PubMed Health⌕ Search

SEARCH · PubMed Health

Results for “Controlled Clinical Trial”

Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 37 records · Page 2Linked to original sources
PubMed1989

A clinical controlled trial of endoscopic sclerotherapy for repeated esophageal variceal bleeding.

Thirty-seven patients with postnecrotic cirrhosis of the liver and 13 patients with primary hepatoma were proven to have repeated bleeding from ruptured esophageal varices. Clinically controlled trials were performed by assigning patients to either sclerotherapy or control arms (25 patients each). Combined intra-variceal and para-variceal injection before an upper endoscopic examination was performed in the sclerotherapy group. In all 25 sclerotherapy cases (100%) hemostasis was successful, which was a statistically significant success rate compared to the control group (52.0%) (p less than 0.01). In the sclerotherapy group 20% (5/25 cases) developed rebleeding, which was less than the 48.0% (7 cases of continuous bleeding and 5 cases of rebleeding) of the control group (p less than 0.05). Four cases (16.0%) in the sclerotherapy group died of erosive gastritis with massive bleeding, compared to 8 fatalities (32.0%) in the control group, because of uncontrolled esophageal variceal bleeding. Endoscopic sclerotherapy is a very effective method for arresting bleeding esophageal varices, and for decreasing the rebleeding rate.

Adult↗
PubMed2004

Efficacy and safety of acupuncture for chronic pain caused by gonarthrosis: a study protocol of an ongoing multi-centre randomised controlled clinical trial [ISRCTN27450856].

BACKGROUND: Controlled clinical trials produced contradictory results with respect to a specific analgesic effect of acupuncture. There is a lack of large multi-centre acupuncture trials. The German Acupuncture Trial represents the largest multi-centre study of acupuncture in the treatment of chronic pain caused by gonarthrosis up to now. METHODS: 900 patients will be randomised to three treatment arms. One group receives verum acupuncture, the second sham acupuncture, and the third conservative standard therapy. The trial protocol is described with eligibility criteria, detailed information on the treatment definition, blinding, endpoints, safety evaluation, statistical methods, sample size determination, monitoring, legal aspects, and the current status of the trial. DISCUSSION: A critical discussion is given regarding the considerations about standardisation of the acupuncture treatment, the choice of the control group, and the blinding of patients and observers.

Acupuncture Therapy↗
PubMed1988

Bulk fracture of amalgam restorations--a 5-year controlled clinical trial.

A controlled clinical study, containing 720 posterior amalgam restorations placed in a group of 103 adult patients by three dentists, was used for examination of the influences on the incidence of occlusal and approximal bulk fractures. These fractures were evaluated from black and white photographs, taken annually, of the occlusal surface of the restorations over a 5-year period, using a three point photo-rating scale for both fracture sites. The influence of the dentist as well as the influence of the alloy and tooth type were statistically analysed. The results of these analyses demonstrated that the dentist, as well as the alloy and tooth type, have a statistically significant influence on the incidence of bulk fracture of amalgam restorations.

Adult↗
PubMedDate not supplied

Increasing the cervical lordosis with chiropractic biophysics seated combined extension-compression and transverse load cervical traction with cervical manipulation: nonrandomized clinical control trial.

BACKGROUND: Cervical lordosis has been shown to be an important outcome of care; however, few conservative methods of rehabilitating sagittal cervical alignment have been reported. OBJECTIVE: To study whether a seated, retracted, extended, and compressed position would cause tension in the anterior cervical ligament, anterior disk, and muscle structures, and thereby restore cervical lordosis or increase the curvature in patients with loss of the cervical lordosis. STUDY DESIGN: Nonrandomized, prospective, clinical control trial. METHODS: Thirty preselected patients, after diagnostic screening for tolerance to cervical extension with compression, were treated for the first 3 weeks of care using cervical manipulation and a new type of cervical extension-compression traction (vertical weight applied to the subject's forehead in the sitting position with a transverse load at the area of kyphosis). Pretreatment and posttreatment Visual Analogue Scale (VAS) pain ratings were compared along with pretreatment and posttreatment lateral cervical radiographs analyzed with the posterior tangent method for changes in alignment. Results are compared to a control group of 33 subjects receiving no treatment and matched for age, sex, weight, height, and pain. RESULTS: Control subjects reported no change in VAS pain ratings and had no statistical significant change in segmental or global cervical alignment on comparative lateral cervical radiographs (difference in all angle mean values < 1.3 degrees ) repeated an average of 8.5 months later. For the traction group, VAS ratings were 4.1 pretreatment and 1.1 posttreatment. On comparative lateral cervical radiographs repeated after an average of 38 visits over 14.6 weeks, 10 angles and 2 distances showed statistically significant improvements, including anterior head weight bearing (mean improvement of 11 mm), Cobb angle at C2-C7 (mean improvement of -13.6 degrees ), and the angle of intersection of the posterior tangents at C2-C7 (mean improvement of 17.9 degrees ). Twenty-one (70%) of the treatment group subjects were followed for an additional 14 months; improvements in cervical lordosis and anterior weight bearing were maintained. CONCLUSIONS: Chiropractic biophysics (CBP) technique's extension-compression 2-way cervical traction combined with spinal manipulation decreased chronic neck pain intensity and improved cervical lordosis in 38 visits over 14.6 weeks, as indicated by increases in segmental and global cervical alignment. Anterior head weight-bearing was reduced by 11 mm; Cobb angles averaged an increase of 13 degrees to 14 degrees; and the angle of intersection of posterior tangents on C2 and C7 averaged 17.9 degrees of improvement.

