AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Study NCT03902106 — intervention group
Intervention type: OTHER
Group type: SHAM_COMPARATOR
Intervention: exercise
Description: subjects undergo 6 weeks of endurance training (3 times weekly)
Study NCT02780219 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: stable amino acid infusion
Description: stable isotopes Such as L-\[ring-13C6\]-Phenylalanine, L-\[ring-D4\]Tyrosine, L-\[Methyl-D3\]Tau-Methylhistidine, trans-\[2,5,5-D3\]4-Hydroxy-L-proline, L-\[Guanido-15N2\]-Arginine, L-\[4,4,5,5-D4-5-13C\]Citruline, L-13C5 -Ornithine, L-15N2-Glutamine, L-\[1,2-13C2\]Glutamic Acid, 1-13C-Glycine, L-15N3-Histidine, L-13C6-Leucine, L-\[methyl-D3\]Methionine, α-1-13C-ketoisocaproic acid, L-1-13C-Methionine, DL-\[3,3,4,4-D4\]Homocysteine, L-\[1,2-13C2\]Taurine, L-(Indole-D5)Tryptophan, 13C-Urea, L-1-13C-Isoleucine, L-13C5-Valine, α-\[Dimethyl-13C2\]ketoisovaleric acid, 2-keto-3-methyl-13C6-pentanoate, 3-hydroxy-\[3,4-methyl-13C3\]isovaleric acid, 13C3-glycerol is given IV simultaneously
Study NCT02780219 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: acute exercise with amino acid infusion
Description: resistance exercise of each limb (i.e., leg (right/left); arm (right/left) on an isokinetic exercise machine allowing control of velocity, force, etc. with stable isotopes such as L-\[ring-13C6\]-Phenylalanine, L-\[ring-D4\]Tyrosine, L-\[Methyl-D3\]Tau-Methylhistidine, trans-\[2,5,5-D3\]4-Hydroxy-L-proline, L-\[Guanido-15N2\]-Arginine, L-\[4,4,5,5-D4-5-13C\]Citruline, L-13C5 -Ornithine, L-15N2-Glutamine, L-\[1,2-13C2\]Glutamic Acid, 1-13C-Glycine, L-15N3-Histidine, L-13C6-Leucine, L-\[methyl-D3\]Methionine, α-1-13C-ketoisocaproic acid, L-1-13C-Methionine, DL-\[3,3,4,4-D4\]Homocysteine, L-\[1,2-13C2\]Taurine, L-(Indole-D5)Tryptophan, 13C-Urea, L-1-13C-Isoleucine, L-13C5-Valine, α-\[Dimethyl-13C2\]ketoisovaleric acid, 2-keto-3-methyl-13C6-pentanoate, 3-hydroxy-\[3,4-methyl-13C3\]isovaleric acid, 13C3-glycerol is given IV simultaneously
Study NCT02780219 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: 24-hour post exercise amino acid infusion
Description: stable isotopes such as L-\[ring-13C6\]-Phenylalanine, L-\[ring-D4\]Tyrosine, L-\[Methyl-D3\]Tau-Methylhistidine, trans-\[2,5,5-D3\]4-Hydroxy-L-proline, L-\[Guanido-15N2\]-Arginine, L-\[4,4,5,5-D4-5-13C\]Citruline, L-13C5 -Ornithine, L-15N2-Glutamine, L-\[1,2-13C2\]Glutamic Acid, 1-13C-Glycine, L-15N3-Histidine, L-13C6-Leucine, L-\[methyl-D3\]Methionine, α-1-13C-ketoisocaproic acid, L-1-13C-Methionine, DL-\[3,3,4,4-D4\]Homocysteine, L-\[1,2-13C2\]Taurine, L-(Indole-D5)Tryptophan, 13C-Urea, L-1-13C-Isoleucine, L-13C5-Valine, α-\[Dimethyl-13C2\]ketoisovaleric acid, 2-keto-3-methyl-13C6-pentanoate, 3-hydroxy-\[3,4-methyl-13C3\]isovaleric acid, 13C3-glycerol is given IV simultaneously
Study NCT01592747 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Memantine Hydrochloride (HCl)
Description: Extended Release Dose ranging from 3mg every other day to 6mg/day; administered orally.
