TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT03278470

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: HL237
Description: Experimental

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: HL237
Description: Experimental

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: HL237
Description: Experimental

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: HL237
Description: Experimental

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: HL237
Description: Experimental

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: HL237
Description: Experimental

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: HL237
Description: Experimental

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo Oral Tablet
Description: placebo with same properties except for active ingredient

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo Oral Tablet
Description: placebo with same properties except for active ingredient

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo Oral Tablet
Description: placebo with same properties except for active ingredient

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo Oral Tablet
Description: placebo with same properties except for active ingredient

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo Oral Tablet
Description: placebo with same properties except for active ingredient

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo Oral Tablet
Description: placebo with same properties except for active ingredient

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo Oral Tablet
Description: placebo with same properties except for active ingredient
Study: NCT01556425

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Vivitrol
Description: Participants receiving this intervention will receive the FDA-approved dose, route, and schedule of administration of VIVITROL. The dose of VIVITROL of 380 mg will be delivered intramuscularly every 4 weeks.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Vivitrol
Description: Participants receiving this intervention will receive the FDA-approved dose, route, and schedule of administration of VIVITROL. The dose of VIVITROL of 380 mg will be delivered intramuscularly every 4 weeks.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Employment-based opiate abstinence reinforcement
Description: This intervention will require participants to provide opiate-negative urine samples on Monday, Wednesday and Friday to maintain their maximum pay. If a participant provides an opiate-positive urine sample, or fails to provide a scheduled sample, their base pay will be reset from $8 per hour to $1 per hour. On each day after the reset that the participant provides a urine sample that meets the opiate abstinence criteria and attends the workplace for at least 5 minutes, their base pay will increase by $1 per hour until it reaches the maximum of $8 per hour.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Employment-based opiate abstinence reinforcement
Description: This intervention will require participants to provide opiate-negative urine samples on Monday, Wednesday and Friday to maintain their maximum pay. If a participant provides an opiate-positive urine sample, or fails to provide a scheduled sample, their base pay will be reset from $8 per hour to $1 per hour. On each day after the reset that the participant provides a urine sample that meets the opiate abstinence criteria and attends the workplace for at least 5 minutes, their base pay will increase by $1 per hour until it reaches the maximum of $8 per hour.

Intervention type: OTHER
Group type: OTHER
Intervention: Usual Care Control
Description: Participants receiving this intervention will be invited to attend the workplace and outpatient drug abuse counseling.
Study: NCT01783080

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Behavioral Activation for return to work
Description: See Arm Description
Study: NCT02774382

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Vancomycin
Description: Already incl. in arm description

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Vancomycin
Description: Already incl. in arm description

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Vancomycin
Description: Already incl. in arm description

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Fecal microbiota transplantation
Description: Already incl. in arm description

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Rectal bacteriotherapy
Description: Already incl. in arm description
Study: NCT02845570

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: 68Ga-DOTANOC PET/MRI

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: 18F-FDG PET/MRI
Study: NCT01734577

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Dry needling
Description: Sterile monofilament needles

Intervention type: PROCEDURE
Group type: SHAM_COMPARATOR
Intervention: Sham needling
Description: Applicator tubes from the sterile monofilament needles
Study: NCT00691002

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Calcipotriol plus hydrocortisone (LEO 80190)
Description: Once daily application

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: LEO 80190 Vehicle

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Hydrocortisone

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Calcipotriol
Study: NCT04618159

Intervention type: OTHER
Group type: OTHER
Intervention: lactobacillus reuteri DSMZ 17648
Description: to evaluate if this product can eradicate helicobacter pylori
Study: NCT01951820

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pliaglis
Description: Apply 0.2mg of compounded topical anesthetic (Pliaglis) to gums for 2.5 minutes before giving patient injection of local anesthetic.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Benzocaine
Description: Apply 0.2mg of topical anesthetic (benzocaine) to gums for 2.5 minutes before giving patient injection of local anesthetic.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Articaine
Description: Injection of 0.4mg of local anesthetic in gum tissue where topical anesthetic was placed

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Articaine
Description: Injection of 0.4mg of local anesthetic in gum tissue where topical anesthetic was placed
Study: NCT03609697

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: group-based lifestyle intervention
Description: Involve education about pre-diabetes self-management, weight loss, behavioural modification skills, nutrition and physical activity.

