TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT04025216

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: CART-TnMUC1
Description: Single intravenous administration of genetically modified autologous T cells engineered to express a TnMUC1-Targeted Genetically-Modified Chimeric Antigen (CAR)

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: CART-TnMUC1
Description: Single intravenous administration of genetically modified autologous T cells engineered to express a TnMUC1-Targeted Genetically-Modified Chimeric Antigen (CAR)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclophosphamide
Description: Patients will receive cyclophosphamide and fludarabine lymphodepletion chemotherapy followed by the investigational product, CART-TnMUC1

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclophosphamide
Description: Patients will receive cyclophosphamide and fludarabine lymphodepletion chemotherapy followed by the investigational product, CART-TnMUC1

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Fludarabine
Description: Patients will receive cyclophosphamide and fludarabine lymphodepletion chemotherapy followed by the investigational product, CART-TnMUC1

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Fludarabine
Description: Patients will receive cyclophosphamide and fludarabine lymphodepletion chemotherapy followed by the investigational product, CART-TnMUC1
Study: NCT03779269

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: meditation
Description: meditation effect assessment using assessment tools.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: meditation
Description: meditation effect assessment using assessment tools.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: meditation
Description: meditation effect assessment using assessment tools.
Study: NCT03961399

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Abbott Medical® CRT device with SyncAVTM stimulation function
Description: patients with Abbott Medical® CRT device will be randomized and SyncAVTM stimulation will be activated.

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Abbott Medical® CRT device with biventricular stimulation (BiV)
Description: patients with Abbott Medical® CRT device will be randomized and biventricular (BiV) stimulation will be activated.
Study: NCT04111835

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Offering an alternative cervical cancer screening method - hrHPV molecular testing.
Description: Women randomized to this screening strategy group will take a hrHPV molecular test.~hrHPV-positive - reflex LBC:~Abnormal reflex LBC (ASC-US or worse) -\> colposcopy~Normal reflex LBC -\> repeat LBC in 6 months~Positive - colposcopy~Negative - rescreen in 3 years~HPV-negative - rescreen in 5 years
Study: NCT04265677

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Telemedicine FCR
Description: Parents/guardians will be able to join family centered rounds using telemedicine (audio and visual)

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Standard of care
Description: Parents/guardians will not be able to join family centered rounds using telemedicine (audio and visual)
Study: NCT02183363

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: BI 1356 - Tablet TFII

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: BI 1356 - Tablet TFII

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: BI 1356 - Tablet TFII

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: BI 1356 - Tablet iFF

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: BI 1356 - Tablet iFF

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: BI 1356 - Tablet iFF

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: BI 1356 - Tablet TFIIb

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: BI 1356 - Tablet TFIIb

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: BI 1356 - Tablet TFIIb
Study: NCT00808340

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: balafilcon A
Description: multifocal contact lens

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: balafilcon A
Description: multifocal contact lens
Study: NCT03924765

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Powered hip exoskeleton
Description: The study team will be testing a powered hip exoskeleton and its capability to improve locomotion in stroke survivors.
Study: NCT03446833

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: The LFP Beta aDBS System
Description: The LFP Beta aDBS System is intended for use in patients receiving DBS for Parkinson's Disease where LFPs may be recorded and analyzed.
Study: NCT01758900

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: CO2 insufflation regulator
Description: The CO2 insufflation regulator is Olympus UCR(Olympus Optical Co., Ltd., Tokyo, Japan). The device connect the medical gas pipe joints and CO2 cylinders, then the CO2 gas will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE.

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Air insufflation
Description: The air will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE.
Study: NCT02902939

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: minimal extracorporeal circulation (MEC)
Description: We should use the modification of extracorporeal circulation to reduce the systemic inflammatory response due to excessive haemodilution, allogenic blood transfusion.

