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

labels class label 5 classes	text stringlengths 3 1.81k	uid int64 0 2.21M
4RESULTS	After 72 h , SP reduced the malaria parasite density ( by 5029 parasites/microL ; P < 0.001 ) , CRP concentrations ( by 10.6 mg/L ; P = 0.001 ) , and the proportion of children infected with malaria ( by 32.4 % ; P < 0.001 ) .	2,211,300
4RESULTS	Vitamin A reduced CRP ( by 9.6 mg/L ; P = 0.011 ) , serum ferritin ( by 18.1 microg/L ; P = 0.042 ) , and erythropoietin ( by 194.7 mIU/mL ; P = 0.011 ) concentrations and increased the reticulocyte production index ( by 0.40 ; P = 0.041 ) .	2,211,301
1CONCLUSIONS	Contrary to our hypothesis , vitamin A significantly decreased erythropoietin concentration .	2,211,302
1CONCLUSIONS	The most important effect of both vitamin A and SP was the rapid reduction of inflammation .	2,211,303
1CONCLUSIONS	Vitamin A also mobilized iron from stores and stimulated the production of new erythrocytes .	2,211,304
0BACKGROUND	An external straightener for colonoscopy which enables proper compression of the abdomen during the entire examination has been developed .	2,211,305
2METHODS	Beginning January 1 , 1997 , patients undergoing outpatient colonoscopy were subjected to either manual abdominal compression or compression with an external straightener .	2,211,306
2METHODS	Two hundred patients were divided into two groups of 100 patients each : group A ( colonoscopy using traditional methods ; 38 men , 62 women , mean age 59.6 years , range 18 to 80 ) and group B ( colonoscopy with the help of the external straightener ; 40 men , 60 women , mean age 59.8 years , range 16 to 75 ) .	2,211,307
2METHODS	Fifteen minutes after the examination , each patient completed a form that assessed the degree of pain during the procedure ( no pain , mild , moderate , severe ) .	2,211,308
4RESULTS	The ileocecal valve was reached in 89 cases in group A and 94 cases in group B.	2,211,309
4RESULTS	The average time required to reach the valve was 9.34 + / -4 minutes ( range 4 to 25 ) in group A and 6.97 + / -3.37 minutes ( range 2 to 21 ) in group B ( p < 0.001 ) .	2,211,310
4RESULTS	With regard to the degree of pain , the results for groups A and B were , respectively : no pain = 25 % and 40 % , mild = 29 % and 34 % , moderate = 30 % and 20 % , severe = 16 % and 6 % ( p < 0.001 ) .	2,211,311
1CONCLUSIONS	The external straightener reduced examination time and decreased the degree of patient pain compared with traditional methods .	2,211,312
0BACKGROUND	Intravenous acetaminophen injection ( paracetamol ) is marketed in Europe for the management of acute pain .	2,211,313
0BACKGROUND	A repeated-dose , randomized , double-blind , placebo-controlled , three-parallel group study was performed to evaluate the analgesic efficacy and safety of intravenous acetaminophen as compared with its prodrug ( propacetamol ) and placebo .	2,211,314
0BACKGROUND	Propacetamol has been available in many European countries for more than 20 yr .	2,211,315
2METHODS	After orthopedic surgery , patients reporting moderate to severe pain received either 1 g intravenous acetaminophen , 2 g propacetamol , or placebo at 6-h intervals over 24 h. Patients were allowed `` rescue '' intravenous patient-controlled analgesia morphine .	2,211,316
2METHODS	Pain intensity , pain relief , and morphine use were measured at selected intervals .	2,211,317
2METHODS	Safety was monitored through adverse event reporting , clinical examination , and laboratory testing .	2,211,318
4RESULTS	One hundred fifty-one patients ( intravenous acetaminophen : 49 ; propacetamol : 50 ; placebo : 52 ) received at least one dose of study medication .	2,211,319
4RESULTS	The intravenous acetaminophen and propacetamol groups differed significantly from the placebo group regarding pain relief from 15 min to 6 h ( P < 0.05 ) and median time to morphine rescue ( intravenous acetaminophen : 3 h ; propacetamol : 2.6 h ; placebo : 0.8 h ) .	2,211,320
4RESULTS	Intravenous acetaminophen and propacetamol significantly reduced morphine consumption over the 24-h period : The total morphine doses received over 24 h were 38.3 + / - 35.1 mg for intravenous acetaminophen , 40.8 + / - 30.2 mg for propacetamol , and 57.4 + / - 52.3 mg for placebo , corresponding to decreases of -33 % ( 19 mg ) and -29 % ( 17 mg ) for intravenous acetaminophen and propacetamol , respectively .	2,211,321
4RESULTS	Drug-related adverse events were reported in 8.2 % , 50 % ( most of them local ) , and 17.3 % of patients treated with intravenous acetaminophen , propacetamol , and placebo , respectively .	2,211,322
