ACID 1 study: Results of a randomized controlled trial of H. pylori eradication in patients on maintenance acid suppression in the community

2001 ◽  
Vol 120 (5) ◽  
pp. A235-A236
Author(s):  
A JOHNMORRIS ◽  
C CRAIG ◽  
C MORRAN ◽  
H BURNS ◽  
K HARDEN ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Acid Suppression ◽  
Randomized Controlled ◽  
Study Results ◽  
H Pylori

ACID 1 study: Results of a randomized controlled trial of H. pylori eradication in patients on maintenance acid suppression in the community

2001 ◽  
Vol 120 (5) ◽  
pp. A235-A236 ◽  
Author(s):  
A. John Morris ◽  
Carol F. Craig ◽  
Christine Morran ◽  
Harry Burns ◽  
Ken Harden ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Acid Suppression ◽  
Randomized Controlled ◽  
Study Results ◽  
H Pylori

scholarly journals A Non-Randomized Controlled Trial for the Effectiveness of the ‘Aibo’ Intervention Program for Distraction in Childhood Vaccination

2021 ◽  
Author(s):  
Kyoko Tanaka ◽  
Maoko Hayakawa ◽  
Chihiro Noda ◽  
Moemi Nakamura ◽  
Akio Nakamura ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Intervention Program ◽  
Controlled Trial ◽  
Intervention Group ◽  
Behavioral Observation ◽  
Childhood Vaccination ◽  
Control Group ◽  
Randomized Controlled ◽  
Study Results ◽  
Face Scale

Abstract Procedures and actions such as injections and immobilization cause pain and distress to children. In the pediatric field, there is a need for interventions and support to alleviate the pain and distress caused by such medical procedures. In recent years, the introduction of robots as a means of distraction has begun to be attempted. In this study, we conducted a non-randomized controlled trial to examine the effect of intervention using ‘aibo’, a dog-like robot which has artificial intelligence (AI), to promote distraction in children after vaccination. As a result, 57 children (32 in the intervention group) participated in the study. Results of a t-test with the control group showed that the intervention group using aibo had significantly less pain following the post-vaccination intervention than the control group using stuffed dog (Face Scale, t(55) = 2.582, p = .0125; Behavioral Observation Scale, t(55) = 2.772, p = .00759). The results support the hypothesis that the aibo intervention group will be less distressed and able to calm down more quickly after vaccination than the control group. Conclusion : AI-powered aibo interventions that allow for interactive interaction can be an effective distraction method during painful procedures such as vaccinations.

Randomized, Controlled Trial of an Easy-to-Read Informed Consent Statement for Clinical Trial Participation: A Study of the Eastern Cooperative Oncology Group

2003 ◽  
Vol 21 (5) ◽  
pp. 836-842 ◽  
Author(s):  
Cathy A. Coyne ◽  
Ronghui Xu ◽  
Peter Raich ◽  
Kathy Plomer ◽  
Mark Dignan ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Controlled Trial ◽  
Informed Consent ◽  
Controlled Trial ◽  
Eastern Cooperative Oncology Group ◽  
Trial Participation ◽  
Patient Anxiety ◽  
Randomized Controlled ◽  
Patient Comprehension ◽  
Study Results

Purpose: Studies have documented that the majority of consent documents for medical diagnosis and treatment are written at a reading level above that of the majority of the U.S. population. This study hypothesized that use of an easy-to-read consent statement, when compared with a standard consent statement, will result in higher patient comprehension of the clinical treatment protocol, lower patient anxiety, higher patient satisfaction, and higher patient accrual. Methods: A randomized controlled trial was conducted in 44 institutions that were members or affiliates of three cooperative oncology groups. Institutions were randomly assigned to administer either an easy-to-read consent statement or the standard consent statement to patients being recruited to participate in selected cancer treatment trials. Telephone interviews were conducted with a total of 207 patients to assess study outcomes. Results: Patients in the intervention arm demonstrated significantly lower consent anxiety and higher satisfaction compared with patients in the control arm. Patient comprehension and state anxiety were not affected by the intervention. Accrual rates into the parent studies also did not differ significantly between the two study groups. Conclusion: Clinical trial informed consent statements can be modified to be easier to read without omitting critical information. Patient anxiety and satisfaction can be affected by the consent document. The generalizability of these study results is limited by the characteristics of the patient sample. Ninety percent of the sample were white women, and the mean Rapid Estimate of Adult Literacy in Medicine score was approximately 64, indicating a literacy level at or above the ninth grade.

scholarly journals Vonoprazan-Based Regimen Is More Useful than PPI-Based One as a First-LineHelicobacter pyloriEradication: A Randomized Controlled Trial

