Develop and Evaluate An Artificial Intelligence Assisted Prehabilitation Program for Returning to Work and Cost-effectiveness Analysis in Patients With Oral Cancer
24. dubna 2026 aktualizováno: Taipei Veterans General Hospital, Taiwan
The goal of this clinical trial is to develop and evaluate an Artificial Intelligence Assisted Prehabilitation Program (AI APP) for returning to work and cost-effectiveness analysis in patients with oral cancer (OC). The main questions it aims to answer are:
- What kinds of needs are related to returning to work (RTW) in patients with OC from diagnosis to survival that we can incorporate into the development of AI APP to assist this population ?
- How is the effect of the AI APP that based on findings from the first question for patients with OC on physical and psychological distress, fear of recurrence, self-efficacy in coping with cancer, communication, motor function, quality of life, and RTW?
- How is the effect of the RTW AI prediction model to identify high-risk groups ? And how is the comprehensive cost effectiveness of benefits and quality of life of the AI APP for OC population?
Researchers will compare patients without using AI APP to see if the AI APP works to assist with coping physical and psychological distress, communication, motor function, quality of life, and RTW issues for individuals with OC?
Participants will:
- Be asked to fulfill a structural questionnaire, or engage in a semi-structured one-by-one interview or a focus group to assess their physical, psychological, and social support needs in the first stage.
- Be invited to participant the pilot testing of AI APP in the second stage.
- Be provided and trained by 3-month AI APP for 3 months or cared as usual in the third stage.
- Complete a structural questionnaire and follow up one year, including the baseline (before using the AI app) and at 1-2 weeks, 3 months, 6 months, 9 months, and 12 months after the baseline.
- Engage in one-by-one interview or a focus group to assess user experiences of the AI APP.
Přehled studie
Postavení
Nábor
Podmínky
Typ studie
Intervenční
Zápis (Odhadovaný)
650
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Shiow-Ching Shun
- Telefonní číslo: +886-911-268-998
- E-mail: scshun@nycu.edu.tw
Studijní místa
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Taipei, Tchaj-wan, 112
- Nábor
- Taipei Veterans General Hospital
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Kontakt:
- Muh-Hwa Yang, PhD
- Telefonní číslo: +886-2-28267000 #66510
- E-mail: mhyang2@nycu.edu.tw
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Taipei, Tchaj-wan, 112
- Nábor
- National Yang Ming Chiao Tung University
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Kontakt:
- Yu-Chi Chen, PhD
- Telefonní číslo: +886-958911922
- E-mail: ycchen2@nycu.edu.tw
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Taipei, Tchaj-wan, 110
- Nábor
- National Taiwan University Hospital
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Kontakt:
- Yueh-Hsia Chen, PhD
- Telefonní číslo: +886-921435981
- E-mail: yuehhsiachen@ntu.edu.tw
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Taipei, Tchaj-wan, 112
- Zápis na pozvánku
- National Yang Ming Chiao Tung University
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ano
Popis
Inclusion Criteria:
- Adult (> 20 years old and younger than 70 years old)
- Newly diagnosed as OC and scheduled to receive cancer-related treatment
- Able to use Mobile phone
- Willing to sign an informed consent form after receiving a detailed explanation of the study's aims and procedures
- Healthcare professionals involved in patients' care, including doctors, nurses, case managers, dietitians, rehabilitation therapists, and psychologists
- Family members who are primary caregivers of the participating patients, engaged in different stages of medical care
Exclusion Criteria:
- Risk populations for walking or performing exercise
- Patients with cognitive impairment or psychiatric diseases
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Nerandomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Aktivní komparátor: Control group Usual care
The patients in this group will not use the AI APP.
They will receive 12 times of physiotherapy and keep receiving usual care.
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masáž jizev a cvičení na mobilizaci čelistí v kombinaci s přístroji nebo depresory
ROM cvičení čelistí, krku, ramen a cvičení zaměřená na lopatky, 30 minut intervence jednou týdně a celkem 12 týdnů
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Experimentální: Intervention group
The patients in this group will receive and use AI APP while receiving usual care.
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ROM cvičení čelistí, krku, ramen a cvičení zaměřená na lopatky vedená technologií AI, 30 minut intervence jednou týdně a celkem 12 týdnů
masáž jizev a cvičení na mobilizaci čelistí v kombinaci s přístroji nebo depresory
Participants will use an Artificial Intelligence Assisted Prehabilitation Program Application (AI Assisted Prehabilitation APP, AI APP), including Generative AI Assisted Psychosocial Support chat, AI-Based Postural Correction Programs Physiotherapy Prehabilitation, and Intelligent Learning-Based Communication Navigation Assistance System to assist individuals with OC dealing with their physical and psychological distress, motor function and communication issues, and social support throughout prehabilitaion and rehabilitation to help them better returning to work.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Returning to work (RTW)
Časové okno: Baseline (before surgery), 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.
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A self-designed structured Employment status with one item collecting patients working status of "not employed", "part-time", or "full-time".