Adult↗
PubMed1989

The trials of clinical trials.

Controlled clinical trials are becoming increasingly frequent in neurology. A review of the literature indicates that several trials have serious flaws in study design and conduct that render the results questionable or uninterpretable. These reports, together with my own experience with the trial of plasmapheresis in the treatment of acute Guillain-Barré syndrome, have led me to conclude that while the formulation of the crucial research question and the definition of outcomes as a measure of efficacy are extremely important, the availability of a compliant patient population of appropriate size and the compliance by the study physicians are essential. Moreover, close cooperation with the statistician in planning the trial and the statistical strategy for analysis is also critical. Suggestions are made to aid the clinician in setting up the most efficacious trial and reporting the results.

Clinical Trials as Topic↗
PubMed2000

Fluoride-releasing elastomerics--a prospective controlled clinical trial.

A prospective controlled clinical trial was undertaken to evaluate the effectiveness of stannous fluoride-releasing elastomeric modules (Fluor-I-Ties) and chain (Fluor-I-Chain) in the prevention of enamel decalcification during fixed appliance therapy. Forty-nine patients (782 teeth) were included in the experimental group, where the fluoride-releasing elastomerics were used. Forty-five patients (740 teeth) who received non fluoride-releasing elastomerics formed the control group. All patients had their elastomerics replaced at each visit. Enamel decalcification incidence and distribution were recorded using an index by direct clinical observation. In the control group enamel decalcification occurred in 73 per cent of patients and in 26 per cent of all teeth. In the experimental group the corresponding incidence was 63 and 16 per cent, respectively. The overall reduction in score per tooth produced by the fluoride-releasing elastomerics was 49 per cent, a highly significant difference (P < 0.001). A significant difference was seen in all but the occlusal enamel zones. The majority (over 50 per cent) of lesions occurred gingivally. The teeth most severely affected were the maxillary lateral incisors and mandibular second premolars. There was no difference in treatment duration between groups.

Adolescent↗
PubMed1999

[Hypnosis and self-hypnosis administered and taught by nurses for relief of chronic pain: a controlled clinical trial].

In this controlled clinical trial hypnosis and self-hypnosis were evaluated when used as an adjuvant treatment to instrumental and pharmacological management of chronic pain. The study took place in a hospital specialized in the treatment of outpatients suffering from chronic pain. Hypnosis and self-hypnosis were administered and taught by nurses who had been trained just recently for this very purpose. Under the conditions of the study it was not possible to measure an effect of hypnosis on pain despite some subjective feeling of usefulness. However, it should be taken into account that this form of adjuvant therapy was used for the first time in that hospital for the purpose of the study and, therefore, took place in an artificial setting. It could well be that the same therapy administered in the proper therapeutic environment of a specialized institution could show beneficial effects on pain.

Autosuggestion↗
PubMed1977

Long-term treatment with sulphamethoxazole/trimethoprim (Bactrim) and nitrofurantoin in chronic urinary tract infections. A controlled clinical trial.

In a controlled clinical trial based on 30 geriatric patients with recurrent urinary tract infection, 12 out of 17 patients fulfilled a 12-month treatment with sulphamethoxazole/trimethoprim (Bactrim) with continuous sterile urine compared to 1 out of 13 patients treated with nitrofurantoin (p less than 0.05). There was a slight but statistically significant increase in serum creatinine during treatment for 12 months in the sulphamethoxazole/trimethoprim group, but this probably does not reflect any deterioration in kidney function. The remaining laboratory values showed no significant changes whatsoever.

Aged↗
PubMed1994

Reducing lengths of stay in the coronary care unit with a practice guideline for patients with congestive heart failure. Insights from a controlled clinical trial.

