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.

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.

An open-label study to evaluate dose and cycle dependence of the pharmacokinetics (PK) of pegylated liposomal doxorubicin (PLD)

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 2012-2012 ◽  
Author(s):  
A. Gabizon ◽  
R. Isacson ◽  
O. Rosengarten ◽  
D. Tzemach ◽  
H. Shmeeda ◽  
...  
Keyword(s):  
Dose Range ◽  
Pegylated Liposomal Doxorubicin ◽  
Skin Toxicity ◽  
Significant Inhibition ◽  
Open Label ◽  
Cycle Number ◽  
Open Label Study ◽  
Label Study ◽  
Mean Values ◽  
Significant Difference

2012 Background: There are no definitive data in humans on the dose dependency and/or cycle dependency of the pharmacokinetics of PLD. The skin toxicity of PLD tends to worsen after several treatment cycles. Therefore, it is important to characterize the PK of PLD after 2 or more cycles. Methods: Fifteen patients with various solid tumors were randomized to two arms of treatment in an open-label study. Arm A received PLD at doses of 60, 30, and 45 mg/m2 in 3 successive cycles every 4 weeks (q4w). Arm B received PLD at doses of 30, 60, and 45 mg/m2 in 3 successive cycles q4w. Twelve patients, 6 on each arm, completed all three cycles and were fully evaluable. Plasma levels of doxorubicin were analyzed by HPLC and fluorimetry following a previously published method (J Chromatogr B, 779:259–69, 2002) with minor modifications. PK analysis was done by non-compartmental method. The following parameters were obtained: Cmax, AUC∞, terminal half-life (T1/2), and Clearance (CL). The paired t test was used for statistical analysis. Results: There was no significant difference in the parameters examined when the dose was increased from 30 to 60 mg/m2. However, when we analyzed the effect of cycle number on the PK, we found a gradual and significant inhibition of CL when patients advance from the 1st through the 3rd cycle of PLD (p=0.0003), with a mean increase of 44% in AUC/mg dose (p=0.0011). Cmax and T1/2 mean values increased by 17% and 18% respectively between the 1st and 3rd cycles, but only the increase in T1/2 was statistically significant (p=0.0127). Conclusion: While the PK of PLD is not dose-dependent within the dose range of 30 to 60mg/m2, there is evidence of a cycle-dependent effect that results in inhibition of CL when patients receive successive cycles of PLD. This effect may account for the delayed skin toxicity of PLD. These results suggest the need for dose adjustments of PLD to minimize the risk of toxicity, such as an initial high loading dose followed by reduced maintenance doses from the 2nd or 3rd cycle onwards. [Table: see text] [Table: see text]

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 An open label study of the safety and efficacy of a single dose of weekly chloroquine and azithromycin administered for malaria prophylaxis in healthy adults challenged with 7G8 chloroquine-resistant Plasmodium falciparum in a controlled human malaria infection model

2020 ◽  
Vol 19 (1) ◽  
Author(s):  
Jeffrey Livezey ◽  
Patrick Twomey ◽  
Meshell Morrison ◽  
Susan Cicatelli ◽  
Elizabeth H. Duncan ◽  
...  
Keyword(s):  
Plasmodium Falciparum ◽  
High Rate ◽  
Control Group ◽  
Infection Model ◽  
Post Challenge ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Malaria Chemoprophylaxis ◽  
To Receive

