Effects of Conversion to a Bicarbonate/Lactate-Buffered, Neutral-PH, LOW-GDP PD Regimen in Prevalent PD: A 2-Year Randomized Clinical Trial

2017 ◽  
Vol 37 (3) ◽  
pp. 273-282 ◽  
Author(s):  
Karima Farhat ◽  
Caroline E. Douma ◽  
E. Ferrantelli ◽  
Pieter M. ter Wee ◽  
Robert H.J. Beelen ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Renal Function ◽  
Growth Factor ◽  
Randomized Clinical Trial ◽  
Residual Renal Function ◽  
Ca 125 ◽  
Secondary Outcome ◽  
Neutral Ph ◽  
Markers Of Inflammation ◽  
Baxter Healthcare

BackgroundThe use of pH-neutral peritoneal dialysis (PD) fluids low in glucose degradation products (GDP) may better preserve the peritoneal membrane and have fewer systemic effects. The effects of conversion from conventional to neutral-pH, low-GDP PD fluids in prevalent patients are unclear. Few studies on the role of neutral-pH, low-GDP PD have studied residual renal function, ultrafiltration, peritonitis incidence and technique failure, transport characteristics, and local and systemic markers of inflammation in prevalent PD patients.MethodsIn a multi-center open-label randomized clinical trial (RCT), we randomly assigned 40 of 78 stable continuous ambulatory PD (CAPD) and automated PD (APD) patients to treatment with bicarbonate/lactate, neutral-pH, low-GDP PD fluid (Physioneal; Baxter Healthcare Corporation, Deerfield, IL, USA) and compared them with 38 patients continuing their current standard lactate-buffered PD fluid (PDF) (Dianeal; Baxter Healthcare Corporation, Deerfield, IL, USA) during 2 years. Primary outcome was residual renal function (RRF) and ultrafiltration (UF) during peritoneal equilibration test (PET); peritonitis incidence was a secondary outcome. Furthermore, clinical parameters as well as several biomarkers in effluents and serum were measured.ResultsDuring follow-up, RRF did not differ between the groups. In the Physioneal group ultrafiltration (UF) during PET remained more or less stable (-20 mL [confidence interval (CI): -163.5 – 123.5 mL]; p = 0.7 over 24 months), whereas it declined in the Dianeal group (-243 mL [CI: -376.6 to -109.4 mL]; p < 0.0001 over 24 months), resulting in a difference of 233.7 mL [95% CI 41.0 – 425.5 mL]; p = 0.017 between the groups at 24 months. The peritonitis rate was lower in the Physioneal group: adjusted odds ratio (OR) 0.38 (0.15 – 0.97) p = 0.043. No differences were observed between the 2 groups in peritoneal adequacy or transport characteristics nor effluent markers of local inflammation (cancer antigen [CA]125, hyaluronan [HA], vascular endothelial growth factor [VEGF], macrophage chemo-attractant protein [MCP]-1, HA and transforming growth factor [TGF]β–1).ConclusionIn prevalent PD patients, our study did not find a difference in RRF after conversion from conventional to neutral-pH, low-GDP PD fluids, although there is a possibility that the study was underpowered to detect a difference. Decline in UF during standardized PET was lower after 2 years in the Physioneal group.

Convergence Insufficiency Treatment Trial – Attention and Reading Trial (CITT-ART): Design and Methods

2015 ◽  
pp. 214-228 ◽  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Health Care Providers ◽  
Developmental Disorders ◽  
Attention Problems ◽  
Secondary Outcome ◽  
Care Providers ◽  
Treatment Trial ◽  
Additional Hypothesis ◽  
Convergence Insufficiency