1CONCLUSIONS	Intravenous acetaminophen , 1 g , administered over a 24-h period in patients with moderate to severe pain after orthopedic surgery provided rapid and effective analgesia and was well tolerated .	2,211,323
3OBJECTIVE	To assess whether heat trapped under ophthalmic drapes is responsible for patient reports of being hot during cataract surgery using local anesthesia .	2,211,324
2METHODS	Departments of Anaesthesia and Intensive Care Medicine and of Ophthalmology and Optometry , Innsbruck University Hospital , Innsbruck , Austria .	2,211,325
2METHODS	In a prospective , randomized , single-blind study , the temperature in the ambient air under 2 types of paper drapes ( Group A : Barrier Ophthalmology Drape , Johnson & Johnson ; Group B : Steri Drape 1062 , 3M ) and a plastic drape ( Group C : cotton drape + Steri Drape 1024 , 3M ) was measured for 25 minutes in 60 patients having cataract surgery under local anesthesia .	2,211,326
4RESULTS	Three minutes after the patient 's head was draped , the mean temperature under the drape began to increase significantly : Group A , 25.7 degrees C + / - 0.3 degree C ( SD ) to 29.17 degrees C + / - 0.9 degree C ( P < or = .001 ) ; Group B , 25.87 degrees C + / - 0.4 degree C to 29.41 degrees C + / - 0.9 degree C ( P < or = .001 ) ; Group C , 25.8 degrees C + / - 0.35 degree C to 29.4 degrees C + / - 0.6 degree C ( P < or = .001 ) .	2,211,327
4RESULTS	It continued to increase in all groups as the operation continued .	2,211,328
4RESULTS	No significant differences in temperature were observed among the 3 drape types studied .	2,211,329
4RESULTS	Subjective thermal discomfort was reported by 35 % to 40 % of patients .	2,211,330
1CONCLUSIONS	Paper drapes did not cause less heat from being trapped than the plastic drape .	2,211,331
1CONCLUSIONS	Trapped heat may impair the comfort of patients having eye surgery under local anesthesia .	2,211,332
0BACKGROUND	Combining targeted treatments for renal cell carcinoma has been suggested as a possible method to improve treatment efficacy .	2,211,333
0BACKGROUND	We aimed to assess the potential synergistic or additive effect of the combination of bevacizumab , directed against the VEGF receptor , and temsirolimus , an mTOR inhibitor , in metastatic renal cell carcinoma .	2,211,334
2METHODS	TORAVA was an open-label , multicentre randomised phase 2 study undertaken in 24 centres in France .	2,211,335
2METHODS	Patients aged 18 years or older who had untreated metastatic renal cell carcinoma were randomly assigned ( 2:1:1 ) to receive the combination of bevacizumab ( 10 mg/kg every 2 weeks ) and temsirolimus ( 25 mg weekly ; group A ) , or one of the standard treatments : sunitinib ( 50 mg/day for 4 weeks followed by 2 weeks off ; group B ) , or the combination of interferon alfa ( 9 mIU three times per week ) and bevacizumab ( 10 mg/kg every 2 weeks ; group C ) .	2,211,336
2METHODS	Randomisation was done centrally and independently from other study procedures with computer-generated permuted blocks of four and eight patients stratified by participating centre and Eastern Cooperative Oncology Group performance status .	2,211,337
2METHODS	The primary endpoint was progression-free survival ( PFS ) at 48 weeks ( four follow-up CT scans ) , which was expected to be above 50 % in group A. Analysis was by intention to treat .	2,211,338
2METHODS	The study is ongoing for long-term overall survival .	2,211,339
2METHODS	This study is registered with ClinicalTrials.gov , number NCT00619268 .	2,211,340
4RESULTS	Between March 3 , 2008 and May 6 , 2009 , 171 patients were randomly assigned : 88 to the experimental group ( group A ) , 42 to group B , and 41 to group C. PFS at 48 weeks was 29.5 % ( 26 of 88 patients , 95 % CI 20.0-39 .1 ) in group A , 35.7 % ( 15 of 42 , 21.2-50 .2 ) in group B , and 61.0 % ( 25 of 41 , 46.0-75 .9 ) in group C. Median PFS was 8.2 months ( 95 % CI 7.0-9 .6 ) in group A , 8.2 months ( 5.5-11 .7 ) in group B , and 16.8 months ( 6.0-26 .0 ) in group C. 45 ( 51 % ) of 88 patients in group A stopped treatment for reasons other than progression compared with five ( 12 % ) of 42 in group B and 15 ( 38 % ) of 40 in group C. Grade 3 or worse adverse events were reported in 68 ( 77 % ) of 88 patients in group A versus 25 ( 60 % ) of 42 in group B and 28 ( 70 % ) of 40 in group C. Serious adverse events were reported in 39 ( 44 % ) of 88 , 13 ( 31 % ) of 42 , and 18 ( 45 % ) of 40 patients in groups A , B , and C , respectively .	2,211,341
1CONCLUSIONS	The toxicity of the temsirolimus and bevacizumab combination was much higher than anticipated and limited treatment continuation over time .	2,211,342
1CONCLUSIONS	Clinical activity was low compared with the benefit expected from sequential use of each targeted therapy .	2,211,343
