scholarly journals A Randomized Controlled Trial of Puncturing and Bloodletting at Twelve Hand Jing Points to Treat Acute Carbon Monoxide Poisoning as Adjunct to First Aid Treatment: A Study Protocol

2015 ◽  
Vol 2015 ◽  
pp. 1-5 ◽  
Author(s):  
Ying Yue ◽  
Xingfang Pan ◽  
Sai Zhang ◽  
Jun Jin ◽  
Wei Wang ◽  
...  
Keyword(s):  
Carbon Monoxide ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Carbon Monoxide Poisoning ◽  
Venous Blood ◽  
First Aid ◽  
Controlled Study ◽  
Care Group ◽  
Randomized Controlled ◽  
Acute Carbon Monoxide Poisoning

Background. Acute carbon monoxide poisoning (ACOP) is a significant cause of morbidity and mortality in many countries. Twelve Hand Jing Points (THJP) have been believed to be effective to treat all kinds of emergency calls in traditional Chinese medicine (TCM) for more than 3000 years. This randomized controlled trial (RCT) is designed to evaluate the effectiveness of THJP in curing acute carbon monoxide poisoning in first aid treatment. This paper reports the protocol of the trial.Methods/Design.This RCT is a multicenter, randomized, controlled study undergoing in China. The compliant patients are divided into the bloodletting group and standard of care group. With first aid treatments given to both of the groups, the bloodletting group is bleeding at THJP upon being hospitalized. Primary outcomes and secondary outcomes will be measured and compared between these two groups. Before treatment, immediately after treatment, and 30 minutes, 1 hour, and 4 hours after treatment, patients’ basic vital signs and state of consciousness were observed. Before treatment and 1 and 4 hours after treatment, carboxyhemoglobin concentration in venous blood samples was detected.Discussion.The objective of this study is to provide convincing evidence to clarify the efficacy and safety of THJP for early treatment of acute carbon monoxide poisoning.

scholarly journals Evaluating the Efficacy of Internet-Delivered Cognitive Behavioral Therapy Blended With Synchronous Chat Sessions to Treat Adolescent Depression: Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Naira Topooco ◽  
Sandra Byléhn ◽  
Ellen Dahlström Nysäter ◽  
Jenny Holmlund ◽  
Johanna Lindegaard ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Adolescent Depression ◽  
Controlled Trial ◽  
National Level ◽  
Cognitive Behavioral ◽  
Controlled Study ◽  
Control Group ◽  
Depression Symptoms ◽  
Group Effect ◽  
Randomized Controlled

BACKGROUND Depression is a common and serious problem among adolescents, but few seek or have access to therapy. Internet-delivered cognitive behavioral therapies (ICBTs), developed to increase treatment access, show promise in reducing depression. The inclusion of coach support in treatment is desired and may be needed. OBJECTIVE The aim of this study was to determine the efficacy of an ICBT protocol blended with weekly real-time therapist sessions via chat; blended treatment, for adolescent depression, including major depressive episode (MDE). The protocol has previously been evaluated in a controlled study. METHODS In a two-arm randomized controlled trial, adolescents 15 to 19 years of age were recruited through a community setting at the national level in Sweden (n=70) and allocated to either 8 weeks of treatment or to minimal attention control. Depression was assessed at baseline, at posttreatment, and at 12 months following treatment (in the intervention group). The primary outcome was self-reported depression level as measured with the Beck Depression Inventory II at posttreatment. The intervention was offered without the need for parental consent. RESULTS Over two weeks, 162 adolescents registered and completed the baseline screening. Eligible participants (n=70) were on average 17.5 years of age (SD 1.15), female (96%, 67/70), suffered from MDE (76%, 53/70), had no previous treatment experience (64%, 45/70), and reported guardian(s) to be aware about their depression state (71%, 50/70). The average intervention completion was 74% (11.8 of 16 modules and sessions). Following the treatment, ICBT participants demonstrated a significant decrease in depression symptoms compared with controls (<italic>P</italic>&lt;.001), corresponding to a large between-group effect (intention-to-treat analysis: <italic>d</italic>=0.86, 95% CI 0.37-1.35; of completer analysis: <italic>d</italic>=0.99, 95% CI 0.48-1.51). A significant between-group effect was observed in the secondary depression outcome (<italic>P</italic>=.003); clinically significant improvement was found in 46% (16/35) of ICBT participants compared with 11% (4/35) in the control group (<italic>P</italic>=.001). CONCLUSIONS The results are in line with our previous study, further demonstrating that adolescents with depression can successfully be engaged in and experience significant improvement following ICBT blended with therapist chat sessions. Findings on participants’ age and baseline depression severity are of interest in relation to used study methods. CLINICALTRIAL ClinicalTrials.gov NCT02363205; https://clinicaltrials.gov/ct2/show/NCT02363205

