TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT04131309

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Daratumumab
Description: As of Protocol Amendment 1, all new subjects are dosed with daratumumab subcutaneous injection (SC) co-formulated with recombinant human hyaluronidase rHuPH20. Subjects who already began treatment with daratumumab intravenous (IV) infusion (i.e., prior to Am 1) switch to SC on the next administration date according to the protocol schedule. Subjects receive daratumumab IV at a dose of 16 mg/kg and daratumumab SC at a fixed dose of 1800 mg for the first 8 weeks (Cycles 1 and 2) of treatment and then every 2 weeks for 4 cycles (Cycles 3 to 6) and then every 4 weeks until progression of disease (according to MOD-PFS), unacceptable toxicity or subsequent therapy, for a maximum of 2 years in total. All treatment cycles are 4 weeks (28 days) in length.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Bortezomib Injection
Description: Subjects who do not achieve either a hematologic VGPR or better, OR a hematologic PR with a major organ response by Cycle 4 Day 1 may receive at Investigator's discretion, in addition to daratumumab, bortezomib at a dose of 1.3 mg/m2 weekly for a maximum of 6 cycles as a subcutaneous injection
Study: NCT00076063

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: LIPO-5
Description: experimental vaccine

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: LIPO-5
Description: experimental vaccine
Study: NCT04131309

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dexamethasone oral tablet
Description: Subjects who do not achieve either a hematologic VGPR or better, OR a hematologic PR with a major organ response by Cycle 4 Day 1 may receive at Investigator's discretion, in addition to daratumumab low dose dexamethasone at a maximum total dose of 20 mg weekly.
Study: NCT03192670

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Low-level light therapy device
Description: Peak wavelength:610nm, Power intensity: 1.7mW/cm2, Energy density: 2.0J/cm2, Skin-adhesive light-emitting probes: spot size, 1cm diameter

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Low-level light therapy device
Description: Peak wavelength:610nm, Power intensity: 1.7mW/cm2, Energy density: 2.0J/cm2, Skin-adhesive light-emitting probes: spot size, 1cm diameter

Intervention type: DEVICE
Group type: SHAM_COMPARATOR
Intervention: Low-level light therapy device
Description: Peak wavelength:610nm, Power intensity: 1.7mW/cm2, Energy density: 2.0J/cm2, Skin-adhesive light-emitting probes: spot size, 1cm diameter

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Low-level light therapy device
Description: Peak wavelength:610nm, Power intensity: 1.7mW/cm2, Energy density: 2.0J/cm2, Skin-adhesive light-emitting probes: spot size, 1cm diameter
Study: NCT00737204

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Armodafinil
Description: Participants will receive 50 mg of armodafinil per day, increasing to 250 mg per day as clinically indicated.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Participants will receive placebo pills matched to the active armodafinil and according to the same dosing strategy
Study: NCT01233960

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: adult human mesenchymal stem cells
Description: PROCHYMAL will be administered IV in a total volume of 300 ml (200 million cells) at a rate of 4-6 ml/minute. Treatments will be administered on Days 42-45, Days 84-87, and Days 126-129 following first infusion in Protocol 603.
Study: NCT05839782

Intervention type: PROCEDURE
Intervention: Mitral valve repair (PLM)
Description: A mitral valve plasty is performed to treat mitral regurgitation
Study: NCT01680302

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: High intensity exercise
Study: NCT05839782

Intervention type: PROCEDURE
Intervention: Mitral valve replacement
Description: A mitral valve replacement with a prosthesis is performed to treat mitral regurgitation
Study: NCT00688701

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Lixisenatide (AVE0010)
Description: Self administered by subcutaneous injections once daily within the hour preceding breakfast.
Study: NCT01680302

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Moderate intensity exercise
Study: NCT00688701

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Lixisenatide (AVE0010)
Description: Self administered by subcutaneous injections once daily within the hour preceding breakfast.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Self administered by subcutaneous injections once daily within the hour preceding breakfast.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Self administered by subcutaneous injections once daily within the hour preceding breakfast.

