AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Study NCT01223248 — intervention group
Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: IGIMRT 27 Gy in 3 fractions
Description: Pts in both the hypofractionated \& single dose arms will receive the same following standard procedures. The only difference between the arms is the dose delivered at each treatment. 20 MSKCC pts (10 per treatment arm) will be accrued to undergo baseline DW-MRI \& DCE-MRI pretreatment for both arms \& within 1 hour after their initial treatment for single fraction pts, \& within one hour of their initial \& final radiation treatment for the hypofractionated pts. Pts will be considered for this scan based on compliance to scan schedule \& MRI availability for performing the scan within one hour of the planned IGRT. 24 MSKCC pts (12 per treatment arm) will be accrued for the blood collection (optional) up to 4 hours prior, 50-90 minutes after, \& approximately 24 hours \[MCPG2.3\]after treatment for single fraction pts. For pts partaking in both sub-studies, the post-treatment blood collection may be done in a 50-120 minute window to account for scheduling conflicts with the research MRI.
Study NCT04382261 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Scaling and root planing
Description: Full mouth or quadrant SRP
Study NCT04382261 — intervention group
Intervention type: PROCEDURE
Group type: PLACEBO_COMPARATOR
Intervention: Scaling and root planing
Description: Full mouth or quadrant SRP
Study NCT00345371 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Topiramate
Study NCT02722239 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Metformin ER (Glucophage® long)
Description: co-administration of a single oral dose of 10 mg dapagliflozin film-coated tablet (Forxiga™) and two tablets 500 mg metformin hydrochloride extended release tablets (Glucophage® long).
Study NCT02722239 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dapagliflozin (Forxiga)
Description: co-administration of a single oral dose of 10 mg dapagliflozin film-coated tablet (Forxiga™) and two tablets 500 mg metformin hydrochloride extended release tablets (Glucophage® long).
Study NCT01277731 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Methylprednisolone
Description: Run-in period: dexamethasone 10-20mg q day iv during chemotherapy Treatment period: methylprednisolone 60-125mg iv during chemotherapy
Study NCT01151631 — intervention group
Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: occipital nerve stimulation
Description: Low occipital bilateral Quad Plus, midline to laterally directed, secured by titan anchors, connected to Versitrel. No trial stimulation. Suggested stimulation parameters: Pulse width: 450, Amplitude: protocol, Rate: 60
Study NCT01151631 — intervention group
Intervention type: DEVICE
Group type: SHAM_COMPARATOR
Intervention: occipital nerve stimulation
Description: Low occipital bilateral Quad Plus, midline to laterally directed, secured by titan anchors, connected to Versitrel. No trial stimulation. Suggested stimulation parameters: Pulse width: 450, Amplitude: protocol, Rate: 60
Study NCT03725735 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: CBT for problem gambling with emotion regulation
Description: CBT group treatment for problem gambling with emotion regulation focus, with 8 sessions.
Study NCT01368731 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Prophylactic use of coagulation therapy
Description: The procedure is completed as per usual, and if the patient has been randomized to the intervention group the appropriate coagulation therapy will be applied immediately after standard EMR to visible vessels within the mucosal resection area.
Study NCT02774720 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Centre-based exercise
Description: Participants will come to a centre (University of Waterloo or Toronto Rehabilitation Institute) for a one-hour, small group exercise class each week. The classes will include progressive aerobic and resistance exercise. They will be prescribed additional exercise to be performed independently (either at home or in the community).
Study NCT02774720 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Home-based exercise
Description: Participants will be prescribed aerobic and resistance exercise to be performed independently (either at home or in the community). They will receive monthly phone calls to discuss achievements and barriers and to tje adjust exercise prescription.
Study NCT02669277 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: IVIG prepared by minipool technology
Description: Drug: To demonstrate the efficacy of new product IVIG prepared by minipool technology as assessed by Bleeding Score and platelet count at 3 days, 1 week, 2 weeks and 4 weeks.
