TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT03383042

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cohort 1 (JP-1366 A mg)
Description: Drug: JP-1366 A mg or JP-1366 Placebo or Esomeprazole 40 mg

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cohort 2 (JP-1366 B mg)
Description: Drug: JP-1366 B mg or JP-1366 Placebo or Esomeprazole 40 mg

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cohort 3 (JP-1366 C mg)
Description: Drug: JP-1366 C mg or JP-1366 Placebo or Esomeprazole 40 mg

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cohort 4 (JP-1366 D mg)
Description: Drug: JP-1366 D mg or JP-1366 Placebo or Esomeprazole 40 mg

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cohort 5 (JP-1366 E mg)
Description: Drug: JP-1366 E mg or JP-1366 Placebo or Esomeprazole 40 mg

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cohort 6 (JP-1366 F mg)
Description: Drug: JP-1366 F mg or JP-1366 Placebo or Esomeprazole 40 mg

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cohort 7 (JP-1366 G mg)
Description: Drug: JP-1366 G mg or JP-1366 Placebo or Esomeprazole 40 mg

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cohort 8 (JP-1366 H mg)
Description: Drug: JP-1366 H mg or JP-1366 Placebo or Esomeprazole 40 mg

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cohort 9 (JP-1366 I mg)
Description: Drug: JP-1366 I mg or JP-1366 Placebo or Esomeprazole 40 mg
Study: NCT01130337

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Capecitabine [Xeloda]
Description: 1.000 mg/m2 orally every 12 hours from day 1 to day 14 of every cycle for 6 cycles

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Oxaliplatin
Description: 130 mg/m2 intravenous infusion day 1 of every cycle

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Trastuzumab [Herceptin]
Description: First dose 8 mg/kg, subsequent cycles 6 mg/kg, intravenously, day of every cycle for 15 cycles
Study: NCT00616642

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: rosiglitazone maleate
Description: Given orally

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: rosiglitazone maleate
Description: Given orally
Study: NCT03632096

Intervention type: RADIATION
Group type: ACTIVE_COMPARATOR
Intervention: Photobiomodulation
Description: The parameters are: Laser Diode ArGaAl, DMC, 808nm, 4J per point, continuously and in contact with the irradiated surface, resulting in irradiance of 3571 mW/cm2, distributed as follows: 6 points in each parotid, 2 points in each sublingual (external) and two in each submandibular (internal), totaling 16 extra oral and 4 intra oral, totaling 20 points. The exposure time will be 40s per point, corresponding to 800s per session and 3600s at the end of the four treatment sessions. The radiant exposure will be 142J/cm2.

Intervention type: RADIATION
Group type: SHAM_COMPARATOR
Intervention: Sham
Description: The sham group will have a simulation of laser application, following the same procedures as the active group, but with the device switched off.
Study: NCT04027647

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dacomitinib
Description: 30mg of oral dacomitinib is administered daily for one cycle. After one cycle, a toxicity assessment will be conducted. Subjects will then continue dacomitinib at either 30mg or 45mg.
Study: NCT04507906

Intervention type: DRUG
Group type: OTHER
Intervention: Nivolumab Combined with Anlotinib
Description: In combination dose finding phase, Phase 1b will begin with Dose Level 1; anlotinib 12 mg/day orally (from days 1 to 14 in a 21-day cycle) and nivolumab (360mg q3w, intravenously) will be administered to eligible subjects on a 21-day treatment cycle. Two dose de-escalation steps are included: Dose Level 2 (anlotinib 10 mg/day orally, from days 1 to 14 in a 21-day cycle) and nivolumab 360mg q3w, intravenously) and Dose Level 3 (anlotinib 8 mg/day orally, from days 1 to 14 in a 21-day cycle) and nivolumab 360mg q3w, intravenously).If RP2D was reached in Part A, eligible patients would be enrolled and receive nivolumab (360mg q3w, intravenously) plus anlotinib (RP2D, QD from day 1 to 14 of a 21-day cycle) .
Study: NCT02980107

