AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Study NCT04153708 — intervention group
Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Retrieval patients lost to follow-up with positive HCV antibodies without RNA request or positive RNA by mail letter
Description: Patients assigned to strategy 2 will receive an invitation letter with an appointment with the hepatologist over a period of 14 days.
Study NCT04567901 — intervention group
Intervention type: OTHER
Intervention: Death
Description: Mortality group
Study NCT04567901 — intervention group
Intervention type: OTHER
Intervention: Survive
Description: Survival group
Study NCT00737451 — intervention group
Intervention type: BEHAVIORAL
Intervention: blood sampling
Description: blood sampling 10ml from the study subjects
Study NCT00002909 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: chemotherapy
Study NCT00002909 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: oral sodium phenylbutyrate
Study NCT02175056 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: HL2351
Description: Dose-escalation For 5 level dose groups A \~ E(each 1, 2, 4, 8, 12mg/kg), 10 subjects (8 for the study drug and 2 for placebo) are randomized to each dose group, and the study drug or placebo is subcutaneously administered for the relevant dose group.
Study NCT02175056 — intervention group
Intervention type: BIOLOGICAL
Group type: PLACEBO_COMPARATOR
Intervention: HL2351
Description: Dose-escalation For 5 level dose groups A \~ E(each 1, 2, 4, 8, 12mg/kg), 10 subjects (8 for the study drug and 2 for placebo) are randomized to each dose group, and the study drug or placebo is subcutaneously administered for the relevant dose group.
Study NCT02175056 — intervention group
Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: Kineret(Anakinra)
Description: Active comparator(group F) is implemented in parallel with dose groups A\~E in an open-label manner and 8 subjects subcutaneously administer Kineret® 100 mg.
Study NCT02163174 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Pentoxifylline (PTX)
Description: Patients were randomly assigned to receive intravenous Pentoxifylline 5 mg/kg/hr for 6 hours on 6 successive days in addition to antibiotics
Study NCT02163174 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Patients were randomly assigned to receive intravenous normal saline 5 mg/kg/hr for 6 hours on 6 successive days as a placebo in addition to antibiotics.
Study NCT01249352 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Nimotuzumab
Description: 200 mg, IV Weekly IV dose for up to 26 weeks.
Study NCT01249352 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Nimotuzumab
Description: 200 mg, IV Weekly IV dose for up to 26 weeks.
Study NCT01249352 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cisplatin
Description: 75 mg/m2, IV dose on D1 of each chemotherapy cycle, for 4 cycles, always after nimotuzumab.
Study NCT01249352 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Cisplatin
Description: 75 mg/m2, IV dose on D1 of each chemotherapy cycle, for 4 cycles, always after nimotuzumab.
Study NCT01249352 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Fluorouracil
Description: 1,000 mg/m2, IV dose in a 24-hour continuous infusion, from D1 to D4, every chemotherapy cycle, for 4 cycles.
Study NCT01249352 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Fluorouracil
Description: 1,000 mg/m2, IV dose in a 24-hour continuous infusion, from D1 to D4, every chemotherapy cycle, for 4 cycles.
Study NCT01249352 — intervention group
Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Radiotherapy
Description: Radiotherapy 50.4 Gy, fractions of 1.8 Gy/day
Study NCT01249352 — intervention group
Intervention type: RADIATION
Group type: ACTIVE_COMPARATOR
Intervention: Radiotherapy
Description: Radiotherapy 50.4 Gy, fractions of 1.8 Gy/day
Study NCT02147483 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Mindfulness Based Relapse Prevention
Description: Mindfulness based relapse prevention therapy provided over eight sessions in person to prevent alcohol relapse.
Study NCT02147483 — intervention group
Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Treatment as usual
Description: Treatment usually provided by clinician
Study NCT05664165 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: dry needling
Description: The needle inserted in the trigger point and stimulation was performed by manipulating it up and down several times. The needle was kept in the trigger point for 1-3 minutes and removed after the muscle spasm regressed
Study NCT05664165 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: cold spray and stretching
Description: The cooler spray (in its content; 0.06% menthol, 2.06% isopropyl alcohol, 2% isopropyl alcohol) was sprayed to the surface at an angle of 30° from a distance of approximately 30-50 cm, while passive stretching was applied.
