TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00867568

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: TPI 287
Description: Three patients will be enrolled to receive single agent TPI 287 IV administered on Days 1, 8 and 15 of the first and second 28-day cycle. The starting dose of 90 mg/m2 (Dose Level 1) is 75% of the established adult MTD for this schedule in adults, which is 125 mg/m2. Dose escalation will take place in a standard 3+3 design, in which doses will increase by approximately 20 to 25% in successive 3-patient cohorts.
Study: NCT01007773

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Precedex
Description: Once this patient is deemed stable on the propofol infusion, the patient will be started on a dexmedetomidine infusion at 0.4 mcg/kg/hr. The dexmedetomidine infusion will be titrated to a Richmond Agitation Sedation Scale (RASS) of 0 to -1 (maximum rate of 1.5 mcg/kg/hr). In the meantime, once sustained ICP control has been achieved, the initial sedative agent (usually propofol) will be weaned. Dexmedetomidine will be infused for up to 7 days or until removal of the ICP or when mechanical ventilation is discontinued. When the patient is ready to come off sedation, the dexmedetomidine will be weaned by 50% every hour over a 4-hour period to off.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Propofol
Description: Propofol will be initiated at 25 mcg/kg/min and titrated to achieve an ICP \< 20 mm Hg (up to a maximum of 75 mcg/kg/min). Propofol will be continued for up to 7 days or until removal of the ICP or when mechanical ventilation is discontinued.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Fentanyl
Description: Fentanyl will be initiated and titrated to achieve adequate pain control.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Propofol
Description: Propofol will be titrated to an ICP \< 20 mm Hg until achievement of sustained ICP control.
Study: NCT04319432

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Voice rest
Description: The first days will take place in hospitalization to assess patient complience to voice rest. Patients will be instructed to continue voice rest at home up to 7 days accourding to group allocation in the study. The confirmation of voice rest will relay on patient report (telephonic approval), after the voice rest period will end.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Voice rest
Description: The first days will take place in hospitalization to assess patient complience to voice rest. Patients will be instructed to continue voice rest at home up to 7 days accourding to group allocation in the study. The confirmation of voice rest will relay on patient report (telephonic approval), after the voice rest period will end.
Study: NCT02829931

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Hypofractionated Stereotactic Irradiation
Description: Hypofractionated Stereotactic Irradiation (HFSRT) prior to nivolumab.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Nivolumab
Description: Nivolumab intravenously (IV): 240 mg every (q) 3 weeks x 4 months followed by 480 mg X 4 months.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Bevacizumab
Description: Bevacizumab intervenously (IV): 15 mg/kg every (q) 3 weeks when given with Ipilumumab and Nivolumab combination. Dose changed to 10mg/kg every 2 weeks when given with Nivolumab only.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ipilimumab
Description: Ipilimumab 1mg/kg intervenously (IV) 200 mg (5 mg/mL) every (q) 3 weeks for 4 months.
Study: NCT02462616

Intervention type: OTHER
Intervention: not intervention
Description: This is a cross-sectional study, no intervention was performed.
Study: NCT04018859

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Platelet Rich Plasma Prep System
Description: intradermal injections of platelet rich plasma to the eyebrows

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Saline
Description: intradermal injections to the eyebrows
Study: NCT02546999

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: botox
Description: The agent will be given only once at point zero in the time scheme for the project.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: placebo
Description: The agent will be given only once at point zero in the time scheme for the project.
Study: NCT03428620

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: High Velocity Low Amplitude mobilization
Description: Mobilizations will be performed one time at each joint, prior to completing the exercise protocol during the first three treatment sessions.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Exercise protocol
Description: This exercise regimen is a modified version of the balance training program described by McKeon et al.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Exercise protocol
Description: This exercise regimen is a modified version of the balance training program described by McKeon et al.
Study: NCT01130194

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Combination of treatment modalities
Description: Intravenous cyclophosphamide, rituximab, and vincristine day 1 and 8 of 28 day cycles for 6 cycles total.~Oral prednisone and procarbazine day 1-14 of every 28 day cycle. Yttrium ibritumomab tiuxetan intravenous injection. Autologous stem cell transplant with intravenous BEAM (BCNU or carmustine, etoposide, ara-C or cytarabine, melphalan) chemotherapy conditioning.
Study: NCT02472275

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Antiandrogen Therapy
Description: Undergo ADT with leuprolide acetate, goserelin acetate, or degarelix

