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Weighted Mean Difference

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104001. Weight changes in women with metastatic breast cancer treated with megestrol acetate: a comparison of standard versus high-dose therapy. (PubMed)

therapy, response to prior endocrine therapy, race, performance status, dominant disease site, and number of disease sites were included in the analysis. At 30 days, patients taking high-dose megestrol acetate had a mean weight gain of 2.5 lb whereas patients taking the standard dose had stable weights. Factors predictive of weight gain were younger age (P = .0012) and fewer disease sites (P = .017). At 90 and 180 days, patients taking high-dose megestrol acetate had consistently gained more weight (...) than those taking the standard dose (9.0 and 16.0 lb v 2.5 and 9.0 lb, respectively). Significant covariables were treatment arm (P = .0006) and younger age (P = .0211). Probability of gaining 20 lb was dependent only on treatment dose (P = .0002), and median time to a 20-lb weight gain was 217 days. Increases in systolic and diastolic blood pressures were seen in both groups, but the differences were not significant. Megestrol acetate is associated with weight gain in women with advanced breast

1990 Seminars in oncology Controlled trial quality: uncertain

104002. Lack of weight gain associated with short-term astemizole treatment. (PubMed)

Lack of weight gain associated with short-term astemizole treatment. The effect of treatment with astemizole for three weeks on weight was assessed in 44 patients with seasonal allergic rhinitis who participated in a randomized, double-blind, placebo-controlled clinical trial. Astemizole 10-mg tablets and identical placebo tablets were used. Compared with baseline, weight increased significantly in astemizole-treated patients (1.07 +/- 1.39 kg; p = 0.0004); however, the mean change in weight (...) in astemizole-treated patients was not statistically significantly different than that seen in placebo-treated patients (0.85 +/- 1.68 kg). No relationship was found between changes in weight and age, sex, initial weight, percentage of obesity, and plasma astemizole concentrations.

1990 DICP : the annals of pharmacotherapy Controlled trial quality: uncertain

104003. Effect of serotonin re-uptake inhibition by fluoxetine on body weight and spontaneous food choice in obesity. (PubMed)

, mean +/- s.e.m.) and age (38.1 +/- 239 vs 37.3 +/- 2.7 years) were not different in either group. No specific diet was prescribed. On four separate days per 14 days food records were collected. Data were analysed with the use of food composition tables. Statistical analysis was performed using Student's t test for independent samples for data on body weight and calorie intake. Macro-nutrient composition of the diet was analysed using multivariate analysis of variance and post hoc Student's t test (...) for independent samples. All subjects lost weight during fluoxetine treatment. Mean (+/- s.e.m.) weight loss in the fluoxetine treated group was 3.6 +/- 0.5 kg, compared to a mean weight gain of 0.3 +/- 0.5 kg in the placebo treated group (P less than 0.001). In all patients food intake was reduced during fluoxetine treatment and this reduction could fully account for the observed weight loss. The mean total caloric intake per day was significantly lower during fluoxetine treatment compared with placebo (FXT

1991 International journal of obesity Controlled trial quality: uncertain

104004. A new low molecular weight heparinoid Org 10172 as anticoagulant in hemodialysis. (PubMed)

A new low molecular weight heparinoid Org 10172 as anticoagulant in hemodialysis. A low molecular weight heparinoid (Org 10172) was compared with unfractionated heparin in 36 patients on chronic hemodialysis in an open randomized cross-over study with three anti-coagulant treatment regimens for a single hemodialysis session. The anti-coagulant regimens were: a) standard heparin (3250-4750 I.U. heparin at start of hemodialysis followed by continuous infusion of 2000-2700 I.U. per hour); b) Org (...) 10172 administered as a single intravenous bolus of 2400 anti-Xa units at start of dialysis; c) Org 10172 administered as a single bolus of 3200 anti-Xa units at start of dialysis. Plasma anti-Xa activity during hemodialysis was highest in regimen; d) and significantly lower when heparin was used. Mean beta-thromboglobulin concentrations changed to the same extent in the three groups. Plasma platelet factor 4 concentrations were higher after the use of heparin. The extracorporeal circuit

1990 The International journal of artificial organs Controlled trial quality: uncertain

104005. Changes in lipoprotein subfractions during diet-induced and exercise-induced weight loss in moderately overweight men. (PubMed)

