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[The scientific writing about the therapeutic accompaniment in Brazil from 1960 to 2003: critical analysis].

This is a bibliographic research that analyses the scientific writing about the theme therapeutic accompaniment from 1960 until 2003. The objective of this study to identify the emerging themes in this writing and establish what the therapeutic accompaniment means for the agents of such practice. Five thematic categories have been selected: objectives, functions and definitions of therapeutic accompaniment, at whom the therapeutic accompaniment is aimed, the therapeutic accompanist characteristics as a professional, the characteristics and ways the therapeutic accompaniment clinic is undergone and the theoretical background for the therapeutic accompaniment. It has been verified that the therapeutic accompaniment is marked by setting larger and may be related to different theoretical perspectives.

Brazil↗

New therapeutic agents marketed in 1993.

In 1993, the Food and Drug Administration (FDA) approved 25 new molecular entities (NMEs), 23 of which are for therapeutic use and two are diagnostic agents. Eleven of the NMEs for therapeutic use, as well a new biological agent intended for therapeutic use, were both approved and marketed in the United States in 1993. In addition, 11 other NMEs that the FDA approved before 1993 (most in late 1992) were marketed during the year. Thus, a total of 23 therapeutic agents reached the U.S. market for the first time in 1993, a considerably lower number than the 30 new therapeutic agents marketed in 1992 and the record number 31 new agents marketed in 1991. Many of the 13 therapeutic agents approved in 1993 but not marketed before the end of the year have become available in early 1994. This review of the therapeutic agents first marketed in 1993 considers their most important properties and, when possible, compares them with other available agents with similar properties. Of the 23 new therapeutic agents, 22 are considered in this paper. The one agent not reviewed is flosequinan, which was withdrawn from the market after being available only several months because of a concern about toxicity. This discussion of new drugs focuses on the most important properties of these agents; when additional information is needed, more comprehensive references and the product literature should be consulted.

Drug Approval↗

New therapeutic agents marketed in 1993.

In 1993, the Food and Drug Administration (FDA) approved 25 new molecular entities (NMEs), 23 of which are for therapeutic use and two are diagnostic agents. Eleven of the NMEs for therapeutic use, as well a new biological agent intended for therapeutic use, were both approved and marketed in the United States in 1993. In addition, 11 other NMEs that the FDA approved before 1993 (most in late 1992) were marketed during the year. Thus, a total of 23 therapeutic agents reached the U.S. market for the first time in 1993, a considerably lower number than the 30 new therapeutic agents marketed in 1992 and the record number 31 new agents marketed in 1991. Many of the 13 therapeutic agents approved in 1993 but not marketed before the end of the year have become available in early 1994. This review of the therapeutic agents first marketed in 1993 considers their most important properties and, when possible, compares them with other available agents with similar properties. Of the 23 new therapeutic agents, 22 are considered in this paper. The one agent not reviewed is flosequinan, which was withdrawn from the market after being available only several months because of a concern about toxicity. This discussion of new drugs focuses on the most important properties of these agents; when additional information is needed, more comprehensive references and the product literature should be consulted.

Adolescent↗

[The therapeutic effort on admission for women with an acute myocardial infarct. The Valencia Group for the Study of Hospital Inequities in Health].

BACKGROUND: Recent studies have suggested that women with ischemic heart disease receive lesser therapeutic care than males. The aim of this study was to verify the hypothesis that sex is an independent predictive factor in therapeutic care upon admission in patients with acute myocardial infarction. METHODS: Secondary analysis was performed by multiple linear regression of 429 males and 124 females admitted to 6 general intensive care units for acute myocardial infarction. Therapeutic effort was measured according to the Therapeutic Intervention Scoring System (TISS) index. Age, initial severity measured by the Simplified Acute Physiological Score (SAPS) and the Killip group were considered as possible variables of confusion upon admission. RESULTS: Upon comparison with males the group of women was characterized by a greater age (p < 0.0001), higher SAPS score (p = 0.0028) and lesser relative therapeutic effort (p = 0.0990), and a higher Killip group upon admission (p < 0.0001). Regression analysis identified the Killip group (p < 0.0001), the SAPS index (p < 0.0001) and age (p = 0.0011) but not sex (p = 0.3875) as independent predictors of therapeutic effort. CONCLUSIONS: The results of the present study do not support the hypothesis that sex is an independent predictor of therapeutic effort. The indexes of lesser relative therapeutic effort in women admitted for acute myocardial infarction were found to be attributed to a higher mean age.

