更新于：2024-11-01

Dr. Soetomo General Hospital

Indonesia

更新于：2024-11-01

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项与 Dr. Soetomo General Hospital 相关的临床试验

NCT06259578 / Recruiting早期临床1期IIT

Immunobridging Study: Immunogenicity and Safety of INAVAC (Vaksin Merah Putih - UNAIR SARS-CoV-2 (Vero Cell Inactivated)) Vaccine as Homologue Booster in Adult Subjects in Indonesia

The goal of this open-label clinical trial is to evaluate the safety and immunogenicity of INAVAC (Vaksin Merah Putih - UNAIR SARS-CoV-2 (Vero Cell Inactivated)) Vaccine as Homologue Booster in Adult Subjects in Indonesia. The main question it aims to answer is: "To evaluate the humoral immunogenicity profile at 28 days following vaccination with INAVAC vaccine as homolog booster administered intramuscularly in healthy adults age 18 years and above". Participants will be administered one dose of vaccination for the third dose (booster vaccination) intramuscularly.

开始日期2024-01-29

申办/合作机构

Dr. Soetomo General Hospital

[+3]

NCT06272253 / Active, not recruiting早期临床1期IIT

Immunobridging Study: Immunogenicity and Safety of INAVAC (Vaksin Merah Putih - UNAIR SARS-CoV-2 (Vero Cell Inactivated)) as Heterologue Booster in Adolescent Subjects in Indonesia

This is an open label trial. There will only be 1 group in the study. All subjects will receive INAVAC vaccine and be followed for 6 months.
The vaccine will be administered intramuscularly. This study will be started after the interim analysis of the phase III INAVAC trial in adolescent. This study will have two interim and one full analysis reports.

开始日期2023-09-19

申办/合作机构

Dr. Soetomo General Hospital

[+2]

NCT06282692 / Recruiting临床3期IIT

An Open Label, Phase III Clinical Trial (Immunobridging Study) of INAVAC (Vaksin Merah Putih - UA-SARS CoV-2 (Vero Cell Inactivated)) in Healthy Population Aged 12 to 17 Years Old

This is an open label, phase III trial - immunobridging study. There will be only 1 group in the study. All subjects (12 to 17 years old) will receive INAVAC 5 µg dose. The vaccine will be administered with 2-dose schedule, intramuscularly, with 28 day interval. All subjects will be followed for 12 months.
INAVAC is an inactivated vaccine made of SARS-CoV-2 virus isolated from a patient in Surabaya, composed with aluminium hydroxy gel, tween 80, and L-histidine, and this study will be the first phase III in adolescents.

开始日期2023-06-19

申办/合作机构

Dr. Soetomo General Hospital

[+2]

100 项与 Dr. Soetomo General Hospital 相关的临床结果

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0 项与 Dr. Soetomo General Hospital 相关的专利（医药）

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157

项与 Dr. Soetomo General Hospital 相关的文献（医药）

2024-08-29·Current HIV Research

Prediction Models for HIV Infection in Infants: Analysis of Scoring Systems on Maternal, Infants, and Mode of Delivery Risk Factors

Article

作者: Saptawati ; Hadinegoro, Sri Rezeki S. ; Ibrahim, Fera ; Aminullah, Asril ; Latupeirissa, Debbie ; Utomo, Budi ; Bardosono, Saptawati ; Akib, Arwin A. P.