%), and increased LDL peak particle diameter (2.4 and 3.2 A). When adjusted to an equivalent change in body mass index by analysis of covariance, 1) exercise-induced and diet-induced weight loss produced comparable mean changes in the mass of small LDL and VLDL, and in LDL peak particle diameter; 2) the exercisers versus control group difference in HDL2 was attributed to the exercisers' reduced body mass index; and 3) HDL2 increased significantly less in dieters than in exercisers. In dieters, low calorie (...) ultracentrifugation, respectively. During the 1-year trial, the exercisers ran (mean +/- SD) 15.6 +/- 9.1 km/wk, and the dieters ate 340 +/- 71 fewer kilocalories per day than at baseline. Total body weight was reduced significantly more in dieters (-7.2 +/- 4.1 kg) and exercisers (-4.0 +/- 3.9 kg) than controls (0.6 +/- 3.7 kg). As compared with mean changes in controls, the exercisers and dieters significantly increased HDL2 mass (48.6% and 47.1%, respectively), decreased VLDL mass (-23.9% and -25.5

1990 Circulation Controlled trial quality: uncertain

104006. Growth, nutrient retention, and metabolic response of low-birth-weight infants fed supplemented and unsupplemented preterm human milk. (PubMed)

resulted in greater rates of weight gain (20.5 +/- 2.3 vs 16.4 +/- 2.2 g.kg-1.d-1) and nitrogen retention (353 +/- 76 vs 270 +/- 53 mg.kg-1.d-1), increase in plasma transthyretin (TTR) concentration (7 +/- 16 vs -3 +/- 9 mg.L-1.wk-1), a higher mean plasma albumin concentration (34 +/- 3 vs 32 +/- 4 g/L), and a higher plasma TTR concentration at discharge (100 +/- 22 vs 75 +/- 24 mg/L). All these variables correlated significantly with total nitrogen intake, suggesting that the differences (...) Growth, nutrient retention, and metabolic response of low-birth-weight infants fed supplemented and unsupplemented preterm human milk. Growth, nutrient retention, and metabolic response of low-birth-weight infants fed human milk provided by their mother; this milk supplemented with bovine milk protein, calcium, phosphorus, and sodium; or pasteurized term human milk with the same supplement were monitored from the time desired intake was tolerated until weight reached 2200 g. The supplement

1990 The American journal of clinical nutrition Controlled trial quality: uncertain

104007. Reduced erythrocyte superoxide dismutase activity in low birth weight infants given iron supplements. (PubMed)

Reduced erythrocyte superoxide dismutase activity in low birth weight infants given iron supplements. Erythrocyte superoxide dismutase (ESOD) activity reflects copper utilization and the risk of copper deficiency. To investigate the possible effects of inorganic iron on the metabolism of copper in low birth weight infants, we have measured ESOD activities in three groups of infants receiving different iron supplements. Fifty-five low birth weight infants were randomly assigned to receive daily (...) from 28 d either 13.8 mg (HiFe), 7 mg (MidFe), or no elemental iron (NatFe) as iron edetate. At 27 d, 8, 12, and 20 wk postnatal age, infants were weighed and measured and hematologic indices, plasma ferritin, zinc, and copper concentrations, and ESOD activities were assayed. Anthropometrical and hematologic indices and plasma copper and zinc concentrations did not differ among treatment groups at any time, but at 20 wk, plasma ferritin concentrations [(micrograms/L) mean; SD] were lower

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1991 Pediatric research Controlled trial quality: uncertain

104008. Randomized, placebo-controlled trial of human surfactant given at birth versus rescue administration in very low birth weight infants with lung immaturity. (PubMed)

(mean 1.0 kg birth weight, 27 to 28 weeks of gestational age) randomly assigned to receive prophylactic treatment received surfactant soon after birth; those assigned to receive rescue surfactant had instillation at a mean age of 220 minutes if the lecithin-sphingomyelin ratio was less than or equal to 2.0 and no phosphatidylglycerol was detected in either amniotic fluid or initial airway aspirate, oxygen requirements were a fraction of inspired oxygen of greater than 0.5, and mean airway pressure (...) Randomized, placebo-controlled trial of human surfactant given at birth versus rescue administration in very low birth weight infants with lung immaturity. A randomized, placebo-controlled trial of human surfactant given intratracheally at birth (prophylactic) versus rescue administration after the onset of severe respiratory distress syndrome (RDS) was conducted among preterm infants born at 24 to 29 weeks of gestation. Singleton fetuses were randomly assigned to receive (1) placebo (air), (2

