Agitation is a frequent complication following traumatic braing injury in patients admitted to the intensive care unit. This agitation frequently results in the liberal use of rescue drugs such as antipsychotics, sedatives and opiates, which in turn may delay rehabilitation, liberation from mechanical ventilation and emergence from posttraumatic amnesia. Dexmedetomidine may be a better agent given it's light sedative properties. The main objective is to assess the feasibility of conducting a multicenter randomized controlled trial of dexmedetomidine following TBI in the ICU.

开始日期2024-10-01

申办/合作机构

Centre integre universitaire de sante & de services sociaux

[+1]

ISRCTN93896690

/ CompletedN/AIIT

Efficacy of the Mirror Effect rehabilitation in acute Bell’s Palsy: a pilot study

开始日期2017-02-27

申办/合作机构

Centre integre universitaire de sante & de services sociaux

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2025-02-10·Journal of Clinical Oncology

Impact of testosterone recovery after androgen deprivation therapy on overall survival in patients with high-risk prostate cancer: Long-term data from a phase III trial.

作者: Vincent, Francois ; Bettahar, Redouane ; Souhami, Luis ; Bahoric, Boris ; Martin, Andre-Guy ; Vass, Sylvie ; Archambault, Robert ; Nabid, Abdenour ; Bahary, Jean-Paul ; Carrier, Nathalie ; Vavassis, Peter ; Duclos, Marie

310Background: To determine the potential impact of persistent hypogonadism on overall survival (OS) after prolonged androgen deprivation therapy (ADT) in patients (pts) with high-risk prostate cancer. Methods: From 10/2000 to 01/2008, 630 pts were randomised to pelvic radiotherapy (RT) plus 36 (310 pts) vs. 18 months (320 pts) of ADT. Serum testosterone (T) was prospectively collected at baseline, then regularly. We defined T recovery as a return of T to within the normal range value of each participating institution, regardless of whether it was initially normal or abnormal. Excluded from the analysis were pts not receiving exactly 18 or 36 months of ADT (48), or had no T measured at baseline or during follow-up (67). We compared OS between patients recovering or not T to a normal level using the log rank test. Multivariable analysis to predict OS included recovered T to a normal level, age, Zubrod, comorbidities, baseline PSA, Gleason score, stage and ADT duration. Results: 515/630 pts had proper T data available (baseline and follow-up) and were retained for the analysis. The results are reported with a median follow-up of 17.4 years. Over a period of 22 years, 6587 T measurements were available. A total of 270/515 pts (52.4%) recovered T to normal level, 188/330 (57%) in the 18-month and 82/185 (44.3%) in the 36-month cohort, p=0.006. Pts not recovering T to a normal level were older, had higher clinical stage and diabetes. Among pts regaining T to a normal level, the median time to T recovery was 3.6 (IQR 2.9-4.9) years.10- and 15-year OS rates were 76% (71-81) and 44% (38-51) for pts recovering T vs. 55% (49-62) and 30% (24-36) for those who did not, p<0.001. A significant lower risk of death favoured pts recovering T when considering the global hazard ratio (HR) [HR (95% CI) = 0.54 (0.44-0.67), p<0.001]. Significant differences in HR for death are maintained for both 18-month [HR = 0.51 (0.39-0.66), p<0.001] and 36-month cohort [HR = 0.58 (0.40-0.84), p=0.004]. In multivariable analyses, the impact of T recovery remains significant for the risk of death [(HR = 0.69 (0.55-0.86), p=0.001], and also for the 18-month [HR = 0.70 (0.53-0.93), p=0.013] and the 36-month cohort [(HR = 0.61 (0.40-0.93), p=0.021]. In a multivariable model, among pts regaining T to a normal level, the time to T recovery had no impact on OS [HR = 0.97 (0.90-1.04), p=0.41]. Of note, there was no significant difference in the rate of death from prostate cancer between pts recovering or not T (11.9% vs. 13.5%, p=0.58). Competing risk analysis confirms this finding [sHR = 0.83 (0.51-1.35), p=0.57]. Conclusions: In high-risk prostate cancer treated with RT and long-term ADT, T recovery to normal level is associated with a significant improvement in overall survival. The increased death rate in pts not recovering T is likely due to causes unrelated to prostate cancer. Clinical trial information: NCT00223171 .

2024-06-01·Journal of Clinical Oncology

Evaluation of recurrence rate in Canadian patients with stage II/III HR+/HER2- early breast cancer in the real-world setting.