scholarly journals HYPOfractionated Radiation Therapy Comparing A Standard Radiotherapy Schedule (Over Three Weeks) with A Novel One Week Schedule in Adjuvant Breast Cancer: An Open-Label Randomised Controlled Study (HYPORT- Adjuvant): Study Protocol for a Multicenter, Randomized Phase III Trial.

2020 ◽  
Author(s):  
Sanjoy Chatterjee ◽  
Santam Chakraborty ◽  
HYPORT Adjuvant Author Group
Keyword(s):  
Breast Cancer ◽  
Randomized Controlled Trial ◽  
Recurrence Rate ◽  
Adjuvant Radiotherapy ◽  
Locoregional Recurrence ◽  
Controlled Trial ◽  
Phase Iii ◽  
Controlled Study ◽  
Randomized Controlled ◽  
Locoregional Recurrence Rate

Abstract Background Hypofractionated radiotherapy is the current standard for adjuvant radiotherapy across many centres. Further hypofractionation may be possible but remains to be investigated in non-caucasian populations with more advanced disease, with a higher proportion of patients requiring mastectomy as well as tumour bed boost. We are reporting the design of randomized controlled trial testing the hypothesis that a one week (5 fractions) regimen of radiotherapy will be non-inferior to a standard three week (15 fractions) schedule. Methods We describe a multicenter, randomized controlled trial recruiting patients at large academic centres across India. Patients without distant metastases who merit adjuvant radiotherapy will be eligible for inclusion in the study. Patients in the control arm will receive adjuvant radiotherapy to the breast or chest wall (with/without regional nodes) to a dose of 40 Gy / 15 fractions / 3 weeks, while those in the experimental arm will receive a dose of 26 Gy / 5 fractions / 1 week (to the same volume). Use of a simultaneous integrated boost (dose of 8 Gy and 6 Gy respectively) is allowed in patients who have undergone breast conservation. A sample size of 2100 patients provides an 80% power to detect a non-inferiority of 3% in the 5-year locoregional recurrence rate with a one-sided type I error of 2.5%, assuming that the locoregional recurrence rate in the control arm is 5% at 5 years (corresponding to a hazard ratio of 1.63). Patients will be recruited over a period of 5 years, and followed up for a further 5 years thereafter. Discussion If a five-fraction regimen of breast cancer is proven to be non-inferior, this will result in a significant improvement in the access to radiotherapy, as well as reduced costs of treatment. The trial gives an opportunity to standardize and quality assure radiotherapy practices across the nation at the same time. Along with the results of the FAST Forward trial, the safety of this intervention in advanced node-positive disease requiring regional nodal radiation will be established. Trial Registration The trial has been registered at the Clinical Trial Registry of India (CTRI) vide registration number: CTRI/2018/12/016816 (31/12/2018) as well as the clinical trial.gov website at NCT03788213 (28/12/2018).

