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At least 361 records · Page 20Linked to original sources
PubMed2006

Hypothermia pediatric head injury trial: the value of a pretrial clinical evaluation phase.

BACKGROUND: The utility of a pretrial clinical evaluation or run-in phase prior to conducting trials of complex interventions such as hypothermia therapy following severe traumatic brain injury in children and adolescents has not been established. METHODS: The primary objective of this study was to prospectively evaluate the ability of investigators to adhere to the clinical protocols of care including the cooling and rewarming procedures as well as management guidelines in patients with severe traumatic brain injury (Glasgow Coma Scale<or=8) treated with 24 h of hypothermia therapy. A secondary objective was to evaluate the ability of study research assistants to complete the study case report form using a procedures manual. The study was conducted at 18 sites in Canada, the United Kingdom and France prior to proceeding to a randomized controlled trial (RCT). After 2 patients were enrolled at each center, an independent clinical evaluation committee examined the process of care and the completeness of data collection. Centers were permitted to enroll patients in the RCT once they met pre-established adherence criteria. RESULTS: Seventeen of the 18 centers completed the pretrial clinical evaluation phase demonstrating compliance with study procedures and proceeded to an RCT of hypothermia therapy. One center enrolled only 1 patient in the pretrial clinical evaluation phase due to small numbers of patients with traumatic brain injury, and therefore, did not proceed to the RCT. Three centers were required to enroll more than 2 patients in the pretrial clinical evaluation phase prior to proceeding to the RCT because of problems with adherence to the clinical protocols at two centers and the training of new study personnel at another center. Of the 39 patients enrolled during the pretrial clinical evaluation phase, 8 (20.5%) died and 22 (62.9%) had a good outcome defined as normal, mild or moderate disability assessed using the Pediatric Cerebral Performance Category score at 6 months following injury. DISCUSSION: The pretrial clinical evaluation phase was useful to ensure compliance with complex hypothermia therapy and consensus-based clinical management guidelines of care successfully implemented across 17 of 18 centers. This study maneuver allowed us to complete a subsequent RCT in 225 children following severe traumatic brain injury.

Algorithms↗
PubMedDate not supplied

Continence for women: a test of AWHONN's evidence-based protocol in clinical practice. Association of Women's Health Obstetric and Neonatal Nurses.

OBJECTIVE: To test the effectiveness of an evidence-based protocol for urinary incontinence in increasing identification of women with the condition and improving their outcomes. DESIGN: Prospective formative evaluation study. SETTING: Twenty-one public, private, and other women's health care sites. PARTICIPANTS: Women in ambulatory care settings (N = 1,474) provided descriptive statistics. Clinical outcomes were tested in 132 cases for whom pre- and posttreatment data were available. INTERVENTIONS: Standardized screening and baseline follow-up forms were used to minimize time burden on clinicians; bladder and pelvic floor muscle training materials were provided to clinicians for distribution. MAIN OUTCOME MEASURES: Self-reported frequency, volume, and quality of life related to incontinence and cost of self-management were used to assess protocol effectiveness. RESULTS: Frequency of incontinence episodes, estimated volume lost per episode, and the cost of self-management decreased. Quality of life improved, as reflected in decreased bother attributed to incontinence and in the number of women avoiding activities such as shopping, exercising, or travel because of incontinence. CONCLUSIONS: This simple program of pelvic floor muscle and bladder training, as it has been systematically implemented in a variety of ambulatory women's health care settings, has benefited women's continence status. The results of this project strongly support widespread application.

Adult↗
PubMed2000

Management of tongue cancer in the patient who is systemically immunosuppressed: a preliminary report.

OBJECTIVE: Renal transplantation is being improved, and life expectancy for patients with transplanted kidneys is being prolonged, but the incidence of malignant tumors in other body organs or tissues is increasing progressively. We investigated effective clinical plans for treating lingual cancer in persons who are long-term renal transplant recipients. STUDY DESIGN: The group included 3 cases of lingual cancer after renal transplantation. All were men. The mean age was 47.5 years (range, 40 to 55). The lingual cancer occurred a mean of 9 years after renal transplantation. The lesions of two patients were in the left lingual margins; the other patient had multiple bilateral lesions. All diagnoses were confirmed microscopically to be squamous cell carcinomas stage I to II. RESULTS: The doses of immunosuppressive agents were decreased, and two patients accepted surgery, chemotherapy, and radiotherapy. The third patient died 1 year after the cancer was diagnosed because of metastases. The other 2 patients had regular follow-up for 2 to 3 years and did not have either local recurrence or metastasis. CONCLUSION: Patients who have lingual cancer develop after renal transplantation have received long-term immunosuppressive therapy. We suggest the following clinical protocol: (1) Besides regular evaluation after renal transplantation, physical examination and biopsy of suspicious oral lesions are necessary because of the possibility of postrenal malignancy. (2) Surgery, along with chemotherapy and radiotherapy, is the main treatment of lingual cancer after renal transplantation. (3) The lingual tumor should be comprehensively treated despite the poor immune state of the body, or tumor recurrence can accelerate and metastases can occur. (4) Treating cancer thoroughly and maintaining the function of the transplanted kidney can decrease the patient's immune status. We should continue to observe and to report the patients' protocol, even if the patients' clinical follow-up periods are limited.

