AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Study NCT00003058 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: troglitazone
Study NCT03472001 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Lecture
Description: Traditional didactic lecture which uses the same clinical cases
Study NCT00109941 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: opioid growth factor
Description: OGF was administered in saline at 250 ug/kg intravenously over 45 minutes
Study NCT00109941 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: metenkephalin, OGF-opioid growth factor
Description: OGF given in saline iv 250 ug/kg weekly
Study NCT03141034 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Irinotecan
Description: -Irinotecan is commercially available and will be billed to insurance.
Study NCT03141034 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ramucirumab
Description: -Ramucirumab will be provided free of charge by Eli Lilly and Company.
Study NCT04025268 — intervention group
Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Group Prenatal Care (GPNC)
Description: GPNC participants will attend 11 group sessions total: 10 during pregnancy and one postpartum. Each session will be 90-100 minutes long. Groups will collectively identify the preferred time of day for these sessions. Groups of 10 women will be led by a locally trained, Samoan nurse-midwife with the study Project Director as a co-facilitator. At each of the visits participants will engage in self-assessments of weight and blood pressure, including learning to take their blood pressure with a digital cuff, calculating BMI, and plotting their weight gain on a graph), receive short individual clinical examinations from a midwife, and participate in group discussions about prenatal care, childbirth preparation, and their postpartum care. The session at 6-weeks postpartum will allow women to introduce their babies to the group and share childbirth stories.
Study NCT04025268 — intervention group
Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Standard of Care
Description: Standard of prenatal care
Study NCT04253847 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Radical antegrade modular pancreatosplenectomy
Description: Radical antegrade modular pancreatosplenectomy (RAMPS) includes the following aspects. Firstly, the surgical approach is antegrade, which means from the right to the left, the pancreatic neck will be transected at first and the spleen will be seperated at last. Secondly, lymph nodes dissection includes not only the regional lymph nodes(No.10,11,18 lymph nodes), but also N1 station lymph nodes (N1: 6, 8a, 8p, 12a2/b2/p2, 13a/b, 14b/c/d, 14v, 17a/b), No.7, 9 lymph nodes, the lymph nodes anterior and left of superior mesenteric artery, as well as the peripheral nerve of celiac trunk. Thirdly, the transection platform is in the pancreatic neck, which is mandatory. At last, left prerenal fascia will be resected. When the tumor abuts or infiltrates the left adrenal gland, left adrenalectomy will be performed, which is also called posterior approach RAMPS. While in normal cases, left adrenal gland will be preserved.
Study NCT04253847 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Standard retrograde pancreatosplenectomy
Description: Standard retrograde pancreatosplenectomy(SRPS) includes several aspects. Firstly, the surgical approach is retrograde, which means from the left to the right, spleen will be seperated at first and the pancreas will be transected later on. Secondly, only the regional lymph nodes will be dissected, which include No.10, No.11, No.18 lymph nodes, and No.9 lymph nodes should be dissected only when the lesion is in pancreatic neck. Thirdly, the transection platform is in the left side of the lesion, but transection at pancreatic neck is not mandatory. At last, the surgical plane is anterior to the left renal fascia, prerenal fascia will be preserved.
Study NCT02075619 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Amlodipine+Rosuvastatin
Description: Amlodipine 10mg will be supplied as white or off-white, emerald shaped tablet. Rosuvastatin 20mg will be supplied as pink round film coated tablet.
Study NCT03141034 — intervention group
Intervention type: GENETIC
Group type: EXPERIMENTAL
Intervention: Blood for angiome profiling
Description: -Before treatment on cycle 1 day 1, cycle 5 day 1, cycle 9 day 1, and end of treatment
Study NCT03141034 — intervention group
Intervention type: GENETIC
Group type: EXPERIMENTAL
Intervention: Blood for cfDNA
Description: -Before treatment on cycle 1 day 1, cycle 3 day 1, cycle 5 day 1, cycle 7 day 1, cycle 9 day 1, and end of treatment
Study NCT03592784 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Food Order Therapy
Description: Instructing patient to, whenever possible, eat carbohydrates at the end of their meal.
Study NCT03592784 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Medical Nutrition Therapy
Description: Key components of this therapy include counseling to incorporate portion control, increased intake of vegetables and low glycemic index carbohydrates, and mild carbohydrate restriction.
Study NCT03592784 — intervention group
Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Medical Nutrition Therapy
Description: Key components of this therapy include counseling to incorporate portion control, increased intake of vegetables and low glycemic index carbohydrates, and mild carbohydrate restriction.