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Infographics
Description: Cochrane started developing infographics, where short textual information about research is supported by visual representations of the main findings and is also aimed at the lay public The investigators will examine whether this format is better in information uptake than standard PLS.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: PLS
Description: Text format with simple explanation of the survey topic main findings and is intended for lay audience.
Study: NCT00577200

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Midazolam
Description: Midazolam

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Midazolam
Description: Midazolam

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Sufentanil
Description: Sufentanil

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Sufentanil
Description: Sufentanil

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Propofol
Description: Propofol bolus of 300 µg/kg + infusion at 75 µg/kg/min.
Study: NCT03434093

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Transcranial Magnetic Stimulation (TMS)
Description: Description: This will comprise single and repeated paired-pulses delivered over motor and non-motor areas.

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Transcranial Magnetic Stimulation (TMS)
Description: Description: This will comprise single and repeated paired-pulses delivered over motor and non-motor areas.

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Working Memory Task
Description: This will consist in remembering an item presented 1 to 5 steps before the inquiry. This task will span the whole duration of the functional MRI acquisition.

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Working Memory Task
Description: This will consist in remembering an item presented 1 to 5 steps before the inquiry. This task will span the whole duration of the functional MRI acquisition.
Study: NCT00968201

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: montelukast sodium
Description: one chewable 4-mg montelukast tablet, once daily at bedtime for 12 weeks

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Comparator: Placebo
Description: one chewable placebo tablet, once daily at bedtime for 12 weeks
Study: NCT03959085

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Biospecimen Collection
Description: Undergo blood sample collection

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Biospecimen Collection
Description: Undergo blood sample collection

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Biospecimen Collection
Description: Undergo blood sample collection

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Biospecimen Collection
Description: Undergo blood sample collection

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Biospecimen Collection
Description: Undergo blood sample collection
Study: NCT05206578

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AGT2, AGZ
Description: Tablet, q.d.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: AGT2
Description: Tablet, q.d.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AGT4, AGZ
Description: Tablet, q.d.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: AGT4
Description: Tablet, q.d.
Study: NCT01162460

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Eslicarbazepine acetate (BIA 2-093)
Description: Week 1 and 2 either 400mg/day Eslicarbazepine acetate (ESL) or 200mg/day Carbamazepine controlled release(CBZ-CR); Week 3 onwards either 800mg/day Eslicarbazepine acetate or 400mg/day CBZ-CR; this dose then to be maintained unless a subject has a seizure.~Subjects experiencing a seizure will have their assigned treatment dose increased to ESL 1200mg/day or CBZ 800mg/day.~Should a subject have another seizure, their assigned treatment is to be increased to ESL 1600mg/day or CBZ 1200mg/day.~Subjects who remain seizure free for 26 weeks at any dose in an Evaluation Period will continue to receive the allocated treatment under double-blind conditions.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Eslicarbazepine acetate (BIA 2-093)
Description: Week 1 and 2 either 400mg/day Eslicarbazepine acetate (ESL) or 200mg/day Carbamazepine controlled release(CBZ-CR); Week 3 onwards either 800mg/day Eslicarbazepine acetate or 400mg/day CBZ-CR; this dose then to be maintained unless a subject has a seizure.~Subjects experiencing a seizure will have their assigned treatment dose increased to ESL 1200mg/day or CBZ 800mg/day.~Should a subject have another seizure, their assigned treatment is to be increased to ESL 1600mg/day or CBZ 1200mg/day.~Subjects who remain seizure free for 26 weeks at any dose in an Evaluation Period will continue to receive the allocated treatment under double-blind conditions.
Study: NCT02384486

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Training to Reduce Stress in Mothers of Children with (ASD)
Description: The main objective of the proposed study is to examine the effect of implementing the proposed intervention on stress in mothers of children with ASD in SA

Intervention type: OTHER
Group type: OTHER
Intervention: Nothing (treatment as usual)
Description: Mothers in the control group will continue to receive treatment as usual during the trial
Study: NCT03959085