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Laboratory Biomarker Analysis
Description: Correlative studies

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Multitargeted Tyrosine Kinase Inhibitor PLX3397
Description: Given PO

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Radiation Therapy
Description: Undergo radiation therapy
Study: NCT02797184

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: KNO3, potassium nitrate
Description: Potassium nitrate (KNO3) will be given orally in 2 gelatin capsules, which will be compounded by the Barnes-Jewish Hospital Pharmacy. The doses are 10 mmol and 20 mmol KNO3.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: KNO3, potassium nitrate
Description: Potassium nitrate (KNO3) will be given orally in 2 gelatin capsules, which will be compounded by the Barnes-Jewish Hospital Pharmacy. The doses are 10 mmol and 20 mmol KNO3.
Study: NCT04857294

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: TMJ unilateral discectomy
Description: All patients underwent general anesthesia with nasotracheal intubation, managed in most cases with intravenous anesthesia protocol, usually with remifentanil infusion. Intraoperative steroids, usually dexamethasone, were administered primarily to minimize postoperative swelling. A classic preauricular incision or a root of helix inter tragus notch incision (RHITNI) was used in most cases, as previously described. No bandage or special care was performed after the surgery. No air washing restrictions were recommended.
Study: NCT01813773

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Intravitreal Aflibercept Injection (IAI)
Description: EYLEA (aflibercept) is a recombinant fusion protein consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 formulated as an iso-osmotic solution for intravitreal administration. Aflibercept is a dimeric glycoprotein with a protein molecular weight of 97 kilodaltons (kDa) and contains glycosylation, constituting an additional 15% of the total molecular mass, resulting in a total molecular weight of 115 kDa. Aflibercept is produced in recombinant Chinese hamster ovary (CHO) cells.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Intravitreal Aflibercept Injection (IAI)
Description: EYLEA (aflibercept) is a recombinant fusion protein consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 formulated as an iso-osmotic solution for intravitreal administration. Aflibercept is a dimeric glycoprotein with a protein molecular weight of 97 kilodaltons (kDa) and contains glycosylation, constituting an additional 15% of the total molecular mass, resulting in a total molecular weight of 115 kDa. Aflibercept is produced in recombinant Chinese hamster ovary (CHO) cells.
Study: NCT03818893

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Combination of GEN0101 and Pembrolizmub
Description: New Combination immunotherapy GEN0101 and Pembrolizmub
Study: NCT04183452

Intervention type: DRUG
Intervention: 17-Hydroxyprogesterone Caproate 250 mg IM Dose
Description: 17-Hydroxyprogesterone Caproate is a progestin indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth.

Intervention type: DRUG
Intervention: 17-Hydroxyprogesterone Caproate 275 mg SC Dose
Description: 17-Hydroxyprogesterone Caproate is a progestin indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth
Study: NCT01596933

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: BioMega SDA®
Description: Echium oil, 15ml/day, 2 times per oral 7.5ml sachet/day, during 7-week radio(chemo)therapy

Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: Sunflower oil high oleic
Description: Sunflower oil high oleic, 15ml/day, 2 times per oral 7.5ml sachet/day, during 7-week radio(chemo)therapy
Study: NCT03201822

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: 100 mg of Cocoa Flavanols/70 kg BW
Description: Fruit-flavored non-dairy drink containing 100 cocoa flavanols/70kg BW.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: 200 mg of Cocoa Flavanols/70 kg BW
Description: Fruit-flavored non-dairy drink containing 200 cocoa flavanols/70kg BW.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: 400 mg of Cocoa Flavanols/70 kg BW
Description: Fruit-flavored non-dairy drink containing 400 cocoa flavanols/70kg BW.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: 1000 mg of Cocoa Flavanols/70 kg BW
Description: Fruit-flavored non-dairy drink containing 1000 cocoa flavanols/70kg BW.
Study: NCT00996229

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Caloric restriction
Description: 20-30% CR for 6 months

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Omega-3 (fish oil capsules)
Description: 2g/day DHA/EPA capsules for 6 months

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Placebo
Description: Daily corn oil capsules for 6 months

Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Daily corn oil capsules for 6 months

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Resveratrol
Description: daily resveratrol for 6 months
Study: NCT00882934

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Induction to efficient treatment
Description: Informative letters.

