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PubMed1992

Molecular dynamics of luteinizing hormone receptors on rat luteal cells.

To better understand the in situ organization of the luteinizing hormone receptor on rat luteal cells, we have examined the molecular motions of this receptor following binding of ovine luteinizing hormone (oLH) or human chorionic gonadotropin (hCG). Fluorescence photobleaching recovery (FPR) measurements of LH receptor lateral diffusion were performed using tetramethylrhodamine isothiocyanate (TRITC)-derivatized oLH or hCG as a probe. These experiments indicate that TRITC-oLH occupied LH receptors on luteal cells obtained from superovulated female rats have a lateral diffusion coefficient D of (1.7 +/- 0.6).10(-10) cm2s-1 at 27 degrees C with fluorescence recovery after photobleaching of 46 +/- 5%. In similar experiments, binding of TRITC-hCG caused a significant decrease in LH receptor lateral diffusion; fluorescence recovery after photobleaching was less than 20%. To determine whether hCG-occupied receptors might exist in large aggregates, we measured the rotational correlation times (RCT) of hCG and oLH bound to the LH receptor on intact cells using single cell polarized fluorescence depletion (PFD). At 4 degrees C, LH receptors occupied by eosin isothiocyanate (EITC)-hCG exhibited a slower RCT (64 microseconds) than did receptors occupied by EITC-oLH (43 microseconds). At this temperature both TRITC-oLH and TRITC-hCG occupied LH receptors were laterally immobile. These FPR and PFD results suggest that the molecular motions of the luteal cell LH receptor are significantly modulated by the subtle structural differences in various bound gonadotropins.

Animals↗

PubMed1993

Epidermoid carcinoma of the anal canal: treatment by combined radiation and chemotherapy.

From June 1985 to September 1991, 44 patients with epidermoid carcinoma of the anal canal were treated prospectively by a protocol of combined radiation and chemotherapy (RCT) with 5-fluorouracil (5-FU) and mitomycin C (MTC). External radiation was delivered with 10 MV photons and single daily fractions between 1.8 and 2 Gy in an uninterrupted course up to a median total dose of 50 Gy. 5-FU was given by a continuous intravenous infusion (1 g/m2/day) for 96 h on days 1-4 and 29-32, MTC by a single bolus intravenous injection of 10 mg/m2 on days 1 and 29. The actuarial survival rate, no evidence of disease (NED) survival rate and local tumour control rate were 84%, 71% and 83% at 5 years. Anorectal function was retained in 33 of 41 patients (80%). Severe acute toxicity including three fatal outcomes was observed and there was an acceptable late morbidity. The only marginally significant prognostic factor (p = 0.06) for local tumour control was T-stage. RCT can provide good local control and preserve anal function with acceptable morbidity.

Adult↗

PubMed1993

Neurophysiological evaluation in myasthenia gravis. A comprehensive study of a complete patient population.

Electrical and mechanical responses to single shocks, slow and fast nerve stimulation (RNS), quantitated EMG, anti-acetylcholine receptor (AChR) and anti-striated muscle (SM) antibodies (ab) were determined in 145 patients with myasthenia gravis (MG). Anti-AChR ab were found in 93% of the myasthenic sera. Decrement of muscle and mechanical responses occurred in 72% and 49%, respectively, the diagnostic yield being positively related to severity of MG. Anti-AChR ab were found in 81% of patients without RNS abnormalities. Decrement at RNS occurred in 33% of the cases without anti-AChR ab compared with 78% of those with elevated titres. Regional curare test (RCT) was diagnostic in 75% of cases with normal RNS. As the combined diagnostic yield of RNS and anti-AChR ab was 96%, RCT and single fibre EMG are rarely indicated. Post-tetanic facilitation and exhaustion, and an abnormal staircase phenomenon occurred in 25%, 44% and 37%, respectively. None of these parameters correlated with severity, type or onset of MG. EMG evidence of myopathy, positively correlated with the presence of anti-SM ab, occurred in 19% of patients examined, 3 times more frequent in those with late onset of MG than in those with early onset; thus myopathy of possible autoimmune origin may coexist with MG. An adequate electrophysiological diagnostic strategy for MG patients is proposed.

