human
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: Background Adjustment for prognostic covariates can lead to increased power in the analysis of r and omized trials . However , adjusted analyses are not often performed in practice . Methods We used simulation to examine the impact of covariate adjustment on 12 outcomes from 8 studies across a range of therapeutic areas . We assessed ( 1 ) how large an increase in power can be expected in practice ; and ( 2 ) the impact of adjustment for covariates that are not prognostic . Results Adjustment for known prognostic covariates led to large increases in power for most outcomes . When power was set to 80 % based on an unadjusted analysis , covariate adjustment led to a median increase in power to 92.6 % across the 12 outcomes ( range 80.6 to 99.4 % ) . Power was increased to over 85 % for 8 of 12 outcomes , and to over 95 % for 5 of 12 outcomes . Conversely , the largest decrease in power from adjustment for covariates that were not prognostic was from 80 % to 78.5 % . Conclusions Adjustment for known prognostic covariates can lead to substantial increases in power , and should be routinely incorporated into the analysis of r and omized trials . The potential benefits of adjusting for a small number of possibly prognostic covariates in trials with moderate or large sample sizes far outweigh the risks of doing so , and so should also be considered PURPOSE The aim of this study was to determine the toxic effect of Nigella sativa powder on the liver function which was evaluated by measuring liver enzymes and through histopathological examination of liver tissue . METHODS Twenty four male Sprague Dawley rats were allotted r and omly to four groups including : control ( taking normal diet ) ; low dose ( supplemented with 0.01 g/kg/day Nigella sativa ) ; normal dose ( supplemented with 0.1 g/kg/day Nigella sativa ) and high dose ( supplemented with 1 g/kg/day Nigella sativa ) . All of supplements administered in powder form mixed with rats ' pellet for 28 days . To assess liver toxicity , liver enzymes measurement and histological study were done at the end of supplementation . RESULTS The finding revealed that there was no significant change in serum alanine aminotransferase ( ALT ) and aspartate aminotransferase ( AST ) between treatment groups . Histopathological study showed very minimal and mild changes in fatty degeneration in normal and high doses of Nigella sativa treated group . Inflammation and necrosis were absent . CONCLUSION The study showed that supplementation of Nigella sativa up to the dose of 1 g/kg supplemented for a period of 28 days result ed no changes in liver enzymes level and did not cause any toxicity effect on the liver function Hypertension ( HT ) is a lifestyle‐related disease and dietary modifications are effective for its management and prevention . We conducted a r and omized , double‐blind , placebo‐controlled trial to evaluate the efficacy of treatment with an oral Nigella sativa ( NS ) seed extract supplement in patients with mild HT . Subjects were r and omized into three groups : a placebo and two test groups that received 100 and 200 mg of NS extract twice a day . After 8 weeks , systolic blood pressure ( SBP ) values in both case groups were found to be significantly reduced when compared with the baseline values for each group . In addition , the decrease in SBP in the two case groups was statistically significant relative to the placebo group ( P < 0.05–0.01 ) . Meanwhile , diastolic blood pressure ( DBP ) values in the case groups were found to be significantly reduced from the baseline and a significant reduction was also observed in these groups ( P < 0.01 ) when compared with the placebo group . In addition , extract administration reduced both SBP and DBP in a dose‐dependent manner . Meanwhile , NS extract caused a significant decline in the level of total and low‐density‐lipoprotein (LDL)‐cholesterol relative to baseline data . No complications caused by NS were observed . The results suggest that the daily use of NS seed extract for 2 months may have a blood pressure‐lowering effect in patients with mild HT BACKGROUND Diabetic patients with hypertension and dyslipidemia are at a high risk of cardiovascular complications . OBJECTIVES To determine the effect of Nigella sativa supplementation on the lipid profile , mean arterial pressure , and heart rate in persons with type 2 diabetes on oral hypoglycemic agents ( OHA ) .  