scholarly journals Acupuncture And Chinese Herb Medicine Yangjing Zhongyu Decoction For The Treatment of Endometriosis-Associated Infertility: A Study Protocol For A Multi-Center, Controlled and Randomized Clinical Trial

2021 ◽  
Author(s):  
Chuting Wu ◽  
Xiaoyun Zhang ◽  
Chunyan Zhang
Keyword(s):  
Clinical Trial ◽  
Treatment Group ◽  
Pregnancy Rate ◽  
Randomized Clinical Trial ◽  
Chinese Herb ◽  
Control Group ◽  
Menstrual Cycles ◽  
Herb Medicine ◽  
Chinese Herb Medicine

Abstract Introduction: Endometriosis is an inflammatory estrogen-dependent gynecological disease, which is one of the common reasons for infertility. The current treatments of endometriosis-associated infertility often involve laparoscopic surgery, medical therapy and in vitro fertilization (IVF) therapy, which are expensive, and the therapeutic effects are far from the expectation. Acupuncture and Yangjing Zhongyu Decoction (YZD) which have the advantages of effective and inexpensive, have been used clinically for the infertile female in China for many years. However, a comprehensive evaluation of the current clinical evidence of their efficacy is lacking. Our study intends to evaluate the efficacy of acupuncture and YZD on endometriosis-associated infertility (EAI).Methods/design: This study is a multi-center, controlled and randomized clinical trial. A total of 224 eligible patients with endometriosis-associated infertility will be randomly assigned into two groups, in a 1:1 ratio as the treatment group or the control group. All participants will receive pregnancy guidance. The participants assigned to the treatment group will be treated with acupuncture and YZD while the control group will receive the GnRH-a therapy. The trial will include three menstrual cycles of treatment and twelve menstrual cycles of follow-up. The primary outcome is pregnancy rate that will be verified by human chorionic gonadotropin (HCG) tests and secondary outcomes include the result of ultrasound, cancer antigen 125 (CA125), anti-Müllerian hormone (AMH), sex hormones, alanine aminotransferase (ALT) and the Endometriosis Health Profile-5 (EHP-5). Outcome will be collected at baseline, the end of treatments and follow-up visits at 3, 6 and 12 menstrual cycles. All the data including the major adverse events will be recorded in electronic case report forms and analysed by SPSS V.25.0.Discussion: This study protocol will help to evaluate whether acupuncture and Chinese herb medicine Yangjing Zhongyu Decoction are effective in increasing pregnancy rate of the infertile female with endometriosis.Trial registration: ChiCTR2100042830; Registered on 29 January 2021.

Anti-Inflammatory Function of Nodosin via Inhibition of IL-2

2010 ◽  
Vol 38 (01) ◽  
pp. 127-142 ◽  
Author(s):  
Jiyu Li ◽  
Junming Du ◽  
Lijuan Sun ◽  
Jianwen Liu ◽  
Zhiwei Quan
Keyword(s):  
Clinical Trial ◽  
T Lymphocytes ◽  
Mrna Level ◽  
Chinese Herb ◽  
Potential Candidate ◽  
Traditional Chinese Herb ◽  
Anti Inflammatory ◽  
Cell Mitosis ◽  
Herb Medicine ◽  
Chinese Herb Medicine

In order to explore the anti-inflammatory effects of Nodosin from Isodon serra, a traditional Chinese herb medicine, mouse T lymphocytes were incubated with Nodosin. In the current study, Nodosin suppressed the overproduction of the T lymphocytes; moreover, cell mitosis cycle was modulated by interfering with DNA replication in G1 stages via inhibition of IL-2 cytokine secretion at the mRNA level by Nodosin. Interestingly, Xylene-induced mouse tumescence model results suggested Nodosin depressed the murine ear-swelling extent and the level of IL-2 in the blood serum. Finally, Nodosin possessed significant anti-inflammatory effects and is a potential candidate for further clinical trial.

