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12,235,452 |
The pharmacokinetics and pharmacodynamics of enoxaparin in obese volunteers.
|
Sanderink Ger-Jan GJ, Le Liboux Aimé A, Jariwala Navin N, Harding Neasa N, Ozoux Marie-Laure ML, Shukla Umesh U, Montay Guy G, Boutouyrie Bruno B, Miro Adelaida A
|
Clinical pharmacology and therapeutics . Vol. 72, No. 3, 2002 Sep
|
OBJECTIVES: The objective of this study was to compare the pharmacokinetics of the low-molecular-weight heparin enoxaparin in obese and nonobese volunteers, by means of two administration regimens. METHODS: Enoxaparin was administered subcutaneously (1.5 mg/kg once daily for 4 days) and in a single 6-hour infusion (1.5 mg/kg) to 24 obese volunteers and 24 age-, sex-, and height-matched nonobese volunteers in a randomized, open-label, 2-way crossover design. Blood plasma was assessed for anti-Xa and anti-IIa activity and activated partial thromboplastin time. RESULTS: After subcutaneous administration, steady-state exposure was achieved after the second dose in nonobese volunteers and after the third dose in obese volunteers. Time to maximum anti-Xa activity was 1 hour longer in obese volunteers, but maximum anti-Xa activity was similar in both groups. For anti-Xa activity, exposure at steady-state was 16% higher in obese volunteers than in nonobese volunteers (90% confidence interval, 108%-125%). After intravenous infusion, total body clearance and volume of distribution at steady state were higher in obese volunteers than in nonobese volunteers, but when adjusted for weight, these values were about 10% lower in obese volunteers. Anti-IIa activity after subcutaneous administration did not differ significantly between obese and nonobese volunteers. Pharmacodynamic analysis of activated partial thromboplastin time showed similar results in obese and nonobese volunteers after both intravenous and subcutaneous administration. No deaths or serious adverse events occurred during the study. CONCLUSIONS: Enoxaparin was well tolerated when administered subcutaneously or intravenously, and there appears to be no need to modify the currently recommended dose for obese volunteers.
|
https://pubmed.ncbi.nlm.nih.gov/12235452/
|
[
"Clinical Trial",
"Comparative Study",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't"
] |
12235452
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12,235,465 |
Lamivudine in chronic hepatitis B virus.
|
Akbar Hisham O HO
|
Saudi medical journal . Vol. 23, No. 8, 2002 Aug
|
OBJECTIVE: To access the effect of one year treatment with Lamivudine, and its durability on patients with compensated chronic hepatitis B. METHODS: Thirty-six patients with hepatitis B surface antigen positive, hepatitis B virus deoxyribonucleic acid (DNA) positive, were treated with 100 mg Lamivudine daily for one year, irrespective of their liver enzymes level, alanine aminotransferase or hepatitis B envelope antigen status. Patients with normal alanine aminotransferase and negative hepatitis B virus DNA at the end of the treatment were responders and those with persistent response 16 weeks off treatment were considered having durable response. RESULTS: Three patients dropped out and 33 patients completed the study. Eight patients (24.2%) had normal alanine aminotransferase, 25 patients (75.8%) had increased alanine aminotransferase. Thirty patients (90.9%) were hepatitis B envelope antigen negative. Two patients (25%) with initial normal alanine aminotransferase and 7 patients (28%) with increased enzyme level, responded at end of treatment. One patient with positive hepatitis B envelope antigen responded to treatment. Only one patient relapsed during follow-up period off treatment. CONCLUSION: Lamivudine is associated with durable response in patients with hepatitis B virus and negative hepatitis B envelope antigen. Longer treatment for more than one year may be required to improve response rates.
|
https://pubmed.ncbi.nlm.nih.gov/12235465/
|
[
"Clinical Trial",
"Journal Article"
] |
12235465
|
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] |
12,235,506 |
Results of a randomized trial of HERMES-assisted versus non-HERMES-assisted laparoscopic antireflux surgery.
|
Luketich J D JD, Fernando H C HC, Buenaventura P O PO, Christie N A NA, Grondin S C SC, Schauer P R PR
|
Surgical endoscopy . Vol. 16, No. 9, 2002 Sep
|
BACKGROUND: Speech recognition technology is a recent development in minimally invasive surgery. This study was designed to assess the impact of HERMES on operating room efficiency and user satisfaction. METHODS: Patients undergoing laparoscopic antireflux operations by surgeons experienced in minimally invasive surgery were randomized to HERMES-assisted or standard laparoscopic operations. The variables of interest were circulating nurse's time spent adjusting devices that are voice-controlled by HERMES, number of adjustments to devices requested, and surgeon and nurse satisfaction measured on a scale from 1 (dissatisfied) to 10 (satisfied). RESULTS: A total of 30 cases were studied. In the non-HERMES cases, nurses were interrupted to make device adjustments an average of 15.3 times per case versus 0.33 times per case in the with-HERMES cases (p < 0.01). The interruptions during the non-HERMES cases averaged 4.35 min per case versus 0.16 min per case in the with-HERMES cases (p = 0.03). Average satisfaction scores for HERMES operations as opposed to non-HERMES operations were 9.2 versus 5.3 for nurses (p < 0.01) and 9.0 versus 5.1 for surgeons (p < 0.01). CONCLUSIONS: Physician and nurse acceptance of HERMES was very high because of the smoother interruption-free environment.
|
https://pubmed.ncbi.nlm.nih.gov/12235506/
|
[
"Clinical Trial",
"Comparative Study",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't"
] |
12235506
|
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] |
12,235,507 |
Controlled trial of the introduction of a robotic camera assistant (EndoAssist) for laparoscopic cholecystectomy.
|
Aiono S S, Gilbert J M JM, Soin B B, Finlay P A PA, Gordan A A
|
Surgical endoscopy . Vol. 16, No. 9, 2002 Sep
|
BACKGROUND: The role of the human camera holder during laparoscopic surgery keeps valuable personnel from other duties. EndoAssist is a robotic camera-holding device controlled by the operator's head movements. This study assesses its introduction into clinical practice. METHOD: Ninety-three patients undergoing laparoscopic cholecystectomy were randomized to have either the robotic (40) or a human (46) assistant. Seven patients converted to open operation were excluded. Six surgeons were evaluated. Operating time and subjective assessments were recorded. Learning curves were constructed. RESULTS: The mean operating time was less using the robotic assistant (66 min) than with human assistance (74 min) (p < 0.05, two-tailed t-test). The learning curves for operating time showed that within three operations surgeons were trained in using the robot. The device was safe in use. CONCLUSION: The EndoAssist operating device is a significant asset in laparoscopic surgery and a suitable substitute for a human assistant. Surgeons became competent in the use of the robot within three operations. The robot offers stability and good control of the television image in laparoscopic surgery.
|
https://pubmed.ncbi.nlm.nih.gov/12235507/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial"
] |
12235507
|
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] |
12,235,516 |
Rapid hematopoietic engraftment following fractionated TBI conditioning and transplantation with CD34(+) enriched hematopoietic progenitor cells from partially mismatched related donors.
|
Redei I I, Langston A A AA, Lonial S S, Cherry J K JK, Allen A J AJ, Hamilton E E, Jones M M, Bartlett V M VM, Waller E K EK
|
Bone marrow transplantation . Vol. 30, No. 6, 2002 Sep
|
Nineteen adult patients with poor-risk hematologic malignancy received T cell-depleted (TCD) hematopoietic progenitor cell (HPC) transplant from partially mismatched related donors (PMRD). The preparative regimen (FITFA) included fractionated TBI, thiotepa, fludarabine, and horse (n = 3) or rabbit (n = 16) anti-thymocyte anti-sera (ATG). GVHD prophylaxis consisted of TCD by positive/negative selection using the Isolex 300i system and pre-transplant ATG with no post-transplant immunosuppression. The mean number (+/-s.d.) of transplanted CD34(+) and CD3(+) cells were 8.9 x 10(6)/kg +/-4.3 (range 2.6-19.3) and 1.4 x 10(4)/kg +/-1.2 (range 0.3-4.6) respectively. Seventeen patients evaluable for neutrophil engraftment achieved an ANC >0.5 x 10(9)/l at a median of 12 days (range 9-27), with evidence of full donor chimerism. Thirteen patients died of the following causes: relapse (n = 6), infections (n = 5), interstitial pneumonia (n = 1), and unknown causes (n = 1) None of the recipients of rabbit ATG required therapy for acute or chronic GVHD. Five patients are alive and disease-free at a median time of 303 days post transplant (range 100-660). The FITFA preparative regimen using fractionated TBI is well tolerated and is sufficiently immunosuppressive to allow rapid and stable donor origin hematopoietic engraftment without 'mega' doses of CD34(+) cells. Combination of stringent ex vivo TCD and pre-transplant ATG is effective GVHD prophylaxis.
|
https://pubmed.ncbi.nlm.nih.gov/12235516/
|
[
"Clinical Trial",
"Journal Article"
] |
12235516
|
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] |
12,235,521 |
Fludarabine/melphalan conditioning for allogeneic transplantation in patients with multiple myeloma.
|
Giralt S S, Aleman A A, Anagnostopoulos A A, Weber D D, Khouri I I, Anderlini P P, Molldrem J J, Ueno N T NT, Donato M M, Korbling M M, Gajewski J J, Alexanian R R, Champlin R R
|
Bone marrow transplantation . Vol. 30, No. 6, 2002 Sep
|
The purpose of the study was to determine the feasibility and efficacy of a reduced intensity conditioning regimen of fludarabine and melphalan for allogeneic transplantation in patients with multiple myeloma. From August 1996 to December 2000, 22 patients received a reduced intensity conditioning regimen with fludarabine and melphalan. Median age was 51 years (range, 45-64), median time from initial therapy to transplant was 36 months (range, 3-135 months). Disease phase prior to transplant was primary refractory in two patients, refractory relapse in 11 patients, sensitive relapse in eight patients and initial remission consolidation in one patient. The median number of prior therapies was five (range, 1-7), and median beta 2 microglobulin prior to transplant was 3.0 mg/l (range, 1.0-7.3). All patients received unmanipulated grafts from either HLA matched sibling donors (n = 13) or matched unrelated donors (n = 9). Eighteen patients received fludarabine 30 mg/m(2) for 4 days with melphalan 140 mg/m(2) as a single dose and four patients received fludarabine 25 mg/m(2) for 5 days with melphalan 90 mg/m(2) daily for 2 days. All 21 patients evaluable for engraftment achieved a neutrophil count of >0.5 x 10(9)/l after a median of 12 days (range, 9-24), 18 patients achieved platelet transfusion independence after a median of 14 days (range, 8-47). All engrafting patients had 100% donor cell engraftment. Seven patients achieved a complete remission. Six patients are currently alive with a median follow-up of 15 months (range, 10-47 months). The actuarial survival and progression-free survival is 30 +/- 11% and 19 +/- 9% at 2 years. Non-relapse mortality at 100 days was 19 +/- 10% and 40 +/- 10% at 1 year. Fludarabine/melphalan combinations are feasible and allow consistent engraftment of allogeneic progenitor cells from both related and unrelated donors in patients with multiple myeloma and should be explored in patients with less advanced disease.
|
https://pubmed.ncbi.nlm.nih.gov/12235521/
|
[
"Clinical Trial",
"Journal Article"
] |
12235521
|
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] |
12,235,524 |
Performance of a hybrid central venous catheter utilized for both peripheral blood stem cell harvest and transplant support of patients undergoing autologous peripheral blood stem cell transplantation.
|
Restrepo A A, Devore P P, Encarnación C E CE, Wholey M H MH, Schneider D D, Callander N S NS, Ferral H H, Postoak D D, Anderson J E JE, Walsh T T, Padayao G G, Gokmen E E, Ehsan A A, Ochoa L L, Neumon B B, West G G, Restrepo M I MI, Przykucki J J, Patterson J J, Freytes C O CO
|
Bone marrow transplantation . Vol. 30, No. 6, 2002 Sep
|
Patients undergoing autologous peripheral blood stem cell transplantation (PBSC) frequently require the sequential insertion of two central venous catheters, one for leukapheresis and one for transplant support. Hybrid catheters suitable for leukapheresis and long-term use have been increasingly used, but there is limited information regarding their performance and complication rate. The purpose of this study was to determine the performance of the Pheres-Flow hybrid catheter when utilized for both leukapheresis and transplant support, with particular emphasis on the incidence of infectious and occlusive complications. We prospectively analyzed the performance of 92 catheters in 82 consecutive patients who underwent autologous peripheral blood stem cell (PBSC) transplantation. Occlusion was the most frequent complication of this catheter with 29% of the patients experiencing difficulty drawing blood or infusing fluids. Infection was another frequent complication. Twenty-two percent of patients developed catheter-related bloodstream infections and 15 catheters had to be removed because of proven or suspected infection that did not respond to antibiotic therapy. Nevertheless, 77% of patients were able to complete leukapheresis and transplant support with only one catheter. We conclude that the utilization of the Pheres-Flow catheter for both leukapheresis and transplant support is feasible, but that new strategies need to be developed to decrease the incidence of occlusive and infectious complications of hybrid catheters.
|
https://pubmed.ncbi.nlm.nih.gov/12235524/
|
[
"Clinical Trial",
"Journal Article"
] |
12235524
|
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] |
12,235,532 |
Prediction of VO(2peak) in wheelchair-dependent athletes from the adapted Léger and Boucher test.
|
Vinet A A, Le Gallais D D, Bouges S S, Bernard P-L PL, Poulain M M, Varray A A, Micallef J-P JP
|
Spinal cord . Vol. 40, No. 10, 2002 Oct
|
PURPOSE: :The purpose of this study was to provide a predictive peak oxygen uptake ([V]O(2) peak) equation in wheelchair-dependent athletes using the Adapted Léger and Boucher test. SUBJECTS AND PROTOCOL: :Fifty-six wheelchair-dependent athletes, 47 males and nine females (30.3+/-4 years), underwent a clinical examination to assess their anthropometric characteristics: height, mass, body mass index (BMI), lean body mass, arm length, and muscular arm volume. They performed a deceleration field test to assess the subject-wheelchair resistance defined as a mechanical variable, and they then performed the Adapted Léger and Boucher test to assess physiological data at maximal exercise ([V]O(2) peak, heart rate max) concomitantly with biomechanical (number of pushes) and performance variables (maximal aerobic velocity Va(max) and maximal distance). The [V]O(2) peak was measured directly using a portable telemetric oxygen analyzer. Subjects were then randomly assigned to an experimental group (n=49) to determine the predictive equation, and a validation group (n=7) to check the external validity of the equation. RESULTS: A stepwise multiple regression with [V]O(2) peak (l min(-1)) as the dependent variable led to the following equation: [V]O(2) peak=0.22 Va(max) - 0.63 log(age)+0.05 BMI 0.25 level+0.52, with r(2)=0.81 and SEE=0.01. Paraplegic subjects with high and low lesion level spinal injuries were attributed the coefficient of 1 and 0, respectively. The external validity of the equation was positive since the predicted [V]O(2) peak values did not significantly differ from directly measured [V]O(2) peak (P>0.05). CONCLUSION: We concluded that [V]O(2) peak in wheelchair-dependent athletes was predictable using the equation of the present study and the described incremental test.
|
https://pubmed.ncbi.nlm.nih.gov/12235532/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial"
] |
12235532
|
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12,235,531 |
Decompression of the spinal subarachnoid space as a solution for syringomyelia without Chiari malformation.
|
Lee J-H JH, Chung C-K CK, Kim H J HJ
|
Spinal cord . Vol. 40, No. 10, 2002 Oct
|
STUDY DESIGN: Review and analysis of seven cases of syringomyelia treated surgically. OBJECTIVE: To demonstrate the beneficial role of decompressive surgery for the altered cerebrospinal fluid (CSF) flow dynamics in syringomyelia not associated with Chiari I malformation. A comparison between the pre- and post-operative syrinx size and CSF flow in the subarachnoid space was made using cine-mode magnetic resonance imaging (cine-MRI) and then correlated with clinical improvement. SETTING: University Hospital, Seoul, Korea. METHODS: Conventional spinal MRI and cine-MRI were performed in the region of CSF flow obstruction preoperatively in seven patients with syringomyelia not associated with Chiari I malformation. The group consisted of one case of syrinx with post-traumatic compression fracture, one case of post-traumatic arachnoiditis, two cases of holocord syrinx associated with hydrocephalus without Chiari malformation, one case of syrinx with post-traumatic pseudomeningeal cyst, one case of post-laminectomy kyphosis-associated syringomyelia and one case of post-tuberculous arachnoiditis syringomyelia. Based on the preoperative cine-MRI, the types of surgery appropriate to correct the CSF flow obstruction were chosen: decompressive laminectomy-adhesiolysis and augmentation duraplasty in arachnoiditis cases, ventriculoperitoneal shunt for hydrocephalus, cyst extirpation in pseudomeningeal cyst and both anterior and posterior decompression-fusion in the case of post-laminectomy kyphosis. A syrinx-draining shunt operation was performed in three cases; where the syringomyelia was associated with post-traumatic compression fracture refractory to a previous decompression, where hydrocephalus was present in which the decompression by ventriculoperitoneal shunt was insufficient and where post-traumatic arachnoiditis was present in which the decompression was impossible due to diffuse adhesion. Change in syrinx size was evaluated with post-operative MRI in all seven cases and restoration of flow dynamics was evaluated with cine-MRI in three of the cases, two patients with clinical improvement and one patient with no change of clinical status, respectively. RESULTS: Four out of seven patients showed symptomatic improvement after each decompressive operation. In the remaining three cases, reconstruction of the spinal subarachnoid space was not possible due to diffuse adhesion or was not the main problem as in the patient with syrinx associated with hydrocephalus who had to undergo a shunt operation. One of these three patients showed clinical improvement after undergoing syringosubarachnoid shunt. A decrease of syrinx size was observed in only two out of the five patients who showed clinical improvement after treatment. Of these five patients, two patients underwent post-operative cine-MRI and the restoration of normal CSF flow dynamics was noted in both patients. Of the remaining two patients, one underwent post-operative cine-MRI and there was no change in the CSF flow dynamics evident. CONCLUSION: These results suggest that the restoration of CSF flow dynamics between the syrinx and the subarachnoid space by decompressive operation is more effective than simple drainage of the syrinx cavity itself in the treatment of syringomyelia without Chiari malformation.
|
https://pubmed.ncbi.nlm.nih.gov/12235531/
|
[
"Case Reports",
"Clinical Trial",
"Comparative Study",
"Journal Article",
"Research Support, Non-U.S. Gov't"
] |
12235531
|
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] |
12,235,596 |
The effect of dynamic versus isometric resistance training on pain and functioning among adults with osteoarthritis of the knee.
|
Topp Robert R, Woolley Sandra S, Hornyak Joseph J, Khuder Sadik S, Kahaleh Bashar B
|
Archives of physical medicine and rehabilitation . Vol. 83, No. 9, 2002 Sep
|
OBJECTIVE: To compare 16 weeks of isometric versus dynamic resistance training versus a control on knee pain and functioning among patients with knee osteoarthritis (OA). DESIGN: Randomized clinical trial. SETTING: Outpatient setting. PARTICIPANTS: A total of 102 volunteer subjects with OA of the knee randomized to isometric (n=32) and dynamic (n=35) resistance training groups or a control (n=35). INTERVENTIONS: Strength exercises for the legs, 3 times weekly for 16 weeks. Dynamic group: exercises across a functional range of motion; isometric: exercises at discrete joint angles. MAIN OUTCOME MEASURES: The time to descend and ascend a flight of 27 stairs and to get down and up off of the floor. Knee pain was assessed immediately after each functional task. The Western Ontario and McMaster Universities Osteoarthritis Index was used to assess perceived pain, stiffness, and functional ability. RESULTS: In the isometric group, time to perform all 4 functional tasks decreased (P<.05) by 16% to 23%. In the dynamic group, time to descend and ascend stairs decreased by 13% to 17%. Both groups decreased knee pain while performing the functional tasks by 28% to 58%. Other measures of pain and functioning were significantly and favorably affected in the training groups. The improvements in the 2 training groups as a result of their respective therapies were not significantly different. The control group did not change over the duration of the study. CONCLUSION: Dynamic or isometric resistance training improves functional ability and reduces knee joint pain of patients with knee OA.
|
https://pubmed.ncbi.nlm.nih.gov/12235596/
|
[
"Clinical Trial",
"Comparative Study",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't",
"Research Support, U.S. Gov't, P.H.S."
] |
12235596
|
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] |
12,235,606 |
Gait outcomes after acute stroke rehabilitation with supported treadmill ambulation training: a randomized controlled pilot study.
|
da Cunha Inácio Teixeira IT, Lim Peter A PA, Qureshy Huma H, Henson Helene H, Monga Trilok T, Protas Elizabeth J EJ
|
Archives of physical medicine and rehabilitation . Vol. 83, No. 9, 2002 Sep
|
OBJECTIVE: To investigate gait outcomes with supported treadmill ambulation training (STAT) associated with regular rehabilitation in acute stroke survivors. DESIGN: Randomized controlled trial, pilot study. SETTING: Rehabilitation medicine service at a Veterans Affairs medical center. PARTICIPANTS: Seven acute stroke survivors assigned to regular intervention group and 6 patients assigned to STAT intervention. INTERVENTIONS: Regular intervention consisted of 3 hours daily of physical therapy, kinesiotherapy, and occupational therapy. STAT group received regular rehabilitation with STAT substituted for usual gait training. Participants were tested at baseline, treated for an average of 3 weeks, and retested on discharge. The analysis of covariance procedure was used to test for differences between the 2 approaches. MAIN OUTCOME MEASURES: Functional Ambulation Category Scale, gait speed, walking distance, gait energy expenditure, and gait energy cost. RESULTS: The small sample size did not generate enough power to detect significant differences in any variable. However, medium to large effect sizes of 0.7 and 1.16 standard deviation units were observed for gait energy cost and walk distance, respectively. CONCLUSIONS: This pilot study indicated that STAT is a safe, feasible, and promising intervention for acute stroke survivors. A larger trial is warranted for statistical relevance.
|
https://pubmed.ncbi.nlm.nih.gov/12235606/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't",
"Research Support, U.S. Gov't, Non-P.H.S."
