TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02222441

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Palbociclib alone
Description: A single 125 mg dose of palbociclib free base capsule given orally alone in the fed state, followed by 120 hours of PK sample collection.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Palbociclib plus Modafinil
Description: For Cohort 1, modafinil 200 mg once daily for 7 days, followed by 400 mg once daily for 25 days; on Day 28, a single oral 125 mg dose of palbociclib will be given with modafinil after a meal, followed by 120 hours of PK sample collection.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Palbociclib alone
Description: A single 125 mg dose of palbociclib free base capsule given orally alone in the fed state, followed by 120 hours of PK sample collection.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Palbociclib plus pioglitazone
Description: For Cohort 2, pioglitazone 45 mg once daily for a total of 19 days; On Day 15, a single oral 125 mg dose of palbociclib will be given with pioglitazone after a meal, followed by 120 hours of PK sample collection.
Study: NCT00083720

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: cetuximab
Description: Initial dose of 400 mg/m2 intravenously (i.v.) over 120 minutes, followed by 250 mg/m2 weekly i.v. over 60 minutes
Study: NCT01324570

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Buprenorphine transdermal system
Description: Buprenorphine transdermal system 2.5 mcg/h, 5 mcg/h, 10 mcg/h or 20 mcg/h applied transdermally for 7-day wear.
Study: NCT01819753

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Percutaneous nephrolithotomy
Description: The procedure is done under general anesthesia in the supine position. A Retrograde pyelogram is done to locate the stone in the kidney. With a small incision in the flank, the percutaneous nephrolithotomy (PCN) needle is passed into the pelvis of the kidney. The position of the needle is confirmed by fluoroscopy. A guide wire is passed through the needle into the pelvis. The needle is then withdrawn with the guide wire still inside the pelvis. Over the guide wire the dilators are passed and a working sheath is introduced. A nephroscope is then passed inside and stones are taken out.

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Percutaneous nephrolithotomy
Description: The procedure is done under general anesthesia in the supine position. A Retrograde pyelogram is done to locate the stone in the kidney. With a small incision in the flank, the percutaneous nephrolithotomy (PCN) needle is passed into the pelvis of the kidney. The position of the needle is confirmed by fluoroscopy. A guide wire is passed through the needle into the pelvis. The needle is then withdrawn with the guide wire still inside the pelvis. Over the guide wire the dilators are passed and a working sheath is introduced. A nephroscope is then passed inside and stones are taken out.
Study: NCT04536870

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Echocardiography
Description: Ultrasound of heart

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Echocardiography
Description: Ultrasound of heart

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: ECG screening
Description: Single lead ECG screening twice daily for two weeks

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: ECG screening
Description: Single lead ECG screening twice daily for two weeks

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: ECG Screening
Description: 12-lead ECG screening
Study: NCT00664456

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Neoadjuvant therapy
Description: 3 cycle of LHRH-A (goserelin acetate 3.6mg/4 weeks or leuprorelin acetate 3.75mg/4 weeks).

Intervention type: RADIATION
Group type: ACTIVE_COMPARATOR
Intervention: Brachytherapy（iodine I 125）
Description: Undergo Iodine I-125 transperineal prostatic brachytherapy (TPPB).

Intervention type: RADIATION
Group type: ACTIVE_COMPARATOR
Intervention: Brachytherapy（iodine I 125）
Description: Undergo Iodine I-125 transperineal prostatic brachytherapy (TPPB).
Study: NCT00816621

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: ABC for Children Adopted Internationally
Description: Participants will participate in 10 weekly in-home intervention sessions aimed at enhancing the ability of children to regulate their attention, behavior, and physiology and to develop secure, organized attachments to their parents.

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: DEF for Children Adopted Internationally
Description: Participants will participate in 10 weekly in-home intervention sessions aimed at enhancing the intellectual and language development of children.
Study: NCT04266613

Intervention type: DIAGNOSTIC_TEST
Intervention: TruGraf® Testing
Description: 5 mL collection PAXgene blood sample
Study: NCT02589418

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Acupuncture
Description: Needle insertion and manipulation at 4 acupuncture points (bilateral LI4, right ST6 and ST7).

