PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT00510497: Autologous Dendritic Cell Vaccine in HIV1 Infection
Official title: Phase I/II Evaluation of Therapeutic Immunization With Autologous Dendritic Cells Pulsed With Autologous, Inactivated HIV-1 Infected, Apoptotic Cells
Conditions: HIV Infections
Summary: This study aims to look at the safety and tolerability of immunization with dendritic cell vaccine prepared using the patient's own cells and virus. It also aims to explore the virologic efficacy of the vaccine as determined by a decrease in the viral load 12 weeks after analytic treatment interruption.
Interventions:
description: Autologous dendritic cells pulsed with autologous, inactivated HIV-1 infected, apoptotic cells given subcutaneously 3 times every other week plus a booster dose 2 weeks after start of treatment interruption
name: Autologous HIV-1 ApB DC Vaccine
type: Biological
Study arms:
design_group_description: Subjects who will receive ApB Dendritic cell vaccine
design_group_title: Autologous HIV-1 ApB DC Vaccine
design_group_type: Experimental
Sponsor: University of Pittsburgh
Collaborators: National Institute of Allergy & Infectious Diseases
Drug name mappings:
name: Dendritic Cell Vaccine(Baylor Research Institute)
lang: EN
Clinical trial NCT00358319: Phase I/II Trial of Valproic Acid and Karenitecin for Melanoma
Official title: Phase I/II Trial of Valproic Acid and Karenitecin for Metastatic Malignant Melanoma
Conditions: Malignant Melanoma
Summary: This is a Phase I study looking at the combination of Valproic Acid (VPA) and Karenitecin to treat patients with metastatic malignant melanoma. We will find the dose-limiting toxicity (DLT) and the highest dose (maximum tolerated dose) of this combination treatment that has acceptable side effects and recommend a Phase II dose level.
There will be seven escalating doses of Valproic acid and one dose escalation step of Karenitecin. Each patient shall receive one cycle of Karenitecin alone (cycle 1 days 1 - 5) followed by the same dose of Karenitecin given in combination with VPA (cycle 2 days 1-7). Patients will receive oral VPA in divided doses for 5 days and Karenitecin starting on the 3rd day every 3 weeks (a treatment cycle).
Treatment will continue until progression of disease or an unacceptable level of toxicity. After 2 cycles of treatment there will be the first efficacy evaluation or restaging of the disease. In the absence of disease progression and if there is continued safety and tolerability, treatment may continue.
Interventions:
name: Karenitecin
type: Drug
name: Valproic Acid
other_name: VPA
type: Drug
Study arms:
design_group_description: Dose escalation phase
design_group_title: Phase I
design_group_type: Experimental
design_group_description: All patients enrolled in the Phase II will be treated with Valproic Acid (VPA) and Karenitecin using the dosing schedule determined to be the Maximum Tolerated Dose (MTD) in Phase I.
design_group_title: Phase II
design_group_type: Experimental
Sponsor: H. Lee Moffitt Cancer Center & Research Institute, Inc.
Collaborators: BioNumerik Pharmaceuticals, Inc.
Drug name mappings:
name: 可司替康
lang: CN
name: Cositecan
lang: EN
name: 丙戊酸
lang: CN
name: Valproic Acid
lang: EN
Clinical trial NCT06284486: A Multi-Site Break Through Cancer Trial: Phase II Study Investigating Dual Inhibition of BCL2 and Menin in AML MRD Using the Combination of Venetoclax and Revumenib
Official title: A Multi-Site Break Through Cancer Trial: Phase II Study Investigating Dual Inhibition of BCL2 and Menin in AML MRD Using the Combination of Venetoclax and Revumenib
Conditions: Acute Myeloid Leukemia
Summary: To learn if the combination of venetoclax and revumenib can help to control MRD-positive AML.
