scholarly journals A NEW METHOD OF EPISTAXIS MANAGEMENT USING NASAL GEL: A SINGLE CENTER, RANDOMIZED CLINICAL TRIAL

2018 ◽  
Vol 11 (3) ◽  
pp. 104 ◽  
Author(s):  
Mehdi Torabi ◽  
Ava Roughani Esfahani ◽  
Shiva Moeinaddini ◽  
Mohammad Reza Baneshi
Keyword(s):  
Clinical Trial ◽  
Side Effects ◽  
Randomized Clinical Trial ◽  
Patients Satisfaction ◽  
Stop Time ◽  
Common Causes ◽  
Procedural Time ◽  
Nasal Bleeding ◽  
The Common ◽  
Discharge Length

 Objective: Epistaxis is one of the common causes of patients’ referral to the emergency departments. In the majority of cases, epistaxis is managed by traditional methods. We investigated the efficacy of nasal gel (NG) in comparison to anterior nasal packing (ANP) to stop mild-to-moderate anterior nasal bleeding.Methods: In this prospective, randomized clinical trial, patients were divided into two groups of ANP (n=60) and NG (n=40). We determined and compared the efficacy of treatment (bleeding stop time and recurrence), patients’ satisfaction at discharge (length of stay in the hospital, pain during the procedure, and procedural time), and safety (less side effects) in both groups.Results: The procedural time ≤2 min was observed in 90% and 58.33 % of NG group and ANP group, respectively (p<0.001). Pain score during procedure ≤4 and patients’ satisfaction ≥7 were, respectively, seen in 87.5% and 65% of NG group, but it was 43.33% and 41.7% in ANP group, respectively (p<0.001, p=0.02). The side effects in ANP group were 35%; however, no side effects were observed in NG group.Conclusion: In the management of mild-to-moderate anterior nasal bleeding although NG efficacy is equivalent to ANP, using NG may be more convenient and satisfactory for patients. In addition, the use of this gel may result in more safety and fewer side effects.

scholarly journals Comparing the efficacy and side-effects of PDLASTA® (Pegfilgrastim) with PDGRASTIM® (Filgrastim) in breast cancer patients: a non-inferiority randomized clinical trial

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Safa Najafi ◽  
Maryam Ansari ◽  
Vahid Kaveh ◽  
Shahpar Haghighat
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Single Dose ◽  
Side Effects ◽  
Randomized Clinical Trial ◽  
Cancer Patients ◽  
Injection Site Reaction ◽  
Study Groups ◽  
Breast Cancer Patients ◽  
Significant Difference

Abstract Background The objective of this study was to compare the efficacy and side effects of a single dose (Pegfilgrastim or PDL) or repeated six daily injections (Filgrastim or PDG) during chemotherapy courses in breast cancer patients in a non-inferiority clinical trial. Methods In this randomized clinical trial, 80 patients were recruited and allocated randomly to two equal arms. In one group, a single subcutaneous dose of PDL was injected the day after receiving the chemotherapy regimen in each cycle. The second arm received a subcutaneous injection of PDG for six consecutive days in each cycle of treatment. The side effects of GCF treatment and its effect on blood parameters were compared in each cycle and during eight cycles of chemotherapy. Results Hematologic parameters showed no significant differences in any of the treatment courses between the two study groups. The comparison of WBC (p = 0.527), Hgb (p = 0.075), Platelet (p = 0.819), Neutrophil (p = 0.575), Lymphocyte (p = 705) and ANC (p = 0.675) changes during the eight courses of treatment also revealed no statistically significant difference between the two study groups. Side effects including headache, injection site reaction and muscle pain had a lower frequency in patients receiving PDL drugs. Conclusion It seems that PDL is non-inferior in efficacy and also less toxic than PDG. Since PDL can be administered in a single dose and is also less costly, it can be regarded as a cost-effective drug for the treatment of chemotherapy-induced neutropenia. Trial registration IRCT20190504043465N1, May 2019.

Insights from the axillary vein puncture guided by ultrasound versus cephalic vein dissection trial

2021 ◽  
Author(s):  
Ana Paula Tagliari ◽  
Adriano Nunes Kochi ◽  
Rodrigo Petersen Saadi ◽  
Bernardo Mastella ◽  
Eduardo Keller Saadi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Success Rate ◽  
Randomized Clinical Trial ◽  
Cephalic Vein ◽  
Axillary Vein ◽  
Ultrasound Guided ◽  
Procedural Time

Axillary vein puncture guided by ultrasound (US-Ax) versus cephalic vein dissection in pacemaker and defibrillator implant: a multicenter randomized clinical trial is a recently published study in which 88 patients were randomized in a 1:1 fashion to one of the two methods. Even being performed by operators with not previous ultrasound-guided axillary vein puncture experience, this group presented a higher success rate, lower procedural time and comparable complication incidence.

Randomized clinical trial of tamoxifen alone or combined with fluoxymesterone in postmenopausal women with metastatic breast cancer.