2017 ◽  
Vol 2017 ◽  
pp. 1-7 ◽  
Author(s):  
Masafumi Maruyama ◽  
Naoki Tanaka ◽  
Daisuke Kubota ◽  
Masayuki Miyajima ◽  
Takefumi Kimura ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Adverse Events ◽  
Eradication Rate ◽  
Controlled Trial ◽  
Eradication Therapy ◽  
Group Versus ◽  
Intention To Treat ◽  
Randomized Controlled ◽  
Primary Endpoints ◽  
H Pylori

Background. A new agent, potassium-competitive acid blocker vonoprazan (VPZ) has potent acid-inhibitory effects and may offer advantages over conventionalH. pylorieradication therapies. We aimed to compare the eradication rate between VPZ-based treatment and PPI-based one.Methods. This randomized controlled trial was designed to assign 141 patients withH. pylori-positive gastritis to VPZ group (VPZ 20 mg, amoxicillin 750 mg, and clarithromycin 200 or 400 mg twice daily for 7 days) or PPI group (rabeprazole 20 mg or lansoprazole 30 mg, amoxicillin 750 mg, and clarithromycin 200 or 400 mg twice daily for 7 days). Primary endpoints were eradication rates and adverse events.Results. Seventy of 72 patients in VPZ group and 63 of 69 patients in PPI group completed the treatment after 7 days. The eradication rate was significantly higher in VPZ group than PPI group by intention-to-treat analysis (95.8% versus 69.6%,P=0.00003, 95% confidence interval [CI] 88.3-99.1% versus 57.3-80.1%) and per-protocol analysis (95.7% versus 71.4%,P=0.0002, 95% CI 88.0-99.1% versus 58.7-82.1%). The incidence of adverse events was not different between the groups (26.3% in VPZ group versus 37.7% in PPI group,P=0.15).Conclusion. VPZ-based regimen is more useful than that PPI-based regimen as a first-lineH. pylorieradication therapy.

scholarly journals Saccharomyces boulardii Combined With Quadruple Therapy for Helicobacter pylori Eradication Decreased the Duration and Severity of Diarrhea: A Multi-Center Prospective Randomized Controlled Trial

2021 ◽  
Vol 8 ◽  
Author(s):  
Yuchong Zhao ◽  
Yilei Yang ◽  
Aruna ◽  
Jun Xiao ◽  
Jun Song ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Side Effects ◽  
Controlled Trial ◽  
Saccharomyces Boulardii ◽  
Quadruple Therapy ◽  
Severe Diarrhea ◽  
Randomized Controlled ◽  
Group A ◽  
H Pylori ◽  
Group B

Background: Whether probiotics helped the Helicobacter pylori (H. pylori) eradication was still highly controversial. The non-bacterial Saccharomyces boulardii (S. boulardii) has demonstrated its efficacy in the treatment of antibiotic-associated and infectious diarrhea. We aimed to evaluate the effects of S. boulardii combined with quadruple therapy for H. pylori eradication and associated side effects.Methods: Three hundred and sixty H. pylori-infected patients were recruited in this multicenter, randomized controlled trial. The patients who underwent H. pylori eradication treatment were randomized in a ratio of 1:1 into two separate groups that received standard quadruple therapy (Group A) and quadruple therapy plus S. boulardii sachets (Group B) for 14 days. The everyday medication and side-effect records were collected for compliance and adverse effect analysis. All patients accepted 13C/14C-urea breath tests 4 weeks after the therapy completion.Results:Saccharomyces boulardii and quadruple therapy-combined intervention significantly reduced the incidences of overall side effects (27.8 vs. 38.5%, p = 0.034) and diarrhea (11.2 vs. 21.2%, p = 0.012) in Group B compared with quadruple therapy alone in Group A, especially reduced the diarrhea duration (5.0 days vs. 7.7 days, p = 0.032) and incidence of severe diarrhea (4.7 vs. 10.1%, p = 0.040). Intention-to-treat (ITT) analysis and per-protocol (PP) analysis both indicated no statistical differences of eradication rate between Groups A and B (ITT: 82.7 vs. 85.8%, p = 0.426; PP: 89.7 vs. 94.2%, p = 0.146). The joint use of S. boulardii and quadruple therapy markedly improved the overall pre-eradication alimentary symptoms (hazard ratio (HR): 2.507, 95% CI: 1.449–4.338) recovery.Conclusion:Saccharomyces boulardii ameliorated H. pylori eradication-induced antibiotic-associated side effects especially reduced the incidence of severe diarrhea and the duration of diarrhea. However, there was no significant effect of S. boulardii on the rate of H. pylori eradication.Trial Registration: The protocol had retrospectively registered at ClinicalTrails.gov, Unique identifier: NCT03688828, date of registration: September 27, 2018; https://clinicaltrials.gov/show/NCT03688828

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