PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT06343532: SXC-2023 Cocaine Interaction Study
Official title: Phase 1, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess Potential Interactions Between Intravenous Cocaine and Oral SXC-2023
Conditions: Cocaine Use Disorder
Summary: The goal of this clinical trial is to determine whether there are any interactions between the study drug and cocaine. Researchers will compare a treatment group and a placebo group to see if they experience any effects when administered cocaine after taking the treatment/placebo.
Interventions:
description: 200 mg capsules
name: SXC-2023
type: Drug
description: 200 mg capsules
name: SXC-2023 Placebo
type: Drug
Study arms:
design_group_description: SXC-2023: 800mg once a day for 7 days
design_group_title: SXC-2023
design_group_type: Experimental
design_group_description: Placebo: 800mg once a day for 7 days
design_group_title: SXC-2023 Placebo
design_group_type: Placebo Comparator
Sponsor: National Institute on Drug Abuse
Collaborators: Technical Resources International, Inc.
Altasciences Co., Inc.
Promentis Pharmaceuticals, Inc.
Drug name mappings:
name: SXC-2023
lang: EN
Clinical trial NCT04721301: Ipilimumab, Maraviroc and Nivolumab in Advanced Metastatic Colorectal and Pancreatic Cancer the LUMINESCENCE Trial
Official title: LUMINESCENCE-001 Ipilimumab, Maraviroc and Nivolumab in Advanced Metastatic Colorectal and Pancreatic Cancer
Conditions: Colorectal Cancer Metastatic
Pancreatic Cancer Metastatic
Summary: The study will be conducted in compliance with Good Clinical Practices (ICH-GCP) and the Declaration of Helsinki, and in accordance with applicable legal and regulatory requirements, including archiving of essential documents.
Interventions:
description: In the single treatment arm, all patients receive Nivolumab, Ipilimumab and Maraviroc
name: Nivolumab plus Ipilimumab plus Maraviroc
type: Combination Product
Study arms:
design_group_description: Treatment arm with Nivolumab, Ipilimumab and Maraviroc combination treatment
design_group_title: Combination immunotherapy
design_group_type: Experimental
Sponsor: University Hospital Heidelberg
Collaborators: German Cancer Research Center
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: 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
name: 马拉韦罗
lang: CN
name: Maraviroc
lang: EN
name: マラビロク
lang: JP
Clinical trial NCT05239676: Autologous Hematopoietic Stem Cell Transplantation Combined With CAR-T Cells in the Treatment of Refractory and Relapsed Malignant Lymphoma
Official title: Clinical Study on the Safety and Effectiveness of Autologous Hematopoietic Stem Cell Transplantation Combined With CAR-T Cells in the Treatment of Refractory and Relapsed Malignant Lymphoma
Conditions: Lymphoma
Summary: Clinical Study on the Safety and Effectiveness of Autologous Hematopoietic Stem Cell Transplantation Combined With CAR-T Cells in the Treatment of Refractory and Relapsed Malignant Lymphoma
Interventions:
description: The patient receives ECHOP chemotherapy or other chemotherapy regimens； G-CSF in the low cell stage mobilizes hematopoietic stem cells and freezes them for later use after collection； Autologous hematopoietic stem cells and prepared CD19 CAR-T cells are reinfused into the patient
name: Autologous hematopoietic stem cell transplantation combined with CD19 CAR-T cells
type: Biological
Study arms:
design_group_description: Refractory and relapsed malignant lymphoma
design_group_title: Treatment of Lymphoma
design_group_type: Experimental
Sponsor: Zhejiang University
Collaborators: Shanghai Yake Biotechnology Co., Ltd
Drug name mappings:
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: Anti-CD19 CART cell therapy (YaKe Biotechnology)
lang: EN
Clinical trial NCT03763084: Impact of Acetaminophen on Postoperative Delirium Elderly Patients After Non-cardiac Surgery
Official title: Impact of Oral Acetaminophen Analgesia on Postoperative Delirium and Long-term Survival in Elderly Patients After Non-cardiac Surgery: A Randomized Controlled Trial
Conditions: Acetaminophen
Delirium in Old Age
Summary: To investigate the impact of acetaminophen analgesia on the frequency of postoperative delirium and 28 days mortality in elderly patients after noncardiac surgery.
