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At least 379 records · Page 21Linked to original sources
PubMed2003

Fetal endoscopic telesurgery using an Internet Protocol connection: clinical and technical challenges.

Until recently, fetoscopic laser surgery to seal the placental anastomoses that cause severe twin-to-twin transfusion syndrome has been available in only a few centres worldwide. The technique typically takes a long time to learn. We have used a dedicated Internet Protocol (IP) connection for tele-education to assist the introduction of fetoscopic laser surgery to Australia. During the implementation of the international telemedicine link, there were multiple clinical and technical problems, which were eventually overcome. The quality of images and of video-sequences was comparable to that supported by an ISDN connection. Pictures of live surgery performed by an expert in Florida, USA, were transmitted and viewed by a novice team in Brisbane, Australia. The Australian team has performed 19 fetoscopic laser operations to date. Preliminary results are comparable to those from centres that have performed over 100 procedures.

Australia↗
PubMed2003

Theory and rationale for surface EMG-assisted stretching as an adjunct to chronic musculoskeletal pain rehabilitation.

A clinical protocol is reviewed, which utilizes supportive intervention, education, and surface EMG biofeedback to facilitate movement and to maximize effective stretching with chronic musculoskeletal pain patients. Support for this clinical protocol is provided with an overview of the physiological basis of stretching, surface EMG patterns associated with stretching, and the effects of pain and emotional factors on stretching and movement inhibition.

Acute Disease↗
PubMed2000

Progress reports on immune gene therapy for stage IV renal cell cancer using lethally irradiated granulocyte-macrophage colony-stimulating factor-transduced autologous renal cancer cells.

There is no effective treatment for patients with stage IV renal cell cancer (RCC), although the introduction of new therapy is imminent. Cancer gene therapy is currently considered to be one of the most promising therapeutic modalities in the field of cancer treatment. Based on the results of animal studies, vaccination using autologous granulocyte-macrophage colony-stimulating factor-transduced renal cancer cells appears promising. Before initiating a clinical study using an ex vivo gene-transduced autologous cell vaccine-based immunogene therapy for RCC in Japan, in 1992 we initially planned a Japanese version of a clinical protocol in collaboration with a US group. In 1993, the original protocol was refined. We performed five preclinical qualification studies using RCC nephrectomy specimens from patients in 1997, and the results showed that preparation of RCC cells for autologous vaccines at the Clinical Cell Technology Facility, Research Hospital of the Institute of Medical Science, University of Tokyo, was feasible. Subsequently in August 1998, the Ministry of Health and Welfare and the Ministry of Education, Science, Culture, and Sport approved our clinical protocol. We have recruited two patients with stage IV RCC to our study so far. Here we report the background to the initiation of cancer gene therapy in Japan.

Adult↗
PubMed1991

Planning and implementing clinical trials.

Careful planning and organization are essential in the design and conduct of a clinical trial. The clinical protocol provides a framework that describes the proposed experiment and outlines the means for achieving specific endpoints. Protecting research participants and assuring quality control are important to the conduct of clinical trials. the participation and responsibilities of oncology nurses contribute to the success of clinical trials.

Clinical Protocols↗
PubMed1996

Diagnosis and treatment of halitosis.

Diagnostic and treatment services for patient complaints of "bad breath" are currently being offered in many dental offices. There are no accepted standards of care for these services, and clinical protocols for the diagnosis and treatment of breath malodor vary widely. This article attempts to review the biological and psychological bases of patients' complaints of bad breath and to describe a clinical protocol for the evaluation and treatment of such complaints. This protocol resulted in a 99% success rate in eliminating objectively measured breath malodor. However, 24% of patients continued to believe that at least some of their bad breath persisted after treatment. The merits of various diagnostic procedures are discussed in light of the psychogenic component of the symptomatology of halitosis sufferers.

Adolescent↗
PubMed2005

Health economic analysis of fluoropyrimidine-based therapies of colorectal cancer from the perspective of statutory sickness funds.