Adult↗

PubMed1988

Study design for technology assessment: critical issues.

The epidemiological methods have become useful tools for the assessment of the effectiveness and safety of health care technologies. The experimental methods, namely the randomized controlled trials (RCT), give the best evidence of the effect of a technology. However, the ethical issues and the very nature of the intervention under study sometimes make it difficult to carry out an RCT. Therefore, quasi-experimental and non-experimental study designs are also applied. The critical issues concerning these designs are discussed. The results of evaluative studies are of importance for decision-makers in health policy. The measurements of the impact of a medical technology should go beyond a statement of its effectiveness, because the essential outcome of an intervention or programme is the health status and quality of life of the individuals and populations concerned.

Clinical Trials as Topic↗

PubMed1981

A method for assessing the quality of a randomized control trial.

A system has been constructed to evaluate the design, implementation, and analysis of randomized control trials (RCT). The degree of quadruple blinding (the randomization process, the physicians and patients as to therapy, and the physicians as to ongoing results) is considered to be the most important aspect of any trial. The analytic techniques are scored with the same emphasis as is placed on the control of bias in the planning and implementation of the studies. Description of the patient and treatment materials and the measurement of various controls of quality have less weight. An index of quality of a RCT is proposed with its pros and cons. If published papers were to approximate these principles, there would be a marked improvement in the quality of randomized control trials. Finally, a reasonable standard design and conduct of trials will facilitate the interpretation of those with conflicting results and help in making valid combinations of undersized trials.

Clinical Trials as Topic↗

PubMed1994

Enhanced neoplastic lesion development with adenine-induced experimental multicystic nephropathy by adenine--a model system for the analysis of renal tumor generation in long-term hemodialysis patients.

To cast light on the high incidence of renal cell tumors (RCT) in long-term hemodialysis patients, the role of background multicystic nephropathy was studied in a rat model. Group 1 animals were initially given N-ethyl-N-hydroryethylnitrosamine (EHEN) then subjected to adenine feeding until killing during weeks 20-27. Groups 2 and 3 received EHEN and adenine, respectively. All rats receiving adenine developed multicystic nephropathy. The incidence of renal cell hyperplasias (RCH) and multiplicities of both RCH and RCT in Group 1 were significantly increased as compared with Group 2, suggesting multicystic nephropathy provides favorable environment for tumor development.

Adenine↗

PubMedDate not supplied

Gender differences in cocaine use and treatment response.

Much of our understanding of treatment efficacy in drug abuse is based on male drug abusers. In order to determine if there are gender differences in baseline drug use and treatment response, we compared male and female cocaine abusers who participated in an outpatient randomized clinical trial (RCT) evaluating pharmacotherapies for cocaine abuse. Although females had more severe drug problems at intake, they were as successful as males in the RCT and more successful at 6-month follow-up.

Adult↗

PubMed1994

Informed consent in European multicentre randomised clinical trials--are patients really informed?

This study was designed to examine the standard of consent used by investigators in European randomised clinical trials (RCT). The participants of 12 multicentre RCTs published in the European Journal of Cancer in the years 1990-1992 were asked to complete a short questionnaire regarding their practice of obtaining consent in the trial reported. Anonymity was assured. Replies were received from 60 of 88 clinicians contacted. Data showed that 12% of clinicians did not inform their patients about the trial prior to randomisation. Thirty-eight per cent of clinicians did not always tell patients that they had been assigned to their treatment randomly. Only 32% of clinicians used written consent, 21% used written information without obligatory signing, 42% used verbal consent, and in 5% no consent was sought. Even when information was given, only 58% of clinicians gave full information on all aspects of the trial and 42% gave information on the proposed treatment arm only (27% revealing inclusion in an RCT). When examined by geographical origin, clinicians in northern Europe were more likely to obtain full consent than those from southern Europe. Similarly, the level of consent was higher in trials of supportive care than in trials testing curative or palliative antitumour therapies.