Study NCT02669277 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: standard IVIG product
Description: to compare efficacy and safety with the minipool IVIG
Study NCT03607643 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cannabidiol
Description: * Sublingual dose of 1 mL (0.910 g) of BRCX014 in the morning, prior to the first meal of the day~* Sublingual dose of 1 mL (0.910 g) of BRCX014 in the afternoon, prior to the evening meal
Study NCT03607643 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Bortezomib
Description: Standard of care (SOC) chemotherapy for multiple myeloma will include a bortezomib-based regimen given at 1.3 mg/m2 on days 1, 4, 8 \& 11 schedule to be repeated every 21 days.
Study NCT03607643 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Bortezomib
Description: Standard of care (SOC) chemotherapy for multiple myeloma will include a bortezomib-based regimen given at 1.3 mg/m2 on days 1, 4, 8 \& 11 schedule to be repeated every 21 days.
Study NCT03607643 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Leucovorin
Description: Standard of care chemotherapy for Stage IV colon or rectal cancer, will include leucovorin 350 mg/m2 IV over 2 hours Day 1, 5-FU 400 mg/m2 IV bolus followed 2400 mg/m2 IV over 46 hours, oxaliplatin 100 mg/m2 IV Day 1, bevacizumab 5 mg/kg IV day1. Irinotecan can be substituted for oxaliplatin.
Study NCT03607643 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Leucovorin
Description: Standard of care chemotherapy for Stage IV colon or rectal cancer, will include leucovorin 350 mg/m2 IV over 2 hours Day 1, 5-FU 400 mg/m2 IV bolus followed 2400 mg/m2 IV over 46 hours, oxaliplatin 100 mg/m2 IV Day 1, bevacizumab 5 mg/kg IV day1. Irinotecan can be substituted for oxaliplatin.
Study NCT02334410 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Whole body vibration (WBV)
Description: Side-alternating WBV
Study NCT03607643 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 5-FU
Description: Standard of care chemotherapy for Stage IV colon or rectal cancer, will include leucovorin 350 mg/m2 IV over 2 hours Day 1, 5-FU 400 mg/m2 IV bolus followed 2400 mg/m2 IV over 46 hours, oxaliplatin 100 mg/m2 IV Day 1, bevacizumab 5 mg/kg IV day1. Irinotecan can be substituted for oxaliplatin.
Study NCT03607643 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: 5-FU
Description: Standard of care chemotherapy for Stage IV colon or rectal cancer, will include leucovorin 350 mg/m2 IV over 2 hours Day 1, 5-FU 400 mg/m2 IV bolus followed 2400 mg/m2 IV over 46 hours, oxaliplatin 100 mg/m2 IV Day 1, bevacizumab 5 mg/kg IV day1. Irinotecan can be substituted for oxaliplatin.
Study NCT03607643 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Oxaliplatin
Description: Standard of care chemotherapy for Stage IV colon or rectal cancer, will include leucovorin 350 mg/m2 IV over 2 hours Day 1, 5-FU 400 mg/m2 IV bolus followed 2400 mg/m2 IV over 46 hours, oxaliplatin 100 mg/m2 IV Day 1, bevacizumab 5 mg/kg IV day1. Irinotecan can be substituted for oxaliplatin.
Study NCT03607643 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Oxaliplatin
Description: Standard of care chemotherapy for Stage IV colon or rectal cancer, will include leucovorin 350 mg/m2 IV over 2 hours Day 1, 5-FU 400 mg/m2 IV bolus followed 2400 mg/m2 IV over 46 hours, oxaliplatin 100 mg/m2 IV Day 1, bevacizumab 5 mg/kg IV day1. Irinotecan can be substituted for oxaliplatin.
Study NCT03607643 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Bevacizumab
Description: Standard of care chemotherapy for Stage IV colon or rectal cancer, will include leucovorin 350 mg/m2 IV over 2 hours Day 1, 5-FU 400 mg/m2 IV bolus followed 2400 mg/m2 IV over 46 hours, oxaliplatin 100 mg/m2 IV Day 1, bevacizumab 5 mg/kg IV day1. Irinotecan can be substituted for oxaliplatin.
