PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT00004070: Gene Therapy in Treating Patients With Unresectable, Recurrent, or Refractory Head and Neck Cancer
Official title: A Multi-Center, Open-Label, Multiple Administration, Rising Dose Study of the Safety, Tolerability, and Efficacy of IL-12 Gene Medicine in Patients With Unresectable or Recurrent/Refractory Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Conditions: Head and Neck Cancer
Summary: Participant with squamous cell cancer of head and neck are invited to participate in this study. In this study the investigators will be Inserting the gene for interleukin-12 into a person's cancer cells with the anticipation to make the body build an immune response to kill more tumor cells.
Interventions:
name: IL-12
other_name: CLMF
Interleukin-12 gene
NFSK
P35
type: Biological
Study arms:
design_group_description: The dosing schedule will consist of eight injections 3 mg/ml of formulated plasmid over a seven week period.
design_group_title: IL-12 Injection 3mg/ml [Phase I]
design_group_type: Experimental
design_group_description: The dosing schedule will consist of eight injections 6mg/ml of formulated plasmid over a seven week period.
design_group_title: IL-12 Injection 6mg/ml [Phase I]
design_group_type: Experimental
design_group_description: The dosing schedule will consist of eight injections over a seven week period of formulated plasmid at the MTD established in the phase I portion.
design_group_title: IL-12 Injection MTD [Phase II]
design_group_type: Experimental
Sponsor: Dana-Farber Cancer Institute, Inc.
Collaborators: National Cancer Institute
Drug name mappings:
name: IL-12 gene therapy(Dana-Farber Cancer Institute/Valentis)
lang: EN
Clinical trial NCT03568422: CFI-402257 in Combination With Paclitaxel in Patients With Advanced/Metastatic HER2-Negative Breast Cancer
Official title: A Phase Ib and Open Label Phase II Study of CFI-402257 in Combination With Weekly Paclitaxel in Patients With Advanced/Metastatic HER2-Negative Breast Cancer
Conditions: Breast Cancer
Summary: The standard or usual treatment for this disease is to undergo chemotherapy to slow the spread of disease and relieve some symptoms of cancer. One of the standard types of chemotherapy is a drug called paclitaxel (Taxol) given in a low dose every week for three out of four weeks.
CFI-402257 is a new type of drug for breast cancer. Laboratory tests show that it may help slow the growth of breast cancer. This drug has been shown to shrink tumours in animals. CFI-402257 has been studied in a few people and appears well tolerated with little side effects. CFI-402257 seems promising but it is not clear if it can offer better results when given with paclitaxel compared to paclitaxel alone.
Interventions:
description: Orally taken on intermittent schedule (days 1, 2, 8, 9, 15 & 16
name: CFI-402257
type: Drug
description: 80 mg/m2 IV days 1, 8 & 15 every 28 days
name: Paclitaxel
type: Drug
Study arms:
design_group_description: Oral CFI-402257 on intermittent schedule:* days 1, 2, 8, 9, 15 & 16 q4w Plus Paclitaxel 80 mg/m2 IV days 1, 8 & 15 every 28 days
design_group_title: CFI-402257 + Paclitaxel
design_group_type: Experimental
Sponsor: Canadian Cancer Trials Group
Collaborators: The Canadian Breast Cancer Foundation
Stand Up To Cancer
Ontario Institute for Cancer Research
Drug name mappings:
name: 白蛋白结合型紫杉醇
lang: CN
name: Albumin-Bound Paclitaxel
lang: EN
name: パクリタキセル(JAN)
lang: JP
name: CFI-402257
lang: EN
Clinical trial NCT02363491: A Phase I/II Study of OPN-305 in Second-line Lower Risk Myelodysplastic Syndrome
Official title: A Prospective, Open Label Phase I/II Study to Assess the Safety and Efficacy of Cycles of Intravenously Infused Doses of OPN-305 in Second-line or Third-line Lower (Low and Intermediate-1) Risk Myelodysplastic Syndrome (MDS)
Conditions: Myelodysplastic Syndrome
Summary: The dose-confirming part of this study, comprising at least 10 patients is designed as a single center, prospective, single arm, open label in patients who have failed or are unresponsive to Azacitidine (AZA) or Decitabine (they may also have additionally failed an Erythropoiesis Stimulating Agent (ESA) followed by a dose expansion part with at least 44 patients; the objective of the whole study being to assess the safety, efficacy, pharmacokinetics and pharmacodynamics of intravenously infused multiple doses of OPN-305 in low and intermediate-1 risk myelodysplastic syndrome (second and third line Lower risk MDS).