Interventions:
description: For patients in the acetaminophen group, oral acetaminophen supplemented dexmedetomidine sedation will be provided after surgery.
name: Acetaminophen
type: Drug
description: For patients in the control group, sufentanil supplemented dexmedetomidine sedation will be provided after surgery.
name: Sufentanil
type: Drug
Study arms:
design_group_description: For patients randomized to OVA group, OVA 500mg was given every 8 hours for the first 48 hours postoperatively. Numeric Pain Rating Scale pain score is assessed every 15 minutes during the 1 hour of ICU stay and when needed.
design_group_title: acetaminophen
design_group_type: Experimental
design_group_description: Sufentanil injection 500μg /10ml in normal saline, total volume 50 ml.Constant infusion dosage is 0.05μg/kg/h. Numeric Pain Rating Scale pain score is assessed every 15 minutes during the 1 hour of ICU stay and when needed.
design_group_title: Sufentanil
design_group_type: Active Comparator
Sponsor: The Third Xiangya Hospital of Central South University
Collaborators: Yale University
Drug name mappings:
name: 对乙酰氨基酚
lang: CN
name: Acetaminophen
lang: EN
name: アセトアミノフェン
lang: JP
Clinical trial NCT07063030: A Study of LX107 Gene Therapy in AIPL1-IRD Patients
Official title: An Exploratory Clinical Study to Evaluate LX107 Gene Therapy in Patients With AIPL1 Biallelic Mutation-related Inherited Retinal Dystrophy (AIPL1-IRD)
Conditions: Retinal Dystrophy
Summary: Administering subretinal injection of LX107 injection (a gene therapy drug) to patients with retinal dystrophy caused by AIPL1 gene mutation to evaluate its efficacy and safety.
Interventions:
description: Subjects will receive subretinal injection of LX107 on Day 0.
name: LX107 Injection
type: Genetic
Study arms:
design_group_description: Experimental: LX107 Injection<br/>Arm Description:<br/>* Low dose group: subretinal injection of LX107 -3×10⁹ VG/eye<br/>* Medium dose group: subretinal injection of LX107- 1×10¹⁰ VG/eye<br/>* High dose group: subretinal injection of LX107 -3×10¹⁰ VG/eye
design_group_title: Intervention
design_group_type: Experimental
Sponsor: Shanghai First People's Hospital
Collaborators: Shanghai Langsheng Biotechnology Co., Ltd.
Drug name mappings:
name: LX-107
lang: EN
Clinical trial NCT06430684: Feasibility Trial of Sodium-GLucose coTransporter 2 INhibitors in Pediatric Chronic KIDney DiSease
Official title: Feasibility Trial of Sodium-GLucose coTransporter 2 INhibitors in Pediatric Chronic KIDney DiSease
Conditions: Chronic Kidney Diseases
Pediatric Kidney Disease
Summary: The goal of this study is to learn if a clinical trial of sodium-glucose co-transporter 2 inhibitors (SGLT2i) is possible in youth with chronic kidney disease (CKD). The investigators also plan to explore whether treatment with SGLT2i (Empagliflozin) helps improve risk factors for worsening kidney and heart disease. The main questions are:
1. Is enrolling 40 youth with CKD into a clinical trial of empagliflozin feasible (ie achievable)?
2. Does taking empagliflozin for 3 months result in positive changes in blood, urine, and heart function tests?
Participants will be randomly selected (like flipping a coin) to either receive empagliflozin or not start treatment with empagliflozin and remain on their usual care.