Study NCT01592747 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo capsules
Description: Once daily, oral administration.
Study NCT00519298 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: SAM-531
Description: dosage form : 0.5 mg and 5 mg capsules 3 different single doses : 1 mg, 3mg and 10 mg of SAM-531
Study NCT00519298 — intervention group
Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: placebo
Description: placebo
Study NCT00519298 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Donepezil
Description: dosage form: 5 mg encapsulated tablets one single dose of 5 mg.
Study NCT00896636 — intervention group
Intervention type: PROCEDURE
Intervention: Random fine need aspiration (rFNA)
Description: Deep infiltration into the tissue of each breast with up to a 21 gauge needle attached to a syringe with about 4-5 passes at each location (up to 8-10 passes per breast) under local anesthesia (lidocaine).
Study NCT00896636 — intervention group
Intervention type: OTHER
Intervention: Mammogram
Description: Standard mammography of both breasts to obtain images for breast density measurement.
Study NCT04458883 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Fast Field Cycling - Magnetic Resonance Imaging
Description: Fast Field Cycling - Magnetic Resonance Imaging Cardiac Scan
Study NCT04458883 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Electrocardiogram
Description: Electrocardiogram
Study NCT04458883 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Echocardiogram
Description: Echocardiogram
Study NCT03530774 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: powdered egg white protein supplement
Description: consumption of egg white protein supplement daily for 6 months
Study NCT03530774 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: maltodextrin supplement
Description: consumption of maltodextrin supplement daily for 6 months
Study NCT03496402 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Sampling on blood, bone marrow and cerebrospinal fluid
Description: biological sampling during treatment and follow-up
Study NCT00766961 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Trans-catheter arterial embolization
Description: Trans-catheter arterial embolization
Study NCT00766961 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Surgery
Description: Surgery
Study NCT03680430 — intervention group
Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Adaptive radiation therapy
Description: Patients will be treated by preoperative or definitive radiotherapy for a limb STS, using an intensity-modulated conformal irradiation (with a static or dynamic technic), over 5 to 7 consecutive weeks. The total dose delivered will be of 50 Gray (preoperative RadioTherapy), or 60 to 70 Gray (exclusive RadioTherapy).
Study NCT03412071 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Oral Tinidazole
Description: Please see description under arms
Study NCT03412071 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Topical metronidazole
Description: Please see description under arms
Study NCT02095522 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo
Study NCT03685617 — intervention group
Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Dual Chamber Pacemaker
Description: 1. Conducting venipuncture. Subclavian vein is our first choice. Then we set up two venous channels and implant two guiding wires into postcava. 2.Putting 2 sheathing canals into heart along with guiding wires. 3.Locating the sheathing canals, and putting electrodes into canals. 3.Adjusting the electrodes and revolving them anticlockwise to lead them to right atrium and right ventricle respectively under the X-ray. 4.Immobilizing electrodes. 5. Some ways to determine whether the electrode is fixed or not: the head of the electrodes could beat rhythmically with atrium or ventricle or by testing damage current. 6.Removing the canals and suturing.
Study NCT03685617 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: His Bundle Pacemaker
Description: 1.Conducting venipuncture. Subclavian vein is our first choice. Then we set up two venous channels and implant two guiding wires into postcava. One of the guide wire is 120cm in length, 0.035 or 0.038 in diameter, which is required to lead the C315 sheathing canal. 2.Putting C315 sheathing canal into heart along with guiding wires. 3.Locating the C315 sheathing canal, and adjusting the head of C315 towards ideal pacing location. 3.Implanting the spiral electrodes and fixing them. Leading the spiral electrode to the side of his bundle along the C315 canal under the X-ray. The other electrode is leaded to right atrium like dual chamber pacemaker under the X-ray. 4.Revolving the 3830 electrode suitably to Immobilizing it in cardiac muscle. If the electrode can get his electric potential and produce his bundle pacing successfully, we revolve the 3830 electrode and immobilize it.
