Patients in both the Phase I and Phase II portion of the study will receive lymphodepleting chemotherapy (unless determined by PI that lymphodepletion is not necessary), followed by a single infusion of the patient-derived SJCAR19 cellular product. The most commonly used lymphodepleting chemotherapy regimen will consist of the agents: Fludarabine and Cyclophosphamide. They will also receive Mesna. Dosing of SJCAR19 on the Phase I study will follow a dose escalation schema, with dose changes based on dose-limiting toxicities. In the Phase II study, SJCAR19 dosing with follow the maximum tolerated dose, as determined in the Phase I portion.

Cells for infusion are prepared using the CliniMACS System.

Cyclophosphamide

Fludarabine

Mesna

The mechanism of action of the CliniMACS Cell Selection System is based on magnetic-activated cell sorting (MACS). The CliniMACS device is a powerful tool for the isolation of many cell types from heterogeneous cell mixtures, (e.g. apheresis products). These can then be separated in a magnetic field using an immunomagnetic label specific for the cell type of interest.

CliniMACS

CD19- specific CAR engineered autologous T-cells (SJCAR19 product)

(closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.

pegfilgrastim

AC regimen

cyclophosphamide

doxorubicin hydrochloride

paclitaxel

(closed 11/10/10) Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days for 15 courses. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I.

(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim or G-CSF as in arm I. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.

(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III.

Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.

Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim as in arm V. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.

Participants will receive placebo intravenously (IV) every 2 weeks (q2w) through Week 10 along with standard-of-care background therapy.

Placebo infusion will be administered intravenously.

Placebo

Participants will receive nipocalimab IV q2w through Week 10 along with standard-of-care background therapy.

Nipocalimab infusions will be administered intravenously.

Nipocalimab

Participants will be asked to continue their usual day to day activities and take their current medications as directed. They will be sent a link by email or through MyChart to the standard video \& education session on managing hypertension. They will watch the video at home on their own time. Participants will use a home blood pressure monitor to track their blood pressure (those without a blood pressure cuff will be provided one) for the 3-month intervention period. Patients will be provided instructions of when they should seek medical attention (clinical symptoms or SBP \<100 or SBP \>160). They will be encouraged to track their blood pressure daily and any symptoms they may be feeling.

Participants will be asked to continue their usual day to day activities and take their current medications as directed. They will be sent a link by email or through MyChart to the educational session described above in the control group section. They will receive an Aetonix aTouchAway platform monitor, which is a disease specific home monitoring device to take home for 3 month intervention period. The device will prompt the participant to check their blood pressure on a daily basis and will send all readings to the UOHI Telehome monitoring program. The telehome monitoring nursing team will monitor the readings for each participant. For hypertensive patients who are not at target with their BP, the telehome monitoring nurse will titrate medications based on an advanced medical directive every 2 weeks. Patients will be provided instructions of when they should seek medical attention (clinical symptoms or SBP \<100 or SBP \>160).

Participants are enrolled into the Telehome Monitoring program

Telehome Monitoring

Ottawa Heart Institute Research Corporation

Participants received a single oral dose of Tepotinib 500 milligrams (mg) followed by Omisertinib 80 mg once daily until disease progression, death, adverse event leading to discontinuation, study withdrawal or consent withdrawal.

Participants were administered with Tepotinib orally once daily at a dose of 500 mg.

Tepotinib

Participants received Osimertinib at a dose of 80 mg orally once daily.

Osimertinib

Participants received a single oral dose of Tepotinib 500 mg until disease progression, death, adverse event leading to discontinuation, study withdrawal or consent withdrawal.

EMD Serono Research & Development Institute, Inc.

Healthy volunteer subject cohorts randomized 6:2 receiving a single dose of QLS12010 or placebo. The starting dose will be 25 mg of QLS12010 or placebo.

QLS12010

Healthy volunteer subject cohorts randomized 8:2 to receive QLS12010 or placebo QD for 14 continuous days. The starting dose of QLS12010 or placebo is based on upcoming data from SAD part.

Part C is a two-cycle, crossover study under fasting and fed (high-fat meal) conditions. In Cycle 1, 12 healthy adult participants will be randomly divided into two groups on D-1, with 6 participants in each group receiving a single oral dose of QLS12010 Capsules under fasting or fed conditions, respectively. After completing washout, they will receive crossover administration for the Cycle 2 study.

Part D of the study plans to enroll 12 adults with moderate to severe atopic dermatitis (AD). Eligible subjects (after screening) will be sequentially assigned to two dose groups (Dose 1 and Dose 2) in the order of their enrollment. Enrollment of Dose 2 may commence only after Dose 1 has completed enrollment of 6 subjects.

