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Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.

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At least 55 records · Page 3Linked to original sources
PubMed1998

Evaluation of two clinical protocols for the management of women with vaginal discharge in southern Thailand.

OBJECTIVES: (1) To compare the effectiveness of two clinical protocols for the management of vaginal discharge in the situations where no laboratory facilities are available but speculum examination is possible and where basic laboratory facilities are available. (2) To determine clinical and simple laboratory indicators for diagnosis of patients with vaginal discharge in the local setting. DESIGN: Alternate allocation of subjects to one of two management protocols. SUBJECTS: Women presenting to university gynaecology outpatients department with a complaint of vaginal discharge. METHODS: Subjects were alternately allocated management according to one of two protocols: one without (group A) and one with (group B) immediate access to results of basic laboratory tests. Full clinical assessment including speculum examination and microbiological assessment for infection with gonorrhoea, chlamydia, candida, trichomonas, and bacterial vaginosis was performed on all women. Follow up assessment of clinical and microbiological response was performed 1-2 weeks later. RESULTS: At initial assessment, both groups were similar in all respects except that more group B women had inflammation of the vulva. The prevalences of various conditions were: candidiasis 22%, bacterial vaginosis 38%, trichomoniasis 4%, chlamydia 4%, gonorrhoea 0.4%. There was no association between any demographic characteristic and diagnosis of cause of the discharge. Both protocols resulted in clinically and statistically significant improvements for women with candidiasis, bacterial vaginosis, and trichomoniasis. There were no clinically important differences in outcomes between the two protocols. The sensitivities and specificities of various indicators were: curd-like vaginal discharge for candidiasis, 72% and 100%; homogeneous vaginal discharge for bacterial vaginosis or trichomoniasis, 94% and 88%; absent or scanty lactobacilli for bacterial vaginosis, 99% and 68%; > 20% clue cells for bacterial vaginosis, 81% and 99%; visible endocervical mucopus for chlamydia or gonorrhoea, 36% and 86%; microscopic endocervical mucopus for chlamydia or gonorrhoea, 64% and 69%. CONCLUSIONS: Both protocols were equally effective in managing women with abnormal vaginal discharge. Simple clinical indicators for candidiasis, bacterial vaginosis, or trichomonas as in protocol A are sufficiently sensitive and specific for use in situations with no laboratory support. A modification to protocol A could increase detection of bacterial vaginosis at basic health service level. Further work is needed to identify appropriate indicators for infection with chlamydia or gonorrhoea.

Adult↗
PubMedDate not supplied

Designing standardized clinical protocols: some organizational and behavioral issues.

In the present environment, the clinical ordering patterns of hospital-based physicians can be expected to come under increasing scrutiny. This paper considers three major aspects of the case for inpatient clinical ordering protocols. First, it reviews the argument that hospitals do not, at present, exercise adequate management over physician-triggered resource consumption. Subsequently, the paper examines existing but partial protocol models in the United States and Scandinavia that could provide a basis for an adequate physician management system. In its third section, the paper explores the fundamental characteristics of a full-fledged Standardized Clinical Protocol (SCP) system, developing two alternative 'ideal-type' models for further discussion. The paper concludes with the argument that physicians, rather than economists or politicians, should control the design of future protocol systems.

Behavior↗
PubMed1991

Temporal-abstraction mechanisms in management of clinical protocols.

We have identified several general temporal-abstraction mechanisms needed for reasoning about time-stamped data, such as are needed in management of patients being treated on clinical protocols: simple temporal abstraction (a mechanism for abstracting several parameter values into one class), temporal inference (a mechanism for inferring sound logical conclusions over a single interval or two meeting intervals), and temporal interpolation (a mechanism for bridging non-meeting temporal intervals). Making explicit the knowledge required for temporal abstractions supports the acquisition of planning knowledge, the identification of clinical problems, and the formulation of clinical-management-plan revisions.

Clinical Protocols↗
PubMed2001

Clinical protocol. A phase 1 open-label clinical trial of the safety and tolerability of single escalating doses of autologous CD4 T cells transduced with VRX496 in HIV-positive subjects.

