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Biomedical subjects

J Montes

Publications and source records attributed to J Montes.

At least 19 recordsLinked to original sources

Development and evaluation of a self-administered version of the ALSFRS-R.

We evaluated the reliability and sensitivity to change over time of a newly developed self-administered version of the ALS functional rating scale-revised (ALSFRS-R) in 60 consecutive patients from an ALS clinic. The self-administered ALSFRS-R showed excellent reliability (intraclass correlation = 0.93, 95% CI: 088 to 0.96) and similar sensitivity to change over time vs the standard evaluator-administered ALSFRS-R.

Activities of Daily Living↗

Randomized controlled phase II trial of glatiramer acetate in ALS.

The authors conducted a randomized controlled trial to test the safety and immunology of glatiramer acetate in ALS. Twenty treated patients were randomly assigned to daily or biweekly injections. Ten control patients were selected from another trial and followed up concurrently. Injection reactions were the only common adverse event (p = 0.01). Treated patients showed enhanced lymphocyte proliferation (p = 0.02). The safety profile and immune effects support conducting larger trials of dose selection and efficacy.

Drug Administration Schedule↗

A two-stage design for a phase II clinical trial of coenzyme Q10 in ALS.

BACKGROUND: The combination of a small pool of patients at any given time with the availability of many potential neuroprotective agents to be tested in ALS requires efficient phase II trial designs. OBJECTIVE: To describe the design of the Clinical Trial of High Dose Coenzyme Q10 (CoQ10) in ALS (QALS study)--a phase II, randomized, placebo-controlled, double-blind, multicenter clinical trial. METHODS: The study design features two stages. The first stage (dose selection) identifies which of two doses of CoQ10 (1800 mg or 2700 mg) is preferred using a selection procedure rather than a formal hypothesis test. The second stage (early efficacy test) compares the preferred dose of CoQ10 against placebo using a non-superiority or futility design. Data from patients assigned to the preferred dose of CoQ10 in the first stage are also used in the second stage. The primary outcome measure is the decline in Amyotrophic Lateral Sclerosis Functional Rating Scale-revised (ALSFRSr) score from baseline to 9 months. RESULTS: The total sample size required is 185 patients, as compared to a much larger sample size estimated to be necessary using a conventional superiority design (total: 852 patients). The authors report a bias correction made necessary by the inclusion of patient data from the first stage in the second stage. CONCLUSIONS: Several features of the Clinical Trial of High Dose Coenzyme Q10 in ALS study design promote efficiency. These features may be beneficial in phase II trials in amyotrophic lateral sclerosis and other fields.

Adult↗

Fatal pulmonary embolism and fatal bleeding in cancer patients with venous thromboembolism: findings from the RIETE registry.

OBJECTIVES: To examine the clinical characteristics and outcomes of cancer patients with venous thromboembolism (VTE) in order to identify factors that place these patients at an increased risk for fatal pulmonary embolism (PE) or fatal bleeding. PATIENTS AND METHODS: Registro Informatizado de la Enfermedad Trombo Embólica (RIETE) is a prospective registry of consecutive patients with symptomatic, objectively confirmed, acute VTE. RESULTS: Up to January 2006, a total of 14 391 patients with symptomatic acute VTE were enrolled in RIETE, of whom 2945 (20%) had cancer. During the 3-month follow-up period the frequency of fatal PE in cancer patients was 2.6%, and that of fatal bleeding 1.0%. These frequencies were significantly higher than in VTE patients without cancer (1.4% and 0.3%, respectively). In patients with cancer, abnormal renal function, metastatic disease, recent major bleeding and recent immobility for >or= 4 days (42% of the 108 patients who died from PE or bleeding had recent immobility) were factors independently associated with an increased risk for both fatal PE and fatal bleeding. In addition, PE diagnosis on admission was an independent risk factor for fatal PE, while body weight < 60 kg was an independent risk factor for fatal bleeding. CONCLUSIONS: Both fatal PE and fatal bleeding are more common in cancer patients with VTE than in those patients without cancer. In cancer patients, abnormal renal function, metastatic disease, recent major bleeding and recent immobility for >or= 4 days are associated with an increased risk for both fatal PE and fatal bleeding.

Aged↗

Control of hypertension in patients at high risk of cardiovascular disease.