Background:Diagnosis for HIV in infants is hard to determine, particularly in limited- resource areas. A delay in the diagnosis of HIV-infected infants will lead to high morbidity and mortality. The purpose of this project is to construct a model of an HIV-positive infant and develop a useful and practical scoring system to estimate the likelihood of mother-to-child transmission that can be applied in the field.Methods:A cross-sectional study on 100 subjects through medical records of infants born to HIV-infected mothers was conducted at four hospitals and one community health center. Several models of risk prediction scores of HIV-infected infants were then made. Furthermore, the performed validation was performed on 20 subjects of infants born to mothers with HIV in three hospitals by comparing the scoring system and the result of the PCR RNA examination performed at the age of 6 weeks old.Results:The risk of HIV-infected infants was higher in mothers who did not receive ARV through PMTCT programs (OR 33.6; 95% CI 4.0 to 282.2), pulmonary TB infection (OR 5.1; IK95% 1.6 to 16.0) and vaginal delivery (OR 9.2; IK95 2.2 to 38.0%). Two models can predict the occurrence of infected HIV infants effectively. Model 1 consists of maternal age, maternal ARVs, lung TB infection, gestational age, mode of delivery, and sex of the infants with sensitivity and specificity of 78.9% and 70.8% (AUC=0.817 [95% CI 0.709 to 0.926]) and likelihood ratio score of 4. Model 2 consists of ARVs to the mother, pulmonary TB infection, and mode of delivery with sensitivity and specificity of 73.7% and 86.1%; AUC value of 0.812 (95% CI 0.687 to 0.938) and likelihood ratio of 5. External Validation gave similar results to the Model 2 scoring system with PCR RNA.Conclusion:The prediction score of HIV-infected infants in Model 2 can be used in newborns of HIV-positive mothers as an effective and practical risk screening tool for HIV-infected infants before the gold standard examination by PCR.

2024-07-01·Journal of Transcultural Nursing

The Javanese Cultural Beliefs and Practices Among Patients With End-Stage Renal Disease Undergoing Hemodialysis

Article

作者: Umam, Khotibul ; Supriyono, Supriyono ; Widyawati, Ika Yuni ; Suarilah, Ira ; Lin, Chiu-Chu ; Purwanti, Rini ; Mundt, Klaus

Introduction: Poor prognosis and higher mortality of chronic kidney disease are linked with cultural beliefs and practices. This study explored cultural beliefs and practices of Javanese people with end-stage renal disease undergoing hemodialysis for ≥5 years. Methods: A qualitative narrative inquiry was applied in this study. Data were collected through in-depth narrative interviews, followed by text messages, calls, and audio-visual calls for 6 weeks. Results: There were 14 participants; their mean age was 51.15 years and hemodialysis duration was 5 years and 2 months up to 10 years and 9 months. Four themes emerged: life-and-death acceptance, expectation of end-of-life care, contemplation of withdrawal from hemodialysis, and wishing for a good death. Discussion: Life values guided the ability to survive for the individual. Adherence to renal disease management regimen clashed with cultural values on occasions, such as social gatherings. Therefore, the unmet needs of patients should be addressed with a transcultural approach to modify personal health behaviors.

2024-06-01·JPMA. The Journal of the Pakistan Medical Association

Percutaneous transcatheter embolization in large tortuous coronary artery fistula patient: a case report.

Article

作者: Pasahari, Diar ; Tri Saputra, Pandit Bagus ; Evan Lusida, Terrence Timothy ; Oktaviono, Yudi Her ; Gunadi, Ruth Irana ; Al Farabi, Makhyan Jibril

Coronary artery fistula is a rare anomaly involving the coronary artery and a heart chamber or vessel. Percutaneous intervention has been shown to be effective and safe in fistulas that are small and nontortuous; however, it is not an absolute contraindication in fistulas that are large and tortuous. We report a delayed diagnosis of a single, large-diameter, tortuous coronary artery fistula that manifested as myocardial ischaemia due to the steal phenomenon in a 49 year old male. The undesirable connection was successfully obliterated by percutaneous embolisation, followed by an improvement in symptoms and daily activities. Steal phenomenon is the fundamental mechanism of myocardial ischaemia in coronary artery fistula, as confirmed by improvement in symptoms and coronary artery perfusion following occlusion of the fistula. Percutaneous catheterization is safe and effective for coronary artery fistula closure, and the occlusion site should be precise to achieve complete occlusion and prevent complications.

100 项与 Dr. Soetomo General Hospital 相关的药物交易

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100 项与 Dr. Soetomo General Hospital 相关的转化医学

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