다발성 골수종 환자의 감염 예방을 위한 새로운 항체 치료의 효과와 안전성을 평가하는 중재적 임상시험입니다.

Immunoglobulin support (subcutaneous or intravenous)

Target trough IgG level of 8-10 g/L

Immunglobulin support (subcutaneous or intravenous)

Target trough IgG level 4-6 g/L

No immunoglobulin support. If pre specified conditions are met, crossover to Group A or B.

If, during follow-up, the patient presents recurrent or severe infections and/or total IgG level less 4 g/L, crossover to group A or B

No history of recurrent or severe infections and total IgG level higher or equal at 4 g/L

면역글로불린 지원(피하 또는 정맥 주사)

목표 최저 IgG 수준 8-10g/L

목표 최저 IgG 수준 4-6 g/L

면역글로불린 지원 없음. 사전 지정된 조건이 충족되면 A군 또는 B군으로 전환.

재발성 또는 중증 감염 병력이 없고 총 IgG 수치가 4g/L 이상인 경우

Philippe Nadeau, PhD

Julie Côté, MD, FRCPC

BCMA 유도 T 세포 결합제를 투여받는 다발성 골수종 환자의 면역글로불린

신경 및 대사 질환 환자의 움직임을 2년간 웨어러블 기기로 관찰하여 미래 임상시험을 위한 유용한 데이터 수집을 목표로 합니다.

Syde is an innovative device intended to be used in a home-based environment. It is composed of two watch-like sensors, each containing a magneto-inertial sensors that record the linear acceleration, the angular velocity, the magnetic field of the movement in all directions.The two watches can be worn as wristwatch or placed near the ankle.

Syde

This test consists of covering the greatest possible distance within 6 minutes, walking back and forth along a 25-meter hallway. The subject may stop if they need to. The evaluator will record the elapsed time after each half-lap, and the final distance that was covered at the end of the test. No help will be allowed during the test.

The 6-minute walk test (6MWT)

During this test, the subject must cover a distance of 10 meters as rapidly as possible. This test will be performed 3 times. The participant will be allowed to rest for one minute after the first and second instances of the test. No help will be allowed during the test.

The 10-meter test (10MWT)

This is a standardized test during which the subject must climb the 4 stair steps as rapidly as possible. This test will be performed 3 times. The participant will be allowed to rest for one minute after the first and second instances of the test, or more if needed.

The 4 stair-climbing test (4SC)

This is a standardized test during which the subject must rise from the floor as rapidly as possible. The test starts with the participant lying on their back. This test will be performed 3 times. The participant will be allowed to rest for one minute after the first and second instances of the test.

Test of rising from the floor (TRF)

PGIC is a patient-reported scale used to assess how a patient feels their condition has changed over time. It typically uses a 7-point scale to capture the patient's overall perception of improvement in symptoms, function, and quality of life.

Patient's Global Impression of Change (PGIC)

Dynamometric measurements of the maximum force of the following functions will be taken with the MyoTools: palmar grip (MyoGrip) and thumb-index pinch (MyoPinch). Test will be realized on the dominant side. Patients will be encouraged during the test. They will be given three trials and the best score will be entered.

Dynamometric measurements of muscle strength

The CMTES is a 28-point composite score that rates the patient's symptoms and signs. It is part of the Charcot-Marie-Tooth (CMT) neuropathy score and has been validated as a reproducible measure of disability in CMT. Higher scores indicate more severe neuropathy.

The Charcot-Marie-Tooth examination score (CMTES)

The 9-HPT is a quantitative test of upper limb function. It is the second component of the Multiple Sclerosis Functional Composite (MSFC). The patient sits at a table with a shallow container containing nine sticks and a wooden or plastic block containing nine empty holes. When a timer is started, the patient places the nine sticks one after the other as quickly as possible into the nine holes and, once they are all in the holes, removes them as quickly as possible. The total time taken to complete the task is recorded. Two consecutive attempts with the dominant hand are immediately followed by two consecutive attempts with the non-dominant hand.

9-Hole Peg Test (9-HPT)

This 8-item scale was developed to assess ataxia severity and disease progression. It evaluates gait and balance, speech, and upper and lower limb coordination. The score ranges from 0 to 40, with higher score indicating a worse clinical outcome.

The Scale for the Assessment and Rating of Ataxia (SARA)

This 74-item clinical rating scale assesses patient performance and capacity in 4 domains: motor function, cognitive function, behavioral abnormalities, and functional capacity.

The Unified Huntington's Disease Rating Scale (UHDRS)

During this standardized test, the subject is observed and timed while he/she rises from a chair, walks 3 meters, performs a 180° turn, walk back toward the chair and sits down.