Age Distribution↗

[Therapeutic exhaustion in patients with an implantable cardioverter-defibrillator. Are there predisposing factors?].

UNLABELLED: In patients (pts) with implantable cardioverter-defibrillators (ICD), antitachycardia pacing (ATP) schemes may be used followed by a limited number of endocavitary shocks in the same episode of ventricular tachycardia (VT) with the potential risk of therapeutic exhaustion. OBJECTIVE: To assess the incidence of episodes of therapeutic exhaustion in a population of ICD carriers with ATP programmes and to attempt to determine their correlation with clinical variables. METHODS: Study of the episodes of VT treated by ICD in 8 patients (6 male; 2 female) with an average age of 56 +/- 17 years with a follow-up > 6 months. The underlying pathology was: ischemic heart disease-5 patients; arrhythmogenic dysplasia of the right ventricle-1 patient; hypertrophic cardiomyopathy-1 patient; and operated pulmonary valve stenosis-1 patient. The authors considered therapeutic exhaustion to be the occurrence of episodes in which VT persisted after the application of ATP and the maximum number of shocks. The patients with episodes of therapeutic exhaustion (group A-3 patients) were compared with the remaining patients (group B-5 patients) with regard to the following parameters: age; ejection fraction; previous myocardial infarction (pMI; cardiac frequency during VT (cfVT); number of episodes of non-maintained VT (NMVT) without therapeutic intervention; > 20% reduction of the VT cycle after ATP (VTATP); intensity of programmable shocks (Icho); and medication with anti-arrhythmia drugs (AA). RESULTS: In a total of 262 VT records (duration > 2.5 sec. after detection) with treatment by ICD during an average follow-up of 11 months, 6 episodes (2.3%) of therapeutic exhaustion were detected in 3 patients. Four of the episodes occurred in the same patient in a period of 4 hours, hospitalisation being necessary following syncope. In the other two cases, there were complaints of dizziness which subsided spontaneously a short time after the application of the last shock by the ICD. [table: see text] CONCLUSION: Therapeutic exhaustion occurred in about 2% of the VT treated with this population. The possibility of a high number of non maintained VT episodes being associated to a greater possibility of therapeutic exhaustion may have implications on ICD programming.

Adult↗

Using therapeutic touch in nursing practice.

This article is an introduction to "therapeutic touch" and its implications for nursing. A case study provides an example of how therapeutic touch was used with an individual who fell from a ladder and injured his elbow. A brief history and assumptions that support the practice of therapeutic touch are discussed. Rogers' Science of Unitary Human Beings, a nursing theory, provides a theoretical basis for therapeutic touch. The method developed by Kunz and Krieger involves four phases and each of these is identified and described. General uses for therapeutic touch are presented and a variety of research studies validate the practice of therapeutic touch in nursing. Resources are provided for those who may be interested in learning more about therapeutic touch.

Holistic Health↗

Long-term predictions of the therapeutic equivalence of daily and less than daily alendronate dosing.

Less than daily alendronate dosing has been identified as an attractive alternative to daily dosing for patients and physicians. A recent 2-year study found bone mineral density (BMD) changes caused by weekly alendronate dosing therapeutically equivalent to that caused by daily dosing. There are no methods that can be used to predict how long therapeutic equivalence will be maintained after the first 2 years of treatment. In addition, it is unclear if dosing less frequently than weekly also might be therapeutically equivalent to daily dosing. In this study we use a computer simulation to develop predictions of the therapeutic equivalence of daily and less than daily dosing over time periods as long as a decade. The computer simulation uses a cell-based computer model of bone remodeling and a quantitative description of alendronate pharmacokinetics/pharmacodynamics (PK/PD). The analyses suggest that less than daily dosing regimens do not increase BMD as much as daily dosing. However, model predictions suggest that dosing as frequent as weekly still may be therapeutically equivalent to daily dosing over periods as long as 10 years. In addition, the simulations predict dosing less frequently than weekly may be therapeutically equivalent to daily dosing within the first year of treatment but may not be therapeutically equivalent after 10 years. Hypotheses based on these simulations may be useful for determining which dosing regimen may be most attractive for clinical trials.