DESIGN Single-blind , nonr and omized . SETTING Diabetes clinic of a university hospital in Saudi Arabia . PATIENTS AND METHODS Type-2 diabetic patients were recruited by purposive sampling and assigned to treatment or control at the discretion of the investigator with the patient blinded to treatment . Before the intervention and every 3 months thereafter until the end of the treatment period , the following parameters were measured : triglycerides ( TG ) , total cholesterol ( TC ) , low density lipoprotein cholesterol ( LDL-C ) , high density lipoprotein cholesterol ( HDL-C ) , systolic blood pressure ( SBP ) , diastolic blood pressure ( DBP ) , mean arterial pressure ( MAP ) , heart rate ( HR ) , and body mass index ( BMI ) . Results at the baseline and each subsequent visit were compared between the two groups . MAIN OUTCOME MEASURE(S ) Lipid and cardiovascular parameters , and BMI . RESULTS Fifty-seven patients were assigned to receive N sativa 2 g daily for one year and 57 were assigned to receive an identical regimen of placebo , along with OHA . A significant decrease in HDL-C and increase in the TC/HDL-C and LDL-C/HDL-C ratios were seen in the control group . The N sativa group had a significant decline in TC , LDL-C , TC/HDL-C and LDL-C/HDL-C ratios , compared with the respective baseline data and the control group . HDL-C was significantly elevated in the N sativa group . The control group showed a significant elevation in MAP . The N sativa group had a significant reduction in SBP , DBP , MAP and HR and a significant decrease in DBP , MAP and HR as compared with the control group . CONCLUSION N sativa supplementation improves total cholesterol , mean arterial pressure and heart rate in type 2 diabetes patients on oral hypoglycemic agents .  LIMITATIONS There were 9 subjects in each group lost to follow up ; thus the sample size could not be maintained as per the sample size calculation . The study was nonr and omized and thus there was a possibility of allocation bias . ( Clinical trial registration number : CTRI/2013/06/003781 , Clinical Trial Registry of India ) Carum carvi L. ( Apiaceae ) is known as caraway , and its derivatives find wide medicinal use for health purpose s , including for gastrointestinal problems and obesity . Since there is inconsistency among the reports on the safety of this plant in humans , this research was aim ed at assessing the safety of a characterized caraway aqueous extract ( CAE ) in a r and omized , triple-blind , placebo-controlled study . Seventy , overweight and obese , healthy women were r and omly assigned into placebo ( n = 35 ) and plant extract ( n = 35 ) groups . Participants received either 30 ml/day of CAE or placebo . Subjects were examined at baseline and after 12 weeks for changes in heart rate , blood pressure , urine test , 25-item blood chemistries , and general health status . No significant changes of blood pressure , heart rate , urine specific gravity , and serum blood tests were observed between the two groups before and after treatment . However , in the complete blood count test , red blood cell levels were significantly ( p < 0.01 ) increased , and platelet distribution width was significantly decreased after the dietary CAE treatment , as compared with placebo . No negative changes were observed in the general health status of the two groups . This preliminary study suggests that the oral intake of CAE appears to be without any adverse effects at a dosage of 30 ml daily for a period of 12 weeks The efficacy and safety of the st and ardized herbal combination preparation of Enteroplant , consisting of peppermint oil ( 90 mg ) and caraway ( 50 mg ) in an enteric coated capsule , have been studied in a double-blind , placebo-controlled multicentre trial in patients with non-ulcer dyspepsia . A total of 45 patients were included in the trial after thorough physical and gastro-enterological examination . The primary outcome variables were the change in the intensity of pain and the global clinical impression ( Clinical Global Impression [ CGI ] , Item 2 ) , which were evaluated for 39 patients ( test preparation : 19 , placebo : 20 ) . After four weeks of treatment both target parameters were significantly improved for the group of patients treated with the peppermint oil/caraway oil combination compared to the placebo group ( p = 0.015 and 0.008 , respectively ) . Before the start of treatment all patients in the test preparation group reported moderate to severe pain , while by the end of the study 63.2 % of these patients were free of pain . The pain symptoms had improved in a total of 89.5 % of the patients in the active treatment group . After 4 weeks the Clinical Global Impressions were improved for 94.5 % of