Efficacy of sinecatechins 10% as proactive sequential therapy of external genital warts after laser CO2 ablative therapy: The PACT study (post-ablation immunomodulator treatment of condylomata with sinecatechins): a randomized, masked outcome assessment, multicenter trial

2018 ◽  
Vol 30 (2) ◽  
pp. 131-136 ◽  
Author(s):  
Mario Puviani ◽  
Marco Galluzzo ◽  
Marina Talamonti ◽  
Sara Mazzilli ◽  
Elena Campione ◽  
...  
Keyword(s):  
Outcome Assessment ◽  
Controlled Trial ◽  
Sequential Therapy ◽  
Genital Warts ◽  
Multicenter Trial ◽  
Burning Sensation ◽  
Application Site ◽  
Control Group ◽  
Transmitted Infection ◽  
External Genital Warts

External genital warts (EGW) are the most common viral sexually transmitted infection. Ablative treatments like cryotherapy, curettage, and CO2 laser therapies offer rapid onset of effect, fast clearance, and reduction of virus load. However, these procedures are associated with high recurrence rates (RRs) ranging from 20% to 77% in the short and medium terms and do not provide sustained clearance. After laser therapy removal of EGW, an RR up to 77% has been reported. Topical sinecatechins (TS) 10% is a patient-applied regimen for the treatment of EGW with a low RR (<6.5%) at three months after completion of the therapy in the pivotal trials conducted so far. Sinecatechins can be considered a suitable proactive sequential therapy (PST) after ablative strategies to obtain a low RR. So far, no prospective data are available regarding the efficacy of sinecatechins 10% as PST. We evaluated the efficacy and tolerability of TS 10% ointment applied twice daily in subjects with “difficult to treat” EGW after CO2 laser ablative treatment in a prospective controlled trial. A total of 87 subjects (76 men and 11 women; mean age 42 years) were enrolled in this three-month masked outcome assessment parallel group trial with imbalanced randomization allocation (2:1). One week after a successful CO2 laser treatment, 60 subjects were randomized to TS 10% treatment and 27 subjects to no treatment (control group: ConTRol (CTR); no sequential therapy). All patients had a history of an average of 4.5 previous ablative treatments in the last 12 months due to recurrent EGW. Mean (standard deviation) baseline number of treated lesions was 6.5 (2.7). One subject in the TS arm dropped out due to burning sensation after the application of the product. Therefore, 86 subjects completed the study. After three months, in the TS group, three subjects presented new EGW lesions (RR: 5%) on treated sites. In the CTR group, eight subjects presented new EGW lesions (RR: 29%) on treated sites (p = 0.0024; odds ratio: 0.16; 95% confidence interval: 0.04–0.68). In the TS group, 34 subjects (56%) reported mild to moderate erythema or burning sensation at the application site. In this prospective multicenter trial, the use of TS 10% as PST after ablative treatment with CO2 laser was associated with a lower recurrence rate of new EGW lesions in the short term in comparison with the control group. Comparative larger trials are warranted to evaluate the role of this approach as PST (Trial Registration Number: ISRCTN44037479).

Treatment of classic mid-trimester preterm premature rupture of membranes (PPROM) with oligo/ anhydramnion between 22 – 26 weeks’ gestation by means of continuous amnioinfusion: a randomized multicentric prospective controlled TRIAL

2021 ◽  
Author(s):  
Michael Tchirikov ◽  
Christian Haiduk ◽  
Miriam Tchirikov ◽  
Marcus Riemer ◽  
Stephan Henschen ◽  
...  
Keyword(s):  
Amniotic Fluid ◽  
Controlled Trial ◽  
Periventricular Leukomalacia ◽  
German Society ◽  
Multicenter Trial ◽  
Control Group ◽  
Amniotic Cavity ◽  
Port System ◽  
One Year ◽  
Interventional Group

