scholarly journals Long Term Evaluation of the Efficacy And And Safety of Nd:Yag Laser Vitreolysis for Symptomatic Vitreous Floaters

2021 ◽  
Author(s):  
Guilherme Nunes ◽  
Gustavo Ludwig ◽  
Henrique Gemelli ◽  
Pedro D Serracarbassa ◽  
Márgara Zanotele
Keyword(s):  
Clinical Trial ◽  
Adverse Effects ◽  
Similar Proportion ◽  
Life Questionnaire ◽  
Double Blind ◽  
Vitreous Floaters ◽  
Significant Difference ◽  
Late Adverse Effects

Abstract PURPOSE: this study evaluates the long-term safety and efficacy of Nd:YAG vitreolysis for symptomatic vitreous floaters, as it remains a controversial procedure due to the lack of robust evidence in the literature for its maintenance of the results and absence of adverse effects. METHODS: this is an observational extension to the previously presented prospective, randomized, double-blind clinical trial study. Eight of thirteen subjects who underwent vitreolysis with YAG laser returned for a late reevaluation, 18 months after the procedure, to evaluate the efficacy and safety of the procedure.RESULTS: all patients maintained the improvement in symptomatology noted after the procedure, with 25% showing complete improvement, and a similar proportion (37.5%) reporting significant or partial improvement. Objective improvement in opacity was similar to that found at 6 months follow-up. The NEI-VFQ 25 quality of life questionnaire showed no statistically significant difference in responses between the sixth and eighteenth month. No adverse effects were noted on clinical examination or reported by patients.CONCLUSION: vitreolysis efficacy observed at 6 months of follow-up was maintained until the eighteenth month, with all patients reporting improvement from the pre-procedure state. No late adverse effects were noted. A larger randomized clinical trial is needed to confirm the safety of the procedure.

scholarly journals A206 EVOLUTION OF PEDIATRIC AUTOIMMUNE CHOLANGITIS AND PRIMARY SCLEROSING CHOLANGITIS INTO ADULTHOOD

2021 ◽  
Vol 4 (Supplement_1) ◽  
pp. 234-236
Author(s):  
P Willems ◽  
J Hercun ◽  
C Vincent ◽  
F Alvarez
Keyword(s):  
Primary Sclerosing Cholangitis ◽  
Sclerosing Cholangitis ◽  
Response To Treatment ◽  
Similar Proportion ◽  
Autoimmune Cholangitis ◽  
Significant Difference ◽  
One Year ◽  
Liver Tests

Abstract Background The natural history of primary sclerosing cholangitis (PSC) in children seems to differ from PSC in adults. However, studies on this matter have been limited by short follow-up periods and inconsistent classification of patients with autoimmune cholangitis (AIC) (or overlap syndrome). Consequently, it remains unclear if long-term outcomes are affected by the clinical phenotype. Aims The aims of this is study are to describe the long-term evolution of PSC and AIC in a pediatric cohort with extension of follow-up into adulthood and to evaluate the influence of phenotype on clinical outcomes. Methods This is a retrospective study of patients with AIC or PSC followed at CHU-Sainte-Justine, a pediatric referral center in Montreal. All charts between January 1998 and December 2019 were reviewed. Patients were classified as either AIC (duct disease on cholangiography with histological features of autoimmune hepatitis) or PSC (large or small duct disease on cholangiography and/or histology). Extension of follow-up after the age of 18 was done for patients followed at the Centre hospitalier de l’Université de Montréal. Clinical features at diagnosis, response to treatment at one year and liver-related outcomes were compared. Results 40 patients (27 PSC and 13 AIC) were followed for a median time of 71 months (range 2 to 347), with 52.5% followed into adulthood. 70% (28/40) had associated inflammatory bowel disease (IBD) (78% PSC vs 54% AIC; p=0.15). A similar proportion of patients had biopsy-proven significant fibrosis at diagnosis (45% PSC vs 67% AIC; p=0.23). Baseline liver tests were similar in both groups. At diagnosis, all patients were treated with ursodeoxycholic acid. Significantly more patients with AIC (77% AIC vs 30 % PSC; p=0.005) were initially treated with immunosuppressive drugs, without a significant difference in the use of Anti-TNF agents (0% AIC vs 15% PSC; p= 0.12). At one year, 55% (15/27) of patients in the PSC group had normal liver tests versus only 15% (2/13) in the AIC group (p=0.02). During follow-up, more liver-related events (cholangitis, liver transplant and cirrhosis) were reported in the AIC group (HR=3.7 (95% CI: 1.4–10), p=0.01). Abnormal liver tests at one year were a strong predictor of liver-related events during follow-up (HR=8.9(95% CI: 1.2–67.4), p=0.03), while having IBD was not (HR=0.48 (95% CI: 0.15–1.5), p=0.22). 5 patients required liver transplantation with no difference between both groups (8% CAI vs 15% CSP; p=0.53). Conclusions Pediatric patients with AIC and PSC show, at onset, similar stage of liver disease with comparable clinical and biochemical characteristics. However, patients with AIC receive more often immunosuppressive therapy and treatment response is less frequent. AIC is associated with more liver-related events and abnormal liver tests at one year are predictor of bad outcomes. Funding Agencies None