] |
12235606
|
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] |
12,235,613 |
Systematic review for the early prediction of motor and functional outcome after stroke by using motor-evoked potentials.
|
Hendricks Henk T HT, Zwarts Machiel J MJ, Plat Erik F EF, van Limbeek Jacques J
|
Archives of physical medicine and rehabilitation . Vol. 83, No. 9, 2002 Sep
|
OBJECTIVE: To clarify the prognostic value of motor-evoked potentials (MEPs) in predicting motor and functional outcomes after acute stroke. DATA SOURCES: A computer-aided search to identify original prognostic studies published from 1988 through 2000; relevant references cited in the retrieved articles were also included. STUDY SELECTION: A preliminary screening selected studies in which transcranial magnetic stimulation was assessed as a prognostic determinant for outcome at the level of impairments (motor recovery) and disabilities (functional recovery). The studies were then subjected to a critical review according to a priori methodologic criteria. DATA EXTRACTION: Data from the studies were used to construct contingency tables with MEPs as a prognostic determinant. The distribution of cells was statistically assessed with the Fisher exact test. The prognostic test properties were expressed as sensitivity and specificity. The clinical significance was determined by odds ratios. DATA SYNTHESIS: Of 85 potentially relevant studies, 20 met the criteria for the preliminary screening; after the critical review, 5 studies were included for analysis and discussion. CONCLUSIONS: Analysis of the data from the 5 studies indicated obvious evidence for the prognostic value of MEPs for both motor and functional recovery. The prognostic test properties for subgroups of patients could be established. In predicting motor recovery of the upper extremity, the specificity was consistently very high for subgroups of patients with paralysis or severe paresis; this test property might be used in clinical practice. We discuss the prognostic value of MEPs and offer suggestions for further research.
|
https://pubmed.ncbi.nlm.nih.gov/12235613/
|
[
"Journal Article",
"Review",
"Systematic Review"
] |
12235613
|
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] |
12,235,650 |
A randomized study of nutritional support in patients with colorectal and gastric cancer.
|
Persson Christina R CR, Johansson Birgitta B K BB, Sjöden Per-Olow PO, Glimelius Bengt L G BL
|
Nutrition and cancer . Vol. 42, No. 1, 2002
|
Involuntary weight loss is often seen among patients with gastrointestinal (GI) cancer. Weight loss may influence quality of life (QoL) and is a predictor of survival. The present study is an attempt to improve body weight development in GI cancer patients by individual support (IS), including nutritional measures. Patients were randomized in a 2 x 2 design between 1) IS, including nutritional support, 2) group rehabilitation (GR), 3) IS + GR (ISGR), or 4) standard care (SC). Data concerning dietary intake (24-h recalls), body weight, and QoL (EORTC-QLQ C-30) were collected over 2 yr for 67 patients with colorectal or gastric cancer, randomized to IS or ISGR. Data on weight and QoL were collected for 70 patients with the same diagnoses randomized to GR or SC. Despite a tendency to greater weight loss at inclusion, the IS + ISGR group managed to gain weight significantly more rapidly and to a greater extent than the GR + SC group. The differences became statistically significant at 12 and 24 mo (P < 0.05). Patients with weight loss at baseline increased their energy intake and weight more than those without weight loss. No differences were seen in QoL ratings between randomization groups, but there was a positive correlation between weight development and QoL and a negative correlation between fatigue and weight development. There was a numerical difference, not statistically significant (P = 0.3), indicating a shorter time of survival in patients in the GR + SC group. IS, including nutritional support, leads to more rapid weight gain than SC in patients with newly diagnosed GI cancer.
|
https://pubmed.ncbi.nlm.nih.gov/12235650/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't"
] |
12235650
|
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] |
12,235,653 |
Effect of vegetables, tea, and soy on endogenous N-nitrosation, fecal ammonia, and fecal water genotoxicity during a high red meat diet in humans.
|
Hughes Roisin R, Pollock Jim R A JR, Bingham Sheila S
|
Nutrition and cancer . Vol. 42, No. 1, 2002
|
Red meat increases colonic N-nitrosation, and this may explain the positive epidemiological relationship between red meat intake and colorectal cancer risk. Vegetables, tea, and soy have been shown to block N-nitroso compound (NOC) formation and are associated with protection against colorectal cancer. To determine whether these supplements affect fecal NOC excretion during consumption of a high red meat (420 g/day) diet, 11 male volunteers were studied over a randomized series of 15-day dietary periods. Seven of these subjects completed a further dietary period to test the effects of soy (100 g/day). Soy significantly suppressed fecal apparent total NOC (ATNC) concentration (P = 0.02), but supplements of vegetables (400 g/day as 134 g broccoli, 134 g brussels sprouts, and 134 g petits pois) and tea extract (3 g/day) did not affect mean levels of fecal ATNC, nitrogen and ammonia excretion, and fecal water genotoxicity. However, fecal weight was increased (P < 0.001) and associated with reduced transit time (r = 0.594, P < 0.0001), so that contact between ATNC, nitrite, and ammonia and the large bowel mucosa would have been reduced. Longer transit times were associated with elevated fecal ATNC concentrations (r = 0.42, P = 0.002). Fecal nitrite was significantly suppressed during the tea supplement compared with the meat-only (P = 0.0028) and meat + vegetables diets (P = 0.005 for microgram NO2/g).
|
https://pubmed.ncbi.nlm.nih.gov/12235653/
|
[
"Clinical Trial",
"Controlled Clinical Trial",
"Journal Article",
"Research Support, Non-U.S. Gov't"
] |
12235653
|
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] |
12,235,719 |
Echocardiographic screening for congenital heart disease: a randomized study.
|
Sands Andrew A, Craig Brian B, Mulholland Connor C, Patterson Christopher C, Dornan James J, Casey Frank F
|
Journal of perinatal medicine . Vol. 30, No. 4, 2002
|
OBJECTIVES: To assess the effectiveness and potential cost of an echocardiographic screening program for congenital heart disease (CHD). PATIENTS AND METHODS: Between 01/11/94 and 28/02/98 there were 9697 deliveries in The Royal Maternity Hospital Belfast. Mothers were randomized before delivery. 4875 infants were allocated to the scan group, while 4822 were assigned to clinical assessment alone. High-risk infants were considered separately. Cases of CHD detected before hospital discharge were documented. The annual cost of screening was estimated and the time to accurate diagnosis in each group was assessed. RESULTS: During the study 124 scan allocated infants and 50 controls were identified as having significant CHD before hospital discharge. With a minimum of 3 years follow-up there were 27 additional late diagnoses in controls and 1 in scanned infants. During a single year of the study the mean time to complete diagnosis was 2 days for scanned cases and 110 in controls. The projected cost of screening for all infants was 22 Pounds/infant for the first year. CONCLUSIONS: Adding echocardiography to clinical examination greatly enhances early detection of CHD. Although screening is expensive, once established it may reduce the cost of unnecessary outpatient referrals.
|
https://pubmed.ncbi.nlm.nih.gov/12235719/
|
[
"Clinical Trial",
"Comparative Study",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't"
] |
12235719
|
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] |
12,235,921 |
Pharmacokinetics of rosiglitazone in patients with end-stage renal disease.
|
Thompson-Culkin K K, Zussman B B, Miller A K AK, Freed M I MI
|
The Journal of international medical research . Vol. 30, No. 4
|
The pharmacokinetics and tolerability of a single 8-mg oral dose of rosiglitazone, an anti-diabetic agent, were compared in 10 long-term haemodialysis patients and 10 healthy volunteers. Haemodialysis patients received rosiglitazone 4 h after haemodialysis (non-dialysis day) and 3 h before haemodialysis (dialysis day). Haemodialysis did not influence rosiglitazone pharmacokinetics, and dialytic clearance was low (0.10 1/h). The mean area under the concentration-time curve (AUC(0-infinity)), the maximum observed plasma concentration (Cmax) and the half-life for rosiglitazone were similar in haemodialysis patients (non-dialysis day) and healthy individuals (2192 +/- 598 ng.h/ml versus 2388 +/- 494 ng.h/ml, 338 +/- 114 ng/ml versus 373 +/- 95 ng/ml, and 3.70 +/- 0.75 h versus 3.81 +/- 0.86 h, respectively). AUC(0-infinity) and Cmax were not markedly influenced by haemodialysis. Rosiglitazone dose adjustments are not warranted in patients with type 2 diabetes with end-stage renal failure on haemodialysis.
|
https://pubmed.ncbi.nlm.nih.gov/12235921/
|
[
"Clinical Trial",
"Comparative Study",
"Journal Article"
] |
12235921
|
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] |
12,235,919 |
The role of triple therapy, age, gender and smoking on the genotoxic effects of Helicobacter pylori infection.
|
Gulten T T, Tokyay N N, Demiray M M, Gulten M M, Ercan I I, Evke E E, Sardas S S, Karakaya A E AE
|
The Journal of international medical research . Vol. 30, No. 4
|
The role of age, gender and smoking on both the genotoxic effects of Helicobacter pylori and the efficacy of eradication therapy in a group of patients with gastritis was investigated. Gastritis was confirmed by endoscopy and biopsy, and the presence of H. pylori by urease testing. Pre- and post-treatment peripheral blood lymphocyte cultures were prepared from 17 patients and 25 metaphases per patients were analysed for sister chromatid exchange (SCE), a well-established technique for the evaluation of human exposure to toxic agents. Treatment with omeprazole, clarithromycin and amoxycillin triple therapy eradicated H. pylori in 94% of patients and significantly reduced the SCE frequency. Pre-treatment SCE frequency was found to be positively correlated with age. Female smokers tended to have higher post-treatment SCE frequencies than male smokers, and pre- and post-treatment SCE frequencies were higher in older males than in older females. Eradication therapy decreased the genotoxicity of H. pylori, but age in males and smoking in females may decrease treatment efficacy.
|
https://pubmed.ncbi.nlm.nih.gov/12235919/
|
[
"Clinical Trial",
"Journal Article"
] |
12235919
|
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] |
12,235,926 |
The effect of the herbal medicine dai-kenchu-to on post-operative ileus.
|
Itoh T T, Yamakawa J J, Mai M M, Yamaguchi N N, Kanda T T
|
The Journal of international medical research . Vol. 30, No. 4
|
Post-operative ileus (PI) is an inevitable adverse consequence of abdominal surgical procedures. We performed a randomized study of the effects of the herbal medicine dai-kenchu-to (DKT) on 24 patients with PI. Patients received either 15 g of oral DKT or placebo daily for 14 days. The effects on upper gastrointestinal motility, frequency of secondary operation and recurrence of PI were investigated. The frequency of surgical operation was significantly lower in patients receiving DKT compared with placebo. Oral administration of DKT was clinically effective for PI in reducing both the need for further surgery and the recurrence of PI.
|
https://pubmed.ncbi.nlm.nih.gov/12235926/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't"
] |
12235926
|
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] |
12,236,023 |
The efficacy and safety of a coumarin-/troxerutin-combination (SB-LOT) in patients with chronic venous insufficiency: a double blind placebo-controlled randomised study.
|
Vanscheidt W W, Rabe E E, Naser-Hijazi B B, Ramelet A A AA, Partsch H H, Diehm C C, Schultz-Ehrenburg U U, Spengel F F, Wirsching M M, Götz V V, Schnitker J J, Henneicke-von Zepelin H H HH
|
VASA. Zeitschrift fur Gefasskrankheiten . Vol. 31, No. 3, 2002 Aug
|
BACKGROUND: The objective was to evaluate the oedema-protective effect of a vasoactive drug (coumarin/troxerutin [SB-LOT]) plus compression stockings in patients suffering from chronic venous insufficiency after decongestion of the legs as recommended by the new guidelines. PATIENTS AND METHODS: 231 patients were randomly assigned medical compression stockings plus SB-LOT (90 mg coumarin and 540 mg troxerutin per day) or medical compression stockings plus placebo for the first 4 weeks and SB-LOT or placebo for the second 12 weeks of the study. The primary efficacy endpoint was the lower leg volume measured by well-established water plethysmometry. RESULTS: 226 patients were evaluated. After ceasing compression stockings, an edema protective effect was detected in the SB-LOT-group but not in the controls. Recurrence of leg volume increase was by 6.5 +/- 12.1 ml and by 36.7 +/- 12.1 ml in the SB-LOT and placebo group, respectively (p = 0.0402). The local complaint score and general aspects of quality of life were also superior for the SB-LOT-group (p = 0.0041). Significant differences were also observed with regard to clinical global impression and therapeutic effect. No serious adverse drug reaction or clinically relevant impairment of laboratory parameters occur. CONCLUSION: This study confirms the oedema-protective effect of SB-LOT in chronic venous insufficiency and provides a treatment option for patients who discontinue compression after a short time.
|
https://pubmed.ncbi.nlm.nih.gov/12236023/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't"
] |
12236023
|
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] |
12,236,025 |
Noninvasive tests for risk stratification in major vascular surgery.
|
Mondillo S S, Ballo P P, Agricola E E, Guerrini F F, Barbati R R, Ammaturo T T, Bertelli P P, Neri E E, Sassi C C
|
VASA. Zeitschrift fur Gefasskrankheiten . Vol. 31, No. 3, 2002 Aug
|
BACKGROUND: The predictive values of noninvasive tests versus perioperative cardiac events in patients undergoing major vascular surgery has not been definitively established. PATIENTS AND METHODS: According to clinical markers and left ventricular function at rest, 188 patients were assigned to the following groups: 40 low, 115 moderate and 33 high risk. They were then randomly submitted to dipyridamole (n = 64), dobutamine (n = 63) stress echocardiography and dipyridamole perfusion scintigraphy (n = 61). RESULTS: No events were observed in low-risk patients, whereas 12 (10.4%) and 8 (24%) events in moderate- and high-risk categories occurred, respectively. Only the high-risk category, as a predictive variable, was significantly related to the onset of cardiac complications (p < 0.05). A positive dipyridamole/dobutamine stress test was related to cardiac events, but multivariate analysis showed that only severity and extent of ischemia were the best predictors of events (p < 0.01 for dipyridamole and p < 0.005 for dobutamine). The presence of reversible, but not fixed, perfusion defects at scintigraphy was significantly related to perioperative events; at multivariate analysis, only > 3 reversible perfusion defects represented a strong predictor of events (p < 0.05). CONCLUSIONS: Among subjects undergoing major vascular surgery, severity and extent of ischemia during dipyridamole/dobutamine stress echocardiography and presence of > 3 reversible perfusion defects are strong predictors of cardiac events, particularly in moderate-risk category of patients.
|
https://pubmed.ncbi.nlm.nih.gov/12236025/
|
[
"Clinical Trial",
"Comparative Study",
"Evaluation Study",
"Journal Article",
"Randomized Controlled Trial"
] |
12236025
|
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] |
12,236,071 |
Ethyl cellulose and polyethylene glycol-based sustained-release sparfloxacin chip: an alternative therapy for advanced periodontitis.
|
Parthasarathy V V, Manavalan R R, Mythili R R, Siby Chennankara T CT, Jeya M M
|
Drug development and industrial pharmacy . Vol. 28, No. 7, 2002 Aug
|
This study reports the development of a sustained-release system of sparfloxacin for use in the treatment of periodontal disease. A sustained-release sparfloxacin device was formulated, based on ethyl cellulose (EC) 10 cps, polyethylene glycol (PEG) 4000, and diethyl phthalate (DEPh). It will hereafter be called the sparfloxacin chip (SRS chip). The chip has dimensions of 10 mm length, 2 mm width, and 0.5 mm thickness. The in vitro drug release pattern and clinical evaluation of the formulations were studied. Reports of the short-term clinical study show that the use of the SRS chip may cause complete eradication of the pathogenic bacteria in the periodontal pockets of patients who have chronic generalized periodontitis. In this clinical study, the baseline and follow-up measurements of various clinical indices, such as oral hygiene index(es), plaque index, sulcular depth component of periodontal disease index, gingival crevicular fluid flow measurement, and dark field microscopic examinations of oral pathogens in plaque samples were studied. Significant improvements were observed in many parameters of the treatment group compared with the placebo group.
|
https://pubmed.ncbi.nlm.nih.gov/12236071/
|
[
"Clinical Trial",
"Controlled Clinical Trial",
"Journal Article"
] |
12236071
|
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] |
12,236,201 |
Proposed diagnostic criteria and nosology of acute transverse myelitis.
|
Neurology . Vol. 59, No. 4, 2002 Aug 27
|
Acute transverse myelitis (ATM) is a focal inflammatory disorder of the spinal cord, resulting in motor, sensory, and autonomic dysfunction. A set of uniform diagnostic criteria and nosology for ATM is proposed to avoid the confusion that inevitably results when investigators use differing criteria. This will ensure a common language of classification, reduce diagnostic confusion, and lay the groundwork necessary for multicenter clinical trials. In addition, a framework is suggested for evaluation of individuals presenting with signs and symptoms of ATM. Best treatment often depends on a timely and accurate diagnosis. Because acute transverse myelopathies are relatively rare, delayed and incomplete work-ups often occur. Rapid and precise diagnosis will ensure not only that compressive lesions are detected and treated but also that idiopathic ATM is distinguished from ATM secondary to a known underlying disease. Identification of etiologies may suggest medical treatment, whereas no clearly established medical treatment currently exists for idiopathic ATM. Establishment of a diagnostic algorithm will likely lead to improved care, although it is recognized that the entire evaluation may not be performed for each patient.
|
https://pubmed.ncbi.nlm.nih.gov/12236201/
|
[
"Guideline",
"Journal Article",
"Practice Guideline",
"Review"
] |
12236201
|
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] |
|
12,236,273 |
Boosting uptake of influenza immunisation: a randomised controlled trial of telephone appointing in general practice.
|
Hull Sally S, Hagdrup Nicola N, Hart Ben B, Griffiths Chris C, Hennessy Enid E
|
The British journal of general practice : the journal of the Royal College of General Practitioners . Vol. 52, No. 482, 2002 Sep
|
BACKGROUND: Immunisation against influenza is an effective intervention that reduces serologically confirmed cases by between 60% and 70%. Almost all influenza immunisation in the UK is done within general practice. Current evidence on the effectiveness of patient reminders for all types of immunisation programmes is largely based on North American studies. AIM: To determine whether telephone appointments offered bygeneral practice receptionists increase the uptake of irfluenza immunisation among the registered population aged over 65 years in east London practices. DESIGN OF STUDY: Randomised controlled trial. SETTING: Three research general practices within the East London and Essex network of researchers (ELENoR). METHOD: Participants were 1,820 low-risk patients aged 65 to 74 years who had not previously been in a recall system for influenza immunisation at their general practice. The intervention, during October 2000, was a telephone call from the practice receptionist to intervention group households, offering an appointment for influenza immunisation at a nurse-run. clinic Main outcome measures were the numbers of individuals in each group receiving immunisation, and practice costs of a telephone-appointing programme. RESULTS: intention to treat analysis showed an immunisation rate in the control group of 44%, compared with 50% in the intervention group (odds ratio = 1.29, 95% confidence interval = 1.03 to 1.63). Of the patients making a telephone appointment, 88% recieved immunisation, while 22% of those not wanting an appointment went on to be immunised. In the controlgroup, income generated was 11.35 pounds per immunisation, for each additional immunisation in the intervention group the income was 5.20 pounds. The 'number needed to telephone' was 17. CONCLUSION: Uptake of influenza immunisation among the low-risk older population in inner-city areas can be boosted by around 6% using a simple intervention by receptionists. Immunisation rates in this low-risk group fell well short of the 60% government target. Improving immunisation rates will require a sustained public health campaign. Retaining the item-of-service payments to practices should support costs of practice-based interventions.
|
https://pubmed.ncbi.nlm.nih.gov/12236273/
|
[
"Clinical Trial",
"Journal Article",
"Multicenter Study",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't"
] |
12236273
|
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] |
12,236,274 |
Improving uptake of influenza vaccination among older people: a randomised controlled trial.
|
Arthur Antony J AJ, Matthews Ruth J RJ, Jagger Carol C, Clarke Michael M, Hipkin Alison A, Bennison Dean P DP
|
The British journal of general practice : the journal of the Royal College of General Practitioners . Vol. 52, No. 482, 2002 Sep
|
BACKGROUND: The uptake of influenza vaccination among older people is suboptimal. Contact with a doctor or nurse is associated with older people deciding to accept influenza vaccination. AIM: To compare different forms of approach in improving uptake of influenza vaccination among patients aged 75 years and over in primary care. DESIGN OF STUDY: Randomised controlled trial. SETTING: One large rural general practice serving the town and surrounding area of Melton Mowbray, Leicestershire. METHOD: All 2,052 patients aged 75 years and over, registered with the practice and not living in nursing/residential homes or sheltered accommodation, were included in the study. One-third of patients were randomised to receive an offer of influenza vaccination as part of an over-75 health check administered by a practice nurse in the patient's home, and two-thirds of patients were randomised to receive a personal letter of invitation to attend an influenza vaccination clinic held at the surgery. The main outcome measure was uptake of influenza vaccination. RESULTS: Six hundred and eighty patients were randomised to the health check arm of the trial and 1,372 were randomised to receive a personal letter. Of those randomised to the health check arm, 468 received the health check from the nurse. Overall, the difference in influenza vaccination uptake was 6.4% (95% confidence interval [CI] = 2.2% to 10.4%) with 67.9% (n = 932) of those who were sent a personal letter actually receiving the vaccine, compared with 74.3% (n = 505) of those offered a combined health check and influenza vaccination (P = 0.003). CONCLUSION: Combining home-based over- 75 health checks with influenza vaccination can improve uptake among older patients. However this intervention is likely to be costly and its effect on influenza vaccination rates is modest. The difference in uptake is greater among those who do not routinely comeforwardfor vaccination and a more viable option may be to target these patients.
|
https://pubmed.ncbi.nlm.nih.gov/12236274/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't"
] |
12236274
|
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] |
12,236,276 |
Randomised controlled trial of nitrofurantoin versus placebo in the treatment of uncomplicated urinary tract infection in adult women.