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Pen auto-injector

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Pen auto-injector

Intervention type: DEVICE
Group type: PLACEBO_COMPARATOR
Intervention: Pen auto-injector

Intervention type: DEVICE
Group type: PLACEBO_COMPARATOR
Intervention: Pen auto-injector
Study: NCT03777332

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PEGCETACOPLAN (APL-2)
Description: Complement (C3) Inhibitor

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PEGCETACOPLAN (APL-2)
Description: Complement (C3) Inhibitor

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PEGCETACOPLAN (APL-2)
Description: Complement (C3) Inhibitor
Study: NCT02319174

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Sphygmo
Description: A team of engineers from Rice University has recently developed Sphygmo, an ambulatory, low-cost blood pressure monitor for use in the diagnosis and management of pre-eclampsia in low-resource hospitals
Study: NCT04068129

Intervention type: DEVICE
Intervention: photoscreen
Description: Determine amblyopia risk factors

Intervention type: DEVICE
Intervention: photoscreen
Description: Determine amblyopia risk factors
Study: NCT01680302

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Control
Description: Advised to follow current guidelines for physical activity, but exercise on their own.
Study: NCT00829647

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: dasatinib and lenalidomide
Description: dasatinib will be started at 70mg/day po and lenalidomide will be started at 2.5mg/day po
Study: NCT02110225

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: rhNGF 60 µg/ml eye drops solution
Description: rhNGF 60 µg/ml eye drops solution, one drop 3 times a day for 24 weeks in both eyes

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: rhNGF 180 µg/ml eye drops solution
Description: rhNGF 180 µg/ml eye drops solution, one drop 3 times a day for 24 weeks in both eyes

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo eye drops solution, one drop 3 times a day for 24 weeks in both eyes
Study: NCT03967093

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: BXQ-350
Description: BXQ-350 is a novel anti-neoplastic therapeutic agent configured from two components: Saposin C (SapC), an expressed (human) lysosomal protein, and the phospholipid dioleoylphosphatidyl-serine (DOPS), a phospholipid located on cell membranes (clinical formulation BXQ-350). BXQ-350 is administered by intravenous (IV) infusion over a minimum of six 28-day cycles.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: BXQ-350
Description: BXQ-350 is a novel anti-neoplastic therapeutic agent configured from two components: Saposin C (SapC), an expressed (human) lysosomal protein, and the phospholipid dioleoylphosphatidyl-serine (DOPS), a phospholipid located on cell membranes (clinical formulation BXQ-350). BXQ-350 is administered by intravenous (IV) infusion over a minimum of six 28-day cycles.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: BXQ-350
Description: BXQ-350 is a novel anti-neoplastic therapeutic agent configured from two components: Saposin C (SapC), an expressed (human) lysosomal protein, and the phospholipid dioleoylphosphatidyl-serine (DOPS), a phospholipid located on cell membranes (clinical formulation BXQ-350). BXQ-350 is administered by intravenous (IV) infusion over a minimum of six 28-day cycles.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: BXQ-350
Description: BXQ-350 is a novel anti-neoplastic therapeutic agent configured from two components: Saposin C (SapC), an expressed (human) lysosomal protein, and the phospholipid dioleoylphosphatidyl-serine (DOPS), a phospholipid located on cell membranes (clinical formulation BXQ-350). BXQ-350 is administered by intravenous (IV) infusion over a minimum of six 28-day cycles.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: BXQ-350
Description: BXQ-350 is a novel anti-neoplastic therapeutic agent configured from two components: Saposin C (SapC), an expressed (human) lysosomal protein, and the phospholipid dioleoylphosphatidyl-serine (DOPS), a phospholipid located on cell membranes (clinical formulation BXQ-350). BXQ-350 is administered by intravenous (IV) infusion over a minimum of six 28-day cycles.
Study: NCT01095601

