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 109 records · Page 6Linked to original sources
PubMed1998

Web-based resources for clinical protocol management.

The data monitoring regulatory procedures, and administrative tasks associated with protocol management have become increasingly complex. Relational database technology and Internet-based connectivity offer resources to improve the quality and efficiency of protocol operations. At Fox Chase Cancer Center, we have developed a suite of database applications for protocol management and tracking of patient accrual. All data transactions and reporting occur through a graphical web browser interface using standard Internet technology. Security and confidentiality have been addressed through encryption, user authentication, address restriction, and database authority. Database management has been tightly integrated with protocol operations to avoid duplication of resources and effort. Data query functions also extend to other institutional resources, such as tumor registry and the hospital clinical laboratory, to further reduce the need for redundant data storage. Newer components, such as chemotherapy orders and toxicity reporting, have been incorporated in a modular fashion. Although custom software development can be expensive and time-consuming, it offers the best opportunity for successful integration with existing resources, staff, and procedures, as well as collaboration with other institutions.

Clinical Protocols↗
PubMed1991

Clinical protocols for the application of tests for circulating tumor markers.

Circulating marker level determination in clinical practice requires an adequate strategy of application, in view of the particular features of the parameter related to the marker. The test result, which is usually expressed in terms of concentration, cannot be considered as an absolute value because every biochemical tumor indicator expresses an activity of the tumor which generally leads to increased levels of a "normal" substance in blood or biological liquids. Therefore, the result should be interpreted as a dynamic variation occurring in time, and should always be related to a previous reference value. This means that marker determination in clinical practice should be repeated periodically, both for the evaluation of tumor response to treatment and for the detection of recurrence after radical surgery. A single measurement at the time of disease presentation can characterize the tumor with regard to its capacity of producing the signal, and consequently regarding its extent and growth. These laboratory findings are of no value whatever if they are not integrated with all the other available clinical and instrumental data concerning the neoplasm; only then can they provide useful additional information. Also, all biological variables should be taken into account which may affect circulating marker levels independently of the history of the tumor such as sex, age, clearing organ function, race, alcohol and tobacco habits, concomitant diseases. These procedural protocols should be outlined and codified for each individual neoplasm since it is useless to work with scattered data which are not ordered in some kind of procedural logic.(ABSTRACT TRUNCATED AT 250 WORDS)

Antigens, Neoplasm↗
PubMed1993

Development of a clinical protocol for hepatic gene transfer: lessons learned in preclinical studies.

Strategies for hepatic gene therapy have been proposed that involve isolation of primary hepatocytes and introduction of recombinant genes into these cells in culture, followed by autologous hepatocellular transplantation (HCT). Consideration of clinical applications requires data suggesting that HCT can be performed safely in human subjects in addition to data indicating that recombinant gene expression can reverse a disease process. This report describes preclinical studies that underlie a clinical trial of HCT in which hepatocytes would be labeled with a marker gene to facilitate assessment of engraftment in the recipient. Human hepatocytes were harvested from liver segments preserved in Belzar's solution and transduced with an amphotropic retroviral vector carrying a recombinant marker gene (neomycin phosphotransferase II). Human hepatocytes were recovered from monolayer culture, stained with the fluorescent dye 1,1'-dioctadecyl-3,3,3,3'-tetra-methylindo-carbocyanine perchlorate (DiI) and transplanted into severe combined immunodeficient mice by splenic injection. Engrafted hepatocytes were identified in the liver and spleen of severe combined immunodeficient mice but not immunocompetent controls. Two large animal models of HCT are described. In a dog model, neomycin phosphotransferase II-containing hepatocytes were identified in the liver 7 wk after transplantation. In a baboon model, autologous HCT with DiI-stained cells demonstrated that transplanted cells assume a normal morphology and constitute up to 5% of hepatocytes. These data demonstrate transduction and transplantation of human hepatocytes and the feasibility of HCT in large animals. On the basis of these studies, the proposed clinical trial for gene transfer and transplantation in human subjects has been approved by the National Institutes of Health and the Food and Drug Administration.(ABSTRACT TRUNCATED AT 250 WORDS)

Animals↗
PubMed2006

Cancer vaccines for patients with acute myeloid leukemia--definition of leukemia-associated antigens and current clinical protocols targeting these antigens.

