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PubMed1979

Safety of postabortion sterilisation compared with interval sterilisation. A controlled study.

406 women--about one-fifth of those requesting an induced abortion and sterilisation over a thirty-three-month period--volunteered to be allocated randomly to either a concurrent induced-abortion/sterilisation group or a group which was sterilised six weeks after abortion. The abortion-attributable and sterilisation-attributable complication rates of 3.8% and 5.2%, respectively, for the concurrent group did not differ significantly from the 6.7% and 6.9% rates for the interval group. The estimated 2%-10% of women who would have changed their minds must be set against the 4% of women who became pregnant again before being sterilised. Efforts should be made to identify women likely to regret sterilisation.

Abortion, Induced↗

PubMed1976

A five-year assessment of controlled trials of in-patient and out-patient treatment and of plaster-of-Paris jackets for tuberculosis of the spine in children on standard chemotherapy. Studies in Masan and Pusan, Korea. Fifth report of the Medical Research Council Working Party on tuberculosis of the spine.

In two centres in Korea 350 patients with a diagnosis of tuberculosis of the thoracic and/or lumbar spine were allocated at random: in Masan to in-patient rest in bed (IP) for six months followed by out-patient treatment or to ambulatory out-patient treatment (OP) from the start; in Pusan to out-patient treatment with a plaster-of-Paris jacket (J) for nine months or to ambulatory treatment without any support (No J). All patients recieved chemotherapy with PAS with isoniazid for eighteen months, either supplemented with streptomycin for the first three months (SPH) or without this supplement (PH), by random allocation. The main analysis of this report concerns 299 patients (eighty-three IP, eighty-three OP, sixty-three J, seventy No J; 143 SPH, 156 PH). Pre-treatment factors were similar in both centres except that the patients in Pusan had, on average, less extensive lesions although in a greater proportion the disease was radiographically active. One patient (J/SPH) died with active spinal disease and three (all No J/SPH) with paraplegia. A fifth patient (IP/PH) who died from cardio respiratory failure also had pulmonary tuberculosis. Twenty-three patients required operation and/or additional chemotherapy for the spinal lesion. A sinus or clinically evident abscess was either present initially or developed during treatment in 41 per cent of patients. Residual lesions persisted in ten patients (four IP, two OP, one J, three No J; six SPH, four PH) at five years. Thirty-two patients had paraparesis on admission or developing later. Complete resolution occurred in twenty on the allocated regimen and in eight after operation or additional chemotherapy or both. Of the remaining four atients, all of whom had operation and additional chemotherapy, three died and one still had paraparesis at five years. Of 295 patients assessed at five years 89 per cent had a favourable status. The proportions of the patients responding favourably were similar in the IP (91 per cent) and OP (89 per cent) series, in the J (90 per cent) and No J (84 per cent) series and in the SPH (86 per cent) and PH (92 per cent) series.

Abscess↗

PubMed1979

Clinical trial of six-month and four-month regimens of chemotherapy in the treatment of pulmonary tuberculosis.

In a study in Singapore, Chinese, Malay, and Indian patients with pulmonary tuberculosis received 2 months of daily treatment with streptomycin, isoniazid, rifampin, and pyrazinamide followed either by daily treatment with isoniazid, rifampin, and pyrazinamide (SHRZ/HRZ regimen) or by daily administration of isoniazid and rifampin (SHRZ/HR regimen) allocated at random. Both regimens were given for either 6 or 4 months by random allocation. All 330 patients with drug-sensitive tubercle bacilli before treatment had a favorable bacteriologic response during chemotherapy. During the first 6 months after the end of chemotherapy, there was only a single bacteriologic relapse among 84 SHRZ/HRZ and 80 SHRZ/HR patients treated for 6 months, but 8 (10 per cent) of 80 SHRZ/HRZ and 4 (5 per cent) of 74 SHRZ/HR patients treated for 4 months relapsed. Of a total of 33 patients with bacilli resistant to isoniazid, streptomycin, or both drugs before treatment, only one had an unfavorable response during chemotherapy, and none of 31 patients relapsed during the first 6 months after stopping chemotherapy. The incidence of adverse reactions was low; 11 (3 per cent) of 397 patients had hepatitis, but not all episodes were attributable to drug toxicity, and one patient had thrombocytopenic purpura.

