TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01263574

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 70% ethanol
Description: Administration of the lock solution will occur between cycles of parenteral nutrition. Lock solutions will be administered three days per week. The pre-measured volume of lock solution will then be injected into the catheter for 4 hours. Prior to the next instillation of medications into the catheter, the lock solution will be aspirated and discarded. Another 5mL flush of saline will then be instilled into the catheter prior to medication or parenteral nutrition administration. Volume of lock solution administered will be determined by catheter size.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: 70% ethanol
Description: Administration of the lock solution will occur between cycles of parenteral nutrition. Lock solutions will be administered three days per week. The pre-measured volume of lock solution will then be injected into the catheter for 4 hours. Prior to the next instillation of medications into the catheter, the lock solution will be aspirated and discarded. Another 5mL flush of saline will then be instilled into the catheter prior to medication or parenteral nutrition administration. Volume of lock solution administered will be determined by catheter size.
Study: NCT03000582

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Creatine monohydrate
Description: Creatine monohydrate (5.0 g creatine monohydrate, 1.5 g dextrose)

Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: Creatine nitrate-1
Description: Creatine nitrate-1 (1.0 g creatine monohydrate, 0.5 g nitrate, 5.0 g dextrose)

Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: Creatine nitrate-2
Description: Creatine nitrate-2 (2.0 g creatine monohydrate, 1.0 g nitrate, 3.5 g dextrose)

Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo (6.5 g dextrose)
Study: NCT03746522

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Setmelanotide
Description: SC injection of setmelanotide

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Setmelanotide
Description: SC injection of setmelanotide

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: SC injection of placebo
Study: NCT04026919

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: OK EN CASA-ZAINDOO
Description: Intervention based on cognitive- behavioural techniques offered in an online format.
Study: NCT02807181

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Cisplatin-gemcitabine
Description: Systemic chemotherapy

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cisplatin-gemcitabine
Description: Systemic chemotherapy

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Radiation: SIRT + chemotherapy (cisplatin-gemcitabine)
Description: SIR-Spheres microspheres followed by systemic chemotherapy
Study: NCT00767676

Intervention type: DEVICE
Group type: OTHER
Intervention: HP828-101
Description: Nine topical patch applications over 3 weeks, rest period of 2 weeks and challenge after 48 hours.
Study: NCT04404959

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: fascia iliaca compartment block with ropivacaine
Description: the fascia iliaca compartment block catheter will be placed with the use of ultrasound till the day of surgery. Bolus doses will be given every 12 hours (40 ml of ropivacaine 0.25%)

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: fascia iliaca compartment block with placebo
Description: the fascia iliaca compartment block catheter will be placed with the use of ultrasound till the day of surgery. Bolus doses will be given every 12 hours (40 ml of normal saline)
Study: NCT04316182

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cabozantinib
Description: Cabozantinib 60 mg/day. Cabozantinib dose will be modified upon development of adverse events.
Study: NCT02346136

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Tai Chi training

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Educational Control
Study: NCT02117037

Intervention type: OTHER
Group type: OTHER
Intervention: blood sample
Study: NCT04426617

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Ultrasound Guided Transversus Abdominis Plane Block
Description: The patient will lie in the supine position. The transducer will be placed in the axial plane on the mid-axillary. transversus abdominis muscle will be visualized. A skin wheel using 3 ml of lidocaine 1 % is made 2 to 3 cm medial to the medial aspect of the transducer and the 22 gauge is inserted in-plane pointing laterally. Then Injection of local anaesthetic mixure in the right plane.

Intervention type: PROCEDURE
Group type: PLACEBO_COMPARATOR
Intervention: Ultrasound Guided Transversus Abdominis Plane Block
Description: The patient will lie in the supine position. The transducer will be placed in the axial plane on the mid-axillary. transversus abdominis muscle will be visualized. A skin wheel using 3 ml of lidocaine 1 % is made 2 to 3 cm medial to the medial aspect of the transducer and the 22 gauge is inserted in-plane pointing laterally. Then Injection of local anaesthetic mixure in the right plane.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Ultrasound Guided Transversus Abdominis Plane Block
Description: The patient will lie in the supine position. The transducer will be placed in the axial plane on the mid-axillary. transversus abdominis muscle will be visualized. A skin wheel using 3 ml of lidocaine 1 % is made 2 to 3 cm medial to the medial aspect of the transducer and the 22 gauge is inserted in-plane pointing laterally. Then Injection of local anaesthetic mixure in the right plane.
Study: NCT02051465

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: LumenR Retractor
Description: Polyp removal using LumenR Retractor Modified overtube

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Removal without overtube
Description: Endoscopic removal of polyp without overtube
Study: NCT01140763