Study NCT03607643 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Bevacizumab
Description: Standard of care chemotherapy for Stage IV colon or rectal cancer, will include leucovorin 350 mg/m2 IV over 2 hours Day 1, 5-FU 400 mg/m2 IV bolus followed 2400 mg/m2 IV over 46 hours, oxaliplatin 100 mg/m2 IV Day 1, bevacizumab 5 mg/kg IV day1. Irinotecan can be substituted for oxaliplatin.
Study NCT03607643 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Irinotecan
Description: Standard of care chemotherapy for Stage IV colon or rectal cancer, will include leucovorin 350 mg/m2 IV over 2 hours Day 1, 5-FU 400 mg/m2 IV bolus followed 2400 mg/m2 IV over 46 hours, oxaliplatin 100 mg/m2 IV Day 1, bevacizumab 5 mg/kg IV day1. Irinotecan can be substituted for oxaliplatin.
Study NCT03607643 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Irinotecan
Description: Standard of care chemotherapy for Stage IV colon or rectal cancer, will include leucovorin 350 mg/m2 IV over 2 hours Day 1, 5-FU 400 mg/m2 IV bolus followed 2400 mg/m2 IV over 46 hours, oxaliplatin 100 mg/m2 IV Day 1, bevacizumab 5 mg/kg IV day1. Irinotecan can be substituted for oxaliplatin.
Study NCT03607643 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Gemcitabine
Description: Stage IV pancreatic cancer will include a gemcitabine-based regiment at 1000 mg/m2 day 1, 7, 15 of a 21-day cycle.
Study NCT03607643 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Gemcitabine
Description: Stage IV pancreatic cancer will include a gemcitabine-based regiment at 1000 mg/m2 day 1, 7, 15 of a 21-day cycle.
Study NCT03607643 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Temozolomide
Description: Standard of care chemotherapy for patients with glioblastoma multiforme includes concurrent radiation therapy (2 Gy per day for a total of 60 Gy) and temozolomide (75 mg per square meter of body-surface area per day, 7 days per week from the first to the last day of radiotherapy), followed by six cycles of adjuvant temozolomide (150 to 200 mg per square meter for 5 days during each 28-day cycle).
Study NCT03607643 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Temozolomide
Description: Standard of care chemotherapy for patients with glioblastoma multiforme includes concurrent radiation therapy (2 Gy per day for a total of 60 Gy) and temozolomide (75 mg per square meter of body-surface area per day, 7 days per week from the first to the last day of radiotherapy), followed by six cycles of adjuvant temozolomide (150 to 200 mg per square meter for 5 days during each 28-day cycle).
Study NCT01408329 — intervention group
Intervention type: DEVICE
Group type: SHAM_COMPARATOR
Intervention: CVAC Device (Cyclic Variations in Altitude Conditioning)
Description: A hypobaric hypoxia chamber
Study NCT01408329 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: CVAC Device (Cyclic Variations in Altitude Conditioning)
Description: A hypobaric hypoxia chamber
Study NCT01186497 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Rabeprazole sodium: Treatment E
Description: The contents of 2 rabeprazole sprinkle capsules equivalent to 10 mg rabeprazole sodium mixed with a tablet vehicle suspension (Treatment E) on Day 1.
Study NCT00345371 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo Oral Tablet
Study NCT02604719 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Tranexamic Acid and Ethamsylate
Description: The intervention will be the intravenous administration of 10 ml blinded vial of the study drugs (either 1 gmTranexamic acid and 1 gm Ethamsylate or placebo according to randomization group) slowly (over 30-60 sec ) in the 2 minutes after birth and the routine prophylactic oxytocin and after the cord has been clamped , all generally by the anesthesiologist or obstetrician then a pad will be placed under women buttocks then weighting the pads to allow objective measurement of blood loss.
