PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT00609336: Perioperative Therapy for Resectable Pancreatic Cancer
Official title: A Phase II Study Induction Chemotherapy, Neoadjuvant Chemoradiotherapy, Surgical Resection and Adjuvant Chemotherapy for Patients With Locally Advanced, Resectable Pancreatic Adenocarcinoma
Conditions: Adenocarcinoma of the Pancreas
Stage IA Pancreatic Cancer
Stage IB Pancreatic Cancer
Stage IIA Pancreatic Cancer
Stage IIB Pancreatic Cancer
Summary: This phase II trial studies how well giving combination chemotherapy together with intensity-modulated radiation therapy (IMRT) and surgery works in treating patients with localized pancreatic cancer that can be removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride, docetaxel, capecitabine, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy, such as IMRT, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving more than one drug (combination chemotherapy) together with intensity-modulated radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery.
Interventions:
description: Given IV
name: gemcitabine hydrochloride
other_name: Gemzar
dFdC
difluorodeoxycytidine hydrochloride
gemcitabine
type: Drug
description: Given IV
name: docetaxel
other_name: RP 56976
TXT
Taxotere
type: Drug
description: Given PO
name: capecitabine
other_name: CAPE
Ro 09-1978/000
Xeloda
type: Drug
description: Undergo IMRT
name: intensity-modulated radiation therapy
other_name: IMRT
type: Radiation
description: Given IV
name: oxaliplatin
other_name: 1-OHP
Dacotin
Dacplat
Eloxatin
L-OHP
type: Drug
description: Undergo pancreaticoduodenectomy
name: pancreatic surgical procedure
other_name: pancreatic surgery
type: Procedure
description: Undergo therapeutic conventional surgery
name: therapeutic conventional surgery
type: Procedure
description: Correlative studies
name: laboratory biomarker analysis
type: Other
Study arms:
design_group_description: See Detailed Description
design_group_title: Treatment (chemotherapy, radiation, pancreaticoduodenectomy)
design_group_type: Experimental
Sponsor: University of Washington
Collaborators: National Cancer Institute
Drug name mappings:
name: 盐酸吉西他滨
lang: CN
name: Gemcitabine Hydrochloride
lang: EN
name: ゲムシタビン塩酸塩
lang: JP
name: 多西他赛
lang: CN
name: Docetaxel
lang: EN
name: ドセタキセル
lang: JP
name: 奥沙利铂
lang: CN
name: Oxaliplatin
lang: EN
name: オキサリプラチン
lang: JP
name: 卡培他滨
lang: CN
name: Capecitabine
lang: EN
name: カペシタビン
lang: JP
Clinical trial NCT02735629: Antagonism of Opioid-Induced Respiratory Depression by CX1739 With Preservation of Opioid Analgesia
Official title: Antagonism of Opioid-Induced Respiratory Depression by CX1739 With Preservation of Opioid Analgesia
Conditions: Opiate Induced Respiratory Depression
Summary: The study is an investigation to assess the capacity of ascending doses of CX1739 to antagonize the respiratory depressive effect of remifentanil. The study will also investigate whether ascending doses of CX1739 reduce the analgesic effect of remifentanil or alter the BIS measure of sedation and will evaluate the safety of CX1739 when used in conjunction with remifentanil.
Interventions:
description: Ampakine CX1739 - 300 mg
name: CX1739 - 300 mg
other_name: Low dose
type: Drug
description: CX1739 - 600 mg
name: CX1739 - 600 mg
other_name: mid dose
type: Drug
description: CX1739 - 900 mg
name: CX1739 - 900 mg
other_name: high dose
type: Drug
description: Placebo to 300 mg CX1739
name: Placebo
other_name: Placebo to 300 mg CX1739
type: Drug
Study arms:
design_group_description: Study Drug - low dose
design_group_title: CX1739 - 300 mg
design_group_type: Experimental
design_group_description: Placebo
design_group_title: Placebo
design_group_type: Placebo Comparator
design_group_description: Study drug - mid Dose
design_group_title: CX1739 - 600 mg
design_group_type: Experimental
design_group_description: Study drug - high dose
design_group_title: CX1739 - 900 mg
design_group_type: Experimental
Sponsor: RespireRx Pharmaceuticals, Inc.