Study NCT01897077 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Peanut Dissolving Film
Study NCT01897077 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Peanut Dissolving Film
Study NCT04417439 — intervention group
Intervention type: OTHER
Intervention: universal goniometer. evaluate the circumference measurement. The biochemical examination of CK (creatine kinase)
Description: The joint range of motion within the affected areas of burn patients was assessed by a universal goniometer. A 7-mm-wide tape measure was used to evaluate circumference measurement in individuals. The biochemical analysis of CK (creatine kinase) was performed by an expert on blood samples taken from patients in the hospital laboratories.
Study NCT03610386 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Adding menthoxypropanediol to the biopsy
Description: Two biopsies of skin (4 mm diameter each) will be taken under local anesthetic in the service of dermatology of Brest CHRU. They will be situated in a pruritic lesion area little or not visible (inside of the arm, the back ...). One of the two biopsies will receive menthoxypropanediol topically.
Study NCT03610386 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: No adding menthoxypropanediol to the biopsy
Description: Two biopsies of skin (4 mm diameter each) will be taken under local anesthetic in the service of dermatology of Brest CHRU. They will be situated in a pruritic lesion area little or not visible (inside of the arm, the back ...). One of the two biopsies will not receive menthoxypropanediol.
Study NCT04439123 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Capivasertib
Description: Given PO
Study NCT03412071 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Topical Clindamycin
Description: Please see description under arms
Study NCT03412071 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Topical Hydrogen Peroxide
Description: Please see description under arms
Study NCT00995865 — intervention group
Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: XRX-001 Inactivated yellow fever vaccine
Description: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10\^8 VE/0.5mL and Mid dose = 2.2 x 10\^7 VE/0.5mL
Study NCT00995865 — intervention group
Intervention type: BIOLOGICAL
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: NaCl Injectable 0.9%
Study NCT02653027 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Lumacaftor-ivacaftor
Description: Subjects who are planning on starting the combination therapy (lumacaftor-ivacaftor) will participate in OGTTs before and after starting the medication.
Study NCT02653027 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: OGTT
Description: A subject is given an oral glucose load and insulin and glucose measurements are taken at specified time periods.
Study NCT04263454 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Endotoxin, Escherichia Coli
Description: Endotoxin is a purified lipopolysaccharide prepared from E. coli O:113 and vialed under good manufacturing practice guidelines.
Study NCT04263454 — intervention group
Intervention type: DRUG
Group type: OTHER
Intervention: Endotoxin, Escherichia Coli
Description: Endotoxin is a purified lipopolysaccharide prepared from E. coli O:113 and vialed under good manufacturing practice guidelines.
Study NCT04263454 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Magnetic Resonance Spectroscopy
Description: MRI is a non-invasive imaging technique and does not utilize ionizing radiation.
Study NCT04263454 — intervention group
Intervention type: PROCEDURE
Group type: OTHER
Intervention: Magnetic Resonance Spectroscopy
Description: MRI is a non-invasive imaging technique and does not utilize ionizing radiation.
Study NCT01674634 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: XIAFLEX / XIAPEX
Description: injection (0.58 mg after reconstitution with sterile diluent \[0.3 mg/mL calcium chloride dihydrate in 0.9% sodium chloride\])
Study NCT01473056 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: JTK-853
Description: Tablets, twice a day for 3 days
Study NCT01473056 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dose 2 JTK-853
Description: Tablets, twice a day for 3 days
Study NCT01473056 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dose 3 JTK-853
Description: Tablets, three times a day for 3 days
Study NCT01473056 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dose 4 JTK-853
Description: Tablets, twice a day for 3 days
Study NCT01473056 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Tablets, twice a day or three times a day for 3 days
Study NCT05591846 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Face-to-face training
Description: Face-to-face training
Study NCT05591846 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: web-based training
Description: web-based training
Study NCT01003444 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Muscle biopsy
Description: Collection of muscle biopsies of the vastus lateralis will be performed by a consulting specialist. The first muscle biopsy (Day 1, 2 hour) will be obtained from the vastus lateralis muscle of the non-dominant leg. The second biopsy (Day 1, 4 hour) will be obtained from the same vastus lateralis muscle on the same leg approximately 10 centimeters from the first muscle biopsy site.