AIMS: 1) to identify the treatment costs of different standard fluoropyrimidine-based therapies, i. e., the Mayo-Clinic and AIO/Ardalan regimens, under real-life conditions in settings routinely used for chemotherapy administration in Germany (inpatient, day-clinic or office-based oncologists) and 2) to investigate the cost implications of the routine use of capecitabine, an oral alternative for the treatment of metastatic colorectal cancer. METHODS: We analysed the actual fee-listings of office based oncologists and projected the results to several hospital-based treatment settings and to oral treatment with capecitabine from the perspective of statutory sickness funds. RESULTS: Office-based setting: the highest quarterly treatment costs of 9.874 were found for the AIO/Ardalan-regimen, followed by the Mayo-Clinic regimen, which incurred costs of 2.497. The cheapest treatment option was capecitabine with quarterly costs of 1.610. Day-clinic setting: the costs of the Mayo-Clinic protocol amounted to 2.036 in a municipal hospital and 8.455 in a university hospital. The respective costs for the AIO/Ardalan regime were 1.294 and 5.374. In-patient setting: the Mayo-Clinic protocol costs were 3.143 in a municipal hospital and 10.5609 in a university hospital. The respective costs found for the AIO/Ardalan-regimen were 1.998 and 6.717. CONCLUSION: From a health economic perspective, substantial cost savings for health insurance may be realised if patients with colorectal carcinoma were treated in the office-based setting with capecitabine instead of a hospital-based treatment. Economic consequences would be positive for municipal hospitals (avoided losses) and negative for university hospitals. Further savings could be realised if drug prices in hospital and retail pharmacies were harmonized.

Administration, Oral↗
PubMed2004

Gender effects on high frequency distortion product otoacoustic emissions in humans.

OBJECTIVE: Gender has been reported to affect many tests of the auditory system, including distortion product otoacoustic emission (DPOAE) group delay and level when elicited with lower frequency stimuli (<8 kHz). Using custom equipment, the effect of gender on DPOAEs at higher frequencies was explored. It is expected that differences in group delay reported at very low frequencies (e.g., 0.78 Hz) will not be replicated at higher frequencies. Additionally, it was hypothesized that female subjects would display larger-level DPOAEs at higher frequencies, based on evidence that female subjects tend to have larger emissions when elicited with lower frequency stimuli. DESIGN: DPOAEs were measured in 37 subjects (20 females and 17 males) with normal behavioral thresholds, middle ear function, and present acoustic reflexes at 1 kHz with contralateral stimulation. Behavioral thresholds were measured through 16 kHz using Békèsy tracking. Ratio and frequency sweeps were used to calculate DPOAE group delay and measure DPOAE levels, respectively. Ratio sweeps were obtained at f2 frequencies of 1, 2, 4, 8, 10, 12, 14, and 16 kHz, with L1 = 60 and L2 = 45 dB SPL, with the ratio (f2/f1) varied from 1.11 to 1.3. Frequency sweeps were measured with L1 = 60 and L2 = 45 dB SPL and an f2/f1 of 1.2 at discrete f2 frequencies between 1 and 16 kHz. Data were subjected to repeated-measures analysis of variance. RESULTS: Significant frequency-by-gender interactions were found for group delay (for data from 1 to 8 kHz) and level (for data from 9 to 15 kHz). The frequency-by-gender interaction and the main effect of gender were not significant for the behavioral results. CONCLUSIONS: Gender-based norms for auditory-evoked potentials measures are standard in clinical settings. The results of the present study, in agreement with previous studies, indicate that significant interactions exist between gender and DPOAE group delay values in the lower frequencies, and between gender and DPOAE levels at the higher frequencies. To reach the goal of using high frequency DPOAEs in clinical protocols, such as for auditory neuropathy/dys-synchrony diagnosis and ototoxicity monitoring, DPOAEs elicited with conventional and higher frequency stimuli must be understood, including the role of gender to determine if an effect on clinical protocols would exist.

Adolescent↗
PubMed1998

Experimental protocol for clinical analysis of cerebrospinal fluid by high resolution proton magnetic resonance spectroscopy.

High resolution magnetic resonance spectroscopy (MRS) of cerebrospinal fluid (CSF) is a non-destructive analytical method which allows rapid and simultaneous detection of molecules involved in intermediary and oxidative metabolic pathways. We developed a protocol suitable for routine MRS analysis of lyophilized CSF samples. This procedure guarantees sample integrity, from CSF collection to spectrum acquisition. MRS analysis of blood serum was included in our protocol as a complementary method to CSF analysis. This protocol can contribute to establish MRS of CSF as a new analytical tool to better understand the metabolic processes involved in neurological diseases.

