AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Study NCT02552810 — intervention group
Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Plasma of Argon
Description: Test group: dental implant underwent argon plasma treatment in a plasma reactor (Diener Electronic, Jettingen, Germany). The treatment conditions were 75 W of power and 1 bar of pressure for 12 minutes.
Study NCT00644176 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: azithromycin immediate release (Zithromax)
Description: azithromycin IR 500 mg tablet by mouth for 1 dose
Study NCT03424005 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ipatasertib
Description: Ipatasertib will be administered by mouth 400 mg once a day, on Day 1-21 of each 28 day cycle.
Study NCT03424005 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: SGN-LIV1A
Description: SGN-LIV1A will be administered IV, 2.5 mg/kg (maximum calculated dose 250 mg), on Day 1 of each 21 day cycle.
Study NCT03424005 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Bevacizumab
Description: Bevacizumab will be administered IV, 10 mg/kg, on Days 1 and 15 of each 28 day cycle.
Study NCT03424005 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Chemotherapy (Gemcitabine + Carboplatin or Eribulin)
Description: Gemcitabine will be administered by IV, 1000 mg/m\^2, along with carboplatin, by IV, AUC 2, on Days 1 and 8 of each 21 day cycle.~Or~Eribulin will be administered by IV, 1.4 mg/m\^2 on days 1 and 8 of each 21 day cycle.
Study NCT03424005 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Selicrelumab
Description: Selicrelumab will be administered by subcutaneous (SC) injection at a fixed dose of 16 mg on Day 1 of Cycles 1 to 4 and every third cycle thereafter (cycle = 28 days).
Study NCT03424005 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Tocilizumab
Description: Tocilizumab will be administered IV, 8 mg/kg infusion on Day 1 of each 28 day cycle.
Study NCT03424005 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Nab-Paclitaxel
Description: Nab-Paclitaxel will be administered by IV, 100 mg/m\^2, on Days 1, 8, and 15 of each 28-day cycle.
Study NCT03424005 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Nab-Paclitaxel
Description: Nab-Paclitaxel will be administered by IV, 100 mg/m\^2, on Days 1, 8, and 15 of each 28-day cycle.
Study NCT03424005 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Sacituzumab Govitecan
Description: Sacituzumab govitecan will be administered by IV, 10 mg/kg, on Days 1 and 8 of each 21-day cycle.
Study NCT03424005 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Abemaciclib
Description: Abemaciclib tablets will be administered at a dose of 150 mg twice daily by mouth on Days 1-28 of each cycle (cycle=28 days).
Study NCT03424005 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Fulvestrant
Description: Fulvestrant IM injection at a dose of 500 mg will be administered on Days 1 and 15 of Cycle 1, and then on Day 1 of each cycle thereafter (cycle=28 days).
Study NCT03424005 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ribociclib (dose #1)
Description: Ribociclib tablets will be administered by mouth once daily.
Study NCT00644176 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: placebo
Description: placebo
Study NCT00644176 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: azithromycin SR
Description: 2.0 g by mouth in the form of liquid for 1 dose
Study NCT01949012 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Capnography
Description: Capnography waveform and capnometry readings
Study NCT01216956 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Extended-release nicotinic acid versus placebo
Description: Voluntary men with mixed dyslipidemia and abdominal obesity will receive extended release nicotinic acid. The dose of niaspan will be up-titrated for 3 weeks starting at 500 mg/d in order to reach 2g/d at start of week 4 dose which will be continued until the end of week 8. After a wash-out period of 3 weeks, they will receive placebo for 8 weeks. According to their randomization arm, subjects will receive either in first place placebo followed by extended release nicotinic acid or the opposite.
Study NCT01216956 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Extended-release nicotinic acid versus placebo
Description: Voluntary men with mixed dyslipidemia and abdominal obesity will receive extended release nicotinic acid. The dose of niaspan will be up-titrated for 3 weeks starting at 500 mg/d in order to reach 2g/d at start of week 4 dose which will be continued until the end of week 8. After a wash-out period of 3 weeks, they will receive placebo for 8 weeks. According to their randomization arm, subjects will receive either in first place placebo followed by extended release nicotinic acid or the opposite.
Study NCT02913014 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: No AAD post Ablation.
