PubMed Health⌕ Search

SEARCH · PubMed Health

Results for “Clinical protocols”

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.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 397 records · Page 22Linked to original sources
PubMed2003

Surgery of Parkinson's disease: inclusion criteria and follow-up.

Parkinson's disease (PD) is a progressive disturbances of movement that affects mainly the motor system. Prolonged pharmacological administration may result in insufficient control of symptoms and significant side effects. Deep brain stimulation (DBS), targeted at the STN, is a recent surgical procedure that, according to the symptoms response, allows modification of stimulation parameters; its effects are also reversible. In this paper management of surgical patients is reported. It includes patient selection, inclusion and exclusion criteria, postoperative clinical protocol. The evaluation rating scale such as UPDRS, Dyskinesias Rating Scale and Self-Reporting Questionnaire usually administrated on PD patients are analyzed. Surgical inclusion criteria are (1) idiopathic PD, (2) IV or V Hoehn-Yahr stage, (3) severe motor disability, and (4) no dementia or psychiatric abnormalities. Postoperative clinical protocol is analyzed and parameter of stimulation after surgery and at the follow up are reported. Generally DBS allows an improvement of rigidity and tremor; bradykinesia also improves with high frequency stimulation. Results obtained by continuous stimulation show a mean improvement of UPDRS of about 60% and a significant reduction in the drug intake.

Electric Stimulation Therapy↗
PubMed1993

Constituting management requires more than creating hierarchy and providing information.

Current efforts to realign authority relationships within hospitals are important, but not sufficient. The rules which underpin the autonomy of medicine and those which are required for constituting management in clinical settings are not 'things' which can be decreed in and out of existence either by altering the lines on a hospital organisation chart, or by improving hospital information systems and allocating managerial responsibility to some clinicians. Accordingly, the ultimate success of the current hospital reform program will depend on the willingness of players in health policy circles to broaden their reform agenda to encompass issues which go well beyond factors internal to the organisation of hospitals. Included here are initiatives in areas such as hospital casemix funding and budgeting; clinical protocols; establishing linkages between the managerial and clinical roles of clinician managers; and recasting the employment of hospital medical staff.

Australia↗
PubMed1998

An expert system for assigning patients into clinical trials based on Bayesian networks.

Assigning patients into clinical trials is a knowledge and data intensive task. Eligibility determination for entry into a clinical trial is based upon specific inclusion and exclusion criteria. This paper investigates the use of an excerpt system to assist the physician through this task. This expert system uses Bayesian networks, a probabilistic method that can take advantage of pre-existing statistical knowledge. The paper also describes the feasibility of such a system by presenting the implementation of three clinical protocols. The experimental results reveal that the approach is feasible. The system gives correct eligibility scores when all evidence is available but also predicts eligibility when there is missing evidence. The system directs the physician to the protocols the patient is most eligible for, according to the current evidence. The system has the ability of learning its prior and conditional probabilities (expert knowledge) from training examples.

Algorithms↗
PubMed1998

The clinical trial protocol of the Metrifonate in Alzheimer's Trial (MALT).

The promising results of early trials in Alzheimer's disease with the acetylcholinesterase inhibitor metrifonate prompted initiation of the Metrifonate in ALzheimer's Trial (MALT). MALT is an international, randomized, double-blind, placebo-controlled, parallel-group study which was designed to determine, over a 26-week period, the efficacy, tolerability and safety of two doses of metrifonate in patients with probable Alzheimer's disease. A total of 605 patients were randomized to receive either a daily dose of oral metrifonate 40/50 mg (n = 200, by body weight <65 kg/> or =65 kg) or metrifonate 60/80 mg (n = 197, by body weight <65 kg/> or = 65 kg). Patients were assessed in the key symptom domains of Alzheimer's disease, i.e. cognition, behavioural and psychiatric disturbances, activities of daily living and global function. In summary, administration of metrifonate for 26 weeks to the intent-to-treat population significantly benefited cognitive performance, global function and certain aspects of behaviour and functional ability compared with placebo. These efficacy results were associated with high levels of acetylcholinesterase inhibition and a good safety and tolerability profile. The protocol of MALT is discussed here. Full results of the study will be available in a separate publication.

Aged↗
PubMed1998

Medical devices; investigational device exemptions--FDA. Final rule.

The Food and Drug Administration (FDA) is amending the Investigational Device Exemptions (IDE) regulation. The regulatory changes are intended to reflect amendments to the Federal Food, Drug, and Cosmetic Act (the act) by the FDA Modernization Act of 1997 (FDAMA). These amendments provide that the sponsor of an IDE may modify the device and/or clinical protocol, without approval of a new application or supplemental application, if the modifications meet certain criteria and if notice is provided to FDA within 5 days of making the change. The rule also defines the credible information to be used by sponsors to determine if the criteria are met.