Communication↗

PubMed2005

Rationale--Trial to Reduce Cardiovascular Events with Aranesp Therapy (TREAT): evolving the management of cardiovascular risk in patients with chronic kidney disease.

BACKGROUND: Patients with chronic kidney disease (CKD) have a high burden of mortality and cardiovascular morbidity. Additional strategies to modulate cardiovascular risk in this population are needed. Data suggest that anemia is a potent and potentially modifiable risk factor for cardiovascular disease in patients with CKD, but these data remain unsubstantiated by any randomized controlled trial (RCT). Furthermore, the clinical practice guidelines for anemia management in patients with CKD are based on limited data. The need for new RCTs to address critical knowledge deficits, particularly with regard to the impact of anemia therapy on cardiovascular disease and survival, is recognized within the guidelines and independent comprehensive reviews of the existing published trial data. STUDY DESIGN: The Trial to Reduce Cardiovascular Events with Aranesp (Amgen Inc, Thousand Oaks, Calif) (darbepoetin alfa) Therapy (TREAT) is a 4000-patient, multicenter, double-blind RCT, designed to determine the impact of anemia therapy with darbepoetin alfa on mortality and nonfatal cardiovascular events in patients with CKD and type 2 diabetes mellitus. Subjects will be randomized in a 1:1 manner to either darbepoetin alfa therapy to a target hemoglobin (Hb) of 13 g/dL or control, consisting of placebo for Hb > or =9 g/dL or darbepoetin alfa for Hb <9 g/dL until Hb is again Hb > or =9 g/dL. TREAT is event-driven and has a composite primary end point comprising time to mortality and nonfatal cardiovascular events, including myocardial infarction, myocardial ischemia, stroke, and heart failure. TREAT will provide data that are critical to evolution of the management of cardiovascular risk in this high-risk population.

Anemia↗

PubMed2026

Rationale, design, and experiences from the vanguard phase of the bariatric surgery for the reduction of cardiovascular events (BRAVE) trial.

BACKGROUND: Observational studies suggest that metabolic/bariatric surgery (MBS) reduces mortality and major adverse cardiovascular events in patients with obesity, but adequately powered randomized trials (RCTs) are lacking. The Bariatric Surgery for the Reduction of Cardiovascular Events (BRAVE) trial was designed to address this evidence gap. METHODS: BRAVE is an investigator-initiated, multi-center, open-label RCT with blinded endpoint adjudication comparing MBS vs guideline-based medical weight management (MWM) in adults with obesity and high-risk cardiovascular disease (CVD). Eligible participants have a body-mass index ≥35 kg/m² or ≥30 kg/m² with type 2 diabetes or age >55 years, and prior myocardial infarction (MI), coronary intervention, heart failure (HF), atrial fibrillation (AF) with elevated CHA₂DS₂-VASc score, cerebrovascular disease, or peripheral arterial disease. Participants are randomized 1:1 to MBS (sleeve gastrectomy, Roux-en-Y gastric bypass, or duodenal switch) or MWM, which includes dietary, behavioral, and pharmacologic therapies. The primary outcome is the composite of all-cause death, MI, stroke, HF events, coronary revascularization, AF hospitalization, and renal events. A vanguard phase of 200 participants was implemented to optimize recruitment and logistics. RESULTS: As of October 2025, 2,514 individuals have been screened from 17 centers in Canada, Brazil, Italy and Spain, with 444 entered MBS work-up, and 200 have been randomized. The randomized cohort (mean age 59.8 years; 37% female; mean BMI 44.0 kg m⁻²) has high burden of hypertension (82%), diabetes (45%), coronary artery disease (44%), HF (39%), and AF (48%). Recruitment barriers were identified and addressed through targeted education and enhanced patient engagement. CONCLUSIONS: BRAVE is the first large RCT evaluating whether MBS safely reduces major cardiovascular events compared with medical therapy in high-risk patients with obesity. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05531474.

