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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 ) .
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4RESULTS
No patient in either treatment group experienced asymptomatic genital viral shedding at delivery .
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4RESULTS
No neonate had evidence of herpes infection or adverse effects from acyclovir .
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1CONCLUSIONS
Suppressive acyclovir therapy reduced the need for cesarean for recurrent herpes in women whose first clinical episode of genital HSV occurred during pregnancy .
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1CONCLUSIONS
Suppressive acyclovir treatment did not increase asymptomatic viral shedding and was not harmful to the term fetus .
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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 .
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2METHODS
Non-blind randomised controlled trial .
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2METHODS
University hospital ; tertiary clinical care .
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2METHODS
22 HIV positive patients with oral candidiasis .
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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 ) .
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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 .
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4RESULTS
11 patients were enrolled in each group .
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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 .
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4RESULTS
Magnesium concentration fell significantly with amphotericin-glucose but not with amphotericin-fat emulsion .
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4RESULTS
Clinical side effects were noted in 36/38 infusions with amphotericin-glucose but 10/44 with amphotericin-fat emulsion .
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4RESULTS
Oral candidiasis score was reduced similarly in both groups .
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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 .
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1CONCLUSIONS
Clinical and renal toxicity of amphotericin are reduced when the drug is prepared in fat emulsion .
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1CONCLUSIONS
Preparation is simple and cost effective .
119
1CONCLUSIONS
Its efficacy is similar to that of conventional amphotericin .
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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 .
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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 .
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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 .
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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 .
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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 .
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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 .
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2METHODS
Eighty-two subjects who had mild category I exposure to rabies were immunized using a purified chick embryo cell vaccine .
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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 .
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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 .
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2METHODS
The mouse neutralization test was used to estimate titres of rabies neutralizing antibody in these subjects on different days after vaccination .
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2METHODS
The subjects were followed up for 1 year .
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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 .
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4RESULTS
There were minimal side-effects and both regimens were well tolerated .
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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 .
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1CONCLUSIONS
The feasibility of using these cost-effective regimens in routine practice needs to be further evaluated under the field conditions prevalent in India .
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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 .
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0BACKGROUND
Little is known about patient preferences for treatment of chronic musculoskeletal pain such as Achilles tendinopathy .
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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 .
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2METHODS
Participants were asked to complete a questionnaire consisting of ten hypothetical treatment scenarios and some sociodemographic questions .
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2METHODS
For each scenario , participants were asked to choose which option they would prefer if seeking treatment for their painful Achilles tendon .
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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 .
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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 .
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4RESULTS
Respondents were willing to pay Australian dollars ( $ A ) 238 ( 95 % CI -312 , 788 ) for a 10 % increase in the chance of treatment success .
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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 .
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1CONCLUSIONS
On average , participants preferred exercises over injections as a stand-alone treatment .
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1CONCLUSIONS
Further research is required to confirm the findings in patients outside of the trial setting .
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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 .
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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 .
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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 .
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4RESULTS
Owing to slow recruitment , the trial was stopped prematurely after enrolment of 548 of 1240 planned patients .
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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 ) .
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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 ) .
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4RESULTS
Results were consistent across various subgroups of patients .
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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 .
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1CONCLUSIONS
However , the results must be interpreted in view of the premature termination of the trial .
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0BACKGROUND
Unique identifier NCT00976092 ( www.clinicaltrials.gov ) .
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3OBJECTIVE
To evaluate the long-term recurrence rates and complication of different techniques of cervical ablation .
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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 .
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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 ) .
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4RESULTS
Fifty pregnancies were observed in 39 patients .
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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 .
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4RESULTS
A total of nine cesarean sections were performed with two cases for cervical dystocia .
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1CONCLUSIONS
There is no major difference in obstetrical outcome between the three techniques .
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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 .
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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 .
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4RESULTS
Overall , changes in Si were associated with the degree of weight loss ( r = -0.57 , p < 0.05 ) .
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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 .
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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 .
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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 .
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2METHODS
A total of 85 patients were included ; 77 completed the study .
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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 .
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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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