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: The cytokines modulations
Description: We should use the modification of cytokines by CytoSorb devices and cytokines removal by PMMA membranes during extracorporeal circulation in patients with risk factors of complications (long duration of extracorporeal circulation, re-do procedures and other)
Study: NCT00415038

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Rostafuroxin
Description: 1 capusle of 50 micrograms of Rostafuroxin or placebo per day in the morning before breakfast for 5 weeks followed by other 5 weeks with placebo or Rostafuroxin

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Rostafuroxin
Description: 1 capusle of 150 micrograms of Rostafuroxin or placebo per day in the morning before breakfast for 5 weeks followed by other 5 weeks with placebo or Rostafuroxin

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Rostafuroxin
Description: 1 capusle of 500 micrograms of Rostafuroxin or placebo per day in the morning before breakfast for 5 weeks followed by other 5 weeks with placebo or Rostafuroxin

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Rostafuroxin
Description: 1 capusle of 1.5 milligrams of Rostafuroxin or placebo per day in the morning before breakfast for 5 weeks followed by other 5 weeks with placebo or Rostafuroxin

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Rostafuroxin
Description: 1 capusle of 5 milligrams of Rostafuroxin or placebo per day in the morning before breakfast for 5 weeks followed by other 5 weeks with placebo or Rostafuroxin
Study: NCT03093623

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Physical activity
Description: In physical activity experimental group, trained study nurses will interview with patients,give health education,teach how to use and record the Activity meter.Professionals will calculate Metabolic Equivalent of Task(MET) with formula weekly.MET = (intensity level 9 points \* time of each exercise (hours) \* Number of times per week + moderate level 5 points \* time per activity (hours) \* number of times per week + low level 3 points \* time per activity (hours) \* number of times per week),investigators hope patients in the first month MET can reach (3.75-7.49 MET-h/ week), and reach moderate or more than moderate activity (\>= 7.5-16.49 MET-h/ week) at the starting of second month for at least one year.
Study: NCT03406650

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Neoadjuvant and adjuvant durvalumab
Description: Neoadjuvant durvalumab 1500 mg q3w for 4 cycles Adjuvant durvalumab 1500 mg q4w for 10 cycles
Study: NCT03957889

Intervention type: OTHER
Intervention: Educational simulation

Intervention type: OTHER
Intervention: Educational simulation
Study: NCT03313375

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Continuous Exercise
Description: Subjects will be asked to perform a 45 min exercise bout. 10 minutes will be a warmup (at a work rate associated with 50% heart rate max), 30 minutes at a wattage that elicits 75-80% heart rate max, and a 5 minute cool down period, returning them to approximately 50% heart rate max.
Study: NCT00808340

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: balafilcon A
Description: multifocal contact lens

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: balafilcon A
Description: multifocal contact lens

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: balafilcon A
Description: multifocal contact lens

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: balafilcon A
Description: multifocal contact lens

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: senofilcon A production
Description: multifocal contact lens

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: senofilcon A production
Description: multifocal contact lens

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: senofilcon A production
Description: multifocal contact lens

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: senofilcon A production
Description: multifocal contact lens

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: senofilcon A production
Description: multifocal contact lens

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: senofilcon A production
Description: multifocal contact lens

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: senofilcon A test
Description: multifocal contact lens

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: senofilcon A test
Description: multifocal contact lens

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: senofilcon A test
Description: multifocal contact lens

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: senofilcon A test
Description: multifocal contact lens

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: senofilcon A test
Description: multifocal contact lens

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: senofilcon A test
Description: multifocal contact lens
Study: NCT01518101

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Vildagliptin/ Metformin
Description: Single pill combination of Vildagliptin/ Metformin (50/1000 mg).

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Vildagliptin/ Metformin
Description: Single pill combination of Vildagliptin/ Metformin (50/1000 mg).

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Liraglutide
Description: 1.2 mg once daily by commercially available injection pens

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Liraglutide
Description: 1.2 mg once daily by commercially available injection pens

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Metformin
Description: 1000 mg tablets twice daily

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Metformin
Description: 1000 mg tablets twice daily
Study: NCT03526042

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Losartan
Description: Competitive blockade of AT1R-antibodies effect by binding to the angiotensin 1 receptor

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Enalapril
Description: Renin-angiotensin-aldosterone system (RAAS) blockade without any effect on AT1R-antibodies effect or concentration (control group)
Study: NCT01061372

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo, orally administered once a day, 1-3 hours before bedtime for 12 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: pregabalin
Description: pregabalin 150 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: pregabalin
Description: pregabalin 300 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 weeks
Study: NCT02284100