Collaborators: Duke University
Drug name mappings:
name: CX-1739
lang: EN
Clinical trial NCT06660368: BCL2i CLAG-M in R/R Acute Myeloid Leukemia
Official title: A Prospective, Multicenter, Randomized, Open-Label, Phase II Study of Salvage BCL2i Plus CLAG-M in Relapsed or Refractory Acute Myeloid Leukemia
Conditions: Relapsed or Refractory Acute Myeloid Leukemia (AML)
Summary: This multicenter, open-label phase II study combines CLAG-based therapy with or without venetoclax in patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) in order to improve measurable residual disease (MRD) clearance and event-free survival. Investigators hypothesize that the addition of venetoclax to CLAG-M in patients with relapsed or refractory AML is safe, and superior to CLAG-M alone in improving patient outcomes.
Interventions:
description: Filgrastim/G-CSF 300 mcg/day for 6 days beginning 24 hours prior to multiagent chemotherapy (days 0-5), cladribine 5 mg/m2 given intravenously over 2 hours for 5 consecutive days (days 1-5), cytarabine given IV over 4 hours for 5 consecutive days (days 1-5) beginning 2 hours after the completion of cladribine, and mitoxantrone 16 mg/m2 given intravenously over 30 minutes for 3 days (days 1-3) after completion of cytarabine.
name: Cladribine, Cytarabine, Mitoxantrone, G-CSF (CLAG-M) regimen
type: Drug
description: Venetoclax will be administered orally, once daily, with food.
name: Venetoclax
type: Drug
Study arms:
design_group_description: Study participants will receive CLAG-M (cladribine, cytarabine, G-CSF, mitoxantrone) and Venetoclax
design_group_title: CLAG-based therapy with venetoclax
design_group_type: Experimental
design_group_description: Study participants will receive CLAG-M (cladribine, cytarabine, G-CSF, mitoxantrone)
design_group_title: CLAG-based therapy without venetoclax
design_group_type: Active Comparator
Sponsor: H. Lee Moffitt Cancer Center & Research Institute, Inc.
Collaborators: AbbVie, Inc.
Drug name mappings:
name: 克拉屈滨
lang: CN
name: Cladribine
lang: EN
name: クラドリビン
lang: JP
name: 维奈克拉
lang: CN
name: Venetoclax
lang: EN
name: ベネトクラクス
lang: JP
name: 非格司亭 （安进）
lang: CN
name: Filgrastim (Amgen)
lang: EN
name: フィルグラスチム（遺伝子組換え）
lang: JP
name: 盐酸米托蒽醌
lang: CN
name: Mitoxantrone Hydrochloride
lang: EN
name: ミトキサントロン塩酸塩
lang: JP
name: 阿糖胞苷
lang: CN
name: Cytarabine
lang: EN
name: シタラビン
lang: JP
Clinical trial NCT04138628: Treatment Of Metastatic Bladder Cancer at the Time Of Biochemical reLApse Following Radical Cystectomy
Official title: Treatment Of Metastatic Bladder Cancer at the Time Of Biochemical reLApse Following Radical Cystectomy
Conditions: Bladder Cancer
Bladder Cancer, Metastatic
Summary: Immunotherapy (checkpoint inhibitors) is approved as first and second line treatment to patients with metastatic bladder cancer. However, response rates are low and no biomarkers have yet shown strong predictive value for patient selection. Moreover, the term 'metastatic' is based on metastases visible on conventional CT scans and, thus, require a certain size of tumour load. Clinical trials are currently being conducted that investigate the use of adjuvant immunotherapy for this group of patients (treatment to all), which will result in massive over-treatment and huge costs to the healthcare system.
This project has the primary objective to identify new indications for initiating immunotherapy in patients with metastatic bladder cancer. Sensitive molecular techniques for detection of tumor DNA in the blood will be used to identify patients with early signs of metastatic disease. In addition, comprehensive biomarker analysis will be performed to identify predictors of treatment response.
