scholarly journals Benefit from the Chin-Down Maneuver in the Swallowing Performance and Self-Perception of Parkinson’s Disease Patients

2017 ◽  
Vol 2017 ◽  
pp. 1-8 ◽  
Author(s):  
Annelise Ayres ◽  
Geraldo Pereira Jotz ◽  
Carlos R. M. Rieder ◽  
Maira Rozenfeld Olchik
Keyword(s):  
Oral Intake ◽  
Control Group ◽  
Cognitive Screening ◽  
Self Perception ◽  
Open Label ◽  
Therapeutic Program ◽  
Quality Life ◽  
Significant Difference ◽  
Functional Oral Intake Scale ◽  
Chin Down

Aims. To verify the effectiveness of the maneuver application in swallowing therapy with PD. Materials and Method. We performed an open-label trial, with three groups compounds by PD individuals: the experimental group, control group, and orientation group. The study included PD patients with dysphagia. A cognitive screening, through a questionnaire about depression and quality of life, was conducted. Swallowing assessment was performed through (1) fiberoptic endoscopic evaluation of swallowing (FEES); (2) clinical evaluation and Functional Oral Intake Scale (FOIS); and (3) assessment of the quality life related to swallowing (SWALQOL). A therapeutic program, which consisted of chin-down postural maneuver and orientations on feeding, was applied. Both groups (EG and OG) received on-month therapeutic program. Results. A significant improvement in swallowing, evaluated by clinical assessment, was observed in solid (p<0.001) and liquid (p=0.022) consistencies in EG when compared to OG and CG. Patients in EG presented improvement in QoL, with the significant difference in comparison with the other groups, about domain frequency of symptoms (p=0.029) in SWALQOL questionnaire. Conclusion. The postural maneuver chin-down improved swallowing performance and self-perception, but not the laryngeal signs. This trial is registered with registration number NCT02973698.

scholarly journals A randomised, open label comparative study of hydroxychloroquine with betamethasone oral mini pulse in the management of patients with alopecia areata

2021 ◽  
Vol 10 (2) ◽  
pp. 187
Author(s):  
Jeyasudha Jambusayee ◽  
Kulur Mukhyaprana Sudha
Keyword(s):  
Alopecia Areata ◽  
Life Quality ◽  
Autoimmune Disorder ◽  
Study Groups ◽  
Pulse Therapy ◽  
The Body ◽  
Control Group ◽  
Study Group ◽  
Open Label ◽  
Significant Difference

Background: Alopecia areata is an autoimmune disorder causing patchy hair loss on scalp and other parts of the body and leading to poor self-esteem and anxiety in patients. Treatment with topical or systemic drugs like steroids or other immunosuppressants is associated with adverse effects. Hydroxychloroquine is an antimalarial drug, with T cell modulating function. This study was undertaken to assess the safety, efficacy and tolerability of Hydroxychloroquine in Alopecia areata compared to betamethasone oral mini pulse (OMP) therapy. Methods: 60 patients with alopecia areata were randomized into two groups of 30 each. Control group received tab. betamethasone 5 mg/day on two consecutive days of week for 12 weeks and Study group received tab. hydroxychloroquine 200 mg/day for 12 weeks. They were followed-up for further 12 weeks. Scale of alopecia tool, dermatology life quality index and global assessment at baseline, 12 weeks and 24 weeks were used to assess the outcome.Results: 94 patients were screened and 60 patients were included. All patients completed the study. At the end of 12 weeks, there was a statistically significant reduction in SALT and DLQI scores in both control and study groups. But at the end of 24 weeks, the study group showed an increase in the scores. Relapses were more in the study group. No significant difference in the incidence of adverse events was noted between the two groups.Conclusions: Hydroxychloroquine 200 mg/day is less efficacious in the management of alopecia areata in comparison to betamethasone oral mini pulse therapy.

scholarly journals Perioperative rifaximin is not associated with enhanced functional and volumetric recovery after major liver resection