Study NCT02547896 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Codeine + Diclofenac
Description: The patients will receive codeine and diclofenac as pain relief medicine after the surgery
Study NCT02547896 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Diclofenac
Description: The patients will receive only diclofenac
Study NCT02314312 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Everolimus + low dose cyclosporin A + prednisolone
Study NCT02314312 — intervention group
Intervention type: DRUG
Group type: OTHER
Intervention: Standard immunosupressive regimen
Study NCT01370616 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ertapenem sodium
Description: Ertapenem sodium, 1.0 g IV daily over 30 minutes at Hour 0 for 5 to 28 days
Study NCT01370616 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Piperacillin/tazobactam sodium
Description: Piperacillin/tazobactam sodium, 4.5 g, IV every 8 hours, given over 30 minutes at Hours 0, 8, and 16 for 5 to 28 days
Study NCT01370616 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Piperacillin/tazobactam-matching placebo
Description: Placebo, IV over 30 minutes, 2 times per day at Hours 8 and 16 for 5 to 28 days
Study NCT01370616 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Amoxicillin/clavulunate potassium
Description: If clinically indicated, participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
Study NCT01370616 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Amoxicillin/clavulunate potassium
Description: If clinically indicated, participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
Study NCT04293172 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Brilinta
Description: Patients in the open-label Run-in period (patients aged 6 to \<24 months only) will receive ticagrelor 5 mg twice a day (body weight 6 to ≤9 kg), 10 mg twice a day (body weight >9 to ≤12 kg) or 15 mg twice a day (body weight >12 to ≤24 kg) for 14 days.~The double-blind IP will be based on 5 weight bands:~* 6 to ≤9 kg: ticagrelor 5 mg or matching placebo, twice a day~* >9 to ≤12 kg: ticagrelor 10 mg or matching placebo, twice a day~* >12 to ≤24 kg: ticagrelor 15 mg or matching placebo, twice a day~* >24 to ≤48 kg: ticagrelor 30 mg or matching placebo, twice a day~* >48 kg: ticagrelor 45 mg or matching placebo, twice a day
Study NCT04293172 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Patients in the open-label Run-in period (patients aged 6 to \<24 months only) will receive ticagrelor 5 mg twice a day (body weight 6 to ≤9 kg), 10 mg twice a day (body weight >9 to ≤12 kg) or 15 mg twice a day (body weight >12 to ≤24 kg) for 14 days.~The double-blind IP will be based on 5 weight bands:~* 6 to ≤9 kg: ticagrelor 5 mg or matching placebo, twice a day~* >9 to ≤12 kg: ticagrelor 10 mg or matching placebo, twice a day~* >12 to ≤24 kg: ticagrelor 15 mg or matching placebo, twice a day~* >24 to ≤48 kg: ticagrelor 30 mg or matching placebo, twice a day~* >48 kg: ticagrelor 45 mg or matching placebo, twice a day
Study NCT00726258 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: ketamine
Description: ketamine with various concentrations
Study NCT00726258 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: placebo
Description: physiological serum
Study NCT00909220 — intervention group
Intervention type: BEHAVIORAL
Intervention: Behavioral Activation
Description: Behavioral Activation included up to 16 weekly 50 minute psychotherapy sessions using BA (Addis \& Martell, 2004; Martell et al., 2001, 2010). Techniques included functional analyses to identify the antecedent and consequential aspects of low mood, and interventions such as monitoring daily activities, assessing pleasure/satisfaction and competence achieved via activities, assigning tasks that induce mastery or pleasure, and reducing skill deficits. Clinicians included postdoctoral fellows in clinical psychology (n = 2) or licensed clinical psychologists (n = 2).
Study NCT04542811 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Acupuncture
Description: Acupuncture is a complementary therapy modality which is used by needle inserted the specific points on the body.
Study NCT04290377 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: BMI-assisted motor imagery OT
Description: As the goal of the intervention is to promote finger extension in participants who are unable to extend his/her finger due to stroke, the pneumatic glove provides extension assist when appropriate brain activity is present. The brain activity is obtained by Functional Near-Infrared Spectroscopy (fNIRS). Hypothetically, this will repeatedly induce brain activation that is related to finger extension.
Study NCT04290377 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Motor imagery OT
Description: In Motor imagery OT, Subjects try to extend their fingers (imagine) without BMI assistance. All other setting is equal to BMI-assisted motor imagery OT.
Study NCT03573570 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Fortified rice kernels
Description: The proposed project will leverage the existing state-run public distribution system (PDS) to provide fortified rice through Fair Price Shops (FPS) using a domestically manufactured rice grain (Fortified Rice Kernels: FRK). FRKs are grains made from rice flour, enriched with iron, zinc, Vitamin A, Vitamins B1, B3, B6, B9 and B12, and shaped like a conventional grain of rice. It is mixed into conventional rice in specified ratio of 1:100. The proposed study will be conducted as a cluster-randomized controlled trial, with baseline and follow-up surveys conducted 12-15 months apart. In the interim, 110 Treatment FPS, and all households receiving rice from them, will be randomly assigned to receive fortified rice, and another 110 randomly assigned Control FPS, and the households receiving rice from them, will continue receiving conventional rice and represents the status quo. This study will be conducted in one sub-district of Tamil Nadu with a population of about 1/2 million people.