Interventions:
description: The study drug will be given according to current recommendations as systemic treatment every third week for 12 months or until progression. Treatment will be initiated within 28 days of detection of ctDNA.
name: Atezolizumab
type: Drug
Study arms:
design_group_description: Flat dose 1200 mg Atezolizumab every three weeks for up to 13 months
design_group_title: ctDNA screening arm
design_group_type: Experimental
Sponsor: Århus Universitetshospital
Collaborators: Aalborg University Hospital
Århus Universitetshospital
Odense University Hospital
Herlev Hospital
Rigshospitalet
Drug name mappings:
name: 阿替利珠单抗
lang: CN
name: Atezolizumab
lang: EN
name: アテゾリズマブ（遺伝子組換え）
lang: JP
Clinical trial NCT01707615: Beneficial Effects of Grape Seed Proanthocyanidin Extrat on Progression of Atherosclerotic Plaques in Clinical Use
Official title: Beneficial Effects of Grape Seed Proanthocyanidin Extrat on Progression of Carotid Intima-media Thickness and Atherosclerotic Plaques in Clinical Use
Conditions: Atherosclerosis of Arteries of the Extremities, Unspecified
Summary: The purpose of this study is to investigate the antiatherogenic effect of GSPE in clinical use
Interventions:
description: GSPE 240 mg/day (120mg bid)
name: GSPE
other_name: Grape seed proanthocyanidin extrat
type: Drug
description: dietary modification making the total ingestion of calories into standard body weight 25 kCal in effect and an individualized home exercise program of a minimum 150 min/week of moderate-intensity physical activity
name: lifestyle intervention
type: Other
Study arms:
design_group_description: In the control group, all patients were enrolled in a lifestyle intervention
design_group_title: control group
design_group_type: Other
design_group_description: GSPE 240 mg/day (120mg bid) in addition to the same lifestyle intervention.
design_group_title: GSPE group
design_group_type: Active Comparator
Sponsor: Shandong University
Collaborators: National Natural Science Foundation of China
Drug name mappings:
name: 葡萄籽提取物
lang: CN
name: Grape Seed Extract
lang: EN
Clinical trial NCT05432414: PVd Versus Vd in NDMM Patients With RI
Official title: Pomalidomide, Bortezomib and Dexamethasone (PVd) Versus Bortezomib and Dexamethasone (Vd) in NDMM Patients With Renal Injury (RI)：A Multicenter, Randomized Controlled, Open-label Trial.
Conditions: Multiple Myeloma
Summary: This is a multicenter, randomized controlled, open-label study, and the purpose of this study is to compare the efficiency and safety of PVD regimen (Pomalidomide & Bortezomib & Dexamethasone) versus VD regimen (Bortezomib & Dexamethasone) in NDMM patients with RI. The main efficacy indicator is VGPR after 4 cycles of induction therapy.
Interventions:
description: Pomalidomide was administered orally at a dose of 4 mg on days 1-14 of each cycle.
name: pomalidomide
other_name: CC-4047
type: Drug
description: Bortezomib was administered intravenously or subcutaneously at a dose of 1.3mg/m2 on days 1, 4, 8, 11 of each cycle.
name: Bortezomib
type: Drug
description: Dexamethasone was administered orally at a dose of 20mg on days the same and next day of bortezomib administration.
name: Dexamethasone
type: Drug
Study arms:
design_group_description: Each cycle is 21 days, after 2 cycles, patients who reached MR continued treatment for 2 cycles, 4 cycles in total. Subsequent treatment regimens after 4 cycles of induction therapy were determined by the investigator.
design_group_title: Pomalidomide, Bortezomib and Dexamethasone (PVD)
design_group_type: Experimental
design_group_description: Each cycle is 21 days, after 2 cycles, patients who reached MR continued treatment for 2 cycles, 4 cycles in total. Subsequent treatment regimens after 4 cycles of induction therapy were determined by the investigator.