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Jan Bednarsch ◽  
Zoltan Czigany ◽  
Sven H. Loosen ◽  
Lara Heij ◽  
Lorenz Ruckgaber ◽  
...  
Keyword(s):  
Liver Function ◽  
Primary Endpoint ◽  
Major Hepatectomy ◽  
Controlled Trial ◽  
Liver Volume ◽  
Relative Increase ◽  
Control Group ◽  
Open Label ◽  
Significant Difference ◽  
The Impact

AbstractThe objective of this randomized controlled trial (RCT) was to assess the impact of rifaximin on the course of liver function, liver regeneration and volumetric recovery in patients undergoing major hepatectomy. The ARROW trial was an investigator initiated, single-center, open-label, phase 3 RCT with two parallel treatment groups, conducted at our hepatobiliary center from 03/2016 to 07/2020. Patients undergoing major hepatectomy were eligible and randomly assigned 1:1 to receive oral rifaximin (550 mg twice daily for 7–10 or 14–21 days in case of portal vein embolization preoperatively and 7 days postoperatively) versus no intervention. Primary endpoint was the relative increase in postoperative liver function measured by LiMAx from postoperative day (POD) 4 to 7. Secondary endpoint were the course of liver function and liver volume during the study period as well as postoperative morbidity and mortality. Between 2016 and 2020, 45 patients were randomized and 35 patients (16 individuals in the rifaximin and 19 individuals in the control group) were eligible for per-protocol analysis. The study was prematurely terminated following interim analysis, due to the unlikelihood of reaching a significant primary endpoint. The median relative increase in liver function from POD 4 to POD 7 was 27% in the rifaximin group and 41% in the control group (p = 0.399). Further, no significant difference was found in terms of any other endpoints of functional liver- and volume regeneration or perioperative surgical complications following the application of rifaximin versus no intervention. Perioperative application of rifaximin has no effect on functional or volumetric regeneration after major hepatectomy (NCT02555293; EudraCT 2013-004644-28).

Colorectal cancer (CRC) patients surveyed by 18FDGPET-CT (PET-CT): An open-label multicenter randomized trial (NCT 00624260).

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 3520-3520 ◽  
Author(s):  
Iradj Sobhani ◽  
Isabelle Baumgaertner ◽  
Emmanuel Itti ◽  
Alain Luciani ◽  
Richard Layese ◽  
...  
Keyword(s):  
Statistical Tests ◽  
Composite Endpoint ◽  
Tumour Marker ◽  
Recurrence Time ◽  
Control Group ◽  
Open Label ◽  
Curative Surgery ◽  
Cox Models ◽  
Pet Ct ◽  
Significant Difference

3520 Background: Curative surgery is the best therapy of CRC and recurrences. We assessed whether adding semi-annual PET-CT to the usual surveillance would be cost-effective in high risk recurrent CRC patients. Methods: CRC patients (stage II tumor perforated, stages III and IV) in remission after curative surgery were randomly assigned (1:1) to trimester usual surveillance (control) or usual surveillance + semi-annual course PET-CT (intervention) for a 3-yr follow up period. Every 3 months, multidisciplinary committee decided about recurrence by yes/no/doubtful. If yes, curative surgery alone (when relevant), or chemotherapy alone (unresecable recurrence) were conducted; additional exams could be performed if doubtful. Primary composite endpoint (failure) comprised unresectable recurrence & death. The economic assessments according to standards (CHEERS) were performed and costs were compared between groups. Statistical tests for calculation of the relative risk (RR) were used and survival was analyzed using Kaplan-Meier method, Log-Rang test and Cox models. Results: Baseline characteristics of 239 patients (120/119) enrolled in 12 centers were balanced. The failure rate was 29.2% (31 unresectable recurrences & 4 deaths) and 23.5% (27 & 1) in Interventional vs Control, respectively with no significant difference (RR = 1.24, 95% CI: 0.81-1.90; P = .32). Similar results were observed in multivariate analysis (Cox models) adjusted for stage and tumor differentiation (HR = 1.33, 95% CI: 0.8-2.19, P = .27). Period until the unresectable recurrence was significantly shorter in Interventional (median = 7; IQR: 3-20 months) than in Control group (14.3; 7.3-27; P= 0.016). This was consistent with lower elevation (median; IQR) of tumour marker in interventional (3.8; 2.8-19) than in control group (10; 5.2-28.6) at the first recurrence time as compared to the baseline (p = 0.007). Overall (mean; SD) cost (euros)/patient was higher in the PET-Scan (9385; 11658) than in the control group (7027; 7656). Conclusions: Although recurrences were detected earlier in PET-CT group, the strategy was less effective, more expensive. This exam should not be advised routinely. Clinical trial information: NCT 00624260.