Shanghai Qilu Pharmaceutical Research and Development Center LTD

Haiyan Li, M.D.

Wenhui Wang, M.D.

Participants assigned to the CGM group will receive the Libre 2+ systems (Abbott Diabetes Care, Alameda, CA) upon randomization. This will include comprehensive training provided by a qualified healthcare professional. The training will cover detailed instructions on sensor placement, how to download and use the associated smartphone application, and guidance on interpreting the glucose data effectively. To ensure continuous and accurate monitoring, the CGM sensor will be routinely replaced every 14 days following randomization. Additionally, in the event of sensor detachment or loss, immediate replacement will be arranged to maintain uninterrupted glucose tracking. Regular sessions are conducted to analyze glucose trends, refine management strategies, and provide additional support or education on device usage.

Abbot Freestyle Libre CGM

Yun Shen, MD

Peter T Katzmarzyk, PhD

Gang Hu, MD PhD MPH

Zubaidah Nor Hanipah, MD

Phillip R Schauer, MD

Cisplatin/capecitabine or cisplatin/5-fluorouracil

Cisplatin

5-fluorouracil or Capecitabine

gastrectomy

Cisplatin/capecitabine plus trastuzumab or cisplatin/5-fluorouracil plus trastuzumab

Trastuzumab

cisplatin/capecitabine plus trastuzumab and pertuzumab or cisplatin/5-fluorouracil plus trastuzumab and pertuzumab

Pertuzumab

European Organisation for Research and Treatment of Cancer - EORTC

On the basis of the original conventional treatment regimen, 2000 mg of fucoidan was administered orally twice a day for 12 weeks.

Background Therapy: Continued pre-existing conventional RA treatment at stable doses Intervention: Oral fucoidan Dosage Form: Size-0 gelatin capsules containing 1000mg fucoidan powder Dosage: 2000mg (2 capsules) per dose, twice daily (BID) Duration: 12 weeks continuous treatment

Fucoidan

On the basis of the original conventional treatment regimen, 2000 mg of placebo was administered orally twice a day for 12 weeks.

Background Therapy: Continued pre-existing conventional RA treatment at stable doses Intervention: Oral Corn starch as Placebo Dosage Form: Size-0 gelatin capsules containing 1000mg Placebo powder Dosage: 2000mg (2 capsules) per dose, twice daily (BID) Duration: 12 weeks continuous treatment

Corn starch

Patients will undergo their standard of care image-guided needle biopsy, aspiration, or injection with the Augmented Reality system. Patients will be monitored for adverse events for two weeks following their procedure.

Subjects will undergo image guided needle aspiration, injection, or biopsy facilitated by the Augmented Reality system. The Augmented Reality guidance system will be operated by the interventional radiologist in the MRI suite.

Augmented Reality System

Karun Sharma, MD, PhD

Emily Leibold, BSE

Karun Sharma, MD/PhD

Patients receive HDVD PO QW for 52 weeks. Patients also undergo collection of blood and DXA scan on study.

Biospecimen Collection

D Vitamin

Dual X-ray Absorptiometry

Quality-of-Life Assessment

Questionnaire Administration

Patients receive placebo PO QW for 52 weeks. Patients also undergo collection of blood and DXA scan on study.

Placebo Administration

University of Rochester NCORP Research Base

Site Public Contact

Gregory A. Masters

Vamsi K. Vasireddy

Bryan A. Faller

Elizabeth M. Wulff-Burchfield

Rajasree P. Chowdry

Brian T. Halbert

Sarah E. Jax

Jay W. Carlson

Khawaja S. Jahangir

Seth M. Miller

Elie B. Choufani

Heath B. Mackley

Michael Humeniuk

Stephen H. Dyar

Asheesh Shipstone

William J. Irvin

Asit K. Paul

Brian L. Burnette

Administer human matrix cells by intravenous infusion or nasal drip once every two weeks, for a total of 5 administrations.

The human-derived stromal cells were administered intravenously once every two weeks, for a total of 5 times. Among them, half of the subjects (10 people) received intranasal administration of human-derived stromal cells once a day, in the morning and evening, from the 6th to the 8th day after each administration; the remaining subjects (10 people) received nasal administration of placebo once a day, in the morning and evening, from the 6th to the 8th day after each administration.

Human-derived stromal cells

Liaoning Medical Diagnosis and Treatment Technology Research and Development Co., Ltd.

