AdaptLLM/RCT · Datasets at Hugging Face

label stringclasses 5 values	text stringlengths 2 1.45k	metadata stringclasses 1 value
METHODS	Approximately , 300 subjects will be randomized in a stratified manner , based on the estimated glomerular filtration rate ( eGFR ) and urine albumin to creatinine ratio , to one of four arms in this dose-ranging study .
METHODS	The primary endpoint is change in eGFR at 48 weeks , and the key secondary endpoint is change in albuminuria .
CONCLUSIONS	Guided by the biology of oxidative stress signaling through ASK1 , the biology of DKD pathogenesis , and solid statistical methods , the decisions made for this Phase 2 study regarding delineating study population , efficacy outcomes , treatment period and statistical methods represent innovative attempts to resolve challenges specific to DKD study design .
BACKGROUND	Adherence to medication is often low .
BACKGROUND	Pharmacists may improve adherence , but a one-size-fits-all approach will not work : different patients have different needs .
BACKGROUND	Goal of the current study is to assess the effectiveness of a patient-tailored , telephone-based intervention by a pharmacist at the start of pharmacotherapy aimed at improving medication adherence , satisfaction with information and counselling and the beliefs about medicines .
METHODS	A cluster randomized controlled intervention trial in 30 Dutch pharmacies , randomly assigned to 1 of 2 intervention groups .
METHODS	Each group consists of an intervention arm and an usual care arm .
METHODS	The intervention arm in the first group is the usual care arm in the second group and vice versa .
METHODS	One intervention arm focuses on patients starting with antidepressants or bisphosphonates and the other on antilipaemic drugs or renin angiotensin system ( RAS ) - inhibitors .
METHODS	The intervention consists of a telephone call by a pharmacist 2 or 3 weeks after a new prescription .
METHODS	A random sample of pharmacies will send questionnaires 3 months after the first prescription .
METHODS	This contains socio-demographic questions , a measure of beliefs about medicines ( BMQ ) , satisfaction with information received ( SIMS , abbreviated ) and frequency of pharmacy counselling ( Consumer Quality Index , CQI , abbreviated ) .
METHODS	The primary outcome measure will be medication adherence calculated from dispensing records retrieved 12 months after the intervention .
METHODS	Patients ' beliefs on medication , perception of the quality of information received and pharmacy counselling are secondary outcomes .
CONCLUSIONS	The TelCIP study will determine the effectiveness of telephone counselling to improve adherence in patients initiating a new treatment .
CONCLUSIONS	By measuring satisfaction with information and counselling and beliefs about medication the study will also give clues for the reason of a potential increase in adherence .
CONCLUSIONS	Finally the study will provide information on which patients are most likely to benefit from this intervention .
BACKGROUND	The trial is registered at http://www.trialregister.nl under the identifier NTR3237 .
OBJECTIVE	The purpose of this study was to examine the effects of including female athletes ' weights in athletic event programs on female spectators ' body image , eating disorder symptoms , self-esteem , and affective state and to investigate whether the magnitude of the athletes ' reported weights had differential effects on female spectators ( i.e. , do female spectators who view heavier athletes respond differently than those who view less heavy athletes ? )
METHODS	We used an experimental design to examine hypotheses derived from competing theories to determine whether exposure to female athletes of varying weight would adversely or beneficially impact female undergraduates ( N = 152 ) who served as athletic event spectators .
RESULTS	Analyses indicated that in this simulated study , female spectators ' body image , eating disorder symptoms , self-esteem , and affective states were not impacted by the presence or by the magnitude of female athletes ' weights in athletic event programs .
