zj88zj/PubMed_200k_RCT · Datasets at Hugging Face

text stringlengths 0 1.82k
METHODS Private practice specializing in the treatment of patients with AIDS .
METHODS Only patients with HIV-1 infection and CD4 + lymphocyte counts between 200 and 500 x 10 ( 6 ) / l were included for study .
METHODS Thirty out of thirty-one patients at study entry completed treatment with placebo , and 29 completed nHuIFN alpha treatment .
METHODS Mean patient age was 36 years ( range , 25-58 years ) .
METHODS The 30 patients included 26 men , of whom 22 were homosexual , and four women ; five were drug users and none were currently on zidovudine therapy , although three had been previously .
METHODS Patients were randomly assigned to cohorts of 10 to receive either 200 IU nHuIFN alpha once daily orally absorbed or placebo with crossover after 6 weeks .
METHODS Every 2 weeks , a detailed history , physical examination , and laboratory tests , including CD4 + and CD8 + lymphocyte counts , were conducted .
RESULTS There was only a slight , transient increase in mean CD4 + lymphocyte counts after 4 weeks of treatment with nHuIFN alpha , compared with a slight decline when placebo was administered .
RESULTS This effect reached statistical significance in a subgroup of patients only and was not sustained after 6 weeks .
RESULTS There were no significant changes in weight and clinical symptoms .
RESULTS All patients remained HIV-1-antibody-positive .
RESULTS Treatment-related adverse reactions were not observed .
CONCLUSIONS Our double-blind , randomized , placebo-controlled clinical trial did not confirm a previous report of efficiency of oral nHuIFN alpha .
CONCLUSIONS Although non-toxic , our data do not justify the widespread use of low-dose oral nHuIFN alpha in HIV-infected patients outside controlled clinical trials .

###22091799
BACKGROUND Blue-light light-emitting diode ( LED ) therapy has become widely used for the treatment of inflammatory acne .
BACKGROUND In this study we evaluated the efficacy of a home use blue-light LED application in improving lesions and shortening their time to clearance .
METHODS This was an IRB approved randomized self-control study .
METHODS For each patient ( n = 30 ) , 2 similar lesions , one of each side of the face were chosen for treatment with either a blue-light LED hand-held or sham device .
METHODS Treatments ( n = 4 ) were conducted twice daily in the clinic and lesions were followed-up till resolution .
METHODS Reduction in blemishes size and erythema and the overall improvement were evaluated by both the physician and the patients .
METHODS Time to lesion resolution was recorded .
RESULTS There was a significant difference in the response of lesions to the blue-light LED application as opposed to the placebo in terms of reduction in lesion size and lesion erythema as well as the improvement in the overall skin condition ( p < 0.025 ) .
RESULTS Signs of improvement were observed as early as post 2 treatments .
RESULTS Time to resolution was significantly shorter for the blue-light LED therapy .
CONCLUSIONS The results support the effectiveness of using blue-light LED therapy on a daily basis for better improvement and faster resolution of inflammatory acne lesions .

###10908213
BACKGROUND Few treatments are available for isolated pulmonary hypertension ( PHT ) , which has a high morbidity and mortality .
BACKGROUND This trial was designed to assess the hemodynamic effects of bosentan , an endothelin receptor antagonist , in patients with PHT , in which local overproduction of endothelin-1 ( ET-1 ) is thought to play a pathogenic role .
RESULTS An open-label , dose-ranging study was performed in 7 female patients with primary PHT ( n = 5 ) or isolated PHT associated with limited scleroderma ( n = 2 ) .
RESULTS Infusions of 50 , 150 , and 300 mg were administered at 2-hour intervals , and the hemodynamic responses were measured .
RESULTS Bosentan caused a dose-dependent fall in total pulmonary resistance ( -20.0 + / -11.0 % , P = 0.01 ) and mean pulmonary artery pressure ( -10.6 + / -11.0 % , P > 0.05 ) .
RESULTS However , there was also a fall in the systemic vascular resistance ( -26.2 + / -12.8 % , P < 0.005 ) and mean arterial pressure ( -19.8 + / -14.4 % , P < 0.001 ) .
RESULTS There was a slight increase in cardiac index ( 15 + / -12 % , P > 0.05 ) and a dose-dependent rise in ET-1 but no significant change in other hemodynamic variables , gas exchange , or other vasoactive mediators .
CONCLUSIONS Intravenous bosentan is a potent but nonselective pulmonary vasodilator at the doses tested , even in patients resistant to inhaled nitric oxide .
CONCLUSIONS Transient increases in plasma ET-1 were observed , consistent with a blockade of endothelial ET ( B ) receptors .
CONCLUSIONS Systemic hypotension and other significant events during the study indicate that its intravenous use in patients with severe PHT may be limited .
CONCLUSIONS Implications for future trial design and studies of chronic oral treatment are discussed .