Objective: To describe the design and methodology of the Convergence Insufficiency Treatment Trial: Attention and Reading Trial (CITT-ART), the first randomized clinical trial evaluating the effect of vision therapy on reading and attention in school-age children with symptomatic convergence insufficiency (CI). Methods: CITT-ART is a multicenter, placebo-controlled, randomized clinical trial of 324 children ages 9 to 14 years in grades 3 to 8 with symptomatic CI. Participants are randomized to 16 weeks of office-based vergence/accommodative therapy (OBVAT) or placebo therapy (OBPT), both supplemented with home therapy. The primary outcome measure is the change in the Wechsler Individual Achievement Test-Version 3 (WIAT-III) reading comprehension subtest score. Secondary outcome measures are changes in attention as measured by the Strengths and Weaknesses of Attention (SWAN) as reported by parents and teachers, tests of binocular visual function, and other measures of reading and attention. The long-term effects of treatment are assessed 1 year after treatment completion. All analyses will test the null hypothesis of no difference in outcomes between the two treatment groups. The study is entering its second year of recruitment. The final results will contribute to a better understanding of the relationship between the treatment of symptomatic CI and its effect on reading and attention. Conclusion: The study will provide an evidence base to help parents, eye professionals, educators, and other health care providers make informed decisions as they care for children with CI and reading and attention problems. Results may also generate additional hypothesis and guide the development of other scientific investigations of the relationships between visual disorders and other developmental disorders in children.

scholarly journals POS-011 THE EFFECT IN RENAL FUNCTION AND VASCULAR DECONGESTION IN TYPE 1 CARDIORENAL SYNDROME TREATED WITH TWO STRATEGIES OF DIURETICS, A RANDOMIZED CLINICAL TRIAL

2021 ◽  
Vol 6 (4) ◽  
pp. S5
Author(s):  
J. Chavez Iñiguez ◽  
A. De la Torre-Quiroga ◽  
A. Aranda G de Quevedo ◽  
A. Romero-Muñoz ◽  
J. Gómez-Fregoso ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Renal Function ◽  
Randomized Clinical Trial ◽  
Cardiorenal Syndrome

scholarly journals Effectiveness of Acromioclavicular Joint Mobilization and Physical Therapy vs Physical Therapy Alone in Patients with Frozen Shoulder: A Randomized Clinical Trial

2021 ◽  
Author(s):  
Mohammad Rahbar ◽  
Sepideh Ranjbar Kiyakalayeh ◽  
Bina Eftekharsadat ◽  
Behzad Izadseresht ◽  
Neda Dolatkhah
Keyword(s):  
Clinical Trial ◽  
Physical Therapy ◽  
Randomized Clinical Trial ◽  
Shoulder Pain ◽  
Acromioclavicular Joint ◽  
Frozen Shoulder ◽  
Secondary Outcome ◽  
Control Group ◽  
Joint Mobilization ◽  
Active Abduction

Abstract Background: Frozen shoulder (FS) is a prevalent musculoskeletal condition characterized by an often prolonged pain, disability and limited active and passive range of motion (ROM), however its management remains challenging yet. The objective of this trial was to compare the efficacy of acromioclavicular joint mobilization and physical therapy versus physical therapy in treatment of FS.Methods: In this single-blind randomized clinical trial, patients with diagnosis of FS were randomly allocated into mobilization + physical therapy (n=28) as experiment group, and physical therapy (n=28) as control group in two outpatient clinics of Tabriz University of Medical Sciences, Iran. The primary outcomes were self-reported shoulder pain-related disability measured by the Shoulder Pain and Disability Index (SPADI) questionnaire and goniometric assessment of shoulder ROM. The secondary outcome was the Visual Analogue Scale (VAS). Measures were performed at the baseline, immediately and one month after beginning the treatments.Results: Totally 51 patients with 25.73 ± 6.88 years old of age completed the study and their data were analyzed. VAS, SPADI, pain and disability improved more significantly in experiment group compared to control group immediately [-4.63 (-5.58- -3.67) vs. -2.22 (-2.96- -1.47), p<0.001; -23.08 (-28.63- -17.53) vs. -13.04 (-17.93- -8.16), p=0.008; -26.00 (-31.71- -20.29) vs. -16.35 (-23.39- -9.31), p=0.034 and -21.25 (-29.11- -13.39) vs. -10.98 (-17.53- -4.43), p=0.042, respectively] and one month after beginning of treatment [-5.58 (-6.45- -4.72) vs. -3.61 (-4.60- -2.62), p<0.001; -33.43 (-40.85- -26.01) vs. -20.03 (-26.00- -14.07), p=0.001; --42.83 (-49.09- -36.57) vs. -25.57 (-33.92- -17.21), p<0.001 and -27.55 (-36.19- -15.94) vs. -16.58 (-24.48- -8.67), p=0.041, respectively]. Active abduction ROM was also improved more significantly immediately after treatment in experiment group compared to control group [25.83 (11.45- 40.13) vs. 10.17 (1.02- 19.15), p=0.025], however there were no significant differences between two groups concerning other measured ROMs immediately and one month after treatment (all p>0.05). Conclusions: Acromioclavicular mobilization along with conventional physical therapy was more efficient in decreasing pain and disability and improving active abduction ROM compared to physical therapy in patients with FS. These findings would suggest a new therapeutic method for shoulder disorders with pain and disability.Trial registrationwww.irct.ir, IRCT20100605004104N7, registered 06.01.2019 (https://www.irct.ir/trial/35900)

