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Results for “Randomized controlled trials”

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At least 1,207 records · Page 67Linked to original sources
PubMed2006

A randomized controlled trial of cognitive therapy for bipolar disorder: focus on long-term change.

BACKGROUND: This study reports the outcome of a randomized controlled trial of cognitive therapy (CT) for bipolar disorder. The treatment protocol differed from other published forms of CT for bipolar disorder through the addition of emotive techniques. METHOD: Fifty-two patients with DSM-IV bipolar I or II disorder were randomly allocated to a 6-month trial of either CT or treatment as usual, with both treatment groups also receiving mood stabilizers. Outcome measures included relapse rates, dysfunctional attitudes, psychosocial functioning, hopelessness, self-control, and medication adherence. Patients were assessed during treatment by independent raters blind to the patients' group status. RESULTS: At posttreatment, patients allocated to CT had experienced less severe depression scores (Beck Depression Inventory and Montgomery-Asberg Depression Rating Scale) and less dysfunctional attitudes. After controlling for the presence of major depressive episode at baseline, there was a statistical trend toward a greater time to depressive relapse (p=.06) for the CT group. At 12-month follow-up, the CT group showed a trend toward lower Young Mania Rating Scale scores and improved behavioral self-control. The Clinical Global Impressions-Improvement scale, comparing the 18 months prior to treatment to the severity of illness status at follow-up, showed a substantial difference between groups in favor of CT. CONCLUSION: Our findings corroborate previous bipolar disorder research in demonstrating the value of CT, particularly immediately post-treatment, and indicate some continuation (albeit diminishing) of benefits in the succeeding 12 months. These findings suggest that psychological booster sessions may be crucial for maintaining the beneficial effects of cognitive therapy.

Adult↗
PubMed2003

Vein versus polytetrafluoroethylene in above-knee femoropopliteal bypass grafting: five-year results of a randomized controlled trial.

OBJECTIVE: Controversy still exists whether polytetrafluoroethylene is equivalent to vein as bypass graft material for the above-knee femoropopliteal bypass. Therefore, a prospective randomized trial was performed to compare vein with polytetrafluoroethylene for femoropopliteal bypasses with the distal anastomosis above the knee. METHODS: Between January 1993 and December 1996, 151 above-knee femoropopliteal bypasses were performed. The indications for operation were severe claudication in 120 cases, rest pain in 20 cases, and ulceration in 11 cases. After randomization, 75 reversed saphenous venous bypasses and 76 polytetrafluoroethylene bypasses were performed. RESULTS: No perioperative mortality was seen, and 5% of the patients had minor infections of the wound, not resulting in loss of the bypass, the limb, or life. After 5 years, 38% of the patients had died and 7% were lost to follow-up. Only once was the saphenous vein necessary for coronary artery bypass grafting. Primary patency rates after 5 years were 75.6% for venous bypass grafts and 51.9% for polytetrafluoroethylene grafts (P =.035). Secondary patency rates were 79.7% for vein and 57.2% for polytetrafluoroethylene bypasses (P =.036). In the venous group, 14 bypasses failed, leading to five new bypasses. In the polytetrafluoroethylene group, 29 bypasses failed, leading to 16 reinterventions. For these 16 new bypasses, in four cases, the ipsilateral preserved saphenous vein was used. In both groups, one above-knee amputation and one below-knee amputation had to be performed. CONCLUSION: We conclude after 5 years of follow-up of this randomized controlled trial that a bypass with saphenous vein has better patency rates at all intervals and needs fewer reoperations. Saphenous vein should be the graft material of choice for above-knee femoropopliteal bypasses and should not be preserved for reinterventions. Polytetrafluoroethylene is an acceptable alternative if the saphenous vein is not available.

Arterial Occlusive Diseases↗
PubMed2002

Randomized controlled trial to evaluate splenectomy in total gastrectomy for proximal gastric carcinoma: Japan clinical oncology group study JCOG 0110-MF.

A randomized controlled trial has started in Japan to evaluate the role of splenectomy in the surgical management of gastric cancer. Patients with T2 or deeper carcinoma in the proximal third of the stomach are intra-operatively randomized to either splenectomy or spleen preservation. Tumors invading the greater curvature of the stomach or those with apparent nodal involvement in the splenic hilum are excluded. Surgeons in 29 specialized institutions will recruit 500 patients. Endpoints are overall survival, operative morbidity, operative time and blood loss.

Adenocarcinoma↗
PubMed2004

A prospective randomized controlled trial of point-of-care testing on the coronary care unit.