|
Christiaens T C M TC, De Meyere M M, Verschraegen G G, Peersman W W, Heytens S S, De Maeseneer J M JM
|
The British journal of general practice : the journal of the Royal College of General Practitioners . Vol. 52, No. 482, 2002 Sep
|
BACKGROUND: Urinary tract infections (UTIs) are very common and have been treated with apparent success with antimicrobials for many years. However, there is a paucity of placebo-controlled clinical trials. AIM: To measure the symptomatic and bacteriological short-term effect of nitrofurantoin treatment versus placebo, in the treatment of uncomplicated UTI in adult non-pregnant women. DESIGN OF STUDY: Randomised placebo-controlled trial in general practice. SETTING: Non-pregnant women, aged between 15 and 54 years old, consulting a general practitioner for symtoms suggestive of uncomplicated lower UTI and with pyuria (positive for leucocyte esterase test). METHOD: A dipslide was inoculated in first-void midstream urine and sent for examinion. The patients were randomised to receive nitrofurantoin 100 mg or placebo four times daily for three days. After three, seven, and 14 days a new dipslide was inoculated and symptoms of UTI were checked or improvement of symptoms and bacteriuria. RESULTS: Of 166 women consulting with symptoms suggestive for UTI, 78 had pyuia and agreed to participate in the study (the clinically suspected UTI group); of these, 40 received nitrofurantoin and 38 received placebo. The result for combined symptomatic improvement and cure after three days was 27/35 in the nitrofurantoin group and 19/35 in the placebo group (c2 with Yates' correction P = 0.008; number needed to treat [NNT] = 4.4, 95% confidence interval [CI] = 2.3 to 79). After seven days, combined improvement and cure was observed in 30/34 and 17/33 respectively (P = 0.003, NNT = 2.7, 95% CI = 1.8 to 6.0). At inclusion, 56 women had bacteriuria of > or = 10(5) CFU/ml (the bacteriologically proven UTI group). Of these, 29 received nitrofurantoin and 27 received placebo. After three days the bacteriological cure was 21/26 in the treatment group, compared with 5/25 in the placebo group (P < 0.001; NNT = 1.6, 95% CI= 1.2 to 2.6). After seven days the bacteriological cure rate was 17/23 in the intervention group and 9/22 in the placebo group (P = 0.05, NNT = 3, 95% CI = 1.7 to 17). CONCLUSION: In women with bacteriologically proven UTI, nitrofurantoin was significantly more effective than placebo in achieving bacteriological cure and symptomatic relief in just three days; this was still present after seven days. In patients with clinically suspected UTI the symptomatic effect was statistically significant after
|
https://pubmed.ncbi.nlm.nih.gov/12236276/
|
[
"Clinical Trial",
"Journal Article",
"Multicenter Study",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't"
] |
12236276
|
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] |
12,236,277 |
Cluster randomised controlled trial of an educational outreach visit to improve influenza and pneumococcal immunisation rates in primary care.
|
Siriwardena A Niroshan AN, Rashid Aly A, Johnson Mark R D MR, Dewey Michael E ME
|
The British journal of general practice : the journal of the Royal College of General Practitioners . Vol. 52, No. 482, 2002 Sep
|
BACKGROUND: Improvement in the delivery of influenza and pneumococcal vaccinations to high-risk groups is an important aspect of preventive care for primary healthcare teams. AIM: To investigate the effect of an educational outreach visit to primary healthcare teams on influenza and pneumococcal vaccination uptake in high-risk patients. DESIGN: Cluster randomised controlled trial. SETTING: Thirty general practices in the Trent region, UK. METHODS: Fifteen practices were randomised to intervention and 15 to the control group after stratifying for baseline vaccination rate. All intervention practices were offered and received an educational outreach visit to primary healthcare teams, in addition to audit and feedback directed at improving influenza and pneumococcal vaccination rates in high-risk groups. Control practices received audit and feedback alone. All practices measured influenza and pneumococcal vaccination rates in high-risk groups. Primary outcomes were improvements in vaccination rates in patients aged 65 years and over, and patients with coronary heart disease (CHD), diabetes and a history of splenectomy. RESULTS: Improvements in pneumococcal vaccination rates in the intervention practices were significantly greater compared with controls in patients with CHD, 14.8% versus 6.5% (odds ratio [OR] = 1.23, 95% confidence interval [CI] = 1.13 to 1.34) and diabetes, 15.5% versus 6.8% (OR = 1.18, 95% CI = 1.08 to 1.29) but not splenectomy, 6.5% versus 4.7% (OR = 0.96, 95% CI = 0.65 to 1.42). Improvements for influenza vaccination were also usually greater in intervention practices but did not reach statistical significance. The increases for influenza vaccination in intervention versus control practices were for CHD, 18.1% versus 13.1% (OR = 1.06, 95% CI = 0.99 to 1.12); diabetes, 15.5% versus 12.0% (OR = 1.07, 95% CI = 0.99 to 1.16), splenectomy 16.1% versus 2.9% (OR = 1.22, 95% CI = 0.78 to 1.93); and those over 65 years 20.7% versus 25.4% (OR = 0.99, 95% CI = 0.96 to 1.02). CONCLUSION: Practices where primary care teams received an educational outreach visit demonstrated a significantly greater improvement in uptake in high-risk groups for pneumococcal but not influenza vaccine.
|
https://pubmed.ncbi.nlm.nih.gov/12236277/
|
[
"Clinical Trial",
"Journal Article",
"Multicenter Study",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't"
] |
12236277
|
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] |
12,236,311 |
The quality of apical canal preparation using hand and rotary instruments with specific criteria for enlargement based on initial apical file size.
|
Tan Boon Tik BT, Messer Harold H HH
|
Journal of endodontics . Vol. 28, No. 9, 2002 Sep
|
The aim of this study was to compare the quality of apical enlargement of mesiobuccal canals of mandibular molars using conventional stainless steel hand files (K files) and nickel-titanium (Ni-Ti) rotary instruments (LightSpeed). Thirty freshly extracted mandibular molars were randomly assigned to three equal groups (n = 10 each group). The mesiobuccal canals were instrumented with K file using step-back technique without coronal flaring (control; group 1), K file using step-back technique after coronal flaring (group 2), and LightSpeed instrumentation (group 3). Specific criteria for apical enlargement based on initial apical size were used. For step-back techniques, the master apical file sizes were based on the Grossman criterion of three sizes larger than the first file that bound at working length, without coronal flaring (group 1) and with flaring (group 2). For the LightSpeed (LS) group, the master apical rotary sizes were based on the manufacturer's recommendation. Canal cleanliness, canal transportation, and final canal shapes were determined histologically at 1-mm and 3-mm levels short of the working length. Canals were prepared to significantly larger sizes using LS instrumentation than with either hand instrumentation techniques (15-17 ISO units, p < 0.001). LS instrumentation allowed greater apical enlargement with significantly cleaner canals, less apical transportation, and better canal shape than both hand instrumentation groups at both levels (p < 0.05). None of the three techniques was totally effective in cleaning the apical canal space. It was concluded that greater apical enlargement using LS rotary instruments is beneficial as an attempt to further debride the apical third region in mesiobuccal canals of mandibular molars. Instrument designs, alloy properties, and canal curvature are important factors that determine the feasibility of greater apical enlargement in narrow canals.
|
https://pubmed.ncbi.nlm.nih.gov/12236311/
|
[
"Clinical Trial",
"Comparative Study",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't"
] |
12236311
|
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12,236,319 |
Prognosis of hypercholesterolemic patients taking pravastatin for five years: the Chiba Lipid Intervention Program (CLIP) Study.
|
Saito Yasushi Y, Shirai Kohji K, Sasaki Norihiro N, Shinomiya Masaki M, Yoshida Sho S,
|
Journal of atherosclerosis and thrombosis . Vol. 9, No. 2, 2002
|
The Chiba Lipid Intervention Program (CLIP) Study was designed to clarify the prognosis of Japanese hypercholesterolemic patients taking pravastatin for 5 years. Hypercholesterolemic patients (n = 2,529) with a total cholesterol level > or = 220 mg/dl and without histories of ischemic coronary heart disease and/or cerebral infarction were administered pravastatin (10-20 mg/day). Among them, 2,131 took pravastatin fully (Pravastatin-continued group), and 398 discontinued the treatment (Discontinued group). The baseline total cholesterol level was 264.3 +/- 34.7 mg/dl (mean +/- standard deviation). The mean reduction rates of total cholesterol and low-density lipoprotein (LDL) cholesterol were 18.0% and 27.2%, respectively. Mild and moderate adverse events occurred in 86 cases (3.6%). Serious adverse events were not observed. Death rates of the pravastatin-continued group and of the discontinued group were 2.6 and 16.0/1,000 persons/year, respectively. Cardiac events (fatal and nonfatal myocardial infarction, cardiac death, angina pectoris) in all, occurred in 35 patients (incidence rate = 2.77/1,000 persons/year). In the pravastatin continued group, 9 causes of fatal and nonfatal myocardial infarction occurred (0.84/1,000 persons/year), whereas in the discontinued group, 4 cases occurred (2.06/1,000 persons/ year). The risk ratio for cardiac events was correlated with the number of risks. In the low-risk group (< or = 1 risk), decreased rates of LDL-cholesterol were less in the cardiac event group than the non-cardiac event group (LDL-cholesterol; 16% vs 25%, p = 0.04). These results suggested the following; 1) Pravastatin maintained a cholesterol lowering effect long-term without serious complications. 2) Pravastatin administration might reduce the mortality rate and myocardial infarction. 3) The combination of multiple risks is a strong factor for a cardiac event in addition to hypercholesterolemia.
|
https://pubmed.ncbi.nlm.nih.gov/12236319/
|
[
"Clinical Trial",
"Journal Article"
] |
12236319
|
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] |
12,236,321 |
Guidelines for mechanical lung function measurements in psychophysiology.
|
Ritz Thomas T, Dahme Bernhard B, Dubois Arthur B AB, Folgering Hans H, Fritz Gregory K GK, Harver Andrew A, Kotses Harry H, Lehrer Paul M PM, Ring Christopher C, Steptoe Andrew A, Van de Woestijne Karel P KP
|
Psychophysiology . Vol. 39, No. 5, 2002 Sep
|
Studies in psychophysiology and behavioral medicine have uncovered associations among psychological processes, behavior, and lung function. However, methodological issues specific to the measurement of mechanical lung function have rarely been discussed. This report presents an overview of the physiology, techniques, and experimental methods of mechanical lung function measurements relevant to this research context. Techniques to measure lung volumes, airflow, airway resistance, respiratory resistance, and airflow perception are introduced and discussed. Confounding factors such as ventilation, medication, environmental factors, physical activity, and instructional and experimenter effects are outlined, and issues specific to children and clinical groups are discussed. Recommendations are presented to increase the degree of standardization in the research application and publication of mechanical lung function measurements in psychophysiology.
|
https://pubmed.ncbi.nlm.nih.gov/12236321/
|
[
"Guideline",
"Journal Article",
"Research Support, Non-U.S. Gov't",
"Review"
] |
12236321
|
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] |
12,236,322 |
Influence of fitness and gender on blood pressure responses during active or passive stress.
|
Dishman Rod K RK, Jackson Erica M EM, Nakamura Yoshio Y
|
Psychophysiology . Vol. 39, No. 5, 2002 Sep
|
We examined hemodynamic and autonomic components of blood pressure responses during active and passive stressor tasks in a sample of young, normotensive men and women who were physically active but differed on fitness (i.e., VO2peak). During the hand cold pressor, increases in systolic blood pressure were inversely related to fitness among women but not men. Regardless of gender, fitter participants had a greater increase in cardiac pace during mental arithmetic, coherent with a decreased cardiac-vagal component of heart rate variability, and a greater compensatory reduction in stroke volume. Fitness was otherwise unrelated to changes in cardiac output and vascular resistance during the stressor tasks. Our findings suggest that cardiorespiratory fitness augments the cardiac-vagal withdrawal that is characteristic of mental arithmetic. The blunted systolic blood pressure response to the hand cold pressor among fitter women suggests that cardiorespiratory fitness should be considered as a covariate in studies that examine the hand cold pressor as a predictor of future hypertension among women.
|
https://pubmed.ncbi.nlm.nih.gov/12236322/
|
[
"Clinical Trial",
"Comparative Study",
"Journal Article"
] |
12236322
|
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] |
12,236,323 |
Hypersensitivity to acoustic change in children with autism: electrophysiological evidence of left frontal cortex dysfunctioning.
|
Gomot Marie M, Giard Marie-Hélène MH, Adrien Jean-Louis JL, Barthelemy Catherine C, Bruneau Nicole N
|
Psychophysiology . Vol. 39, No. 5, 2002 Sep
|
Exaggerated reactions to even small changes in the environment and abnormal behaviors in response to auditory stimuli are frequently observed in children with autism (CWA). Brain mechanisms involved in the automatic detection of auditory frequency change were studied using scalp potential and scalp current density (SCD) mapping of mismatch negativity (MMN) in 15 CWA matched with 15 healthy children. Compared with the response in controls, MMN recorded at the Fz site in CWA showed significantly shorter latency and was followed by a P3a wave. Mapping of potentials indicated significant intergroup differences. Moreover, SCD mapping demonstrated the dynamics of the different MMN generators: Although temporal component was evidenced bilaterally in both groups, it occurred earlier on the left hemisphere in CWA, preceded by an abnormal early left frontal component. The electrophysiological pattern reported here emphasized a left frontal cortex dysfunctioning that might also be implicated in cognitive and behavioral impairment characteristic, of this complex neurodevelopmental disorder.
|
https://pubmed.ncbi.nlm.nih.gov/12236323/
|
[
"Clinical Trial",
"Journal Article",
"Research Support, Non-U.S. Gov't"
] |
12236323
|
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] |
12,236,324 |
Shifting hemodynamics of blood pressure control during prolonged mental stress.
|
Ring Christopher C, Burns Victoria E VE, Carroll Douglas D
|
Psychophysiology . Vol. 39, No. 5, 2002 Sep
|
The present study examined the hemodynamics underlying blood pressure elevations for evidence of a shift in the control of blood pressure during prolonged mental stress. Mean arterial pressure (MAP), cardiac output (CO), and total peripheral resistance (TPR) were measured at rest, during a 28-min mental arithmetic stress task, and during recovery, in 30 young healthy men and women. The stress task elicited a sustained increase in MAP: CO rose during the first half of the task but returned to baseline levels during the last quarter of the task, whereas TPR increased as the task progressed. When participants' hemodynamic reactions were classified as cardiac, vascular, or neither, there were more cardiac reactors early relative to late in the task, whereas there were more vascular reactors late relative to early. Thus, the sustained pressor response was initially supported mainly by cardiac mechanisms but subsequently by predominantly vascular mechanisms.
|
https://pubmed.ncbi.nlm.nih.gov/12236324/
|
[
"Clinical Trial",
"Journal Article"
] |
12236324
|
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] |
12,236,325 |
Influence of control and physical effort on cardiovascular reactivity to a video game task.
|
Weinstein Suzanne E SE, Quigley Karen S KS, Mordkoff J Toby JT
|
Psychophysiology . Vol. 39, No. 5, 2002 Sep
|
This study investigated the influences of both perceived control and physical effort on cardiovascular reactivity. Undergraduates (N = 32) played a video game task interrupted by aversive noise. Perceived control of the noise was manipulated by instructions indicating the presence or absence of a contingency between performance and noise presentations. Physical effort was manipulated by controlling the physical force required to perform the task. There was a significant main effect of control on systolic blood pressure (SBP) and total peripheral resistance (TPR), with both increasing more during low than high control conditions. The results suggest that high perceived control over aversive noise in an effortful task reduces SBP and TPR reactivity relative to low perceived control. The results are consistent with the idea that control buffers the reactivity associated with task performance under aversive conditions.
|
https://pubmed.ncbi.nlm.nih.gov/12236325/
|
[
"Clinical Trial",
"Journal Article",
"Research Support, Non-U.S. Gov't",
"Research Support, U.S. Gov't, P.H.S."
] |
12236325
|
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] |
12,236,327 |
Tracking eye fixations with electroocular and electroencephalographic recordings.
|
Joyce Carrie A CA, Gorodnitsky Irina F IF, King Jonathan W JW, Kutas Marta M
|
Psychophysiology . Vol. 39, No. 5, 2002 Sep
|
We describe a method, based on recordings of the electroencephalogram (EEG) and eye movement potentials (electrooculogram), to track where on a screen (x,y coordinates) an individual is fixating. The method makes use of an empirically derived beam-forming filter (derived from a sequence of calibrated eye movements) to isolate eye motion from other electrophysiological and ambient electrical signals. Electrophysiological researchers may find this method a simple and inexpensive means of tracking eye movements and a useful complement to scalp recordings in studies of cognitive phenomena. The resolution is comparable to that of many commercial systems; the method can be implemented with as few as four electrodes around the eyes to complement the EEG electrodes already in use. This method may also find some specialized applications such as studying eye movements during sleep and in human-machine interfaces that make use of gaze information.
|
https://pubmed.ncbi.nlm.nih.gov/12236327/
|
[
"Clinical Trial",
"Journal Article",
"Research Support, Non-U.S. Gov't",
"Research Support, U.S. Gov't, Non-P.H.S.",
"Research Support, U.S. Gov't, P.H.S."
] |
12236327
|
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] |
12,236,329 |
Effects of perceptual context on event-related brain potentials during auditory spatial attention.
|
Arnott Stephen R SR, Alain Claude C
|
Psychophysiology . Vol. 39, No. 5, 2002 Sep
|
The effects of auditory spatial attention on event-related brain potentials (ERPs) were examined in situations that promoted stream segregation. Short and long noise bursts were presented at three azimuth locations and listeners were asked to respond to the longer sounds occurring at either the right- or left-most location. In the baseline condition, the three sound sources were evenly spaced apart. In the distractor clustering conditions, middle and far sounds were clustered. In the attended clustering conditions, middle and attended sounds were clustered. ERP indices of attention, isolated as negative difference (Nd) waves, were greater over the hemisphere contralateral to the attended location. Nd waves were also larger when the middle sounds were moved toward the far distractors, consistent with an object-based gradient of auditory attention in which higher order information provided by the perceptual context influences selective processing.
|
https://pubmed.ncbi.nlm.nih.gov/12236329/
|
[
"Clinical Trial",
"Journal Article"
] |
12236329
|
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] |
12,236,331 |
Large-scale neural correlates of affective picture processing.
|
Keil Andreas A, Bradley Margaret M MM, Hauk Olaf O, Rockstroh Brigitte B, Elbert Thomas T, Lang Peter J PJ
|
Psychophysiology . Vol. 39, No. 5, 2002 Sep
|
Hemodynamic and electrophysiological studies indicate differential brain response to emotionally arousing, compared to neutral, pictures. The time course and source distribution of electrocortical potentials in response to emotional stimuli, using a high-density electrode (129-sensor) array were examined here. Event-related potentials (ERPs) were recorded while participants viewed pleasant, neutral, and unpleasant pictures. ERP voltages were examined in six time intervals, roughly corresponding to P1, N1, early P3, late P3 and a slow wave window. Differential activity was found for emotional, compared to neutral, pictures at both of the P3 intervals, as well as enhancement of later posterior positivity. Source space projection was performed using a minimum norm procedure that estimates the source currents generating the extracranially measured electrical gradient. Sources of slow wave modulation were located in occipital and posterior parietal cortex, with a right-hemispheric dominance.
|
https://pubmed.ncbi.nlm.nih.gov/12236331/
|
[
"Clinical Trial",
"Journal Article"
] |
12236331
|
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] |
12,236,332 |
The impact of reinforcement density on response differentiation in configural discrimination problems.
|
Lachnit Harald H, Lober Klaus K, Reinhard Günter G, Giurfa Martin M
|
Psychophysiology . Vol. 39, No. 5, 2002 Sep
|
Two human Pavlovian conditioning experiments investigated the impact of reinforcement density (the number of reinforced trials divided by the total number of trials) on discrimination learning. Experiment 1 used a negative patterning problem (A+, B+, AB-) and Experiment 2 used a positive patterning problem (A-, B-, AB+). In both experiments, reinforcement density varied across four levels. Response differentiation between reinforced and non-reinforced stimuli was linearly related to the decrease in reinforcement density. Responses to nonreinforced stimuli did not differ between the four groups in either experiment. In contrast to this, responses to reinforced stimuli were considerably more pronounced in conditions with lower reinforcement density. For negative patterning, this replicates and extends similar observations from other species. For positive patterning, this is a finding that has not yet been reported in other experiments. The results are in agreement with the comparator hypothesis (Miller & Matzel, 1988) and with Wagner's (1981) "standard operating procedures" (SOP) model.
|
https://pubmed.ncbi.nlm.nih.gov/12236332/
|
[
"Clinical Trial",
"Journal Article",
"Research Support, Non-U.S. Gov't"
] |
12236332
|
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] |
12,236,333 |
Effects of musical expertise on the early right anterior negativity: an event-related brain potential study.
|
Koelsch Stefan S, Schmidt Björn-Helmer BH, Kansok Julia J
|
Psychophysiology . Vol. 39, No. 5, 2002 Sep
|
Event-related brain potentials in response to harmonically inappropriate chords were compared for musical experts and novices. Similar to previous studies, these chords elicited an early right anterior negativity (ERAN). The amplitude of the ERAN was clearly larger for musical experts than for novices, presumably because experts had more specific musical expectancies than novices. Chords with a physically deviant timbre elicited a mismatch negativity that did not differentiate the groups, indicating that the larger ERAN in experts was not due to a general enhanced auditory sensitivity. The ERAN reflects fast and automatic neural mechanisms that process complex musical (music-syntactic) irregularities, and the present results indicate that these mechanisms can be modulated by expertise.
|
https://pubmed.ncbi.nlm.nih.gov/12236333/
|
[
"Clinical Trial",
"Journal Article",
"Research Support, Non-U.S. Gov't"
] |
12236333
|
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12,236,334 |
Error rate on the antisaccade task: heritability and developmental change in performance among preadolescent and late-adolescent female twin youth.
|
Malone Stephen M SM, Iacono William G WG
|
Psychophysiology . Vol. 39, No. 5, 2002 Sep
|
We examined heritability of error rate on the antisaccade task among female twin youths. This task appears to be sensitive to prefrontal functioning, providing a measure of individual differences in inhibitory control associated with genetic risk for schizophrenia. The sample consisted of 674 11-year-olds and 616 17-year-olds, comprising the two cohorts of female twins from the Minnesota Twin Family Study, a population-based investigation of substance abuse and related psychopathology. We used biometric model-fitting methods to determine the relative magnitude of genetic and environmental influences on performance. In both age cohorts, the best fitting model contained additive genes and nonshared environment. Despite substantial age-related differences in mean performance levels (effect size = .81), additive genes accounted for greater than half the variance in performance in both age cohorts. These results are consistent with the hypothesis that antisaccade error rate might serve as an endophenotype for behavior disorders reflecting frontal lobe dysfunction or problems with inhibitory control.
|
https://pubmed.ncbi.nlm.nih.gov/12236334/
|
[
"Clinical Trial",
"Journal Article",
"Research Support, U.S. Gov't, P.H.S.",
"Twin Study"
] |
12236334
|
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] |
12,236,335 |
Influence of a monetary incentive upon attentional modification of short-lead prepulse inhibition and long-lead prepulse facilitation of acoustic startle.
|
Hawk Larry W LW, Redford Joshua S JS, Baschnagel Joseph S JS
|
Psychophysiology . Vol. 39, No. 5, 2002 Sep
|
Short-lead prepulse inhibition and long-lead prepulse facilitation of startle are greater during attended than ignored prestimuli. The present work examined whether this attentional modification is influenced by monetary incentive. Participants (43 college students) were randomly assigned to receive a small performance-based monetary incentive or were instructed to try their best. The task was to judge the duration of tones of one of two pitches during a series of 48 tones. Prepulse inhibition of startle eyeblink EMG was assessed at 60, 120, and 240 ms, and prepulse facilitation was assessed at 4,500 ms following tone onset. Short-lead percent prepulse inhibition was greater during attended than ignored prestimuli only at 120 ms among paid participants. Long-lead prepulse facilitation was greater for attended than ignored tones, but this effect did not vary with incentive condition. This study demonstrates that attentional modification of short-lead prepulse inhibition is sensitive to a monetary incentive and provides a basis for further examination of motivational effects on early attentional processing.
|
https://pubmed.ncbi.nlm.nih.gov/12236335/
|
[
"Clinical Trial",
"Comparative Study",
"Journal Article",
"Randomized Controlled Trial"
] |
12236335
|
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] |
12,236,336 |
The human nociceptive flexion reflex threshold is higher during systole than diastole.
|
Edwards Louisa L, McIntyre David D, Carroll Douglas D, Ring Christopher C, Martin Una U
|
Psychophysiology . Vol. 39, No. 5, 2002 Sep
|
A baroreflex mechanism may explain hypertensive hypoalgesia. At rest, arterial baroreceptors are stimulated during the systolic upstroke of the pressure pulse wave. This study examined the effects of naturally occurring variations in baroreceptor activity during the cardiac cycle on an objective measure of pain, the nociceptive flexion reflex (NFR). Two interleaved up-down staircase procedures determined separate NFR thresholds during systole and diastole in 36 healthy, normotensive young adults. On odd-numbered trials, the sural nerve was stimulated electrocutaneously at R + 300 ms whereas on even-numbered trials, stimulation was delivered at R + 600 ms. The NFR threshold was higher at R + 300 ms than R + 600 ms. In contrast, stimulus intensity ratings did not differ between R + 300 ms and R + 600 ms. Stimulation of baroreceptors by natural increases in blood pressure during the systolic phase of the cardiac cycle was associated with dampened nociception.
|
https://pubmed.ncbi.nlm.nih.gov/12236336/
|
[
"Clinical Trial",
"Journal Article",
"Research Support, U.S. Gov't, P.H.S."