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: animal assisted therapy
Description: For the AAT session, a 7 year old Golden Retriever was employed as the therapy animal. Prior to the study, the dog underwent rigorous screening although she had previous experience in Animal Assisted Interventions and was already trained and prepared prior for this type of work. The dog was fully vaccinated, bathed regularly, screened for enteric pathogens, and treated for internal and external parasites on a monthly basis. The dog and handler met hospital policy for participating in animal-assisted therapy, including documentation of the dog's current vaccinations, controllability and temperament.~The welfare of the dog was monitored and certificated by a dedicated veterinary during and at the end of the all sessions.
Study: NCT01813747

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: 1440 nm wavelength laser with handpiece (Cynosure)
Description: To assess the effectiveness of device in skin tightening and laser lipolysis in the mandibular and sub-mandibular areas.
Study: NCT00966368

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: insulin degludec
Description: Single dose of NN1250, formulation 1, 0.4U/kg body weight injected subcutaneously (under the skin)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: insulin degludec
Description: Single dose of NN1250, formulation 2, 0.4U/kg body weight injected subcutaneously (under the skin)
Study: NCT06178692

Intervention type: DIAGNOSTIC_TEST
Intervention: Validation of miRNA-serum signatures associated with IDH1 status
Description: Validation of miRNA-serum signatures associated with IDH1 status and prognosis, as reliable, specific and sensitive circulating diagnostic biomarkers also useful to improve prognostic stratification of patients.

Intervention type: DIAGNOSTIC_TEST
Intervention: Validation of miRNA-serum signatures associated with IDH1 status
Description: Validation of miRNA-serum signatures associated with IDH1 status and prognosis, as reliable, specific and sensitive circulating diagnostic biomarkers also useful to improve prognostic stratification of patients.
Study: NCT01525589

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PM01183
Description: PM01183 drug product (DP) is presented as a lyophilized powder for concentrate for solution for infusion with two strengths: 1 mg/vial and 4 mg/vial
Study: NCT01494558

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Chemoradiotherapy Regimen between PC and PE
Description: etoposide 50mg/m2 d1-5, 29-33 and cisplatin 50mg/m2 d1,8,29 and 36 29-33 during radiotherapy paclitaxel 45mg/m2 weekly and carbplatin AUC =2mg/mL/min weekly during radiotherapy

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Chemoradiotherapy Regimen between PC and PE
Description: etoposide 50mg/m2 d1-5, 29-33 and cisplatin 50mg/m2 d1,8,29 and 36 29-33 during radiotherapy paclitaxel 45mg/m2 weekly and carbplatin AUC =2mg/mL/min weekly during radiotherapy
Study: NCT04390347

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Yakult
Description: A fermented milk product with live microorganisms.

Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: A milk product with no live microorganisms.
Study: NCT02328612

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Intravenous infusion of cells
Description: The treatment administration will be infused intravenously to the subjects after randomization:~An hour after the end of the eASCs administration, all subjects will be given an intravenous dose of LPS. Subjects will be allowed to leave in the evening once deemed clinically stable by the investigator.

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Intravenous infusion of cells
Description: The treatment administration will be infused intravenously to the subjects after randomization:~An hour after the end of the eASCs administration, all subjects will be given an intravenous dose of LPS. Subjects will be allowed to leave in the evening once deemed clinically stable by the investigator.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Intravenous infusion of cells
Description: The treatment administration will be infused intravenously to the subjects after randomization:~An hour after the end of the eASCs administration, all subjects will be given an intravenous dose of LPS. Subjects will be allowed to leave in the evening once deemed clinically stable by the investigator.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Intravenous infusion of cells
Description: The treatment administration will be infused intravenously to the subjects after randomization:~An hour after the end of the eASCs administration, all subjects will be given an intravenous dose of LPS. Subjects will be allowed to leave in the evening once deemed clinically stable by the investigator.
Study: NCT03609047

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Palbociclib
Description: CDK4/6 inhibitor

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Docetaxel / cyclophosphamide
Description: Adjuvant Chemotherapy

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: doxorubicin/cyclophosphamide
Description: Adjuvant Chemotherapy

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: epirubicin/cyclophosphamide
Description: Adjuvant Chemotherapy

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: paclitaxel
Description: Adjuvant Chemotherapy
Study: NCT01948245

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: TaurolockTMHep100
Description: 2-4 ml of the catheter lock solution will be instilled after each infusion of parenteral nutrition/intravenous fluids varying between twice weekly to once daily, depending on the individual patients HPN programme. The instilled solution is kept in the catheter until the next infusion, with a prior flushing with 10 ml of Saline both before the instillation of the catheter lock and before infusion of HPN/fluids.