BACKGROUND: We report the results of a prospective randomized controlled trial comparing point-of-care testing (POCT) with central laboratory testing (CLT) in a six-bed coronary care unit in a district general hospital. METHODS: 263 consecutive admissions with chest pain and suspected acute coronary syndrome were randomized to measurement of cardiac troponin T by POCT or CLT only. Patient management was according to a pre-specified protocol utilizing clinical features, electrocardiographic changes and cardiac biomarkers (creatine kinase and cardiac troponin T) to define management. Outcome measures were diagnostic accuracy compared with CLT as 'gold standard', result turnaround time, mortality and length of stay in all patients and those with a protocol-driven early discharge policy. RESULTS: Diagnostic accuracy and mortality was equivalent in the POCT and CLT arm. Overall there was no difference in length of stay. In the pre-specified early discharge group (n = 64) there was a significant reduction in median length of non-coronary care unit stay (145.3 h versus 79.5 h) and overall hospital stay (209.3 h versus 149.9 h) in those randomized to POCT. CONCLUSION: A combination of rapid biochemical diagnosis and structured decision making reduces length of hospital stay.

Adult↗
PubMed1998

Early extubation following coronary artery bypass surgery: a prospective randomized controlled trial. The Fast Track Cardiac Care Team.

STUDY OBJECTIVES: To determine the safety of early extubation (EE) after coronary artery surgery. DESIGN: Prospective randomized controlled trial. SETTING: The cardiac surgery operating room and ICU of a university-affiliated teaching hospital. PATIENTS: One hundred eligible patients presenting for elective coronary artery surgery. INTERVENTIONS: Patients randomized to the EE group were administered a reduced dose of fentanyl (15 microg/kg) and an anesthetic compatible with EE, while patients randomized to the conventional extubation (CE) group were given fentanyl (50 microg/kg). MEASUREMENTS AND RESULTS: The time to extubation in the EE group (median, 240 min; range, 30 to 930 min) was significantly less than the CE group (median, 420 min; range, 125 to 1,140 min) (p<0.01). Twenty patients were withdrawn from the study according to protocol guidelines. There were no cases of reintubation or complications attributable to EE. CONCLUSIONS: By using an appropriate anesthetic technique and postoperative management, EE can be achieved following coronary artery bypass surgery without major complications.

Anesthesia↗
PubMed2003

Laparoscopic uterosacral ligament resection for dysmenorrhea associated with endometriosis: results of a randomized, controlled trial.

OBJECTIVE: To evaluate the efficacy of laparoscopic resection of the uterosacral ligaments in women with endometriosis and predominantly midline dysmenorrhea. DESIGN: Randomized controlled trial. SETTING: Two academic departments. One hundred eighty patients undergoing operative laparoscopy as first-line therapy for stage I to IV symptomatic endometriosis. INTERVENTION(S): Operative laparoscopy including uterosacral ligament resection or conservative surgery alone. MAIN OUTCOME MEASURE(S): Proportion of women with recurrence of moderate or severe dysmenorrhea 1 year after surgery. RESULT(S): No complications occurred. Among the patients who were evaluable 1 year after operative laparoscopy, 23 of 78 (29%) women who had uterosacral ligament resection and 21 of 78 (27%) women who had conservative surgery only reported recurrent dysmenorrhea. The corresponding numbers of patients at 3 years were 21 of 59 (36%) women and 18 of 57 (32%) women, respectively. Time to recurrence was similar in the two groups. Pain was substantially reduced, and patients in both groups experienced similar and significant improvements in health-related quality of life, psychiatric profile, and sexual satisfaction. Overall, 68 of 90 (75%) patients in the uterosacral ligament resection group and 67 of 90 (74%) patients in the conservative surgery group were satisfied at 1 year. CONCLUSION(S): Addition of uterosacral ligament resection to conservative laparoscopic surgery for endometriosis did not reduce the medium- or long-term frequency and severity of recurrence of dysmenorrhea.

Adult↗
PubMedDate not supplied

Randomized, controlled trial of division of tongue-tie in infants with feeding problems.