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Doubt to the efficacy of treatment
Description: Informative letters.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Induction to ineffective treatment
Description: Informative letters
Study: NCT01989455

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Deferiprone
Description: Deferiprone for infusion, 10mg/mL for intravenous infusion.~Oral dose of deferiprone: 80mg/mL oral solution. (Cohort 2)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Deferiprone
Description: Deferiprone for infusion, 10mg/mL for intravenous infusion.~Oral dose of deferiprone: 80mg/mL oral solution. (Cohort 2)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Deferiprone
Description: Deferiprone for infusion, 10mg/mL for intravenous infusion.~Oral dose of deferiprone: 80mg/mL oral solution. (Cohort 2)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Deferiprone
Description: Deferiprone for infusion, 10mg/mL for intravenous infusion.~Oral dose of deferiprone: 80mg/mL oral solution. (Cohort 2)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: Placebo: normal saline solution.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: Placebo: normal saline solution.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: Placebo: normal saline solution.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: Placebo: normal saline solution.
Study: NCT01070940

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: NG-monomethyl-L-arginine (L-NMMA)
Description: 3 mg/kg IV priming dose + 2 mg/kg/hr IV infusion for 1 hour

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: NG-monomethyl-L-arginine (L-NMMA)
Description: 6 mg/kg IV priming dose + 4 mg/kg/hr IV infusion for 1 hour

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: NG-monomethyl-L-arginine (L-NMMA)
Description: 4.5 mg/kg IV priming dose + 3 mg/kg/hr IV infusion for 1 hour

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Isotonic saline solution IV priming dose + IV infusion for 1 hour
Study: NCT03375892

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Deep Inspiration Breath Hold during Radiation
Description: The DIBH technique involves the patient breathing to a specified threshold and then holding that level of inspiration during every radiation therapy field delivered.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Deep Inspiration Breath Hold during Radiation
Description: The DIBH technique involves the patient breathing to a specified threshold and then holding that level of inspiration during every radiation therapy field delivered.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Free breathing during radiation
Description: The patient will be instructed to breathe freely.
Study: NCT00644124

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: aflibercept
Description: in combination with standard treatment R-CHOP

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: aflibercept
Description: in combination with standard treatment R-CHOP
Study: NCT00822562

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: PRFA or PMCT
Description: PRFA or PMCT 30-35W for 10-15minutes one cycle,three cycles

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: surgery
Description: only surgery
Study: NCT03257618

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Temozolomide
Description: Treatment with TMZ will be given orally according to standard practices. The therapeutic schedule will be left at the investigator's discretion.~Patients will be followed every 3 months during the treatment period, at the end of the treatment with TMZ, 6 months after the end of TMZ, and then annually until tumor progression.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: QoL, neurocognitive and psycholpathological assessment
Description: This assessment will be performed at baseline, at 6 months, 12 months, 18 months, at the end of the treatment with TMZ, 6 months after the end of TMZ
Study: NCT03345368

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: rTMS
Description: Patients will be stimulated in the dorso lateral frontal cortex. First, the motor threshold will be determined for each patient. To induce currents to the left primary sensory-motor cortex hand area (M1/S1) the coil will be placed over the scalp oriented at 45 ° from the mid-sagittal plane while subjects will sit comfortably on a chair. The coil will be systematically moved in this area until a contraction of the abductor will be identified. Motor evoked potentials (MEPs). MEPs will be registered with surface electrodes on the left hand abductor pollicis muscle using the same Magstim equipment. Then the parameters will be adjusted for the stimulation as was described before.

Intervention type: DEVICE
Group type: SHAM_COMPARATOR
Intervention: sham rTMS
Description: As well as the rTMS group, the motor threshold of each patient will be determined. They will experience a similar rTMS session with the difference that they not will be stimulated.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Diet
Description: This intervention will be applied to both groups, rTMS and sham group, as a combined therapy. The diet is low in carbohydrates, like sugary foods, pasta and bread. Instead, patients eat food with protein, natural fats and vegetables.

