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Results for “Randomized trial”

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At least 145 records · Page 8Linked to original sources

PubMed2001

Impact of spinal cord stimulation on sensory characteristics in complex regional pain syndrome type I: a randomized trial.

BACKGROUND: A randomized trial was performed to assess the effect of spinal cord stimulation (SCS) on detection and pain thresholds for pressure, warmth, and cold and on the extent of mechanical hyperalgesia in patients with chronic complex regional pain syndrome type I. METHODS: Fifty-four chronic complex regional pain syndrome type I patients were randomized to receive both SCS and physical therapy (SCS+PT; n = 36), or to receive only physical therapy (PT; n = 18). Twenty-four SCS+PT patients responded positively to trial stimulation and underwent SCS implantation. During a 12-month follow-up period, six quantitative sensory testing sessions were performed. The main analysis compared 24 SCS patients with 29 nonimplanted patients--one PT patient was excluded. RESULTS: SCS showed no effect on detection thresholds for warmth and cold or on pain thresholds for any sensation. The pressure detection threshold initially increased by SCS, but after 3 months, pressure detection thresholds returned to normal. Mechanical hyperalgesia, both dynamic and static, was reduced slightly with SCS. CONCLUSIONS: Although SCS has previously been shown to cause a significant pain reduction in complex regional pain syndrome type I, the treatment has no long-term effect on detection and pain thresholds for pressure, warmth, or cold. The treatment seems to have only minimal influence on mechanical hyperalgesia.

Adolescent↗

PubMed2006

Intracoronary infusion of autologous mononuclear bone marrow cells or peripheral mononuclear blood cells after primary percutaneous coronary intervention: rationale and design of the HEBE trial--a prospective, multicenter, randomized trial.

BACKGROUND: Recently, several preliminary reports have demonstrated that cell transplantation after acute myocardial infarction in humans is safe and leads to better preserved left ventricular function and improved myocardial perfusion and coronary flow reserve. METHODS: The HEBE trial is a multicenter, prospective, randomized, 3-arm open trial with blinded evaluation of end points. Patients with acute large myocardial infarction treated with primary percutaneous coronary intervention (PCI) will undergo magnetic resonance imaging (MRI) and echocardiography. A total of 200 patients are randomized to treatment with (1) intracoronary infusion of autologous mononuclear bone marrow cells, (2) intracoronary infusion of peripheral mononuclear blood cells, or (3) standard therapy. Mononuclear cells are isolated from bone marrow aspirate or venous blood by density gradient centrifugation. Within 7 days after PCI and within 24 hours after bone marrow aspiration or blood collection, a catheterization for intracoronary infusion of the mononuclear cells in the infarct-related artery is performed. In all patients, follow-up will be obtained at 1, 4, and 12 months. MRI and catheterization are repeated at 4 months, and all images are analyzed by a core laboratory blinded to randomization. The primary end point of the study is the change in regional myocardial function in dysfunctional segments at 4 months relative to baseline, based on segmental analysis as measured by MRI. IMPLICATIONS: If intracoronary infusion of autologous mononuclear bone marrow cells or peripheral mononuclear blood cells is proven to be beneficial after primary PCI; it could be a valuable tool in preventing heart failure-related morbidity and mortality after myocardial infarction.

Angioplasty, Balloon, Coronary↗

PubMed1981

Multi-drug chemotherapy with and without radiation for carcinoma of the stomach and pancreas: a prospective randomized trial.

A prospectively randomized trial in advanced gastric and pancreatic carcinoma compared multi-drug chemotherapy, with and without radiotherapy to the local lesion, in terms of median survival and toxicity. Of 29 patients with gastric adenocarcinoma, 14 were randomized to receive 5-FU and Methyl-CCNU, and 15 to receive 5-FU and local radiotherapy to a dose of 4600 rad, and then Methyl-CCNU. Thirty patients with advanced adenocarcinoma of the pancreas were similarly randomized. There was no significant difference between the two arms of the gastric or pancreatic adenocarcinoma groups, with a median survival of 13 months and 11.5 months respectively in gastric carcinoma, and 7.8 months and 7.3 months in pancreatic carcinoma. Complications were minimal in both groups. There was more hematopoietic depression in the radiation-treated patients, but none had radiotherapy discontinued because of toxicity.

Adenocarcinoma↗

PubMed1995

Combination therapy using adrenaline and heater probe to reduce rebleeding in patients with peptic ulcer haemorrhage: a prospective randomized trial.