Interventions:
description: Given by PO
name: Venetoclax
other_name: ABT-199
GDC-0199
type: Drug
description: Given by PO
name: Revumenib
other_name: SNDX-5613
type: Drug
Study arms:
design_group_description: Participants may receive the combination of venetoclax and revumenib for up to 1 year, and then 1 more year of venetoclax alone. You will no longer be able to take the study drug(s) if the disease gets worse or if intolerable side effects occur. Participants will take venetoclax by mouth on 1 time a day at about the same time each day, on Days 1-14 of each cycle. Take each dose with about 1 cup of water within 30 minutes after a meal, preferably breakfast.
design_group_title: Venetoclax + Revumenib
design_group_type: Experimental
Sponsor: The University of Texas MD Anderson Cancer Center
Collaborators: Syndax Pharmaceuticals, Inc.
AbbVie, Inc.
Drug name mappings:
name: 维奈克拉
lang: CN
name: Venetoclax
lang: EN
name: ベネトクラクス
lang: JP
name: 瑞维美尼
lang: CN
name: Revumenib
lang: EN
Clinical trial NCT01098357: Comparative Study of 3 Dose Regimens of BioChaperone to Becaplermin Gel for the Treatment of Diabetic Foot Ulcer
Official title: A Phase I/II, Multicentre, Randomised, Controlled, and Open-label Trial Comparing the Efficacy and Safety of Three Dose Regimens of BioChaperone PDGF-BB to Becaplermin Gel for the Treatment of Diabetic Foot Ulcer
Conditions: Diabetic Foot Ulcers
Summary: This is an open-label, active-control, multicentre, parallel group, randomised and dose-finding efficacy and safety study.
Compare the efficacy and safety of BioChaperone PDGF-BB applied at 12.5 µg/cm² every two days for up to 20 weeks to becaplermin gel (Regranex® Gel 0.01%) applied daily for up to 20 weeks for the treatment of neuropathic diabetic foot ulcer.
Assess the effect of a double dose of BioChaperone PDGF-BB (25 µg/cm²) applied every two days for up to 20 weeks.
Interventions:
description: BioChaperone PDGF-BB low dose is applied as a spray every two days at the dose of 12.5 µg/cm2 for up to 20 weeks
name: Biochaperone PDGF-BB Low dose
other_name: BC low dose
type: Drug
description: BioChaperone PDGF-BB high dose is applied as a spray every two days at the dose of 25 µg/cm2 for up to 20 weeks
name: Biochaperone PDGF-BB High dose
other_name: BC high dose
type: Drug
description: Regranex gel is applied once daily at the dose of 6.25 µg/cm2 for up to 20 weeks
name: Regranex
other_name: Becaplermin
type: Drug
description: BioChaperone PDGF-BB Very Low Dose sprayed on the wound every two days (e.g., Mondays, Wednesdays and Fridays) for 20 weeks or until complete wound healing, at the dose of 4 µg/cm²/application
name: Biochaperone PDGF-BB Very Low Dose
other_name: BC Very low dose
type: Drug
Study arms:
design_group_description: BioChaperone PDGF-BB is a new formulation of the B isoform dimer of recombinant human Platelet-Derived Growth Factor (rhPDGF-BB) containing the new excipient Biochaperone, a dextran modified polymer. The finished product is a sterile multi-dose spray vial.
design_group_title: Biochaperone PDGF-BB low dose
design_group_type: Experimental
design_group_description: BioChaperone PDGF-BB is a new formulation of the B isoform dimer of recombinant human Platelet-Derived Growth Factor (rhPDGF-BB) containing the new excipient Biochaperone, a dextran modified polymer. The finished product is a sterile multi-dose spray vial.
design_group_title: Biochaperone PDGF-BB High dose
design_group_type: Experimental
design_group_description: Becaplermin gel (Regranex® Gel 0.01%, Systagenix, formerly and Johnson & Johnson) is a topical gel of rhPDGF-BB conditioned in a gel tube.
design_group_title: Regranex
design_group_type: Active Comparator
design_group_description: BioChaperone PDGF-BB Very Low Dose sprayed on the wound every two days (e.g., Mondays, Wednesdays and Fridays) for 20 weeks or until complete wound healing, at the dose of 4 µg/cm²/application
design_group_title: Very Low Dose BioChaperone PDGF-BB
design_group_type: Experimental
Sponsor: Virchow Group
Collaborators: Adocia SA
Drug name mappings:
name: 贝卡普勒明生物类似药(Adocia)
lang: CN
name: Becaplermin biosimilar(Adocia)
lang: EN
Clinical trial NCT05230810: Clinical Trial of Alpelisb and Tucatinib in Patients With PIK3CA-Mutant HER2+ Metastatic Breast Cancer.