Intervention type: DRUG
Group type: OTHER
Intervention: Avanafil
Description: * Treatment A: 2x100 mg Formulation II avanafil tablet, fasted~* Treatment B: 2x100 mg Formulation II avanafil tablet, fed~* Treatment C: 2x100 mg Formulation I avanafil tablet, fasted~* Treatment D: 1x50 mg Formulation II avanafil tablet, fasted

Intervention type: DRUG
Group type: OTHER
Intervention: Avanafil
Description: * Treatment A: 2x100 mg Formulation II avanafil tablet, fasted~* Treatment B: 2x100 mg Formulation II avanafil tablet, fed~* Treatment C: 2x100 mg Formulation I avanafil tablet, fasted~* Treatment D: 1x50 mg Formulation II avanafil tablet, fasted

Intervention type: DRUG
Group type: OTHER
Intervention: Avanafil
Description: * Treatment A: 2x100 mg Formulation II avanafil tablet, fasted~* Treatment B: 2x100 mg Formulation II avanafil tablet, fed~* Treatment C: 2x100 mg Formulation I avanafil tablet, fasted~* Treatment D: 1x50 mg Formulation II avanafil tablet, fasted

Intervention type: DRUG
Group type: OTHER
Intervention: Avanafil
Description: * Treatment A: 2x100 mg Formulation II avanafil tablet, fasted~* Treatment B: 2x100 mg Formulation II avanafil tablet, fed~* Treatment C: 2x100 mg Formulation I avanafil tablet, fasted~* Treatment D: 1x50 mg Formulation II avanafil tablet, fasted
Study: NCT02068352

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: OPA-15406
Description: OPA-15406 topical ointment

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: OPA-15406
Description: OPA-15406 topical ointment

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Vehicle ointment
Description: OPA-15406 1%-matching placebo topical ointment
Study: NCT02157688

Intervention type: OTHER
Intervention: no intervention : case control study
Study: NCT02096757

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Pro-Omega
Description: Pro-Omega (Nordic Naturals, Watsonville, CA, USA). Each ProOmega capsule contains 325mg of EPA and 225mg of DHA. 4.4gm/day 2 weeks prior to surgery and continued for 4 weeks after

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Pro-Omega Placebo
Description: Placebo Comparator: soybean (Nordic Naturals, Watsonville, CA, USA); 4.4gm/day 2 weeks prior to surgery and continued for 4 weeks after
Study: NCT03793673

Intervention type: BEHAVIORAL
Group type: OTHER
Intervention: CoYoT1 Care
Description: Selected providers will be trained in the CoYoT1 Care protocol for completing medical appointments (both telehealth/standard appointments). There are three key components: (1) Shared decision making: Providers and YA will mutually agree on priorities for each medical visit using a shared decision making tool completed by both the provider and patient. (2) Autonomy supportive care: Providers will be trained in communication strategies, such as motivational interviewing, designed to support YA autonomy and intrinsic motivation. YA will also direct extent of eligible family involvement. (3) Goal setting and action planning: Providers will be trained to coach YA in setting SMART goals, developing action plans, and establishing a plan for follow-up between visits as appropriate.

Intervention type: BEHAVIORAL
Group type: OTHER
Intervention: CoYoT1 Care
Description: Selected providers will be trained in the CoYoT1 Care protocol for completing medical appointments (both telehealth/standard appointments). There are three key components: (1) Shared decision making: Providers and YA will mutually agree on priorities for each medical visit using a shared decision making tool completed by both the provider and patient. (2) Autonomy supportive care: Providers will be trained in communication strategies, such as motivational interviewing, designed to support YA autonomy and intrinsic motivation. YA will also direct extent of eligible family involvement. (3) Goal setting and action planning: Providers will be trained to coach YA in setting SMART goals, developing action plans, and establishing a plan for follow-up between visits as appropriate.

Intervention type: OTHER
Group type: OTHER
Intervention: Standard Care
Description: Providers selected for the Standard Care group will complete medical appointments in their usual manner, without specific training or guidelines regarding how to deliver care.~NOTE: Per COVID-19 hospital policies, current clinic appointments consist of telehealth appointments.