Effectiveness of a conversational chatbot in the smartphone to cease smoking in the adult population: pragmatic, controlled, randomized clinical trial in primary care (Dejal@). (Preprint)

2021 ◽  
Author(s):  
EDUARDO OLANO-ESPINOSA ◽  
Jose Francisco Avila-Tomas ◽  
Cesar Minue-Lorenzo ◽  
Blanca Matilla Pardo ◽  
Encarnación Serrano-Serrano ◽  
...  
Keyword(s):  
Primary Care ◽  
Clinical Trial ◽  
Clinical Practice ◽  
Randomized Clinical Trial ◽  
Control Group ◽  
Evidence Based ◽  
Intention To Treat ◽  
Usual Clinical Practice ◽  
Treat Analysis

BACKGROUND The magnitude and severity of smoking, the benefits of quitting, and the existence of effective and efficient interventions make it a priority problem. Health professionals intervene less than they should, and the most effective interventions are more expensive, require specific training and more time, which is a disadvantage for the service provider and for the accessibility of the services. Information and communication technologies avoid these problems thanks to their accessibility, privacy, customization possibilities, access to social support, and scalability. OBJECTIVE To assess the effectiveness of an evidence-based intervention to cease smoking via a chatbot in the smartphone compared to usual clinical practice in primary care. METHODS Pragmatic randomized clinical trial in 34 primary healthcare centers within the Madrid Health Service (Spain). Smokers over 18 years of age who attended on-site consultation and accepted help to quit tobacco were recruited by their doctor or nurse and randomly allocated to receive usual care (control group, CG) or an evidence-based chatbot intervention (intervention group, IG). The interventions in both arms were based on the 5A´s by the US clinical practice guideline, which combines behavioral and pharmacological treatments and is structured in several follow-up appointments. The primary outcome was continuous abstinence from smoking that was biochemically validated after 6 months by the collaborators. The outcome analysis was blinded to allocation of subjects although participants were unblinded to group assignment. An intention-to-treat analysis, entering the basal observation carried forward in cases of missing data, and logistic regression models with robust estimators were employed for assessing the primary outcomes. RESULTS The trial was conducted between October 1st of 2018 and March 31st of 2019. The sample comprised 513 patients (242 in the IG and 271 in the CG), with an average age of 49.8 years (SD 10.82) and gender ratio of 59.3% women and 40.7% men. Of them, 232 patients (45.2%) completed the follow-up, 104 (42.9%) in the IG and 128 (47.2%) in the CG. Main outcome: In the intention-to-treat analysis, the biochemically-validated abstinence rate at 6 months was higher in the IG with 26.03% (63/242) versus 18.82% (51/271) in the CG (odds ratio (OR)=1.52, 95% CI: 1.00–2.31, P=.05). After adjusting for basal CO-oxymetry and bupropion intake, no substantial changes were observed (OR=1.52, 95% CI 0.99–2.33 P= .053; pseudo R2=0.045). In the IG, 61.16% (148/242) of users accessed the chatbot, average bot-patient interaction time was 121 minutes (CI 95% 121.1–140.0), and average number of contacts was 45.56 (SD 36.32). CONCLUSIONS A treatment including a chatbot for helping in tobacco cessation was more effective than usual clinical practice in primary care. CLINICALTRIAL ClinicalTrials.gov, reference number NCT 03445507.

scholarly journals Marginal Bone Remodeling around healing Abutment vs Final Abutment Placement at Second Stage Implant Surgery: A 12-month Randomized Clinical Trial

2016 ◽  
Vol 17 (1) ◽  
pp. 7-15 ◽  
Author(s):  
Ronald Younes ◽  
Antoine Berberi ◽  
Nabih Nader ◽  
Maissa Aboulhosn ◽  
Cordahi Manal
Keyword(s):  
Clinical Trial ◽  
Bone Loss ◽  
Randomized Clinical Trial ◽  
Bone Remodeling ◽  
Test Group ◽  
Control Group ◽  
Marginal Bone Loss ◽  
Second Stage ◽  
Stable Connection