CONCLUSIONS	The results imply that including athletes ' weights in game-day programs at women 's athletic events does not affect female spectators on an individual level .
BACKGROUND	Approximately 20 % of patients are not satisfied with the outcome of total knee replacement , great volumes of which are carried out yearly .
BACKGROUND	Physiotherapy is often provided by the NHS to address dysfunction following knee replacement ; however the efficacy of this is unknown .
BACKGROUND	Although clinically it is accepted that therapy is useful , provision of physiotherapy to all patients post-operatively does not enhance outcomes at one year .
BACKGROUND	No study has previously assessed the effect of targeting therapy to individuals struggling to recover in the early post-operative phase.The aim of the TRIO study is to determine whether stratifying care by targeting physiotherapy to those individuals performing poorly following knee replacement is effective in improving the one year outcomes .
BACKGROUND	We are also investigating whether the structure of the physiotherapy provision itself influences outcomes .
METHODS	The study is a multi-centre prospective randomised controlled trial ( RCT ) of patients undergoing primary total knee replacement , with treatment targeted at those deemed most susceptible to gain from it .
METHODS	Use of the national PROMS programme for pre-operative data collection allows us to screen all patients at initial post-operative clinical review , and recruit only those deemed to be recovering slowly.We aim to recruit 440 patients through various NHS orthopaedic centres who will undergo six weeks of physiotherapy .
METHODS	The intervention will be either ` intensive ' involving both hospital and home-based functional exercise rehabilitation , or ` standard of care ' consisting of home exercises .
METHODS	Patients will be randomised to either group using a web-based system .
METHODS	Both groups will receive pre and post-intervention physiotherapy review .
METHODS	Patients will be followed-up to one year post-operation .
METHODS	The primary outcome measure is the Oxford Knee Score .
METHODS	Secondary outcomes are patient satisfaction , functional ability , pain scores and cost-effectiveness .
BACKGROUND	Current Controlled Trials ISRCTN23357609 .
BACKGROUND	ClinicalTrials.gov NCT01849445 .
BACKGROUND	In developing countries , mortality in children with very severe pneumonia is high , even with the provision of appropriate antibiotics , standard oxygen therapy , and other supportive care .
BACKGROUND	We assessed whether oxygen therapy delivered by bubble continuous positive airway pressure ( CPAP ) improved outcomes compared with standard low-flow and high-flow oxygen therapies .
METHODS	This open , randomised , controlled trial took place in Dhaka Hospital of the International Centre for Diarrhoeal Disease Research , Bangladesh .
METHODS	We randomly assigned children younger than 5 years with severe pneumonia and hypoxaemia to receive oxygen therapy by either bubble CPAP ( 5 L/min starting at a CPAP level of 5 cm H2O ) , standard low-flow nasal cannula ( 2 L/min ) , or high-flow nasal cannula ( 2 L/kg per min up to the maximum of 12 L/min ) .
METHODS	Randomisation was done with use of the permuted block methods ( block size of 15 patients ) and Fisher and Yates tables of random permutations .
METHODS	The primary outcome was treatment failure ( ie , clinical failure , intubation and mechanical ventilation , death , or termination of hospital stay against medical advice ) after more than 1 h of treatment .
METHODS	Primary and safety analyses were by intention to treat .
METHODS	We did two interim analyses and stopped the trial after the second interim analysis on Aug 3 , 2013 , as directed by the data safety and monitoring board .
METHODS	This trial is registered at ClinicalTrials.gov , number NCT01396759 .
RESULTS	Between Aug 4 , 2011 , and July 17 , 2013 , 225 eligible children were recruited .
RESULTS	We randomly allocated 79 ( 35 % ) children to receive oxygen therapy by bubble CPAP , 67 ( 30 % ) to low-flow oxygen therapy , and 79 ( 35 % ) to high-flow oxygen therapy .
