pietrolesci/pubmed-200k-rct · Datasets at Hugging Face

labels class label 5 classes	text stringlengths 3 1.81k	uid int64 0 2.21M
4RESULTS	No woman treated with acyclovir had a cesarean for herpes , compared with nine of 25 ( 36 % ) of those treated with placebo ( OR 0.04 , CI 0.002-0 .745 ; P = .002 ) .	100
4RESULTS	No patient in either treatment group experienced asymptomatic genital viral shedding at delivery .	101
4RESULTS	No neonate had evidence of herpes infection or adverse effects from acyclovir .	102
1CONCLUSIONS	Suppressive acyclovir therapy reduced the need for cesarean for recurrent herpes in women whose first clinical episode of genital HSV occurred during pregnancy .	103
1CONCLUSIONS	Suppressive acyclovir treatment did not increase asymptomatic viral shedding and was not harmful to the term fetus .	104
3OBJECTIVE	To compare the tolerance , efficacy , and pharmacokinetics of amphotericin deoxycholate ( Fungizone ) prepared in a parenteral fat emulsion ( Intralipid 20 % ) or glucose in HIV patients with candidiasis .	105
2METHODS	Non-blind randomised controlled trial .	106
2METHODS	University hospital ; tertiary clinical care .	107
2METHODS	22 HIV positive patients with oral candidiasis .	108
2METHODS	Amphotericin 1 mg/kg/day given on four consecutive days as a one hour infusion dissolved in either 5 % glucose ( amphotericin-glucose ) or parenteral fat emulsion at a final concentration of 2 g/l fat emulsion ( amphotericin-fat emulsion ) .	109
2METHODS	Clinical tolerance ( fever , chills , sweats , nausea , arterial pressure , and pulse rate ) ; biological tolerance ( serum creatinine , electrolyte , and magnesium values ) ; clinical score of candidiasis ; and serum concentrations of amphotericin .	110
4RESULTS	11 patients were enrolled in each group .	111
4RESULTS	All the amphotericin-fat emulsion infusions were given without serious problem whereas four amphotericin-glucose infusions were stopped because of renal impairment ( n = 3 ) or severe chills ( n = 2 ) , or both .	112
4RESULTS	For patients completing the amphotericin-glucose treatment creatine concentration increased by 42 mumol/l ; four of seven patients had at least one creatinine value > or = 133 mumol/l versus one of 11 receiving amphotericin-fat emulsion .	113
4RESULTS	Magnesium concentration fell significantly with amphotericin-glucose but not with amphotericin-fat emulsion .	114
4RESULTS	Clinical side effects were noted in 36/38 infusions with amphotericin-glucose but 10/44 with amphotericin-fat emulsion .	115
4RESULTS	Oral candidiasis score was reduced similarly in both groups .	116
4RESULTS	Serum amphotericin concentrations were significantly lower and the volume of distribution of the drug higher after infusion of amphotericin-fat emulsion than after amphotericin-glucose .	117
1CONCLUSIONS	Clinical and renal toxicity of amphotericin are reduced when the drug is prepared in fat emulsion .	118
1CONCLUSIONS	Preparation is simple and cost effective .	119
1CONCLUSIONS	Its efficacy is similar to that of conventional amphotericin .	120
3OBJECTIVE	Rate control of atrial fibrillation ( AF ) has become a main treatment modality , but we need more knowledge regarding the different drugs used for this purpose .	121
3OBJECTIVE	In this study , we aimed to compare the effect of four common rate-reducing drugs on exercise capacity and levels of N-terminal pro-B-type natriuretic peptide ( NT-proBNP ) in patients with permanent AF .	122
4RESULTS	We included 60 patients ( mean age 71 9 years , 18 women ) with permanent AF and normal left ventricular function in a randomized , cross-over , investigator-blind study .	123
4RESULTS	Diltiazem 360 mg , verapamil 240 mg , metoprolol 100 mg , and carvedilol 25 mg were administered o.d. for 3 weeks .	124
4RESULTS	At baseline and on the last day of each treatment period , the patients underwent a maximal cardiopulmonary exercise test and blood samples were obtained at rest and at peak exercise .	125
4RESULTS	The exercise capacity ( peak VO2 ) was significantly lower during treatment with metoprolol and carvedilol compared with baseline ( no treatment ) or treatment with diltiazem and verapamil ( P < 0.001 for all ) .	126