Adult↗
PubMed1997

Results of a screening program for Chlamydia trachomatis infection in men attending a sexually transmitted diseases clinic.

BACKGROUND: Screening programs for Chlamydia trachomatis infection in men are uncommon. GOAL: To report the results of a screening program using the Syva MicroTrak direct fluorescent antibody (DFA) test (Palo Alto, CA) for diagnosis of C. trachomatis infection in men attending a sexually transmitted diseases (STD) clinic. STUDY DESIGN: DFA testing was performed on an additional urethral specimen obtained during male new patient or new complaint visits between July 1, 1994 and June 30, 1996. Positive and negative test results were compared according to patient demographic characteristics, symptoms, diagnoses, and treatments received. RESULTS: 474 of 9,662 (4.9%) DFA tests were positive. Men with chlamydial infection were more likely to be African-American (p < 10(-7)) and less than 24 years of age (p < 10(-7)). C. trachomatis infection was present in 10.7% of those with gonorrhea and 10.0% of those with nongonococcal urethritis. Forty percent of chlamydia cases were asymptomatic, and 97% were treated at the visit owing to existing clinic protocols. CONCLUSIONS: C. trachomatis infection is common and often asymptomatic in men attending STD Clinics. Infected men are likely to be young and African-American. Routine screening with the Syva MicroTrak DFA test will detect unsuspected cases of chlamydial infection; however, in the clinic in this report, most cases were already treated according to standard clinic protocols.

Adolescent↗
PubMed1992

Magnetic resonance image synthesis from analytic solutions of spin-echo and radio frequency-spoiled gradient-echo images.

RATIONALE AND OBJECTIVES: To synthesize magnetic resonance images (MRI) in real-time using a minimal data set obtained with routine clinical protocols and stored in a picture archiving and communication system (PACS) database. METHODS: Analytic solutions for T1 and T2 were obtained from a double and a single spin-echo set, with routine parameters. Analytic solutions from radio frequency-spoiled gradient-echo images, with TRs as low as 33 mseconds, also were used to synthesize gradient-echo images. RESULTS: Phantom studies showed that the errors in the synthesized images were significantly smaller than the errors in the T1- and T2-calculated images and similar to the source images. The gradient-echo images resulted in significant scan time savings. CONCLUSION: MRI synthesis from analytic solutions of T1, T2, and rho saves computational time and yields accurate values for the intrinsic parameters while allowing the use of routine clinical protocols. The availability of clinical images in the PACS database and the ability to synthesize images in real-time has allowed the development of a practical interactive teaching module.

Brain↗
PubMed2004

Genotyping of single-nucleotide polymorphisms by high-resolution melting of small amplicons.

BACKGROUND: High-resolution melting of PCR amplicons with the DNA dye LCGreen I was recently introduced as a homogeneous, closed-tube method of genotyping that does not require probes or real-time PCR. We adapted this system to genotype single-nucleotide polymorphisms (SNPs) after rapid-cycle PCR (12 min) of small amplicons (</=50 bp). METHODS: Engineered plasmids were used to study all possible SNP base changes. In addition, clinical protocols for factor V (Leiden) 1691G>A, prothrombin 20210G>A, methylenetetrahydrofolate reductase (MTHFR) 1298A>C, hemochromatosis (HFE) 187C>G, and beta-globin (hemoglobin S) 17A>T were developed. LCGreen I was included in the reaction mixture before PCR, and high-resolution melting was obtained within 2 min after amplification. RESULTS: In all cases, heterozygotes were easily identified because heteroduplexes altered the shape of the melting curves. Approximately 84% of human SNPs involve a base exchange between A::T and G::C base pairs, and the homozygotes are easily genotyped by melting temperatures (T(m)s) that differ by 0.8-1.4 degrees C. However, in approximately 16% of SNPs, the bases only switch strands and preserve the base pair, producing very small T(m) differences between homozygotes (<0.4 degrees C). Although most of these cases can be genotyped by T(m), one-fourth (4% of total SNPs) show nearest-neighbor symmetry, and, as predicted, the homozygotes cannot be resolved from each other. In these cases, adding 15% of a known homozygous genotype to unknown samples allows melting curve separation of all three genotypes. This approach was used for the HFE 187C>G protocol, but, as predicted from the sequence changes, was not needed for the other four clinical protocols. CONCLUSIONS: SNP genotyping by high-resolution melting analysis is simple, rapid, and inexpensive, requiring only PCR, a DNA dye, and melting instrumentation. The method is closed-tube, performed without probes or real-time PCR, and can be completed in less than 2 min after completion of PCR.

