PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT00361296: Vaccine Therapy in Treating Patients With Myelodysplastic Syndromes
Official title: K562/GM-CSF Vaccination in Patients With Myelodysplastic Syndrome
Conditions: Myelodysplastic Syndromes
Summary: RATIONALE: Vaccines made from cancer cells may help the body build an effective immune response to kill abnormal cells.
PURPOSE: This clinical trial is studying how well vaccine therapy works in treating patients with myelodysplastic syndromes (MDS).
Interventions:
name: K562/GM-CSF cell vaccine
type: Biological
Study arms:
design_group_description: Vaccinations of 1x10^8 cells are given to participants at weeks 0, 3, 6, 9, and 17.
design_group_title: K562/GM-CSF cell vaccine
design_group_type: Experimental
Sponsor: The Sidney Kimmel Comprehensive Cancer Center
Collaborators: National Cancer Institute
Alliance for Cancer Gene Therapy, Inc.
Drug name mappings:
name: K562/GM-CSF vaccine(The Johns Hopkins University)
lang: EN
Clinical trial NCT05903690: Safety and Tolerance of RAG-17 in Amyotrophic Lateral Sclerosis Patients With SOD1 Gene Mutation
Official title: Safety and Tolerance of RAG-17 in Amyotrophic Lateral Sclerosis Patients With SOD1 Gene Mutation
Conditions: Gene Mutation
Summary: The goal of this clinical trial is to evaluate the safety, tolerability and pharmacokinetics of RAG-17 in adult amyotrophic lateral sclerosis (ALS) patients with SOD1 mutation. Patients will receive drug treamtent via dose escalation which ranging from minimum of 60 mg to the maximum tolerated dose (MTD), after reaching the tolerated dose, a fixed dose of the drug is given once every two months for continuous treatment, and the total treatment cycle is 8 months. The duration of this study is two years.
Interventions:
description: RAG-17 60mg is used
name: RAG-17
type: Drug
Study arms:
design_group_description: Doses of RAG-17 will range from a minimum of 60 mg to the maximum tolerated dose (MTD). Dosing once every two weeks, starting from 60 mg, with dose escalation. After reaching the tolerated dose, a fixed dose of the drug is given once every two months for continuous treatment, and the total treatment cycle is 8 months.
design_group_title: RAG-17
design_group_type: Experimental
Sponsor: Beijing Tiantan Hospital
Collaborators: Ractigen Therapeutics
Drug name mappings:
name: RAG-17
lang: EN
Clinical trial NCT06989853: Methamphetamine and Troriluzole
Official title: Advancing Troiluzole as a Treatment for Methamphetamine Use Disorder: A Human Laboratory Study
Conditions: Methamphetamine Use Disorder
Summary: This will be a human laboratory study evaluating the influence of troriluzole treatment on the effects of methamphetamine. Supported by and included in the Helping to End Addiction Long-term® (HEAL) Initiative.
Interventions:
description: The effects of placebo will be determined.
name: Placebo
type: Drug
description: Placebo and methamphetamine will be administered intravenously during experimental sessions.
name: Methamphetamine
type: Drug
Study arms:
design_group_description: Subjects will be treated daily with an oral placebo.
design_group_title: Placebo
design_group_type: Placebo Comparator
design_group_description: Subjects will be treated daily with oral troriluzole (140 mg).
design_group_title: Troriluzole Dose 1
design_group_type: Experimental
design_group_description: Subjects will be treated daily with oral troriluzole (280 mg).
design_group_title: Troriluzole Dose 2
design_group_type: Experimental
Sponsor: University of Kentucky
Collaborators: National Institute on Drug Abuse
Drug name mappings:
name: 盐酸去氧麻黄碱
lang: CN
name: Methamphetamine Hydrochloride
lang: EN
name: メタンフェタミン塩酸塩
lang: JP
Clinical trial NCT00795665: Bevacizumab and Carmustine in Treating Patients With Relapsed or Progressive High-Grade Glioma
Official title: Phase II Study of Bevacizumab (Avastin) and BCNU for Treatment of Relapsed, High Grade Gliomas
Conditions: Glioma
Summary: RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as carmustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with carmustine may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving bevacizumab together with carmustine works in treating patients with relapsed or progressive high-grade glioma.