4RESULTS	Compared with baseline , treatment with diltiazem and verapamil significantly reduced the NT-proBNP levels both at rest and at peak exercise , whereas treatment with metoprolol and carvedilol increased the levels ( P < 0.05 for all ) .	127
1CONCLUSIONS	Rate-reducing treatment with diltiazem or verapamil preserved exercise capacity and reduced levels of NT-proBNP compared with baseline , whereas treatment with metoprolol or carvedilol reduced the exercise capacity and increased levels of NT-proBNP .	128
0BACKGROUND	Post-exposure prophylaxis for rabies with cell culture vaccines by the conventional intramuscular regimen is very expensive .	129
0BACKGROUND	The World Health Organization has advocated two cost-effective intradermal regimens with cell culture vaccines for use in developing countries .	130
0BACKGROUND	We evaluated these two regimens -- the 2-site and the 8-site regimens -- in terms of immunogenicity , safety and tolerance in people with category I exposure to rabies .	131
2METHODS	Eighty-two subjects who had mild category I exposure to rabies were immunized using a purified chick embryo cell vaccine .	132
2METHODS	The first regimen given to 43 subjects , consisted of intradermal administration of 0.2 ml of vaccine at 2 sites on days 0 , 3 and 7 and at one site on days 28 and 90 .	133
2METHODS	The second regimen , given to 39 subjects , consisted of intradermal administration of 0.1 ml of vaccine at 8 sites on day 0 , at 4 sites on day 7 and at one site on days 28 and 90 .	134
2METHODS	The mouse neutralization test was used to estimate titres of rabies neutralizing antibody in these subjects on different days after vaccination .	135
2METHODS	The subjects were followed up for 1 year .	136
4RESULTS	Both regimens produced adequate neutralizing antibody titres from day 14 onwards , though the second regimen produced a more rapid antibody response and significantly higher titres ( p < 0.001 ) on all days tested .	137
4RESULTS	There were minimal side-effects and both regimens were well tolerated .	138
1CONCLUSIONS	Both the 2-site and 8-site intradermal regimens with purified chick embryo cell vaccine produce adequate levels of neutralizing antibodies but the 8-site regimen appears to be more immunogenic .	139
1CONCLUSIONS	The feasibility of using these cost-effective regimens in routine practice needs to be further evaluated under the field conditions prevalent in India .	140
0BACKGROUND	Discrete-choice experiments are based on the premise that any good or service can be described by its characteristics ( or attributes ) , and the extent to which an individual values a good or service depends on the levels of these characteristics .	141
0BACKGROUND	Little is known about patient preferences for treatment of chronic musculoskeletal pain such as Achilles tendinopathy .	142
2METHODS	A discrete-choice experiment was conducted in 58 adults with a history of Achilles tendon pain at the conclusion of a three-arm randomized clinical trial .	143
2METHODS	Participants were asked to complete a questionnaire consisting of ten hypothetical treatment scenarios and some sociodemographic questions .	144
2METHODS	For each scenario , participants were asked to choose which option they would prefer if seeking treatment for their painful Achilles tendon .	145
2METHODS	A mixed logit model was estimated to quantify subject preferences and marginal willingness to pay for the treatment attributes .	146
4RESULTS	A response rate of 62 % was achieved .	147
4RESULTS	A significant positive impact on utility was observed for chance of treatment success .	148
4RESULTS	A significant negative impact on utility was observed for cost , weeks before exercise can be completed free of pain , chance of side effects ( p = 0.06 ) , and injections as a stand-alone treatment .	149
4RESULTS	Respondents were willing to pay Australian dollars ( $ A ) 238 ( 95 % CI -312 , 788 ) for a 10 % increase in the chance of treatment success .	150
1CONCLUSIONS	Study participants with Achilles tendon pain who had either participated or expressed an interest in participating in a randomized trial prefer a treatment that costs less , has a greater chance of success , has a shorter duration before being able to exercise free of pain , and has less likelihood of side effects .	151