Interventions:
description: For the dose confirming part of the study, patients will receive a starting dose of 5 mg/kg OPN-305.
name: OPN-305
type: Drug
Study arms:
design_group_description: OPN-305
design_group_title: OPN-305
design_group_type: Experimental
Sponsor: Opsona Therapeutics Ltd.
Collaborators: The University of Texas MD Anderson Cancer Center
Montefiore Medical Center
H. Lee Moffitt Cancer Center & Research Institute, Inc.
Drug name mappings:
name: 托拉利单抗
lang: CN
name: Tomaralimab
lang: EN
Clinical trial NCT01486810: Open-Label Pilot Study of Lisdexamfetamine for Cocaine Dependence
Official title: Open-Label Pilot Study of Lisdexamfetamine for Cocaine Dependence
Conditions: Cocaine Dependence
Summary: The proposed protocol is an open-label pilot study of the treatment of cocaine dependence using lisdexamfetamine (LDX), a prodrug of d-amphetamine. The investigators plan to enroll 12 patients in an eight-week open-label trial to obtain preliminary data regarding the safety, tolerability, and potential utility of lisdexamfetamine for treatment of cocaine dependence and to determine an effective dosage range.
Interventions:
description: Patients will be titrated to the tolerated dose over a two week period, with a maximum of 140mg daily, and then maintained on the highest tolerated dose for four weeks
name: Lisdexamfetamine
other_name: Vyvance
type: Drug
description: All participants will receive medication management counseling and individual therapy using a structured compliance enhancement manual designed for pharmacotherapy trials in subjects with substance use disorders.
name: medication management
type: Behavioral
Study arms:
design_group_description: Patients will be titrated to the tolerated dose of Lisdexamfetamine over a two week period, with a maximum of 140mg daily, and then maintained on the highest tolerated dose for four weeks. All participants will receive medication management counseling and individual therapy using a structured compliance enhancement manual designed for pharmacotherapy trials in subjects with substance use disorders.
design_group_title: Lisdexamfetamine and medication management
design_group_type: Experimental
Sponsor: The New York State Psychiatric Institute
Collaborators: National Institute on Drug Abuse
Drug name mappings:
name: 二甲磺酸赖右苯丙胺
lang: CN
name: Lisdexamfetamine Dimesylate
lang: EN
name: リスデキサンフェタミンメシル酸塩
lang: JP
Clinical trial NCT04111497: Glasdegib for Chronic Graft-Versus-Host Disease
Official title: A Single-Arm, Open-Label, Phase I/II Study of Glasdegib for Sclerotic Chronic Graft-Vs-Host Disease
Conditions: Chronic Graft Versus Host Disease
Fasciitis
Summary: This phase I/II trial studies whether glasdegib is helpful in treating sclerosis associated with chronic graft-versus-host disease. It will also investigate the safety of glasdegib in treating patients with chronic graft-versus-host disease.
Interventions:
description: Given PO
name: Glasdegib
other_name: 1095173-27-5
PF 04449913
PF-04449913
PF04449913
type: Drug
Study arms:
design_group_description: Patients receive glasdegib PO QD on days 1-28. Cycles repeat every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
design_group_title: Treatment (glasdegib)
design_group_type: Experimental
Sponsor: Fred Hutchinson Cancer Research Center
Collaborators: Pfizer Inc.