Abstract Background: The classic mid-trimester preterm premature rupture of membranes (PPROM), is defined as rupture of fetal membranes prior to 28 weeks’ gestation (WG) with oligo/ anhydramnion, complicates approximately 0.4-0.7% of all pregnancies and is associated with very high neonatal mortality and morbidity.Antibiotics have limited success to prevent bacterial growth, chorioamnionitis and fetal inflammation. The repetitive amnioinfusion doesn’t work because of immediately fluid lost after the intervention. The continuous amnioinfusion through the transabdomianal port system or catheter in patients with classic PPROM shows promise by flush out of bacteria and inflammatory components from the amniotic cavity, replacing amniotic fluid and thus prolonging PPROM-to-delivery interval.Aim: This multicenter trial tests the effect of continuous amnioinfusion on the neonatal survival without the typical major morbidities, like severe bronchopulmonary dysplasia, intraventricular hemorrhage, cystic periventricular leukomalacia and necrotizing enterocolitis one year after the delivery.Methods/Design: randomized multicenter trial; two-arm parallel design. Control group: PPROM patients between 22/0 (20/0) -26/0 WG treated with antibiotics and corticosteroids in accordance to guidelines of German Society of Obstetrics and Gynecology (standard PPROM therapy). In the interventional group the standard PPROM therapy will be complemented by “Amnion Flush Method” with the amnioinfusion of artificial amniotic fluid (up to 100 ml/h, 2400 ml/day).Subjects: 68 patients with classic PPROM between 22/0 (20/0)-26/0 WG.TRIAL-registration: ClinicalTrials.gov ID: NCT04696003 and German Clinical Trials Register: DRKS00024503, January 2021.The trial is approved by the Ethic committee of the Martin-Luther University Halle-Wittenberg (2020-185, January 25, 2021).

Could the human papillomavirus vaccine prevent recurrence of ano-genital warts?: a systematic review and meta-analysis

2020 ◽  
Vol 31 (7) ◽  
pp. 606-612
Author(s):  
Husein Husein-ElAhmed
Keyword(s):  
Human Papillomavirus ◽  
Meta Analysis ◽  
Hpv Vaccination ◽  
Genital Warts ◽  
Control Group ◽  
Effect Estimate ◽  
Human Papillomavirus Vaccine ◽  
Eligibility Criteria ◽  
Transmitted Infection ◽  
Sexually Transmitted

Human papillomavirus (HPV) is the most prevalent sexually transmitted infection worldwide and ano-genital warts (AGWs) are highly infectious. This virus is transmitted through sexual, anal, or oral contact as well as skin-to-skin contacts. Treatment for this condition has significant morbidity and it can be frustrating in certain cases. The HPV vaccination has been demonstrated as a promising strategy of secondary prevention in HPV-related diseases such as head and neck cancers, cervical diseases, and recurrent respiratory papillomatosis. Regarding AGWs, it is unclear whether vaccination can provide analogous clinical benefit. The aim of this work is to systematically review the literature regarding HPV vaccination for secondary disease prevention after treatment of AGWs. From October to December 2018, a systematic search for clinical trials was conducted in five databases: PubMed, MEDLINE, EMBASE, Cochrane, and clinicaltrials.gov using a combination of the following descriptors: ‘gardasil’ OR ‘cervarix’ OR ‘nine-valent’ OR ‘9-valent’ OR ‘vaccine’ AND ‘recurrence’ OR ‘relapse’ AND ‘hpv’ OR ‘papillomavirus’ AND ‘warts’ OR ‘condyloma.’ Data were synthetized and entered in the Review Manager software (RevMan 5.3.5) to perform the meta-analysis. The search yielded 824 potentially relevant studies. Two studies fulfilled the eligibility criteria involving 656 participants. The meta-analysis estimated the rate of recurrence of AGWs was similar between the vaccine group and the control group. The overall effect estimate was 1.02 (0.75–1.38). This is the first meta-analysis exploring the effect of HPV vaccine in preventing the relapse of AGWs. These results suggest that HPV vaccination does not provide secondary benefit in patients with previous AGWs. However, these results cannot be generalized due to the scarce number of RCTs currently available in the literature. The outcomes from future randomized controlled trials (RCTs) are warranted to further clarify the precise effect of the vaccine.

scholarly journals Effectiveness of a Dental Intervention to Improve Oral Health among Home Care Recipients: A Randomized Controlled Trial

2021 ◽  
Vol 18 (17) ◽  
pp. 9339
Author(s):  
Jonas Czwikla ◽  
Alexandra Herzberg ◽  
Sonja Kapp ◽  
Stephan Kloep ◽  
Heinz Rothgang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Oral Health ◽  
Home Care ◽  
Outcome Assessment ◽  
Assessment Tool ◽  
Controlled Trial ◽  
Health Assessment ◽  
Control Group ◽  
Randomized Controlled ◽  
Care Recipients

