only one week before starting each of cycle + R-CHOP and group three received famotidine (FAM) 40 mg p.o. once daily one week before cycle and continues daily through the cycle + R-CHOP for six cycles. Blood samples were obtained for biochemical analysis of transforming growth factor-β (TGF-β), Basic fibroblast growth factor (bFGF), interleukin-9 (IL-9), nuclear factor-kappa B (NF-κB) and Caspase 3 before and after six cycles of therapy. The obtained data showed that LAN and FAM resulted in significant decrease in (LDH, TGF-β, bFGF and IL-9, respectively) and significant increase in (Caspase-3). In addition, LAN produced a significant elevation in the response rate compared to the control group or the FAM group. Both LAN and FAM as adjuvant therapy represents a promising anticancer strategy in DLBCL by modulation of malignancy homeostasis mechanisms and boosting chemotherapy antitumor effects without further toxicity. In addition, LAN has a synergetic effect in improving the response rate.Trial registration Clinical Trial.gov Identifier: NCT0364707.

This study does not have a target drug

Comparative randomized trial evaluating the effect of proton pump inhibitor versus histamine 2 receptor antagonist as an adjuvant therapy in diffuse large B-cell lymphoma.

The development of drug resistance remains the major obstacle to clinical efficacy of cancer chemotherapy. Consequently, finding new therapeutic options for cancerous patients is an urgent need. Sixty newly diagnosed diffuse large B-cell lymphoma (DLBCL) patients were recruited from Clinical Oncology Department, Faculty of Medicine, Menoufia University, Egypt prospectively randomized to three groups (n = 20 for each group). Group one (control group) received R-CHOP standard chemotherapy {Rituximab, Cyclophosphamide, Hydroxyldaunorubicin (Doxorubicin)®, Vincristine (oncovin)®, prednisolone in the first five days of cycle}, group two received lansoprazole (LAN) 60 mg p.o. bid for only one week before starting each of cycle + R-CHOP and group three received famotidine (FAM) 40 mg p.o. once daily one week before cycle and continues daily through the cycle + R-CHOP for six cycles. Blood samples were obtained for biochemical analysis of transforming growth factor-β (TGF-β), Basic fibroblast growth factor (bFGF), interleukin-9 (IL-9), nuclear factor-kappa B (NF-κB) and Caspase 3 before and after six cycles of therapy. The obtained data showed that LAN and FAM resulted in significant decrease in (LDH, TGF-β, bFGF and IL-9, respectively) and significant increase in (Caspase-3). In addition, LAN produced a significant elevation in the response rate compared to the control group or the FAM group. Both LAN and FAM as adjuvant therapy represents a promising anticancer strategy in DLBCL by modulation of malignancy homeostasis mechanisms and boosting chemotherapy antitumor effects without further toxicity. In addition, LAN has a synergetic effect in improving the response rate.Trial registration Clinical Trial.gov Identifier: NCT0364707.

This study has a target disease

Comparative randomized trial evaluating the effect of proton pump inhibitor versus histamine 2 receptor antagonist as an adjuvant therapy in diffuse large B-cell lymphoma.

The development of drug resistance remains the major obstacle to clinical efficacy of cancer chemotherapy. Consequently, finding new therapeutic options for cancerous patients is an urgent need. Sixty newly diagnosed diffuse large B-cell lymphoma (DLBCL) patients were recruited from Clinical Oncology Department, Faculty of Medicine, Menoufia University, Egypt prospectively randomized to three groups (n = 20 for each group). Group one (control group) received R-CHOP standard chemotherapy {Rituximab, Cyclophosphamide, Hydroxyldaunorubicin (Doxorubicin)®, Vincristine (oncovin)®, prednisolone in the first five days of cycle}, group two received lansoprazole (LAN) 60 mg p.o. bid for only one week before starting each of cycle + R-CHOP and group three received famotidine (FAM) 40 mg p.o. once daily one week before cycle and continues daily through the cycle + R-CHOP for six cycles. Blood samples were obtained for biochemical analysis of transforming growth factor-β (TGF-β), Basic fibroblast growth factor (bFGF), interleukin-9 (IL-9), nuclear factor-kappa B (NF-κB) and Caspase 3 before and after six cycles of therapy. The obtained data showed that LAN and FAM resulted in significant decrease in (LDH, TGF-β, bFGF and IL-9, respectively) and significant increase in (Caspase-3). In addition, LAN produced a significant elevation in the response rate compared to the control group or the FAM group. Both LAN and FAM as adjuvant therapy represents a promising anticancer strategy in DLBCL by modulation of malignancy homeostasis mechanisms and boosting chemotherapy antitumor effects without further toxicity. In addition, LAN has a synergetic effect in improving the response rate.Trial registration Clinical Trial.gov Identifier: NCT0364707.

This study does not have a target disease

Determinants of compliance with methylphenidate therapy in children.

To get more insight into factors that influence compliance with the use of methylphenidate. 22 pharmacies detected children who used methylphenidate. Their parents were sent a questionnaire on the use of methylphenidate. In a case-control study, the influence of patient- and drug-related factors on compliance, as reported by parents, was determined. Parents returned 117 (75%) of 157 questionnaires sent out. Of these, 47.8% of the children missed a dose two times a month or more. Forgetting to take the medication (87.9%) was the most important reason. The case-control study showed that children of 16-18 y were more likely to miss doses. Other patient- and drug-related factors did not influence the missing of doses. A number of known determinants for compliance do not influence the missing of doses of methylphenidate. With about 80% of the parents reporting that their child missed doses of methylphenidate less than 5 times per month, compliance was quite good for the majority of the children.

This study has a cohort study or clinical trial

Determinants of compliance with methylphenidate therapy in children.

To get more insight into factors that influence compliance with the use of methylphenidate. 22 pharmacies detected children who used methylphenidate. Their parents were sent a questionnaire on the use of methylphenidate. In a case-control study, the influence of patient- and drug-related factors on compliance, as reported by parents, was determined. Parents returned 117 (75%) of 157 questionnaires sent out. Of these, 47.8% of the children missed a dose two times a month or more. Forgetting to take the medication (87.9%) was the most important reason. The case-control study showed that children of 16-18 y were more likely to miss doses. Other patient- and drug-related factors did not influence the missing of doses. A number of known determinants for compliance do not influence the missing of doses of methylphenidate. With about 80% of the parents reporting that their child missed doses of methylphenidate less than 5 times per month, compliance was quite good for the majority of the children.

This study does not have any cohorts or clinical trial

Determinants of compliance with methylphenidate therapy in children.

To get more insight into factors that influence compliance with the use of methylphenidate. 22 pharmacies detected children who used methylphenidate. Their parents were sent a questionnaire on the use of methylphenidate. In a case-control study, the influence of patient- and drug-related factors on compliance, as reported by parents, was determined. Parents returned 117 (75%) of 157 questionnaires sent out. Of these, 47.8% of the children missed a dose two times a month or more. Forgetting to take the medication (87.9%) was the most important reason. The case-control study showed that children of 16-18 y were more likely to miss doses. Other patient- and drug-related factors did not influence the missing of doses. A number of known determinants for compliance do not influence the missing of doses of methylphenidate. With about 80% of the parents reporting that their child missed doses of methylphenidate less than 5 times per month, compliance was quite good for the majority of the children.

This study has a control, double-blind, or comparison patient group

Determinants of compliance with methylphenidate therapy in children.

To get more insight into factors that influence compliance with the use of methylphenidate. 22 pharmacies detected children who used methylphenidate. Their parents were sent a questionnaire on the use of methylphenidate. In a case-control study, the influence of patient- and drug-related factors on compliance, as reported by parents, was determined. Parents returned 117 (75%) of 157 questionnaires sent out. Of these, 47.8% of the children missed a dose two times a month or more. Forgetting to take the medication (87.9%) was the most important reason. The case-control study showed that children of 16-18 y were more likely to miss doses. Other patient- and drug-related factors did not influence the missing of doses. A number of known determinants for compliance do not influence the missing of doses of methylphenidate. With about 80% of the parents reporting that their child missed doses of methylphenidate less than 5 times per month, compliance was quite good for the majority of the children.

This study does not have any comparison patient group

Determinants of compliance with methylphenidate therapy in children.

To get more insight into factors that influence compliance with the use of methylphenidate. 22 pharmacies detected children who used methylphenidate. Their parents were sent a questionnaire on the use of methylphenidate. In a case-control study, the influence of patient- and drug-related factors on compliance, as reported by parents, was determined. Parents returned 117 (75%) of 157 questionnaires sent out. Of these, 47.8% of the children missed a dose two times a month or more. Forgetting to take the medication (87.9%) was the most important reason. The case-control study showed that children of 16-18 y were more likely to miss doses. Other patient- and drug-related factors did not influence the missing of doses. A number of known determinants for compliance do not influence the missing of doses of methylphenidate. With about 80% of the parents reporting that their child missed doses of methylphenidate less than 5 times per month, compliance was quite good for the majority of the children.

This study has human subjects

Determinants of compliance with methylphenidate therapy in children.

To get more insight into factors that influence compliance with the use of methylphenidate. 22 pharmacies detected children who used methylphenidate. Their parents were sent a questionnaire on the use of methylphenidate. In a case-control study, the influence of patient- and drug-related factors on compliance, as reported by parents, was determined. Parents returned 117 (75%) of 157 questionnaires sent out. Of these, 47.8% of the children missed a dose two times a month or more. Forgetting to take the medication (87.9%) was the most important reason. The case-control study showed that children of 16-18 y were more likely to miss doses. Other patient- and drug-related factors did not influence the missing of doses. A number of known determinants for compliance do not influence the missing of doses of methylphenidate. With about 80% of the parents reporting that their child missed doses of methylphenidate less than 5 times per month, compliance was quite good for the majority of the children.

This study does not have human subjects

Determinants of compliance with methylphenidate therapy in children.

To get more insight into factors that influence compliance with the use of methylphenidate. 22 pharmacies detected children who used methylphenidate. Their parents were sent a questionnaire on the use of methylphenidate. In a case-control study, the influence of patient- and drug-related factors on compliance, as reported by parents, was determined. Parents returned 117 (75%) of 157 questionnaires sent out. Of these, 47.8% of the children missed a dose two times a month or more. Forgetting to take the medication (87.9%) was the most important reason. The case-control study showed that children of 16-18 y were more likely to miss doses. Other patient- and drug-related factors did not influence the missing of doses. A number of known determinants for compliance do not influence the missing of doses of methylphenidate. With about 80% of the parents reporting that their child missed doses of methylphenidate less than 5 times per month, compliance was quite good for the majority of the children.

This study contains population size or sample size information

Determinants of compliance with methylphenidate therapy in children.

To get more insight into factors that influence compliance with the use of methylphenidate. 22 pharmacies detected children who used methylphenidate. Their parents were sent a questionnaire on the use of methylphenidate. In a case-control study, the influence of patient- and drug-related factors on compliance, as reported by parents, was determined. Parents returned 117 (75%) of 157 questionnaires sent out. Of these, 47.8% of the children missed a dose two times a month or more. Forgetting to take the medication (87.9%) was the most important reason. The case-control study showed that children of 16-18 y were more likely to miss doses. Other patient- and drug-related factors did not influence the missing of doses. A number of known determinants for compliance do not influence the missing of doses of methylphenidate. With about 80% of the parents reporting that their child missed doses of methylphenidate less than 5 times per month, compliance was quite good for the majority of the children.

This study does not contain population size information

Determinants of compliance with methylphenidate therapy in children.

To get more insight into factors that influence compliance with the use of methylphenidate. 22 pharmacies detected children who used methylphenidate. Their parents were sent a questionnaire on the use of methylphenidate. In a case-control study, the influence of patient- and drug-related factors on compliance, as reported by parents, was determined. Parents returned 117 (75%) of 157 questionnaires sent out. Of these, 47.8% of the children missed a dose two times a month or more. Forgetting to take the medication (87.9%) was the most important reason. The case-control study showed that children of 16-18 y were more likely to miss doses. Other patient- and drug-related factors did not influence the missing of doses. A number of known determinants for compliance do not influence the missing of doses of methylphenidate. With about 80% of the parents reporting that their child missed doses of methylphenidate less than 5 times per month, compliance was quite good for the majority of the children.

This study has quantitative outcomes like numbers, P-value, OR, CI, HR, RR, or patient ratios

Determinants of compliance with methylphenidate therapy in children.

To get more insight into factors that influence compliance with the use of methylphenidate. 22 pharmacies detected children who used methylphenidate. Their parents were sent a questionnaire on the use of methylphenidate. In a case-control study, the influence of patient- and drug-related factors on compliance, as reported by parents, was determined. Parents returned 117 (75%) of 157 questionnaires sent out. Of these, 47.8% of the children missed a dose two times a month or more. Forgetting to take the medication (87.9%) was the most important reason. The case-control study showed that children of 16-18 y were more likely to miss doses. Other patient- and drug-related factors did not influence the missing of doses. A number of known determinants for compliance do not influence the missing of doses of methylphenidate. With about 80% of the parents reporting that their child missed doses of methylphenidate less than 5 times per month, compliance was quite good for the majority of the children.

This study does not have any quantitative outcomes

Determinants of compliance with methylphenidate therapy in children.

To get more insight into factors that influence compliance with the use of methylphenidate. 22 pharmacies detected children who used methylphenidate. Their parents were sent a questionnaire on the use of methylphenidate. In a case-control study, the influence of patient- and drug-related factors on compliance, as reported by parents, was determined. Parents returned 117 (75%) of 157 questionnaires sent out. Of these, 47.8% of the children missed a dose two times a month or more. Forgetting to take the medication (87.9%) was the most important reason. The case-control study showed that children of 16-18 y were more likely to miss doses. Other patient- and drug-related factors did not influence the missing of doses. A number of known determinants for compliance do not influence the missing of doses of methylphenidate. With about 80% of the parents reporting that their child missed doses of methylphenidate less than 5 times per month, compliance was quite good for the majority of the children.

This study has a target drug

Determinants of compliance with methylphenidate therapy in children.

To get more insight into factors that influence compliance with the use of methylphenidate. 22 pharmacies detected children who used methylphenidate. Their parents were sent a questionnaire on the use of methylphenidate. In a case-control study, the influence of patient- and drug-related factors on compliance, as reported by parents, was determined. Parents returned 117 (75%) of 157 questionnaires sent out. Of these, 47.8% of the children missed a dose two times a month or more. Forgetting to take the medication (87.9%) was the most important reason. The case-control study showed that children of 16-18 y were more likely to miss doses. Other patient- and drug-related factors did not influence the missing of doses. A number of known determinants for compliance do not influence the missing of doses of methylphenidate. With about 80% of the parents reporting that their child missed doses of methylphenidate less than 5 times per month, compliance was quite good for the majority of the children.

This study does not have a target drug

Determinants of compliance with methylphenidate therapy in children.

To get more insight into factors that influence compliance with the use of methylphenidate. 22 pharmacies detected children who used methylphenidate. Their parents were sent a questionnaire on the use of methylphenidate. In a case-control study, the influence of patient- and drug-related factors on compliance, as reported by parents, was determined. Parents returned 117 (75%) of 157 questionnaires sent out. Of these, 47.8% of the children missed a dose two times a month or more. Forgetting to take the medication (87.9%) was the most important reason. The case-control study showed that children of 16-18 y were more likely to miss doses. Other patient- and drug-related factors did not influence the missing of doses. A number of known determinants for compliance do not influence the missing of doses of methylphenidate. With about 80% of the parents reporting that their child missed doses of methylphenidate less than 5 times per month, compliance was quite good for the majority of the children.

This study has a target disease

Determinants of compliance with methylphenidate therapy in children.

To get more insight into factors that influence compliance with the use of methylphenidate. 22 pharmacies detected children who used methylphenidate. Their parents were sent a questionnaire on the use of methylphenidate. In a case-control study, the influence of patient- and drug-related factors on compliance, as reported by parents, was determined. Parents returned 117 (75%) of 157 questionnaires sent out. Of these, 47.8% of the children missed a dose two times a month or more. Forgetting to take the medication (87.9%) was the most important reason. The case-control study showed that children of 16-18 y were more likely to miss doses. Other patient- and drug-related factors did not influence the missing of doses. A number of known determinants for compliance do not influence the missing of doses of methylphenidate. With about 80% of the parents reporting that their child missed doses of methylphenidate less than 5 times per month, compliance was quite good for the majority of the children.

This study does not have a target disease

Efficacy of adjunctive sertraline for the treatment of HIV-associated cryptococcal meningitis: an open-label dose-ranging study.

Cryptococcus is the most common cause of adult meningitis in Africa. We assessed the safety and microbiological efficacy of adjunctive sertraline, previously shown to have in-vitro and in-vivo activity against cryptococcus. In this open-label dose-finding study, we recruited HIV-infected individuals with cryptococcal meningitis who presented to Mulago Hospital in Kampala, Uganda between Aug 14, 2013, and Aug 30, 2014. To assess safety and tolerability, the first 60 participants were given sertraline at escalating doses of 100 mg/day, 200 mg/day, 300 mg/day, or 400 mg/day as induction therapy for 2 weeks, followed by consolidation therapy with 200 mg/day for an additional 8 weeks. From Nov 29, 2013, participants were randomly assigned (1:1) to receive open-label sertraline at predetermined doses of 200 mg/day, 300 mg/day, or 400 mg/day as induction therapy for 2 weeks, followed by consolidation therapy with 200 mg/day for 8 weeks. Dose assignment was made via computer-generated, permuted block randomisation stratified by antiretroviral therapy (ART) status for people with a first episode of meningitis. The primary outcome was 2-week cerebrospinal fluid (CSF) clearance rate of cryptococcus, termed early fungicidal activity, measured in patients with a first episode of culture-positive meningitis and two or more CSF cultures. This study is registered with ClinicalTrials.gov, number NCT01802385. Of the 330 individuals assessed, 172 HIV-infected adults with cryptococcal meningitis were enrolled. We gave 100 mg/day sertraline to 17 patients, 200 mg/day to 12 patients, 300 mg/day to 14 patients, and 400 mg/day to 17 patients. 112 participants were randomly assigned to receive sertraline at 200 mg (n=48), 300 mg (n=36), or 400 mg (n=28) daily for the first 2 weeks, and 200 mg/day thereafter. The final population consisted of 17 participants in the 100 mg group, 60 in the 200 mg group, 50 in the 300 mg group, and 45 in the 400 mg in group. Participants receiving any sertraline dose averaged a CSF clearance rate of -0·37 colony forming units per mL per day (95% CI -0·41 to -0·33). Incidence of paradoxical immune reconstitution inflammatory syndrome was 5% (two of 43 newly starting ART) and no cases of relapse occurred over the 12-week study period. 38 (22%) of 172 participants had died at 2 weeks, and 69 (40%) had died at 12 weeks. Six grade 4 adverse events occurred in 17 participants receiving 100 mg, 14 events in 60 participants receiving 200 mg, 19 events in 50 participants receiving 300 mg, and eight events in 45 participants receiving 400 mg. Grade 4 or 5 adverse event risk did not differ between current US Food and Drug Administration-approved dosing of 100-200 mg/day and higher doses of 300-400 mg/day (hazard ratio 1·27, 95% CI 0·69-2·32; p=0·45). Participants receiving sertraline had faster cryptococcal CSF clearance and a lower incidence of immune reconstitution inflammatory syndrome and relapse than that reported in the past. This inexpensive and off-patent oral medication is a promising adjunctive antifungal therapy. National Institutes of Health, Grand Challenges Canada.

This study has a cohort study or clinical trial

Efficacy of adjunctive sertraline for the treatment of HIV-associated cryptococcal meningitis: an open-label dose-ranging study.