Alendronate↗

A descriptive study of the status of therapeutic recreation at the seven state-operated comprehensive rehabilitation centers in the United States.

The intent of this article is to present a systematic overview of therapeutic recreation services at the seven state-operated Comprehensive Rehabilitation Centers. These seven Centers are located in Hot Springs, Arkansas; Warm Spring, Georgia; Thelma, Kentucky; Baltimore, Maryland; Johnstown, Pennsylvania; Institute, West Virginia; and Fisherville, Virginia. This paper is a result of a study which was conducted from October 1978 to May 1979. The study showed that each of the Centers provided recreation and leisure activities: however, none of the Centers utilized therapeutic recreation as the title of their specific department. In general, the Centers have difficulties in the following areas: 1. defining therapeutic recreation; 2. structuring their department; 3. delivery of therapeutic recreation services; 4. conception of therapeutic recreation as part of the rehabilitation process; 5. inadequately trained personnel in leadership and supervisory positions; 6. staff training; 7. assessment and evaluation instruments for clients; 8. discharge planning; and 9. recreation therapy as a treatment component within the delivery of therapeutic recreation services, All of which need resolution. The research demonstrated that most of the recreation directors saw a need for therapeutic recreation services to be refined further to meet the needs and abilities of the clients.

Humans↗

Therapeutic cloning and the constitution--a Canadian perspective.

Recent developments in the field of therapeutic cloning have been welcomed by many in the medical community as important breakthroughs that may help provide a better understanding of a variety of human diseases. Nevertheless, research in this field appears to have struck a sensitive nerve in society. A large amount of social debate has been generated regarding the validity of therapeutic cloning, and there are many seeking legislation to have the practice restricted. It is unclear, however, whether such restrictions can be legally justified. Analysing cloning in such a social and legal context raises a number of questions. What scientific procedures are behind therapeutic cloning? What is the legal status of the cultured or unimplanted embryo? Can cloning be considered an aspect of reproductive liberty as protected by the constitution? What medical advances might therapeutic cloning further? What social benefits and harms might arise from its promotion or restriction? Such questions, and the broader debate surrounding human therapeutic cloning, are addressed in this paper in three parts. Part 1 presents an overview of the basic biological principles behind cloning and the science behind the therapeutic cloning of specific cells and tissues. Part 2 analyses ss. 7, 2, 15(1) and 1 of the Canadian Charter of Rights and Freedoms and how they may be implicated by legal incursions into the field of human cloning. Several Charter-based arguments, both for and against the practice, are presented. Finally, Part 3 assesses some recent scientific developments in cloning technology, and how they affect the debate over the constitutionality of human therapeutic cloning.

Canada↗

Therapeutic substitution and the hospital formulary system.

Physicians consent and statutory regulations relating to therapeutic substitution are discussed. Some hospitals have adopted policies allowing the interchange of a chemically inequivalent product deemed therapeutically identical by the P & T committee. In the absence of statutory regulation, hospital pharmacists usually refer to (1) the physician's agreement to abide by hospital bylaws (including the formulary system) when joining the hospital staff, or (2) prescription blanks and order sheets preprinted with the statement "substitution permitted unless otherwise indicated" as the legal authority for therapeutic substitution. Only two states have addressed the legality of therapeutic substitution. An opinion of the Oregon Attorney General and a Washington state statute both authorize therapeutic substitution under certain circumstances if the prescriber has given prior consent. Neither of the states specifies, however, whether the agreement of prescribers to abide by hospital bylaws constitutes authorization of therapeutic substitution. It is proposed that state boards of pharmacy and state legislatures draft laws that address therapeutic substitution and specify acceptable methods of consent.

Formularies, Hospital as Topic↗

Effect of therapeutic footwear on foot reulceration in patients with diabetes: a randomized controlled trial.

