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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 127 records · Page 7Linked to original sources
PubMed2004

[Antithrombotic prophylaxis in day surgery: proposal of a clinical protocol].

The considerable diffusion of the day surgery has new problems such as the use of antithrombotic prophylaxis, now carried out systematically in major surgery. An the basis of the poor data present in the literature, a protocol of study is proposed to evaluate the real effectiveness of this type of prophylaxis in DS, dividing the patients into 3 groups, according to the patient's risk factors to the intervention and to the disease.

Ambulatory Surgical Procedures↗
PubMed1998

Management of rHuEPO resistance in CRF patients: a clinical protocol at Winthrop-University Hospital.

An inadequate response to recombinant human erythropoietin (rHuEPO) therapy may be attributable to many underlying causes, with the major cause being iron deficiency. Since improved rHuEPO response can improve quality of life in end-stage renal disease (ESRD) patients, rHuEPO resistance should be investigated and corrected whenever possible. This article will discuss the Winthrop-University Hospital's continuous quality improvement (CQI) initiative that was developed to improve recognition and treatment of rHuEPO resistance.

Algorithms↗
PubMed1997

Clinical protocol for pregnancy termination in bitches using prostaglandin F2 alpha.

Sixty-seven pregnant bitches were given atropine sulphate (0.025 mg kg-1), prifinium bromide (0.1 ml kg-1) and metopimazine (0.5 mg kg-1) and 15 min later 2.5 micrograms cloprostenol kg-1 s.c., three times at 48 h intervals (day 1, day 3, day 5). After one treatment, 53 of the 67 bitches had aborted, and after a second treatment, 62 of the 67 bitches had aborted. In 18 bitches, progesteronemia kinetics were followed-up: the first injection of cloprostenol resulted in a significant (P < 0.01) fall in progesteronemia. In 12 of the 18 bitches that had aborted following the first protocol, this rapid fall in progesterone was noteworthy as it decreased progesterone concentration on average from 17.07 +/- 8.20 ng ml-1 on day 1 to 1.31 +/- 0.34 ng ml-1 on day 3. The premedication administered 15 min before the injection of prostaglandins, prevented the appearance of side effects in 39 of the 67 bitches (58.2%).

Abortifacient Agents, Nonsteroidal↗
PubMed2005

Inhibition of Unnecessary RV Pacing with AV Search Hysteresis in ICDs (INTRINSIC RV): design and clinical protocol.

Implantable cardioverter defibrillators (ICDs) reduce sudden arrhythmic death risk but when these devices are programmed DDD and pace in the right ventricle (RV), they can be associated with increased mortality and heart failure morbidity compared to an ICD programmed to back-up RV. An ideal ICD would provide effective treatment for life-threatening tachyarrhythmias, reduce unnecessary RV pacing and maintain AV synchrony. The Inhibition of Unnecessary RV Pacing with AV Search Hysteresis (AVSH) in ICDs (INTRINSIC RV) study will assess whether an ICD programmed to DDDR with AVSH is equal to an ICD programmed to VVI with regard to mortality, heart failure hospitalizations, and several predefined secondary enpoints. AVSH allows intrinsic AV conduction beyond the programmed AV delay to help minimize ventricular pacing. INTRINSIC RV, a multi-center, randomized, prospective trial will enroll >1,200 participants who receive a Guidant VITALITY AVT ICD. ICDs are programmed initially to DDDR AVSH 60-130. Then, after a week, if the %RV pacing <20%, patients are randomized to VVI-40 or DDDR 60-130 with AVSH. Those with RV pacing > or =20% are placed in an obvservational arm and programmed ad libitum by the treating physician. Patients are followed for one year. This large, randomized, controlled, clinical trial will address whether DDDR with AVSH programming is equivalent to VVI programming in an ICD with regard to mortality and heart failure hospitalization.

Clinical Protocols↗
PubMed1990

The ADA human gene therapy clinical protocol.

Severe combined immunodeficiency (SCID) due to deficiency of the purine metabolic enzyme adenosine deaminase (ADA) is a fatal childhood immunodeficiency disease. Immune reconstitution by transplantation with HLA-identical bone marrow is the treatment of choice. For patients not candidates for bone marrow transplantation, we propose to attempt immune reconstitution by using infusions of autologous T lymphocytes expanded in tissue culture and genetically corrected by insertion of a normal ADA gene using retroviral-mediated gene transfer. The vector is LASN, in which the human ADA gene is promoted by the LTR while the NeoR gene is driven by the SV40 early gene promoter. The packaging line is PA317. The protocol is designed to have two parts. In Part 1, autologous gene-corrected T lymphocytes would be infused repeatedly in low numbers in order to build an immune repertoire of T cells and also to obtain information as to how long gene corrected T cells survive in vivo. In Part 2A, the gene-corrected T cells would be selected in G418 and/or 2'deoxyadenosine and reinfused into the patient at monthly intervals for approximately 6 months. The goals would be essentially the same as in Part 1. In Part 2B, the number of gene-corrected T cells would be escalated in half-log increments to the predicted therapeutic level (probably around 1 x 10(9)/kg). 1-3 x 10(9)/kg gene-corrected cells would be infused several times and the patients would be monitored in order to determine if significant clinical improvement has occurred.

