scholarly journals The effect of maintaining high hemoglobin levels on long-term kidney function in kidney transplant recipients: a randomized controlled trial

2018 ◽  
Vol 34 (8) ◽  
pp. 1409-1416 ◽  
Author(s):  
Makoto Tsujita ◽  
Tomoki Kosugi ◽  
Norihiko Goto ◽  
Kenta Futamura ◽  
Morikuni Nishihira ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Graft Function ◽  
Target Range ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial ◽  
Decline Rate ◽  
The Mean ◽  
Hb Concentration ◽  
The Impact

Abstract Background Posttransplant anemia may be a major determinant of chronic allograft nephropathy. However, the impact of correcting anemia on graft function remains controversial. Methods A 3-year follow-up of an open-label, multicenter, randomized controlled trial involving kidney transplantation recipients examined whether sustained maintenance of target hemoglobin (Hb) concentrations at a high level (12.5–13.5 g/dL, n = 64) with either darbepoetin alfa or epoetin beta pegol would slow the graft function decline rate as the primary efficacy endpoint, compared with maintenance of a low Hb concentration (10.5–11.5 g/dL, n = 63). Results The mean blood pressures in the two groups were well controlled throughout the study. In the high Hb group, mean Hb concentrations increased to >12 g/dL at 3 months, reaching the target range at 18 months. At the end of this study (36 months), the mean Hb concentration was 12.8 ± 0.7 g/dL in the high Hb group and 11.5 ± 1.2 g/dL in the low Hb group. The decline rate of the estimated glomerular filtration (eGFR) rate was considerably greater in the low Hb group (ΔeGFR, −5.1 ± 9.5 mL/min/1.73 m2) than in the high Hb group (−1.0 ± 8.4 mL/min/1.73 m2) (P = 0.02). Of note, only a few high Hb patients developed cardiovascular events and returned to hemodialysis, but the low Hb patients did not. Conclusion This prospective study suggests that correcting anemia to the target Hb level range (12.5–13.5 g/dL) slows renal function deterioration by >3 years in the chronic phase of allograft nephropathy.

scholarly journals The impact of vildagliptin on the daily glucose profile and coronary plaque stability in impaired glucose tolerance patients with coronary artery disease: VOGUE—A multicenter randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Hiroyuki Yamamoto ◽  
Akihide Konishi ◽  
Toshiro Shinke ◽  
Hiromasa Otake ◽  
Masaru Kuroda ◽  
...  
Keyword(s):  
Coronary Artery Disease ◽  
Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Fibrous Cap ◽  
Multicenter Randomized Controlled Trial ◽  
The Mean ◽  
Artery Disease ◽  
Fibrous Cap Thickness ◽  
The Impact

Abstract Background The impact of reduction in glycemic excursion on coronary plaques remains unknown. This study aimed to elucidate whether a dipeptidyl peptidase 4 inhibitor could reduce the glycemic excursion and stabilize the coronary plaques compared with conventional management in coronary artery disease (CAD) patients with impaired glucose tolerance (IGT). Methods This was a multicenter, randomized controlled trial including CAD patients with IGT under lipid-lowering therapy receiving either vildagliptin (50 mg once a day) or no medication (control group) regarding glycemic treatment. The primary endpoint was changes in the minimum fibrous cap thickness and lipid arc in non-significant native coronary plaques detected by optical coherence tomography at 6 months after intervention. Glycemic variability expressed as the mean amplitude of glycemic excursion (MAGE) measured with a continuous glucose monitoring system was evaluated before and 6 months after intervention. Results A total of 20 participants with 47 lesions were allocated to either the vildagliptin group (10 participants, 22 lesions) or the control group (10 participants, 25 lesions). The adjusted difference of mean changes between the groups was − 18.8 mg/dl (95% confidence interval, − 30.8 to − 6.8) (p = 0.0064) for the MAGE (vildagliptin, − 20.1 ± 18.0 mg/dl vs. control, 2.6 ± 12.7 mg/dl), − 22.8° (− 40.6° to − 5.1°) (p = 0.0012) for the mean lipid arc (vildagliptin, − 9.0° ± 25.5° vs. control, 15.8° ± 16.8°), and 42.7 μm (15.3 to 70.1 μm) (p = 0.0022) for the minimum fibrous cap thickness (vildagliptin, 35.7 ± 50.8 μm vs. control, − 15.1 ± 25.2 μm). Conclusions Vildagliptin could reduce the MAGE at 6 months and may be associated with the decreased lipid arc and increased minimum FCT of the coronary plaques in CAD patients with IGT as compared with the control group. These findings may represent its potential stabilization effect on coronary plaques, which are characteristic in this patient subset. Trial registration Registered in the UMIN clinical trial registry (UMIN000008620), Name of the registry: VOGUE trial, Date of registration: Aug 6, 2012, URL: https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000010058

scholarly journals Assessing the impact of the addition of pyriproxyfen on the durability of permethrin-treated bed nets in Burkina Faso: a compound-randomized controlled trial

