TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT05331196

Intervention type: DIAGNOSTIC_TEST
Intervention: Preoperative cardiopulmonary exercise tetsing
Description: Patients underwent a cardiopulmonary exercise test prior to surgery.
Study: NCT05360940

Intervention type: DIAGNOSTIC_TEST
Intervention: H.pylori stool antigen rapid test and stool parasitological examination
Description: 200 stool samples ( 100 positive and 100 negative for H.pylori) after performance of H.pylori stool rapid antigen test then parasitological stool examination will be done

Intervention type: DIAGNOSTIC_TEST
Intervention: H.pylori stool antigen rapid test and stool parasitological examination
Description: 200 stool samples ( 100 positive and 100 negative for H.pylori) after performance of H.pylori stool rapid antigen test then parasitological stool examination will be done
Study: NCT05458180

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Lposomal mitoxantrone hydrochloride,Cyclophosphamide,Vincristine,Etoposide and Prednisone(CMOEP)
Description: Drug: Liposomal mitoxantrone hydrochloride (15 mg/m2, 18 mg/m2, 20 mg/m2) will be administered by an intravenous infusion on day 1 of each 21-day cycle.~Drug: Cyclophosphamide (750 mg/ m2) will be administered by an intravenous infusion on day 1 of each 21-day cycle.~Drug: Vincristine (1.4mg/ m2，Max dose 2mg) will be administered by an intravenous injection on day 1of each 21-day cycle.~Drug: Etoposide (60 mg/ m2) will be administered by an intravenous infusion on day 1-3 of each 21-day cycle.~Drug: Prednisone (100 mg) will be taken orally from day 1-5 of each 21-day cycle.
Study: NCT05911516

Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo
Study: NCT05130398

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: rVSVΔG-ZEBOV-GP, V920
Description: The experimental vaccine is the rVSVΔG-ZEBOV-GP, an Ebola vaccine.

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Fibre and equilibrate breakfast and lunch
Description: Participants receive fibres and caloric equilibrate diet during breakfast and lunch every day for 21 consecutive days.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Active detection and treatment of pathogens
Description: Monthly diagnostic and treatment of childhood infections Active detection and treatment of pathogens.

Intervention type: COMBINATION_PRODUCT
Group type: EXPERIMENTAL
Intervention: Fibre and equilibrate breakfast and lunch plus Active detection and treatment of pathogens
Description: Participants receive fibres and caloric equilibrate diet during breakfast and lunch every day for 21 consecutive days and diagnostic and treatment of childhood infections Active detection and treatment of pathogens every month for 12 months

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: Chikenpox or Varicella vaccine (VARILRIX)
Description: The active comparator vaccine, a Varicella vaccine (VARILRIX®)

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: About 30 children do not receive diet, nor active pathogen detection
Study: NCT05443789

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Proton pump inhibitor education
Description: A 15 minutes (preferable) one-on-one educational visit about deprescription of proton pump inhibitor

Intervention type: BEHAVIORAL
Group type: PLACEBO_COMPARATOR
Intervention: Other education
Description: A 15 minutes (preferable) one-on-one educational visit about another topic (NOT asthma).
Study: NCT01303107

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Bupivacaine
Description: single dose of 15 mg by a slow injection rate of 1 mL/s

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Bupivacaine
Description: single dose of 15 mg by a slow injection rate of 1 mL/s
Study: NCT05349916

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Control
Description: 300 g rice porridge + 150 ml drinking water

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Isomaltodextrin Low Dose
Description: 300 g rice porridge + (5 g IMD in 150 ml drinking water)

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Isomaltodextrin High Dose
Description: 300 g rice porridge + (10 g IMD in 150 ml drinking water)

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: GPC partially digestible maltodextrin
Description: 300 g rice porridge + (15 g GPC fiber in 150 ml drinking water)

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Resistant Starch Type 4
Description: 300 g rice porridge + (15 g RS4 starch in 150 ml drinking water)
Study: NCT04592315

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Lipovirtide Injection
Description: Single dosage of Lipovirtide Injection

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Lipovirtide Injection
Description: Single dosage of Lipovirtide Injection

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Lipovirtide Injection
Description: Single dosage of Lipovirtide Injection

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Lipovirtide Injection
Description: Single dosage of Lipovirtide Injection

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Lipovirtide Injection
Description: Single dosage of Lipovirtide Injection

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Lipovirtide Injection
Description: Single dosage of Lipovirtide Injection
Study: NCT05804994

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Elgydium Clinic Sensileave Gel (V063B - DP3003)
Description: Tested product is applied/used only once a day before whitening tray wear.
Study: NCT04445545

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: High intensity laser therapy (HILT)
Description: Laser application with powers greater than 500 milliwatts (mW) in the myofascial trigger point and muscle belly of the upper trapezius. Laser therapy will be applied to the upper trapezius muscle with a total energy delivery of 1,060J divided into 3 phases will be achieved (phase 1, 500J; phase 2, 60J; phase 3, 500J). It will work with an average power of 3W and an energy density of 50J/cm2. For the application of laser therapy, the 12W BTL-6000 equipment that emits infrared wavelengths of 1064nm will be used.