Adult↗
PubMed2001

Scoring accuracy using the comprehensive system for the Rorschach.

The Comprehensive System (CS; Exner, 1974, 1978) for scoring Rorschach responses is the most widely taught and most widely accepted system in use today. The complexity and labor- intensive nature of the CS makes the issue of scoring accuracy a central concern. Twenty-one graduate psychology students and 12 professionals scored 20 Rorschach responses drawn from normal and clinical protocols. In general. accuracy scores for both students and professionals were below acceptable levels. Accuracy scores were clearly better for the code categories of Location, DQ, Pairs, Popular, and Z than for Determinants, FQ, Content, and Special Scores. Responses from clinical protocols were subject to more error. The results suggest that high levels of scoring errors may exist in the field use of the CS. Training standards may need to be devised to insure scoring competence.

Clinical Competence↗
PubMed1996

Selective use of the intensive care unit after nonaortic arterial surgery.

PURPOSE: The purpose of this study was to determine whether the institution of a clinical protocol combining 6 hours of recovery room observation and guidelines for intensive care unit (ICU) admission would allow selected patients to be safely transferred directly to a surgical floor after nonaortic arterial reconstruction. METHODS: After a clinical pathway was formed, 134 consecutive patients undergoing 154 nonaortic arterial operations were prospectively enrolled in this study. Patients requiring ICU care and the responsible factors were identified. Comparisons of risk factors and demographics were made between those patients who did and did not require ICU care. RESULTS: Twelve (7.8%) patients spent a total of 27 days in the ICU (range 1 to 11 days). As per our guidelines four patients were transferred to the ICU for invasive monitoring, and four were sent to the ICU because of refractory hemodynamic instability or arrhythmia in the postanesthetic recovery room. An additional four patients were transferred to the ICU after having been on the surgical floor for 24 to 72 hours because of the following perioperative complications: prolonged chest pain (one), pneumonia (one), heart failure (one), and graft occlusion requiring a urokinase infusion. Patients admitted to the ICU were more likely to have heart disease (p = 0.02) and to have had an operation other than carotid endarterectomy (p = 0.04) than those who were not. The 30-day mortality rate was 1.4%. CONCLUSIONS: The implementation of a clinical protocol similar to the one used in this study will allow many patients undergoing nonaortic vascular surgery to avoid the use of the ICU. This approach will conserve hospital and financial resources without adversely affecting patient morbidity and mortality rates.

Aged↗
PubMed2003

Effect of MTAD on flexural strength and modulus of elasticity of dentin.

The purpose of this study was to evaluate the effect of MTAD on the flexural strength and modulus of elasticity of dentin. Dentin bars were randomly assigned to eight groups treated with various concentrations of NaOCl (5.25%, 2.65%, 1.31%, 0.66%), 17% EDTA, MTAD, saline, or according to a clinical protocol with 1.3% NaOCl and then 5 min of MTAD. Specimens were subjected to flexural strength and modulus of elasticity tests. Two-sample t test (alpha = 0.05) showed no statistically significant differences between various groups except for a reduction in flexural strength for the 2-h MTAD group (p = 0.002) and the EDTA group (p = 0.002). A significant reduction of modulus of elasticity for the 2-h MTAD group (p < 0.001), EDTA group (p < 0.001), and 0.6% NaOCl (p < 0.002) also was noted. There was no significant difference in flexural strength and modulus of elasticity between the dentin bars exposed to saline or MTAD when applied according to the clinical protocol (p > 0.05). These results indicate that MTAD can be used as prescribed for clinical use without affecting the physical properties of the dentin.

Analysis of Variance↗
PubMed2002

Development of resistance mutations in women receiving standard antiretroviral therapy who received intrapartum nevirapine to prevent perinatal human immunodeficiency virus type 1 transmission: a substudy of pediatric AIDS clinical trials group protocol 316.