1CONCLUSIONS	This combination can not be recommended for first-line treatment in patients with metastatic renal cell carcinoma .	2,211,344
0BACKGROUND	French Ministry of Health and Wyeth Pharmaceuticals .	2,211,345
0BACKGROUND	Wound pain is a serious problem for people with chronic wounds .	2,211,346
0BACKGROUND	The aim of this real-life study was to compare the effect of a foam dressing that releases ibuprofen ( Biatain Ibu ) with local best practice on the treatment of painful exuding wounds .	2,211,347
2METHODS	A total of 185 patients with painful exuding wounds were randomized to either ibuprofen foam treatment ( n = 98 ) or local best practice ( n = 87 ) .	2,211,348
2METHODS	The primary endpoint was pain relief over 7 days of treatment , assessed daily using a 5-point verbal rating scale ( no relief , slight relief , moderate relief , lots of relief , and complete relief ) .	2,211,349
2METHODS	Secondary endpoints included a total reduction in pain intensity for the whole study period ( using an 11-point Numeric Box Scale : 0 = no pain to 10 = worst possible pain ) and incidence of adverse events ( AEs ) .	2,211,350
4RESULTS	More patients in the ibuprofen foam treatment group reported wound pain relief and lower wound pain intensity values after 7 days ( p < 0.0001 for both variables ) .	2,211,351
4RESULTS	Within the four most common ulcer aetiolgies , patients reported significantly more effective pain relief with ibuprofen foam treatment ( venous : p = 0.009 , mixed arterial venous : p < 0.0001 , arterial : p = 0.0009 , and vasculitis : p = 0.009 ) .	2,211,352
4RESULTS	In all groups , patients from the ibuprofen foam group reported lower pain intensities .	2,211,353
4RESULTS	The results were significant for patients with venous ( p < 0.002 ) and arterial ( p < 0.0001 ) leg ulcers .	2,211,354
4RESULTS	Two AEs were reported .	2,211,355
1CONCLUSIONS	The ibuprofen foam represents an effective and safe alternative to local best practice in the management of painful exuding wounds .	2,211,356
3OBJECTIVE	To determine if a 6-month course of therapy with IMREG-1 , a leukocyte-derived immunomodulator , slows disease progression in patients with AIDS-related complex .	2,211,357
2METHODS	Randomized , double-blind trial .	2,211,358
2METHODS	Five academic - and three community-based clinics .	2,211,359
2METHODS	Immunocompromised patients ( 143 ) with HIV .	2,211,360
2METHODS	IMREG-1 or placebo every 2 weeks ( 13 doses ) .	2,211,361
4RESULTS	Twelve of forty-eight patients on placebo and 5 of 95 patients on IMREG-1 experienced adverse events ( AIDS-defining opportunistic infection or neoplasm , wasting syndrome , HIV-associated encephalopathy , or peripheral sensory neuropathy ) .	2,211,362
4RESULTS	Based on an intention-to-treat analysis , Kaplan-Meier event probabilities were 26 % for the placebo group and 6 % for the IMREG-1 group ( P less than 0.001 ) ; based on the Cox proportional hazards model , the relative risk for patients on placebo compared with patients on IMREG-1 was 5.1 ( 95 % CI , 1.8 to 14.8 ) .	2,211,363
4RESULTS	The frequency of symptoms significantly increased from baseline in patients receiving placebo .	2,211,364
4RESULTS	The mean decrease in CD4 + cells from baseline was 80 x 10 ( 6 ) cells/L in the placebo group and 29 x 10 ( 6 ) cells/L in patients on IMREG-1 , with 20 % ( 8 ) and 38 % ( 32 ) of patients , respectively , showing a trend toward an increase ( P = 0.04 ) .	2,211,365
4RESULTS	In patients receiving IMREG-1 , the size and rate of delayed hypersensitivity responses were larger than in the placebo group .	2,211,366
1CONCLUSIONS	Patients with AIDS-related complex experienced fewer adverse events and constitutional symptoms after IMREG-1 treatment .	2,211,367
1CONCLUSIONS	The slower loss of CD4 + cells and increased size and rate of delayed hypersensitivity responses most likely reflect the effect of IMREG-1 on the immune system .	2,211,368
1CONCLUSIONS	No toxicity related to IMREG-1 administration was observed .	2,211,369
0BACKGROUND	Tracheal intubation in the lateral position is difficult because the laryngeal view is compromised during direct laryngoscopy .	2,211,370
0BACKGROUND	The Airway Scope facilitates intubation even when laryngeal views are poor with direct laryngoscopy , as they often are in the lateral position .	2,211,371
0BACKGROUND	We thus compared the efficacy of the Airway Scope in supine patients with those in the left - and right-lateral positions .	2,211,372
2METHODS	Anesthetized adults were randomly assigned to supine , left-lateral , or right-lateral position ( n = 43 for each group ) .	2,211,373