The proposed study is a Phase I trial to evaluate a HIV-based lentiviral vector carrying an antisense sequence targeted to HIV in the treatment of HIV infection. The primary objective of this Phase I study is to determine the safety and tolerability of treatment with autologous CD4+ T cells modified (transduced) ex vivo with VRX496 when administered to HIV-infected patients. VRX496 is a completely gutted lentiviral vector and does not code for any viral proteins. The viral vector contains an antisense sequence targeted to the HIV envelope (env) gene. VRX496 directly interferes with wild-type HIV (wt-HIV) expression via anti-env antisense expression in vector transduced CD4 cells that become infected with wt-HIV. Expression of the anti-HIV antisense env from a HIV vector transcript would target wt-HIV RNA and destroy it, and hence, decrease productive HIV replication from CD4 T cells. The clinical goal for this treatment approach is to decrease viral loads and promote CD4 T cell survival in vivo. Data from in vitro studies suggest that HIV vectors such as VRX496 could potentially reduce viral loads in HIV-infected individuals and thus could delay the onset to AIDS while promoting CD4 T cell survival and providing the immune system with a better chance to control the infection. Additionally, preliminary results from experiments in SCID mice (mice with transplanted human immune cells) indicate that the human cells transduced with VRX496 and implanted into the SCID mice do not elicit any overt adverse effects. HIV-infected patients (CD4 T cell count of >200/mm3, discontinued from HAART therapy) will undergo leukoapheresis with subsequent CD4 T cell isolation. Patient CD4 T cells will be transduced ex vivo with the vector, expanded for 8-11 days, and then the modified cells will be reintroduced into the patient. Each subject will receive a single intravenous injection infused over 30 minutes; subjects will be examined 24, 48, and 72 hours post-injection and weekly for 4 weeks. Patients will receive one of four different ascending doses (1 x 10(9), 3 x 10(9), 1 x 10(10), and 3 X 10(10) cells/patient). Doses will be administered to four independent, sequential subject cohorts of 3 patients. Groups will be administered escalating doses at 6-week intervals after safety has been demonstrated in the previous group. Follow-up examinations will be conducted 1, 3, and 6 months post-injection. Long term follow-up including RCR testing will be performed.

Adolescent↗
PubMed1993

A modular knowledge base for the follow-up of clinical protocols.

From the knowledge engineering point of view, the observation of patients subjected to clinical protocols of therapy constitutes a domain characterized by the existence of strongly structured knowledge. We have approached the problem from the perspective of a homogeneous and modular knowledge representation theory, based on the concept of Generalized Magnitude. This concept arises from identifying and collecting all possible facts of a domain established a priori, and being inspired by the concept of physical magnitudes. The Generalized Magnitudes scheme includes temporal extensions necessary to solve a medical problem for which exists a therapy and a follow-up plan with temporal specifications, and also facilitates the creation of advisory expert systems.

Drug Therapy, Computer-Assisted↗
PubMedDate not supplied

Application of restricted sequential design in a clinical protocol.

Restricted sequential design is an alternative to fixed-sample analysis as a statistical tool in clinical trials. This paper presents a specific example of the rationale which led to the choice of sequential design in a clinical protocol evaluating granulocyte transfusions in children with leukemia. The main advantage of sequential design is that fewer patients may be necessary to declare statistical significance. Its application is limited to trials where (a) the result of therapy is easily defined, (b) the result of therapy is discernible in a short time interval, and (c) one randomization is being tested, although patients may be stratified. The main disadvantage of sequential design is that if the therapies being tested are similar in efficacy, the trial may require more patients than fixed-sample analysis. This potential disadvantage may be acceptable when the concern in designing a trial is to evaluate as quickly as possible a reputedly superior therapy.

Agranulocytosis↗
PubMed2003

Direct adhesive restoration of anterior teeth: Part 2. Clinical protocol.