] |
12236336
|
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] |
12,236,384 |
Issues in conducting randomized controlled trials of health services research interventions in nonacademic practice settings: the case of retail pharmacies.
|
Weinberger Morris M, Murray Michael D MD, Marrero David G DG, Brewer Nancy N, Lykens Michael M, Harris Lisa E LE, Newell A Jeffrey AJ, Collins Joyce J, Tierney William M WM
|
Health services research . Vol. 37, No. 4, 2002 Aug
|
OBJECTIVE: To describe unexpected challenges and strategies to overcome them when conducting randomized controlled trials (RCT) of health services research interventions in retail pharmacies. STUDY SETTING: Thirty-six retail drug stores in Indianapolis. STUDY DESIGN: We conducted an RCT to evaluate the effectiveness of an intervention to increase pharmacists' involvement in caring for customers. We describe: (1) our RCT as originally designed, (2) unexpected challenges we faced; and (3) how we resolved those challenges. DATA COLLECTION/EXTRACTION METHODS: Randomized controlled trial. PRINCIPAL FINDINGS: Major modifications in research design were necessitated by factors such as corporate restructuring, heightened sensitivity to patient confidentiality, and difficulties altering employees' behavior. We overcame these barriers by conducting research that is consistent with corporate goals, involving appropriate corporate administrators and technical personnel early in the process, and being flexible. CONCLUSIONS: Health services researchers should conduct RCTs in a variety of non-academic practice settings to increase generalizability and better reflect the true impact of interventions. Pragmatic problems, although significant, can be successfully overcome.
|
https://pubmed.ncbi.nlm.nih.gov/12236384/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, U.S. Gov't, Non-P.H.S.",
"Research Support, U.S. Gov't, P.H.S."
] |
12236384
|
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] |
12,236,394 |
Effects of CAHPS health plan performance information on plan choices by New Jersey Medicaid beneficiaries.
|
Farley Donna O DO, Short Pamela Farley PF, Elliott Marc N MN, Kanouse David E DE, Brown Julie A JA, Hays Ron D RD
|
Health services research . Vol. 37, No. 4, 2002 Aug
|
OBJECTIVE: To assess the effects of CAHPS health plan performance information on plan choices and decision processes by New Jersey Medicaid beneficiaries. DATA SOURCES/STUDY SETTING: The study sample was a statewide sample of all new Medicaid cases that chose Medicaid health plans during April 1998. The study used state data on health maintenance organization (HMO) enrollments and survey data for a subset of these cases. STUDY DESIGN: An experimental design was used, with new Medicaid cases randomly assigned to experimental or control groups. The experimental group received a CAHPS report along with the standard enrollment materials, and the control group did not. DATA COLLECTION: The HMO enrollment data were obtained from the state in June 1998, and evaluation survey data were collected from July to October 1998. PRINCIPAL FINDINGS: No effects of CAHPS information on HMO choices were found for the total sample. Further examination revealed that only about half the Medicaid cases said they received and read the plan report and there was an HMO with dominant Medicaid market share but low CAHPS performance scores. The subset of cases who read the report and did not choose this dominant HMO chose HMOs with higher CAHPS scores, on average, than did those in an equivalent control group. CONCLUSIONS: Health plan performance information can influence plan choices by Medicaid beneficiaries, but will do so only if they actually read it. These findings suggest a need for enhancing dissemination of the information as well as further education to encourage informed choices.
|
https://pubmed.ncbi.nlm.nih.gov/12236394/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, U.S. Gov't, P.H.S."
] |
12236394
|
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12,236,412 |
Assertive community treatment in Amsterdam.
|
Dekker J J, Wijdenes W W, Koning Y A YA, Gardien R R, Hermandes-Willenborg L L, Nusselder H H
|
Community mental health journal . Vol. 38, No. 5, 2002 Oct
|
In Amsterdam in the Netherlands, in 1993, an intensive case management project was initiated. This article describes this well-known Dutch project as it was tested in a randomised clinical trial using regular outpatient and inpatient care as the control conditions. All the patients in this project are very ill and most of them suffer from schizophrenia. The new form of care has the same effect on everyday problems as regular care. The basis of this data is too narrow for the drawing of conclusions about the risk of suicide. Longer follow-up would be advisable in order to improve our understanding of this problem. There has been no drop in compulsory admissions. On the other hand, there has been a spectacular decrease in the number of bed days (a reduction of 66% in the second year of the ACT programme).
|
https://pubmed.ncbi.nlm.nih.gov/12236412/
|
[
"Clinical Trial",
"Comparative Study",
"Journal Article",
"Randomized Controlled Trial"
] |
12236412
|
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12,236,411 |
Family-responsive psychoeducation groups for families with an adult member with mental illness: pilot results.
|
Pollio David E DE, North Carol S CS, Osborne Victoria A VA
|
Community mental health journal . Vol. 38, No. 5, 2002 Oct
|
This paper documents recent pilot efforts of the Psychoeducation Responsive to Family (PERF) model, a yearlong group for families with an adult member coping with mental illness. PERF advances state-of-the-art in its: (a) application in community settings; (b) utility for families coping with all types of mental illness; (c) use of a standardized model, yet retaining a flexible curriculum responsive to family group membership concerns; and (d) recruitment from one-day family workshops of participants eager to further explore their issues. This report examines changes in these families' knowledge and mastery in a small random assignment study comparing the PERF model (n = 9) with a "usual services" (n = 10) condition. Study participants completed surveys measuring perceived mastery and knowledge at baseline and at 3, 6, and 12 months for both conditions. Families in the active PERF intervention demonstrated significant post-intervention improvements in four of five variables analyzed. For one of these items, PERF demonstrated significantly greater improvement than the usual care condition. Achievement of significant changes in these measures was examined in relation to timing of presentation of curriculum topics in the groups. Gains in perceived crisis effectiveness temporally correlated with coverage of that topic in the PERF groups, while gains in other items were instead steadily cumulative across the entire year. The encouraging results of this second pilot effort serve to substantiate the initial efforts in developing the PERF group model.
|
https://pubmed.ncbi.nlm.nih.gov/12236411/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't",
"Research Support, U.S. Gov't, P.H.S."
] |
12236411
|
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] |
12,236,426 |
The efficacy of combined zidovudine and lamivudine compared with that of combined zidovudine, lamivudine and nelfinavir in asymptomatic and early symptomatic HIV-infected children.
|
Moolasart Pikul P, Likanonsakul Sirirat S
|
The Southeast Asian journal of tropical medicine and public health . Vol. 33, No. 2, 2002 Jun
|
In this 6-month prospective study, we compared the efficacy of two treatment regimens: double-drug therapy with zidovudine (ZDV) and lamivudine (3TC) and triple-drug therapy with ZDV plus 3TC plus nelfinavir (NFV), in the treatment of asymptomatic and early symptomatic HIV-infected children. Twenty-five children were enrolled in this study and were divided into 2 groups: group A, consisting of 13 children who were given ZDV+3TC; group B, consisting of 12 children who were given ZDV+3TC+NFV. Serial determinations of weight, CD4-cell count, HIV RNA or plasma viral load (VL) and complete blood counts (CBC), liver function tests (LFT), blood urea nitrogen (BUN) tests, creatinine and serum amylase tests were performed at study entry and at 1, 3 and 6 months. The side-effects of drugs were recorded. Over the 6-month period, the median weight increase in group B (24%) was higher than in group A (2%). The median CD4-cell count increase from baseline in group B (94.5%) was better than in group A (9.4%). The reduction of VL below baseline in group B (1.2 log10; 20.8%) was also better than in group A (0.72 log10; 13.8%). However, these differences were not statistically significant (p>0.05). Both combination regimens could not completely suppress HIV RNA below detectable limits (<400 copies/ml). Both groups tolerated the regimens well; no side-effects or toxicities occurred. The efficacy levels of triple-drug therapy (ZDV+3TC+NFV) and double-drug therapy (ZDV+3TC) were not different. There were no side-effects and no deaths during the 6-month study period.
|
https://pubmed.ncbi.nlm.nih.gov/12236426/
|
[
"Clinical Trial",
"Comparative Study",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't"
] |
12236426
|
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] |
12,236,441 |
The effects of rehydration on cycling performance after exercise-induced dehydration.
|
Singh R R, Brouns F F, Kovacs E E
|
The Southeast Asian journal of tropical medicine and public health . Vol. 33, No. 2, 2002 Jun
|
The effects of 7.6% carbohydrate-electrolyte solution (CES) and placebos (P) on rehydration (R) after exercise-induced dehydration and on a subsequent time-trial (TT) of cycling performance were studied. Thirteen male subjects exercised in a thermally-controlled environment (28 degrees C, 63% RH) until 3% of their body weight was lost. After exercise, the subjects moved to a neutral environment (22 degrees C) and rested for 30 minutes prior to a 2-hour R period. During R, subjects were fed CES or P to a maximum volume of 120% of previous body mass loss at 0, 30, and 60 minutes, in bolus-doses of 50%, 40% and 30% respectively. After R, subjects performed a 1-hour TT with no further fluid intake. % R with CES was significantly higher than with P (70 +/- 3% vs 60 +/- 5%; p < 0.01). During the TT, blood glucose dropped in the CES group but not in the P group. It was found that, despite a more effective R with CES, the performance results did not differ between groups (65.1 +/- 2.2 minutes and 65.2 +/- 2.3 minutes for CES and P respectively). It is suggested that an insulin-mediated rebound effect on CHO metabolism during TT, in which no further CHO was supplied, nullified the benefits of rehydration.
|
https://pubmed.ncbi.nlm.nih.gov/12236441/
|
[
"Clinical Trial",
"Controlled Clinical Trial",
"Journal Article",
"Research Support, Non-U.S. Gov't"
] |
12236441
|
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] |
12,236,448 |
The influence of weight and starting height on lifting mechanics in lower extremity amputees.
|
Lieber Susan J SJ, Boston J Robert JR, Rudy Thomas E TE, Munin Michael C MC
|
IEEE transactions on neural systems and rehabilitation engineering : a publication of the IEEE Engineering in Medicine and Biology Society . Vol. 10, No. 2, 2002 Jun
|
This study compares the lifting mechanics of lower extremity amputees to controls and describes the influence of weight lifted and starting height on lifting style. Subjects included three individuals with transtibial amputation (TTA), two individuals with transfemoral amputation (TFA), and three able-bodied controls (CO). Amputee subjects performed six repetitions of six weights, randomly ordered, from two starting heights. TTA lifted from 30 cm and knee height, TFA from knee and thigh height, and controls from all three heights. Data were obtained from a work simulator, force plate, and a motion analysis system, with starting posture index, lateral sway index, lift duration, synchrony index, and hip moments and elbow moments as dependent measures. The results for each lifting height were analyzed using a mixed model repeated measures MANOVA to test for group and weight differences and post hoc tests were applied when appropriate. Results suggest that healthy lower extremity amputees who have had a number of years to adjust to their prosthesis and develop compensatory strategies can complete a repetitive lifting task at a performance level very similar to able-bodied controls. The most consistent group differences detected were in the timing parameters: synchrony and duration. TTA and TFA tended to lift with less synchronization of hip and knee movements than able-bodied controls and to initiate the lift with their upper bodies. In contrast, able-bodied controls tended to move their upper and lower bodies more synchronously during the lift. TTA had longer lift durations than CO. In terms of stability and moments generated, TTA lifted very similarly to controls. TFA used a different lifting style that involved higher moments and more use of the upper body, particularly for lifts of heavier weights. TFA appeared to be less stable than CO, while TTA did not appear to be less stable than CO.
|
https://pubmed.ncbi.nlm.nih.gov/12236448/
|
[
"Clinical Trial",
"Comparative Study",
"Controlled Clinical Trial",
"Journal Article",
"Research Support, U.S. Gov't, P.H.S."
] |
12236448
|
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] |
12,236,459 |
Problem drinking and the workplace: an individualized approach to prevention.
|
Anderson Britt K BK, Larimer Mary E ME
|
Psychology of addictive behaviors : journal of the Society of Psychologists in Addictive Behaviors . Vol. 16, No. 3, 2002 Sep
|
The present study evaluated the efficacy of a brief, individualized, alcohol abuse prevention program designed to reduce problem drinking within the workplace environment. One hundred fifty-five randomly selected employees of a medium-sized company in the food and retail services sector participated in a 6-month controlled worksite prevention trial. Female problem drinkers who received the intervention were more likely than those in the no-treatment control group to reduce alcohol-related negative consequences at follow-up. In addition, there was a significant multivariate treatment effect, suggesting that participants who received the intervention were significantly more likely to reduce drinking frequency at follow-up. Evaluation of attrition rates and reports of participant satisfaction suggest that the intervention was effective in engaging participants at all levels of alcohol consumption.
|
https://pubmed.ncbi.nlm.nih.gov/12236459/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't"
] |
12236459
|
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] |
12,236,457 |
Relation of depression diagnoses to 2-year outcomes in cocaine-dependent patients in a randomized continuing care study.
|
McKay James R JR, Pettinati Helen M HM, Morrison Rebecca R, Feeley Michael M, Mulvaney Francis D FD, Gallop Robert R
|
Psychology of addictive behaviors : journal of the Society of Psychologists in Addictive Behaviors . Vol. 16, No. 3, 2002 Sep
|
This study examined the relation between depression diagnoses and outcomes in 132 cocaine-dependent patients who were randomized to relapse prevention (RP) or standard 12-step focused group continuing care and followed for 2 years. Depressed patients attended more treatment sessions and had more cocaine-free urines during treatment than participants without depression, but they drank alcohol more frequently before treatment and during the 18-month posttreatment follow-up. Cocaine outcomes in depressed patients deteriorated to a greater degree after treatment than did cocaine outcomes in patients without depression, particularly in patients in RP who had a current depressive disorder at baseline. The best alcohol outcomes were obtained in nondepressed patients who received RP. The results suggest that extended continuing care treatment may be warranted for cocaine-dependent patients with co-occurring depressive disorders.
|
https://pubmed.ncbi.nlm.nih.gov/12236457/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, U.S. Gov't, Non-P.H.S.",
"Research Support, U.S. Gov't, P.H.S."
] |
12236457
|
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] |
12,236,487 |
Improved liver tests and greater biliary enrichment with high dose ursodeoxycholic acid in early stage primary biliary cirrhosis.
|
Roda E E, Azzaroli F F, Nigro G G, Piazza F F, Jaboli F F, Ferrara F F, Liva S S, Giovanelli S S, Miracolo A A, Colecchia A A, Festi D D, Mazzeo C C, Bacchi L L, Roda A A, Mazzella G G
|
Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver . Vol. 34, No. 7, 2002 Jul
|
BACKGROUND: Ursodeoxycholic acid is currently used for the treatment of primary biliary cirrhosis at 13-15 mg/kg/day, but liver tests of some patients do not return to normal at this dose. Studies reported here were designed to test whether a higher dose of ursodeoxycholic acid than is currently used would induce still greater biliary enrichment of ursodeoxycholic acid and whether such enrichment would lead to still further improvement in liver tests in patients with early primary biliary cirrhosis. METHODS: A total of 20 patients with histologically proven primary biliary cirrhosis were enrolled. Patients had early stage primary biliary cirrhosis as serum bilirubin levels were normal and the Mayo risk score 4.2 +/- 0.5. Group 1 received 600, 1200 and 1800 mg/day of ursodeoxycholic acid; group 2 received 900, 1500 and 2100 mg/day. The order of periods was randomized. Each treatment period lasted 3 months followed by a further 3 months during which a standard dose of ursodeoxycholic acid was given. At the end of each treatment period, liver tests were evaluated, and biliary bile acid pattern of duodenal bile was determined using high pressure liquid chromatography. RESULTS: Biliary bile acid became enriched in ursodeoxycholic acid in direct relationship to dosage [r = 0.84, p < 0.001). At doses of 1800 mg/day (25-35 mg/kg/day), biliary ursodeoxycholic acid averaged 69 +/- 6.6%. A progressive decrease of alanine aminotransferase [p < 0.0001), aspartate aminotransferase [p < 0.001) and alkaline phosphatase [p < 0.02) was observed with increasing concentrations of ursodeoxycholic acid in bile. Biochemical liver tests showed a stronger correlation with biliary concentrations of ursodeoxycholic acid than with the administered dose. CONCLUSIONS: In early primary biliary cirrhosis, higher dose ursodeoxycholic acid appears to be more effective than doses currently recommended.
|
https://pubmed.ncbi.nlm.nih.gov/12236487/
|
[
"Clinical Trial",
"Comparative Study",
"Controlled Clinical Trial",
"Journal Article",
"Research Support, Non-U.S. Gov't"
] |
12236487
|
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] |
12,236,606 |
School-based indicated prevention: a randomised trial of group therapy.
|
McArdle Paul P, Moseley David D, Quibell Toby T, Johnson Rob R, Allen Ann A, Hammal Donna D, leCouteur Ann A
|
Journal of child psychology and psychiatry, and allied disciplines . Vol. 43, No. 6, 2002 Sep
|
BACKGROUND: One hundred and twenty-two children identified by teachers as at risk for behavioural or emotional problems were randomly allocated to drama-group therapy or to a curriculum-studies control, based in school. METHODS: One hundred and seventeen completed the intervention phase of the trial, which comprised 12 hour-long sessions. Post-intervention self-reports showed significant effects associated with both interventions. RESULTS: However, there was a clear advantage of group therapy over both a waiting list control and curriculum studies, according to teacher reports. This was true also of categorical analyses focusing on those with the most severe symptoms. CONCLUSIONS: These analyses confirmed sustained teacher-reported improvement over a year-long follow-up period.
|
https://pubmed.ncbi.nlm.nih.gov/12236606/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial"
] |
12236606
|
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] |
12,236,607 |
Nighttime sleep-wake patterns and self-soothing from birth to one year of age: a longitudinal intervention study.
|
Burnham Melissa M MM, Goodlin-Jones Beth L BL, Gaylor Erika E EE, Anders Thomas F TF
|
Journal of child psychology and psychiatry, and allied disciplines . Vol. 43, No. 6, 2002 Sep
|
BACKGROUND: The objectives of this study were to: (1) describe the longitudinal development of sleep-wake patterns of solitary-sleeping infants from 1 to 12 months of age, (2) identify effects on sleep patterns and on self-soothing behaviors of introducing a novel sleep aid, and (3) identify predictive factors of self-soothing at 12 months using a transactional model as a guide. METHODS: Eighty infants' nighttime sleep-wake patterns and associated variables were studied at 5 times across the first year of life using videosomnography and questionnaires. RESULTS: Sleep-wake state developmental changes, as reported in investigations of infant sleep, were replicated, although a great deal of individual variability in the development of all sleep-related variables was noted. No major effects on sleep or on self-soothing behavior were evident from the introduction of the novel sleep aid. Three variables were identified as significant predictors of self-soothing at 12 months: decreasing amounts of time spent out of crib across the first year, high levels of quiet sleep at birth, and longer parental response times to infant awakenings at 3 months. CONCLUSIONS: These data lend preliminary support for the transactional model and suggest that infant and parental factors interact to influence the development of self-soothing.
|
https://pubmed.ncbi.nlm.nih.gov/12236607/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, U.S. Gov't, P.H.S."