Official title: This is a Multicenter, Single Arm, Open-label, run-in Phase Ib / Roll-over Phase II Study of Tucatinib in Combination With Alpelisib in Subjects With PIK3CA-mutant HER2-positive Locally Advanced Unresectable or Metastatic Breast Cancer.
Conditions: HER2-positive Metastatic Breast Cancer
Summary: Phase IB/II clinical trial of Alpelisb and Tucatinib in patients with PIK3CA-Mutant HER2-positive metastatic breast cancer.
Interventions:
description: Orally twice a day
name: Alpelisib
other_name: Piqray
type: Drug
description: Orally once a day
name: Tucatinib
other_name: Tukysa
type: Drug
description: 500 mg intramuscularly into the buttocks slowly<br/>*Fulvestrant will be administered only in patients with HR+/HER2+ metastatic breast cancer
name: Fulvestrant
other_name: Faslodex,
type: Drug
Study arms:
design_group_description: In phase Ib, the tolerability of tucatinib and alpelisib combination will be confirmed and maximum tolerated dose determined. Therapy will be administered in 28 day cycles of tucatinib 300 mg PO BID and alpelisib 250 mg PO daily (dose level 1). Treatment will continue until unacceptable toxicity, disease progression, withdrawal of consent, or study closure. Fulvestrant will also be administered in patients with HR+/HER2+ metastatic breast cancer. Once RP2D is determined, the study will be continued to phase II, and new patients will enroll at RP2D. All patients in phase IB part, who are remaining on study at the time of initiation of phase II, will be rolled over to phase II. At that time, their study drug doses will be modified as follows: (1) if a patient is on the drug doses lower than RP2D, doses will not be increased; (2) if a patient is on a higher doses compared to RP2D, doses of study drugs will be changed to RP2D.
design_group_title: Ib Safety Cohort /II Expansion Cohort
design_group_type: Experimental
Sponsor: CRITERIUM, Inc.
Collaborators: Novartis AG
Seagen, Inc.
Drug name mappings:
name: 氟维司群
lang: CN
name: Fulvestrant
lang: EN
name: フルベストラント
lang: JP
name: 阿培利司
lang: CN
name: Alpelisib
lang: EN
name: 妥卡替尼
lang: CN
name: Tucatinib
lang: EN
name: ツカチニブ エタノール付加物
lang: JP
Clinical trial NCT00237627: Doxorubicin Hydrochloride Liposome and Bortezomib in Treating Patients With Refractory Hematologic Cancer or Malignant Solid Tumor or Metastatic Breast Cancer
Official title: A Phase I Evaluation of the Combination of Pegylated Liposomal Doxorubicin (Doxil®) With PS-341 in Patients With Refractory Hematologic and Solid Malignancies
Conditions: Breast Cancer
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Ovarian Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Summary: RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving doxorubicin hydrochloride liposome together with bortezomib may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of bortezomib when given together with doxorubicin hydrochloride liposome and to see how well they work in treating patients with refractory hematologic cancer or malignant solid tumor or metastatic breast cancer.