CONTEXT: Many people with diabetes experience lower-limb ulcers. Footwear has been implicated as a primary cause of foot ulcers, yet research is limited on the efficacy of shoe and insert combinations to prevent reulceration. OBJECTIVE: To determine whether extra-depth and -width therapeutic shoes used with 2 types of inserts reduce reulceration in diabetic individuals with a history of foot ulcer. DESIGN, SETTING, AND PARTICIPANTS: Randomized clinical trial of 400 diabetes patients with history of foot ulcer in 2 Washington State health care organizations who did not require custom shoes for foot deformity and were enrolled between August 1997 and December 1998 and followed up for 2 years. Data collected at regular intervals documented physical, foot, and diabetes characteristics; footwear use; foot lesions; and ulcers. INTERVENTIONS: Participants were randomly assigned to receive 3 pairs of therapeutic shoes and 3 pairs of customized medium-density cork inserts with a neoprene closed-cell cover (n = 121); to receive 3 pairs of therapeutic shoes and 3 pairs of prefabricated, tapered polyurethane inserts with a brushed nylon cover (n = 119); or to wear their usual footwear (controls; n = 160). MAIN OUTCOME MEASURE: Foot reulceration, compared among the 3 groups. RESULTS: Two-year cumulative reulceration incidence across the 3 groups was low: 15% in the cork-insert group, 14% in the prefabricated-insert group, and 17% in controls. In the intent-to-treat analysis, patients assigned to therapeutic shoes did not have a significantly lower risk of reulceration compared with controls (risk ratio [RR] for the cork-insert group, 0.88; 95% confidence interval [CI], 0.51-1.52 and RR the for prefabricated-insert group, 0.85; 95% CI, 0.48-1.48). All ulcer episodes in patients assigned to therapeutic shoes and 88% wearing nonstudy shoes occurred in patients with foot insensitivity. CONCLUSIONS: This study of persons without severe foot deformity does not provide evidence to support widespread dispensing of therapeutic shoes and inserts to diabetic patients with a history of foot ulcer. Study shoes and custom cork or preformed polyurethane inserts conferred no significant ulcer reduction compared with control footwear. This study suggests that careful attention to foot care by health care professionals may be more important than therapeutic footwear but does not negate the possibility that special footwear is beneficial in persons with diabetes who do not receive such close attention to foot care by their health care providers or in individuals with severe foot deformities.

Aged↗

Therapeutic ultrasound for osteoarthritis of the knee.

BACKGROUND: Therapeutic ultrasound is one of several physical therapy modalities suggested for the management of pain and loss of function due to OA. OBJECTIVES: To assess the effectiveness of therapeutic ultrasound therapy for treating OA. SEARCH STRATEGY: We searched the Cochrane Musculoskeletal Group trials register, and MEDLINE, up to the end of December 2000, using the sensitive search strategy developed by the Cochrane Collaboration. The search was complemented with bibliography searching of the reference list of the trials retrieved from the electronic search. Key experts in the area were contacted for further published and unpublished articles. SELECTION CRITERIA: All randomized controlled trials (RCTs) and controlled clinical trials (CCTs) comparing therapeutic ultrasound against placebo or another active intervention in patients with OA were selected. DATA COLLECTION AND ANALYSIS: Two reviewers determined the studies to be included based on inclusion and exclusion criteria (LB, VW). Data were independently abstracted by two reviewers (VW, LB), and checked by a third reviewer (BS) using a pre-developed adapted form for the OA sub-group of the Cochrane Musculoskeletal Group. The same two reviewers, using a validated scale, assessed the methodological quality of the RCTs and CCTs independently. OA outcome measures were extracted from the publications. The pooled analysis was performed using weighted mean differences (WMDs) for joint counts, pain, global and functional assessments. A chi-square test was used to assess heterogeneity among trials. Fixed effects models were used throughout and random effects for outcomes showing heterogeneity. MAIN RESULTS: Three trials, including 294 patients with knee OA were included. Only one trial (n=74) compared therapeutic ultrasound to placebo. This trial showed no difference in range of motion, pain or gait velocity after 4 weeks of therapeutic ultrasound. Two trials compared therapeutic ultrasound to an active therapy (n=220). These trials showed no statistical difference between galvanic current or short wave diathermy for the outcomes of pain and patient-assessed improvement. REVIEWER'S CONCLUSIONS: Ultrasound therapy appears to have no benefit over placebo or short wave diathermy for patients with knee OA. These conclusions are limited by the poor reporting of the characteristics of the device, of the population, of the OA,and therapeutic application of the ultrasound and low methodological quality of the trials included. No conclusions can be drawn about the use of ultrasound in smaller joints such as the wrists or hands.