design_group_title: Bortezomib and Dexamethasone (VD)
design_group_type: Active Comparator
Sponsor: Shanghai Renji Hospital
Collaborators: The First Affiliated Hospital of Ningbo University
Xinhua Hospital
Shanghai Changzheng Hospital
Peking University Shenzhen Hospital
Peking University People's Hospital
Third Affiliated Hospital of Nanjing Medical University
Chengdu No. 3 People's Hospital
The First Affiliated Hospital of Nanchang University
Drug name mappings:
name: 地塞米松磷酸钠
lang: CN
name: Dexamethasone Sodium Phosphate
lang: EN
name: デキサメタゾンリン酸エステルナトリウム
lang: JP
name: 泊马度胺
lang: CN
name: Pomalidomide
lang: EN
name: ポマリドミド
lang: JP
name: 硼替佐米
lang: CN
name: Bortezomib
lang: EN
name: ボルテゾミブ
lang: JP
Clinical trial NCT00080236: Safety and Efficacy Study of a Caspase Inhibitor in Patients Undergoing Liver Transplantation
Official title: Safety, Tolerability and Efficacy Study of a Caspase Inhibitor, IDN-6556, in Patients Undergoing Orthotopic Liver Transplantation (OLT)
Conditions: Liver Transplantation
Hepatitis
Cholestasis
Carcinoma, Hepatocellular
Summary: The purpose of the study is to test the safety and effectiveness of IDN-6556 in preventing liver damage that normally occurs when livers are transported before being transplanted and in the immediate post-transplant period.
Interventions:
name: IDN-6556
type: Drug
name: Placebo
type: Drug
Study arms:
design_group_title: Donor organ placebo and Recipient placebo
design_group_type: Placebo Comparator
design_group_title: Donor organ: IDN-6556 (15μg/ml), Recipient: Placebo
design_group_type: Active Comparator
design_group_title: Donor organ: IDN-6556 (5 μg/ml), Recipient: IDN-6556 0.5 mg/kg
design_group_type: Active Comparator
design_group_title: Donor organ: IDN-6556(15 μg/ml), Recipient: IDN-6556 0.5 mg/kg
design_group_type: Active Comparator
Sponsor: Conatus Pharmaceuticals, Inc.
Collaborators: Idun Pharmaceuticals, Inc.
Drug name mappings:
name: 恩利卡生
lang: CN
name: Emricasan
lang: EN
Clinical trial NCT01348412: Hepatic Arterial Chemotherapy With Raltitrexed and Oxaliplatin Versus Standard Chemotherapy in Unresectable Liver Metastases From Colorectal Cancer After Conventional Chemotherapy Failure
Official title: Phase II Randomized Study Comparing the Association of Intraarterial Perfusion of Raltitrexed and Oxaliplatin Versus Standard Chemotherapy Using Intravenous Perfusion for Colorectal Cancer Patient With Metastases Localized to Liver After Failure of Conventional Treatments.
Conditions: Colorectal Cancer
Liver Metastases
Summary: Standard treatment of metastatic colorectal cancers relies on fluoropyrimidines, irinotecan alone or in association with fluoropyrimidines, oxaliplatin in association with fluoropyrimidines, bevacizumab and anti EGFR antibodies. After failure of classical regimen the national reference frame on the basis of phase II study proposes an association of fluoropyrimidine and mitomycin. These treatments give response rates of 10-20% with progression free survivals from 2 to 3 months. Hepatic intra-arterial chemotherapy is logical in the case of isolated hepatic metastases nonaccessible to curative resection: 1) hepatic metastases are vascularized by hepatic arterial system in contrast to nontumoral hepatic parenchyma; 2) arterial perfusion of oxaliplatin leads to a strong extraction by the liver during the first passage, a high intra-tumoral concentration and a low systemic concentration. So oxaliplatin is a drug of choice for arterial treatment but combination with fluoropyrimidines is impossible because of need for prolonged perfusion. Floxuridin is not available in France. Raltitrexed, a definitive inhibitor of the thymidylate synthase, does not require a prolonged perfusion and could be a good substitute.In a previous pilot study we demonstrated the feasibility, safety and efficacy of combination of raltitrexed and oxaliplatin arterial perfusion. Now we propose a phase II randomized clinical trial to evaluate the efficacy of hepatic arterial infusion of raltitrexed and oxaliplatin association versus standard chemotherapy for patients with metastases of colorectal origin restricted to the liver after failure of conventional chemotherapy.
