Pharmacokinetics and Tolerability of Factor XIII Concentrates Prepared from Human Placenta or Plasma: a Crossover Randomised Study

SummaryThe pharmacokinetics and tolerability of factor XIII (FXIII) from plasma were compared with those of FXIII from placenta in a randomised, double-blind, crossover study involving 13 patients with congenital FXIII deficiency. Both FXIII activity and FXIII antigen were monitored. No difference was seen in the mean half-lives of the two preparations (9.3 days and 9.1 days for plasma and placenta FXIII activity, respectively). Response was similar for both preparations, but was slightly greater for FXIII from plasma.Similar results were found for recovery (65% vs 60%). The area under the data completed by extrapolation was significantly higher for FXIII from plasma. No differences between preparations in terms of efficacy or tolerability were observed. It can be concluded that treatment with FXIII concentrate from plasma is as efficient as with FXIII concentrate from placenta in terms of recovery and half-life. Both preparations were equivalent in terms of safety during the observation period. With the administration of monthly injections of approximately 30 U/kg serious bleeding events were prevented and no other serious adverse events occurred.

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The Antihypertensive Effect of Verapamil in Twice and Thrice Daily Dose Regimens. A Randomized, Double-Blind, Crossover Trial

Journal of International Medical Research ◽

10.1177/030006058301100311 ◽

1983 ◽

Vol 11 (3) ◽

pp. 190-193 ◽

Cited By ~ 2

Author(s):

B Hedbäck ◽

K Parment

Keyword(s):

Dose Regimen ◽

Crossover Trial ◽

Antihypertensive Effect ◽

Morning Dose ◽

Double Blind ◽

Daily Dose ◽

The Mean ◽

Daily Dose Regimen ◽

Blind Crossover Study ◽

Double Blind Crossover Study

The antihypertensive effect of verapamil 200 mg b.i.d. was compared with that of verapamil 120 mg t.i.d. in a double-blind crossover study in eight out-patients with essential hypertension. The mean supine blood pressure measured before the morning dose was 150/87 mm Hg in patients treated with verapamil 200 mg b.i.d. and 151/87 mm Hg in those treated with verapamil 120 mg t.i.d. The recently reported prolonged half-life and accumulation of verapamil during steady-state conditions explains the lasting antihypertensive effect with the twice-daily dose regimen. Such a twice daily dose regimen is presumed to be more convenient to the patients and thus improve their compliance.

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Cow's Milk Whey Protein Elicits Symptoms of Infantile Colic in Colicky Formula-Fed Infants: A Double-Blind Crossover Study

PEDIATRICS ◽

10.1542/peds.83.2.262 ◽

1989 ◽

Vol 83 (2) ◽

pp. 262-266 ◽

Cited By ~ 3

Author(s):

Lasse Lothe ◽

Tor Lindberg

Keyword(s):

Crossover Study ◽

Whey Protein ◽

Cow’S Milk ◽

Infantile Colic ◽

Double Blind ◽

Milk Whey ◽

Cow's Milk ◽

The Mean ◽

Blind Crossover Study ◽

Double Blind Crossover Study

There are several causes of infantile colic. The aim of this study was to evaluate, under controlled conditions, whether bovine whey proteins can elicit symptoms of infantile colic in colicky formula-fed infants. The mean age for entering the study was 6.4 weeks and the mean age for colic debut was 3.7 weeks. In 24 of 27 infants with severe colic, the symptoms disappeared when they were given a cow's milk-free diet (Nutramigen). These 24 infants were entered into a double-blind crossover study. The infants (receiving cow's milk-free diet) were given the contents of identical capsules with each meal during day 6. The same procedure was repeated on day 10. The capsules contained either whey protein powder (with Nutramigen added) or human albumin powder (with Nutramigen added). Eighteen infants receiving the whey protein-containing capsules reacted with colic, two infants receiving placebo reacted with colic (P< .001), and four infants did not react at all. Crying hours per day for the 24 infants were 5.6 hours for formula-fed infants and 0.7 hour for cow's milk-free diet-fed infants (P< .001). Crying hours per day were 3.2 hours for the infants receiving whey protein capsules and 1.0 hour for those receiving placebo (P< .001). In conclusion, bovine whey protein can elicit symptoms of infantile colic in colicky formula-fed infants.

