TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02020330

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Artemether-lumefantrine 3 days
Description: One tablet contains 20mg artemether and 120mg lumefantrine. The standard regimen is twice daily for 3 days with a delay of at least 8 hours between the first and second dose. It is dosed by weight categories. One gram of fish oil will be given to half of the participants in the 3 days arm.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Artemether-lumefantrine 5 days
Description: One tablet contains 20mg artemether and 120mg lumefantrine. The experiment regimen is twice daily for 5 days with a delay of at least 8 hours between the first and second dose. It is dosed by weight categories. One gram of fish oil will be given to half of the participants in the 5 days arm.
Study: NCT02408315

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: misoprostol/placebo
Description: buccal or vaginal routes of administration/ placebo to compare methods for efficacy and safety during induction.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: misoprostol/placebo
Description: buccal or vaginal routes of administration/ placebo to compare methods for efficacy and safety during induction.
Study: NCT04119882

Intervention type: DIAGNOSTIC_TEST
Intervention: Blood collection
Description: New biomarker test

Intervention type: DIAGNOSTIC_TEST
Intervention: Blood collection
Description: New biomarker test
Study: NCT03749070

Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: Silymarin
Description: It is a randomized, double-blind, controlled clinical trial to be performed at outpatient level. The intervention will last 12 weeks and the invited participants will be patients attended at the outpatient clinic of the Edgard Santos Hospital, which will be randomized into two groups: control and intervention. Data on laboratory and clinical markers, imaging, nutritional and dietary assessment will be collected at the beginning and end of the trial for comparison purposes.

Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: Silymarin
Description: It is a randomized, double-blind, controlled clinical trial to be performed at outpatient level. The intervention will last 12 weeks and the invited participants will be patients attended at the outpatient clinic of the Edgard Santos Hospital, which will be randomized into two groups: control and intervention. Data on laboratory and clinical markers, imaging, nutritional and dietary assessment will be collected at the beginning and end of the trial for comparison purposes.
Study: NCT01421108

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Framing (Gain-framed messages)
Description: The adolescents will randomly assign to three groups: gain-framed message and loss- framed message. Each group of adolescents will read the respective pamphlets with the exception of the control group. The gain-framed pamphlet contains six positive messages with three related full-color images(6.1 X 4.5). The gain-framed pamphlet, entitled The Benefits of good oral hygiene, emphasizes the benefits of brushing, and flossing.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Framing (Loss-framed messages)
Description: The adolescents will randomly assign to three groups: gain-framed message , loss- framed message and a control group. Each group of adolescents will read the respective pamphlets with the exception of the control group.~The loss-framed pamphlet contains six negative messages with three related full-color images (6.1 X 4.5). The loss-framed pamphlet, entitled The disadvantages of poor oral hygiene, emphasizes the costs of not brushing and flossing.
Study: NCT01053416

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Yag laser iridotomy
Description: the procedure will be performed by using a Yag laser. Single spot, 1 mJ power, beam aimed to an existing iris crypt
Study: NCT01428544

Intervention type: DRUG
Intervention: Fondaparinux sodium
Description: For patients whose body weight is 100 kg or more, fondaparinux is injected 10 mg subcutaneously once daily for treatment of acute pulmonary thromboembolism or acute deep venous thrombosis.
Study: NCT00888368

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Transpatellar Approach
Description: The transpateller approach for the injection of the dye will be used.
Study: NCT03011528

Intervention type: RADIATION
Group type: OTHER
Intervention: Local treatment by radiotherapy
Description: Radiotherapy of whole site of the primary tumour and metastatic sites (outside pulmonary sites) can take place before or after the high dose consolidation chemotherapy
Study: NCT01662986

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: tiotropium bromide
Description: 18 mcg once a day (QD)

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Once a day (QD)
Study: NCT02515851

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Exparel
Study: NCT00888368

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Suprapatellar
Description: The suprapatellar approach will be used for the injection of the dye.
Study: NCT03907358

Intervention type: PROCEDURE
Intervention: phacoemulsification

Intervention type: PROCEDURE
Intervention: phacoemulsification
Study: NCT02596308

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Plague vaccine
Description: Plague vaccine is comrised by native fraction 1 capsule (F1) and recombine virulence-associated (V) antigens.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Plague vaccine
Description: Plague vaccine is comrised by native fraction 1 capsule (F1) and recombine virulence-associated (V) antigens.
Study: NCT04943094

Intervention type: OTHER
Intervention: Urodynamic examination
Description: A urodynamic examination is performed in all patients four to six weeks following TURBT and repeated six months later in order to obtain bladder function and possible changes.