A prospective randomized trial was performed to assess the efficacy of the combined therapy of endoscopic injection of adrenaline and heater probe application in the management of patients with major peptic ulcer haemorrhage. Some 153 consecutive patients were randomized to receive either local injection of adrenaline (1:10,000) followed by heater probe thermocoagulation (74 patients) or no endoscopic treatment (79 patients). The two groups were well matched with regard to age, haemoglobin concentration on admission, non-steroidal anti-inflammatory drug usage and endoscopic findings. More patients in the treatment group were in shock on admission (21 versus 13). Initial haemostasis was achieved in all patients randomized to endoscopic therapy. Rebleeding occurred in fewer treated than control patients (five versus 16, P = 0.01). The treated group also had fewer deaths (zero versus two) and requirement for operation (two versus six). The results show that the combination of sclerotherapy with adrenaline and subsequent thermocoagulation reduces the rate of rebleeding in peptic ulcer haemorrhage.

Adult↗

PubMed1989

Metaphylactic effect of mitomycin C with and without hyaluronidase after transurethral resection of bladder cancer: randomized trial.

In a randomized trial 2 groups of 28 patients who had undergone transurethral resection of bladder tumors were treated with 20 mg. mitomycin C alone or with 200,000 units hyaluronidase to determine whether adjuvant hyaluronidase would improve tumor recurrence rates. Patient groups were comparable statistically. In the group receiving additive hyaluronidase the percentage of tumor recurrences was decreased significantly (p less than 0.05). Side effects were not increased. Thus, adjuvant hyaluronidase appears to have a role in the metaphylaxis of bladder tumors. The potential reduction of the hyaluronidase dose without loss of protective action and the role of additive hyaluronidase in the systemic treatment of metastatic urothelial tumors remain to be investigated.

Adult↗

PubMed1998

Prevention of lymphorrhea by means of fibrin glue after axillary lymphadenectomy in breast cancer: prospective randomized trial.

A prospective randomized trial was carried out to evaluate the efficacy of fibrin glue in preventing lymphorrhea after axillary lymphadenectomy in breast cancer. One hundred and eight breast cancer patients, operated on by two senior surgeons, were randomized into two groups: group 1 (n = 58) without fibrin glue and group 2 (n = 50) with 2 ml of fibrin glue applied to the axillary dissection area at the end of the lymphadenectomy procedure. Early postoperative morbidity was 2/58 and 0/50 in groups 1 and 2, respectively. Mean daily postoperative drainage was significantly greater in group 1. The mean cumulative drainage quantity 6 days after the operation was 407.8 ml and 214.4 ml in groups 1 and 2, respectively (p = 0.001). The mean postoperative hospital stay was 10.1 days and 8.0 days in groups 1 and 2, respectively (p = 0.006). One delayed seroma was observed in each group. Fibrin glue seems to reduce daily postoperative drainage and hospital stay, but did not affect delayed seroma formation after axillary lymphadenectomy for breast cancer.

Aged↗

PubMed1995

Maintenance of serum albumin levels in pediatric burn patients: a prospective, randomized trial.

A prospective, randomized trial was performed to determine whether maintaining serum albumin levels in burned pediatric patients had any effect on morbidity and mortality. Patients < 19 years of age with burns > 20% total body surface area were randomized to receive supplemental albumin to maintain levels 2.5 to 3.5 g/dL ("High Albumin") or were given albumin only if levels dropped < 1.5 g/dL ("Low Albumin") after completing burn shock resuscitation. The 36 patients in the Low Albumin group were well matched for age, burn size, depth of injury, and inhalation injury when compared with the High Albumin group (34 patients). As expected, serum albumin levels were significantly lower in the Low Albumin group when compared with the High Albumin group. No differences between groups were noted for resuscitation needs, maintenance fluid requirements, urine output, tube feedings received, days of antibiotic treatment, or ventilatory requirements. No differences in hematology, electrolytes, or nutritional laboratories were found. Finally, length of stay, complication rate, and mortality were not affected by albumin treatment. Albumin supplementation to maintain normal serum levels does not seem to be warranted in previously healthy children who suffer severe burns and who receive adequate nutrition.

Adolescent↗

PubMed2001

Integrated medical care for patients with serious psychiatric illness: a randomized trial.

