Evaluating a Topical Adjunctive Post Submental ATX-101 (Deoxycholic Acid) Injections for Improved Recovery: A Single Center, Double-Blind, Randomized Controlled Pilot Study

Abstract Background Optimizing post procedural recovery and outcomes for patients is the aim for all physicians. TransFORM Body Treatment with TriHex Technology (TFB) is a topical product that aids in the elimination of fat particles created during procedures and the reduction of associated inflammation, thus, speeding up post procedure recovery time. Objectives Evaluation of post procedural symptoms, signs and healing following submental deoxycholic acid (DCA) injections in combination with TFB post treatment. Methods Participants received two treatments of submental DCA injections. Post treatment 1 every participant received TFB to apply twice daily to the submental area. Follow-up visits included weeks 1, 2 and 4. After week 4, participants discontinued TFB for 30 days prior to the second treatment. At the second treatment visit, participants were randomized to receive either TFB or a bland moisturizer to apply twice daily with the same follow-up visits as post treatment one. Skinfibrometer measurements (objective induration measurements), submental fullness grading and standardized photography were captured at every visit. At all follow-up visits and prior to treatment 2, investigator assessments and participant assessments were completed. Results Post treatment two, investigator assessments of edema and induration decreased in participants using TFB at weeks 1 and 2 compared to the bland moisturizer. Skinfibrometer measurements objectively showed a statistically significant reduction in induration at week 2 (post treatment two) in participants using TFB compared to the bland moisturizer. Furthermore, participants reported less tenderness and soreness in the TFB group over the bland moisturizer. Conclusions Investigator assessments, participant query and objective skinfibrometer analyses have demonstrated that the use of TFB post DCA injections may reduce induration, edema and discomfort associated with this procedure.

Clinical efficacy of Tailin formulation combined with continuous low-dose antimicrobial therapy for recurrent urinary tract infection: study protocol for a multicenter, double-blind, randomized, controlled clinical trial

Trials ◽

10.1186/s13063-021-05830-4 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Tonglu Li ◽

Yingru Xu ◽

Xuezhong Gong

Keyword(s):

Clinical Trial ◽

Urinary Tract Infection ◽

Urinary Tract ◽

Tract Infection ◽

Post Treatment ◽

Controlled Clinical Trial ◽

Double Blind ◽

Randomized Controlled ◽

Treatment Changes

Abstract Background Given the increasing rates of antimicrobial resistance (AMR), recurrent urinary tract infection (rUTI) is becoming refractory more and more. Antibiotic prophylaxis including continuous low-dose antibiotic therapy (CLAT), is the common treatment for rUTI of the world. However, the presumably adverse reactions caused by CLAT alone should be paid more attention. Studies indicated that Chinese herbal medicine (CHM) might be an available treatment method for rUTI. Tailin formulation (TLF) is a herbal prescription developed for the treatment of rUTI in the 2000s in Shanghai Municipal Hospital of Traditional Chinese Medicine. Our previous studies have shown TLF could prevent urinary tract infection both in pyelonephritis (PN) rat model and in PN patients. Additionally, our published data demonstrated TLF is helpful to reduce the recurrence of rUTI and protect renal tubular function in clinic. In order to find a novel treating project for rUTI to increase the clinical curative effect, we thus try to combine TLF with CLAT to treat rUTI and design an optimized, pragmatically clinical trial to evaluate the efficacy and safety of this project. Methods/design This is a multicenter, double-blind, randomized, controlled clinical trial. We will enroll 200 eligible patients diagnosed with uncomplicated rUTI and then divide them randomly into two groups with a 1:1 ratio: TLF + CLAT group and placebo + CLAT group. This trial consists of two stages, a 12-week period of treatment and a 12-week period of post-treatment follow-up, respectively. The primary outcome will be the recurrence rate at the 12th week of the follow-up period; the second outcomes will be the post-treatment changes in renal and liver function; furthermore, traditional Chinese medicine (TCM) symptoms, non-infection-related physical signs, and subjective symptoms will be scored, and the number of episodes of each subject will be also recorded; meanwhile, vital signs indicators and serious adverse events (SAEs) will be monitored throughout the trial. Discussion This study will provide convictive research-derived data to evaluate clinical efficacy and safety of TLF combined with CLAT for rUTI, and provide an evidence-based recommendation for clinicians. Moreover, post-treatment changes in non-infection-related physical signs and subjective symptoms were included in the efficacy evaluation, which is important and more significant for assessing the clinical benefits for those rUTI patients. Trial registration Chinese Clinical Trial Registry ChiCTR2100041914. Registered on 10 January 2021. Protocol date and version: September 12, 2020; version 1.