Clinical trial enrollment and follow-up visit rates among survivors of childhood cancer.

2017 ◽  
Vol 35 (5_suppl) ◽  
pp. 22-22
Author(s):  
Kelley Kennedy Hutchins ◽  
Sureyya Savasan ◽  
Ronald Thomas ◽  
Laura Strathdee ◽  
Jeffrey Warren Taub
Keyword(s):  
Clinical Trial ◽  
Cancer Treatment ◽  
Childhood Cancer ◽  
Survival Rates ◽  
Age At Diagnosis ◽  
Treatment Center ◽  
Increased Risk ◽  
Significant Difference

22 Background: Childhood cancer treatment outcomes have improved substantially with five-year overall survival rates reaching greater than 80%. However, survivors are at increased risk of long-term complications, and long-term follow-up (LTFU) is critical. Distance from a cancer treatment center and increased time from completion of therapy have been associated with decreased LTFU rates. We studied whether lack of enrollment in a therapeutic clinical trial may be an additional barrier to receiving LTFU care. Methods: We conducted a retrospective review of 353 patient records at the Children’s Hospital of Michigan enrolled in our Children’s Oncology Group (COG) registry between 1/1/05-12/31/10. All patients were ≤ 25 years of age at diagnosis.Sixty-seven patients were excluded (died prior to follow-up, n = 61; still on therapy, n = 5; insufficient information, n = 1). A total of 286 patient charts were available for analysis after exclusion. One hundred sixty-two (57%) patients were enrolled in a therapeutic clinical trial, and 124 (43%) were enrolled in a biology study alone due to lack of an open therapeutic clinical trial at the time of diagnosis. One hundred eighty-six (65%) patients were < 10 years of age at diagnosis. Results: Follow-up rates at one-, two- and five-years following completion of therapy for patients enrolled in a therapeutic clinical trial were 94.5%, 91.9% and 74%, respectively, compared to 82.9% (p = 0.002), 74% (p < 0.001) and 66% (p = 0.029) for patients not enrolled. The follow-up rate at five-years for patients who were < 10 years of age was 77.5% compared to 70.7% (p = 0.007) for patients > 10 years. There was no significant difference at one- or two-years based on age at diagnosis. Conclusions: Our findings demonstrate that patients enrolled in a therapeutic clinical trial have significantly superior LTFU rates compared to patients enrolled in biology studies alone. Younger age at diagnosis demonstrated a superior rate at five-years of follow-up. Our findings suggest that additional resources/strategies must be utilized to ensure better LTFU for patients not enrolled in therapeutic clinical trials.