###9793814
OBJECTIVE To compare the prophylactic administration of ondansetron plus droperidol , droperidol plus metoclopramide , and perphenazine to determine effects on postoperative nausea , vomiting , and sedation after laparoscopic cholecystectomy .
METHODS Prospective , randomized , double-blind study .
METHODS University medical center .
METHODS 212 ASA physical status I and II adults presenting for laparoscopic cholecystectomy .
METHODS Patients were randomly assigned to receive one of three prophylactic antiemetic drug combinations : ondansetron 4 mg plus droperidol 0.625 mg ( Group OD ) , droperidol 0.625 mg plus metoclopramide 10 mg ( Group DM ) , or perphenazine 5 mg ( Group P ) .
METHODS Study drugs were administered intravenously after induction of general anesthesia .
RESULTS The groups were similar with respect to gender , age , weight , duration of surgery , numbers of patients receiving intraoperative atropine or ephedrine , number admitted overnight , and time to discharge home .
RESULTS Patients in Group P used lower total doses of opioids than did patients in Group OD .
RESULTS There were no significant differences in postoperative nausea , pain , or sedation scores , in numbers of patients requiring antiemetics ( Group OD , 13 of 66 ; Group DM , 15 of 66 ; Group P , 14 of 68 ) , or in numbers of patients vomiting , either in hospital or during the first postoperative day .
CONCLUSIONS These three drug regimens are equivalent for antiemetic prophylaxis before laparoscopic cholecystectomy .

###24095618
BACKGROUND In prior studies , pregabalin reduced rectal or colonic pain in patients with irritable bowel syndrome and healthy adults , suggesting reduction of afferent function .
OBJECTIVE To assess effects of pregabalin on colonic compliance , sensory and motor functions in patients with constipation-predominant irritable bowel syndrome .
METHODS In a pilot , double-blind , placebo-controlled , parallel-group study , we tested oral pregabalin , 200mg , in 18 patients with constipation-predominant irritable bowel syndrome .
METHODS With a barostatically controlled polyethylene balloon in the left colon , we assessed sensation thresholds and colonic compliance using ascending method of limits , sensation ratings over 4 levels of distension , fasting and postprandial colonic tone and phasic motility .
METHODS Analysis of covariance ( adjusted for the corresponding pre-drug response ) was used to compare placebo and pregabalin .
METHODS After 45 % participants completed studies , we conducted an interim analysis to assess the conditional power to detect pre-specified treatment effects given the observed variation and treatment group differences based on the planned sample size for the trial .
RESULTS Pregabalin did not significantly affect colonic compliance , sensation thresholds , sensation ratings , fasting or postprandial tone or motility index .
RESULTS The study was stopped for futility to detect an effect on visceral pain with the planned design and sample size .
CONCLUSIONS Pregabalin , 200mg , might not reduce distension-related colonic pain in constipation-predominant irritable bowel syndrome patients .