Intervention type: OTHER
Intervention: Urodynamic examination
Description: A urodynamic examination is performed in all patients four to six weeks following TURBT and repeated six months later in order to obtain bladder function and possible changes.

Intervention type: OTHER
Intervention: Urodynamic examination
Description: A urodynamic examination is performed in all patients four to six weeks following TURBT and repeated six months later in order to obtain bladder function and possible changes.
Study: NCT00673465

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: SCH 497079
Description: SCH 497079 100 mg capsule, administered orally, once daily for 4 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: SCH 497079
Description: SCH 497079 100 mg capsule, administered orally, once daily for 4 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: SCH 497079
Description: SCH 497079 100 mg capsule, administered orally, once daily for 4 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: SCH 497079
Description: SCH 497079 100 mg capsule, administered orally, once daily for 4 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: SCH 497079
Description: SCH 497079 100 mg capsule, administered orally, once daily for 4 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: SCH 497079
Description: SCH 497079 100 mg capsule, administered orally, once daily for 4 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: Placebo capsules matching SCH 497079, administered orally, once daily for 4 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: Placebo capsules matching SCH 497079, administered orally, once daily for 4 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: Placebo capsules matching SCH 497079, administered orally, once daily for 4 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: Placebo capsules matching SCH 497079, administered orally, once daily for 4 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: Placebo capsules matching SCH 497079, administered orally, once daily for 4 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: Placebo capsules matching SCH 497079, administered orally, once daily for 4 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Metformin
Description: Metformin extended release 750 mg, 2 tablets administered orally, once daily for 4 weeks (1500 mg total daily dose)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Metformin
Description: Metformin extended release 750 mg, 2 tablets administered orally, once daily for 4 weeks (1500 mg total daily dose)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Metformin
Description: Metformin extended release 750 mg, 2 tablets administered orally, once daily for 4 weeks (1500 mg total daily dose)
Study: NCT02515851

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Study: NCT02516891

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Drug-Eluting Stents implantation in bifurcation lesions
Study: NCT01614366

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: AM 5 + DM 0
Description: Amlodipine 5 mg + DMTA07 0mg, once daily

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AM 5 + DM 0
Description: Amlodipine 5 mg + DMTA07 0mg, once daily

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AM 5 + DM 0
Description: Amlodipine 5 mg + DMTA07 0mg, once daily

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AM 5 + DM 0
Description: Amlodipine 5 mg + DMTA07 0mg, once daily

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AM 5 + DM 2.5
Description: Amlodipine 5 mg + DMTA07 2.5mg, once daily

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AM 5 + DM 2.5
Description: Amlodipine 5 mg + DMTA07 2.5mg, once daily

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AM 5 + DM 2.5
Description: Amlodipine 5 mg + DMTA07 2.5mg, once daily

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AM 5 + DM 7.5
Description: Amlodipine 5 mg + DMTA07 7.5mg, once daily

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AM 5 + DM 7.5
Description: Amlodipine 5 mg + DMTA07 7.5mg, once daily

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AM 5 + DM 30
Description: Amlodipine 5 mg + DMTA07 30mg, once daily
Study: NCT03908866

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: PICC(Peripherally inserted central catheter)
Description: The peripherally inserted central catheter with different sizes (French scale). Trained vascular access nurses will perform the insertion of the PICC, guided by ultrasound at bedside using the Seldinger technique. A suitable sterile field will be established.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: CVC(Central venous catheter )
Description: The central venous catheter with different sizes (French scale). Trained doctors will perform the insertion of the CVC, using the Seldinger technique. A suitable sterile field will be established.
Study: NCT02980263

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Canakinumab
Study: NCT01935674

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Switch ritonavir-boosted PI
Description: Switch their existing ritonavir-boosted PI to another potent ART drug with lesser effects on serum cholesterol selected by the investigator.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Continue Ritonavir-boosted PI+Rosuvastatin
Description: Continue ritonavir-boosted PI-based ART and commence rosuvastatin 10 mg daily (5 mg daily in Asian participants).
Study: NCT03160066

Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: Lactobacillus Rhamnosus (JB-1)
Description: Lactobacillus Rhamnosus (JB-1) capsule

Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo
Study: NCT03710291

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: TRC101
Description: Oral, non-absorbed, polymeric hydrochloric acid binder

