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81.
An increasing number of drugs removed from the market because of unacceptable toxicity raises concerns regarding preapproval
testing of drug safety. In the present paper it is postulated that the non-inferiority type of trial should be abandoned in
favor of the superiority trial with active controls and less stringent (p<0.1, both for efficacy and toxicity) statistics.
This approach will increase sensitivity of detection of drug-induced adverse effects at the expense of increasing false positive
results regarding the difference in efficacy between the tested and reference drug. Such a move will increase the protection
of future patients. In addition, the proposed design is far more acceptable from the clinical (e.g. no need to specify the
statistically expected “unimportant” number of deaths) and ethical points of view, as well as being favored by the strong
incentive of involved parties. In the second part of this paper arguments are presented in favor of the hypothesis that placebo
(still used in some superiority trials) does not induce adverse effects. The assertion that placebo may induce adverse effects
is probably biased by the nature of the clinical experiment. Such a conclusion is supported by studies indicating that placebo-induced
adverse effects are disease — and treatment — specific. The modification of clinical trials according to the proposed changes
may increase the trials’ sensitivity at detecting adverse effects of drugs.
A lecture on the subject of this paper was presented at the 6th International Bioethics Conference on the subject of ‘The
Responsible Conduct of Basic and Clinical Research’, held in Warsaw, Poland, 3–4 June 2005. 相似文献
82.
The Lambek calculus introduced in Lambek [6] is a strengthening of the type reduction calculus of Ajdukiewicz [1]. We study
Associative Lambek Calculus L in Gentzen style axiomatization enriched with a finite set Γ of nonlogical axioms, denoted by
L(Γ).It is known that finite axiomatic extensions of Associative Lambek Calculus generate all recursively enumerable languages
(see Buszkowski [2]). Then we confine nonlogical axioms to sequents of the form p → q, where p and q are atomic types. For calculus L(Γ) we prove interpolation lemma (modifying the Roorda proof for L [10]) and the binary reduction
lemma (using the Pentus method [9] with modification from [3]). In consequence we obtain the weak equivalence of the Context-Free
Grammars and grammars based on L(Γ). 相似文献
83.
Joanna?Golińska-PilarekEmail author Taneli?Huuskonen 《Journal of Philosophical Logic》2005,34(2):193-206
We show that there are continuum many different extensions of SCI (the basic theory of non-Fregean propositional logic) that lie below WF (the Fregean extension) and are closed under substitution. Moreover, continuum many of them are independent from WB (the Boolean extension), continuum many lie above WB and are independent from WH (the Boolean extension with only two values for the equality relation), and only countably many lie between WH and WF. 相似文献
84.
85.
Zygmunt Ziembiński 《Studia Logica》1964,15(1):261-269
Allatum est die 3 Junii 1963 相似文献
86.
Although Directive 2001/20/EC of the European Parliament and of Council of 4 April 2001 on the approximation of the laws regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use does not contain an exception for emergency situations, and requires the informed consent of a legal representative in all cases where research is conducted on legally competent individuals who are unable to give informed consent, in Poland, emergency research can be conducted without consent. Polish regulations on emergency research can hardly be treated as a result of intentional legislative policy. Our provisions arise from multiple and sophisticated interpretations of different regulations that govern medical experiments on human subjects and clinical trials. These interpretations can be summarized as follows: (1) There are two categories of medical experiments: therapeutic and non-therapeutic experiments. Emergency research without consent may be conducted in the category of therapeutic experiment only (therapeutic experiment consists of the introduction by the physician of new or only partially proven diagnostic, therapeutic or preventive methods in order to achieve direct benefit to the health of the patients, and it can be carried out when hitherto applied methods were ineffective or their effectiveness was insufficient). (2). Emergency research may be conducted without consent if there is a situation of great urgency in which the research subject's life is in danger and there is no possibility of obtaining immediate consent from the research subject him or herself, or from his or her legal representative or guardianship court, and the research subject has not refused to give consent for the participation in an emergency therapeutic experiment. The legal representative or guardianship court shall be provided with all the relevant information concerning subject's participation in an experiment as soon as possible. All projects of emergency research with intent to be done without the research subject's consent must be approved by an independent bioethics committee. Because these five requirements seem to provide insufficient protection for a subject's autonomy and rights it is necessary to add to them two other conditions: (1) the emergency research could not be conducted using other research participants capable of giving informed consent; and (2) informed consent for continued participation in the emergency research shall be obtained from either the participant him or herself or the legally authorized representative as soon as possible (requirement of obtaining deferred consent). A consolidated single Act that will govern all aspects of medical experiments on human subjects, including emergency research, should be prepared and enacted as soon as possible. 相似文献
87.
88.
Tomasz Rzepiński 《Theoretical medicine and bioethics》2014,35(4):271-288
The present paper deals with the problem of evaluating empirical evidence for therapeutic decisions in medicine. The article discusses the views of Nancy Cartwright and John Worrall on the function that randomization plays in ascertaining causal relations with reference to the therapies applied. The main purpose of the paper is to present a general idea of alternative method of evaluating empirical evidence. The method builds on data analysis that makes use of rough set theory. The first attempts to apply the method show that it is an interesting alternative to randomized controlled trials. 相似文献
89.
SCIENCE,RELIGION, AND THE MEANING OF LIFE AND THE UNIVERSE: “AMALGAM” NARRATIVES OF POLISH NATURAL SCIENTISTS 下载免费PDF全文
Maria Rogińska 《Zygon》2016,51(4):904-924
This article deals with phenomena occurring at the interface of the existential, the religious, and scientific inquiry. On the basis of in‐depth interviews with Polish physicists and biologists, I examine the role that science and religion play in their narrative of the meaning of the Universe and human life. I show that the narratives about meaning have a system‐related (“amalgam") character that is associated with responses to adjacent metaphysical questions, including those based on scientific knowledge. I reconstruct the typical amalgam questions of Polish scientists and come to a conclusion about the stability of religious and nonreligious amalgams in this group. Critically referring to the thesis concerning the secularizing impact of science, I conclude that science by itself does not have a destructive effect on Polish scientists’ confidence that life and the Universe are meaningful, but is rather an exacerbating factor of the existing worldview system. 相似文献
90.