Humans↗

PubMed2005

Acupuncture for upper-extremity rehabilitation in chronic stroke: a randomized sham-controlled study.

OBJECTIVE: To compare the effects of traditional Chinese acupuncture with sham acupuncture on upper-extremity (UE) function and quality of life (QOL) in patients with chronic hemiparesis from stroke. DESIGN: A prospective, sham-controlled, randomized controlled trial (RCT). SETTING: Patients recruited through a hospital stroke rehabilitation program. PARTICIPANTS: Thirty-three subjects who incurred a stroke 0.8 to 24 years previously and had moderate to severe UE functional impairment. INTERVENTIONS: Active acupuncture tailored to traditional Chinese medicine diagnoses, including electroacupuncture, or sham acupuncture. Up to 20 treatment sessions (mean, 16.9) over a mean of 10.5 weeks. MAIN OUTCOME MEASURES: UE motor function, spasticity, grip strength, range of motion (ROM), activities of daily living, QOL, and mood. All outcomes were measured at baseline and after treatment. RESULTS: Intention-to-treat (ITT) analyses found no statistically significant differences in outcomes between active and sham acupuncture groups. Analyses of protocol-compliant subjects revealed significant improvement in wrist spasticity (P<.01) and both wrist (P<.01) and shoulder (P<.01) ROM in the active acupuncture group, and improvement trends in UE motor function (P=.09) and digit ROM (P=.06). CONCLUSIONS: Based on ITT analyses, we conclude that acupuncture does not improve UE function or QOL in patients with chronic stroke symptoms. However, gains in UE function observed in protocol-compliant subjects suggest traditional Chinese acupuncture may help patients with chronic stroke symptoms. These results must be interpreted cautiously because of small sample sizes and multiple, unadjusted, post hoc comparisons. A larger, more definitive RCT using a similar design is feasible and warranted.

Activities of Daily Living↗

PubMed2026

Development, feasibility, acceptability, and preliminary impact of NutriSOS®: A behavioral mobile app to promote sustainable diets.

The primary objective of this study was to describe the development of the NutriSOS® app and to evaluate its feasibility and acceptability for its use in the NutriSOS® Randomized Controlled Trial (RCT) to promote sustainable diets. A secondary objective was to explore preliminary changes in dietary and physical activity behaviors and environmental impact following app use. The NutriSOS® app integrates personalized dietary advice, educational content, self-monitoring, and social interaction features. A single-arm, pre-post pilot study was conducted in 37 young Mexican adults over four weeks. Feasibility, acceptability, quality, and usability were assessed using online surveys, alongside exploratory changes in dietary and physical activity behaviors, environmental indicators, and their association with perceived behavioral determinants. Feasibility and acceptability were high overall, with favorable responses reaching up to 100% in key components such as the nutritional guide and learning modules, and above 90% for messaging, registration, and design. Greater variability was observed in some sections, particularly the 24-h recall (41-86%). Reductions in red and processed meat and ultra-processed food consumption were observed (from 3 to 1 times/week, p < 0.01), with ∼60% decreases in their related environmental footprints (p < 0.01) and favorable self-reported behavioral determinants (p < 0.0001). Physical activity type and intensity changed (p < 0.05). These findings support NutriSOS® as a feasible and acceptable tool, while highlighting areas for refinement, particularly those related to the time and effort required for data entry, prior to its implementation in the NutriSOS® RCT, in which its effectiveness will be formally evaluated.

Humans↗

PubMed2006

5-fluorouracil and weekly oxaliplatin combined with radiotherapy for locally advanced rectal cancer: surgical complications and long-term results.