OBJECTIVE: To determine whether, in infants with a tongue-tie and a feeding problem, the current medical treatment (referral to a lactation consultant) or immediate division works best and enables the infants to feed normally. METHODS: Between March and July 2002, all the babies in the district of Southampton with tongue-ties were followed in order to see if they had any feeding problems. If they developed problems, the mothers gave written consent and were enrolled in an ethics committee approved, randomized, controlled trial, comparing 48 h of intensive lactation consultant support (control) with immediate division. RESULTS: A total of 201 babies had tongue-tie, of whom 88 had breast-feeding or bottle-feeding problems. Thirty-one were not enrolled, so 57 were randomized. Of the 29 controls, one improved (3%) and breast-fed for 8 months, but 28 did not. At 48 h, these 28 were offered division, which all accepted, and 27 improved (96%) and fed normally. Of the 28 babies who had immediate division, 27 improved and fed normally but one remained on a nipple shield (P < 0.001). Twenty-four mothers breast-fed for 4 months (24/40, 60%). Overall, division of the tongue-tie babies resulted in improved feeding in 54/57 (95%) babies. CONCLUSIONS: This randomized, controlled trial has clearly shown that tongue-ties can affect feeding and that division is safe, successful and improved feeding for mother and baby significantly better than the intensive skilled support of a lactation consultant.

Bottle Feeding↗
PubMed2003

Carbon dioxide field flooding versus mechanical de-airing during open-heart surgery: a prospective randomized controlled trial.

Removal of intracardiac air during valvular surgery should be accomplished in the most effective manner. We conducted a prospective randomized controlled trial to compare mechanical de-airing and carbon dioxide (CO2) field flooding in 18 patients undergoing elective valvular surgery. Transoesophageal echocardiography was used to record intracardiac bubbles, and this was assessed postoperatively by two independent echocardiographers blinded to treatment group. Both assessors graded the bubble count higher in the mechanical deairing group compared with the CO2 flooding group, and there was good agreement between assessors. CO2 field flooding is more effective than mechanical de-airing in removing intracardiac bubbles following valvular surgery.

Adult↗
PubMed1990

A pilot randomized control trial of proglumide (a gastrin receptor antagonist) in advanced colorectal cancer.

Forty-one patients with advanced colorectal cancer were entered into a randomized controlled trial of treatment with proglumide--a gastrin receptor antagonist. There was no difference in survival between the treated and the untreated groups of patients, although there was a trend towards increased survival in those treated patients with hepatic metastases alone. Proglumide does not cause regression in advanced colorectal cancer but larger studies would be required to detect an effect on tumour growth.

Adenocarcinoma↗
PubMed2004

Expected poor responders on the basis of an antral follicle count do not benefit from a higher starting dose of gonadotrophins in IVF treatment: a randomized controlled trial.

BACKGROUND: The aim of this study was to evaluate the effect of doubling the starting dose of gonadotrophins on the ovarian response in IVF patients with a low antral follicle count (AFC). METHODS: Fifty-two patients with an AFC of <5 follicles of 2-5 mm diameter before starting their first IVF cycle participated in this randomized controlled trial. They were randomized by opening a sealed envelope, receiving either 150 IU (group I, n = 26) or 300 IU (group II, n = 26) of rFSH as a starting dose. The main outcome measures of the study were number of oocytes, poor response (<4 oocytes at retrieval or cancellation due to insufficient follicle growth) and ongoing pregnancy (12 weeks of gestation). RESULTS: The groups were comparable regarding patient characteristics and outcome of the IVF treatment. The median number of oocytes collected was 3 for both groups (P = 0.79). The difference in the mean number of oocytes was 0.3 oocytes in favour of group I (P=0.69). Sixty-five per cent of the patients in group I experienced a poor response and 62% in group II. The ongoing pregnancy rate was 8% in group I and 4% in group II (P = 0.55). CONCLUSIONS: Expected poor response patients, defined as patients with an AFC <5, are likely not to benefit from a higher starting dose of gonadotrophins in IVF.

Adult↗
PubMed2002

A randomized controlled trial of azithromycin versus doxycycline/ciprofloxacin for the syndromic management of sexually transmitted infections in a resource-poor setting.

A randomized controlled trial was carried out to assess the effectiveness of azithromycin versus a standard regimen with doxycycline/ciprofloxacin in the treatment of sexually transmitted infections in a resource-poor environment. Infection with Chlamydia trachomatis was cured in 23/24 (95.8%) of women in the azithromycin arm versus 19/21 (90.5%) in the doxycycline arm (P = 0.6), resulting in three treatment failures. Gonorrhoea was cured in 55/56 (98.2%) women, with one treatment failure in a patient with concomitant C. trachomatis infection. These results indicate that a single oral dose of azithromycin may prove to be a more effective and convenient treatment for sexually transmitted infections in women in a resource-poor environment

Anti-Bacterial Agents↗
PubMed2003

Evaluation of a stroke family support organiser: a randomized controlled trial.