Abstract Background Malaria remains the top infectious disease threat facing the U.S. military in many forward operating environments. Compliance with malaria chemoprophylaxis remains a critical component in preventing malaria in the deployed Service Member. Studies of previous military operations show that compliance is consistently higher with weekly versus daily dosing regimens. Current FDA approved weekly chemoprophylaxis options have contraindications that can limit prescribing. The combination of chloroquine (CQ) with azithromycin (AZ) has previously been shown to be an efficacious treatment option for malaria, has pharmacokinetics compatible with weekly dosing, and has shown synergy when combined in vitro. Methods In this open label study, 18 healthy volunteers, aged 18–50 years (inclusive), were randomly assigned to receive either 300 mg CQ or 300 mg CQ and 2 gm azithromycin (CQAZ) of directly observed therapy, weekly for 3 weeks prior to undergoing mosquito bite challenge with chloroquine-resistant Plasmodium falciparum. Volunteers that remained asymptomatic and had no evidence of parasitaemia continued to receive weekly post-exposure chemoprophylaxis for 3 weeks following malaria challenge. The primary endpoint was the number of volunteers that remained asymptomatic and had no evidence of parasitaemia 28 days after the malaria challenge. Results All 6 (100%) volunteers randomized to the CQ control group became symptomatic with parasitaemia during the 28-day post-challenge period. Only 1/12 (8.3%) of volunteers in the CQAZ group developed symptoms and parasitaemia during the 28-day post-challenge period. However, after chemoprophylaxis was discontinued an additional 6 volunteers developed parasitaemia between days 28–41 after challenge, with 4 of 6 experiencing symptoms. 80% of subjects in the CQAZ group experienced treatment related gastrointestinal adverse events (including 13% that experienced severe nausea) compared to 38% in the CQ group. A comparison of the pharmacokinetics in the CQAZ group demonstrated higher azithromycin Cmax (p = 0.03) and AUC (p = 0.044) levels in those volunteers who never became parasitaemic compared to those who did. Conclusion Given the high rate of side effects and poor efficacy when administered for 3 weeks before and after challenge, the combination of weekly chloroquine and azithromycin is a suboptimal regimen combination for weekly malaria chemoprophylaxis. Trial registration ClinicalTrials.gov NCT03278808

scholarly journals Igg Food Antibody Guided Elimination-Rotation Diet Was More Effective than FODMAP Diet and Control Diet in the Treatment of Women with Mixed IBS—Results from an Open Label Study

2021 ◽  
Vol 10 (19) ◽  
pp. 4317
Author(s):  
Lucyna Ostrowska ◽  
Diana Wasiluk ◽  
Camille F. J. Lieners ◽  
Mirosława Gałęcka ◽  
Anna Bartnicka ◽  
...  
Keyword(s):  
Irritable Bowel Syndrome ◽  
Abdominal Pain ◽  
Control Diet ◽  
Dietary Treatment ◽  
Control Group ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Irritable Bowel ◽  
Fodmap Diet

Irritable bowel syndrome (IBS) is a chronic disease with recurrent abdominal pain, disturbed bowel emptying, and changes in stool consistency. We compared the effectiveness of three different dietary treatment plans (G1-FM-low FODMAP diet, G2-IP IgG based elimination-rotation-diet, and as control group, the G3-K control diet recommended by an attending gastroenterologist) in treating patients diagnosed with mixed irritable bowel syndrome. A total of seventy-three female patients diagnosed with a mixed form of irritable bowel syndrome (IBS-M) were enrolled in the study. The diet of each patient in Group 1 (G1-FM) and 2 (G2-IP) was determined individually during a meeting with a dietitian. Patients from Group 3 (G3-K) received nutrition advice from a gastroenterologist. Significant differences in the reduction of IBS symptoms were found between the groups. IBS symptoms as well as comorbid symptoms significantly improved or disappeared completely in the G2-IP group (idiopathic abdominal pain, p < 0.001; abdominal pain after a meal, p < 0.001; abdominal pain during defecation, p = 0.008), while in the G1-FM group, some of the IBS symptoms significantly improved (mucus in stool, p = 0.031; bloating, p < 0.001). In group G3-K no significant improvement was seen. Based on the results of this open-label study, it was concluded that various dietary interventions in the treatment of IBS-M patients do not uniformly affect the course and outcomes of disease management. Rotation diets based on IgG show significantly better results compared to other diets.

scholarly journals Prospective Trial of a Novel Nomogram to Achieve Updated Vancomycin Trough Concentrations

2013 ◽  
Vol 2013 ◽  
pp. 1-8 ◽  
Author(s):  
Amber R. Wesner ◽  
Marcia L. Brackbill ◽  
Larissa L. Coyle ◽  
Robert S. Kidd
Keyword(s):  
Prospective Trial ◽  
Active Group ◽  
Control Group ◽  
New Order ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Dosing Regimens ◽  
Vancomycin Trough ◽  
Trough Concentrations