Adolescent↗

PubMed1992

Histopathology of experimental spinal cord trauma. Comparison of treatment with TRH, naloxone, and dexamethasone.

The results of treatment with thyrotropin-releasing hormone (TRH), naloxone and dexamethasone treatments albino rats with experimental spinal cord injury were compared. All the animals were made paraplegic by the application clip method of Rivlin and Tator. Treatment was administered i.p. as bolus injections in two doses, at 45 and 120 min after the injury. Animals were allocated randomly to four experimental groups: (1) TRH (0.6 mg per dose), (2) naloxone (0.8 mg per dose), (3) dexamethasone (0.6 mg per dose), and (4) control (saline). TRH-treated rats showed significantly better histopathological scores than either naloxone or dexamethasone-treated ones (Kruskal Wallis: 24.058 P less than 0.001).

Animals↗

PubMed1991

Effect of PaCO2 on cerebral blood flow distribution during halothane compared with isoflurane anaesthesia in the rat.

In order to examine anaesthetic effects on the distribution of cerebral blood flow (CBF) during normo- and hypocapnia, male adult Sprague-Dawley rats were allocated randomly to four groups in a 2 x 2 factorial design, using PaCO2 value and anaesthetic agent as between-group factors. Animals were anesthetized with either 1.38% isoflurane (inspired) or 1.05% halothane (inspired) and the lungs ventilated mechanically at either normocapnia (PaCO2 5.1-5.6 kPa) or hypocapnia (PaCO2 3.1-3.3 kPa) for 1 h. CBF was measured using 14C-iodoantipyrine autoradiography. Local CBF in selected cortical and subcortical regions of interest and area-weighted mean global CBF were calculated. Data were compared by analysis of variance. Normocapnic (mean (SE] CBF for halothane (n = 6) and isoflurane (n = 7) was 120 (8) ml/100 g min-1 (PaCO2 5.6 (0.49) kPa) and 117 (9) ml/100 g min-1 (PaCO2 5.4 (0.5) kPa), respectively. Hypocapnic CBF for halothane (n = 6) and isoflurane (n = 6) was 82 (7) ml/100 g min-1 (PaCO2 3.3 (0.12) kPa) and 82 (6) ml/100 g min-1 (PaCO2 3.2 (0.12) kPa), respectively. Hypocapnia reduced global CBF for both groups by 30% (P less than 0.001), but there was no difference between anaesthetic agents (P greater than 0.8). Hypocapnia decreased CBF in all local structures examined. Although subcortical structures had similar CBF at both normocapnia and hypocapnia, CBF in three cortical samples was greater (P less than 0.05) in both the normocapnic and hypocapnic halothane groups than the corresponding isoflurane groups. The CBF reactivity to changes in PaCO2 was similar for both agents (approximately 2 ml/100 g min-1 mm Hg). (ABSTRACT TRUNCATED AT 250 WORDS)

Anesthesia, Inhalation↗

PubMed1992

Differential effects of vecuronium on diaphragm and geniohyoid muscle in anaesthetized dogs.

We have examined the sensitivity of the geniohyoid, an upper airway dilating muscle, to vecuronium in 12 anaesthetized dogs undergoing mechanical ventilation of the lungs and compared it with that of the diaphragm. Dogs were allocated randomly to two groups: pentobarbitone alone (group 1, n = 7); pentobarbitone combined with 0.2 MAC (0.44%) of enflurane anaesthesia (group 2, n = 5). Supramaximal single twitch stimulations (0.1 Hz) were applied to the phrenic nerves in the upper thorax and the geniohyoid branches of the hypoglossal nerves at the neck. The evoked responses were assessed by the transdiaphragmatic pressure (Pdi) and the isometric force of the geniohyoid muscles (Tgh) until complete recovery of these variables after i.v. administration of vecuronium 0.02 mg kg-1. In both groups, the magnitude of the depression of twitch response was greater and time required to reach control amplitude was longer in the geniohyoid than the diaphragm. The depression of Tgh was significantly greater in group 2 than in group 1, whereas no change was observed in Pdi between the two groups. We conclude that the geniohyoid is more sensitive to vecuronium than the diaphragm and the differential effects of vecuronium are facilitated by a low concentration of enflurane.