Faculty Opinions recommendation of Anterior versus posterior peroral endoscopic myotomy: 2-years post-procedure follow-up from a randomized controlled trial.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.738197862.793576344 ◽

2020 ◽

Author(s):

Louis M Wong Kee Song

Keyword(s):

Controlled Trial ◽

Peroral Endoscopic Myotomy ◽

Randomized Controlled ◽

Post Procedure ◽

Endoscopic Myotomy

Radiofrequency ablation for markedly incompetent perforators versus compression therapy in the management of post-phelebtic venous ulcers: A randomized controlled trial

Vascular ◽

10.1177/17085381211010022 ◽

2021 ◽

pp. 170853812110100

Author(s):

Mohamed Shukri Abdelgawad ◽

Amr M El-Shafei ◽

Hesham A Sharaf El-Din ◽

Ehab M Saad ◽

Tamer A Khafagy ◽

...

Keyword(s):

Radiofrequency Ablation ◽

Controlled Trial ◽

Compression Therapy ◽

Randomized Controlled ◽

Venous Ulcers ◽

Group A ◽

Group B ◽

Background Venus ulcers developed mainly due to reflux of incompetent venous valves in perforating veins. Patients and methods In this randomized controlled trial, 119 patients recruited over two years, with post-phelebtic venous leg ulcers, were randomly assigned into one of two groups: either to receive radiofrequency ablation of markedly incompetent perforators (Group A, n = 62 patients) or to receive conventional compression therapy (Group B, n = 57 patients). Follow-up duration required for ulcer healing continued for 24 months post randomization. Results Statistically significant shorter time to healing (ulcer complete healing or satisfactory clinical improvement) between both groups (56 patients, 90.3% of cases in Group A versus 44 patients 77.2% of cases in Group B) over the follow-up period of 24 months was attained ( p = 0.001). Also, significantly different ulcer recurrence was recorded between both groups, 8 patients (12.9%) in Group A versus 19 patients (33.3%) in Group B ( p = 0.004). Conclusion In absence of deep venous obstruction, the monopolar radiofrequency ablation for incompetent perforators is a feasible and effective method that surpasses the traditional compression protocol for incompetent perforator-induced venous ulcers in terms of time required for healing even in the presence of unresolved deep venous valvular reflux.

Efficacy of Mobile phone use on adherence to Nevirapine prophylaxis and retention in care among the HIV-exposed infants in prevention of mother to child transmission of HIV: a randomized controlled trial

BMC Pediatrics ◽

10.1186/s12887-021-02660-w ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Lilian M. N. Kebaya ◽

Dalton Wamalwa ◽

Nyambura Kariuki ◽

Bashir Admani ◽

Philip Ayieko ◽

...

Keyword(s):

Mobile Phone ◽

Infant Feeding ◽

Retention In Care ◽

Control Group ◽

Hiv Exposed Infants ◽

Randomized Controlled ◽

Phone Calls ◽

Hiv Exposed ◽

Abstract Background HIV is a major contributor to infant mortality. A significant gap remains between the uptake of infant and maternal antiretroviral regimens and only a minority of HIV-exposed infants receives prophylaxis and safe infant feeding. Losses to follow-up of HIV-exposed infants are associated with shortcomings of facility-based PMTCT models with weak community support of linkages. Use of mobile phones offers an opportunity for improving care and promoting retention assessed by timely attendance of scheduled appointments for the mother-baby pairs and achievement of an HIV-free generation. The objective of this study was to compare self-reported adherence to infant Nevirapine (NVP) prophylaxis and retention in care assessed by timely attendance of scheduled appointments over 10 weeks in HIV exposed infants randomized to 2-weekly mobile phone calls (intervention) versus no phone calls (control). Methods In this open label randomized controlled study, one hundred and fifty HIV infected women drawn from 3 health facilities in Western Kenya and their infants were randomly assigned to receive either phone-based reminders on PMTCT messages or standard health care messages (no calls) within 24 h of delivery. Women in the intervention arm continued to receive fortnightly phone calls. At 6- and 10-weeks following randomization we collected data on infant adherence to Nevirapine, mode of infant feeding, early HIV testing and retention in care in both study arms. All analyses were intention to treat. Results At 6 weeks follow-up, 90.7% (n = 68) of participants receiving phone calls reported adherence to infant NVP prophylaxis, compared with 72% (n = 54) of participants in the control group (p = 0.005). Participants in the intervention arm were also significantly more likely to remain in care than participants in the control group [78.7% (n = 59) vs. 58.7% (n = 44), p = 0.009 at 6 weeks and 69.3% (n = 52) vs. 37.3% (n = 28), p < 0.001 at 10 weeks]. Conclusions These results suggest that phone calls are potentially an important tool to improve adherence to infant NVP prophylaxis and retention in care for HIV-exposed infants. Trial registration PACTR202007654729602. Registered 6 June 2018 - Retrospectively registered, https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=3449

