NONPARAMETRIC ANALYSIS OF COVARIANCE FOR HYPOTHESIS TESTING WITH LOGRANK AND WILCOXON SCORES AND SURVIVAL-RATE ESTIMATION IN A RANDOMIZED CLINICAL TRIAL

1999 ◽  
Vol 9 (2) ◽  
pp. 307-338 ◽  
Author(s):  
Catherine M. Tangen ◽  
Gary G. Koch
2005 ◽  
Vol 17 (3) ◽  
pp. 487-498 ◽  
Author(s):  
F. E. Taragano ◽  
P. Bagnatti ◽  
R. F. Allegri

Background: Cerebrovascular disease may cause “vascular depression” (VaD). Calcium-channel blockers are presumed treatments for cerebrovascular disease and might be expected to improve depression and prevent recurrence.Objective: To examine the efficacy and tolerability of the use of nimodipine as an augmentation of fluoxetine in the treatment of VaD.Design: A double-blind, randomized clinical trial in which 101 patients with VaD (Alexopoulos criteria) were treated with fluoxetine at standard doses. Patients were randomized to placebo (n=51) or nimodipine (n=50). Treatment outcomes were assessed using the Hamilton Depression Rating Scale (HDRS) regularly up to 8 months after treatment initiation.Results: Depression was reduced in 63% of patients, but those whose treatment was enhanced with nimodipine had greater improvements overall by repeated measures analysis of covariance (ANCOVA) (F(1.80)=9.76, p=0.001). In addition, a greater proportion of patients treated with fluoxetine–nimodipine (54% vs. 27%) exhibited full remission (χ2(d.f. 1)=7.3, p=0.006), with the number needed to treat (NNT) equal to 4 (95% CI 2–12). Of those experiencing full remission in the first 61 days, fewer patients on fluoxetine–nimodipine (3.7%) developed recurrence of major depression as compared to those on fluoxetine alone (35.7%) (χ2(d.f. 1)=7.56, p=0.006), NNT 3 (95% CI 2–9). Side-effects were noted in 33.3% of patients in the control group and 48% of the experimental group (χ2(d.f. 1)=2.25, p=0.133).Conclusions: In treating VaD, augmentation of fluoxetine with nimodipine led to better treatment results and lower rates of recurrence. These findings support the argument that augmentation of antidepressant therapy might be helpful in the treatment of cerebrovascular disease, which is involved in the pathogenesis of this type of depression.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Rodolfo de Carvalho Oliveira ◽  
Lucila Basto Camargo ◽  
Tatiane Fernandes Novaes ◽  
Laura Regina Antunes Pontes ◽  
Isabel Cristina Olegário ◽  
...  

Abstract Background Glass ionomer cements (GIC) have been considered the top option to restore primary teeth by dentists. The most common supply forms are hand mixed and encapsulated GIC. There is a lack of information about the impact of different GIC supply forms on restoration survival. Methods This randomized clinical trial compared the survival rate of occlusal and occlusoproximal restorations in primary molars using two glass ionomer cements versions: hand-mixed (H/M) and encapsulated (ENC) after 24 months. Children aged 3–10 years who presented dentin caries lesions in primary molars were selected at School of Dentistry, University of São Paulo, Brazil. They were randomly assigned to groups: H /M (Fuji IX®, GC Europe) or ENC (Equia Fill®, GC Europe). The occurrence of restoration failure was evaluated by two blinded and calibrated examiners. The analyses were performed in Stata 13 (StataCorp, USA). To evaluate the primary outcome (restoration survival), we  performed a survival analysis. Additionally an intention to treat (ITT) analysis were done at 24 months of follow-up. Cox Regression with shared frailty was performed to assess association between restoration failure and independent variables (α = 5%). Results A total of 324 restorations were performed in 145 children. The survival for H/M group was 58.2% and 60.1% for ENC, with no difference (p = 0.738). Occlusoproximal restorations had lower survival rate when compared to occlusal ones (HR = 3.83; p < 0.001). Conclusions The survival rate in primary molars is not influenced by the different supply forms of GIC. Also, occlusoproximal restorations present reduced performances when compared to occlusal cavities. Trial Registration This randomized clinical trial was registered on ClinicalTrials.Gov on 10/15/2014 under protocol (NCT 02274142).


2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Saeid Doaei ◽  
Somayeh Gholami ◽  
Samira Rastgoo ◽  
Maryam Gholamalizadeh ◽  
Fatemeh Bourbour ◽  
...  

