TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01059786

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Rituximab
Description: Rituximab 375 mg/m\^2 on day 1, 15 for 6 x 28-day cycles

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Rituximab
Description: Rituximab 375 mg/m\^2 on day 1, 15 for 6 x 28-day cycles

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Rituximab
Description: Rituximab 375 mg/m\^2 on day 1, 15 for 6 x 28-day cycles

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Rituximab
Description: Rituximab 375 mg/m\^2 on day 1, 15 for 6 x 28-day cycles

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Rituximab
Description: Rituximab 375 mg/m\^2 on day 1, 15 for 6 x 28-day cycles

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Bendamustine
Description: 1-4 participants to bendamustine 90 mg/m\^2/day, days 1 and 2 each cycle

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Bendamustine
Description: 1-4 participants to bendamustine 90 mg/m\^2/day, days 1 and 2 each cycle

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Bendamustine
Description: 1-4 participants to bendamustine 90 mg/m\^2/day, days 1 and 2 each cycle

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Bendamustine
Description: 1-4 participants to bendamustine 90 mg/m\^2/day, days 1 and 2 each cycle

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Acetaminophen
Description: Treatment of infusion-related symptoms with acetaminophen is recommended.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Acetaminophen
Description: Treatment of infusion-related symptoms with acetaminophen is recommended.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Acetaminophen
Description: Treatment of infusion-related symptoms with acetaminophen is recommended.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Acetaminophen
Description: Treatment of infusion-related symptoms with acetaminophen is recommended.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Acetaminophen
Description: Treatment of infusion-related symptoms with acetaminophen is recommended.
Study: NCT01998724

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Group Walking
Description: 24 week group walking intervention
Study: NCT04167540

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: AAV2-GDNF
Description: Bilateral image-guided infusion of AAV2-GDNF into putamen, single dose

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: AAV2-GDNF
Description: Bilateral image-guided infusion of AAV2-GDNF into putamen, single dose
Study: NCT03364543

Intervention type: OTHER
Intervention: Access to the Medical-Legal Partnership Group
Description: The Medical-Legal Partnership Group are lawyers in clinics who address health-harming legal needs.

Intervention type: OTHER
Intervention: Access to social worker and a community worker
Description: Access to social worker and a community worker, but no systematic process for addressing health-harming legal needs.

Intervention type: OTHER
Intervention: Access to social worker and a community worker
Description: Access to social worker and a community worker, but no systematic process for addressing health-harming legal needs.
Study: NCT04219826

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CK-3773274 (5 - 15 mg)
Description: CK-3773274 tablets administered orally

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CK-3773274 (5 - 15 mg)
Description: CK-3773274 tablets administered orally

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CK-3773274 (5 - 15 mg)
Description: CK-3773274 tablets administered orally

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CK-3773274 (10 - 30 mg)
Description: CK-3773274 tablets administered orally

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo for CK-3773274
Description: Placebo administered orally

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo for CK-3773274
Description: Placebo administered orally
Study: NCT02794246

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: CART-19 cells
Study: NCT01090518

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Prolonged Exposure therapy
Description: 10 weekly sessions

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Hydrocortisone
Description: 30mg 20 minutes prior to each PE session including imaginal exposure (8 total)

Intervention type: BEHAVIORAL
Group type: PLACEBO_COMPARATOR
Intervention: Prolonged Exposure therapy
Description: 10 weekly sessions
Study: NCT03946280

Intervention type: PROCEDURE
Group type: OTHER
Intervention: conventional X-ray based Fluoroscopy
Description: catheter tracking via conventional X-ray based Fluoroscopy

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: low X-ray 3D navigation technique
Description: catheter tracking via low X-ray 3D navigation technique
Study: NCT00878176

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: First stage tined lead procedure
Description: bilateral first stage tined lead placement
Study: NCT02950649

Intervention type: DEVICE
Intervention: invasive Hemodynamic monitoring via Clearsight/Nexfin Systems from Edwards Lifesciences
Description: Experimental: Hemodynamic Monitored Guided Assesment This group will have the non-invasive hemodynamic monitoring device placed and its data will help guide (intervention) patient's management decisions (experimental).