the patients treated with the peppermint oil/caraway oil combination . The trial medication was also superior to placebo with respect to pain frequency , medical prognosis , the severity of the disorder and the efficacy index ( CGI , Items 1 and 3 ) , which were adopted as secondary end-points for evaluation of efficacy . There were similarly favourable findings for the herbal combination , compared with placebo , with respect to the reduction of other gastrointestinal symptoms . The combination preparation was found to be excellently tolerated . There was a total of 7 adverse events ( test preparation : 4 , placebo : 3 ) , with a causal association with the treatment being ascribed in one case for the test preparation group and one case for the placebo group This study aims to evaluate efficacy and safety of Nigella sativa oil supplementation in patients with chronic kidney disease Stage 3 and 4 due to diabetic nephropathy . It was a prospect i ve , comparative , and open-label study . Patients were r and omized into two groups . Group 1 ( Control ) received conservative management of diabetic nephropathy , whereas Group 2 ( Test ) received N. sativa oil ( 2.5 mL , once daily and per orally ) along with conservative management for 12 weeks .  Blood glucose , hemogram , and kidney function test were done at 0 , 6 , and 12 weeks of treatment . Significance of differences between pre- and post-treatment values in each group was assessed using Student 's paired t-test and between the groups using unpaired t-test . We found a drop in blood glucose , serum creatinine , blood urea , and 24 h total urinary protein levels and a rise in glomerular filtration rate , 24 h total urinary volume , and hemoglobin level in the treatment group compared to the control group BACKGROUND Experimental evidence s have demonstrated that Nigella sativa Linn . seed ( NS ) has positive modulation effects on aged rats with memory impairments , prevents against hippocampal pyramidal cell loss and enhances consolidation of recall capability of stored information and spatial memory in rats .  NS has neuroprotective , nephroprotective , lung protective , cardioprotective , hepatoprotective activities as established by previous studies on animals . Several clinical trials with NS on human have also demonstrated beneficial effect . AIM OF THE STUDY The present study was design ed to investigate the effects of NS on memory , attention and cognition in healthy elderly volunteers . Furthermore , safety profile of NS was assessed during the nine-week study period . METHODS Forty elderly volunteers were recruited and divided r and omly into group A and group B -- each consisting of 20 volunteers . The treatment procedure for group A was 500 mg NS capsule twice daily for nine weeks and Group B received placebo instead of NS in the similar manner . All the volunteers were assessed for neuropsychological state and safety profile twice before treatment and after nine weeks . The neuropsychological tests were logical memory test , digit span test , Rey-Osterrieth complex figure test , letter cancellation test , trail making test and stroop test . Safety profile was assessed by measuring biochemical markers of Cardiac ( total cholesterol , triglycerides and high density lipoprotein cholesterol , very low density lipoprotein , low density lipoprotein cholesterol , creatine kinase-MB ) ; Liver ( aspartate aminotransferase , alanin aminotransferase , alkaline phosphatase , total protein , albumin , bilirubin ) and Kidney ( creatinine and blood urea nitrogen ) through using commercial kits . RESULTS There was significant difference ( p<0.05 ) in the score of logical memory test-I and II , total score of digit span , 30 min delayed-recall , percent score in Rey-Osterrieth complex figure test , time taken to complete letter cancellation test , time taken in trail making test-A and test-B , score in part C of stroop test due to ingestion of NS for nine weeks . There were not statistically significant changes ( p>0.05 ) in any of the biochemical markers of cardiac , liver , kidney function during this nine-week study period . CONCLUSIONS The current study demonstrates the role of NS in enhancing memory , attention and cognition . Therefore , whether NS could be considered as potential food supplement for preventing or slow progressing of Alzheimer disease needs further investigations . However , study with Alzheimer 's patients with 
    Output:
    
agent
Our data suggested that N.S supplementation had significant impacts on liver and kidney parameters leading to a decrease in ALP and BUN levels .