Interventions:
description: 130 mg/m²Every 21 days
name: oxaliplatin
type: Drug
description: 3 mg/m² with a maximum of 6 mg every 21 days
name: raltitrexed
type: Drug
name: other intravenous chemotherapy drugs
type: Drug
Study arms:
design_group_description: Hepatic artery infusion through an implanted arterial catheter of the combination of raltitrexed (3 mg/m ²) and oxaliplatin (100 mg/m ²) every 21 days.
design_group_title: ARM A
design_group_type: Experimental
design_group_description: Intravenous standard chemotherapy.
design_group_title: ARM B
design_group_type: Active Comparator
Sponsor: Centre Georges François Leclerc
Collaborators: National Cancer Institute
Hospira, Inc.
Drug name mappings:
name: 奥沙利铂
lang: CN
name: Oxaliplatin
lang: EN
name: オキサリプラチン
lang: JP
name: 雷替曲塞
lang: CN
name: Raltitrexed
lang: EN
Clinical trial NCT01328535: Individualized Temozolomide in Treating Patients With Stage IV Melanoma That Cannot Be Removed By Surgery
Official title: Individualized (Timed) Temozolomide Administration as a Means of Immune Reconstitution in Patients With Metastatic Melanoma
Conditions: Recurrent Melanoma
Stage IV Melanoma
Summary: This clinical trial studies individualized temozolomide (TMZ) in treating patients with stage IV melanoma that cannot be removed by surgery. Drugs used in chemotherapy, such as TMZ, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving TMZ at different times, which are determined individually for each patient based on the phase (biorhythm) of the immune system response against the tumor may allow for a better drug response and may kill more tumor cells
Interventions:
description: Given PO
name: temozolomide
other_name: SCH 52365
TMZ
Temodal
Temodar
type: Drug
description: Correlative studies
name: flow cytometry
type: Other
description: Correlative studies
name: staining method
other_name: Staining
type: Other
description: Optional correlative studies
name: biopsy
other_name: biopsies
type: Procedure
description: Correlative studies
name: laboratory biomarker analysis
type: Other
Study arms:
design_group_description: Patients with an established biorhythm receive TMZ PO on recommended day for 5 days. Treatment repeats every 21-42 days until disease progression or unacceptable toxicity. Patients without an established biorhythm receive TMZ PO on days 1-5. Courses repeat every 28 days until disease progression or unacceptable toxicity.
design_group_title: Treatment (individualized chemotherapy)
design_group_type: Experimental
Sponsor: Mayo Clinic
Collaborators: National Cancer Institute
Drug name mappings:
name: 替莫唑胺
lang: CN
name: Temozolomide
lang: EN
name: テモゾロミド
lang: JP
Clinical trial NCT02276937: Randomized Phase IIb Trial of DVC1-0101
Official title: DVC1-0101 for Intermittent Claudication Secondary to Peripheral Artery Disease: a Randomized Phase IIb Trial
Conditions: Intermittent Claudication
Peripheral Arterial Disease
Summary: DVC1-0101 is a gene therapy medicine to treat peripheral arterial disease (PAD) based on recombinant F-gene-deleted, non-transmissible Sendai virus (rSeV/dF) expressing human fibroblast growth factor-2 (FGF-2) gene.
The primary objective of the current Phase IIb study is to investigate the clinical efficacy of DVC1-0101 (1x10^9 ciu/leg, 5x10^9 ciu/leg) in patients with IC.
