2.40 A Multicenter, Randomized, Active-Control Registration Trial of Software Treatment for Actively Reducing Severity of ADHD (Stars-Adhd) to Assess the Efficacy and Safety of a Novel, Home-Based, Digital Treatment for Pediatric ADHD

2018 ◽  
Vol 57 (10) ◽  
pp. S172 ◽  
Author(s):  
Scott H. Kollins ◽  
Jeffrey Bower ◽  
Robert L. Findling ◽  
Richard Keefe ◽  
Jeffrey Epstein ◽  
...  
Keyword(s):  
Active Control ◽  
Efficacy And Safety ◽  
Home Based ◽  
Registration Trial

Efficacy and safety of rolapitant for prevention of chemotherapy-induced nausea and vomiting (CINV) over multiple cycles of highly or moderately emetogenic chemotherapy (HEC, MEC).

2015 ◽  
Vol 33 (29_suppl) ◽  
pp. 210-210 ◽  
Author(s):  
Bernardo Leon Rapoport ◽  
Lee Steven Schwartzberg ◽  
Martin Robert Chasen ◽  
Daniel Powers ◽  
Sujata Arora ◽  
...  
Keyword(s):  
Receptor Antagonist ◽  
Active Control ◽  
Pooled Analysis ◽  
Emetogenic Chemotherapy ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Multiple Cycles ◽  
Neurokinin 1 ◽  
Long Acting ◽  
And Control

210 Background: The long-acting neurokinin-1 receptor antagonist (NK-1 RA) rolapitant has demonstrated efficacy for CINV prevention in patients receiving HEC and MEC during Cycle 1. The efficacy and safety of rolapitant was examined during subsequent cycles 2–6 in a pooled analysis. Methods: In 4 double-blind, active-controlled studies, patients were randomized to oral rolapitant 180 mg or placebo 1–2 hours before chemotherapy. All patients received active control: 5HT3 receptor antagonist + oral dexamethasone. Patients completing Cycle 1 could receive the same anti-emetic treatment in subsequent cycles. On Days 6-8 of subsequent cycles, patients self-reported the incidence of emesis, or of nausea interfering with normal daily life following Day 1 of chemotherapy. Results: A greater proportion of patients on rolapitant than on active control reported no emesis or interfering nausea separately for each subsequent cycle. Results of individual studies and pooled analysis are shown in the Table. During cycles 2-6, the incidence of treatment-related adverse events (AEs) was similar for rolapitant (5.5%) and control (6.8%). The most common treatment-related AEs were similar in both arms: constipation (rolapitant: 1.2%; control: 0.8%) and fatigue (rolapitant: 1.3%; control: 1.8%). Conclusions: Rolapitant was superior to active control in reducing CINV when administered over multiple cycles of moderately or highly emetogenic chemotherapy, with no increase in toxicity. Clinical trial information: NCT00394966 - NCT01500213 - NCT01500226 - NCT01499849. [Table: see text]

PD-036: Association of HPV/p16 status with efficacy and safety in pts with OPC in the phase 3 RT/cetuximab registration trial

2015 ◽  
Vol 114 ◽  
pp. 21-22 ◽  
Author(s):  
J.A. Bonner ◽  
P.M. Harari ◽  
J. Giralt ◽  
D. Bell ◽  
D. Raben ◽  
...  
Keyword(s):  
Efficacy And Safety ◽  
Phase 3 ◽  
Registration Trial

scholarly journals Acute effects of Square Stepping Exercise on cognitive and social functions in sedentary young adults: a home-based online trial

2021 ◽  
Vol 13 (1) ◽  
Author(s):  
Masato Kawabata ◽  
Su Ren Gan ◽  
Gint Goh ◽  
Siti Aisha Binte Omar ◽  
Ivan T. F. Oh ◽  
...  
Keyword(s):  
Older Adults ◽  
Young Adults ◽  
Executive Function ◽  
Active Control ◽  
Repeated Measures ◽  
Group Cohesion ◽  
Acute Effects ◽  
Social Functions ◽  
Home Based ◽  
Stepping Exercise