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Sham-Acupuncture
Description: Needle insertion and manipulation at 4 non-acupoints

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: No Acupuncture
Description: Control intervention: No needle insertion and manipulation
Study: NCT00962221

Intervention type: PROCEDURE
Intervention: laboratory analysis
Description: laboratory analysis
Study: NCT03966534

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Blood diversion
Description: Diversion of initial blood obtained at venipuncture to biochemistry tube in order to try and reduce incidence of blood culture contamination
Study: NCT04145609

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Multidisciplinary team (MDT) care and Acute kidney disease (AKD) clinic
Description: Multidisciplinary team (MDT) care: NPDS care model Acute kidney disease (AKD) clinic: layered approach
Study: NCT02440646

Intervention type: RADIATION
Intervention: Coronary computed tomography angiography
Description: The coronary arteries will be visualized with the MSCT scan CT 5000 Ingenuity (Philips, The Netherlands) or systems from any other vendors.

Intervention type: RADIATION
Intervention: Quantitative coronary angiography, intravascular imaging with percutaneous intervention
Description: Coronaries will be shot with Artis zee (Siemens, Germany) or systems from any other vendors. In case if necessary the procedure will be delayed for intravascular imaging (FFR, QFR, OCT, IVUS, VH-IVUS) and/ or percutaneous intervention (with implantation of the medical device).
Study: NCT03439098

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Fermented Codonopsis lanceolata 525mg
Description: Fermented Codonopsis lanceolata 525mg daily for 8 weeks

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Fermented Codonopsis lanceolata 1050mg
Description: Fermented Codonopsis lanceolata 1050mg daily for 8 weeks

Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo daily for 8 weeks
Study: NCT04536870

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: ECG Screening
Description: 12-lead ECG screening
Study: NCT00932659

Intervention type: DEVICE
Intervention: continuous cardiac monitoring device (REVEAL, Medtronic)
Description: hemodialysis patients without a prior history of cardiac arrhythmias will undergo implantation of a continuous cardiac monitoring device, and will undergo 6 months of follow-up
Study: NCT04488978

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Irbesartan/Amlodipine
Description: QID

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Irbesartan/Amlodipine
Description: QID
Study: NCT03285659

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Intervention: INDI Implementation
Description: Implementation of a collaborative care model in the context of primary care to manage depression
Study: NCT04488978

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Irbesartan/Amlodipine
Description: QID

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Irbesartan/Amlodipine
Description: QID

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Irbesartan/Amlodipine
Description: QID

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Irbesartan/Amlodipine
Description: QID

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Irbesartan/Amlodipine
Description: QID

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Irbesartan/Amlodipine
Description: QID
Study: NCT02750553

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: SHR0534

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: SHR0534

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: SHR0534

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: SHR0534

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: SHR0534

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: SHR0534

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Study: NCT02867241

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Behavioral Early
Description: Participants will receive an intervention which includes motivational interviewing, biochemical feedback, air quality feedback, phone calls, and social media

Intervention type: BEHAVIORAL
Group type: OTHER
Intervention: Behavioral Late
Description: After the close of the study, Participants will receive an intervention which includes motivational interviewing, biochemical feedback, air quality feedback, phone calls, and social media

Intervention type: BEHAVIORAL
Group type: OTHER
Intervention: Behavioral Late
Description: After the close of the study, Participants will receive an intervention which includes motivational interviewing, biochemical feedback, air quality feedback, phone calls, and social media
Study: NCT06014970

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Health and Wellness Curriculum
Description: The curriculum includes instructions, activities, and lessons on mindfulness, neurobiology, meditation, positive thinking, movement, and nutrition.
Study: NCT02206087

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PER977
Description: Reversal of heparin-induced anticoagulation

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PER977
Description: Reversal of heparin-induced anticoagulation

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PER977
Description: Reversal of heparin-induced anticoagulation

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PER977
Description: Reversal of heparin-induced anticoagulation

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PER977
Description: Reversal of heparin-induced anticoagulation

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PER977
Description: Reversal of heparin-induced anticoagulation

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: Reversal of heparin-induced anticoagulation

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: Reversal of heparin-induced anticoagulation

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: Reversal of heparin-induced anticoagulation

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: Reversal of heparin-induced anticoagulation

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: Reversal of heparin-induced anticoagulation

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: Reversal of heparin-induced anticoagulation

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Heparin Sodium

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Heparin Sodium

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Heparin Sodium

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Heparin Sodium

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Heparin Sodium

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Heparin Sodium
Study: NCT02604706

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: NADA Acupuncture
Description: NADA-acupuncture was delivered in three phases: (1) one treatment each day during the first of a total of five weeks; (2) three treatments each week during the following two weeks; (3) two treatments each week during the two remaining weeks. each session consisted of approximately 40 minutes with acupuncture at five ear points called Sympathetic, Shen Men, Kidney, Liver and Lung, which are believed to be the best points for substance abuse patients. Acupuncture was administered to both ears using stainless steel needles. NADA-acupuncture were given as a supplement to treatment as usual consisting of Motivational Interview, pharmacological treatment, and control of drug use with urine tests.