BACKGROUND: Hypertension is a major cardiovascular risk factor, but knowledge about the real magnitude of the problem and its determinants is lacking. AIM: To assess control of hypertension and evaluate medical resource use, in patients at high risk of cardiovascular disease. DESIGN: Multicentric cross-sectional study. METHODS: We collected data for 2205 adult patients from 36 centres, representative of all regions of Spain. Patients had attended out-patient clinics from July 2002 to August 2003, had an absolute cardiovascular risk > or =20% at 10 years (according to the Framingham guidelines), and had a diagnosis of hypertension. Pregnant and terminally ill patients were excluded. RESULTS: Hypertension was inadequately controlled in 1384 patients (62.8%). LDL cholesterol was higher in patients with uncontrolled hypertension (median 130.2 vs. 120.0 mg/dl, p < 0.001). Haemoglobin A(1c) in diabetic patients was also greater in those with uncontrolled hypertension (median 7.10% vs. 6.90%, p = 0.010). Uncontrolled hypertension was associated with the following variables, in descending strength of association: higher LDL cholesterol, taking antihypertensive medication, living in non-metropolitan areas, and higher body mass index. DISCUSSION: Hypertension is poorly controlled in most patients with a high risk of cardiovascular disease. Uncontrolled hypertension is frequently associated with poor control of other risk factors.

Aged↗

[Home versus inpatient therapy for deep venous thrombosis. A cost-comparative analysis].

AIMS: To compare the home-care management of deep vein thromboses (DVT) by a Home Care Unit (HCU) respect to conventional inpatient treatment. METHODS: Twenty-one patients with a doppler-ecography diagnosis of DVT were managed by the HCU during 2002. In 7 out 13 a concomitant diagnosis of pulmonary embolism (PE) was made by lung scan. Median age was 81 years, 52% were women and all, except one case, showed severe medical concomitant conditions. All patients received low-weight molecular heparin, followed by oral anticoagulants in 3 patients. No patients died and only one was hospitalized briefly due to a poor thrombosis-related pain control. Costs of this patient were added to those of HCU. A comparison was made between ambulatory and hospitalary costs for EP and DVT. Pharmacological treatment costs were calculated for a 10-days period. RESULTS: The length of inhospital stay was 1 day for HCU vs. 8 days (DVT) and 13 days (EP). There was a estimated cost-saving of 1680 per patient. CONCLUSIONS: The management of DVT in patients with serious conditions, can be accomplished safely and in a cost-saving manner by a Home Care Unit.

Adult↗

Osteopathia striata with cranial sclerosis: clinical, radiological, and bone histological findings in an adolescent girl.

Osteopathia striata with cranial sclerosis (OS-CS) is a rare skeletal dysplasia characterized by linear striations of the long bones, osteosclerosis of the cranium, and extra-skeletal anomalies. We provide a comprehensive description of the skeletal phenotype in a French-Canadian girl with a moderate to severe form of sporadic OS-CS. Multiple medical problems, including anal stenosis and the Pierre-Robin sequence, were evident in the first few years of life. At 14 years, she was fully mobile, with normal intellect and stature. She suffered chronic lower extremity pain in the absence of fractures, as well as severe headaches, unilateral facial paralysis, and bilateral mixed hearing loss. Biochemical indices of bone and mineral metabolism were within normal limits. Bone densitometry showed increased areal bone mineral density in the skull, trunk, and pelvis, but not in the upper and lower extremities. An iliac bone biopsy specimen revealed an increased amount of trabecular bone. Trabeculae were abnormally thick, but there was no evidence of disturbed bone remodeling. In a cranial bone specimen, multiple layers of periosteal bone were found that covered a compact cortical compartment containing tightly packed haversian canals. Bone lamellation was normal in both the iliac and skull samples. Osteoclast differentiation studies showed that peripheral blood osteoclast precursors from this patient formed functional osteoclasts in vitro. Thus, studies of bone metabolism did not explain why bone mass is increased in most skeletal areas of this patient. Cranial histology points to exuberant periosteal bone formation as a potential cause of the cranial sclerosis.

Adolescent↗

Posterior quadrantic dysplasia or hemi-hemimegalencephaly: a characteristic brain malformation.