Anesthesia, Inhalation↗

PubMed1992

Induction of anaesthesia with propofol using a target-controlled infusion system.

Sixty patients premedicated with temazepam were allocated randomly to receive an infusion of propofol designed to achieve and maintain a target blood concentration of 3, 4 or 5 micrograms.ml-1. Induction time was measured from the start of infusion to loss of verbal contact. The success rate of inducing anaesthesia within 3 min of achieving the target concentration was 40% when the predicted target concentration was 3 micrograms.ml-1, 75% when the predicted target was 4 micrograms.ml-1 and 90% when the target was 5 micrograms.ml-1. There were no significant differences between the three groups for time to loss of verbal contact in patients who were induced successfully within 3 min. There were significant reductions in arterial pressure 3 min after achieving the target concentrations within the groups but not between them. The frequency of apnoea and pain on injection was small in all groups. Selecting a target concentration of 5 microgram.ml-1 would successfully induce anaesthesia in the majority of patients premedicated with temazepam without major haemodynamic or respiratory side effects.

Adolescent↗

PubMed1991

Involvement of lipid mediators in the pathogenesis of experimental nephrosis in rats: its pharmacological modulation.

The administration of a single-injection of Adriamycin (ADR) to rats results in marked proteinuria and glomerular morphological changes that are similar to minimal change disease in humans. We have hypothesized that Adriamycin, by itself or through the release of some mediators from resident glomerular cells, could provoke a damage to epithelial glomerular cells. Sprague-Dawley rats received a single injection of Adriamycin, 7.5 mg/kg bw, allocated randomly in several groups and treated throughout 2 weeks of follow-up. All control nontreated animals developed important nephrotic syndrome and degenerative lesions of epithelial glomerular cells. Isolated glomeruli from animals injected with adriamycin 14 days before synthesized thromboxane (TxB2) and platelet activating factor (PAF) in amounts above the rates of control glomeruli. Animals treated with three structurally different PAF receptor antagonists did not present proteinuria or only to a very low extent (p less than 0.0005). In these rats no alterations in epithelial cells were noted. Furthermore, no significant changes in the TxB2 production were noted in rats treated with BN 52021, a PAF receptor antagonist. Leukotrienes also seem to participate since treatment with a 5-lipoxygenase inhibitor partially corrected proteinuria. Moreover, glomeruli from animals with nephrosis and treated with this compound presented only a discrete reduction in the PAF synthesis. On the whole, these data suggest a key role for PAF in the pathogenesis of adriamycin nephropathy. Other lipid meditors, released in cascade simultaneously or thereafter, could perpetuate the renal damage.

Animals↗

PubMed2026

Durvalumab and tremelimumab, with or without lenvatinib, combined with transarterial chemoembolisation in participants with embolisation-eligible hepatocellular carcinoma (EMERALD-3): a global, randomised, open-label, sponsor-blinded, phase 3 study.