RESULTS	Treatment failed for 31 ( 14 % ) children , of whom five ( 6 % ) had received bubble CPAP , 16 ( 24 % ) had received low-flow oxygen therapy , and ten ( 13 % ) had received high-flow oxygen therapy .
RESULTS	Significantly fewer children in the bubble CPAP group had treatment failure than in the low-flow oxygen therapy group ( relative risk [ RR ] 027 , 997 % CI 007-099 ; p = 00026 ) .
RESULTS	No difference in treatment failure was noted between patients in the bubble CPAP and those in the high-flow oxygen therapy group ( RR 050 , 997 % 011-229 ; p = 0175 ) .
RESULTS	23 ( 10 % ) children died .
RESULTS	Three ( 4 % ) children died in the bubble CPAP group , ten ( 15 % ) children died in the low-flow oxygen therapy group , and ten ( 13 % ) children died in the high-flow oxygen therapy group .
RESULTS	Children who received oxygen by bubble CPAP had significantly lower rates of death than the children who received oxygen by low-flow oxygen therapy ( RR 025 , 95 % CI 007-089 ; p = 0022 ) .
CONCLUSIONS	Oxygen therapy delivered by bubble CPAP improved outcomes in Bangladeshi children with very severe pneumonia and hypoxaemia compared with standard low-flow oxygen therapy .
CONCLUSIONS	Use of bubble CPAP oxygen therapy could have a large effect in hospitals in developing countries where the only respiratory support for severe childhood pneumonia and hypoxaemia is low-flow oxygen therapy .
CONCLUSIONS	The trial was stopped early because of higher mortality in the low-flow oxygen group than in the bubble CPAP group , and we acknowledge that the early cessation of the trial reduces the certainty of the findings .
CONCLUSIONS	Further research is needed to test the feasibility of scaling up bubble CPAP in district hospitals and to improve bubble CPAP delivery technology .
BACKGROUND	International Centre for Diarrhoeal Disease Research , Bangladesh , and Centre for International Child Health , University of Melbourne .
BACKGROUND	Blood Pressure related disease affected 118 million people in India in the year 2000 ; this figure will double by 2025 .
BACKGROUND	Around one in four adults in rural India have hypertension , and of those , only a minority are accessing appropriate care .
BACKGROUND	Health systems in India face substantial challenges to meet these gaps in care , and innovative solutions are needed .
METHODS	We hypothesise that a multifaceted intervention involving capacity strengthening of primary healthcare doctors and non-physician healthcare workers through use of a mobile device-based clinical decision support system will result in improved blood pressure control for individuals at high risk of a cardiovascular disease event when compared with usual healthcare .
METHODS	This intervention will be implemented as a stepped wedge , cluster randomised controlled trial in 18 primary health centres and 54 villages in rural Andhra Pradesh involving adults aged 40 years at high cardiovascular disease event risk ( approximately 15,000 people ) .
METHODS	Cardiovascular disease event risk will be calculated based on World Health Organisation/International Society of Hypertension 's region-specific risk charts .
METHODS	Cluster randomisation will occur at the level of the primary health centres .
METHODS	Outcome analyses will be conducted blinded to intervention allocation .
OBJECTIVE	The primary study outcome is the difference in the proportion of people meeting guideline-recommended blood pressure targets in the intervention period vs. the control period .
OBJECTIVE	Secondary outcomes include mean reduction in blood pressure levels ; change in other cardiovascular disease risk factors , including body mass index , current smoking , reported healthy eating habits , and reported physical activity levels ; self-reported use of blood pressure and other cardiovascular medicines ; quality of life ( using the EQ-5D ) ; and cardiovascular disease events ( using hospitalisation data ) .
OBJECTIVE	Trial outcomes will be accompanied by detailed process and economic evaluations .
CONCLUSIONS	The findings are likely to inform policy on a scalable strategy to overcome entrenched inequities in access to effective healthcare for under-served populations in low and middle income country settings .
BACKGROUND	Clinical Trial Registry India CTRI/2013/06 / 003753 .