Intervention type: OTHER
Group type: SHAM_COMPARATOR
Intervention: Diet
Description: This intervention will be applied to both groups, rTMS and sham group, as a combined therapy. The diet is low in carbohydrates, like sugary foods, pasta and bread. Instead, patients eat food with protein, natural fats and vegetables.
Study: NCT02190630

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Modified Clark Twin Block
Description: The Modified Clark Twin Block is a type of functional orthodontic appliance used to posture the lower jaw forward to treat discrepancies between the upper and lower jaw bones

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Modified Clark Twin Block
Description: The Modified Clark Twin Block is a type of functional orthodontic appliance used to posture the lower jaw forward to treat discrepancies between the upper and lower jaw bones
Study: NCT00888212

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Bronchoscopy
Description: Bronchoscopy, only if no diagnosis is obtained, patients go for EUS-FNA or EBUS-TBNA, only if no diagnosis is obtained, patients go for surgical biopsy
Study: NCT02653443

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Autologous apheresis Platelet Components, prepared with the INTERCEPT Blood System for Platelets.
Description: Each subject will provide two apheresis platelet donations (one per period) and receive two infusions (one per period) of autologous radiolabeled fresh platelets combined with INTERCEPT treated platelet components stored for either 6 or 7 days (approximately 10 to 30 mL). Platelets are administered by intravenous infusion in a peripheral vein via 19-gauge butterfly infusion needle.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Autologous apheresis Conventional untreated Platelet Components
Description: Each subject will provide two apheresis platelet donations (one per period) and receive two infusions (one per period) of autologous radiolabeled fresh platelets combined with conventional untreated platelet components stored for either 6 or 7 days (approximately 10 to 30 mL). Platelets are administered by intravenous infusion in a peripheral vein via 19-gauge butterfly infusion needle.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Autologous apheresis Conventional untreated Platelet Components
Description: Each subject will provide two apheresis platelet donations (one per period) and receive two infusions (one per period) of autologous radiolabeled fresh platelets combined with conventional untreated platelet components stored for either 6 or 7 days (approximately 10 to 30 mL). Platelets are administered by intravenous infusion in a peripheral vein via 19-gauge butterfly infusion needle.
Study: NCT02120768

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: barrier resection/1cm resection
Description: For Arm Barrier resection, if a recurrence occurs, patients would be assigned to 1cm resection for their recurrent sarcomas; For Arm 1cm resection, if a recurrence occurs, patients would be assigned to barrier resection for their recurrent sarcomas.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: barrier resection/1cm resection
Description: For Arm Barrier resection, if a recurrence occurs, patients would be assigned to 1cm resection for their recurrent sarcomas; For Arm 1cm resection, if a recurrence occurs, patients would be assigned to barrier resection for their recurrent sarcomas.
Study: NCT02705105

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Mogamulizumab + Nivolumab
Description: i.v. administration

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Mogamulizumab + Nivolumab
Description: i.v. administration
Study: NCT04019964

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Nivolumab
Description: Nivolumab 480mg intravenously every 4 weeks
Study: NCT04589572

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: XLIF
Description: the XLIF procedure, a minimally invasive procedure that approaches the spine from the lateral via the space between the 12th rib and the highest point of the iliac crest.

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: PLIF
Description: open posterior lumbar interbody fusion (PLIF) or transforaminal lumbar interbody fusion (TLIF) are used to treat degenerative diseases of the spinal column.
Study: NCT01738815

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Valproic Acid
Description: 500 mg orally, once daily for up to 30 days
Study: NCT00428181

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Brief alcohol intervention
Description: Brief alcohol intervention

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Brief alcohol intervention plus booster
Description: Brief alcohol intervention plus booster in a later session
Study: NCT00648921

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Olanzapine Tablets 5 mg
Description: 5mg, single dose fasting

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Zyprexa® Tablets 5 mg
Description: 5mg, single dose fasting
Study: NCT02821065

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Remote Patient Monitoring
Study: NCT00864175

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: INCB007839
Description: 100 mg BID

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: INCB007839
Description: 200 mg BID

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: INCB007839
Description: 300 mg BID

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: INCB007839
Description: 300 mg BID

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: trastuzumab
Description: trastuzumab will be administered at a loading dose of 8 mg/kg as a 90 minute intravenous infusion on Day 8. In all subsequent 21-day cycles, trastuzumab will be administered at 6 mg/kg as a 90 minute intravenous infusion on Day 1.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: trastuzumab
Description: trastuzumab will be administered at a loading dose of 8 mg/kg as a 90 minute intravenous infusion on Day 8. In all subsequent 21-day cycles, trastuzumab will be administered at 6 mg/kg as a 90 minute intravenous infusion on Day 1.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: trastuzumab
Description: trastuzumab will be administered at a loading dose of 8 mg/kg as a 90 minute intravenous infusion on Day 8. In all subsequent 21-day cycles, trastuzumab will be administered at 6 mg/kg as a 90 minute intravenous infusion on Day 1.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Docetaxel