Rate of complete chemotherapy as planned with comprehensive geriatric assessment guided intervention among vulnerable elderly cancer patients: A randomized-open-label study.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e24021-e24021
Author(s):  
Manupol Maikami ◽  
Napa Parinyanitikul ◽  
Nattaya Poovorawan
Keyword(s):  
Usual Care ◽  
Cancer Patients ◽  
Comprehensive Geriatric Assessment ◽  
Intervention Group ◽  
Control Group ◽  
Open Label ◽  
Elderly Cancer Patients ◽  
Open Label Study ◽  
Label Study ◽  
Significant Difference

e24021 Background: The Geriatric 8 (G8) is a simplified screening tool to select the appropriate elderly patients for chemotherapy. Vulnerable patients with impaired G8 score might need additional comprehensive geriatric assessment (CGA) with intervention for individual problem. However, the impact of CGA and therapeutic intervention on rate of complete chemotherapy among these patients is rarely addressed. This study aims to evaluate the benefit of CGA guided intervention. Methods: A single center, randomized, open-label study which included newly diagnosed elderly cancer patients (age ≥ 65) with impaired G8 score (≤ 14) who were designated for chemotherapy. After the enrollment, patients were randomized to 1:1 ratio to receive CGA guided intervention (intervention group) or usual care (control group). The primary end point was the rate of complete chemotherapy at 90-day. Associated factors for complete chemotherapy were evaluated. Results: Between June 2019 and December 2019, 52 patients were randomized (26 patients for intervention group and 26 patients for control group). Mean age was 72 years, 59.6% was female, 40.4% had breast cancer and 51.9% had early stage cancer. With G8 assessment, 55.8% had intermediate (score 11-14) and 44.2% had low (score < 11) impaired G8 score. All baseline characteristics were balanced. Using per protocol analysis, there was no significant difference in rate of complete chemotherapy between groups (61.9% vs 50%, OR 1.63; 95%Cl 0.51-5.23; p = 0.42). Considering subgroup analysis in the intermediate G8 score patients, the intervention group had a significant higher rate of complete chemotherapy than control group (81.8% vs 66.7%, OR 2.71; p = 0.02), but no significant difference in low G8 score group (40% vs 27.3%, OR 1.78; p = 0.58). In univariate analysis, age below 75 years, BMI > 20 kg/m2 and intermediate G8 score showed significant factors for improving rate of complete chemotherapy. Conclusions: This is the first study in south-east Asia using CGA and intervention to improve rate of completion in chemotherapy. Although the CGA and intervention had no significant difference but had tendency to be better in completion rate of chemotherapy than usual care. The intermediate-impaired G8 score subgroup is more likely to benefit from CGA guided intervention for complete chemotherapy as planned.