Cryptococcus is the most common cause of adult meningitis in Africa. We assessed the safety and microbiological efficacy of adjunctive sertraline, previously shown to have in-vitro and in-vivo activity against cryptococcus. In this open-label dose-finding study, we recruited HIV-infected individuals with cryptococcal meningitis who presented to Mulago Hospital in Kampala, Uganda between Aug 14, 2013, and Aug 30, 2014. To assess safety and tolerability, the first 60 participants were given sertraline at escalating doses of 100 mg/day, 200 mg/day, 300 mg/day, or 400 mg/day as induction therapy for 2 weeks, followed by consolidation therapy with 200 mg/day for an additional 8 weeks. From Nov 29, 2013, participants were randomly assigned (1:1) to receive open-label sertraline at predetermined doses of 200 mg/day, 300 mg/day, or 400 mg/day as induction therapy for 2 weeks, followed by consolidation therapy with 200 mg/day for 8 weeks. Dose assignment was made via computer-generated, permuted block randomisation stratified by antiretroviral therapy (ART) status for people with a first episode of meningitis. The primary outcome was 2-week cerebrospinal fluid (CSF) clearance rate of cryptococcus, termed early fungicidal activity, measured in patients with a first episode of culture-positive meningitis and two or more CSF cultures. This study is registered with ClinicalTrials.gov, number NCT01802385. Of the 330 individuals assessed, 172 HIV-infected adults with cryptococcal meningitis were enrolled. We gave 100 mg/day sertraline to 17 patients, 200 mg/day to 12 patients, 300 mg/day to 14 patients, and 400 mg/day to 17 patients. 112 participants were randomly assigned to receive sertraline at 200 mg (n=48), 300 mg (n=36), or 400 mg (n=28) daily for the first 2 weeks, and 200 mg/day thereafter. The final population consisted of 17 participants in the 100 mg group, 60 in the 200 mg group, 50 in the 300 mg group, and 45 in the 400 mg in group. Participants receiving any sertraline dose averaged a CSF clearance rate of -0·37 colony forming units per mL per day (95% CI -0·41 to -0·33). Incidence of paradoxical immune reconstitution inflammatory syndrome was 5% (two of 43 newly starting ART) and no cases of relapse occurred over the 12-week study period. 38 (22%) of 172 participants had died at 2 weeks, and 69 (40%) had died at 12 weeks. Six grade 4 adverse events occurred in 17 participants receiving 100 mg, 14 events in 60 participants receiving 200 mg, 19 events in 50 participants receiving 300 mg, and eight events in 45 participants receiving 400 mg. Grade 4 or 5 adverse event risk did not differ between current US Food and Drug Administration-approved dosing of 100-200 mg/day and higher doses of 300-400 mg/day (hazard ratio 1·27, 95% CI 0·69-2·32; p=0·45). Participants receiving sertraline had faster cryptococcal CSF clearance and a lower incidence of immune reconstitution inflammatory syndrome and relapse than that reported in the past. This inexpensive and off-patent oral medication is a promising adjunctive antifungal therapy. National Institutes of Health, Grand Challenges Canada.

This study does not have any cohorts or clinical trial

Efficacy of adjunctive sertraline for the treatment of HIV-associated cryptococcal meningitis: an open-label dose-ranging study.

Cryptococcus is the most common cause of adult meningitis in Africa. We assessed the safety and microbiological efficacy of adjunctive sertraline, previously shown to have in-vitro and in-vivo activity against cryptococcus. In this open-label dose-finding study, we recruited HIV-infected individuals with cryptococcal meningitis who presented to Mulago Hospital in Kampala, Uganda between Aug 14, 2013, and Aug 30, 2014. To assess safety and tolerability, the first 60 participants were given sertraline at escalating doses of 100 mg/day, 200 mg/day, 300 mg/day, or 400 mg/day as induction therapy for 2 weeks, followed by consolidation therapy with 200 mg/day for an additional 8 weeks. From Nov 29, 2013, participants were randomly assigned (1:1) to receive open-label sertraline at predetermined doses of 200 mg/day, 300 mg/day, or 400 mg/day as induction therapy for 2 weeks, followed by consolidation therapy with 200 mg/day for 8 weeks. Dose assignment was made via computer-generated, permuted block randomisation stratified by antiretroviral therapy (ART) status for people with a first episode of meningitis. The primary outcome was 2-week cerebrospinal fluid (CSF) clearance rate of cryptococcus, termed early fungicidal activity, measured in patients with a first episode of culture-positive meningitis and two or more CSF cultures. This study is registered with ClinicalTrials.gov, number NCT01802385. Of the 330 individuals assessed, 172 HIV-infected adults with cryptococcal meningitis were enrolled. We gave 100 mg/day sertraline to 17 patients, 200 mg/day to 12 patients, 300 mg/day to 14 patients, and 400 mg/day to 17 patients. 112 participants were randomly assigned to receive sertraline at 200 mg (n=48), 300 mg (n=36), or 400 mg (n=28) daily for the first 2 weeks, and 200 mg/day thereafter. The final population consisted of 17 participants in the 100 mg group, 60 in the 200 mg group, 50 in the 300 mg group, and 45 in the 400 mg in group. Participants receiving any sertraline dose averaged a CSF clearance rate of -0·37 colony forming units per mL per day (95% CI -0·41 to -0·33). Incidence of paradoxical immune reconstitution inflammatory syndrome was 5% (two of 43 newly starting ART) and no cases of relapse occurred over the 12-week study period. 38 (22%) of 172 participants had died at 2 weeks, and 69 (40%) had died at 12 weeks. Six grade 4 adverse events occurred in 17 participants receiving 100 mg, 14 events in 60 participants receiving 200 mg, 19 events in 50 participants receiving 300 mg, and eight events in 45 participants receiving 400 mg. Grade 4 or 5 adverse event risk did not differ between current US Food and Drug Administration-approved dosing of 100-200 mg/day and higher doses of 300-400 mg/day (hazard ratio 1·27, 95% CI 0·69-2·32; p=0·45). Participants receiving sertraline had faster cryptococcal CSF clearance and a lower incidence of immune reconstitution inflammatory syndrome and relapse than that reported in the past. This inexpensive and off-patent oral medication is a promising adjunctive antifungal therapy. National Institutes of Health, Grand Challenges Canada.

This study has a control, double-blind, or comparison patient group

Efficacy of adjunctive sertraline for the treatment of HIV-associated cryptococcal meningitis: an open-label dose-ranging study.

Cryptococcus is the most common cause of adult meningitis in Africa. We assessed the safety and microbiological efficacy of adjunctive sertraline, previously shown to have in-vitro and in-vivo activity against cryptococcus. In this open-label dose-finding study, we recruited HIV-infected individuals with cryptococcal meningitis who presented to Mulago Hospital in Kampala, Uganda between Aug 14, 2013, and Aug 30, 2014. To assess safety and tolerability, the first 60 participants were given sertraline at escalating doses of 100 mg/day, 200 mg/day, 300 mg/day, or 400 mg/day as induction therapy for 2 weeks, followed by consolidation therapy with 200 mg/day for an additional 8 weeks. From Nov 29, 2013, participants were randomly assigned (1:1) to receive open-label sertraline at predetermined doses of 200 mg/day, 300 mg/day, or 400 mg/day as induction therapy for 2 weeks, followed by consolidation therapy with 200 mg/day for 8 weeks. Dose assignment was made via computer-generated, permuted block randomisation stratified by antiretroviral therapy (ART) status for people with a first episode of meningitis. The primary outcome was 2-week cerebrospinal fluid (CSF) clearance rate of cryptococcus, termed early fungicidal activity, measured in patients with a first episode of culture-positive meningitis and two or more CSF cultures. This study is registered with ClinicalTrials.gov, number NCT01802385. Of the 330 individuals assessed, 172 HIV-infected adults with cryptococcal meningitis were enrolled. We gave 100 mg/day sertraline to 17 patients, 200 mg/day to 12 patients, 300 mg/day to 14 patients, and 400 mg/day to 17 patients. 112 participants were randomly assigned to receive sertraline at 200 mg (n=48), 300 mg (n=36), or 400 mg (n=28) daily for the first 2 weeks, and 200 mg/day thereafter. The final population consisted of 17 participants in the 100 mg group, 60 in the 200 mg group, 50 in the 300 mg group, and 45 in the 400 mg in group. Participants receiving any sertraline dose averaged a CSF clearance rate of -0·37 colony forming units per mL per day (95% CI -0·41 to -0·33). Incidence of paradoxical immune reconstitution inflammatory syndrome was 5% (two of 43 newly starting ART) and no cases of relapse occurred over the 12-week study period. 38 (22%) of 172 participants had died at 2 weeks, and 69 (40%) had died at 12 weeks. Six grade 4 adverse events occurred in 17 participants receiving 100 mg, 14 events in 60 participants receiving 200 mg, 19 events in 50 participants receiving 300 mg, and eight events in 45 participants receiving 400 mg. Grade 4 or 5 adverse event risk did not differ between current US Food and Drug Administration-approved dosing of 100-200 mg/day and higher doses of 300-400 mg/day (hazard ratio 1·27, 95% CI 0·69-2·32; p=0·45). Participants receiving sertraline had faster cryptococcal CSF clearance and a lower incidence of immune reconstitution inflammatory syndrome and relapse than that reported in the past. This inexpensive and off-patent oral medication is a promising adjunctive antifungal therapy. National Institutes of Health, Grand Challenges Canada.

This study does not have any comparison patient group

Efficacy of adjunctive sertraline for the treatment of HIV-associated cryptococcal meningitis: an open-label dose-ranging study.

Cryptococcus is the most common cause of adult meningitis in Africa. We assessed the safety and microbiological efficacy of adjunctive sertraline, previously shown to have in-vitro and in-vivo activity against cryptococcus. In this open-label dose-finding study, we recruited HIV-infected individuals with cryptococcal meningitis who presented to Mulago Hospital in Kampala, Uganda between Aug 14, 2013, and Aug 30, 2014. To assess safety and tolerability, the first 60 participants were given sertraline at escalating doses of 100 mg/day, 200 mg/day, 300 mg/day, or 400 mg/day as induction therapy for 2 weeks, followed by consolidation therapy with 200 mg/day for an additional 8 weeks. From Nov 29, 2013, participants were randomly assigned (1:1) to receive open-label sertraline at predetermined doses of 200 mg/day, 300 mg/day, or 400 mg/day as induction therapy for 2 weeks, followed by consolidation therapy with 200 mg/day for 8 weeks. Dose assignment was made via computer-generated, permuted block randomisation stratified by antiretroviral therapy (ART) status for people with a first episode of meningitis. The primary outcome was 2-week cerebrospinal fluid (CSF) clearance rate of cryptococcus, termed early fungicidal activity, measured in patients with a first episode of culture-positive meningitis and two or more CSF cultures. This study is registered with ClinicalTrials.gov, number NCT01802385. Of the 330 individuals assessed, 172 HIV-infected adults with cryptococcal meningitis were enrolled. We gave 100 mg/day sertraline to 17 patients, 200 mg/day to 12 patients, 300 mg/day to 14 patients, and 400 mg/day to 17 patients. 112 participants were randomly assigned to receive sertraline at 200 mg (n=48), 300 mg (n=36), or 400 mg (n=28) daily for the first 2 weeks, and 200 mg/day thereafter. The final population consisted of 17 participants in the 100 mg group, 60 in the 200 mg group, 50 in the 300 mg group, and 45 in the 400 mg in group. Participants receiving any sertraline dose averaged a CSF clearance rate of -0·37 colony forming units per mL per day (95% CI -0·41 to -0·33). Incidence of paradoxical immune reconstitution inflammatory syndrome was 5% (two of 43 newly starting ART) and no cases of relapse occurred over the 12-week study period. 38 (22%) of 172 participants had died at 2 weeks, and 69 (40%) had died at 12 weeks. Six grade 4 adverse events occurred in 17 participants receiving 100 mg, 14 events in 60 participants receiving 200 mg, 19 events in 50 participants receiving 300 mg, and eight events in 45 participants receiving 400 mg. Grade 4 or 5 adverse event risk did not differ between current US Food and Drug Administration-approved dosing of 100-200 mg/day and higher doses of 300-400 mg/day (hazard ratio 1·27, 95% CI 0·69-2·32; p=0·45). Participants receiving sertraline had faster cryptococcal CSF clearance and a lower incidence of immune reconstitution inflammatory syndrome and relapse than that reported in the past. This inexpensive and off-patent oral medication is a promising adjunctive antifungal therapy. National Institutes of Health, Grand Challenges Canada.

This study has human subjects

Efficacy of adjunctive sertraline for the treatment of HIV-associated cryptococcal meningitis: an open-label dose-ranging study.

Cryptococcus is the most common cause of adult meningitis in Africa. We assessed the safety and microbiological efficacy of adjunctive sertraline, previously shown to have in-vitro and in-vivo activity against cryptococcus. In this open-label dose-finding study, we recruited HIV-infected individuals with cryptococcal meningitis who presented to Mulago Hospital in Kampala, Uganda between Aug 14, 2013, and Aug 30, 2014. To assess safety and tolerability, the first 60 participants were given sertraline at escalating doses of 100 mg/day, 200 mg/day, 300 mg/day, or 400 mg/day as induction therapy for 2 weeks, followed by consolidation therapy with 200 mg/day for an additional 8 weeks. From Nov 29, 2013, participants were randomly assigned (1:1) to receive open-label sertraline at predetermined doses of 200 mg/day, 300 mg/day, or 400 mg/day as induction therapy for 2 weeks, followed by consolidation therapy with 200 mg/day for 8 weeks. Dose assignment was made via computer-generated, permuted block randomisation stratified by antiretroviral therapy (ART) status for people with a first episode of meningitis. The primary outcome was 2-week cerebrospinal fluid (CSF) clearance rate of cryptococcus, termed early fungicidal activity, measured in patients with a first episode of culture-positive meningitis and two or more CSF cultures. This study is registered with ClinicalTrials.gov, number NCT01802385. Of the 330 individuals assessed, 172 HIV-infected adults with cryptococcal meningitis were enrolled. We gave 100 mg/day sertraline to 17 patients, 200 mg/day to 12 patients, 300 mg/day to 14 patients, and 400 mg/day to 17 patients. 112 participants were randomly assigned to receive sertraline at 200 mg (n=48), 300 mg (n=36), or 400 mg (n=28) daily for the first 2 weeks, and 200 mg/day thereafter. The final population consisted of 17 participants in the 100 mg group, 60 in the 200 mg group, 50 in the 300 mg group, and 45 in the 400 mg in group. Participants receiving any sertraline dose averaged a CSF clearance rate of -0·37 colony forming units per mL per day (95% CI -0·41 to -0·33). Incidence of paradoxical immune reconstitution inflammatory syndrome was 5% (two of 43 newly starting ART) and no cases of relapse occurred over the 12-week study period. 38 (22%) of 172 participants had died at 2 weeks, and 69 (40%) had died at 12 weeks. Six grade 4 adverse events occurred in 17 participants receiving 100 mg, 14 events in 60 participants receiving 200 mg, 19 events in 50 participants receiving 300 mg, and eight events in 45 participants receiving 400 mg. Grade 4 or 5 adverse event risk did not differ between current US Food and Drug Administration-approved dosing of 100-200 mg/day and higher doses of 300-400 mg/day (hazard ratio 1·27, 95% CI 0·69-2·32; p=0·45). Participants receiving sertraline had faster cryptococcal CSF clearance and a lower incidence of immune reconstitution inflammatory syndrome and relapse than that reported in the past. This inexpensive and off-patent oral medication is a promising adjunctive antifungal therapy. National Institutes of Health, Grand Challenges Canada.

This study does not have human subjects

Efficacy of adjunctive sertraline for the treatment of HIV-associated cryptococcal meningitis: an open-label dose-ranging study.

Cryptococcus is the most common cause of adult meningitis in Africa. We assessed the safety and microbiological efficacy of adjunctive sertraline, previously shown to have in-vitro and in-vivo activity against cryptococcus. In this open-label dose-finding study, we recruited HIV-infected individuals with cryptococcal meningitis who presented to Mulago Hospital in Kampala, Uganda between Aug 14, 2013, and Aug 30, 2014. To assess safety and tolerability, the first 60 participants were given sertraline at escalating doses of 100 mg/day, 200 mg/day, 300 mg/day, or 400 mg/day as induction therapy for 2 weeks, followed by consolidation therapy with 200 mg/day for an additional 8 weeks. From Nov 29, 2013, participants were randomly assigned (1:1) to receive open-label sertraline at predetermined doses of 200 mg/day, 300 mg/day, or 400 mg/day as induction therapy for 2 weeks, followed by consolidation therapy with 200 mg/day for 8 weeks. Dose assignment was made via computer-generated, permuted block randomisation stratified by antiretroviral therapy (ART) status for people with a first episode of meningitis. The primary outcome was 2-week cerebrospinal fluid (CSF) clearance rate of cryptococcus, termed early fungicidal activity, measured in patients with a first episode of culture-positive meningitis and two or more CSF cultures. This study is registered with ClinicalTrials.gov, number NCT01802385. Of the 330 individuals assessed, 172 HIV-infected adults with cryptococcal meningitis were enrolled. We gave 100 mg/day sertraline to 17 patients, 200 mg/day to 12 patients, 300 mg/day to 14 patients, and 400 mg/day to 17 patients. 112 participants were randomly assigned to receive sertraline at 200 mg (n=48), 300 mg (n=36), or 400 mg (n=28) daily for the first 2 weeks, and 200 mg/day thereafter. The final population consisted of 17 participants in the 100 mg group, 60 in the 200 mg group, 50 in the 300 mg group, and 45 in the 400 mg in group. Participants receiving any sertraline dose averaged a CSF clearance rate of -0·37 colony forming units per mL per day (95% CI -0·41 to -0·33). Incidence of paradoxical immune reconstitution inflammatory syndrome was 5% (two of 43 newly starting ART) and no cases of relapse occurred over the 12-week study period. 38 (22%) of 172 participants had died at 2 weeks, and 69 (40%) had died at 12 weeks. Six grade 4 adverse events occurred in 17 participants receiving 100 mg, 14 events in 60 participants receiving 200 mg, 19 events in 50 participants receiving 300 mg, and eight events in 45 participants receiving 400 mg. Grade 4 or 5 adverse event risk did not differ between current US Food and Drug Administration-approved dosing of 100-200 mg/day and higher doses of 300-400 mg/day (hazard ratio 1·27, 95% CI 0·69-2·32; p=0·45). Participants receiving sertraline had faster cryptococcal CSF clearance and a lower incidence of immune reconstitution inflammatory syndrome and relapse than that reported in the past. This inexpensive and off-patent oral medication is a promising adjunctive antifungal therapy. National Institutes of Health, Grand Challenges Canada.

This study contains population size or sample size information

Efficacy of adjunctive sertraline for the treatment of HIV-associated cryptococcal meningitis: an open-label dose-ranging study.

Cryptococcus is the most common cause of adult meningitis in Africa. We assessed the safety and microbiological efficacy of adjunctive sertraline, previously shown to have in-vitro and in-vivo activity against cryptococcus. In this open-label dose-finding study, we recruited HIV-infected individuals with cryptococcal meningitis who presented to Mulago Hospital in Kampala, Uganda between Aug 14, 2013, and Aug 30, 2014. To assess safety and tolerability, the first 60 participants were given sertraline at escalating doses of 100 mg/day, 200 mg/day, 300 mg/day, or 400 mg/day as induction therapy for 2 weeks, followed by consolidation therapy with 200 mg/day for an additional 8 weeks. From Nov 29, 2013, participants were randomly assigned (1:1) to receive open-label sertraline at predetermined doses of 200 mg/day, 300 mg/day, or 400 mg/day as induction therapy for 2 weeks, followed by consolidation therapy with 200 mg/day for 8 weeks. Dose assignment was made via computer-generated, permuted block randomisation stratified by antiretroviral therapy (ART) status for people with a first episode of meningitis. The primary outcome was 2-week cerebrospinal fluid (CSF) clearance rate of cryptococcus, termed early fungicidal activity, measured in patients with a first episode of culture-positive meningitis and two or more CSF cultures. This study is registered with ClinicalTrials.gov, number NCT01802385. Of the 330 individuals assessed, 172 HIV-infected adults with cryptococcal meningitis were enrolled. We gave 100 mg/day sertraline to 17 patients, 200 mg/day to 12 patients, 300 mg/day to 14 patients, and 400 mg/day to 17 patients. 112 participants were randomly assigned to receive sertraline at 200 mg (n=48), 300 mg (n=36), or 400 mg (n=28) daily for the first 2 weeks, and 200 mg/day thereafter. The final population consisted of 17 participants in the 100 mg group, 60 in the 200 mg group, 50 in the 300 mg group, and 45 in the 400 mg in group. Participants receiving any sertraline dose averaged a CSF clearance rate of -0·37 colony forming units per mL per day (95% CI -0·41 to -0·33). Incidence of paradoxical immune reconstitution inflammatory syndrome was 5% (two of 43 newly starting ART) and no cases of relapse occurred over the 12-week study period. 38 (22%) of 172 participants had died at 2 weeks, and 69 (40%) had died at 12 weeks. Six grade 4 adverse events occurred in 17 participants receiving 100 mg, 14 events in 60 participants receiving 200 mg, 19 events in 50 participants receiving 300 mg, and eight events in 45 participants receiving 400 mg. Grade 4 or 5 adverse event risk did not differ between current US Food and Drug Administration-approved dosing of 100-200 mg/day and higher doses of 300-400 mg/day (hazard ratio 1·27, 95% CI 0·69-2·32; p=0·45). Participants receiving sertraline had faster cryptococcal CSF clearance and a lower incidence of immune reconstitution inflammatory syndrome and relapse than that reported in the past. This inexpensive and off-patent oral medication is a promising adjunctive antifungal therapy. National Institutes of Health, Grand Challenges Canada.