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: Background Adjustment for prognostic covariates can lead to increased power in the analysis of r and omized trials . However , adjusted analyses are not often performed in practice . Methods We used simulation to examine the impact of covariate adjustment on 12 outcomes from 8 studies across a range of therapeutic areas . We assessed ( 1 ) how large an increase in power can be expected in practice ; and ( 2 ) the impact of adjustment for covariates that are not prognostic . Results Adjustment for known prognostic covariates led to large increases in power for most outcomes . When power was set to 80 % based on an unadjusted analysis , covariate adjustment led to a median increase in power to 92.6 % across the 12 outcomes ( range 80.6 to 99.4 % ) . Power was increased to over 85 % for 8 of 12 outcomes , and to over 95 % for 5 of 12 outcomes . Conversely , the largest decrease in power from adjustment for covariates that were not prognostic was from 80 % to 78.5 % . Conclusions Adjustment for known prognostic covariates can lead to substantial increases in power , and should be routinely incorporated into the analysis of r and omized trials . The potential benefits of adjusting for a small number of possibly prognostic covariates in trials with moderate or large sample sizes far outweigh the risks of doing so , and so should also be considered PURPOSE The aim of this study was to determine the toxic effect of Nigella sativa powder on the liver function which was evaluated by measuring liver enzymes and through histopathological examination of liver tissue . METHODS Twenty four male Sprague Dawley rats were allotted r and omly to four groups including : control ( taking normal diet ) ; low dose ( supplemented with 0.01 g/kg/day Nigella sativa ) ; normal dose ( supplemented with 0.1 g/kg/day Nigella sativa ) and high dose ( supplemented with 1 g/kg/day Nigella sativa ) . All of supplements administered in powder form mixed with rats ' pellet for 28 days . To assess liver toxicity , liver enzymes measurement and histological study were done at the end of supplementation . RESULTS The finding revealed that there was no significant change in serum alanine aminotransferase ( ALT ) and aspartate aminotransferase ( AST ) between treatment groups . Histopathological study showed very minimal and mild changes in fatty degeneration in normal and high doses of Nigella sativa treated group . Inflammation and necrosis were absent . CONCLUSION The study showed that supplementation of Nigella sativa up to the dose of 1 g/kg supplemented for a period of 28 days result ed no changes in liver enzymes level and did not cause any toxicity effect on the liver function Hypertension ( HT ) is a lifestyle‐related disease and dietary modifications are effective for its management and prevention . We conducted a r and omized , double‐blind , placebo‐controlled trial to evaluate the efficacy of treatment with an oral Nigella sativa ( NS ) seed extract supplement in patients with mild HT . Subjects were r and omized into three groups : a placebo and two test groups that received 100 and 200 mg of NS extract twice a day . After 8 weeks , systolic blood pressure ( SBP ) values in both case groups were found to be significantly reduced when compared with the baseline values for each group . In addition , the decrease in SBP in the two case groups was statistically significant relative to the placebo group ( P < 0.05–0.01 ) . Meanwhile , diastolic blood pressure ( DBP ) values in the case groups were found to be significantly reduced from the baseline and a significant reduction was also observed in these groups ( P < 0.01 ) when compared with the placebo group . In addition , extract administration reduced both SBP and DBP in a dose‐dependent manner . Meanwhile , NS extract caused a significant decline in the level of total and low‐density‐lipoprotein (LDL)‐cholesterol relative to baseline data . No complications caused by NS were observed . The results suggest that the daily use of NS seed extract for 2 months may have a blood pressure‐lowering effect in patients with mild HT BACKGROUND Diabetic patients with hypertension and dyslipidemia are at a high risk of cardiovascular complications . OBJECTIVES To determine the effect of Nigella sativa supplementation on the lipid profile , mean arterial pressure , and heart rate in persons with type 2 diabetes on oral hypoglycemic agents ( OHA ) .  