We quantified the effectiveness of an oral health intervention among home care recipients. Seven German insurance funds invited home care recipients to participate in a two-arm randomized controlled trial. At t0, the treatment group (TG) received an intervention comprising an oral health assessment, dental treatment recommendations and oral health education. The control group (CG) received usual care. At t1, blinded observers assessed objective (Oral Health Assessment Tool (OHAT)) and subjective (Oral Health Impact Profile (OHIP)) oral health and the objective periodontal situation (Periodontal Screening Index (PSI)). Of 9656 invited individuals, 527 (5.5%) participated. In the TG, 164 of 259 (63.3%) participants received the intervention and 112 (43.2%) received an outcome assessment. In the CG, 137 of 268 (51.1%) participants received an outcome assessment. The OHAT mean score (2.83 vs. 3.31, p = 0.0665) and the OHIP mean score (8.92 vs. 7.99, p = 0.1884) did not differ significantly. The prevalence of any periodontal problems (77.1% vs. 92.0%, p = 0.0027) was significantly lower in the TG than in the CG, but the prevalence of periodontitis was not (35.4% vs. 44.6%, p = 0.1764). Future studies should investigate whether other recruitment strategies and a more comprehensive intervention might be more successful in improving oral health among home care recipients.

The effect of Baduanjin sequential therapy on the quality of life and cardiac function in patients with acute myocardial infarction after percutaneous coronary intervention：A randomized controlled trial (Preprint)

2019 ◽  
Author(s):  
Ming-Gui Chen ◽  
Xuefei Liang ◽  
Lili Kong ◽  
Jingjing Wang ◽  
Fangfang Wang ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Cardiac Function ◽  
Controlled Trial ◽  
Sequential Therapy ◽  
Abdominal Circumference ◽  
Control Group ◽  
Sf 36 ◽  
Percutaneous Coronary ◽  
Significant Difference

BACKGROUND Acute myocardial infarction (AMI) is a serious type of coronary artery disease (CAD) with the potential for substantial morbidity and mortalit. Percutaneous coronary intervention (PCI) is an effective treatment. However, most patients still suffer from angina pectoris, anxiety, depression and reduced cardiac function after PCI. OBJECTIVE The purpose of this study was to examine the effects of Baduanjin sequential therapy (BST) on the quality of life and cardiac function in patients with AMI after PCI. METHODS The study was a randomized controlled trial. Patients with AMI after PCI randomly assigned to a BST group (N = 48) or a control group (N = 48). The BST exercise consists of the sitting and standing forms. The sitting Baduanjin was conducted twice a day in the hospital, for 30 min/session. After the patient was discharged from the hospital, the standing Baduanjin was performed fifth weekly, lasting up to 24-weeks, for 30 min/session. The control group received usual care without Baduanjin. The primary outcomes were the changes of SF-36 subscales. Secondary outcomes included measures of left ventricular ejection fraction(LVEF), N-terminal pro B-type natriuretic peptide (NT-pro-BNP), the Body Mass Index (BMI) and the abdominal circumference. RESULTS Of the 96 participants, 82 total patients completed the entire study. At 12 weeks, Role Physical and Health Transition of SF-36 were significantly different between the two groups, with a difference of 26.12 [95% CI, 11.59 to 40.64] in Role physical and a difference of 15.94 [95% CI, 5.60 to 26.28] in Health Transition (p<0.05). However, there were statistically significant differences in all aspects of SF-36 between the two groups at 24 weeks (p<0.05). The BST also lowered the abdominal circumference and BMI as compared with control group. In the 24-week follow-up, a significant difference was found in the decline of the LVEF in control group (p=0.020),while there was non-significant difference in the BST group (p=0.552). Compared with control group, the BST group reduced 50pg/ml on the NT-Pro-BNP at 24 weeks(p=0.013). The effects of BST exercise were maintained at 24weeks after the intervention. No serious adverse events were observed. CONCLUSIONS The BST appears to improve the quality of life in patients with AMI, with additional benefits of lowered the abdominal circumference and BMI and improved the level of cardiac function. CLINICALTRIAL Clinical Trials.gov:NCT02693795. https://clinicaltrials.gov/ct2/ show/NCT02693795?term=NCT02693795&rank=1.

Goal Attainment and Treatment Compliance in a Cognitive-Behavioral Telephone Intervention for Family Caregivers of Persons with Dementia

GeroPsych ◽  
2011 ◽  
Vol 24 (3) ◽  
pp. 115-125 ◽  
Author(s):  
Gabriele Wilz ◽  
Denise Schinköthe ◽  
Renate Soellner
Keyword(s):  
Family Caregivers ◽  
Mentally Ill ◽  
Goal Attainment ◽  
Outcome Measurement ◽  
Controlled Trial ◽  
Treatment Success ◽  
Treatment Compliance ◽  
Control Group ◽  
Telephone Intervention ◽  
Effective Interventions

Introduction: The evaluation of effective interventions is still needed to prevent family caregivers of persons with dementia from becoming physically or mentally ill. However, in most existing intervention studies, primary outcomes are not well matched to the treatment goals. Method: A randomized controlled trial (N = 229) was conducted to compare a treatment group (CBT), a treated control group, and an untreated control group. In theses analyses we focused on the primary outcome measurement (GAS) as a perceived treatment success as well as treatment compliance and participants’ evaluation. Results: Results showed that 30.1% achieved complete goal attainment, 39.8% partial goal attainment, and 24.1% declared no change (overachievement 2.4%; deterioration 3.6%). Discussion: The intervention can be considered to have been successful.