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo comparator
Study: NCT04323917

Intervention type: DIAGNOSTIC_TEST
Intervention: Liquid biopsy
Description: Detection and quantification of EMT-transcription factor mRNA levels in blood

Intervention type: DIAGNOSTIC_TEST
Intervention: Liquid biopsy
Description: Detection and quantification of EMT-transcription factor mRNA levels in blood
Study: NCT00673465

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Metformin
Description: Metformin extended release 750 mg, 2 tablets administered orally, once daily for 4 weeks (1500 mg total daily dose)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Metformin
Description: Metformin extended release 750 mg, 2 tablets administered orally, once daily for 4 weeks (1500 mg total daily dose)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Metformin
Description: Metformin extended release 750 mg, 2 tablets administered orally, once daily for 4 weeks (1500 mg total daily dose)
Study: NCT04247828

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Experimental AAC
Description: Participant receives an AAC system comprising a single hybrid wearable sensor for head-mediated cursor control that is integrated with an adaptive and individualized keyboard to test communication performance.

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Generic AAC
Description: Participant receives an AAC system comprising a single hybrid wearable sensor for head-mediated cursor control that is integrated with a generic QWERTY keyboard to test communication performance.
Study: NCT04555811

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: FT596
Description: FT596 is given 2-3 days after rituximab; however, it may be delayed for up to 7 days until all rituximab infusion related toxicities resolve to ≤Grade 1.
Study: NCT02905552

Intervention type: OTHER
Intervention: No intervention

Intervention type: OTHER
Intervention: No intervention
Study: NCT03568994

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Atovaquone
Description: Patients will receive standard of care MRC based Induction chemotherapy (such as ADE 10+3+5 with daily atovaquone dosing starting on day 6. In order to accommodate potential drug shortages modifications to ADE 10+3+5 that retain the MRC based induction backbone regimen of DA are allowed (see second Arm). These include but are not limited to substitution of etopophos for etoposide, exclusion of etoposide, use of CPX-351 (VYXEOS (daunorubicin and cytarabine) liposome) only, and daunorubicin and cytarabine (DA) + gemtuzumab ozogamicin (GO).~Patients will be monitored for adherence to and tolerance of daily dosing of atovaquone. Peripheral blood (PB) and bone marrow plasma samples will be obtained to measure atovaquone concentrations.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Atovaquone
Description: Patients will receive standard of care MRC based Induction chemotherapy (such as ADE 10+3+5 with daily atovaquone dosing starting on day 6. In order to accommodate potential drug shortages modifications to ADE 10+3+5 that retain the MRC based induction backbone regimen of DA are allowed (see second Arm). These include but are not limited to substitution of etopophos for etoposide, exclusion of etoposide, use of CPX-351 (VYXEOS (daunorubicin and cytarabine) liposome) only, and daunorubicin and cytarabine (DA) + gemtuzumab ozogamicin (GO).~Patients will be monitored for adherence to and tolerance of daily dosing of atovaquone. Peripheral blood (PB) and bone marrow plasma samples will be obtained to measure atovaquone concentrations.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cytarabine
Description: As part of routine Induction 1 chemotherapy (ADE 10+3+5)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cytarabine
Description: As part of routine Induction 1 chemotherapy (ADE 10+3+5)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Daunorubicin
Description: As part of routine Induction 1 chemotherapy (ADE 10+3+5)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Daunorubicin
Description: As part of routine Induction 1 chemotherapy (ADE 10+3+5)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Etoposide
Description: As part of routine Induction 1 chemotherapy (ADE 10+3+5)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Gemtuzumab Ozogamicin
Description: As part of routine Induction 1 chemotherapy(DA 3+10 + GO)
Study: NCT04555811

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: FT596
Description: FT596 is given 2-3 days after rituximab; however, it may be delayed for up to 7 days until all rituximab infusion related toxicities resolve to ≤Grade 1.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: FT596
Description: FT596 is given 2-3 days after rituximab; however, it may be delayed for up to 7 days until all rituximab infusion related toxicities resolve to ≤Grade 1.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Rituximab
Description: Rituximab 375 mg/m\^2 is administered as an IV infusion per institutional standard of care and package insert on 2-3 days (48 to 72 hours) prior to the FT596 infusion

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Rituximab
Description: Rituximab 375 mg/m\^2 is administered as an IV infusion per institutional standard of care and package insert on 2-3 days (48 to 72 hours) prior to the FT596 infusion