Intervention type: DEVICE
Group type: SHAM_COMPARATOR
Intervention: High intensity laser therapy (HILT)
Description: Laser application with powers greater than 500 milliwatts (mW) in the myofascial trigger point and muscle belly of the upper trapezius. Laser therapy will be applied to the upper trapezius muscle with a total energy delivery of 1,060J divided into 3 phases will be achieved (phase 1, 500J; phase 2, 60J; phase 3, 500J). It will work with an average power of 3W and an energy density of 50J/cm2. For the application of laser therapy, the 12W BTL-6000 equipment that emits infrared wavelengths of 1064nm will be used.

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Therapeutic Ultrasound (US)
Description: Application of ultrasound therapy in the myofascial trigger point of the upper trapezius muscle. The ultrasound application will be performed with the person in a seated position. The ultrasound parameters will consist of a frequency of 1MHz, the intensity of 1.5 W/cm2, a Duty cycle of 100%, an ERA of 5cm2, and a treatment time of 6 minutes.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Stretching exercise
Description: t the end of the assigned treatment will be added a treatment protocol of upper trapezius stretching exercises for the evaluated limb with shortening. The stretches will consist of 4 series of 30 seconds with an interval of 30 seconds between series

Intervention type: PROCEDURE
Group type: SHAM_COMPARATOR
Intervention: Stretching exercise
Description: t the end of the assigned treatment will be added a treatment protocol of upper trapezius stretching exercises for the evaluated limb with shortening. The stretches will consist of 4 series of 30 seconds with an interval of 30 seconds between series
Study: NCT05119972

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ZSP1603
Description: ZSP1603 administered orally

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ZSP1603
Description: ZSP1603 administered orally

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ZSP1603
Description: ZSP1603 administered orally

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ZSP1603
Description: ZSP1603 administered orally

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo administered orally
Study: NCT04745689

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Durvalumab
Description: IV infusions through induction phase.~IV infusions through maintenance phase until PD or other discontinuation criteria.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AZD2811
Description: IV infusions through maintenance phase until PD or other discontinuation criteria.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Carboplatin
Description: IV infusions through induction phase if chosen by Investigator.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cisplatin
Description: IV infusions through induction phase if chosen by Investigator.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Etoposide
Description: IV infusions through induction phase.
Study: NCT06078306

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Azacitidine Injection
Description: Azacitidine Injection 75mg/square meter/day, day1-7, subcutaneous injection

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Venetoclax
Description: Venetoclax 100mg day 1, 200mg day 2, 400mg d3-d21, oral

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CD19CD22 CAR-T
Description: After induction chemotherapy with Azacitidine+Venetoclax, each subject receives CD19CD22 CAR-T cells by intravenous infusion
Study: NCT04445545

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Stretching exercise
Description: t the end of the assigned treatment will be added a treatment protocol of upper trapezius stretching exercises for the evaluated limb with shortening. The stretches will consist of 4 series of 30 seconds with an interval of 30 seconds between series
Study: NCT05479071

Intervention type: DIAGNOSTIC_TEST
Intervention: Blood test
Description: Screening of antibodies against LDL

Intervention type: DIAGNOSTIC_TEST
Intervention: Blood test
Description: Screening of antibodies against LDL
Study: NCT05468827

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: lymphatic mapping with indocyanine green
Description: subserosal injection of indocyanine green near the primary tumour with subsequent assessment of the dye spread along lymphatics
Study: NCT05267145

Intervention type: COMBINATION_PRODUCT
Group type: EXPERIMENTAL
Intervention: blood preservation solution III
Description: Blood bag added blood preservation solution III
Study: NCT05385913

Intervention type: OTHER
Intervention: Multivitamin-no intervention
Description: No intervention. All participants will be given a multi-vitamin to take for the duration of the study

Intervention type: OTHER
Intervention: Multivitamin-no intervention
Description: No intervention. All participants will be given a multi-vitamin to take for the duration of the study
Study: NCT05708092

