Group A (Control). Home decongestive exercise regimen + daytime use of a compression sleeve (12 hours per day)

Compression sleeve worn for at least 12 hours per day, seven days a week.

Compression sleeve, daytime wear

Participants are provided with a home exercise program that follows the decongestive exercise sequence and instructed to perform the exercise sequence once daily for a 10-15 minute period.

Home exercise program

Group B. Decongestive Progressive Resistance Exercise + compression sleeve use during exercise + daytime use of a compression sleeve (12 hours per day)

Participants wear their daytime compression sleeve during the DPRE program.

Compression sleeve, worn during exercise

Supervised DPRE exercise program, twice a week for 12 weeks. Exercises will be individualized and offered in a group-based format.

After the 12-week intervention, participants will continue the same program (independently) twice weekly for an additional 12 weeks at home or in a community-based fitness center or attend supervised group exercise sessions virtually.

Decongestive Progressive Resistance Exercise program

Group C. Decongestive Progressive Resistance Exercise + Adjustable Compression (AC) garment use during exercise + daytime use of a compression sleeve (12 hours per day).

Participants wear an Adjustable Compression (AC) garment during the DPRE program. Participants will be fitted for an Adjustable Compression garment and instructed in its application by a physical therapist.

Adjustable Compression (AC) garment, worn during exercise

The study consists of a total of six dose groups, with the lowest dose group being 3×10\^6 and the highest dose reaching 1×10\^9 PFU. In case the maximum dose of 1×10\^9 PFU fails to achieve the Maximum Tolerated Dose (MTD), the Safety Monitoring Committee (SMC) will convene to discuss whether to designate it as Maximum Feasible Dose (MFD) or consider escalating further based on current safety and preliminary efficacy data. However, any escalation beyond that of similar drugs' Phase I clinical trials, such as JX-594:NCT00629759 and JX-929:NCT00574977, where the highest administered dose was 3×10\^9 PFU, shall be avoided. This precaution ensures adherence to established safety protocols.

A single dose of GC001 will be administered up to 4mL (The injection volume is based on the length of the lesion).

The maximum number of lesions that each participant is allowed to inject at one time is two.

A Phase I Clinical Study of Intratumoral Injection Oncolytic Vaccinia Virus GC001 in Patients With Advanced Solid Tumors

MO guoyu

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

듀크 대학교에서 진행하는 이 연구는 과분극 129 제논 가스를 이용해 진행성 폐섬유증 환자의 치료 효과를 MRI로 비교하는 시험입니다.

Whether magnetic resonance imaging (MRI) using inhaled hyper-polarized 129 Xenon gas can help visualize impaired lung function to detect changes over time in Progressive Pulmonary Fibrosis patients receiving approved treatments.

Whether magnetic resonance imaging (MRI) using inhaled hyper-polarized 129 Xenon gas can help visualize impaired lung function to detect changes over time in Progressive Pulmonary Fibrosis

운동 중 착용하는 압박 슬리브, 운동 중 착용하는 조절형 압박(AC) 의류, 압박 슬리브, 주간 착용, 울혈 완화 진행성 저항 운동 프로그램, 가정 운동 프로그램

진행성 고형 종양 환자를 대상으로 종양 내 주입 용균성 백신 바이러스 GC001의 1상 임상 연구

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

과분극 129 제논 가스를 이용한 진행성 폐섬유증 치료 비교