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At least 415 records · Page 23Linked to original sources
PubMed2000

Avoidance of radiation injuries from medical interventional procedures.

Interventional radiology (fluoroscopically-guided) techniques are being used by an increasing number of clinicians not adequately trained in radiation safety or radiobiology. Many of these interventionists are not aware of the potential for injury from these procedures or the simple methods for decreasing their incidence. Many patients are not being counselled on the radiation risks, nor followed up when radiation doses from difficult procedures may lead to injury. Some patients are suffering radiation-induced skin injuries and younger patients may face an increased risk of future cancer. Interventionists are having their practice limited or suffering injury, and are exposing their staff to high doses. In some interventional procedures, skin doses to patients approach those experienced in some cancer radiotherapy fractions. Radiation-induced skin injuries are occurring in patients due to the use of inappropriate equipment and, more often, poor operational technique. Injuries to physicians and staff performing interventional procedures have also been observed. Acute radiation doses (to patients) may cause erythema at 2 Gy, cataract at 2 Gy, permanent epilation at 7 Gy, and delayed skin necrosis at 12 Gy. Protracted (occupational) exposures to the eye may cause cataract at 4 Gy if the dose is received in less than 3 months, at 5.5 Gy if received over a period exceeding 3 months. Practical actions to control dose to the patient and to the staff are listed. The absorbed dose to the patient in the area of skin that receives the maximum dose is of priority concern. Each local clinical protocol should include, for each type of interventional procedure, a statement on the cumulative skin doses and skin sites associated with the various parts of the procedure. Interventionists should be trained to use information on skin dose and on practical techniques to control dose. Maximum cumulative absorbed doses that appear to approach or exceed 1 Gy (for procedures that may be repeated) or 3 Gy (for any procedure) should be recorded in the patient record, and there should be a patient follow-up procedure for such cases. Patients should be counselled if there is a significant risk of radiation-induced injury, and the patient's personal physician should be informed of the possibility of radiation effects. Training in radiological protection for patients and staff should be an integral part of the education for those using interventional techniques. All interventionists should audit and review the outcomes of their procedures for radiation injury. Risks and benefits, including radiation risks, should be taken into account when new interventional techniques are introduced.A concluding list of recommendations is given. Annexes list procedures, patient and staff doses, a sample local clinical protocol, dose quantities used, and a procurement checklist.

Adult↗
PubMed2003

Modeling stem cell population growth: incorporating terms for proliferative heterogeneity.

Expansion of the undifferentiated stem cell phenotype is one of the most challenging aspects in stem cell research. Clinical protocols for stem cell therapeutics will require standardization of defined culture conditions. A first step in the development of predictable and reproducible, scalable bioreactor processes is the development of mathematical growth models. This paper provides practical models for describing cell growth in general, which are particularly well suited for examining stem cell populations. The nonexponential kinetics of stem cells derive from proliferative heterogeneity, which is biologically recognized as mitosis, quiescence, senescence, differentiation, or death. Here, we examined the assumptions of the Sherley model, which describes heterogeneous expansion in the absence of cell loss. We next incorporated terms into the model to account for A) cell loss or apoptosis and B) cell differentiation. We conclude that the basic assumptions of the model are valid and a high correlation between the modified equations and experimental data obtained using muscle-derived stem cells was observed. Finally, we demonstrate an improved estimation of the kinetic parameters. This study contributes to both the biological and mathematical understanding of stem cell dynamics. Further, it is expected that the models will prove useful in establishing standardization of cell culture conditions and scalable systems and will be required to develop clinical protocols for stem cell therapeutics.

Apoptosis↗
PubMed2005

Reliability and validity of static knee strength measurements obtained with a chair-fixed dynamometer in subjects with hip or knee arthroplasty.