BACKGROUND: Transarterial chemoembolisation (TACE), a standard treatment for embolisation-eligible hepatocellular carcinoma (HCC), induces tumour immune responses. Single tremelimumab regular interval durvalumab (STRIDE) is a standard treatment in advanced HCC. In this phase 3 trial, we assessed the efficacy and safety of STRIDE, with or without lenvatinib, plus TACE, in participants with embolisation-eligible HCC. METHODS: EMERALD-3 is a phase 3, randomised, open-label, sponsor-blinded study, conducted at 177 medical sites in 21 countries. Eligible participants were 18 years or older (aged ≥21 years in Egypt or Singapore) at screening and had confirmed HCC (by imaging or histopathologically from biopsy specimen, surgery, or both) not amenable to curative surgery, curative ablation, or transplantation but amenable to TACE. Participants had Child-Pugh class A liver function, an Eastern Cooperative Oncology Group performance status of 0-1, and at least one measurable target intrahepatic lesion per modified Response Evaluation Criteria in Solid Tumours. Participants were randomly allocated in a 1:1:1 ratio to receive STRIDE plus lenvatinib plus TACE, STRIDE plus TACE, or TACE until each group reached its preplanned enrolment target of 175 participants. After the STRIDE plus TACE group reached its enrolment target, randomisation was adjusted to continue in a 1:1 ratio between the STRIDE plus lenvatinib plus TACE group and TACE group until approximately 275 participants were enrolled in each of these two groups. Randomisation used a centrally assigned interactive response technology system, stratified by region, baseline tumour burden, and previous palliative embolisation. In the STRIDE plus lenvatinib plus TACE group, on the first day, participants were given 300 mg tremelimumab intravenously, followed by 1500 mg durvalumab plus oral lenvatinib (8 mg for <60 kg bodyweight or 12 mg for ≥60 kg bodyweight); participants then received 1500 mg durvalumab every 4 weeks plus once-daily lenvatinib for up to 36 cycles. In the STRIDE plus TACE group, participants were given 300 mg tremelimumab and 1500 mg durvalumab intravenously on the first day, followed by 1500 mg durvalumab every 4 weeks. The technique and number of TACE procedures were at the investigators' discretion, with the first procedure administered at least 7 days after the first dose of durvalumab in the two investigation treatment groups and within 7 days of random allocation in the TACE group. The primary endpoint was progression-free survival for STRIDE plus lenvatinib plus TACE versus TACE. Key secondary endpoints were overall survival for STRIDE plus lenvatinib plus TACE versus TACE and progression-free survival and overall survival for STRIDE plus TACE versus TACE. This study was registered with ClinicalTrials.gov (NCT05301842), with enrolment completed. FINDINGS: From March 28, 2022, to Nov 20, 2024, 1124 participants were screened. The full analysis set comprised 760 participants, who were randomly allocated to STRIDE plus lenvatinib plus TACE (n=293), STRIDE plus TACE (n=175), or TACE (n=292). 633 (83%) participants were male and 127 (17%) were female; 548 (72%) were Asian. At the first data cutoff (Sept 2, 2025); the overall median follow-up for progression-free survival was 10·0 months (IQR 4·6-17·2); median follow-up for progression-free survival was 11·0 months (IQR 4·8-18·4) for STRIDE plus lenvatinib plus TACE and 8·3 months (4·1-15·5) for TACE. Median progression-free survival was 13·0 months (95% CI 12·2-16·7) for STRIDE plus lenvatinib plus TACE versus 9·8 months (8·0-11·4) for TACE (HR 0·70 [95% CI 0·57-0·86]; p=0·0007). At the second data cutoff (Feb 23, 2026) and a median follow-up for overall survival of 24·6 months (IQR 16·5-31·5) for STRIDE plus lenvatinib plus TACE and 22·9 months (14·9-30·2) for TACE, median overall survival was 39·5 months (95% CI 34·1-not reached) for STRIDE plus lenvatinib plus TACE and 34·7 months (28·8-not reached) for TACE (HR 0·84 [95% CI 0·65-1·09]; p=0·18). At this data cutoff, median progression-free survival was 12·9 months (95% CI 10·2-15·9) for STRIDE plus TACE and 8·1 months (6·5-10·2) for the first 175 participants randomised to TACE (HR 0·71 [95% CI 0·56-0·91]), with median follow-up of 10·3 months (IQR 4·6-23·7) for STRIDE plus TACE and 7·7 months (3·0-18·5) for the first 175 participants randomly allocated to TACE. The most common adverse events of maximum grade 3 or 4 were hypertension (34 [12%] of 287) for STRIDE plus lenvatinib plus TACE, post-embolisation syndrome and anaemia (ten [6%] of 175 each) for STRIDE plus TACE, and post-embolisation (17 [6%] of 290) for TACE. 184 (64%) participants receiving STRIDE plus lenvatinib plus TACE, 89 (51%) receiving STRIDE plus TACE, and 68 (23%) receiving TACE had serious adverse events. Treatment-related adverse events with an outcome of death during the treatment-emergent period occurred in seven (2%) of 287 participants who received STRIDE plus lenvatinib plus TACE (two for myocarditis; and one each for hepatic failure, haemophagocytic lymphohistiocytosis, septic shock, cardiac failure, and unknown cause), none of 175 participants who received STRIDE plus TACE, and two (1%) of 290 participants who received TACE (one each for acute myocardial infarction and unknown cause). INTERPRETATION: STRIDE plus lenvatinib plus TACE showed a statistically significant progression-free survival improvement versus TACE. These findings support a STRIDE-based regimen as a potential new treatment option for people with embolisation-eligible HCC; additional follow-up is being conducted for final analysis of overall survival across treatment groups. FUNDING: AstraZeneca.