BACKGROUND AND PURPOSE: There is inconclusive evidence of the effectiveness of the Stroke Family Support Organiser (FSO) service. We report the results from a randomized controlled trial of the service. METHODS: Stroke patients admitted to hospital and their informal caregivers were randomly allocated to receive the FSO service (n=126) or standard care (n=124). Outcome assessments were undertaken 4 and 9 months after recruitment with the General Health Questionnaire 12, Carer Strain Index, Barthel Index, Extended Activities of Daily Living scale, and a specially designed questionnaire to determine knowledge of stroke and satisfaction with services. RESULTS: There were no significant differences between groups in patients' mood and independence in personal or instrumental activities of daily living or caregivers' mood, strain, or independence. Patients in the intervention group were significantly more knowledgeable about whom to contact for stroke information, reducing the risk of stroke, practical help, community services, and emotional support. Patients in the intervention group were also significantly more satisfied with the stroke information received. Caregivers in the intervention group were significantly more knowledgeable about whom to contact for information on stroke, reducing the risk of stroke, community services, and emotional support. Caregivers in the intervention group were also significantly more satisfied with stroke information. CONCLUSIONS: The FSO service had no significant effect on mood, independence in activities of daily living, or reduction in caregiver strain, but it did increase knowledge of stroke and satisfaction with that knowledge. The results may not be representative of all FSO services, and the sample was small relative to the heterogeneity of the participants. However, results suggest that the policies and training procedures of FSOs need to be evaluated to ensure that a cost-effective service is being provided to stroke patients and their caregivers.

Aged↗
PubMedDate not supplied

Double-blind randomized controlled trial to assess the efficacy of intravenous gammaglobulin for the management of chronic fatigue syndrome in adolescents.

A double blind randomized controlled trial was conducted in 71 adolescents aged 11-18 years. Inclusion in the trial required fulfilment of the diagnostic criteria, (Fukuda et al., 1994). Three infusions of 1 gm/kg (max 1 litre of 6 gm/100 ml in 10% w/v maltose solution) were given one month apart. The dummy solution was a 10% w/v maltose solution with 1% albumin of equivalent volume for weight. Efficacy was assessed by difference in a mean functional score including school attendance, school work, social activity and physical activity, between baseline, three months and six months after the final infusion. There was a significant mean functional improvement at the six month follow-up of 70 adolescents with Chronic Fatigue Syndrome of average duration 18 months. There was also a significant improvement for both groups from the beginning of the trial to the six month post infusion follow-up. Adverse effects were common with both solutions but not predictive of response. Neither solution could be identified by recipients.

Adolescent↗
PubMed2005

Randomized, controlled trial of dexamethasone in neonatal chronic lung disease: 13- to 17-year follow-up study: I. Neurologic, psychological, and educational outcomes.

OBJECTIVES: To study neurologic, educational, and psychological status in adolescence of neonates enrolled in a double-blind, randomized, controlled trial of dexamethasone therapy for chronic lung disease. PARTICIPANTS: A total of 287 infants who were chronically dependent on supplementary oxygen and were 2 to 12 weeks of age were recruited from 31 centers in 6 countries to a randomized, controlled trial of dexamethasone base (0.5 mg/kg per day for 1 week); 95% of survivors were reviewed at 3 years. Survivors from the 25 British and Irish centers were retraced at 13 to 17 years of age. OUTCOME MEASURES: Nonverbal reasoning, British Picture Vocabulary Scale, Goodman Strengths and Difficulties Questionnaire behavior scores, school national test results, teacher ability ratings, and parental and general practitioner questionnaires. RESULTS: A total of 195 children were eligible for the follow-up study. Information was available for 150 children (77%), with 142 (73%) being assessed in home visits. No baseline differences were detected between the children included in the follow-up study and those not included. There was a slight excess of cerebral palsy in the steroid group, which was not statistically significant (relative risk: 1.58; 95% confidence interval: 0.81-3.07). Overall disability rates in both groups were high (21% moderate and 14% severe), but with no difference between the 2 groups (for severe disability, relative risk: 0.84; 95% confidence interval: 0.37-1.86). CONCLUSIONS: Information was obtained for 150 adolescents randomized to receive dexamethasone or placebo for neonatal chronic lung disease. Rates of disabilities and educational difficulties were high, but with no significant differences between the 2 groups. Some use of open-label steroids in the placebo group plus losses to long-term follow-up monitoring reduced the power of this study to detect clinically important differences, and this study cannot rule out a real increase in cerebral palsy, as reported by others.