1CONCLUSIONS	On average , participants preferred exercises over injections as a stand-alone treatment .	152
1CONCLUSIONS	Further research is required to confirm the findings in patients outside of the trial setting .	153
1CONCLUSIONS	Nevertheless , this study contributes to an area that is deficient in research by identifying priorities and marginal willingness to pay for attributes related to Achilles tendinopathy .	154
3OBJECTIVE	Whether prasugrel plus bivalirudin is a superior strategy to unfractionated heparin plus clopidogrel in patients with ST-segment elevation myocardial infarction ( STEMI ) undergoing primary percutaneous coronary intervention ( PCI ) has never been assessed in specifically designed randomized trials .	155
4RESULTS	The Bavarian Reperfusion Alternatives Evaluation ( BRAVE ) 4 study is an investigator-initiated , randomized , open-label , multicentre trial , designed to test the hypothesis that in STEMI patients with planned primary PCI a strategy based on prasugrel plus bivalirudin is superior to a strategy based on clopidogrel plus heparin in terms of net clinical outcome .	156
4RESULTS	Owing to slow recruitment , the trial was stopped prematurely after enrolment of 548 of 1240 planned patients .	157
4RESULTS	At 30 days , the primary composite endpoint of death , myocardial infarction , unplanned revascularization of the infarct related artery , stent thrombosis , stroke , or bleeding was observed in 42 patients ( 15.6 % ) randomized to prasugrel plus bivalirudin and 40 patients ( 14.5 % ) randomized to clopidogrel plus heparin [ relative risk , 1.09 ; one-sided 97.5 % confidence interval ( CI ) 0-1 .79 , P = 0.680 ] .	158
4RESULTS	The composite ischaemic endpoint of death , myocardial infarction , unplanned revascularization of the infarct-related artery , stent thrombosis , or stroke occurred in 13 patients ( 4.8 % ) in the prasugrel plus bivalirudin group and 15 patients ( 5.5 % ) in the clopidogrel plus heparin group ( relative risk , 0.89 ; 95 % CI 0.40-1 .96 , P = 0.894 ) .	159
4RESULTS	Bleeding according to the HORIZONS-AMI definition was observed in 38 patients ( 14.1 % ) in the prasugrel plus bivalirudin group and 33 patients ( 12.0 % ) in the clopidogrel plus heparin group ( relative risk , 1.18 ; 95 % CI 0.74-1 .88 , P = 0.543 ) .	160
4RESULTS	Results were consistent across various subgroups of patients .	161
1CONCLUSIONS	In this randomized trial of STEMI patients , we were unable to demonstrate significant differences in net clinical outcome between prasugrel plus bivalirudin and clopidogrel plus heparin .	162
1CONCLUSIONS	Neither the composite of ischaemic complications nor bleeding were favourably affected by prasugrel plus bivalirudin compared with a regimen of clopidogrel plus unfractionated heparin .	163
1CONCLUSIONS	However , the results must be interpreted in view of the premature termination of the trial .	164
0BACKGROUND	Unique identifier NCT00976092 ( www.clinicaltrials.gov ) .	165
3OBJECTIVE	To evaluate the long-term recurrence rates and complication of different techniques of cervical ablation .	166
2METHODS	A randomized trial of three techniques of conization ( cold knife , laser , and loop electrosurgical excisional procedure ( LEEP ) ) for cervical intraepithelial neoplasia ( CIN ) in which 110 patients had been recruited .	167
4RESULTS	Eighty-six patients were followed-up for more than 3 years .	168
4RESULTS	Of these 28 had been treated with the cold knife , 29 with LEEP and 29 by laser .	169
4RESULTS	Five recurrences were observed , one in the cold knife group , two in the LEEP group and two in the laser group ( P = NS ) .	170
4RESULTS	The only observed complication was cervical stenosis : zero cases in the laser group , one case in the LEEP group and four cases in the cold knife group ( laser versus cold knife : P = 0.03 ; LEEP versus cold knife : P = 0.06 ) .	171
4RESULTS	Fifty pregnancies were observed in 39 patients .	172
4RESULTS	First and second trimester outcomes of pregnancy were without complications .	173