###10863225
BACKGROUND Topical corticosteroids , commonly used for psoriasis , show diminished response on continuous use .
OBJECTIVE We tested efficacy of topical corticosteroid and calcipotriene used on alternate weeks versus daily corticosteroid in patients with psoriasis .
METHODS In a randomized , observer-blind design , the experimental group of 25 patients with stable plaque psoriasis received augmented betamethasone dipropionate 0.05 % cream once daily in the first and third weeks and calcipotriene 0.005 % ointment twice daily in the second and fourth weeks .
METHODS The control group of 27 patients received augmented betamethasone once daily for 4 weeks .
RESULTS The experimental regimen was more effective than the control regimen as evidenced by ( 1 ) more patients with at least a 90 % reduction in Psoriasis Area and Severity Index ( PASI ) score ( difference 49.5 % , 95 % confidence interval [ CI ] , 26.1 % -72.9 % , P < .
RESULTS 001 ) , ( 2 ) lower PASI after 2 weeks ( P < or = .04 ) , and ( 3 ) greater percentage reduction in PASI after 2 and 4 weeks ( difference 23.1 % [ CI , 11.1 % -35.1 % ] and 46.4 % [ 28.9 % -63.8 % ] , respectively ; P < .001 ) .
RESULTS The study had power of 93.7 % .
RESULTS No patient had skin irritation .
CONCLUSIONS Use of augmented betamethasone and calcipotriene on alternate weeks is more effective than daily corticosteroid and represents a novel strategy for treating psoriasis .

###23482590
BACKGROUND Ghrelin stimulates GH secretion and regulates energy and glucose metabolism .
BACKGROUND The two circulating isoforms , acyl ( AG ) and des-acyl ( DAG ) ghrelin , have distinct metabolic effects and are under active investigation for their therapeutic potentials .
BACKGROUND However , there is only limited data on the pharmacokinetics of AG and DAG .
OBJECTIVE To evaluate key pharmacokinetic parameters of AG , DAG , and total ghrelin in healthy men and women .
METHODS In study 1 , AG ( 1 , 3 , and 5 g/kg per h ) was infused over 65 min in 12 healthy ( 8 F/4 M ) subjects in randomized order .
METHODS In study 2 , AG ( 1 g/kg per h ) , DAG ( 4 g/kg per h ) , or both were infused over 210 min in ten healthy individuals ( 5 F/5 M ) .
METHODS Plasma AG and DAG were measured using specific two-site ELISAs ( study 1 and 2 ) , and total ghrelin with a commercial RIA ( study 1 ) .
METHODS Pharmacokinetic parameters were estimated by non-compartmental analysis .
RESULTS After the 1 , 3 , and 5 g/kg per h doses of AG , there was a dose-dependent increase in the maximum concentration ( C ( max ) ) and area under the curve ( AUC ( 0-last ) ) of AG and total ghrelin .
RESULTS Among the different AG doses , there was no difference in the elimination half-life , systemic clearance ( CL ) , and volume of distribution .
RESULTS DAG had decreased CL relative to AG .
RESULTS The plasma DAG : AG ratio was ~ 2:1 during steady-state infusion of AG .
RESULTS Infusion of AG caused an increase in DAG , but DAG administration did not change plasma AG .
RESULTS Ghrelin administration did not affect plasma acylase activity .
CONCLUSIONS The pharmacokinetics of AG and total ghrelin appears to be linear and proportional in the dose range tested .
CONCLUSIONS AG and DAG have very distinct metabolic fates in the circulation .
CONCLUSIONS There is deacylation of AG in the plasma but no evidence of acylation .

###10049988
OBJECTIVE Chest physiotherapy ( CPT ) is an integral part of the treatment of patients with cystic fibrosis ( CF ) .
OBJECTIVE CPT imposes additional respiratory work that may carry a risk of respiratory muscle fatigue .
OBJECTIVE Inspiratory pressure support ventilation ( PSV ) is a new mode of ventilatory assistance designed to maintain a constant preset positive airway pressure during spontaneous inspiration with the goal of decreasing the patient 's inspiratory work .
OBJECTIVE The aim of our study was 1 ) to evaluate respiratory muscle fatigue and oxygen desaturation during CPT and 2 ) to determine whether noninvasive PSV can relieve these potential adverse effects of CPT .
METHODS Sixteen CF patients in stable condition with a mean age of 13 + / - 4 years participated to the study .