Study NCT03183674 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Oxytocin
Description: Single dose oxytocin 45 minutes before the test
Study NCT03183674 — intervention group
Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: placebo
Description: saline solution 0,9% spray nasal
Study NCT00848354 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Phase 1: Etanercept
Description: Phase 1: prefilled syringe 50mg/ml, administered once weekly for study weeks 0 - 24
Study NCT00848354 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Phase 1: Methotrexate
Description: Phase 1: oral tablet, 2.5mg, dose variable from 7.5mg to 25mg, once weekly for study weeks 0 - 24.
Study NCT00848354 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Phase 2: Optional ETN, SSZ, HCQ, MTX
Description: Phase 2: All therapies are optional and may include any combination of the following: ETN, SSZ, HCQ, MTX Phase 2: Optional ETN: prefilled syringe 50mg/ml, dose variable after study week 24 to week 128.~Phase 2: Optional SSZ: oral tablet, 0.5gm, dose variable per approved local label recommendations after study week 24 to week 128.~Phase 2: HCQ: oral tablet, 200mg, dose variable per approved local label recommendations after study week 24 to week 128.~Phase 2: MTX: oral tablet, 2.5mg dose variable after week 24 to week 128.
Study NCT00848354 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Phase 1: Methotrexate
Description: Phase 1: oral tablet, 2.5mg dose variable from 7.5mg to 25mg, once weekly for study weeks 0 - 24.
Study NCT00848354 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Phase 1: Conventiaonal DMARD
Description: Phase 1: SSZ: oral tablet, 0.5gm, dose variable per approved local label recommendations. OR Phase 1: HCQ: oral tablet, 200mg, dose variable per approved local label recommendations.
Study NCT05788939 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Planned Visual Education Based on Health Belief Model
Description: The students in IG were administered the planned visual education based on Health Belief Model for a period of seven months.~The education materials were a PowerPoint presentation, a skin cancer model, videos titled Dear 16 years old me, Mr. Sun, a brochure, and 3 posters.~.
Study NCT00609596 — intervention group
Intervention type: DRUG
Group type: OTHER
Intervention: GI198745
Study NCT02604940 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dexmedetomidine
Description: 1mcg/kg IV dexmedetomidine over 10 minutes from 60ml syringe in OR upon notification of surgical closure
Study NCT02604940 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Normal Saline
Description: 60ml Saline delivered over 10 minutes in OR upon notification of surgical closure.
Study NCT01507376 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: recombinant hCG
Description: recombinant hCG(250 µg Ovitrell)
Study NCT01507376 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: recombinant hCG
Description: recombinant hCG(500 µg Ovitrell)
Study NCT01507376 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: urinary hCG
Description: 10,000 IU urinary hCG
Study NCT01407783 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Problem Solving Tools (PST)
Description: The problem solving tools was chosen as the depression treatment because it is well suited for use by non-mental health professionals and for in-home treatment. It is also a brief treatment (4-8 sessions) that takes a non-pathologizing approach.
Study NCT03949270 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: BETA-Text text messaging intervention
Description: Patients in the text messaging arm will receive daily, weekly, and monthly text messages. The daily message asks whether or not the patient has taken their breast cancer medication. The weekly message asks about any side effects and their severity. The monthly text message asks about any barriers that the patient might be experiencing. Concerning responses to any of the text messages will prompt contact from the office of the treating physician.
Study NCT02394977 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Compression with Feedback
Description: Patients in the intervention group received CPR in accordance to published guidelines using the CFA device per manufacturer instructions. The Cardio First Angel™ (CFA; INOTECH, Nubberg, Germany) is a lightweight device that consists of three components . Application of400 ± 30 Newtons of force (41 kg or 90 lb of pressure), which correlates toa sternum compression depth of 50-60 mm, is followed by an audible click sound to alert the rescuer to cease compression. The click sound is also audible upon spring decompression alerting the rescuer to resume compression. The device does not require an electrical power supply.
Study NCT02394977 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Standard chest compression
Description: CPR in accordance with published international guidelines using standard manual chest compression.
Study NCT00874250 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: GORE CTAG Device
Description: Endovascular aortic stent-graft
Study NCT05630287 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: [14C] Selpercatinib
Description: Administered as an oral solution
Study NCT05630287 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Selpercatinib
Description: Administered orally
Study NCT05630287 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: [14C] Selpercatinib
Description: Administered intravenously
Study NCT01657578 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Omeprazole
Description: administration of Omeprazole
Study NCT02445586 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Docetaxel
Description: Participants will receive docetaxel in line with locally approved Prescribing Information. After Cycle 6 (cycle length = 21 days), continuation of docetaxel treatment will be at the discretion of the investigator. Docetaxel will be administered after pertuzumab and trastuzumab.