Intervention type: BEHAVIORAL
Group type: OTHER
Intervention: Minimal intervention (SMS intervention)
Description: Text message related to general information about T2DM, pre-diabetes, and lifestyle modification.
Study: NCT01888029

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: transcranial direct current stimulation

Intervention type: DEVICE
Group type: PLACEBO_COMPARATOR
Intervention: sham stimulation
Study: NCT01445821

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Peripheral Blood Stem Cells
Description: Mobilized leukapheresis product

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: Peripheral Blood Stem Cells
Description: Mobilized leukapheresis product

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclophosphamide
Description: An alkylating agent which causes prevention of cell division by forming adducts with DNA

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Cyclophosphamide
Description: An alkylating agent which causes prevention of cell division by forming adducts with DNA

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Mesna
Description: Medication used to decrease the risk of hemorrhagic cystitis prophylaxis

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Mesna
Description: Medication used to decrease the risk of hemorrhagic cystitis prophylaxis

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: rATG
Description: A predominantly lymphocyte-specific immunosuppressive agent which contains antibodies specific to the antigens commonly found on the surface of T cells

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: rATG
Description: A predominantly lymphocyte-specific immunosuppressive agent which contains antibodies specific to the antigens commonly found on the surface of T cells

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Methylprednisolone
Description: Steroid

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Methylprednisolone
Description: Steroid

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Filgrastim
Description: Granulocyte-colony stimulating factor (G-CSF); a glycoprotein that stimulates the bone marrow to produce granulocytes and stem cells and release them into the bloodstream

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Filgrastim
Description: Granulocyte-colony stimulating factor (G-CSF); a glycoprotein that stimulates the bone marrow to produce granulocytes and stem cells and release them into the bloodstream

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Fludarabine
Description: Purine analog which inhibits DNA synthesis or repair
Study: NCT01627899

Intervention type: DEVICE
Group type: OTHER
Intervention: One Touch VerioIQ Blood Glucose Monitor
Description: BGM with pattern alert technology and with associated pattern guide
Study: NCT04344938

Intervention type: OTHER
Intervention: questionnair about Emerging Legal and Ehical Disputes Over Patient Confidentiality
Description: Many critical ethical questions arise in pandemic covid 19planning, preparedness and response. These include: Who will get priority access to medications, vaccines and intensive care unit beds, given the potential shortage of these essential resources? In the face of a pandemic, what obligations do health-care workers have to work notwithstanding risks to their own health and the health of their families? How can surveillance, isolation, quarantine and social-distancing measures be undertaken in a way that respects ethical norms? What obligations do countries have to one another with respect to pandemic covid 19 planning and response efforts?

Intervention type: OTHER
Intervention: questionnair about Emerging Legal and Ehical Disputes Over Patient Confidentiality
Description: Many critical ethical questions arise in pandemic covid 19planning, preparedness and response. These include: Who will get priority access to medications, vaccines and intensive care unit beds, given the potential shortage of these essential resources? In the face of a pandemic, what obligations do health-care workers have to work notwithstanding risks to their own health and the health of their families? How can surveillance, isolation, quarantine and social-distancing measures be undertaken in a way that respects ethical norms? What obligations do countries have to one another with respect to pandemic covid 19 planning and response efforts?
Study: NCT04588779

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Graston
Description: Ultrasound for 10 mins/1 set/ (3 sessions/week), Graston for 5 mins/1 set/ (3 sessions/week), Piriformis stretching exercises/ 10 reps with 30 sec hold/ 1 set/(3 sessions/week), Hip abductor strengthening/10 reps/1 set/(3 weeks), Hip extensor strengthening/10 reps/1 set/(3 weeks),~A total of 9 sessions for 3 weeks (3 sessions/week) were given each consisting of 20 mins.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Manual myofascial release
Description: Ultrasound for 10 mins/1 set/ (3 sessions/week), Manual myofascial release for 5 mins/1 set/ (3 sessions/week), Piriformis stretching exercises/ 10 reps with 30 sec hold/ 1 set/(3 sessions/week), Hip abductor strengthening/10 reps/1 set/(3 weeks), Hip extensor strengthening/10 reps/1 set/(3 weeks),~A total of 9 sessions for 3 weeks (3 sessions/week) were given each consisting of 20 mins.
Study: NCT04486950