4RESULTS	One patient treated with the LEEP presented with a premature rupture of membranes and premature labor at 36 weeks .	174
4RESULTS	A total of nine cesarean sections were performed with two cases for cervical dystocia .	175
1CONCLUSIONS	There is no major difference in obstetrical outcome between the three techniques .	176
3OBJECTIVE	To determine whether macronutrient composition of a hypocaloric diet can enhance its effectiveness and whether insulin sensitivity ( Si ) affects the response to hypocaloric diets .	177
2METHODS	Obese nondiabetic insulin-sensitive ( fasting insulin < 10 microU/mL ; n = 12 ) and obese nondiabetic insulin-resistant ( fasting insulin > 15 microU/mL ; n = 9 ) women ( 23 to 53 years old ) were randomized to either a high carbohydrate ( CHO ) ( HC ) / low fat ( LF ) ( 60 % CHO , 20 % fat ) or low CHO ( LC ) / high fat ( HF ) ( 40 % CHO , 40 % fat ) hypocaloric diet .	178
2METHODS	Primary outcome measures after a 16-week dietary intervention were : changes in body weight ( BW ) , Si , resting metabolic rate , and fasting lipids .	179
4RESULTS	Insulin-sensitive women on the HC/LF diet lost 13.5 + / - 1.2 % ( p < 0.001 ) of their initial BW , whereas those on the LC/HF diet lost 6.8 + / - 1.2 % ( p < 0.001 ; p < 0.002 between the groups ) .	180
4RESULTS	In contrast , among the insulin-resistant women , those on the LC/HF diet lost 13.4 + / - 1.3 % ( p < 0.001 ) of their initial BW as compared with 8.5 + / - 1.4 % ( p < 0.001 ) lost by those on the HC/LF diet ( p < 0.04 between two groups ) .	181
4RESULTS	These differences could not be explained by changes in resting metabolic rate , activity , or intake .	182
4RESULTS	Overall , changes in Si were associated with the degree of weight loss ( r = -0.57 , p < 0.05 ) .	183
1CONCLUSIONS	The state of Si determines the effectiveness of macronutrient composition of hypocaloric diets in obese women .	184
1CONCLUSIONS	For maximal benefit , the macronutrient composition of a hypocaloric diet may need to be adjusted to correspond to the state of Si .	185
3OBJECTIVE	To compare the effects of dry needling of myofascial trigger points in the neck region to metoprolol in migraine prophylaxis .	186
2METHODS	Randomized , group comparative study .	187
2METHODS	patients , investigator and statistician were blinded as to treatment , the therapist was blinded as to results .	188
2METHODS	Outpatient pain clinic in the northern Copenhagen area .	189
2METHODS	Patients were referred by general practitioners or respondents to newspaper advertisements .	190
2METHODS	Included were patients with a history of migraine with or without aura for at least 2 years .	191
2METHODS	Excluded were persons with contraindications against treatment with beta blockers , chronic pain syndromes , pregnancy or previous experience with acupuncture or beta-blocking agents .	192
2METHODS	A total of 85 patients were included ; 77 completed the study .	193
2METHODS	After a 4-week run-in period , patients were allocated to a 17-week regimen either with acupuncture and placebo tablets or to placebo stimulation and metoprolol 100 mg daily .	194
4RESULTS	Both groups exhibited significant reduction in attack frequency ( P < 0.01 ) .	195
4RESULTS	No difference was found between the groups regarding frequency ( P > 0.20 ) or duration ( P > 0.10 ) of attacks , whereas we found a significant difference in global rating of attacks in favour of metoprolol ( P < 0.05 ) .	196
1CONCLUSIONS	Trigger point inactivation by dry needling is a valuable supplement to the list of migraine prophylactic tools , being equipotent to metoprolol in the influence on frequency and duration ( but not severity ) of attacks , and superior in terms of negative side-effects .	197
3OBJECTIVE	This study aimed to evaluate the effects of monophasic estrogen-progestogen therapy on the sexuality and climacteric symptoms of postmenopausal women .	198
2METHODS	A prospective , randomised , double-blind , crossover , placebo-controlled , single-centre study was carried out over a total of 12 consecutive months in 40 postmenopausal women with an intact uterus who had no contraindications to hormone therapy .	199