2019 ◽  
Vol 18 (1) ◽  
Author(s):  
Kobié H. Toé ◽  
Frank Mechan ◽  
Julie-Anne A. Tangena ◽  
Marion Morris ◽  
Joanna Solino ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Burkina Faso ◽  
Pyrethroid Resistance ◽  
Controlled Trial ◽  
Sub Saharan Africa ◽  
World Health ◽  
Target Range ◽  
Bed Nets ◽  
Randomized Controlled ◽  
The Impact

Abstract Background Long-lasting insecticidal nets (LLINs) treated with pyrethroids are the foundation of malaria control in sub-Saharan Africa. Rising pyrethroid resistance in vectors, however, has driven the development of alternative net formulations. Here the durability of polyethylene nets with a novel combination of a pyrethroid, permethrin, and the insect juvenile hormone mimic, pyriproxyfen (PPF), compared to a standard permethrin LLIN, was assessed in rural Burkina Faso. Methods A compound-randomized controlled trial was completed in two villages. In one village 326 of the PPF-permethrin nets (Olyset Duo) and 327 standard LLINs (Olyset) were distributed to assess bioefficacy. In a second village, 170 PPF-permethrin nets and 376 LLINs were distributed to assess survivorship. Nets were followed at 6-monthly intervals for 3 years. Bioefficacy was assessed by exposing permethrin-susceptible and resistant Anopheles gambiae sensu lato mosquito strains to standard World Health Organization (WHO) cone and tunnel tests with impacts on fertility measured in the resistant strain. Insecticide content was measured using high-performance liquid chromatography. LLIN survivorship was recorded with a questionnaire and assessed by comparing the physical integrity using the proportionate hole index (pHI). Results The PPF-permethrin net met WHO bioefficacy criteria (≥ 80% mortality or ≥ 95% knockdown) for the first 18 months, compared to 6 months for the standard LLIN. Mean mosquito mortality for PPF-permethrin nets, across all time points, was 8.6% (CI 2.6–14.6%) higher than the standard LLIN. Fertility rates were reduced after PPF-permethrin net exposure at 1-month post distribution, but not later. Permethrin content of both types of nets remained within the target range of 20 g/kg ± 25% for 242/248 nets tested. The pyriproxyfen content of PPF-permethrin nets declined by 54%, from 10.4 g/kg (CI 10.2–10.6) to 4.7 g/kg (CI 3.5–6.0, p < 0.001) over 36 months. Net survivorship was poor, with only 13% of PPF-permethrin nets and 12% of LLINs still present in the original household after 36 months. There was no difference in the fabric integrity or survivorship between the two net types. Conclusion The PPF-permethrin net, Olyset Duo, met or exceeded the performance of the WHO-recommended standard LLIN (Olyset) in the current study but both net types failed the 3-year WHO bioefficacy criteria.

The impact of narrow band imaging for colon polyp detection: a multicenter randomized controlled trial by tandem colonoscopy

2012 ◽  
Vol 47 (10) ◽  
pp. 1099-1107 ◽  
Author(s):  
Hiroaki Ikematsu ◽  
Yutaka Saito ◽  
Shinji Tanaka ◽  
Toshio Uraoka ◽  
Yasushi Sano ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Narrow Band ◽  
Narrow Band Imaging ◽  
Controlled Trial ◽  
Colon Polyp ◽  
Polyp Detection ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial ◽  
The Impact

A multicenter, randomized, controlled trial comparing the occurrence of major adverse cardiovascular events (MACEs) in patients (pts) with prostate cancer (pc) and cardiovascular disease (CVD) receiving degarelix (GnRH receptor antagonist) or leuprolide (GnRH receptor agonist).