Adult↗

PubMed2026

Once-weekly IcoSema versus once-daily insulin glargine U100 in type 2 diabetes management (COMBINE 4): an open-label, multicentre, treat-to-target, randomised, phase 3b trial.

BACKGROUND: Stepwise treatment intensification is recommended for managing type 2 diabetes, including insulin initiation when non-insulin glucose-lowering medications are insufficient. Guidelines recommend combining a GLP-1 receptor agonist with basal insulin to improve glycaemic efficacy while reducing weight gain and hypoglycaemia risk. COMBINE 4 evaluated the efficacy and safety of IcoSema, a once-weekly combination therapy of basal insulin icodec and semaglutide (a GLP-1-receptor agonist) versus insulin glargine U100 (glargine U100) in people with type 2 diabetes on oral glucose-lowering medications. METHODS: COMBINE 4 was a 40-week, randomised, open-label, treat-to-target, phase 3b trial conducted across 97 sites in nine countries. Adults (aged ≥18 years) with type 2 diabetes (HbA1c ≥8·0%) receiving oral glucose-lowering medications were randomly allocated in a 1:1 ratio without stratification to IcoSema or once-daily glargine U100. The titration target was 3·9-5·0 mmol/L (70-90 mg/dL). The primary endpoint was change in HbA1c and the secondary confirmatory endpoint was change in bodyweight, both from baseline to week 40, evaluated in all randomly allocated participants. Adverse events were recorded during weeks 0-45. This trial is registered with ClinicalTrials.gov (NCT06269107) and is complete. FINDINGS: Of 653 individuals screened between Feb 15 and Aug 6, 2024, 151 did not meet screening criteria and 17 withdrew before initiating treatment; 243 were randomised to IcoSema and 242 to glargine U100. Of the 485 randomly allocated participants, 286 (59%) were male and 199 (41%) were female, and median age was 58 years (range 26-82). For HbA1c, from baseline (9·57% for IcoSema and 9·50% for glargine U100), mean change to week 40 was greater with IcoSema versus glargine U100 (-3·32 vs -2·44 percentage points; estimated treatment difference [ETD] -0·88 percentage points [95% CI -1·12 to -0·63]), confirming superiority of IcoSema (p<0·001). From baseline to week 40, mean bodyweight decreased with IcoSema and increased with glargine U100 (-0·79 vs 3·81 kg; ETD -4·61 kg [95% CI -5·46 to -3·75]), confirming superiority of IcoSema (p<0·001). Rate of combined clinically significant (blood glucose <3·0 mmol/L [<54 mg/dL], confirmed with a blood glucose meter) or severe hypoglycaemia (severe cognitive impairment requiring external assistance for recovery) was statistically significantly lower with IcoSema versus glargine U100 (0·29 vs 0·59 episodes per person-year of exposure; estimated rate ratio 0·56 [95% CI 0·32 to 0·97]; p=0·04). Gastrointestinal disorders were the most frequently reported adverse events with IcoSema. INTERPRETATION: Once-weekly IcoSema demonstrated superior HbA1c reduction and bodyweight change, with lower rates of clinically significant or severe hypoglycaemia, versus glargine U100, suggesting that IcoSema might be an effective once-weekly treatment option for insulin-naive individuals with type 2 diabetes inadequately controlled on oral glucose-lowering medications. FUNDING: Novo Nordisk.