BACKGROUND: This randomized trial evaluated an integrated model of primary medical care for a cohort of patients with serious mental disorders. METHODS: A total of 120 individuals enrolled in a Veterans Affairs (VA) mental health clinic were randomized to receive primary medical care through an integrated care initiative located in the mental health clinic (n = 59) or through the VA general medicine clinic (n = 61). Veterans who obtained care in the integrated care clinic received on-site primary care and case management that emphasized preventive medical care, patient education, and close collaboration with mental health providers to improve access to and continuity of care. Analyses compared health process (use of medical services, quality of care, and satisfaction) and outcomes (health and mental health status and costs) between the groups in the year after randomization. RESULTS: Patients treated in the integrated care clinic were significantly more likely to have made a primary care visit and had a greater mean number of primary care visits than those in the usual care group. They were more likely to have received 15 of the 17 preventive measures outlined in clinical practice guidelines. Patients assigned to the integrated care clinic had a significantly greater improvement in health as measured by the physical component summary score of the 36-Item Short-Form Health Survey than patients assigned to the general medicine clinic (4.7 points vs -0.3 points, P<.001). There were no significant differences between the 2 groups in any of the measures of mental health symptoms or in total health care costs. CONCLUSION: On-site, integrated primary care was associated with improved quality and outcomes of medical care.

Adult↗

PubMed1993

Air and liquid contrast agents in the management of intussusception: a controlled, randomized trial.

A randomized study comparing air and liquid contrast agents for diagnosis and reduction of intussusception involved 101 patients. Fifty received liquid contrast material and 51 received air. Rates of diagnosis were 49% (25 of 51) for air and 54% (27 of 50) for liquid contrast material (P = .62). Rates of reduction were 76% (19 of 25) for air and 63% (17 of 27) for liquid contrast material (P = .31). Air enemas resulted in shorter fluoroscopic times in patients without an intussusception and for examinations by radiologists who had performed four or more air enemas. Air enemas were found to be accurate in demonstration of intussusception and at least as effective as liquid contrast medium for reduction of intussusception. In experienced hands, the shorter fluoroscopic time with resultant lower radiation exposure associated with air is an important benefit. There still may be clinical situations, however, in which a liquid contrast agent is preferred.

Air↗

PubMed1999

Artificial Valve Endocarditis Reduction Trial (AVERT): protocol of a multicenter randomized trial.

BACKGROUND AND AIM OF THE STUDY: This article presents the protocol of the Artificial Valve Endocarditis Reduction Trial (AVERT), a multicenter, international randomized trial to assess the efficacy of the SilzoneTM coating of St. Jude Medical Masters Series mechanical heart valves in the prevention of prosthetic heart valve endocarditis (PVE). A total of 4,400 eligible patients will be randomized within three years of study commencement at 17 participating clinical centers in North America and Europe, with study completion within four years. ELIGIBILITY CRITERIA: Eligible patients are candidates for St. Jude mechanical valves with either the Silzone or conventional cuff, in the mitral and/or aortic position, who give informed written consent to participate. Major exclusion criteria are the presence of prosthetic valves that do not require replacement, and the need for tricuspid valve replacement. Bypass surgery and valve repair are allowed during the implant operation. Patients will be randomized using an envelope-based intraoperative randomization scheme, stratified by clinical center and by the presence of endocarditis at the time of surgery. FOLLOW UP: Patients will be contacted at discharge, three months, and each anniversary of the implant procedure. A brief follow up survey, administered via clinic interview, telephone or mail, will elicit events associated with possible endocarditis (unexplained fever, worsening angina, hospitalization) that will initiate contact with the patient's following physician. OUTCOME ANALYSIS: The primary PVE endpoint will be based upon a published algorithm, with two infectious disease specialists making the final determination of cases classified as possible endocarditis. Study data will be periodically reviewed by a Data Safety Monitoring Board. The primary analysis will be an intention-to-treat comparison of freedom from PVE curves between the Silzone and conventional cuff treatment groups. CONCLUSIONS: AVERT will provide much-needed information on the effectiveness of Silzone in preventing PVE, as well as practice patterns and outcomes of valve replacement.

Clinical Protocols↗

PubMed1991

Prevention of central venous catheter sepsis: a prospective randomized trial.

A prospective randomized trial was undertaken to evaluate the influence of routine 72-hour catheter exchange and the use of an implantable collagen cuff in preventing central venous catheter infection in critically ill patients requiring multiple lumen central venous access. Patients were randomized to one of four groups, which determined whether the central venous catheter placed would be removed at 3 or 7 days and whether an implantable collagen cuff would be used or not. Upon removal, cultures of the central line tip, the insertion site, and peripheral blood were obtained. One hundred and fifty-nine catheters were studied in 85 patients during a 14-month period. There were 26 (16.4%) episodes of catheter colonization and four (2.5%) episodes of catheter infection in the entire population. Catheter colonization rates (same organisms cultured from catheter tip and skin site) were 14.5 per cent at 3 days and 18.4 per cent at 7 days. Infection rates (same organism cultured from catheter tip and peripheral blood culture) were 2.4 per cent at 3 days and 2.6 per cent at 7 days. With regard to the use of the collagen cuff, colonization rates were 14.5 per cent with the use of the cuff and 18.1 per cent without the use of the cuff. Infection rates were 5.3 per cent with the use of the cuff and 0 per cent without the use of the cuff. None of these differences reached statistical significance.(ABSTRACT TRUNCATED AT 250 WORDS)

Bacterial Infections↗

PubMed1991

Conservative treatment of postmastectomy lymphedema: a controlled, randomized trial.