This study does not contain population size information

Efficacy of adjunctive sertraline for the treatment of HIV-associated cryptococcal meningitis: an open-label dose-ranging study.

Cryptococcus is the most common cause of adult meningitis in Africa. We assessed the safety and microbiological efficacy of adjunctive sertraline, previously shown to have in-vitro and in-vivo activity against cryptococcus. In this open-label dose-finding study, we recruited HIV-infected individuals with cryptococcal meningitis who presented to Mulago Hospital in Kampala, Uganda between Aug 14, 2013, and Aug 30, 2014. To assess safety and tolerability, the first 60 participants were given sertraline at escalating doses of 100 mg/day, 200 mg/day, 300 mg/day, or 400 mg/day as induction therapy for 2 weeks, followed by consolidation therapy with 200 mg/day for an additional 8 weeks. From Nov 29, 2013, participants were randomly assigned (1:1) to receive open-label sertraline at predetermined doses of 200 mg/day, 300 mg/day, or 400 mg/day as induction therapy for 2 weeks, followed by consolidation therapy with 200 mg/day for 8 weeks. Dose assignment was made via computer-generated, permuted block randomisation stratified by antiretroviral therapy (ART) status for people with a first episode of meningitis. The primary outcome was 2-week cerebrospinal fluid (CSF) clearance rate of cryptococcus, termed early fungicidal activity, measured in patients with a first episode of culture-positive meningitis and two or more CSF cultures. This study is registered with ClinicalTrials.gov, number NCT01802385. Of the 330 individuals assessed, 172 HIV-infected adults with cryptococcal meningitis were enrolled. We gave 100 mg/day sertraline to 17 patients, 200 mg/day to 12 patients, 300 mg/day to 14 patients, and 400 mg/day to 17 patients. 112 participants were randomly assigned to receive sertraline at 200 mg (n=48), 300 mg (n=36), or 400 mg (n=28) daily for the first 2 weeks, and 200 mg/day thereafter. The final population consisted of 17 participants in the 100 mg group, 60 in the 200 mg group, 50 in the 300 mg group, and 45 in the 400 mg in group. Participants receiving any sertraline dose averaged a CSF clearance rate of -0·37 colony forming units per mL per day (95% CI -0·41 to -0·33). Incidence of paradoxical immune reconstitution inflammatory syndrome was 5% (two of 43 newly starting ART) and no cases of relapse occurred over the 12-week study period. 38 (22%) of 172 participants had died at 2 weeks, and 69 (40%) had died at 12 weeks. Six grade 4 adverse events occurred in 17 participants receiving 100 mg, 14 events in 60 participants receiving 200 mg, 19 events in 50 participants receiving 300 mg, and eight events in 45 participants receiving 400 mg. Grade 4 or 5 adverse event risk did not differ between current US Food and Drug Administration-approved dosing of 100-200 mg/day and higher doses of 300-400 mg/day (hazard ratio 1·27, 95% CI 0·69-2·32; p=0·45). Participants receiving sertraline had faster cryptococcal CSF clearance and a lower incidence of immune reconstitution inflammatory syndrome and relapse than that reported in the past. This inexpensive and off-patent oral medication is a promising adjunctive antifungal therapy. National Institutes of Health, Grand Challenges Canada.

This study has quantitative outcomes like numbers, P-value, OR, CI, HR, RR, or patient ratios

Efficacy of adjunctive sertraline for the treatment of HIV-associated cryptococcal meningitis: an open-label dose-ranging study.

Cryptococcus is the most common cause of adult meningitis in Africa. We assessed the safety and microbiological efficacy of adjunctive sertraline, previously shown to have in-vitro and in-vivo activity against cryptococcus. In this open-label dose-finding study, we recruited HIV-infected individuals with cryptococcal meningitis who presented to Mulago Hospital in Kampala, Uganda between Aug 14, 2013, and Aug 30, 2014. To assess safety and tolerability, the first 60 participants were given sertraline at escalating doses of 100 mg/day, 200 mg/day, 300 mg/day, or 400 mg/day as induction therapy for 2 weeks, followed by consolidation therapy with 200 mg/day for an additional 8 weeks. From Nov 29, 2013, participants were randomly assigned (1:1) to receive open-label sertraline at predetermined doses of 200 mg/day, 300 mg/day, or 400 mg/day as induction therapy for 2 weeks, followed by consolidation therapy with 200 mg/day for 8 weeks. Dose assignment was made via computer-generated, permuted block randomisation stratified by antiretroviral therapy (ART) status for people with a first episode of meningitis. The primary outcome was 2-week cerebrospinal fluid (CSF) clearance rate of cryptococcus, termed early fungicidal activity, measured in patients with a first episode of culture-positive meningitis and two or more CSF cultures. This study is registered with ClinicalTrials.gov, number NCT01802385. Of the 330 individuals assessed, 172 HIV-infected adults with cryptococcal meningitis were enrolled. We gave 100 mg/day sertraline to 17 patients, 200 mg/day to 12 patients, 300 mg/day to 14 patients, and 400 mg/day to 17 patients. 112 participants were randomly assigned to receive sertraline at 200 mg (n=48), 300 mg (n=36), or 400 mg (n=28) daily for the first 2 weeks, and 200 mg/day thereafter. The final population consisted of 17 participants in the 100 mg group, 60 in the 200 mg group, 50 in the 300 mg group, and 45 in the 400 mg in group. Participants receiving any sertraline dose averaged a CSF clearance rate of -0·37 colony forming units per mL per day (95% CI -0·41 to -0·33). Incidence of paradoxical immune reconstitution inflammatory syndrome was 5% (two of 43 newly starting ART) and no cases of relapse occurred over the 12-week study period. 38 (22%) of 172 participants had died at 2 weeks, and 69 (40%) had died at 12 weeks. Six grade 4 adverse events occurred in 17 participants receiving 100 mg, 14 events in 60 participants receiving 200 mg, 19 events in 50 participants receiving 300 mg, and eight events in 45 participants receiving 400 mg. Grade 4 or 5 adverse event risk did not differ between current US Food and Drug Administration-approved dosing of 100-200 mg/day and higher doses of 300-400 mg/day (hazard ratio 1·27, 95% CI 0·69-2·32; p=0·45). Participants receiving sertraline had faster cryptococcal CSF clearance and a lower incidence of immune reconstitution inflammatory syndrome and relapse than that reported in the past. This inexpensive and off-patent oral medication is a promising adjunctive antifungal therapy. National Institutes of Health, Grand Challenges Canada.

This study does not have any quantitative outcomes

Efficacy of adjunctive sertraline for the treatment of HIV-associated cryptococcal meningitis: an open-label dose-ranging study.

Cryptococcus is the most common cause of adult meningitis in Africa. We assessed the safety and microbiological efficacy of adjunctive sertraline, previously shown to have in-vitro and in-vivo activity against cryptococcus. In this open-label dose-finding study, we recruited HIV-infected individuals with cryptococcal meningitis who presented to Mulago Hospital in Kampala, Uganda between Aug 14, 2013, and Aug 30, 2014. To assess safety and tolerability, the first 60 participants were given sertraline at escalating doses of 100 mg/day, 200 mg/day, 300 mg/day, or 400 mg/day as induction therapy for 2 weeks, followed by consolidation therapy with 200 mg/day for an additional 8 weeks. From Nov 29, 2013, participants were randomly assigned (1:1) to receive open-label sertraline at predetermined doses of 200 mg/day, 300 mg/day, or 400 mg/day as induction therapy for 2 weeks, followed by consolidation therapy with 200 mg/day for 8 weeks. Dose assignment was made via computer-generated, permuted block randomisation stratified by antiretroviral therapy (ART) status for people with a first episode of meningitis. The primary outcome was 2-week cerebrospinal fluid (CSF) clearance rate of cryptococcus, termed early fungicidal activity, measured in patients with a first episode of culture-positive meningitis and two or more CSF cultures. This study is registered with ClinicalTrials.gov, number NCT01802385. Of the 330 individuals assessed, 172 HIV-infected adults with cryptococcal meningitis were enrolled. We gave 100 mg/day sertraline to 17 patients, 200 mg/day to 12 patients, 300 mg/day to 14 patients, and 400 mg/day to 17 patients. 112 participants were randomly assigned to receive sertraline at 200 mg (n=48), 300 mg (n=36), or 400 mg (n=28) daily for the first 2 weeks, and 200 mg/day thereafter. The final population consisted of 17 participants in the 100 mg group, 60 in the 200 mg group, 50 in the 300 mg group, and 45 in the 400 mg in group. Participants receiving any sertraline dose averaged a CSF clearance rate of -0·37 colony forming units per mL per day (95% CI -0·41 to -0·33). Incidence of paradoxical immune reconstitution inflammatory syndrome was 5% (two of 43 newly starting ART) and no cases of relapse occurred over the 12-week study period. 38 (22%) of 172 participants had died at 2 weeks, and 69 (40%) had died at 12 weeks. Six grade 4 adverse events occurred in 17 participants receiving 100 mg, 14 events in 60 participants receiving 200 mg, 19 events in 50 participants receiving 300 mg, and eight events in 45 participants receiving 400 mg. Grade 4 or 5 adverse event risk did not differ between current US Food and Drug Administration-approved dosing of 100-200 mg/day and higher doses of 300-400 mg/day (hazard ratio 1·27, 95% CI 0·69-2·32; p=0·45). Participants receiving sertraline had faster cryptococcal CSF clearance and a lower incidence of immune reconstitution inflammatory syndrome and relapse than that reported in the past. This inexpensive and off-patent oral medication is a promising adjunctive antifungal therapy. National Institutes of Health, Grand Challenges Canada.

This study has a target drug

Efficacy of adjunctive sertraline for the treatment of HIV-associated cryptococcal meningitis: an open-label dose-ranging study.

Cryptococcus is the most common cause of adult meningitis in Africa. We assessed the safety and microbiological efficacy of adjunctive sertraline, previously shown to have in-vitro and in-vivo activity against cryptococcus. In this open-label dose-finding study, we recruited HIV-infected individuals with cryptococcal meningitis who presented to Mulago Hospital in Kampala, Uganda between Aug 14, 2013, and Aug 30, 2014. To assess safety and tolerability, the first 60 participants were given sertraline at escalating doses of 100 mg/day, 200 mg/day, 300 mg/day, or 400 mg/day as induction therapy for 2 weeks, followed by consolidation therapy with 200 mg/day for an additional 8 weeks. From Nov 29, 2013, participants were randomly assigned (1:1) to receive open-label sertraline at predetermined doses of 200 mg/day, 300 mg/day, or 400 mg/day as induction therapy for 2 weeks, followed by consolidation therapy with 200 mg/day for 8 weeks. Dose assignment was made via computer-generated, permuted block randomisation stratified by antiretroviral therapy (ART) status for people with a first episode of meningitis. The primary outcome was 2-week cerebrospinal fluid (CSF) clearance rate of cryptococcus, termed early fungicidal activity, measured in patients with a first episode of culture-positive meningitis and two or more CSF cultures. This study is registered with ClinicalTrials.gov, number NCT01802385. Of the 330 individuals assessed, 172 HIV-infected adults with cryptococcal meningitis were enrolled. We gave 100 mg/day sertraline to 17 patients, 200 mg/day to 12 patients, 300 mg/day to 14 patients, and 400 mg/day to 17 patients. 112 participants were randomly assigned to receive sertraline at 200 mg (n=48), 300 mg (n=36), or 400 mg (n=28) daily for the first 2 weeks, and 200 mg/day thereafter. The final population consisted of 17 participants in the 100 mg group, 60 in the 200 mg group, 50 in the 300 mg group, and 45 in the 400 mg in group. Participants receiving any sertraline dose averaged a CSF clearance rate of -0·37 colony forming units per mL per day (95% CI -0·41 to -0·33). Incidence of paradoxical immune reconstitution inflammatory syndrome was 5% (two of 43 newly starting ART) and no cases of relapse occurred over the 12-week study period. 38 (22%) of 172 participants had died at 2 weeks, and 69 (40%) had died at 12 weeks. Six grade 4 adverse events occurred in 17 participants receiving 100 mg, 14 events in 60 participants receiving 200 mg, 19 events in 50 participants receiving 300 mg, and eight events in 45 participants receiving 400 mg. Grade 4 or 5 adverse event risk did not differ between current US Food and Drug Administration-approved dosing of 100-200 mg/day and higher doses of 300-400 mg/day (hazard ratio 1·27, 95% CI 0·69-2·32; p=0·45). Participants receiving sertraline had faster cryptococcal CSF clearance and a lower incidence of immune reconstitution inflammatory syndrome and relapse than that reported in the past. This inexpensive and off-patent oral medication is a promising adjunctive antifungal therapy. National Institutes of Health, Grand Challenges Canada.

This study does not have a target drug

Efficacy of adjunctive sertraline for the treatment of HIV-associated cryptococcal meningitis: an open-label dose-ranging study.

Cryptococcus is the most common cause of adult meningitis in Africa. We assessed the safety and microbiological efficacy of adjunctive sertraline, previously shown to have in-vitro and in-vivo activity against cryptococcus. In this open-label dose-finding study, we recruited HIV-infected individuals with cryptococcal meningitis who presented to Mulago Hospital in Kampala, Uganda between Aug 14, 2013, and Aug 30, 2014. To assess safety and tolerability, the first 60 participants were given sertraline at escalating doses of 100 mg/day, 200 mg/day, 300 mg/day, or 400 mg/day as induction therapy for 2 weeks, followed by consolidation therapy with 200 mg/day for an additional 8 weeks. From Nov 29, 2013, participants were randomly assigned (1:1) to receive open-label sertraline at predetermined doses of 200 mg/day, 300 mg/day, or 400 mg/day as induction therapy for 2 weeks, followed by consolidation therapy with 200 mg/day for 8 weeks. Dose assignment was made via computer-generated, permuted block randomisation stratified by antiretroviral therapy (ART) status for people with a first episode of meningitis. The primary outcome was 2-week cerebrospinal fluid (CSF) clearance rate of cryptococcus, termed early fungicidal activity, measured in patients with a first episode of culture-positive meningitis and two or more CSF cultures. This study is registered with ClinicalTrials.gov, number NCT01802385. Of the 330 individuals assessed, 172 HIV-infected adults with cryptococcal meningitis were enrolled. We gave 100 mg/day sertraline to 17 patients, 200 mg/day to 12 patients, 300 mg/day to 14 patients, and 400 mg/day to 17 patients. 112 participants were randomly assigned to receive sertraline at 200 mg (n=48), 300 mg (n=36), or 400 mg (n=28) daily for the first 2 weeks, and 200 mg/day thereafter. The final population consisted of 17 participants in the 100 mg group, 60 in the 200 mg group, 50 in the 300 mg group, and 45 in the 400 mg in group. Participants receiving any sertraline dose averaged a CSF clearance rate of -0·37 colony forming units per mL per day (95% CI -0·41 to -0·33). Incidence of paradoxical immune reconstitution inflammatory syndrome was 5% (two of 43 newly starting ART) and no cases of relapse occurred over the 12-week study period. 38 (22%) of 172 participants had died at 2 weeks, and 69 (40%) had died at 12 weeks. Six grade 4 adverse events occurred in 17 participants receiving 100 mg, 14 events in 60 participants receiving 200 mg, 19 events in 50 participants receiving 300 mg, and eight events in 45 participants receiving 400 mg. Grade 4 or 5 adverse event risk did not differ between current US Food and Drug Administration-approved dosing of 100-200 mg/day and higher doses of 300-400 mg/day (hazard ratio 1·27, 95% CI 0·69-2·32; p=0·45). Participants receiving sertraline had faster cryptococcal CSF clearance and a lower incidence of immune reconstitution inflammatory syndrome and relapse than that reported in the past. This inexpensive and off-patent oral medication is a promising adjunctive antifungal therapy. National Institutes of Health, Grand Challenges Canada.

This study has a target disease

Efficacy of adjunctive sertraline for the treatment of HIV-associated cryptococcal meningitis: an open-label dose-ranging study.

Cryptococcus is the most common cause of adult meningitis in Africa. We assessed the safety and microbiological efficacy of adjunctive sertraline, previously shown to have in-vitro and in-vivo activity against cryptococcus. In this open-label dose-finding study, we recruited HIV-infected individuals with cryptococcal meningitis who presented to Mulago Hospital in Kampala, Uganda between Aug 14, 2013, and Aug 30, 2014. To assess safety and tolerability, the first 60 participants were given sertraline at escalating doses of 100 mg/day, 200 mg/day, 300 mg/day, or 400 mg/day as induction therapy for 2 weeks, followed by consolidation therapy with 200 mg/day for an additional 8 weeks. From Nov 29, 2013, participants were randomly assigned (1:1) to receive open-label sertraline at predetermined doses of 200 mg/day, 300 mg/day, or 400 mg/day as induction therapy for 2 weeks, followed by consolidation therapy with 200 mg/day for 8 weeks. Dose assignment was made via computer-generated, permuted block randomisation stratified by antiretroviral therapy (ART) status for people with a first episode of meningitis. The primary outcome was 2-week cerebrospinal fluid (CSF) clearance rate of cryptococcus, termed early fungicidal activity, measured in patients with a first episode of culture-positive meningitis and two or more CSF cultures. This study is registered with ClinicalTrials.gov, number NCT01802385. Of the 330 individuals assessed, 172 HIV-infected adults with cryptococcal meningitis were enrolled. We gave 100 mg/day sertraline to 17 patients, 200 mg/day to 12 patients, 300 mg/day to 14 patients, and 400 mg/day to 17 patients. 112 participants were randomly assigned to receive sertraline at 200 mg (n=48), 300 mg (n=36), or 400 mg (n=28) daily for the first 2 weeks, and 200 mg/day thereafter. The final population consisted of 17 participants in the 100 mg group, 60 in the 200 mg group, 50 in the 300 mg group, and 45 in the 400 mg in group. Participants receiving any sertraline dose averaged a CSF clearance rate of -0·37 colony forming units per mL per day (95% CI -0·41 to -0·33). Incidence of paradoxical immune reconstitution inflammatory syndrome was 5% (two of 43 newly starting ART) and no cases of relapse occurred over the 12-week study period. 38 (22%) of 172 participants had died at 2 weeks, and 69 (40%) had died at 12 weeks. Six grade 4 adverse events occurred in 17 participants receiving 100 mg, 14 events in 60 participants receiving 200 mg, 19 events in 50 participants receiving 300 mg, and eight events in 45 participants receiving 400 mg. Grade 4 or 5 adverse event risk did not differ between current US Food and Drug Administration-approved dosing of 100-200 mg/day and higher doses of 300-400 mg/day (hazard ratio 1·27, 95% CI 0·69-2·32; p=0·45). Participants receiving sertraline had faster cryptococcal CSF clearance and a lower incidence of immune reconstitution inflammatory syndrome and relapse than that reported in the past. This inexpensive and off-patent oral medication is a promising adjunctive antifungal therapy. National Institutes of Health, Grand Challenges Canada.

This study does not have a target disease

Detrusor contraction duration may predict response to alpha-blocker therapy for lower urinary tract symptoms.

Baseline pressure/flow parameters have not correlated well with response to medical therapy for lower urinary tract symptoms (LUTS). This open-label, nonrandomized retrospective study was designed to evaluate whether the urodynamic parameter duration (in seconds) of the detrusor contraction (DCD) correlates better with alpha-blocker response than previously described urodynamic parameters. 93 men (mean age 62.6+/-8.5) with LUTS underwent urodynamic evaluation prior to initiating therapy with doxazosin titrated to 8 mg and followed for 6 months. Parameters of evaluation included the AUA symptom score (AUASx), peak urinary flow rate (Q(max)), maximal detrusor pressure (P(max)), detrusor pressure at maximal flow (P(det)) and DCD. The correlation and predictive value of therapeutic response and baseline urodynamic parameters were assessed. 85 patients were evaluable at 6 months. For the entire group, AUASx decreased from 15.1+/-6.9 to 9.7+/-5.1 (-36%) and Q(max) increased from 9.3+/-3.7 to 11.9+/-5.7 ml/s (+28%). Baseline P(max) was 74.8+/-19.6 cm H(2)O, P(det) was 61.6+/-18.9 cm H(2)O and DCD was 107.6+/-28.6 s. There was weak correlation between either baseline P(max) or P(det) and therapeutic response (defined as a decrease in AUASx of 40% and an increase in Q(max) of 30%). Utilizing a baseline DCD of 90 s or more, there was a significant correlation to therapeutic response (r = 0.48, p = 0.002). These preliminary data suggest that DCD may be a useful urodynamic parameter to predict and optimize therapy with a-blockade. The potential utility and cost-effectiveness of DCD remains to be determined.