Autologous HB-adMSCs

Pilates training will be given individually for approximately 1 hour, 3 days a week for 8 weeks.

Pilates training will be given individually for approximately 1 hour, 3 days a week for 8 weeks. Before starting the exercise training, all participants will be taught the basic elements of Pilates in 1 session. Pilates training will begin with standing exercises for warming up and centering in the supine position. Training will continue with upper and lower extremity movements. The intensity of the exercises will be increased by using different positions and elastic bands. Stretching exercises and posture exercises will be used during the cool-down period. All exercises will start with 10 repetitions and will be increased to 20 later. Each movement will be shown by the physiotherapist first so that the patients can do the movements correctly. The movements that the patients cannot do will be modified appropriately and applied.

Pilates Group

Routine medication will be continued for 8 weeks.

No exercise will be allowed for 8 weeks and routine medication will continue.

Control Group

Seizure frequency will be calculated based on the patient's diary in the 2 months prior to the assessment. Patients without a seizure diary will be given one and asked to record their seizures for 2 months.

"Core" stability was evaluated with two important dimensions, "core" strength and endurance tests.

Balance will be assessed separately with static and dynamic balance tests. The Balance Error Scoring System test will be used to assess static balance, and the Four-Step Square Test will be used to assess dynamic balance.

Functional exercise capacity was evaluated using the 6 Minute Walking Test (6-MWT).

Cognitive function will be assessed with the Standardized Mini Mental State Examination and the Neuropsychological Test Battery for Cognitive Potentials.

Dual task will be evaluated by adding a second task to the Timed Up and Go Test (TUG).

Fatigue will be assessed using the Fatigue Severity Scale (FSS).

Kinesiophobia will be assessed with the Tampa Kinesiophobia Scale (TKS).

Sleep quality will be assessed by the Pittsburgh Sleep Quality Index (PSQI).

The Inventory of Neurological Disorders Depression in Epilepsy will be used to assess depression.

Quality of Life In Epilepsy (QOLIE-31) will be used to determine health-related quality of life in epilepsy.

Recep Tayyip Erdogan University Training and Research Hospital

All participants will complete one, 60-minute bout of stationary cycling

Exercise Mode

All participants will complete one, 60-minute bout of treadmill walking

INDUCTION: Patients receive bortezomib SC or IV on days 1, 4, 8, and 11; lenalidomide PO QD on days 1-14; and dexamethasone PO or IV on days 1, 2, 4, 5, 8, 9, 11, and 12. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity (patients who received a course of chemotherapy prior to registration will begin protocol treatment with course 2 and receive a total of 7 courses of protocol therapy).

MAINTENANCE: Patients receive bortezomib SC or IV on days 1, 8, and 15; lenalidomide PO QD on days 1-21; and dexamethasone PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Bortezomib

Dexamethasone

Laboratory Biomarker Analysis

Lenalidomide

INDUCTION: Patients receive bortezomib, lenalidomide, and dexamethasone as in Arm I. Patients also receive elotuzumab IV on days 1, 8, and 15 of courses 1 and 2 and on days 1 and 11 of courses 3-8. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.

MAINTENANCE: Patients receive bortezomib, lenalidomide, and dexamethasone as in Arm I. Patients also receive elotuzumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Elotuzumab

Prior to receiving CD79b-19 CAR T cells, participants will undergo two preparatory processes:

* Leukapheresis: During Week -3 white blood cells will be collected.
* Lymphodepletion: On days, -5 to -3 participants will receive 3 days of chemotherapy to decrease the number of lymphocytes

CD79b-19 CAR T cells will be administered intravenously on day 0 only. The dose you will receive will depend on the number of participants who have been enrolled prior and how well the dose was tolerated. The CD79b-19 CAR T cells will be administered over approximately 1 hour.

CD79b-19 CAR T cells

Matthew Frigault, MD

The clinician training is a generic, skills- and attitude-based approach for clinicians to acknowledge their decision making conversations with patients that 1) there is more than one option, and 2) patient's views matter in deciding what to do next. This tools-free approach can be used on the spot when needed and is termed fostering choice awareness (FCA). The one-hour training consists of 4 parts: 1) a knowledge session on evidence and guidelines on effective conversations and SDM, 2) video-review of behaviors which foster or hinder choice awareness, 3) clinical simulations in which clinicians practice fostering choice awareness behaviors, and 4) a reminder card for use in future clinic visits. Video clips will be of patient-clinician conversations around treatment decision making to prompt and probe clinicians' experiences, improve understanding, and improve practice.