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Rituximab
Description: Rituximab 375 mg/m\^2 is administered as an IV infusion per institutional standard of care and package insert on 2-3 days (48 to 72 hours) prior to the FT596 infusion
Study: NCT01782612

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Multimodal analgesic techniques
Description: Postoperative pain was controlled for all patients routinely by intravenous sulfentanil patient-controlled analgesia (PICA) in combination with Parecoxib(40 mg, every 12 h). PICA was continued with sulfentanil (1.25 µg.h-1) and 1.25 µg sulfentanil bolus with a 8-min lockout time. Oral oxycodone 0.2 mg was administered necessarily.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Multimodal analgesic techniques
Description: Postoperative pain was controlled for all patients routinely by intravenous sulfentanil patient-controlled analgesia (PICA) in combination with Parecoxib(40 mg, every 12 h). PICA was continued with sulfentanil (1.25 µg.h-1) and 1.25 µg sulfentanil bolus with a 8-min lockout time. Oral oxycodone 0.2 mg was administered necessarily.
Study: NCT01885026

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: eScreen
Description: Access to the eScreen platform offering assessment of alcohol and drug use, with automated feedback on problematic or non-problematic use. Follow-up over time based on user needs.
Study: NCT01782612

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Total uni-Hip Replacement
Description: All subjects will undergo standard Total uni-Hip Replacement

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Total uni-Hip Replacement
Description: All subjects will undergo standard Total uni-Hip Replacement
Study: NCT01885026

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Assessment only of alcohol and drug use.
Description: Assessment of alcohol and drug use at baseline and follow-up.
Study: NCT04456803

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ferric citrate tablet
Description: 250mg/tablet, manufactured by Sinomune Pharmaceutical

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Sevelamer carbonate tablet
Description: 800 mg/tablet, manufactured by Genzyme Ireland Limited
Study: NCT01910649

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Drisapersen
Description: Subcutaneous and Intravenous
Study: NCT04804111

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: arm 0
Description: placebo group

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: arm 1
Description: 3 mg of the URC102 group

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: arm 2
Description: 6 mg of the URC102 group

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: arm 3
Description: 9 mg of the URC102 group

Intervention type: DRUG
Group type: OTHER
Intervention: arm 4
Description: Febuxostat 80 mg
Study: NCT03640728

Intervention type: DRUG
Intervention: Tenofovir Alafenamide
Description: Tenofovir alafenamide 25 mg/day orally

Intervention type: DRUG
Intervention: Entecavir
Description: Entecavir 0.5 mg/day orally

Intervention type: DRUG
Intervention: Tenofovir disoproxil fumarate
Description: Tenofovir Disoproxil Fumarate 300 mg/day orally
Study: NCT01885026

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Internet-based treatment for depression or anxiety
Description: Internet-based treatment for primary diagnoses of depression, panic anxiety or social phobia.
Study: NCT03862586

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: N-acetyl cysteine

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebos
Study: NCT03198728

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: SOV2012-F1
Description: oral preparation of testosterone undecanoate (TU)

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: AndroGel
Description: topical testosterone gel 1.62%
Study: NCT01481428

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Computer-facilitated HIV intervention
Description: Individuals assigned to the experimental condition will complete the self-directed CARE HIV intervention during each of their first three sessions. The 20 minute intervention sessions involve several components including a brief risk assessment, review of identified risks, structured skill building videos, and the development of a risk prevention action plan. Because of the adaptive nature of the CARE program, the content of each session will be tailored to address the current risks of the participant. While the main focus of the intervention is on risk, individuals who report being HIV infected will receive a referral to treatment if they are not currently receiving medical care and their session will address, among other things, adherence to HIV care.

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Attention Control
Description: Life skills training DVDs that match the duration of the anticipated experimental condition. The DVDs address topics such as positive listening skills, anger management, and stress reduction.
Study: NCT00960635

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: 1,25-dihydroxy-vitamin D3 (calcitriol)

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: placebo
Description: pill without agent
Study: NCT03250819

Intervention type: OTHER
Intervention: SNP analysis
Description: The collected blood samples will be used to investigate the occurrence of SNPs (single nucleotide polymorphisms) in both study groups

Intervention type: OTHER
Intervention: SNP analysis
Description: The collected blood samples will be used to investigate the occurrence of SNPs (single nucleotide polymorphisms) in both study groups
Study: NCT00684463

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Palonosetron
Description: 0.25 mg IV single dose, 30 minutes prior to the administration of the major chemotherapeutic agent.