scholarly journals The Effects of Tai Chi on Grade 1 Hypertension: A Study Protocol for a Randomized Controlled Trial

2019 ◽  
Author(s):  
Sang Hyun Lee ◽  
Byung-Jun Kim ◽  
In-Hwa Park ◽  
Eui-Hyoung Hwang ◽  
Eun Ju Park ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Randomized Controlled Trial ◽  
Tai Chi ◽  
Salt Intake ◽  
Controlled Trial ◽  
Treatment Options ◽  
Treatment Method ◽  
Care Group ◽  
Randomized Controlled

Abstract Background Medication is generally recommended to reduce the morbidity and mortality caused by cardiovascular disease in hypertensive patients. However, considering the difficulties and economic factors associated with long-term medication, interest in tai chi as an exercise treatment method has been recently increasing in Korean medical practice. Numerous studies have suggested that tai chi can be used to treat various diseases and affect psychosomatic factors such as anxiety. This study aims to evaluate the effect of tai chi in reducing blood pressure among grade 1 hypertensive patients.Methods In this randomized, active-controlled, assessor-blinded, two parallel-armed trial, 80 grade 1 hypertension patients will be recruited and randomly assigned to the usual care group or to the tai chi group (n = 40 in each group). Subjects who voluntarily signed a study agreement will be educated to manage their own blood pressure by restricting salt intake, losing weight, moderating alcohol consumption, performing exercise, and regulating dietary intake at their first visit. In addition to self-management, the tai chi group will perform two 60-minute tai chi sessions per week for a total of 8 weeks. Blood pressure will be measured as the primary outcome. In addition, body composition, heart rate, and the perceived strength and difficulty of the exercise will be measured as secondary outcomes.Discussion This study intends to conduct a randomized controlled trial of tai chi, which is not widely practiced in Korea. This study will provide valuable data on the effects of tai chi on hypertension, to inform non-pharmaceutical treatment options for this disorder.

scholarly journals HYPOfractionated Radiation Therapy comparing a standard radiotherapy schedule (over three weeks) with a novel one week schedule in Adjuvant breast cancer: An open-label randomised controlled study (HYPORT- Adjuvant): study protocol for a multicenter, randomized phase III trial.

2020 ◽  
Author(s):  
Sanjoy Chatterjee ◽  
Santam Chakraborty ◽  
HYPORT Adjuvant Author Group
Keyword(s):  
Breast Cancer ◽  
Randomized Controlled Trial ◽  
Recurrence Rate ◽  
Adjuvant Radiotherapy ◽  
Locoregional Recurrence ◽  
Controlled Trial ◽  
Phase Iii ◽  
Controlled Study ◽  
Randomized Controlled ◽  
Locoregional Recurrence Rate

Abstract Background Hypofractionated radiotherapy is the current standard for adjuvant radiotherapy across many centres. Further hypofractionation may be possible but remains to be investigated in non-caucasian populations with more advanced disease, with a higher proportion of patients requiring mastectomy as well as tumour bed boost. We are reporting the design of randomized controlled trial testing the hypothesis that a one week (5 fractions) regimen of radiotherapy will be non-inferior to a standard three week (15 fractions) schedule. Methods We describe a multicenter, randomized controlled trial recruiting patients at large academic centres across India. Patients without distant metastases who merit adjuvant radiotherapy will be eligible for inclusion in the study. Patients in the control arm will receive adjuvant radiotherapy to the breast or chest wall (with/without regional nodes) to a dose of 40 Gy / 15 fractions / 3 weeks, while those in the experimental arm will receive a dose of 26 Gy / 5 fractions / 1 week (to the same volume). Use of a simultaneous integrated boost (dose of 8 Gy and 6 Gy respectively) is allowed in patients who have undergone breast conservation. A sample size of 2100 patients provides an 80% power to detect a non-inferiority of 3% in the 5-year locoregional recurrence rate with a one-sided type I error of 2.5%, assuming that the locoregional recurrence rate in the control arm is 5% at 5 years (corresponding to a hazard ratio of 1.63). Patients will be recruited over a period of 5 years, and followed up for a further 5 years thereafter. Discussion If a five-fraction regimen of breast cancer is proven to be non-inferior, this will result in a significant improvement in the access to radiotherapy, as well as reduced costs of treatment. The trial gives an opportunity to standardize and quality assure radiotherapy practices across the nation at the same time. Along with the results of the FAST Forward trial, the safety of this intervention in advanced node-positive disease requiring regional nodal radiation will be established. Trial Registration The trial has been registered at the Clinical Trial Registry of India (CTRI) vide registration number: CTRI/2018/12/016816 (31/12/2018) as well as the clinical trial.gov website at NCT03788213 (28/12/2018).