Effect of personalized wrist orthosis for wrist pain with three-dimensional scanning and printing technique: A preliminary, randomized, controlled, open-label study

2018 ◽  
Vol 42 (6) ◽  
pp. 636-643 ◽  
Author(s):  
Sang Jun Kim ◽  
Sung Jae Kim ◽  
Yong Ho Cha ◽  
Keun Ho Lee ◽  
Jeong-Yi Kwon
Keyword(s):  
Hand Function ◽  
Three Dimensional ◽  
Wrist Pain ◽  
Control Group ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
High Satisfaction ◽  
Significant Difference ◽  
Experimental Group

Background: Three-dimensional printer technology can produce the personalized orthosis in various forms. Objective: To develop a personalized wrist orthosis using a three-dimensional scanner and three-dimensional printer for patients with wrist pain. Study design: A preliminary, prospective, randomized, open-label study. Methods: A total of 22 patients with wrist pain were randomly assigned to the control and experimental groups. The control group wore a cock-up orthosis and the experimental group wore a three-dimensional-printed wrist orthosis for 1 week. The Patient-Rated Wrist Evaluation, Jebsen Hand Function Test, and Orthotics and Prosthetics Users’ Survey were checked before and 1 week after the application. Results: The Patient-Rated Wrist Evaluation showed significant pain relief in both groups. Two items of the 28 Orthotics and Prosthetics Users’ Survey questions, “Put toothpaste on brush and brush teeth” and “Dial a touch tone phone,” showed high satisfaction scores, with statistically significant difference in the experimental group ( p = 0.036 and 0.004). Conclusion: The three-dimensional-printed wrist orthosis was superior to the cock-up orthosis for two items of the Orthotics and Prosthetics Users’ Survey. Wrist pain was reduced in the group wearing the three-dimensional-printed wrist orthosis as well as the group wearing the cock-up orthosis, so the three-dimensional-printed wrist orthosis could possibly play the same role as the cock-up orthosis. Clinical relevance A three-dimensional-printed wrist orthosis can be a substitute for a conventional ready-made wrist orthosis for patients with wrist pain with more satisfaction.

scholarly journals Quantifying Withdrawal of Consent, Loss to Follow-Up, Early Drug Discontinuation, and Censoring in Oncology Trials

2021 ◽  
pp. 1-8
Author(s):  
Brooke E. Wilson ◽  
Michelle B. Nadler ◽  
Alexandra Desnoyers ◽  
Eitan Amir
Keyword(s):  
Censored Data ◽  
Control Group ◽  
Drug Discontinuation ◽  
Open Label ◽  
Loss To Follow Up ◽  
Significant Difference ◽  
And Control ◽  
Experimental Group ◽  
Early Drug

Background: Censoring due to early drug discontinuation (EDD) or withdrawal of consent or loss to follow-up (WCLFU) can result in postrandomization bias. In oncology, censoring rules vary with no defined standards. In this study, we sought to describe the planned handling and transparency of censoring data in oncology trials supporting FDA approval and to compare EDD and WCLFU in experimental and control arms. Methods: We searched FDA archives to identify solid tumor drug approvals and their associated trials between 2015 and 2019, and extracted the planned handling and reporting of censored data. We compared the proportion of WCLFU and EDD between the experimental and control arms by using generalized estimating equations, and performed logistic regression to identify trial characteristics associated with WCLFU occurring more frequently in the control group. Results: Censoring rules were defined adequately in 48 (59%) of 81 included studies. Only 14 (17%) reported proportions of censored participants clearly. The proportion of WCLFU was higher in the control group than in the experimental group (mean, 3.9% vs 2.5%; β-coefficient, −2.2; 95% CI, −3.1 to −1.3; P<.001). EDD was numerically higher in the experimental arm in 61% of studies, but there was no statistically significant difference in the proportion of EDD between the experimental and control groups (mean, 21.6% vs 19.9%, respectively; β-coefficient, 0.27; 95% CI, −0.32 to 0.87; P=.37). The proportion of EDD due to adverse effects (AEs) was higher in the experimental group (mean, 13.2% vs 8.5%; β-coefficient, 1.5; 95% CI, 0.57–2.45; P=.002). WCLFU was higher in the control group in studies with an active control group (odds ratio [OR], 10.1; P<.001) and in open label studies (OR, 3.00; P=.08). Conclusions: There are significant differences in WCLFU and EDD for AEs between the experimental and control arms in oncology trials. This may introduce postrandomization bias. Trials should improve the reporting and handling of censored data so that clinicians and patients are fully informed regarding the expected benefits of a treatment.