] |
12236607
|
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] |
12,236,625 |
Striatal dopamine D2 receptor binding of risperidone in schizophrenic patients as assessed by 123I-iodobenzamide SPECT: a comparative study with olanzapine.
|
Schmitt G J E GJ, Meisenzahl E M EM, Dresel S S, Tatsch K K, Rossmüller B B, Frodl T T, Preuss U W UW, Hahn K K, Möller H J HJ
|
Journal of psychopharmacology (Oxford, England) . Vol. 16, No. 3, 2002 Sep
|
The aim of this investigation was to compare the degree of striatal dopamine-(D2) receptor blockade by two atypical antipsychotic drugs, risperidone and olanzapine. The percentage of D2 receptor occupancy during treatment was calculated by comparing the results of 123I-iodobenzamide SPECT with those from healthy control subjects. Twenty inpatients suffering from schizophrenia or schizoaffective psychosis according to DSM IV/ICD-10 criteria were treated with clinically recommended doses of risperidone and compared with 13 inpatients treated with up to 20 mg olanzapine. Neuroleptic dose and D2 receptor blockade correlated strongly for both risperidone (Pearson r = -0.86, p = 0.0001) and olanzapine (Pearson r = -0.77, p = 0.002). There was no significant difference between the D2 receptor occupancy of the two substances when given in the clinically recommended dose range (unpaired t-test, t = -0.112, p = 0.911).
|
https://pubmed.ncbi.nlm.nih.gov/12236625/
|
[
"Clinical Trial",
"Comparative Study",
"Evaluation Study",
"Journal Article"
] |
12236625
|
[
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] |
12,236,626 |
Additional dopamine reuptake inhibition attenuates vigilance impairment induced by serotonin reuptake inhibition in man.
|
Schmitt Jeroen A J JA, Ramaekers Johannes G JG, Kruizinga Monique J MJ, van Boxtel Martin P J MP, Vuurman Eric F P M EF, Riedel Wim J WJ
|
Journal of psychopharmacology (Oxford, England) . Vol. 16, No. 3, 2002 Sep
|
There is evidence for a specific impairment of human vigilance following enhancement of serotonergic activity by antidepressant drugs. In the present study, we investigated the putative role of serotonergic-dopaminergic interactions in diminished vigilance by comparing the attentional effects of sertraline, a selective serotonin reuptake inhibitor (SSRI) with additional mild dopamine stimulating effects, with those of paroxetine, a SSRI without dopamine activity, using a placebo-controlled, double-blind, three-way cross-over design. Twenty-one (of 24) healthy middle-aged subjects completed the three treatment periods of 2 weeks in which sertraline (50 mg, days 1-7; 100 mg, days 8-14), paroxetine (20 mg, days 1-7; 40 mg, days 8-14) and placebo were administered. Vigilance (Mackworth Clock Test), selective (Stroop, Dichotic Listening) and divided attention (Dichotic Listening) were assessed at baseline and on days 7 and 14 of each treatment period. Selective and divided attention were unaffected by SSRI treatment. Subchronic administration of paroxetine impaired vigilance performance at each investigated dose. Sertraline did not produce a significant decline in vigilance performance, presumably due to its concomitant effects on dopamine activity, counteracting the negative effects of serotonin on dopamine neurotransmission. It is concluded that a serotonergically mediated reduction of dopamine activity plays an important role in the reduction of human vigilance following SSRI administration.
|
https://pubmed.ncbi.nlm.nih.gov/12236626/
|
[
"Clinical Trial",
"Comparative Study",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't"
] |
12236626
|
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] |
12,236,630 |
Acute effects of low-dose interferon-alpha on serum cortisol and plasma interleukin-6.
|
Cassidy Eugene M EM, Manning Diarmuid D, Byrne Sinead S, Bolger Emer E, Murray Frank F, Sharifi Neda N, Wallace Eleanor E, Keogan Mary M, O'Keane Veronica V
|
Journal of psychopharmacology (Oxford, England) . Vol. 16, No. 3, 2002 Sep
|
Major depression is associated with both hypothalamic-pituitary-adrenal (HPA) axis overactivity and immune system activation. Depression is a common occurrence following interferon (IFN)-a treatment. While IFN-alpha is known to stimulate the HPA axis, little is known about the effects of exogenous IFN-a in humans on the proinflammatory cytokine interleukin (IL)-6, a marker of immune system activation. This study examined the acute effects of IFN-alpha on cortisol and IL-6 release, and the time course of any changes in these variables. Serum cortisol and plasma IL-6 were assessed in healthy volunteers over an 8-h period following 3 million units subcutaneous IFN-alpha or placebo using a double-blind, placebo-controlled crossover design. IFN-alpha resulted in a significant increase in both cortisol and IL-6. Regular sampling over 8 h did not delineate any sequential effect of the rise in these variables over time. We conclude that IFN-alpha acutely stimulates both the HPA axis and proinflammatory cytokine release. The hypothesis that the effect of IFN-alpha on the HPA axis is indirect and mediated by IL-6 was not supported by this study. Our findings are nonetheless of relevance to the aetiology of depression following IFN-alpha.
|
https://pubmed.ncbi.nlm.nih.gov/12236630/
|
[
"Clinical Trial",
"Controlled Clinical Trial",
"Journal Article"
] |
12236630
|
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] |
12,236,632 |
The effect of glucose administration and the emotional content of words on heart rate and memory.
|
Ford Claire E CE, Scholey Andrew B AB, Ayre Gareth G, Wesnes Keith K
|
Journal of psychopharmacology (Oxford, England) . Vol. 16, No. 3, 2002 Sep
|
The effects of glucose administration and emotionality of target material on heart rate and memory were examined in a double-blind, placebo-controlled, balanced crossover study. Memory for neutral and emotional words was tested in 20 young adults following a glucose drink and a placebo. Heart rate and blood glucose were also measured. Emotional words were recalled and recognized better than neutral words in both drink conditions but there was no direct effect of drink type on memory. During the neutral word memory tasks, similar heart rate deceleration was observed in both drink conditions. However, during the processing of emotional material, heart rates were lowered in the placebo condition and relatively increased in the glucose condition. These results further differentiate the physiological responses involved during memory for affective and neutral material.
|
https://pubmed.ncbi.nlm.nih.gov/12236632/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial"
] |
12236632
|
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] |
12,236,631 |
Enhancement of stress-induced pituitary hormone release and cardiovascular activation by antidepressant treatment in healthy men.
|
Jezová Daniela D, Duncko Roman R
|
Journal of psychopharmacology (Oxford, England) . Vol. 16, No. 3, 2002 Sep
|
A randomized, double-blind, placebo-controlled trial was performed to verify the suggestion that (i) in accordance with the results of animal studies, treatment with antidepressants inhibits hormone release in response to stressful stimulation in humans and (ii) drugs with opposing effects on brain serotonine (citalopram and tianeptine) exert similar modulatory effects on neuroendocrine activation during stress. Healthy male volunteers were treated with citalopram (20 mg), tianeptine (37.5 mg) or placebo for 7 days. As a stress stimulus, insulin-induced hypoglycaemia was used. Measurement of hormone concentrations revealed an enhanced release of adrenocorticotropic hormone and growth hormone in response to stress of hypoglycaemia in subjects treated with both antidepressants used. A similar augmentation was observed in systolic blood pressure. Stress-induced prolactin release was potenciated by citalopram only. Plasma renin activity, epinephrine, norepinephrine and cortisol levels failed to be modified by antidepressants. The present study demonstrates that (i) repeated antidepressant treatment in healthy men does not inhibit, but enhances, neuroendocrine activation during stress and (ii) such effects were observed after treatment with antidepressants having opposing actions on brain serotonin, indicating involvement of nonserotoninergic mechanisms.
|
https://pubmed.ncbi.nlm.nih.gov/12236631/
|
[
"Clinical Trial",
"Comparative Study",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't"
] |
12236631
|
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] |
12,236,643 |
The influence of occlusal finish line configuration on microleakage of indirect composite inlays.
|
Peixoto Rogéli Tibúrcio Ribeiro RT, Poletto Luiz Thadeu de Abreu LT, Lanza Marcos Dias MD, Buono Vicente Tadeu Lopes VT
|
The journal of adhesive dentistry . Vol. 4, No. 2, 2002
|
PURPOSE: The aim of this in vitro study was to evaluate the influence of occlusal finish line configuration on microleakage of indirect composite inlays. MATERIALS AND METHODS: Forty-five recently extracted premolars were randomly assigned into three groups with different types of occlusal finish line preparations: bevel, chamfer, and butt joint. All restorations were made in Artglass (Heraeus Kulzer) and luted according to the manufacturer's recommendations. The teeth were sealed and then thermocycled 500 times between 5 degrees C and 55 degrees C. After that they were immersed in a 2% methylene blue (pH 7.2) solution for 24 hours. Each tooth was bisectioned in the buccal/lingual direction and then examined microscopically at each section to evaluate the microleakage score. The data were analyzed with chi-square and Fisher's Exact tests. RESULTS: There were no significant differences between the buccal margins of maxillary premolars with occlusal bevel or butt joint; the chamfer had the worst performance. In the buccal margin of mandibular premolars, the bevel and chamfer showed significantly smaller amounts of leakage than the butt joint. No significant differences were observed between the three types of occlusal cavosurface preparations in the lingual margin of maxillary and mandibular premolars. CONCLUSIONS: The finish line configuration, the position of the teeth in the arch, and the margin (buccal vs lingual) influenced microleakage. Whenever microleakage was observed in this study, it was always observed at the tooth-cement interface.
|
https://pubmed.ncbi.nlm.nih.gov/12236643/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial"
] |
12236643
|
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] |
12,236,642 |
Microleakage in class II composite resin restorations: total bonding and open sandwich technique.
|
Loguercio Alessandro Dourado AD, Alessandra Reis R, Mazzocco Kelly Cristina KC, Dias André Lozano AL, Busato Adair Luiz Stefanello AL, Singer Julio da Motta Jda M, Rosa Patricia P
|
The journal of adhesive dentistry . Vol. 4, No. 2, 2002
|
PURPOSE: The objective of this in vitro study was to evaluate gingival microleakage in Class II total bond resin restorations in comparison to open sandwich technique restorations using different materials. MATERIALS AND METHODS: Forty-eight human molar teeth were disinfected and stored in a 0.9% saline solution. In each tooth, two standardized Class II cavities (3 mm x 6 mm x 2 mm) were prepared with the gingival cavosurface margins located 1 mm below the cementoenamel junction. The teeth were divided into 4 equally sized groups (n = 12), and the proximal boxes were treated as follows: in Group 1, no base material was used and the cavity was restored using SyntacSprint (SS) and Tetric Ceram (TC); in Groups 2, 3, and 4 the gingival portion of the cavity was restored with different base materials (Group 2, Dyract; Group 3, Vitremer; Group 4, Chelon-fil) prior to the placement of the composite resin. After a storage time of 7 days, the restorations were finished and polished. Then, specimens were submitted to thermocycling (500 cycles, 5 degrees C to 55 degrees C, 15 s dwell time) and immersed in a 0.5% methylene blue solution for 24 h. After washing, they were sectioned in a mesio-distal direction. Each restoration was evaluated under a stereomicroscope at 20x by 2 examiners and scored on a 0 to 3 scale according to the marginal leakage. Kappa statistics were used to evaluate the agreement between the examiners. Given the ordinal nature of the scoring system, data were submitted to a nonparametric repeated measures ANOVA. The results were confirmed with a parametric repeated measures ANOVA. RESULTS: Significant differences (p < 0.001) among the four groups with respect to dye penetration were detected, with the association Vitremer/Tetric showing the best results. CONCLUSION: The use of Vitremer in the open sandwich technique presents the lowest degree of microleakage among the treatments considered in this study.
|
https://pubmed.ncbi.nlm.nih.gov/12236642/
|
[
"Clinical Trial",
"Comparative Study",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't"
] |
12236642
|
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] |
12,236,804 |
Cost-effectiveness comparison of tizanidine and baclofen in the management of spasticity.
|
Rushton David N DN, Lloyd Adam C AC, Anderson Pippa M PM
|
PharmacoEconomics . Vol. 20, No. 12, 2002
|
OBJECTIVE: Baclofen and tizanidine are both used for the treatment of muscle spasticity of spinal origin. Their effectiveness, cost and adverse-effect profiles differ. This paper sets out to estimate the cost effectiveness of each drug, and the impact of changing from baclofen to tizanidine. DESIGN: A simplified but realistic model of physician behaviour and patient response was developed as a decision tree and populated with data derived from the available published clinical comparative trials. We considered patients with spasticity caused by multiple sclerosis or spinal cord injury. The outcome measure used was 'cost per successfully treated day' (STD). Costs were estimated from the perspective of the UK National Health Service at 2000 values. RESULTS: Expected cost for a cohort of 100 patients over 1 year was estimated to be pound 181 545 with baclofen and pound 211 930 with tizanidine. The estimated number of STDs was 20,192 with tizanidine and 17,289 with baclofen. The overall cost effectiveness of managing spasticity using baclofen and tizanidine was very similar ( pound 10.50 and pound 10.49 per STD respectively). The incremental cost effectiveness (ICE) of using tinzanidine as an alternative to baclofen for first-line treatment was pound 10.47 per STD. Sensitivity analysis found the model to be robust to changes in key parameters CONCLUSION: Drug cost should not be a determining factor in making this treatment choice, as the cost effectiveness ratios are similar for both products.
|
https://pubmed.ncbi.nlm.nih.gov/12236804/
|
[
"Clinical Trial",
"Comparative Study",
"Journal Article",
"Research Support, Non-U.S. Gov't"
] |
12236804
|
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] |
12,236,806 |
Costs and effectiveness of using coumarins before, during and after coronary angioplasty.
|
ten Berg Jurrien M JM, Kelder Johannas C JC, Plokker Thys H W TH, van Hout Ben A BA
|
PharmacoEconomics . Vol. 20, No. 12, 2002
|
BACKGROUND: In the Balloon Angioplasty and Anticoagulation Study (BAAS), coumarins added to routine aspirin therapy before coronary angioplasty reduced cardiac events at the cost of a slightly higher risk of bleeding complications. OBJECTIVE: To determine the cost effectiveness of coumarin treatment, based on the occurrence of both cardiac and bleeding events. METHODS: Effectiveness was measured, applying two definitions, in terms of the number of events occurring at one year. In the first definition, the occurrence of death, myocardial infarction (MI), or stroke was assessed. The second definition also included revascularisations and major bleeding episodes as an event. Costs were limited to direct medical costs. Cost effectiveness was addressed by probability ellipses representing the point estimates and uncertainties surrounding both costs and effectiveness. RESULTS: At 1 year, death, MI or stroke occurred 1.1% less often when treating with aspirin plus coumarins rather than aspirin therapy alone. When revascularisations and major bleeding events were also included, the difference was 5.0%. Overall, the additional costs in relation to coumarin treatment were compensated by a reduction in repeat interventions. When including all costs, the savings associated with coumarin treatment were estimated at Euros 235 per patient after 1 year. The probability that coumarins are cost saving was estimated at 0.85. The probability that coumarins combine additional effectiveness with cost savings was estimated at 0.70 when survival free of MI or stroke as an effectiveness measure was considered, and at 0.83 when survival free of MI, stroke, revascularisation or major bleeding was considered. CONCLUSION: Coumarin therapy added to routine aspirin therapy before coronary angioplasty, and continued during follow-up, may not only be considered more effective but also cost saving relative to aspirin therapy alone.
|
https://pubmed.ncbi.nlm.nih.gov/12236806/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't"
] |
12236806
|
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] |
12,236,827 |
Effectiveness of chlorhexidine-thymol varnish for caries reduction in permanent first molars of 6-7-year-old children: 24-month clinical trial.
|
Baca Pilar P, Muñoz M José MJ, Bravo Manuel M, Junco Pilar P, Baca Adela P AP
|
Community dentistry and oral epidemiology . Vol. 30, No. 5, 2002 Oct
|
OBJECTIVES: To determine the effect of chlorhexidine varnish on the prevention of caries in permanent first molars. METHODS: Two groups of 6-7-year-old school children were followed up in a clinical trial, a group of 86 children whose teeth were treated with a chlorhexidine-thymol varnish (Cervitec) and a control group of 95 children. The varnish was reapplied every 3 months and the caries increments were compared at 24 months. RESULTS: The DFS (decayed and filled surfaces in permanent first molars) increment in the control group (mean = 1.85; SD = 2.27) was higher than in the test group (mean = 0.95; SD = 1.38), resulting in a 48.6% caries reduction. This difference was statistically significant (P = 0.032). CONCLUSIONS: Chlorhexidine-thymol varnish is effective in preventing caries in permanent first molars.
|
https://pubmed.ncbi.nlm.nih.gov/12236827/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't"
] |
12236827
|
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] |
12,236,844 |
Quinidine does not affect the renal clearance of moxonidine.
|
Wise Stephen D SD, Chan Clark C, Schaefer Hans G HG, He Minxia M MM, Pouliquen Isabelle J IJ, Mitchell Malcolm I MI
|
British journal of clinical pharmacology . Vol. 54, No. 3, 2002 Sep
|
AIMS: To test the hypothesis that the renal clearance of moxonidine decreases when dosed with quinidine. METHODS: A randomized, two-period study was conducted with six healthy, male subjects orally dosed with either 0.2 mg moxonidine alone or 1 h after 400 mg quinidine sulphate. Pharmacokinetic parameters were calculated using a noncompartmental analysis method. RESULTS: When coadministered, quinidine significantly increased moxonidine AUC and t1/2 by 11% and 15%, respectively, and decreased CL/F by 10% compared with the control dosing. CLR and Aeur were not significantly different. Clinically, both treatments were well tolerated. CONCLUSIONS: Quinidine does not affect the renal clearance of moxonidine. The decrease in apparent total clearance of moxonidine with quinidine coadministration was possibly due to metabolic inhibition, though not likely to be clinically significant.
|
https://pubmed.ncbi.nlm.nih.gov/12236844/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial"
] |
12236844
|
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] |
12,236,845 |
Pharmacokinetics and gamma scintigraphy evaluation of two enteric coated formulations of didanosine in healthy volunteers.
|
Damle Bharat B, Ullah Ismat I, Doll Walter W, Wiley Gary G, Knupp Catherine C
|
British journal of clinical pharmacology . Vol. 54, No. 3, 2002 Sep
|
AIMS: The aims of the study were to evaluate the bioavailability of didanosine from the encapsulated enteric coated beads (1 x 200 mg; enteric beads) and enteric coated mini-tablets (4 x 50 mg; enteric tablet) formulations relative to the chewable/dispersible buffered tablets (2 x 100 mg; buffered tablet), and to study their rate of gastrointestinal transit. METHODS: This was a single-dose, randomized, three-way crossover study in 18 healthy male volunteers. A 200 mg dose of didanosine was given in each period and each formulation contained a gamma radiation-emitting isotope. Pharmacokinetic parameters determined were Cmax, tmax, AUC(0, infinity ) and t1/2. Bioequivalence was assessed using the confidence interval (CI) of 0.80, 1.25 for Cmax and AUC(0, infinity ). Scintigraphic images were recorded and gastrointestinal transit profiles were generated. RESULTS: The point estimate and 90% CI of the ratio of Cmax for the enteric beads and enteric tablet relative to the buffered tablet was 0.71 (0.59, 0.85) and 0.55 (0.46, 0.66), respectively. The tmax was significantly different for the enteric beads (median, 1.33 h) and the enteric tablet (median, 2.83 h) than for the buffered tablet (median, 0.67 h). The AUC(0, infinity ) satisfied the bioequivalence criteria, and the point estimate and 90% CI of the ratio were 1.02 (0.91, 1.15) and 0.92 (0.82, 1.04) for the enteric beads and enteric tablet, respectively. The AUC(0, infinity ) values appeared to be less variable with the enteric beads (% CV = 19%) than with the enteric tablet (% CV = 33%). The t1/2 values were not significantly different between formulations, and the mean values ranged from 1.82 to 1.92 h. Inspection of the individual scintigraphy profiles and concentration-time curves suggested that didanosine was absorbed throughout the small intestine. Gastrointestinal transit parameters were higher for both enteric formulations than for the buffered tablet, indicating slower transit of the enteric formulations. Between the enteric formulations, gastric emptying was slower for the enteric beads than for the enteric tablet; however, plasma didanosine concentrations were observed sooner for the enteric beads, suggesting that the enteric coat for the beads dissolved more rapidly. CONCLUSIONS: The enteric beads and enteric tablet formulations of didanosine were equivalent to the buffered tablet in their extent of absorption. Although the gastric emptying of the enteric tablet was faster, based on the rapid uncoating and the lower variability in AUC, the enteric beads were chosen for further clinical development.
|
https://pubmed.ncbi.nlm.nih.gov/12236845/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial"
] |
12236845
|
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] |
12,236,847 |
Early clinical experience with the novel proteasome inhibitor PS-519.
|
Shah I M IM, Lees K R KR, Pien C P CP, Elliott P J PJ
|
British journal of clinical pharmacology . Vol. 54, No. 3, 2002 Sep
|
AIMS: The main objective of this study was to investigate the safety, tolerability and pharmacodynamics of the novel proteasome inhibitor PS-519 in young male volunteers. Many pro-inflammatory mediators such as cytokines and cell adhesion molecules that are responsible for the development of the cerebral infarct are under the control of the transcription factor Nuclear Factor kappa-B (NF-kappaB). The activity of NF-kappaB is itself tightly regulated through the multicatalytic enzyme known as the proteasome. PS-519 is a novel and highly selective small molecule that inhibits the proteasome. An ex vivo assay of 20S proteasome activity allows monitoring of the drug effect in blood. PS-519 is protective in multiple animal models of cerebral ischaemia over a range of doses that achieve 20S inhibition of 40%-80%. METHODS: PS-519 has been administered to healthy male volunteers as single and repeated doses up to 1.6 mg m(-2). It was given as an intravenous bolus over 20-30 s in a double blind, randomized, placebo-controlled phase I study, examining vital signs, safety, tolerability and blood 20S proteasome inhibition. RESULTS: Thirty-nine subjects received single doses of 0.012 mg m-2-1.6 mg m(-2) and 28 subjects received doses of 0.5 mg m(-2)-1.6 mg m(-2) on three consecutive days. The drug was well tolerated. There was no clear treatment-emergent symptom or abnormality of laboratory tests. Proteasome inhibition in blood samples as measured by 20S assay achieved the intended maximum target level of 70-80% with 1.6 mg m(-2), and was reproducible with repeated dosing. CONCLUSIONS: This study has demonstrated that proteasome inhibition is well tolerated by healthy subjects at levels that are maximally neuroprotective in experimental conditions. Further clinical evaluation appears justified.
|
https://pubmed.ncbi.nlm.nih.gov/12236847/
|
[
"Clinical Trial",
"Clinical Trial, Phase I",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't"
] |
12236847
|
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] |
12,236,848 |
The effects of St John's wort extract on heart rate variability, cognitive function and quantitative EEG: a comparison with amitriptyline and placebo in healthy men.