METHODS Private practice specializing in the treatment of patients with AIDS .

METHODS Only patients with HIV-1 infection and CD4 + lymphocyte counts between 200 and 500 x 10 ( 6 ) / l were included for study .

METHODS Thirty out of thirty-one patients at study entry completed treatment with placebo , and 29 completed nHuIFN alpha treatment .

METHODS Mean patient age was 36 years ( range , 25-58 years ) .

METHODS The 30 patients included 26 men , of whom 22 were homosexual , and four women ; five were drug users and none were currently on zidovudine therapy , although three had been previously .

METHODS Patients were randomly assigned to cohorts of 10 to receive either 200 IU nHuIFN alpha once daily orally absorbed or placebo with crossover after 6 weeks .

METHODS Every 2 weeks , a detailed history , physical examination , and laboratory tests , including CD4 + and CD8 + lymphocyte counts , were conducted .

RESULTS There was only a slight , transient increase in mean CD4 + lymphocyte counts after 4 weeks of treatment with nHuIFN alpha , compared with a slight decline when placebo was administered .

RESULTS This effect reached statistical significance in a subgroup of patients only and was not sustained after 6 weeks .

RESULTS There were no significant changes in weight and clinical symptoms .

RESULTS All patients remained HIV-1-antibody-positive .

RESULTS Treatment-related adverse reactions were not observed .

CONCLUSIONS Our double-blind , randomized , placebo-controlled clinical trial did not confirm a previous report of efficiency of oral nHuIFN alpha .

CONCLUSIONS Although non-toxic , our data do not justify the widespread use of low-dose oral nHuIFN alpha in HIV-infected patients outside controlled clinical trials .

###22091799

BACKGROUND Blue-light light-emitting diode ( LED ) therapy has become widely used for the treatment of inflammatory acne .

BACKGROUND In this study we evaluated the efficacy of a home use blue-light LED application in improving lesions and shortening their time to clearance .

METHODS This was an IRB approved randomized self-control study .

METHODS For each patient ( n = 30 ) , 2 similar lesions , one of each side of the face were chosen for treatment with either a blue-light LED hand-held or sham device .

METHODS Treatments ( n = 4 ) were conducted twice daily in the clinic and lesions were followed-up till resolution .

METHODS Reduction in blemishes size and erythema and the overall improvement were evaluated by both the physician and the patients .

METHODS Time to lesion resolution was recorded .

RESULTS There was a significant difference in the response of lesions to the blue-light LED application as opposed to the placebo in terms of reduction in lesion size and lesion erythema as well as the improvement in the overall skin condition ( p < 0.025 ) .

RESULTS Signs of improvement were observed as early as post 2 treatments .

RESULTS Time to resolution was significantly shorter for the blue-light LED therapy .

CONCLUSIONS The results support the effectiveness of using blue-light LED therapy on a daily basis for better improvement and faster resolution of inflammatory acne lesions .

###10908213

BACKGROUND Few treatments are available for isolated pulmonary hypertension ( PHT ) , which has a high morbidity and mortality .

BACKGROUND This trial was designed to assess the hemodynamic effects of bosentan , an endothelin receptor antagonist , in patients with PHT , in which local overproduction of endothelin-1 ( ET-1 ) is thought to play a pathogenic role .

RESULTS An open-label , dose-ranging study was performed in 7 female patients with primary PHT ( n = 5 ) or isolated PHT associated with limited scleroderma ( n = 2 ) .

RESULTS Infusions of 50 , 150 , and 300 mg were administered at 2-hour intervals , and the hemodynamic responses were measured .

RESULTS Bosentan caused a dose-dependent fall in total pulmonary resistance ( -20.0 + / -11.0 % , P = 0.01 ) and mean pulmonary artery pressure ( -10.6 + / -11.0 % , P > 0.05 ) .

RESULTS However , there was also a fall in the systemic vascular resistance ( -26.2 + / -12.8 % , P < 0.005 ) and mean arterial pressure ( -19.8 + / -14.4 % , P < 0.001 ) .