INTRODUCTION: Posterior quadrantic dysplasia (PQD), a developmental malformation involving the temporal, parietal, and occipital lobes of one cerebral hemisphere, leads to intractable epilepsy. OBJECTIVE: To characterize the clinical features of 19 patients with PQD and analyze the postsurgical outcome of those who underwent resection of dysplastic tissue. METHODS: The extent and nature of the malformation were primarily assessed with high-resolution brain imaging. Fourteen patients underwent complete or partial temporoparieto-occipital resection or temporal resection associated with parieto-occipital disconnection. Postoperative follow-up period ranged from 8 months to 7 years. The authors used the Engel classification for postoperative outcome. RESULTS: All patients were sporadic. Clinical features included infantile spasms, partial seizures, mental retardation, mild hemiparesis, and visual field defects. Neuroimaging localized the malformation within the posterior cerebral quadrant contralateral to the neurologic deficit and demonstrated hemi-hemimegalencephaly in 14 of 19 patients and multilobar cortical dysplasia in 5 of 19 patients. The authors observed class I outcome in six patients. Two patients had class II and four patients had class III outcome. Class IV outcome was seen in two patients. After surgery, two patients developed mild hemiparesis, and two developed a visual field defect. CONCLUSIONS: Widespread cortical dysplasia is more frequent in the posterior quadrant. In our series, posterior quadrantic dysplasia represents either hemi-hemimegalencephaly or multilobar cortical dysplasia. Individuals with posterior quadrantic dysplasia share a spectrum of clinical features. The intractable epilepsy in these patients may be alleviated by a large quadrantic temporoparieto-occipital resection.

Adolescent↗

Factors related to non-participation in a population-based breast cancer screening programme.

The main objectives were to describe the measures taken by women to detect breast disease prior to invitation to participate in a screening programme for breast cancer, and to identify factors related to non-participation in this programme. A cross-sectional study was designed at the Breast Cancer Early Detection Program of Sabadell-Cerdanyola (BCEDP), using data collected in interviews conducted face to face or over the telephone with 13 760 women participating in the programme and 280 non-participants. A total of 74.2% of the participants versus 70.4% of the non-participants reported having taken measures to detect breast disease, and 71.7% of the participants had undergone mammography versus 69.6% of the non-participants. Of the 10 057 women who had had mammograms, 58% had done so less than 2 years previously. Factors found to be associated to non-participation in the multivariate analysis were: higher level of education, higher occupational skills or working at home, self- or gynaecological examination of breasts, and having received hormone replacement therapy. Higher age group was the only factor that increased the probability of not having undergone mammography previously. Despite the high prevalence of prior measures to detect breast cancer and the similar prevalence between participating and non-participating women, this behaviour is much less prevalent in the group of women 60 years of age or older.

Age Factors↗

Resection of the lesion in patients with hypothalamic hamartomas and catastrophic epilepsy.

BACKGROUND: Patients with hypothalamic hamartomas (HH) often have severe refractory epilepsy, incapacitating behavioral abnormalities, and cognitive decline. Attempts to control the seizure disorder by resection of apparently epileptogenic mesial temporal or other cortical structures have failed consistently. OBJECTIVE: To report a series of 13 patients in whom the hamartoma itself was resected. METHODS: All patients underwent preoperative evaluation between ages 2 and 33 years and had subtotal or complete resection of the hamartoma. Follow-up ranged from 1 to 5.5 years (mean: 2.8 y). RESULTS: Preoperatively, all patients had variable combinations of gelastic, complex partial, and generalized seizures. Eight had drop attacks. In addition, all had marked behavior abnormalities and cognitive impairment. Postoperatively, two patients are completely seizure-free and 11 are either seizure-free or have achieved a greater than 90% reduction of drop attacks and generalized tonic-clonic seizures. However, minor gelastic, complex partial, and atypical absence seizures have persisted in 11 patients, although at significantly reduced rates. In addition, there has been a dramatic improvement in behavior and cognition. Three patients had an anterior thalamic and one a capsular infarct, which left only minimal long-term deficits. Exact location of the lesion in relation to the interpeduncular fossa and the walls of the third ventricle correlated with extent of excision, seizure control, and complication rate. CONCLUSION: Resection can alleviate both the seizures and the behavioral and cognitive abnormalities of hypothalamic hamartomas, but complications are frequent.

Adolescent↗

Ciprofibrate versus gemfibrozil in the treatment of mixed hyperlipidemias: an open-label, multicenter study.