Interventions:
description: Bevacizumab (10 mg/kg) will be given intravenously every other week starting one week before the first dose of BCNU. Treatment with both BCNU and bevacizumab for 6-months, after which the participant may continue to receive bevacizumab every 2 weeks for a maximum of one year and three additional cycles of BCNU.
name: bevacizumab
other_name: Avastin
type: Drug
description: BCNU (200 mg/m2), will be given over 4 hours as a continuous intravenous infusion every 8 weeks. Treatment with both BCNU and bevacizumab for 6-months, after which the participant may continue to receive bevacizumab every 2 weeks for a maximum of one year and three additional cycles of BCNU.
name: carmustine
other_name: BCNU
type: Drug
Study arms:
design_group_title: Bevacizumab and Carmustine
design_group_type: Experimental
Sponsor: University of California, Davis
Collaborators: National Cancer Institute
Genentech, Inc.
Drug name mappings:
name: 卡莫司汀
lang: CN
name: Carmustine
lang: EN
name: カルムスチン
lang: JP
name: 贝伐珠单抗
lang: CN
name: Bevacizumab
lang: EN
name: ベバシズマブ（遺伝子組換え）
lang: JP
Clinical trial NCT03529890: Radio-Immunotherapy Before Cystectomy in Locally Advanced Urothelial Carcinoma of the Bladder
Official title: A Prospective, Single Arm, Multicenter, Phase II-Trial to Assess Safety and Efficacy of Preoperative RAdiation Therapy Before Radical CystEctomy Combined With ImmunoTherapy in Locally Advanced Urothelial Carcinoma of the Bladder
Conditions: Urinary Bladder Cancer
Summary: A prospective, single arm, multicenter, Phase II-Trial to assess safety and efficacy of preoperative Radiation therapy before radical CystEctomy combined with ImmunoTherapy in locally advanced urothelial carcinoma of the bladder
Interventions:
description: Experimental intervention:<br/>Immunotherapy with 4 cycles of Nivolumab: 240 mg intravenously every 2 weeks, starting one week before radiotherapy (week1, d1), last infusion on week 7, d1
name: Nivolumab
other_name: Opdivo
type: Drug
description: Neoadjuvant radiation therapy of pelvis with 45+5,4 Gy for 6 weeks: 28 x 1.8 Gy including a boost of bladder with 5.4 Gy, starting with week 2 (d1)
name: Radiation therapy of the pelvis
type: Radiation
description: Radical cystectomy with standardized bilateral pelvic lymphadenectomy: performed between week 11 - 15 (Aim: week 13)
name: Radical cystectomy with standardized pelvic lymphadenectomy
type: Procedure
Study arms:
design_group_description: Single arm treatment with Nivolumab during a neoadjuvant radiation therapy of the pelvis before radical cystectomy with standardized pelvic lymphadenectomy
design_group_title: Radio-Immunotherapy before cystectomy
design_group_type: Experimental
Sponsor: Technische Universität München
Collaborators: Bristol Myers Squibb Co.
Drug name mappings:
name: 纳武利尤单抗
lang: CN
name: Nivolumab
lang: EN
name: ニボルマブ（遺伝子組換え）
lang: JP
Clinical trial NCT01791387: 1st-line Activity of Dovitinib and Correlation With Genetic Changes in RCC
Official title: Dovitinib In 1st-Line Renal Cell Carcinoma, an Investigation Into Tumour GENe Status and Correlation With Efficacy - 1st Exploratory Study
Conditions: Clear Cell Renal Cell Carcinoma
Summary: The main purpose of this study is to find out how useful dovitinib is when given as the initial treatment to participants with advanced kidney cancer, that has spread to other parts of the body. The usefulness of dovitinib will be assessed by: how long the disease is controlled while participants are receiving the drug, the proportion of participants who get a reduction in the size of their tumours and how long participants live (both while on dovitinib and on any subsequent therapy they may receive).
If participants have secondary disease in the bones, the study will evaluate how useful dovitinib is in controlling this site of disease. In addition, this study will look for changes in the genetic makeup of tumour cells and see if some of these changes are associated with a benefit from dovitinib. The study will also compare and contrast the genetic changes in the primary tumour cells with cells from secondary tumour specimens, and with cells from tumour specimens taken if a participant's disease has worsened. The purpose of the latter is to identify possible ways in which the tumour becomes resistant to the study drug.