2018 ◽  
Vol 36 (6_suppl) ◽  
pp. TPS395-TPS395 ◽  
Author(s):  
Susan F. Slovin ◽  
Chiara Melloni ◽  
Samreen Mansor-Lefebvre ◽  
Anders Neijber ◽  
Matthew Roe
Keyword(s):  
Randomized Controlled Trial ◽  
Gnrh Agonist ◽  
Receptor Agonist ◽  
Controlled Trial ◽  
Locally Advanced ◽  
Gnrh Receptor ◽  
Randomized Controlled ◽  
Increased Risk ◽  
Multicenter Randomized Controlled Trial ◽  
The Impact

TPS395 Background: Epidemiological studies showed an association between GnRH agonists and a long-term increased risk of CVD, early after treatment initiation and with a higher risk seen in pts with pre-existing CVD. Retrospective pooled safety analyses of 6 randomized trials showed that significantly fewer pts treated with the GnRH receptor antagonists, degarelix, had a CV event or death compared with pts receiving a GnRH receptor agonist. In those studies showing an increased CV risk, Androgen-Deprivation Therapy (ADT) was primarily with GnRH receptor agonists. The mechanistic differences between GnRH antagonists and agonists, including testosterone surge and time to suppression at initiation, effect on follicle-stimulating hormone and on GnRH receptors e.g. T-lymphocytes in atherosclerotic plaque, raises the possibility of different CV risk profiles. The PRONOUNCE trial is the first to prospectively assess whether a GnRH agonist/antagonist can worsen pre-existing CVD; assess the impact of GnRH agonist/antagonist on CV risk biomarkers; and effects of hormonal therapy on immune system. Methods: PRONOUNCE is a multi-center, randomized, controlled trial of 900 men with pc and concomitant CVD, assessing adjudicated MACEs, i.e. myocardial infarction (fatal, non-fatal), stroke (fatal, non-fatal), or death in pts randomized 1:1 to either degarelix or leuprolide according to label recommendations for up to one year. Eligibility include pre-defined CVD, metastatic or locally advanced pc; high-risk disease with plan for definitive radiation therapy (RT); recurrence after local therapy with PSA doubling time <12 months; or salvage RT with neoadjuvant/adjuvant ADT for at least 12 months. Serum samples are collected for the analysis of various CV, inflammatory, and immune biomarkers. The primary endpoint will be based on Kaplan-Meier estimator of survival function and stratified for age group and region. Interim analysis is scheduled when 50% of MACE events have occurred allowing the DSMB to recommend for sample size correction. Clinical trial information: NCT02663908.

scholarly journals THE EFFECT OF EDUCATIONAL PROGRAM-BASED ON SEXUAL INTIMACY CONCEPT VIA SMARTPHONE IN WOMEN FOLLOWING MASTECTOMY: A RANDOMIZED CONTROLLED TRIAL

2020 ◽  
Vol 17 (34) ◽  
pp. 23-32
Author(s):  
Zahra ARJMANDI ◽  
Zohreh MAHMOODI ◽  
Zahra BEHBOODI MOGHADAM ◽  
Habibollah MAHMOODZADEH ◽  
Mostafa QORBANI
Keyword(s):  
Breast Cancer ◽  
Randomized Controlled Trial ◽  
Educational Program ◽  
Controlled Trial ◽  
Intervention Group ◽  
Sexual Intimacy ◽  
Care Education ◽  
Randomized Controlled ◽  
The Mean ◽  
The Impact

The most common malignancy among women around the world is breast cancer. Mastectomy is one of the most commonly used breast cancer treatments, which has a direct impact on the sexual performance of these patients. The purpose of this study was to examine the impact of Educational program through Smartphone on the sexual intimacy of women with breast cancer. In a randomized controlled trial, 60 women with mastectomy referred to Imam Khomeini Hospital from April to July 2018 and were randomly divided into two intervention (sexual intimacy with routine mastectomy and chemotherapy care education) and control groups (routine mastectomy and chemotherapy care education) using four randomized blocks. Six sessions via smartphone were held for both groups the sexual intimacy questionnaire was completed by participants before and after the intervention. The data were analyzed by SPSS 21 at a significance level of p 0. 05. According to the findings, the mean score of overall sexual intimacy before intervention was not significantly different (p=0.143) between the two groups. However, after the intervention, the mean score of total sexual intimacy was significantly different in the control and intervention groups being higher in the intervention group (p 0.001). The present study showed that education via smartphone was effective in improving the sexual intimacy of women with breast cancer and consequently enhancing the couples' sexual relations.

scholarly journals The effectiveness of a web-based decision aid for patients with hip osteoarthritis: study protocol for a randomized controlled trial.