Study NCT03545633 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Treatment with High Intensity Focused ElectroMagnetic system.
Description: The treatment administration phase will consist of four (4) treatments, delivered twice a week. The applicator will be applied over the abdomen area.~Visible contractions will be induced by the device.
Study NCT02187029 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PF-06743649
Description: Daily dosing (dose level 1) tablet for 14 days
Study NCT02187029 — intervention group
Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Daily dosing (tablet) for 14 days
Study NCT02187029 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PF-06743649
Description: Daily dosing (dose level 2) tablet(s) for 14 days
Study NCT02187029 — intervention group
Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Daily dosing (tablets) for 14 days
Study NCT03349489 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Exercise 1
Description: Participants will be admitted at the research center at 14:00. At 14:30, participant's insulin basal rate will be reduced by 80%. At 16:00, participants will perform a 60-minute exercise on a stationary bicycle at 60% of their maximal cardiorespiratory capacity (VO2 max). During the exercise period, muscle oxygenation and muscle oxygen extraction will be measure by near infrared spectroscopy. Glucose levels will be measured every 10 minutes during the exercise period. At 17:30, the participant will be discharged.
Study NCT03349489 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Exercise 2
Description: Participants will be admitted at the research center at 14:00. At 15:20, participant's insulin basal rate will be reduced by 80%. At 16:00, participants will perform a 60-minute exercise on a stationary bicycle at 60% of their maximal cardiorespiratory capacity (VO2 max). During the exercise period, muscle oxygenation and muscle oxygen extraction will be measure by near infrared spectroscopy. Glucose levels will be measured every 10 minutes during the exercise period. At 17:30, the participant will be discharged.
Study NCT02075619 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: GSK3074477 FDC - 1
Description: GSK3074477 containing combination of 10mg amlodipine and 20mg rosuvastatin, will be supplied as white caplet shaped film coated tablet.
Study NCT02075619 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: GSK3074477 FDC - 2
Description: GSK3074477 containing combination of 10mg amlodipine and 20mg rosuvastatin, will be supplied as white caplet shaped film coated tablet.
Study NCT02154906 — intervention group
Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: DFDBA
Study NCT02154906 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: autologous platelet rich fibrin
Study NCT03181659 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Manual Therapy, Therapeutic Education, Therapeutic Exercice
Description: They will receive 8 sessions (2 sessions per week) of joint and neural manual therapy, and will receive 4 sessions (1 session per week) of neuroscience education in which mirror therapy and image observation. The therapeutic exercise program is based on stabilization of the lumbopelvic region.
Study NCT03181659 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Therapeutic Education, Therapeutic Exercice
Description: They will receive a total of 8 sessions (2 sessions per week) of therapeutic exercise based on the stabilization of the lumbopelvic region and will receive 4 sessions (1 session per week) of neuroscience education in which mirror therapy and image observation.
Study NCT00620269 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Erlotinib
Description: Erlotinib 150 mg p.o. daily x21 days every 3 weeks
Study NCT00620269 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Induction or consolidation IP chemotherapy
Description: Irinotecan 65mg/m2 + Cisplatin 30mg/m2 IV on D1,D8 every 3 weeks X 3 cycles
Study NCT00620269 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Induction or consolidation IP chemotherapy
Description: Irinotecan 65mg/m2 + Cisplatin 30mg/m2 IV on D1,D8 every 3 weeks X 3 cycles
Study NCT00620269 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: CCRT with IP chemotherapy (Irinotecan + Cisplatin)
Description: Irinotecan (60mg/m2) + cisplatin (30mg/m2) IV on D1 \& 8 every 3 weeks X 2 cycles
Study NCT00620269 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CCRT with IP chemotherapy (Irinotecan + Cisplatin)
Description: Irinotecan (60mg/m2) + cisplatin (30mg/m2) IV on D1 \& 8 every 3 weeks X 2 cycles
Study NCT00620269 — intervention group
Intervention type: RADIATION
Group type: ACTIVE_COMPARATOR
Intervention: CCRT
Description: CCRT :Concurrent Thoracic Radiotherapy (2.4 Gy/fr, Total 60 Gy, 25fr over 5 weeks)
Study NCT00620269 — intervention group
Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: CCRT
Description: CCRT :Concurrent Thoracic Radiotherapy (2.4 Gy/fr, Total 60 Gy, 25fr over 5 weeks)
Study NCT01782521 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: No primer
Description: Primer not used when bonding orthodontic brackets
Study NCT00867737 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Advair HFA MDI 115/21
Description: Two puffs from MDI twice daily for 4 weeks
Study NCT00867737 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Symbicort 160/4.5 pMDI
Description: Symbicort 160/4.5 pMDI~Two puffs from MDI twice daily for 4 weeks
Study NCT04626804 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Remember Stuff: A Dyadic-focused Technology to Support Persons with Alzheimer's Disease in the Community
Description: testing the usability, perceptions, and acceptability of R/S among dyads of older adults with early Alzheimer's disease and other related dementias
Study NCT01958242 — intervention group
Intervention type: OTHER
Group type: NO_INTERVENTION
Intervention: Preoperative blood harvesting
Description: There is no true intervention, there is a protocol of preoperative blood harvesting ,and post operative administration of the same blood/
Study NCT01793636 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AZD2014
Description: AZD2014 vs Everolimus
Study NCT01793636 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Everolimus
Description: comparing PFS in patients treated with AZD2014 vs Everolimus
Study NCT04490785 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: MRI
Description: 1 MRI 5 days after surgery (-1; +4 days), with intravenous administration of gadolinium
Study NCT04490785 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Postoperative dosage of released troponin
Description: Dosage of troponin I Hs H4, H8, H12, H24, H48, and H72 after the aortic cross-unclamping.