Pediatric AIDS Clinical Trials Group protocol 316 was an international, multicenter, placebo-controlled trial comparing single-dose oral nevirapine (200 mg to mother and 2 mg/kg to infant) with placebo in human immunodeficiency virus (HIV)-infected pregnant women receiving standard antiretroviral therapy. This substudy evaluated the emergence of nevirapine-resistance mutations at 6 weeks postpartum in a subgroup of participants. Maternal risk factors for the emergence of nevirapine-resistance mutations were evaluated. Mutations associated with nevirapine resistance were detectable at delivery, prior to receipt of study drug, in 5 (2.3%) of 217 women. Fourteen (15%; 95% confidence interval, 8%-23%) of 95 women who received intrapartum nevirapine developed a nevirapine-resistance mutation 6 weeks postpartum. The most common mutation was K103N, which was present in 10 women. The risk for development of a new nevirapine-resistance mutation did not correlate with CD4 cell count or HIV-1 RNA load at delivery or with type of antepartum antiretroviral therapy. The risk of nevirapine resistance should be considered when determining the risks or benefits of intrapartum nevirapine in women receiving antepartum antiretroviral therapy.

Acquired Immunodeficiency Syndrome↗
PubMed1999

Efficacy of zidovudine and human immunodeficiency virus (HIV) hyperimmune immunoglobulin for reducing perinatal HIV transmission from HIV-infected women with advanced disease: results of Pediatric AIDS Clinical Trials Group protocol 185.

Pediatric AIDS Clinical Trials Group protocol 185 evaluated whether zidovudine combined with human immunodeficiency virus (HIV) hyperimmune immunoglobulin (HIVIG) infusions administered monthly during pregnancy and to the neonate at birth would significantly lower perinatal HIV transmission compared with treatment with zidovudine and intravenous immunoglobulin (IVIG) without HIV antibody. Subjects had baseline CD4 cell counts </=500/microL (22% had counts <200/microL) and required zidovudine for maternal health (24% received zidovudine before pregnancy). Transmission was associated with lower maternal baseline CD4 cell count (odds ratio, 1.58 per 100-cell decrement; P=.005; 10.0% vs. 3.6% transmission for count <200 vs. >/=200/microL) but not with time of zidovudine initiation (5.6% vs. 4.8% if started before vs. during pregnancy; P=. 75). The Kaplan-Meier transmission rate for HIVIG recipients was 4. 1% (95% confidence interval, 1.5%-6.7%) and for IVIG recipients was 6.0% (2.8%-9.1%) (P=.36). The unexpectedly low transmission confirmed that zidovudine prophylaxis is highly effective, even for women with advanced HIV disease and prior zidovudine therapy, although it limited the study's ability to address whether passive immunization diminishes perinatal transmission.

Adult↗
PubMed1999

A phase I/II study of hepatic artery infusion with wtp53-CMV-Ad in metastatic malignant liver tumours.

Colorectal cancer (CRC) is the second commonest cause of cancer death in the UK, with greater than 40% of these patients destined to die of the disease despite current medical management. Death is commonly due to liver metastases with sequelae including progressive liver dysfunction. Most patients with liver metastases present with tumours that are unresectable and incurable with existing therapies. The median survival for CRC patients after diagnosis with liver metastases is approximately 6 months or less. The human p53 gene is a tumour suppressor gene involved in the control of cell proliferation. Loss of wild-type p53 function is associated with the uncontrolled growth of many types of human cancers. The reintroduction and expression of wild-type p53 into p53 altered tumour cells has been shown to suppress tumour growth or induce apoptosis in both in vitro and in vivo models. In our experience greater than 50% of CRC tumours have p53 alterations. This study seeks to evaluate the safety, biological efficacy and the effectiveness of wtp53-CMV-Ad treatment which is a recombinant adenoviral vector containing the wild-type human p53 gene. It will be administered by infusion via the hepatic artery, for the regional gene therapy of malignant liver tumours. Study patients will have incurable metastatic (CRC) malignant tumours of the liver with evidence of p53 alteration in their liver tumours. In vitro studies have demonstrated p53-specific antiproliferative effects of wtp53-CMV-Ad on human liver tumour cells and in vivo studies have demonstrated p53-specific antiproliferative effects on human liver tumour cells. The vector Ad-p53 is a recombinant, replication-defective adenovirus based on adenovirus serotype 5. It contains a sequence encoding wild-type p53 whose expression is under the control of the human cytomegalovirus immediate early promoter-enhancer. This construct will be growth in 293 cells which contain the adenoviral E1A and E1B coding sequences which have been removed from the vector to render it replication defective. The study design is an open-label, non-randomised, single-dose, dose escalation Phase I/II clinical trial anticipated to involve a maximum of 19 patients. wtp53-CMV-Ad will be administered by infusion in a reservoir connected to the hepatic artery, for regional gene therapy (surgically implanted pump) in 3 escalating doses to successive cohorts of 3 patients each until the maximum tolerated dose is determined. Subsequently, 10 patients will be treated with this dose. Regional wtp53-CMV-Ad therapy will be administered as a single bolus infusion via hepatic artery catheter. The route of administration of wtp53-CMV-Ad via hepatic artery infusion is designed to maximise gene therapy exposure to the malignant tumours while minimising exposure to normal tissues outside the liver. The clinical protocol is designed to monitor treatment toxicity. Another objective is to evaluate the biological efficacy, including efficiency and stability of gene transfer by analysis of tumour tissues following therapy. As an important part of this objective the pharmacokinetics of wtp53-CMV-Ad will be studied. Clinical evidence of anti-tumour efficacy will also be collected. In addition, the safety and efficacy of different doses levels of wtp53-CMV-Ad will be studied.

