Modified Atkins Diet - high fat, low carbohydrate, outpatient initiated approach. Parents will check urine ketones twice weekly and follow by email, phone and clinic. Labs at baseline and 3 months. Dietitian support.

Low carb (20g/day), high fat, moderate protein diet. Started as an outpatient in clinic.

Modified Atkins Diet

Families will have the usual care for absence epilepsy at the discretion of the family's neurologist and the family choice. Typically ethosuximide bis in die (BID), however, if convulsions have occurred or other factors are involved, the child may be started on valproate or lamotrigine. The child will continue medications with dose adjustment and antiseizure drug levels checked as usual. \*\*OF NOTE, THIS ARM IS COMPLETED

At neurologist's discretion. \*OF NOTE\< THIS ARM IS COMPLETED

Absence epilepsy medications

Eric H Kossoff, MD

Zahava Turner, RD

Courtney Haney, RD

Eva Catenaccio, MD

Danielle DeCampo, MD

Rachel Penn, MD

Ania Dabrowski, MD

Lindsay Schleifer, MD

This group will stop their heart failure medication(s) under the supervision of the study team. The investigators expect most participants in the STOP group to only be on beta-blockers (BB) and/or angiotensin-converting-enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARB). The ACEi or ARB will be stopped first. The ACEi or ARB will be reduced by 50% every 7 days and stopped 7 days after 25% of maximal recommended dose for HF is reached. At this point (or at baseline if only on BB), the BB dose will be reduced by 50% every 7 days then stopped once 25% of the maximal dose is reached. Participants on 75% of the maximal dose will be reduced to 50% of the maximal dose before reducing by 50% every 7 days. Other HF medications will be stopped as follows: MRA: reduce by 50% every 7 days then stop once 50% of maximal dose is reached; SGLT2i: stopped without titration, ARNi: reduce by 50% every 7 days then stop once 25% of the maximal dose.

This group will stop their heart failure medication(s) under the supervision of the study team.

Stopping Heart Failure Medication(s)

This group with continue with their heart failure medication(s) for at least 1 year.

Tom Marwick, MD

James White, MD

Edith Pituskin, PhD

Davinder Jassal, MD

Darryl Leong, MD

Ian Paterson, MD

Kim Connelly, MD

Paaladinesh Thavendiranathan, MD

Charlotte Manisty, MD

Anju Nohria, MD

Eligible patients with ER-positive breast cancer will undergo a biopsy and be randomized to receive endocrine therapy (ET) versus endocrine therapy with palbociclib (PET) in a 1:2 ratio. A 1:2 ratio means that twice as many participants will be assigned to the PET arm as compared to the ET arm. After 1 cycle (28 days) another biopsy will be obtained, and both arms will receive avelumab (A) for 3 additional cycles. Patients will then undergo breast surgery.

Avelumab (10 mg/kg) will be given intravenously on cycles 2 - 4, every 2 weeks.

Avelumab

The endocrine therapy given will depend on menopausal status.

Premenopausal women will receive tamoxifen AND either Goserelin or Leuprolide:

* Tamoxifen (20mg) will be given orally daily x 4 cycles. (Other Names: Nolvadex)
* Goserelin (3.6mg) will be given subcutaneously (under the skin) on Day 1 of each cycle x 4 cycles. (Other Names: Zoladex)
* Leuprolide (3.75mg) will be given intramuscularly (in the buttock, thigh, or upper arm) on Day 1 of each cycle x 4 cycles. (Other Names: Leuprorelin, Lupron, Eligard)

Postmenopausal women will receive letrozole:

\- Letrozole (2.5mg) will be given orally daily each cycle x 4 cycles. (Other Names: Femara)

Endocrine therapy

Palbociclib (125 mg) will be given orally on days 1-21 of each cycle x 4 cycles.

Palbociclib

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Gemcitabine (2.5 g/m²) (Days -9 and -3), Busulfan (3.2 mg/kg) (Days -9 to -7), and Thiotepa (5 mg/kg) (Days -5, -4, and -3) were all administered intravenously.

Gemcitabine (2.5 g/m²) (Days -9 and -3), Busulfan (3.2 mg/kg) (Days -9 to -7), and Thiotepa (5 mg/kg) (Days -5, -4, and -3) were all administered intravenously. Peripheral stem cells were infused on Day 0.

High dose Gemcitabine, Busulfan, and Thiotepa as conditioning therapy

Jie Ji, MD

The study doctors will provide standard of care with routine reactive topical products for atopic dermatitis flares

Participants' eczema will be managed by their primary physician, i.e. standard of care with routine reactive topical products for atopic dermatitis flares.

Standard of Care

Participants will receive proactive sequential skin care with the twice-daily use of a tri-lipid skin barrier cream (SBC). Clinically apparent eczema in this group will be managed with a short course of topical steroids (fluticasone propionate cream and/or hydrocortisone).