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GASTRIC RESIDUAL VOLUME BY MAGNETIC RESSONANCE AFTER INTAKE OF MALTODEXTRIN AND GLUTAMINE: a randomized double-blind, crossover study

Arquivos de Gastroenterologia ◽

10.1590/s0004-28032014000200010 ◽

2014 ◽

Vol 51 (2) ◽

pp. 123-127 ◽

Cited By ~ 3

Author(s):

Luigi R BRIANEZ ◽

Cervantes CAPOROSSI ◽

Yure W de MOURA ◽

Lorena A DIAS ◽

Regis V LEAL ◽

...

Keyword(s):

Magnetic Resonance Imaging ◽

Preoperative Care ◽

Crossover Fashion ◽

Residual Volume ◽

Resonance Imaging ◽

Gastric Residual Volume ◽

Double Blind ◽

The Mean ◽

Blind Crossover Study ◽

Double Blind Crossover Study

ContextThe addition of glutamine in preoperative drinks may enhance the benefits of carbohydrate alone.ObjectivesTo evaluate the gastric residual volume after the intake of a beverage containing carbohydrate plus glutamine.MethodsEleven healthy volunteers (24-30 years-old) were randomized in a crossover fashion to intake 400 mL (4h before) and 200 mL (2h before) of a beverage containing either 12.5% maltodextrin (carbohydrate group) or 12.5% maltodextrin plus 15 g of glutamine (glutamine group) in two different moments 7 days apart. Magnetic ressonance was performed to measure the gastric residual volume (mL) 120 and 180 minutes after the last ingestion.ResultsGastric residual volume similar to basal condition was found after 2h and 3h of the intake of beverages. There was no difference in the mean ±SD GRV (mL) found at 120 minutes (carbohydrate group: 22.9±16.6 and glutamine group: 19.7±10.7) and at 180 minutes (carbohydrate group: 21.5±24.1 and glutamine group: 15.1±10.1) between the two drinks.ConclusionsGastric emptying is efficient, and occurs in up to two hours after the intake of a beverage containing either carbohydrate alone or carbohydrate associated with glutamine. The addition of glutamine to carbohydrate-enriched drink seems to be safe for the use up to 2h before an operation. HEADINGS - Gastric emptying. Preoperative care. Carbohydrates. Glutamine. Magnetic resonance imaging.

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Effectiveness ofMentha piperitain the Treatment of Infantile Colic: A Crossover Study

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2012/981352 ◽

2012 ◽

Vol 2012 ◽

pp. 1-4 ◽

Cited By ~ 10

Author(s):

João Guilherme Bezerra Alves ◽

Rita de Cássia Coelho Moraes de Brito ◽

Telma Samila Cavalcanti

Keyword(s):

Crossover Study ◽

Standard Treatment ◽

Mentha Piperita ◽

Infantile Colic ◽

Common Condition ◽

Chi Square ◽

Double Blind ◽

The Mean ◽

Blind Crossover Study ◽

Double Blind Crossover Study

Background. Infantile colic is a distressing and common condition for which there is no proven standard treatment.Objective. To compare the efficacy ofMentha piperitawith simethicone in treatment for infantile colic.Methods. A double-blind crossover study was performed with 30 infants attending IMIP, Recife, Brazil. They were randomized to useMentha piperitaor simethicone in the treatment of infantile colic during 7 days with each drug. Primary outcomes were mother_s opinion about responses to the treatment, number of daily episodes of colic, and time spent crying, measured by a chronometer. Mann-Whitney and chi-square tests were used to compare the results. This study was previously approved by the Ethical Committee in Research at IMIP.Results. At baseline daily episodes of infantile colic was 3.9 (±1.1) and the mean crying time per day was 192 minutes (±51.6). At the end of the study daily episodes of colic fell to 1.6 (±0.6) and the crying duration decreased to 111 (±28) minutes. All mothers reported decrease of frequency and duration of the episodes of infantile colic and there were no differences between responses toMentha piperitaand simethicone.Conclusions. These findings suggest thatMentha piperitamay be used to help control infantile colic. However, these results must be repeated by others studies.