Intervention type: DEVICE
Group type: PLACEBO_COMPARATOR
Intervention: Heparin 100 IE/ml
Description: 2-4 ml of the catheter lock solution will be instilled after each infusion of parenteral nutrition/intravenous fluids varying between twice weekly to once daily, depending on the individual patients HPN programme. The instilled solution is kept in the catheter until the next infusion, with a prior flushing with 10 ml of Saline both before the instillation of the catheter lock and before infusion of HPN/fluids.
Study: NCT03805841

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: tarloxotinib bromide
Description: weekly intravenous infusion
Study: NCT02808988

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: periodontal phase 1 therapy
Description: periodontal phase 1 therapy consisted of scaling and root planning with ultrasonic and hand instruments under local anesthesia and gingival crevicular fluid collection by the same investigator.

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: periodontal phase 1 therapy
Description: periodontal phase 1 therapy consisted of scaling and root planning with ultrasonic and hand instruments under local anesthesia and gingival crevicular fluid collection by the same investigator.

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: gingival crevicular fluid collection
Description: gingival crevicular fluid collection by periopapers

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: gingival crevicular fluid collection
Description: gingival crevicular fluid collection by periopapers

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: zoledronic acid
Description: 5 mg/year zoledronic acid (i.v.)

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: zoledronic acid
Description: 5 mg/year zoledronic acid (i.v.)
Study: NCT06524258

Intervention type: DIAGNOSTIC_TEST
Group type: OTHER
Intervention: testicular elastography
Description: testicular elastography for predicting non obstructive azoospermia

Intervention type: DIAGNOSTIC_TEST
Group type: OTHER
Intervention: testicular elastography
Description: testicular elastography for predicting non obstructive azoospermia
Study: NCT03779555

Intervention type: OTHER
Intervention: Medication Event Monitoring System
Description: -Microchipped bottle cap
Study: NCT00465179

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Sunitinib Malate
Description: 50 mg by mouth daily for 4 weeks, then 2 weeks off.
Study: NCT03297190

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: SMS
Description: Receipt of SMS messages on nutrition and health topics

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: SMS
Description: Receipt of SMS messages on nutrition and health topics

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Interpersonal Counselling
Description: Interpersonal counselling on health and nutrition topics

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Interpersonal Counselling
Description: Interpersonal counselling on health and nutrition topics
Study: NCT04539977

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: TQB2450
Description: Inductive therapy: TQB2450 + EC(4 cycles) Maintenance therapy: TQB2450+EC(2 cycles) followed byTQB2450 (1 year)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: TQB2450
Description: Inductive therapy: TQB2450 + EC(4 cycles) Maintenance therapy: TQB2450+EC(2 cycles) followed byTQB2450 (1 year)
Study: NCT01369381

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Endotracheal intubation
Description: Study patients undergo endotracheal intubation using both a conventional direct laryngoscope (Macintosh) and an alternative indirect laryngoscope (Airtraq). The order of intubation (Macintosh then Airtraq--or--Airtraq then Macintosh) is randomized.

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Endotracheal intubation
Description: Study patients undergo endotracheal intubation using both a conventional direct laryngoscope (Macintosh) and an alternative indirect laryngoscope (Airtraq). The order of intubation (Macintosh then Airtraq--or--Airtraq then Macintosh) is randomized.
Study: NCT03313375

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Aerobic Interval Exercise
Description: Subjects will be asked to complete a 43 minute exercise session. To warm up, subjects will cycle at a work rate associated with 50% HRmax for 10 minutes. Wattage will then increase and subjects will do four 4-minute intervals at a work rate associated with 90%-95% HRmax, separated by 3 minutes of active recovery at a work rate associated with 50% HRmax. Subjects will be given a 5-minute cool-down period at a work rate associated with 50% HRmax.
Study: NCT03888053

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: BB-101
Description: Within each cohort, 8 subjects will be randomized to receive BB-101 and 4 subjects to receive placebo.