The aim is to compare the effect of proactive sequential skin care, including the twice daily use of a tri-lipid skin barrier cream (Epiceram) and proactive use of fluticasone proprionate cream, against reactive AD therapy, to reduce the occurrence and severity of AD in early infancy and thereby prevent food allergy (FA).

Tri-lipid skin barrier cream (Epiceram)

Proactive use of fluticasone proprionate cream for inflammation of the skin, to reduce the occurrence and severity of AD in early infancy and thereby prevent food allergy (FA).

Fluticasone propionate Cream 0.05%

Adebellizumab: intravenous drip, 1200mg, the infusion time is controlled between 30-60 minutes, and the infusion is completed within 2 hours at most. It is administered on the first day of each cycle and repeated once every 3 weeks.Irinotecan liposome: intravenous drip, 80mg/m2, infusion time of 30 minutes, the first dose of each cycle, repeated once every 3 weeks.After 4-6 cycles of adebelizumab combined with irinotecan liposome treatment, the subjects who did not develop the disease continued to use adebelizumab (1200mg, D1, Q3W) for maintenance treatment until the disease progressed, the toxicity was intolerable, the subjects voluntarily asked to withdraw and the researchers judged that the subjects needed to withdraw from the study.

Adebelizumab combined with irinotecan liposome as second-line therapy

Peking University Cancer Hospital & Institute

Yang Wang, MD

Giredestrant 30 milligrams (mg) will be administered orally once a day (QD) on Days 1-28 of each 28-day cycle for 5 years or until disease recurrence or unacceptable toxicity (whichever occurs first).

Giredestrant

A luteinizing hormone-releasing hormone (LHRH) agonist will be administered to male participants and premenopausal/perimenopausal participants according to local prescribing information. The investigator may determine and supply the appropriate LHRH agonist locally approved for use in breast cancer.

LHRH Agonist

The endocrine therapy of physician's choice (TPC) is limited to tamoxifen or one of the specified third generation aromatase inhibitors: letrozole, anastrozole, or exemestane. Participants will receive TPC daily on Days 1-28 of each 28-day cycle for 5 years or until disease recurrence or unacceptable toxicity (whichever occurs first). Continuing TPC after 5 years is at the discretion of the investigator and per local standard of care. Dose administration of TPC should be performed in accordance with the local prescribing information for the respective product.

Endocrine Therapy of Physician's Choice

In this substudy, participants will receive giredestrant in combination with abemaciclib for up to 2 years. Participants will continue with giredestrant monotherapy for an additional 3 years in order to complete a total of 5 years on study treatment.

Abemaciclib 150 mg will be administered orally (PO) twice a day (BID) on Days 1-28 during each 28-day cycle for 2 years or until disease recurrence or unacceptable toxicity (whichever occurs first).

Abemaciclib

Patients receive UD TGFbetai NK cells IV over 30 minutes on day 1 and temozolomide PO daily on days 1-5. Treatment with UD TGFbetai NK cells repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Cycles of temozolomide repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Natural Killer Cell Therapy

Temozolomide

Kari L. Kendra, MD

allergologic skin tests (prick tests and intradermal tests)

Drug skin tests (investigating hypersensitivity to a biotherapy)

Martine MORISSET

Dominique LUET

Jonathan FAHRU

Youssef OULKHOUIR

Yannick LE CORRE

Patients receive standard of care fludarabine IV over 1 hour and standard of care cyclophosphamide IV over 30-60 minutes on days -5 to -3, AFM13-NK IV over 4 hours on day 0, and then AFM13 IV over 4 hours on days 7, 14, and 21.

Anti-CD30/CD16A Monoclonal Antibody AFM13

Cyclophosphamide

Fludarabine

Fludarabine Phosphate

Genetically Engineered Lymphocyte Therapy

IV Cyclophosphamide x 2 doses AND Rituximab AND Prednisone x 4 weeks

IV Cyclophosphamide 15mg/kg/dose (age and eGFR adjusted), 2 doses 2 weeks apart

Prednisone

Rituximab infusions, dosing and schedule at clinician/investigator discretion

Rituximab (R)

Participants in this arm receive standard of care treatment induction agent and glucocorticoid dose/duration, left to the discretion of the investigator

Participants will receive standard of care induction agent and glucocorticoid taper, at investigator discretion

Standard of Care (SOC)

3 loading doses followed by administration every 4 weeks as per label

Ofatumumab

Participants randomized to the continued therapy arm will continue to take their disease modifying treatment (DMT) as prescribed commercially by their physician.