2METHODS	Laryngeal views were obtained in the designated position with a Macintosh laryngoscope , and patients ' tracheas were subsequently intubated with the Airway Scope .	2,211,374
2METHODS	Specifically , we tested the hypothesis that the time required for intubation in the left - and right-lateral positions is not increased by > 10 seconds compared with tracheal intubation in the supine position .	2,211,375
4RESULTS	Overall intubation success was 100 % in the 2 lateral positions , and 98 % in the supine position .	2,211,376
4RESULTS	Intubation times were similar in the left-lateral ( 24 [ 5 ] seconds , mean [ SD ] ) , right-lateral ( 24 [ 6 ] seconds ) , and supine ( 22 [ 7 ] seconds ) positions .	2,211,377
4RESULTS	The numbers of required intubation attempts were similar in the 2 lateral positions and in the supine and left-lateral positions .	2,211,378
4RESULTS	However , more intubation attempts were required in the supine position than in the right-lateral position ( P = 0.004 ) .	2,211,379
4RESULTS	The incidences of airway complications were similar in each position ; no hypoxia , dental injury , or esophageal intubation was observed .	2,211,380
4RESULTS	Modified Cormack-Lehane and the percentage of glottic opening scores obtained with the Macintosh laryngoscope did not differ between the 2 lateral positions , but the modified Cormack-Lehane and percentage of glottic opening scores were superior in the supine position ( all P < 0.001 ) compared with either of the lateral positions .	2,211,381
1CONCLUSIONS	Despite worse laryngoscopic views in either lateral position than when patients were supine , intubation with the Airway Scope offered high success rates .	2,211,382
1CONCLUSIONS	Furthermore , intubation time using the Airway Scope in either lateral position was not longer by > 10 seconds than in the supine position .	2,211,383
1CONCLUSIONS	The Airway Scope thus seems to be a useful tool when tracheal intubation is required in a laterally positioned patient .	2,211,384
3OBJECTIVE	To evaluate the effect of veno-venous continuous renal replacement therapy ( CRRT ) on the plasma levels of endotoxin and cytokines in severely burned patients with sepsis .	2,211,385
2METHODS	Twenty adult severely burned patients with sepsis were studied .	2,211,386
2METHODS	For the diagnosis of sepsis , patients were randomly divided into CRRT ( n = 10 ) and Control ( n = 10 ) .	2,211,387
2METHODS	Both groups received conventional therapy after admission .	2,211,388
2METHODS	Veno-venous CRRT was administered to 10 patients in the CRRT group whenever patients were determined to be septic .	2,211,389
2METHODS	The plasma level of endotoxin , TNF-alpha , IL-1 beta , IL-6 and IL-8 were measured at 0 , 1 , 2 , 6 , 12 , 36 and 60 h after CRRT initiation , and at 0 , 12 , 36 and 60 h after the patients were diagnosed as having sepsis in the Control group .	2,211,390
4RESULTS	Plasma level of endotoxin and all the cytokines after CRRT initiation were significantly lower than those before the treatment ( P < 0.01 ) .	2,211,391
4RESULTS	The serial change of endotoxin , IL-1 beta , IL-6 and IL-8 was significantly lower at 12 , 36 and 60 h after treatment compared with Control groups ( P < 0.01 ) .	2,211,392
4RESULTS	A significant decrease in plasma TNF-alpha levels was seen at 36 and 60 h after treatment compared with Control groups ( P < 0.01 ) .	2,211,393
1CONCLUSIONS	Plasma endotoxin and cytokines ( TNF-alpha , IL-1 beta , IL-6 and IL-8 ) can be removed effectively with CRRT in severely burned patients with sepsis .	2,211,394
3OBJECTIVE	To study the effect of Shenqi Fuzheng Injection ( SFI ) on cellular immune in patients with mammary cancer ( MC ) after chemotherapy .	2,211,395
2METHODS	One hundred and ten patients with MC were randomly assigned to two groups .	2,211,396
2METHODS	The 58 patients in the tested group were treated with SFI in cooperation with chemotherapy of CAF protocol ( Cyclophosphamide , Doxorubicin and Fluorouracil ) , while the 52 patients in the control group were treated with chemotherapy of the same protocol alone .	2,211,397
2METHODS	Changes of the patients ' quality of life ( QOF ) , adverse reaction that occurred , peripheral lymphocyte count and killing activity of single karyocyte before and after treatment between the two groups were compared .	2,211,398
4RESULTS	Patients ' QOF elevating rate after treatment in the tested group and the control group was 34.5 % and 13.5 % respectively ; The lowering of peripheral blood cell count of WBC , platelet and lymphocyte as well as that of the killing activity of single peripheral karyocyte on various kinds of MC cells were all milder and recovery sooner than those in the control group .	2,211,399