1991 The Journal of pediatrics Controlled trial quality: predicted high

104009. Randomized clinical trials of weight reduction in nonhypertensive persons. (PubMed)

/diastolic) compared to controls, but both weight loss and blood pressure changes were smaller when combined with decreased sodium intake. A Stanford University trial achieved weight losses of 7.4 and 5.1 kg over 12 months with diet and exercise, respectively. Effects on clinic BP were in the range of 1.5 to 3.0 mm Hg and did not differ by intervention approach. The sole trial in children, conducted at University of Michigan, found similar weight loss (about 7 kg) and BP effects from limiting caloric (...) intake over 20 weeks, regardless of inclusion of an exercise program; the latter did, however, result in greater reductions in percent body fat, heart rate, and serum insulin levels. The Primary Prevention of Hypertension trial tested a multifactor intervention including reductions in weight (mean, 2.7 kg), sodium and alcohol intake, and increased physical activity. During a 5-year period, clinic BP was reduced by 2.0/1.9 mm Hg, and the incidence of hypertension, by 52%. It is concluded that weight

1991 Annals of epidemiology Controlled trial quality: uncertain

104010. Selenium absorption and retention by very-low-birth-weight infants: studies with the extrinsic stable isotope tag 74Se. (PubMed)

microgram of Se/dl) or a selenium-supplemented version of that formula (2.03 micrograms of Se/dl). Each study consisted of one feeding that had been extrinsically labeled with 74Se (1.03 microgram/kg) and a timed stool and urine collection. The percent 74Se absorption was 91.2 +/- 5.4% (mean +/- SD) from the standard formula and 86.2 +/- 3.0% from the selenium-supplemented formula (p less than 0.05), but the percent of the absorbed 74Se retained was not different, i.e., 96.6 +/- 2.1% and 95.0 +/- 2.8 (...) Selenium absorption and retention by very-low-birth-weight infants: studies with the extrinsic stable isotope tag 74Se. Measurements of dietary selenium absorption and retention were obtained after administration of a single dose of the extrinsic stable isotope tag 74Se in 20 appropriate for gestational age premature infants with birth weights between 720 and 1,630 g and gestational ages between 26 and 33 weeks. Infants were assigned randomly to receive a standard premature formula (1.34

1991 Journal of pediatric gastroenterology and nutrition Controlled trial quality: uncertain

104011. Fluoxetine's effect on weight loss in obese subjects. (PubMed)

group's significantly greater mean weight loss continued through week 45. However, those on fluoxetine regained a mean of 4.2 kg from their lowest weight (P less than 0.001) whereas the placebo group did not. By the end of the study, each group weighed significantly less than they did at baseline (fluoxetine: -8.2 kg; placebo: -4.5 kg; P less than 0.05) although the difference between groups was no longer significant (P greater than 0.05). Several factors were considered as possible causes (...) Fluoxetine's effect on weight loss in obese subjects. Forty-five obese subjects with a mean weight of 102.9 kg and a body mass index (in kg/m2) of 37.6 were randomly assigned to a fluoxetine-diet group (n = 23) or a placebo-diet group (n = 22) for 52 wk. At week 29, 14 subjects on fluoxetine who completed the study attained their maximum weight loss of 12.4 kg, an amount significantly greater than the maximum weight loss of 4.5 kg for the 16 on placebo who completed the study. The fluoxetine

1991 The American journal of clinical nutrition Controlled trial quality: uncertain

104012. Dose finding study of a low molecular weight heparin, Innohep, in haemodialysis. (PubMed)

Dose finding study of a low molecular weight heparin, Innohep, in haemodialysis. A pilot investigation was performed with Innohep, a low molecular weight (LMWH) preparation (peak maximum molecular mass 3,000-6,000), to determine possible dose regimens for patients undergoing regular maintenance haemodialysis for chronic renal failure. Results from this study suggested that suppression of macroscopic clot formation and fibrinopeptide A (FPA), a marker of fibrin formation, could be achieved (...) additional UFH to enable completion of a prolonged (up to 7 h) dialysis, was observed in all patients on the 1,250 AFXa u dose (mean duration of dialysis prior to UFH, 3 h) but in a single patient only receiving the other LMWH doses. A dose-related response in the AFXa activity, measured by chromogenic substrate (CS) assay was seen in the three LMWH groups, with levels declining significantly (p less than 0.05) from 1-7 h. This contrasted with the constant levels maintained during dialysis with UFH. FPA