OBJECTIVES: To evaluate the reliability (intertrial, interevaluator) and the concurrent validity of strength measurements obtained with a chair-fixed dynamometer and to recommend a clinical protocol that minimizes standard error of measurement (SEM). DESIGN: Within-session repeated measures of maximal static strength of knee flexors and extensors at 30 degrees and 60 degrees of flexion on the chair-fixed and Cybex dynamometers. SETTING: Ambulatory physiotherapy department of a rehabilitation hospital. PARTICIPANTS: Convenience sample of 50 subjects with total hip (n=25) or knee (n=25) arthroplasty. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Reliability was quantified by indices of dependability and corresponding SEMs estimated with the generalizability theory, whereas coefficients of correlation were used to assess the validity. RESULTS: Indices of dependability confirmed excellent intertrial (0.98-1.00) and a very good interevaluator (.92-.99) reliability for the strength measures obtained for different movements and positions. An average of 3 trials minimized the magnitude of the SEMs (>2 Nm for all measurements). When comparing the strength values obtained with the Cybex dynamometer to those measured with the chair-fixed dynamometer, strongest relations were attained when the tested knee was positioned at 60 degrees compared with 30 degrees for subjects with a total knee (.78-.92 vs .87-.93) or hip (.73-.85 vs .86-.91) arthroplasty. CONCLUSIONS: A clinical protocol averaging 3 trials with the knee positioned at 60 degrees after a familiarization period, both for knee flexors and extensors, performed by a trained therapist is recommended to minimize measurement errors on strength values measured with the chair-fixed dynamometer.

Aged↗
PubMed2001

Protocol for clinical neurophysiologic examination of the pelvic floor.

Clinical neurophysiologic examination of the pelvic floor is performed worldwide, but there is no consensus on the choice of tests, nor on technical details of individual methods. Standardized methods are, however, necessary to obtain their valid application in different laboratories for the purpose of collection of normative data, comparison of patient data and organization of multi-center studies. It is proposed that in patients with suspected "lower motor neuron" type lesions concentric needle electromyography (CNEMG) is the most informative test to detect pelvic floor denervation/reinnervation, and the external anal sphincter (EAS) muscle is the most appropriate muscle to be examined (either in isolation-when a selective lesion is suspected-or in addition to examination of other muscles). An algorithm consisting of standardized tests including a standardized approach to CNEMG examination of the EAS is presented. The proposed electrophysiologic assessment consists of a computer-assisted analysis of denervation and reinnervation features of the CNEMG signal, a qualitative assessment of reflex and voluntary activation of EAS motor units, and of electrical (or mechanical) elicitation of the bulbocavernosus reflex in those patients in whom manual anogenital stimulation failed to elicit a robust response in the EAS. The proposed protocol could serve as a basis for further studies on validity, sensitivity and specificity of electrophysiologic assessment in patients with different types of "lower motor neuron" involvement of pelvic floor muscles and sacral dysfunction.

Algorithms↗
PubMed1995

The final analysis of the EORTC Genito-Urinary Tract Cancer Co-Operative Group phase III clinical trial (protocol 30805) comparing orchidectomy, orchidectomy plus cyproterone acetate and low dose stilboestrol in the management of metastatic carcinoma of the prostate.

This report is the final analysis of an EORTC Genito-Urinary Group Phase III trial (Protocol 30805) comparing orchidectomy, orchidectomy plus cyproterone acetate 50 mg 3 times a day and stilboestrol 1 mg daily in the management of metastatic carcinoma of the prostate. Three hundred and twenty-eight eligible patients admitted into the study have been followed up for a median period of 4 years. There was no difference in time to metastatic progression and overall survival between the treatment arms. The cardiovascular toxicity of stilboestrol 1 mg daily has resulted in more cardiovascular deaths as compared with the orchidectomy treatment arm. The outcome for individual patients has been determined by on-study prognostic factors, especially the performance status, rather than the treatment given.

Adenocarcinoma↗
PubMed1993

The impact of clinical trial protocols on patient care systems in a large city hospital. Access for the socially disadvantaged.