4RESULTS

After 72 h , SP reduced the malaria parasite density ( by 5029 parasites/microL ; P < 0.001 ) , CRP concentrations ( by 10.6 mg/L ; P = 0.001 ) , and the proportion of children infected with malaria ( by 32.4 % ; P < 0.001 ) .

2,211,300

4RESULTS

Vitamin A reduced CRP ( by 9.6 mg/L ; P = 0.011 ) , serum ferritin ( by 18.1 microg/L ; P = 0.042 ) , and erythropoietin ( by 194.7 mIU/mL ; P = 0.011 ) concentrations and increased the reticulocyte production index ( by 0.40 ; P = 0.041 ) .

2,211,301

1CONCLUSIONS

Contrary to our hypothesis , vitamin A significantly decreased erythropoietin concentration .

2,211,302

1CONCLUSIONS

The most important effect of both vitamin A and SP was the rapid reduction of inflammation .

2,211,303

1CONCLUSIONS

Vitamin A also mobilized iron from stores and stimulated the production of new erythrocytes .

2,211,304

0BACKGROUND

An external straightener for colonoscopy which enables proper compression of the abdomen during the entire examination has been developed .

2,211,305

2METHODS

Beginning January 1 , 1997 , patients undergoing outpatient colonoscopy were subjected to either manual abdominal compression or compression with an external straightener .

2,211,306

2METHODS

Two hundred patients were divided into two groups of 100 patients each : group A ( colonoscopy using traditional methods ; 38 men , 62 women , mean age 59.6 years , range 18 to 80 ) and group B ( colonoscopy with the help of the external straightener ; 40 men , 60 women , mean age 59.8 years , range 16 to 75 ) .

2,211,307

2METHODS

Fifteen minutes after the examination , each patient completed a form that assessed the degree of pain during the procedure ( no pain , mild , moderate , severe ) .

2,211,308

4RESULTS

The ileocecal valve was reached in 89 cases in group A and 94 cases in group B.

2,211,309

4RESULTS

The average time required to reach the valve was 9.34 + / -4 minutes ( range 4 to 25 ) in group A and 6.97 + / -3.37 minutes ( range 2 to 21 ) in group B ( p < 0.001 ) .

2,211,310

4RESULTS

With regard to the degree of pain , the results for groups A and B were , respectively : no pain = 25 % and 40 % , mild = 29 % and 34 % , moderate = 30 % and 20 % , severe = 16 % and 6 % ( p < 0.001 ) .

2,211,311

1CONCLUSIONS

The external straightener reduced examination time and decreased the degree of patient pain compared with traditional methods .

2,211,312

0BACKGROUND

Intravenous acetaminophen injection ( paracetamol ) is marketed in Europe for the management of acute pain .

2,211,313

0BACKGROUND

A repeated-dose , randomized , double-blind , placebo-controlled , three-parallel group study was performed to evaluate the analgesic efficacy and safety of intravenous acetaminophen as compared with its prodrug ( propacetamol ) and placebo .

2,211,314

0BACKGROUND

Propacetamol has been available in many European countries for more than 20 yr .

2,211,315

2METHODS

After orthopedic surgery , patients reporting moderate to severe pain received either 1 g intravenous acetaminophen , 2 g propacetamol , or placebo at 6-h intervals over 24 h. Patients were allowed `` rescue '' intravenous patient-controlled analgesia morphine .

2,211,316

2METHODS

Pain intensity , pain relief , and morphine use were measured at selected intervals .

2,211,317

2METHODS

Safety was monitored through adverse event reporting , clinical examination , and laboratory testing .

2,211,318

4RESULTS

One hundred fifty-one patients ( intravenous acetaminophen : 49 ; propacetamol : 50 ; placebo : 52 ) received at least one dose of study medication .

2,211,319

4RESULTS

The intravenous acetaminophen and propacetamol groups differed significantly from the placebo group regarding pain relief from 15 min to 6 h ( P < 0.05 ) and median time to morphine rescue ( intravenous acetaminophen : 3 h ; propacetamol : 2.6 h ; placebo : 0.8 h ) .

2,211,320

4RESULTS

Intravenous acetaminophen and propacetamol significantly reduced morphine consumption over the 24-h period : The total morphine doses received over 24 h were 38.3 + / - 35.1 mg for intravenous acetaminophen , 40.8 + / - 30.2 mg for propacetamol , and 57.4 + / - 52.3 mg for placebo , corresponding to decreases of -33 % ( 19 mg ) and -29 % ( 17 mg ) for intravenous acetaminophen and propacetamol , respectively .