A controlled, randomized trial was carried out to evaluate the effectiveness of a new conservative treatment for postmastectomy lymphedema. Seventy-four patients were randomized to wear only an elastic sleeve for six months (group A) or to receive additionally an induction treatment with electrically stimulated lymphatic drainage (group B). The evaluation of results was focused not only on the mean variations in limb measurements in the two groups, but also on the frequency of clinically significant reductions of lymphedema (i.e., at least 25% compared to the initial values). A mean reduction of limb girth of about 17% was obtained in both groups, without significant differences between the two treatments. An 'objective response', however, was not achieved by the majority of patients. On the other hand, compliance to therapy was good and a significant result could be obtained simply and economically also in the group of patients treated only with the elastic sleeve.

Aged↗

PubMed2001

A comparison of early intensive methotrexate/mercaptopurine with early intensive alternating combination chemotherapy for high-risk B-precursor acute lymphoblastic leukemia: a Pediatric Oncology Group phase III randomized trial.

A prospective, randomized multicenter study was performed to evaluate the relative efficacy of two different concepts for early intensive therapy in a randomized trial of children with B-precursor acute lymphoblastic leukemia (ALL) at high risk (HR) for relapse. Four hundred and ninety eligible children with HR-ALL were randomized on the Pediatric Oncology Group (POG) 9006 phase III trial between 7 January 1991 and 12 January 1994. After prednisone (PDN), vincristine (VCR), asparaginase (ASP) and daunorubicin (DNR) induction, 470 patients received either 12 intensive parenteral treatments of intermediate dose (1 g/m2 each) methotrexate (MTX) and mercaptopurine (MP) over 24 weeks (regimen A) or 12 intensive course of alternating myelosuppressive drug combinations given over 30 weeks (regimen B). These drug combinations included MTX/MP, teniposide (VM-26)/cytosine arabinoside (AC) and VCR/PDN/DNR/AC/ASP. Central nervous system (CNS) prophylaxis was age-adjusted triple intrathecal chemotherapy. Patients with CNS disease at diagnosis were treated with craniospinal irradiation after the intensive phase. Continuation was standard doses of MTX and MP for 2 years. This trial was closed early because of an apparent early difference favoring regimen B. Results show that 470 patients achieved remission (97%). Two hundred and thirty two were randomized to regimen A and 238 to regimen B. The estimated 4-year event-free survival (EFS) for patients treated with regimen A is 61.6 % (s.e. = 3.3%) and with regimen B is 69.4% (s.e. = 3.1%), P = 0.091. Toxicities were more frequent on regimen B. In conclusion, for children with B-precursor ALL at high risk to relapse, early intensification with myelosuppressive combination chemotherapy was more toxic but produced no significant difference in EFS when compared to those treated with parenteral methotrexate and mercaptopurine.

Adolescent↗

PubMed2004

Covariate-based constrained randomization of group-randomized trials.

Group-randomized study designs are useful when individually randomized designs are either not possible, or will not be able to estimate the parameters of interest. Blocked and/or stratified (for example, pair-matched) designs have been used, and their properties statistically evaluated by many researchers. Group-randomized trials often have small numbers of experimental units, and strong, geographically induced between-unit correlation, which increase the chance of obtaining a "bad" randomization outcome. This article describes a procedure--random selection from a list of acceptable allocations--to allocate treatment conditions in a way that ensures balance on relevant covariates. Numerous individual- and group-level covariates can be balanced using exact or caliper criteria. Simulation results indicate that this method has good frequency properties, but some care may be needed not to overly constrain the randomization. There is a trade-off between achieving good balance through a highly constrained design, and jeopardizing the appearance of impartiality of the investigator and potentially departing from the nominal Type I error.

Algorithms↗

PubMed1988

Postoperative radiation as adjuvant treatment for carcinoma of the oral cavity, larynx, and pharynx: preliminary report of a prospective randomized trial.