Clinical Protocols↗
PubMed1998

Medical devices; investigational device exemptions--FDA. Proposed rule.

The Food and Drug Administration (FDA) is proposing to amend the Investigational Device Exemptions (IDE) regulation. The proposed regulatory changes are intended to reflect amendments to the Federal Food, Drug, and Cosmetic Act (the act) by the FDA Modernization Act of 1997 (FDAMA). These amendments provide that the sponsor of an IDE may modify the device and/or clinical protocol, without approval of a new application or supplemental application, if the modifications meet certain criteria and if notice is provided to FDA within 5 days of making the change. The proposed rule also defines the credible information to be used by sponsors to determine if the criteria are met.

Clinical Protocols↗
PubMed2003

Good clinical practice: a nuisance, a help or a necessity for clinical pharmacology?

This article reviews the impact of good clinical practice (GCP) on clinical pharmacology with particular reference to the new European Union Clinical Trial Directive. The Directive will be applied to both commercial and noncommercial studies on medicinal products for human use. The Directive requires that GCP should be used in all clinical trials except noninterventional studies. GCP is likely to follow the International Conference on Harmonization GCP guidelines in many aspects. GCP will enforce tighter guidelines on ethical aspects of a clinical study. Higher standards will be required in terms of comprehensive documentation for the clinical protocol, record keeping, training, and facilities including computers. Quality assurance and inspections will ensure that these standards are achieved. The additional requirements of GCP are discussed and any advantage to the study subject. The impact of the new Directive within the Research Governance Framework of the UK Department of Health is reviewed.

Clinical Protocols↗
PubMed1993

Speech motor control in Parkinson's disease: a comparison between a clinical assessment protocol and a quantitative analysis of mandibular movements.

Nine individuals with Parkinson's disease (PD) and nine normal control subjects, matched for sex and age, were compared on a standardized assessment protocol for dysarthria. Simple measures of hand and gait motility were also obtained. A kinematic analysis of vertical jaw movements during speech was performed by using an optoelectronic technique. The PD subjects were examined during both induced off L-dopa and on L-dopa states, and their performance was compared between the two conditions. Significant group differences were found for all kinematic measures during a syllable repetition task, as well as for the total dysarthria test scores and certain individual test items. Implications and clinical usefulness of the kinematic approach to the study of oral motor functions are discussed.

Aged↗
PubMed1998

Cord Blood Transplantation Study (COBLT): cord blood bank standard operating procedures.

In 1995, the National Heart Lung and Blood Institute (NHLBI) solicited requests for a proposal (RFP) entitled "Transplant Centers for Clinical Research on Transplantation of Umbilical Cord Stem and Progenitor Cells." Three banks, six transplant centers, and one medical coordinating center (MCC) (Table 1) were funded with the overall goal of banking cord blood units (CBU) using a single manual of operations. Furthermore, the clinical protocols to evaluate the transplant outcome for adult and pediatric recipients of these well-characterized CBU would be analyzed in a uniform fashion. Because of the intense interest of the transplantation community in the policies and procedures for cord blood collection and processing, the principal investigators of the cord blood banks (CBB) and NHLBI elected to submit for publication the rationale and an abridged, but detailed, version of the standard operating procedures (SOP) developed between October 1996 and July 1998 prior to the initiation of the clinical protocols to be performed with these CBU. As the SOP will be refined over time, the complete SOP and subsequent amendments will be published and continually updated on the websites from the MCC-The EMMES Corporation (www.EMMES.com). All forms referred to in this document may be obtained from the EMMES website. It is hoped that the publication of this document will lay down a framework that will not only facilitate the development of other CBB but also help us more rapidly define what constitutes an "acceptable" CBU product.

Adult↗
PubMed2006

Acute insulin response (AIR): review of protocols and clinical interest in islet transplantation.

Various stimuli have been used in clinical practice to test islet function, including intravenous glucose, arginine--both at basal glucose levels and with the hyperglycaemic clamp, tolbutamide, glucagon and glucagon-like peptide 1. The subsequent first phase insulin response (also termed acute insulin response or AIR) to intravenous glucose or arginine has been quantified in a variety of ways, from the mean serum insulin measured at multiple times after glucose injection to the mean value above baseline of serum insulin at 2 to 10 min. The purpose of this study was to review the different protocols of AIR calculation and their pitfalls, and to assess the results of AIR in the islet transplantation field. By investigating the first phase of insulin secretion, AIR provides both a qualitative and a quantitative approach to insulin secretion. In islet transplantation, post-glucose AIR (AIRg) may predict graft survival while post-arginine AIR (AIRa) may be better correlated with engrafted beta cell mass, despite these facts need to be confirmed. AIRa also limits intravenous hyperglycaemia glucotoxicity. In conclusion, AIR could help to predict the need for a second or third islet injection in islet transplantation. These specific indications, however, need to be confirmed by future studies and completed by other approaches such as insulin sensitivity studies and in vivo morphological assessment of islet mass.