Humans↗

PubMed2026

Efficacy and safety of mitapivat in adults with transfusion-dependent α-thalassaemia or β-thalassaemia (ENERGIZE-T): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial.

BACKGROUND: The absence of disease-modifying therapies for patients with α-thalassaemia and oral disease-modifying therapies for patients with β-thalassaemia has been a substantial unmet need in these patients. We assessed the efficacy and safety of mitapivat, an oral allosteric activator of pyruvate kinase, in adults with transfusion-dependent thalassaemia. METHODS: ENERGIZE-T is a global, double-blind, randomised, placebo-controlled, phase 3 trial, conducted across 19 countries in North America, Europe, Asia-Pacific, South America, and the Middle East. Patients aged 18 years or older with transfusion-dependent α-thalassaemia or β-thalassaemia were randomly allocated (2:1) with a central interactive response technology system, stratified by geographical region and thalassaemia genotype, to receive 100 mg mitapivat or placebo orally twice a day for 48 weeks. The primary endpoint was transfusion reduction response (TRR), defined as a reduction of at least 50% in transfused red blood cell units with a reduction of at least two units in any consecutive 12-week period until week 48 compared with baseline. Efficacy was analysed in the full analysis set, comprising all randomly allocated patients. Type, severity, and relationship of adverse events and serious adverse events were assessed in patients who received at least one dose of study treatment. This study is registered with ClinicalTrials.gov (NCT04770779) and is active but not recruiting. FINDINGS: Between Nov 30, 2021 and May 2, 2023, 305 patients were screened, of whom 258 were randomly allocated (median age 33·5 years [IQR 27·0-44·0]; 136 [53%] female and 122 [47%] male participants). Of 258 patients allocated, 238 (92%) completed the double-blind treatment period. All patients were required to have a safety follow-up approximately 4 weeks after the final dose of study drug, regardless of completion of the double-blind period or continuation into the open-label extension period. In the full analysis set, TRRs occurred in 52 (30%) of 171 patients in the mitapivat group and 11 (13%) of 87 in the placebo group (adjusted difference 18 percentage points [95% CI 8-27]; two-sided p=0·0003). The safety analysis set comprised 172 patients in the mitapivat group (including one patient allocated to the placebo group who received one dose of mitapivat in error) and 85 in the placebo group. Adverse events were reported in 155 (90%) patients treated with mitapivat and 71 (84%) treated with placebo; the most common events with mitapivat were headache, upper respiratory tract infection, initial insomnia, diarrhoea, and fatigue. Serious adverse events were reported in 19 (11%) patients treated with mitapivat and 13 (15%) treated with placebo. Ten (6%) patients who received mitapivat and one (1%) who received placebo discontinued study treatment due to adverse events. No deaths were reported. INTERPRETATION: Mitapivat significantly reduced the transfusion burden and was generally well tolerated, showing a favourable benefit-risk profile. These findings support mitapivat as the first oral disease-modifying therapy for adults with transfusion-dependent α-thalassaemia or β-thalassaemia, providing a new treatment option to reduce transfusion burden in this patient population. FUNDING: Agios Pharmaceuticals, Inc.

Adult↗

PubMed1992

The pain and discomfort experienced during orthodontic treatment: a randomized controlled clinical trial of two initial aligning arch wires.