DESIGN Single-blind , nonr and omized . SETTING Diabetes clinic of a university hospital in Saudi Arabia . PATIENTS AND METHODS Type-2 diabetic patients were recruited by purposive sampling and assigned to treatment or control at the discretion of the investigator with the patient blinded to treatment . Before the intervention and every 3 months thereafter until the end of the treatment period , the following parameters were measured : triglycerides ( TG ) , total cholesterol ( TC ) , low density lipoprotein cholesterol ( LDL-C ) , high density lipoprotein cholesterol ( HDL-C ) , systolic blood pressure ( SBP ) , diastolic blood pressure ( DBP ) , mean arterial pressure ( MAP ) , heart rate ( HR ) , and body mass index ( BMI ) . Results at the baseline and each subsequent visit were compared between the two groups . MAIN OUTCOME MEASURE(S ) Lipid and cardiovascular parameters , and BMI . RESULTS Fifty-seven patients were assigned to receive N sativa 2 g daily for one year and 57 were assigned to receive an identical regimen of placebo , along with OHA . A significant decrease in HDL-C and increase in the TC/HDL-C and LDL-C/HDL-C ratios were seen in the control group . The N sativa group had a significant decline in TC , LDL-C , TC/HDL-C and LDL-C/HDL-C ratios , compared with the respective baseline data and the control group . HDL-C was significantly elevated in the N sativa group . The control group showed a significant elevation in MAP . The N sativa group had a significant reduction in SBP , DBP , MAP and HR and a significant decrease in DBP , MAP and HR as compared with the control group . CONCLUSION N sativa supplementation improves total cholesterol , mean arterial pressure and heart rate in type 2 diabetes patients on oral hypoglycemic agents .  LIMITATIONS There were 9 subjects in each group lost to follow up ; thus the sample size could not be maintained as per the sample size calculation . The study was nonr and omized and thus there was a possibility of allocation bias . ( Clinical trial registration number : CTRI/2013/06/003781 , Clinical Trial Registry of India ) Carum carvi L. ( Apiaceae ) is known as caraway , and its derivatives find wide medicinal use for health purpose s , including for gastrointestinal problems and obesity . Since there is inconsistency among the reports on the safety of this plant in humans , this research was aim ed at assessing the safety of a characterized caraway aqueous extract ( CAE ) in a r and omized , triple-blind , placebo-controlled study . Seventy , overweight and obese , healthy women were r and omly assigned into placebo ( n = 35 ) and plant extract ( n = 35 ) groups . Participants received either 30 ml/day of CAE or placebo . Subjects were examined at baseline and after 12 weeks for changes in heart rate , blood pressure , urine test , 25-item blood chemistries , and general health status . No significant changes of blood pressure , heart rate , urine specific gravity , and serum blood tests were observed between the two groups before and after treatment . However , in the complete blood count test , red blood cell levels were significantly ( p < 0.01 ) increased , and platelet distribution width was significantly decreased after the dietary CAE treatment , as compared with placebo . No negative changes were observed in the general health status of the two groups . This preliminary study suggests that the oral intake of CAE appears to be without any adverse effects at a dosage of 30 ml daily for a period of 12 weeks The efficacy and safety of the st and ardized herbal combination preparation of Enteroplant , consisting of peppermint oil ( 90 mg ) and caraway ( 50 mg ) in an enteric coated capsule , have been studied in a double-blind , placebo-controlled multicentre trial in patients with non-ulcer dyspepsia . A total of 45 patients were included in the trial after thorough physical and gastro-enterological examination . The primary outcome variables were the change in the intensity of pain and the global clinical impression ( Clinical Global Impression [ CGI ] , Item 2 ) , which were evaluated for 39 patients ( test preparation : 19 , placebo : 20 ) . After four weeks of treatment both target parameters were significantly improved for the group of patients treated with the peppermint oil/caraway oil combination compared to the placebo group ( p = 0.015 and 0.008 , respectively ) . Before the start of treatment all patients in the test preparation group reported moderate to severe pain , while by the end of the study 63.2 % of these patients were free of pain . The pain symptoms had improved in a total of 89.5 % of the patients in