Interventions:
description: Patients will be treated with dovitinib (500 mg orally, once daily 5 days on/2 days off) until disease progression, intolerability, patient refusal, death or study drug discontinuation for any other reason. Dovitinib should be ingested at least 1 hour prior to a meal or at least 2 hours following a meal at approximately the same time each day.<br/>If patients cannot tolerate the protocol-specified dosing schedule, dose reductions or treatment interruptions are permitted. When necessary, dovitinib may be reduced to 400 mg for 5 days on/2 days off. If an additional dose reduction is required, dovitinib may be reduced to 300 mg dose 5 days on/2 days off. Once dose is reduced due to an adverse event, it cannot be re-escalated. Patients are allowed only 2 dose reductions.
name: Dovitinib
other_name: TKI258
type: Drug
Study arms:
design_group_description: Dovitinib 500 mg taken orally once daily 5 days on / 2 days off, until disease progression
design_group_title: Dovitinib
design_group_type: Experimental
Sponsor: Auckland District Health Board
Collaborators: IGENZ, Ltd., Auckland
Novartis AG
Auckland University
Drug name mappings:
name: 多维替尼乳酸盐
lang: CN
name: Dovitinib
lang: EN
Clinical trial NCT04691388: A Trial of Sintilimab Plus Anlotinib For Metastatic NSCLC After First-Line PD-1 Inhibitor
Official title: An Open-Label, Single-Arm, Phase II Trial of Sintilimab Combined With Anlotinib For Metastatic Non-Small Cell Lung Cancer After First-Line PD-1 Inhibitor
Conditions: NSCLC
Summary: The combination of immunocheckpoint inhibitors and anti-angiogenesis therapy has synergistic anti-tumor effect and is a reasonable method to improve the prognosis of patients. Therefore, in this study, it is hoped that sintilimab combined with anlotinib can overcome immunotherapy resistance, improve the efficacy of immunotherapy, and further improve the survival of patients, so as to provide more clinical evidence for the treatment of advanced NSCLC patients with negative driver gene after first-line treatment with anti-PD-1 antibody.
Interventions:
description: All patients will receive sintilimab combined with anlotinib every 3 weeks
name: sintilimab combined with anlotinib
type: Drug
Study arms:
design_group_title: sintilimab +anlotinib
design_group_type: Experimental
Sponsor: Zhejiang Cancer Hospital
Collaborators: Innovent Biologics (Suzhou) Co. Ltd.
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Drug name mappings:
name: 盐酸安罗替尼
lang: CN
name: Anlotinib Dihydrochloride
lang: EN
name: 信迪利单抗
lang: CN
name: Sintilimab
lang: EN
Clinical trial NCT04382755: Zilucoplan® in Improving Oxygenation, Short-, Longterm Outcome of COVID19 Patients With Acute Hypoxic Respiratory Failure
Official title: A Prospective Randomized Open-label Interventional Study to Investigate the Efficacy of Complement C5 Inhibition With Zilucoplan® in Improving Oxygenation and Short-and Longterm Outcome of COVID19 Patients With Acute Hypoxic Respiratory Failure
Conditions: COVID-19
Summary: The study is a randomized controlled, open-label trial comparing subcutaneous Zilucoplan® with standard of care to standard of care alone.
In the active group, Zilucoplan® will be administered subcutaneously once daily for 14 days or till discharge from the hospital, whichever comes first.
The hypothesis of the proposed intervention is that Zilucoplan® (complement C5 inhibitor) has profound effects on inhibiting acute lung injury post COVID-19, and can promote lung repair mechanisms, that lead to a 25% improvement in lung oxygenation parameters. This hypothesis is based on experiments performed in mice showing that C5a blockade can prevent mortality and prevent ARDS in mice with post-viral acute lung injury.
Eligible patients include patients with confirmed COVID-19 infection suffering from hypoxic respiratory failure defined as O2 saturation below 93% on minimal 2l/min O2 therapy and/or ratio PaO2/FiO2 below 350.
Interventions:
description: 14 days of SC Zilucoplan® on top of standard of care + prophylactic antibiotics until 14 days after last Zilucoplan®
name: Zilucoplan®
type: Drug
description: standard of care treatment + 1 week of prophylactic antibiotics (or until hospital discharge, whichever comes first)
name: Placebo
type: Drug
Study arms:
design_group_description: Standard of Care (SoC) + subcutaneous Zilucoplan® + prophylactic antibiotics until 14 days after last Zilucoplan®
design_group_title: Group A (active)
design_group_type: Active Comparator
design_group_description: Standard of Care (SoC) + 1 week of prophylactic antibiotics (or until hospital discharge, whichever comes first)
design_group_title: Group B (control)
design_group_type: Placebo Comparator
Sponsor: Ghent University Hospital
Collaborators: UCB Pharma GmbH
Drug name mappings:
name: 泽卢克布仑钠
lang: CN
name: Zilucoplan
lang: EN
name: ジルコプランナトリウム
lang: JP
Clinical trial NCT01650428: Bevacizumab And Combination Chemotherapy in Rectal Cancer Until Surgery
Official title: A Phase II, Multicentre, Open-Label, Randomised Study of Neoadjuvant Chemotherapy and Bevacizumab in Patients With MRI Defined High-Risk Cancer of the Rectum
Conditions: Rectal Cancer
Summary: The purpose of this study is to evaluate the efficacy, toxicity and feasibility of FOLFOX/ bevacizumab and FOLFOXIRI/ bevacizumab neoadjuvant therapy in poor prognosis rectal cancer as defined by MRI.