Study Procedures Include
* For participants randomly selected for treatment, take empagliflozin once daily for 3 months
* Phone calls with researchers every 2 weeks for check-ins
* For participants taking empagliflozin, clinic visits 4 and 8 weeks after starting for check-ups and tests
* All study participants will have clinic visits at the beginning and end (3 months) where researchers will collect information about their health and perform tests
Interventions:
description: Empagliflozin is a sodium glucose co-transporter 2 inhibitor (SGLT2i) that is approved for the treatment of chronic kidney disease (CKD) in persons aged 18 years or older
name: Empagliflozin 10 MG
type: Drug
Study arms:
design_group_description: Empagliflozin 10mg daily for 3 months (n=20)
design_group_title: Treatment
design_group_type: Experimental
design_group_description: Participants will not take empagliflozin (n=20)
design_group_title: Standard of Care
design_group_type: No Intervention
Sponsor: Ann & Robert H. Lurie Children's Hospital of Chicago
Collaborators: National Institute of Diabetes & Digestive & Kidney Diseases
Drug name mappings:
name: 恩格列净
lang: CN
name: Empagliflozin
lang: EN
name: エンパグリフロジン
lang: JP
Clinical trial NCT05111509: A First-in-human Clinical Trial to Evaluate an Alpha-radiation Imaging Agent
Official title: A Phase 0 First-in-human Clinical Trial of [203Pb]VMT-?-NET SPECT/CT for Somatostatin Receptor Imaging of Neuroendocrine Tumors
Conditions: Neuroendocrine Tumor Grade 2
Neuroendocrine Tumor Grade 1
Summary: This is a first in man study to determine if [203Pb]VMT-?-NET identifies neuroendocrine tumors with SPECT/CT. This is the first step to testing [212Pb]-based alpha radiation therapy in neuroendocrine therapy.
Interventions:
description: 3 to 5 miliCuries of [203]Pb administered intravenously 60 minutes before the start of the scans.
name: [203Pb]VMT-?-NET
type: Drug
description: Scans are administered over 3 days: 1 hour post injection, 4 to 8 hours post-injection, 24 to 30 hours post-injection, and 42 to 52 hours post-injection.
name: SPECT/CT
type: Device
Study arms:
design_group_description: injection of [203Pb]VMT-?-NET with serialized imaging and dosimetry measurements
design_group_title: [203Pb]VMT-?-NET SPECT/CT
design_group_type: Experimental
Sponsor: University of Iowa
Collaborators: National Cancer Institute
The Holden Comprehensive Cancer Center
Perspective Therapeutics, Inc.
Drug name mappings:
name: [203Pb]VMT-α-NET
lang: EN
Clinical trial NCT06081153: Mechanistic Clinical Trial of PCSK9 Inhibition for AAA
Official title: A Randomized, Placebo-Controlled Mechanistic Clinical Trial of PCSK9 Inhibition With Evolocumab in Patients Undergoing Open Abdominal Aortic Aneurysm Repair
Conditions: Abdominal Aortic Aneurysm
Summary: The goal of this mechanistic clinical trial is to assess whether lowering the low-density lipoprotein cholesterol (LDL-C) levels in the blood with the injections of the medication evolocumab will have any effect on the tissue or cells of patients with abdominal aortic aneurysm (AAA). Researchers will compare participants receiving evolocumab injections to participants receiving placebo injections to see how the tissue and cells of the aorta are affected by changes in LDL-C levels.
Interventions:
description: See arm description.
name: Evolocumab
type: Drug
description: See arm description.
name: Placebo
type: Drug
Study arms:
design_group_description: Evolocumab is the drug that will be administered in this study. It will be administered as a 140mg subcutaneous injection every 14 days for 5 weeks (for a total of 3 doses).
design_group_title: Evolocumab
design_group_type: Experimental
design_group_description: This arm is a matching placebo that will be administered in the same fashion as the study drug if the patient is randomized to placebo.