Some Americans suffer a higher cancer incidence and mortality than those in mainstream American society, and, in general, do not enjoy the same health status. Black Americans, for example, have higher cancer incidence and lower survival rates than do white Americans. To date, there is no known genetic basis to account for the disparities in cancer incidence and outcome between these races. Controlling for socioeconomic status greatly reduces, and sometimes nearly eliminates, the apparent contrast in cancer mortality and incidence between ethnic groups. Poverty clearly is associated with diminished access to health care, an increased incidence of cancer, and 10-15% lower 5-year survival rates. Diminished access often is manifested by low quality and inadequate continuity of health care, as well as insufficient access to methods of disease detection, diagnosis, treatment, and rehabilitation. Poor people tend to concentrate on day-to-day survival, often feel hopeless and powerless, and may become socially isolated. It is more difficult to conduct cancer treatment trials in a population characterized by such dramatic socioeconomic and cultural differences. Lack of insurance and lack of compliance become trial-limiting issues. This paper examines what must be done to tear down the economic and cultural barriers to prevention, early detection, and treatment of cancer.

Clinical Trials as Topic↗
PubMed2002

Ex vivo expanded cord blood cells provide rapid engraftment in fetal sheep but lack long-term engrafting potential.

OBJECTIVE: Cord blood (CB) products are becoming routinely used in unrelated allogeneic transplantation for smaller pediatric patients. Because of the low numbers of cells in CB compared to bone marrow or peripheral blood progenitor cells, their use is more limited in larger adults. Therefore, we developed ex vivo expansion conditions for CB and currently are transplanting ex vivo expanded CB products to patients receiving high-dose chemotherapy. As there is concern that ex vivo expansion may exhaust long-term engrafting cells, the current clinical protocols consist of both an expanded fraction and an unexpanded fraction. To determine the effect of expansion culture on long-term engrafting cells, we evaluated the short- and long-term engrafting potential of ex vivo expanded CB using a fetal sheep xenogeneic transplant model. MATERIAL AND METHODS: CD 34(+) cells were selected from CB products and cultured in a two-step procedure in the presence of stem cell factor, megakaryocyte growth and differentiation factor, and granulocyte colony-stimulating factor for 14 days. Starting cells (CD34(+) cells), and cultured cells (day 7 and day 14 cells) were transplanted in 60-day-old fetal sheep and evaluated at various time points post transplant for the presence of human cells. Long-term engrafting cells were assessed by serial passage into secondary and tertiary recipients. RESULTS: Day 14 expanded CB cells provided more rapid engraftment than either the day 7 expanded cells or the day 0 cells; however, this engraftment was transient, and no human cells were detectable at 16 months post transplant in the animals that received the day 14 expanded cells. Day 0 cells had engrafted animals at 2 months post transplant and both the day 0 and day 7 cells persisted to 16 months or longer. In the secondary animals, the day 0 and day 7 cells engrafted equivalently at 3 months post transplant; however, no secondary engraftment resulted from the day 14 cells. The levels of engraftment in secondary animals receiving day 7 cells decreased with time to barely detectable levels at 12 months post transplant. CONCLUSIONS: Ex vivo expansion of CB CD34(+) cells under the conditions described results in the generation of increased mature cells and progenitors that are capable of more rapid engraftment in fetal sheep compared to unexpanded CB CD34(+) cells. The expanded cells engrafted primary sheep but lacked secondary and tertiary engrafting potential. These studies demonstrate that although ex vivo expanded cells may be able to provide rapid short-term engraftment, the long-term potential of expanded grafts may be compromised. Therefore, clinical protocols may require transplantation of two fractions of cells, an expanded CB graft to provide rapid short-term engraftment and an unmanipulated fraction of CB graft to provide stem cells for long-term engraftment.

Animals↗
PubMed2006

Intraoperative adverse events and related postoperative complications in spine surgery: implications for enhancing patient safety founded on evidence-based protocols.