Adult↗

Capillary electrophoresis for therapeutic drug monitoring.

Therapeutic drug monitoring is commonly used in both the ambulatory and hospital patient care settings. Routine measurement of concentrations of therapeutic agents in biological fluids is critical for certain drugs to maintain therapeutic benefit with minimizing drug-associated toxicities. Many analytical laboratory techniques are currently available to measure drug concentrations in biological samples. Recently there has been an increased interest in the use of capillary electrophoresis (CE) for measuring concentrations of therapeutic drugs in patient samples. However, while there are numerous reports of CE being used to measure drug concentrations in solution and pharmaceutical dosage forms, there are relatively few reports of the use of CE for measuring therapeutic agents in patient samples. The purpose of this paper is to provide an overview of methods currently used to measure therapeutic drugs in patient samples along with possible future trends for the use of CE in therapeutic drug monitoring.

Drug Monitoring↗

Peri-tumor interleukin-2 causes systemic therapeutic effect via interferon-gamma induction.

This study compares the direct local therapeutic effects of multiple peri-tumor injections of interleukin-2 (IL-2) and interferon gamma (IFN-gamma), also the associated systemic therapeutic effects on distant untreated tumors resulting from the peritumor injections. The therapeutic effects were tested against intramammary implants of an immunogenic, syngeneic C3H mammary carcinoma. Peritumor IL-2 and IFN-gamma had nearly equal local and systemic therapeutic effects. In a comparison of the therapeutic effects of IL-2 and IFN-gamma injected systemically, only the IFN-gamma injections resulted in a significant number of cures. IL-2 and IFN-gamma did not have an additive effect when used in combination, suggesting that they have connected, rather than separate, paths of action in the anti-tumor immune response. The injection of anti-IFN-gamma-MAb abrogated the systemic therapeutic effect of peri-tumor IL-2, indicating that the systemic therapeutic effect was the result of IFN-gamma induction at the IL-2 injection site.

Animals↗

Therapeutic ultrasound and fracture healing: a survey of beliefs and practices.

OBJECTIVE: To explore current beliefs among senior physiotherapy (PT) students and orthopedic surgeons on the clinical utility of therapeutic ultrasound for assisting fracture healing. DESIGN: Cross-sectional survey. SETTING: University. PARTICIPANTS: Orthopedic surgeons, senior orthopedic surgery residents, and PT students in their final 6 months of study. INTERVENTIONS: Not applicable. Main outcome measures Percentage of respondents reporting specific perceptions on (1) the role of therapeutic ultrasound in fracture healing, (2) clinical use of therapeutic ultrasound for fracture healing, (3) rationale for not using therapeutic ultrasound for healing fractures, and (4) what constitutes a clinically significant difference in fracture healing time. Between-group comparisons were conducted for survey responses. RESULTS: The response rate was 20 of 22 (90.9%) orthopedic surgeons, 5 of 5 (100%) senior orthopedic residents, and 34 of 50 (68.0%) senior PT students. The majority of senior PT students (58.8%) and orthopedic residents and surgeons (60.0%) surveyed reported the belief that therapeutic ultrasound may help in assisting fracture healing in some cases. However, the majority of respondents do not use this modality (60.0% of surgeons, 88.2% of Senior PT students), with most surgeons (32.0%) citing lack of evidence and most senior PT students (58.8%) indicating lack of availability as the predominant barrier. Thirty-two percent of surgeons felt that ultrasound was contraindicated and harmful to healing fractures, or that it was of no use, and 20.5% of PT students reported the belief that ultrasound was contraindicated and was, or may be, harmful to healing bone. Most orthopedic residents and surgeons (52.0%) reported that a reduction in fracture healing time of 4 weeks would be clinically significant versus senior PT students, the majority of whom (64.7%) indicated that a reduction of 2 weeks would be clinically significant. CONCLUSIONS: Some surgeons and PT students believed that therapeutic ultrasound is contraindicated and harmful to healing bone; however, most believed that therapeutic ultrasound may help in assisting fracture healing, in at least some cases. Current usage of this modality is rare, primarily due to the perceived lack of evidence and lack of availability. Large randomized trials are needed to define further the role of ultrasound in fracture healing.