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: University of Pennsylvania
Collaborators: National Heart, Lung & Blood Institute
Amgen, Inc.
Drug name mappings:
name: 依洛尤单抗
lang: CN
name: Evolocumab
lang: EN
name: エボロクマブ（遺伝子組換え）
lang: JP
Clinical trial NCT04740580: Glutathione, Brain Metabolism and Inflammation in Alzheimer's Disease
Official title: Glutathione, Brain Metabolism and Inflammation in Alzheimer's Disease
Conditions: Alzheimer Disease
Summary: Alzheimer's disease (AD) is associated with significant, progressive cognitive decline. Key defects in mitochondrial fuel metabolism insulin resistance, inflammation and decreased brain glucose uptake are linked to AD. This trial will investigate the effects of supplementing glycine and N-acetylcysteine vs. alanine as placebo on these defects in AD, and examine the effects on cognition.
Interventions:
description: The active arm will supplement a combination of glycine and N-acetylcysteine (GlyNAC)
name: Glycine
type: Dietary Supplement
description: The active arm will supplement a combination of glycine and N-acetylcysteine (GlyNAC)
name: N-acetylcysteine
type: Dietary Supplement
description: The placebo arm will supplement Alanine
name: Alanine
type: Dietary Supplement
Study arms:
design_group_description: Glycine and cysteine are amino-acid (protein) precursors of glutathione. Cysteine is provided as N-acetylcysteine
design_group_title: Glycine plus N-acetylcysteine
design_group_type: Experimental
design_group_description: Alanine is an amino-acid (protein), and not a precursor of glutathione synthesis
design_group_title: Alanine
design_group_type: Placebo Comparator
Sponsor: Baylor College of Medicine
Collaborators: The Methodist Hospital Research Institute
Drug name mappings:
name: 甘氨酸
lang: CN
name: Glycine
lang: EN
name: 乙酰半胱氨酸
lang: CN
name: Acetylcysteine
lang: EN
name: アセチルシステイン
lang: JP
Clinical trial NCT03477110: Temozolomide, Radiation Therapy, and Tumor Treating Fields Therapy in Treating Participants With Glioblastoma
Official title: SPARE-Scalp Preservation and Radiation Plus Alternating Electric Tumor Treatment Field (NovoTTF, Optune) for Patients With Glioblastoma: A Pilot Study
Conditions: Glioblastoma
Summary: This pilot early phase I trial studies the side effects of temozolomide, radiation therapy, and tumor treating fields therapy using Novo tumor treatment fields (TTF)-200A device in participants with glioblastoma. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. NovoTTF-200A device is a portable device that produces alternating electrical fields that may disrupt growth of cancer cells. Giving temozolomide, radiation therapy, and tumor treating fields therapy using NovoTTF-200A device may work better in treating participants with glioblastoma.
Interventions:
description: Given PO
name: Temozolomide
other_name: 362856
Methazolastone
Temcad
Temodal
Temodar
type: Drug
description: Undergo radiation therapy
name: Radiation Therapy
other_name: Cancer Radiotherapy
Irradiate
RT
type: Radiation
description: Undergo tumor treatment fields therapy using NovoTTF-200A device
name: NovoTTF-200A Device
other_name: Optune
type: Device
description: Undergo tumor treatment fields therapy using NovoTTF-200A device
name: Tumor Treating Fields Therapy
other_name: Alternating Electric Field Therapy
type: Procedure
Study arms:
design_group_description: Participants receive temozolomide PO QD starting day 1 to the end of radiation therapy and undergo 30 fractions of radiation therapy over 15-20 minutes each, 5 days a week (Monday-Friday) for 6 weeks. Beginning day 1 of radiation therapy, participants undergo tumor treatment fields therapy using NovoTTF-200A device over 18 hours or more daily in the absence of disease progression or unacceptable toxicity. Beginning 28 days after the last dose of radiation therapy, participants receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
design_group_title: Treatment (temozolomide, radiation, NovoTTF-200A device)
design_group_type: Experimental
Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University
Collaborators: NovoCure Ltd.