|
Siepmann M M, Krause S S, Joraschky P P, Mück-Weymann M M, Kirch W W
|
British journal of clinical pharmacology . Vol. 54, No. 3, 2002 Sep
|
AIMS: To compare the effects of multiple dosing with St John's wort (Hypericum perforatum) extract and amitriptyline on heart rate variability, cognitive function and quantitative EEG (qEEG) with placebo in healthy humans. METHODS: A randomized, double-blind, cross over study of 12 healthy male volunteers. Subjects orally received capsules with 255-285 mg St John's wort extract (900 micro g hypericin content), 25 mg amitriptyline and placebo three times daily for periods of 14 days each with at least 14 days between. The doses of amitriptyline and St John's wort extract are comparable with respect to their antidepressant activity. Compliance was confirmed by coadministration of 10 mg of riboflavin with each capsule and detection of urinary vitamin B2 on treatment day 11 with high performance liquid chromatography. Measurements of heart rate variability, psychometric tests and qEEG were performed before start of medication and repeatedly on the last treatment day. RESULTS: St John's wort extract did not affect heart rate variability (HRV) whereas amitripytline significantly decreased it: the difference in the percentage number of adjacent RR intervals> 50 ms (pNN50) was 8.6 (-2.6, 19.9; mean; 95% confidence interval) between St John's wort extract and placebo and -17.6 (-24.7, -10.4) between amitriptyline and placebo. Neither St John's wort extract nor amitriptyline had an influence on cognitive performance such as choice reaction, psychomotor coordination, short-term memory and responsiveness to distractive stimuli. Amitriptyline but not St John's wort extract decreased self rated activity (P < 0.05). Both drugs caused significant qEEG changes. St John's wort extract increased theta power density. Amitriptyline increased theta as well as fast alpha power density. CONCLUSIONS: Multiple doses of St John's wort extract do not affect heart rate variability nor cognitive function. Chronic administration of amitriptyline causes a decrement of HRV and subjective sedation but it does not impair cognitive performance.
|
https://pubmed.ncbi.nlm.nih.gov/12236848/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial"
] |
12236848
|
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] |
12,236,851 |
Absence of an interaction between the synthetic pentasaccharide fondaparinux and oral warfarin.
|
Faaij R A RA, Burggraaf J J, Schoemaker R C RC, Van Amsterdam R G M RG, Cohen A F AF
|
British journal of clinical pharmacology . Vol. 54, No. 3, 2002 Sep
|
AIMS: To investigate the pharmacokinetic and pharmacodynamic interaction of the antithrombotic pentasaccharide fondaparinux (Org31540/SR90107A), given subcutaneously, and oral warfarin in healthy subjects. METHODS: This study was performed according to a randomised, three-way cross-over, placebo-controlled, double-blind design in 12 healthy male subjects. The treatment consisted of five subcutaneous (s.c.) injections of fondaparinux (4 mg) or placebo at 24 h intervals. Oral dosing of warfarin or placebo was added to the fourth (15 mg) and fifth (10 mg) s.c. injection. Blood samples for pentasaccharide assay, PT and APTT were drawn before the first s.c. dose of the pentasaccharide and over a 6 day period thereafter. RESULTS: Fondaparinux administered to healthy male volunteers alone or in combination with oral warfarin was well tolerated and no serious adverse events were observed. No differences were found in the AUC (43 vs 44 mg l(-1) h), Cmax (645 vs 678 ng ml(-1)) or elimination half-life (13.8 vs 14.1 h) of fondaparinux between the pentasaccharide-only and the combination treatment. The effect of warfarin on PT (mean maximal increase: 8.2 s.) was not influenced by the presence of the pentasaccharide (mean maximal increase in PT: 9.1 s.). After all treatments a small rise in APTT was seen. No further differences could be detected in the pharmacodynamic parameters following the three treatments. CONCLUSIONS: The coadministration of warfarin did not influence the pharmacokinetics of fondaparinux in healthy subjects. PT can still be used to monitor the effect of oral anticoagulants during the switch from antithrombotic treatment with pentasaccharide to full oral anticoagulant therapy.
|
https://pubmed.ncbi.nlm.nih.gov/12236851/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't"
] |
12236851
|
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12,236,853 |
Dose-response relationships between individual nonaspirin nonsteroidal anti-inflammatory drugs (NANSAIDs) and serious upper gastrointestinal bleeding: a meta-analysis based on individual patient data.
|
Lewis S C SC, Langman M J S MJ, Laporte Joan-Ramon JR, Matthews John N S JN, Rawlins Michael D MD, Wiholm Bengt-Erik BE
|
British journal of clinical pharmacology . Vol. 54, No. 3, 2002 Sep
|
AIMS: To define by amalgamation of data obtained in contemporaneous case-control studies, the risks associated with individual nonaspirin nonsteroidal anti-inflammatory drugs (NANSAIDs) according to doses used. METHODS: Meta-analysis of individual patient data from three retrospective case-control studies using similar data collection protocols was carried out in hospitals in Catalonia, England, Scotland and Sweden. 2472 cases of upper gastrointestinal bleeding and 5877 controls were studied. Main outcome measures were risks associated with individual NANSAIDs according to dose used and the period of time for which they were given. RESULTS: Ibuprofen showed the lowest odds ratio (OR = 1.7; 95% confidence interval 1.1, 2.5), followed by diclofenac (4.9; 3.3, 7.1), indomethacin (6.0; 3.6, 10.0), naproxen (9.1; 6.0-13.7), piroxicam (13.1; 7.9-21.8) and ketoprofen (34.9; 12.7, 96.5). Striking dose-response relationships were seen with four to eight-fold increases in risk within conventionally used dose ranges for all except ketoprofen, where numbers were too few to allow dose analysis. Across the class, risk was highest during the first week of use (11.7; 6.5, 21.0), decreased thereafter with continuing use (5.6; 4.6, 7.0), and fell to 3.2 (2.1, 5.1) 1 week after discontinuing use. Concurrent use of more than one NANSAID substantially increased risk. CONCLUSIONS: The risk of upper gastrointestinal bleeding with NANSAIDs varies twenty-fold depending on the drug, and by three to seven-fold depending on the dose chosen. Risk is maximal during the first week and decreases thereafter. Paracetamol (acetaminophen) is not associated with upper gastrointestinal bleeding at any dose and should be the first-line analgesic wherever possible.
|
https://pubmed.ncbi.nlm.nih.gov/12236853/
|
[
"Journal Article",
"Meta-Analysis",
"Research Support, Non-U.S. Gov't"
] |
12236853
|
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] |
12,236,852 |
Pharmacodynamic interaction between the new selective cholesterol absorption inhibitor ezetimibe and simvastatin.
|
Kosoglou Teddy T, Meyer Ingo I, Veltri Enrico P EP, Statkevich Paul P, Yang Bo B, Zhu Yali Y, Mellars Lillian L, Maxwell Stephen E SE, Patrick James E JE, Cutler David L DL, Batra Vijay K VK, Affrime Melton B MB
|
British journal of clinical pharmacology . Vol. 54, No. 3, 2002 Sep
|
AIMS: The primary aims of these two single-centre, randomized, evaluator-blind, placebo/positive-controlled, parallel-group studies were to evaluate the potential for pharmacodynamic and pharmacokinetic interaction between ezetimibe 0.25, 1, or 10 mg and simvastatin 10 mg (Study 1), and a pharmacodynamic interaction between ezetimibe 10 mg and simvastatin 20 mg (Study 2). Evaluation of the tolerance of the coadministration of ezetimibe and simvastatin was a secondary objective. METHODS: Eighty-two healthy men with low-density lipoprotein cholesterol (LDL-C) >or=130 mg dl-1 received study drug once daily in the morning for 14 days. In Study 1 (n=58), five groups of 11-12 subjects received simvastatin 10 mg alone, or with ezetimibe 0.25, 1, or 10 mg or placebo. In Study 2 (n=24), three groups of eight subjects received simvastatin 20 mg alone, ezetimibe 10 mg alone, or the combination. Blood samples were collected to measure serum lipids in both studies. Steady-state pharmacokinetics of simvastatin and its beta-hydroxy metabolite were evaluated in Study 1 only. RESULTS: In both studies, reported side-effects were generally mild, nonspecific, and similar among treatment groups. In Study 1, there were no indications of pharmacokinetic interactions between simvastatin and ezetimibe. All active treatments caused statistically significant (P<0.01) decreases in LDL-C concentration vs placebo from baseline to day 14. The coadministration of ezetimibe and simvastatin caused a dose-dependent reduction in LDL-C and total cholesterol, with no apparent effect on high-density lipoprotein cholesterol (HDL-C) or triglycerides. The coadministration of ezetimibe 10 mg and simvastatin 10 mg or 20 mg caused a statistically (P<0.01) greater percentage reduction (mean -17%, 95% CI -27.7, -6.2, and -18%, -28.4, -7.4, respectively) in LDL-C than simvastatin alone. CONCLUSIONS: The coadministration of ezetimibe at doses up to 10 mg with simvastatin 10 or 20 mg daily was well tolerated and caused a significant additive reduction in LDL-C compared with simvastatin alone. Additional clinical studies to assess the efficacy and safety of coadministration of ezetimibe and simvastatin are warranted.
|
https://pubmed.ncbi.nlm.nih.gov/12236852/
|
[
"Clinical Trial",
"Journal Article",
"Meta-Analysis",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't"
] |
12236852
|
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] |
12,236,885 |
Split face study on the cutaneous tensile effect of 2-dimethylaminoethanol (deanol) gel.
|
Uhoda Isabelle I, Faska Najat N, Robert Caroline C, Cauwenbergh Geert G, Piérard Gérald E GE
|
Skin research and technology : official journal of International Society for Bioengineering and the Skin (ISBS) [and] International Society for Digital Imaging of Skin (ISDIS) [and] International Society for Skin Imaging (ISSI) . Vol. 8, No. 3, 2002 Aug
|
BACKGROUND/AIMS: Beyond subjective assessments, the effect of skin tensors is difficult to assess. The present 2-phase randomized double-blind split face study was designed to compare the effect of a gel containing 3% 2-dimethylaminoethanol (deanol, DMAE) with the same formulation without DMAE. METHODS: In a first pilot study, sensorial assessments and measures of the skin distension under suction were performed in eight volunteers. In a second study conducted in 30 volunteers, shear wave propagation was measured. RESULTS: Large interindividual variations precluded any significant finding in the first study. The DMAE formulation showed, however, a significant effect characterized by increased shear wave velocity in the direction where the mechanical anisotropy of skin showed looseness. CONCLUSION: The DMAE formulation under investigation increased skin firmness.
|
https://pubmed.ncbi.nlm.nih.gov/12236885/
|
[
"Clinical Trial",
"Comparative Study",
"Journal Article",
"Randomized Controlled Trial"
] |
12236885
|
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0.1782476305961609,
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] |
12,237,046 |
Developmental aspects of infant's cry melody and formants.
|
Wermke K K, Mende W W, Manfredi C C, Bruscaglioni P P
|
Medical engineering & physics . Vol. 24, No. 7-8
|
This paper deals with the analysis of cry melodies (time variations of the fundamental frequency) as well as vocal tract resonance frequencies (formants) from infant cry signals. The increase of complexity of cry melodies is a good indicator for neuro-muscular maturation as well as for the evaluation of pre-speech development. The variation of formant frequencies allows an estimation of articulatory activity during pre-speech vocalization. Subjects are three pairs of healthy identical twins (monocygozity determined by DNA-fingerprint). Spontaneous cries of these six children were recorded at different ages: 8th-9th week, 15th-17th week and 23rd-24th week. Analysis of 136 cry melodies and intensity contours was made using KAY-CSL 4300/MDVP. For formant estimation a spectral parametric technique was applied, which was based on autoregressive models (Digital spectral analysis with applications, 1987) whose order is adaptively estimated on subsequent signal frames by means of a new method (Med. Eng. Phys. 20 (1998) 432; Utras. Med. Biol. 21 (1995) 793). Cry melodies exhibited an increasing complexity during the observation period. Beginning with the second observation period (15th-17th week) an increasing coupling and tuning between melody and resonance frequencies was observed, which was interpreted as "intentional" articulatory activity. Possible applications are in cry diagnosis as well as in the evaluation of pre-speech development.
|
https://pubmed.ncbi.nlm.nih.gov/12237046/
|
[
"Clinical Trial",
"Journal Article"
] |
12237046
|
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] |
12,237,172 |
Effects of a 'healthy' diet and of acute and long-term vitamin C on vascular function in healthy older subjects.
|
Singh Nivedita N, Graves Jonathan J, Taylor Paul D PD, MacAllister Raymond J RJ, Singer Donald R J DR
|
Cardiovascular research . Vol. 56, No. 1, 2002 Oct
|
OBJECTIVE: Aging is associated with endothelial dysfunction. We studied the acute and longer-term effects of vitamin C compared to a 'Mediterranean-type' diet on endothelial function in healthy older subjects. METHODS: Bilateral venous occlusion plethysmography was used to measure forearm blood flow in subjects aged 57-80 years. Responses to cumulative intra-arterial doses of the endothelium-dependent dilator bradykinin (BK; n=56; 20, 40, 80 pmol/min) and the nitric oxide donor glyceryl trinitrate (GTN; n=54; 4, 8, 16 nmol/min), were determined alone and in the presence of vitamin C (25 mg/min). We then randomised 54 subjects to a 'healthy' diet (n=18), vitamin C (1 g/day; n=18) or placebo for 6 weeks and reassessed endothelial and smooth muscle function. RESULTS: Acute intra-arterial vitamin C did not alter dilatation to BK or GTN. Similar increases in plasma vitamin C occurred on oral vitamin C (83+/-4 to 135+/-8 micromol/l) and 'healthy' diet (84+/-5 to 135+/-27 micromol/l; P<0.01 for both), with no change seen on placebo. Treatment with a 'healthy' diet but not oral vitamin C improved endothelium-dependent (P=0.043) and endothelium-independent dilatation (P=0.011). CONCLUSIONS: A 'Mediterranean-type' diet rich in vitamin C improves vascular function. Neither acute intra-arterial nor sustained administration of oral vitamin C improves vascular function in healthy older subjects.
|
https://pubmed.ncbi.nlm.nih.gov/12237172/
|
[
"Clinical Trial",
"Comparative Study",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't"
] |
12237172
|
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] |
12,237,183 |
Enhanced temporal summation of second pain and its central modulation in fibromyalgia patients.
|
Price Donald D DD, Staud Roland R, Robinson Michael E ME, Mauderli Andre P AP, Cannon Richard R, Vierck Charles J CJ
|
Pain . Vol. 99, No. 1-2, 2002 Sep
|
We have previously shown that fibromyalgia (FMS) patients have enhanced temporal summation (windup) and prolonged decay of heat-induced second pain in comparison to control subjects, consistent with central sensitization. It has been hypothesized that sensory abnormalities of FMS patients are related to deficient pain modulatory mechanisms. Therefore, we conducted several analyses to further characterize enhanced windup in FMS patients and to determine whether it can be centrally modulated by placebo, naloxone, or fentanyl. Pre-drug baseline ratings of FMS and normal control (NC) groups were compared with determine whether FMS had higher pain sensitivity in response to several types of thermal tests used to predominantly activate A-delta heat, C heat, or cold nociceptors. Our results confirmed and extended our earlier study in showing that FMS patients had larger magnitudes of heat tap as well as cold tap-induced windup when compared with age- and sex-matched NC subjects. The groups differed less in their ratings of sensory tests that rely predominantly on A-delta-nociceptive afferent input. Heat and cold-induced windup were attenuated by saline placebo injections and by fentanyl (0.75 and 1.5 microg/kg). However, naloxone injection had the same magnitudes of effect on first or second pain as that produced by placebo injection. Hypoalgesic effects of saline placebo and fentanyl on windup were at least as large in FMS as compared to NC subjects and therefore do not support the hypothesis that pain modulatory mechanisms are deficient in FMS. To the extent that temporal summation of second pain (windup) contributes to processes underlying hyperalgesia and persistent pain states, these results indirectly suggest that these processes can be centrally modulated in FMS patients by endogenous and exogenous analgesic manipulations.
|
https://pubmed.ncbi.nlm.nih.gov/12237183/
|
[
"Clinical Trial",
"Controlled Clinical Trial",
"Journal Article",
"Research Support, Non-U.S. Gov't",
"Research Support, U.S. Gov't, P.H.S."
] |
12237183
|
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] |
12,237,187 |
Blinding effectiveness and association of pretreatment expectations with pain improvement in a double-blind randomized controlled trial.
|
Turner Judith A JA, Jensen Mark P MP, Warms Catherine A CA, Cardenas Diana D DD
|
Pain . Vol. 99, No. 1-2, 2002 Sep
|
Patient, provider, and clinical investigator expectations concerning treatments are believed to play important roles in patient response. This study examined the association of patient and research nurse/physician pretreatment expectations of pain relief with actual pain relief, the accuracy of patient and research nurse guesses about patient medication assignment, and changes in research nurse and patient pain relief expectations over the course of a randomized double-blind trial of amitriptyline versus an active placebo for patients with chronic pain and spinal cord injuries (SCI). Patient expectations of pain relief with amitriptyline were associated significantly with actual pain decrease for patients in the amitriptyline, but not placebo, condition. Research nurse/physician expectations did not predict patient pain relief. Both patients and the research nurse were able to guess patient medication assignment at a rate significantly greater than chance. The research nurse's, but not the patients', expectations of pain relief with amitriptyline decreased significantly over the course of the study. These findings have implications for future randomized controlled trials. Fully double-blind conditions are very difficult to achieve, and it is informative to assess patient and research clinician expectations and guesses regarding medication assignment.
|
https://pubmed.ncbi.nlm.nih.gov/12237187/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, U.S. Gov't, P.H.S."
] |
12237187
|
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] |
12,237,186 |
Immediate effects of dry needling and acupuncture at distant points in chronic neck pain: results of a randomized, double-blind, sham-controlled crossover trial.
|
Irnich Dominik D, Behrens Nicolas N, Gleditsch Jochen M JM, Stör Wolfram W, Schreiber Martin A MA, Schöps Peter P, Vickers Andrew J AJ, Beyer Antje A
|
Pain . Vol. 99, No. 1-2, 2002 Sep
|
To evaluate immediate effects of two different modes of acupuncture on motion-related pain and cervical spine mobility in chronic neck pain patients compared to a sham procedure. Thirty-six patients with chronic neck pain and limited cervical spine mobility participated in a prospective, randomized, double-blind, sham-controlled crossover trial. Every patient was treated once with needle acupuncture at distant points, dry needling (DN) of local myofascial trigger points and sham laser acupuncture (Sham). Outcome measures were motion-related pain intensity (visual analogue scale, 0-100 mm) and range of motion (ROM). In addition, patients scored changes of general complaints using an 11-point verbal rating scale. Patients were assessed immediately before and after each treatment by an independent (blinded) investigator. Multivariate analysis was used to assess the effects of true acupuncture and needle site independently. For motion-related pain, use of acupuncture at non-local points reduced pain scores by about a third (11.2 mm; 95% CI 5.7, 16.7; P = 0.00006) compared to DN and sham. DN led to an estimated reduction in pain of 1.0 mm (95% CI -4.5, 6.5; P = 0.7). Use of DN slightly improved ROM by 1.7 degrees (95% CI 0.2, 3.2; P = 0.032) with use of non-local points improving ROM by an additional 1.9 degrees (95% CI 0.3, 3.4; P = 0.016). For patient assessment of change, non-local acupuncture was significantly superior both to Sham (1.7 points; 95% CI 1.0, 2.5; P = 0.0001) and DN (1.5 points; 95% CI 0.4, 2.6; P = 0.008) but there was no difference between DN and Sham (0.1 point; 95% CI -1.0, 1.2; P = 0.8). Acupuncture is superior to Sham in improving motion-related pain and ROM following a single session of treatment in chronic neck pain patients. Acupuncture at distant points improves ROM more than DN; DN was ineffective for motion-related pain.
|
https://pubmed.ncbi.nlm.nih.gov/12237186/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't"
] |
12237186
|
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] |
12,237,188 |
Postsurgical pain outcome assessment.
|
Jensen Mark P MP, Chen Connie C, Brugger Andrew M AM
|
Pain . Vol. 99, No. 1-2, 2002 Sep
|
Reliable and valid measures of pain are essential for conducting clinical trials of pain treatments. Perhaps the most important aspect of a pain measure's validity is its sensitivity, or ability to detect changes in pain over time and due to treatment. Several factors may affect a measure's sensitivity, including the complexity of the rating task for the measure, the number of pain intensity levels assessed by the measure, the dimension of pain assessed (e.g. pain intensity vs. pain relief), and the number of individual ratings (e.g. single rating vs. composite score) used to create the measure. The purpose of this study was to compare the relative sensitivity of three measures of outcome and a composite made up of all three measures for detecting analgesic effects in two samples of persons participating in a randomized controlled trial. One hundred and twenty-three patients who had undergone knee surgery and 124 women who had undergone a laparotomy were given one of three medications in the day after their surgery: morphine, ketorolac, or placebo. Two measures of pain intensity (a visual analog scale (VAS) and a 4-point verbal rating scale (VRS)) were administered at baseline, and these measures plus a 5-point VRS of pain relief were administered at 16 additional time points up to 24 h following surgery. As predicted, we found variability in the sensitivity of the outcome measures used in these studies, with the 4-point VRS showing less sensitivity than the VAS or relief ratings. However, contrary to our prediction, a composite measure of outcome made up of all three measures was not consistently superior to the individual measures for detecting treatment effects. Finally, we found that pain relief ratings were related to, but also distinct from, change in pain intensity as measured by changes in pain intensity ratings from baseline to each postmedication assessment point. These findings have important implications for the assessment of pain in clinical trials.
|
https://pubmed.ncbi.nlm.nih.gov/12237188/
|
[
"Clinical Trial",
"Comparative Study",
"Journal Article",
"Randomized Controlled Trial"
] |
12237188
|
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] |
12,237,193 |
Systematic review of randomised controlled trials of psychological therapy for chronic pain in children and adolescents, with a subset meta-analysis of pain relief.
|
Eccleston Christopher C, Morley Stephen S, Williams Amanda A, Yorke Louise L, Mastroyannopoulou Kiki K
|
Pain . Vol. 99, No. 1-2, 2002 Sep
|
A systematic review and subset meta-analysis of published randomised controlled trials of psychological therapies for children and adolescents with chronic pain is reported. A search of four computerised abstracting services recovered 123 papers from which 28 potential trials were identified. Eighteen met the criteria for inclusion in the review. The majority of these papers reported brief behavioural and cognitive behavioural interventions for children with headache and many were conducted in community (i.e. school) settings. Meta-analysis was applicable for 12 headache trials and one trial of recurrent abdominal pain using the Pain Index. The odds-ratio for a 50% reduction in pain was 9.62 and the number needed to treat was 2.32, indicating that the psychological treatments examined are effective in reducing the pain of headache. The quality of the 18 trials retrieved is narratively reviewed and suggestions for the development of trials in this field are made.
|
https://pubmed.ncbi.nlm.nih.gov/12237193/
|
[
"Journal Article",
"Meta-Analysis",
"Systematic Review"
] |
12237193
|
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] |
12,237,198 |
Naloxone increases pain induced by topical capsaicin in healthy human volunteers.
|
Anderson William S WS, Sheth Rishi N RN, Bencherif Badreddine B, Frost James J JJ, Campbell James N JN
|
Pain . Vol. 99, No. 1-2, 2002 Sep
|
Opioid receptors occur in locations of strategic importance within the central nervous system for modulation of pain. Is pain reduced by ongoing inhibition mediated by activation of these receptors? Experiments to date in which the opioid-receptor antagonist, naloxone, is administered during a painful event have yielded unclear results. Topically applied capsaicin can be used to induce tonic pain of moderate to severe intensity without tissue injury and is an ideal stimulus for studying acute pain modulation. We therefore conducted a placebo-controlled double-blind crossover study to investigate the effects of naloxone on capsaicin-induced pain (five men, four women, aged 29 +/- 5 years). Capsaicin (10%) was applied topically and subjects rated pain every 2 min. The subjects were told that any drug given to them could increase, decrease, or not change their pain sensation. Pain plateaued after 20 min. At 26 min subjects received either naloxone or placebo in double-blind fashion. At 56 min subjects received the alternative (placebo or naloxone). In a second session the order of presentation was reversed. The naloxone induced a significant increase in pain compared both to baseline (P < 0.01) and placebo (P < 0.01). The peak effect, reached at 12-20 min after naloxone delivery, was 59% greater than placebo. This experiment suggests that acute pain is actively suppressed by endogenous opioid-receptor activation.
|
https://pubmed.ncbi.nlm.nih.gov/12237198/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't",
"Research Support, U.S. Gov't, P.H.S."