RESULTS There was a slight increase in cardiac index ( 15 + / -12 % , P > 0.05 ) and a dose-dependent rise in ET-1 but no significant change in other hemodynamic variables , gas exchange , or other vasoactive mediators .

CONCLUSIONS Intravenous bosentan is a potent but nonselective pulmonary vasodilator at the doses tested , even in patients resistant to inhaled nitric oxide .

CONCLUSIONS Transient increases in plasma ET-1 were observed , consistent with a blockade of endothelial ET ( B ) receptors .

CONCLUSIONS Systemic hypotension and other significant events during the study indicate that its intravenous use in patients with severe PHT may be limited .

CONCLUSIONS Implications for future trial design and studies of chronic oral treatment are discussed .

###9793814

OBJECTIVE To compare the prophylactic administration of ondansetron plus droperidol , droperidol plus metoclopramide , and perphenazine to determine effects on postoperative nausea , vomiting , and sedation after laparoscopic cholecystectomy .

METHODS Prospective , randomized , double-blind study .

METHODS University medical center .

METHODS 212 ASA physical status I and II adults presenting for laparoscopic cholecystectomy .

METHODS Patients were randomly assigned to receive one of three prophylactic antiemetic drug combinations : ondansetron 4 mg plus droperidol 0.625 mg ( Group OD ) , droperidol 0.625 mg plus metoclopramide 10 mg ( Group DM ) , or perphenazine 5 mg ( Group P ) .

METHODS Study drugs were administered intravenously after induction of general anesthesia .

RESULTS The groups were similar with respect to gender , age , weight , duration of surgery , numbers of patients receiving intraoperative atropine or ephedrine , number admitted overnight , and time to discharge home .

RESULTS Patients in Group P used lower total doses of opioids than did patients in Group OD .

RESULTS There were no significant differences in postoperative nausea , pain , or sedation scores , in numbers of patients requiring antiemetics ( Group OD , 13 of 66 ; Group DM , 15 of 66 ; Group P , 14 of 68 ) , or in numbers of patients vomiting , either in hospital or during the first postoperative day .

CONCLUSIONS These three drug regimens are equivalent for antiemetic prophylaxis before laparoscopic cholecystectomy .

###24095618

BACKGROUND In prior studies , pregabalin reduced rectal or colonic pain in patients with irritable bowel syndrome and healthy adults , suggesting reduction of afferent function .

OBJECTIVE To assess effects of pregabalin on colonic compliance , sensory and motor functions in patients with constipation-predominant irritable bowel syndrome .

METHODS In a pilot , double-blind , placebo-controlled , parallel-group study , we tested oral pregabalin , 200mg , in 18 patients with constipation-predominant irritable bowel syndrome .

METHODS With a barostatically controlled polyethylene balloon in the left colon , we assessed sensation thresholds and colonic compliance using ascending method of limits , sensation ratings over 4 levels of distension , fasting and postprandial colonic tone and phasic motility .

METHODS Analysis of covariance ( adjusted for the corresponding pre-drug response ) was used to compare placebo and pregabalin .

METHODS After 45 % participants completed studies , we conducted an interim analysis to assess the conditional power to detect pre-specified treatment effects given the observed variation and treatment group differences based on the planned sample size for the trial .

RESULTS Pregabalin did not significantly affect colonic compliance , sensation thresholds , sensation ratings , fasting or postprandial tone or motility index .

RESULTS The study was stopped for futility to detect an effect on visceral pain with the planned design and sample size .

CONCLUSIONS Pregabalin , 200mg , might not reduce distension-related colonic pain in constipation-predominant irritable bowel syndrome patients .

###10863225

BACKGROUND Topical corticosteroids , commonly used for psoriasis , show diminished response on continuous use .

OBJECTIVE We tested efficacy of topical corticosteroid and calcipotriene used on alternate weeks versus daily corticosteroid in patients with psoriasis .