Targeted immunotherapies require the identification and characterization of appropriate antigen structures. Initially, T-cell based cancer vaccines were designed for patients with solid tumors after the definition of suitable tumor-associated antigens. Several immunological and even clinical responses prompted researchers and clinicians to extend the spectrum of cancer vaccines towards hematologic malignancies such as acute myeloid leukemia (AML). Only 20-40% of all patients with AML achieve a disease-free survival of more than 5 years. The graft-versus-leukemia (GVL) effect observed after allogeneic stem cell transplantation and donor lymphocyte infusions strongly suggests that T lymphocytes play a major role in the rejection of leukemic cells. Therefore, immunotherapy directed against leukemia-associated antigens might elicit specific immune responses that could eliminate minimal residual disease after chemotherapy, or enhance the GVL effect after hematopoietic stem cell transplantation. This review summarizes hitherto identified and characterized LAA as targets for T-cell-based immunotherapies. Current clinical peptide vaccination trials targeting different epitopes of the Wilms' tumor gene 1 (WT1), the proteinase-3 derived epitope peptide (PR1) and the receptor for hyaluronic acid mediated motility (RHAMM/CD168)-derived epitope R3 are reviewed, and perspectives but also limitations of immunotherapeutic approaches for AML patients are discussed.

Antigens, Neoplasm↗
PubMedDate not supplied

C. parvum clinical protocols: prototypes and summary results in U. S. trials with Wellcome Coparvax.

Clinical investigations utilizing Wellcome C. parvum in cancer therapy number more than one hundred in multiple institutions. Multiple diseases in various stages are being attacked by multi-modality therapy, making the role of immunotherapy very difficult to assess. Fundamental laboratory observations have suggested ways of weaving non-specific with specific immunotherapy, and these with chemotherapy and radiation to yield maximum therapeutic benefit. Current protocols include examples of the critical interactions as well as instructive information on dosing, timing and adjunctive symptomatic therapies. Several protocols will be reviewed, especially where promising clinical results are expected. Important differences between systemic and regional administration are observed.

Clinical Trials as Topic↗
PubMed2005

Four-dimensional computed tomography: image formation and clinical protocol.

Respiratory motion can introduce significant errors in radiotherapy. Conventional CT scans as commonly used for treatment planning can include severe motion artifacts that result from interplay effects between the advancing scan plane and object motion. To explicitly include organ/target motion in treatment planning and delivery, time-resolved CT data acquisition (4D Computed Tomography) is needed. 4DCT can be accomplished by oversampled CT data acquisition at each slice. During several CT tube rotations projection data are collected in axial cine mode for the duration of the patient's respiratory cycle (plus the time needed for a full CT gantry rotation). Multiple images are then reconstructed per slice that are evenly distributed over the acquisition time. Each of these images represents a different anatomical state during a respiratory cycle. After data acquisition at one couch position is completed, x rays are turned off and the couch advances to begin data acquisition again until full coverage of the scan length has been obtained. Concurrent to CT data acquisition the patient's abdominal surface motion is recorded in precise temporal correlation. To obtain CT volumes at different respiratory states, reconstructed images are sorted into different spatio-temporally coherent volumes based on respiratory phase as obtained from the patient's surface motion. During binning, phase tolerances are chosen to obtain complete volumetric information since images at different couch positions are reconstructed at different respiratory phases. We describe 4DCT image formation and associated experiments that characterize the properties of 4DCT. Residual motion artifacts remain due to partial projection effects. Temporal coherence within resorted 4DCT volumes is dominated by the number of reconstructed images per slice. The more images are reconstructed, the smaller phase tolerances can be for retrospective sorting. From phantom studies a precision of about 2.5 mm for quasiregular motion and typical respiratory periods could be concluded. A protocol for 4DCT scanning was evaluated and clinically implemented at the MGH. Patient data are presented to elucidate how additional patient specific parameters can impact 4DCT imaging.

Algorithms↗