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 NCT03815084: A Study of PD1 Combined With DC-NK Cell in the Treatment of Solid Tumors
Official title: Clinical Study on the Safety and Efficacy of PD1 Combined With DC-NK Cell in the Treatment of Solid Tumors
Conditions: Solid Tumor
Summary: clinical study on the safety and efficacy of PD1 combined with dc-Nk in the treatment of solid tumors
Interventions:
description: total dose of 10ml KEYTRUDA® (pembrolizumab) will be administered at day0, 60million DC cells and 3 billion NK at day1, 3 billion NK cells at day2, 3 billion NK cells at day3 .
name: pd-1 and DC-NK cells
type: Drug
Study arms:
design_group_title: PD-1 and DC-NK treatment group
design_group_type: Experimental
Sponsor: Beijing Allife Medicine Technology Co., Ltd.
Collaborators: Henan Provincial Peoples Hospital
Beijing Hospital of the Ministry of Health
Drug name mappings:
name: DC-NK cells(Allife Medicine Technology)
lang: EN
name: 帕博利珠单抗
lang: CN
name: Pembrolizumab
lang: EN
name: ペムブロリズマブ（遺伝子組換え）
lang: JP
Clinical trial NCT05747469: Use of Allograft Adipose Matrix for Small Joint Arthritis of the Hand
Official title: Use of Allograft Adipose Matrix for Small Joint Arthritis of the Hand
Conditions: Osteoarthritis Hand
Summary: The purpose the research is to evaluate the safety and efficacy of injection of adipose allograft matrix (AAM) to the small joints of the hand for treatment of early stage osteoarthritis. The hypothesis is that use of AAM injected directly into the joint will show improvements in pain and disability while providing a safe, off-the-shelf alternative which can obviate the need for, and risks associated with, current treatment options with autologous fat transfer.
As standard of care, routine strength, pain scale scores (VAS) and range of motion will be recorded, a baseline disability survey (DASH score) will also be administered. After these have all been recorded and administered in a separate visit the patient will undergo the lipofilling procedure.
The subject population will include patients over the age of 18 who present with joint pain of the hand with radiographic evidence of osteoarthritis.
Interventions:
description: Subcutaneous local anesthesia with 1% lidocaine without epinephrine is administered to the skin overlying the joint.
name: local anaesthetic injection
other_name: Lidocaine
type: Drug
description: Light axial traction of the digit is used to open the joint space when introducing the 18-gauge needle. Fluoroscopy is used to assist with visualization 1 cc of Leneva is injected into the CMC joint and 0.5 cc in the IP, PIP and DIP joints. The puncture is dressed with a band-aid and coban wrap, which will be worn for 48 hours. Return to work and normal use of the hand is recommended at 48 hours. No narcotics are prescribed.
name: Human Adipose Allograft
other_name: Leneva
type: Procedure
Study arms:
design_group_description: Using fluoroscopic guidance (X-ray), a needle will be injected into the joint space. 1 cc of Leneva (adipose allograft matrix, MTF Biologics) will be injected into the joint.
design_group_title: Adipose Allograft Matrix (AAM)
design_group_type: Other
Sponsor: Cedars-Sinai Medical Center
Collaborators: Musculoskeletal Transplant Foundation
Drug name mappings:
name: 利多卡因
lang: CN
name: Lidocaine
lang: EN
name: リドカイン
lang: JP
Clinical trial NCT06212271: Mechanistic Clinical Trial of Colchicine in Patients With Peripheral Artery Disease
Official title: A Randomized, Placebo-Controlled Mechanistic Clinical Trial of Colchicine in Patients With Peripheral Artery Disease
Conditions: Peripheral Artery Disease
Summary: The goal of this mechanistic clinical trial is to test the effects of reducing inflammatory signaling in femoral artery atherosclerotic plaques. Researchers will compare patients receiving colchicine to patients receiving placebo to determine the effect of colchicine on the inflammatory state of atherosclerotic femoral arteries.