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Baseline (before surgery), 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.
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Change of the level of symptom severity on Symptom Severity Scale (SSS) questionnaire
Časové okno: Baseline (before surgery), 1-2 weeks after surgery, 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.
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The Symptom Severity Scale (SSS): This scale is used to assess the severity of symptoms in cancer patients, demonstrating good validity through testing in HNC patients [30].
It includes 13 items of common symptoms among cancer patients, including swallowing difficulty, eating difficulty, oral mucositis, speech difficulty, fatigue, poor appetite, pain, cough, apnea, constipation, diarrhea, nausea, and vomiting.
Scores range from 0 to 10, where 0 indicates the absence of the symptom, and 10 represents the most severe symptoms.
Higher scores indicate a higher severity of symptoms.
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Baseline (before surgery), 1-2 weeks after surgery, 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.
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Change of the level of distress on Distress Thermometer (DT) questionnaire
Časové okno: Baseline (before surgery), 1-2 weeks after surgery, 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.
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Distress Thermometer (DT): It is a screening tool developed by The National Comprehensive Cancer Network® (NCCN®) to identify the clinical severity of psychological distress and specific problems causing distress among cancer patients.
The DT is a self-report one-item measure assessing the level of distress that patients have experienced in the previous week; the scale ranges from 0 (no distress) to 10 (extreme distress).
The DT consists of 36 problems answered with "no" or "yes," and it is clustered into five domains: practical problems, family problems, emotional problems, spiritual problems, and physical problems.
This scale has been validated and used in Chinese cancer patients and has shown good reliability.
It has also been validated with a good sensitivity (72.2%), specificity (80.0%), and accuracy (79.2%) in Taiwanese cancer patients.
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Baseline (before surgery), 1-2 weeks after surgery, 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.
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Change of the level of fear of recurrence on the Fear of Cancer Recurrence Inventory-Short Form (FCRI-SF) questionnaire
Časové okno: Baseline (before surgery), 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.
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Fear of Cancer Recurrence Inventory-Short Form (FCRI-SF): The FCRI-SF with nine items is a self-report measure designed to evaluate the presence and severity of intrusive thoughts associated with fear of cancer recurrence (FCR).
Each item is rated on a 0 (not at all) to 4 (all the time) numerical rating scale.
The total score is the sum of the items, ranging from 0 to 36.
Higher scores indicate a higher level of FCR.
A threshold of 13 or greater was categorized for patients with FCR.
The FCRI-SF is a valid and reliable instrument in oncology patients in both English and Chinese.
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Baseline (before surgery), 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.
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Change from baseline in maximal mouth opening
Časové okno: Baseline (before surgery), 1-2 weeks after surgery, 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.
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Average maximal mouth opening measured 3 times in mm
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Baseline (before surgery), 1-2 weeks after surgery, 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.
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Change from baseline in shoulder joint range of motion
Časové okno: Baseline (before surgery), 1-2 weeks after surgery, 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.
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Average range of motion of shoulder abduction measured 3 times in degrees
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Baseline (before surgery), 1-2 weeks after surgery, 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.
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Change of the level of self efficacy on the Cancer Behavior Inventory (CBI) questionnaire
Časové okno: Baseline (before surgery), 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.
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Cancer Behavior Inventory (CBI): This scale is used to measure cancer patients' self-efficacy during the cancer trajectory.
Heitzmann et al. (2011) further developed a short form with 14 items containing four dimensions: maintaining independence and positive attitude, participating in medical care, coping and stress management, and managing effect.
It has been translated into Chinese version by modifying the scale to an 11-point Likert scale, ranging from 0 (not at all confident) to 10 (totally confident) with good internal consistency (Cronbach's alpha=0.789)
and test-retest reliability over a week.
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Baseline (before surgery), 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.
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Change of the level of health engagement on the Patient Health Engagement (PHE) questionnaire
Časové okno: Baseline (before surgery), 1-2 weeks after surgery, 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.
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Patient Health Engagement (PHE): Scores are arranged in sequential order, and the median score represents the patient's level of health engagement.
Higher numbers indicate greater patient engagement.
The scale demonstrates strong validity and consistency.
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Baseline (before surgery), 1-2 weeks after surgery, 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.
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Change of the level of perceived voice handicap on the Voice Handicap Index-10 (VHI-10) questionnaire
Časové okno: Baseline (before surgery), 1-2 weeks after surgery, 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.
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Voice Handicap Index-10 (VHI-10): The Voice Handicap Index (VHI) was designed to assess the impact of voice disorders on quality of life.
Original form comprises 30 items across functional, physical, and emotional dimensions, a short form 10-item version was introduced in 2004.
Responses are scored on a scale from 0 (never) to 4 (always), with higher scores indicating a greater perceived voice handicap.
The Mandarin version had good substantiated validity and reliability (Cronbach's alpha= 0.934).
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Baseline (before surgery), 1-2 weeks after surgery, 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.