Factor V↗
PubMed2000

Use of human immunodeficiency virus (HIV) human hyperimmune immunoglobulin in HIV type 1-infected children (Pediatric AIDS clinical trials group protocol 273).

The clinical, immunologic, and virologic effects and the pharmacokinetics of human immunodeficiency virus (HIV) human hyperimmune immunoglobulin (HIVIG) were assessed in 30 HIV-infected children aged 2-11 years. All had moderately advanced disease with an immune complex-dissociated (ICD) p24 antigen >70 pg/mL and were on stable antiviral therapy. Three groups of 10 children received 6 monthly infusions of 200, 400, or 800 mg/kg of HIVIG, and serial immunologic and virologic assays were performed. HIVIG doses as high as 800 mg/kg were safe and well tolerated. The half-life of HIVIG, determined by serial p24 antibody titers, was 13-16 days, the volume of distribution was 102-113 mL/kg, and clearance was 5.6-6.0 mL/kg/day. Plasma ICD p24 decreased during the infusions, but CD4 cell levels, plasma RNA copy number, cellular virus, immunoglobulin levels, and neutralizing antibody titers were minimally affected by the infusions. Clinical status did not change during the 6-month infusion and 3-month follow-up periods.

Cells, Cultured↗
PubMed2001

In vitro preclinical models for a rational design of chemotherapy combinations in human tumors.

Today, drug combinations are frequently used in the treatment of cancer to increase therapeutic efficacy. Currently used clinical protocols for cancer combination therapies are mainly obtained empirically or on the basis of results from previous clinical trials. Information obtained from clinical protocols is invaluable, but it is time-consuming, expensive and does not provide data on the biochemical and molecular mechanisms of interaction of the drugs used in combination treatments at cellular level. Therefore, in vitro drug combination studies on established cell lines or primary cell cultures play an important role in designing and optimising combination protocols. A variety of in vitro assays and different mathematics models have been developed to investigate cytotoxic effects and to analyse the type of drug interactions. Increased knowledge of the cellular targets of traditional and new drugs and the development of new technologies have resulted in a new role for the in vitro tests which are no longer used only to evaluate the cytotoxic effects of drugs, but also to investigate the interference on cell cycle, induction of apoptosis and molecular or biochemical interactions. A review on in vitro preclinical tests used to evaluate the effects of drug combinations and to design the rationale of combined chemotherapy protocols is presented.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1982

Recommendations for clinical research protocols for dental materials. Federation Dentaire Internationale, Commission on Dental Products.

This report recommends factors to be considered by investigators in planning, initiating and promulgating clinical research. The phrase 'factors to be considered' implies that not all factors outlined will be utilized in any one project, and that the extent of utilization of certain individual factors must be tailored to the specific project in mind. These factors have been designed primarily to aid the investigator in planning, initiating and carrying through a clinical research project. The report deals with projects evaluating materials used in (1) operative dentistry, (2) endodontics, (3) orthodontics, (4) removable prosthodontics and (5) fixed prosthodontics. In each section detailed attention is given to (a) identification of the problem, (b) background information, (c) materials and methods, and (d) administrative aspects.

Clinical Trials as Topic↗
PubMed1995

Protocol-directed shared care in cardiology.

In the new market-oriented UK National Health Service, hospitals succeed or fail on the quality of service they provide to their customers. It is therefore important that institutions like the Royal Brompton Hospital can meet the information and communication needs of General Practitioners and hospitals who use their services so that co-ordination between healthcare professionals involved in the co-operative care of individual patients can be ensured. One method of improving the relationship between healthcare professionals is by the use of consensus-based clinical protocols which define "best practice' co-operative care for a particular condition. The Royal Brompton Hospital has been a clinical partner in the AIM project DILEMMA which has been examining technology and methodologies for applying clinical protocols supported by telematics to general practice and shared care. A detailed requirements analysis has been carried out to look at the problems of shared care in cardiology and this has resulted in a demonstration system being developed to show how protocol-directed shared care and its supporting technology could be implemented to solve real clinical problems. Conclusions have been drawn that concern the use of protocols and information technology generally in routine clinical care.