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: LP acupuncture
Description: The LP-acupuncture was delivered in two phases: (1) three treatments each week during the two first weeks; (2) two treatments each week for two weeks. each session consisted of approximately 40 minutes with acupuncture at five ear points called Sympathetic, Shen Men, Kidney, Liver and Lung, which are believed to be the best points for substance abuse patients. Acupuncture was administered to both ears using stainless steel needles. LP-acupuncture were given as a supplement to treatment as usual consisting of Motivational Interview, pharmacological treatment, and control of drug use with urine tests.

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Relaxation
Description: Relaxation consisted of listening to soft music in a quiet room with dampened light and was delivered to match the amount and phases of the LP-acupuncture. Relaxation were given as a supplement to treatment as usual consisting of Motivational Interview, pharmacological treatment, and control of drug use with urine tests.
Study: NCT01742234

Intervention type: PROCEDURE
Intervention: Organ Donation
Description: People in this study will donate either a lung or kidney

Intervention type: PROCEDURE
Intervention: Organ Donation
Description: People in this study will donate either a lung or kidney
Study: NCT04049240

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Device: low-flow nasal oxygenation (LFNO) 18<BMI<30 kg/m2
Description: Active comparator LFNO: O2 flow 5 L/min, FiO2 40%

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Device: low-flow nasal oxygenation (LFNO) 30≤BMI<35 kg/m2
Description: Active comparator LFNO: O2 flow 5 L/min, FiO2 40%

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Device: low-flow nasal oxygenation (LFNO) BMI≥35 kg/m2
Description: Active comparator LFNO: O2 flow 5 L/min, FiO2 40%

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Device: High-flow nasal oxygenation (HFNO) 18<BMI<30 kg/m2
Description: Experimental HFNO: O2 flow 40 L/min, FiO2 40%

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Device: High-flow nasal oxygenation (HFNO) 30≤BMI<35 kg/m2
Description: Experimental HFNO: O2 flow 40 L/min, FiO2 40%

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Device: High-flow nasal oxygenation (HFNO) BMI≥35 kg/m2
Description: Experimental HFNO: O2 flow 40 L/min, FiO2 40%
Study: NCT03148483

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Early PT
Description: Women will receive conventional non-surgical periodontal therapy (PT), consisting of prophylactic dental polishing to remove the sticky bacterial film that forms on the teeth over time, scaling and root planing, as necessary throughout pregnancy, up to delivery

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Early PT
Description: Women will receive conventional non-surgical periodontal therapy (PT), consisting of prophylactic dental polishing to remove the sticky bacterial film that forms on the teeth over time, scaling and root planing, as necessary throughout pregnancy, up to delivery

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Delayed PT
Description: Women will receive conventional non-surgical PT delayed until after delivery.

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Delayed PT
Description: Women will receive conventional non-surgical PT delayed until after delivery.

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Fortified Milk
Description: participants will be advised to take two servings of a powdered milk-based drink enriched with calcium and vitamin D daily during breakfast and afternoon snack or supper to avoid concomitant intake of the prenatal iron supplements routinely prescribed for consumption with hot main meals (e.g. lunch or dinner). Women will be advised to consume 20 g of commercially available semi-skimmed milk powder (provided by the study) and one sachet with 500 IU of vitamin D3 and 1,2 g of a calcium supplement from milk extract (300 mg of calcium) twice a day.

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Fortified Milk
Description: participants will be advised to take two servings of a powdered milk-based drink enriched with calcium and vitamin D daily during breakfast and afternoon snack or supper to avoid concomitant intake of the prenatal iron supplements routinely prescribed for consumption with hot main meals (e.g. lunch or dinner). Women will be advised to consume 20 g of commercially available semi-skimmed milk powder (provided by the study) and one sachet with 500 IU of vitamin D3 and 1,2 g of a calcium supplement from milk extract (300 mg of calcium) twice a day.

Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: Plain Milk
Description: Women will be advised to consume 20 g of commercially available semi-skimmed milk powder (provided by the study) and one sachet with flour (placebo).