METHODS In a randomized , observer-blind design , the experimental group of 25 patients with stable plaque psoriasis received augmented betamethasone dipropionate 0.05 % cream once daily in the first and third weeks and calcipotriene 0.005 % ointment twice daily in the second and fourth weeks .

METHODS The control group of 27 patients received augmented betamethasone once daily for 4 weeks .

RESULTS The experimental regimen was more effective than the control regimen as evidenced by ( 1 ) more patients with at least a 90 % reduction in Psoriasis Area and Severity Index ( PASI ) score ( difference 49.5 % , 95 % confidence interval [ CI ] , 26.1 % -72.9 % , P < .

RESULTS 001 ) , ( 2 ) lower PASI after 2 weeks ( P < or = .04 ) , and ( 3 ) greater percentage reduction in PASI after 2 and 4 weeks ( difference 23.1 % [ CI , 11.1 % -35.1 % ] and 46.4 % [ 28.9 % -63.8 % ] , respectively ; P < .001 ) .

RESULTS The study had power of 93.7 % .

RESULTS No patient had skin irritation .

CONCLUSIONS Use of augmented betamethasone and calcipotriene on alternate weeks is more effective than daily corticosteroid and represents a novel strategy for treating psoriasis .

###23482590

BACKGROUND Ghrelin stimulates GH secretion and regulates energy and glucose metabolism .

BACKGROUND The two circulating isoforms , acyl ( AG ) and des-acyl ( DAG ) ghrelin , have distinct metabolic effects and are under active investigation for their therapeutic potentials .

BACKGROUND However , there is only limited data on the pharmacokinetics of AG and DAG .

OBJECTIVE To evaluate key pharmacokinetic parameters of AG , DAG , and total ghrelin in healthy men and women .

METHODS In study 1 , AG ( 1 , 3 , and 5 g/kg per h ) was infused over 65 min in 12 healthy ( 8 F/4 M ) subjects in randomized order .

METHODS In study 2 , AG ( 1 g/kg per h ) , DAG ( 4 g/kg per h ) , or both were infused over 210 min in ten healthy individuals ( 5 F/5 M ) .

METHODS Plasma AG and DAG were measured using specific two-site ELISAs ( study 1 and 2 ) , and total ghrelin with a commercial RIA ( study 1 ) .

METHODS Pharmacokinetic parameters were estimated by non-compartmental analysis .

RESULTS After the 1 , 3 , and 5 g/kg per h doses of AG , there was a dose-dependent increase in the maximum concentration ( C ( max ) ) and area under the curve ( AUC ( 0-last ) ) of AG and total ghrelin .

RESULTS Among the different AG doses , there was no difference in the elimination half-life , systemic clearance ( CL ) , and volume of distribution .

RESULTS DAG had decreased CL relative to AG .

RESULTS The plasma DAG : AG ratio was ~ 2:1 during steady-state infusion of AG .

RESULTS Infusion of AG caused an increase in DAG , but DAG administration did not change plasma AG .

RESULTS Ghrelin administration did not affect plasma acylase activity .

CONCLUSIONS The pharmacokinetics of AG and total ghrelin appears to be linear and proportional in the dose range tested .

CONCLUSIONS AG and DAG have very distinct metabolic fates in the circulation .

CONCLUSIONS There is deacylation of AG in the plasma but no evidence of acylation .

###10049988

OBJECTIVE Chest physiotherapy ( CPT ) is an integral part of the treatment of patients with cystic fibrosis ( CF ) .

OBJECTIVE CPT imposes additional respiratory work that may carry a risk of respiratory muscle fatigue .

OBJECTIVE Inspiratory pressure support ventilation ( PSV ) is a new mode of ventilatory assistance designed to maintain a constant preset positive airway pressure during spontaneous inspiration with the goal of decreasing the patient 's inspiratory work .

OBJECTIVE The aim of our study was 1 ) to evaluate respiratory muscle fatigue and oxygen desaturation during CPT and 2 ) to determine whether noninvasive PSV can relieve these potential adverse effects of CPT .

METHODS Sixteen CF patients in stable condition with a mean age of 13 + / - 4 years participated to the study .