Cardiology↗
PubMed2005

Sinus floor elevation via hydraulic detachment and elevation of the Schneiderian membrane.

OBJECTIVES: Minor sinus floor elevation is a method with relatively high predictability but is technically demanding. Improvement of the technique and increase in the predictability are desirable. MATERIAL AND METHODS: A clinical protocol for minor sinus floor elevation with SLA-ITI (large grit acid-etched implants with diameter of 4.8 mm) is described. Using trephine instead of spiral burrs enables the harvesting of autogenous grafts from the implant socket and guarantees a perfect implant socket. The latter is necessary for optimal implant anchoring and for the hydraulic seal between socket and the osteotome. The whole allows a hydraulic detachment of the Schneiderian membrane, where the blood cushion gradually detaches and elevates the membrane, preventing its contact with the graft. RESULTS: Eight patients were successfully treated with the method described above. No membrane perforation occurred and an uneventful healing was observed in all patients. All implants were loaded prosthodontically 3 months after the implantation. CONCLUSIONS: The clinical protocol presented provides high predictability in clinical outcome, together with extremely low morbidity and shortened surgery.

Adult↗
PubMed2002

3D CT imaging method for measuring temporal bone aeration.

OBJECTIVE: 3D volume reconstruction of CT images can be used to measure temporal bone aeration. This study evaluates the technique with respect to reproducibility and acquisition parameters. MATERIAL AND METHODS: Helical CT images acquired from patients with radiographically normal temporal bones using standard clinical protocols were retrospectively analyzed. 3D image reconstruction was performed to measure the volume of air within the temporal bone. The appropriate threshold values for air were determined from reconstruction of a phantom with a known air volume imaged using the same clinical protocols. The appropriate air threshold values were applied to the clinical material. RESULTS: Air volume was measured according to an acquisition algorithm. The average volume in the temporal bone CT group was 5.56 ml, compared to 5.19 ml in the head CT group (p = 0.59). The correlation coefficient between examiners was > 0.92. There was a wide range of aeration volumes among individual ears (0.76-18.84 ml); however, paired temporal bones differed by an average of just 1.11 ml. CONCLUSIONS: The method of volume measurement from 3D reconstruction reported here is widely available, easy to perform and produces consistent results among examiners. Application of the technique to archival CT data is possible using corrections for air segmentation thresholds according to acquisition parameters.

Adult↗
PubMed2000

Optimizing drug regimens in cancer chemotherapy by an efficacy-toxicity mathematical model.

In cancer chemotherapy, it is important to design treatment strategies that ensure a desired rate of tumor cell kill without unacceptable toxicity. To optimize treatment, we used a mathematical model describing the pharmacokinetics of anticancer drugs, antitumor efficacy, and drug toxicity. This model was associated with constraints on the allowed plasma concentrations, drug exposure, and leukopenia. Given a schedule of drug administrations, the mathematical model optimized the drug doses that can minimize the tumor burden while limiting toxicity at the level of the white blood cells. The main result is that the optimal drug administration is an initial high-dose chemotherapy up to saturation of constraints associated with normal cell toxicity and a maintenance continuous infusion at a moderate rate. Data related to etoposide investigations were used in a feasibility study. Simulations with the optimized protocol showed better performances than usual clinical protocols. Model-based optimal drug doses provide for greater cytoreduction, while limiting the risk of unacceptable toxicity.

Antineoplastic Agents↗
PubMed2001

Alternative 1-(13)C glucose infusion protocols for clinical (13)C MRS examinations of the brain.

Clinical utility of (13)C MRS is limited by cost and long examination times. Three 1-(13)C glucose infusion protocols-a high-dose i.v., low-dose i.v., and oral administration of 1-(13)C glucose-were compared on a GE 1.5T MR scanner. Resolution and sensitivity were sufficient to identify (13)C glucose (1alpha and 1beta), glutamate (C1-C4), glutamine (C1-C4), aspartate (C2 and C3), lactate, alanine, and bicarbonate in brain spectra. The three protocols were efficacious, as measured by cerebral enrichment of 1-(13)C glucose (62%, 42%, and 38%) and its principal metabolite, 4-(13)C glutamate (13%, 11%, and 16%), respectively. Intravenous infusion of 1-(13)C glucose 0.23 g/kg body weight (low dose) provides equivalent information at one third the cost of previous regimes. Magn Reson Med 46:39-48, 2001.

