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991.
CONTEXT: Taping and orthoses are frequently applied to control excessive foot pronation to treat or prevent musculoskeletal pain and injury of the lower limb. The mechanism(s) by which these devices bring about their clinical effects are at best speculative and require systematic evaluation. OBJECTIVE: To determine the initial effect of the augmented low Dye taping technique (ALD) on plantar foot pressures during walking and jogging. DESIGN: Within-subjects, repeated-measures randomized control trial. SETTING: Gait research laboratory. PATIENTS OR OTHER PARTICIPANTS: Fifteen women and 7 men with an average age of 28.0 +/- 7.4 years who were asymptomatic. INTERVENTION(S): Participants walked and jogged along a 12-m walkway before and after the application of ALD. The untaped side served as the control. MAIN OUTCOME MEASURE(S): Peak and mean maximum plantar pressure data were calculated for the medial and lateral areas of the rear and midfoot and the medial, central, and lateral forefoot areas. Thus, a 3-factor model was tested: condition (ALD, control) x time (preapplication, postapplication) x area (medial and lateral rearfoot and midfoot and medial, central, and lateral forefoot). RESULTS: Significant 3-way interactions were present for both peak and mean maximum plantar pressure during walking (F (6,126) = 9.55, P = .006 and F (6,126) = 11.36, P = .003, respectively) and jogging (F (6,126) = 5.76, P = .026 and F (6,126) = 4.56, P = .045, respectively) tasks. The ALD predominantly increased plantar pressures in the lateral midfoot during walking and jogging. In addition, tape reduced mean maximum pressure at the medial forefoot and at the medial rearfoot during walking. CONCLUSIONS: The ALD, which has previously been shown to reduce excessive pronation, produced significant increases in lateral midfoot plantar pressures, thereby providing additional information to be considered when the mechanism(s) of action of such a treatment are modeled.  相似文献   
992.
Gut microbiota and development of atopic eczema in 3 European birth cohorts   总被引:3,自引:1,他引:2  
BACKGROUND: Stimulation of the immune system by gut microbes might prevent allergy development. OBJECTIVE: The present study examined the hypothesis that sensitization to food allergens and atopic eczema are influenced by the infantile intestinal colonization pattern. METHODS: Infants were recruited perinatally in G?teborg (n = 116), London (n = 108), and Rome (n = 100). Commensal bacteria were identified to the genus or species level in rectal (3 days) and quantitative stool cultures (7, 14, and 28 days and 2, 6, and 12 months of age). At 18 months of age, atopic eczema and total and food-specific IgE levels were assessed. These outcomes were modeled in relation to time to colonization with 11 bacterial groups and to ratios of strict anaerobic to facultative anaerobic bacteria and gram-positive to gram-negative bacteria at certain time points. Study center, mode of delivery, parity, and infant diet were included as covariates. RESULTS: Neither atopic eczema nor food-specific IgE by 18 months of age were associated with time of acquisition of any particular bacterial group. Cesarean section delayed colonization by Escherichia coli and Bacteroides and Bifidobacterium species, giving way to, for example, Clostridium species. Lack of older siblings was associated with earlier colonization by Clostridium species and lower strict anaerobic/facultative anaerobic ratio at 12 months. CONCLUSIONS: This study does not support the hypothesis that sensitization to foods or atopic eczema in European infants in early life is associated with lack of any particular culturable intestinal commensal bacteria. CLINICAL IMPLICATIONS: The nature of the microbial stimulus required for protection from allergy remains to be identified.  相似文献   
993.
BACKGROUND: Severe asthma causes the majority of asthma morbidity. Understanding mechanisms that contribute to the development of severe disease is important. OBJECTIVE: The goal of the Severe Asthma Research Program is to identify and characterize subjects with severe asthma to understand pathophysiologic mechanisms in severe asthma. METHODS: We performed a comprehensive phenotypic characterization (questionnaires, atopy and pulmonary function testing, phlebotomy, exhaled nitric oxide) in subjects with severe and not severe asthma. RESULTS: A total of 438 subjects with asthma were studied (204 severe, 70 moderate, 164 mild). Severe subjects with asthma were older with longer disease duration (P < .0001), more daily symptoms, intense urgent health care utilization, sinusitis, and pneumonia (P < or = .0001). Lung function was lower in severe asthma with marked bronchodilator reversibility (P < .001). The severe group had less atopy by skin tests (P = .0007), but blood eosinophils, IgE, and exhaled nitric oxide levels did not differentiate disease severity. A reduced FEV(1), history of pneumonia, and fewer positive skin tests were risk factors for severe disease. Early disease onset (age < 12 years) in severe asthma was associated with longer disease duration (P < .0001) and more urgent health care, especially intensive care (P = .002). Later disease onset (age > or = 12 years) was associated with lower lung function and sinopulmonary infections (P < or = .02). CONCLUSION: Severe asthma is characterized by abnormal lung function that is responsive to bronchodilators, a history of sinopulmonary infections, persistent symptoms, and increased health care utilization. CLINICAL IMPLICATIONS: Lung function abnormalities in severe asthma are reversible in most patients, and pneumonia is a risk factor for the development of severe disease.  相似文献   
994.
Participation of children in focus groups has received scant attention despite the effectiveness of group interviews in eliciting children's views. Focus groups are a valuable approach for generating qualitative data from children; however, conducting school-based focus groups involves challenges specific to the school milieu and the ages and development of the participants. Lessons learned from conducting school-based focus groups during the Child-Adolescent Teasing Scale (CATS) project are applied to examination of key issues including entry to schools, informed consent and confidentiality, students' cognitive development, safety within the group, and appropriate procedures.  相似文献   
995.