scholarly journals A study of effect of topical anaesthetics on injection pain during immunization in infants

2020 ◽  
Vol 7 (7) ◽  
pp. 1463
Author(s):  
Magesh Kumar ◽  
V. Venkateshwar
Keyword(s):  
Intervention Group ◽  
Injection Pain ◽  
Control Group ◽  
P Value ◽  
Open Label ◽  
Topical Anesthetic ◽  
Vaccine Injection ◽  
Pain Scores ◽  
Significant Difference ◽  
Group B

Background: Immunization is a necessary aspect of health care of children and injections are there for unavoidable. Many factors affect injection pain during immunization in infants. This study aims to see the effect of use of local anesthetics delivered by various modes for attenuation of vaccine related injection pain in infants and to compare them.Methods: An Open Label Four-Arm Randomized Control Trial of 300 healthy infants of age group 6 weeks to 6 months reported to immunization clinic for immunization with DPT-HiB-Hepatitis B combination vaccine were taken for study. The enrolled subjects were allocated into control group and intervention group (who were applied some form of local anesthesia).Results: Among the four groups of the patients studied we observed a statistical difference in the mean pain scores of the patients recorded at 15 second, 60 second and 5 min after vaccine injection (p value 0.0024 - 0.000). Group A (Infants with topical occlusive LA cream) showed minimum pain scores values at 15 second, 60 second and 5 min after vaccine injection, followed by Group C (Infants with topical LA spray with vapocoolant) whereas Control group (Infants not received any local anaesthesia) and Group B (Infants with topical LA spray without vapocoolant) exhibited the maximum pain scores.Conclusions: Topical occlusive local anesthetic cream and topical LA spray with vapocoolent, were found to be better than topical LA spray without vapocoolant or no topical anesthetic. Use of topical occlusive LA cream led to a lowest pain score. There was no significant difference in the profile of side effects following injection in the four group.

scholarly journals A randomised controlled trial to evaluate a medication monitoring system for TB treatment

2022 ◽  
Vol 26 (1) ◽  
pp. 44-49
Author(s):  
J. Acosta ◽  
P. Flores ◽  
M. Alarcón ◽  
M. Grande-Ortiz ◽  
L. Moreno-Exebio ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Treatment Success ◽  
Intervention Group ◽  
Controlled Study ◽  
Control Group ◽  
Second Phase ◽  
Open Label ◽  
Pulmonary Tb ◽  
Tb Treatment ◽  
Significant Difference

BACKGROUND: Adherence to TB treatment and therefore treatment success could be improved using digital adherence technology.OBJECTIVE: To evaluate the effectiveness of a medication event reminder monitor system (MERM) on treatment success and treatment adherence in patients with drug-susceptible pulmonary TB in Perú.METHODS: This was an experimental, randomised, open-label, controlled study conducted among patients in the second phase of TB treatment. The intervention group received their medications through MERM with the support of a treatment monitor, whereas the control group used the usual strategy. Participants were followed until they completed the 54 doses of the second phase of treatment.RESULTS: The study included 53 patients in each group; four in the intervention group withdrew from the study. Treatment success was significantly more frequent in the MERM group (RR 1.15, 95% CI 1.02–1.30; P = 0.0322). There was no significant difference in the adherence outcomes; however, the percentage of patients who missed at least one dose and patients with more than 10% of total doses missed were lower in the intervention group.CONCLUSION: The use of MERM in the second phase of treatment showed a significant improvement in the treatment success rate in patients with drug-susceptible pulmonary TB.