Adenoviridae↗
PubMed2005

Promethazine for the treatment of agitation after electroconvulsive therapy: a case series.

OBJECTIVES: Agitation after electroconvulsive therapy (ECT) is observed in approximately 7% of patients. Promethazine is an antihistamine with sedative properties that has no antiseizure effects and therefore can be administered before ECT to prevent the onset of agitation. In the current study, we present a series of 8 patients who reacted to ECT with severe agitation and improved under the treatment of promethazine. METHODS: Eight patients were included (5 women, 3 men), ages 22 to 77 years. All patients showed severe post-ECT agitation as demonstrated by severe restlessness, crying, or mumbling loudly. Seven of them required the administration of intravenous midazolam. ECT was given according to established clinical protocols at the Sheba Medical Center. All patients were prescribed either 25 to 50 mg of promethazine 2 hours before the treatment to avoid agitation. RESULTS: All 8 patients suffered from extreme agitation after ECT treatment, and 7 required the administration of intravenous midazolam. After a clinical protocol, these patients were prescribed 25-50 mg of promethazine orally 60-120 minutes before the ECT. Improvement was observed in all patients both immediately post-ECT and also in their overall sense of well-being after the ECT. No patient complained of adverse reactions to the promethazine. Most patients reported a relief in pre-ECT fears. CONCLUSION: In this small case series, we found that promethazine can be used to prevent post-ECT agitation. Further double-blind controlled studies are needed to better evaluate the usefulness and appropriateness of promethazine in the prevention of pre-ECT fears and post-ECT agitation.

Adult↗
PubMed1995

The outcome of a clinical trial of a dentin bonding system. Justice or injustice?

PURPOSE: To review the findings and to question the outcome of a clinical evaluation of a dentin bonding system. MATERIALS AND METHODS: The study was a split mouth, single blind (to patient), randomised within patient, clinical trial of Tripton used in conjunction with Opalux and the ultrafine compact-filled, experimental visible light cured resin composite M221784 (ICI Dental) in the restoration of mixed (enamel/dentin), caries free buccal-surface cervical lesions in vital, permanent canine and premolar teeth. The design of the trial was based on the then current American Dental Association (ADA) Clinical Protocol Guidelines for Dentin and Enamel Adhesive Materials. Restorations were placed as dictated by a predetermined randomised number scheme with each patient recruited to the study receiving at least one pair of matched restorations, comprising one restoration of each resin composite. RESULTS: The study reported was discontinued at 1 year subsequent to a 17% loss rate between 6 and 12 months after placement, with most of the restorations lost having been placed in what has subsequently become shown to be relatively unfavorable situations. It is suggested that the outcome of clinical trials of the type considered may warrant review in the light of new knowledge and understanding, and that regulatory bodies setting clinical protocol guidelines must give careful consideration as to whether the criteria for this type of trial should be more restrictive or required to include a representative range of clinically relevant situations.

Adolescent↗