This study has a cohort study or clinical trial

Detrusor contraction duration may predict response to alpha-blocker therapy for lower urinary tract symptoms.

Baseline pressure/flow parameters have not correlated well with response to medical therapy for lower urinary tract symptoms (LUTS). This open-label, nonrandomized retrospective study was designed to evaluate whether the urodynamic parameter duration (in seconds) of the detrusor contraction (DCD) correlates better with alpha-blocker response than previously described urodynamic parameters. 93 men (mean age 62.6+/-8.5) with LUTS underwent urodynamic evaluation prior to initiating therapy with doxazosin titrated to 8 mg and followed for 6 months. Parameters of evaluation included the AUA symptom score (AUASx), peak urinary flow rate (Q(max)), maximal detrusor pressure (P(max)), detrusor pressure at maximal flow (P(det)) and DCD. The correlation and predictive value of therapeutic response and baseline urodynamic parameters were assessed. 85 patients were evaluable at 6 months. For the entire group, AUASx decreased from 15.1+/-6.9 to 9.7+/-5.1 (-36%) and Q(max) increased from 9.3+/-3.7 to 11.9+/-5.7 ml/s (+28%). Baseline P(max) was 74.8+/-19.6 cm H(2)O, P(det) was 61.6+/-18.9 cm H(2)O and DCD was 107.6+/-28.6 s. There was weak correlation between either baseline P(max) or P(det) and therapeutic response (defined as a decrease in AUASx of 40% and an increase in Q(max) of 30%). Utilizing a baseline DCD of 90 s or more, there was a significant correlation to therapeutic response (r = 0.48, p = 0.002). These preliminary data suggest that DCD may be a useful urodynamic parameter to predict and optimize therapy with a-blockade. The potential utility and cost-effectiveness of DCD remains to be determined.

This study does not have any cohorts or clinical trial

Detrusor contraction duration may predict response to alpha-blocker therapy for lower urinary tract symptoms.

Baseline pressure/flow parameters have not correlated well with response to medical therapy for lower urinary tract symptoms (LUTS). This open-label, nonrandomized retrospective study was designed to evaluate whether the urodynamic parameter duration (in seconds) of the detrusor contraction (DCD) correlates better with alpha-blocker response than previously described urodynamic parameters. 93 men (mean age 62.6+/-8.5) with LUTS underwent urodynamic evaluation prior to initiating therapy with doxazosin titrated to 8 mg and followed for 6 months. Parameters of evaluation included the AUA symptom score (AUASx), peak urinary flow rate (Q(max)), maximal detrusor pressure (P(max)), detrusor pressure at maximal flow (P(det)) and DCD. The correlation and predictive value of therapeutic response and baseline urodynamic parameters were assessed. 85 patients were evaluable at 6 months. For the entire group, AUASx decreased from 15.1+/-6.9 to 9.7+/-5.1 (-36%) and Q(max) increased from 9.3+/-3.7 to 11.9+/-5.7 ml/s (+28%). Baseline P(max) was 74.8+/-19.6 cm H(2)O, P(det) was 61.6+/-18.9 cm H(2)O and DCD was 107.6+/-28.6 s. There was weak correlation between either baseline P(max) or P(det) and therapeutic response (defined as a decrease in AUASx of 40% and an increase in Q(max) of 30%). Utilizing a baseline DCD of 90 s or more, there was a significant correlation to therapeutic response (r = 0.48, p = 0.002). These preliminary data suggest that DCD may be a useful urodynamic parameter to predict and optimize therapy with a-blockade. The potential utility and cost-effectiveness of DCD remains to be determined.

This study has a control, double-blind, or comparison patient group

Detrusor contraction duration may predict response to alpha-blocker therapy for lower urinary tract symptoms.

Baseline pressure/flow parameters have not correlated well with response to medical therapy for lower urinary tract symptoms (LUTS). This open-label, nonrandomized retrospective study was designed to evaluate whether the urodynamic parameter duration (in seconds) of the detrusor contraction (DCD) correlates better with alpha-blocker response than previously described urodynamic parameters. 93 men (mean age 62.6+/-8.5) with LUTS underwent urodynamic evaluation prior to initiating therapy with doxazosin titrated to 8 mg and followed for 6 months. Parameters of evaluation included the AUA symptom score (AUASx), peak urinary flow rate (Q(max)), maximal detrusor pressure (P(max)), detrusor pressure at maximal flow (P(det)) and DCD. The correlation and predictive value of therapeutic response and baseline urodynamic parameters were assessed. 85 patients were evaluable at 6 months. For the entire group, AUASx decreased from 15.1+/-6.9 to 9.7+/-5.1 (-36%) and Q(max) increased from 9.3+/-3.7 to 11.9+/-5.7 ml/s (+28%). Baseline P(max) was 74.8+/-19.6 cm H(2)O, P(det) was 61.6+/-18.9 cm H(2)O and DCD was 107.6+/-28.6 s. There was weak correlation between either baseline P(max) or P(det) and therapeutic response (defined as a decrease in AUASx of 40% and an increase in Q(max) of 30%). Utilizing a baseline DCD of 90 s or more, there was a significant correlation to therapeutic response (r = 0.48, p = 0.002). These preliminary data suggest that DCD may be a useful urodynamic parameter to predict and optimize therapy with a-blockade. The potential utility and cost-effectiveness of DCD remains to be determined.

This study does not have any comparison patient group

Detrusor contraction duration may predict response to alpha-blocker therapy for lower urinary tract symptoms.

Baseline pressure/flow parameters have not correlated well with response to medical therapy for lower urinary tract symptoms (LUTS). This open-label, nonrandomized retrospective study was designed to evaluate whether the urodynamic parameter duration (in seconds) of the detrusor contraction (DCD) correlates better with alpha-blocker response than previously described urodynamic parameters. 93 men (mean age 62.6+/-8.5) with LUTS underwent urodynamic evaluation prior to initiating therapy with doxazosin titrated to 8 mg and followed for 6 months. Parameters of evaluation included the AUA symptom score (AUASx), peak urinary flow rate (Q(max)), maximal detrusor pressure (P(max)), detrusor pressure at maximal flow (P(det)) and DCD. The correlation and predictive value of therapeutic response and baseline urodynamic parameters were assessed. 85 patients were evaluable at 6 months. For the entire group, AUASx decreased from 15.1+/-6.9 to 9.7+/-5.1 (-36%) and Q(max) increased from 9.3+/-3.7 to 11.9+/-5.7 ml/s (+28%). Baseline P(max) was 74.8+/-19.6 cm H(2)O, P(det) was 61.6+/-18.9 cm H(2)O and DCD was 107.6+/-28.6 s. There was weak correlation between either baseline P(max) or P(det) and therapeutic response (defined as a decrease in AUASx of 40% and an increase in Q(max) of 30%). Utilizing a baseline DCD of 90 s or more, there was a significant correlation to therapeutic response (r = 0.48, p = 0.002). These preliminary data suggest that DCD may be a useful urodynamic parameter to predict and optimize therapy with a-blockade. The potential utility and cost-effectiveness of DCD remains to be determined.

This study has human subjects

Detrusor contraction duration may predict response to alpha-blocker therapy for lower urinary tract symptoms.

Baseline pressure/flow parameters have not correlated well with response to medical therapy for lower urinary tract symptoms (LUTS). This open-label, nonrandomized retrospective study was designed to evaluate whether the urodynamic parameter duration (in seconds) of the detrusor contraction (DCD) correlates better with alpha-blocker response than previously described urodynamic parameters. 93 men (mean age 62.6+/-8.5) with LUTS underwent urodynamic evaluation prior to initiating therapy with doxazosin titrated to 8 mg and followed for 6 months. Parameters of evaluation included the AUA symptom score (AUASx), peak urinary flow rate (Q(max)), maximal detrusor pressure (P(max)), detrusor pressure at maximal flow (P(det)) and DCD. The correlation and predictive value of therapeutic response and baseline urodynamic parameters were assessed. 85 patients were evaluable at 6 months. For the entire group, AUASx decreased from 15.1+/-6.9 to 9.7+/-5.1 (-36%) and Q(max) increased from 9.3+/-3.7 to 11.9+/-5.7 ml/s (+28%). Baseline P(max) was 74.8+/-19.6 cm H(2)O, P(det) was 61.6+/-18.9 cm H(2)O and DCD was 107.6+/-28.6 s. There was weak correlation between either baseline P(max) or P(det) and therapeutic response (defined as a decrease in AUASx of 40% and an increase in Q(max) of 30%). Utilizing a baseline DCD of 90 s or more, there was a significant correlation to therapeutic response (r = 0.48, p = 0.002). These preliminary data suggest that DCD may be a useful urodynamic parameter to predict and optimize therapy with a-blockade. The potential utility and cost-effectiveness of DCD remains to be determined.

This study does not have human subjects

Detrusor contraction duration may predict response to alpha-blocker therapy for lower urinary tract symptoms.

Baseline pressure/flow parameters have not correlated well with response to medical therapy for lower urinary tract symptoms (LUTS). This open-label, nonrandomized retrospective study was designed to evaluate whether the urodynamic parameter duration (in seconds) of the detrusor contraction (DCD) correlates better with alpha-blocker response than previously described urodynamic parameters. 93 men (mean age 62.6+/-8.5) with LUTS underwent urodynamic evaluation prior to initiating therapy with doxazosin titrated to 8 mg and followed for 6 months. Parameters of evaluation included the AUA symptom score (AUASx), peak urinary flow rate (Q(max)), maximal detrusor pressure (P(max)), detrusor pressure at maximal flow (P(det)) and DCD. The correlation and predictive value of therapeutic response and baseline urodynamic parameters were assessed. 85 patients were evaluable at 6 months. For the entire group, AUASx decreased from 15.1+/-6.9 to 9.7+/-5.1 (-36%) and Q(max) increased from 9.3+/-3.7 to 11.9+/-5.7 ml/s (+28%). Baseline P(max) was 74.8+/-19.6 cm H(2)O, P(det) was 61.6+/-18.9 cm H(2)O and DCD was 107.6+/-28.6 s. There was weak correlation between either baseline P(max) or P(det) and therapeutic response (defined as a decrease in AUASx of 40% and an increase in Q(max) of 30%). Utilizing a baseline DCD of 90 s or more, there was a significant correlation to therapeutic response (r = 0.48, p = 0.002). These preliminary data suggest that DCD may be a useful urodynamic parameter to predict and optimize therapy with a-blockade. The potential utility and cost-effectiveness of DCD remains to be determined.

This study contains population size or sample size information

Detrusor contraction duration may predict response to alpha-blocker therapy for lower urinary tract symptoms.

Baseline pressure/flow parameters have not correlated well with response to medical therapy for lower urinary tract symptoms (LUTS). This open-label, nonrandomized retrospective study was designed to evaluate whether the urodynamic parameter duration (in seconds) of the detrusor contraction (DCD) correlates better with alpha-blocker response than previously described urodynamic parameters. 93 men (mean age 62.6+/-8.5) with LUTS underwent urodynamic evaluation prior to initiating therapy with doxazosin titrated to 8 mg and followed for 6 months. Parameters of evaluation included the AUA symptom score (AUASx), peak urinary flow rate (Q(max)), maximal detrusor pressure (P(max)), detrusor pressure at maximal flow (P(det)) and DCD. The correlation and predictive value of therapeutic response and baseline urodynamic parameters were assessed. 85 patients were evaluable at 6 months. For the entire group, AUASx decreased from 15.1+/-6.9 to 9.7+/-5.1 (-36%) and Q(max) increased from 9.3+/-3.7 to 11.9+/-5.7 ml/s (+28%). Baseline P(max) was 74.8+/-19.6 cm H(2)O, P(det) was 61.6+/-18.9 cm H(2)O and DCD was 107.6+/-28.6 s. There was weak correlation between either baseline P(max) or P(det) and therapeutic response (defined as a decrease in AUASx of 40% and an increase in Q(max) of 30%). Utilizing a baseline DCD of 90 s or more, there was a significant correlation to therapeutic response (r = 0.48, p = 0.002). These preliminary data suggest that DCD may be a useful urodynamic parameter to predict and optimize therapy with a-blockade. The potential utility and cost-effectiveness of DCD remains to be determined.

This study does not contain population size information

Detrusor contraction duration may predict response to alpha-blocker therapy for lower urinary tract symptoms.

Baseline pressure/flow parameters have not correlated well with response to medical therapy for lower urinary tract symptoms (LUTS). This open-label, nonrandomized retrospective study was designed to evaluate whether the urodynamic parameter duration (in seconds) of the detrusor contraction (DCD) correlates better with alpha-blocker response than previously described urodynamic parameters. 93 men (mean age 62.6+/-8.5) with LUTS underwent urodynamic evaluation prior to initiating therapy with doxazosin titrated to 8 mg and followed for 6 months. Parameters of evaluation included the AUA symptom score (AUASx), peak urinary flow rate (Q(max)), maximal detrusor pressure (P(max)), detrusor pressure at maximal flow (P(det)) and DCD. The correlation and predictive value of therapeutic response and baseline urodynamic parameters were assessed. 85 patients were evaluable at 6 months. For the entire group, AUASx decreased from 15.1+/-6.9 to 9.7+/-5.1 (-36%) and Q(max) increased from 9.3+/-3.7 to 11.9+/-5.7 ml/s (+28%). Baseline P(max) was 74.8+/-19.6 cm H(2)O, P(det) was 61.6+/-18.9 cm H(2)O and DCD was 107.6+/-28.6 s. There was weak correlation between either baseline P(max) or P(det) and therapeutic response (defined as a decrease in AUASx of 40% and an increase in Q(max) of 30%). Utilizing a baseline DCD of 90 s or more, there was a significant correlation to therapeutic response (r = 0.48, p = 0.002). These preliminary data suggest that DCD may be a useful urodynamic parameter to predict and optimize therapy with a-blockade. The potential utility and cost-effectiveness of DCD remains to be determined.

This study has quantitative outcomes like numbers, P-value, OR, CI, HR, RR, or patient ratios

Detrusor contraction duration may predict response to alpha-blocker therapy for lower urinary tract symptoms.

Baseline pressure/flow parameters have not correlated well with response to medical therapy for lower urinary tract symptoms (LUTS). This open-label, nonrandomized retrospective study was designed to evaluate whether the urodynamic parameter duration (in seconds) of the detrusor contraction (DCD) correlates better with alpha-blocker response than previously described urodynamic parameters. 93 men (mean age 62.6+/-8.5) with LUTS underwent urodynamic evaluation prior to initiating therapy with doxazosin titrated to 8 mg and followed for 6 months. Parameters of evaluation included the AUA symptom score (AUASx), peak urinary flow rate (Q(max)), maximal detrusor pressure (P(max)), detrusor pressure at maximal flow (P(det)) and DCD. The correlation and predictive value of therapeutic response and baseline urodynamic parameters were assessed. 85 patients were evaluable at 6 months. For the entire group, AUASx decreased from 15.1+/-6.9 to 9.7+/-5.1 (-36%) and Q(max) increased from 9.3+/-3.7 to 11.9+/-5.7 ml/s (+28%). Baseline P(max) was 74.8+/-19.6 cm H(2)O, P(det) was 61.6+/-18.9 cm H(2)O and DCD was 107.6+/-28.6 s. There was weak correlation between either baseline P(max) or P(det) and therapeutic response (defined as a decrease in AUASx of 40% and an increase in Q(max) of 30%). Utilizing a baseline DCD of 90 s or more, there was a significant correlation to therapeutic response (r = 0.48, p = 0.002). These preliminary data suggest that DCD may be a useful urodynamic parameter to predict and optimize therapy with a-blockade. The potential utility and cost-effectiveness of DCD remains to be determined.

This study does not have any quantitative outcomes

Detrusor contraction duration may predict response to alpha-blocker therapy for lower urinary tract symptoms.

Baseline pressure/flow parameters have not correlated well with response to medical therapy for lower urinary tract symptoms (LUTS). This open-label, nonrandomized retrospective study was designed to evaluate whether the urodynamic parameter duration (in seconds) of the detrusor contraction (DCD) correlates better with alpha-blocker response than previously described urodynamic parameters. 93 men (mean age 62.6+/-8.5) with LUTS underwent urodynamic evaluation prior to initiating therapy with doxazosin titrated to 8 mg and followed for 6 months. Parameters of evaluation included the AUA symptom score (AUASx), peak urinary flow rate (Q(max)), maximal detrusor pressure (P(max)), detrusor pressure at maximal flow (P(det)) and DCD. The correlation and predictive value of therapeutic response and baseline urodynamic parameters were assessed. 85 patients were evaluable at 6 months. For the entire group, AUASx decreased from 15.1+/-6.9 to 9.7+/-5.1 (-36%) and Q(max) increased from 9.3+/-3.7 to 11.9+/-5.7 ml/s (+28%). Baseline P(max) was 74.8+/-19.6 cm H(2)O, P(det) was 61.6+/-18.9 cm H(2)O and DCD was 107.6+/-28.6 s. There was weak correlation between either baseline P(max) or P(det) and therapeutic response (defined as a decrease in AUASx of 40% and an increase in Q(max) of 30%). Utilizing a baseline DCD of 90 s or more, there was a significant correlation to therapeutic response (r = 0.48, p = 0.002). These preliminary data suggest that DCD may be a useful urodynamic parameter to predict and optimize therapy with a-blockade. The potential utility and cost-effectiveness of DCD remains to be determined.

This study has a target drug

Detrusor contraction duration may predict response to alpha-blocker therapy for lower urinary tract symptoms.

Baseline pressure/flow parameters have not correlated well with response to medical therapy for lower urinary tract symptoms (LUTS). This open-label, nonrandomized retrospective study was designed to evaluate whether the urodynamic parameter duration (in seconds) of the detrusor contraction (DCD) correlates better with alpha-blocker response than previously described urodynamic parameters. 93 men (mean age 62.6+/-8.5) with LUTS underwent urodynamic evaluation prior to initiating therapy with doxazosin titrated to 8 mg and followed for 6 months. Parameters of evaluation included the AUA symptom score (AUASx), peak urinary flow rate (Q(max)), maximal detrusor pressure (P(max)), detrusor pressure at maximal flow (P(det)) and DCD. The correlation and predictive value of therapeutic response and baseline urodynamic parameters were assessed. 85 patients were evaluable at 6 months. For the entire group, AUASx decreased from 15.1+/-6.9 to 9.7+/-5.1 (-36%) and Q(max) increased from 9.3+/-3.7 to 11.9+/-5.7 ml/s (+28%). Baseline P(max) was 74.8+/-19.6 cm H(2)O, P(det) was 61.6+/-18.9 cm H(2)O and DCD was 107.6+/-28.6 s. There was weak correlation between either baseline P(max) or P(det) and therapeutic response (defined as a decrease in AUASx of 40% and an increase in Q(max) of 30%). Utilizing a baseline DCD of 90 s or more, there was a significant correlation to therapeutic response (r = 0.48, p = 0.002). These preliminary data suggest that DCD may be a useful urodynamic parameter to predict and optimize therapy with a-blockade. The potential utility and cost-effectiveness of DCD remains to be determined.

This study does not have a target drug

Detrusor contraction duration may predict response to alpha-blocker therapy for lower urinary tract symptoms.

Baseline pressure/flow parameters have not correlated well with response to medical therapy for lower urinary tract symptoms (LUTS). This open-label, nonrandomized retrospective study was designed to evaluate whether the urodynamic parameter duration (in seconds) of the detrusor contraction (DCD) correlates better with alpha-blocker response than previously described urodynamic parameters. 93 men (mean age 62.6+/-8.5) with LUTS underwent urodynamic evaluation prior to initiating therapy with doxazosin titrated to 8 mg and followed for 6 months. Parameters of evaluation included the AUA symptom score (AUASx), peak urinary flow rate (Q(max)), maximal detrusor pressure (P(max)), detrusor pressure at maximal flow (P(det)) and DCD. The correlation and predictive value of therapeutic response and baseline urodynamic parameters were assessed. 85 patients were evaluable at 6 months. For the entire group, AUASx decreased from 15.1+/-6.9 to 9.7+/-5.1 (-36%) and Q(max) increased from 9.3+/-3.7 to 11.9+/-5.7 ml/s (+28%). Baseline P(max) was 74.8+/-19.6 cm H(2)O, P(det) was 61.6+/-18.9 cm H(2)O and DCD was 107.6+/-28.6 s. There was weak correlation between either baseline P(max) or P(det) and therapeutic response (defined as a decrease in AUASx of 40% and an increase in Q(max) of 30%). Utilizing a baseline DCD of 90 s or more, there was a significant correlation to therapeutic response (r = 0.48, p = 0.002). These preliminary data suggest that DCD may be a useful urodynamic parameter to predict and optimize therapy with a-blockade. The potential utility and cost-effectiveness of DCD remains to be determined.