the active treatment group . After 4 weeks the Clinical Global Impressions were improved for 94.5 % of the patients treated with the peppermint oil/caraway oil combination . The trial medication was also superior to placebo with respect to pain frequency , medical prognosis , the severity of the disorder and the efficacy index ( CGI , Items 1 and 3 ) , which were adopted as secondary end-points for evaluation of efficacy . There were similarly favourable findings for the herbal combination , compared with placebo , with respect to the reduction of other gastrointestinal symptoms . The combination preparation was found to be excellently tolerated . There was a total of 7 adverse events ( test preparation : 4 , placebo : 3 ) , with a causal association with the treatment being ascribed in one case for the test preparation group and one case for the placebo group This study aims to evaluate efficacy and safety of Nigella sativa oil supplementation in patients with chronic kidney disease Stage 3 and 4 due to diabetic nephropathy . It was a prospect i ve , comparative , and open-label study . Patients were r and omized into two groups . Group 1 ( Control ) received conservative management of diabetic nephropathy , whereas Group 2 ( Test ) received N. sativa oil ( 2.5 mL , once daily and per orally ) along with conservative management for 12 weeks .  Blood glucose , hemogram , and kidney function test were done at 0 , 6 , and 12 weeks of treatment . Significance of differences between pre- and post-treatment values in each group was assessed using Student 's paired t-test and between the groups using unpaired t-test . We found a drop in blood glucose , serum creatinine , blood urea , and 24 h total urinary protein levels and a rise in glomerular filtration rate , 24 h total urinary volume , and hemoglobin level in the treatment group compared to the control group BACKGROUND Experimental evidence s have demonstrated that Nigella sativa Linn . seed ( NS ) has positive modulation effects on aged rats with memory impairments , prevents against hippocampal pyramidal cell loss and enhances consolidation of recall capability of stored information and spatial memory in rats .  NS has neuroprotective , nephroprotective , lung protective , cardioprotective , hepatoprotective activities as established by previous studies on animals . Several clinical trials with NS on human have also demonstrated beneficial effect . AIM OF THE STUDY The present study was design ed to investigate the effects of NS on memory , attention and cognition in healthy elderly volunteers . Furthermore , safety profile of NS was assessed during the nine-week study period . METHODS Forty elderly volunteers were recruited and divided r and omly into group A and group B -- each consisting of 20 volunteers . The treatment procedure for group A was 500 mg NS capsule twice daily for nine weeks and Group B received placebo instead of NS in the similar manner . All the volunteers were assessed for neuropsychological state and safety profile twice before treatment and after nine weeks . The neuropsychological tests were logical memory test , digit span test , Rey-Osterrieth complex figure test , letter cancellation test , trail making test and stroop test . Safety profile was assessed by measuring biochemical markers of Cardiac ( total cholesterol , triglycerides and high density lipoprotein cholesterol , very low density lipoprotein , low density lipoprotein cholesterol , creatine kinase-MB ) ; Liver ( aspartate aminotransferase , alanin aminotransferase , alkaline phosphatase , total protein , albumin , bilirubin ) and Kidney ( creatinine and blood urea nitrogen ) through using commercial kits . RESULTS There was significant difference ( p<0.05 ) in the score of logical memory test-I and II , total score of digit span , 30 min delayed-recall , percent score in Rey-Osterrieth complex figure test , time taken to complete letter cancellation test , time taken in trail making test-A and test-B , score in part C of stroop test due to ingestion of NS for nine weeks . There were not statistically significant changes ( p>0.05 ) in any of the biochemical markers of cardiac , liver , kidney function during this nine-week study period . CONCLUSIONS The current study demonstrates the role of NS in enhancing memory , attention and cognition . Therefore , whether NS could be considered as potential food supplement for preventing or slow progressing of Alzheimer disease needs further investigations . However , study with Alzheimer 's patients with 
    Output:
    