Although more than 1,000 medical practice guidelines have been developed, there have been few evaluations of their use in clinical practice or information to judge whether practice guidelines can be used to reduce health care costs. For this reason, the authors conducted a prospective controlled clinical trial with an alternating-month design at a large teaching community hospital to study the use of a practice guideline to promote early transfer of patients admitted to a hospital with congestive heart failure (CHF) from the coronary care unit (CCU) and intermediate care unit to unmonitored beds. The practice guideline was supported by locally derived risk information and recommended consideration of early "step-down" transfer of low-risk patients with CHF 24 hours after hospital admission. Physicians caring for patients identified as "low risk" received concurrent personalized written and verbal reminders concerning the guideline recommendation. Study subjects were patients admitted to a hospital CCU and intermediate care unit between November 1, 1991 and April 30, 1993 with a diagnosis of CHF or pulmonary edema. Ninety patients with CHF were identified as low risk according to the guideline during the study period. Feedback of the practice guideline recommendation was not associated with a significant increase in physician adoption of the guideline or shorter lengths of stay in the CCU or intermediate care unit. Physicians may have compensated for statistically insignificant reductions in monitored lengths of stay by increasing the length of stay in unmonitored beds (1.80 +/- 2.32 to 4.02 +/- 4.09 days, P = .002) and the total length of stay (4.73 +/- 2.43 to 6.71 +/- 5.44 days, P = .03). Quality of patient care, patient outcomes, and patient satisfaction were not affected by the guideline. Our study results suggest that implementation of a locally derived practice guideline for patients with CHF did not result in adoption of the guideline by physicians. The complexity of implementing the guideline, changes in physician practice before the study, and the failure of the guideline to address the continuum of patient care across monitored and unmonitored beds may have accounted for rejection of the guideline. Our experience demonstrates that practice guidelines, whenever possible, should be evaluated in prospective trials before they should be disseminated for widespread use.

Adult↗
PubMedDate not supplied

Acupressure therapy for morning sickness. A controlled clinical trial.

A prospective, controlled clinical trial examined the efficacy of acupressure therapy for morning sickness, using a two group, random assignment, crossover design. Subjects in Group 1 (N = 8) used acupressure wristbands for five days, followed by five days without therapy. Subjects in Group 2 (N = 8) had no therapy for five days, followed by five days use of wristbands. The Multiple Affect Adjective Checklist and Sickness Impact Profile were used, and extent of nausea was assessed at baseline, day five, and day ten. Use of acupressure wristbands relieved morning sickness for 12 of 16 subjects (chi 2 = 5.31 with Yates' correction factor, df = 1, p less than .025). Acupressure therapy resulted in statistically significant (p less than .05) reductions in anxiety, depression, behavioral dysfunction, and nausea. Limitations of the study and suggestions for future research are presented.

Acupuncture Therapy↗
PubMed1981

The drainage of subretinal fluid: a randomized controlled clinical trial.

A randomized controlled clinical trial was conducted on a series of 120 consecutive cases of rhegmatogenous retinal detachment. One group of 60 eyes, randomly selected, was managed with a scleral buckling operation that included the drainage of subretinal fluid. The other group of 60 had a similar operation without drainage. A new method for evaluating complications, the "Complications Score," was devised. The score was higher (P = 0.005) for the drainage group, but this did not decrease the final anatomic or visual results. Eighty-seven percent of the drainage group was reattached with one operation, a figure not significantly different from the 83% reattached in the nondrainage group. The final cure rate after reoperations was 97% for both groups. The best corrected visual acuity, measured six months after operation, was not significantly different for the two groups. This study concludes that equally good results can be obtained with either a drainage or nondrainage operation.

Body Fluids↗
PubMed1981

Antifibrinolysis with tranexamic acid in aneurysmal subarachnoid hemorrhage: a consecutive controlled clinical trial.

A randomized controlled clinical trial was carried out to study the effect of tranexamic acid (AMCA, Cyklokapron; AB Kabi, Stockholm, Sweden) in the prevention of early rebleeding after the rupture of an intracranial aneurysm. The incidence of vasospasm, hydrocephalus, cerebral ischemic and thromboembolic complications, morbidity, and mortality was also evaluated. The series comprises 59 patients, 30 treated with tranexamic acid and 29 controls. The treatment was stopped if there was rebleeding, operation, or discharge from the hospital. There were 6 recurrent hemorrhages in 6 patients in the tranexamic acid-treated group and 11 recurrences in 7 patients in the control group. Recurrent hemorrhages occurred later in tranexamic acid-treated patients than in controls. Five patients in each group died from rebleeding. Five additional treated patients and 2 controls died from cerebral ischemic dysfunction. The results suggest that tranexamic acid may protect patients with ruptured aneurysms from rebleeding for 1 or 2 weeks, but that it also may produce cerebral ischemic complications.

Adult↗
PubMed1981

The drainage of subretinal fluid: a randomized controlled clinical trial.