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: TAK-951
Description: TAK-951 intravenous infusion.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: TAK-951
Description: TAK-951 intravenous infusion.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: TAK-951
Description: TAK-951 intravenous infusion.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: TAK-951 Placebo
Description: TAK-951 placebo-matching intravenous infusion.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: TAK-951 Placebo
Description: TAK-951 placebo-matching intravenous infusion.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: TAK-951 Placebo
Description: TAK-951 placebo-matching intravenous infusion.
Study: NCT01624662

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Fluticasone propionate
Description: Delivered via Optinose Exhalation Delivery System

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Fluticasone propionate
Description: Delivered via Optinose Exhalation Delivery System

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Fluticasone propionate
Description: Delivered via Optinose Exhalation Delivery System

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Fluticasone propionate
Description: Delivered via Optinose Exhalation Delivery System
Study: NCT03814070

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Fiber-reinforced framework
Description: Glass fiber- reinforced framework is to be picked up over the implant abutments to strengthen the full arch acrylic restorations

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: No framework
Description: Non-reinforced acrylic full arch prosthesis is to be picked up directly over the implant abutments.
Study: NCT00361270

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Hyp-8
Description: 8 weekly 1-hour sessions of therapist-guided hypnosis

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Hyp-2 w recordings
Description: 2 weeks of 1-hour sessions of therapist-guided hypnosis + 6 weeks of daily home practice with hypnosis CDs

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Hyp-8
Description: 8 weekly 1-hour sessions of therapist-guided hypnosis

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Hyp-8 w recordings
Description: 8 weekly 1-hour sessions of therapist-guided hypnosis + daily home practice with hypnosis CDs

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Hyp-2 w recordings
Description: 2 weeks of 1-hour sessions of therapist-guided hypnosis + 6 weeks of daily home practice with hypnosis CDs

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Hyp-8
Description: 8 weekly 1-hour sessions of therapist-guided hypnosis

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Hyp-8 w recordings
Description: 8 weekly 1-hour sessions of therapist-guided hypnosis + daily home practice with hypnosis CDs

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: BIO
Description: 8 weekly 1-hour sessions of EMG Biofeedback without hypnotic suggestion
Study: NCT02952274

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: mandibular overdenture retained with single midline implant using locator attachment

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: mandibular overdenture retained with single midline implant using ball attachment
Study: NCT02821715

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Active comparator: Modafinil + placebo

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: THN102 300/3

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: THN102 300/27
Study: NCT00137111

Intervention type: DRUG
Group type: OTHER
Intervention: Prednisone, Dexamethasone, Vincristine, Daunorubicin
Description: See Detailed Description sections for details on treatment interventions.

Intervention type: DRUG
Group type: OTHER
Intervention: Prednisone, Dexamethasone, Vincristine, Daunorubicin
Description: See Detailed Description sections for details on treatment interventions.

Intervention type: DRUG
Group type: OTHER
Intervention: Doxorubicin, L-asparaginase, PEG-L-asparaginase, Erwinia asparaginase
Description: See Detailed Description sections for details on treatment interventions.

Intervention type: DRUG
Group type: OTHER
Intervention: Doxorubicin, L-asparaginase, PEG-L-asparaginase, Erwinia asparaginase
Description: See Detailed Description sections for details on treatment interventions.

Intervention type: DRUG
Group type: OTHER
Intervention: Methotrexate, Cyclophosphamide, Cytarabine, Etoposide
Description: See Detailed Description sections for details on treatment interventions.

Intervention type: DRUG
Group type: OTHER
Intervention: Methotrexate, Cyclophosphamide, Cytarabine, Etoposide
Description: See Detailed Description sections for details on treatment interventions.

Intervention type: DRUG
Group type: OTHER
Intervention: Mercaptopurine, Imatinib
Description: See Detailed Description sections for details on treatment interventions.

Intervention type: DRUG
Group type: OTHER
Intervention: Mercaptopurine, Imatinib
Description: See Detailed Description sections for details on treatment interventions.

Intervention type: PROCEDURE
Group type: OTHER
Intervention: chemotherapy, intrathecal chemotherapy
Description: See Detailed Description sections for details on treatment interventions.