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: NeuroResource Facilitation (NRF)
Description: NRF is defined as a specialized service that promotes access to services and coordinates care specific to the needs of individuals with brain injury.~Possible resources include vocational services, medical assistance, Social Security (SSI or SSDI if appropriate), and other organizations that can support reentry. If needed to gain access to services and organizations, the facilitator will also provide participants with a summary that includes results from brain injury screenings questionnaire, neurocognitive (thinking abilities) tests, and symptoms. The researchers will share information and coordinate with prison and parole staff about participation in the study. Participant's information will also be shared with resources that could help participants after release, such as funding sources and brain injury services. After release from SCI, the NRF facilitator will assist the participant with all the preparation and logistics associated with the resources the participant applied to.
Study: NCT03184155

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Nicardipine
Description: 200 mcg intracoronary nicardipine injection prior to PCI followed by an additional 2-4 doses of 100 mcg intracoronary nicardipine depending on complexity of PCI

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Sterile Saline
Description: Bolus of intracoronary sterile saline injection prior to PCI followed by an additional 2-4 doses of sterile saline depending on complexity of PCI
Study: NCT06284603

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Hyperbaric Oxygen Therapy - HBOT
Description: Each session includes exposure of 60 minutes to 100% oxygen at 2.5 atmosphere absolute (ATA), with 5-minute air breaks every 20 minutes

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Hyperbaric Oxygen Therapy - HBOT
Description: Each session includes exposure of 60 minutes to 100% oxygen at 2.5 atmosphere absolute (ATA), with 5-minute air breaks every 20 minutes
Study: NCT04505956

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Holmium laser lithotripsy with Moses Technology
Description: Holmium laser energy will be delivered for the ureteroscopic fragmenting of kidney stones. Energy will be generated by the commercial available, FDA approved Lumenis PulseTM P120H laser system and Moses laser fiber. Renal stones will be fragmented using a dusting technique. Moses laser settings will be turned on.
Study: NCT04810312

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Combined exercise and nutrition intervention
Description: Back extensor strengthening exercise and nutritional supplementation for 12 weeks
Study: NCT04574869

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: RLS-0071 10 mg/kg
Description: Single dose IV infusion of 10 mg/kg RLS-0071

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: RLS-0071 40 mg/kg
Description: Single dose IV infusion of 40 mg/kg RLS-0071

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: The placebo control will be commercial sterile saline (0.9% Sodium Chloride Injection, United States Pharmacopoeia \[USP\]).

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: The placebo control will be commercial sterile saline (0.9% Sodium Chloride Injection, United States Pharmacopoeia \[USP\]).

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: The placebo control will be commercial sterile saline (0.9% Sodium Chloride Injection, United States Pharmacopoeia \[USP\]).

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: The placebo control will be commercial sterile saline (0.9% Sodium Chloride Injection, United States Pharmacopoeia \[USP\]).

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: The placebo control will be commercial sterile saline (0.9% Sodium Chloride Injection, United States Pharmacopoeia \[USP\]).

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: The placebo control will be commercial sterile saline (0.9% Sodium Chloride Injection, United States Pharmacopoeia \[USP\]).

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: RLS-0071 10 mg/kg
Description: Multiple dose IV infusion of 10 mg/kg RLS-0071 administered every 8 hours for approximately 3 days (9 consecutive doses)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: RLS-0071 40 mg/kg
Description: Multiple dose IV infusion of 40 mg/kg RLS-0071 administered every 8 hours for approximately 3 days (9 consecutive doses)
Study: NCT04505956

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Holmium laser lithotripsy without Moses Technology
Description: Holmium laser energy will be delivered for the ureteroscopic fragmenting of kidney stones. Energy will be generated by the commercial available, FDA approved Lumenis PulseTM P120H laser system and Moses laser fiber. Renal stones will be fragmented using a dusting technique. Moses laser settings will be turned off.
Study: NCT06609226

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Etavopivat A
Description: Participants will receive an oral dose of Etavopivat A.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Etavopivat A
Description: Participants will receive an oral dose of Etavopivat A.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Etavopivat A
Description: Participants will receive an oral dose of Etavopivat A.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Etavopivat A
Description: Participants will receive an oral dose of Etavopivat A.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Etavopivat A
Description: Participants will receive an oral dose of Etavopivat A.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Etavopivat B
Description: Participants will receive an oral dose of Etavopivat B.
Study: NCT06633484

Intervention type: OTHER
Intervention: functional magnetic resonance imaging
Description: non-diagnostic, non-invasive, passive measurement of the brain\&#39;s structure and function

Intervention type: OTHER
Intervention: functional magnetic resonance imaging
Description: non-diagnostic, non-invasive, passive measurement of the brain\&#39;s structure and function
Study: NCT06634108