Promoting the Community's Ability to Detect and Respond to Suicide Risk Through an Online Bystander Intervention Model-Informed Tool

Crisis ◽  
2020 ◽  
pp. 1-7
Author(s):  
Karien Hill ◽  
Shawn Somerset ◽  
Ralf Schwarzer ◽  
Carina Chan
Keyword(s):  
Suicide Prevention ◽  
Suicide Risk ◽  
Controlled Trial ◽  
Intervention Group ◽  
Bystander Intervention ◽  
Self Report ◽  
Innovative Technology ◽  
Control Group ◽  
Intervention Model ◽  
Standard Material

Abstract. Background: The public health sector has advocated for more innovative, technology-based, suicide prevention education for the community, to improve their ability to detect and respond to suicide risk. Emerging evidence suggests addressing the bystander effect through the Bystander Intervention Model (BIM) in education material may have potential for suicide prevention. Aims: The current study aimed to assess whether BIM-informed tools can lead to improved readiness, confidence and intent in the community to detect and respond to suicide risk in others. Method: A sample of 281 adults recruited from the community participated in a randomized controlled trial comprising a factsheet designed according to the BIM (intervention group) and a standard factsheet about suicide and mental health (control group). Participants' self-reported detecting and responding to suicide risk readiness, confidence, and intent when presented with a suicidal peer was tested pre- and postintervention and compared across time and between groups. Results: The intervention group had significantly higher levels of detecting and responding to suicide risk readiness, confidence, and intent than the control group at postintervention (all p < .001) with moderate-to-large effect sizes. Limitations: The study was limited by a homogenous sample, too low numbers at follow-up to report, and self-report data only. Conclusion: This study demonstrates BIM-informed suicide prevention training may enhance the community's intervention readiness, confidence, and intent better than current standard material. Further testing in this area is recommended. While results were statistically significant, clinical significance requires further exploration.

Controlled Trial of the Sequential Use of Streptokinase and Ancrod in the Treatment of Deep Vein Thrombosis of Lower Limb

1977 ◽  
Vol 37 (02) ◽  
pp. 222-232 ◽  
Author(s):  
D. A Tibbutt ◽  
C. N Chesterman ◽  
E. W Williams ◽  
T Faulkner ◽  
A. A Sharp
Keyword(s):  
Deep Vein Thrombosis ◽  
Clinical Improvement ◽  
Anticoagulant Therapy ◽  
Lower Limb ◽  
Oral Anticoagulant ◽  
Controlled Trial ◽  
Oral Anticoagulant Therapy ◽  
Control Group ◽  
Vein Thrombosis ◽  
Deep Vein

SummaryTreatment with streptokinase (‘Kabikinase’) was given to 26 patients with venographically confirmed deep vein thrombosis extending into the popliteal vein or above. Treatment was continued for 4 days and the patients were allocated randomly to oral anticoagulant therapy or a course of treatment with ancrod (‘Arvin’) for 6 days followed by oral anticoagulant therapy. The degree of thrombolysis as judged by further venographic examination at 10 days was not significantly different between the 2 groups. The majority of patients showed clinical improvement but there was no appreciable difference between the groups at 3 and 6 months. Haemorrhagic complications were a more serious problem during the period of treatment with ancrod than during the equivalent period in the control group.

Effectiveness of Child to Parent Communication Using Information Package on Food Hygiene

2018 ◽  
Vol 3 (07) ◽  
Author(s):  
Ms. Sonam Yangchen Bhutia ◽  
Dr. Sushma Kumari Saini ◽  
Dr. Manmeet Kaur ◽  
Dr. Sandhya Ghai
Keyword(s):  
School Children ◽  
Home Visit ◽  
Controlled Trial ◽  
Family Members ◽  
Sampling Technique ◽  
Control Group ◽  
Food Hygiene ◽  
Parent Communication ◽  
Post Test ◽  
Randomised Controlled