The SNAP Trial: 2-Year Results of a Double-Blind Multicenter Randomized Controlled Trial of a Silicon Nitride Versus a PEEK Cage in Patients After Lumbar Fusion Surgery

Global Spine Journal ◽

10.1177/2192568220985472 ◽

2021 ◽

pp. 219256822098547

Author(s):

R. F. M. R. Kersten ◽

F. C. Öner ◽

M. P. Arts ◽

M. Mitroiu ◽

K. C. B. Roes ◽

...

Keyword(s):

Silicon Nitride ◽

Interbody Fusion ◽

Controlled Trial ◽

Segmental Motion ◽

Lumbar Interbody Fusion ◽

Double Blind ◽

Randomized Controlled ◽

Disability Questionnaire

Study Design: Randomized controlled trial. Objectives: Lumbar interbody fusion with cages is performed to provide vertebral stability, restore alignment, and maintain disc and foraminal height. Polyetheretherketone (PEEK) is commonly used. Silicon nitride (Si3N4) is an alternative material with good osteointegrative properties. This study was designed to assess if Si3N4 cages perform similar to PEEK. Methods: A non-inferiority double-blind multicenter RCT was designed. Patients presenting with chronic low-back pain with or without leg pain were included. Single- or double-level instrumented transforaminal lumbar interbody fusion (TLIF) using an oblique PEEK or Si3N4 cage was performed. The primary outcome was the Roland-Morris Disability Questionnaire (RMDQ). The non-inferiority margin for the RMDQ was 2.6 points on a scale of 24. Secondary outcomes included the Oswestry Disability Questionnaire (ODI), Visual Analogue Scales (VAS), SF-36 Physical Function, patient and surgeon Likert scores, radiographic evaluations for subsidence, segmental motion, and fusion. Follow-up was planned at 3, 6, 12, and 24-months. Results: Ninety-two patients were randomized ( i.e. 48 to PEEK and 44 to Si3N4). Both groups showed good clinical improvements on the RMDQ scores of up to 5-8 points during follow-up. No statistically significant differences were observed in clinical and radiographic outcomes. Mean operative time and blood loss were statistically significantly higher for the Si3N4 cohort. Although not statistically significant, there was a higher incidence of complications and revisions associated with the Si3N4 cage. Conclusions: There was insufficient evidence to conclude that Si3N4 was non-inferior to PEEK.

Brief Intermittent Neuroleptic Prophylaxis for Selected Schizophrenic Out-patients

The British Journal of Psychiatry ◽

10.1192/s0007125000018237 ◽

1989 ◽

Vol 155 (05) ◽

pp. 702-706 ◽

Cited By ~ 3

Author(s):

H. A. McClelland ◽

G. Harrison ◽

S. D. Soni

Keyword(s):

Psychotic Symptoms ◽

Intermittent Treatment ◽

Double Blind ◽

Prodromal Symptoms ◽

Novel Approach ◽

Depot Neuroleptic ◽

One Year ◽

Depot Injections ◽

“A study was conducted to investigate a novel approach to the prophylaxis of schizophrenic relapse. The treatment strategy comprised brief intermittent courses of neuroleptic agents begun as soon as non-psychotic symptoms believed to be early signs of relapse appeared. Fifty four stable, remitted outpatients meeting the American Psychiatric Association's DSM–III criteria for schizophrenia were randomised double blind to receive brief intermittent treatment with either active or placebo depot neuroleptic injections. Only three patients given placebo injections and two controls were admitted to hospital during one year of follow up. Eight (30%) of the patients given placebo injections and only 2 (7%) of the controls, however, had a recurrence of schizophrenic symptoms. Patients given placebo injections experienced fewer extrapyramidal side effects and showed a trend towards a reduction in tardive dyskinesia. Dysphoric and neurotic symptoms were identified before eight out of 11 relapses, and these symptoms were more frequent in patients given placebo depot injections. These results suggest a viable but not necessarily better alternative to continuous oral or depot treatment for less ill, chronic, stabilised schizophrenics based on the early treatment of putative prodromal symptoms of relapse.”

Awareness Is Not Enough: A Double-Blind Randomized Controlled Trial of the Effects of Providing Discipline Disproportionality Data Reports to School Administrators

Educational Researcher ◽

10.3102/0013189x20939937 ◽

2020 ◽

Vol 49 (7) ◽

pp. 533-537

Author(s):

Kent McIntosh ◽

Keith Smolkowski ◽

Cody M. Gion ◽

Lauren Witherspoon ◽

Eoin Bastable ◽

...