Does an Eczema Action Plan Improve Atopic Dermatitis? A Single-Site Randomized Controlled Trial

2018 ◽  
Vol 57 (14) ◽  
pp. 1624-1629 ◽  
Author(s):  
Julia Brown ◽  
Nicole W. Weitz ◽  
Amy Liang ◽  
Melissa S. Stockwell ◽  
Suzanne Friedman
Keyword(s):  
Randomized Controlled Trial ◽  
Atopic Dermatitis ◽  
Positive Impact ◽  
Action Plan ◽  
Controlled Trial ◽  
Treatment Options ◽  
Single Site ◽  
Care Group ◽  
Randomized Controlled ◽  
The Impact

The multitude of treatment options for atopic dermatitis (AD) makes management frustrating for providers and patients. Eczema action plans (EAPs) have been proposed to improve parental and provider management. We developed a single-site randomized controlled trial to evaluate the impact of an EAP on quality of life (QOL), provider knowledge, and comfort with AD management. Providers were randomized into an EAP-use group and a traditional care group. All patients completed validated AD QOL surveys, and those with AD were verbally administered the survey 1 month later. Providers’ perceptions on managing AD were compared in the EAP and usual use groups. Parents in the EAP group demonstrated a significantly increased understanding of AD treatment, and providers in the EAP group had a significantly increased understanding and management of AD. The EAP is a feasible tool that can be integrated into a busy clinic practice with a positive impact on physicians and patients.

scholarly journals Pharmacist-led counselling intervention to improve antiretroviral drug adherence in Pakistan: a randomized controlled trial

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Zeenat Fatima Chatha ◽  
Usman Rashid ◽  
Sharon Olsen ◽  
Fakhar ud Din ◽  
Amjad Khan ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Care Group ◽  
People Living With Hiv ◽  
Post Intervention ◽  
Randomized Controlled ◽  
Cell Counts ◽  
Cd4 Cell

Abstract Background Pakistan is facing a growing population of people living with human immunodeficiency (HIV). In this randomized controlled trial, we investigate if a pharmacist-led intervention can increase adherence to antiretroviral therapy (ART) for people living with HIV (PLWH). Methods Adults with HIV, who have been taking ART for more than 3 months were randomly assigned to receive either a pharmacist-led intervention or their usual care. Measures of adherence were collected at 1) baseline 2) just prior to delivery of intervention and 3) 8 weeks later. The primary outcomes were CD4 cell count and self-reported adherence measured with the AIDS Clinical Trial Group (ACTG) questionnaire. Results Post-intervention, the intervention group showed a statistically significant increase in CD4 cell counts as compared to the usual care group (p = 0.0054). In addition, adherence improved in the intervention group, with participants being 5.96 times more likely to report having not missed their medication for longer periods of time (p = 0.0086) while participants in the intervention group were 7.74 times more likely to report missing their ART less frequently (p < 0.0001). Conclusions The findings support the improvement in ART adherence and HIV management. Trial registration The trial is registered with Australian New Zealand Clinical Trials Registry (ACTRN12618001882213). Registered 20 November 2018.

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