Study NCT02604719 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Tranexamic Acid and Ethamsylate
Description: The intervention will be the intravenous administration of 10 ml blinded vial of the study drugs (either 1 gmTranexamic acid and 1 gm Ethamsylate or placebo according to randomization group) slowly (over 30-60 sec ) in the 2 minutes after birth and the routine prophylactic oxytocin and after the cord has been clamped , all generally by the anesthesiologist or obstetrician then a pad will be placed under women buttocks then weighting the pads to allow objective measurement of blood loss.
Study NCT04049188 — intervention group
Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Single-Fraction Palliative Radiation Therapy
Description: All subjects will be undergo single-fraction palliative radiation therapy who have cancer and associated bone metastases and symptomatic bone pain.
Study NCT00059761 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: cisplatin
Study NCT00059761 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: irinotecan hydrochloride
Study NCT01512537 — intervention group
Intervention type: RADIATION
Group type: ACTIVE_COMPARATOR
Intervention: Narrowband UVB
Description: UVB 3 times a week
Study NCT01186497 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Rabeprazole sodium: Treatment C
Description: The contents of 2 rabeprazole sprinkle capsules equivalent to 10 mg rabeprazole sodium sprinkled on 1 tablespoon of applesauce (Treatment C) on Day 1.
Study NCT01512537 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: Vitamin D and calcium
Description: 1 daily tablet of 1600 IU vitamin D3 and 1000 mg calcium
Study NCT01186497 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Rabeprazole sodium: Treatment D
Description: The contents of 2 rabeprazole sprinkle capsules containing 10 mg rabeprazole sodium mixed with 5 mL (1 teaspoon) of formula milk (Treatment D) on Day 1.
Study NCT04786496 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: ITP+SA Wise intervention
Description: Intervention designed to promote well-being and resilience in late adolescents and young adults. It includes two components: a self-affirmation (SA) activity and an ITP intervention. The SA component includes a list of values so that they could choose the three most important for them. Next, they are asked to write why those selected values are the most important to them. The ITP component resembled the intervention developed by David S. Yeager and colleagues and it was adapted to first year university students. It consisted of three parts. First, participants are asked to read scientific studies that provide evidence that behaviors are controlled pathways in the brain that have the potential to be changed under the right circumstances. Second, participants read several testimonials purportedly written by second year university students to bring credibility to the ITP. Finally, participants are asked to write their own version of such a narrative (self-persuasive writing exercise).
Study NCT04786496 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: ITP Wise intervention
Description: Intervention designed to promote well-being and resilience in late adolescents and young adults based on four general types of change strategies: (1) scientific knowledge, (2) generation of new meanings, (3) commitment through action, and (4) active reflection. It includes the ITP component described above for the ITP+SA Wise intervention.
Study NCT04786496 — intervention group
Intervention type: BEHAVIORAL
Group type: OTHER
Intervention: Control condition
Description: The control intervention was designed to have a similar structure than the experimental interventions, including also reading and writing tasks, but that they were not in any way related to the contents of the experimental interventions. In particular, participants were asked to read an article about the fire that took place in the Notre Dame cathedral in Paris that had been recently published in a newspaper. Starting from the accident of the Notre Dame cathedral, the article focuses on reflecting on the problem of heritage conservation and analyzing the situation of other important cathedrals. After reading the article, the participants were asked to write a few lines evaluating in their opinion the importance of the conservation of historical buildings such as those mentioned and how much of the public economic budget should be used for heritage conservation.