Drug name mappings:
name: 马来酸格拉吉布
lang: CN
name: Glasdegib Maleate
lang: EN
Clinical trial NCT02452281: Pilot Study to Evaluate the Effects of a Vaccine (HSPPC-96) Combined With Ipilimumab in Patients With Advanced Melanoma
Official title: Phase I-II Pilot Study to Evaluate the Immune-mediated Effects of an Autologous Tumor-derived Heat Shock Protein-peptide Complex 96 (HSPPC-96) Combined With Ipilimumab in Patients With Therapeutically Unresectable Stage III or Stage IV Malignant Melanoma
Conditions: Melanoma
Summary: The purpose of this research study is to see if the combination of HSPPC-96 and ipilimumab is safe and effective in the treatment of advanced melanoma. HSPPC-96 is an investigational vaccine created from tissue from the patient's tumor. The vaccine is designed to capture the cancer's "fingerprint." Injection of the vaccine may cause the patient's immune system to recognize and attack any cells with the specific cancer fingerprint. Ipilimumab is a drug approved by the FDA for the treatment of metastatic melanoma that boosts immune response.
Interventions:
description: 3 mg/kg, IV one day (a minimum of 12 hours and not more than 48 hours) before HSPPC-96 every 21-25 days for a total of 4 cycles.
name: ipilimumab
other_name: Yervoy ®
type: Drug
description: 25 μg by intradermal injection always 12 - 48 hours following ipilimumab on a weekly basis for the first 4 weeks and then every 3 weeks always 12 - 48 hours after ipilimumab; for at least 6 cycles of HSPPC-96 up to 12 doses.
name: HSPPC-96
other_name: heat shock protein-peptide complex 96; Prophage; Vitespen
type: Drug
Study arms:
design_group_description: * Ipilimumab is administered intravenously at a dose of 3 mg/kg one day (a minimum of 12 hours and not more than 48 hours) before HSPPC-96 every 21-25 days for a total of 4 cycles.<br/>* HSPPC-96 is administered at a dose of 25 μg by intradermal injection always 12 - 48 hours following ipilimumab on a weekly basis for the first 4 weeks and then every 3 weeks always 12 - 48 hours after ipilimumab.<br/>* Length of Treatment: 4 cycles of ipilimumab and at least 6 cycles of HSPPC-96 up to 12 doses.<br/>* Booster doses of HSPCC-96 following 6 administrations on subsequent cycles will be administered every 21-23 days according to availability of vaccine.
design_group_title: ipilimumab + HSPPC-96
design_group_type: Experimental
Sponsor: The University of Texas Health Science Center at Houston
Collaborators: Agenus, Inc.
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
name: Oncophage, NewVac adjuvanted(Agenus, Inc.)
lang: EN
Clinical trial NCT03384524: Evaluation of Bromocriptine, Metoprolol and Tamsulosin in Eyes With Non-Central DME
Official title: A Phase I/II Evaluation of Bromocriptine, Metoprolol and Tamsulosin Combination Therapy in Eyes With Non-Central Diabetic Macular Edema
Conditions: Diabetic Macular Edema
Summary: This phase I/II trial is designed to provide proof of concept evidence that combination therapy can have a beneficial effect on DME and possibly prevent increases in retinal volume or progression of non-central DME into the central subfield of the macula. If a beneficial effect is apparent in this phase I/II study involving a relatively small sample size and short follow-up period, its results could be used to in plan future phase III trials. We believe this study will be the first to show that a systems pharmacology approach can successfully address diabetic macular edema, and thus revolutionize the treatment of complex retinal diseases for which there are a paucity of effective treatment options.