Interventions:
description: PS-341 will be administered as an intravenous push into a side arm of either a peripheral or central intravenous line infusing normal saline at 100 ml/hr. Patients will be treated twice weekly for two weeks, followed by a one week rest period, such that the typical days of treatment will be days 1, 4, 8, 11 of each three-week cycle. The initial dose level for PS-341 will be 0.9 mg/m2/dose intravenously, while subsequent dose levels will be determined according to a modified Fibonacci schema
name: PS-341
type: Drug
description: Doxil will be administered at a dose of 30 mg/m2 as a 1 hour infusion through either a peripheral or central intravenous line every 3 weeks (on day 4 of each 21 day cycle)
name: Doxil
other_name: pegylated liposomal doxorubicin
type: Drug
description: Velcade will be adminstered intravenously at 1.3 mg/m2 days 1, 4, 8, 11 every 3 weeks
name: Velcade
other_name: Bortezomib
type: Drug
Study arms:
design_group_description: Doxil + PS-341
design_group_title: Part 1
design_group_type: Experimental
design_group_description: Doxil + Velcade
design_group_title: Part 2
design_group_type: Experimental
Sponsor: Lineberger Comprehensive Cancer Center
Collaborators: National Cancer Institute
Drug name mappings:
name: 盐酸多柔比星脂质体
lang: CN
name: Doxorubicin Hydrochloride liposomal
lang: EN
name: 硼替佐米
lang: CN
name: Bortezomib
lang: EN
name: ボルテゾミブ
lang: JP
Clinical trial NCT00352235: Phase I/II Trial of KRN7000 in Patients With Chronic Hepatitis C Infection
Official title: Phase I/II Trial of KRN7000 in Patients With Chronic Hepatitis C Infection
Conditions: Chronic Hepatitis C
Summary: Phase I/II trial of KRN7000 in patients with chronic hepatitis C.
Study objectives: To evaluate and compare the safety and tolerability of 3 ascending doses of a-GalCer.
The primary efficacy parameter: HCV-RNA response at the end of treatment. Secondary efficacy parameter: Serum ALT response. Further objectives of the study are to evaluate the effect of a-GalCer on serum cytokines IFNg and TNFa and on iNKT cells.
Number of dose levels: 3 Investigational product: KRN7000 Route of administration: intravenous Dosages and frequency: 0.1, 1, 10 mcg/kg, monthly injection, 3 times (day 0, day 28 and day 56)
Interventions:
name: KRN7000
type: Drug
Study arms:
Sponsor: Foundation for Liver Research
Collaborators: Kyowa Kirin Co., Ltd.
Drug name mappings:
name: KRN-7000 liposomal
lang: EN
Clinical trial NCT02851472: Prevention of Transfusion Related Acute Gut Injury (TRAGI) in Extremely Low Gestational Age Neonates (ELGANs) Using iNO
Official title: Prevention of Transfusion Related Acute Gut Injury (TRAGI) in Extremely Low Gestational Age Neonates (ELGAN) Neonates Using iNO
Conditions: Anemia
Summary: The investigators seek to determine whether providing inhaled nitric oxide (iNO; a vasodilator) will improve the delivery of oxygen to the brain, kidney and intestines of preterm neonates during and after the subject receives a packed red blood cell transfusion (PRBC) for anemia vs. baseline period. The investigators will observe the effect of inhaled nitric oxide vs. placebo at these body sites to determine whether iNO will alter the fractional tissue oxygen extraction. Treatment and control groups will be compared to each other at equivalent epochs as will individual patients before, during and after the PRBC transfusion.
Interventions:
description: Nitric oxide gas will be added to the inhaled gas mixture that the patient was already receiving at baseline, using standard of care gas delivery systems adapted specifically for this study.
name: Inhaled Nitric Oxide
other_name: iNO
type: Drug
description: Placebo gas (nitrogen) will be added to the inhaled gas mixture that the patient was already receiving at baseline, using standard of care gas delivery systems specifically adapted for this study.
