Partial Removal of Carious Dentine: A Multicenter Randomized Controlled Trial and 18-Month Follow-Up Results

Background: Doxycycline was demonstrated in a retrospective study to be associated with greater survival in patients with light chain (AL) amyloidosis. Therefore, we prospectively compared the efficacy of bortezomib-cyclophosphamide-dexamethasone (CyBorD) and CyBorD combined with doxycycline for cardiac AL amyloidosis. Methods: This was a multicenter, open-label randomized controlled trial. Patients with Mayo 2004 stage II-III AL amyloidosis were included. Patients were randomized to doxycycline 100 mg twice daily along with 9 cycles of CyBorD (doxycycline group) or to 9 cycles of CyBorD alone (control group). The primary outcome was 2-year progression-free survival (PFS). PFS was defined as the time from randomization to death, hematologic progression or organ progression (heart, kidney or liver). Hematologic progression was defined based on substantial increase in free light chain. Increase in either N-terminal pro B-type natriuretic peptide or cardiac troponin was the main criterion for defining cardiac progression. Cardiac PFS, defined as the time from randomization to cardiac progression or death, was compared between groups in an exploratory analysis. The corresponding treatment hazard ratio was estimated using a Cox regression model. Results: 140 patients underwent randomization, with 70 in each group. The median age was 61 (range, 33-78) years with a male: female ratio of 1.75:1. Stage II disease was present in 34 (48.6%) and 33 (47.1%) patients in the doxycycline and control groups, respectively. After a median follow-up duration of 24.4 months, 32/70 (45.7%) of patients in the doxycycline group and 30/70 (42.9%) of patients in the control group experienced progression. PFS was not significantly different between groups (hazard ratio 0.97, 95% CI, 0.59-1.60, p =0.91). Cardiac progression occurred in 29/70 (41.4%) of patients in the doxycycline group and 26/70 (37.1%) of patients in the control group. The death rates for both groups by the end of follow-up was the same, 25/70 (35.7%). There were no significant differences observed for either cardiac PFS (hazard ratio 0.91, 95% CI, 0.54-1.55, p =0.74) or overall survival (hazard ratio 1.04, 95% CI, 0.60-1.81, p =0.89). Conclusions: Our trial demonstrated that doxycycline combined with CyBorD failed to prolong PFS or cardiac PFS compared with CyBorD alone in cardiac AL amyloidosis. Clinical Trial Registration: URL: https://clinicaltrials.gov Unique Identifier: NCT03401372.

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Lateral Internal Sphincterotomy is Superior to Topical Nitroglycerin for Healing Chronic Anal Fissure and does not Compromise Long-Term Fecal Continence: Six-Year Follow-Up of a Multicenter, Randomized, Controlled Trial

Yearbook of Gastroenterology ◽

10.1016/s0739-5930(08)79167-0 ◽

2008 ◽

Vol 2008 ◽

pp. 164-165

Author(s):

M.T. Osterman

Keyword(s):

Randomized Controlled Trial ◽

Anal Fissure ◽

Chronic Anal Fissure ◽

Controlled Trial ◽

Fecal Continence ◽

Randomized Controlled ◽

Multicenter Randomized Controlled Trial ◽

Topical Nitroglycerin

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Mobile-Based Lifestyle Intervention in Women with Glucose Intolerance after Gestational Diabetes Mellitus (MELINDA), A Multicenter Randomized Controlled Trial: Methodology and Design

Journal of Clinical Medicine ◽

10.3390/jcm9082635 ◽

2020 ◽

Vol 9 (8) ◽

pp. 2635

Author(s):

Caro Minschart ◽

Toon Maes ◽

Christophe De Block ◽

Inge Van Pottelbergh ◽

Nele Myngheer ◽

...

Keyword(s):

Diabetes Mellitus ◽

Randomized Controlled Trial ◽

Gestational Diabetes ◽

Gestational Diabetes Mellitus ◽

Lifestyle Intervention ◽

Glucose Intolerance ◽

Controlled Trial ◽

Randomized Controlled ◽

Multicenter Randomized Controlled Trial

The aims of the ‘Mobile-based lifestyle intervention in women with glucose intolerance after gestational diabetes mellitus (GDM)’ study (MELINDA) are: (1) to evaluate the prevalence and risk factors of glucose intolerance after a recent history of GDM; and (2) to evaluate the efficacy and feasibility of a telephone- and mobile-based lifestyle intervention in women with glucose intolerance after GDM. This is a Belgian multicenter randomized controlled trial (RCT) in seven hospitals with the aim of recruiting 236 women. Women in the intervention group will receive a blended program, based on one face-to-face education session and further follow-up through a mobile application and monthly telephone advice. Women in the control group will receive follow-up as in normal routine with referral to primary care. Participants will receive an oral glucose tolerance test (OGTT) one year after baseline. Primary endpoint is the frequency of weight goal achievement (≥5% weight loss if pre-pregnancy BMI ≥ 25 Kg/m2 or return to pre-gravid weight if BMI < 25 Kg/m2). At each visit blood samples are collected, anthropometric measurements are obtained, and self-administered questionnaires are completed. Recruitment began in May 2019.

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Role of New Hydrophilic Surfaces on Early Success Rate and Implant Stability: 1-Year Post-loading Results of a Multicenter, Split-Mouth, Randomized Controlled Trial

European Journal of Dentistry ◽

10.1055/s-0040-1713952 ◽

2020 ◽

Author(s):

Marco Tallarico ◽

Nicola Baldini ◽

Fulvio Gatti ◽

Matteo Martinolli ◽

Erta Xhanari ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Survival Rates ◽

Insertion Torque ◽

Implant Stability ◽

Randomized Controlled ◽

Group Outcomes ◽

Significant Difference ◽

Multicenter Randomized Controlled Trial

Abstract Objective To compare early implant failure and implant stability of one-stage Hiossen ET III implants with its new hydrophilic (NH) surface, compared with Hiossen ET III implants with the sandblasted and acid-etched (SA) surface at 1-year follow-up. Materials and Methods This study was designed as a split-mouth, multicenter randomized controlled trial aimed to compare SA surface implants (SA group) and NH surface, (NH group). Outcomes were implant and prosthetic survival rates, complications, the insertion torque at implant placement, and implant stability quotient (ISQ) values. Results Twenty-nine patients (mean age 59.9 ± 11.3 years) were treated and followed up to 1 year after loading. No patient dropped out. Fifty-eight implants (29 SA group and 29 NH group) were placed. No implants or prostheses failed and no complications were experienced during follow-up. The mean insertion torque was 40.5 ± 3.23 (38.17–41.83) Ncm in the SA group and 40.48 ± 3.49 (38.02–41.98) Ncm in the NH group (p = 0.981). There was a statistically significant difference at the second week (T2) with higher values in the NH group (p = 0.041). Similar results were found in the maxilla (p = 0.045), but not in the mandible (p = 0.362). A positive correlation was found between initial insertion torque and ISQ with higher value in the NH group (0.73 vs. 0.66). Conclusions NH implants are a viable alternative to SA surface, as they seem to avoid the ISQ drop during the bone remodeling phase.

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