STUDY DESIGN: Prospective observational study. OBJECTIVE: To assess the incidence and clinical consequence of intraoperative adverse events from a wide variety of spinal surgical procedures. SUMMARY OF BACKGROUND DATA: In this study, adverse events were defined as any unexpected or undesirable event(s) occurring as a result of spinal surgery. A complication was defined as a disease or disorder, which, as a consequence of a surgical procedure, will negatively affect the outcome of the patient. We hypothesized that most adverse events would not result in complications that would be normally flagged through traditional practice audit approaches. By defining the incidence and types of adverse events seen in a spine surgical practice, we hope to develop preventative approaches to enhance patient safety. METHODS: All postoperative clinical sequelae (i.e., complications) were prospectively identified, classified as to type, and graded (0 [none] to IV [death]) in 700 consecutive patients who underwent spine surgery (excluding > 300-day surgery microdiscectomies) at a university center from January 2002 to June 2003. To confirm data accuracy and assess the clinical sequelae of any adverse events, the medical records of these 700 patients were reviewed. RESULTS: The overall incidence of intraoperative adverse events was 14% (98/700). A total of 23 adverse events led to postoperative clinical sequelae for an overall intraoperative complication incidence of 3.2% (23/700). Specific adverse events included dural tears (n = 58), spinal instrumentation-related events (n = 12), blood loss exceeding 5000 mL (n = 10), anesthesia/medical (n = 4), suspected or actual vertebral artery injury (n = 3), approach-related events (n = 3), esophageal/pharyngeal injury (n = 2), and miscellaneous (n = 6). CONCLUSIONS: Adverse events can frequently occur (14%) during spinal surgery, however, the majority (76.5%) are not associated with complications. Improved patient safety can only be maximized by independent practice audit and the development of prospective methods to record adverse event data so that enhanced, evidence-based, clinical protocols can be developed.

Clinical Protocols↗
PubMed1998

Targeted adenoviral vectors for cancer gene therapy.

The delineation of the molecular basis of cancer allows for the possibility of specific intervention at the molecular level for therapeutic purposes. To this end, viral and nonviral vectors have been designed for delivery and expression of genes into target malignant and non-malignant cells. Gene transfer by available vectors, applied both in the ex vivo and in in vivo contexts, has resulted frequently in the desired cellular phenotypical changes. In this regard, recombinant adenoviruses have been particularly efficient for in vivo gene transfer. Importantly, numerous human clinical protocols using adenoviruses have rapidly entered Phase I clinical trials. However, major vector-related problems remain to be solved before the transfer of therapeutic genes by adenoviruses can become an effective and common place strategy for cancer. An overriding obstacle is the basic ability to deliver therapeutic genes specifically into tumor cells. Here we review a diverse number of advances in adenoviral vectors being developed for overcoming this obstacle. As vector technology fulfills these requirements for obtaining the "targetable-injectable" vector, it is anticipated that promising results already observed in pre-clinical studies will translate quickly into the clinic.

Adenoviridae↗
PubMed2003

Morphological assessment of radical prostatectomy specimens. A protocol with clinical relevance.

The increase in prostate cancer detection has induced a sharp increase in the number of radical prostatectomies Proper examination of radical prostatectomy (RP) specimens by pathologists is critical in determining the need for adjuvant treatment and prediction of patient outcome. The pathology report should include relevant clinical information as well as provide prognostically useful information derived from the macroscopic examination and microscopic evaluation of the RP specimen

Histological Techniques↗
PubMed2006

MDCT in the evaluation of skeletal trauma: principles, protocols, and clinical applications.