Blood Glucose↗
PubMed2000

Suicide gene therapy for urogenital cancer: current outcome and prospects.

Viral-mediated transfer of the herpes simplex virus thymidine kinase (HSV-tk) gene has been demonstrated by several investigators to confer sensitivity to nucleoside analogs such as ganciclovir (GCV) in a variety of tumor cells including brain, prostate, bladder, kidney, ovary, head and neck, lung, pancreas, and liver cancers. Fourteen suicide gene clinical protocols using adenovirus vectors have been conducted, including four in prostate cancer. Two additional protocols for prostate cancer are in preparation in Japan and the Netherlands. A study conducted at Baylor College of Medicine was the first to demonstrate the safety of HSV-tk plus GCV therapy for human prostate cancer and the anticancer activity of gene therapy in this disease. However, it is still in the early stage of its development, with a number of problems to be overcome. Systemic delivery, specific introduction, and specific expression of the target gene are the major issues to be managed in order to establish a clinically relevant treatment strategy.

Clinical Protocols↗
PubMed2004

A novel method for the determination of biliary clearance in humans.

Biliary excretion is an important route of elimination and the biliary tract is a potential site of toxicity for many drugs and xenobiotics. Quantification of biliary excretion in healthy human volunteers is logistically challenging and is rarely defined during drug development. The current study uses a novel oroenteric tube coupled with a specialized clinical protocol to examine the pharmacokinetics of 99mTechnetium (Tc-99m) mebrofenin, a compound that undergoes rapid hepatic uptake and extensive biliary excretion. A custom-made multilumen oroenteric tube was positioned in the duodenum of healthy human volunteers. Subjects were positioned under a gamma camera and 2.5 mCi of Tc-99m mebrofenin was administered intravenously. Duodenal aspirates, blood samples, and urine were collected periodically for 3 hours. Two hours after Tc-99m mebrofenin administration, the gallbladder was contracted with an intravenous infusion of cholecystokinin-8. Gamma scintigraphy was used to determine the gallbladder ejection fraction in each subject. Total systemic clearance of Tc-99m mebrofenin approximated liver blood flow (Cl(total) 17.3 degrees 1.7 mL/min/kg), and 35% to 84% of the Tc-99m mebrofenin dose was recovered in bile. However, when the data were corrected for the gallbladder ejection fraction, 71% to 92% of the excreted Tc-99m mebrofenin dose was recovered. This novel oroenteric tube and clinical protocol provide a useful method to quantify biliary excretion of xenobiotics in healthy human volunteers.

Adult↗
PubMed1999

Transdermal fentanyl in children with cancer pain: feasibility, tolerability, and pharmacokinetic correlates.

OBJECTIVES: (1) To assess the feasibility and tolerability of the therapeutic transdermal fentanyl system (TTS-fentanyl) by using a clinical protocol developed for children with cancer pain. (2) To estimate the pediatric pharmacokinetic parameters of TTS-fentanyl. METHODS: The drug was administered in open-label fashion; and measures of analgesia, side effects, and skin changes were obtained for a minimum of 2 doses (6 treatment days). Blood specimens were analyzed for plasma fentanyl concentrations. The pharmacokinetics of TTS-fentanyl were estimated by using a mixed effect modeling approach. RESULTS: Treatment was well tolerated. Ten of the 11 patients who completed the 2 doses continued treatment with TTS-fentanyl. The duration of treatment ranged from 6 to 275 days. The time to reach peak plasma concentration ranged from 18 hours to >66 hours in patients receiving the 25 microg/h patch. Compared with published pharmacokinetic data from adults, the mean clearance and volume of distribution of transdermal fentanyl were the same, but the variability was less. CONCLUSIONS: Treatment of children with TTS-fentanyl is feasible and well tolerated and yields fentanyl pharmacokinetic parameter estimates similar to those for adults. A larger study is required to confirm these findings and further test the clinical protocol.

Administration, Cutaneous↗
PubMed2002

Chlamydia trachomatis infection and non-gonococcal urethritis in homosexual and heterosexual men in Edinburgh.

In 1998, when ligase chain reaction testing for chlamydial infection was introduced in our clinic in Edinburgh, routine clinic protocol included the testing of all heterosexual, but not homosexual, men for urethral chlamydial infection. We audited all new homosexual and bisexual male attendees with a diagnosis of chlamydial infection or non-gonococcal urethritis (NGU) in 1999, together with heterosexual men with the same diagnoses attending in alternate months of the same year. Urethral Chlamydia trachomatis infection was detected in 14.6% (350/2402) of heterosexual men and 2.4% (11/465) of homosexual men tested. Fifty percent of chlamydial infections were asymptomatic. In this population 44% (84/190) of NGU in heterosexual men is attributable to C. trachomatis as opposed to only 10% (6/59) of that in homosexual men. These rates of chlamydial infection differ from previous reports in Scotland and recent studies from the USA. Our clinic protocol has been revised to include routine testing for chlamydial infection in all men.