作者: Mackay, Helen ; Gambaro, Karen ; Abdelsalam, Mahmoud ; Boudreau, Dominique ; Basik, Mark ; Patel, Chandni ; St-Hilaire, Eve ; Guillemette, Stephanie ; Hassan, Saima Noor ; Saad, Fred ; Caron, Marc-Andre ; Leite, Ricardo ; Vincent, Francois ; Batist, Gerald ; Marques, Maud

e23303 Background: Breast cancer is the most prevalent cancer and second leading cause of cancer-related mortality among Canadian women. Most of cases belong to the HR+/HER2- subtype, representing approximately two-thirds of all instances. Treatment for this subtype encompasses a multifaceted approach with a curative intent. This real-world evidence study aims to comprehensively analyze the clinical outcomes of Canadian patients diagnosed with early-stage HR+/HER2- breast cancer, focusing on recurrence rates after initiation of adjuvant endocrine therapy to identify opportunities for enhancing patient care. Methods: This is a retrospective, longitudinal cohort study involving 541 patients enrolled in the pan-Canadian cancer patient registry PMT (Personalize My Treatment), with newly diagnosed or recurrent stage II or III HR+/HER2- breast cancer between January 1st, 1996, and May 31st, 2022. We evaluated disease recurrence rates, time to recurrence, and overall survival (OS). Furthermore, the study explored duration of endocrine therapy (ET) in the adjuvant setting. Results: 409 patients received adjuvant ET representing 75.6% of the total cohort, emphasizing the role of ET as standard of care for adjuvant treatment in this patient population. The median duration of adjuvant ET was 4.5 years. In the overall adjuvant patient population, recurrence rates progressively increased over time from 13.2% after 2 years, 21.4% after 3 years, 30.3% after 5 years, and peaking at 58.4% after 10 years. Median time to recurrence for the overall patient population on ET was 7.76 years. OS rate for patients on ET was 94.6% at 5 years and 78.3% at 10 years. Conclusions: This study marks a pioneering real-world analysis utilizing pan-Canadian EHR data, demonstrating increasing recurrence rates over time in HR+/HER2- early breast cancer. It highlights the high unmet need in stage II and stage III breast cancer, with 1 patient out of 3 recurring after 5 years, and more than half recurring after 10 years despites adjuvant treatment with ET alone. This indicates the need for more efficacious and tolerable treatment options to reduce short- and long-term recurrence and to prolong survival, not only in the higher risk patient population, but in the overall HR+/HER2- breast cancer patients at increased risk of recurrence.

2024-06-01·Journal of Clinical Oncology

Quality of life and testosterone recovery after androgen deprivation therapy in patients with high-risk prostate cancer: Long-term data from a phase III trial.

作者: Vincent, Francois ; Bettahar, Redouane ; Bahoric, Boris ; Vass, Sylvie ; Archambault, Robert ; Martin, André-Guy ; Nabid, Abdenour ; Souhami, Luis ; Carrier, Nathalie ; Vavassis, Peter ; Bahary, Jean-Paul

11098 Background: No prospectively collected data exist assessing the impact a hypogonadal status has on quality of life (QoL). Using data from a randomized Phase III trial in high-risk prostate cancer (HRPC) and based on Patient Reported Outcomes (PRO), we compared QoL between patients (pts) with or without testosterone (T) recovery after ADT. Methods: From 10/2000 to 01/2008, 630 pts with HRPC were randomised to 36 (310 pts) vs. 18 months (320 pts) of ADT. We assessed QoL by the validated EORTC 30 items regrouped into 9 scales and the PR 25 items into 5 scales. All items and scales scores were linearly transformed to a 0 to100 points scale. T measured at baseline and during follow-ups. T recovery was defined as a return to normal level. PRO measured up to 5 years. We estimated means and standard deviation of items and scales for each group at each time point. We analyzed all items and scales scores with general linear model with repeated measures to evaluate changes between patients who did versus those who did not recover T to a normal level, over time, in both ADT groups. P-value <0.01 was considered statistically significant to account for multiple comparisons and a difference in mean scores of ≥10 points was considered clinically relevant. Results: 494/630 patients were retained for the analysis. 515 had proper T data available (baseline and follow-up) from whom 21 were excluded (no QoL data). With a median follow-up of 13.1 years, the two groups were well-balanced. Over a period of 21 years, 5 982 T measurements were available: 3590 in 314 pts in the and 2392 in the 18- and 36-month cohort, respectively. A total of 256 (51.8%) recovered T to, at least, a pre-castrate level. A significantly higher percentage of pts recovered a normal T level in the 18-month cohort as compared to the 36-month (56.4% vs. 43.9%, p=0.008). Among pts regaining T to a normal level, the median time to recovery was significantly faster for the 18 compared to the 36-month cohort, 3.0 (95% CI: 2.55 to 3.65) vs. 5.00 (4.50 to 5.96) years, p<0.001. Considering the unified 55 items, overall adherence to QoL questionnaires (QoLQ) was 83.1% (4554/5480), 88.2% vs. 93.3% at baseline and 61.5% vs 58.3% at 5 years, for 18 vs. 36-month, respectively. Patients recovering T had a significantly better QoL. In 32 out of 55 items and in 10 out of 21 scales (p<0.01) in the 18-month and 30 out of 55 items and 10 out of 21 scales the 36-month cohort. Also 9 items and one scale reached clinical relevance in the 18-month cohort and 10 items and one scale in the 36-month cohort. Conclusions: In HRPC treated with RT and long-term ADT, T recovery to normal level is associated with major improvements in QoL in several domains. Since a higher proportion of pts recover a normal T level in a much shorter time without apparent detriment in long term outcomes, our results suggest that 18-month may be the most appropriate ADT duration for these pts.

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