Attitude of Health Personnel↗

A comparison of new drug availability in Canada and the United States and potential therapeutic implications of differences.

BACKGROUND: Claims are made that new valuable drugs are not available in Canada at the time that they are marketed in the United States. This study uses a convenience sample of new drugs marketed in the United States and determines how many of these products are initially unavailable in Canada and their therapeutic value. METHODS: Issues of the Canadian edition of The Medical Letter from May 12, 2003 to June 21, 2004 were hand searched for evaluations of new drugs and the following information was recorded: indication, availability in Canada and conclusions about therapeutic value. For drugs not available in Canada two clinical pharmacologists rated the therapeutic value of the products and the type of FDA review (standard or priority) was recorded. A database from the Therapeutic Products Directorate was searched to see if any of the drugs initially unavailable were subsequently marketed. RESULTS: Thirty-two of 37 drugs were not available in Canada. Between 9 and 11 of these products were rated as offering moderate to significant therapeutic gains. Twelve of the 32 drugs eventually were marketed in Canada. INTERPRETATION: Although the majority of new drugs marketed in the United States but not available in Canada do not offer any therapeutic advantage, between about a quarter and a third of may offer moderate to significant therapeutic gains. The reasons why these drugs are unavailable and how much their absence affects the treatment Canadians receive should be the subject of future research.

Canada↗

Guideline-based modeling of therapeutic strategies in the special case of chronic diseases.

Despite the availability of evidence-based clinical practice guidelines in most countries, patients with chronic diseases are still generally inadequately managed. One difficulty lies in the optimal synchronization of a patient with the guideline therapeutic strategy, especially when the history of her past treatments does not follow the recommended sequence of therapies. We propose a formal model to represent guideline-based therapeutic strategies as a two-level decision tree. The clinical level is used to identify a patient-specific clinical situation, on the basis of key elements of clinical examination (complication of hypertension, associated diseases). The therapeutic level is derived from the formalization of guideline-based strategies first represented as bidimensional matrices structured in lines of therapy and levels of therapeutic intention. A revised version based on the ordering of levels of therapeutic combination is then developed. The aim is to dynamically provide the best next step of treatment from the patient's therapeutic-history-based customization of the general therapeutic sequence established in the guideline for the corresponding clinical situation. A preliminary in vitro evaluation of the system on actual clinical cases showed a positive impact on physician compliance with a significant increase from 16 to 57%.

Canada↗

A novel method for detecting neutralizing antibodies against therapeutic proteins by measuring gene expression.

The presence of neutralizing antibodies against protein therapeutics is a concern in the biomedical field. Such antibodies not only reduce the efficacy of protein therapeutics, but also impose potential dangers to the patients receiving them. To date, a small number of in vitro cell-based bioassays for detecting neutralizing antibodies against therapeutic proteins have been developed. Most of the existing assays, however, either involve the use of radioactive materials or have limited sensitivities and/or poor specificities. With advances in mRNA profiling and detection techniques, we have established a novel and non-radioactive bioassay system using branched DNA (bDNA) technology for detecting protein-therapeutic neutralizing antibodies in patient serum. Our assay measures the variations of target gene expression that reflect the biologic effect of the therapeutic agent and the capability of the antibodies, if present, to neutralize the therapeutics. Compared with most existing assays, the new assay is more sensitive and specific, and completely eliminates the use of radioactive materials. Application of the new assay system can be widely expanded if new target genes and responding cell lines for other therapeutics are identified or engineered.

Antibodies↗