Adenosine Deaminase↗
PubMedDate not supplied

[Validation of a clinical protocol for the detection of dementia in the population].

AIMS: To analyse the validity of a set of neuropsychological and functional tests, and to study their value in detecting and diagnosing dementia through a pilot study. PATIENTS AND METHODS: A total of 131 subjects (101 controls and 30 with dementia) were evaluated using a comprehensive neuropsychological and functional battery. Validity analyses were conducted using ROC curves in accordance with the definitions of diagnostic test validation. Finally, a discriminant analysis was performed with the tests that showed greater diagnostic validity in the study of the ROC curves. RESULTS: The case and control groups were not significantly different as regards age, sex and level of schooling. The ROC curves analyses showed the following to be the tests with the highest diagnostic validity: the MMSE, delayed recall of a short story, delayed recall of six pictures, the Spanish version of the S IQCODE (shortened) and Pfeffer s FAQ. The discriminant analysis evidenced the fact that the joint utilisation of all the foregoing tests, except delayed recall of six pictures, classified 96.55% of our sample correctly. CONCLUSIONS: By combining direct cognitive evaluation of the subject and functional performance evaluated by a trustworthy informer, the vast majority of participants in the pilot study were correctly classified into patients with and without dementia. The high diagnostic validity of four relatively short tests lends support to their use in broader clinical or population studies.

Aged↗
PubMed2001

Clinical protocol. Purging of autologous stem cell sources with bcl-x(s) adenovirus for women undergoing high-dose chemotherapy for stage IV breast carcinoma.

High-dose chemotherapy (HDCT) and autologous bone marrow transplantation (BMT) is frequently used to treat patients with metastatic cancer including breast cancer and neuroblastoma. However, the bone marrow of such patients is often contaminated with tumor cells. Recently, we have found that a recombinant adenovirus vector that contains a bcl-x, minigene (a dominant negative inhibitor of the bcl-2 family), called the bcl-x(s) adenovirus, is lethal to cancer cells derived from epithelial tissues, but not to normal human hematopoietic cells. To determine the mechanism, by which this virus spares normal hematopoietic cells, we isolated normal mouse hematopoietic stem cells and infected them with an adenovirus that contains a beta-galactosidase minigene. Such cells do not express beta-galactosidase, indicating that hematopoietic stem cells do not express transgene encoded by adenovirus vectors based upon the RSV-AD5 vector system. When breast cancer cells mixed with hematopoietic cells were infected with the bcl-x(s) adenovirus, cancer cells were selectively killed by the suicide adenoviruses. Hematopoietic cells exposed to the suicide vectors were able to reconstitute the bone marrow of mice exposed to lethal doses of y-irradiation. These studies suggest that adenovirus suicide vectors may provide a simple and effective method to selectively eliminate cancer cells derived from epithelial tissue that contaminate bone marrow to be used for autologous BMT. We therefore propose to initiate a phase I clinical trial to test the safety of this virus in women with breast cancer undergoing high does chemotherapy and autologous BMT.

Adenoviridae↗
PubMed1999

Brain activity and language assessment using event-related potentials: development of a clinical protocol.

To test the validity of a new computerized task to assess children's receptive vocabulary, event-related potentials (ERPs) were recorded from 56 typically developing children ranging in age from 5 to 12 years. This ERP-computerized vocabulary task does not require a child to give a verbal or motor (i.e. pointing) response. Single pictures, from an existing standardized test of receptive vocabulary, were presented on a computer screen and simultaneously named either correctly (congruent) or incorrectly (incongruent) via a computer. As predicted, the N400 amplitude was found to be significantly higher to the incongruent picture-word pair (i.e. the child knew it was an incorrect pairing) than to the congruent picture-word pair (i.e. the child knew it was a correct pairing). This effect was found for each of the four age groups (5 to 6 years, 7 to 8 years, 9 to 10 years, 11 to 12 years). This task accurately estimated current receptive vocabulary in typically developing children. Although still in the development stage, it may eventually serve as an adjunct to a thorough neurological and neurodevelopmental assessment of some children presenting with moderate to severe cerebral palsy.

Brain↗
PubMed1988

The development of a clinical protocol for the radiolabelling of mixed leucocytes with 99Tcm-hexamethylpropyleneamine oxime.

To devise a protocol for the radiolabelling of mixed leucocytes with 99Tcm-hexamethylpropyleneamine oxime (99Tcm-HMPAO), the effect of HMPAO concentration, cell concentration, plasma concentration and anticoagulant on the uptake of the lipophilic complex was measured, together with the stability of the 99Tcm on the labelled cells. It was found that cell uptake was rapid, independent of HMPAO concentration over the range 20-80 micrograms ml-1, but dependent on cell and plasma concentration. Incubation of mixed leucocytes from 85 ml blood with 1 ml ACD-plasma and 4 ml 99Tcm-HMPAO containing 400 MBq 99Tcm for 10 min at room temperature gave optimum results and was used in 90 patients. The mean labelling efficiency, which was the amount of added 99Tcm incorporated by the cells, was 55% (+/- 13 S.D.), of which 77% were incorporated by the granulocytes, 17% by the mononuclear cells and 6% by the platelets and erythrocytes. During a 1 h incubation in plasma 9% (+/- 4% S.D.) of the 99Tcm were released from the labelled mixed leucocytes. This occurred predominantly from the mononuclear cells.