Intervention type: DEVICE
Intervention: Sysmex's 5-blade lymph node cutter
Description: A maximum of 3 dissected sentinel lymph nodes (SLN) per subject will be included in this study. Lymph nodes will be sliced at 1 mm intervals with Sysmex's 5-blade lymph node cutter. Alternate slices will be allocated to either reference histopathology or test histopathology. Three serial sections will be cut every 200 µm (level): the 1st section per level for hematoxylin \& eosin (H\&E), the middle section of the 3rd level for Immunohistochemistry (IHC)(pan- cytokeratin antibody clone AE1/AE3). All other sections will be blanks in case further analysis is needed.
Study: NCT02448212

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: TS-121
Description: Oral
Study: NCT01451346

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: B. Infantis 35624
Description: One sachet daily for 12 weeks

Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: B. Infantis 35624
Description: One sachet daily for 12 weeks
Study: NCT01391728

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Active Lifestyle all your Life
Description: Intervention After the first data collection the participants are randomised in an intervention and control group. The control group receives the normal treatment that may be given after a radius fracture and may vary from one care unit to another (but there is no preventive programme within the normal activity as far as we know). In groups of 6-8 participants the intervention group starts the programme Active lifestyle all your life with group meetings around every other week (10-12 times) and with 2 individual meetings directed at discussing fall risks in the participant's own home environment. After a summer break, Christmas and New Year three follow-up meetings take place, one of which is an individual meeting. The intervention is then terminated, but the participants are encouraged to continue the activity themselves.
Study: NCT03608488

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Vitamin D
Description: Vitamin D3 50.000 IU/per week, for 8 weeks

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Vitamin D
Description: Vitamin D3 50.000 IU/per week, for 8 weeks

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Exercise
Description: Core stability, balance exercises
Study: NCT02448212

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: [11C]TASP0410699
Description: Intravenous radiotracer

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: [11C]TASP0410699
Description: Intravenous radiotracer

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Positron Emission Tomography (PET)
Description: Imaging scanning procedure
Study: NCT03608488

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Exercise
Description: Core stability, balance exercises
Study: NCT02075320

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Stationary Digital Chest Tomosynthesis
Description: The study scan, s-DCT, will be performed within two weeks of his/her clinical evaluations by chest CT and CR. There cannot be any intervening therapies or procedures (i.e. biopsy or excision of lesions) done in between the SOC imaging and the s-DCT. In the event that CRs are not included in the SOC imaging or are unusable (outside of acceptable window or poor quality), the scout image acquired by CT will be used in place of a CR.~Images will be acquired by a trained radiologist technologist. The technologist will comfortably position the patient in the supine position on the imaging table. Then, all patients will have a breath held s-DCT scan in an anterior-posterior direction.
Study: NCT01397695

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Bevacizumab
Description: The bevacizumab will then be sprayed by the treating physician in the clinic, under direct observation. Spray will be achieved by administering the bevacizumab through a mucosal atomization device. 0.1cc will be sprayed into both nares. Patients will then sit for 5 minutes, the application will be repeated for a total of 40 applications, thereby administering 50mgs into each nostril, a total of 100mgs into each patient. The 5 minute spacing has been arbitrarily chosen as sufficient time for 0.1cc of solution to be absorbed by the nasal mucosa. That will complete the treatment.
Study: NCT02003625

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: GCSF

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: GCSF

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: meloxicam

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Study: NCT03766100

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Cognitive behavioural therapy (CBT-i)
Description: CBT-i aims to alter behaviours that sustain or add to insomnia and correct cognitions that drive these behaviours. The behavioural components of CBT-i are stimulus control (SC) and Sleep Restriction Therapy (SRT). SC works through the extinction of a conditioned arousal that emerges when bed and bedroom have become associated with wakefulness. With SRT time in bed is reduced to build up sleep pressure. When wakefulness is decreased, time in bed is gradually increased until optimal sleep is attained. With the cognitive component, insomnia is treated by identifying and changing unhelpful or inaccurate thinking regarding sleep and distressing emotional responses to insomnia. The last component of CBT-i aims to reduce hyperarousal with relaxation techniques, scheduled worry time, creating a time to unwind, and employing cognitive therapy strategies.
Study: NCT00684424

Intervention type: OTHER
Intervention: Non-Interventional Study
Description: Observational Only
Study: NCT03296306