Interventions:
description: 5 mg/kg, IV (in the vein) over 30-90 minutes, on day 1 of each 2 weekly cycles. Number of cycles: 1-5 (bevacizumab should not be administered during cycle 6).
name: Bevacizumab
other_name: Avastin
type: Biological
description: 165 mg/m2 IV (intravenous) over 1 hour on day 1 of two weekly cycle. Number of cycles: 1-6
name: Irinotecan
other_name: Campto
type: Drug
description: 165 mg/m2 IV (intravenous) over 1 hour on day 1 of two weekly cycle. Number of cycles: 1-6
name: Oxaliplatin
other_name: Eloxatin
type: Drug
description: 3200 mg/m2 IV (intravenous), continuous infusion over 48 hours starting on day 1 of two weekly cycle. Number of cycles: 1-6
name: 5-Fluorouracil
other_name: 5-FU
type: Drug
Study arms:
design_group_description: Bevacizumab - 5 mg/kg IV over 30-90 minutes (cycles 1-5 only), Oxaliplatin - 85 mg/m2 IV over 2 hours, Folinic acid - 350 mg IV over 2 hours, 5-Fluorouracil - 3200 mg/m2 IV continuous infusion over 48 hour.<br/>Treatment given every 2 weeks for 12 weeks (for 6 cycles)
design_group_title: FOLFOX & Bevacizumab
design_group_type: Experimental
design_group_description: Bevacizumab - 5 mg/kg IV over 30-90 minutes (cycles 1-5 only), Irinotecan - 165 mg/m2 IV over 1 hour, Oxaliplatin - 85 mg/m2 IV over 2 hours, Folinic acid - 350 mg IV over 2 hours, 5-Fluorouracil - 3200 mg/m2 IV continuous infusion over 48 hour.<br/>Treatment given every 2 weeks for 12 weeks (for 6 cycles)
design_group_title: FOLFOXIRI & Bevacizumab
design_group_type: Experimental
Sponsor: University College London
Collaborators: Hoffmann-La Roche, Inc.
Cancer Research UK
Drug name mappings:
name: 贝伐珠单抗
lang: CN
name: Bevacizumab
lang: EN
name: ベバシズマブ（遺伝子組換え）
lang: JP
name: 盐酸伊立替康
lang: CN
name: Irinotecan Hydrochloride
lang: EN
name: イリノテカン塩酸塩水和物
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: 氟尿嘧啶
lang: CN
name: Fluorouracil
lang: EN
name: フルオロウラシル
lang: JP
Clinical trial NCT02662725: Ipilimumab Combined With a Stereotactic Radiosurgery in Melanoma Patients With Brain Metastases
Official title: A Multicenter Phase II Study of Ipilimumab Combined With a Stereotactic Radiosurgery in Melanoma Patients With Brain Metastases
Conditions: Melanoma
Brain Metastasis
Summary: This is a non-controlled, open label, Phase II Study of ipilimumab combined with a Stereotactic Radiosurgery. The study included an induction phase of four IV infusions of Ipilimumab at 10 mg/kg every 3 weeks associated with a stereotactic radiosurgery performed 3 days before 2nd ipilimumab administration. A Maintenance phase included Ipilimumab, IV, 10 mg/kg once every 12 weeks, starting at week 24, in the absence of PD, unacceptable toxicity or withdrawal of consent or disease progression. The primary objective is the overall survival. The Secondary objectives include safety, ORR, PFS and peripheral blood absolute lymphocyte count (ALC) as a predictive biomarker.
Interventions:
name: IPILIMUMAB
type: Drug
name: Stereotactic radiosurgery
type: Radiation
Study arms:
design_group_description: ipilimumab combined with a Stereotactic Radiosurgery in Melanoma Patients with Brain Metastases
design_group_title: ipilimumab + Stereotactic Radiosurgery
design_group_type: Experimental
Sponsor: Centre Hospitalier Universitaire de Lille
Collaborators: Bristol Myers Squibb Co.