This study has a target disease

Detrusor contraction duration may predict response to alpha-blocker therapy for lower urinary tract symptoms.

Baseline pressure/flow parameters have not correlated well with response to medical therapy for lower urinary tract symptoms (LUTS). This open-label, nonrandomized retrospective study was designed to evaluate whether the urodynamic parameter duration (in seconds) of the detrusor contraction (DCD) correlates better with alpha-blocker response than previously described urodynamic parameters. 93 men (mean age 62.6+/-8.5) with LUTS underwent urodynamic evaluation prior to initiating therapy with doxazosin titrated to 8 mg and followed for 6 months. Parameters of evaluation included the AUA symptom score (AUASx), peak urinary flow rate (Q(max)), maximal detrusor pressure (P(max)), detrusor pressure at maximal flow (P(det)) and DCD. The correlation and predictive value of therapeutic response and baseline urodynamic parameters were assessed. 85 patients were evaluable at 6 months. For the entire group, AUASx decreased from 15.1+/-6.9 to 9.7+/-5.1 (-36%) and Q(max) increased from 9.3+/-3.7 to 11.9+/-5.7 ml/s (+28%). Baseline P(max) was 74.8+/-19.6 cm H(2)O, P(det) was 61.6+/-18.9 cm H(2)O and DCD was 107.6+/-28.6 s. There was weak correlation between either baseline P(max) or P(det) and therapeutic response (defined as a decrease in AUASx of 40% and an increase in Q(max) of 30%). Utilizing a baseline DCD of 90 s or more, there was a significant correlation to therapeutic response (r = 0.48, p = 0.002). These preliminary data suggest that DCD may be a useful urodynamic parameter to predict and optimize therapy with a-blockade. The potential utility and cost-effectiveness of DCD remains to be determined.

This study does not have a target disease

Effects of angiotensin II receptor blocker on proteinuria in renal transplant recipients.

Therapeutic approaches directed at reducing proteinuria are under development. The aim of the present study was to prospectively elucidate the impact of losartan treatment in renal transplant recipients with persistent proteinuria. Twenty-eight patients with persistent proteinuria or mild hypertension were assigned to receive losartan. Proteinuria was defined as a ratio of urinary protein to urinary creatinine (U(P)/U(Cr)) >0.5 in continual urinary tests in the outpatient setting. All patients with mild hypertension reached target blood pressure (BP) with losartan treatment, but the change was not significant. In twelve patients with proteinuria before initiation of the study, urinary protein excretion was significantly reduced with treatment. No correlation was observed between reductions in proteinuria and mean BP. A significant decrease was identified in the hemoglobin concentration of patients with serum creatinine concentrations >2.0 mg/dl before the study. Losartan efficiently reduces proteinuria in renal transplant recipients with adequate tolerance. Multicentric prospective studies are required to confirm its clinical effectiveness.

This study has a cohort study or clinical trial

Effects of angiotensin II receptor blocker on proteinuria in renal transplant recipients.

Therapeutic approaches directed at reducing proteinuria are under development. The aim of the present study was to prospectively elucidate the impact of losartan treatment in renal transplant recipients with persistent proteinuria. Twenty-eight patients with persistent proteinuria or mild hypertension were assigned to receive losartan. Proteinuria was defined as a ratio of urinary protein to urinary creatinine (U(P)/U(Cr)) >0.5 in continual urinary tests in the outpatient setting. All patients with mild hypertension reached target blood pressure (BP) with losartan treatment, but the change was not significant. In twelve patients with proteinuria before initiation of the study, urinary protein excretion was significantly reduced with treatment. No correlation was observed between reductions in proteinuria and mean BP. A significant decrease was identified in the hemoglobin concentration of patients with serum creatinine concentrations >2.0 mg/dl before the study. Losartan efficiently reduces proteinuria in renal transplant recipients with adequate tolerance. Multicentric prospective studies are required to confirm its clinical effectiveness.

This study does not have any cohorts or clinical trial

Effects of angiotensin II receptor blocker on proteinuria in renal transplant recipients.

Therapeutic approaches directed at reducing proteinuria are under development. The aim of the present study was to prospectively elucidate the impact of losartan treatment in renal transplant recipients with persistent proteinuria. Twenty-eight patients with persistent proteinuria or mild hypertension were assigned to receive losartan. Proteinuria was defined as a ratio of urinary protein to urinary creatinine (U(P)/U(Cr)) >0.5 in continual urinary tests in the outpatient setting. All patients with mild hypertension reached target blood pressure (BP) with losartan treatment, but the change was not significant. In twelve patients with proteinuria before initiation of the study, urinary protein excretion was significantly reduced with treatment. No correlation was observed between reductions in proteinuria and mean BP. A significant decrease was identified in the hemoglobin concentration of patients with serum creatinine concentrations >2.0 mg/dl before the study. Losartan efficiently reduces proteinuria in renal transplant recipients with adequate tolerance. Multicentric prospective studies are required to confirm its clinical effectiveness.

This study has a control, double-blind, or comparison patient group

Effects of angiotensin II receptor blocker on proteinuria in renal transplant recipients.

Therapeutic approaches directed at reducing proteinuria are under development. The aim of the present study was to prospectively elucidate the impact of losartan treatment in renal transplant recipients with persistent proteinuria. Twenty-eight patients with persistent proteinuria or mild hypertension were assigned to receive losartan. Proteinuria was defined as a ratio of urinary protein to urinary creatinine (U(P)/U(Cr)) >0.5 in continual urinary tests in the outpatient setting. All patients with mild hypertension reached target blood pressure (BP) with losartan treatment, but the change was not significant. In twelve patients with proteinuria before initiation of the study, urinary protein excretion was significantly reduced with treatment. No correlation was observed between reductions in proteinuria and mean BP. A significant decrease was identified in the hemoglobin concentration of patients with serum creatinine concentrations >2.0 mg/dl before the study. Losartan efficiently reduces proteinuria in renal transplant recipients with adequate tolerance. Multicentric prospective studies are required to confirm its clinical effectiveness.

This study does not have any comparison patient group

Effects of angiotensin II receptor blocker on proteinuria in renal transplant recipients.

Therapeutic approaches directed at reducing proteinuria are under development. The aim of the present study was to prospectively elucidate the impact of losartan treatment in renal transplant recipients with persistent proteinuria. Twenty-eight patients with persistent proteinuria or mild hypertension were assigned to receive losartan. Proteinuria was defined as a ratio of urinary protein to urinary creatinine (U(P)/U(Cr)) >0.5 in continual urinary tests in the outpatient setting. All patients with mild hypertension reached target blood pressure (BP) with losartan treatment, but the change was not significant. In twelve patients with proteinuria before initiation of the study, urinary protein excretion was significantly reduced with treatment. No correlation was observed between reductions in proteinuria and mean BP. A significant decrease was identified in the hemoglobin concentration of patients with serum creatinine concentrations >2.0 mg/dl before the study. Losartan efficiently reduces proteinuria in renal transplant recipients with adequate tolerance. Multicentric prospective studies are required to confirm its clinical effectiveness.

This study has human subjects

Effects of angiotensin II receptor blocker on proteinuria in renal transplant recipients.

Therapeutic approaches directed at reducing proteinuria are under development. The aim of the present study was to prospectively elucidate the impact of losartan treatment in renal transplant recipients with persistent proteinuria. Twenty-eight patients with persistent proteinuria or mild hypertension were assigned to receive losartan. Proteinuria was defined as a ratio of urinary protein to urinary creatinine (U(P)/U(Cr)) >0.5 in continual urinary tests in the outpatient setting. All patients with mild hypertension reached target blood pressure (BP) with losartan treatment, but the change was not significant. In twelve patients with proteinuria before initiation of the study, urinary protein excretion was significantly reduced with treatment. No correlation was observed between reductions in proteinuria and mean BP. A significant decrease was identified in the hemoglobin concentration of patients with serum creatinine concentrations >2.0 mg/dl before the study. Losartan efficiently reduces proteinuria in renal transplant recipients with adequate tolerance. Multicentric prospective studies are required to confirm its clinical effectiveness.

This study does not have human subjects

Effects of angiotensin II receptor blocker on proteinuria in renal transplant recipients.

Therapeutic approaches directed at reducing proteinuria are under development. The aim of the present study was to prospectively elucidate the impact of losartan treatment in renal transplant recipients with persistent proteinuria. Twenty-eight patients with persistent proteinuria or mild hypertension were assigned to receive losartan. Proteinuria was defined as a ratio of urinary protein to urinary creatinine (U(P)/U(Cr)) >0.5 in continual urinary tests in the outpatient setting. All patients with mild hypertension reached target blood pressure (BP) with losartan treatment, but the change was not significant. In twelve patients with proteinuria before initiation of the study, urinary protein excretion was significantly reduced with treatment. No correlation was observed between reductions in proteinuria and mean BP. A significant decrease was identified in the hemoglobin concentration of patients with serum creatinine concentrations >2.0 mg/dl before the study. Losartan efficiently reduces proteinuria in renal transplant recipients with adequate tolerance. Multicentric prospective studies are required to confirm its clinical effectiveness.

This study contains population size or sample size information

Effects of angiotensin II receptor blocker on proteinuria in renal transplant recipients.

Therapeutic approaches directed at reducing proteinuria are under development. The aim of the present study was to prospectively elucidate the impact of losartan treatment in renal transplant recipients with persistent proteinuria. Twenty-eight patients with persistent proteinuria or mild hypertension were assigned to receive losartan. Proteinuria was defined as a ratio of urinary protein to urinary creatinine (U(P)/U(Cr)) >0.5 in continual urinary tests in the outpatient setting. All patients with mild hypertension reached target blood pressure (BP) with losartan treatment, but the change was not significant. In twelve patients with proteinuria before initiation of the study, urinary protein excretion was significantly reduced with treatment. No correlation was observed between reductions in proteinuria and mean BP. A significant decrease was identified in the hemoglobin concentration of patients with serum creatinine concentrations >2.0 mg/dl before the study. Losartan efficiently reduces proteinuria in renal transplant recipients with adequate tolerance. Multicentric prospective studies are required to confirm its clinical effectiveness.

This study does not contain population size information

Effects of angiotensin II receptor blocker on proteinuria in renal transplant recipients.

Therapeutic approaches directed at reducing proteinuria are under development. The aim of the present study was to prospectively elucidate the impact of losartan treatment in renal transplant recipients with persistent proteinuria. Twenty-eight patients with persistent proteinuria or mild hypertension were assigned to receive losartan. Proteinuria was defined as a ratio of urinary protein to urinary creatinine (U(P)/U(Cr)) >0.5 in continual urinary tests in the outpatient setting. All patients with mild hypertension reached target blood pressure (BP) with losartan treatment, but the change was not significant. In twelve patients with proteinuria before initiation of the study, urinary protein excretion was significantly reduced with treatment. No correlation was observed between reductions in proteinuria and mean BP. A significant decrease was identified in the hemoglobin concentration of patients with serum creatinine concentrations >2.0 mg/dl before the study. Losartan efficiently reduces proteinuria in renal transplant recipients with adequate tolerance. Multicentric prospective studies are required to confirm its clinical effectiveness.

This study has quantitative outcomes like numbers, P-value, OR, CI, HR, RR, or patient ratios

Effects of angiotensin II receptor blocker on proteinuria in renal transplant recipients.

Therapeutic approaches directed at reducing proteinuria are under development. The aim of the present study was to prospectively elucidate the impact of losartan treatment in renal transplant recipients with persistent proteinuria. Twenty-eight patients with persistent proteinuria or mild hypertension were assigned to receive losartan. Proteinuria was defined as a ratio of urinary protein to urinary creatinine (U(P)/U(Cr)) >0.5 in continual urinary tests in the outpatient setting. All patients with mild hypertension reached target blood pressure (BP) with losartan treatment, but the change was not significant. In twelve patients with proteinuria before initiation of the study, urinary protein excretion was significantly reduced with treatment. No correlation was observed between reductions in proteinuria and mean BP. A significant decrease was identified in the hemoglobin concentration of patients with serum creatinine concentrations >2.0 mg/dl before the study. Losartan efficiently reduces proteinuria in renal transplant recipients with adequate tolerance. Multicentric prospective studies are required to confirm its clinical effectiveness.

This study does not have any quantitative outcomes

Effects of angiotensin II receptor blocker on proteinuria in renal transplant recipients.

Therapeutic approaches directed at reducing proteinuria are under development. The aim of the present study was to prospectively elucidate the impact of losartan treatment in renal transplant recipients with persistent proteinuria. Twenty-eight patients with persistent proteinuria or mild hypertension were assigned to receive losartan. Proteinuria was defined as a ratio of urinary protein to urinary creatinine (U(P)/U(Cr)) >0.5 in continual urinary tests in the outpatient setting. All patients with mild hypertension reached target blood pressure (BP) with losartan treatment, but the change was not significant. In twelve patients with proteinuria before initiation of the study, urinary protein excretion was significantly reduced with treatment. No correlation was observed between reductions in proteinuria and mean BP. A significant decrease was identified in the hemoglobin concentration of patients with serum creatinine concentrations >2.0 mg/dl before the study. Losartan efficiently reduces proteinuria in renal transplant recipients with adequate tolerance. Multicentric prospective studies are required to confirm its clinical effectiveness.

This study has a target drug

Effects of angiotensin II receptor blocker on proteinuria in renal transplant recipients.

Therapeutic approaches directed at reducing proteinuria are under development. The aim of the present study was to prospectively elucidate the impact of losartan treatment in renal transplant recipients with persistent proteinuria. Twenty-eight patients with persistent proteinuria or mild hypertension were assigned to receive losartan. Proteinuria was defined as a ratio of urinary protein to urinary creatinine (U(P)/U(Cr)) >0.5 in continual urinary tests in the outpatient setting. All patients with mild hypertension reached target blood pressure (BP) with losartan treatment, but the change was not significant. In twelve patients with proteinuria before initiation of the study, urinary protein excretion was significantly reduced with treatment. No correlation was observed between reductions in proteinuria and mean BP. A significant decrease was identified in the hemoglobin concentration of patients with serum creatinine concentrations >2.0 mg/dl before the study. Losartan efficiently reduces proteinuria in renal transplant recipients with adequate tolerance. Multicentric prospective studies are required to confirm its clinical effectiveness.

This study does not have a target drug

Effects of angiotensin II receptor blocker on proteinuria in renal transplant recipients.

Therapeutic approaches directed at reducing proteinuria are under development. The aim of the present study was to prospectively elucidate the impact of losartan treatment in renal transplant recipients with persistent proteinuria. Twenty-eight patients with persistent proteinuria or mild hypertension were assigned to receive losartan. Proteinuria was defined as a ratio of urinary protein to urinary creatinine (U(P)/U(Cr)) >0.5 in continual urinary tests in the outpatient setting. All patients with mild hypertension reached target blood pressure (BP) with losartan treatment, but the change was not significant. In twelve patients with proteinuria before initiation of the study, urinary protein excretion was significantly reduced with treatment. No correlation was observed between reductions in proteinuria and mean BP. A significant decrease was identified in the hemoglobin concentration of patients with serum creatinine concentrations >2.0 mg/dl before the study. Losartan efficiently reduces proteinuria in renal transplant recipients with adequate tolerance. Multicentric prospective studies are required to confirm its clinical effectiveness.

This study has a target disease

Effects of angiotensin II receptor blocker on proteinuria in renal transplant recipients.

Therapeutic approaches directed at reducing proteinuria are under development. The aim of the present study was to prospectively elucidate the impact of losartan treatment in renal transplant recipients with persistent proteinuria. Twenty-eight patients with persistent proteinuria or mild hypertension were assigned to receive losartan. Proteinuria was defined as a ratio of urinary protein to urinary creatinine (U(P)/U(Cr)) >0.5 in continual urinary tests in the outpatient setting. All patients with mild hypertension reached target blood pressure (BP) with losartan treatment, but the change was not significant. In twelve patients with proteinuria before initiation of the study, urinary protein excretion was significantly reduced with treatment. No correlation was observed between reductions in proteinuria and mean BP. A significant decrease was identified in the hemoglobin concentration of patients with serum creatinine concentrations >2.0 mg/dl before the study. Losartan efficiently reduces proteinuria in renal transplant recipients with adequate tolerance. Multicentric prospective studies are required to confirm its clinical effectiveness.

This study does not have a target disease

Gastroduodenal ulcers in the Helicobacter pylori era.

The aim of the study was to evaluate the current spectrum of gastroduodenal ulcers in children referred to a regional paediatric unit in the United Kingdom. During a 5-y period (1994-98), all children with a visibly discrete gastric and/or duodenal ulcer diagnosed at endoscopy were prospectively identified. Patients with ulcers associated with Helicobacter pylori gastritis underwent repeat endoscopy 2-3 mo after medical treatment. Thirty-seven children, 21 boys and 16 girls of median age 11 y (range 7 mo to 16 y), had gastric and/or duodenal ulceration. Specific aetiological factors were identified in 21 of 22 with H. pylori negative ulcers, including Crohn's disease (n = 6), coeliac disease (n = 4) and treatment with ulcerogenic drugs (n = 4). Fifteen children (41%) had ulcers associated with H. pylori gastritis, including all 10 children with a chronic ulcer. Endoscopically confirmed ulcer healing was achieved in 14 of these using a 1 wk triple therapy regimen (omeprazole and a combination of two antibiotics). In conclusion, the recognized spectrum and the management of gastroduodenal ulceration have changed during the last decade. Although H. pylori gastritis is an important aetiological factor, a wide range of other conditions needs to be considered. Surgical intervention is only rarely necessary.

This study has a cohort study or clinical trial

Gastroduodenal ulcers in the Helicobacter pylori era.

The aim of the study was to evaluate the current spectrum of gastroduodenal ulcers in children referred to a regional paediatric unit in the United Kingdom. During a 5-y period (1994-98), all children with a visibly discrete gastric and/or duodenal ulcer diagnosed at endoscopy were prospectively identified. Patients with ulcers associated with Helicobacter pylori gastritis underwent repeat endoscopy 2-3 mo after medical treatment. Thirty-seven children, 21 boys and 16 girls of median age 11 y (range 7 mo to 16 y), had gastric and/or duodenal ulceration. Specific aetiological factors were identified in 21 of 22 with H. pylori negative ulcers, including Crohn's disease (n = 6), coeliac disease (n = 4) and treatment with ulcerogenic drugs (n = 4). Fifteen children (41%) had ulcers associated with H. pylori gastritis, including all 10 children with a chronic ulcer. Endoscopically confirmed ulcer healing was achieved in 14 of these using a 1 wk triple therapy regimen (omeprazole and a combination of two antibiotics). In conclusion, the recognized spectrum and the management of gastroduodenal ulceration have changed during the last decade. Although H. pylori gastritis is an important aetiological factor, a wide range of other conditions needs to be considered. Surgical intervention is only rarely necessary.

This study does not have any cohorts or clinical trial

Gastroduodenal ulcers in the Helicobacter pylori era.

The aim of the study was to evaluate the current spectrum of gastroduodenal ulcers in children referred to a regional paediatric unit in the United Kingdom. During a 5-y period (1994-98), all children with a visibly discrete gastric and/or duodenal ulcer diagnosed at endoscopy were prospectively identified. Patients with ulcers associated with Helicobacter pylori gastritis underwent repeat endoscopy 2-3 mo after medical treatment. Thirty-seven children, 21 boys and 16 girls of median age 11 y (range 7 mo to 16 y), had gastric and/or duodenal ulceration. Specific aetiological factors were identified in 21 of 22 with H. pylori negative ulcers, including Crohn's disease (n = 6), coeliac disease (n = 4) and treatment with ulcerogenic drugs (n = 4). Fifteen children (41%) had ulcers associated with H. pylori gastritis, including all 10 children with a chronic ulcer. Endoscopically confirmed ulcer healing was achieved in 14 of these using a 1 wk triple therapy regimen (omeprazole and a combination of two antibiotics). In conclusion, the recognized spectrum and the management of gastroduodenal ulceration have changed during the last decade. Although H. pylori gastritis is an important aetiological factor, a wide range of other conditions needs to be considered. Surgical intervention is only rarely necessary.