Study NCT04451811 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: OPL-002
Description: Spray dried dispersion and tablet formulation
Study NCT01472029 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 5-FU, leucovorin, docetaxel, oxaliplatin (FLOT), trastuzumab
Description: Pre-operative treatment 4 cycles and post-operative treatment 4 cycles:~Trastuzumab 4 mg/kg BW (6 mg loading dose at 1st administration), iv over 1 h on day 1 of each 14 day cycle~Docetaxel 50 mg/m², iv over 2 h on day 1 of each 14 day cycle~Oxaliplatin 85 mg/m² in 500 ml G5%, iv over 2h on day 1 of each 14 day cycle~Leucovorin 200 mg/m² in 250 ml NaCl 0,9%, iv over 1 h on day 1 of each cycle~5-FU 2600 mg/m², iv over 24 h on day 1 of each 14 day cycle
Study NCT01472029 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Post-operative treatment trastuzumab mono therapy
Description: Trastuzumab mono therapy for 9 cycles:~Trastuzumab 6 mg/kg BW, iv over 1 h on day 1 of each 21 day cycle
Study NCT04513353 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Rehabilitation using Digital Healthcare System (Uincare Homeplus)
Description: Uincare Homeplus is a device using infrared, kinect camera and motion capture technology to track 3D motion of the patients' posture and joint articulations. It also has embedded exercise training software dedicated to total knee arthroplasty post-op rehabilitation at home.~Home-based self-rehabilitation using brochure for 3 weeks post surgery (same as the active comparator)~Home-based self-rehabilitation using digital healthcare system(Uincare Homeplus) for 3 to 12 weeks post surgery.
Study NCT04513353 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Conventional Rehabilitation
Description: Home-based self-rehabilitation using brochure for 12 weeks post surgery.
Study NCT03810651 — intervention group
Intervention type: OTHER
Group type: OTHER
Intervention: Proton beam radiation using pencil beam scanning
Description: Proton beam radiation using pencil beam scanning, characterized by Bragg peak dose deposition and high conformality of dose to target regions
Study NCT04218474 — intervention group
Intervention type: PROCEDURE
Group type: OTHER
Intervention: Evaluation Of Cross Mental Nerve Transfer In Restoration Of Chin &Lip Sensation Post Inferior Alveolar Nerve Injury
Description: -sural nerve harvest ,and use it as conduit between injured mental nerve and the normal one
Study NCT01601613 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: activated recombinant human factor VII
Description: 100 mcg/kg body weight administered i.v. (into the vein) followed by standard haemostatic replacement therapy (SHRT) at the Investigator's discretion.
Study NCT01601613 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: placebo
Description: 100 mcg/kg body weight administered i.v. (into the vein) followed by standard haemostatic replacement therapy (SHRT) at the Investigator's discretion.
Study NCT02911194 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: a2 milk
Description: replace all milk with a2 milk
Study NCT02911194 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: a1 containing milk
Description: use a1 containing milk
Study NCT04005716 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Tislelizumab, Carboplatin /Cisplatin, Etoposide
Description: Tislelizumab (200 mg IV Q3W) in combination with chemotherapy consisting of etoposide (100 mg/m² IV Days 1-3 of each 21-day cycle) and platinum (cisplatin 75 mg/m² IV Q3W or carboplatin area under the plasma or serum concentration-time curve (AUC) 5 IV Q3W) for 4 cycles. Then maintenance consists of Tislelizumab Q3W and will continue until disease progression, loss of clinical benefit, unacceptable toxicity, or withdrawal of informed consent.