AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Study NCT04471714 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Baclofen
Description: Participants will come in for two visits. In a randomized manor, they will receive baclofen on one visit and a placebo on the other. During each visit the soleus H-reflex will be measured and conditioned by common peroneal nerve stimulation to assess presynaptic inhibition.
Study NCT00755664 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: Low-dose complex B-vitamins
Description: The complex B vitamins supplement has been made as capsule and packaging 31 capsules in 1 bottle with a pre-determined code number on its cover. The main content contains either vitamin C 50mg alone or combination with folate 0.4 mg, vitamin B6 2mg, vitamin B12 10μg and vitamin C 50 mg. Two kinds of the supplements could not be discriminated by appearance, smell, taste, size and package.volunteers in either arms are required to take 1 capsule per day and last for 48 weeks.
Study NCT00755664 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: Low-dose complex B-vitamins
Description: The complex B vitamins supplement has been made as capsule and packaging 31 capsules in 1 bottle with a pre-determined code number on its cover. The main content contains either vitamin C 50mg alone or combination with folate 0.4 mg, vitamin B6 2mg, vitamin B12 10μg and vitamin C 50 mg. Two kinds of the supplements could not be discriminated by appearance, smell, taste, size and package.volunteers in either arms are required to take 1 capsule per day and last for 48 weeks.
Study NCT02177123 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: InnFocus MicroShunt implantation
Description: Implantation will include the use of Mitomycin C applied with sponges.
Study NCT02257567 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Obinutuzumab
Description: Obinutuzumab 1000 milligrams (mg) IV on Days 1, 8, and 15 of Cycle 1 and on Day 1 of each subsequent cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
Study NCT02257567 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Polatuzumab vedotin (Liquid)
Description: Polatuzumab vedotin 1.8 milligrams per kilogram (mg/kg) administered IV on Day 2 of Cycle 1, then on Day 1 of each subsequent cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
Study NCT00562224 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PCI-24781
Description: Up to 7 cohorts will receive PCI-24781 orally at doses starting at 30 mg/m2 three times a day approximately 4 hours apart (TID), up to 90 mg/m2, administered 5 days/week during the first 21 days of each 28 day cycle until MTD is reached. If a dose limiting toxicity (DLT) occurs, then the next cohort will receive PCI-24781 twice a day approximately 4 hours apart (BID). If a DLT occurs on the BID schedule, the subsequent cohort will receive PCI-24781 BID for 7 days every other week (2 times in a 28 day cycle). If a DLT occurs on this dosing schedule, then the next cohort will receive PCI-24781 BID for 5 days/week every other week (2 times in a 28 day cycle) until the maximum tolerated dose is reached.
Study NCT04665401 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Tailored MERIT
Description: see arm description
Study NCT04665401 — intervention group
Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Standard MERIT
Description: see arm description
Study NCT03572517 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Subarachnoid block
Description: Balanced general anesthesia (Induction of anesthesia: Propofol, fentanyl and rocuronium. Maintenance: Desflurane /remifentanil) associated with subarachnoid block (bupivacaine and morphine)
Study NCT03572517 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Spinal morphine
Description: Balanced general anesthesia (Induction of anesthesia: Propofol, fentanyl and rocuronium. Maintenance: Desflurane /remifentanil) and spinal analgesia with morphine
Study NCT00311675 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur)
Description: Monovalent subvirion H5N1 vaccine (HA of A/Vietnam/1203/04) provided in single-dose vials containing 90-mcg/mL A/H5N1 HA. Dosage is two 90 mcg doses administered intramuscularly separated by approximately 28 days.
Study NCT01703195 — intervention group
Intervention type: PROCEDURE
Group type: OTHER
Intervention: Magnetic Resonance Imaging (MRI)
Description: Magnetic Resonance Imaging (MRI) obtained pre-treatment and 4-6 weeks post-treatment.
Study NCT01703195 — intervention group
Intervention type: PROCEDURE
Group type: OTHER
Intervention: Diffusion Weighted Magnetic Resonance Imaging (DWMR)
Description: Diffusion Weighted Magnetic Resonance Imaging (DWMR) obtained pre-treatment and 4-6 weeks post-treatment.