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Change of the level of communication quality on the Communication Quality Assessment questionnaire
Časové okno: Baseline (before surgery), 1-2 weeks after surgery, 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.
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Communication Quality Assessment: A communication quality assessment scale was developed by the research team to evaluate the patient's communication experience across five dimensions: clarity of communication, level of understanding, problem-solving effectiveness, communication efficiency, and overall satisfaction with communication.
Each item is rated on a 5-point Likert scale (1 to 5), with higher scores indicating better communication quality.
The items can be analyzed individually to assess specific aspects of communication, or summed to generate a total score representing overall communication quality.
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Baseline (before surgery), 1-2 weeks after surgery, 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.
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Change of the level of health-related quality of life on the Functional Assessment of Cancer Therapy (FACT-G7) and The EuroQol instrument (EQ-5D) questionnaire
Časové okno: Baseline (before surgery), 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.
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Functional Assessment of Cancer Therapy, FACT-G version 4: It has been developed to measure the health-related quality of life in cancer patients. It comprises 27 items categorized into four domains: physical (7 items), social/family (7 items), emotional (6 items), and functional well-being (7 items). It is a 5-point Likert scale, ranging from 0 (not at all) to 4 (very much). The total score ranges from 0 to 108, with higher scores indicating a better quality of life. Its traditional Chinese version demonstrated good reliability with a Cronbach's alpha of 0.85. The EuroQol instrument, EQ-5D: It has been developed to measure the health-related quality of life. It consists of two parts. The first part includes 5 items to present 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each item has 5 levels. The second part is a thermometer-like visual analog scale from 0 to 100. Its traditional Chinese version demonstrated good validity. |
Baseline (before surgery), 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change from baseline in function on Disabilities of the Arm, Shoulder, and Hand outcome questionnaire
Časové okno: Baseline (before surgery), 1-2 weeks after surgery, 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.
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A total scale from 1 to 100.
Higher scores indicate greater disability.
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Baseline (before surgery), 1-2 weeks after surgery, 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.
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Change from baseline in health-related function on EORTC QLQ-C30 questionnaire
Časové okno: Baseline (before surgery), 1-2 weeks after surgery, 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.
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European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30): The questionnaire includes five functional subscales: physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning.
In addition, it assesses a range of cancer-related symptoms, including fatigue, pain, nausea and vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties.
Most of the items are scored on a 4-point Likert-type scale, ranging from 1 ("not at all") to 4 ("very much"), with higher scores indicating greater symptom burden or lower functioning.
Two items assess global health status/overall quality of life, scored on a 7-point Likert-type scale ranging from 1 ("very poor") to 7 ("excellent"), where higher scores reflect better quality of life.
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Baseline (before surgery), 1-2 weeks after surgery, 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.
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Change from baseline in whole-body physical function on 6-minute walk test
Časové okno: Baseline (before surgery), 1-2 weeks after surgery, 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.
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Walking distance measured in meters.
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Baseline (before surgery), 1-2 weeks after surgery, 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.
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Change from baseline in shoulder pain
Časové okno: Baseline (before surgery), 1-2 weeks after surgery, 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.
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Visual analog scale from 0 to 10. Higher scores indicate most pain.
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Baseline (before surgery), 1-2 weeks after surgery, 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.
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The user experience of the APP intervention
Časové okno: 3 months after surgery, and 6 months after surgery
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The user experience will use a self-designed questionnaire developed using the Technology Acceptance Model (TAM) and individual interview
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3 months after surgery, and 6 months after surgery
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
27. září 2024
Primární dokončení (Odhadovaný)
31. července 2028
Dokončení studie (Odhadovaný)
1. prosince 2029
Termíny zápisu do studia
První předloženo
27. února 2025
První předloženo, které splnilo kritéria kontroly kvality
24. dubna 2026
První zveřejněno (Aktuální)
1. května 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
1. května 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
24. dubna 2026
Naposledy ověřeno
1. dubna 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2024-03-011BC
- NSTC 113-2314-B-A49 -076 - (Jiné číslo grantu/financování: National Science and Technology Council)
- NSTC 114-2314-B-A49 -016 - (Jiné číslo grantu/financování: National Science and Technology Council)
- NSTC 113-2314-B-A49 -077 - (Jiné číslo grantu/financování: National Science and Technology Council)
- NSTC 114-2314-B-A49 -017 - (Jiné číslo grantu/financování: National Science and Technology Council)
- NSTC 113-2314-B-002 -298 - (Jiné číslo grantu/financování: National Science and Technology Council)
- NSTC 113-2314-B-A49 -078 - (Jiné číslo grantu/financování: National Science and Technology Council)
- NSTC 114-2314-B-002 -044 - (Jiné číslo grantu/financování: National Science and Technology Council)
- NSTC 114-2314-B-A49 -018 - (Jiné číslo grantu/financování: National Science and Technology Council)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
NE
Popis plánu IPD
Based on the Institutional Review Board of the study site, the patients does not agree to give their data to other study.
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
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