BACKGROUND: We undertook this study to evaluate early surgical complications and long-term results after preoperative radiotherapy and chemotherapy (RCT) using 5-fluorouracil (5-FU) and oxaliplatin (OXA) for rectal cancer. METHODS: Forty six TNM stage II-III rectal cancer patients were studied, who were given preoperative RT (50.4 Gy/28 fractions) combined with 5-FU (200-225 mg/m(2)/day by continuous venous infusion) and weekly OXA (25-60 mg/m(2)). Major complications and reoperations were recorded overall, whereas outcome analyses were performed only for patients who received the recommended regimen dosage. RESULTS: Forty three patients (M:F, 25:18; median age 59 years) were available for analysis. All patients received the planned RT dose. There were no postoperative deaths; seven patients had early major surgical complications, four requiring re-operation. One additional patient had a second surgical procedure due to a duodenal fistula complicating the resection of an aortic aneurysm performed concomitantly with rectal cancer surgery. At a median follow-up of 49 months, two of the 23 patients treated at the recommended doses developed recurrence (one local, and one local and distant), and two died of cancer progression. Following the Kaplan-Meier method, the estimated 5-year overall and disease-free survival rates were 92 and 89%, respectively. CONCLUSIONS: The preoperative RCT regimen used in the present study incurs a low rate of recurrence with an acceptable surgical morbidity.

Adult↗

PubMed2005

Human scavenger receptor class B type I is expressed with cell-specific fashion in both initial and terminal site of reverse cholesterol transport.

The reverse cholesterol transport (RCT) is one of the major protective systems against atherosclerosis, in which high-density lipoprotein (HDL) removes cholesterol from lipid-laden cells and delivers it to the liver. Scavenger receptor class B type I (SR-BI) is a HDL receptor in the liver and adrenal glands and is involved in the selective uptake of cholesteryl ester from HDL, which has been extensively, analyzed using rodent models. However, the expression and regulation of the human homologue of this receptor are not known yet. We previously reported that this receptor is expressed in in vitro differentiated macrophages and its expression is up-regulated by the addition of modified lipoproteins into the medium [Hirano K, Yamashita S, Nakagawa Y, et al. Expression of human scavenger receptor class B type I in cultured human monocyte-derived macrophages and atherosclerotic lesions. Circ Res 1999;85:108-16]. In order to further investigate the physiological significance of this receptor in humans, we have performed extensive immunohistochemical analyses with specimens of the liver and adrenal glands as well as arteries with different stages of atherosclerotic lesions. In human liver and adrenal glands, a positive SR-BI immunoreactivity was detected in both hepatic and adrenal parenchymal cells as well as Kupffer cells. These parenchymal cells had a strong signal on the cell surface, whereas Kupffer cells showed a heterogeneous and punctate pattern. In human aorta and coronary arteries, SR-BI was highly expressed in atherosclerotic plaques, but not in non-atherosclerotic lesions. Double immunostaining revealed that SR-BI was expressed in a subpopulation of macrophages, of which staining pattern was similar to that observed in Kupffer cells. These data clearly demonstrated that SR-BI was expressed with cell-specific fashions in both the initial and terminal step of RCT in humans. Thus, SR-BI might be physiologically relevant and have distinct tissue-specific functions.

Adrenal Glands↗

PubMed2006

Scavenger receptor class B Type I (SR-BI) assembles into detergent-sensitive dimers and tetramers.

High density lipoproteins (HDL) are protective against cardiovascular disease due to their important role in the reverse cholesterol transport (RCT) pathway. The selective transfer of cholesteryl ester (CE) from the HDL core to cells, the last step in RCT, is mediated by scavenger receptor class B type I (SR-BI). SR-BI is a heavily glycosylated cell surface receptor that is highly expressed in the liver, ovaries, testes and adrenal glands, where selective uptake of HDL-CE is most prevalent. Previous studies have shown that SR-BI oligomerizes with itself in steroidogenic tissues as well as in diverse cell lines. In the present study, we provide further evidence for the homo-oligomerization of SR-BI. We show by FPLC and blue native PAGE that SR-BI forms complexes whose sizes suggest the formation of monomers, dimers, and tetramers. Interestingly, homo-oligomerization occurs even with the absence of SR-BI's C-terminal cytoplasmic domain. Finally, we report that an inhibitor of SR-BI-mediated cholesterol transport, BLT-1, and mutations in the putative leucine zipper region of SR-BI have profound effects on SR-BI function, however, they do not affect receptor self-association. These observations indicate that SR-BI homo-oligomerization occurs even when the receptor is non-functional.