] |
12237198
|
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] |
12,237,200 |
Anger and pain sensitivity in chronic low back pain patients and pain-free controls: the role of endogenous opioids.
|
Bruehl Stephen S, Burns John W JW, Chung Ok Yung OY, Ward Pamela P, Johnson Benjamin B
|
Pain . Vol. 99, No. 1-2, 2002 Sep
|
The experience of anger (i.e. trait anger) and anger management style (i.e. anger-in, anger-out) are related to sensitivity to acute and chronic pain stimuli, although underlying mechanisms are unknown. This study tested whether anger variables are associated with impaired endogenous opioid antinociceptive activity, and whether these relationships differed between chronic pain patients and healthy normals. Forty-three chronic low back pain (LBP) sufferers and 45 pain-free normals received opioid blockade (8 mg naloxone i.v.) or placebo blockade (saline) in randomized, counterbalanced order in separate sessions. During each session, subjects participated in a 1-min finger pressure pain task followed by an ischemic forearm pain task (maximum duration 5 min), providing pain intensity ratings during and immediately following each task. As a measure of opioid antinociceptive function, drug effects were derived by subtracting placebo from blockade condition pain ratings. Multivariate general linear model analyses indicated that anger-out, but not anger-in, had significant main effects on both finger pressure drug effects (P < 0.05) and ischemic task drug effects (P < 0.05). As hypothesized, high anger-out scores were associated with an absence of opioid analgesia during the acute pain tasks; low anger-out scores were associated with effective opioid analgesia. A similar non-significant trend was noted for trait anger on finger pressure drug effects (P < 0.06). Anger-out x LBP/normal interactions were non-significant, suggesting that links between anger-out and drug effects were similar for patients and normals. Controlling for depression did not eliminate the significant relationship between anger-out and drug effects. Findings suggest that anger-in and anger-out affect pain sensitivity through different mechanisms: only the effects of anger-out may be mediated by endogenous opioid dysfunction.
|
https://pubmed.ncbi.nlm.nih.gov/12237200/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, U.S. Gov't, P.H.S."
] |
12237200
|
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] |
12,237,201 |
Magnesium Bier's block for treatment of chronic limb pain: a randomised, double-blind, cross-over study.
|
Tramèr Martin R MR, Glynn Chris J CJ
|
Pain . Vol. 99, No. 1-2, 2002 Sep
|
Magnesium is a physiological antagonist of both calcium and the NMDA receptor. Patients with chronic pain of a limb (>1 month's duration) were treated with two Bier's blocks (250 mmHg, 10 m) in a randomised, double-blind, cross-over design. They received once 20% magnesium sulphate (500 mg) + lignocaine 1% (75 mg), and once physiological saline + lignocaine 1% (75 mg). The volume of both treatments was 10 ml. Efficacy data from 49 treatments (25 magnesium, 24 placebo) could be analysed. With magnesium-lignocaine, the duration of pain relief as reported by the patients was on average 23 days (95% CI 8-38) compared with 6 days (95% CI 2-10) with lignocaine alone (P = 0.043). With magnesium-lignocaine, 54.2% of patients had more than 50% pain relief compared with 25% with lignocaine alone (number-needed-to-treat 3.5, P = 0.075). With magnesium-lignocaine, 20% of patients had a treatment failure (i.e. pain relief <24 h) compared with 50% with lignocaine alone (number needed-to-treat 3.3, 95% CI 1.8-29, P = 0.038). The magnesium-lignocaine treatment was painful in 52% of patients compared with 8% with lignocaine alone (number-needed-to-harm 2.3, 95% CI 1.5-4.5, P =0.0008). For patients with chronic limb pain, the addition of magnesium to a Bier's block with lignocaine improves and prolongs pain relief and reduces the number of treatment failures. The optimal dose of lignocaine to prevent magnesium-induced aching of the treated limb needs to be established. Bier's block with magnesium-lignocaine may provide a possible treatment alternative in these patients.
|
https://pubmed.ncbi.nlm.nih.gov/12237201/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial"
] |
12237201
|
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] |
12,237,203 |
Sensory stimulation (TENS): effects of parameter manipulation on mechanical pain thresholds in healthy human subjects.
|
Chesterton Linda S LS, Barlas Panos P, Foster Nadine E NE, Lundeberg Thomas T, Wright Christine C CC, Baxter G David GD
|
Pain . Vol. 99, No. 1-2, 2002 Sep
|
Transcutaneous electrical nerve stimulation (TENS) is a popular form of electrostimulation. Despite an extensive research base, there remains no consensus regarding the parameter selection required to achieve maximal hypoalgesic effects. The aim of this double blind, sham-controlled study was to investigate the relative hypoalgesic effects of different TENS parameters (frequency, intensity and stimulation site) upon experimentally induced mechanical pain. Two hundred and forty participants were recruited in order to provide statistical analysis with 80% power at alpha = 0.05. Subjects were randomised to one of the six TENS groups, a control, and a sham TENS group (n = 30, 15 males, 15 females, per group). TENS groups differed in their combinations of stimulation; frequency (4 or 110 Hz), intensity ('to tolerance' or 'strong but comfortable') and stimulation site (segmental--over the distribution of the radial nerve or, extrasegmental--over acupuncture point 'gall bladder 34', or a combination of both segmental and extrasegmental). Pulse duration was fixed at 200 micros. Stimulation was delivered for 30 min and subjects were then monitored for a further 30 min. Mechanical pain threshold (MPT) was measured using a pressure algometer and taken from the first dorsal interosseous muscle of the dominant hand, ipsilateral to the stimulation site. MPT measures were taken, at baseline, and at 10-min intervals for 60 min. Difference scores were analysed using repeated measures and one-way ANOVA and relevant post hoc tests. Low frequency, high intensity, extrasegmental stimulation produced a rapid onset hypoalgesic effect, which increased during the stimulation period (P < 0.0005 control and sham) and was sustained for 30 min post-stimulation (P < 0.0005(control), P = 0.024(sham)). Whilst high frequency, 'strong but comfortable' intensity, segmental stimulation produced comparable hypoalgesic levels during stimulation, this effect was not sustained post-stimulation. Stimulation at a combination of the two sites did not produce any greater hypoalgesic effects. These results may have implications for the clinical use of sensory stimulation.
|
https://pubmed.ncbi.nlm.nih.gov/12237203/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't"
] |
12237203
|
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] |
12,237,211 |
Assessment of the reproducibility of intradermal administration of capsaicin as a model for inducing human pain.
|
Hughes Andrew A, Macleod Angela A, Growcott Jim J, Thomas I I
|
Pain . Vol. 99, No. 1-2, 2002 Sep
|
The reproducibility and tolerability of intradermal (i.d.) administration of capsaicin as a method for eliciting human pain was assessed in healthy male volunteers (n = 12). The primary endpoints for assessing pain were spontaneous pain response and areas of allodynia, pinprick hyperalgesia and neurogenic inflammation. These were recorded before, immediately after, and at regular intervals following each of four doses (250 microg) of capsaicin (two per trial day). Within- and between-subject variability to the technique was assessed by measuring the maximum recorded values (max), time to maximum value (t(max)) and area under the curve (AUC(0-1 h)) of each of the endpoints. Tolerability to the technique was addressed by recording adverse events. Reproducibility of the i.d. capsaicin model was demonstrated for each type of capsaicin-induced pain. Following each dose, the magnitude and profile of response and overall AUC values were similar for each parameter although some decrease in pinprick hyperalgesia was observed over time. For spontaneous pain, evidence of a period effect was observed in mean AUC data, with values increasing following the second dose of each trial day. This effect was confounded by the possibility of an arm effect, with the non-dominant arm appearing to be more sensitive to pain than the dominant arm. The data were not sufficient to confirm the existence of these effects. Between-subject variability and within-day, within-subject variability accounted for most of the variability observed in the trial. By optimising study design to eliminate these sources of variability, it was estimated that spontaneous pain and the area of allodynia would be the least variable endpoints. A positive correlation was found between the area of allodynia and area of pinprick hyperalgesia (r(2) = 0.835). Overall, the model was well tolerated with no reports of adverse events. We conclude that the tolerability profile, and variability of i.d. capsaicin-induced pain is acceptable for pharmacological profiling of novel anti-nociceptive agents, with limited number of subjects.
|
https://pubmed.ncbi.nlm.nih.gov/12237211/
|
[
"Clinical Trial",
"Journal Article"
] |
12237211
|
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] |
12,237,213 |
Comparative study of electronic vs. paper VAS ratings: a randomized, crossover trial using healthy volunteers.
|
Jamison Robert N RN, Gracely Richard H RH, Raymond Stephen A SA, Levine Jonathan G JG, Marino Barbara B, Herrmann Timothy J TJ, Daly Margaret M, Fram David D, Katz Nathaniel P NP
|
Pain . Vol. 99, No. 1-2, 2002 Sep
|
The visual analogue scale (VAS) is an established, validated, self-report measure usually consisting of a 10 cm line on paper with verbal anchors labeling the ends. Palmtop computers (PTCs also known as personal digital appliances) have incorporated VAS entry by use of a touch screen. However, the validity and psychophysical properties of the electronic VAS have never been formally compared with the conventional paper VAS. The aim of this study is to determine the agreement between the electronic (eVAS) and paper (pVAS) modes. Twenty-four healthy volunteers were recruited for this study. Each study participant provided input using both measurement methods by marking the eVAS and pVAS in response to two kinds of stimuli, cognitive and sensory. A verbal rating scale of seven descriptors of intensity represented the cognitive stimuli. Participants were asked to mark the location that best corresponded to the pain intensity described by each word on scales from 'no pain' to 'worst possible pain'. The sensory stimuli used were a set of test weights consisting of plastic containers ranging from 7 to 129 g. The VAS for sensory stimuli ranged from 0 (no weight) to 'reference weight' (the heaviest weight outside the range of test weights). There were two types of input stimuli and two modes for recording responses for a total of four experimental conditions. Two evaluators independently measured and recorded all the pVAS forms to the nearest millimeter. A total of 2016 stimuli were rated. The overall correlation for ratings of both sensory and cognitive stimuli on eVAS and pVAS was r = 0.91. For paired verbal stimuli the correlation was r = 0.97. For paired sensory stimuli the correlation was r = 0.86. The correlation between group eVAS and pVAS ratings to common verbal stimuli was r = 0.99. For common sensory stimuli the group correlation was r = 0.99. The median of correlations comparing eVAS and pVAS ratings was 0.99 for verbal stimuli and 0.98 for sensory stimuli. Multivariate analyses showed equivalent stimuli to be rated much the same whether entered on paper VAS or PTC touch screen VAS (P < 0.0001). Support was found for the validity of the computer version of the VAS scale.
|
https://pubmed.ncbi.nlm.nih.gov/12237213/
|
[
"Clinical Trial",
"Comparative Study",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't"
] |
12237213
|
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] |
12,237,477 |
Acute effects of glibenclamide on reactive hyperaemia in the lower limbs in humans.
|
Capecchi P L PL, Guideri F F, Colafati M M, Acampa M M, Cuomo A A, Lazzerini P E PE, Pasini F Laghi FL
|
Clinical hemorheology and microcirculation . Vol. 27, No. 2, 2002
|
Three episodes of 1 min ischemia in the lower limbs in humans reduced the metabolic debt repayment (expressed as AUC of reactive hyperaemia) following more prolonged ischemia (666.6+/-86.6 vs 500.0+/-33.5 ml/100 ml). The administration of the ATP-dependent K(+) channel blocker glibenclamide was associated with a significant reduction in the AUC of reactive hyperaemia (666.6+/-86.6 vs 563.1+/-76.6 ml/100 ml), and with the removal of the protective effect produced by 3 episodes of 1 min ischemia (563.1+/-76.6 vs 551.8+/-71.3 ml/100 ml). Plasma level of glibenclamide reached the peak value of 1.295+/-0.15 micromol/l 2 h after drug administration, ranging around the 1 micromol/l concentration in the following 3 hours. Our findings produce indirect evidence that, similarly to the ischemic preconditioning of the heart, the protective effects towards ischemia of brief repeated episodes of sub-maximal occlusion in the peripheral circulation of the lower limbs in humans are mediated by ATP-dependent K(+) channels.
|
https://pubmed.ncbi.nlm.nih.gov/12237477/
|
[
"Clinical Trial",
"Journal Article"
] |
12237477
|
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] |
12,237,596 |
Dynamics of pneumococcal nasopharyngeal carriage in children with nonresponsive acute otitis media treated with two regimens of intramuscular ceftriaxone.
|
Haiman Tamar T, Leibovitz Eugene E, Piglansky Lolita L, Press Joseph J, Yagupsky Pablo P, Leiberman Alberto A, Dagan Ron R
|
The Pediatric infectious disease journal . Vol. 21, No. 7, 2002 Jul
|
BACKGROUND: A 3-day intramuscular ceftriaxone regimen was superior to a 1-day regimen in the treatment of nonresponsive acute otitis media caused by resistant Streptococcus pneumoniae. However, the effect of various regimens of intramuscular cefriaxone on the nasopharyngeal carriage of S. pneumoniae and especially that of resistant strains during and after therapy has not been thoughtfully studied. OBJECTIVES: To compare the effect of one dose and three dose intramuscular ceftriaxone regimens on the nasopharyngeal carriage of S. pneumoniae in patients with nonresponsive acute otitis media treated with these two regimens and to document the dynamics of nasopharyngeal colonization with S. pneumoniae during and after completion of these two therapeutic regimens. PATIENTS AND METHODS: In a prospective study performed during January, 1998, through September, 1999, 170 evaluable patients ages 3 to 36 months with nonresponsive acute otitis media were randomized to receive the 1 (n = 83)- or 3 (n = 87)-day intramuscular ceftriaxone regimen (50 mg/kg/day), respectively. Nasopharyngeal cultures for S. pneumoniae were obtained on Days 1, 4 to 5, 11 to 14 and 28 to 30. Susceptibility of S. pneumoniae to penicillin and ceftriaxone was determined by E-test. RESULTS: On Day 1 nasopharyngeal S. pneumoniae carriage was found in 108 (64%) patients, 54 in each treatment group. Forty-seven of 54 (87%) and 9 of 54 (17%) S. pneumoniae isolates from the one dose group were nonsusceptible to penicillin and ceftriaxone, respectively; the respective values in the three dose group were 49 of 54 (91%) and 8 of 54 (15%). On Days 4 and 5 negative nasopharyngeal cultures were achieved in 43 of 83 (52%) and 70 of 87 (80%) cases from the one dose and three dose group, respectively (P < 0.001). Eradication of penicillin-nonsusceptible S. pneumoniae was achieved on Day 4 to 5 in 18 of 49 (37%) and 39 of 49 (80%) organisms isolated from the one dose and three dose groups, respectively (P < 0.001). Nasopharyngeal S. pneumoniae carriage among evaluable patients on Days 11 to 14 and Days 28 to 30 was 43 of 69 (62%) and 31 of 45 (69%) for the one dose group and 42 of 73 (58%) and 31 of 50 (62%) for the three dose group, respectively (P not significant). A decrease was observed during the study period in the proportion of highly penicillin-resistant S. pneumoniae isolated in the three dose group compared with the one dose group (30, 24, 17 and 13% vs. 30, 27, 19 and 26% at Days 1, 4 to 5, 11 to 14 and 28 to 30, respectively; P = 0.05). CONCLUSIONS: A marked reduction in the carriage of penicillin-nonsusceptible S. pneumoniae (including highly penicillin-resistant organisms) was achieved on Days 4 to 5 of therapy with both ceftriaxone regimens. The 3-day intramuscular ceftriaxone regimen was significantly superior to the 1-day regimen in the reduction of carriage during the treatment period. The reduction of overall S. pneumoniae nasopharyngeal carriage by both ceftriaxone regimens was a short-lived phenomenon followed by rapid recolonization of the nasopharynx.
|
https://pubmed.ncbi.nlm.nih.gov/12237596/
|
[
"Clinical Trial",
"Comparative Study",
"Journal Article",
"Randomized Controlled Trial"
] |
12237596
|
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12,237,598 |
Safety and antiretroviral activity of chronic subcutaneous administration of T-20 in human immunodeficiency virus 1-infected children.
|
Church Joseph A JA, Cunningham Coleen C, Hughes Michael M, Palumbo Paul P, Mofenson Lynne M LM, Delora Patricia P, Smith Elizabeth E, Wiznia Andrew A, Purdue Lynette L, Hawkins Elizabeth E, Sista Prakash P,
|
The Pediatric infectious disease journal . Vol. 21, No. 7, 2002 Jul
|
BACKGROUND: Entry inhibitors, a new class of antiretroviral agents, interfere with the attachment, coreceptor interaction or fusion of HIV-1 with host target cells. The fusion inhibitor T-20 is the first in this new class, and the present study is the first to examine chronic s.c. administration of T-20 to HIV-1-infected children. METHODS: Fourteen children, 4 to 12 years of age, with incompletely suppressed HIV-1 were studied. The median plasma viral load at baseline was 26,866 copies/ml (4.4 log10), and the median CD4 count was 523 cells/mm3. T-20 was administered twice daily by s.c. injection at 30 or 60 mg per m2 of body surface area per dose. For 7 days T-20 was added to the patients' background antiretroviral regimens; at Day 7 each subject's background therapy was changed to a regimen that was predicted to be virologically active, while T-20 was continued. Results are presented for the first 24 weeks of chronic T-20 dosing. RESULTS: T-20 was generally well-tolerated. One child discontinued the drug because of aversion to injections, but no child discontinued because of adverse events. Eleven (79%) of 14 children had local injection site reactions at some time during the chronic T-20 dosing. Eleven of 14 subjects achieved the protocol-specified milestone of at least a 0.7-log10 reduction in plasma HIV-1 RNA by Day 7. In 10 subjects (71%) virologic suppression of 1.0 log10 or greater was achieved at 24 weeks; 6 subjects (43%) had viral loads <400 copies/ml and 3 (21%) had fewer than 50 copies/ml at 24 weeks. CONCLUSIONS: These results indicate that a 24-week regimen of twice daily s.c. dosing of T-20 in HIV-1-infected children is safe and tolerable and that it is associated with suppression of HIV-1 replication during 24 weeks of administration.
|
https://pubmed.ncbi.nlm.nih.gov/12237598/
|
[
"Clinical Trial",
"Clinical Trial, Phase I",
"Clinical Trial, Phase II",
"Comparative Study",
"Journal Article"
] |
12237598
|
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12,237,599 |
Efavirenz liquid formulation in human immunodeficiency virus-infected children.
|
Starr Stuart E SE, Fletcher Courtney V CV, Spector Stephen A SA, Brundage Richard C RC, Yong Florence H FH, Douglas Steven D SD, Flynn Patricia M PM, Kline Mark W MW,
|
The Pediatric infectious disease journal . Vol. 21, No. 7, 2002 Jul
|
BACKGROUND: This study determined the safety, pharmacokinetics, antiviral activity and immunologic effects of efavirenz liquid formulation, nelfinavir and nucleoside reverse transcriptase inhibitors (NRTIs) in HIV-infected children, 3 to 9 years of age. METHODS: Plasma HIV-1 RNA and lymphocyte subsets were measured at various intervals after initiation of therapy. Pharmacokinetic studies were performed at Week 2, and doses of efavirenz and nelfinavir were adjusted if area under the curve values fell outside specified target ranges. RESULTS: This combination of antiretrovirals was well-tolerated. Pharmacokinetic values were similar to those observed in a previous study of older children who received efavirenz capsules in combination with nelfinavir and NRTIs. After 48 weeks of therapy 63% of subjects had plasma HIV RNA levels of <400 copies/ml, and 58% had <50 copies/ml in an intent-to-treat analysis. CD4 cell count and percentage rose significantly over this time, whereas the number of activated CD8 cells declined. CONCLUSIONS: Combination therapy with efavirenz liquid formulation, nelfinavir and NRTIs is an attractive treatment option for HIV-infected children >3 years of age who are unable to take efavirenz capsules.
|
https://pubmed.ncbi.nlm.nih.gov/12237599/
|
[
"Clinical Trial",
"Clinical Trial, Phase I",
"Clinical Trial, Phase II",
"Comparative Study",
"Journal Article",
"Multicenter Study",
"Research Support, Non-U.S. Gov't",
"Research Support, U.S. Gov't, P.H.S."