A randomized controlled clinical trial was performed to compare the nature, prevalence, intensity, and duration of pain related to the use of a relatively recently developed superelastic arch wire and a more traditional multistranded steel arch wire. Other factors likely to influence the pain experience were also investigated. Forty-three subjects participated in the study, the pain response being assessed by each of the visual analogue scales, the questionnaires, and an analgesic consumption record. In 18 of the 43 subjects a standardized preliminary dental extraction procedure was used as a control. Subsequent to the random allocation of an initial arch wire in 43 patients, 22 of them underwent a second arch wire in the opposing arch, the wire again being determined by random allocation. It was found that the prevalence, intensity, and duration of pain after the insertion of the two types of wire was similar but much greater than in the postextraction control phase. The pain score peaked on the morning after the placement of the arch wire, lasting typically for 5 to 6 days. The pain and discomfort experienced after the insertion of the second arch wire was similar to that of the first, no conditioning response being evident. Overall a diurnal variation was found with a tendency to an increase in pain in the evenings and nights, although this did not greatly affect sleep. The pain response was found to be highly and consistently subjective, not related to the dental arch, crowding, sex, or social class; however, a statistically significant association was found between the age and the pain experienced.

Adolescent↗

PubMed1978

Manchester regional breast study. Preliminary results.

1020 patients with early breast cancer were treated between March, 1970, and October, 1975, according to a prospective clinical trial. The results have been recorded after a follow-up of two to seven years. 713 cases of clinical stage-1 cancer were randomly allocated to treatment by simple mastectomy and postoperative radiotherapy, or simple mastectomy alone. There was no statistically significant difference in overall survival or in survival without distant metastases between the two groups. There was a significant reduction in the incidence of local recurrence in those who had received early postoperative radiotherapy compared with those who had not. 307 cases of clinical stage-11 cancer were randomly allocated to treatment by simple mastectomy and postoperative radiotherapy or radical mastectomy alone. There was no statistically significant difference in survival or in the incidence of local recurrence or distant metastases between the two groups.

Adult↗

PubMed1992

Renal scars and parenchymal thinning in children with vesicoureteral reflux: a 5-year report of the International Reflux Study in Children (European branch).

A total of 321 children less than 11 years old with nonobstructive grade III or IV vesicoureteral reflux and with previous urinary tract infection was randomly allocated to medical or surgical treatment in the European branch of the International Reflux Study in Children. (Randomization was stratified for age, sex, grade of reflux, presence of renal scarring, interval since last urinary tract infection and treating hospital). The results of excretory urography are reported for 233 girls and 73 boys treated according to the random allocation, 89% of whom were followed for 5 years. After 5 years in the medical group (155 children) new renal scars were seen in 19 and new renal parenchymal thinning in 11. The proportions were almost identical among 151 children allocated to surgical treatment with 20 new scars and 15 new thinnings. Progression of established scars was also similar in both groups. However, the new scars developed sooner after surgery than during medical treatment. In 6 surgically treated children postoperative obstruction was followed by the development of new scars. In addition, 12 patients showed new scars approximately 6 months after successful surgery, while in only 2 children scars developed more than 6 months after surgery. In 11 children of the medical group new scars were seen more than 6 months after allocation. More new scars developed in the children with parenchymal thinning at entry (23%) than in those with scarred or normal kidneys at entry (10% each) (p < 0.05). The younger the patients at entry, the higher the frequency of new scars (less than 2 years 19.8%) 2 to 4 years 9.8% and 5 years or more 4.6%, p < 0.05).

Child↗

PubMed1975

Randomised clinical trial of strategies for improving medication compliance in primary hypertension.

230 Canadian steelworkers with hypertension took part in a randomised trial to see if compliance with antihypertensive drug regimens could be improved. For care and follow-up these men were randomly allocated to see either their own family doctors outside working-hours or industrial physicians during work shifts; the same men were randomly allocated to receive or not receive an educational programme aimed at instructing them about hypertension and its treatment. Surprisingly, the convenience of follow-up at work had no effect upon these men's compliance with antihypertensive drug regimens. Similarly, although men receiving health education learned a lot about hypertension, they were not more likely to take their medicine.