A Moxifloxacin-based Regimen for the Treatment of Recurrent, Drug-sensitive Pulmonary Tuberculosis: An Open-label, Randomized, Controlled Trial

2019 ◽  
Vol 70 (1) ◽  
pp. 90-98 ◽  
Author(s):  
Rubeshan Perumal ◽  
Nesri Padayatchi ◽  
Nonhlanhla Yende-Zuma ◽  
Anushka Naidoo ◽  
Dhineshree Govender ◽  
...  
Keyword(s):  
Adverse Events ◽  
Absolute Risk ◽  
Controlled Trial ◽  
Treatment Success ◽  
Control Group ◽  
Open Label ◽  
Serious Adverse Events ◽  
Conversion Rates ◽  
Significant Difference ◽  
Culture Conversion

Abstract Background The substitution of moxifloxacin for ethambutol produced promising results for improved tuberculosis treatment outcomes. Methods We conducted an open-label, randomized trial to test whether a moxifloxacin-containing treatment regimen was superior to the standard regimen for the treatment of recurrent tuberculosis. The primary and secondary outcomes were the sputum culture conversion rate at the end of 8 weeks and the proportion of participants with a favorable outcome, respectively. Results We enrolled 196 participants; 69.9% were male and 70.4% were co-infected with human immunodeficiency virus (HIV). There was no significant difference between the study groups in the proportion of patients achieving culture conversion at the end of 8 weeks (83.0% [moxifloxacin] vs 78.5% [control]; P = .463); however, the median time to culture conversion was significantly shorter (6.0 weeks, interquartile range [IQR] 4.0–8.3) in the moxifloxacin group than the control group (7.9 weeks, IQR 4.0– 11.4; P = .018). A favorable end-of-treatment outcome was reported in 86 participants (87.8%) in the moxifloxacin group and 93 participants (94.9%) in the control group, for an adjusted absolute risk difference of −5.5 (95% confidence interval −13.8 to 2.8; P = .193) percentage points. There were significantly higher proportions of participants with Grade 3 or 4 adverse events (43.9% [43/98] vs 25.5% [25/98]; P = .01) and serious adverse events (27.6% [27/98] vs 12.2% [12/98]; P = .012) in the moxifloxacin group. Conclusions The replacement of ethambutol with moxifloxacin did not significantly improve either culture conversion rates at the end of 8 weeks or treatment success, and was associated with a higher incidence of adverse events. Clinical Trials Registration NCT02114684.

scholarly journals Efficacy of Myofunctional Therapy Associated with Voice Therapy in the Rehabilitation of Neurogenic Oropharyngeal Dysphagia: a pilot study

2017 ◽  
Vol 22 (03) ◽  
pp. 225-230 ◽  
Author(s):  
Bruno Fraga ◽  
Sheila Almeida ◽  
Márcia Santana ◽  
Mauriceia Cassol
Keyword(s):  
Pilot Study ◽  
Oropharyngeal Dysphagia ◽  
Oral Intake ◽  
Control Group ◽  
Stroke Patients ◽  
Swallowing Rehabilitation ◽  
Significant Difference ◽  
Vocal Exercises ◽  
Experimental Group ◽  
Post Therapy

Introduction Dysphagia causes changes in the laryngeal and stomatognathic structures; however, the use of vocal exercises is poorly described. Objective To verify whether the therapy consisting of myofunctional exercises associated with vocal exercises is more effective in rehabilitating deglutition in stroke patients. Methods This is a pilot study made up of two distinct groups: a control group, which performed only myofunctional exercises, and an experimental group, which performed myofunctional and vocal exercises. The assessment used for oral intake was the functional oral intake scale (FOIS). Results The FOIS levels reveal that the pre-therapy median of the experimental group was 4, and increased to 7 after therapy, while in the control group the values were 5 and 6 respectively. Thus, the experimental group had a statistically significant difference between the pre- and post-therapy assessments (p = 0.039), which indicates that the combination of myofunctional and vocal exercises was more effective in improving the oral intake levels than the myofunctional exercises alone (p = 0.059). On the other hand, the control group also improved, albeit at a lower rate compared with the experimental group; hence, there was no statistically significant difference between the groups post-therapy (p = 0.126). Conclusion This pilot study showed indications that using vocal exercises in swallowing rehabilitation in stroke patients was able to yield a greater increase in the oral intake levels. Nevertheless, further controlled blind clinical trials with larger samples are required to confirm such evidence, as this study points to the feasibility of conducting this type of research.

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