] |
12237599
|
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] |
12,237,625 |
Hysteroscopic transcervical endometrial resection versus thermal destruction for menorrhagia: a prospective randomized trial on satisfaction rate.
|
Pellicano Massimiliano M, Guida Maurizio M, Acunzo Giuseppe G, Cirillo Domenico D, Bifulco Giuseppe G, Nappi Carmine C
|
American journal of obstetrics and gynecology . Vol. 187, No. 3, 2002 Sep
|
OBJECTIVE: The purpose of this study was to compare the satisfaction rate and the effectiveness of transcervical hysteroscopic endometrial resection and thermal destruction of the endometrium in the treatment of menorrhagia. STUDY DESIGN: A prospective randomized trial with 2 years of follow-up was carried out in the Department of Gynecology of the University of Naples. Eighty-two patients who were affected by menorrhagia that was unresponsive to medical treatment were respectively randomized to transcervical hysteroscopic endometrial resection or to thermal destruction of the endometrium. Satisfaction rate, operative time, discharge time, complication rate, reintervention rate, and resumption of normal activity were evaluated in each group. RESULTS: The satisfaction rate was significantly higher in the thermal destruction group. Operative time was significantly shorter in the thermal destruction group (24 +/- 4 minutes vs 37 +/- 6 minutes). Intraoperative blood loss was significantly lower in the thermal destruction group (7.2 +/- 2.8 mL vs 89 +/- 38 mL). Reintervention rates were higher in the transcervical hysteroscopic endometrial resection group, although postoperative pain was not significantly different between the two groups. Discharge time, complication rate, and resumption of normal activity were not significantly different between the two groups. CONCLUSION: Thermal destruction of the endometrium for the treatment of menorrhagia should be considered an effective therapeutic option because of its acceptability among patients, shorter operative time, and lower blood loss.
|
https://pubmed.ncbi.nlm.nih.gov/12237625/
|
[
"Clinical Trial",
"Comparative Study",
"Journal Article",
"Randomized Controlled Trial"
] |
12237625
|
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12,237,626 |
Safety and efficacy of fluoxetine in patients who receive oral contraceptive therapy.
|
Koke Stephanie C SC, Brown Eileen B EB, Miner Cherri M CM
|
American journal of obstetrics and gynecology . Vol. 187, No. 3, 2002 Sep
|
OBJECTIVE: Because many women who receive pharmacologic therapy with antidepressants are also prescribed oral contraceptives, it is important to assess the risk of clinically significant drug interactions. We reviewed the United States fluoxetine clinical trial database, specifically analyzing women ages 18 to 45 years, for differences in safety, antidepressant efficacy, and unplanned pregnancies that were associated with oral contraceptive use. STUDY DESIGN: Data from 17 double-blind, placebo-controlled clinical trials in 1698 women were analyzed retrospectively. A subgroup of women with oral contraceptive use was compared with a subgroup of women with no oral contraceptive use. Differences in treatment-emergent adverse events, unplanned pregnancies, and 17-item Hamilton Depression Scale (HAMD-17) scores were analyzed. RESULTS: The only treatment-emergent adverse events that showed a statistically significantly different odds ratio for oral contraceptive use versus no oral contraceptive use were headache, asthenia, and pain. There was not a statistically significant interaction in the incidence of unintended pregnancies (P =.111) or in the changes from baseline in HAMDD-17 scores. CONCLUSION: There is no clinical evidence that concomitant use of oral contraceptives and fluoxetine affects the safety or efficacy of either agent.
|
https://pubmed.ncbi.nlm.nih.gov/12237626/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't"
] |
12237626
|
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] |
12,237,621 |
Adverse events that are associated with the selective estrogen receptor modulator levormeloxifene in an aborted phase III osteoporosis treatment study.
|
Goldstein Steven R SR, Nanavati Nayan N
|
American journal of obstetrics and gynecology . Vol. 187, No. 3, 2002 Sep
|
OBJECTIVE: Selective estrogen receptor modulators are novel compounds that bind to the estrogen receptor and have mixed agonistic and antagonistic activities. Recently, an increase in urinary incontinence has been reported with hormone replacement therapy use. A decrease in surgical procedures for pelvic floor relaxation has been recently reported with raloxifene, a selective estrogen receptor modulator that is not uterotropic. Levormeloxifene is a selective estrogen receptor modulator that was developed for the purpose of the treatment and prevention of postmenopausal osteoporosis. STUDY DESIGN: This was a multicentered prospective study of healthy women aged >or=65 years with osteoporosis who were randomized to blindly receive placebo or levormeloxifene 0.5 mg or 1.25 mg daily as part of a planned 3-year osteoporosis treatment study. Multiple medical and gynecologic evaluations were performed. Adverse events were reported to investigators and coded with the use of World Health Organization terminology. This study was halted after 10 months because of the large number of gynecologic and other adverse events. RESULTS: Among 2924 women who were studied, those women who were treated with levormeloxifene had a marked increase compared with placebo in leukorrhea (30% vs 3%), increased endometrial thickness on ultrasound scan (19% vs 1%), enlarged uterus (17% vs 3%), uterovaginal prolapse (7% vs 2%), urinary incontinence (17% vs 4%), increased micturition frequency (9% vs 4%), lower abdominal pain (17% vs 6%), hot flushes (10% vs 3%), and leg cramps (6% vs 0.8%). All of these differences were highly statistically significant with a probability value of.0001 for each. CONCLUSION: Levormeloxifene results in multiple adverse gynecologic and other events in postmenopausal women with osteoporosis.
|
https://pubmed.ncbi.nlm.nih.gov/12237621/
|
[
"Clinical Trial",
"Clinical Trial, Phase III",
"Journal Article",
"Multicenter Study",
"Randomized Controlled Trial"
] |
12237621
|
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] |
12,237,643 |
A prospective randomized safety trial of celecoxib for treatment of preterm labor.
|
Stika Catherine S CS, Gross Gilad A GA, Leguizamon Gustavo G, Gerber Susan S, Levy Roni R, Mathur Amit A, Bernhard Lisa M LM, Nelson D Michael DM, Sadovsky Yoel Y
|
American journal of obstetrics and gynecology . Vol. 187, No. 3, 2002 Sep
|
OBJECTIVE: We compared the safety of celecoxib, a selective cyclo-oxygenase-2 inhibitor, with the safety of the nonselective cyclo-oxygenase inhibitor indomethacin, when it was administered for treatment of preterm labor. STUDY DESIGN: In a randomized, double-blind, placebo-controlled trial, 24 pregnant women in preterm labor at 24 to 34 weeks of gestation received either indomethacin or celecoxib for 48 hours. Clinical assessment, fetal sonography, and Doppler blood flow studies of the fetal ductus arteriosus were performed daily. RESULTS: Mean maximum ductal flow velocity was significantly elevated over baseline (82.9 +/- 4.6 cm/s vs 111.14 +/- 14.3 cm/s; P =.02) after 24 hours of indomethacin, but not celecoxib. Both medications were associated with a transient decrease in amniotic fluid volume, with a greater effect by indomethacin. The medications were equally effective in the maintenance of tocolysis. There were no significant maternal or neonatal adverse events. CONCLUSION: In this initial evaluation, the safety of short-term celecoxib in women with preterm labor was superior to that of indomethacin.
|
https://pubmed.ncbi.nlm.nih.gov/12237643/
|
[
"Clinical Trial",
"Comparative Study",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't"
] |
12237643
|
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] |
12,237,663 |
Vitamin C and E supplementation in women at risk of preeclampsia is associated with changes in indices of oxidative stress and placental function.
|
Chappell Lucy C LC, Seed Paul T PT, Kelly Frank J FJ, Briley Annette A, Hunt Beverley J BJ, Charnock-Jones D Stephen DS, Mallet Anthony A, Poston Lucilla L
|
American journal of obstetrics and gynecology . Vol. 187, No. 3, 2002 Sep
|
OBJECTIVE: We have previously reported a reduced incidence of preeclampsia in women who were at risk and were taking vitamin C (1000 mg/d) and vitamin E (400 IU/d) supplements. In this study, we determined whether supplementation in the same cohort was associated with an improvement in indices of placental dysfunction and oxidative stress toward values determined in women who were at low risk of preeclampsia. STUDY DESIGN: Seventy-nine women who were at high risk and who were taking vitamin supplements and 81 who were taking placebos were compared with 32 women who were at low risk and who were not taking supplements who were studied simultaneously. RESULTS: Indices of oxidative stress and placental function were abnormal in the placebo group. When the placebo group was compared with the women who were at low risk, ascorbic acid, plasminogen activator inhibitor-2, and placenta growth factor concentrations were decreased; and 8-epi-prostaglandin F(2alpha),leptin, and the plasminogen activator inhibitor-1/-2 ratio were increased. In the group that received vitamin supplements, ascorbic acid, 8-epi-prostaglandin F(2alpha), leptin, and plasminogen activator inhibitor-1/-2 values were similar to women who were at low risk. CONCLUSION: Antioxidant supplementation in women who were at risk of preeclampsia was associated with improvement in biochemical indices of the disease.
|
https://pubmed.ncbi.nlm.nih.gov/12237663/
|
[
"Clinical Trial",
"Controlled Clinical Trial",
"Journal Article",
"Research Support, Non-U.S. Gov't"
] |
12237663
|
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12,237,738 |
A randomized, double-blind comparison of 10 and 20 mg lercanidipine in patients with stable effort angina: effects on myocardial ischemia and heart rate variability.
|
Acanfora Domenico D, Trojano Luigi L, Gheorghiade Mihai M, Picone Costantino C, Papa Antimo A, Furgi Giuseppe G, Giuliano Franca F, Maestri Roberto R, Rengo Franco F
|
American journal of therapeutics . Vol. 9, No. 5
|
We evaluated the anti-ischemic action and the effects on autonomic function of lercanidipine, a long-acting dihydropyridine calcium antagonist, in 25 patients with stable effort angina in a randomized, double-blind, parallel trial. After a 2-week placebo run-in period, patients entered a 2-week treatment period with 10 or 20 mg of lercanidipine once daily. During the placebo run-in period and at the study end, the patients underwent clinical examination, electrocardiography, exercise tests, 24-hour Holter electrocardiography for long-term heart rate variability evaluation, and short-term spectral analysis of heart rate and systolic blood pressure variability and plasma epinephrine and norepinephrine levels at rest and during tilting. Results showed that time to onset of ST segment depression > or =1 mm was significantly increased by both drug doses. No significant change was recorded in the average hourly heart rate after treatment with both 10 and 20 mg of lercanidipine. During the 24-hour recordings, no significant change was observed in low-frequency power, high-frequency power, or low frequency/high frequency. In the standing position, there was a significant increase in plasma norepinephrine and epinephrine concentration in both groups, and no change in the supine position after 10 and 20 mg of lercanidipine. When considering short-term heart rate variability, no significant difference was observed in either treatment group in low frequency, high frequency, or their ratio on electrocardiographic R-R spectra. The blood pressure spectral component was also unchanged. In conclusion, lercanidipine is effective in reducing ischemia in patients with stable effort angina. Moreover, lercanidipine does not cause adrenergic activation, which is the main mechanism hypothesized to explain the negative effect on cardiovascular mortality assigned to short-acting dihydropyridine calcium antagonists.
|
https://pubmed.ncbi.nlm.nih.gov/12237738/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't"
] |
12237738
|
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] |
12,237,768 |
A phase I trial of antibody directed enzyme prodrug therapy (ADEPT) in patients with advanced colorectal carcinoma or other CEA producing tumours.
|
Francis R J RJ, Sharma S K SK, Springer C C, Green A J AJ, Hope-Stone L D LD, Sena L L, Martin J J, Adamson K L KL, Robbins A A, Gumbrell L L, O'Malley D D, Tsiompanou E E, Shahbakhti H H, Webley S S, Hochhauser D D, Hilson A J AJ, Blakey D D, Begent R H J RH
|
British journal of cancer . Vol. 87, No. 6, 2002 Sep 09
|
Antibody-directed enzyme prodrug therapy is a targeted therapy in which a prodrug is activated selectively at the tumour site by an enzyme, which has been targeted to the tumour by an antibody (antibody-enzyme conjugate). Previous clinical trials have shown evidence of tumour response, however, the activated drug had a long half-life, which resulted in dose-limiting myelosuppression. Also, the targeting system, although giving high tumour to blood ratios of antibody-enzyme conjugate (10 000 : 1) required administration of a clearing antibody in addition to the antibody-enzyme conjugate. The purpose of this current study therefore was to attempt tumour targeting of the antibody-enzyme conjugate without the clearing antibody, and to investigate a new prodrug (bis-iodo phenol mustard, ZD2767P) whose activated form is highly potent and has a short half-life. Twenty-seven patients were treated with antibody-directed enzyme prodrug therapy using A5CP antibody-enzyme conjugate and ZD2767P prodrug, in a dose-escalating phase I trial. The maximum tolerated dose of ZD2767P was reached at 15.5 mg m(-2)x three administrations with a serum carboxypeptidase G2 level of 0.05 U ml(-1). Myelosuppression limited dose escalation. Other toxicities were mild. Patients' quality of life was not adversely affected during the trial as assessed by the measures used. There were no clinical or radiological responses seen in the study, but three patients had stable disease at day 56. Human anti-mouse antibody and human anti-carboxypeptidase G2 antibody were produced in response to the antibody enzyme conjugate (A5CP). The antibody-enzyme conjugate localisation data (carboxypeptidase G2 enzyme levels by HPLC on tumour and normal tissue samples, and gamma camera analysis of I-131 radiolabelled conjugate) are consistent with inadequate tumour localisation (median tumour: normal tissue ratios of antibody-enzyme conjugate of less than 1). A clearance system is therefore desirable with this antibody-enzyme conjugate or a more efficient targeting system is required. ZD2767P was shown to clear rapidly from the circulation and activated drug was not measurable in the blood. ZD2767P has potential for use in future antibody-directed enzyme prodrug therapy systems.
|
https://pubmed.ncbi.nlm.nih.gov/12237768/
|
[
"Clinical Trial",
"Clinical Trial, Phase I",
"Comparative Study",
"Journal Article",
"Research Support, Non-U.S. Gov't"
] |
12237768
|
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] |
12,237,770 |
Effects of patient selection on the applicability of results from a randomised clinical trial (EORTC 10853) investigating breast-conserving therapy for DCIS.
|
Bijker N N, Peterse J L JL, Fentiman I S IS, Julien J-P JP, Hart A A M AA, Avril A A, Cataliotti L L, Rutgers E J T EJ
|
British journal of cancer . Vol. 87, No. 6, 2002 Sep 09
|
Selection of patients for randomised clinical trials may have a large impact on the applicability of the study results to the general population presenting the same disorder. However, clinical characteristics and outcome data on non-entered patients are usually not available. The effects of patient selection for the EORTC 10853 trial investigating the role of radiotherapy in breast conserving therapy for ductal carcinoma in situ have been studied, in an analysis of all patients treated for ductal carcinoma in situ in five participating institutes. The reasons for not entering patients were evaluated and treatment results of the randomised patients were compared to those not entered. A total of 910 patients were treated for ductal carcinoma in situ. Of these, 477 (52%) were ineligible, with the size of the lesion being the main reason for ineligibility (30% of all ductal carcinoma in situ). Of the 433 eligible patients, 278 (64%) were randomised into the trial. The main reasons for non-entry of eligible patients were either physicians' preference for one of the treatment arms (26%) or patients' refusal (9%). These percentages showed significant variation among the institutes. At 4 years follow-up, those patients not entered in the trial and treated with local excision and radiotherapy, had higher local recurrence rates than the patients randomised in the trial and treated with the same approach, (17 vs 2%, P=0.03). The patients treated with local excision alone had equal local recurrence rates (11% in both groups). Selection of patients may explain the differences in outcome of the randomised patients, and those not-entered. Thus, the results of this trial may not be applicable to all patients with ductal carcinoma in situ.
|
https://pubmed.ncbi.nlm.nih.gov/12237770/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial"
] |
12237770
|
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] |
12,237,769 |
A phase I and pharmacokinetic study of MAG-CPT, a water-soluble polymer conjugate of camptothecin.
|
Schoemaker N E NE, van Kesteren C C, Rosing H H, Jansen S S, Swart M M, Lieverst J J, Fraier D D, Breda M M, Pellizzoni C C, Spinelli R R, Grazia Porro M M, Beijnen J H JH, Schellens J H M JH, ten Bokkel Huinink W W WW
|
British journal of cancer . Vol. 87, No. 6, 2002 Sep 09
|
Polymeric drug conjugates are a new and experimental class of drug delivery systems with pharmacokinetic promises. The antineoplastic drug camptothecin was linked to a water-soluble polymeric backbone (MAG-CPT) and administrated as a 30 min infusion over 3 consecutive days every 4 weeks to patients with malignant solid tumours. The objectives of our study were to determine the maximal tolerated dose, the dose-limiting toxicities, and the plasma and urine pharmacokinetics of MAG-CPT, and to document anti-tumour activity. The starting dose was 17 mg m(-2) day(-1). Sixteen patients received 39 courses at seven dose levels. Maximal tolerated dose was at 68 mg m(-2) day(-1) and dose-limiting toxicities consisted of cumulative bladder toxicity. MAG-CPT and free camptothecin were accumulated during days 1-3 and considerable amounts of MAG-CPT could still be retrieved in plasma and urine after 4-5 weeks. The half-lives of bound and free camptothecin were equal indicating that the kinetics of free camptothecin were release rate dependent. In summary, the pharmacokinetics of camptothecin were dramatically changed, showing controlled prolonged exposure of camptothecin. Haematological toxicity was relatively mild, but serious bladder toxicity was encountered which is typical for camptothecin and was found dose limiting.
|
https://pubmed.ncbi.nlm.nih.gov/12237769/
|
[
"Clinical Trial",
"Clinical Trial, Phase I",
"Journal Article"
] |
12237769
|
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] |
12,237,786 |
Detoxification of opiate addicts with multiple drug abuse: a comparison of buprenorphine vs. methadone.
|
Seifert J J, Metzner C C, Paetzold W W, Borsutzky M M, Passie T T, Rollnik J J, Wiese B B, Emrich H M HM, Schneider U U
|
Pharmacopsychiatry . Vol. 35, No. 5, 2002 Sep
|
Over the last few years, there has been a growing tendency for opioid addicts to abuse multiple drugs, although many patients are in substitution therapy with methadone. Abuse of multiple drugs leads to a more complicated withdrawal syndrome; it is therefore necessary to investigate new drug strategies as a treatment for detoxification. Buprenorphine appears to be an effective and safe drug in opioid-addicted patient detoxification. In this study, we have compared the short-term efficacy of an 11-day low-dose buprenorphine/14-day carbamazepine regime [BPN/CBZ] (n = 14) to an 11-day methadone/14-day carbamazepine regime [MET/CBZ] (n = 12) in a double-dummy, randomized 14-day inpatient detoxification treatment study. Twenty-six inpatients met the DSM-IV criteria for opioid dependence and were included in this study. All patients abused various additional drugs. Fourteen of 26 patients (53.8 %) completed the study. Seven non-completers (seven of 12 = 58.3 %) were treated with methadone/carbamazepine and five non-completers (five of 14 = 35.7 %) received buprenorphine/carbamazepine, but the difference in the dropout rate was not significant. However, patients with buprenorphine/carbamazepine showed significantly fewer withdrawal symptoms after the first two weeks of treatment. The present study supports the hypothesis that buprenorphine/carbamazepine is more effective than methadone/carbamazepine in detoxification strategies for opioid addict with additional multiple drug abuse. No severe side effects occurred during treatment in either group.
|
https://pubmed.ncbi.nlm.nih.gov/12237786/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial"
] |
12237786
|
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12,237,787 |
Trimipramine in primary insomnia: results of a polysomnographic double-blind controlled study.
|
Riemann D D, Voderholzer U U, Cohrs S S, Rodenbeck A A, Hajak G G, Rüther E E, Wiegand M H MH, Laakmann G G, Baghai T T, Fischer W W, Hoffmann M M, Hohagen F F, Mayer G G, Berger M M
|
Pharmacopsychiatry . Vol. 35, No. 5, 2002 Sep
|
In recent years, sedating antidepressants have been increasingly used to treat primary insomnia. Up to now, only one open pilot study with trimipramine and one double-blind placebo-controlled study with doxepin have provided scientific support for this approach in treating primary insomnia. In order to test the hypothesis that sedating antidepressants are useful in the treatment of primary insomnia, the effect of trimipramine on objectively and subjectively measured parameters of sleep was investigated in a double-blind placebo- and lormetazepam-controlled study in a sample of 55 patients with primary insomnia attending outpatient sleep-disorder clinics. Trimipramine was selected since it has shown positive effects on sleep continuity with a lack of REM sleep suppression in studies on depressed patients and in one pilot study on patients with primary insomnia. Trimipramine at an average dose of 100 mg over a period of 4 weeks significantly enhanced sleep efficiency, but not total sleep time (which had been the primary target variable) compared to placebo as measured by polysomnography. Changes in objective sleep parameters were paralleled by changes in subjective sleep parameters. Trimipramine did not suppress REM sleep. Lormetazepam decreased wake time and sleep stage 3 and increased REM sleep compared to placebo. After switching trimipramine to placebo, sleep parameters returned to baseline. There was no evidence of any rebound effect from trimipramine. Side effects from trimipramine were only marginal. This first double-blind placebo-controlled study with trimipramine suggests its efficacy in the treatment of primary insomnia. However, due to the large intra- and interindividual variance in the parameters of interest before and during treatment a larger sample size would have been necessary to strengthen the validity of our findings.
|
https://pubmed.ncbi.nlm.nih.gov/12237787/
|
[
"Clinical Trial",
"Controlled Clinical Trial",
"Journal Article",
"Research Support, Non-U.S. Gov't"
] |
12237787
|
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] |
12,237,788 |
Plasma levels of catecholamine metabolites predict the response to sulpiride or fluvoxamine in major depression.
|
Ueda N N, Yoshimura R R, Shinkai K K, Nakamura J J
|
Pharmacopsychiatry . Vol. 35, No. 5, 2002 Sep
|
We investigated the relationships between the changes in plasma catecholamine metabolites obtained from depressed patients before and after administration of sulpiride, a benzamide compound, or fluvoxamine, a selective serotonin reuptake inhibitor (SSRI), and between clinical responses to treatment with each of these drugs. Responders to sulpiride had significantly lower plasma homovanillic acid (pHVA) levels before administration of sulpiride than did non-responders or controls (responders: 4.5 +/- 3.1 ng/ml, non-responders: 11.1 +/- 5.9 ng/ml, controls: 10.9 +/- 5.3 ng/ml). Positive relationships were observed between changes in pHVA levels and improvement rates in the 17-item Hamilton Depression Rating Scale (Ham-D). In contrast, responders to fluvoxamine had significantly higher plasma free 3-methoxy-4-hydroxyphenylglycol (pMHPG) levels before administration of fluvoxamine than did non-responders or controls (responders: 8.5 +/- 1.8 ng/ml, non-responders: 5.9 +/- 2.I ng/ml, controls: 5.2 +/- 2.9 ng/ml). Negative relationships were observed between changes in pMHPG levels and improvement rates in Ham-D. These results suggest that lower pretreatment pHVA levels and higher pretreatment levels of pMHPG might be predictors of response to sulpiride and fluvoxamine, respectively, and that sulpiride might produce a functional increase in the dopaminergic system, resulting in improvement in some depressive symptoms; fluvoxamine, on the other hand, might produce a functional decrease in the noradrenergic system via serotonergic neurons, resulting in improvement of those symptoms.
|
https://pubmed.ncbi.nlm.nih.gov/12237788/
|
[
"Clinical Trial",
"Controlled Clinical Trial",
"Journal Article",
"Research Support, Non-U.S. Gov't"
] |
12237788
|
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