Intervention type: PROCEDURE
Group type: OTHER
Intervention: chemotherapy, intrathecal chemotherapy
Description: See Detailed Description sections for details on treatment interventions.

Intervention type: PROCEDURE
Group type: OTHER
Intervention: steroid therapy, hematopoietic stem cell transplantation
Description: See Detailed Description sections for details on treatment interventions.

Intervention type: PROCEDURE
Group type: OTHER
Intervention: steroid therapy, hematopoietic stem cell transplantation
Description: See Detailed Description sections for details on treatment interventions.
Study: NCT04577235

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: severity of lung involvement with COVID-19.
Description: transthoracic lung ultrasound and throcic CT

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: severity of lung involvement with COVID-19.
Description: transthoracic lung ultrasound and throcic CT
Study: NCT02721680

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Internal Awareness Training Program

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: External Awareness Training Program
Study: NCT00610987

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: cefazolin
Description: Both groups will receive 1 gram (g) of IV cefazolin prior to incision, per standard protocol at our institution. A 2-g dose of cefazolin will be administered IV for patients weighing more than 80 kg. A second 1-g dose of cefazolin will be given three hours later if the patient is still in the operating room. Upon completion of the surgical procedure, Group I will receive 1-g doses of cefazolin every eight hours for the next 24 hours.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Patients will be randomly assigned to one of two groups. Both groups will receive 1 gram (g) of IV cefazolin prior to incision, per standard protocol at our institution. A 2-g dose of cefazolin will be administered IV for patients weighing more than 80 kg. A second 1-g dose of cefazolin will be given three hours later if the patient is still in the operating room. Upon completion of the surgical procedure, Group II will receive no additional antibiotic. Instead, they will receive normal saline injection every eight hours as a placebo.
Study: NCT01714687

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: balloon sinus dilation

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: medical therapy

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: medical therapy
Study: NCT00784654

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Lisdexamfetamine dimesylate (LDX)
Description: LDX 30, 50, or 70mg capsule once per day (open-label and double-blind periods)

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo capsule once per day (double-blind period)
Study: NCT02989064

Intervention type: GENETIC
Group type: EXPERIMENTAL
Intervention: Autologous genetically modified MAGE A10ᶜ⁷⁹⁶T cells
Description: Infusion of autologous genetically modified MAGE A10ᶜ⁷⁹⁶T on Day 1
Study: NCT03448250

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Optimune
Description: Optimune is a web-based psychological intervention developed for women with breast cancer.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Care-As-Usual
Description: Participants are free to continue to engage with any treatment they require (i.e., CAU).
Study: NCT00827021

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Erythropoiesis Stimulating Agents (ESAs): epoetin alfa, beta or any other epoetin in equivalent dose.
Description: 4000 IU/week I.V. Until the end of the trial

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Erythropoiesis Stimulating Agents (ESAs): epoetin alfa, beta or any other epoetin in equivalent dose.
Description: 18000 IU/week I.V. Until the end of the trial
Study: NCT01187953

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Prograf (tacrolimus)
Description: Administered per current product labeling

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: LCP-Tacro
Description: Tacrolimus, once-per-day The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels.
Study: NCT02572752

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Nintedanib
Description: 1 soft gelatine capsule, single dose, oral

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Nintedanib
Description: Nintedanib, 2 soft gelatine capsules, single dose, oral

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Nintedanib
Study: NCT03143140

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: PAFA
Description: percutaneous ablation of tumor feeding artery

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: tumor ablation
Description: ablation of tumor area directly

Intervention type: OTHER
Group type: OTHER
Intervention: tumor ablation
Description: ablation of tumor area directly
Study: NCT02302482

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: The Lawton Instrumental Activities of Daily Living score (IADL), and the disability assessment of dementia score (DAD-6
Study: NCT04676997

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Camrelizumab
Description: 200mg on days1,15 of Cycles 1-4 (Q2W); IV infusion. 200mg on day 1 of Cycles 5-8 (Q2W); IV infusion.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Nab paclitaxel
Description: 125 mg/m² on day 1, 8 and 15 of Cycles 1-4 (QW 3/4); IV infusion.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Epirubicin
Description: 90 mg/m² on day 1 of Cycles 5-8 (Q2W); IV infusion.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclophosphamide
Description: 600 mg/m² on day 1 of Cycles 5-8 (Q2W); IV infusion.