2,211,321

4RESULTS

Drug-related adverse events were reported in 8.2 % , 50 % ( most of them local ) , and 17.3 % of patients treated with intravenous acetaminophen , propacetamol , and placebo , respectively .

2,211,322

1CONCLUSIONS

Intravenous acetaminophen , 1 g , administered over a 24-h period in patients with moderate to severe pain after orthopedic surgery provided rapid and effective analgesia and was well tolerated .

2,211,323

3OBJECTIVE

To assess whether heat trapped under ophthalmic drapes is responsible for patient reports of being hot during cataract surgery using local anesthesia .

2,211,324

2METHODS

Departments of Anaesthesia and Intensive Care Medicine and of Ophthalmology and Optometry , Innsbruck University Hospital , Innsbruck , Austria .

2,211,325

2METHODS

In a prospective , randomized , single-blind study , the temperature in the ambient air under 2 types of paper drapes ( Group A : Barrier Ophthalmology Drape , Johnson & Johnson ; Group B : Steri Drape 1062 , 3M ) and a plastic drape ( Group C : cotton drape + Steri Drape 1024 , 3M ) was measured for 25 minutes in 60 patients having cataract surgery under local anesthesia .

2,211,326

4RESULTS

Three minutes after the patient 's head was draped , the mean temperature under the drape began to increase significantly : Group A , 25.7 degrees C + / - 0.3 degree C ( SD ) to 29.17 degrees C + / - 0.9 degree C ( P < or = .001 ) ; Group B , 25.87 degrees C + / - 0.4 degree C to 29.41 degrees C + / - 0.9 degree C ( P < or = .001 ) ; Group C , 25.8 degrees C + / - 0.35 degree C to 29.4 degrees C + / - 0.6 degree C ( P < or = .001 ) .

2,211,327

4RESULTS

It continued to increase in all groups as the operation continued .

2,211,328

4RESULTS

No significant differences in temperature were observed among the 3 drape types studied .

2,211,329

4RESULTS

Subjective thermal discomfort was reported by 35 % to 40 % of patients .

2,211,330

1CONCLUSIONS

Paper drapes did not cause less heat from being trapped than the plastic drape .

2,211,331

1CONCLUSIONS

Trapped heat may impair the comfort of patients having eye surgery under local anesthesia .

2,211,332

0BACKGROUND

Combining targeted treatments for renal cell carcinoma has been suggested as a possible method to improve treatment efficacy .

2,211,333

0BACKGROUND

We aimed to assess the potential synergistic or additive effect of the combination of bevacizumab , directed against the VEGF receptor , and temsirolimus , an mTOR inhibitor , in metastatic renal cell carcinoma .

2,211,334

2METHODS

TORAVA was an open-label , multicentre randomised phase 2 study undertaken in 24 centres in France .

2,211,335

2METHODS

Patients aged 18 years or older who had untreated metastatic renal cell carcinoma were randomly assigned ( 2:1:1 ) to receive the combination of bevacizumab ( 10 mg/kg every 2 weeks ) and temsirolimus ( 25 mg weekly ; group A ) , or one of the standard treatments : sunitinib ( 50 mg/day for 4 weeks followed by 2 weeks off ; group B ) , or the combination of interferon alfa ( 9 mIU three times per week ) and bevacizumab ( 10 mg/kg every 2 weeks ; group C ) .

2,211,336

2METHODS

Randomisation was done centrally and independently from other study procedures with computer-generated permuted blocks of four and eight patients stratified by participating centre and Eastern Cooperative Oncology Group performance status .

2,211,337

2METHODS

The primary endpoint was progression-free survival ( PFS ) at 48 weeks ( four follow-up CT scans ) , which was expected to be above 50 % in group A. Analysis was by intention to treat .

2,211,338

2METHODS

The study is ongoing for long-term overall survival .

2,211,339

2METHODS

This study is registered with ClinicalTrials.gov , number NCT00619268 .

2,211,340

4RESULTS

Between March 3 , 2008 and May 6 , 2009 , 171 patients were randomly assigned : 88 to the experimental group ( group A ) , 42 to group B , and 41 to group C. PFS at 48 weeks was 29.5 % ( 26 of 88 patients , 95 % CI 20.0-39 .1 ) in group A , 35.7 % ( 15 of 42 , 21.2-50 .2 ) in group B , and 61.0 % ( 25 of 41 , 46.0-75 .9 ) in group C. Median PFS was 8.2 months ( 95 % CI 7.0-9 .6 ) in group A , 8.2 months ( 5.5-11 .7 ) in group B , and 16.8 months ( 6.0-26 .0 ) in group C. 45 ( 51 % ) of 88 patients in group A stopped treatment for reasons other than progression compared with five ( 12 % ) of 42 in group B and 15 ( 38 % ) of 40 in group C. Grade 3 or worse adverse events were reported in 68 ( 77 % ) of 88 patients in group A versus 25 ( 60 % ) of 42 in group B and 28 ( 70 % ) of 40 in group C. Serious adverse events were reported in 39 ( 44 % ) of 88 , 13 ( 31 % ) of 42 , and 18 ( 45 % ) of 40 patients in groups A , B , and C , respectively .