scholarly journals Anastrozole and Levonorgrestrel-Releasing Intrauterine Device in the Treatment of Endometriosis: A Randomized Clinical Trial.

2020 ◽  
Author(s):  
Pedro Acién ◽  
Irene Velasco ◽  
Maribel Acién
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Transvaginal Ultrasound ◽  
Intrauterine Device ◽  
Conservative Surgery ◽  
University Hospital ◽  
Ca 125 ◽  
Fertility Sparing ◽  
Ultrasound Guided Puncture ◽  
Guided Puncture

Abstract Background: To study the effectiveness of an aromatase inhibitor (Anastrozole) associated to levonorgestrel-releasing intrauterine device (LNG-IUD, Mirena®) in the treatment of endometriosis.Methods: Prospective, randomized clinical trial. Setting: University Hospital (single center). Elegibility criteria: Endometriomas >3×4 cm, CA-125>35 U/mL and endometriosis symptoms. Patients: Thirty-one women randomized to anastrozole+Mirena®+Conservative Surgery(CS) (n=8), anastrozole+Mirena®+transvaginal ultrasound-guided puncture-aspiration (TUGPA) (n=7), Mirena®+CS (n=9), or Mirena®+TUGPA (n=7). Interventions: Anastrozole 1 mg/day and/or only Mirena® for 6 months; CS (ovarian and fertility-sparing) or TUGPA of endometriomas one month after starting medical treatment. Main Outcome Measures: Visual analogic scale for symptoms, CA-125 levels, ultrasound findings of endometriomas and recurrences. Results: A significant improvement in symptoms during the treatment (difference of 43%, 95% CI 29.9-56.2) occurred, which was maintained at 1 and 2 years. It was more significant in patients treated with anastrozole (51%, 95% CI 33.3-68.7). For CA-125, the most significant decrease was observed without anastrozole (73.8%, 95% CI 64.2-83.4 vs. 53.8%, 95% CI 25.7-81.6 under Mirena®+anastrozole). After CS for endometriosis, a reduction of findings of endometriomas and long-term recurrences occurred, with or without anastrozole. At 4,2±1,7 years (95% CI 3,57-4,85), 88% of the patients who underwent CS were asymptomatic, without medication or reoperation, compared to only 21% if TUGPA was performed, with or without anastrozole (p=0.019). Conclusions: Dosing anastrozole for 6 months, starting one month before CS of endometriosis, reduces more significantly the painful symptoms and delays recurrences, but has no other significant advantages over the single insertion of LNG-IUD (Mirena®) during the same time. Anastrozole and/or only Mirena® associated with TUGPA are not effective.

scholarly journals Effectiveness of Ginger in the Treatment of Type 2 Diabetes Mellitus: A Pilot Study of the Randomized Clinical Trial Type

Aquichan ◽  
2021 ◽  
Vol 21 (1) ◽  
pp. 1-14
Author(s):  
Gerdane Celene Nunes Carvalho ◽  
Jose Claudio Garcia Lira Neto ◽  
Lívio César Cunha Nunes ◽  
Ana Maria Parente Garcia Alencar ◽  
Regina Lúcia Lino Marques ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Clinical Trial ◽  
Type 2 Diabetes Mellitus ◽  
Pilot Study ◽  
Randomized Clinical Trial ◽  
Trial Type ◽  
Secondary Outcome ◽  
Lipid Levels