Purpose. To determine if the use of a novel vancomycin nomogram predicts dosing regimens that achieve target trough concentrations equal to or more accurate than dosing regimens calculated using traditional pharmacokinetic calculations, evaluate the incidence of subtherapeutic and supratherapeutic troughs, and assess pharmacist's impressions of the nomogram.Methods. Prospective, open-label study in 473 patients who had a new order for vancomycin and were >18 years of age and ≤120 kg. Patients were randomized to the active group, dosed using the nomogram, or to the control group, dosed using traditional pharmacokinetic calculations already in place at our institution.Results. Patients dosed via nomogram were within the appropriate trough range in 44% of cases compared to 33% in the control group (P=0.014). Vancomycin troughs less than 10 mcg/mL were significantly decreased with the use of nomogram (P=0.032). Incidence of supratherapeutic troughs, greater than 20 mcg/mL, was not significantly different between groups (P=0.706), and pharmacists agreed that the nomogram was easy to use and saved their time.Conclusions. A novel vancomycin nomogram was prospectively validated and found to be more effective than traditional pharmacokinetic dosing. The nomogram is being implemented as the standard dosing protocol at our institution.

scholarly journals An open label study of the safety and efficacy of a single dose of weekly chloroquine and azithromycin administered for malaria prophylaxis in healthy adults challenged with 7G8 chloroquine-resistant Plasmodium falciparum in a controlled human malaria infection model

2020 ◽  
Author(s):  
Jeffrey Livezey ◽  
Patrick Twomey ◽  
Meshell Morrison ◽  
Susan Cicatelli ◽  
Elizabeth H Duncan ◽  
...  
Keyword(s):  
Plasmodium Falciparum ◽  
High Rate ◽  
Control Group ◽  
Infection Model ◽  
Post Challenge ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Malaria Chemoprophylaxis ◽  
To Receive

Abstract BackgroundMalaria remains the top infectious disease threat facing the U.S. military in many forward operating environments. Compliance with malaria chemoprophylaxis remains a critical component in preventing malaria in the deployed Service Member. Studies of previous military operations show that compliance is consistently higher with weekly versus daily dosing regimens. Current FDA approved weekly chemoprophylaxis options have contraindications that can limit prescribing. The combination of chloroquine (CQ) with azithromycin (AZ) has previously been shown to be an efficacious treatment option for malaria, has pharmacokinetics compatible with weekly dosing, and has shown synergy when combined in vitro. MethodsIn this open label study 18 healthy volunteers, aged 18-50 years (inclusive), were randomly assigned to receive either 300 mg CQ or 300 mg CQ and 2 gm azithromycin (CQAZ) of directly observed therapy, weekly for 3 weeks prior to undergoing mosquito bite challenge with chloroquine-resistant Plasmodium falciparum. Volunteers that remained asymptomatic and had no evidence of parasitaemia continued to receive weekly post-exposure chemoprophylaxis for 3 weeks following malaria challenge. The primary endpoint was the number of volunteers that remained asymptomatic and had no evidence of parasitaemia 28 days after the malaria challenge.ResultsAll 6 (100%) volunteers randomized to the CQ control group became symptomatic with parasitaemia during the 28-day post-challenge period. Only 1/12 (8.3%) of volunteers in the CQAZ group developed symptoms and parasitaemia during the 28-day post-challenge period. However, after chemoprophylaxis was discontinued an additional 6 volunteers developed parasitaemia between days 28-41 after challenge, with 4 of 6 experiencing symptoms. 80% of subjects in the CQAZ group experienced treatment related gastrointestinal adverse events (including 13 % that experienced severe nausea) compared to 38% in the CQ group. A comparison of the pharmacokinetics in the CQAZ group demonstrated higher azithromycin Cmax (p0.03) and AUC (p0.044) levels in those volunteers who never became parasitaemic compared to those who did. ConclusionGiven the high rate of side effects and poor efficacy when administered for 3 weeks before and after challenge, the combination of weekly chloroquine and azithromycin is a suboptimal regimen combination for weekly malaria chemoprophylaxis.Trial registration: ClinicalTrials.gov NCT03278808

scholarly journals An Open Label Study of the Safety and Efficacy of a Single Dose of Weekly Chloroquine and Azithromycin Administered for Malaria Prophylaxis in Healthy Adults Challenged with 7G8 Chloroquine-Resistant Plasmodium falciparum in a Controlled Human Malaria Infection (CHMI) Model