Description: Subjects will not resume their pre-ablation anti-arrhythmic medications during the 90 following cryo ablation for Atrial Fibrillation
Study NCT00003407 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: amifostine trihydrate
Study NCT00003407 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: cytarabine
Study NCT00003407 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: mitoxantrone hydrochloride
Study NCT02348151 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Treadmill
Description: The volunteers will perform the shuttle walk test on the treadmill
Study NCT02348151 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Corridor
Description: The volunteers will perform the shuttle walk test on the corridor
Study NCT00981669 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: rotavirus vaccine
Description: 3 doses with 6 weeks interval
Study NCT00981669 — intervention group
Intervention type: BIOLOGICAL
Group type: PLACEBO_COMPARATOR
Intervention: placebo
Description: 3 doses with 6 weeks interval
Study NCT00811330 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Atorvastatin 80 mg
Description: Atorvastatin 80 mg PO every day for one year. The treatment will start 4 weeks before aortic valve replacement.
Study NCT03554174 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Low Dose Psilocybin
Description: 0.1 mg/kg psilocybin capsule
Study NCT03554174 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: microcrystalline cellulose capsule
Study NCT03554174 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Medium Dose Psilocybin
Description: 0.3 mg/kg psilocybin capsule
Study NCT01535508 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Liquid Vitamin D
Description: 300 IU/Kg/day not to exceed 10,000 IU/day.
Study NCT04694365 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Fluzoparib
Description: A single oral dose of 50 mg Fluzoparib will be administered.
Study NCT01877967 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: VSL#3
Description: The intervention group will be asked to ingest two sachets (2x4.4g) of the food supplement (VSL#3) each day for 12 weeks, either both at the same time, or one in the morning and one in the evening. This food supplement is in powder form and can be ingested with either cold food or any non-carbonated cold drink. The control group will be given a placebo, although as it is a double-blind intervention, will not know it is a placebo. They will similarly to the intervention group be asked to take two sachets (2x4.4g) of a powder rach day for 12 weeks, either both at the same time, or one in the morning and one in the evening.
Study NCT03424005 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Inavolisib (dose #2)
Description: Inavolisib tablets will be administered by mouth once daily.
Study NCT03424005 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Trastuzumab Deruxtecan
Description: Trastuzumab Deruxtecan will be administered at a dose of 5.4 mg/kg by IV infusion on Day 1 of each 21-day cycle.
Study NCT01877967 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: placebo
Study NCT03424005 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ribociclib (dose #2)
Description: Ribociclib tablets will be administered by mouth once daily.
Study NCT03424005 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Letrozole
Description: Letrozole tablets will be administered at a dose of 2.5 mg once a day by mouth on Days 1-28 of each cycle (cycle = 28 days).
Study NCT03424005 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Inavolisib (dose #1)
Description: Inavolisib tablets will be administered by mouth once daily.
Study NCT03424005 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Inavolisib
Description: Inavolisib tablets will be administered by mouth once daily.
Study NCT01442311 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: enhanced DOT (both pegylated interferon alfa-2a and ribavirin)
Description: Subjects randomized to the PEG/RBV-DOT arm receive weekly provider-administered pegylated interferon alfa-2a injections plus modified directly observed ribavirin therapy. We describe this as modified because ribavirin ingestion is observed at the methadone window three to six days per week based on the participants' methadone pick-up schedule, and only one of two daily doses is observed.
Study NCT01442311 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: standard DOT (PEG-DOT control arm)
Description: Subjects randomized to the Peg-DOT arm receive standard on-site treatment (weekly provider-administered pegylated interferon alfa-2a injections) and self-administered twice-daily oral ribavirin. Subjects in the PEG-DOT arm are dispensed monthly medication bottles of ribavirin, and ingest the ribavirin at home.
Study NCT04614922 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Acceptance and Commitment Therapy
Description: ACT-based rehabilitation is an interdisciplinary group rehabilitation which includes 7 sessions of group-based ACT therapy. Each session lasts 2½ hours and is offered twice a week. The ACT sessions will be based on a detailed intervention manual, developed specifically for group treatment. Each group will include a maximum of eight patients. The patients are asked to do homework between each ACT-group session.
Study NCT00841256 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo was given in the same way as the sublingual active treatment. Symptomatic standard treatment, i.e. antihistamines and glucocorticoids as well as alphamimetics is allowed during grass pollen season.