Abstract Background The Square Stepping Exercise (SSE) is an exercise training program incorporating cognitive and physical exercise components, which was originally developed for older adults to reduce falling risks. SSE’s potential in delaying cognitive decline in older adults seems to be promising. However, there is scarce research on the SSE program with young adults. Furthermore, the outbreak of coronavirus disease has imposed people to change their lifestyle and behaviors, including exercise behaviors. Hence, the purpose of this study was to examine the acute effects of a home-based online SSE trial on cognitive and social functions in sedentary young adults. Methods A total of 18 young adults (6 males, 12 females) participated in the present study. They completed two exercise conditions (SSE and active control exercise), consisting of 3 sessions per week, over 2 weeks. A 2 times (pre vs. post) × 2 conditions (SSE vs. active control) repeated-measures ANCOVA was conducted on the score of the Modified Card Sorting Task with age and education year as covariates. A one-way repeated-measures MANOVA was performed on the subscale scores of the Physical Activity Group Environment Questionnaire to examine the effects of the exercise conditions (SSE vs. active control) on group cohesion. Results SSE was found effective to improve executive function such as abstract reasoning, mental flexibility, and problem-solving skills. Furthermore, participants’ perceptions of social interaction with their group, and closeness and bonding existing in their group were significantly higher in the SSE condition than the active control condition. Conclusions In the present study, SSE was conducted online and found to be effective to enhance executive function and group cohesion in sedentary young adults. These novel approach and findings are the strengths of the present study. People aged 60 years and over are more vulnerable to the coronavirus and at higher risk of developing serious illness. Given the coronavirus pandemic circumstances, it is worthwhile to explore the possibility of the online SSE approach to older adults in future research.

scholarly journals Home-based (virtual) rehabilitation improves motor and cognitive function for stroke patients: a randomized controlled trial of the Elements (EDNA-22) system

2021 ◽  
Vol 18 (1) ◽  
Author(s):  
Peter H. Wilson ◽  
Jeffrey M. Rogers ◽  
Karin Vogel ◽  
Bert Steenbergen ◽  
Thomas B. McGuckian ◽  
...  
Keyword(s):  
Active Control ◽  
Data Storage ◽  
Performance Monitoring ◽  
Brain Injuries ◽  
Controlled Trial ◽  
Training Group ◽  
Trial Registration ◽  
Future Research ◽  
Virtual Rehabilitation ◽  
Home Based

Abstract Background Home-based rehabilitation of arm function is a significant gap in service provision for adult stroke. The EDNA-22 tablet is a portable virtual rehabilitation-based system that provides a viable option for home-based rehabilitation using a suite of tailored movement tasks, and performance monitoring via cloud computing data storage. The study reported here aimed to compare use of the EDNA system with an active control (Graded Repetitive Arm Supplementary Program—GRASP training) group using a parallel RCT design. Methods Of 19 originally randomized, 17 acute-care patients with upper-extremity dysfunction following unilateral stroke completed training in either the treatment (n = 10) or active control groups (n = 7), each receiving 8-weeks of in-home training involving 30-min sessions scheduled 3–4 times weekly. Performance was assessed across motor, cognitive and functional behaviour in the home. Primary motor measures, collected by a blinded assessor, were the Box and Blocks Task (BBT) and 9-Hole Pegboard Test (9HPT), and for cognition the Montreal Cognitive Assessment (MoCA). Functional behaviour was assessed using the Stroke Impact Scale (SIS) and Neurobehavioural Functioning Inventory (NFI). Results One participant from each group withdrew for personal reasons. No adverse events were reported. Results showed a significant and large improvement in performance on the BBT for the more-affected hand in the EDNA training group, only (g = 0.90). There was a mild-to-moderate effect of training on the 9HPT for EDNA (g = 0.55) and control (g = 0.42) groups, again for the more affected hand. In relation to cognition, performance on the MoCA improved for the EDNA group (g = 0.70). Finally, the EDNA group showed moderate (but non-significant) improvement in functional behaviour on the SIS (g = 0.57) and NFI (g = 0.49). Conclusion A short course of home-based training using the EDNA-22 system can yield significant gains in motor and cognitive performance, over and above an active control training that also targets upper-limb function. Intriguingly, these changes in performance were corroborated only tentatively in the reports of caregivers. We suggest that future research consider how the implementation of home-based rehabilitation technology can be optimized. We contend that self-administered digitally-enhanced training needs to become part of the health literacy of all stakeholders who are impacted by stroke and other acquired brain injuries. Trial registration Australian New Zealand Clinical Trials Registry (ANZCTR) Number: ACTRN12619001557123. Registered 12 November 2019, http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378298&isReview=true

scholarly journals The Fares Study: A Multicenter, Randomized, Active-Control, Pragmatic, Phase 2 Pilot Study Comparing Prothrombin Complex Concentrate Versus Frozen Plasma in Bleeding Adult Cardiac Surgical Patients

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 28-29
Author(s):  
Keyvan Karkouti ◽  
Jeannie L Callum
Keyword(s):  
Cardiac Surgery ◽  
Pilot Study ◽  
Active Control ◽  
Research Funding ◽  
Coagulation Factor ◽  
Surgical Patients ◽  
Phase 2 ◽  
Efficacy And Safety ◽  
Services Research ◽  
Frozen Plasma