Study NCT01277510 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: cinacalcet capsule
Description: Cinacalcet was prepared for oral administration as both capsules for sprinkling and film coated tablets for swallowing.
Study NCT01277510 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: placebo
Description: Placebo tablets and capsules for sprinkling identical to active treatment.
Study NCT01277510 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Standard of Care
Description: All participants, regardless of treatment assignment, will receive standard of care with vitamin D sterols (calcitriol and its analogs), as prescribed by the treating physician.
Study NCT01277510 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Standard of Care
Description: All participants, regardless of treatment assignment, will receive standard of care with vitamin D sterols (calcitriol and its analogs), as prescribed by the treating physician.
Study NCT03670758 — intervention group
Intervention type: DIAGNOSTIC_TEST
Intervention: Protein S activity
Description: Intravenous blood sample
Study NCT04262245 — intervention group
Intervention type: PROCEDURE
Group type: OTHER
Intervention: Traditional Irrigation
Description: irrigation with syringe
Study NCT04262245 — intervention group
Intervention type: DEVICE
Group type: OTHER
Intervention: Xp-endo Finisher (XPF)
Description: irrigation activation file
Study NCT04262245 — intervention group
Intervention type: DEVICE
Group type: OTHER
Intervention: Passive Ultrasonic Irrigation
Description: irrigation activation method
Study NCT04262245 — intervention group
Intervention type: DEVICE
Group type: OTHER
Intervention: EndoActivator
Description: irrigation activation method
Study NCT00885898 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Non-invasive-ventilation
Description: increased oxygen fraction, continuous positive pressure ventilation, if necessary pressure support ventilation or even intermittent positive pressure ventilation
Study NCT02025517 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Cognitive Tasks.
Description: The Experimental Group underwent treadmill gait training simultaneously to a protocol of cognitive tasks created specifically for this study, based on cognitive activities proposed in previous studies. The training sessions lasted 20 minutes. The first three minutes allowed subjects to familiarize themselves with the treadmill. From the 4th minute onward, the volunteer walked for 1 minute while performing cognitive tasks, and in the following minute, only walked. Thus, the 17 remaining minutes on the treadmill alternated between one minute of treadmill training combined with a cognitive task and the following minute only treadmill training. Treadmill gait speed was that reported by the patient as the fastest possible speed while maintaining a suitable comfort level.
Study NCT01762046 — intervention group
Intervention type: DRUG
Group type: OTHER
Intervention: Glipizide
Study NCT04337658 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Pertuzumab
Description: Participants will receive 840 milligrams (mg) loading dose of pertuzumab, followed every 3 weeks thereafter by a dose of 420 mg via intravenous (IV) infusion until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
Study NCT00885898 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: conventional treatment
Description: oxygen, diuretics, bronchodilators, positive inotropic drugs
Study NCT00124657 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Erlotinib hydrochloride
Description: This study has 2 components: a Phase I component which estimated the MTD and DLT(s) of erlotinib given once a day during and after conventionally fractionated RT for a period of 8 weeks (DLT-evaluation period), followed by continuous administration of this medication for up to 3 years; and a Phase II component where erlotinib will be given at the MTD during and after RT for 2 years. The recommended dose of erlotinib for the Phase II component of the current study is 120mg/m2 per day (maximum dose of 200mg per day).