2020 ◽  
Author(s):  
Jeffrey Livezey ◽  
Patrick Twomey ◽  
Meshell Morrison ◽  
Susan Cicatelli ◽  
Elizabeth H Duncan ◽  
...  
Keyword(s):  
Plasmodium Falciparum ◽  
High Rate ◽  
Control Group ◽  
Directly Observed Therapy ◽  
Post Challenge ◽  
Open Label ◽  
Severe Nausea ◽  
Open Label Study ◽  
Label Study ◽  
To Receive

Abstract Background: Malaria remains the top infectious disease threat facing the U.S. military in many forward operating environments. Compliance with malaria chemoprophylaxis remains a critical component in preventing malaria in the deployed Service Member. Studies of previous military operations show that compliance is consistently higher with weekly versus daily dosing regimens. Current FDA approved weekly chemoprophylaxis options have contraindications that can limit prescribing. The combination of chloroquine (CQ) with azithromycin (AZ) has previously been shown to be an efficacious treatment option for malaria, has pharmacokinetics compatible with weekly dosing, and has shown synergy when combined in vitro. Methods: In this open label study 18 healthy volunteers, aged 18-50 years (inclusive), were randomly assigned to receive either 300 mg CQ or 300 mg CQ and 2 gm azithromycin (CQAZ) of directly observed therapy, weekly for 3 weeks prior to undergoing mosquito bite challenge with chloroquine-resistant Plasmodium falciparum. Volunteers that remained asymptomatic and had no evidence of parasitemia continued to receive weekly post-exposure chemoprophylaxis for 3 weeks following malaria challenge. The primary endpoint was the number of volunteers that remained asymptomatic and had no evidence of parasitemia 28 days after the malaria challenge.Results: All 6 (100%) volunteers randomized to the CQ control group became symptomatic with parasitemia during the 28 day post-challenge period. Only 1/12 (8.3%) of volunteers in the CQAZ group developed symptoms and parasitemia during the 28-day post-challenge period. However, after chemoprophylaxis was discontinued an additional 6 volunteers developed parasitemia between days 28-41 after challenge, with 4 of 6 experiencing symptoms. 80% of subjects in the CQAZ group experienced treatment related gastrointestinal adverse events (including 13 % that experienced severe nausea) compared to 38% in the CQ group. A comparison of the pharmacokinetics in the CQAZ group demonstrated higher azithromycin Cmax (p0.03) and AUC (p0.044) levels in those volunteers who never became parasitemic compared to those who did. Conclusion: Given the high rate of side effects and poor efficacy when administered for 3 weeks before and after challenge, the combination of weekly chloroquine and azithromycin is a suboptimal regimen combination for weekly malaria chemoprophylaxis.Trial registration: ClinicalTrials.gov NCT03278808

scholarly journals Effect of Dietary Modification for Targeting Histamine Activity in Patients of Allergic Rhinitis: a Randomised Open Label Study

2020 ◽  
Author(s):  
Mohsin Ali Khan ◽  
Zaw Ali Khan ◽  
Abdul Naeem ◽  
Nigar Naqvi ◽  
Shikha Srivast ◽  
...  
Keyword(s):  
Allergic Rhinitis ◽  
Cell Activation ◽  
Standard Treatment ◽  
Immunoglobulin E ◽  
Mast Cell Activation ◽  
Dietary Modification ◽  
Control Group ◽  
Open Label ◽  
Open Label Study ◽  
Label Study

Abstract Allergic Rhinitis refers to immunoglobulin E mediated inflammation of the nasal cavity. Mast cell activation releases histamine, the inflammatory mediator that plays a central role in the biochemical mechanism of this disease. It is metabolised by Diamine Oxidase (DAO) and Histamine N-methyltransferase (HNMT). In this randomised open label study, we recruited 60 patients out of which 30 patients were provided standard treatment and 30 were provided standard treatment along with instructions for dietary modification. The dietary modification consisted of excluding commonly consumed histamine-rich foods and foods containing pro-histamine or anti-DAO active constituents. Each patient was followed up 3 times over the course of 15 days. The patients in the dietary modification group showed significant improvement in rhinitis symptoms within 7 days, while the control group’s improvement was not significant in the same amount of time. The overall improvement between the first and last visits was more significant in the dietary modification group as compared to the control group. Thus, the exclusion of histamine-rich foods and foods containing pro-histamine or anti-DAO compounds may be recommended to patients of allergic rhinitis for quicker and better recovery. This approach may also be explored in other conditions where histamine is implicated such as asthma and infections caused by coronaviruses.

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