Introduction: Coagulopathic bleeding is a frequent complication of cardiac surgery and can lead to excessive blood loss, blood product transfusion, and bleeding-related complications. Hemostatic management in bleeding surgical patients is evolving towards targeted therapy with purified products undergoing pathogen reduction technology. Unlike frozen plasma (FP), purified prothrombin complex concentrates (PCCs) do not require ABO blood type matching or thawing, are pathogen-reduced, and are associated with a lower risk of transfusion-associated circulatory overload and transfusion-related acute lung injury. The FARES study will compare the efficacy and safety of PCC (Octaplex; Octapharma) versus FP in bleeding cardiac surgical patients with confirmed or suspected coagulopathy. Preliminary non-randomized studies suggest PCC may be superior to plasma for management of bleeding after cardiac surgery. Methods: The randomized, active-control, single-blinded, pragmatic, investigator-initiated, Phase 2 FARES pilot study will enrolled 120 bleeding adult cardiac surgery patients requiring coagulation factor replacement from two hospitals to achieve 100 treated patients. The study outline is shown in Figure 1. Patients were randomized to PCC or FP, with two weight-based doses, for management of bleeding where coagulation factor deficiency is known or suspected (patients over 50 kg were transfused either 2000 IU of PCC or 4 units of plasma; patients under 50 kg were transfused 1500 IU of PCC or 3 units of plasma). Required second doses will be given according to randomization group allocation, but all patients will receive FP for their third and any subsequent doses. The primary endpoint is hemostatic effectiveness and transfusion requirements. Adverse events will be recorded from the beginning of surgery. Results: The study commenced in September of 2019 and completed enrollment of the last patient in June of 2020. Results were monitored and overseen by the Independent Data and Safety Monitoring Committee. The database will be locked in August 2020 after 28 day follow-up is complete for all patients. Statistical analysis plan is complete. The results will inform a definitive, pragmatic, multi-center trial to determine if PCCs can replace plasma for the management of coagulopathy in the bleeding cardiac surgery patient. Conclusions: This study will determine the feasibility, and inform the design and primary outcome parameter, of a definitive Phase 3 trial comparing the efficacy and safety of PCC versus FP in bleeding cardiac surgical patients requiring coagulation factor replacement. The pilot study results will also be used in sample size calculations and to aid detection of any safety issues. Disclosures Karkouti: Octapharma: Research Funding; Canadian blood services: Research Funding. Callum:Canadian Blood Services: Research Funding; Octapharma: Research Funding. OffLabel Disclosure: Coagulation factor replacement with Prothrmobin Complex Concentrates (off-label in the USA and on label in Canada/Europe)

scholarly journals Efficacy and Safety of Intra-Articular Hyaluronic Acid Injection (NRD101 / SUVENYL®) in Patients With Knee Osteoarthritis: a Multicenter, Randomized, Double-blind, Parallel, Active Control, Non-Inferiority Clinical Study

2021 ◽  
Author(s):  
Haoyang Wang ◽  
Wei Wang ◽  
Yongsheng Xu ◽  
Jianan Li ◽  
Kang Liu ◽  
...  
Keyword(s):  
Molecular Weight ◽  
Hyaluronic Acid ◽  
Knee Osteoarthritis ◽  
Active Control ◽  
Subscale Score ◽  
Chinese Patients ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Pain Subscale ◽  
Significant Difference

Abstract BackgroundIntra-articular injection of hyaluronic acid (HA) has favorable effects on pain relief and knee function along with the low incidence of serious adverse reactions. Although various HA products are available for the treatment of knee osteoarthritis, it is still controversial whether differences in HA products have any clinically significant difference in efficacy and safety. In light of the above, the efficacy and safety of intra-articular injection of biological fermentation–derived high-molecular-weight HA (NRD101) was investigated in a double-blind comparative manner in Chinese patients with knee osteoarthritis.MethodA multicenter, prospective, randomized, double-blind, parallel, active control, non-inferiority study was conducted in Chinese patients with knee osteoarthritis. Patients were randomized to receive five consecutive weekly injections of either NRD101 or Artz (a non-crosslinked low-molecular-weight HA derived from combs of roosters) followed by 4 weeks follow-up. The primary efficacy endpoint was the change from baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) NRS pain subscale score at Week 5. Secondary efficacy endpoints included WOMAC stiffness and physical function subscale score, local pain, range of joint motion, and overall improvement.ResultsAmong 267 randomized patients, 259 patients completed the study. The change from baseline in WOMAC NRS pain subscale score at Week 5 was −2.98 ± 0.193 in the NRD101 group and −2.66 ± 0.194 in the Artz group, and the trial met the non-inferiority criteria. Efficacy in the NRD101 group tended to be consistently higher than in the Artz group for most items of WOMAC. Several subgroup analyses also showed differences between the two groups, tending to favor NRD101. Adverse events were seen in 26.0% (34/131) of patients in the NRD101 group and 38.3% (51/133) in the Artz group.ConclusionsNRD101 improved knee pain in Chinese patients with osteoarthritis after five consecutive weekly injections. NRD101 tended to be somewhat more effective than Artz. No new safety concerns were identified.Trial registration: JapicCTI, JapicCTI-173531. Registered 10 March 2017, https://www.clinicaltrials.jp/cti-user/trial/Search.jsp

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