OBJECTIVE	To observe the effect of external application of Zhuangshenling Recipe ( ZR ) combined with Western medicine ( WM ) on the heart function of chronic heart failure ( CHF ) patients of Xin-Shen yang deficiency , interior retention of water-fluid syndrome ( XSYDIRWFS ) .
METHODS	Totally 140 CHF patients of XSYDIRWFS were randomly assigned to two groups , the treatment group and the control group , 70 in each group .
METHODS	All patients received WM therapy .
METHODS	Those in the treatment group were applied with ZR at Xinshu ( BL15 ) and Shenshu ( BL23 ) , while those in the control group were applied with placebos at Xinshu ( BL15 ) and Shenshu ( BL23 ) .
METHODS	The therapeutic course for all was 12 weeks .
METHODS	The integrals of TCM syndrome , grading of cardiac function , brain natriuretic polypeptide ( BNP ) , and 6 min walking distance were observed before and after treatment .
RESULTS	After twelve weeks of treatment , the effective rate of improved grading of cardiac function , the total effective rate of TCM syndrome efficacy , and the BNP level were obviously better in the treatment group ( P < 0.05 ) .
RESULTS	There was no statistical difference in 6 min walking distance between the two groups ( P > 0.05 ) .
CONCLUSIONS	External application of ZR combined with WM could improve the heart function of CHF patients of XSYDIRWFS .
BACKGROUND	High levels of circulating fibroblast growth factor 23 ( FGF23 ) are associated with chronic kidney disease ( CKD ) progression and high mortality .
BACKGROUND	In the Phosphate Reduction Evaluation of FGF23 in Early CKD Treatment ( PREFECT ) study , we assessed the effect of reducing intestinal phosphate absorption using lanthanum carbonate on FGF23 levels in normophosphatemic patients with CKD stage 3 .
METHODS	Thirty-five individuals were randomized to lanthanum carbonate 3000 mg/day ( n = 23 ) or placebo ( n = 12 ) for 12 weeks .
METHODS	Levels of intact FGF23 ( iFGF23 ) , C-terminal FGF23 , serum and urinary phosphate and calcium , intact parathyroid hormone and 1,25-dihydroxyvitamin D were assessed .
RESULTS	The median age was 65 years in the lanthanum group and 73 years in the placebo group ; 58.8 % and 41.7 % were men , respectively .
RESULTS	No significant difference was seen in mean iFGF23 between groups at week 12 .
RESULTS	There was , however , a transient reduction from baseline in iFGF23 in the lanthanum group at week 1 , from 70.5 pg/ml to 51.9 pg/ml , which was not seen in the placebo group ; this between-group difference in percentage change from baseline was significant in post hoc analyses ( p = 0.0102 ) .
RESULTS	Urinary phosphate decreased after 1 week of lanthanum treatment and remained low at week 12 .
CONCLUSIONS	Reducing intestinal phosphate absorption with lanthanum carbonate did not lead to sustained reductions in iFGF23 in patients with CKD stage 3 , although phosphaturia decreased .
CONCLUSIONS	This suggests that factors other than phosphate burden may be responsible for driving increases in circulating FGF23 in patients with CKD .
BACKGROUND	ClinicalTrials.gov NCT01128179 , 20 May 2010 .
OBJECTIVE	This study sought to compare the efficacy of drug-eluting balloons ( DEB ) with that of everolimus-eluting stents ( EES ) in patients with bare-metal stents ( BMS ) in-stent restenosis ( ISR ) .
BACKGROUND	Treatment of patients with ISR remains a challenge .
METHODS	This was a prospective , multicenter , randomized trial comparing DEB with EES in patients with bare-metal stents ( BMS ) in-stent restenosis ( ISR ) .
METHODS	The primary endpoint was the minimal lumen diameter at 9 months ' follow-up .
RESULTS	A total of 189 patients with BMS-ISR from 25 Spanish sites were included ( 95 were allocated to DEB and 94 to EES ) .
RESULTS	Procedural success was achieved in all patients .
RESULTS	At late angiography ( median 249 days ; 92 % of eligible patients ) , patients in the EES arm had a significantly larger minimal lumen diameter ( 2.36 0.6 mm vs. 2.01 0.6 mm , p < 0.001 ; absolute mean difference : 0.35 mm ; 95 % confidence interval [ CI ] : 0.16 to 0.53 ) and a lower percent of diameter stenosis ( 13 17 % vs. 25 20 % , p < 0.001 ) .