Study NCT02273934 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Reablement
Description: The intervention deals with improving function in daily activities the person defines as important in the areas of self-care, productivity and leisure.
Study NCT02273934 — intervention group
Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Standard treatment
Description: The control intervention is standard home-based treatment/care in Norway.
Study NCT01280903 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: STAR Intervention
Description: The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up.
Study NCT01280903 — intervention group
Intervention type: BEHAVIORAL
Group type: PLACEBO_COMPARATOR
Intervention: Attention-Control
Description: Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up.
Study NCT02250326 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: nab-paclitaxel IV
Description: nab-Paclitaxel intravenous (IV) infusion
Study NCT02250326 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CC-486
Description: Oral CC-486
Study NCT02250326 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Duravalumab
Study NCT04199351 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AMG 171
Description: 2 SAD cohorts of 8 subjects per cohort randomized 3:1 in Part A; 1 cohort of 8 subjects 3:1 ratio in Part B; and 24 subjects enrolled into 1 of 3 cohorts with 8 subjects randomized to receive 2 to 3 consecutive doses (titration) 3:1 ratio in Part C.
Study NCT04199351 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: AMG 171 placebo
Study NCT04132661 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Bisacodyl 5 milligram
Description: one single dose
Study NCT04132661 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo oral tablet
Description: one single dose
Study NCT04255719 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: DBS
Description: Unilateral DBS for treatment of patients with PD
Study NCT01432171 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Lacosamide
Description: Given PO
Study NCT04188743 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Allogenic FMT
Description: Transplantation of fecal microbiota from a donor into a recipient
Study NCT04188743 — intervention group
Intervention type: BIOLOGICAL
Group type: PLACEBO_COMPARATOR
Intervention: Autologous FMT
Description: Transplantation of autologous fecal microbiota
Study NCT02443688 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CTX-4430
Study NCT02257567 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Rituximab
Description: Rituximab standard dose, 375 mg/m\^2 IV on Day 1 of each cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
Study NCT02257567 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Rituximab
Description: Rituximab standard dose, 375 mg/m\^2 IV on Day 1 of each cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
Study NCT02443688 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Study NCT01223534 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Preventive treatment with Isoniazid.
Description: If TST positive: participant will be treated with Isoniazid 300 mg/d, for 6 months.
Study NCT01223534 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Preventive treatment with Isoniazid
Description: If QFT-IT positive, Isoniazid 300 mg/d, for 6 months.
Study NCT00688987 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Hydrocortisone
Description: Subjects will receive in random order daily (split) dosing of hydrocortisone: a low dose of 15 mg (10 in AM, 5 in PM); a medium dose of 25 mg (15 in AM, 10 in PM) and high dose of 40 mg (30 in AM, 10 in PM) for 4 months.
Study NCT00688987 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: Isocaloric Diet
Description: Subjects will eat an isocaloric diet for 4 weeks while taking hydrocortisone
Study NCT01251965 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ruxolitinib
Description: Phase I - Starting dose of 50 mg by mouth twice a day for 28 day cycle.~Phase II - MTD reached in Phase I.
Study NCT00492999 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: dexamethasone
Description: Given by hepatic arterial infusion
Study NCT00492999 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: floxuridine
Description: Given by hepatic arterial infusion
Study NCT00492999 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: fluorouracil
Description: Given IV
Study NCT00492999 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: irinotecan hydrochloride
Description: Given IV
Study NCT00492999 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: leucovorin calcium
Description: Given IV
Study NCT00492999 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: oxaliplatin
Description: Given IV
Study NCT02870738 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Pelvic Floor Physical Therapy
Description: Internal and/or external myofascial release of the pelvic floor muscles
Study NCT02870738 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Bladder Instillations
Description: A solution of heparin sulphate 40,000 IU (4 cc of 10,000 units/cc), lidocaine 2% 16 ml, Sodium bicarbonate 8.4% 4 ml and Kenalog 40 mg (1cc) to reach a total fluid volume of 25 ml will be instilled into the bladder with a urinary catheter
Study NCT04904692 — intervention group
Intervention type: PROCEDURE
Intervention: Blood draw
Description: 8x9mL EDTA tubes. In subjects treated with hydroxychloroquine treatment an extra EDTA tube (4mL) will be collected for the REVIVE substudy.
