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The TCu380A, TCu220C, multiload 250 and Nova T IUDS at 3,5 and 7 years of use--results from three randomized multicentre trials. World Health Organization. Special Programme of Research, Development and Research Training in Human Reproduction: Task Force on the Safety and Efficacy of Fertility Regulating Methods.

The WHO Special Programme of Research, Development and Research Training in Human Reproduction has conducted between 1979 and the present, three randomized comparative clinical trials of the TCu220C, Multiload 250, Nova T and TCu380A devices in 24 centres in 14 countries. The comparative study of the TCu220C and the Multiload 250 devices was completed after three years of use with no significant differences in event rates between the devices (three-year cumulative pregnancy rates of 1.7% and 2.8%, respectively). The Nova T device was discontinued from the comparative study with the TCu220C after five years of use having shown significantly higher cumulative pregnancy rates at three and at five years of use-6.6% and 12.3%, respectively, compared to 4.4% and 6.6%, respectively, for the TCu220C. In the comparative study of the TCu220C and TCu380A, the latter device had significantly lower cumulative pregnancy rates of 1.0%, 1.4% and 1.6% at three, five and seven years of use, respectively (comparative results for the TCu220C: 3.4%, 4.0% and 4.9%, respectively). It is suggested that the TCu380A life span be extended to at least seven years of use and the device be considered as a non-surgical, potentially reversible, alternative to tubal ligation for women needing long-term fertility regulation.

Adult

[WHO Special Program of Research, Development and Research Training in Human Reproduction (HRP). A summary].

The world population is still increasing dramatically. This rapid growth takes place mainly in developing countries and represents a considerable obstacle to the improvement of the economic and social conditions in these countries. A higher acceptance of various fertility-regulating methods is one important factor in the reduction of the population growth. An increasing acceptance cannot be realised without the general availability of safe and effective methods for all users while considering and respecting the multiple different cultural backgrounds. The WHO Special Programme of Research, Development and Research Training in Human Reproduction (HRP), a programme of an international organisation with high esteem particularly in developing countries, contributes considerably to this field, therefore should be supported more widely.

Contraception

Research for the research phobic: developing research expertise in hospital social work.

The need for professional accountability and empirically based practice in hospital social work is growing. Yet, many clinicians are hampered by doubts about their knowledge and skill in research. A staff development program was designed by the author to increase staff awareness of empirical practice techniques and to reduce staff anxiety about their ability to consume and produce research. The program combines peer support and an incremental approach to learning research skills. Many of the participants were able to complete research-related activities after completing the program.

Anxiety

The WHO multicentre trial of the vasopressor effects of combined oral contraceptives: 1. Comparisons with IUD. Task Force on Oral Contraceptives. WHO Special Programme of Research, Development and Research Training in Human Reproduction.

Changes in blood pressure were measured at three-monthly intervals over one year in a prospective study of 704 women using an oral contraceptive (OC) containing levonorgestrel 250 ug with ethinyl estradiol 50 ug and 703 women using an intrauterine device (IUD). The study was conducted in 11 centres in seven developing and three developed countries. Women using OC developed systolic blood pressures which were 3.6-5.0 mmHg higher than those using IUDs; their diastolic pressures became 1.9-2.7 mm higher. The OC-induced change was not affected by climate, age, a family history of hypertension, stroke or heart disease or by a history of hypertension in pregnancy. The life-table rate of hypertension (BP 140/90 or more) in the first year of OC treatment was 0.6 +/- 0.4 in the developing countries and 1.1 +/- 0.8 in the developed ones, per 100 woman-years of use. The vasopressor response to OC varied widely between centres but was not obviously related to the economic development of the country.

Adolescent

The WHO multicentre trial of the vasopressor effects of combined oral contraceptives: 2. Lack of effect of estrogen. Task Force on Oral Contraceptives. WHO Special Programme of Research, Development and Research Training in Human Reproduction.

Changes in blood pressure were measured in a randomized double-blind trial of 680 women using oral contraceptives containing either 50 or 30 ug of ethinyl estradiol combined with 250 mg levonorgestrel. The trial was done in 6 centres in Thailand, India, Zambia, Cuba, The Philippines, and Hungary. There were no significant differences between the two pills at any of 4 follow-up visits at approximately 3, 6, 9 and 12 months, nor in the life-table probability of developing hypertension within one year. These findings are evidence against the hypothesis that it is the estrogen in oral contraceptives which causes their vasopressor effect.

Adolescent

A multicentre study of coagulation and haemostatic variables during oral contraception: variations with geographical location and ethnicity. Task Force on Oral Contraceptives--WHO Special Programme of Research, Development and Research Training in Human Reproduction.

A comparative study of the effects of combined oral contraceptives (OC) on coagulation and fibrinolytic variables using standardized laboratory technique and methodology has been performed in Dublin (Ireland), Salvador (Brazil), Santiago (Chile) and Singapore. Of 777 entrants to the study, 622 were randomly allocated to receive one of four different OC formulations. The remainder did not opt for OC. The progestogenic component was levonorgestrel (LNG) in three of the OC formulations and norethisterone acetate (NEA) in the fourth. Results for the three LNG user groups were pooled. The changes in haematological variables observed over 12 months in the LNG and NEA users were examined in relation to the changes seen in the women not on OC. Women in Salvador differed markedly from those in the other three centres, in showing no acceleration of the prothrombin time and no increase in either fibrin plate lysis or plasminogen following the use of OC. After adjusting the findings in OC users for those in non-users, significant differences in response between centres were also detected for activated partial thromboplastin time (accelerated only in Dublin and Santiago), factor VII activity (increased mainly in Salvador and Santiago) and fibrinogen (for which the most marked changes were an increase in Dublin and a decrease in Salvador). This variability between centres in the effects of OC on coagulation and fibrinolysis suggests that OC administration in different populations may not carry equal thrombotic risks.