scholarly journals The Kansas University DHA Outcomes Study (KUDOS) clinical trial: long-term behavioral follow-up of the effects of prenatal DHA supplementation

2019 ◽  
Vol 109 (5) ◽  
pp. 1380-1392 ◽  
Author(s):  
John Colombo ◽  
D Jill Shaddy ◽  
Kathleen Gustafson ◽  
Byron J Gajewski ◽  
Jocelynn M Thodosoff ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Preterm Birth ◽  
Visual Attention ◽  
Maternal Blood ◽  
Chain Polyunsaturated Fatty Acid ◽  
Long Term Effects ◽  
Double Blind ◽  
Early Preterm Birth

ABSTRACT Background Docosahexaenoic acid (DHA) is a long-chain polyunsaturated fatty acid that has been linked to improved vision and cognition in postnatal feeding studies and has been consistently associated with reduction of early preterm birth in prenatal supplementation trials. This is a report of the first long-term follow-up of infants from mothers receiving prenatal DHA supplementation in a US cohort. Objective Our objective was to evaluate the efficacy of the prenatal supplementation on both global and granular longitudinal assessments of cognitive and behavioral development. Methods In a randomized double-blind clinical trial, mothers received either 600 mg/d of DHA or a placebo beginning at 14.5 weeks of gestation and capsules were provided until delivery. Children from those pregnancies were followed by cognitive and behavioral assessments administered from 10 mo through 6 y of age. From 301 mothers in the initial study, ∼200 infants completed the longitudinal schedule. Results Although this intervention had been shown to reduce high-risk pregnancies and improve visual attention in infants during the first year, only a few positive long-term effects of prenatal DHA supplementation emerged from analyses of this follow-up. Increases in maternal blood DHA during pregnancy were related to verbal and full scale intelligence quotient (IQ) scores at 5 and 6 y, but these effects disappeared after controlling for SES. Maternal blood DHA concentrations at delivery were unrelated to outcomes, although maternal DHA at enrollment was related to productive vocabulary at 18 mo. Conclusions Although prenatal DHA supplementation substantially reduced early preterm birth and improved visual attention in infancy in this sample, no consistent long-term benefits were observed into childhood. Increases in maternal blood DHA concentration in pregnancy were related to higher IQs but this effect was confounded with SES and disappeared when SES was statistically controlled. This trial was registered at http://www.clinicaltrials.gov as NCT00266825 and NCT02487771.

scholarly journals The comparison of the effect of flaxseed oil and vitamin E on mastalgia and nodularity of breast fibrocystic: a randomized double-blind clinical trial

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Gholamali Godazandeh ◽  
Shahram Ala ◽  
Tahereh Madani Motlaq ◽  
Adeleh Sahebnasagh ◽  
Aliyeh Bazi
Keyword(s):  
Clinical Trial ◽  
Vitamin E ◽  
Luteal Phase ◽  
Flaxseed Oil ◽  
Breast Pain ◽  
Double Blind ◽  
Benign Condition ◽  
Double Blind Clinical Trial ◽  
Significant Difference