Study NCT02445586 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pertuzumab
Description: Participants will receive pertuzumab at an initial dose of 840 milligrams (mg) as a 60-minute intravenous infusion on Cycle 1 Day 1 (cycle length = 21 days), followed by every 3 weeks at a dose of 420 mg as a 30 to 60-minute intravenous infusion until disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first.
Study NCT02445586 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Trastuzumab
Description: Participants will receive trastuzumab at an initial dose of 8 milligrams per kilogram (mg/kg) as a 90-minute intravenous infusion on Cycle 1 Day 1 (cycle length = 21 days), followed by every 3 weeks at a dose of 6 mg/kg as a 30 to 90-minute intravenous infusion until disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first.
Study NCT03550066 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Values affirmation
Description: A health message with a prompt asking participants to reflect on important personal values
Study NCT03550066 — intervention group
Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: No affirmation
Description: A health message alone
Study NCT01833884 — intervention group
Intervention type: OTHER
Group type: OTHER
Intervention: Collection of blood specimen
Description: Collection of blood specimen for Cytokines dosing scheduled before , during and after treatment of Hodgkin's lymphoma (last collection date about 90 days after the end of treatment)
Study NCT02635971 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Transcatheter arterial infusion
Study NCT02635971 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Intravenous chemotherapy
Study NCT02635971 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Gemcitabine
Study NCT02635971 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Gemcitabine
Study NCT02635971 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Oxaliplatin
Study NCT02635971 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Oxaliplatin
Study NCT01604005 — intervention group
Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Prophylactic Irradiation of Tracts (PIT)
Description: 21 Gy in 3 fractions
Study NCT02439658 — intervention group
Intervention type: DRUG
Intervention: Dofetilide and/or sotalol
Description: This is an observational study of patients receiving Dofetilide and/or sotalol as part of their routine clinical care. Patients receiving either of these medications will be compared with population controls for genetic analysis.
Study NCT01284166 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: dorzolamide hydrochloride 2.0%/brimonidine tartrate 0.2%/timolol 0.5% ophthalmic solution
Description: 1 drop of Triple Combination Therapy (dorzolamide hydrochloride 2.0%/brimonidine tartrate 0.2%/timolol 0.5% ophthalmic solution) administered to each eye, twice daily for 12 weeks.
Study NCT03923205 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Dietary Intervention
Description: The effect of a buckwheat beverage on postprandial glucose metabolism in healthy individuals and those with T2D controlled by medication and diet will be studied.
Study NCT04121247 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: nonpharmacological approaches to parents of children with sickle cell disease training program
Description: use of non-pharmacological approaches in children with sickle cell disease, parent education
Study NCT03436186 — intervention group
Intervention type: OTHER
Description: no intervention
Study NCT01002079 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: BMS-708163
Description: Capsule, Oral, 125 mg, Once daily, 1 day
Study NCT01002079 — intervention group
Intervention type: DRUG
Group type: OTHER
Intervention: Rifampin
Description: Capsule, Oral, 600 mg, Once daily, 7 days
Study NCT01002079 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Rifampin
Description: Capsule, Oral, 600 mg, Once daily, 6 days
Study NCT04665830 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Evolocumab
Description: treated patients with evolocumab for high cholesterol
Study NCT04665830 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Evolocumab
Description: treated patients with evolocumab for high cholesterol
Study NCT01150266 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Alteplase (tPA)
Description: 0.9mg/KG (maximum 90mg), 10% bolus over one minutes, remainder over one hour.
Study NCT01612715 — intervention group
Intervention type: OTHER
Intervention: Segmental Allergen Challenge
Description: segmental allergen challenge
Study NCT00146263 — intervention group
Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Savyon
Description: Computerized cognitive training
Study NCT00146263 — intervention group
Intervention type: BEHAVIORAL
Group type: PLACEBO_COMPARATOR
Intervention: Control
Description: Usual activity
Study NCT02674438 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Risk stratification and transitional care intervention
Description: Intervention consists of 2 components:~1. Risk stratification: Determination of risk using the EHMRG 7-day and 30-day risk scores (EHMRG30-ST), where decision to admit, observe, or discharge the patient will be guided by the result of the risk scores~2. Transitional care: Follow-up care in the RAPID-HF transitional care clinic begins at 48-72 hours after emergency department or hospital discharge. Care provided by cardiologist + nurse for up to 30 days after emergency department or hospital discharge.