1991 Thrombosis and haemostasis Controlled trial quality: uncertain

104013. Identification of risk factors for bleeding during treatment of acute venous thromboembolism with heparin or low molecular weight heparin. (PubMed)

Identification of risk factors for bleeding during treatment of acute venous thromboembolism with heparin or low molecular weight heparin. In a prospective double-blind trial, we treated 194 patients with acute venous thromboembolism with heparin or low molecular weight heparin (LMWH; Fragmin). To evaluate the most important prognostic factors for bleeding, the presenting clinical features of the patients, the patients' anticoagulant responses, and the doses of the drugs were analyzed using (...) univariate and multivariate regression analyses. No significant differences in clinical risk factors associated with bleeding were observed between heparin and LMWH. The univariate analyses ranked the parameters in the following order of importance: World Health Organization (WHO) performance status, history of bleeding tendency, cardiopulmonary resuscitation, recent trauma or surgery, leukocyte counts, platelet counts, duration of symptoms, and body surface area. Patients with WHO grade 4 had

1991 Blood Controlled trial quality: uncertain

104014. Nasal continuous positive airway pressure facilitates extubation of very low birth weight neonates. (PubMed)

improving pulmonary status, fraction of inspired oxygen (FIO2) less than or equal to 0.35, mean airway pressure less than or equal to 7 cm H2O, ventilator rate less than or equal to 20 breaths per minute, and weight at least 80% of birth weight. Informed consent was obtained and neonates were randomized to NCPAP or oxyhood following extubation. Success was defined as remaining free of additional ventilatory support for at least 5 days. Failure criteria included FIO2 greater than or equal to 0.60 (...) Nasal continuous positive airway pressure facilitates extubation of very low birth weight neonates. A prospective randomized trial was performed in 58 neonates comparing nasal continuous positive airway pressure (NCPAP) vs oxyhood following extubation of neonates weighing less than 1 kg. All neonates had been ventilated for the treatment of respiratory distress syndrome for at least 24 hours and weighed less than 1 kg at the time of extubation. Clinical criteria for elective extubation included

1991 Pediatrics Controlled trial quality: uncertain

104015. Efficacy of calcium glycerophosphate vs conventional mineral salts for total parenteral nutrition in low-birth-weight infants: a randomized clinical trial. (PubMed)

) containing approximately 1.5 mmol Ca and P.kg-1.d-1 for 5 d. Net retentions of calcium (1.2 +/- 0.2 vs 1.0 +/- 0.2 mmol.kg-1.d-1, means +/- SD) and phosphorus (1.1 +/- 0.3 vs 0.8 +/- 0.3 mmol.kg-1.d-1) from CaGluc + P vs CaGlyP, respectively, were similar, as were retentions of magnesium and sodium, urinary pH, and net acid excretion. Plasma ionized calcium, inorganic phosphorus, alkaline phosphatase, and osteocalcin were normal and not different between groups. CaGlyP is as effective as CaGluc + P (...) Efficacy of calcium glycerophosphate vs conventional mineral salts for total parenteral nutrition in low-birth-weight infants: a randomized clinical trial. To test the efficacy of calcium glycerophosphate (CaGlyP) vs the conventional mineral salts, calcium gluconate plus KH2PO4 + K2HPO4 (CaGluc + P), in promoting mineral retention, 72-h mineral balance, biochemical status, net acid excretion, and growth were assessed in 16 low-birth-weight infants receiving total parenteral nutrition (TPN

1991 The American journal of clinical nutrition Controlled trial quality: uncertain

104016. Low-molecular-weight sodium hyaluronate in the treatment of bacterial corneal ulcers. (PubMed)

was adjusted according to a type I error of 0.01 and type a II error of 0.05 for a minimal expected difference of 35%. The healing time was calculated from the beginning of treatment to the day on which a follow-up fluorescein test proved to be negative. The mean healing time (+/- SD) was 3.5 +/- 0.9 days in the sodium hyaluronate group and 5.9 +/- 1.5 days in the saline group (P less than 0.001). These results suggest that treatment with an antibiotic dissolved in low-molecular-weight sodium hyaluronate (...) Low-molecular-weight sodium hyaluronate in the treatment of bacterial corneal ulcers. A double-blind clinical trial was performed on 26 patients suffering from corneal ulcers of proven (i.e., culture-positive) bacterial etiology. After their recruitment, the subjects were randomly assigned to one of the following treatment protocols: (1) tobramycin (15 mg/ml) in saline applied at 1 drop/h or (2) tobramycin (15 mg/ml) in low-molecular-weight hyaluronic acid applied at 1 drop/h. The sample size