The Timed up and go test (TUG)

This 28-item clinician-rated scale assesses motor and non-motor symptom severity in patients with PSP, with a score ranging from 0 (normal) to 100.

The Progressive Supranuclear Palsy Rating Scale (PSP-RS)

The MOCA was designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive function, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. Scores on the MOCA range from 0 to 30, with higher score being better outcome.

The Montreal Cognitive Assessment (MOCA)

The QMG is a clinician-rated 13-item scale used to quantify disease severity in patients with MG. The scale grades each domain (ocular, bulbar, respiratory, and limb function), with a total score ranging from 0 to 39 (lower score indicating a better clinical outcome).

Quantitative Myasthenia Gravis (QMG)

This is an 8-item patient-reported scale assessing MG symptoms and their effects on daily activities. The score ranges from 0 to 24, with higher score indicating a worse clinical outcome.

The Myasthenia Gravis Activities of Daily Living Scale (MG-ADL)

6분 걷기 테스트(6MWT)

10m 테스트(10MWT)

4계단 오르기 테스트(4SC)

바닥에서 일어나는 테스트(TRF)

환자의 변화에 대한 전반적인 인상(PGIC)

근력의 동력학적 측정

샤르코-마리-투스 시험 점수(CMTES)

9홀 페그 테스트(9-HPT)

운동실조 평가 및 등급 척도(SARA)

통합 헌팅턴병 평가 척도(UHDRS)

시간 제한 테스트(TUG)

진행성 초핵성 마비 평가 척도(PSP-RS)

몬트리올 인지 평가(MOCA)

정량적 중증 근무력증(QMG)

중증 근무력증 일상생활활동척도(MG-ADL)

Centre Hospitalier Universitaire de Liege

Nicolas Bovy

Laurent Servais, MD

신경학적 또는 대사적 병리를 가진 성인 환자의 보행 분석 매개변수 및 상지 평가

중등도에서 중증 류마티스 관절염 환자를 대상으로 두 가지 약물 조합의 효과를 비교하는 시험입니다.

This intervention is open label. Both patient and investigator will know about the intervention. Participants are allocated according to block randomization. Total two groups with each contain 48 patients. One group will be given Tofacitinib, Methotrexate and another group will be given Upadacitinib, Methotrexate

To see the efficacy of Upadacitinib, Methotrexate versus Tofacitinib, Methotrexate in moderate to severe Rheumatoid arthritis

중등도에서 중증 류마티스 관절염에서 우파다시티닙, 메토트렉세이트와 토파시티닙, 메토트렉세이트의 효능을 비교하려면

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

중등도에서 중증 류마티스 관절염에서 토파시티닙과 메토트렉세이트 병용 요법의 효능과 우파다시티닙과 메토트렉세이트 병용 요법의 효능 비교

급성 골수성 백혈병 등 혈액암 노인 환자를 대상으로 원격진료 프로그램이 의료 소통과 불안, 서류 작성을 돕는지 확인하는 초기 시험입니다.

The adapted telehealth Serious Illness Care Program is a multilevel intervention engaging the patient, caregiver, clinician, and system. It consists of tools, training, and system change. Tools include: 1) The Serious Illness Conversation Guide for clinicians; and 2) Education materials for patients on the importance of Serious Illness Conversations (Patient Preparation Pamphlet) and of the involvement of caregivers (Family Communication Guide).

Telehealth Serious Illness Care Program

Education materials developed by the NCI on "Communication in Cancer Care (PDQ®) - Patient Version"

Education Control

적응형 원격진료 중증 질환 관리 프로그램은 환자, 간병인, 임상의, 그리고 시스템이 참여하는 다단계 개입 프로그램입니다. 이 프로그램은 도구, 교육, 그리고 시스템 변화로 구성됩니다. 도구에는 1) 임상의를 위한 중증 질환 대화 가이드, 2) 중증 질환 대화의 중요성(환자 준비 팸플릿)과 간병인 참여(가족 소통 가이드)에 대한 환자 교육 자료가 포함됩니다.

원격 진료 중증 질환 치료 프로그램

NCI가 개발한 "암 치료에서의 커뮤니케이션(PDQ®) - 환자 버전" 교육 자료

BCMA 유도 T 세포 결합제를 투여받는 다발성 골수종 환자의 면역글로불린

신경학적 또는 대사적 병리를 가진 성인 환자의 보행 분석 매개변수 및 상지 평가

중등도에서 중증 류마티스 관절염에서 토파시티닙과 메토트렉세이트 병용 요법의 효능과 우파다시티닙과 메토트렉세이트 병용 요법의 효능 비교

원격 진료 사전 치료 계획 개입