METHODS

Approximately , 300 subjects will be randomized in a stratified manner , based on the estimated glomerular filtration rate ( eGFR ) and urine albumin to creatinine ratio , to one of four arms in this dose-ranging study .

METHODS

The primary endpoint is change in eGFR at 48 weeks , and the key secondary endpoint is change in albuminuria .

CONCLUSIONS

Guided by the biology of oxidative stress signaling through ASK1 , the biology of DKD pathogenesis , and solid statistical methods , the decisions made for this Phase 2 study regarding delineating study population , efficacy outcomes , treatment period and statistical methods represent innovative attempts to resolve challenges specific to DKD study design .

BACKGROUND

Adherence to medication is often low .

BACKGROUND

Pharmacists may improve adherence , but a one-size-fits-all approach will not work : different patients have different needs .

BACKGROUND

Goal of the current study is to assess the effectiveness of a patient-tailored , telephone-based intervention by a pharmacist at the start of pharmacotherapy aimed at improving medication adherence , satisfaction with information and counselling and the beliefs about medicines .

METHODS

A cluster randomized controlled intervention trial in 30 Dutch pharmacies , randomly assigned to 1 of 2 intervention groups .

METHODS

Each group consists of an intervention arm and an usual care arm .

METHODS

The intervention arm in the first group is the usual care arm in the second group and vice versa .

METHODS

One intervention arm focuses on patients starting with antidepressants or bisphosphonates and the other on antilipaemic drugs or renin angiotensin system ( RAS ) - inhibitors .

METHODS

The intervention consists of a telephone call by a pharmacist 2 or 3 weeks after a new prescription .

METHODS

A random sample of pharmacies will send questionnaires 3 months after the first prescription .

METHODS

This contains socio-demographic questions , a measure of beliefs about medicines ( BMQ ) , satisfaction with information received ( SIMS , abbreviated ) and frequency of pharmacy counselling ( Consumer Quality Index , CQI , abbreviated ) .

METHODS

The primary outcome measure will be medication adherence calculated from dispensing records retrieved 12 months after the intervention .

METHODS

Patients ' beliefs on medication , perception of the quality of information received and pharmacy counselling are secondary outcomes .

CONCLUSIONS

The TelCIP study will determine the effectiveness of telephone counselling to improve adherence in patients initiating a new treatment .

CONCLUSIONS

By measuring satisfaction with information and counselling and beliefs about medication the study will also give clues for the reason of a potential increase in adherence .

CONCLUSIONS

Finally the study will provide information on which patients are most likely to benefit from this intervention .

BACKGROUND

The trial is registered at http://www.trialregister.nl under the identifier NTR3237 .

OBJECTIVE

The purpose of this study was to examine the effects of including female athletes ' weights in athletic event programs on female spectators ' body image , eating disorder symptoms , self-esteem , and affective state and to investigate whether the magnitude of the athletes ' reported weights had differential effects on female spectators ( i.e. , do female spectators who view heavier athletes respond differently than those who view less heavy athletes ? )

METHODS

We used an experimental design to examine hypotheses derived from competing theories to determine whether exposure to female athletes of varying weight would adversely or beneficially impact female undergraduates ( N = 152 ) who served as athletic event spectators .

RESULTS

Analyses indicated that in this simulated study , female spectators ' body image , eating disorder symptoms , self-esteem , and affective states were not impacted by the presence or by the magnitude of female athletes ' weights in athletic event programs .

CONCLUSIONS

The results imply that including athletes ' weights in game-day programs at women 's athletic events does not affect female spectators on an individual level .

BACKGROUND

Approximately 20 % of patients are not satisfied with the outcome of total knee replacement , great volumes of which are carried out yearly .

BACKGROUND

Physiotherapy is often provided by the NHS to address dysfunction following knee replacement ; however the efficacy of this is unknown .