Interventions:
description: See arm description.
name: Colchicine
type: Drug
description: See arm description.
name: Placebo
type: Drug
Study arms:
design_group_description: Colchicine (0.6 mg oral daily for 4-weeks) will be the drug administered in this study.
design_group_title: Colchicine
design_group_type: Experimental
design_group_description: This arm is a matching placebo that will be administered in the same fashion as the experimental arm.
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: University of Pennsylvania
Collaborators: Doris Duke Foundation
Drug name mappings:
name: 秋水仙碱
lang: CN
name: Colchicine
lang: EN
name: コルヒチン
lang: JP
Clinical trial NCT06212388: Allogeneic Gammadelta T Cells Combined With Interferon-α1b or PD-1 Monoclonal Antibody in Stage III-IV Amenable to Surgical Resection Melanoma
Official title: Efficacy and Safety of Allogeneic γδ T Cells (γδ T Cells) Combined With Interferon-alpha1b (IFN-α1b) or PD-1 Monoclonal Antibody in Neoadjuvant Treatment of Stage III-IV Resectable Melanoma
Conditions: Melanoma
Summary: The purpose of this study is to evaluate the efficacy and safety of allogeneic γδ T cells combined with recombinant human interferon-α1b (IFN-α1b) or PD-1 monoclonal antibody in neoadjuvant treatment of patients with Stage III-IV resectable melanoma.
Interventions:
description: Cells will be extracted from a healthy donor by apheresis, followed by ex-vivo expansion and activation. The ex-vivo expanded γδT cells from donors will be adoptively transfused.
name: Ex-vivo expanded allogeneic γδ T cells
type: Biological
description: Recombinant human interferon α1b is a protein with potent antiviral, antiproliferative and immunomodulatory properties.
name: Recombinant human interferon α1b
type: Drug
description: Pembrolizumab is a recombinant, humanized programmed death receptor (PD-1) monoclonal antibody that binds to PD- and prevents binding of PD-1 with programed death ligands 1 (PD-L1) and PD-L2. It can function to activate cytotoxic T lymphocytes and inhibit tumor growth.
name: Pembrolizumab
type: Drug
Study arms:
design_group_description: Stage 1: Neoadjuvant stage (Week 1-9, 3 cycles)<br/>Stage 2: Surgical period (2 weeks, ±7 days after the last dose of neoadjuvant therapy) After multidisciplinary MDT team evaluation, the primary lesion and metastasis were resected in the corresponding departments.<br/>Stage 3: Postoperative adjuvant period (3 weeks ±7 days -45 weeks, 15 cycles) γδ T cells administered intravenously every three weeks. Recombinant human interferon α1b administered 300μg every other day.
design_group_title: group A: IFN-α1B+ γδ T cells
design_group_type: Experimental
design_group_description: Stage 1: Neoadjuvant stage (Week 1-9, 3 cycles)<br/>Stage 2: Surgical period (2 weeks, ±7 days after the last dose of neoadjuvant therapy) After multidisciplinary MDT team evaluation, the primary lesion and metastasis were resected in the corresponding departments.<br/>Stage 3: Postoperative adjuvant period (3 weeks ±7 days -45 weeks, 15 cycles) γδ T cells administered intravenously every three weeks.Pembrolizumab administered 200mg intravenously every three weeks.
design_group_title: group B: Palizizumab+ γδ T cells
design_group_type: Active Comparator
Sponsor: Xijing Hospital
Collaborators: Beijing Jiadehe Cell Therapy Technology Co., Ltd
Drug name mappings:
name: Allogenic gamma delta T cell therapy (Beijing GD Initiative Cell Therapy Technology)
lang: EN