ABSTRACT Background The periimplant bone level has been used as one of the criteria to assess the success of dental implants. It has been documented that the bone supporting two-piece implants undergoes resorption first following the second-stage surgery and later on further to abutment connection and delivery of the final prosthesis. Objective The aim of this multicentric randomized clinical trial was to evaluate the crestal bone resorption around internal connection dental implants using a new surgical protocol that aims to respect the biological distance, relying on the benefit of a friction fit connection abutment (test group) compared with implants receiving conventional healing abutments at secondstage surgery (control group). Materials and methods A total of partially edentulous patients were consecutively treated at two private clinics, with two adjacent two-stage implants. Three months after the first surgery, one of the implants was randomly allocated to the control group and was uncovered using a healing abutment, while the other implant received a standard final abutment and was seated and tightened to 30 Ncm. At each step of the prosthetic try-in, the abutment in the test group was removed and then retightened to 30 Ncm. Horizontal bone changes were assessed using periapical radiographs immediately after implant placement and at 3 (second-stage surgery), 6, 9 and 12 months follow-up examinations. Results At 12 months follow-up, no implant failure was reported in both groups. In the control group, the mean periimplant bone resorption was 0.249 ± 0.362 at M3, 0.773 ± 0.413 at M6, 0.904 ± 0.36 at M9 and 1.047 ± 0.395 at M12. The test group revealed a statistically significant lower marginal bone loss of 20.88% at M3 (0.197 ± 0.262), 22.25% at M6 (0.601 ± 0.386), 24.23% at M9 (0.685 ± 0.341) and 19.2% at M9 (0.846 ± 0.454). The results revealed that bone loss increased over time, with the greatest change in bone loss occurring between 3 and 6 months. Alveolar bone loss was significantly greater in the control condition than the test condition. Conclusion The results of this prospective study demonstrated the benefit of placing a prosthetic component with a stable connection at second-stage surgery, in terms of reduced marginal bone remodeling when compared with conventional procedure. Clinical significance. The use of a stable connection in a healing component during try-in stages prior to final restoration placement leads to less periimplant marginal bone loss. How to cite this article Nader N, Aboulhosn M, Berberi A, Manal C, Younes R. Marginal Bone Remodeling around healing Abutment vs Final Abutment Placement at Second Stage Surgery: A 12-month Randomized Clinical Trial. J Contemp Dent Pract 2016;17(1):7-15.

scholarly journals Efficacy of Hydroxychloroquine in Patients with COVID-19 (Chen et al., 2020): Moderate Evidence for a Treatment Effect on Pneumonia

2020 ◽  
Author(s):  
Eric-Jan Wagenmakers ◽  
Quentin Frederik Gronau
Keyword(s):  
Clinical Trial ◽  
Treatment Group ◽  
Body Temperature ◽  
Randomized Clinical Trial ◽  
Treatment Effect ◽  
Recovery Time ◽  
The Body ◽  
Control Group ◽  
Moderate Evidence ◽  
Temperature Recovery

A recent randomized clinical trial assessed the efficacy of hydroxychloroquine (HCQ) in the treatment of patients with common coronavirus disease-19 (COVID-19). 1 The results showed that “the body temperature recovery time and the cough remission time were significantly shortened in the HCQ treatment group. Besides, a larger proportion of patients with improved pneumonia in the HCQ treatment group (80.6%, 25 of 31) compared with the control group (54.8%, 17 of 31).” A Bayesian reanalysis of the pneumonia data provides support for the hypothesis that HCQ improves pneumonia in patients with COVID-19. However, the degree of this support is moderate. In line with the authors’ conclusion, more data are needed to draw definite conclusions.

scholarly journals Comparison of Analgesic Effects of UST with NSAIDs and without NSAIDs in Patients with De Quervain’s Disease

2019 ◽  
Vol 32 (1) ◽  
pp. 25-32
Author(s):  
ABM Zafar Sadeque ◽  
AKM Salek ◽  
Md Tariqul Islam Khan ◽  
Badrunnesa Ahmed ◽  
Hasan Habibur Rahman ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Pain Treatment ◽  
Control Group ◽  
De Quervain’S Disease ◽  
Significant Difference ◽  
Group A ◽  
Anti Inflammatory ◽  
Group B

Background: De Quervain's disease has been described as an entrapment of the extensor pollicis brevis and abductor pollicis longus tendons in the first dorsal compartment of the wrist is a common cause of wrist and hand pain Treatment of the disease consists of pharmacological & non-pharmacological. The non-pharmacological includes immobilization, therapeutic heat and cold, electrical nerve stimulator, thumb stabilizer splint, postural correction at work and the adjustment of tools and equipment. This randomized clinical trial was performed to find out the effects of UST with NSAIDs and without NSAIDs in the patients of De Quervain’s disease. Methods: This randomized clinical trial was performed in the Department of Physical Medicine and Rehabilitation, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh, over a period of six months. Group A-experimental or interventional group and group B-control group by randomization with the help of lottery. Experimental group was managed by activities of daily living (ADLs) instructions, ultrasound therapy (UST) with non-steroidal anti-inflammatory agents (NSAIDs gel), along with thumb spica splint. Control group B received previous management except non-steroidal anti-inflammatory agents (NSAIDs gel). All patients received therapeutic ultrasound in a same dosage (1 watt/ cm 2/min) for 8 minutes. An evaluation was made at initial visit and two weeks interval for 6 weeks. So, there were three follow up visits and these evaluations were performed by the same investigator. In each visit, measurement of pain intensity and disability level were performed by using visual analogue scale (VAS), Tenderness Index and Patient rated wrist evaluation (PRWE) respectively. All results was recorded systematically. A post intervention result was compared with baseline result by SPSS-20 Results: Out of 60 total patients 60(100%) had Finkelstein test positive. Significant difference between Group A and Group B was found at week 4 and Week 6 follow up (P<0.05) whereas other early follow up was non-significant in VAS analysis (p>0.05). Significant difference between Group A and Group B was found at week 4 and week 6 follow up (P<0.05) regarding change of tenderness and PRWE. Conclusion: Regarding treatment of De Quervain's disease, present study shown that UST with NSAIDs gel reduces the morbidity and relief of pain of patients when in comparison to other conventional treatment. TAJ 2019; 32(1): 25-32