BACKGROUND

Although clinically it is accepted that therapy is useful , provision of physiotherapy to all patients post-operatively does not enhance outcomes at one year .

BACKGROUND

No study has previously assessed the effect of targeting therapy to individuals struggling to recover in the early post-operative phase.The aim of the TRIO study is to determine whether stratifying care by targeting physiotherapy to those individuals performing poorly following knee replacement is effective in improving the one year outcomes .

BACKGROUND

We are also investigating whether the structure of the physiotherapy provision itself influences outcomes .

METHODS

The study is a multi-centre prospective randomised controlled trial ( RCT ) of patients undergoing primary total knee replacement , with treatment targeted at those deemed most susceptible to gain from it .

METHODS

Use of the national PROMS programme for pre-operative data collection allows us to screen all patients at initial post-operative clinical review , and recruit only those deemed to be recovering slowly.We aim to recruit 440 patients through various NHS orthopaedic centres who will undergo six weeks of physiotherapy .

METHODS

The intervention will be either ` intensive ' involving both hospital and home-based functional exercise rehabilitation , or ` standard of care ' consisting of home exercises .

METHODS

Patients will be randomised to either group using a web-based system .

METHODS

Both groups will receive pre and post-intervention physiotherapy review .

METHODS

Patients will be followed-up to one year post-operation .

METHODS

The primary outcome measure is the Oxford Knee Score .

METHODS

Secondary outcomes are patient satisfaction , functional ability , pain scores and cost-effectiveness .

BACKGROUND

Current Controlled Trials ISRCTN23357609 .

BACKGROUND

ClinicalTrials.gov NCT01849445 .

BACKGROUND

In developing countries , mortality in children with very severe pneumonia is high , even with the provision of appropriate antibiotics , standard oxygen therapy , and other supportive care .

BACKGROUND

We assessed whether oxygen therapy delivered by bubble continuous positive airway pressure ( CPAP ) improved outcomes compared with standard low-flow and high-flow oxygen therapies .

METHODS

This open , randomised , controlled trial took place in Dhaka Hospital of the International Centre for Diarrhoeal Disease Research , Bangladesh .

METHODS

We randomly assigned children younger than 5 years with severe pneumonia and hypoxaemia to receive oxygen therapy by either bubble CPAP ( 5 L/min starting at a CPAP level of 5 cm H2O ) , standard low-flow nasal cannula ( 2 L/min ) , or high-flow nasal cannula ( 2 L/kg per min up to the maximum of 12 L/min ) .

METHODS

Randomisation was done with use of the permuted block methods ( block size of 15 patients ) and Fisher and Yates tables of random permutations .

METHODS

The primary outcome was treatment failure ( ie , clinical failure , intubation and mechanical ventilation , death , or termination of hospital stay against medical advice ) after more than 1 h of treatment .

METHODS

Primary and safety analyses were by intention to treat .

METHODS

We did two interim analyses and stopped the trial after the second interim analysis on Aug 3 , 2013 , as directed by the data safety and monitoring board .

METHODS

This trial is registered at ClinicalTrials.gov , number NCT01396759 .

RESULTS

Between Aug 4 , 2011 , and July 17 , 2013 , 225 eligible children were recruited .

RESULTS

We randomly allocated 79 ( 35 % ) children to receive oxygen therapy by bubble CPAP , 67 ( 30 % ) to low-flow oxygen therapy , and 79 ( 35 % ) to high-flow oxygen therapy .

RESULTS

Treatment failed for 31 ( 14 % ) children , of whom five ( 6 % ) had received bubble CPAP , 16 ( 24 % ) had received low-flow oxygen therapy , and ten ( 13 % ) had received high-flow oxygen therapy .

RESULTS

Significantly fewer children in the bubble CPAP group had treatment failure than in the low-flow oxygen therapy group ( relative risk [ RR ] 027 , 997 % CI 007-099 ; p = 00026 ) .

RESULTS

No difference in treatment failure was noted between patients in the bubble CPAP and those in the high-flow oxygen therapy group ( RR 050 , 997 % 011-229 ; p = 0175 ) .