This study has a control, double-blind, or comparison patient group

Gastroduodenal ulcers in the Helicobacter pylori era.

The aim of the study was to evaluate the current spectrum of gastroduodenal ulcers in children referred to a regional paediatric unit in the United Kingdom. During a 5-y period (1994-98), all children with a visibly discrete gastric and/or duodenal ulcer diagnosed at endoscopy were prospectively identified. Patients with ulcers associated with Helicobacter pylori gastritis underwent repeat endoscopy 2-3 mo after medical treatment. Thirty-seven children, 21 boys and 16 girls of median age 11 y (range 7 mo to 16 y), had gastric and/or duodenal ulceration. Specific aetiological factors were identified in 21 of 22 with H. pylori negative ulcers, including Crohn's disease (n = 6), coeliac disease (n = 4) and treatment with ulcerogenic drugs (n = 4). Fifteen children (41%) had ulcers associated with H. pylori gastritis, including all 10 children with a chronic ulcer. Endoscopically confirmed ulcer healing was achieved in 14 of these using a 1 wk triple therapy regimen (omeprazole and a combination of two antibiotics). In conclusion, the recognized spectrum and the management of gastroduodenal ulceration have changed during the last decade. Although H. pylori gastritis is an important aetiological factor, a wide range of other conditions needs to be considered. Surgical intervention is only rarely necessary.

This study does not have any comparison patient group

Gastroduodenal ulcers in the Helicobacter pylori era.

The aim of the study was to evaluate the current spectrum of gastroduodenal ulcers in children referred to a regional paediatric unit in the United Kingdom. During a 5-y period (1994-98), all children with a visibly discrete gastric and/or duodenal ulcer diagnosed at endoscopy were prospectively identified. Patients with ulcers associated with Helicobacter pylori gastritis underwent repeat endoscopy 2-3 mo after medical treatment. Thirty-seven children, 21 boys and 16 girls of median age 11 y (range 7 mo to 16 y), had gastric and/or duodenal ulceration. Specific aetiological factors were identified in 21 of 22 with H. pylori negative ulcers, including Crohn's disease (n = 6), coeliac disease (n = 4) and treatment with ulcerogenic drugs (n = 4). Fifteen children (41%) had ulcers associated with H. pylori gastritis, including all 10 children with a chronic ulcer. Endoscopically confirmed ulcer healing was achieved in 14 of these using a 1 wk triple therapy regimen (omeprazole and a combination of two antibiotics). In conclusion, the recognized spectrum and the management of gastroduodenal ulceration have changed during the last decade. Although H. pylori gastritis is an important aetiological factor, a wide range of other conditions needs to be considered. Surgical intervention is only rarely necessary.

This study has human subjects

Gastroduodenal ulcers in the Helicobacter pylori era.

The aim of the study was to evaluate the current spectrum of gastroduodenal ulcers in children referred to a regional paediatric unit in the United Kingdom. During a 5-y period (1994-98), all children with a visibly discrete gastric and/or duodenal ulcer diagnosed at endoscopy were prospectively identified. Patients with ulcers associated with Helicobacter pylori gastritis underwent repeat endoscopy 2-3 mo after medical treatment. Thirty-seven children, 21 boys and 16 girls of median age 11 y (range 7 mo to 16 y), had gastric and/or duodenal ulceration. Specific aetiological factors were identified in 21 of 22 with H. pylori negative ulcers, including Crohn's disease (n = 6), coeliac disease (n = 4) and treatment with ulcerogenic drugs (n = 4). Fifteen children (41%) had ulcers associated with H. pylori gastritis, including all 10 children with a chronic ulcer. Endoscopically confirmed ulcer healing was achieved in 14 of these using a 1 wk triple therapy regimen (omeprazole and a combination of two antibiotics). In conclusion, the recognized spectrum and the management of gastroduodenal ulceration have changed during the last decade. Although H. pylori gastritis is an important aetiological factor, a wide range of other conditions needs to be considered. Surgical intervention is only rarely necessary.

This study does not have human subjects

Gastroduodenal ulcers in the Helicobacter pylori era.

The aim of the study was to evaluate the current spectrum of gastroduodenal ulcers in children referred to a regional paediatric unit in the United Kingdom. During a 5-y period (1994-98), all children with a visibly discrete gastric and/or duodenal ulcer diagnosed at endoscopy were prospectively identified. Patients with ulcers associated with Helicobacter pylori gastritis underwent repeat endoscopy 2-3 mo after medical treatment. Thirty-seven children, 21 boys and 16 girls of median age 11 y (range 7 mo to 16 y), had gastric and/or duodenal ulceration. Specific aetiological factors were identified in 21 of 22 with H. pylori negative ulcers, including Crohn's disease (n = 6), coeliac disease (n = 4) and treatment with ulcerogenic drugs (n = 4). Fifteen children (41%) had ulcers associated with H. pylori gastritis, including all 10 children with a chronic ulcer. Endoscopically confirmed ulcer healing was achieved in 14 of these using a 1 wk triple therapy regimen (omeprazole and a combination of two antibiotics). In conclusion, the recognized spectrum and the management of gastroduodenal ulceration have changed during the last decade. Although H. pylori gastritis is an important aetiological factor, a wide range of other conditions needs to be considered. Surgical intervention is only rarely necessary.

This study contains population size or sample size information

Gastroduodenal ulcers in the Helicobacter pylori era.

The aim of the study was to evaluate the current spectrum of gastroduodenal ulcers in children referred to a regional paediatric unit in the United Kingdom. During a 5-y period (1994-98), all children with a visibly discrete gastric and/or duodenal ulcer diagnosed at endoscopy were prospectively identified. Patients with ulcers associated with Helicobacter pylori gastritis underwent repeat endoscopy 2-3 mo after medical treatment. Thirty-seven children, 21 boys and 16 girls of median age 11 y (range 7 mo to 16 y), had gastric and/or duodenal ulceration. Specific aetiological factors were identified in 21 of 22 with H. pylori negative ulcers, including Crohn's disease (n = 6), coeliac disease (n = 4) and treatment with ulcerogenic drugs (n = 4). Fifteen children (41%) had ulcers associated with H. pylori gastritis, including all 10 children with a chronic ulcer. Endoscopically confirmed ulcer healing was achieved in 14 of these using a 1 wk triple therapy regimen (omeprazole and a combination of two antibiotics). In conclusion, the recognized spectrum and the management of gastroduodenal ulceration have changed during the last decade. Although H. pylori gastritis is an important aetiological factor, a wide range of other conditions needs to be considered. Surgical intervention is only rarely necessary.

This study does not contain population size information

Gastroduodenal ulcers in the Helicobacter pylori era.

The aim of the study was to evaluate the current spectrum of gastroduodenal ulcers in children referred to a regional paediatric unit in the United Kingdom. During a 5-y period (1994-98), all children with a visibly discrete gastric and/or duodenal ulcer diagnosed at endoscopy were prospectively identified. Patients with ulcers associated with Helicobacter pylori gastritis underwent repeat endoscopy 2-3 mo after medical treatment. Thirty-seven children, 21 boys and 16 girls of median age 11 y (range 7 mo to 16 y), had gastric and/or duodenal ulceration. Specific aetiological factors were identified in 21 of 22 with H. pylori negative ulcers, including Crohn's disease (n = 6), coeliac disease (n = 4) and treatment with ulcerogenic drugs (n = 4). Fifteen children (41%) had ulcers associated with H. pylori gastritis, including all 10 children with a chronic ulcer. Endoscopically confirmed ulcer healing was achieved in 14 of these using a 1 wk triple therapy regimen (omeprazole and a combination of two antibiotics). In conclusion, the recognized spectrum and the management of gastroduodenal ulceration have changed during the last decade. Although H. pylori gastritis is an important aetiological factor, a wide range of other conditions needs to be considered. Surgical intervention is only rarely necessary.

This study has quantitative outcomes like numbers, P-value, OR, CI, HR, RR, or patient ratios

Gastroduodenal ulcers in the Helicobacter pylori era.

The aim of the study was to evaluate the current spectrum of gastroduodenal ulcers in children referred to a regional paediatric unit in the United Kingdom. During a 5-y period (1994-98), all children with a visibly discrete gastric and/or duodenal ulcer diagnosed at endoscopy were prospectively identified. Patients with ulcers associated with Helicobacter pylori gastritis underwent repeat endoscopy 2-3 mo after medical treatment. Thirty-seven children, 21 boys and 16 girls of median age 11 y (range 7 mo to 16 y), had gastric and/or duodenal ulceration. Specific aetiological factors were identified in 21 of 22 with H. pylori negative ulcers, including Crohn's disease (n = 6), coeliac disease (n = 4) and treatment with ulcerogenic drugs (n = 4). Fifteen children (41%) had ulcers associated with H. pylori gastritis, including all 10 children with a chronic ulcer. Endoscopically confirmed ulcer healing was achieved in 14 of these using a 1 wk triple therapy regimen (omeprazole and a combination of two antibiotics). In conclusion, the recognized spectrum and the management of gastroduodenal ulceration have changed during the last decade. Although H. pylori gastritis is an important aetiological factor, a wide range of other conditions needs to be considered. Surgical intervention is only rarely necessary.

This study does not have any quantitative outcomes

Gastroduodenal ulcers in the Helicobacter pylori era.

The aim of the study was to evaluate the current spectrum of gastroduodenal ulcers in children referred to a regional paediatric unit in the United Kingdom. During a 5-y period (1994-98), all children with a visibly discrete gastric and/or duodenal ulcer diagnosed at endoscopy were prospectively identified. Patients with ulcers associated with Helicobacter pylori gastritis underwent repeat endoscopy 2-3 mo after medical treatment. Thirty-seven children, 21 boys and 16 girls of median age 11 y (range 7 mo to 16 y), had gastric and/or duodenal ulceration. Specific aetiological factors were identified in 21 of 22 with H. pylori negative ulcers, including Crohn's disease (n = 6), coeliac disease (n = 4) and treatment with ulcerogenic drugs (n = 4). Fifteen children (41%) had ulcers associated with H. pylori gastritis, including all 10 children with a chronic ulcer. Endoscopically confirmed ulcer healing was achieved in 14 of these using a 1 wk triple therapy regimen (omeprazole and a combination of two antibiotics). In conclusion, the recognized spectrum and the management of gastroduodenal ulceration have changed during the last decade. Although H. pylori gastritis is an important aetiological factor, a wide range of other conditions needs to be considered. Surgical intervention is only rarely necessary.

This study has a target drug

Gastroduodenal ulcers in the Helicobacter pylori era.

The aim of the study was to evaluate the current spectrum of gastroduodenal ulcers in children referred to a regional paediatric unit in the United Kingdom. During a 5-y period (1994-98), all children with a visibly discrete gastric and/or duodenal ulcer diagnosed at endoscopy were prospectively identified. Patients with ulcers associated with Helicobacter pylori gastritis underwent repeat endoscopy 2-3 mo after medical treatment. Thirty-seven children, 21 boys and 16 girls of median age 11 y (range 7 mo to 16 y), had gastric and/or duodenal ulceration. Specific aetiological factors were identified in 21 of 22 with H. pylori negative ulcers, including Crohn's disease (n = 6), coeliac disease (n = 4) and treatment with ulcerogenic drugs (n = 4). Fifteen children (41%) had ulcers associated with H. pylori gastritis, including all 10 children with a chronic ulcer. Endoscopically confirmed ulcer healing was achieved in 14 of these using a 1 wk triple therapy regimen (omeprazole and a combination of two antibiotics). In conclusion, the recognized spectrum and the management of gastroduodenal ulceration have changed during the last decade. Although H. pylori gastritis is an important aetiological factor, a wide range of other conditions needs to be considered. Surgical intervention is only rarely necessary.

This study does not have a target drug

Gastroduodenal ulcers in the Helicobacter pylori era.

The aim of the study was to evaluate the current spectrum of gastroduodenal ulcers in children referred to a regional paediatric unit in the United Kingdom. During a 5-y period (1994-98), all children with a visibly discrete gastric and/or duodenal ulcer diagnosed at endoscopy were prospectively identified. Patients with ulcers associated with Helicobacter pylori gastritis underwent repeat endoscopy 2-3 mo after medical treatment. Thirty-seven children, 21 boys and 16 girls of median age 11 y (range 7 mo to 16 y), had gastric and/or duodenal ulceration. Specific aetiological factors were identified in 21 of 22 with H. pylori negative ulcers, including Crohn's disease (n = 6), coeliac disease (n = 4) and treatment with ulcerogenic drugs (n = 4). Fifteen children (41%) had ulcers associated with H. pylori gastritis, including all 10 children with a chronic ulcer. Endoscopically confirmed ulcer healing was achieved in 14 of these using a 1 wk triple therapy regimen (omeprazole and a combination of two antibiotics). In conclusion, the recognized spectrum and the management of gastroduodenal ulceration have changed during the last decade. Although H. pylori gastritis is an important aetiological factor, a wide range of other conditions needs to be considered. Surgical intervention is only rarely necessary.

This study has a target disease

Gastroduodenal ulcers in the Helicobacter pylori era.

The aim of the study was to evaluate the current spectrum of gastroduodenal ulcers in children referred to a regional paediatric unit in the United Kingdom. During a 5-y period (1994-98), all children with a visibly discrete gastric and/or duodenal ulcer diagnosed at endoscopy were prospectively identified. Patients with ulcers associated with Helicobacter pylori gastritis underwent repeat endoscopy 2-3 mo after medical treatment. Thirty-seven children, 21 boys and 16 girls of median age 11 y (range 7 mo to 16 y), had gastric and/or duodenal ulceration. Specific aetiological factors were identified in 21 of 22 with H. pylori negative ulcers, including Crohn's disease (n = 6), coeliac disease (n = 4) and treatment with ulcerogenic drugs (n = 4). Fifteen children (41%) had ulcers associated with H. pylori gastritis, including all 10 children with a chronic ulcer. Endoscopically confirmed ulcer healing was achieved in 14 of these using a 1 wk triple therapy regimen (omeprazole and a combination of two antibiotics). In conclusion, the recognized spectrum and the management of gastroduodenal ulceration have changed during the last decade. Although H. pylori gastritis is an important aetiological factor, a wide range of other conditions needs to be considered. Surgical intervention is only rarely necessary.

This study does not have a target disease

An improved LC-MS/MS method for quantitative determination of ilaprazole and its metabolites in human plasma and its application to a pharmacokinetic study.

To improve and validate an analytical method based on liquid chromatography and electrospray ionization tandem mass spectrometry (LC-ESI-MS/MS) for the quantitative measurement of ilaprazole and its two metablites in human plasma. Separation of analytes and the internal standard (IS), omeprazole, was performed on a Thermo HyPURITY C18 column (150x2.1 mm, 5 microm) with a mobile phase consisting of 10 mmol/L ammonium formate water-acetonitrile solution (50:50, v/v) at a flow rate of 0.25 mL/min. The API4000 triple quadruple mass spectrometer was operated in multiple reactions monitoring mode via positive electrospray ionization interface using the transition m/z 367.2 --> m/z184.0 for ilaprazole, m/z 383.3 --> m/z 184.1 for ilaprazole sulfone, m/z 351.2 --> m/z 168.1 for ilaprazole thiol ether and m/z 346.2 --> m/z 198.0 for omeprazole. The method was linear over the concentration range of 0.23-2400.00 ng/mL for ilaprazole, 0.05-105.00 ng/mL for ilaprazole thiol ether and 0.06-45.00 ng/mL for ilaprazole sulfone. The intra- and inter-day precisions were all less than 15% in terms of relative standard deviation (RSD), and the accuracy was within 15% in terms of relative error (RE) for ilaprazole, ilaprazole sulfone and ilaprazole thiol ether. The lower limit of quantification (LLOQ) was identifiable and reproducible at 0.23, 0.05 and 0.06 ng/mL with acceptable precision and accuracy for ilaprazole, ilaprazole sulfone and ilaprazole thiol ether, respectively. The validated method offered sensitivity and a wide linear concentration range. This method was successfully applied for the evaluation of the pharmacokinetics of ilaprazole and its two metabolites after single oral doses of 5 mg ilaprazole to 12 healthy Chinese volunteers.

This study has a cohort study or clinical trial

An improved LC-MS/MS method for quantitative determination of ilaprazole and its metabolites in human plasma and its application to a pharmacokinetic study.

To improve and validate an analytical method based on liquid chromatography and electrospray ionization tandem mass spectrometry (LC-ESI-MS/MS) for the quantitative measurement of ilaprazole and its two metablites in human plasma. Separation of analytes and the internal standard (IS), omeprazole, was performed on a Thermo HyPURITY C18 column (150x2.1 mm, 5 microm) with a mobile phase consisting of 10 mmol/L ammonium formate water-acetonitrile solution (50:50, v/v) at a flow rate of 0.25 mL/min. The API4000 triple quadruple mass spectrometer was operated in multiple reactions monitoring mode via positive electrospray ionization interface using the transition m/z 367.2 --> m/z184.0 for ilaprazole, m/z 383.3 --> m/z 184.1 for ilaprazole sulfone, m/z 351.2 --> m/z 168.1 for ilaprazole thiol ether and m/z 346.2 --> m/z 198.0 for omeprazole. The method was linear over the concentration range of 0.23-2400.00 ng/mL for ilaprazole, 0.05-105.00 ng/mL for ilaprazole thiol ether and 0.06-45.00 ng/mL for ilaprazole sulfone. The intra- and inter-day precisions were all less than 15% in terms of relative standard deviation (RSD), and the accuracy was within 15% in terms of relative error (RE) for ilaprazole, ilaprazole sulfone and ilaprazole thiol ether. The lower limit of quantification (LLOQ) was identifiable and reproducible at 0.23, 0.05 and 0.06 ng/mL with acceptable precision and accuracy for ilaprazole, ilaprazole sulfone and ilaprazole thiol ether, respectively. The validated method offered sensitivity and a wide linear concentration range. This method was successfully applied for the evaluation of the pharmacokinetics of ilaprazole and its two metabolites after single oral doses of 5 mg ilaprazole to 12 healthy Chinese volunteers.

This study does not have any cohorts or clinical trial

An improved LC-MS/MS method for quantitative determination of ilaprazole and its metabolites in human plasma and its application to a pharmacokinetic study.

To improve and validate an analytical method based on liquid chromatography and electrospray ionization tandem mass spectrometry (LC-ESI-MS/MS) for the quantitative measurement of ilaprazole and its two metablites in human plasma. Separation of analytes and the internal standard (IS), omeprazole, was performed on a Thermo HyPURITY C18 column (150x2.1 mm, 5 microm) with a mobile phase consisting of 10 mmol/L ammonium formate water-acetonitrile solution (50:50, v/v) at a flow rate of 0.25 mL/min. The API4000 triple quadruple mass spectrometer was operated in multiple reactions monitoring mode via positive electrospray ionization interface using the transition m/z 367.2 --> m/z184.0 for ilaprazole, m/z 383.3 --> m/z 184.1 for ilaprazole sulfone, m/z 351.2 --> m/z 168.1 for ilaprazole thiol ether and m/z 346.2 --> m/z 198.0 for omeprazole. The method was linear over the concentration range of 0.23-2400.00 ng/mL for ilaprazole, 0.05-105.00 ng/mL for ilaprazole thiol ether and 0.06-45.00 ng/mL for ilaprazole sulfone. The intra- and inter-day precisions were all less than 15% in terms of relative standard deviation (RSD), and the accuracy was within 15% in terms of relative error (RE) for ilaprazole, ilaprazole sulfone and ilaprazole thiol ether. The lower limit of quantification (LLOQ) was identifiable and reproducible at 0.23, 0.05 and 0.06 ng/mL with acceptable precision and accuracy for ilaprazole, ilaprazole sulfone and ilaprazole thiol ether, respectively. The validated method offered sensitivity and a wide linear concentration range. This method was successfully applied for the evaluation of the pharmacokinetics of ilaprazole and its two metabolites after single oral doses of 5 mg ilaprazole to 12 healthy Chinese volunteers.

This study has a control, double-blind, or comparison patient group

An improved LC-MS/MS method for quantitative determination of ilaprazole and its metabolites in human plasma and its application to a pharmacokinetic study.