Abstract Background Omega-3 polyunsaturated fatty acids (n3-PUFAs) may exert beneficial effects on the immune system of patients with viral infections. This paper aimed to examine the effect of n3-PUFA supplementation on inflammatory and biochemical markers in critically ill patients with COVID-19. Methods A double-blind, randomized clinical trial study was conducted on 128 critically ill patients infected with COVID-19 who were randomly assigned to the intervention (fortified formula with n3-PUFA) (n = 42) and control (n = 86) groups. Data on 1 month survival rate, blood glucose, sodium (Na), potassium (K), blood urea nitrogen (BUN), creatinine (Cr), albumin, hematocrit (HCT), calcium (Ca), phosphorus (P), mean arterial pressure (MAP), O2 saturation (O2sat), arterial pH, partial pressure of oxygen (PO2), partial pressure of carbon dioxide (PCO2), bicarbonate (HCO3), base excess (Be), white blood cells (WBCs), Glasgow Coma Scale (GCS), hemoglobin (Hb), platelet (Plt), and the partial thromboplastin time (PTT) were collected at baseline and after 14 days of the intervention. Results The intervention group had significantly higher 1-month survival rate and higher levels of arterial pH, HCO3, and Be and lower levels of BUN, Cr, and K compared with the control group after intervention (all P < 0.05). There were no significant differences between blood glucose, Na, HCT, Ca, P, MAP, O2sat, PO2, PCO2, WBCs, GCS, Hb, Plt, PTT, and albumin between two groups. Conclusion Omega-3 supplementation improved the levels of several parameters of respiratory and renal function in critically ill patients with COVID-19. Further clinical studies are warranted. Trial registry Name of the registry: This study was registered in the Iranian Registry of Clinical Trials (IRCT); Trial registration number: IRCT20151226025699N3; Date of registration: 2020.5.20; URL of trial registry record: https://en.irct.ir/trial/48213


2021 ◽  
Author(s):  
Rodolfo de Carvalho Oliveira ◽  
Lucila Basto Camargo ◽  
Tatiane Fernandes Novaes ◽  
Laura Regina Antunes Pontes ◽  
Isabel Cristina Olegário ◽  
...  

Abstract Background: Glass ionomer cements (GIC) have been considered the top option to restore primary teeth by dentists. The most common supply forms are hand-mixed and encapsulated GIC. There is a lack of information about the impact of different GIC supply forms on restoration survival. This randomized clinical trial compared the survival rate of occlusal and occlusoproximal restorations in primary molars using two of glass ionomer cements versions: hand-mixed (H/M) and encapsulated (ENC) after 24 months. Children aged 3-10 years who presented dentin caries lesions in primary molars were selected at School of Dentistry, University of São Paulo, Brazil. They were randomly assigned to groups: H /M (Fuji IX®, GC Europe) or ENC (Equia Fill®, GC Europe). The occurrence of restoration failure was evaluated by two blinded and calibrated examiners. The analyses were performed in Stata 13 (StataCorp, USA). To evaluate the primary outcome (restoration survival), we performed an intention to treat (ITT) analysis at 24 months of follow-up. Kaplan-Meier survival analysis was used to verify the survival of the restorations while Cox Regression with shared frailty was performed to assess association between restoration failure and independent variables (α=5%). Results: A total of 324 restorations were performed in 145 children. The survival for H/M group was 58.2% and 60.1% for ENC, with no difference (p=0.738). Occlusoproximal restorations had lower survival rate when compared to occlusal ones (HR=3.83; p<0.001). Conclusions: The survival rate in primary molar is not influenced by the different supply forms of GIC This randomized clinical trial was registered on ClinicalTrials.Gov on 10/15/2014 under protocol (NCT 02274142).


2020 ◽  
Vol 27 (12) ◽  
pp. 2586-2590
Author(s):  
Rashad Qamar Rao ◽  
Wamiq Mehmood ◽  
Raza Ali ◽  
Akifa Abbas ◽  
Waseem Sajjad ◽  
...  

Objectives: Glaucoma is the most common blinding condition in South Punjab of Pakistan and its management is a challenge due to illiteracy and lack of financial resources. Study Design: Randomized Clinical Trial. Setting: Department of Ophthalmology Nishtar Hospital Multan. Period: June 2016 - June 2018. Material & Methods: We have randomly selected patients on the basis of Cup to Disc ratio and applied randomized clinical trial of both medical and surgical modalities of glaucoma management to observe the visual outcomes in terms of Intraocular pressure and Cup to disc ratio. We have also linked the effects of our management with lenticular status of the patients which has shown significant results. Results: The vision survival of trabeculectomy in pseudophakics was 88.77% while only 9.8% was the survival rate of trabeculectomy in phakics. 90% of 31 phakic patients who underwent trabeculectomy failed. Similarly patients on 3 IOP lowering drugs had 70% vision survival rate out of 260 patients treated. Patients with C-D ratio 0.8 had maximum failure rate of 69% out of 78 patients in which medical treatment failed. Conclusion: Trabeculectomy significantly reduced the intraocular pressure in patients in which pharmacological treatment failed.The success rate of trabeculectomy among pseudophakics is high. In Phakics, when only Trabeculectomy is done, success rate is low. When trabeculectomy and clear lens extraction is done simultaneously, the success rate is slightly higher. When trabeculectomy is done after clear lens extraction, the success rate is highest. In case of Cataract, cataract extraction and trabeculectomy when done simultaneously, show low success rate. When trabeculectomy was done after cataract extraction, shows highest success rate.


2002 ◽  
Vol 89 (2) ◽  
pp. 154-157 ◽  
Author(s):  
F. F Palazzo ◽  
D. L Francis ◽  
M. A Clifton

2001 ◽  
Vol 120 (5) ◽  
pp. A453-A453 ◽  
Author(s):  
B SHEN ◽  
J ACHKAR ◽  
B LASHNER ◽  
A ORMSBY ◽  
F REMZI ◽  
...  

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