Background

Wearable devices offer huge potential to collect rich sources of data to provide insights into the effects of treatment interventions. Despite this, at the time of writing this report, limited regulatory guidance on the use of wearables in clinical trial programs has been published.

Objectives

To present recommendations from the Critical Path Institute’s Electronic Patient-Reported Outcome Consortium regarding the selection and evaluation of wearable devices and their measurements for use in regulatory trials and to support labeling claims.

Methods

The evaluation group was composed of Critical Path Institute’s clinical outcome assessment (COA) scientists and COA specialists from pharmaceutical trial eCOA solution providers, including COA development and validation specialists. The resulting recommendations were drawn from a broad range of backgrounds, perspectives, and expertise that enriched the development of this report. Recommendations were developed through analysis of existing regulatory guidance relating to COA development and use in clinical trials, medical device certification/clearance regulations, literature-reported best practice, and practical experience of wearable technology application in clinical trials.

Results

We identify the essential properties of fit-for-purpose wearables and propose evidence needed to support their use. In addition, we overview the activities required to establish clinical endpoints derived from wearables data.

Conclusions

Using this framework, we believe there is enough current understanding to promote the appropriate use of wearables in study protocols. We hope this will provide a basis for discussion among clinical trial stakeholders and catalyze the development of more robust regulatory guidance.  相似文献   
996.

Background

Studies comparing different forms of asbestos are rare, and limited by the failure to compare results with unexposed populations. We compare autoimmune responses among former workers and residents of the crocidolite mining and milling town of Wittenoom, Western Australia, with an unexposed population.

Methods

ANA testing using indirect immunofluorescence was performed on randomly selected serum samples from Wittenoom workers or residents and compared with those from participants of another unexposed cohort study.

Results

ANA scores were higher in the Wittenoom participants compared with Busselton and the odds of being ANA positive was fivefold greater among Wittenoom participants than Busselton (OR 5.5, 95%CI 2.3‐13.0).

Conclusions

This study is the first to report increased ANA positivity among persons exposed exclusively to crocidolite. This finding of a high frequency of positive ANA tests among crocidolite‐exposed subjects may be an indicator for an increased risk of systemic autoimmune diseases and needs further scrutiny.
  相似文献   
997.
System development for image-guided therapy (IGT), or image-guided interventions (IGI), continues to be an area of active interest across academic and industry groups. This is an emerging field that is growing rapidly: major academic institutions and medical device manufacturers have produced IGT technologies that are in routine clinical use, dozens of high-impact publications are published in well regarded journals each year, and several small companies have successfully commercialized sophisticated IGT systems. In meetings between IGT investigators over the last two years, a consensus has emerged that several key areas must be addressed collaboratively by the community to reach the next level of impact and efficiency in IGT research and development to improve patient care. These meetings culminated in a two-day workshop that brought together several academic and industrial leaders in the field today. The goals of the workshop were to identify gaps in the engineering infrastructure available to IGT researchers, develop the role of research funding agencies and the recently established US-based National Center for Image Guided Therapy (NCIGT), and ultimately to facilitate the transfer of technology among research centers that are sponsored by the National Institutes of Health (NIH). Workshop discussions spanned many of the current challenges in the development and deployment of new IGT systems. Key challenges were identified in a number of areas, including: validation standards; workflows, use-cases, and application requirements; component reusability; and device interface standards. This report elaborates on these key points and proposes research challenges that are to be addressed by a joint effort between academic, industry, and NIH participants.  相似文献   
998.
999.
1000.
In this paper we report on current experience and review magnetic resonance safety protocols and literature in order to define practices surrounding MRI-guided interventional and surgical procedures. Direct experience, the American College of Radiology White paper on MR Safety, and various other sources are summarized. Additional recommendations for interventional and surgical MRI-guided procedures cover suite location/layout, accessibility, safety policy, personnel training, and MRI compatibility issues. Further information is freely available for sites to establish practices to minimize risk and ensure safety. Interventional and intraoperative MRI is emerging from its infancy, with twelve years since the advent of the field and well over 10,000 cases collectively performed. Thus, users of interventional and intraoperative MRI should adapt guidelines utilizing universal standards and terminology and establish a site-specific policy. With policy enforcement and proper training, the interventional and intraoperative MR imaging suite can be a safe and effective environment.  相似文献   
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