A prospective randomized trial was performed in patients with advanced squamous cell carcinomas (SCC) of the oral cavity, larynx, and pharynx to examine the effect of adjuvant postoperative radiation therapy on locoregional recurrence and survival following "curative" resection. Fifty-one patients with stage III or IV SCC treated from 1981 through 1984 were randomized to receive either surgery alone (n = 27) or surgery with postoperative radiation (n = 24). Five patients were excluded from the study after randomization because of ineligibility or protocol violations. Overall recurrence rates of 55.6% and 36.8% were noted in the surgery and surgery with adjuvant radiotherapy arms, respectively (p = NS). This trend towards a higher recurrence rate in the surgery only arm was in part due to the development of lymph node metastases in the contralateral, nonoperated neck. Thus far, no significant differences in either locoregional or overall survival have been noted between the two treatment arms. In this preliminary analysis, adjuvant postoperative radiotherapy does not appear to improve disease-free or overall survival.

Adult↗

PubMed2004

The sensitivity and specificity of functional capacity evaluations in determining maximal effort: a randomized trial.

STUDY DESIGN: Randomized trial. OBJECTIVES: To determine the sensitivity and specificity of maximal effort testing in functional capacity evaluations. SUMMARY OF BACKGROUND DATA: Functional capacity evaluations are widely used to determine when an injured worker is able to return to work. The accurate assessment of function is dependent on a patient's willingness to exert maximal effort during evaluation. Although many tests are used to suggest the presence of maximal or submaximal effort, it is unclear whether these tests can actually do what they are hoped to do. METHODS: Ninety study participants with low back pain were randomized into either a 100% effort group or a 60% effort group. After a thorough evaluation, the blinded tester was asked to give an overall opinion as to whether or not the participant was giving 100% effort or 60% effort. RESULTS: The tester's opinion on maximal effort tests within the functional capacity evaluation had an overall specificity of 84.1% and a sensitivity of 65.2%. Only 5 of 17 commonly used maximal effort tests were able to individually differentiate between maximal and submaximal effort. The final logistic regression model was able to find three covariates with reasonable explanation of the proportion of variance in the outcome variable of effort (R 3 0.444) with goodness of fit. CONCLUSIONS: The determination of maximal effort in a functional capacity evaluation is complex. Because of the wide-ranging medicolegal and ethical considerations, caution is recommended in the labeling of patients as exerting either maximal or submaximal effort.

Adult↗

PubMed1996

Laparoscopic versus open appendectomy: prospective randomized trial.

A prospective randomized trial comparing laparoscopic appendectomy with open appendectomy in patients with a diagnosis of acute appendicitis was conducted between October 1992 and April 1994. Of the 158 patients randomized, 7 patients were excluded because of protocol violations (conversion to laparotomy in 4, appendix not removed in 3). The 151 patients randomized to either a laparoscopic (n = 79) or an open appendectomy (n = 72) showed no difference in sex, age, American Society of Anesthesiology (ASA) rating, or previous abdominal surgery. The histologic classification of normal, catarrhal, inflamed, suppurative, and gangrenous appendicitis was not different between the two groups. Conversion from laparoscopic to open appendectomy was necessary in seven patients (9%) who had advanced forms of appendiceal inflammation. When compared to open appendectomy the laparoscopic group had a longer median operating time (63 minutes versus 40 minutes), fewer wound infections (2% versus 11%), less requirement for narcotic analgesia, and an earlier return to normal activity (median 7 days versus 14 days). There was no difference in morbidity, and both groups had a median time to discharge of 3 days. Laparoscopic appendectomy is as safe as open appendectomy; and despite the longer operating time, the advantages such as fewer wound infections and earlier return to normal activity make it a worthwhile alternative for patients with a clinical diagnosis of acute appendicitis.

Adolescent↗

PubMed1998

Vaginal misoprostol compared with vaginal gemeprost in termination of second trimester pregnancy. A randomized trial.

A prospective randomized trial was conducted in 140 women to compare the efficacy of vaginal gemeprost with vaginal misoprostol for termination of second trimester pregnancy. Women requesting termination of second trimester pregnancy were randomized into two groups. Group A women were given 1 mg vaginal gemeprost every 3 h for a maximum of five doses in the first 24 h, whereas group B women were given 400 micrograms vaginal misoprostol every 3 h for a maximum of five doses in 24 h. The median induction-abortion interval in the vaginal misoprostol group (14.1 h) was significantly shorter than that in the gemeprost group (19.5 h). The percentage of women who achieved successful abortion within 24 h in the misoprostol group (80.0%) was significantly higher than that in the gemeprost group (58.6%). There was no significant difference in the incidence of side effects between the two groups except for diarrhea, which was more common in the gemeprost group. The incidence of fever was more common in the misoprostol group. It is concluded that vaginal misoprostol is more effective than gemeprost in termination of second trimester pregnancy.

Abortifacient Agents, Nonsteroidal↗