To improve and validate an analytical method based on liquid chromatography and electrospray ionization tandem mass spectrometry (LC-ESI-MS/MS) for the quantitative measurement of ilaprazole and its two metablites in human plasma. Separation of analytes and the internal standard (IS), omeprazole, was performed on a Thermo HyPURITY C18 column (150x2.1 mm, 5 microm) with a mobile phase consisting of 10 mmol/L ammonium formate water-acetonitrile solution (50:50, v/v) at a flow rate of 0.25 mL/min. The API4000 triple quadruple mass spectrometer was operated in multiple reactions monitoring mode via positive electrospray ionization interface using the transition m/z 367.2 --> m/z184.0 for ilaprazole, m/z 383.3 --> m/z 184.1 for ilaprazole sulfone, m/z 351.2 --> m/z 168.1 for ilaprazole thiol ether and m/z 346.2 --> m/z 198.0 for omeprazole. The method was linear over the concentration range of 0.23-2400.00 ng/mL for ilaprazole, 0.05-105.00 ng/mL for ilaprazole thiol ether and 0.06-45.00 ng/mL for ilaprazole sulfone. The intra- and inter-day precisions were all less than 15% in terms of relative standard deviation (RSD), and the accuracy was within 15% in terms of relative error (RE) for ilaprazole, ilaprazole sulfone and ilaprazole thiol ether. The lower limit of quantification (LLOQ) was identifiable and reproducible at 0.23, 0.05 and 0.06 ng/mL with acceptable precision and accuracy for ilaprazole, ilaprazole sulfone and ilaprazole thiol ether, respectively. The validated method offered sensitivity and a wide linear concentration range. This method was successfully applied for the evaluation of the pharmacokinetics of ilaprazole and its two metabolites after single oral doses of 5 mg ilaprazole to 12 healthy Chinese volunteers.

This study does not have any comparison patient group

An improved LC-MS/MS method for quantitative determination of ilaprazole and its metabolites in human plasma and its application to a pharmacokinetic study.

To improve and validate an analytical method based on liquid chromatography and electrospray ionization tandem mass spectrometry (LC-ESI-MS/MS) for the quantitative measurement of ilaprazole and its two metablites in human plasma. Separation of analytes and the internal standard (IS), omeprazole, was performed on a Thermo HyPURITY C18 column (150x2.1 mm, 5 microm) with a mobile phase consisting of 10 mmol/L ammonium formate water-acetonitrile solution (50:50, v/v) at a flow rate of 0.25 mL/min. The API4000 triple quadruple mass spectrometer was operated in multiple reactions monitoring mode via positive electrospray ionization interface using the transition m/z 367.2 --> m/z184.0 for ilaprazole, m/z 383.3 --> m/z 184.1 for ilaprazole sulfone, m/z 351.2 --> m/z 168.1 for ilaprazole thiol ether and m/z 346.2 --> m/z 198.0 for omeprazole. The method was linear over the concentration range of 0.23-2400.00 ng/mL for ilaprazole, 0.05-105.00 ng/mL for ilaprazole thiol ether and 0.06-45.00 ng/mL for ilaprazole sulfone. The intra- and inter-day precisions were all less than 15% in terms of relative standard deviation (RSD), and the accuracy was within 15% in terms of relative error (RE) for ilaprazole, ilaprazole sulfone and ilaprazole thiol ether. The lower limit of quantification (LLOQ) was identifiable and reproducible at 0.23, 0.05 and 0.06 ng/mL with acceptable precision and accuracy for ilaprazole, ilaprazole sulfone and ilaprazole thiol ether, respectively. The validated method offered sensitivity and a wide linear concentration range. This method was successfully applied for the evaluation of the pharmacokinetics of ilaprazole and its two metabolites after single oral doses of 5 mg ilaprazole to 12 healthy Chinese volunteers.

This study has human subjects

An improved LC-MS/MS method for quantitative determination of ilaprazole and its metabolites in human plasma and its application to a pharmacokinetic study.

To improve and validate an analytical method based on liquid chromatography and electrospray ionization tandem mass spectrometry (LC-ESI-MS/MS) for the quantitative measurement of ilaprazole and its two metablites in human plasma. Separation of analytes and the internal standard (IS), omeprazole, was performed on a Thermo HyPURITY C18 column (150x2.1 mm, 5 microm) with a mobile phase consisting of 10 mmol/L ammonium formate water-acetonitrile solution (50:50, v/v) at a flow rate of 0.25 mL/min. The API4000 triple quadruple mass spectrometer was operated in multiple reactions monitoring mode via positive electrospray ionization interface using the transition m/z 367.2 --> m/z184.0 for ilaprazole, m/z 383.3 --> m/z 184.1 for ilaprazole sulfone, m/z 351.2 --> m/z 168.1 for ilaprazole thiol ether and m/z 346.2 --> m/z 198.0 for omeprazole. The method was linear over the concentration range of 0.23-2400.00 ng/mL for ilaprazole, 0.05-105.00 ng/mL for ilaprazole thiol ether and 0.06-45.00 ng/mL for ilaprazole sulfone. The intra- and inter-day precisions were all less than 15% in terms of relative standard deviation (RSD), and the accuracy was within 15% in terms of relative error (RE) for ilaprazole, ilaprazole sulfone and ilaprazole thiol ether. The lower limit of quantification (LLOQ) was identifiable and reproducible at 0.23, 0.05 and 0.06 ng/mL with acceptable precision and accuracy for ilaprazole, ilaprazole sulfone and ilaprazole thiol ether, respectively. The validated method offered sensitivity and a wide linear concentration range. This method was successfully applied for the evaluation of the pharmacokinetics of ilaprazole and its two metabolites after single oral doses of 5 mg ilaprazole to 12 healthy Chinese volunteers.

This study does not have human subjects

An improved LC-MS/MS method for quantitative determination of ilaprazole and its metabolites in human plasma and its application to a pharmacokinetic study.

To improve and validate an analytical method based on liquid chromatography and electrospray ionization tandem mass spectrometry (LC-ESI-MS/MS) for the quantitative measurement of ilaprazole and its two metablites in human plasma. Separation of analytes and the internal standard (IS), omeprazole, was performed on a Thermo HyPURITY C18 column (150x2.1 mm, 5 microm) with a mobile phase consisting of 10 mmol/L ammonium formate water-acetonitrile solution (50:50, v/v) at a flow rate of 0.25 mL/min. The API4000 triple quadruple mass spectrometer was operated in multiple reactions monitoring mode via positive electrospray ionization interface using the transition m/z 367.2 --> m/z184.0 for ilaprazole, m/z 383.3 --> m/z 184.1 for ilaprazole sulfone, m/z 351.2 --> m/z 168.1 for ilaprazole thiol ether and m/z 346.2 --> m/z 198.0 for omeprazole. The method was linear over the concentration range of 0.23-2400.00 ng/mL for ilaprazole, 0.05-105.00 ng/mL for ilaprazole thiol ether and 0.06-45.00 ng/mL for ilaprazole sulfone. The intra- and inter-day precisions were all less than 15% in terms of relative standard deviation (RSD), and the accuracy was within 15% in terms of relative error (RE) for ilaprazole, ilaprazole sulfone and ilaprazole thiol ether. The lower limit of quantification (LLOQ) was identifiable and reproducible at 0.23, 0.05 and 0.06 ng/mL with acceptable precision and accuracy for ilaprazole, ilaprazole sulfone and ilaprazole thiol ether, respectively. The validated method offered sensitivity and a wide linear concentration range. This method was successfully applied for the evaluation of the pharmacokinetics of ilaprazole and its two metabolites after single oral doses of 5 mg ilaprazole to 12 healthy Chinese volunteers.

This study contains population size or sample size information

An improved LC-MS/MS method for quantitative determination of ilaprazole and its metabolites in human plasma and its application to a pharmacokinetic study.

To improve and validate an analytical method based on liquid chromatography and electrospray ionization tandem mass spectrometry (LC-ESI-MS/MS) for the quantitative measurement of ilaprazole and its two metablites in human plasma. Separation of analytes and the internal standard (IS), omeprazole, was performed on a Thermo HyPURITY C18 column (150x2.1 mm, 5 microm) with a mobile phase consisting of 10 mmol/L ammonium formate water-acetonitrile solution (50:50, v/v) at a flow rate of 0.25 mL/min. The API4000 triple quadruple mass spectrometer was operated in multiple reactions monitoring mode via positive electrospray ionization interface using the transition m/z 367.2 --> m/z184.0 for ilaprazole, m/z 383.3 --> m/z 184.1 for ilaprazole sulfone, m/z 351.2 --> m/z 168.1 for ilaprazole thiol ether and m/z 346.2 --> m/z 198.0 for omeprazole. The method was linear over the concentration range of 0.23-2400.00 ng/mL for ilaprazole, 0.05-105.00 ng/mL for ilaprazole thiol ether and 0.06-45.00 ng/mL for ilaprazole sulfone. The intra- and inter-day precisions were all less than 15% in terms of relative standard deviation (RSD), and the accuracy was within 15% in terms of relative error (RE) for ilaprazole, ilaprazole sulfone and ilaprazole thiol ether. The lower limit of quantification (LLOQ) was identifiable and reproducible at 0.23, 0.05 and 0.06 ng/mL with acceptable precision and accuracy for ilaprazole, ilaprazole sulfone and ilaprazole thiol ether, respectively. The validated method offered sensitivity and a wide linear concentration range. This method was successfully applied for the evaluation of the pharmacokinetics of ilaprazole and its two metabolites after single oral doses of 5 mg ilaprazole to 12 healthy Chinese volunteers.

This study does not contain population size information

An improved LC-MS/MS method for quantitative determination of ilaprazole and its metabolites in human plasma and its application to a pharmacokinetic study.

To improve and validate an analytical method based on liquid chromatography and electrospray ionization tandem mass spectrometry (LC-ESI-MS/MS) for the quantitative measurement of ilaprazole and its two metablites in human plasma. Separation of analytes and the internal standard (IS), omeprazole, was performed on a Thermo HyPURITY C18 column (150x2.1 mm, 5 microm) with a mobile phase consisting of 10 mmol/L ammonium formate water-acetonitrile solution (50:50, v/v) at a flow rate of 0.25 mL/min. The API4000 triple quadruple mass spectrometer was operated in multiple reactions monitoring mode via positive electrospray ionization interface using the transition m/z 367.2 --> m/z184.0 for ilaprazole, m/z 383.3 --> m/z 184.1 for ilaprazole sulfone, m/z 351.2 --> m/z 168.1 for ilaprazole thiol ether and m/z 346.2 --> m/z 198.0 for omeprazole. The method was linear over the concentration range of 0.23-2400.00 ng/mL for ilaprazole, 0.05-105.00 ng/mL for ilaprazole thiol ether and 0.06-45.00 ng/mL for ilaprazole sulfone. The intra- and inter-day precisions were all less than 15% in terms of relative standard deviation (RSD), and the accuracy was within 15% in terms of relative error (RE) for ilaprazole, ilaprazole sulfone and ilaprazole thiol ether. The lower limit of quantification (LLOQ) was identifiable and reproducible at 0.23, 0.05 and 0.06 ng/mL with acceptable precision and accuracy for ilaprazole, ilaprazole sulfone and ilaprazole thiol ether, respectively. The validated method offered sensitivity and a wide linear concentration range. This method was successfully applied for the evaluation of the pharmacokinetics of ilaprazole and its two metabolites after single oral doses of 5 mg ilaprazole to 12 healthy Chinese volunteers.

This study has quantitative outcomes like numbers, P-value, OR, CI, HR, RR, or patient ratios

An improved LC-MS/MS method for quantitative determination of ilaprazole and its metabolites in human plasma and its application to a pharmacokinetic study.

To improve and validate an analytical method based on liquid chromatography and electrospray ionization tandem mass spectrometry (LC-ESI-MS/MS) for the quantitative measurement of ilaprazole and its two metablites in human plasma. Separation of analytes and the internal standard (IS), omeprazole, was performed on a Thermo HyPURITY C18 column (150x2.1 mm, 5 microm) with a mobile phase consisting of 10 mmol/L ammonium formate water-acetonitrile solution (50:50, v/v) at a flow rate of 0.25 mL/min. The API4000 triple quadruple mass spectrometer was operated in multiple reactions monitoring mode via positive electrospray ionization interface using the transition m/z 367.2 --> m/z184.0 for ilaprazole, m/z 383.3 --> m/z 184.1 for ilaprazole sulfone, m/z 351.2 --> m/z 168.1 for ilaprazole thiol ether and m/z 346.2 --> m/z 198.0 for omeprazole. The method was linear over the concentration range of 0.23-2400.00 ng/mL for ilaprazole, 0.05-105.00 ng/mL for ilaprazole thiol ether and 0.06-45.00 ng/mL for ilaprazole sulfone. The intra- and inter-day precisions were all less than 15% in terms of relative standard deviation (RSD), and the accuracy was within 15% in terms of relative error (RE) for ilaprazole, ilaprazole sulfone and ilaprazole thiol ether. The lower limit of quantification (LLOQ) was identifiable and reproducible at 0.23, 0.05 and 0.06 ng/mL with acceptable precision and accuracy for ilaprazole, ilaprazole sulfone and ilaprazole thiol ether, respectively. The validated method offered sensitivity and a wide linear concentration range. This method was successfully applied for the evaluation of the pharmacokinetics of ilaprazole and its two metabolites after single oral doses of 5 mg ilaprazole to 12 healthy Chinese volunteers.

This study does not have any quantitative outcomes

An improved LC-MS/MS method for quantitative determination of ilaprazole and its metabolites in human plasma and its application to a pharmacokinetic study.

To improve and validate an analytical method based on liquid chromatography and electrospray ionization tandem mass spectrometry (LC-ESI-MS/MS) for the quantitative measurement of ilaprazole and its two metablites in human plasma. Separation of analytes and the internal standard (IS), omeprazole, was performed on a Thermo HyPURITY C18 column (150x2.1 mm, 5 microm) with a mobile phase consisting of 10 mmol/L ammonium formate water-acetonitrile solution (50:50, v/v) at a flow rate of 0.25 mL/min. The API4000 triple quadruple mass spectrometer was operated in multiple reactions monitoring mode via positive electrospray ionization interface using the transition m/z 367.2 --> m/z184.0 for ilaprazole, m/z 383.3 --> m/z 184.1 for ilaprazole sulfone, m/z 351.2 --> m/z 168.1 for ilaprazole thiol ether and m/z 346.2 --> m/z 198.0 for omeprazole. The method was linear over the concentration range of 0.23-2400.00 ng/mL for ilaprazole, 0.05-105.00 ng/mL for ilaprazole thiol ether and 0.06-45.00 ng/mL for ilaprazole sulfone. The intra- and inter-day precisions were all less than 15% in terms of relative standard deviation (RSD), and the accuracy was within 15% in terms of relative error (RE) for ilaprazole, ilaprazole sulfone and ilaprazole thiol ether. The lower limit of quantification (LLOQ) was identifiable and reproducible at 0.23, 0.05 and 0.06 ng/mL with acceptable precision and accuracy for ilaprazole, ilaprazole sulfone and ilaprazole thiol ether, respectively. The validated method offered sensitivity and a wide linear concentration range. This method was successfully applied for the evaluation of the pharmacokinetics of ilaprazole and its two metabolites after single oral doses of 5 mg ilaprazole to 12 healthy Chinese volunteers.

This study has a target drug

An improved LC-MS/MS method for quantitative determination of ilaprazole and its metabolites in human plasma and its application to a pharmacokinetic study.

To improve and validate an analytical method based on liquid chromatography and electrospray ionization tandem mass spectrometry (LC-ESI-MS/MS) for the quantitative measurement of ilaprazole and its two metablites in human plasma. Separation of analytes and the internal standard (IS), omeprazole, was performed on a Thermo HyPURITY C18 column (150x2.1 mm, 5 microm) with a mobile phase consisting of 10 mmol/L ammonium formate water-acetonitrile solution (50:50, v/v) at a flow rate of 0.25 mL/min. The API4000 triple quadruple mass spectrometer was operated in multiple reactions monitoring mode via positive electrospray ionization interface using the transition m/z 367.2 --> m/z184.0 for ilaprazole, m/z 383.3 --> m/z 184.1 for ilaprazole sulfone, m/z 351.2 --> m/z 168.1 for ilaprazole thiol ether and m/z 346.2 --> m/z 198.0 for omeprazole. The method was linear over the concentration range of 0.23-2400.00 ng/mL for ilaprazole, 0.05-105.00 ng/mL for ilaprazole thiol ether and 0.06-45.00 ng/mL for ilaprazole sulfone. The intra- and inter-day precisions were all less than 15% in terms of relative standard deviation (RSD), and the accuracy was within 15% in terms of relative error (RE) for ilaprazole, ilaprazole sulfone and ilaprazole thiol ether. The lower limit of quantification (LLOQ) was identifiable and reproducible at 0.23, 0.05 and 0.06 ng/mL with acceptable precision and accuracy for ilaprazole, ilaprazole sulfone and ilaprazole thiol ether, respectively. The validated method offered sensitivity and a wide linear concentration range. This method was successfully applied for the evaluation of the pharmacokinetics of ilaprazole and its two metabolites after single oral doses of 5 mg ilaprazole to 12 healthy Chinese volunteers.

This study does not have a target drug

An improved LC-MS/MS method for quantitative determination of ilaprazole and its metabolites in human plasma and its application to a pharmacokinetic study.

To improve and validate an analytical method based on liquid chromatography and electrospray ionization tandem mass spectrometry (LC-ESI-MS/MS) for the quantitative measurement of ilaprazole and its two metablites in human plasma. Separation of analytes and the internal standard (IS), omeprazole, was performed on a Thermo HyPURITY C18 column (150x2.1 mm, 5 microm) with a mobile phase consisting of 10 mmol/L ammonium formate water-acetonitrile solution (50:50, v/v) at a flow rate of 0.25 mL/min. The API4000 triple quadruple mass spectrometer was operated in multiple reactions monitoring mode via positive electrospray ionization interface using the transition m/z 367.2 --> m/z184.0 for ilaprazole, m/z 383.3 --> m/z 184.1 for ilaprazole sulfone, m/z 351.2 --> m/z 168.1 for ilaprazole thiol ether and m/z 346.2 --> m/z 198.0 for omeprazole. The method was linear over the concentration range of 0.23-2400.00 ng/mL for ilaprazole, 0.05-105.00 ng/mL for ilaprazole thiol ether and 0.06-45.00 ng/mL for ilaprazole sulfone. The intra- and inter-day precisions were all less than 15% in terms of relative standard deviation (RSD), and the accuracy was within 15% in terms of relative error (RE) for ilaprazole, ilaprazole sulfone and ilaprazole thiol ether. The lower limit of quantification (LLOQ) was identifiable and reproducible at 0.23, 0.05 and 0.06 ng/mL with acceptable precision and accuracy for ilaprazole, ilaprazole sulfone and ilaprazole thiol ether, respectively. The validated method offered sensitivity and a wide linear concentration range. This method was successfully applied for the evaluation of the pharmacokinetics of ilaprazole and its two metabolites after single oral doses of 5 mg ilaprazole to 12 healthy Chinese volunteers.

This study has a target disease

An improved LC-MS/MS method for quantitative determination of ilaprazole and its metabolites in human plasma and its application to a pharmacokinetic study.

To improve and validate an analytical method based on liquid chromatography and electrospray ionization tandem mass spectrometry (LC-ESI-MS/MS) for the quantitative measurement of ilaprazole and its two metablites in human plasma. Separation of analytes and the internal standard (IS), omeprazole, was performed on a Thermo HyPURITY C18 column (150x2.1 mm, 5 microm) with a mobile phase consisting of 10 mmol/L ammonium formate water-acetonitrile solution (50:50, v/v) at a flow rate of 0.25 mL/min. The API4000 triple quadruple mass spectrometer was operated in multiple reactions monitoring mode via positive electrospray ionization interface using the transition m/z 367.2 --> m/z184.0 for ilaprazole, m/z 383.3 --> m/z 184.1 for ilaprazole sulfone, m/z 351.2 --> m/z 168.1 for ilaprazole thiol ether and m/z 346.2 --> m/z 198.0 for omeprazole. The method was linear over the concentration range of 0.23-2400.00 ng/mL for ilaprazole, 0.05-105.00 ng/mL for ilaprazole thiol ether and 0.06-45.00 ng/mL for ilaprazole sulfone. The intra- and inter-day precisions were all less than 15% in terms of relative standard deviation (RSD), and the accuracy was within 15% in terms of relative error (RE) for ilaprazole, ilaprazole sulfone and ilaprazole thiol ether. The lower limit of quantification (LLOQ) was identifiable and reproducible at 0.23, 0.05 and 0.06 ng/mL with acceptable precision and accuracy for ilaprazole, ilaprazole sulfone and ilaprazole thiol ether, respectively. The validated method offered sensitivity and a wide linear concentration range. This method was successfully applied for the evaluation of the pharmacokinetics of ilaprazole and its two metabolites after single oral doses of 5 mg ilaprazole to 12 healthy Chinese volunteers.