Drug name mappings:
name: 伊匹木单抗
lang: CN
name: Ipilimumab
lang: EN
name: イピリムマブ（遺伝子組換え）
lang: JP
Clinical trial NCT01451593: Neuroprotection With Phenytoin in Optic Neuritis
Official title: A Phase II Double Blind, Randomized, Placebo Controlled Trial of Neuroprotection With Phenytoin in Acute Optic Neuritis
Conditions: Optic Neuritis
Multiple Sclerosis
Summary: Optic neuritis is caused by inflammation of the optic nerve and causes loss of vision in the affected eye. It is often associated with multiple sclerosis. Loss of vision after an attack of optic neuritis is caused by damage to the nerve fibres in the optic nerve. There are a number of factors that contribute to nerve fibre damage including increased levels of sodium within them, so blocking sodium entry could help to protect them against damage.
The purpose of this study is determine whether phenytoin (which blocks sodium entry into cells) can protect against loss of nerve fibres and prevent loss of vision after optic neuritis.
Interventions:
description: Phenytoin will be loaded using at total dose of 15mg/kg (rounded to the nearest 100mg) divided into three equal doses given once daily for 3 days.This will be followed by a daily maintenance dose of 4mg/kg once a day (rounded up to the nearest 50mg, with a maximum dose of 300mg)for 13 weeks.Phenytoin levels will be taken at 1 and 3 months.
name: Phenytoin
other_name: Epanutin (Flynn Pharma)
Phenytoin sodium
type: Drug
description: placebo identical in appearance to active IMP (phenytoin)
name: Placebo
type: Drug
Study arms:
design_group_description: active arm of trial 1:1 allocation active versus placebo
design_group_title: phenytoin
design_group_type: Experimental
design_group_description: 1:1 allocation active versus placebo
design_group_title: placebo
design_group_type: Placebo Comparator
Sponsor: University College London
Collaborators: The National Multiple Sclerosis Society
Drug name mappings:
name: 苯妥英
lang: CN
name: Phenytoin
lang: EN
name: フェニトイン
lang: JP
Clinical trial NCT01682031: Selenomethionine in Reducing Mucositis in Patients With Locally Advanced Head and Neck Cancer Who Are Receiving Cisplatin and Radiation Therapy
Official title: Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Phase II Trial of Selenomethionine as a Modulator of Efficacy and Toxicity of Chemoradiation in Locally-Advanced Squamous Cell Carcinoma of the Head and Neck
Conditions: Chemotherapeutic Agent Toxicity
Mucositis
Radiation Toxicity
Stage III Squamous Cell Carcinoma of the Hypopharynx
Stage III Squamous Cell Carcinoma of the Larynx
Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity
Stage III Squamous Cell Carcinoma of the Nasopharynx
Stage III Squamous Cell Carcinoma of the Oropharynx
Stage III Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
Stage IV Squamous Cell Carcinoma of the Hypopharynx
Stage IV Squamous Cell Carcinoma of the Larynx
Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity
Stage IV Squamous Cell Carcinoma of the Nasopharynx
Stage IV Squamous Cell Carcinoma of the Oropharynx
Stage IV Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
Xerostomia
Summary: This randomized phase II trial is studying how well selenomethionine (SLM) works in reducing mucositis in patients with locally advanced head and neck cancer who are receiving cisplatin and radiation therapy. SLM may help prevent or reduce mucositis, or mouth sores, in patients receiving chemotherapy and radiation therapy. It is not yet known whether SLM is more effective than a placebo in reducing mucositis
Interventions:
description: Given PO
name: selenomethionine
type: Dietary Supplement
description: Given PO
name: placebo
other_name: PLCB
type: Other
description: Given IV
name: cisplatin
other_name: CACP
CDDP
CPDD
DDP
type: Drug
description: Undergo radiotherapy
name: radiation therapy
other_name: irradiation
radiotherapy
therapy, radiation
type: Radiation
description: Ancillary studies
name: quality-of-life assessment
other_name: quality of life assessment
type: Procedure
Study arms:
design_group_description: Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.
design_group_title: Arm I (placebo, cisplatin, and radiotherapy)
design_group_type: Placebo Comparator
design_group_description: Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.
design_group_title: Arm II (selenomethionine, cisplatin, and radiotherapy)
design_group_type: Experimental
Sponsor: Roswell Park Comprehensive Cancer Center
Collaborators: National Cancer Institute
Drug name mappings:
name: 顺铂
lang: CN
name: Cisplatin
lang: EN
name: シスプラチン
lang: JP