2020 ◽  
Author(s):  
Lilisbeth Perestelo-Perez ◽  
Yolanda Alvarez-Perez ◽  
Amado Rivero-Santana ◽  
Vanesa Ramos-García ◽  
Andrea Duarte-Díaz ◽  
...  
Keyword(s):  
Decision Making ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Treatment Options ◽  
Hip Osteoarthritis ◽  
Decision Making Process ◽  
Web Based ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial ◽  
The Impact

Abstract Background: Osteoarthritis (OA) is a health condition sensitive to patient’s preferences and values regarding the benefits and risks of the different treatment options. In this sense, patient decision aids (PtDA) can play an important role in helping patients to incorporate their values, needs and preferences into the decision-making process, thus improving Person-Centred Care. Previous research has focused almost exclusively on knee OA, and therefore the aim of this study is to develop and evaluate the effectiveness of a PtDA for patients with hip OA.Methods: The general design consists of two phases: 1) design a web-based PtDA for patients with hip OA, following the recommended procedures: systematic review of safety/effectiveness of treatments, and an iterative process of development with the help of an Advisory Committee composed of health professionals and patients; 2) To evaluate the impact of the PtDA on hip OA patients’ decision-making process related with their treatment. For that aim, a multicenter randomized controlled trial will be carried out with 124 patients with hip OA in Tenerife (Spain) comparing intervention or usual care.Discussion: PtDAs have been recommended as a useful and effective resource for improving PCC in many health conditions. The intervention is intended to empower patients by fostering their active participation during the decision-making process about their treatment, and by ensuring they make informed decisions congruent with their values and preferences. This study will contribute to the scientific knowledge about effectiveness of PtDAs in hip OA, in order to improve the quality of health care offered to these patients.Trial registration: ClinicalTrials.gob (NCT04241978). Registered on 24 January 2020.

scholarly journals The effectiveness of a web-based decision aid for patients with hip osteoarthritis: study protocol for a randomized controlled trial

2020 ◽  
Author(s):  
Lilisbeth Perestelo-Perez ◽  
Yolanda Alvarez-Perez ◽  
Amado Rivero-Santana ◽  
Vanesa Ramos-García ◽  
Andrea Duarte-Díaz ◽  
...  
Keyword(s):  
Decision Making ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Treatment Options ◽  
Hip Osteoarthritis ◽  
Decision Making Process ◽  
Web Based ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial ◽  
The Impact

Abstract Background: Osteoarthritis (OA) is a health condition sensitive to patient’s preferences and values regarding the benefits and risks of the different treatment options. In this sense, patient decision aids (PtDA) can play an important role in helping patients to incorporate their values, needs and preferences into the decision-making process, thus improving Person-Centred Care. Previous research has focused almost exclusively on knee OA, and therefore the aim of this study is to develop and evaluate the effectiveness of a PtDA for patients with hip OA.Methods: The general design consists of two phases: 1) design a web-based PtDA for patients with hip OA, following the recommended procedures: systematic review of safety/effectiveness of treatments, and an iterative process of development with the help of an Advisory Committee composed of health professionals and patients; 2) To evaluate the impact of the PtDA on hip OA patients’ decision-making process related with their treatment. For that aim, a multicenter randomized controlled trial will be carried out with 124 patients with hip OA in Tenerife (Spain) comparing intervention or usual care.Discussion: PtDAs have been recommended as a useful and effective resource for improving PCC in many health conditions. The intervention is intended to empower patients by fostering their active participation during the decision-making process about their treatment, and by ensuring they make informed decisions congruent with their values and preferences. This study will contribute to the scientific knowledge about effectiveness of PtDAs in hip OA, in order to improve the quality of health care offered to these patients.Trial registration: ClinicalTrials.gob (NCT04241978). Registered on 24 January 2020.

Multicenter randomized controlled trial assessing the impact of a cervical traction maneuver (Amr's maneuver) on the incidence of postpartum hemorrhage

2018 ◽  
Vol 144 (1) ◽  
pp. 56-61 ◽  
Author(s):  
Amr Hamdy ◽  
Osama Azmy ◽  
Rehab Lotfy ◽  
Ahmed A. Attia ◽  
Moutaz M. Elsherbini ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Postpartum Hemorrhage ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial ◽  
Cervical Traction ◽  
The Impact
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