RESULTS

23 ( 10 % ) children died .

RESULTS

Three ( 4 % ) children died in the bubble CPAP group , ten ( 15 % ) children died in the low-flow oxygen therapy group , and ten ( 13 % ) children died in the high-flow oxygen therapy group .

RESULTS

Children who received oxygen by bubble CPAP had significantly lower rates of death than the children who received oxygen by low-flow oxygen therapy ( RR 025 , 95 % CI 007-089 ; p = 0022 ) .

CONCLUSIONS

Oxygen therapy delivered by bubble CPAP improved outcomes in Bangladeshi children with very severe pneumonia and hypoxaemia compared with standard low-flow oxygen therapy .

CONCLUSIONS

Use of bubble CPAP oxygen therapy could have a large effect in hospitals in developing countries where the only respiratory support for severe childhood pneumonia and hypoxaemia is low-flow oxygen therapy .

CONCLUSIONS

The trial was stopped early because of higher mortality in the low-flow oxygen group than in the bubble CPAP group , and we acknowledge that the early cessation of the trial reduces the certainty of the findings .

CONCLUSIONS

Further research is needed to test the feasibility of scaling up bubble CPAP in district hospitals and to improve bubble CPAP delivery technology .

BACKGROUND

International Centre for Diarrhoeal Disease Research , Bangladesh , and Centre for International Child Health , University of Melbourne .

BACKGROUND

Blood Pressure related disease affected 118 million people in India in the year 2000 ; this figure will double by 2025 .

BACKGROUND

Around one in four adults in rural India have hypertension , and of those , only a minority are accessing appropriate care .

BACKGROUND

Health systems in India face substantial challenges to meet these gaps in care , and innovative solutions are needed .

METHODS

We hypothesise that a multifaceted intervention involving capacity strengthening of primary healthcare doctors and non-physician healthcare workers through use of a mobile device-based clinical decision support system will result in improved blood pressure control for individuals at high risk of a cardiovascular disease event when compared with usual healthcare .

METHODS

This intervention will be implemented as a stepped wedge , cluster randomised controlled trial in 18 primary health centres and 54 villages in rural Andhra Pradesh involving adults aged 40 years at high cardiovascular disease event risk ( approximately 15,000 people ) .

METHODS

Cardiovascular disease event risk will be calculated based on World Health Organisation/International Society of Hypertension 's region-specific risk charts .

METHODS

Cluster randomisation will occur at the level of the primary health centres .

METHODS

Outcome analyses will be conducted blinded to intervention allocation .

OBJECTIVE

The primary study outcome is the difference in the proportion of people meeting guideline-recommended blood pressure targets in the intervention period vs. the control period .

OBJECTIVE

Secondary outcomes include mean reduction in blood pressure levels ; change in other cardiovascular disease risk factors , including body mass index , current smoking , reported healthy eating habits , and reported physical activity levels ; self-reported use of blood pressure and other cardiovascular medicines ; quality of life ( using the EQ-5D ) ; and cardiovascular disease events ( using hospitalisation data ) .

OBJECTIVE

Trial outcomes will be accompanied by detailed process and economic evaluations .

CONCLUSIONS

The findings are likely to inform policy on a scalable strategy to overcome entrenched inequities in access to effective healthcare for under-served populations in low and middle income country settings .

BACKGROUND

Clinical Trial Registry India CTRI/2013/06 / 003753 .

OBJECTIVE

To observe the effect of external application of Zhuangshenling Recipe ( ZR ) combined with Western medicine ( WM ) on the heart function of chronic heart failure ( CHF ) patients of Xin-Shen yang deficiency , interior retention of water-fluid syndrome ( XSYDIRWFS ) .

METHODS

Totally 140 CHF patients of XSYDIRWFS were randomly assigned to two groups , the treatment group and the control group , 70 in each group .

METHODS

All patients received WM therapy .