Intervention type: OTHER
Group type: OTHER
Intervention: Standard Care
Description: Providers selected for the Standard Care group will complete medical appointments in their usual manner, without specific training or guidelines regarding how to deliver care.~NOTE: Per COVID-19 hospital policies, current clinic appointments consist of telehealth appointments.
Study: NCT04210908

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Visual biofeedback
Description: Patient will observe the descent of the fetal head as they push during contractions
Study: NCT03722953

Intervention type: OTHER
Group type: OTHER
Intervention: Control
Description: 1. Ultrasound~2. Blood Pressure~3. Heart Rate~4. Oxygen Saturation

Intervention type: OTHER
Group type: OTHER
Intervention: Aerobic Exercise
Description: 1. Ultrasound~2. Blood Pressure~3. Heart Rate~4. Oxygen Saturation
Study: NCT03989206

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Nemolizumab
Description: Nemolizumab
Study: NCT01182597

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Pantoprazole (Pantoloc)
Description: Pantoprazole (Pantoloc) 3.3mg/hr for 72hrs

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Lansoprazole (Takepron OD)
Description: Lansoprazole (Takepron OD) 30mg q12h PO
Study: NCT03875274

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ropivacaine, Morphine
Description: Morphine added to ropivacaine for fascia iliaca compartment block

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Ropivacaine, Saline
Description: Normal saline added to ropivacaine for fascia iliaca compartment block
Study: NCT02607345

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Zusto
Description: 25gr

Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: Glucomedics®
Description: 25gr
Study: NCT00292305

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Percutaneous coronary intervention
Description: Implantation of coronary stent in bifurcation lesions

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Percutaneous coronary intervention
Description: Implantation of coronary stent in bifurcation lesions
Study: NCT01659177

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: LY2140023
Description: Administered orally

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: LY2140023
Description: Administered orally
Study: NCT01968083

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: RSV cps2 Vaccine
Description: 10\^5.3 plaque forming units (PFUs) or RSV cps2 vaccine will be administered as nose drops (0.25 mL per nostril, for a total of 0.5 mL).

Intervention type: BIOLOGICAL
Group type: PLACEBO_COMPARATOR
Intervention: Placebo Vaccine
Description: Placebo vaccine will be administered as nose drops (0.25 mL per nostril, for a total of 0.5 mL).
Study: NCT01083420

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Minocycline
Description: Minocycline 0.2% mouthwash

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Dexamethasone
Description: Dexamethasone 0.01% mouthwash
Study: NCT01566305

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Buttermilk without added egg-yolk
Description: Buttermilk without added egg-yolk

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Buttermilk with added egg yolk
Description: Buttermilk with added egg yolk

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Skimmed milk with added egg-yolk
Description: Skimmed milk with added egg-yolk

Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: Skimmed milk without added egg yolk
Description: Skimmed milk without added egg yolk
Study: NCT00251927

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: esomeprazole
Description: 40 mg oral tablet administered daily

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Laparoscopic fundoplication (surgery)
Description: Surgery
Study: NCT02111226

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: SMS text messaging
Description: short message service

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: SMS text messaging
Description: short message service
Study: NCT01205321

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Bombesin (68Ga) labeled (BAY86-7548)
Description: Cancer patients, single intravenous bolus injection of 140 MBq BAY86-7548 on day one of the treatment period, PET/CT

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Bombesin (68Ga) labeled (BAY86-7548)
Description: Healthy volunteers, single intravenous bolus injection of 140 MBq BAY86-7548 on day one of the treatment period, whole body PET/CT for determination of effective dose, kinetics of BAY86-7548 in blood
Study: NCT01393080