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Bone Marrow Aspiration
Description: Undergo bone marrow aspiration

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Bone Marrow Aspiration
Description: Undergo bone marrow aspiration

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Bone Marrow Aspiration
Description: Undergo bone marrow aspiration

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Bone Marrow Aspiration
Description: Undergo bone marrow aspiration

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Bone Marrow Aspiration
Description: Undergo bone marrow aspiration

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Bone Marrow Biopsy
Description: Undergo bone marrow biopsy

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Bone Marrow Biopsy
Description: Undergo bone marrow biopsy

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Bone Marrow Biopsy
Description: Undergo bone marrow biopsy

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Bone Marrow Biopsy
Description: Undergo bone marrow biopsy

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Bone Marrow Biopsy
Description: Undergo bone marrow biopsy

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Bone Scan
Description: Undergo bone scan

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Calaspargase Pegol
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Calaspargase Pegol
Description: Given IV

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Calaspargase Pegol
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Calaspargase Pegol
Description: Given IV
Study: NCT03312478

Intervention type: DRUG
Group type: OTHER
Intervention: Blood draw for insulin auto-anti body tests*
Description: Pharmaceutical form: N/A~Route of administration: N/A

Intervention type: DRUG
Group type: OTHER
Intervention: Blood draw for insulin auto-anti body tests*
Description: Pharmaceutical form: N/A~Route of administration: N/A
Study: NCT03302234

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Pembrolizumab
Description: Administered as an intravenous (IV) infusion every 3 weeks (Q3W)

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: Pembrolizumab
Description: Administered as an intravenous (IV) infusion every 3 weeks (Q3W)
Study: NCT03959085

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Calaspargase Pegol
Description: Given IV

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Computed Tomography
Description: Undergo CT

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclophosphamide
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclophosphamide
Description: Given IV
Study: NCT01211405

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Full dose MDMA
Description: 125 mg MDMA administered p.o. once at start of an experimental session. Upon mutual agreement, this may be followed by a supplemental dose of 62.5 mg MDMA 1.5 to 2 hours later

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Therapy
Description: Non-directive therapy during each session
Study: NCT00823940

Intervention type: DRUG
Group type: OTHER
Intervention: Glucagon
Description: 0.5mg IV bolus

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Glucagon + GSK1362885
Description: 0.5mg Glucagon IV bolus + selected dose of GSK1362885
Study: NCT03959085

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Cyclophosphamide
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclophosphamide
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclophosphamide
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cytarabine
Description: Given IV, IT, or SC

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cytarabine
Description: Given IV, IT, or SC

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Cytarabine
Description: Given IV, IT, or SC

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cytarabine
Description: Given IV, IT, or SC

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cytarabine
Description: Given IV, IT, or SC

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Daunorubicin Hydrochloride
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Daunorubicin Hydrochloride
Description: Given IV

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Daunorubicin Hydrochloride
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Daunorubicin Hydrochloride
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Daunorubicin Hydrochloride
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dexamethasone
Description: Given PO or IV
Study: NCT00854256

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Canaloplasty
Description: Canaloplasty surgery

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Trabeculectomy with mitomycin C
Description: Trabeculectomy with mitomycin C surgery
Study: NCT00645918

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: clopidogrel
Description: oral, 75 mg daily for 6 months starting on day of randomization
Study: NCT03959085

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dexamethasone
Description: Given PO or IV

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Dexamethasone
Description: Given PO or IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dexamethasone
Description: Given PO or IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dexamethasone
Description: Given PO or IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Doxorubicin Hydrochloride
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Doxorubicin Hydrochloride
Description: Given IV

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Doxorubicin Hydrochloride
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Doxorubicin Hydrochloride
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Doxorubicin Hydrochloride
Description: Given IV

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Inotuzumab Ozogamicin
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Leucovorin Calcium
Description: Given PO or IV
Study: NCT01211405

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Therapy
Description: Non-directive therapy during each session

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Therapy
Description: Non-directive therapy during each session
Study: NCT01130246