Study NCT01456403 — intervention group
Intervention type: OTHER
Intervention: Histological validation
Description: 3D ultrasound, PET/CT, MRI, contrast ultrasound
Study NCT03410771 — intervention group
Intervention type: DRUG
Intervention: Monitor antibiotic exposure (PK profile)
Description: several plasma samples to measure drug exposure
Study NCT03410771 — intervention group
Intervention type: DEVICE
Intervention: Bioelectrical impedance analysis to measure body composition
Description: non invasive analysis (electrodes) to measure extra- and intracellular, and total body water.
Study NCT04321031 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Tablet
Study NCT04321031 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PF-06865571
Description: Tablet
Study NCT04337658 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pertuzumab
Description: Participants will receive 840 milligrams (mg) loading dose of pertuzumab, followed every 3 weeks thereafter by a dose of 420 mg via intravenous (IV) infusion until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
Study NCT04337658 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Trastuzumab
Description: Participants will receive trastuzumab (8 mg/kg loading dose for Cycle 1, followed by 6 mg/kg for subsequent cycles) administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
Study NCT04337658 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Trastuzumab
Description: Participants will receive trastuzumab (8 mg/kg loading dose for Cycle 1, followed by 6 mg/kg for subsequent cycles) administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
Study NCT04337658 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Fulvestrant
Description: 500mg intramuscular injections at day 1, 15, 28 and 4 weeks thereafter
Study NCT04337658 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Capecitabine
Description: 1000mg/m2 orally Bid on day 1 to day 14 every 3 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
Study NCT04321031 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PF-05221304
Description: Tablet
Study NCT01762046 — intervention group
Intervention type: DRUG
Group type: OTHER
Intervention: Metformin
Study NCT01762046 — intervention group
Intervention type: OTHER
Group type: OTHER
Intervention: Oral Glucose Tolerance Test
Study NCT03702686 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: FEEDBACK System
Description: Smart Nipple Shield and Monitor Unit
Study NCT03571321 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ruxolitinib
Description: Participants will receive one of 3 doses \[taken by mouth\] (30 mg, 40 mg, or 50 mg) depending on when they are enrolled to the study.~Remission consolidation regimen:~* Days 1-14 and 29-43~Interim maintenance regimen:~* Days 1-14 and 29-43~Delayed Intensification regimen:~* Days 1-14 and 29-43
Study NCT03571321 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclophosphamide
Description: Remission consolidation regimen:~* 1000 mg/m2 by intravenous infusion (IV) on Day 1 and Day 29~Delayed Intensification regimen:~* 1000 mg/m2 IV on Day 29
Study NCT03571321 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cytarabine
Description: Remission consolidation regimen:~* 75 mg/m2/day IV or subcutaneously (SC) on Days 1-4 (i.e., 4 doses), 8-11, 29-32, and 36-39~Delayed Intensification regimen:~* 75 mg/m2/day IV or SC on Days 29-32 and 36-39
Study NCT03571321 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Mercaptopurine
Description: Taken by mouth.~Remission consolidation regimen:~* 60 mg/m2 on Days 1-14 and 29-42~Maintenance Therapy:~* 75 mg/m2 on Days 1-84
Study NCT03571321 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Vincristine
Description: Remission consolidation regimen:~* 1.5 mg/m2 (maximum 2 mg) IV once per week on Days 15, 22, 43, and 50~Interim maintenance regimen:~* 1.5 mg/m2 (maximum 2 mg) IV on Days 1, 11, 21, 31, and 41~Delayed Intensification regimen:~* 1.5 mg/m2 (maximum 2 mg) IV on Days 1, 8, 15, 43, and 50~Maintenance Therapy:~* 1.5 mg/m2 (maximum 2 mg) IV on Days 1, 29, and 57
Study NCT03571321 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pegaspargase
Description: Remission consolidation regimen:~* 2500 IU/m2 given by intramuscular (IM) injection or IV on Days 15 and 43~Interim maintenance regimen:~* 2500 IU/m2 IM or IV on Days 2 and 22~Delayed Intensification regimen:~* 2500 IU/m2 IM or IV on Day 4 (OR Day 5 OR Day 6) AND Day 43.