Interventions:
description: Administered daily
name: Bromocriptine 2.5 MG
other_name: Bromocriptine Mesylate
type: Drug
description: Administered daily
name: Metoprolol 25 MG
other_name: Metoprolol Tartrate
type: Drug
description: Administered daily
name: Tamsulosin 0.4 MG
other_name: Tamsulosin HCL
Tamsulosin Hydrochloride
type: Drug
description: Three pills, matching active drugs to be administered daily
name: Placebo
type: Other
Study arms:
design_group_description: A combination regiment of Bromocriptine (2.5 mg/day), Metoprolol (25 mg/day) and Tamsulosin (0.4 mg/day)
design_group_title: Combination regiment
design_group_type: Active Comparator
design_group_description: Three placebo pills, matching the external appearance of active drugs
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: University of Southern California
Collaborators: Case Western Reserve University
Drug name mappings:
name: 盐酸坦洛新
lang: CN
name: Tamsulosin Hydrochloride
lang: EN
name: タムスロシン塩酸塩
lang: JP
name: 甲磺酸溴隐亭
lang: CN
name: Bromocriptine Mesylate
lang: EN
name: ブロモクリプチンメシル酸塩
lang: JP
name: 酒石酸美托洛尔
lang: CN
name: Metoprolol Tartrate
lang: EN
name: メトプロロール酒石酸塩
lang: JP
Clinical trial NCT06492863: Gene Therapy(FT-003) for Wet AMD
Official title: A Dose-escalation and Dose-expanded Phase I/II Clinical Study to Evaluate the Safety, and Efficacy of FT-003 in Subjects With Wet AMD
Conditions: Neovascular Age-related Macular Degeneration
Summary: The goal of this clinical trial is to evaluate the safety, tolerability and efficacy of disposable vitreous injection of FT-003 in subjects with neovascular age-related Macular Degeneration (nAMD). The study was divided into two phases, Phase 1 dose escalation and Phase II dose expansion.
Interventions:
description: Administered via intraocular injection.
name: FT-003
type: Genetic
Study arms:
design_group_description: Low dose of FT-003
design_group_title: FT003 Dose 1
design_group_type: Experimental
design_group_description: Mid dose of FT-003
design_group_title: FT003 Dose 2
design_group_type: Experimental
design_group_description: High dose of FT-003
design_group_title: FT003 Dose 3
design_group_type: Experimental
Sponsor: Frontera Therapeutics, Inc.
Collaborators: Peking Union Medical College Hospital
The First Affiliated Hospital of Soochow University
Beijing Hospital of the Ministry of Health
Drug name mappings:
name: FT-003
lang: EN
Clinical trial NCT05507697: Treatment With Human Umbilical Cord Mesenchymal Stem Cells for Refractory Diabetic Peripheral Neuropathy
Official title: Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Refractory Diabetic Peripheral Neuropathy
Conditions: Diabetic Peripheral Neuropathy Type 2
Summary: Diabetic Peripheral Neuropathy (DPN) is one of the most common chronic complications in type 2 diabetes, conventional drug therapy can only target a single pathogenesis but not treat Diabetic Peripheral Neuropathy (DPN) fundamentally. As a novel technique, stem cell transplantation provides a new option for patients with DPN. In 2012, Wuhan Central Hospital, took the lead in carrying out clinical research on the treatment of DPN with autologous bone marrow stem cells in China, and patients were significantly relieved. Based on this research, our clinical trial is to evaluate the safety and efficacy of HUC-MSCs in the treatment of refractory diabetic peripheral neuropathy (DPN) by formulating standard operating procedures (SOP) and quality standards (QS) to explore the possible mechanism of HUC-MSCs in the treatment of DPN.