Intervention type: DEVICE
Intervention: No Hemodynamic Monitored Guided Assesment
Description: Arm: Active Comparator: No Hemodynamic Monitored Guided Assesment This group will have the non-invasive hemodynamic monitoring device placed but its data will NOT be factored for intervention of the patient's management decisions.
Study: NCT03133650

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: WST 11-mediated VTP therapy
Description: Administration of WST11 in conjunction with endoscopic illumination at 753 nm emitted by a diode laser and administered to the participant by optical fibre catheters (cylindrical light diffusers) and a standard upper GI endoscope.
Study: NCT01355809

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Inhalation gas
Description: Inhalated gas, medicinal oxygen 100% via NIV with Fi O2 0.35, one time by random, 6 minutes
Study: NCT00195338

Intervention type: DRUG
Intervention: etanercept
Study: NCT01577940

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Infusion of ropivacaine
Description: TAP block with ropivacaine 20 ml 0,5%. Catheter with infusion of ropivacaine 0,2% 5 ml/h 24 hours on one side of the abdomen.

Intervention type: PROCEDURE
Group type: PLACEBO_COMPARATOR
Intervention: Infusion of saline
Description: TAP block with ropivacaine 0,5% 20 ml. Catheter with infusion of saline 5 ml/h 24 hours.
Study: NCT00048737

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Zevalin Radioimmunotherapy
Description: Escalating single dose of 90Y Zevalin 0.2-0.3-0.4 mCi/kg

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Rituximab
Description: 250 mg/m\^2 on day 1 and day 8

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Fludarabine
Description: 30 mg/m\^2/day for 3 days

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclophosphamide
Description: 750 mg/m\^2/day for 3 days, given on the same days as fludarabine, at 4-hour intervals

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Allogeneic Stem Cell Transplantation
Description: Allogeneic stem cell transplantation 2 days after chemotherapy
Study: NCT03905720

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Acupuncture
Description: A licensed acupuncturist will assess participants' symptoms and administer acupuncture needles in accordance with traditional Chinese medicine principles and the study protocol. Treatments will provided daily for up to four hospital days.
Study: NCT01355809

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Inhalation Nitrogen/Oxygen
Description: Inhalated gas, Nitrogen/Oxygen (65%/35%), one time by random, 6 minutes

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Inhalation Helium/Oxygen
Description: Inhalated gas, Helium/Oxygen (65%/35%) one time by random, 6 minutes
Study: NCT00579839

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Delayed Cord Clamping
Description: Delayed Cord Clamping: 30-35 seconds after birth
Study: NCT03905720

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Acupuncture
Description: A licensed acupuncturist will assess participants' symptoms and administer acupuncture needles in accordance with traditional Chinese medicine principles and the study protocol. Treatments will provided daily for up to four hospital days.

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Pain Counseling
Description: Participants will receive sessions with a counselor trained in pain management. The pain counselor will explain, review, and discuss the contents of a Pain Control booklet. Sessions will include pain assessment, pain education, and coping skills, provided daily for up to four hospital days.

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Pain Counseling
Description: Participants will receive sessions with a counselor trained in pain management. The pain counselor will explain, review, and discuss the contents of a Pain Control booklet. Sessions will include pain assessment, pain education, and coping skills, provided daily for up to four hospital days.
Study: NCT02813265

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: KPI-121 0.25% Ophthalmic Suspension

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Vehicle of KPI-121 0.25% Ophthalmic Suspension
Study: NCT00863772

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: tanezumab
Description: 5 mg dose Intravenously every 8 weeks for duration of study

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: tanezumab
Description: 10 mg dose Intravenously every 8 weeks for duration of study

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo, Intravenously, every 8 weeks for duration of study
Study: NCT00997204

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Icatibant
Description: Single subcutaneous injection of icatibant, 30 mg

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Icatibant
Description: Single subcutaneous injection of icatibant, 30 mg
Study: NCT00996892

