Sirolimus-based, calcineurin inhibitor- free regimen in kidney transplant patients: An open-label, randomized, controlled trial

Objective To evaluate the effectiveness of cognitive training in improving tinnitus bother and to identify predictors of patient response. Study Design Prospective open-label randomized controlled trial. Setting Online. Methods Participants were adults with subjective idiopathic nonpulsatile tinnitus causing significant tinnitus-related distress. The intervention group trained by using auditory-intensive exercises for 20 minutes per day, 5 days per week, for 8 weeks. The active control group trained on the same schedule with non–auditory intensive games. Surveys were completed at baseline, 8 weeks, and 12 weeks. Results A total of 64 participants completed the study. The median age was 63 years (range, 25-69) in the intervention group and 61 years (34-68) in the control group. Mixed model analysis revealed that within-subject change in Tinnitus Functional Index in the intervention group was not different than the control group, with marginal mean differences (95% CI): 0.24 (–11.20 to 10.7) and 2.17 (–8.50 to 12.83) at 8 weeks and 2.33 (–8.6 to 13.3) and 3.36 (–7.91 to 14.6) at 12 weeks, respectively. When the 2 study groups were compared, the control group had higher Tinnitus Functional Index scores than the intervention group by 10.5 points at baseline (95% CI, –0.92 to 29.89), 8.1 at 8 weeks (95% CI, –3.27 to 19.42), and 9.4 at 12 weeks (95% CI, –2.45 to 21.34). Conclusion Auditory-intensive cognitive training was not associated with changes in self-reported tinnitus bother. Given the potential for neuroplasticity to affect tinnitus, we believe that future studies on cognitive training for tinnitus remain relevant.

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Long-Term Efficacy and Safety of Zonisamide for Treatment of Parkinsonism in Patients with Dementia with Lewy Bodies: An Open-label Extension of a Phase 3 Randomized Controlled Trial

American Journal of Geriatric Psychiatry ◽

10.1016/j.jagp.2021.07.002 ◽

2021 ◽

Author(s):

Toshinari Odawara ◽

Kazuko Hasegawa ◽

Ritsuko Kajiwara ◽

Hisao Takeuchi ◽

Masaaki Tagawa ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Dementia With Lewy Bodies ◽

Controlled Trial ◽

Lewy Bodies ◽

Efficacy And Safety ◽

Open Label ◽

Phase 3 ◽

Randomized Controlled ◽

Open Label Extension

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Clinical Relevance of Corticosteroid Withdrawal on Graft Histological Lesions in Low-Immunological-Risk Kidney Transplant Patients

Journal of Clinical Medicine ◽

10.3390/jcm10092005 ◽

2021 ◽

Vol 10 (9) ◽

pp. 2005

Author(s):

Domingo Hernández ◽

Juana Alonso-Titos ◽

Teresa Vázquez ◽

Myriam León ◽

Abelardo Caballero ◽

...

Keyword(s):

Kidney Transplant ◽

Rejection Rate ◽

Open Label ◽

Post Transplantation ◽

Protocol Biopsy ◽

Corticosteroid Withdrawal ◽

Transplant Patients ◽

Prospective Phase ◽

Kidney Transplant Patients ◽

The Impact

The impact of corticosteroid withdrawal on medium-term graft histological changes in kidney transplant (KT) recipients under standard immunosuppression is uncertain. As part of an open-label, multicenter, prospective, phase IV, 24-month clinical trial (ClinicalTrials.gov, NCT02284464) in low-immunological-risk KT recipients, 105 patients were randomized, after a protocol-biopsy at 3 months, to corticosteroid continuation (CSC, n = 52) or corticosteroid withdrawal (CSW, n = 53). Both groups received tacrolimus and MMF and had another protocol-biopsy at 24 months. The acute rejection rate, including subclinical inflammation (SCI), was comparable between groups (21.2 vs. 24.5%). No patients developed dnDSA. Inflammatory and chronicity scores increased from 3 to 24 months in patients with, at baseline, no inflammation (NI) or SCI, regardless of treatment. CSW patients with SCI at 3 months had a significantly increased chronicity score at 24 months. HbA1c levels were lower in CSW patients (6.4 ± 1.2 vs. 5.7 ± 0.6%; p = 0.013) at 24 months, as was systolic blood pressure (134.2 ± 14.9 vs. 125.7 ± 15.3 mmHg; p = 0.016). Allograft function was comparable between groups and no patients died or lost their graft. An increase in chronicity scores at 2-years post-transplantation was observed in low-immunological-risk KT recipients with initial NI or SCI, but CSW may accelerate chronicity changes, especially in patients with early SCI. This strategy did, however, improve the cardiovascular profiles of patients.

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