1988 ◽  
Vol 6 (5) ◽  
pp. 825-831 ◽  
Author(s):  
J N Ingle ◽  
D I Twito ◽  
D J Schaid ◽  
S A Cullinan ◽  
J E Krook ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Metastatic Breast Cancer ◽  
Side Effects ◽  
Postmenopausal Women ◽  
Randomized Clinical Trial ◽  
Statistical Significance ◽  
Metastatic Breast ◽  
Rank Test ◽  
Breast Cancer Patients

A randomized clinical trial was performed to determine if combination hormonal therapy with tamoxifen (TAM) and fluoxymesterone (FLU) was more efficacious than TAM alone for the treatment of postmenopausal women with metastatic breast cancer. Patients failing TAM could subsequently receive FLU. The dose of both drugs was 10 mg orally twice daily. Objective responses were seen in 50 of 119 TAM patients (42%) and 63 of 119 TAM plus FLU patients (53%) (one-sided P = .05). Time to disease progression distributions were better for TAM plus FLU (median, 350 days v 199 days), but the log rank test only approached statistical significance (one-sided P = .07). Duration of response and survival distributions were similar between the two treatment arms. Toxicities, in terms of androgenic side effects, were greater on the TAM plus FLU regimen. Fifty-two patients are evaluable for response with FLU following TAM and 21 (40%) have achieved a response. We conclude that the advantages in terms of response rate and time to progression observed with TAM plus FLU probably represent a biological effect, but are not of sufficient magnitude to justify the routine clinical use of this combination given the lack of survival advantage and side effects encountered.

scholarly journals Oxytocin 10 IU as Prophylactic for Uterine Atony : a Randomized Clinical Trial

2019 ◽  
pp. 170-178
Author(s):  
Ridwan A Putra ◽  
Iskandar Zulqarnain ◽  
Zaimursyaf Azis ◽  
Jusuf S Effendi ◽  
Wiryawan Permadi ◽  
...  
Keyword(s):  
Risk Factors ◽  
Clinical Trial ◽  
Risk Factor ◽  
Side Effects ◽  
Cesarean Section ◽  
Randomized Clinical Trial ◽  
Uterine Atony ◽  
Transverse Incision ◽  
Double Blind ◽  
Emergency Cesarean

Abstract Objective : To compare the effectiveness of oxytocin dose of 10 IU and 20 IU for preventing uterine atony in women undergoing cesarean section. Methods : This was a double-blind, randomized clinical trial with good matching selection with randomization block of patients who had risk factors for the occurrence of uterine atony such as preeclampsia, patients were receiving MgSO4, oxytocin intrapartum and chorioamnionitis who performed stratified randomization prospectively with two kinds of oxytocin doses which are 10 IU and 20 IU as a prophylaxis for uterine atony in women who performed emergency cesarean section with transverse incision and were using a general anesthesia. Results : This study found no any significant differences between the use of 10 IU and 20 IU as prophylaxis for uterine atony during cesarean section either in its action at the time or while in recovery room, especially on the cases without chorioamnionitis thus using oxytocin 10 IU regimen can be considered, besides the effectiveness did no differ, it will cost cheaper than oxytocin 20 IU regimen which frequently used. Conclusions : There were no significant differences in the incidence of blood loss during the cesarean section between the treatment of oxytocin 10 IU group and oxytocin 20 IU group. The additional uterotonic was using during the action of the cesarean section between the treatment of oxytocin 10 IU group, and oxytocin 20 IU group gave no significant differences. The side effects in this study at least form of chills and vomiting found no significant differences between both of groups despite the side effects that arise in oxytocin 20 IU group was higher at 23.08% than oxytocin 10 IU group at 15.19%. Chorioamnionitis would be a risk factor for the occurrence of uterine atony during the action of the cesarean section if it associated with the use of additional uterotonic in oxytocin 10 IU group if compared with oxytocin 20 IU group. Keywords : cesarean section, oxytocin, uterine atony.   Abstrak Tujuan : Untuk membandingkan efektifitas penggunaan dosis 10 IU dan 20 IU sebagai profilaksis atonia uteri pada saat seksio sesarea. Metode : Penelitian ini menggunakan uji klinis acak ganda dengan seleksi yang sesuai dengan blok acak pada pasien-pasien yang memiliki faktor risiko terjadinya atonia uteri seperti preeklamsia, pasien yang diberikana MgSO4 dan oxytocin intrapartum sebelumnya serta chorioamnionitis yang dilakukan pengacakan secara prosfektif bertingkat yang diberikan dua jenis dosis oksitosin yaitu 10 IU dan 20 IU sebagai profilaksis atonia uteri pada perempuan yang dilakukan seksio sesarea darurat dengan insisi transversal dan menggunakan anestesi umum. Hasil : Penelitian ini menemukan tidak adanya perbedaan yang bermakna antara penggunaan dosis oksitosin 10 IU dan 20 IU sebagai profilaksis atonia uteri pada seksio sesarea baik saat tindakan operasi maupun saat berada di ruang pemulihan, terutama pada kasus-kasus tanpa khorioamnionitis dimana memerlukan oksitosin tambahan pada kelompok 10 IU, selain efektifitasnya tidak berbeda, akan lebih murah dari pada rejimen oksitosin 20 IU yang sering digunakan saat ini. Kesimpulan : Berdasarkan hasil penelitian ini, tidak ada perbedaan yang bermakna dalam kejadian kehilangan darah selama operasi seksio sesarea antara perlakuan kelompok oksitosin 10 IU dan kelompok oksitosin 20 IU. Penggunaan uterotonik tambahan selama tindakan seksio sesarea antara perlakuan kelompok oksitosin 10 IU dan kelompok oksitosin 20 IU tidak memberikan perbedaan yang signifikan. Efek samping dalam penelitian ini yakni menggigil dan muntah, tidak ditemukan perbedaan yang bermakna antara kedua kelompok meskipun efek samping yang muncul pada kelompok oksitosin 20 IU lebih tinggi 23,08% dibandingkan kelompok oksitosin 10 IU pada 15,19%. Khorioamnionitis merupakan faktor risiko terjadinya atonia uteri selama tindakan seksio sesarea jika dikaitkan dengan penggunaan uterotonika tambahan pada kelompok oksitosin 10 IU jika dibandingkan dengan kelompok oksitosin 20 IU. Kata kunci : atonia uteri, oksitosin, seksio sesarea.

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