Abstract Background Fibrocystic changes are a common benign condition in women aged 20–50. The medical intervention aims to stop fibrocystic disease progress and relieve the breast’s pain and tenderness. In the long-term, reversing the fibrocystic changes is also desirable. Methods In this randomized double-blind clinical trial, the effect of flaxseed oil on the severity of pain and breast nodularity was investigated against vitamin E. This study was conducted on 100 women with mastalgia. The intervention group received Flaxseed oil pearls and the control group received vitamin E pearl 200 IU twice a day for 2 months. The duration and severity of breast pain were evaluated by Cardiff chart and VAS (Visual Analogue Scale). The nodularity was assessed by Lucknow-Cardiff scale at baseline, then the first and second months of intervention. Results At baseline, there was no statistically significant difference between the two groups in characteristics. The breast pain improved in both groups during the first and second months of intervention (P-value within group< 0.001). However, the mean breast pain was not significantly different between the two groups at the end of the first and second month (P1= 0.54, P2= 0.73). Furthermore, the breast pain during four phases of the menstrual cycle showed no difference between vitamin E and flaxseed oil groups (menstruation phase= 0.76, follicular phase= 0.48, the first week of luteal phase= 0.86, the second week of luteal phase=0.30). The breast nodularity also decreased during the first and second months of intervention, yet no significant difference between the two groups was found (p= 0.9). Conclusions This study showed that flaxseed oil and vitamin E both could be effective in breast pain-relieving and decreasing nodularity with minimal side effects in contrast with the baseline. But there are no significant differences between these two agents. Larger scale prospective studies are needed to evaluate these effects in the long-term. Trial registration IRCT201612243014N18, Registration date: 2017-10-15.

Continuation therapy with lithium and amitriptyline in unipolar depressive illness: a randomized, double-blind, controlled trial

1984 ◽  
Vol 14 (1) ◽  
pp. 37-50 ◽  
Author(s):  
A. I. M. Glen ◽  
A. L. Johnson ◽  
M. Shepherd
Keyword(s):  
Clinical Trial ◽  
Adverse Effects ◽  
Detailed Analysis ◽  
Controlled Trial ◽  
Depressive Illness ◽  
Double Blind ◽  
Prophylactic Efficacy ◽  
Continuation Therapy ◽  
Significant Difference ◽  
Clinically Significant

SynopsisA detailed analysis of the results of a multi-centre clinical trial shows that, while the relapse rate following recovery from an operationally defined depressive illness was smaller among patients subsequently treated with either amitryptiline or lithium than with a placebo, there was no clinically significant difference between the prophylactic efficacy of the 2 antidepressants. An account is given of the relative adverse effects of the treatments, and the implications of the findings are discussed.

A Prospective Randomised Clinical Trial of the Intra-Operative Use of 5-Fluorouracil on the Outcome of Dupuytren’s Disease

2004 ◽  
Vol 29 (1) ◽  
pp. 18-21 ◽  
Author(s):  
N. W. BULSTRODE ◽  
M. BISSON ◽  
B. JEMEC ◽  
A. L. PRATT ◽  
D. A. MCGROUTHER ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Joint Angle ◽  
Randomised Clinical Trial ◽  
Angle Measurement ◽  
Flexion Deformity ◽  
Double Blind ◽  
Significant Difference ◽  
Operative Complications

5-Fluorouracil reduces proliferation rates of fibroblasts, myofibroblast differentiation and contractility of ocular fibroblasts in vitro. This double-blind randomized clinical trial assesses whether intra-operative topical treatment with 5-fluorouracil reduces the recurrence rate after limited excision of Dupuytren’s tissue. Patients with two-digit disease were randomized to having 5-fluorouracil (25 mg/ml) treatment for 5 minutes on one digit and placebo on the other. Fifteen patients were enrolled with 18 months follow-up. There were no peri-operative complications. Wound healing was not delayed and there was no deterioration in the flexion deformity of the 5-fluorouracil treated digits. Patients were subsequently assessed by joint angle measurement at 3, 6, 12 and 18 months. There was no significant difference between control and 5-fluorouracil treated digits.

scholarly journals Evaluation and Comparison of Efficacy of Gluma® and D/Sense® Desensitizer in the Treatment of Root Sensitivity Induced by Non-Surgical Periodontal Therapy

2019 ◽  
Vol 7 (10) ◽  
pp. 1685-1690 ◽  
Author(s):  
Saad Mohammed Al-Qahtani
Keyword(s):  
Clinical Investigation ◽  
Periodontal Therapy ◽  
Double Blind ◽  
Prime Concern ◽  
Significant Difference ◽  
The Mean ◽  
Dentinal Hypersensitivity ◽  
Root Planning