scholarly journals Effects of auricular acupuncture on chronic pain in people with back musculoskeletal disorders: a randomized clinical trial

2019 ◽  
Vol 53 ◽  
Author(s):  
Caroline de Castro Moura ◽  
Erika de Cássia Lopes Chaves ◽  
Tânia Couto Machado Chianca ◽  
Silvia Graciela Ruginsk ◽  
Denismar Alves Nogueira ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Chronic Pain ◽  
Treatment Group ◽  
Pain Intensity ◽  
Randomized Clinical Trial ◽  
Musculoskeletal Disorders ◽  
Pain Threshold ◽  
Daily Activities ◽  
Auricular Acupuncture

ABSTRACT Objective: To evaluate the effects of auricular acupuncture on pain intensity, its impact on daily activities, the relief provided by the intervention, and the pain threshold in people with back musculoskeletal disorders. Methods: Randomized clinical trial carried out with people randomly allocated into three groups: treatment, placebo, and control. Evaluations were performed using the Brief Pain Inventory and a digital algometer before (initial) and after (final) the treatment and after a 15-day follow-up period. Results: The sample was 110 people. There was a decrease in pain intensity in the treatment and placebo groups as revealed by the comparison between the initial and final evaluations (p<0.05), and in the treatment group in the comparison between the initial and follow-up evaluations (p<0.05). A decreased impact of pain on daily activities in the treatment and placebo groups over time was found (p<0.05). At the final evaluation, the impact of pain was lower in the treatment group (p<0.05). Auricular acupuncture did not increase the pain threshold. Conclusion: Auricular acupuncture presented positive effects by reducing the chronic pain intensity and its impact on daily activities in people with back musculoskeletal disorders. Brazilian Clinical Trials Registry: RBR-5X69X2

scholarly journals Home visit improves knowledge, self-care and adhesion in heart failure: randomized Clinical Trial HELEN-I

2013 ◽  
Vol 21 (spe) ◽  
pp. 20-28 ◽  
Author(s):  
Cláudia Motta Mussi ◽  
Karen Ruschel ◽  
Emiliane Nogueira de Souza ◽  
Alexandra Nogueira Mello Lopes ◽  
Melina Maria Trojahn ◽  
...  
Keyword(s):  
Heart Failure ◽  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Intervention Group ◽  
Self Care ◽  
Home Visits ◽  
Decompensated Heart Failure ◽  
Control Group ◽  
Phone Calls

OBJECTIVE: To verify the effect of an educative nursing intervention composed of home visits and phone calls on patients' knowledge about the disease, self-care and adhesion to the treatment. METHODS: Randomized clinical trial with patients with recent hospitalization caused by decompensated heart failure. There were two groups: the intervention group, which has received four home visits and four phone calls to reinforce the guidelines during six months of follow up; and the control group, which has received conventional follow up with no visits or phone calls. RESULTS: Two hundred patients were randomized (101 in the intervention group and 99 in the control group). After six months, a significant improvement was observed in self-care and knowledge about the disease in the intervention group (P=0.001 and P<0.001), respectively; the adhesion to the treatment, measured and compared between the groups, was significantly higher in the intervention group (P=0.001). CONCLUSION: the strategy of home visits to patients who were recently hospitalized with decompensated heart failure was effective in improving the outcomes assessed and its implementation deserves to be considered in Brazil aiming at avoiding unplanned hospitalizations. NCT-01213862