Administration, Oral↗
PubMed2006

The use of rapid assessment of enteric ICC and neuronal morphology may improve patient management in pediatric surgery: a new clinical pathological protocol.

Alterations in interstitial cells of Cajal (ICC) distribution and density may seriously influence gut motility. We and others have documented a disturbance of ICC and neurons in Hirschsprung's disease (HD), intestinal ischemia, and inflammation. The ability to remove intestine with permanent dysmotility improves significantly the prognosis. This may be important in the developing intestine especially in HD. More complete pathological information increases the accuracy of surgical decisions. Therefore we sought to develop a rapid, intraoperative immunohistochemical protocol for ICC and neurons in surgical specimens for routine diagnostic and therapeutic assessment of pediatric patients. To date, cKit is the only reliable immunohistochemistry for ICC identification. There are multiple antibodies in use for neuronal identification. A comparison of fixation methods and immunostaining using cKit and multiple intestinal neuronal antibodies was done. Fresh segments of surgically resected intestine were sectioned and stained using antibodies for ICC cell identification (anti-cKit) and for neuronal characterization. By carefully changing tissue fixation methods, different neuronal antibodies were tested to determine an optimal rapid protocol. Each suggested protocol was tested on normal and pathological intestinal tissue and compared to the previous overnight immunostaining of the same tissue. A new rapid tissue fixation and immunostaining protocol using cKit for ICC identification and NF 68 was developed. By employing this protocol, we could obtain ICC and neuro-immunohistochemistry in unfixed frozen sections within 1 h with tissue vibration to diminish the time for immunostaining. Without vibration the protocol takes 3 h. ICC and enteric neuronal changes could be readily observed and the quality of staining was comparable to standard immunohistochemistry. Each gut pathology displayed characteristic changes in ICC and neuronal density/distribution in the affected bowel. The time-scale of the 1-h immunoprocessing is still longer than the standard clinical pathological "quick" sections using H&E staining; however, the protocol duration is within the surgery timescale. Standard H&E stain used in combination with our rapid neuronal and ICC immunohistochemistry protocol enables a fast, comprehensive, and accurate assessment of the pathophysiology of signaling networks controlling gut motility while the patient is still in the operating room. We propose that the addition of this simple and rapid immunohistochemical assessment in the pathologist evaluation of surgical specimens would result in a more complete characterization for diagnosis and prognosis of the pediatric patient. Specifically, we propose that this test will differentiate good versus poor prognosis HD patients based on their neuron/ICC ratio and present a rapid, standardized method for use in general pathology.

Colon↗
PubMed1994

[Is bladder conservation possible in infiltrating cancer?].

We describe the different therapeutic modalities available for the conservative treatment of invasive bladder cancer. Bladder preservation may be possible in selected cases. However, to better define the role of chemotherapy and combined chemotherapy we have to wait until several ongoing investigative clinical protocols have been completed. At the present moment radical cystectomy still remains the gold standard for the treatment of invasive bladder cancer.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1998

High-level gene transfer to cord blood progenitors using gibbon ape leukemia virus pseudotype retroviral vectors and an improved clinically applicable protocol.

The best methods for transducing hematopoietic progenitor cells usually involve either direct co-cultivation with virus-producing cells or human stromal supportive cells. However, these methods cannot be safely or easily applied to clinical use. Therefore, we aimed at improving retrovirus-mediated gene transfer into hematopoietic progenitors derived from cord blood CD34+ cells using viral supernatant to levels achieved at least with direct co-cultivation and under conditions that are suitable for clinical applications. In a first set of experiments, CD34+ cells were infected with supernatant containing amphotropic retroviral particles carrying the nls-lacZ reporter gene and the effects of centrifugation, cell adhesion to fibronectin, and Polybrene on the transduction of both clonogenic progenitors (CFC) and long-term culture initiating cells (LTC-IC) were studied. Transduction efficiency was evaluated on the percentage and total number of progenitors expressing the beta-galactosidase activity. Results show that a 48-hr infection of CD34+ cells with viral supernatant combining centrifugation at 1000 x g for 3 hr followed by adhesion to fibronectin allows transduction levels for both CFC and LTC-IC to be reached that are as good as using direct co-cultivation. In a second set of experiments, CD34+ cells were infected using this optimized protocol with pseudotyped retroviral particles carrying the gibbon ape leukemia virus (GALV) envelope protein. Under these conditions, between 50 and 100% of CFC and LTC-IC were transduced. Thus, we have developed a protocol capable of highly transducing cord blood progenitors under conditions suitable for a therapeutical use.

Antigens, CD34↗