2,211,341

1CONCLUSIONS

The toxicity of the temsirolimus and bevacizumab combination was much higher than anticipated and limited treatment continuation over time .

2,211,342

1CONCLUSIONS

Clinical activity was low compared with the benefit expected from sequential use of each targeted therapy .

2,211,343

1CONCLUSIONS

This combination can not be recommended for first-line treatment in patients with metastatic renal cell carcinoma .

2,211,344

0BACKGROUND

French Ministry of Health and Wyeth Pharmaceuticals .

2,211,345

0BACKGROUND

Wound pain is a serious problem for people with chronic wounds .

2,211,346

0BACKGROUND

The aim of this real-life study was to compare the effect of a foam dressing that releases ibuprofen ( Biatain Ibu ) with local best practice on the treatment of painful exuding wounds .

2,211,347

2METHODS

A total of 185 patients with painful exuding wounds were randomized to either ibuprofen foam treatment ( n = 98 ) or local best practice ( n = 87 ) .

2,211,348

2METHODS

The primary endpoint was pain relief over 7 days of treatment , assessed daily using a 5-point verbal rating scale ( no relief , slight relief , moderate relief , lots of relief , and complete relief ) .

2,211,349

2METHODS

Secondary endpoints included a total reduction in pain intensity for the whole study period ( using an 11-point Numeric Box Scale : 0 = no pain to 10 = worst possible pain ) and incidence of adverse events ( AEs ) .

2,211,350

4RESULTS

More patients in the ibuprofen foam treatment group reported wound pain relief and lower wound pain intensity values after 7 days ( p < 0.0001 for both variables ) .

2,211,351

4RESULTS

Within the four most common ulcer aetiolgies , patients reported significantly more effective pain relief with ibuprofen foam treatment ( venous : p = 0.009 , mixed arterial venous : p < 0.0001 , arterial : p = 0.0009 , and vasculitis : p = 0.009 ) .

2,211,352

4RESULTS

In all groups , patients from the ibuprofen foam group reported lower pain intensities .

2,211,353

4RESULTS

The results were significant for patients with venous ( p < 0.002 ) and arterial ( p < 0.0001 ) leg ulcers .

2,211,354

4RESULTS

Two AEs were reported .

2,211,355

1CONCLUSIONS

The ibuprofen foam represents an effective and safe alternative to local best practice in the management of painful exuding wounds .

2,211,356

3OBJECTIVE

To determine if a 6-month course of therapy with IMREG-1 , a leukocyte-derived immunomodulator , slows disease progression in patients with AIDS-related complex .

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2METHODS

Randomized , double-blind trial .

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2METHODS

Five academic - and three community-based clinics .

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2METHODS

Immunocompromised patients ( 143 ) with HIV .

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2METHODS

IMREG-1 or placebo every 2 weeks ( 13 doses ) .

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4RESULTS

Twelve of forty-eight patients on placebo and 5 of 95 patients on IMREG-1 experienced adverse events ( AIDS-defining opportunistic infection or neoplasm , wasting syndrome , HIV-associated encephalopathy , or peripheral sensory neuropathy ) .

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4RESULTS

Based on an intention-to-treat analysis , Kaplan-Meier event probabilities were 26 % for the placebo group and 6 % for the IMREG-1 group ( P less than 0.001 ) ; based on the Cox proportional hazards model , the relative risk for patients on placebo compared with patients on IMREG-1 was 5.1 ( 95 % CI , 1.8 to 14.8 ) .

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4RESULTS

The frequency of symptoms significantly increased from baseline in patients receiving placebo .

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4RESULTS

The mean decrease in CD4 + cells from baseline was 80 x 10 ( 6 ) cells/L in the placebo group and 29 x 10 ( 6 ) cells/L in patients on IMREG-1 , with 20 % ( 8 ) and 38 % ( 32 ) of patients , respectively , showing a trend toward an increase ( P = 0.04 ) .

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4RESULTS

In patients receiving IMREG-1 , the size and rate of delayed hypersensitivity responses were larger than in the placebo group .

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1CONCLUSIONS

Patients with AIDS-related complex experienced fewer adverse events and constitutional symptoms after IMREG-1 treatment .

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1CONCLUSIONS

The slower loss of CD4 + cells and increased size and rate of delayed hypersensitivity responses most likely reflect the effect of IMREG-1 on the immune system .

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1CONCLUSIONS

No toxicity related to IMREG-1 administration was observed .

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0BACKGROUND

Tracheal intubation in the lateral position is difficult because the laryngeal view is compromised during direct laryngoscopy .