Adolescent↗
PubMed2006

A randomized controlled trial of a psychoeducational group program for unipolar depression in adults in Norway (NCT00319540).

BACKGROUND: Coping with Depression Course (CWD) has shown to be effective in the treatment of depression. However, there are very few randomized controlled trials on unipolar depression in adults. AIMS: To test the effect of a modified CWD on unipolar depression in a randomized controlled trial design in adults. METHODS: Participants were recruited through mass media, tested by BDI and clinical interview, and randomized into intervention group (N = 81) and control group (N = 74). The program was mainly conducted by nurses with background in psychiatry and primary health care, and the intervention encompassed 8 weekly sessions of 2 1/2 hours, with 3 booster sessions. RESULTS: By "intention-to-treat" analysis a statistically significant effect on depressive symptoms at follow up at 6 months was found, and the level of symptoms was sustained after 12 months. CONCLUSION: The study shows that the intervention is effective in the treatment of unipolar depression, and suitable for specialized psychiatric services as well as primary health care.

Journal Article↗
PubMed2000

Randomized controlled trial of nettle sting for treatment of base-of-thumb pain.

There are numerous published references to use of nettle sting for arthritis pain but no randomized controlled trials have been reported. We conducted a randomized controlled double-blind crossover study in 27 patients with osteoarthritic pain at the base of the thumb or index finger. Patients applied stinging nettle leaf (Urtica dioica) daily for one week to the painful area. The effect of this treatment was compared with that of placebo, white deadnettle leaf (Lamium album), for one week after a five-week washout period. Observations of pain and disability were recorded for the twelve weeks of the study. After one week's treatment with nettle sting, score reductions on both visual analogue scale (pain) and health assessment questionnaire (disability) were significantly greater than with placebo (P = 0.026 and P = 0.0027).

Aged↗
PubMed2026

Oblique Lateral Interbody Fusion With Lateral Vertebral Screw Fixation Versus Transforaminal Lumbar Interbody Fusion for Severe Lumbar Stenosis: Results of a Multicenter Randomized Controlled Trial.

BACKGROUND AND OBJECTIVES: The benefits of oblique lateral interbody fusion (OLIF) vs transforaminal lumbar interbody fusion (TLIF) in severe lumbar stenosis (Schizas C/D) remain uncertain. This randomized trial compared clinical, radiographic, and safety outcomes of OLIF and TLIF. METHODS: From November 2018 to December 2021, a prospective, multicenter, randomized controlled trial enrolled 260 adults with single-level severe stenosis and instability. In total, 224 patients were randomized to OLIF or TLIF. Prespecified outcomes followed consolidated standards of reporting trials. Primary outcomes were visual analog scale back/leg pain and Oswestry Disability Index (ODI), with minimal clinically important difference thresholds of ODI &#x2265;12-13 points or &#x2265;30% improvement, and visual analog scale &#x2265;1.5-2.0 points. Radiographic measures included disc height, lumbar and segmental lordosis, and canal cross-sectional area (CSA). Complications were recorded. Ethics approval was obtained from the institutional review board, the trial was registered with ISRCTN.com , and all patients provided written informed consent. RESULTS: In total, 224 patients were randomized, 5 were lost to follow-up (TLIF n = 2, OLIF n = 3). Baseline features were comparable. OLIF was associated with shorter operative time, less blood loss, earlier ambulation, and shorter hospital stay (all P < .05). Both groups achieved significant, clinically meaningful improvements. OLIF showed greater back pain reduction at 3-6 months and 2 years ( P < .05) and superior ODI improvement at 3 and 6 months ( P < .001), although long-term ODI scores were similar. Radiographically, OLIF provided greater restoration of disc height and segmental lordosis (all P < .001) and demonstrated progressive CSA increase (dynamic decompression), whereas TLIF achieved immediate, sustained CSA enlargement. Fusion rates were comparable at 1-2 years. Complication rates were low and similar (7.3% TLIF vs 5.5% OLIF), with most OLIF-specific events transient. CONCLUSION: Both OLIF and TLIF yield improvements in severe lumbar stenosis. OLIF offers perioperative advantages, earlier functional recovery, radiographic restoration, and dynamic canal remodeling, supporting its role as an equivalent alternative for lumbar spinal stenosis with some secondary advantages.

Humans↗