Study NCT04371978 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Linagliptin 5 MG
Description: Linagliptin 5 mg PO once daily
Study NCT01479881 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: tacrolimus
Description: a single 2-mg dose of tacrolimus (on Day 1 in treatment C and on Day 7 in treatment D).
Study NCT01479881 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: TMC435
Description: TMC435, 150 mg daily for 12 days (Days 1 to 12 in treatment D).
Study NCT01479881 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: cyclosporine
Description: A single 100-mg dose of cyclosporine (on Day 1 of treatment A and on Day 7 of treatment B).
Study NCT01479881 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: TMC435
Description: TMC435, 150 mg daily for 10 days (Day 1 - 10 in treatment B).
Study NCT03892759 — intervention group
Intervention type: OTHER
Group type: OTHER
Intervention: Osteopathic Manipulative Therapy
Description: A set of hands-on techniques used by Osteopathic Physicians for the assessment and treatment of somatic dysfunction.
Study NCT01573091 — intervention group
Intervention type: PROCEDURE
Intervention: Cardiac Resynchronization Therapy
Description: Any commercially available Cardiac Resynchronization Therapy devices with or without defibrillation backup (CRT-D/CRT-P) can be used upon discretion of the investigator according to current guidelines
Study NCT00949130 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: NXL103
Description: BID for 7-14 days
Study NCT01740908 — intervention group
Intervention type: OTHER
Intervention: Hyperbaric Oxygen Treatment
Description: Hyperabric oxygen will be delivered via a PerryPerry-Sigma Monoplace Hyperbaric Chambers. Oxygen is supplied by Air Gas, Seattle.~All gases will meet Health Standards for oxygen and air. The hyperbaric chamber technicians employed by Restorix Health are trained health personnel who will be assisting our study participant and monitoring the HBO treatment. Oxygen will be delivered at a pressure of 2.0 ATA for 90 minutes, once a day for 5 consective days.
Study NCT03956680 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: BMS-986301
Description: Specified dose on specified days
Study NCT03956680 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Nivolumab
Description: Specified dose on specified days
Study NCT00949130 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Linezolid
Description: BID for 7-14 days
Study NCT04195698 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Upadacitinib
Description: Upadacitinib will be administered oral as tablet
Study NCT03956680 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Ipilimumab
Description: Specified dose on specified days
Study NCT02764957 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: green coffee extract
Study NCT01320930 — intervention group
Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Pulmonary rehabilitation
Study NCT01320930 — intervention group
Intervention type: BEHAVIORAL
Group type: PLACEBO_COMPARATOR
Intervention: conventional care
Study NCT01521884 — intervention group
Intervention type: OTHER
Intervention: SC anti-TNF
Description: SC anti-TNF
Study NCT02764957 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: placebo
Study NCT00004465 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: SYNSORB Pk
Study NCT02505100 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Touching relaxant
Study NCT02505100 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Hypnoses
Study NCT03422926 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Social marketing campaign
Description: Messaging campaign designed to help mothers in choosing healthful options when dining out.
Study NCT04001608 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Seraprevir
Description: Subjects will receive oral tablets of Seraprevir 100 mg, twice a day from Day 1 up to Week 12
Study NCT04001608 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Sofosbuvir
Description: Subjects will receive oral tablet of sofosbuvir 400 mg, once a day from Day 1 up to Week 12
Study NCT02318121 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Amniotomy first
Description: rupture of membranes to augment labor
Study NCT02318121 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Oxytocin first
Description: Administration of oxytocin to augment labor
Study NCT02318121 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Amniotomy and oxytocin
Description: Rupture of membranes and administration of oxytocin to augment labor
Study NCT02318121 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Oxytocin
Study NCT01689259 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: SL TNX-102 at 2.4 mg
Description: 1 TNX-102 SL Tablet at 2.4 mg held under the tongue until dissolution, without swallowing or chewing it.
Study NCT01689259 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: SL TNX-102 at 4.8 mg
Description: 2 TNX-102 SL Tablet at 2.4 mg held under the tongue until dissolution, without swallowing or chewing them.
Study NCT01689259 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: SL TNX-102-A at 2.4 mg
Description: 1 TNX-102-A SL Tablet at 2.4 mg held under the tongue until dissolution, without swallowing or chewing it.