Keyword(s):

School Improvement ◽

School Administrators ◽

Controlled Trial ◽

School Improvement Plan ◽

Double Blind ◽

Racial Disproportionality ◽

Randomized Controlled ◽

Discipline Disproportionality ◽

One commonly used strategy used in attempts to decrease racial disproportionality in school discipline across the country is sharing data with school administrators that discipline disparities are a problem in their schools with the assumption that it will increase attention to equity and improve outcomes. The purpose of this study was to assess the effects of providing monthly disciplinary equity reports to school administrators in 35 schools on levels of (a) disciplinary equity report viewing, (b) disciplinary equity, and (c) inclusion of disciplinary equity into school improvement plan goals. We used a small, double-blind randomized controlled trial in which half of the schools were randomly assigned to receive either monthly disciplinary equity reports or monthly general discipline reports. Results showed that schools receiving the equity reports had significantly increased rates of viewing equity reports but no meaningful change in disciplinary equity or equity goal setting.

Personalized attention control therapy for PTSD: effectiveness and moderators of outcome in a randomized controlled trial

Psychological Medicine ◽

10.1017/s0033291720004304 ◽

2020 ◽

pp. 1-11

Author(s):

Adva Segal ◽

Daniel S. Pine ◽

Yair Bar-Haim

Keyword(s):

Treatment Outcome ◽

Clinical Symptoms ◽

Controlled Trial ◽

Post Treatment ◽

Attention Control ◽

Randomized Controlled ◽

Control Therapy ◽

Pre Treatment ◽

Attentional Interference

Abstract Background Previous randomized controlled trials (RCTs) suggest that attention control therapy (ACT), targeting aberrant fluctuations of attention toward and away from threats in patients with PTSD, may be effective in reducing symptoms. The current RCT examined whether the use of personalized-trauma stimuli enhances ACT efficacy in patients with PTSD. Additional moderators of treatment outcome were tested on an exploratory basis. Methods Sixty patients with PTSD were randomly assigned to either personalized ACT, non-personalized ACT, or a control condition. Changes in symptoms were examined across pre-treatment, post-treatment, and a 3-month follow-up. Attentional interference was examined pre- and post-treatment. Baseline clinical and cognitive indices as well as the time elapsed since the trauma were tested as potential moderators of treatment outcome. Results A significant reduction in clinical symptoms was noted for all three conditions with no between-group differences. Attention bias variability decreased following ACT treatment. Personalized ACT was more effective relative to the control condition when less time had elapsed since the trauma. Baseline clinical and cognitive indices did not moderate treatment outcome. Conclusions In this RCT of patients with PTSD, ACT was no more effective in reducing PTSD symptoms than a control condition. The data also suggest a potential benefit of personalized ACT for patients who experienced their trauma more recently.

A Double-Blind Randomized Prospective Study Comparing Ondansetron with Droperidol in the Prevention of Emesis following Strabismus Surgery

Anaesthesia and Intensive Care ◽

10.1177/0310057x9502300404 ◽

1995 ◽

Vol 23 (4) ◽

pp. 438-443 ◽

Cited By ~ 25

Author(s):

A. Davis ◽

S. Krige ◽

D. Moyes

Keyword(s):

Recovery Time ◽

Strabismus Surgery ◽

Double Blind Study ◽

Double Blind ◽

Oral Fluids ◽

Group A ◽

The Mean ◽

Group B ◽

To Receive ◽

Mean Time

A prospective double-blind study was conducted to compare the anti-emetic efficacy of ondansetron and droperidol in preventing postoperative emesis following strabismus surgery. A sample size of 213 patients was divided into three equal groups to receive ondansetron 150 μg/kg (Group A), ondansetron 75 μg/kg (Group B), or droperidol 75 fig/kg (Group C). All patients received a standardized anaesthetic technique. All episodes of emesis, recovery time, and time to tolerating oral fluids were recorded. The incidence of emesis during 24 hours was Groups A and B 19.7%, and Group C 28.2%. The lower incidence of emesis recorded by the ondansetron groups compared with the droperidol group was not statistically significant. Ondansetron at 75 μg/kg was as effective as 150 μg/kg in reducing emesis when compared with droperidol. Mean time to discharge from the recovery room was 75.3 minutes (Group A), 44.4 minutes (Group B), and 41.0 minutes (Group C). The mean time to tolerating oral fluids was 356.5 minutes (Group A), 402.8 minutes (Group B), and 378.1 minutes (Group C). There was no statistical difference in discharge times from recovery or time to tolerating oral fluids in any of the three groups.