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Genistein
Description: The genistein capsules are manufactured and obtained from MCS Formulas, and each capsule contains 250 mg genistein and 50 mg inulin. The genistein is certified to be 98% pure genistein by HPLC and is certified by Good Laboratory Practice (GLP). They will consume 250 mg of genistein BID (500 mg total) by mouth for the first 4 weeks before blood and stool samples are collected. Then, participants will take 500 mg of genistein BID (1000 mg total) for the next 4 weeks before collecting fasting blood and stool samples. Afterward, participants will take 750 mg of genistein BID (1500 mg total) for 4 weeks before collecting fasting blood and stool samples. Afterward, participants will have a washout for 6 weeks before returning for fasting blood and stool sample collection.
Study: NCT05495828

Intervention type: DRUG
Intervention: Orelabrutinib
Description: Orelabrutinib, 150mg, po, qd
Study: NCT05551819

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: MDF then RUTF/RUSF
Description: Children randomized to feeding order 1: children will be provided MDF for the first two weeks then crossover to consume RUTF/RUSF for a second two weeks.

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: RUTF/RUSF then MDF
Description: Children randomized to feeding order 2: children will be provided RUTF/RUSF for the first two weeks then crossover to consume MDF for a second two weeks.
Study: NCT04987697

Intervention type: BEHAVIORAL
Group type: OTHER
Intervention: counseling
Description: nine 90-minute weekly psychoeducational group sessions facilitated by a licensed mental health counselor (LMHC).
Study: NCT05496660

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: NHE+KT
Description: the Nodic hamstring exercise plus the kinesio taping with tension during 4-week consisting 12 sessions
Study: NCT05935293

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Dexmedetomidine
Description: iv administration dexmedetomidine

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dexmedetomidine
Description: iv administration dexmedetomidine
Study: NCT05808972

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Sodium chloride 0.9% (SC)
Description: This trial looks specifically at the type of hydratation liquid. The patients included will receive SC. The volume, frequency of fluid administration and other severe DKA therapies, such as insulin therapy and electrolytes, are prescribed similarly. The intervention will continue for 48 hours from admission to the ICU with a blood gas control (including base excess) + Blood glucose + ionogram (Na, K, chlorine) + lactates on admission (or H0), H6, H12, H24 and H48.
Study: NCT05953363

Intervention type: DEVICE
Intervention: BD NRFit™ Spinal Needles, BD NRFit™ Spinal Introducer Needles, and BD NRFit™ Syringes
Description: Insertion of a BD NRFit™ spinal needle and optional BD NRFit™ Spinal Introducer Needle using a BD NRFit™ Syringe to perform the neuraxial procedure.
Study: NCT04900467

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Pfizer
Description: BNT162b2 (Comirnaty®), Pfizer/BioNTech, mARN vaccine,
Study: NCT05496660

Intervention type: OTHER
Group type: SHAM_COMPARATOR
Intervention: NHE
Description: the Nodic hamstring exercise plus the kinesio taping without tension during 4-week consisting 12 sessions
Study: NCT06182761

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Sunvozertinib combination with Anlotinib
Description: Sunvozertinib 300 mg once daily (QD) with Anlotinib 12mg once daily （QD in Day 1-14） ，21 days in one cycle.
Study: NCT05808972

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Ringer lactate (RL)
Description: The intervention will continue for 48 hours from admission to the ICU with a blood gas control (including base excess) + Blood glucose + ionogram (Na, K, chlorine) + lactates on admission (or H0), H6, H12, H24 and H48.
Study: NCT05723874

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: BI 425809
Description: BI 425809

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: BI 425809
Description: BI 425809

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: bosentan
Description: bosentan
Study: NCT05942677

Intervention type: PROCEDURE
Intervention: proportion of colorectal lesions
Description: Evaluation of the proportion of colorectal lesions detected by a computer-aided detection system (CADe) compared with experienced endoscopists.
Study: NCT04809688

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Saskatoon berry
Description: Freeze dried Saskatoon berry (30 g) will be orally administrated daily for 10 weeks.
Study: NCT05102214

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: HLX301
Description: A Recombinant Humanized Anti-PDL1 and Anti-TIGIT Bispecific Antibody, HLX301 will be administered as a single intravenous (IV) infusion on Day 1 in each 14-day cycle
Study: NCT04900467

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Pfizer
Description: BNT162b2 (Comirnaty®), Pfizer/BioNTech, mARN vaccine,

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: Pfizer
Description: BNT162b2 (Comirnaty®), Pfizer/BioNTech, mARN vaccine,
Study: NCT05102214

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: HLX301
Description: A Recombinant Humanized Anti-PDL1 and Anti-TIGIT Bispecific Antibody, HLX301 will be administered as a single intravenous (IV) infusion on Day 1 in each 14-day cycle

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: HLX301
Description: A Recombinant Humanized Anti-PDL1 and Anti-TIGIT Bispecific Antibody, HLX301 will be administered as a single intravenous (IV) infusion on Day 1 in each 14-day cycle