name: Placebo
other_name: Control
type: Drug
Study arms:
design_group_description: iNO will be given at 20 ppm, continuous, via inhalation before (1 hour), during (3 hours) and after (2 hours) elective blood transfusion and NIRS monitoring
design_group_title: Inhaled Nitric Oxide
design_group_type: Experimental
design_group_description: Placebo gas (nitrogen) will be given continuous, via inhalation at the same ppm, before (1 hour), during (3 hours) and after (2 hours) elective blood transfusion and NIRS monitoring
design_group_title: Placebo
design_group_type: Active Comparator
Sponsor: New York Medical College
Collaborators: Stony Brook University
East Carolina University
New York University
Baystate Medical Center
Drug name mappings:
name: 一酸化窒素
lang: CN
name: Nitric oxide (inhaled)
lang: EN
Clinical trial NCT03750071: VXM01 Plus Avelumab Combination Study in Progressive Glioblastoma
Official title: An Open-label, Phase I/II Multicenter Clinical Trial of VXM01 in Combination With Avelumab in Patients With Progressive Glioblastoma Following Standard Treatment, With or Without Second Surgery
Conditions: Recurrent Glioblastoma
Summary: VXM01 in combination with avelumab in n=30 patients with progressive glioblastoma following standard treatment, with or without second surgery
Interventions:
description: Ty21a transformed with a eukaryotic VEGFR-2 Expression Plasmid
name: VXM01
other_name: Investigational VEGFR-2 DNA Vaccine
type: Biological
description: Monoclonal anti-PD-L1 Antibody
name: Avelumab
other_name: Bavencio
type: Biological
Study arms:
design_group_description: Combination of VXM01, Ty21a transformed with a eukaryotic expression cassette encoding VEGFR-2, and anti-PD-L1 Checkpoint Inhibitor Avelumab
design_group_title: VXM01/Avelumab
design_group_type: Experimental
Sponsor: Vaximm AG
Collaborators: Pfizer Inc.
Merck KGaA
Drug name mappings:
name: 阿维单抗
lang: CN
name: Avelumab
lang: EN
name: アベルマブ（遺伝子組換え）
lang: JP
name: VXM-01
lang: EN
Clinical trial NCT04216849: Clinical Study of Umbilical Cord Mesenchymal Stem Cells in the Treatment of Type 2 Diabetic Nephropathy
Official title: Clinical Study of Umbilical Cord Mesenchymal Stem Cells in the Treatment of Type 2 Diabetic Nephropathy
Conditions: Type 2 Diabetes With Renal Manifestations
Summary: The study was a 48-week multicenter, randomized, double-blind, placebo-controlled trial that included 8 weeks of pre-screening and lifestyle education, 32 weeks of treatment, and 16 weeks of follow-up.To observe the efficacy and safety of umbilical cord mesenchymal stem cell infusion in Chinese patients with type 2 diabetic nephropathy who received traditional hypoglycemic therapy.
Interventions:
description: human umbilical cord mesenchymal stem cells were peripheral intravenous infused to experimental group
name: human umbilical cord mesenchymal stem cells
type: Biological
description: Saline solution containing human serum albumin will be infused to the control group
name: saline
type: Other
Study arms:
design_group_description: The volunteers of the experimental group will be given peripheral intravenously a dose of 1.5*10^6/kg human umbilical cord mesenchymal stem cells at 0,8,16,24,32 week.
design_group_title: experimental group
design_group_type: Experimental
design_group_description: The control group will be given the same dose of saline containing human albumin.
design_group_title: control group
design_group_type: Placebo Comparator
Sponsor: Shanghai East Hospital
Collaborators: Chinese People's Liberation Army General Hospital
Drug name mappings:
name: Umbilical Cord Mesenchymal Stem Cells(Shanghai East Hospital)
lang: EN
Clinical trial NCT01935635: A Clinical Trial on HB-Vac Activated-DCs Combined With Peg-IFN or NAs in CHB
Official title: A Clinical Trial on Hepatitis B Vaccine Activated-DCs Combined With Peg-interferon or Nucleotide Analogs in Chronic Hepatitis B
Conditions: Chronic Hepatitis B
Summary: The purpose of this study is to investigate whether HB-Vac Activated-DCs Combined With Peg-IFN or NAs has more efficacy than Peg-IFN or NAs alone in the treatment of chronic hepatitis B patients
Interventions:
description: HPDCs-T immune therapy:one time every 2 weeks during 12 weeks to 36 weeks, IV (in the vein), about 2*105-1*106 cells per time,total 12 times;