Adult

A multicentre study of coagulation and haemostatic variables during oral contraception: variations with four formulations. Task Force on Oral Contraceptives--WHO Special Programme of Research, Development and Research Training in Human Reproduction, World Health Organization, Geneva, Switzerland.

OBJECTIVE: To explore the extent to which progestogen type and oestrogen and progestogen dose may modify the effects of combined oral contraceptives (OC) on coagulation and haemostasis. DESIGN: Randomized double-blind clinical trial. SETTING: Gynaecological clinics in Salvador (Brazil), Santiago (Chile), Singapore, and Dublin (Ireland). SUBJECTS: 622 women aged 18-35 years who had opted for oral contraception. A contrast group of 155 women who were not to receive OC was also studied. Both groups included approximately equal numbers from each of the four centres. INTERVENTIONS: Treatment of approximately equal numbers of women at each centre with one of the following OC preparations for at least 12 months: Norethisterone acetate (NEA) 1 mg + ethinyl oestradiol (EE) 50 micrograms; levonorgestrel (LNG) 250 micrograms + EE 50 micrograms; LNG 250 micrograms + EE 30 micrograms; LNG 150 micrograms + EE 30 micrograms. MAIN OUTCOME MEASURES: Changes over 12 months in 12 coagulation and haemostatic variables. RESULTS: At 12-month follow-up, the women on each OC preparation showed acceleration of prothrombin time and increase in factor X and fibrinogen. With the OC containing NEA there was also a persistent rise in factor VIIC, and reduction of antithrombin III and alpha 2-antiplasmin. The formulation which contained low doses of both LNG and EE showed the least adverse coagulation changes. Large increases in fibrinolysis were found in all OC groups. CONCLUSIONS: The adverse effects of combined OC on clotting are affected by the type and dose of progestogen as well as the dose of oestrogen.

Adolescent

Team research: development of "we" in nursing research.

Team (tem) n. 1. a. Two or more draft animals harnessed to a vehicle or farm implement, b. A vehicle along with the animal or animals harnessed to it. 2. A group of animals exhibited or performing together. 3. A group of players on the same side in a game. 4. Any group organized to work together.

Humans

[Music therapy single case process research--development and organization of a research field].

Music therapy yet to be discovered as a target of psychotherapy research. A first step consists in creating adequate samples of significant musical dialogues. Video-recording is an essential requirement for establishing such data. To test the clinical view that the emotional content of the musical dialogue in music therapy reflects the basic relationship issues of a patient was the objective of this study. By using ratings of significant musical dialogue sequences with the instrument of semantic differential comparing groups with varying clinical expertise (music therapists, psychoanalyts, lay persons) the results demonstrate that there is considerable stability of the judgments; however, systematic differences exists among the three groups of raters.

Adult

Accessing community development research methodologies.

This paper is a perspective on the strengths and weaknesses of community development research offered to health promoters by a community development insider. The author provides her rationale for the opinion that no research paradigm other than the qualitative one satisfies the naturalistic context of either community development or health promotion, including inquiry into concepts such as community health, community wellbeing, community competence and community self-reliance. Attention is drawn to key aspects of the community development process with relevance to health promoters which are largely undertheorized, including clarity about the central issue of the nature of the interaction among learning, action and change. Finally, the paper specifies three implications of the naturalistic paradigm for either research or practice. These include academic prejudice against qualitative research from some quarters, the limitations of all research paradigms for some questions, and essential uncertainties of naturalistic inquiry.

Community Health Services

Moral and ethical development research in nursing education.

Research in moral development is breaking into exciting new territory with the long overdue inclusion of the female perspective. Nursing education needs to be on the forefront of this cutting edge, seeking new ways to help students confront the difficult moral dilemmas they will face daily as members of the nursing profession.

Curriculum

Drug research, development and expenditure - what about the future?

Drug research and development today is an undertaking requiring special skills and understanding, formidable financial resources and the closely co-ordinated co-operation of everyone concerned with the drug programme in all its aspects. Incorrect results, wrong deductions or decisions and unrealistic delays due to bureaucratic obstructions, all have an adverse effect in the final analysis. The price (financially and otherwise) we have to pay for the end-product is invariably intimately related to what happened during the entire development process. Everyone connected with drug development, in whatever capacity, has a moral obligation to ensure that the development programme follows a path which is as smooth as possible.

Forecasting

The role of the individual and the community in the research, development, and use of biologicals with criteria for guidelines: a memorandum.

In view of the widely recognized need to use available vaccines and other biologicals and to develop new ones to control many diseases of world-wide importance, this Memorandum considers the increasingly complex problems that face investigators and public authorities that must review and approve pre-licensing studies and also large-scale regular use. It is stressed that the proper conduct of biologicals research in human beings must be considered from the scientific, sociological, ethical, and legal points of view. The Declaration of Helsinki is regarded of fundamental importance and its applicability to biologicals research is discussed. Recommendations are made for continued international collaboration in this field and "Criteria on the Role of the Individual and the Community in the Research, Development, and Use of Biologicals" are formulated. General criteria and specific criteria related to the design of field trials, human involvement in field trials, and surveillance of safety and effectiveness of biologicals in routine use are discussed.

Biological Products