Contemporary adhesive restorations allow clinicians to deliver minimally invasive, functional, and aesthetic treatment for compromised dentition in the anterior and posterior regions. Part 1 of this article discussed the state-of-the-art relating to composite restorations, both in situations deemed to be relatively uncomplicated and those that are more complicated. This second part discusses the clinical protocol for the placement of direct composite materials as well as the tooth preparation considerations that must be addressed when providing minimally invasive treatment options.

Clinical Protocols↗
PubMed1993

Gene transfer into human hematopoietic progenitor cells: a review of current clinical protocols.

Recent reviews by Clay Smith (1992) in this journal and by W. French Anderson (1990) and A. Dusty Miller (1992) have described the technologies used for gene transfer, the potential applications of the approach, and the safety issues that require consideration. This review will have a narrower focus. It will deal specifically with current and forthcoming clinical protocols for gene transfer into hemopoietic progenitor cells, because a major goal of gene therapy for malignant and nonmalignant disease is to transfer and express genes on a long-term basis in these cells or their progeny.

Acute Disease↗
PubMed2002

[Importance of a clinical protocol in the treatment of severe acute pancreatitis].

BACKGROUND: Selection of the optimal treatment strategy in severe acute pancreatitis (SAP) is a serious clinical challenge largely due to difficult differential diagnosis of patients with early SAP. The aim of this study is a retrospective evaluation of the first experiences in the treatment of patients with SAP and early SAP according to a new complex clinical protocol (CCP). METHODS: A total of 210 patients complied with Atlanta recommendations for SAP and were included in the retrospective study. Patients were stratified into two groups according to the diagnostic and treatment strategy. Non-protocol (NP) group comprised 154 patients who had received their treatment based on previous clinical routine and subjective decision of physicians in charge. 56 patients who were managed according to the new CCP developed for SAP comprised the CCP group. CCP included:- Early assessment of the severity of acute pancreatitis (APACHE II score, presence of SIRS and/or organ dysfunction); - Immediate ICU monitoring including routine measurement of the intraabdominal pressure; - Conservative treatment including early enteral nutrition, colloids, antibacterial prophylaxis and early continuous venovenous hemofiltration (CVVHF) when indicated; - Surgical treatment when conservative treatment was not effective (progression of the organ dysfunction) or presence of infection was evident. Hospital, ICU stays and outcomes were analysed. Statistical comparison was done by Mann-Whitney U-test and Chi-square test. RESULTS: The age structure and severity of the disease were similar in both groups with mean of 51.3 (15.6) vs. 46.8 (15.2) years and 9.7 (5.1) vs. 9.8 (4.4) APACHE II points in groups NP and CCP, respectively. Male/female ratio was 2 : 1, and alcohol was the main etiologic factor in about 55 % of cases in both groups. Early SAP was diagnosed in 33 % to 46 % of patients according to the results of the SOFA scoring. The results of the conservative therapy considerably improved after implementation of the CCP treatment. Surgical intervention was done in 46-52 % of patients. MODS was the main cause of death in both groups. Remarkable decrease in early mortality (within the first week from admission) was a real advantage of CCP treatment comprising 1.8 % vs. 22.1 % in NP patients, p < 0.01. Mortality from early SAP was reduced by CCP treatment to 3.8 % compared to 33 % in NP group, p < 0.01. There was a considerable reduction in postoperative mortality with CCP treatment comprising 10.3 % vs. 32.7 % in patients who did not receive CCP treatment, p < 0.05. Overall mortality associated with CCP treatment ranged to 5 %, compared to 34 % mortality in the NP treatment group, p < 0.01. Due to the considerable number of early deaths among NP patients, there was statistically longer ICU and hospital stay in CP group with mean of 14.1 (14.1) vs. 9.6 (15.2) days and 37.9 (26.7) vs. 23.4 (21.8) days, compared to NP group, p < 0.01. CONCLUSIONS: Timely recognition and complex therapy of SAP including ICU monitoring, colloids, antibacterial prophylaxis, early enteral nutrition, and CVVHF is the most effective way how to manage this category of patients. Implementation of a specialised treatment protocol considerably improves outcome and reduces the number of deaths associated with surgery and early SAP.

APACHE↗