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Effect Of Diet And Clofibrate On Increased Platelet Function In Hyperlipoproteinemia

10.1055/s-0038-1653306 ◽

1981 ◽

Author(s):

J H Joist ◽

R K Baker ◽

G Schonfeld

Keyword(s):

Platelet Function ◽

Placebo Treatment ◽

Lipid Lowering ◽

Double Blind ◽

Serum Triglycerides ◽

Coagulant Activity ◽

Respective Type ◽

The Mean ◽

Double Blind Crossover Study ◽

Observation Period

We have previously reported shortened template bleeding times (BT) in patients with type IIb and IV-hyperlipoproteinemia (HLP) and increased platelet coagulant activity (PF3a) in patients with types IIa, IIb and IV-HLP. We now report on a randomized, double-blind crossover study designed to assess the efficacy of lipid lowering diets appropriate for the respective type of HLP and Clofibrate versus placebo in reversing platelet hypersensitivity. 8 patients with IIa, 9 patients with IIb, and 9 patients with IV-HLP completed the study which included (a) baseline study (regular diet), (b) controlled diet (2 months), (c) controlled diet and Clofibrate (6 months), (d) controlled diet and placebo (6 months) (crossover design). In IIa-HLP patients the mean BT remained significantly shortened throughout all study periods whereas PF3a had reversed to normal at the end of the diet period without significant further changes thereafter. In IIb- and IV-HLP patients both shortened BT and increased PF3a observed at baseline normalized at the end of the diet period with a continuous further decline of PF3a thereafter regardless of Clofibrate or placebo. A small but significant decrease in total and LDL-cholesterol in serum was observed during the diet period in IIa-HLP patients and this decrease was not enhanced by Clofibrate. In IV-HLP patients, serum triglycerides had declined by 50% at the end of the diet period and stabilized at 25% of the initial value at the end of the first 6 month treatment period irrespective of Clofibrate or placebo treatment. No significant changes in triglyceride levels were observed in IIa- or IIb-HLP patients throughout the 14 month observation period. The findings indicate that lipid lowering diets may reverse platelet hypersensitivity in HLP patients and that Clofibrate has no effect on platelet function in HLP patients on a controlled lipid lowering diet.

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L-5-Hydroxytryptophan Versus Placebo in Childhood Migraine Prophylaxis: A Double-Blind Crossover Study

Cephalalgia ◽

10.1046/j.1468-2982.1986.0603155.x ◽

1986 ◽

Vol 6 (3) ◽

pp. 155-157 ◽

Cited By ~ 23

Author(s):

Margherita Santucci ◽

Pietro Cortelli ◽

Paola Giovanardi Rossi ◽

Agostino Baruzzi ◽

Tommaso Sacquegna

Keyword(s):

Crossover Study ◽

Treatment Period ◽

Double Blind ◽

Daily Dose ◽

Headache Diary ◽

Group A ◽

The Mean ◽

Group B ◽

Blind Crossover Study ◽

Double Blind Crossover Study

L-5HTP was tested versus placebo in a double-blind crossover study of 27 migraine children aged 6–12 years, who recorded their headaches in a headache diary for 1 month. Twenty-one patients subsequently started the trial. The mean daily dose of L-5HTP was 5 mg/kg body weight, and each treatment period with either L-5HTP or placebo lasted 12 weeks. In group A (L-5HTP—placebo; 10 patients) and group B (placebo—L-5HTP; 11 patients) both L-5HTP and placebo led to a significant reduction of the migraine index and frequency of migraine attacks during the 3rd month of each treatment period. However, we found a treatment x period interaction because the efficacy determinants decreased significantly during the first and the second treatment periods in both groups irrespective of the sequence of treatments. No differences were found between L-5HTP (first period of group A) and placebo (first period of group B).

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Inhibition of Spontaneous Platelet Aggregation by Sulfinpyrazone

Thrombosis and Haemostasis ◽

10.1055/s-0038-1666900 ◽

1979 ◽

Vol 42 (02) ◽

pp. 621-625 ◽

Cited By ~ 1

Author(s):

G G Nenci ◽

G Agnelli ◽

M Berrettini ◽

P Parise ◽

E Ballatori

Keyword(s):

Platelet Aggregation ◽

Crossover Study ◽

Double Blind ◽

Platelet Aggregability ◽

Initiation Of Therapy ◽

Spontaneous Platelet Aggregation ◽

Blind Crossover Study ◽

Double Blind Crossover Study

SummaryIn a randomized double-blind crossover study in 16 patients with enhanced in vitro spontaneous platelet aggregation, sulfinpyrazone proved to be effective in normalizing platelet aggregability within 4 days after initiation of therapy.

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