A multicentred phase III comparative study of two hormonal contraceptive preparations given once-a-month by intramuscular injection: I. Contraceptive efficacy and side effects

Contraception ◽  
1988 ◽  
Vol 37 (1) ◽  
pp. 1-20 ◽  
Author(s):  
S. Said ◽  
W. Sadek ◽  
A. Knoieif ◽  
Suporn Koetsawang ◽  
Orawan Kiriwat ◽  
...  
Keyword(s):  
Side Effects ◽  
Comparative Study ◽  
Intramuscular Injection ◽  
Hormonal Contraceptive ◽  
Phase Iii ◽  
Contraceptive Efficacy

scholarly journals A Dutch phase III randomized multicenter trial: whole brain radiotherapy vs. stereotactic radiotherapy for 4-10 brain metastases

2021 ◽  
Author(s):  
Dianne Hartgerink ◽  
Anna Bruynzeel ◽  
Danielle Eekers ◽  
Ans Swinnen ◽  
Coen Hurkmans ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Side Effects ◽  
Brain Metastases ◽  
Survival Rates ◽  
Whole Brain Radiotherapy ◽  
Phase Iii ◽  
Whole Brain ◽  
Brain Radiotherapy ◽  
One Year

Abstract Background The clinical value of whole brain radiotherapy (WBRT) for brain metastases (BM) is a matter of debate due to the significant side effects involved. Stereotactic radiosurgery (SRS) is an attractive alternative treatment option that may avoid these side effects and improve local tumor control. We initiated a randomized trial (NCT02353000) to investigate whether quality of life is better preserved after SRS compared with WBRT in patients with multiple brain metastases. Methods Patients with 4 to 10 BM were randomized between the standard arm WBRT (total dose 20 Gy in 5 fractions) or SRS (single fraction or 3 fractions). The primary endpoint was the difference in quality of life (QOL) at three months post-treatment. Results The study was prematurely closed due to poor accrual. A total of 29 patients (13%) were randomized, of which 15 patients have been treated with SRS and 14 patients with WBRT. The median number of lesions were 6 (range, 4-9) and the median total treatment volume was 13.0 cc 3 (range, 1.8-25.9 cc 3). QOL at three months decreased in the SRS group by 0.1 (SD=0.2), compared to 0.2 (SD=0.2) in the WBRT group (p=0.23). The actuarial one-year survival rates were 57% (SRS) and 31% (WBRT) (p=0.52). The actuarial one-year brain salvage-free survival rates were 50% (SRS) and 78% (WBRT) (p=0.22). Conclusion In patients with 4 to 10 BM, SRS alone resulted in one-year survival for 57% of patients while maintaining quality of life. Due to the premature closure of the trial, no statistically significant differences could be determined.

Time to Progression in Metastatic Breast Cancer Patients Treated With Epirubicin Is Not Improved by the Addition of Either Cisplatin or Lonidamine: Final Results of a Phase III Study With a Factorial Design

2002 ◽  
Vol 20 (20) ◽  
pp. 4150-4159 ◽  
Author(s):  
Alfredo Berruti ◽  
Raffaella Bitossi ◽  
Gabriella Gorzegno ◽  
Alberto Bottini ◽  
Palmiro Alquati ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Side Effects ◽  
Factorial Design ◽  
Cancer Patients ◽  
Metastatic Breast ◽  
Phase Iii ◽  
Breast Cancer Patients ◽  
Time To Progression ◽  
Phase Iii Study

PURPOSE: To investigate the value of the addition of either cisplatin (CDDP) or lonidamine (LND) to epirubicin (EPI) in the first-line treatment of advanced breast cancer. PATIENTS AND METHODS: Three hundred seventy-one metastatic breast cancer patients with no prior systemic chemotherapy for advanced disease were randomized to receive either EPI alone (60 mg/m2 on days 1 and 2 every 21 days), EPI and CDDP (30 mg/m2 on days 1 and 2 every 21 days), EPI and LND (450 mg orally daily, given continuously), or EPI, CDDP, and LND. Time to progression, response rates, side effects, and survival were compared according to the 2 × 2 factorial design of this study. RESULTS: The groups were well balanced with respect to prognostic factors. Time to progression did not differ in the comparison between CDDP arms and non-CDDP arms (median, 10.9 months v 9.4 months, respectively; P = .10) or between that of LND arms and non-LND arms (median, 10.8 months v 9.9 months, respectively; P = .47), nor did overall survival. The response rate did not significantly differ in the comparison between LND arms and non-LND arms (62.9% v 54.0%, P = .08). No difference in treatment activity was observed between CDDP arms and non-CDDP arms. Toxicity was significantly higher in the CDDP arms, leading to CDDP dose adjustment in 40% of cases. The most frequent side effects were of a hematologic and gastrointestinal nature. The addition of LND produced more myalgias and fatigue. CONCLUSION: Neither CDDP nor LND was able to significantly improve the time to progression obtained by EPI. CDDP, however, significantly worsened the drug’s tolerability.

scholarly journals A comparative study to ascertain the efficacy of intravenous dexmedetomidine versus intravenous tramadol to prevent post-operative shivering after laparoscopic surgery

2019 ◽  
Vol 6 (3) ◽  
pp. 713
Author(s):  
Kishore K. ◽  
Syed Ali Aasim ◽  
Manish Kumar J.
Keyword(s):  
Laparoscopic Surgery ◽  
Side Effects ◽  
Comparative Study ◽  
General Anaesthesia ◽  
Power Number ◽  
Group Iii ◽  
Group I ◽  
Number Of Patients ◽  
Envelope Method ◽  
Level Of Significance

Background: Shivering is commonly encountered both after regional and general anaesthesia (GA) with a little higher incidence in patients receiving GA. The aim of study was to compare the effectiveness of dexmedetomidine and tramadol in decreasing postoperative shivering in patients undergoing laparoscopic surgery.Methods: Total 120 patients were included in this study. In order to get a 5% level of significance and 80% power number of patients required in each group was 40, with a total of 120 patients. Randomization of groups was done based on closed envelope method. Patients were allocated into three groups group I, II and III of 40 patients each. Patients in group I and group II were administered 0.75 μg/kg of dexmedetomidine and 1.5 mg /kg of tramadol in 100 ml NS respectively half a before extubation, while patients in group III did not receive any pharmacological intervention.Results: All three groups were comparable regarding distribution of age, gender, ASA grade and temperature at beginning and end of surgery and were non-significant.Conclusions: Dexmedetomidine seems to possess anti-shivering properties and was found to reduce the occurrence of shivering in patients undergoing general anaesthesia with minimal side effects although its anti-shivering effect was not superior to tramadol.

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