4RESULTS

No woman treated with acyclovir had a cesarean for herpes , compared with nine of 25 ( 36 % ) of those treated with placebo ( OR 0.04 , CI 0.002-0 .745 ; P = .002 ) .

100

4RESULTS

No patient in either treatment group experienced asymptomatic genital viral shedding at delivery .

101

4RESULTS

No neonate had evidence of herpes infection or adverse effects from acyclovir .

102

1CONCLUSIONS

Suppressive acyclovir therapy reduced the need for cesarean for recurrent herpes in women whose first clinical episode of genital HSV occurred during pregnancy .

103

1CONCLUSIONS

Suppressive acyclovir treatment did not increase asymptomatic viral shedding and was not harmful to the term fetus .

104

3OBJECTIVE

To compare the tolerance , efficacy , and pharmacokinetics of amphotericin deoxycholate ( Fungizone ) prepared in a parenteral fat emulsion ( Intralipid 20 % ) or glucose in HIV patients with candidiasis .

105

2METHODS

Non-blind randomised controlled trial .

106

2METHODS

University hospital ; tertiary clinical care .

107

2METHODS

22 HIV positive patients with oral candidiasis .

108

2METHODS

Amphotericin 1 mg/kg/day given on four consecutive days as a one hour infusion dissolved in either 5 % glucose ( amphotericin-glucose ) or parenteral fat emulsion at a final concentration of 2 g/l fat emulsion ( amphotericin-fat emulsion ) .

109

2METHODS

Clinical tolerance ( fever , chills , sweats , nausea , arterial pressure , and pulse rate ) ; biological tolerance ( serum creatinine , electrolyte , and magnesium values ) ; clinical score of candidiasis ; and serum concentrations of amphotericin .

110

4RESULTS

11 patients were enrolled in each group .

111

4RESULTS

All the amphotericin-fat emulsion infusions were given without serious problem whereas four amphotericin-glucose infusions were stopped because of renal impairment ( n = 3 ) or severe chills ( n = 2 ) , or both .

112

4RESULTS

For patients completing the amphotericin-glucose treatment creatine concentration increased by 42 mumol/l ; four of seven patients had at least one creatinine value > or = 133 mumol/l versus one of 11 receiving amphotericin-fat emulsion .

113

4RESULTS

Magnesium concentration fell significantly with amphotericin-glucose but not with amphotericin-fat emulsion .

114

4RESULTS

Clinical side effects were noted in 36/38 infusions with amphotericin-glucose but 10/44 with amphotericin-fat emulsion .

115

4RESULTS

Oral candidiasis score was reduced similarly in both groups .

116

4RESULTS

Serum amphotericin concentrations were significantly lower and the volume of distribution of the drug higher after infusion of amphotericin-fat emulsion than after amphotericin-glucose .

117

1CONCLUSIONS

Clinical and renal toxicity of amphotericin are reduced when the drug is prepared in fat emulsion .

118

1CONCLUSIONS

Preparation is simple and cost effective .

119

1CONCLUSIONS

Its efficacy is similar to that of conventional amphotericin .

120

3OBJECTIVE

Rate control of atrial fibrillation ( AF ) has become a main treatment modality , but we need more knowledge regarding the different drugs used for this purpose .

121

3OBJECTIVE

In this study , we aimed to compare the effect of four common rate-reducing drugs on exercise capacity and levels of N-terminal pro-B-type natriuretic peptide ( NT-proBNP ) in patients with permanent AF .

122

4RESULTS

We included 60 patients ( mean age 71 9 years , 18 women ) with permanent AF and normal left ventricular function in a randomized , cross-over , investigator-blind study .

123

4RESULTS

Diltiazem 360 mg , verapamil 240 mg , metoprolol 100 mg , and carvedilol 25 mg were administered o.d. for 3 weeks .

124

4RESULTS

At baseline and on the last day of each treatment period , the patients underwent a maximal cardiopulmonary exercise test and blood samples were obtained at rest and at peak exercise .