Study NCT01689259 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Cyclobenzaprine tablets
Description: 1 x 5 mg cyclobenzaprine tablet, swallowed with 240 mL of room-temperature water
Study NCT00981604 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: SILS
Description: Single Incision Laparoscopic Cholecystectomy
Study NCT00981604 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Standard Laparoscopic Cholecystectomy
Description: 4 port technique
Study NCT00858000 — intervention group
Intervention type: OTHER
Intervention: Retrospective analysis of already archived samples
Description: RNA extracted from tissue samples already archived
Study NCT00319956 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Azithromycin
Description: Give 10 mg/kg IV/PO daily for first 7 days, then give 5 mg/kg IV/PO daily for 35 days.
Study NCT00004465 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Study NCT00319956 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: vehicle dose given daily, IV/PO, same volume that Azithromycin would be to equal 10 mg/kg for first 7 days, then 5 mg/kg for 5 weeks.
Study NCT03199807 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: NRT
Description: Peripheral blood lymphocytes will be collected and neoantigen reactive T cells(NRTs) will be generated in the laboratory. NRTs 0.5\~1 x 10\^10, will be i.v.Q3 weeks for total 4-6 doses.
Study NCT03199807 — intervention group
Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Radiotherapy
Description: Radiotherapy of the major mass by dose of 5Gy/F \* 10F
Study NCT03953053 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Femtosecond Laser Assissted Cataract Surgery
Description: During routine Catarct Surgery the Femtolaser cuts a ACCC (Anterior Continous Curvilinear Capsulotomy) into the lensbag and fragmentise the cataract affilited lens body
Study NCT03953053 — intervention group
Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Femtosecond Laser Assissted Cataract Surgery
Description: During routine Catarct Surgery the Femtolaser cuts a ACCC (Anterior Continous Curvilinear Capsulotomy) into the lensbag and fragmentise the cataract affilited lens body
Study NCT00784303 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Lenvatinib (DTC Cohort)
Description: 24 mg lenvatinib (two 10 mg tablets and one 4 mg tablet) given orally, once daily, or 10 mg lenvatinib orally twice daily (20 mg total). Out of 58 participants in the DTC cohort, 56 participants received 24 mg lenvatinib once daily and 2 participants received 10 mg lenvatinib twice daily (total 20 mg daily), given continuously in 28-day treatment cycles.
Study NCT00784303 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Lenvatinib (MTC Cohort)
Description: 24 mg lenvatinib (two 10 mg tablets and one 4 mg tablet) given orally, once daily given continuously in 28-day treatment cycles.
Study NCT04376944 — intervention group
Intervention type: OTHER
Intervention: Survey
Description: questionnaire on their symptoms and their exposures
Study NCT02255305 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: FMT
Description: Patients in the FMT group will receive \~50 grams of fecal material suspended in bacteriostatic normal saline and glycerol.
Study NCT02255305 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Antimicrobials
Description: Patients randomized to the control group will receive antimicrobials targeting C. difficile.
Study NCT01167881 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: BI 10773
Description: Medium dose once daily
Study NCT01167881 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Glimepiride
Description: 1-4 mg once daily
Study NCT01167881 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Placebo
Description: Placebo matching BI 10773
Study NCT01167881 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: Placebo matching Glimepiride
Study NCT00537316 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Infliximab (IFX)
Description: IFX intravenous (IV) infusion dosed at 5mg/kg of body weight
Study NCT00537316 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Azathioprine (AZA)
Description: AZA 50 mg tablet dosed at 2.5 mg/kg of body weight orally every day
Study NCT00537316 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Azathioprine (AZA)
Description: AZA 50 mg tablet dosed at 2.5 mg/kg of body weight orally every day
Study NCT02178709 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: FOLFIRINOX
Description: FOLFIRINOX consists of the following combination of drugs:~1. Oxaliplatin, 85 mg/m2, IV over 2 hours prior to irinotecan, administered on days 1 and 15 of each 28 day cycle~2. Leucovorin, 400 mg/m2, IV over 2 hours with irinotecan, administered on days 1 and 15 of each 28 day cycle~3. Irinotecan, 180 mg/m2, IV over 90 minutes with leucovorin, administered on days 1 and 15 of each 28 day cycle 4.5 FU, 400 mg/m2, IV bolus over 2 minutes after irinotecan, administered on days 1 and 15 of each 28 day cycle.~5.5FU, 2400 mg/m2, IV infusion over 46 hours after 5FU bolus injection, administered on days 1 and 15 of each 28 day cycle.