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: A-002, varespladib methyl
Description: A-002 administered once daily in addition to atorvastatin and standard of care

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo administered once daily in addition to atorvastatin and standard of care
Study: NCT00885924

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Desmopressin
Description: Desmopressin 0.3 microgram/kg as an intravenous infusion given during 20 min.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: NaCl 0.9%
Study: NCT01369004

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Daily Self-weighing + weekly feedback+ weekly lessons
Description: Daily self-weighing as a form of self-monitoring of body weight using a smart scale that sends their weights directly to a website (www.bodytrace.com) via the cellular network. They will be able to review weight trends overtime on this website via a graph showing both changes in weight and BMI. They will also receive weekly emailed feedback on their weight loss progress and compliance to the daily self-weighing prescription from a registered dietitian, as well as weekly emailed lessons with content related to behavioral weight control (e.g, how to control portion sizes, how to develop and exercise routine).
Study: NCT02909192

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Light Therapy Device

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Light Therapy Device
Study: NCT01897870

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: HomeCoMe-program
Description: A home visit by patients own community pharmacist within seven days after hospital discharge. The community pharmacist will perform a semi-structured interview on (1) use of the prescribed medication, (2) ADEs, (3) adherence issues, by (A) assessing patient's needs and concerns around his pharmacotherapy, (B) identifying and solving obstacles for medicines intake, (C) checking on the need for a compliance aid, (D) collecting spare medication and finally (4) knowledge on medication use, when to take which medicine and why, and medication changes made during the hospitalisation.
Study: NCT03011489

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Vacuum formed aligners
Description: Infants will receive this appliance which is a maxillary plate with nasal stent in addition to taping on the upper lip (taping is a modified step in Figueroa's technique.
Study: NCT00103324

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: lapatinib ditosylate
Description: Given orally

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: laboratory biomarker analysis
Description: Correlative studies
Study: NCT03302234

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Ipilimumab
Description: Administered as an IV infusion every 6 weeks (Q6W)

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Placebo
Description: Normal saline solution administered as an IV infusion Q6W
Study: NCT02325037

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: GLPG1837 single ascending doses
Description: Single dose, oral suspension

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo single dose
Description: Single dose, oral suspension matching placebo

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: GLPG1837 multiple ascending doses
Description: Multiple doses, daily for 14 days, oral suspension
Study: NCT01362153

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Golimumab
Description: SC injection of 100 mg every 4 weeks through Week 20

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Golimumab
Description: IV infusions of 2 mg/kg golimumab on Days 1 and 85.
Study: NCT03959085

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Leucovorin Calcium
Description: Given PO or IV

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Leucovorin Calcium
Description: Given PO or IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Leucovorin Calcium
Description: Given PO or IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Leucovorin Calcium
Description: Given PO or IV

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Magnetic Resonance Imaging
Description: Undergo MRI

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Mercaptopurine
Description: Given PO

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Mercaptopurine
Description: Given PO

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Mercaptopurine
Description: Given PO

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Mercaptopurine
Description: Given PO

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Methotrexate
Description: Given IT or IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Methotrexate
Description: Given IT or IV

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Methotrexate
Description: Given IT or IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Methotrexate
Description: Given IT or IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Methotrexate
Description: Given IT or IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pegaspargase
Description: Given IV or IM

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pegaspargase
Description: Given IV or IM

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Pegaspargase
Description: Given IV or IM

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pegaspargase
Description: Given IV or IM

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pegaspargase
Description: Given IV or IM

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Positron Emission Tomography
Description: Undergo PET

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Prednisolone
Description: Given PO or IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Prednisolone
Description: Given PO or IV
Study: NCT00547352

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: tadalafil
Description: 20 mg tadalafil tablets taken by mouth, as needed, no more than once a day for 8 weeks.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: sildenafil
Description: Current users of sildenafil citrate for a minimum of 6 weeks prior to visit 1 will continue with an individual dosage to be taken no more than once a day for an additional 4 weeks.