Clinical Protocols↗
PubMed2003

[Monitoring of pregnancy complicated by maternal-fetal isoimmunization. A comparison between two clinical protocols].

AIM: Invasive techniques such as amniocentesis and cordocentesis are used for the diagnosis and treatment of fetus at risk for anemia due to maternal red-cell alloimmunization. The purpose of this study was to determine the value of non invasive measurements of the peak velocity middle cerebral artery in the fetus (PVMCA) for the diagnosis of fetal anemia. METHODS: From 1996 to September 2002, we studied 23 pregnancies with anti D title >1:32. In the 1(st) group of 11 women (from 1996 to 1999) fetal anemia was detected by invasive techniques (amniocentesis and cordocentesis). In the 2(nd) group of 12 women (from 1999 to 2002) fetal anemia was suspected on the basis of PVMCA. When PVMCA was significantly increased, cordocentesis was performed in order to rule out fetal anemia and to provide in utero transfusions. RESULTS: In the 1(st) period we performed 23 invasive techniques (7 amniocentesis and 16 cordocentesis) in 11 women, but we identified fetal anemia only in 4 cases. In the 2(nd) period we performed only 2 cordocentesis in women in which PVMCA was increased; the blood sampling confirmed fetal anemia in both cases. CONCLUSION: PVMCA and fetal hematocrit are highly significantly correlated: high values of PVMCA are associated with fetal anemia. Doppler velocity of PVMCA is related to fetal anemia with positive predictive value 100% and negative predictive value 100%. The middle cerebral artery blood velocity is a non invasive technique for detecting anemia in pregnancies complicated by alloimmunization.

Adult↗
PubMed1996

Otoplasty. Clinical protocol and long-term results.

OBJECTIVE: To evaluate the long-term results after otoplasty on prominent ears. DESIGN: Between 1988 and 1993, ear protrusion was measured preoperatively and postoperatively in pediatric patients undergoing otoplasty by means of a standard protocol based on the Frankfort horizontal line. Patients were asked to return for follow-up measurements a minimum of 1 year after surgery. At the time of follow-up, a patient satisfaction survey was completed by the patients and their families. SETTING: The Hospital for Sick Children, Toronto, Ontario, a tertiary care children's hospital. PARTICIPANTS: Thirty-one of 51 patients returned for follow-up an average of 3.7 years after surgery. RESULTS: One third of ears returned to their original position, one third of ears stayed in a position equal to the immediate postoperative position, and one third of ears had final positions between the preoperative and post-operative positions. At the superior rim, an average of 58% of the operative medialization was lost. Good to excellent ear-to-ear symmetry was obtained in 78% of patients who returned for follow-up. Retrospective chart review showed a revision surgery rate of 3%; stitch granulomas were removed in 9% of patients. The patient satisfaction survey found that 85% of patients were happy or very happy with their ears. CONCLUSIONS: With time, a substantial loss of correction can be expected in most (but not all) patients who undergo otoplasty, particularly at the upper pole. Overall, patients and their families are happy with the results of otoplasty surgery.

Adolescent↗
PubMed1991

Technetium-labelled autologous lymphocytes: clinical protocol for radiolabelling using a high concentration and low volume of 99Tcm-exametazime.

Little clinical work has been performed using technetium-labelled lymphocytes due to the difficulty of effecting an imaging dose of technetium on the small number of lymphocytes available. We have successfully labelled lymphocytes using a high concentration and low volume of 99Tcm-exametazime. In eight readings from three patients and two volunteers, the labelling efficiency was 27% (4 S.D.). The radiolabel was stable in plasma in vitro up to 4 h. Viability of the lymphocytes as determined by trypan blue exclusion was greater than 95%.

Blood Specimen Collection↗
PubMed2004

Facilitating knowledge maintenance of clinical guidelines and protocols.

Clinical protocols and guidelines are widely used in the medi-cal domain to improve disease management techniques. Different software systems are in development to support the de-sign and the execution of such guidelines. The bottleneck in the guideline software developing process is the transformation of the text-based clinical guidelines into a formal representation, which can be used by the execution software. This paper introduces a method and a tool that was designed to provide a solution for that bottleneck. The so-called Guideline Markup Tool (GMT) facilitates the translation of guidelines into a formal representation written in XML. This tool enables the protocol designer to create links between the original guideline and its formal representation and ease the editing of guidelines applying design patterns in the form of macros. The usefulness of our approach is illustrated using GMT to edit Asbru protocols. We performed a usability study with eight participants to examine the usefulness of the GMT and of the Asbru macros, which showed that the proposed approach is very appropriate to author and maintain clinical guidelines.

Clinical Protocols↗