Interventions:
description: 5 × 10^6 cells/mL, 1 mL per injection, each injection point is 2 cm apart ,1.0-1.5 cm deep, total amount of injection is estimated based on the surface area of the patient's lower limb
name: HUC-MSCs
type: Biological
description: Lipoic Acid Injection，600 mg/d for 15 consecutive days
name: Lipoic Acid
type: Biological
Study arms:
design_group_description: MSCs Participants will received i. m. HUC-MSCs both lower extremities
design_group_title: Experimental
design_group_type: Experimental
design_group_description: The control group will receive i.v Lipoic Acid Injection
design_group_title: Comparator
design_group_type: Placebo Comparator
Sponsor: The Central Hospital Of Wuhan
Collaborators: Vcanbio Cell & Gene Technology Co., Ltd.
Wuhan Optics Valley Vcanbiopharma Co., Ltd.
Drug name mappings:
name: 人脐带源间充质干细胞(武汉光谷中源)
lang: CN
name: VUM-02
lang: EN
Clinical trial NCT03232138: Clinical Trial of Lung Cancer Chemoprevention With Sulforaphane in Former Smokers
Official title: Randomized Clinical Trial of Lung Cancer Chemoprevention With Sulforaphane in Former Smokers
Conditions: Lung Cancer
Summary: This research study involves taking an experimental anti-cancer dietary supplement called Sulforaphane (SF) or a placebo (product without any supplement content) over a period of twelve months in order to determine if it is a useful dietary supplement for prevention of lung cancer in humans.
The main goals of this research study are:
1. To learn about the effects of giving Sulforaphane (SF) to former smokers who are still at high risk of developing cancer due to their smoking history and whether or not their condition improves, stays the same or becomes worse after Sulforaphane (SF) is given.
2. To learn whether Sulforaphane (SF) might reverse some of the lung cell changes associated with future development of lung cancer.
Interventions:
description: Sulforaphane (SF) is a naturally occurring substance (phytochemical) found in cruciferous vegetables.
name: Sulforaphane
other_name: Avmacol®
type: Dietary Supplement
description: Inactive ingredients
name: Placebo
type: Drug
Study arms:
design_group_description: Sulforaphane four tablets 2 times per day with breakfast and dinner each dose contains approximately 120 micromole of Sulforaphane
design_group_title: Sulforaphane (Study Drug)
design_group_type: Experimental
design_group_description: Placebo (containing no active drug) four tablets 2 times per day with breakfast and dinner
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: University of Pittsburgh
Collaborators: National Cancer Institute
Drug name mappings:
name: 磺胺葡聚糖
lang: CN
name: Sulforadex
lang: EN
Clinical trial NCT00937235: Treatment of Smoking Among Individuals With PTSD
Official title: Treatment of Smoking Among Individuals With PTSD: A Phase II, Randomized Study of Varenicline and Cognitive Behavioral Therapy
Conditions: Cigarette Smoking
Nicotine Dependence
Post-traumatic Stress Disorder
Tobacco Use Disorder
Summary: This study will examine the effect of combining prolonged exposure, a cognitive-behavioral treatment program for post-traumatic stress disorder (PTSD) with medication (varenicline) and counseling treatments for smoking cessation. Subjects will be randomly assigned to a 3-month treatment of either: 1) varenicline and smoking cessation counseling alone, or 2) prolonged exposure, varenicline, and smoking cessation counseling. Assessments will be completed at the end of treatment and 6-month follow-up.
We hypothesize that, at the end of treatment and at follow-up, abstinence rates and decrease in cigarettes smoked will be greater among participants who receive the combined treatment for both PTSD and smoking.