1992 Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie Controlled trial quality: uncertain

104017. Effect of chloroquine chemoprophylaxis during pregnancy on birth weight: results of a randomized trial. (PubMed)

placental infection (4.1% infected placentas in the treated group versus 19.0% in the controls), the mean difference in birth weights between the two groups (6 g) was not significant. The difference in the proportion of low birth weight (LBW) newborn babies in two groups (16.3% versus 16.4%) was also not significant. However, there was a strong relationship between placental infection and birth weight (the mean birth weight difference between infected and uninfected placentas was 113 g (...) , and the proportion of LBW babies was 26.0% in infected placentas versus 14.8% in uninfected placentas). The small difference in birth weights observed between the two groups may be due to the fact that the prevalence rate of placental infection is low and that prophylaxis is effective only on a portion of the subjects in the treated group. It may also indicate that malaria is only one of several risk factors responsible for LBW. The relatively small increase in birth weight, the expected poor acceptance of mass

1992 The American journal of tropical medicine and hygiene Controlled trial quality: uncertain

104018. A controlled trial of insulin infusion and parenteral nutrition in extremely low birth weight infants with glucose intolerance. (PubMed)

A controlled trial of insulin infusion and parenteral nutrition in extremely low birth weight infants with glucose intolerance. To determine whether a continuous insulin infusion improves glucose tolerance in extremely low birth weight infants, we conducted a prospective, randomized trial in 24 neonates 4 to 14 days old (mean birth weight 772.9 +/- 128 gm; mean gestational age 26.3 +/- 1.6 weeks). Infants who had glucose intolerance were randomly assigned to receive either intravenous glucose (...) and total parenteral nutrition with insulin through a microliter-sensitive pump or standard intravenous therapy alone. One infant assigned to receive insulin never required it. The groups were similar in birth weight, gestational age, race, gender, medical condition, and energy intake before the study. The mean duration of therapy was 14.6 days (range 7 to 21 days). During the study, the 11 insulin-treated infants tolerated higher glucose infusion rates (20.1 +/- 2.5 vs 13.2 +/- 3.2 mg/kg/min (1.1

1991 The Journal of pediatrics Controlled trial quality: uncertain

104019. Weight-loss experience of black and white participants in NHLBI-sponsored clinical trials. (PubMed)

Weight-loss experience of black and white participants in NHLBI-sponsored clinical trials. We examined race-specific weight-loss results from two randomized, multicenter trials; the Hypertension Prevention Trial (HPT) and the Trials of Hypertension Prevention (TOHP). Mean weight change from baseline averaged 2.2 kg less in black women than in white women during 18 mo of follow-up in TOHP and 2.7 kg less during 36 mo of follow-up in HPT. Mean weight loss averaged 2.0 kg less in black than (...) in white men in TOHP and 1.4 kg less in HPT. Because of greater weight gain in black control subjects, a comparison of net weight loss (change in intervention minus change in control participants, within-race) showed a less marked difference than did black-white differences in weight loss within the actively treated group. Thus, relative to weight that would have been gained without the intervention, the experience of blacks and whites was more similar. Racial differences in weight loss may result from

1991 The American journal of clinical nutrition Controlled trial quality: uncertain

104020. Fluid restriction for preventing bronchopulmonary dysplasia? Reduced fluid intake during the first weeks of life improves the outcome of low-birth-weight infants. (PubMed)

and 150 ml/kg/day during the first week and 200 ml/kg afterwards. The diagnosis of bronchopulmonary dysplasia was based on typical roentgenographic findings, clinical symptoms and a supplemental oxygen requirement at age one month. Mean weight loss was greater in the dry group than in the control group (8.8 vs 6.2%), but there was no difference in weight between the groups at the age of four weeks. Twelve of the patients died, one in the dry group and 11 in the control group (five died during (...) Fluid restriction for preventing bronchopulmonary dysplasia? Reduced fluid intake during the first weeks of life improves the outcome of low-birth-weight infants. One hundred consecutive low-birth-weight infants (less than 1751 g) were randomized equally into "dry" and "control" groups. Fluid administration in the dry group followed the schema 50, 60, 70, 80, 90, 100 and 120 ml/kg/day during the first week and 150 ml/kg/day until aged four weeks and that of the control group 80, 100, 120

1992 Acta paediatrica (Oslo, Norway : 1992) Controlled trial quality: uncertain

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