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0BACKGROUND

The Airway Scope facilitates intubation even when laryngeal views are poor with direct laryngoscopy , as they often are in the lateral position .

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0BACKGROUND

We thus compared the efficacy of the Airway Scope in supine patients with those in the left - and right-lateral positions .

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2METHODS

Anesthetized adults were randomly assigned to supine , left-lateral , or right-lateral position ( n = 43 for each group ) .

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2METHODS

Laryngeal views were obtained in the designated position with a Macintosh laryngoscope , and patients ' tracheas were subsequently intubated with the Airway Scope .

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2METHODS

Specifically , we tested the hypothesis that the time required for intubation in the left - and right-lateral positions is not increased by > 10 seconds compared with tracheal intubation in the supine position .

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4RESULTS

Overall intubation success was 100 % in the 2 lateral positions , and 98 % in the supine position .

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4RESULTS

Intubation times were similar in the left-lateral ( 24 [ 5 ] seconds , mean [ SD ] ) , right-lateral ( 24 [ 6 ] seconds ) , and supine ( 22 [ 7 ] seconds ) positions .

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4RESULTS

The numbers of required intubation attempts were similar in the 2 lateral positions and in the supine and left-lateral positions .

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4RESULTS

However , more intubation attempts were required in the supine position than in the right-lateral position ( P = 0.004 ) .

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4RESULTS

The incidences of airway complications were similar in each position ; no hypoxia , dental injury , or esophageal intubation was observed .

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4RESULTS

Modified Cormack-Lehane and the percentage of glottic opening scores obtained with the Macintosh laryngoscope did not differ between the 2 lateral positions , but the modified Cormack-Lehane and percentage of glottic opening scores were superior in the supine position ( all P < 0.001 ) compared with either of the lateral positions .

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1CONCLUSIONS

Despite worse laryngoscopic views in either lateral position than when patients were supine , intubation with the Airway Scope offered high success rates .

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1CONCLUSIONS

Furthermore , intubation time using the Airway Scope in either lateral position was not longer by > 10 seconds than in the supine position .

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1CONCLUSIONS

The Airway Scope thus seems to be a useful tool when tracheal intubation is required in a laterally positioned patient .

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3OBJECTIVE

To evaluate the effect of veno-venous continuous renal replacement therapy ( CRRT ) on the plasma levels of endotoxin and cytokines in severely burned patients with sepsis .

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2METHODS

Twenty adult severely burned patients with sepsis were studied .

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2METHODS

For the diagnosis of sepsis , patients were randomly divided into CRRT ( n = 10 ) and Control ( n = 10 ) .

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2METHODS

Both groups received conventional therapy after admission .

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2METHODS

Veno-venous CRRT was administered to 10 patients in the CRRT group whenever patients were determined to be septic .

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2METHODS

The plasma level of endotoxin , TNF-alpha , IL-1 beta , IL-6 and IL-8 were measured at 0 , 1 , 2 , 6 , 12 , 36 and 60 h after CRRT initiation , and at 0 , 12 , 36 and 60 h after the patients were diagnosed as having sepsis in the Control group .

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4RESULTS

Plasma level of endotoxin and all the cytokines after CRRT initiation were significantly lower than those before the treatment ( P < 0.01 ) .

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4RESULTS

The serial change of endotoxin , IL-1 beta , IL-6 and IL-8 was significantly lower at 12 , 36 and 60 h after treatment compared with Control groups ( P < 0.01 ) .

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4RESULTS

A significant decrease in plasma TNF-alpha levels was seen at 36 and 60 h after treatment compared with Control groups ( P < 0.01 ) .

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1CONCLUSIONS

Plasma endotoxin and cytokines ( TNF-alpha , IL-1 beta , IL-6 and IL-8 ) can be removed effectively with CRRT in severely burned patients with sepsis .

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3OBJECTIVE

To study the effect of Shenqi Fuzheng Injection ( SFI ) on cellular immune in patients with mammary cancer ( MC ) after chemotherapy .

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2METHODS

One hundred and ten patients with MC were randomly assigned to two groups .

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2METHODS

The 58 patients in the tested group were treated with SFI in cooperation with chemotherapy of CAF protocol ( Cyclophosphamide , Doxorubicin and Fluorouracil ) , while the 52 patients in the control group were treated with chemotherapy of the same protocol alone .

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2METHODS

Changes of the patients ' quality of life ( QOF ) , adverse reaction that occurred , peripheral lymphocyte count and killing activity of single karyocyte before and after treatment between the two groups were compared .

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4RESULTS

Patients ' QOF elevating rate after treatment in the tested group and the control group was 34.5 % and 13.5 % respectively ; The lowering of peripheral blood cell count of WBC , platelet and lymphocyte as well as that of the killing activity of single peripheral karyocyte on various kinds of MC cells were all milder and recovery sooner than those in the control group .

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