125

4RESULTS

The exercise capacity ( peak VO2 ) was significantly lower during treatment with metoprolol and carvedilol compared with baseline ( no treatment ) or treatment with diltiazem and verapamil ( P < 0.001 for all ) .

126

4RESULTS

Compared with baseline , treatment with diltiazem and verapamil significantly reduced the NT-proBNP levels both at rest and at peak exercise , whereas treatment with metoprolol and carvedilol increased the levels ( P < 0.05 for all ) .

127

1CONCLUSIONS

Rate-reducing treatment with diltiazem or verapamil preserved exercise capacity and reduced levels of NT-proBNP compared with baseline , whereas treatment with metoprolol or carvedilol reduced the exercise capacity and increased levels of NT-proBNP .

128

0BACKGROUND

Post-exposure prophylaxis for rabies with cell culture vaccines by the conventional intramuscular regimen is very expensive .

129

0BACKGROUND

The World Health Organization has advocated two cost-effective intradermal regimens with cell culture vaccines for use in developing countries .

130

0BACKGROUND

We evaluated these two regimens -- the 2-site and the 8-site regimens -- in terms of immunogenicity , safety and tolerance in people with category I exposure to rabies .

131

2METHODS

Eighty-two subjects who had mild category I exposure to rabies were immunized using a purified chick embryo cell vaccine .

132

2METHODS

The first regimen given to 43 subjects , consisted of intradermal administration of 0.2 ml of vaccine at 2 sites on days 0 , 3 and 7 and at one site on days 28 and 90 .

133

2METHODS

The second regimen , given to 39 subjects , consisted of intradermal administration of 0.1 ml of vaccine at 8 sites on day 0 , at 4 sites on day 7 and at one site on days 28 and 90 .

134

2METHODS

The mouse neutralization test was used to estimate titres of rabies neutralizing antibody in these subjects on different days after vaccination .

135

2METHODS

The subjects were followed up for 1 year .

136

4RESULTS

Both regimens produced adequate neutralizing antibody titres from day 14 onwards , though the second regimen produced a more rapid antibody response and significantly higher titres ( p < 0.001 ) on all days tested .

137

4RESULTS

There were minimal side-effects and both regimens were well tolerated .

138

1CONCLUSIONS

Both the 2-site and 8-site intradermal regimens with purified chick embryo cell vaccine produce adequate levels of neutralizing antibodies but the 8-site regimen appears to be more immunogenic .

139

1CONCLUSIONS

The feasibility of using these cost-effective regimens in routine practice needs to be further evaluated under the field conditions prevalent in India .

140

0BACKGROUND

Discrete-choice experiments are based on the premise that any good or service can be described by its characteristics ( or attributes ) , and the extent to which an individual values a good or service depends on the levels of these characteristics .

141

0BACKGROUND

Little is known about patient preferences for treatment of chronic musculoskeletal pain such as Achilles tendinopathy .

142

2METHODS

A discrete-choice experiment was conducted in 58 adults with a history of Achilles tendon pain at the conclusion of a three-arm randomized clinical trial .

143

2METHODS

Participants were asked to complete a questionnaire consisting of ten hypothetical treatment scenarios and some sociodemographic questions .

144

2METHODS

For each scenario , participants were asked to choose which option they would prefer if seeking treatment for their painful Achilles tendon .

145

2METHODS

A mixed logit model was estimated to quantify subject preferences and marginal willingness to pay for the treatment attributes .

146

4RESULTS

A response rate of 62 % was achieved .

147

4RESULTS

A significant positive impact on utility was observed for chance of treatment success .

148

4RESULTS

A significant negative impact on utility was observed for cost , weeks before exercise can be completed free of pain , chance of side effects ( p = 0.06 ) , and injections as a stand-alone treatment .

149

4RESULTS

Respondents were willing to pay Australian dollars ( $ A ) 238 ( 95 % CI -312 , 788 ) for a 10 % increase in the chance of treatment success .

150

1CONCLUSIONS

Study participants with Achilles tendon pain who had either participated or expressed an interest in participating in a randomized trial prefer a treatment that costs less , has a greater chance of success , has a shorter duration before being able to exercise free of pain , and has less likelihood of side effects .

151

1CONCLUSIONS

On average , participants preferred exercises over injections as a stand-alone treatment .