Antihypertensive Agents↗

PubMed1977

Blood glucose control and glomerular capillary basement membrane thickening in experimental diabetes.

Glomerular capillary basement membrane thickness (BMT) was measured in 23 rats which had had streptozocin-induced diabetes for 14 months and in 12 age-matched controls. Diabetic rats were randomly allocated to different groups, either receiving no treatment or treated with a low carbohydrate diet or insulin, or both. Control rats were randomly allocated to a normal or low carbohydrate diet. Among the diabetic rats mean plasma glucose concentrations for the groups ranged from 27-4 mmol/l (494 mg/100 ml) in the untreated rats to 9-8 mmol/l (177 mg/100 ml) in those receiving both a low carbohydrate diet and insulin. A highly significant positive relation was found between BMT and plasma glucose concentration for individual rats. When BMT was corrected for body weight a similar relation was observed.

Animals↗

PubMed2026

Moderate alcohol intake and heart rate variability adaptations to high-intensity interval training in healthy young adults: the BEER-HIIT study.

BACKGROUND: It is unknown whether daily alcohol consumption influences training effects on heart rate variability (HRV). This study investigated: (i) the effects of a 10-week high-intensity interval training (HIIT) on HRV in healthy young adults; and (ii) the effects of daily alcohol consumption on HRV responses to exercise. METHODS: 71 healthy young adults (18-40 years old; 52.1% women) participated in the BEER-HIIT study. We conducted a 10-week (2 days/week) controlled trial (ClinicalTrials.gov ID: NCT03660579). Participants were allocated to 5 groups: a non-training group (N-T) and four HIIT groups. Participants in the training groups chose whether to consume alcohol. Those choosing alcohol were randomly allocated to receive beer (5.4%; T-Beer) or an equivalent amount of alcohol (vodka; T-Ethanol) in sparkling water. Those choosing no alcohol were randomly allocated to receive alcohol-free beer (0.0%; T-Zero) or sparkling water (T-Water). Training comprised eight weight-bearing exercises performed in circuit form. HRV was measured before and after the intervention. RESULTS: No statistically significant between-group differences in HRV outcomes were detected after the intervention (all p > 0.05). CONCLUSIONS: Our findings indicate that: (i) no statistically significant differences in HRV responses were detected following a 10-week HIIT program using weight-bearing exercises performed twice per week; and (ii) no statistically significant differences in HRV responses were observed among the assigned beverage intervention groups. These findings should be interpreted cautiously because HRV was a secondary outcome and the study was not specifically powered to detect differences in these parameters.

alcohol↗

PubMed1992

Effects of skirting on processing characteristics of Targhee wool.

Ninety mature Targhee ewes were randomly allocated to nine lots. Lots were randomly assigned to three fleece preparation treatments: 1) nonskirted (control); 2) bellies removed, in which bellies and topknots were removed on the shearing floor; and 3) skirted, in which bellies and topknots were removed and remaining fleece was thrown on a table and lightly skirted. Bellies and topknots composed about 6 to 7% of the fleece weight. An additional 6.6% was removed when fleeces were skirted. Top fiber diameters were not affected (P greater than .10) by skirting. Although not significant (P greater than .10), percentage yield, vegetable content, percentage of noilage, top fiber length, and yellowness indexes tended to be most desirable for skirted lots and least desirable for unskirted lots. Lots with bellies removed were intermediate. Removal of bellies reduced vegetable contamination by 8.4%, with an additional reduction of about .5% by further skirting. Skirting reduced the number of fibers less than 25.4 mm (P less than .10) by 42%. Minimal colored fiber contamination of top was observed. One colored fiber per 15 g of top was detected in two lots of the treatment with bellies removed. All other lots contained no colored fibers. All wools evaluated were well below industry limits set for use in high-quality white or pastel fabrics. All skirted lots of wool evaluated in this study had improved processing characteristics for all processing traits evaluated.

Animal Husbandry↗