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Treatment duration of cisplatin based chemotherapy
Description: * GP regimen: Gemcitabine (1000 mg/m2 D1, D8), Cisplatin (60 mg/m2 D1), every 3 weeks~* GP-S regimen: Gemcitabine (1000 mg/m2 D1, D8), Cisplatin (35 mg/m2 D1,D 2 or D8), every 3 weeks~* MVAC regimen: Methotrexate (30 mg/m2 IV bolus, D1, 15, 22), Vinblastine (3 mg/m2 IV bolus, D2, 15, 22), Doxorubicin (30 mg/m2 IV bolus D2), Cisplatin (70 mg/m2 D2), every 4 weeks~* HD-MVAC with GCSF regimen: Methotrexate (30 mg/m2 IV bolus, D1), Vinblastine (3 mg/m2 IV bolus, D2), Doxorubicin (30 mg/m2 IV bolus D2), Cisplatin (70 mg/m2 D2), G-CSF (240 ug/m2 SC, D4-10), every 2 weeks

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Treatment duration of cisplatin based chemotherapy
Description: * GP regimen: Gemcitabine (1000 mg/m2 D1, D8), Cisplatin (60 mg/m2 D1), every 3 weeks~* GP-S regimen: Gemcitabine (1000 mg/m2 D1, D8), Cisplatin (35 mg/m2 D1,D 2 or D8), every 3 weeks~* MVAC regimen: Methotrexate (30 mg/m2 IV bolus, D1, 15, 22), Vinblastine (3 mg/m2 IV bolus, D2, 15, 22), Doxorubicin (30 mg/m2 IV bolus D2), Cisplatin (70 mg/m2 D2), every 4 weeks~* HD-MVAC with GCSF regimen: Methotrexate (30 mg/m2 IV bolus, D1), Vinblastine (3 mg/m2 IV bolus, D2), Doxorubicin (30 mg/m2 IV bolus D2), Cisplatin (70 mg/m2 D2), G-CSF (240 ug/m2 SC, D4-10), every 2 weeks
Study: NCT01072851

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Multimedia Education
Description: A four minute exposure to an educational video with controlled content on the importance of colorectal cancer screening and explaining the processes and procedures.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Print Media
Description: Exposure to a printed brochure with controlled content on the importance of colorectal cancer screening and explaining the processes and procedures.

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Usual and customary waiting room process
Description: No specialized educational intervention to promote colorectal cancer screening or to explain the process
Study: NCT04059848

Intervention type: COMBINATION_PRODUCT
Group type: SHAM_COMPARATOR
Intervention: tDCS(Intelect Mobile Stimulation and Combination, DJO, France)
Study: NCT02448212

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Positron Emission Tomography (PET)
Description: Imaging scanning procedure
Study: NCT00622752

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: EVT 302, 10 mg
Description: 2 X EVT 302, 5 mg tablets

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: EVT 302, 10 mg
Description: 2 X EVT 302, 5 mg tablets

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: placebo
Description: 2 X placebo tablets to match EVT 302 5 mg

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Nicotine replacement therapy (NRT)
Description: NRT patch containing 21 mg of nicotine

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Nicotine replacement therapy (NRT)
Description: NRT patch containing 21 mg of nicotine

Intervention type: DEVICE
Group type: PLACEBO_COMPARATOR
Intervention: NRT placebo
Description: Medically inert plaster cut to match the NRT plaster
Study: NCT01326611

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Clarithromycin

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Dextrose
Study: NCT05167994

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Anlotinib hydrochloride
Description: Anlotinib 12mgQD, from D1 of pre-operative IMRT to 1 month after end of IMRT
Study: NCT02626273

Intervention type: RADIATION
Group type: OTHER
Intervention: weight loss

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: weight loss
Study: NCT02457780

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Relaxation Response Resiliency Program (3RP)
Description: The 3RP is designed to decrease psychiatric and physical health symptoms and build resiliency by teaching skills to (1) elicit the relaxation response, (2) decrease stress reactivity and (3) increase social connectedness. Eliciting the relaxation response involves sustained mental focus with an attitude of receptive awareness with strategies aimed at reducing muscle tension, breathing rate, heart rate, and blood pressure. Decreasing stress reactivity involves increasing awareness of the stress response and learning skills to proactively address stress. Increasing connectedness involves skills to promote positive growth, self-efficacy and social support. Other skills and experiential exercises focus on increasing acceptance, optimism, empathy, and appreciation to promote resiliency.