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Plain Milk
Description: Women will be advised to consume 20 g of commercially available semi-skimmed milk powder (provided by the study) and one sachet with flour (placebo).
Study: NCT03163836

Intervention type: PROCEDURE
Intervention: double valve replacement
Description: After median sternotomy, cardiopulmonary bypass was established via bicaval and aortic cannulation. After cross-clamping of the aorta and cardioplegia, mitral and aortic replacement were performed. Supplementary procedures such tricuspid annuloplasty, ascending aorta replacement and coronary artery bypass grafting were performed as required. The left atrial appendage was excised to avoid thrombus formation.

Intervention type: PROCEDURE
Intervention: double valve replacement
Description: After median sternotomy, cardiopulmonary bypass was established via bicaval and aortic cannulation. After cross-clamping of the aorta and cardioplegia, mitral and aortic replacement were performed. Supplementary procedures such tricuspid annuloplasty, ascending aorta replacement and coronary artery bypass grafting were performed as required. The left atrial appendage was excised to avoid thrombus formation.

Intervention type: PROCEDURE
Intervention: surgical ablation
Description: Both left and right atrial ablation were performed using a bi-polar radiofrequency ablation clamp.
Study: NCT02072278

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Vortioxetine 10 mg

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Vortioxetine 20 mg

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Escitalopram 15 mg

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Study: NCT03453424

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: TEA+DEX
Description: intra and post operative TEA infusion of (bupivacaine +fentanyl 2 mic/ ml+ dexmedetomidine 0.5 mic/ ml) Under strict aseptic precautions thoracic epidural was performed using a 16 gauge,Tuhy epidural needle by a paramedian approach. T8-T9 inter space was chosen for the injection. Skin at insertion site was anesthetized by 3 ml of lidocaine 1%, the epidural space was identified by the loss of resistance technique, the catheter was introduced approximately 2-4 cm into the epidural space, epidural test dose consisted of 3 ml of lidocaine 2 % with 1: 200,000 adrenaline.

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: TEA
Description: Under strict aseptic precautions thoracic epidural was performed using a 16 gauge,Tuhy epidural needle by a paramedian approach. T8-T9 interspace was chosen for the injection. Skin at insertion site was anesthetized by 3 ml of lidocaine 1%, the epidural space was identified by the loss of resistance technique, the catheter was introduced approximately 2-4 cm into the epidural space, epidural test dose consisted of 3 ml of lidocaine 2 % with 1: 200,000 adrenaline.~then, intra and post operative TEA infusion of bupivacaine 0.125%+fentanyl 2 mic/ ml.
Study: NCT00815022

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: bupivacaine/fentanyl/morphine
Description: Hyperbaric bupivacaine 12 mg, fentanyl 10 microg and morphine 200 microg

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: bupivacaine/fentanyl/morphine
Description: Hyperbaric bupivacaine 12 mg, fentanyl 10 microg and morphine 200 microg

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: bupivacaine/fentanyl/morphine
Description: Hyperbaric bupivacaine 12 mg, fentanyl 10 microg and morphine 200 microg

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: bupivacaine/fentanyl/morphine
Description: Hyperbaric bupivacaine 12 mg, fentanyl 10 microg and morphine 200 microg

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: bupivacaine/fentanyl/morphine
Description: Hyperbaric bupivacaine 12 mg, fentanyl 10 microg and morphine 200 microg

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: bupivacaine/fentanyl/morphine
Description: Hyperbaric bupivacaine 12 mg, fentanyl 10 microg and morphine 200 microg
Study: NCT06442163

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: AVAPS study was performed within 1 week of the CPAP titration attempt failure, using the auto-titrating EPAP (AE), the OmniLab Advanced +, System One device (Philips Respironics, Murrysville, PA, U.S.
Description: After attending an educational session (in the presence of a family member) with hands-on training, the AVAP -AE devices were provided to the patients.~During the study, one month after AVAPS -AE initiation, patients had direct immediate access to medical and technical support through phone contact during daytime working hours.
Study: NCT01801423

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Hydroxyurea
Description: Hydroxyurea will be prescribed as an investigational therapy by the treating physician. Recommended guidelines for titration of hydroxyurea to maximal tolerated dose are below. The study intervention will include hydroxyurea to begin at \~20 mg/kg/day (range 17.5 - 26 mg/kg/day). No dose escalation will occur as this dose was shown to have some efficacy in infants with SCA and was associated with rare myelosuppression.(1)