METHODS

Those in the treatment group were applied with ZR at Xinshu ( BL15 ) and Shenshu ( BL23 ) , while those in the control group were applied with placebos at Xinshu ( BL15 ) and Shenshu ( BL23 ) .

METHODS

The therapeutic course for all was 12 weeks .

METHODS

The integrals of TCM syndrome , grading of cardiac function , brain natriuretic polypeptide ( BNP ) , and 6 min walking distance were observed before and after treatment .

RESULTS

After twelve weeks of treatment , the effective rate of improved grading of cardiac function , the total effective rate of TCM syndrome efficacy , and the BNP level were obviously better in the treatment group ( P < 0.05 ) .

RESULTS

There was no statistical difference in 6 min walking distance between the two groups ( P > 0.05 ) .

CONCLUSIONS

External application of ZR combined with WM could improve the heart function of CHF patients of XSYDIRWFS .

BACKGROUND

High levels of circulating fibroblast growth factor 23 ( FGF23 ) are associated with chronic kidney disease ( CKD ) progression and high mortality .

BACKGROUND

In the Phosphate Reduction Evaluation of FGF23 in Early CKD Treatment ( PREFECT ) study , we assessed the effect of reducing intestinal phosphate absorption using lanthanum carbonate on FGF23 levels in normophosphatemic patients with CKD stage 3 .

METHODS

Thirty-five individuals were randomized to lanthanum carbonate 3000 mg/day ( n = 23 ) or placebo ( n = 12 ) for 12 weeks .

METHODS

Levels of intact FGF23 ( iFGF23 ) , C-terminal FGF23 , serum and urinary phosphate and calcium , intact parathyroid hormone and 1,25-dihydroxyvitamin D were assessed .

RESULTS

The median age was 65 years in the lanthanum group and 73 years in the placebo group ; 58.8 % and 41.7 % were men , respectively .

RESULTS

No significant difference was seen in mean iFGF23 between groups at week 12 .

RESULTS

There was , however , a transient reduction from baseline in iFGF23 in the lanthanum group at week 1 , from 70.5 pg/ml to 51.9 pg/ml , which was not seen in the placebo group ; this between-group difference in percentage change from baseline was significant in post hoc analyses ( p = 0.0102 ) .

RESULTS

Urinary phosphate decreased after 1 week of lanthanum treatment and remained low at week 12 .

CONCLUSIONS

Reducing intestinal phosphate absorption with lanthanum carbonate did not lead to sustained reductions in iFGF23 in patients with CKD stage 3 , although phosphaturia decreased .

CONCLUSIONS

This suggests that factors other than phosphate burden may be responsible for driving increases in circulating FGF23 in patients with CKD .

BACKGROUND

ClinicalTrials.gov NCT01128179 , 20 May 2010 .

OBJECTIVE

This study sought to compare the efficacy of drug-eluting balloons ( DEB ) with that of everolimus-eluting stents ( EES ) in patients with bare-metal stents ( BMS ) in-stent restenosis ( ISR ) .

BACKGROUND

Treatment of patients with ISR remains a challenge .

METHODS

This was a prospective , multicenter , randomized trial comparing DEB with EES in patients with bare-metal stents ( BMS ) in-stent restenosis ( ISR ) .

METHODS

The primary endpoint was the minimal lumen diameter at 9 months ' follow-up .

RESULTS

A total of 189 patients with BMS-ISR from 25 Spanish sites were included ( 95 were allocated to DEB and 94 to EES ) .

RESULTS

Procedural success was achieved in all patients .

RESULTS

At late angiography ( median 249 days ; 92 % of eligible patients ) , patients in the EES arm had a significantly larger minimal lumen diameter ( 2.36 0.6 mm vs. 2.01 0.6 mm , p < 0.001 ; absolute mean difference : 0.35 mm ; 95 % confidence interval [ CI ] : 0.16 to 0.53 ) and a lower percent of diameter stenosis ( 13 17 % vs. 25 20 % , p < 0.001 ) .