Clinician communication training

The patient activation component consists of three questions patients can ask their clinician to help them become more involved: "1. What are my options?; 2. What are the possible benefits and harms of those options?; 3. How likely are each of those benefits and harms to happen to me?" These questions have been used in studies to promote improved communication in a number of conditions including cardiovascular disease, cancer, and women's health.

Patient activation

RA Choice presents information on FDA-approved RA treatments in a set of cards, which can be used alone or in combination based on a patient's preference, values, and the clinician's experience. The RA medication summary guide describes options for medication, physical therapy, occupational therapy, and ways to stay healthy with diet and exercise. Tool development followed key principles of creating low literacy materials that featured icons, short phrases written in plain language, and included topics of interest to RA patients faced with a medication decision. For the proposed study, we will include a paper-based version of the tool, or a web-based version available for telephone or VA Video Connect (VVC) visits. The tools will be updated to include new FDA-approved therapies (e.g., JAK inhibitors).

RA Medication summary guide and RA Choice

Gabriela Schmajuk, MD

Anna Montgomery

Madhavi Valiveti, MD

LaShaunda Isaac, MBA

Benjamin J Morasco, PhD MA

Alexandra P Bennett

Anais Tuepker, PhD MPH

Benjamin J. Morasco, PhD MA

Jennifer Barton, MD

Travis I. Lovejoy, PhD MPH

Joshua Baker, MD

Mariana Olave, BA

patients in group A received the two-drug antiemetic regimen (placebo cycle) during the first cycle followed by the three-drug regimen (aprepitant cycle) during the second cycle.

The two-drug regimen (placebo cycle) consisted of intravenous placebo 130 mg, intravenous ondansetron 8 mg, and intravenous dexamethasone 12 mg, all administered 30 minutes before chemotherapy on day 1, followed by oral dexamethasone 8 mg once daily on days 2-4.

The three-drug regimen (aprepitant cycle) replaced placebo with intravenous aprepitant 130 mg on day 1, with all other medications administered as in the two-drug regime

Two antiemetic groups use placebo, dexamethasone and ondansetron. Three antiemetic groups use aprepitant, dexamethasone and ondansetron.

Aprepitant Injection

patients in group B received the regimens in the reverse order. The three-drug regimen (aprepitant cycle) replaced placebo with intravenous aprepitant 130 mg on day 1, with all other medications administered as in the two-drug regime.

The two-drug regimen (placebo cycle) consisted of intravenous placebo 130 mg, intravenous ondansetron 8 mg, and intravenous dexamethasone 12 mg, all administered 30 minutes before chemotherapy on day 1, followed by oral dexamethasone 8 mg once daily on days 2-4.

Sichuan Cancer Hospital and Research Institute

Participants will receive their regularly scheduled hemodialysis treatments using a super high-flux dialyzer (Nipro Elisio HX).

A hemodialysis filter (known as a dialyzer) that is currently approved by Health Canada and available for use across Canada. This filter has larger pores than a high-flux dialyzer that allow for greater removal of potential toxins and wastes in the blood that would regularly be filtered out by healthy kidneys.

Super High-Flux Dialyzer

Participants will receive their regularly scheduled hemodialysis treatments using a high-flux dialyzer (as prescribed in routine care).

A hemodialysis filter (known as a dialyzer) that is that is widely used across Canada for hemodialysis treatments.

High-Flux Dialyzer

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

사이클로포스파마이드, 플루다라빈, 메스나, 클리니맥스, CD19 특이적 CAR 엔지니어링 자가 T 세포(SJCAR19 제품)

페그필그라스팀, AC 요법, 사이클로포스파마이드, 독소루비신 염산염, 파클리탁셀

위약, 니포칼리맙

텔레홈 모니터링

테포티닙, 오시머티닙

QLS12010, 위약

애벗 프리스타일 리브레 CGM

시스플라틴, 5-플루오로우라실 또는 카페시타빈, 트라스투주맙, 페르투주맙, 위절제술

후코이단, 옥수수 전분

증강현실 시스템

생체 시료 채취, 비타민 D, 이중 X선 흡수 측정법, 위약 투여, 삶의 질 평가, 설문지 투여

인간 유래 기질 세포

자가 HB-adMSC

필라테스 그룹, 컨트롤 그룹

운동 모드

보르테조밉, 덱사메타손, 엘로투주맙, 실험실 바이오마커 분석, 레날리도마이드

CD79b-19 CAR T 세포, 사이클로포스파마이드, 플루다라빈

임상의사 소통 교육, 환자 활성화, RA 약물 요약 가이드 및 RA 선택

아프레피탄트 주사제

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