Interventions:
description: 1 mg tablets, orally, twice daily x 12 weeks
name: Varenicline
other_name: Chantix
type: Drug
description: 15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation
name: Medication Management Counseling
type: Behavioral
description: 75-90 minute weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders
name: Prolonged Exposure
other_name: Cognitive-Behavioral Therapy
type: Behavioral
Study arms:
design_group_description: Prolonged Exposure + Varenicline + Medication Management Counseling
design_group_title: Integrated Treatment
design_group_type: Experimental
design_group_description: Varenicline + Medication Management Counseling
design_group_title: Varenicline
design_group_type: Active Comparator
Sponsor: University of Pennsylvania
Collaborators: National Institute on Drug Abuse
Drug name mappings:
name: 酒石酸伐尼克兰
lang: CN
name: Varenicline Tartrate
lang: EN
name: バレニクリン酒石酸塩
lang: JP
Clinical trial NCT03126799: A Study of Tarceva vs. Avastin+Tarceva for Advanced NSCLC With EGFR m(+)
Official title: A Randomized Phase II Study of Erlotinib Alone Versus Erlotinib Plus Bevacizumab for Advanced Non-small Cell Lung Cancer With Epidermal Growth Factor Receptor Activating Mutations
Conditions: EGFR Positive Non-small Cell Lung Cancer
Summary: Korean data of treating EGFR mutation positive NSCLC patients with Erlotinib and Bevacizumab is significantly necessary for developing new standard treatment in first-line therapy in Korean EGFR mutant NSCLC patients.
In this study, The investigators will investigate the efficacy and safety of Erlotinib and Bevacizumab combination compare to Erlotinib alone in Korean EGFR-mutant NSCLC patients.
Interventions:
description: Erlotinib 150mg, po, daily, q 3weeks plus Bevacizumab 15mg/kg, IV, on D1 Q 3 weeks
name: Erlotinib plus Bevacizumab
other_name: Tarceva plus Avastin
type: Drug
description: Erlotinib 150mg, po, daily, Q weeks
name: Erlotinib
other_name: Tarceva
type: Drug
Study arms:
design_group_description: Standard therapy arm:<br/>Erlotinib 150mg. po, qd, daily, q 3weeks
design_group_title: A: Erlotinib only
design_group_type: Active Comparator
design_group_description: Study treatment arm; Erlotinib 150mg, po. qd, daily, q 3weeks plus Bevacizumab 15mg/kg, iv, on D1, q 3weeks.
design_group_title: B: Erlotinib plus Bevacizumab
design_group_type: Experimental
Sponsor: National Cancer Center Korea
Collaborators: Roche Korea Co., Ltd.
Drug name mappings:
name: 盐酸厄洛替尼
lang: CN
name: Erlotinib Hydrochloride
lang: EN
name: エルロチニブ塩酸塩
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 NCT05291390: Pyronaridine in Acute Lymphoblastic Leukemia (ALL) and Acute Myeloid Leukemia (AML)
Official title: A Phase 2a, Multi-centre, Randomised, Double-blinded, Placebo-controlled Clinical Trial to Evaluate the Safety and Efficacy of Pyronaridine as an Add-on Therapy in Adults With Acute Lymphoblastic Leukemia and Acute Myeloid Leukemia
Conditions: Acute Myeloid Leukemia (AML)
Acute Lymphoblastic Leukemia (ALL)
Summary: A Phase 2a clinical trial on up to n=200 male and female subjects 18 years and over who were diagnosed with acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL). Subjects are randomised in approximately a 1:1 ratio to receive standard of care treatment plus either pyronaridine (PND) or placebo. Quality of life parameters are measured. Visits include physical examinations, and blood draws for complete blood count with differential (CBC) and complete metabolic panel (CMP). Survival of subjects is tracked in Year 2.
Interventions:
description: Via oral capsules.
name: Pyronaridine Tetraphosphate
other_name: Placebo
type: Drug
Study arms:
design_group_description: Standard of care treatment plus pyronaridine
design_group_title: Standard of care treatment plus pyronaridine
design_group_type: Active Comparator
design_group_description: Standard of care treatment plus placebo
design_group_title: Standard of care treatment plus placebo
design_group_type: Placebo Comparator
Sponsor: Armaceutica, Inc.
Collaborators: Ifakara Health Institute
Drug name mappings:
name: 磷酸咯萘啶
lang: CN
name: Pyronaridine Phosphate
lang: EN