Effectiveness of Resin-Based Sealants with and without Fluoride Placed in a High Caries Risk Population: Multicentric 2-Year Randomized Clinical Trial

2018 ◽  
Vol 52 (4) ◽  
pp. 312-322 ◽  
Author(s):  
Michèle Muller-Bolla ◽  
Fréderic Courson ◽  
Laurence Lupi-Pégurier ◽  
Corinne Tardieu ◽  
Shrisha Mohit ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Retention Rate ◽  
Intervention Group ◽  
Assessment System ◽  
Caries Detection ◽  
Control Group ◽  
Caries Risk ◽  
High Caries Risk

A split-mouth randomized clinical trial was carried out to assess the effectiveness of sealants in preventing carious ICDAS (International Caries Detection and Assessment System) 3–6 lesions within a 2-year follow-up. We evaluated the effectiveness of 2 types of resin-based sealants, with and without fluoride, their retention rates, and the caries risk factors related to their outcomes. The study included 663 tooth pairs in 400 children (aged 5–15 years) considered to be at high individual caries risk (ICR) and presenting permanent molars free of caries or affected by ICDAS 1–2 lesions. In the first randomization, molars were either randomized to the treatment group receiving a dental sealant or the control group (nontreatment), and in the second randomization the sealant material to be used in the intervention group was selected. Uni- and multivariate Cox proportional hazard models were employed. At the 2-year follow-up, 483 tooth pairs were assessed: sealed molars had 83% (adjusted HR = 0.17; 95% CI: 0.15–0.20) less risk of developing ICDAS 3–6 lesions than molars without sealant. The magnitude of the protective effect was lower among teeth with ICDAS 1–2 lesions or with occlusal deep fissures than without. If the total retention rate of sealants was 70% at 2 years, sealant loss was not associated with the risk of caries (HR = 1.29, 95% CI: 0.92–1.79, p = 0.14). Sealants allow the prevention of new ICDAS 3–6 lesions or progression of noncavitated carious lesions in children at high ICR, and the effect of the sealant was similar regardless of whether it contained fluoride or not.

The effectiveness of a program of physical activity and diet to modify cardiovascular risk factors in patients with severe mental illness after 3-month follow-up: CAPiCOR randomized clinical trial

2015 ◽  
Vol 30 (8) ◽  
pp. 1028-1036 ◽  
Author(s):  
R. Masa-Font ◽  
M.I. Fernández-San-Martín ◽  
L.M. Martín López ◽  
A.M. Alba Muñoz ◽  
S. Oller Canet ◽  
...  
Keyword(s):  
Physical Activity ◽  
Clinical Trial ◽  
Mental Illness ◽  
Severe Mental Illness ◽  
Randomized Clinical Trial ◽  
Dietary Habits ◽  
Intervention Group ◽  
Control Group ◽  
Laboratory Parameters

AbstractBackgroundThe aim of this randomized clinical trial follow-up at three months was to evaluate the effectiveness of an educational intervention with a focus on diet and physical activity (PA) to change the amount of PA, body mass index (BMI) and the waist circumference (WC) in patients with severe mental illness.MethodsWe recruited 332 outpatients with severe mental disorders undergoing treatment with antipsychotic medication from Mental Healthcare Centers of Barcelona. They were randomly assigned to an intervention or a control group. The patients in the intervention group participated in a group PA and diet educational program. The blinded measurements at 0 and 3 months were: the level of PA (IPAQ questionnaire), BMI, WC, blood pressure, dietary habits (PREDIMED questionnaire), quality of life (SF-36 questionnaire) and laboratory parameters (cholesterol, triglycerides, glucose).ResultsThe average age was 46.7 years and 55% were males. Schizophrenia had been diagnosed in 67.1% of them. At 3 months, the average weekly walking METs rose significantly in the IG 266.05 METs (95%CI: 16.86 to 515.25; P = 0.036). The total MET average also rose although not significantly: 191.38 METs (95%CI: 1.38 to 381.38; P = 0.086). However, the BMI decreased significantly more in the CG, by 0.26 kg/m2 (95%CI: 0.02 to 0.51; P = 0.038), than in the IG. There were no significant differences in the WC.ConclusionsThe short-term results suggest that the intervention increases the level of PA, but does not improve physical or laboratory parameters.Trial registrationClinicaltrials.gov NCT01729650 (effectiveness of a physical activity and diet program in patients with psychotic disorder [CAPiCOR]).

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