Interventions:
description: The investigational product will be drawn into a disposable 1 mL syringe using a 23G needle. A total of 0.5 mL of investigational product will be injected intramuscularly into each administration site. After administration, the administration sites will be wrapped with dressings.
name: DVC1-0101
other_name: rSeV/dF expressing human FGF-2 gene
type: Drug
Study arms:
design_group_description: Placebo control
design_group_title: Placebo (0 ciu/limb)
design_group_type: Placebo Comparator
design_group_description: Low dose cohort
design_group_title: DVC1-0101 low dose (1x10^9 ciu/limb)
design_group_type: Active Comparator
design_group_description: High dose cohort
design_group_title: DVC1-0101 high dose (5x10^9 ciu/limb)
design_group_type: Active Comparator
Sponsor: Kyushu University
Collaborators: Japan Agency for Medical Research & Development
Drug name mappings:
name: 成纤维细胞生长因子2基因疗法(Id Pharma Co., Ltd.)
lang: CN
name: Fibroblast growth factor 2 gene therapy(Id Pharma Co., Ltd.)
lang: EN
Clinical trial NCT05495464: A Pilot "Window-3" Study of Acalabrutinib Plus Rituximab Followed by Brexucabtagene Autoleucel Therapy in Patients With Previously Untreated High-risk Mantle Cell Lymphoma
Official title: A Pilot "Window-3" Study of Acalabrutinib Plus Rituximab Followed by Brexucabtagene Autoleucel Therapy in Patients With Previously Untreated High-risk Mantle Cell Lymphoma
Conditions: Lymphoma
Mantle Cell Lymphoma
Summary: To learn if giving acalabrutinib, rituximab, and brexucabtagene autoleucel to patients with previously untreated high-risk mantle cell lymphoma (MCL) can help to control the disease.
Interventions:
description: Given by PO
name: Acalabrutinib
type: Drug
description: Given by IV (vein)
name: Rituximab
other_name: Rituxan
type: Drug
description: Given by IV (vein)
name: Brexucabtagene Autoleucel
type: Other
description: Given by IV (vein)
name: Cyclophosphamide
other_name: Cytoxan®
Neosar®
type: Drug
description: Given by IV (vein)
name: Fludarabine Phosphate
other_name: Fludarabine
Fludara®
type: Drug
Study arms:
design_group_description: Participants may receive acalabrutinib and rituximab for up to 12 cycles. Each cycle is 28 days.
design_group_title: Acalabrutinib and Rituximab (Part 1)
design_group_type: Experimental
design_group_description: Participants will have a procedure called leukapheresis to collect enough T cells.
design_group_title: Brexucabtagene Autoleucel (Part 2)
design_group_type: Experimental
Sponsor: The University of Texas MD Anderson Cancer Center
Collaborators: Kite Pharma, Inc.
Acerta Pharma BV
Drug name mappings:
name: 磷酸氟达拉滨
lang: CN
name: Fludarabine Phosphate
lang: EN
name: フルダラビンリン酸エステル
lang: JP
name: 环磷酰胺
lang: CN
name: Cyclophosphamide
lang: EN
name: シクロホスファミド水和物
lang: JP
name: 阿可替尼
lang: CN
name: Acalabrutinib
lang: EN
name: アカラブルチニブ
lang: JP
name: 利妥昔单抗
lang: CN
name: Rituximab
lang: EN
name: リツキシマブ（遺伝子組換え）
lang: JP
name: 布瑞基奥仑赛
lang: CN
name: Brexucabtagene Autoleucel
lang: EN
Clinical trial NCT04657861: APRIL CAR-T Cell Therapy for Patients With BCMA/TACI Positive Relapsed and/or Refractory Multiple Myeloma
Official title: Clinical Trial for the Safety and Efficacy of APRIL CAR-T Cells Therapy for Patients With BCMA/TACI Positive Relapsed and/or Refractory Multiple Myeloma
Conditions: Multiple Myeloma in Relapse
Multiple Myeloma, Refractory
Summary: A study of APRIL CAR-T cells therapy for patients with BCMA/TACI positive relapsed and/or refractory multiple myeloma
Interventions:
description: Each subject receive APRIL CAR T-cells by intravenous infusion
name: APRIL CAR-T cells
other_name: APRIL CAR-T cells injection
type: Drug
Study arms:
design_group_description: Each subject receive APRIL CAR T-cells by intravenous infusion
design_group_title: Administration of APRIL CAR T-cells
design_group_type: Experimental
Sponsor: Zhejiang University
Collaborators: Shanghai Yake Biotechnology Co., Ltd
Drug name mappings:
name: APRIL chimeric antigen receptor-T cell therapy  (Yake Biotechnology)
lang: EN