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cobimetinib
Description: Repeated oral dosing.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cobimetinib
Description: Repeated oral dosing.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cobimetinib
Description: Repeated oral dosing.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cobimetinib
Description: Repeated oral dosing.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cobimetinib
Description: Repeated oral dosing.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cobimetinib
Description: Repeated oral dosing.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pictilisib
Description: Repeated oral dosing.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pictilisib
Description: Repeated oral dosing.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pictilisib
Description: Repeated oral dosing.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pictilisib
Description: Repeated oral dosing.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pictilisib
Description: Repeated oral dosing.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pictilisib
Description: Repeated oral dosing.
Study: NCT02202707

Intervention type: DRUG
Group type: OTHER
Intervention: Gabapentin
Description: Study medication, gabapentin, will be distributed to all study participants and participants will be instructed as to how to take and titrate the medication dose. Participants will take gabapentin daily for up to six weeks.
Study: NCT00588458

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: CT cholangiography
Description: Cholografin 20ml will be diluted in 100 ml of normal saline and infused over 30 minute time interval. Following the infusion of the cholografin, morphine (0.04 mg/kg) will be administered to contract the sphincter of Oddi and improve bile duct distension and visualization. Thirty minutes following the administration of morphine a test scan (CT cholangiography) will be performed through the liver to determine if there is adequate biliary excretion. The test scan will consist of 10 mm thick image obtained through the mid liver. If there is evidence of biliary excretion, high-resolution images will be performed through the liver and bile ducts. The axial images will be reconstructed into maximum intensity projection models and volume rendered models that can be viewed in 3-dimension.
Study: NCT02295540

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: hypofractionated radiation therapy
Description: Undergo hypofractionated IMRT

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: intensity-modulated radiation therapy
Description: Undergo hypofractionated IMRT

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: therapeutic conventional surgery
Description: Undergo surgery

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: laboratory biomarker analysis
Description: Correlative studies
Study: NCT02908087

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Victoza® (liraglutide)
Description: Daily subcutaneous injections with increasing doses up to 1.8 mg per day. Duration of treatment 6 months. Duration of follow-up 6 months.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Daily subcutaneous injections with increasing doses up to 1.8 mg per day. Duration of treatment 6 months. Duration of follow-up 6 months.
Study: NCT03385850

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: enteral nutrition
Description: early enteral nutrition group or delayed enteral nutrition group

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: enteral nutrition
Description: early enteral nutrition group or delayed enteral nutrition group
Study: NCT03680989

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Bright Light Exposure
Description: For 10 consecutive days, participants will use an Ultralux(R) V HD-LED light therapy light for 30 minutes beginning 30 minutes after waking. The light will be preset to deliver \~10,000 lux at 22.

Intervention type: DEVICE
Group type: PLACEBO_COMPARATOR
Intervention: Natural Light Exposure
Description: For 10 consecutive days, participants will use an Ultralux(R) V HD-LED light therapy light for 30 minutes beginning 30 minutes after waking. The light will be preset to deliver \~500 lux at 22.
Study: NCT02339662

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Gabapentin
Description: muscles pain treatment

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Amitriptyline
Description: muscles pain treatment
Study: NCT02836314

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Anorganic Bovine Bone Mineral (ABBM)
Description: In the control group, periodontal intrabony defects were treated with ABBM alone.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Anorganic Bovine Bone Mineral and Platelet Rich Fibrin (PRF)
Description: In the test group, periodontal intrabony defects were treated with ABBM and PRF combination.
Study: NCT00282919

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Azithromycin plus chloroquine
Description: dose of 2000 mg Azithromycin plus 600 mg chloroquine base
Study: NCT00627861

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Aliskiren
Description: 150mg orally daily for 6 weeks. Dose may increase to 300mg orally daily dependent upon blood pressure parameters set by the protocol.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Extended-release metoprolol
Description: 50mg orally daily for 1 week, dose will increase to 100mg orally daily or decrease to 25mg daily for a second week dependent upon blood pressure parameters set by the protocol. Subjects will take metoprolol for a total of 2 weeks, then be tapered off of it over 5-7 days.
Study: NCT01266031

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: vorinostat
Description: Vorinostat 400mg/day will be administered on day 1 to 7 and day 15 to 21 orally on a 28 day cycle in the arm with combination of vorinostat and bevacizumab. Vorinostat will be administered orally. Vorinostat capsules should not be opened or crushed and must be administered whole.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: bevacizumab
Description: Bevacizumab 10mg/kg will be administered on day 1 and 15 intravenously on a 28 day cycle in both arms.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: bevacizumab
Description: Bevacizumab 10mg/kg will be administered on day 1 and 15 intravenously on a 28 day cycle in both arms.
Study: NCT03526159