152

1CONCLUSIONS

Further research is required to confirm the findings in patients outside of the trial setting .

153

1CONCLUSIONS

Nevertheless , this study contributes to an area that is deficient in research by identifying priorities and marginal willingness to pay for attributes related to Achilles tendinopathy .

154

3OBJECTIVE

Whether prasugrel plus bivalirudin is a superior strategy to unfractionated heparin plus clopidogrel in patients with ST-segment elevation myocardial infarction ( STEMI ) undergoing primary percutaneous coronary intervention ( PCI ) has never been assessed in specifically designed randomized trials .

155

4RESULTS

The Bavarian Reperfusion Alternatives Evaluation ( BRAVE ) 4 study is an investigator-initiated , randomized , open-label , multicentre trial , designed to test the hypothesis that in STEMI patients with planned primary PCI a strategy based on prasugrel plus bivalirudin is superior to a strategy based on clopidogrel plus heparin in terms of net clinical outcome .

156

4RESULTS

Owing to slow recruitment , the trial was stopped prematurely after enrolment of 548 of 1240 planned patients .

157

4RESULTS

At 30 days , the primary composite endpoint of death , myocardial infarction , unplanned revascularization of the infarct related artery , stent thrombosis , stroke , or bleeding was observed in 42 patients ( 15.6 % ) randomized to prasugrel plus bivalirudin and 40 patients ( 14.5 % ) randomized to clopidogrel plus heparin [ relative risk , 1.09 ; one-sided 97.5 % confidence interval ( CI ) 0-1 .79 , P = 0.680 ] .

158

4RESULTS

The composite ischaemic endpoint of death , myocardial infarction , unplanned revascularization of the infarct-related artery , stent thrombosis , or stroke occurred in 13 patients ( 4.8 % ) in the prasugrel plus bivalirudin group and 15 patients ( 5.5 % ) in the clopidogrel plus heparin group ( relative risk , 0.89 ; 95 % CI 0.40-1 .96 , P = 0.894 ) .

159

4RESULTS

Bleeding according to the HORIZONS-AMI definition was observed in 38 patients ( 14.1 % ) in the prasugrel plus bivalirudin group and 33 patients ( 12.0 % ) in the clopidogrel plus heparin group ( relative risk , 1.18 ; 95 % CI 0.74-1 .88 , P = 0.543 ) .

160

4RESULTS

Results were consistent across various subgroups of patients .

161

1CONCLUSIONS

In this randomized trial of STEMI patients , we were unable to demonstrate significant differences in net clinical outcome between prasugrel plus bivalirudin and clopidogrel plus heparin .

162

1CONCLUSIONS

Neither the composite of ischaemic complications nor bleeding were favourably affected by prasugrel plus bivalirudin compared with a regimen of clopidogrel plus unfractionated heparin .

163

1CONCLUSIONS

However , the results must be interpreted in view of the premature termination of the trial .

164

0BACKGROUND

Unique identifier NCT00976092 ( www.clinicaltrials.gov ) .

165

3OBJECTIVE

To evaluate the long-term recurrence rates and complication of different techniques of cervical ablation .

166

2METHODS

A randomized trial of three techniques of conization ( cold knife , laser , and loop electrosurgical excisional procedure ( LEEP ) ) for cervical intraepithelial neoplasia ( CIN ) in which 110 patients had been recruited .

167

4RESULTS

Eighty-six patients were followed-up for more than 3 years .

168

4RESULTS

Of these 28 had been treated with the cold knife , 29 with LEEP and 29 by laser .

169

4RESULTS

Five recurrences were observed , one in the cold knife group , two in the LEEP group and two in the laser group ( P = NS ) .

170

4RESULTS

The only observed complication was cervical stenosis : zero cases in the laser group , one case in the LEEP group and four cases in the cold knife group ( laser versus cold knife : P = 0.03 ; LEEP versus cold knife : P = 0.06 ) .

171

4RESULTS

Fifty pregnancies were observed in 39 patients .

172

4RESULTS

First and second trimester outcomes of pregnancy were without complications .

173

4RESULTS

One patient treated with the LEEP presented with a premature rupture of membranes and premature labor at 36 weeks .