Study NCT04904692 — intervention group
Intervention type: PROCEDURE
Intervention: Bronchoalveolar lavage
Description: Only in case of diagnostic or therapeutic indication.
Study NCT04904692 — intervention group
Intervention type: PROCEDURE
Intervention: SARS CoV-2 swabs
Description: Nasopharyngeal, oropharyngeal and nasal swabs
Study NCT04445753 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Tai Chi exercise
Description: Individuals in the intervention group will perform a 12-week Tai Chi exercise in company with a researcher.Following the warm-up movements (Qi-gong), the training protocol of the Tai Chi movements, which includes the 10-form Yang style, will continue for 12 weeks, with two sessions per week determined by the researchers.The first and second weeks of the exercise protocol will include introducing the Tai Chi philosophy and teaching 10 forms of Yang style to patients. For 12 weeks, individuals will practice 10 forms of Tai Chi exercises with a researcher in each session. Each session will be planned as one hour.
Study NCT04445753 — intervention group
Intervention type: BEHAVIORAL
Group type: OTHER
Intervention: Education (control group)
Description: Individuals in the control group will also be trained on heart failure, which will be applied to individuals in the intervention group. The only attempt to be made to the control group will be education.
Study NCT01325077 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: model of health care service
Description: Conventional model(C): Nurses give fixed-dose analgesic according to surgeons' prescription Study model(S): Nurses give initial-dose analgesic according to surgeons' prescription. In case of inadequate pain relief, another half of initial dose will be given twice at 15-min interval and acute pain service will be consulted if there is still pain.
Study NCT00006359 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: LHRH agonist
Description: Lupron: 22.5mg IM injection q 12 wks x 2 OR Zoladex: 10.8 mg subQ injection q 12 wks x 2
Study NCT00006359 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: antiandrogen
Description: flutamide 250 mg PO tid for 4 wks OR casodex 50 mg PO daily for 4 wks
Study NCT00006359 — intervention group
Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: radiation therapy
Description: 4500 cGy total dose given days 1-5 for 5 weeks following initiation of androgen suppression (25 fractions)
Study NCT00006359 — intervention group
Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Brachytherapy boost
Description: Iodine 125 0.3 to 0.5 U per seed OR palladium 103 1.04 to 1.4 U per seed as implant; prescribed dose of I-125 100 Gy (TG-43) and Pd-103 90 Gy
Study NCT00434317 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Zoledronic acid
Study NCT04092504 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: gero-erat
Description: The intervention is a standardize Care Plan which will be developed based on the evidence of caring for elderly patients in a trauma setting. The Care Plan will have its base in, the concept of ERAS and CGA. Also, patient experience will be taken in consideration and complement the care pathway.~Patients admitted to the trauma unit will be given the care and asked to be a part of the study witch include to fill out surveys at baseline, six months and 1 year.
Study NCT01894139 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: High-Protein/Low-GI Diet
Study NCT01894139 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Low-protein/High-GI Diet
Study NCT00687596 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: TAC-101
Description: Participants were randomized to TAC 101 received TAC 101 20 mg (administered as 2 10 mg formulated tablets) PO daily with approximately 240 mL (8 oz) of water under fed conditions (no later than 1 hour after a meal) for 14 days followed by a 7 day recovery period. This cycle was repeated every 21 days.
Study NCT00687596 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Participants randomized to placebo received 2 placebo tablets (identical in appearance to the TAC 101 tablets) administered PO daily with approximately 240 mL (8 oz) of water under fed conditions (no later than 1 hour after a meal) in a regimen identical to that for TAC 101.
Study NCT04361396 — intervention group
Intervention type: OTHER
Group type: OTHER
Intervention: Collection of samples
Description: Only in enrolled patient : different samples will be taken at different times of the surgery (3 samples of pneumoperitoneum, 1 sample of peritoneal effusion or peritoneal lavage fluid and 1 sample of bile, in case of cholecystectomy.