A randomized controlled clinical trial was conducted on a series of 120 consecutive cases of rhegmatogenous retinal detachment. One group of 60 eyes, randomly selected, was managed with a scleral buckling operation which included the drainage of subretinal fluid. The other group of 60 had a similar operation without drainage of subretinal fluid. A new method for evaluating complications, the "Complications Score," was devised. The score was significantly higher for the drainage group but this did not decrease the final anatomic or visual results. Eight-seven percent of the drainage group were reattached with one operation, a figure not significantly different from the 83% reattached in the nondrainage group. The final cure rate after reoperations was 97% for both groups. The best corrected visual acuity, measured six months postoperatively, was not significantly different for the two groups. This study concludes that equally good results can be obtained with either a drainage or nondrainage operation.

Aged↗
PubMed1990

Methylprednisolone therapy for acute asthma in infants and toddlers: a controlled clinical trial.

A controlled double-blind trial was carried out to assess the effect of the early introduction of combined corticosteroid and beta-adrenergic drugs for the treatment of acute asthma in infants and toddlers. Seventy-four emergency room patients (aged 7 to 54 months) who were treated for acute asthma were studied. Treatment included, in addition to salbutamol inhalations, a single dose of intramuscular methylprednisolone (4 mg/kg) or normal saline as placebo. The patients were reevaluated 3 hours after initiation of treatment. At that time, patients were either admitted or discharged based on a clinical decision. Only 8 (20%) of 39 patients treated with steroids were admitted, compared with 15 (43%) of 35 in the placebo group (P less than .05). Sequential analysis of 33 pairs, matched by age and severity of symptoms, revealed statistically significant reduced admission rates in patients treated with steroids. In the younger patients (6 to 24 months), admission rate was significantly lower for those treated with steroids (18%) as compared with those treated without steroids (50%) (P less than .05). In the older group (24 to 54 months), the trend was similar but not statistically significant: 23% vs 31% in the steroid and placebo groups, respectively. These data indicate that corticosteroid treatment combined with an adrenergic agent, given early during an acute asthmatic episode, significantly reduces the hospital admission rate of infants and toddlers.

Acute Disease↗
PubMed1996

Maintenance therapy for chronic depression. A controlled clinical trial of desipramine.

BACKGROUND: Previous studies have shown the efficacy of antidepressants in the treatment of chronic depression. We report the results of a long-term study comparing desipramine hydrochloride and placebo for maintenance therapy of remitted patients with chronic depression. METHODS: Outpatients who met DSM-III-R diagnostic criteria for "pure" dysthymia (n = 51), dysthymia with current major depression ("double depression") (n = 64), or chronic major depression (n = 14) were treated on an open basis with desipramine. Full and partial remitters after 10 weeks entered a continuation phase of open treatment with desipramine for 16 weeks. Remitted patients then were randomized to continue desipramine treatment or tapered to placebo treatment for a maintenance phase of up to 2 years. Relapse rates and time to relapse during maintenance therapy were compared between the two treatment groups. RESULTS: Acute-phase treatment results did not differ significantly according to chronic depression subtype. Remission persisted with a high degree of stability during the continuation phase. Relapse rates during the maintenance phase were 52% for the placebo group and 11% for the active desipramine group (chi 2 = 8.1, P = .004). Most placebo relapses occurred during the first 6 months of maintenance therapy. Active medication was significantly more effective than placebo in that subgroup entering the maintenance phase in full remission and in those patients who fulfilled criteria for a diagnosis of pure dysthymia or double depression on entry to the study. CONCLUSION: Long-term maintenance treatment with desipramine appeared to be effective in the prevention or postponement of relapse of depression in patients who responded to desipramine during the acute and continuation phases.

Adult↗
PubMed1979

3-Methoxy-4-hydroxyphenylglycol excretion in acutely schizophrenic patients during a controlled clinical trial of the isomers of flupenthixol.

Urinary MHPG excretion in patients with acute schizophrenia was studied before and during a trial of the isomers of flupenthixol and placebo. Pretrial MHPG excretion was not related to severity of illness before the trial or to other pretrial clinical variables. In male subjects higher pretrial MHPG excretion was associated with a better outcome 1 year post-trial. However in females no relationship between MHPG excretion and outcome was established. During the trial there was a reduction in MHPG excretion in patients treated with beta-flupenthixol but no decrease in the group treated with alpha-flupenthixol or chlorpromazine. In patients on placebo there was a reduction in MHPG excretion in those who did well clinically, but not in those who did poorly. Thus low MHPG excretion may be a predictor of poor outcome in schizophrenia, but MHPG excretion also changes both as a function of clinical state and of neuroleptic drug administration.

Adult↗