Mixed hyperlipidemia is a common risk factor for cardiovascular disease. The aim of this trial was to evaluate the efficacy and safety of ciprofibrate versus gemfibrozil for the treatment of patients with mixed hyperlipidemia carefully selected for similar lipid profiles. A total of 68 patients who had mixed hyperlipidemia after following an isocaloric American Heart Association (AHA) phase I diet for 4 weeks were included. The plasma lipid levels at the inclusion were low-density lipoprotein-cholesterol (LDL-C) > or = 130 mg/dL, cholesterol > or = 240 mg/dL, and triglycerides > or = 200 mg/dL. Patients were randomly assigned to receive ciprofibrate 100 mg/d or gemfibrozil 1,200 mg/d. At the end of the 8-week treatment period, efficacy and safety parameters were compared with baseline values. The primary efficacy parameters of the study were percentage changes in triglycerides and LDL-C from baseline. After 8 weeks, plasma triglyceride concentrations were decreased by 43.5% and 54% compared with baseline during ciprofibrate and gemfibrozil therapy, respectively (P <.001). High-density lipoprotein-cholesterol (HDL-C) concentrations were increased 20.8% and 19.3% during ciprofibrate and gemfibrozil, respectively (P <.001). Apoprotein B, cholesterol, and very-low-density lipoprotein-cholesterol (VLDL-C) concentrations were also improved by the study drugs (18.6%, 13.2%, and 30.9%, respectively, during ciprofibrate and 44%, 13.8%, and 14.4%, respectively, during gemfibrozil). Meanwhile, the effect of the drug was minimal on LDL-C. A significant decrease in non-HDL-C resulted from both treatments (19% and 19.5%, respectively, P <.05). The only statistically significant difference observed between treatments was the effects on fibrinogen concentration, a coronary risk factor. Ciprofibrate significantly decreased its concentration by 18.8%, fibrinogen was slightly increased during gemfibrozil treatment. No patient had a significant modification on any of the safety tests. In summary, ciprofibrate and gemfibrozil are well-tolerated and efficacious treatments for mixed hyperlipidemia. Significant reductions in triglycerides, non-HDL-C, and apolipoprotein B were achieved with both drugs. A significant fibrinogen reduction was obtained with ciprofibrate.

Adolescent↗

[New trends in the regulation of medical practice in the context of health care reform: the Mexico case].

The recent panorama of medical practice regulation in Mexico is exposed. The dynamics of regulation changes is observed in different areas, with particular intensity in the labor market. Changes seem to be moving towards the constitution of a new regulatory model. A full state regulation for the last 50 years, is being substituted by a model where private and professional corporations are increasing their influence through informal mechanisms of regulation. In the constitution of this new model, the presence of a wide variety of actors claiming regulatory authority is notorious. Three of these new actors are analyzed: The National Commission for Medical Arbitrage, managed care models of medical services, and Specialists Certification Councils. The changes that have occurred in the process of regulation and its future transformation have an intimate link with the reform of the Mexican health care system.

Certification↗

[Prospective assessment of clinical outcomes in patients with lung cancer].

BACKGROUND: The aim of this study was to assess the outcome in patients with lung cancer. PATIENTS AND METHODS: Prospective study in 93 patients with lung cancer in 3 community hospitals. In each evaluation (4-6 weeks) the following results were obtained: a) questionnaire on the quality of life or performance status (QoL/PS), based on different instruments (Karnofsky Performance Scale [KPS], ECOG, QLQ-C30, and the Nottingham Health Profile [NHP], and b) a clinical questionnaire. Active follow-up was for 18 months and survival tracking was to five years. A descriptive analysis of the outcome variables and a survival analysis (Kaplan-Meier) were done. The prognostic value of each instrument (Cox) and the correlation between the instruments (Spearman) were also evaluated. RESULTS: The mean values recorded at the time of diagnosis between 60% and 70% of the maximum value possible. Mean survival was 12.4 months; accumulated survival was 30% to one year and 4% to 55 months. Only 17% of patients presented any disease-free period. Toxicity of treatment was almost always irrelevant. The correlation between the KPS, the QLQ-30 and the NHP was acceptable and their initial values were important prognostic factors. The QoL/PS scores for the survivors were similar to their initial values, but the global values were 11%. CONCLUSIONS: The outcomes measures used in this study provide very useful information, although registration and analysis of the necessary data should be systematic. The KPS was comparable to the other QoL/PS indicators used, but it is shorter, more acceptable and easier to use. Better QoL/PS measurement instruments are needed to evaluate outcomes in the practice of clinical oncology.

Adult↗

A revised description of Haplosporidium armoricanum, parasite of Ostrea edulis L. from Galicia, northwestern Spain, with special reference to the spore-wall filaments.

Haplosporidian spores from Ostrea edulis, previously described as Minchinia armoricana, were reexamined by light and electron microscopy. These spores were either free among host cells or enclosed in sporocysts. They contained two long epispore cytoplasm extensions (ECE), each possessing cytoskeletal structures corresponding to the filaments. After lysis and degradation of the ECE, these extensions disappeared and the spores became devoid of membrane-bound extensions. However, 2 long filaments (approximately 130 microm long) persisted that were closely attached, in opposition to the spore wall, by a bundle of 9-13 fibers each. Thus, we propose a revised description of M. armoricana (= H. armoricana) to confirm its placement in the genus Haplosporidium as H. armoricanum.

Animals↗