174

4RESULTS

A total of nine cesarean sections were performed with two cases for cervical dystocia .

175

1CONCLUSIONS

There is no major difference in obstetrical outcome between the three techniques .

176

3OBJECTIVE

To determine whether macronutrient composition of a hypocaloric diet can enhance its effectiveness and whether insulin sensitivity ( Si ) affects the response to hypocaloric diets .

177

2METHODS

Obese nondiabetic insulin-sensitive ( fasting insulin < 10 microU/mL ; n = 12 ) and obese nondiabetic insulin-resistant ( fasting insulin > 15 microU/mL ; n = 9 ) women ( 23 to 53 years old ) were randomized to either a high carbohydrate ( CHO ) ( HC ) / low fat ( LF ) ( 60 % CHO , 20 % fat ) or low CHO ( LC ) / high fat ( HF ) ( 40 % CHO , 40 % fat ) hypocaloric diet .

178

2METHODS

Primary outcome measures after a 16-week dietary intervention were : changes in body weight ( BW ) , Si , resting metabolic rate , and fasting lipids .

179

4RESULTS

Insulin-sensitive women on the HC/LF diet lost 13.5 + / - 1.2 % ( p < 0.001 ) of their initial BW , whereas those on the LC/HF diet lost 6.8 + / - 1.2 % ( p < 0.001 ; p < 0.002 between the groups ) .

180

4RESULTS

In contrast , among the insulin-resistant women , those on the LC/HF diet lost 13.4 + / - 1.3 % ( p < 0.001 ) of their initial BW as compared with 8.5 + / - 1.4 % ( p < 0.001 ) lost by those on the HC/LF diet ( p < 0.04 between two groups ) .

181

4RESULTS

These differences could not be explained by changes in resting metabolic rate , activity , or intake .

182

4RESULTS

Overall , changes in Si were associated with the degree of weight loss ( r = -0.57 , p < 0.05 ) .

183

1CONCLUSIONS

The state of Si determines the effectiveness of macronutrient composition of hypocaloric diets in obese women .

184

1CONCLUSIONS

For maximal benefit , the macronutrient composition of a hypocaloric diet may need to be adjusted to correspond to the state of Si .

185

3OBJECTIVE

To compare the effects of dry needling of myofascial trigger points in the neck region to metoprolol in migraine prophylaxis .

186

2METHODS

Randomized , group comparative study .

187

2METHODS

patients , investigator and statistician were blinded as to treatment , the therapist was blinded as to results .

188

2METHODS

Outpatient pain clinic in the northern Copenhagen area .

189

2METHODS

Patients were referred by general practitioners or respondents to newspaper advertisements .

190

2METHODS

Included were patients with a history of migraine with or without aura for at least 2 years .

191

2METHODS

Excluded were persons with contraindications against treatment with beta blockers , chronic pain syndromes , pregnancy or previous experience with acupuncture or beta-blocking agents .

192

2METHODS

A total of 85 patients were included ; 77 completed the study .

193

2METHODS

After a 4-week run-in period , patients were allocated to a 17-week regimen either with acupuncture and placebo tablets or to placebo stimulation and metoprolol 100 mg daily .

194

4RESULTS

Both groups exhibited significant reduction in attack frequency ( P < 0.01 ) .

195

4RESULTS

No difference was found between the groups regarding frequency ( P > 0.20 ) or duration ( P > 0.10 ) of attacks , whereas we found a significant difference in global rating of attacks in favour of metoprolol ( P < 0.05 ) .

196

1CONCLUSIONS

Trigger point inactivation by dry needling is a valuable supplement to the list of migraine prophylactic tools , being equipotent to metoprolol in the influence on frequency and duration ( but not severity ) of attacks , and superior in terms of negative side-effects .

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3OBJECTIVE

This study aimed to evaluate the effects of monophasic estrogen-progestogen therapy on the sexuality and climacteric symptoms of postmenopausal women .

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2METHODS

A prospective , randomised , double-blind , crossover , placebo-controlled , single-centre study was carried out over a total of 12 consecutive months in 40 postmenopausal women with an intact uterus who had no contraindications to hormone therapy .

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