School children can act as change agent not only for families but for community. The study aimed to assess effectiveness of information package on knowledge and practices of parents/family members of school children studying in Govt. Sr. Sec. School on food hygiene in Dhanas and Daddu Majra Colony, UT, Chandigarh. A non-randomised controlled trial was conducted on 201 school children studying in VIIth standard and their parents/family members. Purposive sampling technique was utilised to enrol 101 in case and 100 participants in control group. Interview schedule for knowledge assessment and observation checklist for assessing the practices of parents/ family members was used. Pre assessment of both the groups was done by a home visit. Experimental group school children were educated on food hygiene as per the protocol. Pre and post-test knowledge of school children on food hygiene was assessed and were asked to disseminate the information to their parents/family members.  After 15 days, second time home visit was done to the parents/family members of both the groups for the post assessment of knowledge and practices. Significant improvement in knowledge and practices of parents/family members related to food hygiene was observed. Hence, school children can be an effective tool in health related knowledge dissemination which can further promote healthy practices.

Reducing the Social Stigma Associated with Obsessive Compulsive Disorder: A Controlled Trial of an Intervention Program in a Turkish Community Sample

2020 ◽  
Vol 20 (2) ◽  
pp. 101-120
Author(s):  
Ayça Aktaç Gürbüz ◽  
Orçun YORULMAZ ◽  
Gülşah DURNA
Keyword(s):  
Obsessive Compulsive Disorder ◽  
Intervention Program ◽  
Controlled Trial ◽  
Community Sample ◽  
Case Vignette ◽  
Control Group ◽  
Obsessive Compulsive ◽  
Compulsive Disorder ◽  
Significant Difference ◽  
The Impact

Scientific research into the reduction of stigmatization, particularly related to specific problems such as Obsessive-Compulsive Disorder (OCD), is scarce. In the present study, we examine the impact of a video-based antistigma intervention program for OCD in a pretest-posttest control group research. After being randomly assigned to either an intervention (n= 101) or control group (n= 96), the participants reported their attitudes on a hypothetical case vignette before and after OCD vs. Multiple Sclerosis (MS) videos, and again six months later as a follow up assessment. The mixed design analyses for the group comparisons indicated that although there was no significant difference in the measures of the control group, the participants watching the anti-stigma OCD video, in which the focus was psychoeducation and interaction strategies, reported significantly lower scores on social distances and negative beliefs for the case vignettes they read, and this difference was maintained six months later. Then, the present results indicate the effectiveness of our anti-stigma intervention program for OCD. Interventions to reduce stigmatization can also be viewed as effective tools for changing the attitudes of people toward OCD, although further research and applications are needed related to specific disorders if a longlasting impact is to be achieved.

Breastfeeding Training through Role-Play and Effects on Mother-infant Attachment Behaviours: A Randomised Controlled Trial

2020 ◽  
Vol 22 (1) ◽  
Author(s):  
Farokh Saljughi ◽  
Mitra Savabi-Esfahani ◽  
Shahnaz Kohan ◽  
Soheila Ehsanpour
Keyword(s):  
Pregnant Women ◽  
Maternal Employment ◽  
Controlled Trial ◽  
Role Play ◽  
Intervention Group ◽  
Control Group ◽  
Maternal Behaviour ◽  
Infant Attachment ◽  
Significant Difference ◽  
History Of

Mother-infant attachment is an intimate, lasting and satisfying relationship that leads to better cognitive, emotional and social growth of the infant. The aim of this study was to determine the effects of breastfeeding training by role-play on mother-infant attachment behaviours. This research was a randomised clinical trial (parallel design). Inclusion criteria were: no history of mental disorders; ability to read and write the Persian language to complete the questionnaire; no history of drug and tobacco intake in primigravida women. The sample comprised 100 pregnant women (in 2 groups), selected through simple random sampling at healthcare centres. The researcher reviewed prenatal care registries of selected healthcare centres and extracted the names of pregnant women in their early third trimester. The data were imported into randomisation software. The control group received routine breastfeeding training, while the intervention group received routine training together with training through role-play. The data collection tool was the Maternal Behaviour Inventory Questionnaire. Consequently 75 samples were analysed in SPSS16. Independent t-tests and chi-square tests were used to examine the difference between the two groups. Results showed that the mean score of mother-infant attachment one week after delivery was significantly higher in the intervention group in comparison to that in the control group (p<0.001). No significant difference was observed between the two groups in maternal age, age of marriage, neonatal gender, maternal employment and education, number of parity, and number of abortions (P>0.05). Since breastfeeding training through role-play could affect mother-infant attachment, it is suggested that this type of training should be provided for pregnant women to promote mother-infant attachment and exclusive breastfeeding.

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