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Gentamicin Sulfate
Description: Gentamicin (formulated as gentamicin sulfate) is a well-known, well-characterized antibiotic that has been used for four decades as a treatment against gram negative bacteria. It, like other aminoglycoside antibiotics, has the well documented added potential to facilitate readthrough of premature termination codons in eukaryotic cells and organisms.
Study: NCT01254383

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Sildenafil Tablet
Description: Tablet, 50 mg, Single Dose

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Sildenafil ODT
Description: Orally Disintegrating Tablet, 50 mg, Single Dose

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Sildenafil ODT
Description: Orally Disintegrating Tablet, 50 mg, Single Dose
Study: NCT00579839

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Immediate Cord Clamping
Description: Immediate Cord Clamping: within 5 seconds of birth
Study: NCT00997906

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

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

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: gemcitabine hydrochloride
Description: Given IV

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

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: intensity-modulated radiation therapy
Description: Given once daily 5 days a week for 6½ weeks.

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: intensity-modulated radiation therapy
Description: Given once daily 5 days a week for 6½ weeks.
Study: NCT03849092

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Financial incentives
Description: Cessation programs in municipalities will offer a financial incentive of 1200 DKK to smokers who achieve continuous abstinence from smoking when attending a group-based smoking cessation program. Aimed at smokers with low socioeconomic status but other smokers are also included.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Campaigns
Description: Municipalities will design anti-smoking campaigns targeting smokers, recommending to use a municipal free group-based smoking cessation program. Aimed at smokers with low socioeconomic status but other smokers are also included.
Study: NCT00017173

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Ad5CMV-p53 gene
Description: 2 intraoperative and one post-operative injection of Ad5CMV-p53.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: cisplatin
Description: 100 mg/m2 IV Day 1 every 21 days for 3 cycles

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

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: radiation therapy
Description: 200 cGy per day Days 105 every week for 6 weeks
Study: NCT00529113

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Bardoxolone methyl
Description: Bardoxolone methyl capsules (150 mg/day) for 21 days

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Bardoxolone methyl
Description: Bardoxolone methyl capsules (300 mg/day) for 21 days

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Bardoxolone methyl
Description: Bardoxolone methyl capsules (150 mg/day) for 28 days

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Bardoxolone methyl
Description: Bardoxolone methyl capsules (200 mg/day) for 28 days

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Bardoxolone methyl
Description: Bardoxolone methyl capsules (250 mg/day) for 28 days

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Bardoxolone methyl
Description: Bardoxlone methyl capsules (300 mg/day) x 28 days

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Bardoxolone methyl
Description: Bardoxolone methyl capsules (350 mg/day) x 28 days

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Gemcitabine
Description: 1,000 mg/m2 administered as an intravenous infusion on days 1, 8, and 15

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Gemcitabine
Description: 1,000 mg/m2 administered as an intravenous infusion on days 1, 8, and 15

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Gemcitabine
Description: 1,000 mg/m2 administered as an intravenous infusion on days 1, 8, and 15

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Gemcitabine
Description: 1,000 mg/m2 administered as an intravenous infusion on days 1, 8, and 15

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Gemcitabine
Description: 1,000 mg/m2 administered as an intravenous infusion on days 1, 8, and 15

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Gemcitabine
Description: 1,000 mg/m2 administered as an intravenous infusion on days 1, 8, and 15

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Gemcitabine
Description: 1,000 mg/m2 administered as an intravenous infusion on days 1, 8, and 15

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Gemcitabine
Description: 1,000 mg/m2 administered as an intravenous infusion on days 1, 8, and 15

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Gemcitabine
Description: 1,000 mg/m2 administered as an intravenous infusion on days 1, 8, and 15

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo capsules x 28 days

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Bardoxolone methyl
Description: Bardoxolone methyl maximum tolerated dose (as determined in the Phase 1 portion of the study)/day x 28 days