BACKGROUND: Dentinal hypersensitivity is one of the most common sequels of non-surgical periodontal therapy. Resulted discomfort may restrain patients from oral hygiene maintenance, thus affects the long-term success of periodontal therapy. So, it becomes a prime concern of the clinician to manage the post-operative hypersensitivity. AIM: This clinical investigation aimed to evaluate and compare the efficacy of D/Sense® and Gluma® in preventing post-operative sensitivity after non-surgical periodontal therapy. MATERIAL AND METHODS: The present randomised, double-blind, split-mouth study was conducted on forty-five (22 male, 23 female) systemically healthy patients, with the mean age of 40 ± 17.5 years. Visual Analogue scale was used to evaluate root sensitivity after application of tactile and cold stimuli at baseline, 1, 2, 4 and 6 weeks after scaling and root planing. After scaling and root planning, the sites were randomly divided into different groups for the application of desensitising agents. Collected data were analysed by using, analysis of variance (ANOVA) for inter-group and paired t-test for intra-group comparisons. RESULTS: No adverse or side effects were reported by any of the patients throughout the study period. Gluma® showed a statistically significant reduction in the VAS score for root sensitivity as compared to D/Sense®, at 1, 2- and 4-weeks follow-up period (p < 0.05). Whereas, at 6th-week follow-up, both the solution showed almost similar score for root hypersensitivity. Intragroup comparison for D/Sense® revealed a significant difference in scores from baseline to all intervals (p < 0.05), except baseline to 6 weeks (p > 0.05). Whereas Gluma® showed a significant difference in scores from baseline to 2nd-week follow-up (p < 0.05). CONCLUSION: The result of the present investigation revealed that application of Gluma® resulted in better control on iatrogenic root hypersensitivity as compared to the D/Sense® during the initial follow-up period.

scholarly journals Lovastatin as an Adjuvant to Lithium for Treating Manic Phase of Bipolar Disorder: A 4-Week, Randomized, Double-Blind, Placebo-Controlled Clinical Trial

2014 ◽  
Vol 2014 ◽  
pp. 1-6 ◽  
Author(s):  
Ahmad Ghanizadeh ◽  
Motahhar OmraniSigaroodi ◽  
Ali Javadpour ◽  
Mohammad Hossein Dabbaghmanesh ◽  
Sara Shafiee
Keyword(s):  
Clinical Trial ◽  
Bipolar Disorder ◽  
Placebo Group ◽  
Adverse Effects ◽  
Rating Scale ◽  
Clinical Symptoms ◽  
Controlled Clinical Trial ◽  
Young Mania ◽  
Double Blind ◽  
Significant Difference

Objectives. Many patients with bipolar disorder suffer from metabolic disorder. Lovastatin is effective for treating major depression. This double-blind randomized placebo controlled clinical trial investigates whether lovastatin is a useful adjuvant to lithium for treating mania.Methods. Fifty-four patients with bipolar disorder-manic phase were randomly allocated into lovastatin or placebo group. The clinical symptoms were assessed at baseline, week 2, and week 4 using Young Mania Rating Scale. Adverse effects were checked.Results. Forty-six out of 54 patients completed this trial. The mania score in the lovastatin group decreased from 40.6 (11.1) at baseline to 12.9 (8.7) and 4.1 (5.4) at weeks 2 and 4, respectively. The score in the placebo group decreased from 41.0 (11.2) at baseline to 12.8 (8.07) and 5.8 (4.6) at weeks 2 and 4, respectively. However, there was no significant difference between groups at week 2 and week 4. The adverse effects rates were comparable between the two groups. No serious adverse effect was found. Tremor and nausea were the most common adverse effects.Conclusions. Lovastatin neither exacerbated nor decreased the symptoms of mania in patients with bipolar disorder. Current results support that the combination of lovastatin with lithium is tolerated well in bipolar disorder. The trial was registered with the Iranian Clinical Trials Registry (IRCT201302203930N18).

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