Multidetector computed tomography (MDCT) scanners have made volume imaging possible and are used extensively to study polytrauma patients, especially in the evaluation of the spine and peripheral skeleton. An MDCT scanner coupled with a modern workstation has become an essential diagnostic tool for any emergency department. Familiarity with the basic physical principles of MDCT such as projection data, section collimation, and beam collimation is important to achieve high-quality imaging while keeping unnecessary radiation to a minimum. After a polytrauma MDCT examination, images can be reconstructed to obtain different slice thickness, slice interval, fields of view, or reconstruction kernels. No additional scanning is needed for imaging the thoracolumbar spine or bony pelvis. High-quality multiplanar reformation (MPR) and three-dimensional (3-D) images can be created at the workstation using the volumetric data. However, MDCT is a high-dose examination, and care should be taken to use as low a dose as possible. In the musculoskeletal system, MDCT has long been used for evaluation of spinal and pelvic trauma; however, the frequency of its use in extremity trauma has been low. In the extremities, radiography seems to underestimate the extent and severity of injury, especially in complex areas such as the shoulder, elbow, wrist, knee, and ankle. MDCT in the extremities is helpful in fracture detection, evaluation, characterization, and treatment planning. The MPR images give excellent structural detail, and the 3-D images help in understanding the spatial relations, which is important for fracture classification and for preoperative planning. MDCT is also helpful in the follow-up of postoperative results, even in the presence of hardware. Tendon injuries can also be evaluated with MDCT.

Artificial Intelligence↗
PubMed2006

Assessing treatment outcomes for a graduate orthodontics program: follow-up study for the classes of 2001-2003.

INTRODUCTION: Based on an initial 3-year study (1998-2000) of clinical outcomes, specific changes were made in the clinical protocol in the orthodontic clinic at Indiana University, Indianapolis, Ind. To evaluate these adjustments, a follow-up study with the same methods assessed the clinical outcomes for the next 3 years (2001-2003). METHODS: The 3 changes introduced in 2000 were assessment of prefinish records, education of residents about previous outcomes, and more frequent practice evaluations by the program director. The American Board of Orthodontics (ABO) objective grading system (OGS) and a supplemental comprehensive clinical assessment (CCA) were used to evaluate the results for all patients completed by the classes of 2001 through 2003 (n = 437). RESULTS: The mean ABO OGS, CCA, and combined scores were 25.19 +/- 11.16, 4.38 +/- 2.74, and 29.57 +/- 13.01, respectively. A progressive improvement was noted from 2001 to 2003. The ABO OGS and the combined scores were significantly (P <.001) improved in 2001 through 2003 compared with 1998 through 2000. The CCA score tended to improve, but it was not significantly different. Significant improvements were seen for maxillary and mandibular first order, mandibular second order, mandibular third order, overjet, occlusal contacts, occlusal relationships, and root angulations (P <.001). As with the previous study, excessive treatment times correlated with worse clinical outcomes. CONCLUSIONS: Changes implemented by the graduate program were effective for improving treatment outcomes. Cast scores were more amenable to improvement than other more comprehensive outcomes.

Adolescent↗
PubMed2006

Outcomes of surveillance protocol of clinical stage I nonseminomatous germ cell tumors-is shift to risk adapted policy justified?

PURPOSE: We evaluated the potential risk factors for disease relapse in patients with clinical stage I nonseminomatous germ cell tumors treated with surveillance and reevaluated our treatment of these patients. MATERIALS AND METHODS: A total of 211 consecutive patients with clinical stage I nonseminomatous germ cell tumors treated with surveillance after orchiectomy between 1993 and 2005 were included in this retrospective study. Risk factors evaluated were presence of vascular invasion, proportion of embryonal carcinoma, age, tumor size, preoperatively increased serum alpha-fetoprotein and the absence of yolk sac component. RESULTS: Of the 211 patients 66 (31.3%) had disease relapse. Recurrence ranged from 2 to 32 months after orchiectomy (median 6). A total of 52 (78.8%) cases of relapse were diagnosed in year 1 of followup, 11 (16.7%) during year 2 and only 3 cases were diagnosed thereafter. The first evidence of relapse was most commonly the increase in serum tumor markers alone (28.8%) or in combination with other modalities (66.7%, overall 95.5%). While 40.9% of patients with more than 50% embryonal carcinoma had disease relapse, the relapse rate was 20.8% in patients with less than 50% embryonal carcinoma (p = 0.002). Relapse rates in patients with and without vascular invasion were 75.5% and 17.9%, respectively (p = 0.000). The relapse rates were 6.1% and 75.7% in patients with no risk factors (no vascular invasion and less than 50% embryonal carcinoma) and 2 risk factors (vascular invasion and more than 50% embryonal carcinoma), respectively (p < 0.001). Multivariate analysis revealed that vascular invasion was the most powerful predictor of relapse (OR 16.350, 95% CI 5.582-47.893). Disease-free and disease specific survival rates were 97.6% at a median followup of 75 months. CONCLUSIONS: In light of our results we suggest that all patients with vascular invasion should receive chemotherapy. However, patients with no risk factors and those with more than 50% embryonal carcinoma but without vascular invasion should be on surveillance after orchiectomy since the relapse rate is less than 30%. Although strict followup in the first year is justified, followup schemas may be reassessed for the frequency of radiological investigations.

