W1178 Clinical Efficacy and Safety of Mesalamine Suppositories in the Treatment of Pediatric Patients with Ulcerative Proctitis: A Multicenter, Open-Label Study

2009 ◽  
Vol 136 (5) ◽  
pp. A-671
Author(s):  
Melvin B. Heyman ◽  
Jaroslaw Kierkus ◽  
Jean Spénard ◽  
Monique Giguere
Keyword(s):  
Clinical Efficacy ◽  
Pediatric Patients ◽  
Efficacy And Safety ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Ulcerative Proctitis

Clinical Efficacy and Safety of Brahma Rasayana in Apparently Healthy Elderly Persons: A Prospective Multicenter Open-label Study

2018 ◽  
Vol 2 (4) ◽  
pp. 217-224
Author(s):  
Pradeep Dua ◽  
Rakesh Rana ◽  
Richa Singhal ◽  
Bhagwan Sahai Sharma ◽  
G Venkateswarlu ◽  
...  
Keyword(s):  
Clinical Efficacy ◽  
Elderly Persons ◽  
Efficacy And Safety ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Healthy Elderly ◽  
Apparently Healthy

Open-label study to evaluate the pharmacodynamics, clinical efficacy, and safety of meropenem for adult bacterial meningitis in Japan

2014 ◽  
Vol 20 (9) ◽  
pp. 535-540 ◽  
Author(s):  
Akihiko Morita ◽  
Satoshi Kamei ◽  
Masayuki Minami ◽  
Kazuto Yoshida ◽  
Satoshi Kawabata ◽  
...  
Keyword(s):  
Bacterial Meningitis ◽  
Clinical Efficacy ◽  
Efficacy And Safety ◽  
Open Label ◽  
Open Label Study ◽  
Label Study

scholarly journals Phase II, Randomized, Open-Label Study of Pegfilgrastim-Supported VDC/IE Chemotherapy in Pediatric Sarcoma Patients

2010 ◽  
Vol 28 (8) ◽  
pp. 1329-1336 ◽  
Author(s):  
Sheri L. Spunt ◽  
Helen Irving ◽  
Jami Frost ◽  
Leonard Sender ◽  
Matthew Guo ◽  
...  
Keyword(s):  
Pediatric Patients ◽  
Age Groups ◽  
Efficacy And Safety ◽  
Older Children ◽  
Open Label ◽  
Myelosuppressive Chemotherapy ◽  
Open Label Study ◽  
Label Study ◽  
Pediatric Sarcoma ◽  
To Receive

Purpose This multicenter, randomized, open-label study evaluated the efficacy, safety, and pharmacokinetics of a single subcutaneous pegfilgrastim injection with daily subcutaneous filgrastim administration in pediatric patients receiving myelosuppressive chemotherapy for sarcoma. Patients and Methods Forty-four patients with previously untreated, biopsy-proven sarcoma stratified into three age groups (0-5, 6-11, and 12-21 years) were randomly assigned in a 6:1 randomization ratio to receive a single pegfilgrastim dose of 100 μg/kg (n = 38) or daily filgrastim doses of 5 μg/kg (n = 6) after chemotherapy (cycles 1 and 3: vincristine-doxorubicin-cyclophosphamide; cycles 2 and 4: ifosfamide-etoposide). The duration of grade 4 neutropenia, time to neutrophil recovery, incidence of febrile neutropenia, and adverse events were recorded. Results Pegfilgrastim and filgrastim were similar for all efficacy and safety end points, and their pharmacokinetic profiles were consistent with those in adults. Younger children experienced more protracted neutropenia and had higher median pegfilgrastim exposure than older children. Conclusion A single dose of pegfilgrastim at 100 μg/kg administered once per chemotherapy cycle is comparable to daily injections of filgrastim at 5 μg/kg for pediatric sarcoma patients receiving myelosuppressive chemotherapy.

Clinical Efficacy and Safety of Sarasvata Ghrita in the Management of Cognitive Deficit–A Prospective Open Label Study

2018 ◽  
Vol 2 (2) ◽  
pp. 63-69
Author(s):  
Shweta Chaudhary ◽  
Chandra Shekhar Rao ◽  
Srinibash Sahu ◽  
Hemant K Gupta ◽  
Guru Charan Bhuyan
Keyword(s):  
Clinical Efficacy ◽  
Cognitive Deficit ◽  
Efficacy And Safety ◽  
Open Label ◽  
Open Label Study ◽  
Label Study

Clinical Efficacy and Safety of Brihat Gangadhara Churna in the Management of Irritable Bowel Syndrome: A Prospective Open-label Study

2019 ◽  
Vol 3 (3) ◽  
pp. 92-99
Author(s):  
Narayanam Srikanth ◽  
Shruti Khanduri ◽  
Rakesh Rana ◽  
Richa Singhal ◽  
Bhagwan Sahai Sharma ◽  
...  
Keyword(s):  
Irritable Bowel Syndrome ◽  
Clinical Efficacy ◽  
Efficacy And Safety ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Irritable Bowel
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