name: HPDCs-T immune therapy
other_name: HBsAg Pulse DCs-T
The HBsAg sensitized dendritic cells activated T cells
type: Biological
Study arms:
design_group_description: HPDCs-T immune therapy:one time every 2 weeks during 12 weeks to 36 weeks, about 2*105-1*106 cells per time,total 12 times; IFN therapy (Peg-IFN α-2b/2a):one time every 1 week according to the standards for 48 weeks
design_group_title: HPDCs-T immune therapy combined with IFN
design_group_type: Experimental
design_group_description: HPDCs-T immune therapy:one time every 2 weeks during 12 weeks to 36 weeks, about 2*105-1*106 cells per time,total 12 times; Entecavir(ETV)therapy:0.5mg per day according guidelines for the treatment of chronic hepatitis B in the Asia Pacific Region
design_group_title: HPDCs-T immune therapy combined with ETV
design_group_type: Experimental
design_group_description: HPDCs-T immune therapy:one time every 2 weeks during 12 weeks to 36 weeks, about 2*105-1*106 cells per time,total 12 times; Telbivudine(LdT)therapy:600mg per day according guidelines for the treatment of chronic hepatitis B in the Asia Pacific Region
design_group_title: HPDCs-T immune therapy combined with LdT
design_group_type: Experimental
design_group_description: IFN therapy (Peg-IFN α-2b/2a):one time every 1 week according to the standards for 48 weeks
design_group_title: IFN treatment
design_group_type: No Intervention
design_group_description: Entecavir(ETV)therapy:0.5mg per day according guidelines for the treatment of chronic hepatitis B in the Asia Pacific Region
design_group_title: ETV treatment
design_group_type: No Intervention
design_group_description: Telbivudine(LdT)therapy:600mg per day according guidelines for the treatment of chronic hepatitis B in the Asia Pacific Region
design_group_title: LdT treatment
design_group_type: No Intervention
Sponsor: The Third Affiliated Hospital, Sun Yat-Sen University
Collaborators: Ruijin Hospital
Yunnan No. 2 People's Hospital
Drug name mappings:
name: 恩替卡韦
lang: CN
name: Entecavir
lang: EN
name: エンテカビル水和物
lang: JP
Clinical trial NCT03981549: Treatment of Central Retinal Vein Occlusion Using Stem Cells Study
Official title: Phase I/II Randomized, Prospective, Double-masked, Sham-controlled Study of Intravitreal Autologous Bone Marrow CD34+ Stem Cell Therapy for Central Retinal Vein Occlusion
Conditions: Central Retinal Vein Occlusion
Summary: This study evaluates whether intravitreal autologous CD34+ stem cell therapy is safe, feasible and potentially beneficial in eyes with vision loss from central retinal vein occlusion (CRVO). Half of the participants will receive immediate cellular therapy followed by sham therapy 6 months later, while the other half will receive immediate sham therapy followed by cellular therapy 6 months later. Participants will be followed for a total of 1 year.
Interventions:
description: Single intravitreal injection of autologous bone marrow CD34+ stem cells. The number of cells to be injected per eye will range from 800,000 to 10 million, depending on the yield of the bone marrow aspiration and the isolation procedure.
name: Autologous Bone Marrow CD34+ Stem Cells
type: Biological
description: Sham bone marrow aspiration procedure that penetrates the skin, but does not penetrate the bone followed by sham intravitreal injection without penetration of the eye
name: Sham Therapy
type: Biological
Study arms:
design_group_description: At baseline: Bone marrow aspiration followed by intravitreal injection of CD34+ cells.<br/>At 6 months: Sham bone marrow aspiration and sham intravitreal injection.
design_group_title: Immediate Cellular Therapy / Deferred Sham Therapy
design_group_type: Active Comparator
design_group_description: At baseline: Sham bone marrow aspiration followed by sham intravitreal injection.<br/>At 6 months: Bone marrow aspiration followed by intravitreal injection of CD34+ cells.
design_group_title: Immediate Sham Therapy / Deferred Cellular Therapy
design_group_type: Sham Comparator
Sponsor: The Emmes Co. LLC
Collaborators: University of California, Davis
National Eye Institute
Drug name mappings:
name: Autologous Bone Marrow CD34+ Stem Cells (Emmes)
lang: EN