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Health Enhancement Program (HEP)
Description: The HEP is designed to address comorbid physical and mental health symptoms via psychoeducation, self-monitoring and goal setting techniques. It is an 8 session manualized group intervention which addresses topics including sleep hygiene, nutrition, exercise, working with a healthcare team, and substance use. The program uses a variety of in-session activities to engage participants in discussion related to self-care and wellness principles. Relapse prevention and long-term goal setting are addressed. The program is designed to be implemented by professionals with a background in mental health.
Study: NCT04059848

Intervention type: COMBINATION_PRODUCT
Group type: EXPERIMENTAL
Intervention: tDCS(Intelect Mobile Stimulation and Combination, DJO, France)

Intervention type: COMBINATION_PRODUCT
Group type: ACTIVE_COMPARATOR
Intervention: tDCS(Intelect Mobile Stimulation and Combination, DJO, France)

Intervention type: COMBINATION_PRODUCT
Group type: SHAM_COMPARATOR
Intervention: NMES(Enraf Nonius, Endomed-182, Netherlands)

Intervention type: COMBINATION_PRODUCT
Group type: EXPERIMENTAL
Intervention: NMES(Enraf Nonius, Endomed-182, Netherlands)

Intervention type: COMBINATION_PRODUCT
Group type: ACTIVE_COMPARATOR
Intervention: NMES(Enraf Nonius, Endomed-182, Netherlands)
Study: NCT01561768

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Novavax Quadrivalent vaccine
Description: Quadrivalent VLP vaccine: low dose; intramuscular injection, deltoid

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Novavax Quadrivalent vaccine
Description: Quadrivalent VLP vaccine: medium dose; intramuscular injection, deltoid

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Novavax Quadrivalent vaccine
Description: Quadrivalent VLP vaccine: high dose; intramuscular injection, deltoid

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Novavax Trivalent vaccine
Description: Trivalent Dose; intramuscular injection, deltoid

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: cTIV
Description: Preconfigured dose; intramuscular injection, deltoid
Study: NCT00892970

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Azithromycin ophthalmic solution, 1%
Description: One drop in each eye twice a day for the first two days; then one drop in each eye once a day for 12 days

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: One drop in each eye twice a day for the first two days; then one drop in each eye once a day for 12 days
Study: NCT04270500

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Prehabilitation program
Description: The preoperative period (prehabilitation) represents a more appropriate time than the postoperative period to implement an intervention. Prehabilitation is a process of enhancing an individual's functional capacity before the scheduled surgery, aimed at improving the patient's tolerance to upcoming physiologic stress, by three principal elements: exercise training, nutritional intervention, and psychological support.
Study: NCT00855309

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: acyclovir sodium
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: acyclovir sodium
Description: Given IV
Study: NCT04086264

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Azacitidine
Description: Commercially available formulation given subcutaneously (SC) or intravenous (IV)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Azacitidine
Description: Commercially available formulation given subcutaneously (SC) or intravenous (IV)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: IMGN632
Description: Study formulation given intravenously (IV)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: IMGN632
Description: Study formulation given intravenously (IV)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: IMGN632
Description: Study formulation given intravenously (IV)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: IMGN632
Description: Study formulation given intravenously (IV)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Venetoclax
Description: Commercially available formulation administered orally

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Venetoclax
Description: Commercially available formulation administered orally
Study: NCT03904771

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Nutrition counselling + peer support
Description: Behavioral nutrition counselling and peer support, delivered in small groups. Includes six sessions extending over 8 weeks, with participatory activities facilitated by a nutrition therapist.

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Social activation + peer support
Description: Social activation and peer support, delivered in small groups. Includes six sessions extending over 8 weeks, with participatory activities facilitated by group leader.
Study: NCT03732911

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Intervention
Description: Participants will receive the following intervention bundle (1) educational materials about child development and developmental monitoring checklists; (2) age and language appropriate picture books; and (3) two tailored text messages per week for a 6-month period.
Study: NCT03671902

Intervention type: DEVICE
Group type: OTHER
Intervention: Fluid shift
Description: We are using lower body negative and positive pressure to create a fluid shift in the body. This study is investigating if there are changes in phonocardiographic parameters related to changes in blood volume caused by this fluid shift
Study: NCT01120210

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: JNJ-39588146 5 ng/kg/min
Description: 1-hour infusion of JNJ-39588146 5 ng/kg/min on Day 1

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: JNJ-39588146 15 ng/kg/min
Description: 1-hour infusion of JNJ-39588146 15 ng/kg/min on Day 1

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: JNJ-39588146 30 ng/kg/min
Description: 1-hour infusion of JNJ-39588146 30 ng/kg/min on Day 1

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: 1-hour infusion of matching placebo on Day 1

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: 1-hour infusion of matching placebo on Day 1

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: JNJ-39588146 5, 15, or 30 ng/kg/min
Description: 18-hour infusion of JNJ-39588146 or matching placebo on Day 1 immediately folllowing the 3-hour infusion at a dose equal to the maximum dose tolerated by that patient during the 3-hour infusion in Part 1 of the study.