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Nimotuzumab and TP regimen
Description: 1. TP Regims：Paclitaxel Liposome,135mg/m2,d1;Carbopatin（AUC=5） d2, 3 weeks/cycle, for 4 cycles.~2. Nimotuzumab: 200mg/w, weekly, for 6 weeks; Consolidation treatment， 200mg every 2 weeks, until the end of 4 cycles of chemotherapy or the disease progression.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: TP regimen
Description: TP Regimen：Paclitaxel Liposome,135mg/m2,d1;Carbopatin（AUC=5） d2, 3 weeks/cycle,for 4 cycles.
Study: NCT01077726

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: capecitabine [Xeloda]
Description: 1000mg/m2 po bid on days 1-14 of each 3 week cycle
Study: NCT03122730

Intervention type: COMBINATION_PRODUCT
Group type: EXPERIMENTAL
Intervention: VentaProst
Description: Part I - an equivalent dose of VentaProst compared to conventionally-administered aerosolized epoprostenol with subsequent dose titration to achieve a clinically significant hemodynamic response Part II - Dose titration to achieve a clinically significant hemodynamic response.
Study: NCT01850368

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Stereotactic ablative radiotherapy
Description: The HCC patients with major portal vein tumor thrombosis (tumor thrombosis in the main portal vein or 1st branch of portal vein) will be included in this study. Total stereotactic ablative radiotherapy (SABR) doses will be 40 Gy in 4 fractionations. Patients receive 4 fractionations separated by \>48 hours.~At least 700 ml of normal liver (entire liver minus cumulative GTV) should not receive a total dose of \> 19.2 Gy in three fractions. If volume of normal liver does not exceed 700 ml, at least 70% of normal liver should not receive a total dose of \> 19.2 Gy. Dose of spinal cord do not exceed 26 Gy. Dose of esophagus, stomach and intestine do not exceed 35 Gy.
Study: NCT01454453

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Patients- dose titration
Description: dose titration (patients) - 4-10 weeks
Study: NCT02019134

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: relaxation exercise
Description: relaxation exercise

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: ususal care
Study: NCT01373996

Intervention type: DEVICE
Intervention: Wireless invasive blood pressure monitoring (Hybymed® Wireless IBPM System)
Description: The readings of invasive arterial pressure were obtained from 2 identical pressure transducers, connected to a common arterial line via a Y connector. Data was collected from one transducer via a direct cable connection and from the second transducer via wireless transmission of the signal to the patient's bedside monitor using the HMW 10 Wireless System.~A comparison of data received by patient's bedside monitor from the two transducers was done (standard connection vs. wireless connection), as well as a comparison of data collected by the transmitter and data received by the receiver of the HMW 10 Wireless System.
Study: NCT04176159

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: MOTOR IMAGERY AND TASK-ORIENTED TRAINING
Description: The intervention will be divided into two modules. A first module will include activities of activation and relaxation of the body, prediction and sequencing of movement and motor imagery. The second module, task-oriented training, will be divided into analytical work phase (visual coordination, balance, muscular strength, fine motor skills ...), a second phase of integration into specific tasks and, at end, the inclusion of the free (and supervised) practice of a sport.~The investigators will apply 20 sessions of 40 minutes.
Study: NCT00079456

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: temsirolimus
Description: Given IV

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: pharmacological study
Description: Correlative studies

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: laboratory biomarker analysis
Description: Correlative studies
Study: NCT03604757

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 68Ga-PSMA-617 PET/CT
Description: PET/CT Imaging with 68Ga-PSMA-617 injection

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 68Ga-RM2 PET/CT
Description: PET/CT Imaging with 68Ga-RM2 injection
Study: NCT02117934

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: HEPLISAV
Description: Intramuscular injections at Week 0 and Week 4, plus a placebo injection at Week 24

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: Engerix-B
Description: Intramuscular injections at Week 0, Week 4, and Week 24
Study: NCT01503840

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: sugammadex
Description: sugammadex 10 mg/ml diluted solution dosage: 1mg/kg i.v. (0,1 ml/kg)

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Sodium chloride solution
Description: Sodium chloride solution 0,9% dosage: 0,1 ml/kg i.v.