Study NCT04230759 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Chemotherapy
Description: Patients receive chemotherapy cycles as followed:~Mitomycin-C 12 mg/m², day 1 (maximum single dose 20 mg) 5-FU: 1000 mg/m² per day, continuous i.v. infusion, on day 1-4 and 29-32
Study NCT04230759 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Chemotherapy
Description: Patients receive chemotherapy cycles as followed:~Mitomycin-C 12 mg/m², day 1 (maximum single dose 20 mg) 5-FU: 1000 mg/m² per day, continuous i.v. infusion, on day 1-4 and 29-32
Study NCT04230759 — intervention group
Intervention type: RADIATION
Group type: ACTIVE_COMPARATOR
Intervention: Radiation
Description: PTV_A (primary tumor): T1-T2\<4cm N+: 28 x 1.9 Gy=53.2 Gy, five fractions per week or PTV_A (primary tumor): T2>=4cm, T3-4 Nany: 31 x 1.9 Gy=58.9 Gy, five fractions per week PTV_N (involved node): 28 x 1.8 Gy=50.4 Gy, five fractions per weeks PTV_Elec (elective node): 28 x 1.43 Gy=40.0 Gy, five fractions per week
Study NCT04230759 — intervention group
Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Radiation
Description: PTV_A (primary tumor): T1-T2\<4cm N+: 28 x 1.9 Gy=53.2 Gy, five fractions per week or PTV_A (primary tumor): T2>=4cm, T3-4 Nany: 31 x 1.9 Gy=58.9 Gy, five fractions per week PTV_N (involved node): 28 x 1.8 Gy=50.4 Gy, five fractions per weeks PTV_Elec (elective node): 28 x 1.43 Gy=40.0 Gy, five fractions per week
Study NCT04230759 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Durvalumab
Description: 1500 mg, 1h-civ, every 4 weeks (q4w) applied on day -14 (that is 14 days prior to initiation of RCT), day 15 (during RCT), and thereafter q4w (+/- 3d) for a total of 12 doses
Study NCT04244253 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: OPC-64005 20 mg , Once-daily
Description: Active, High Dose
Study NCT04244253 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: OPC-64005 10 mg , Once-daily
Description: Active, Low Dose
Study NCT04244253 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo, Once-daily
Description: Placebo
Study NCT02730858 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Palliative and Oncology Care
Description: Patients randomized to the intervention will receive collaborative care from palliative care and oncology for the remainder of their illness. The initial five visits with palliative care will be conducted in accordance with the study specific clinical practice guidelines and occur at least monthly.
Study NCT02730858 — intervention group
Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Standard Oncology Care
Description: Patients randomized to oncology care alone will continue to receive routine care identical to what they would have received if they had not participated in the trial. Either patients or their oncologists can request palliative care consultation at any point in time.
Study NCT02257567 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Polatuzumab vedotin (Lyophilized)
Description: Participants in the New Formulation (NF) Cohort (Arms G and H) will follow the same schedule and dosing requirements as participants in the other Phase II cohorts (Arms A-F).
Study NCT01752426 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Heavy Water (2H2O)
Description: 50 ml 70% 2H2O 3 times a day for the first 5 days followed by 60 ml daily for a total of 4 weeks. After the 5-day loading period, a 60 ml maintenance dose of 2H2O will be drunk at bedtime. At end of the 4th week, subjects stop drinking 2H2O (washout phase) and be followed from 6-12 weeks until beginning treatment with PCI-32765.
Study NCT01752426 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PCI-32765
Description: 420 mg orally once daily.
Study NCT02210572 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Bimuno Galacto-oligosaccharide 1.37 g/d
Description: Prebiotic versus low-FODMAPs diet
Study NCT02210572 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: Low- FODMAPs diet
Study NCT04413500 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Reminder
Description: A reminder to take the anti-hypertension medication with adjustable frequency.
Study NCT04413500 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Educational message
Description: An educational message to increase the knowledge about various facts around hypertension. The short messages are supposed to be sent based on the patient's needs.
Study NCT04413500 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Motivational messages
Description: The motivational short messages to increase the motivational levels.
Study NCT04413500 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: showing trends
Description: Short messages contain different trends of medication intake rate, BP, physical activity rate, and so on.
Study NCT04205448 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Physical exercize
Description: 10 weeks group exercize followed by community-based voluntary exercize
Study NCT02278510 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Topotecan
Description: Topotecan is a chemotherapy that is approved by the FDA to treat cancers. It is normally given by an intravenous injection, and not directly into a tumor. That is why it is considered to be an investigational drug for this study