Adolescent↗
PubMed2007

Loser cows in Danish dairy herds: definition, prevalence and consequences.

During the last few years, many Danish dairy farmers have expressed increasing concerns regarding a group of cows, which we have chosen to term 'loser cows'. Until now, a loser cow has not been described scientifically. We defined a loser cow on the basis of a clinical examination of the cow. A total of 15,151 clinical examinations were made on 6,451 individual cows from 39 randomly selected, large Danish dairy herds with loose-housing systems using a clinical protocol. Scores for the clinical signs lameness, body condition, hock lesions, other cutaneous lesions, vaginal discharge, condition of hair coat and general condition were converted into a loser cow score. Cows with a loser cow score of 8 or more were classified as loser cows. The overall prevalence of loser cows was 2.15%, 4.50% and 2.98% during the first, second and third round of herd visits, respectively. The associations between the loser cow state and milk production, mortality, morbidity, culling and workload for the farmer were evaluated using data from herd visits and from the Danish Cattle Database and a number of different statistical techniques. It was concluded that the loser cow state has significant negative consequences for both the farmer and the cow. On average, loser cows yielded 0.61 to 2.24 kg energy corrected milk less per day than non-loser cows depending on parity. Hazard ratio for death or euthanasia was 5.69 for loser cows compared to non-loser cows. Incidence rate ratio for disease treatments was 0.69 for non-loser cows compared to loser cows. Loser cows were often culled in an 'unfavourable' way and generally caused extra workload for the farmer. A simplified version of the loser cow score was evaluated and is recommended for future research and use in practice.

Animals↗
PubMed1985

Massive hemoptysis in patients with cystic fibrosis: three case reports and a protocol for clinical management.

The clinical management of massive hemoptysis in patients with cystic fibrosis proceeds according to the following paradigm. The site of bleeding is identified by bronchoscopy, ideally under general anesthesia. Then selective bronchial arteriography is performed. If collaterals to the spinal cord are visualized, arterial embolization is abandoned and pulmonary resection is undertaken within the limits of pulmonary function.

Adult↗
PubMed1987

Cryopreservation of human spermatozoa. II. Postthaw chronology of motility and of zona-free hamster ova penetration.

Postthaw dynamics of motility maintenance and ability to penetrate zona-free hamster ova were examined with human sperm. Ten semen samples were each divided into two equal volumes; one was cryopreserved while the other half remained untreated. Frozen samples were thawed, and initial evaluations for motility and hamster egg penetration were made on both untreated and frozen-thawed samples. The time difference between the initial evaluations for the two treatment groups was approximately 30 minutes as a result of the time required to freeze and thaw aliquots. Subsequent evaluations were made 6, 12, 24, and 48 hours later. Over all times both the motility and fertilizability of cryopreserved spermatozoa were significantly reduced (P less than 0.05) when compared with those of untreated sperm. The pattern of motility loss over time was similar between untreated and frozen-thawed sperm (P greater than 0.10). Conversely, differences between untreated and frozen-thawed sperm in fertilizability patterns were dramatic (P less than 0.05). This was evidenced by penetration rates for cryopreserved sperm highest at 0 hour and decreasing over time, whereas penetration by untreated spermatozoa was lowest at 0 hour, increasing to a maximum at 24 hours. These observations may be important in the development of laboratory protocols for freezing and clinical protocols for using frozen-thawed sperm.

Animals↗