Study NCT03560843 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: MBSR
Description: Mindfulness Based Stress Reduction
Study NCT03751748 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: AFR implantation
Description: Implantation of atrial flow regulator (AFR) device
Study NCT03751748 — intervention group
Intervention type: DEVICE
Group type: SHAM_COMPARATOR
Intervention: Sham procedure
Description: Sham procedure to include cardiac catheterization and hemodynamic. Ongoing management at the discretion of the treating physician. Patient to undergo
Study NCT02970123 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Sit Less, Interact, Move More (SLIMM)
Study NCT04411680 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Sargramostim
Description: Sargramostim is a glycosylated, yeast-derived recombinant human granulocyte-macrophage colony stimulating factor (rhu-GM-CSF). Dosage for inhaled sargramostim: 125 mcg twice a day. Dosage for intravenous sargramostim: 125mcg/m2/day given over a 4 hour period.
Study NCT04411680 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Standard of care
Description: Standard of care for COVID-19
Study NCT04411680 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Standard of care
Description: Standard of care for COVID-19
Study NCT03129841 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Early dinner+Diet
Description: Subjects are asked to eat dinner meals between 7:00- 7:30 PM in the ED group, while they are on a multidisciplinary weight loss plan for 12 weeks.
Study NCT03129841 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Late dinner+Diet
Description: Subjects are asked to eat their dinner meal between 10:30-11:00PM, while they are on a multidisciplinary weight loss plan for 12 weeks.
Study NCT02173886 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Bupropion SR and XL
Study NCT01341938 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Commit® nicotine lozenges (4 mg) & self-help materials
Description: Participants provided with instructions on standard use of lozenge for nicotine replacement therapy (NRT) \& instructed to use the lozenge any time they have a craving or urge to use ST or tobacco. Dosing: weeks 1-6 one lozenge every 1-2 hours/16 per day, weeks 7-9 one lozenge every 2-4 hours/8 per day, weeks 10-12 one lozenge every 4-8 hours/4 per day + The Enough Snuff video and printed guide providing strategies for tobacco cessation.
Study NCT01341938 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Commit® nicotine lozenges (4 mg) & self-help materials
Description: Participants provided with instructions on standard use of lozenge for nicotine replacement therapy (NRT) \& instructed to use the lozenge any time they have a craving or urge to use ST or tobacco. Dosing: weeks 1-6 one lozenge every 1-2 hours/16 per day, weeks 7-9 one lozenge every 2-4 hours/8 per day, weeks 10-12 one lozenge every 4-8 hours/4 per day + The Enough Snuff video and printed guide providing strategies for tobacco cessation.
Study NCT01341938 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Commit® nicotine lozenges (4 mg) & phone counseling & self-help materials
Description: Three phone counseling sessions to assist in cessation from use of all tobacco + lozenge nicotine replacement therapy (NRT) + The Enough Snuff video and printed guide providing strategies for tobacco cessation.
Study NCT01341938 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Phone counseling & self-help materials
Description: Three phone counseling sessions to assist in cessation from use of all tobacco + The Enough Snuff video and printed guide providing strategies for tobacco cessation.
Study NCT01341938 — intervention group
Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Phone counseling & self-help materials
Description: Three phone counseling sessions to assist in cessation from use of all tobacco + The Enough Snuff video and printed guide providing strategies for tobacco cessation.
Study NCT03710733 — intervention group
Intervention type: RADIATION
Group type: ACTIVE_COMPARATOR
Intervention: Sequential boost
Description: Boost (10 Gy/4 fx/1 week) is given after whole breast irradiation
Study NCT03710733 — intervention group
Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Concomitant boost
Description: Boost (8 Gy/15 fx/3 weeks) is given with whole breast irradiation
Study NCT00008333 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: vinorelbine tartrate
Study NCT01755156 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Omarigliptin
Description: Omarigliptin 25 mg capsule administered orally once weekly (preferably on the same day of each week)
Study NCT01755156 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Matching placebo to omarigliptin
Description: Matching placebo to omarigliptin capsule administered orally once weekly (preferably on the same day of each week)
Study NCT01755156 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Glimepiride
Description: Glimepiride 1 or 2 mg tablet/capsule administered orally once daily and up-titrated to a maximum dose of 6 mg daily. Participants rescued with open-label glimepiride during Phase A will not receive glimepiride or matching placebo to glimepiride during Phase B.