Animals↗

PubMed2026

Implementing a novel digital health platform for self-management of postmenopausal osteoporosis: A qualitative study of user experiences, perspectives and implementation outcomes.

BACKGROUND: Osteoporosis self-management requires scalable support, and digital health platforms may meet this need. This study aimed to characterise the experiences and perspectives of postmenopausal women who participated in a 12-month randomised controlled trial (RCT) of a digital voice assistant (DVA) delivered osteoporosis self-management intervention, and to assess key implementation outcomes. METHODS: This was a qualitative analysis of interviews with postmenopausal women from the intervention arm (DVA group) of the RCT. The DVA program broadcast education videos, medication reminders, home-based exercise, nutrition advice and monthly quizzes through a DVA device. Semi-structured interviews were recorded, transcribed and managed in NVivo through reflexive thematic analysis, guided by the Practical Planning for Implementation and Scale-Up and Proctor's implementation outcome taxonomy frameworks. Evidence weighting summarised participant coverage and code density. RESULTS: Twenty-two of 25 (88%) DVA group participants completed semi-structured interviews. Thematic analysis identified seven themes mapped to Proctor's implementation outcomes. Evidence weighting indicated strong support for the intervention's appropriateness and acceptability, moderate support for its adoption, fidelity, feasibility and sustainability, and limited support for costs. Participants valued clear audiovisual guidance, conversation-based interactions with natural language, and flexible home-based access to self-management. CONCLUSION: Digital health platforms for osteoporosis self-management appear feasible, acceptable and sustainable among postmenopausal women. Findings indicate that these platforms are approaching readiness for evaluation in implementation-focused settings, contingent on streamlined content, reliable delivery modalities, accessible user support, clear privacy regulations and pragmatic pricing models.

Humans↗

PubMed2004

Searching for evidence: Refractory questions in advanced heart failure.

BACKGROUND: Despite ample data from randomized clinical trials (RCTs), the management of advanced heart failure (HF) varies greatly. We examined the most common refractory questions arising in routine inpatient management of advanced HF. METHODS: From the inpatient HF service at 1 hospital, we prospectively recorded clinical questions arising for which there were no clear answers available about HF management. When possible, patients received angiotensin-converting enzyme (ACE) inhibitors, beta-blockers, and spironolactone as used in RCTs. We identified the topics and frequencies of questions and categorized them as Group 1--whether to use a therapy--or Group 2--how to use a therapy. RESULTS: During 2 separate months, 318 questions arose among 57 patients. The most common topics involved the use of diuretics, potassium, and ACE inhibitors, most often about how to titrate diuretics, what targets to use to optimize diuretic therapy, and how to select discharge doses of diuretics. Questions of whether to use a therapy occurred 73 times, and how to use a therapy, 242 times. RCT data were difficult to apply to these questions because little information exists about how to combine and titrate HF drugs and how to adjust diuretics. Questions about individual drugs arose in patients who fell outside the average RCT entry criteria for age, blood pressure, and creatinine. CONCLUSION: Most refractory questions focused on how to integrate and adjust therapies within the overall medical regimen and how to apply data to patients not represented in RCTs. Future studies should evaluate strategies of care for the advanced HF population.

Aged↗

PubMed2005

Are certain multicenter randomized clinical trial structures misleading clinical and policy decisions?

Multicenter studies involving randomized clinical trials (RCTs) may have different structures. We discuss four general types. The first two, an "ideal" multicenter RCT and decentralized multicenter collaborative RCTs, we feel are, in different circumstances, highly recommended approaches. The other two, the multicenter RCT that ignores site differences and centralized multicenter collaborative RCTs, we argue, are not only not cost-effective but may also produce misleading results, thus impeding scientific progress and possibly putting patients at unnecessary risk.

Data Interpretation, Statistical↗