Study NCT01016639 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: oxaliplatin, capecitabine, radiotherapy
Study NCT04003688 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Magnesium sulfate through real weight group
Description: Magnesium sulfate dose 40 mg/kg of actual patient's weight
Study NCT04003688 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo group
Description: Saline solution (instead of magnesium sulfate, as in the other groups)
Study NCT04003688 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Magnesium sulfate through ideal corrected weight group
Description: Magnesium sulfate dose 40 mg/kg of ideal corrected patient's weight
Study NCT03751865 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: CBT
Description: A total of 8 CBT sessions will be provided to the participants, each session lasts for approximately 1.5 hour.
Study NCT03751865 — intervention group
Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Psychoeducation
Description: A total of 8 psychoeducation sessions will be provided to the participants, each session lasts for approximately 1.5 hour.
Study NCT01448200 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PPI-668
Description: capsules
Study NCT01448200 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: capsules
Study NCT04154501 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CNTX-6016
Description: Oral Dose CNTX-6016
Study NCT04154501 — intervention group
Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Other: Placebo
Description: Oral Dose Placebo
Study NCT03885128 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: High frequency extra thoracic oscillations vest
Description: Oscillations applied extra thoracic through vest device aiming for airway clearance
Study NCT03885128 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Intrathoracic oscillatory quake
Description: Oscillation introduced intrathoracic through quake device through placing quake in mouth and ordering patient to breathing to move secretions
Study NCT00458731 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: bevacizumab
Description: Given IV
Study NCT00458731 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: cediranib maleate
Description: Given orally
Study NCT02491164 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: BAC TWO
Description: BAC TWO administration
Study NCT02491164 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: FE and Cellvizio viewer software
Description: Fibre based endomicroscopy to visualise fluorescent signal emitted by optical agents.
Study NCT03368651 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: TAI
Description: transarterial chemoinfusion with mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)
Study NCT04752995 — intervention group
Intervention type: PROCEDURE
Group type: OTHER
Intervention: osteotomy
Description: osteotomy osteoclasis of upper tibia
Study NCT01457742 — intervention group
Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Ivivi SofPulse
Description: 15 minute Pulsed Radio Frequency (PRF) treatment twice per day
Study NCT01457742 — intervention group
Intervention type: DEVICE
Group type: SHAM_COMPARATOR
Intervention: Ivivi SofPulse
Description: 15 minute simulated treatment using Sham Device twice per day
Study NCT02627495 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: transcranial Direct Current Stimulation (tDCS): (Soterix ©)
Description: Subjects will undergo tDCS stimulation. We will use electrodes of 35cm\^2, at an intensity of 2mA on the primary motor cortex contralateral to the amputated limb (or for bilateral amputees contralateral to the most painful side). The subject will undergo stimulation for 20 minutes. The subject will have 5 sessions of stimulation during a 1 week time period.
Study NCT00880893 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: CYD Dengue vaccine
Description: 0.5 mL, Subcutaneous on Day 0, Months 6 and 12
Study NCT00880893 — intervention group
Intervention type: BIOLOGICAL
Group type: SHAM_COMPARATOR
Intervention: NaCl + influenza virus or hepatitis A vaccine
Description: 0.5 mL, Subcutaneous (Intramuscular - Hepatitis A)
Study NCT00479154 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Botulinum Toxin A
Description: Maximum dose of 90 units/leg was injected.
Study NCT00479154 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Botulinum Toxin A
Description: Maximum dose of 90 units/leg was injected.
Study NCT00510627 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Radiofrequency Ablation (RFA)
Description: The RF3000 radiofrequency generator has the capacity to deliver 200 watts of alternating current to the needle electrode for the coagulation necrosis of soft tissue.
Study NCT00510627 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Chemotherapy
Description: Standard of care chemotherapy regimen
Study NCT01099072 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Methylphenidate+placebo
Description: methylphenidate at a dose of 20-30 mg/day depending on weight (20 mg/day for \<30 Kg and 30 mg/day for >30 Kg)+ Placebo