Other DMT with approved label use for treatment which participants were on at least 6 months prior to Screening

Disease modifying treatment (DMT)

Emily Sherill Riser

Christopher LaGanke

Osman Salim

Leslie Zuniga

Bijal Mehta

Alicia Cabrera

Jorge Diaz

Angel Carrasco

William David Honeycutt

Tiffany Gilliard

Amparo Gutierrez

David Bear

John Ciotti

Nina Bozinov

Ariel Antezana-Antezana

Daniel Becker

Candace Leblanc

Gary Keilson

Mirela Cerghet

Jeanie Lynn Cote

Mary Willis

Mathew Tremblay

David Duncan

Corey McGraw

Irena Dujmovic Basuroski

Matthew Carraro

Casey Farin

Robert Carlile

Sibyl Wray

Santiago Rios

Djamchid Lotfi

Jontel Pierce

Bhupesh Dihenia

Cathy Sabouni

Amber Christian

Razi Rashid

Michelle Betz-Kuczma

Jason Poon

Pavle Repovic

James Napier

Ahmed Obeidat

Standard treatment for severe pneumonia and pneumonia in HIV-infected infants:

Ceftriaxone 80 mg/k/day or Ampicillin plus Gentamicin ampicillin 50 mg/kg, or benzylpenicillin 50,000 unit/kg im/iv every six hours plus Gentamicin 7.5 mg/kg/im or iv once a day Cotrimoxazole trimethoprim (TMP) 8mg/kg/dose + sulfamethoxazole (SMX) 40mg/kg/dose three times daily Prednisolone 2mg/kg during 7 days, plus 1mg/kg other 7 days, plus 0.5 mg/kg for 7 days

Treatment for cytomegalovirus (CMV) Valganciclovir (powder for suspension, 50 mg/mL) oral, 16 mg/kg/12 hours for 15 days, and Standard or Care as described in Control Group

Valganciclovir Oral Solution [Valcyte]

Treatment for tuberculosis Fixed-dose dispersible tablet of rifampicin, isoniazid, pyrazinamide (75/50/150 mg) Fixed-dose dispersible tablet of rifampicin/isoniazid (75/50 mg) Ethambutol 100 mg dispersible tablet Plus Standard of Care described in the Control Group

Doses of tuberculosis treatment:

Isoniazid 10 mg/kg (range 7-15 mg/kg)/day; maximum dose 300 mg/day for 6 months.

Rifampicin 15 mg/kg (range 10-20 mg/kg)/day; maximum dose 600 mg/day for 6 months.

Pyrazinamide 35 mg/kg (range 30-40 mg/kg)/day for 2 months. Ethambutol 20 mg/kg (range 15-25 mg/kg)/day for 2 months.

Tuberculostatic Agents

Treatment for CMV and for tuberculosis. Fixed-dose dispersible tablet of rifampicin, isoniazid, pyrazinamide (75/50/150 mg) Fixed-dose dispersible tablet of rifampicin/isoniazid (75/50 mg) Ethambutol 100 mg dispersible tablet Valganciclovir (powder for suspension, 50 mg/mL) oral, 16 mg/kg/12 hours for 15 days, Plus Standard of Care described in the Control Group

Doses of tuberculosis treatment:

Isoniazid 10 mg/kg (range 7-15 mg/kg)/day; maximum dose 300 mg/day for 6 months.

Rifampicin 15 mg/kg (range 10-20 mg/kg)/day; maximum dose 600 mg/day for 6 months.

Pyrazinamide 35 mg/kg (range 30-40 mg/kg)/day for 2 months. Ethambutol 20 mg/kg (range 15-25 mg/kg)/day for 2 months.

변형된 아킨스 다이어트, 결석 간질 치료제

심부전 치료제 복용 중단

아벨루맙, 내분비 치료제, 팔보시클리브

고용량 젬시타빈, 부설판, 티오테파를 컨디셔닝 치료제로 사용

트리리피드 피부장벽 크림(에피세람), 플루티카손 프로피오네이트 크림 0.05%, 표준치료제

2차 치료제로서 이리노테칸 리포좀과 병용한 아데벨리주맙

기레데스트란트, 의사가 선택한 내분비 치료제, LHRH 작용제, 아베마시클리브

자연살해세포치료제, 테모졸로마이드

약물 피부 테스트(생물학적 치료제에 대한 과민증 조사)

항-CD30/CD16A 단일클론 항체 AFM13, 사이클로포스파마이드, 플루다라빈, 플루다라빈 인산염, 유전자 조작 림프구 치료제

사이클로포스파마이드, 표준치료제(SOC), 프레드니손, 리툭시맙(R)

오파투무맙, 질병 개선 치료제(DMT)

발간시클로비르 경구용액[발사이트], 결핵 치료제

프라바스타틴(약물), 펜톡시필린, 케토프로펜, 피르페니도네온, 표준치료제(SOC), 토코페롤