Objective: To analyze the effectiveness of ginger in the reduction of the glycemic, lipid and anthropometric levels in people with Type 2 Diabetes Mellitus. Materials and method: A double-blind pilot study of the randomized clinical trial type, conducted between October 2017 and January 2018. The inclusion criteria were as follows: individuals with type 2 diabetes, aged from 18 to 80 years old, using oral antidiabetic drugs, and with glycated hemoglobin values between 7 % and 10 %. The participants were randomized and allocated in two different groups. In the experimental group, the participants used 1.2 g of ginger and, in the control group, 1.2 g of placebo. The primary outcome was the reduction in blood glucose. The reduction in the lipid and anthropometric levels was the secondary outcome. The intervention lasted four weeks. Results: A total of 21 participants were included in the study. The use of 1.2 g of ginger resulted in noticeable reductions in the anthropometric and lipid levels in 30 days of follow-up, but it did not reduce the glycemic levels. Conclusions: In this study, it was shown that ginger capsules, in doses of 1.2 g a day, can help to reduce anthropometric measures and lipid levels in the population under study; however, it had no effect on the glycemic levels.

scholarly journals Anastrozole and Levonorgrestrel-Releasing Intrauterine Device in the Treatment of Endometriosis: A Randomized Clinical Trial.

2020 ◽  
Author(s):  
Pedro Acién ◽  
Irene Velasco ◽  
Maribel Acién
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Transvaginal Ultrasound ◽  
Intrauterine Device ◽  
Conservative Surgery ◽  
University Hospital ◽  
Ca 125 ◽  
European Medicines Agency ◽  
Fertility Sparing ◽  
Ultrasound Guided Puncture

Abstract Background: To study the effectiveness of an aromatase inhibitor (Anastrozole) associated to levonorgestrel-releasing intrauterine device (LNG-IUD, Mirena®) in the treatment of endometriosis.Methods: Prospective, randomized clinical trial. Setting: University Hospital (single center). Elegibility criteria: Endometriomas >3×4 cm, CA-125>35 U/mL and endometriosis symptoms. Patients: Thirty-one women randomized to anastrozole+Mirena®+Conservative Surgery(CS) (n=8), anastrozole+Mirena®+transvaginal ultrasound-guided puncture-aspiration (TUGPA) (n=7), Mirena®+CS (n=9), or Mirena®+TUGPA (n=7). Interventions: Anastrozole 1 mg/day and/or only Mirena® for 6 months; CS (ovarian and fertility-sparing) or TUGPA of endometriomas one month after starting medical treatment. Main Outcome Measures: Visual analogic scale for symptoms, CA-125 levels, ultrasound findings of endometriomas and recurrences.Results: A significant improvement in symptoms during the treatment (difference of 43%, 95% CI 29.9-56.2) occurred, which was maintained at 1 and 2 years. It was more significant in patients treated with anastrozole (51%, 95% CI 33.3-68.7). For CA-125, the most significant decrease was observed without anastrozole (73.8%, 95% CI 64.2-83.4 vs. 53.8%, 95% CI 25.7-81.6 under Mirena®+anastrozole). After CS for endometriosis, a reduction of findings of endometriomas and long-term recurrences occurred, with or without anastrozole. At 4,2±1,7 years (95% CI 3,57-4,85), 88% of the patients who underwent CS were asymptomatic, without medication or reoperation, compared to only 21% if TUGPA was performed, with or without anastrozole (p=0.019).Conclusions: Dosing anastrozole for 6 months, starting one month before CS of endometriosis, reduces more significantly the painful symptoms and delays recurrences, but has no other significant advantages over the single insertion of LNG-IUD (Mirena®) during the same time. Anastrozole and/or only Mirena® associated with TUGPA are not effective.Details of trial registration: Eudra CT System of the European Medicines Agency (London, 29-Sept-2008) Nº EudraCT: 2008-005744-17 (07/11/2008). Date of enrolment of first patient: 15/01/2009.

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