This study does not have a target disease

Point-of-care platelet reactivity determination with VerifyNow-P2Y12 following administration of clopidogrel or prasugrel: data from a real-world, clinical care inpatient setting.

To describe VerifyNow-P2Y12 (VN-P2Y12, Accumetrics, San Diego, CA) results from patients treated with either clopidogrel or prasugrel who were seeking care in a hospital setting. VN-P2Y12 is a point-of-care device that measures platelet reactivity to adenosine diphosphate. Past assessments of thienopyridine therapy utilizing VN-P2Y12 have largely come from clinical trial settings. There are limited data from real-world settings. Electronic medical record data from Huntsville Hospital (Huntsville, AL) for those who underwent VN-P2Y12 testing for clopidogrel or prasugrel between January 1, 2009 and October 31, 2010 were analyzed. The VN-P2Y12 data included P2Y12 reaction units (PRUs) and device-reported percentage of inhibition. Descriptive analyses were conducted with t tests, and a logistic regression model was estimated to assess the association between patient characteristics and the likelihood of platelet nonresponse. In total, 2882 tests (2476 with clopidogrel and 406 with prasugrel) were analyzed. For clopidogrel and prasugrel, respectively, mean PRU standard deviation (SD) was 206 (90) and 107 (93; P < 0.0001) and mean % inhibition (SD) was 31% (26%) and 63% (31%; P < 0.0001). Treatment with clopidogrel alone (odds ratio [OR] = 5.25; P < 0.0001), being non-Caucasian (OR = 1.48; P = 0.0440), obese (OR = 1.49; P = 0.0010), anemic (OR = 3.29; P < 0.0001), diabetic (OR = 1.75; P < 0.0001), and having a history of myocardial infarction (OR = 1.57; P < 0.0001) were significant predictors of having PRU ≥ 235. This real-world data analysis shows results that are consistent with clinical trial results, namely that compared with clopidogrel, prasugrel is associated with significantly lower PRU and greater percentage of inhibition, regardless of age, race, gender, diabetes, obesity, or proton pump inhibitor use.

This study has a cohort study or clinical trial

Point-of-care platelet reactivity determination with VerifyNow-P2Y12 following administration of clopidogrel or prasugrel: data from a real-world, clinical care inpatient setting.

To describe VerifyNow-P2Y12 (VN-P2Y12, Accumetrics, San Diego, CA) results from patients treated with either clopidogrel or prasugrel who were seeking care in a hospital setting. VN-P2Y12 is a point-of-care device that measures platelet reactivity to adenosine diphosphate. Past assessments of thienopyridine therapy utilizing VN-P2Y12 have largely come from clinical trial settings. There are limited data from real-world settings. Electronic medical record data from Huntsville Hospital (Huntsville, AL) for those who underwent VN-P2Y12 testing for clopidogrel or prasugrel between January 1, 2009 and October 31, 2010 were analyzed. The VN-P2Y12 data included P2Y12 reaction units (PRUs) and device-reported percentage of inhibition. Descriptive analyses were conducted with t tests, and a logistic regression model was estimated to assess the association between patient characteristics and the likelihood of platelet nonresponse. In total, 2882 tests (2476 with clopidogrel and 406 with prasugrel) were analyzed. For clopidogrel and prasugrel, respectively, mean PRU standard deviation (SD) was 206 (90) and 107 (93; P < 0.0001) and mean % inhibition (SD) was 31% (26%) and 63% (31%; P < 0.0001). Treatment with clopidogrel alone (odds ratio [OR] = 5.25; P < 0.0001), being non-Caucasian (OR = 1.48; P = 0.0440), obese (OR = 1.49; P = 0.0010), anemic (OR = 3.29; P < 0.0001), diabetic (OR = 1.75; P < 0.0001), and having a history of myocardial infarction (OR = 1.57; P < 0.0001) were significant predictors of having PRU ≥ 235. This real-world data analysis shows results that are consistent with clinical trial results, namely that compared with clopidogrel, prasugrel is associated with significantly lower PRU and greater percentage of inhibition, regardless of age, race, gender, diabetes, obesity, or proton pump inhibitor use.

This study does not have any cohorts or clinical trial

Point-of-care platelet reactivity determination with VerifyNow-P2Y12 following administration of clopidogrel or prasugrel: data from a real-world, clinical care inpatient setting.

To describe VerifyNow-P2Y12 (VN-P2Y12, Accumetrics, San Diego, CA) results from patients treated with either clopidogrel or prasugrel who were seeking care in a hospital setting. VN-P2Y12 is a point-of-care device that measures platelet reactivity to adenosine diphosphate. Past assessments of thienopyridine therapy utilizing VN-P2Y12 have largely come from clinical trial settings. There are limited data from real-world settings. Electronic medical record data from Huntsville Hospital (Huntsville, AL) for those who underwent VN-P2Y12 testing for clopidogrel or prasugrel between January 1, 2009 and October 31, 2010 were analyzed. The VN-P2Y12 data included P2Y12 reaction units (PRUs) and device-reported percentage of inhibition. Descriptive analyses were conducted with t tests, and a logistic regression model was estimated to assess the association between patient characteristics and the likelihood of platelet nonresponse. In total, 2882 tests (2476 with clopidogrel and 406 with prasugrel) were analyzed. For clopidogrel and prasugrel, respectively, mean PRU standard deviation (SD) was 206 (90) and 107 (93; P < 0.0001) and mean % inhibition (SD) was 31% (26%) and 63% (31%; P < 0.0001). Treatment with clopidogrel alone (odds ratio [OR] = 5.25; P < 0.0001), being non-Caucasian (OR = 1.48; P = 0.0440), obese (OR = 1.49; P = 0.0010), anemic (OR = 3.29; P < 0.0001), diabetic (OR = 1.75; P < 0.0001), and having a history of myocardial infarction (OR = 1.57; P < 0.0001) were significant predictors of having PRU ≥ 235. This real-world data analysis shows results that are consistent with clinical trial results, namely that compared with clopidogrel, prasugrel is associated with significantly lower PRU and greater percentage of inhibition, regardless of age, race, gender, diabetes, obesity, or proton pump inhibitor use.

This study has a control, double-blind, or comparison patient group

Point-of-care platelet reactivity determination with VerifyNow-P2Y12 following administration of clopidogrel or prasugrel: data from a real-world, clinical care inpatient setting.

To describe VerifyNow-P2Y12 (VN-P2Y12, Accumetrics, San Diego, CA) results from patients treated with either clopidogrel or prasugrel who were seeking care in a hospital setting. VN-P2Y12 is a point-of-care device that measures platelet reactivity to adenosine diphosphate. Past assessments of thienopyridine therapy utilizing VN-P2Y12 have largely come from clinical trial settings. There are limited data from real-world settings. Electronic medical record data from Huntsville Hospital (Huntsville, AL) for those who underwent VN-P2Y12 testing for clopidogrel or prasugrel between January 1, 2009 and October 31, 2010 were analyzed. The VN-P2Y12 data included P2Y12 reaction units (PRUs) and device-reported percentage of inhibition. Descriptive analyses were conducted with t tests, and a logistic regression model was estimated to assess the association between patient characteristics and the likelihood of platelet nonresponse. In total, 2882 tests (2476 with clopidogrel and 406 with prasugrel) were analyzed. For clopidogrel and prasugrel, respectively, mean PRU standard deviation (SD) was 206 (90) and 107 (93; P < 0.0001) and mean % inhibition (SD) was 31% (26%) and 63% (31%; P < 0.0001). Treatment with clopidogrel alone (odds ratio [OR] = 5.25; P < 0.0001), being non-Caucasian (OR = 1.48; P = 0.0440), obese (OR = 1.49; P = 0.0010), anemic (OR = 3.29; P < 0.0001), diabetic (OR = 1.75; P < 0.0001), and having a history of myocardial infarction (OR = 1.57; P < 0.0001) were significant predictors of having PRU ≥ 235. This real-world data analysis shows results that are consistent with clinical trial results, namely that compared with clopidogrel, prasugrel is associated with significantly lower PRU and greater percentage of inhibition, regardless of age, race, gender, diabetes, obesity, or proton pump inhibitor use.

This study does not have any comparison patient group

Point-of-care platelet reactivity determination with VerifyNow-P2Y12 following administration of clopidogrel or prasugrel: data from a real-world, clinical care inpatient setting.

To describe VerifyNow-P2Y12 (VN-P2Y12, Accumetrics, San Diego, CA) results from patients treated with either clopidogrel or prasugrel who were seeking care in a hospital setting. VN-P2Y12 is a point-of-care device that measures platelet reactivity to adenosine diphosphate. Past assessments of thienopyridine therapy utilizing VN-P2Y12 have largely come from clinical trial settings. There are limited data from real-world settings. Electronic medical record data from Huntsville Hospital (Huntsville, AL) for those who underwent VN-P2Y12 testing for clopidogrel or prasugrel between January 1, 2009 and October 31, 2010 were analyzed. The VN-P2Y12 data included P2Y12 reaction units (PRUs) and device-reported percentage of inhibition. Descriptive analyses were conducted with t tests, and a logistic regression model was estimated to assess the association between patient characteristics and the likelihood of platelet nonresponse. In total, 2882 tests (2476 with clopidogrel and 406 with prasugrel) were analyzed. For clopidogrel and prasugrel, respectively, mean PRU standard deviation (SD) was 206 (90) and 107 (93; P < 0.0001) and mean % inhibition (SD) was 31% (26%) and 63% (31%; P < 0.0001). Treatment with clopidogrel alone (odds ratio [OR] = 5.25; P < 0.0001), being non-Caucasian (OR = 1.48; P = 0.0440), obese (OR = 1.49; P = 0.0010), anemic (OR = 3.29; P < 0.0001), diabetic (OR = 1.75; P < 0.0001), and having a history of myocardial infarction (OR = 1.57; P < 0.0001) were significant predictors of having PRU ≥ 235. This real-world data analysis shows results that are consistent with clinical trial results, namely that compared with clopidogrel, prasugrel is associated with significantly lower PRU and greater percentage of inhibition, regardless of age, race, gender, diabetes, obesity, or proton pump inhibitor use.

This study has human subjects

Point-of-care platelet reactivity determination with VerifyNow-P2Y12 following administration of clopidogrel or prasugrel: data from a real-world, clinical care inpatient setting.

To describe VerifyNow-P2Y12 (VN-P2Y12, Accumetrics, San Diego, CA) results from patients treated with either clopidogrel or prasugrel who were seeking care in a hospital setting. VN-P2Y12 is a point-of-care device that measures platelet reactivity to adenosine diphosphate. Past assessments of thienopyridine therapy utilizing VN-P2Y12 have largely come from clinical trial settings. There are limited data from real-world settings. Electronic medical record data from Huntsville Hospital (Huntsville, AL) for those who underwent VN-P2Y12 testing for clopidogrel or prasugrel between January 1, 2009 and October 31, 2010 were analyzed. The VN-P2Y12 data included P2Y12 reaction units (PRUs) and device-reported percentage of inhibition. Descriptive analyses were conducted with t tests, and a logistic regression model was estimated to assess the association between patient characteristics and the likelihood of platelet nonresponse. In total, 2882 tests (2476 with clopidogrel and 406 with prasugrel) were analyzed. For clopidogrel and prasugrel, respectively, mean PRU standard deviation (SD) was 206 (90) and 107 (93; P < 0.0001) and mean % inhibition (SD) was 31% (26%) and 63% (31%; P < 0.0001). Treatment with clopidogrel alone (odds ratio [OR] = 5.25; P < 0.0001), being non-Caucasian (OR = 1.48; P = 0.0440), obese (OR = 1.49; P = 0.0010), anemic (OR = 3.29; P < 0.0001), diabetic (OR = 1.75; P < 0.0001), and having a history of myocardial infarction (OR = 1.57; P < 0.0001) were significant predictors of having PRU ≥ 235. This real-world data analysis shows results that are consistent with clinical trial results, namely that compared with clopidogrel, prasugrel is associated with significantly lower PRU and greater percentage of inhibition, regardless of age, race, gender, diabetes, obesity, or proton pump inhibitor use.

This study does not have human subjects

Point-of-care platelet reactivity determination with VerifyNow-P2Y12 following administration of clopidogrel or prasugrel: data from a real-world, clinical care inpatient setting.

To describe VerifyNow-P2Y12 (VN-P2Y12, Accumetrics, San Diego, CA) results from patients treated with either clopidogrel or prasugrel who were seeking care in a hospital setting. VN-P2Y12 is a point-of-care device that measures platelet reactivity to adenosine diphosphate. Past assessments of thienopyridine therapy utilizing VN-P2Y12 have largely come from clinical trial settings. There are limited data from real-world settings. Electronic medical record data from Huntsville Hospital (Huntsville, AL) for those who underwent VN-P2Y12 testing for clopidogrel or prasugrel between January 1, 2009 and October 31, 2010 were analyzed. The VN-P2Y12 data included P2Y12 reaction units (PRUs) and device-reported percentage of inhibition. Descriptive analyses were conducted with t tests, and a logistic regression model was estimated to assess the association between patient characteristics and the likelihood of platelet nonresponse. In total, 2882 tests (2476 with clopidogrel and 406 with prasugrel) were analyzed. For clopidogrel and prasugrel, respectively, mean PRU standard deviation (SD) was 206 (90) and 107 (93; P < 0.0001) and mean % inhibition (SD) was 31% (26%) and 63% (31%; P < 0.0001). Treatment with clopidogrel alone (odds ratio [OR] = 5.25; P < 0.0001), being non-Caucasian (OR = 1.48; P = 0.0440), obese (OR = 1.49; P = 0.0010), anemic (OR = 3.29; P < 0.0001), diabetic (OR = 1.75; P < 0.0001), and having a history of myocardial infarction (OR = 1.57; P < 0.0001) were significant predictors of having PRU ≥ 235. This real-world data analysis shows results that are consistent with clinical trial results, namely that compared with clopidogrel, prasugrel is associated with significantly lower PRU and greater percentage of inhibition, regardless of age, race, gender, diabetes, obesity, or proton pump inhibitor use.

This study contains population size or sample size information

Point-of-care platelet reactivity determination with VerifyNow-P2Y12 following administration of clopidogrel or prasugrel: data from a real-world, clinical care inpatient setting.

To describe VerifyNow-P2Y12 (VN-P2Y12, Accumetrics, San Diego, CA) results from patients treated with either clopidogrel or prasugrel who were seeking care in a hospital setting. VN-P2Y12 is a point-of-care device that measures platelet reactivity to adenosine diphosphate. Past assessments of thienopyridine therapy utilizing VN-P2Y12 have largely come from clinical trial settings. There are limited data from real-world settings. Electronic medical record data from Huntsville Hospital (Huntsville, AL) for those who underwent VN-P2Y12 testing for clopidogrel or prasugrel between January 1, 2009 and October 31, 2010 were analyzed. The VN-P2Y12 data included P2Y12 reaction units (PRUs) and device-reported percentage of inhibition. Descriptive analyses were conducted with t tests, and a logistic regression model was estimated to assess the association between patient characteristics and the likelihood of platelet nonresponse. In total, 2882 tests (2476 with clopidogrel and 406 with prasugrel) were analyzed. For clopidogrel and prasugrel, respectively, mean PRU standard deviation (SD) was 206 (90) and 107 (93; P < 0.0001) and mean % inhibition (SD) was 31% (26%) and 63% (31%; P < 0.0001). Treatment with clopidogrel alone (odds ratio [OR] = 5.25; P < 0.0001), being non-Caucasian (OR = 1.48; P = 0.0440), obese (OR = 1.49; P = 0.0010), anemic (OR = 3.29; P < 0.0001), diabetic (OR = 1.75; P < 0.0001), and having a history of myocardial infarction (OR = 1.57; P < 0.0001) were significant predictors of having PRU ≥ 235. This real-world data analysis shows results that are consistent with clinical trial results, namely that compared with clopidogrel, prasugrel is associated with significantly lower PRU and greater percentage of inhibition, regardless of age, race, gender, diabetes, obesity, or proton pump inhibitor use.

This study does not contain population size information

Point-of-care platelet reactivity determination with VerifyNow-P2Y12 following administration of clopidogrel or prasugrel: data from a real-world, clinical care inpatient setting.

To describe VerifyNow-P2Y12 (VN-P2Y12, Accumetrics, San Diego, CA) results from patients treated with either clopidogrel or prasugrel who were seeking care in a hospital setting. VN-P2Y12 is a point-of-care device that measures platelet reactivity to adenosine diphosphate. Past assessments of thienopyridine therapy utilizing VN-P2Y12 have largely come from clinical trial settings. There are limited data from real-world settings. Electronic medical record data from Huntsville Hospital (Huntsville, AL) for those who underwent VN-P2Y12 testing for clopidogrel or prasugrel between January 1, 2009 and October 31, 2010 were analyzed. The VN-P2Y12 data included P2Y12 reaction units (PRUs) and device-reported percentage of inhibition. Descriptive analyses were conducted with t tests, and a logistic regression model was estimated to assess the association between patient characteristics and the likelihood of platelet nonresponse. In total, 2882 tests (2476 with clopidogrel and 406 with prasugrel) were analyzed. For clopidogrel and prasugrel, respectively, mean PRU standard deviation (SD) was 206 (90) and 107 (93; P < 0.0001) and mean % inhibition (SD) was 31% (26%) and 63% (31%; P < 0.0001). Treatment with clopidogrel alone (odds ratio [OR] = 5.25; P < 0.0001), being non-Caucasian (OR = 1.48; P = 0.0440), obese (OR = 1.49; P = 0.0010), anemic (OR = 3.29; P < 0.0001), diabetic (OR = 1.75; P < 0.0001), and having a history of myocardial infarction (OR = 1.57; P < 0.0001) were significant predictors of having PRU ≥ 235. This real-world data analysis shows results that are consistent with clinical trial results, namely that compared with clopidogrel, prasugrel is associated with significantly lower PRU and greater percentage of inhibition, regardless of age, race, gender, diabetes, obesity, or proton pump inhibitor use.

This study has quantitative outcomes like numbers, P-value, OR, CI, HR, RR, or patient ratios

Point-of-care platelet reactivity determination with VerifyNow-P2Y12 following administration of clopidogrel or prasugrel: data from a real-world, clinical care inpatient setting.

To describe VerifyNow-P2Y12 (VN-P2Y12, Accumetrics, San Diego, CA) results from patients treated with either clopidogrel or prasugrel who were seeking care in a hospital setting. VN-P2Y12 is a point-of-care device that measures platelet reactivity to adenosine diphosphate. Past assessments of thienopyridine therapy utilizing VN-P2Y12 have largely come from clinical trial settings. There are limited data from real-world settings. Electronic medical record data from Huntsville Hospital (Huntsville, AL) for those who underwent VN-P2Y12 testing for clopidogrel or prasugrel between January 1, 2009 and October 31, 2010 were analyzed. The VN-P2Y12 data included P2Y12 reaction units (PRUs) and device-reported percentage of inhibition. Descriptive analyses were conducted with t tests, and a logistic regression model was estimated to assess the association between patient characteristics and the likelihood of platelet nonresponse. In total, 2882 tests (2476 with clopidogrel and 406 with prasugrel) were analyzed. For clopidogrel and prasugrel, respectively, mean PRU standard deviation (SD) was 206 (90) and 107 (93; P < 0.0001) and mean % inhibition (SD) was 31% (26%) and 63% (31%; P < 0.0001). Treatment with clopidogrel alone (odds ratio [OR] = 5.25; P < 0.0001), being non-Caucasian (OR = 1.48; P = 0.0440), obese (OR = 1.49; P = 0.0010), anemic (OR = 3.29; P < 0.0001), diabetic (OR = 1.75; P < 0.0001), and having a history of myocardial infarction (OR = 1.57; P < 0.0001) were significant predictors of having PRU ≥ 235. This real-world data analysis shows results that are consistent with clinical trial results, namely that compared with clopidogrel, prasugrel is associated with significantly lower PRU and greater percentage of inhibition, regardless of age, race, gender, diabetes, obesity, or proton pump inhibitor use.

This study does not have any quantitative outcomes