Ambulatory Care↗
PubMed1991

Oxytocin pharmacodynamics: effect of long infusions on uterine activity.

Despite common use in obstetrics for almost 50 years, there is still disagreement concerning optimal clinical protocols for the use of oxytocin. This disagreement arises in part from inadequate data on oxytocin pharmacokinetics and pharmacodynamics. This report evaluates the uterine response to fixed doses of oxytocin (1-3 mIU/min) over long infusion times (up to 120 min) in 10 patients with secondary arrest of dilatation. The uterine activity increased from 132 +/- 61 Alexandria units during the control period to 199 +/- 64 Alexandria units at an infusion rate of 1 mIU/min. Increasing the infusion rate to 2 mIU/min increased the uterine activity to 240 +/- 64 Alexandria units. The uterine activity increased until a steady state was achieved between 40 and 70 min after the initiation of infusion. Continuing the infusion at a fixed rate for more than 90 min appears to result in a decreasing uterine activity. Patients requiring oxytocin for augmentation of labor developed adequate uterine activity with dose rates of 1-3 mIU/min. Clinical protocols for oxytocin augmentation with an interval of 40-60 min between increases in the dosing seem reasonable based on these pharmacodynamic data.

Dose-Response Relationship, Drug↗
PubMedDate not supplied

[Assessment of radiation dose to patients in hysterosalpingography].

INTRODUCTION: The optimization principle applied to the patient radioprotection, recently introduced in Italian legislation, requires a careful analysis of the working procedures and clinical protocols generally used in radiological practice, to avoid unnecessary exposures with no loss in diagnostic information. We carried out this analysis in hysterosalpingography, which is the radiological examination usually performed on fertile women to detect uterine and tubal conditions. MATERIALS AND METHODS: The dosimetric survey was carried out on 35 patients, 22 to 40 years old, to evaluate: a) entrance dose and dose x area product; b) doses to the most irradiated organs, that is ovaries and uterus; c) effective dose equivalent and effective dose. The doses were measured with LiF thermoluminescent dosimeters, while an ionization chamber enabled us to the calculate dose area product. Ovaries and uterus doses were calculated with a Monte Carlo program using skin entrance exposure data and some technical parameters of the examination. RESULTS: The good agreement of the results obtained with both dosimetric methods demonstrated their equivalence in this specific case where the use of a clinical protocol, with no lateral projection, made the dosimeters lie always within the X-ray beam. DISCUSSION AND CONCLUSIONS: The mean dose was 4.5 mGy for the ovaries and 6.2 mGy for the uterus. Following the recommendations of the International Commission on Radiological Protection, both effective dose equivalent, with a mean value of 2.0 mSv, and effective dose, with a mean value of 1.95 mSv, were estimated. In conclusion, our results show that the patient dose can be reduced by limiting the use of fluoroscopy, using small size films and decreasing the number of exposures.

Adult↗
PubMed2001

Analysis of complex relationships between age, p53, epidermal growth factor receptor, and survival in glioblastoma patients.

Glioblastoma multiforme (GBM) carries a dismal prognosis. However, a range of survival times exists, and parameters that define prognostic groups may help to optimize treatment. To identify such prognostic groups, we analyzed tumor tissue from 110 cases of newly diagnosed GBM from two clinical protocols. Similar to other studies, we found no association of epidermal growth factor receptor (EGFR) overexpression (as assessed by immunohistochemistry), p53 immunopositivity, or p53 mutation with survival in the entire sample. However, EGFR overexpression showed trends toward worse prognosis in patients younger than the median age, but better prognosis in patients older than the median age. This interaction of EGFR with age group was statistically significant and led us to focus our further analyses on the younger patients. In this group, a statistically significant association of EGFR overexpression with worse survival was identified in the p53-negative but not p53-positive tumors. We found a similar result after screening these cases for mutations in p53: EGFR overexpression was negatively associated with survival only in the p53 wild-type cases. To confirm this unexpected result, this finding was reproduced in a validation sample of an additional 42 tumors from younger patients on the same two clinical protocols. This complex relationship between EGFR and p53 in younger patients remained in a multivariate analysis that incorporated additional prognostic variables. The results suggest that analysis of prognostic markers in GBM is complex, and maximal information may require analysis of subgroups based on age and the status of specific markers such as p53. In addition, they suggest a specific group of patients on which to focus promising therapies targeting EGFR.

Adult↗