PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT06788431: A Clinical Study of IMC-001 for Injection in Improving Atherosclerotic Plaque Stability in Patients With Acute Coronary Syndrome.
Official title: A Two-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Investigator-Initiated Trial (IIT) Evaluating the Safety and Preliminary Efficacy of IMC-001 for Injection in Improving Atherosclerotic Plaque Stability in Patients With Acute Coronary Syndrome.
Conditions: Atherosclerosis
Summary: A two-center, randomized, double-blind, placebo-controlled, dose-escalation IIT clinical study evaluating the safety and preliminary efficacy of injectable IMC-001 in improving atherosclerotic plaque stability in patients with acute coronary syndrome. The plan is to conduct 2 dose groups, with 9 subjects enrolled in each group, including 6 in the treatment group and 3 in the control group. The treatment group will receive IMC-001 along with optimal drug therapy, with a total of 12 subjects included, while the control group will receive a placebo along with optimal drug therapy, with a total of 6 subjects included.
Interventions:
description: Subjects receive IMC-001 administered by injection and also receive optimal medical treatment.
name: IMC-001 and Optimal medical treatment
type: Drug
description: Subjects receive IMC-001 placebo administered by injection and also receive optimal medical treatment.
name: IMC-001 placebo and optimal medical treatment
type: Drug
Study arms:
design_group_title: IMC-001 and Optimal medical treatment
design_group_type: Experimental
design_group_title: IMC-001 placebo and Optimal medical treatment
design_group_type: Placebo Comparator
Sponsor: ImmuneOnco Biopharmaceuticals (Shanghai), Inc.
Collaborators: ImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd.
The First Affiliated Hospital of Nanyang Medical College
Drug name mappings:
name: 替达派西普
lang: CN
name: Timdarpacept
lang: EN
Clinical trial NCT04495920: Clinical Evaluation of the Residual Antimicrobial Activity
Official title: Clinical Evaluation of the Residual Antimicrobial Activity of One Test Product Based on the ASTM E2752 Test Method
Conditions: Bacterial Overgrowth
Summary: The purpose of this study is to evaluate the residual antimicrobial efficacy of one test product as defined by the difference between the number of a challenge bacterial species recovered following exposure to the test product and the number recovered when untreated (negative control). The challenge bacterial species to be used is Staphylococcus aureus (ATCC #6538) (S. aureus). Testing will be carried out using a modification of the standardized test method described in ASTM E2752-10 (2015) Standard Guide for Evaluation of Residual Effectiveness of Antibacterial Personal Cleansing Products. Bacterial recoveries will be assayed after application oftest material, using the forearms as a substrate.
Interventions:
description: Alcohol and choline geranate
name: CGB-S-100
other_name: IonLAST gel (CGB-S-100 gel)
type: Drug
Study arms:
design_group_title: Test product
design_group_type: Experimental
Sponsor: CAGE Bio, Inc.
Collaborators: Nelson Laboratories Bozeman LLC
Drug name mappings:
name: CGB-S-100
lang: EN
Clinical trial NCT04130152: Palbociclib Plus Letrozole in Hormone Receptor Positive Residual Disease After Neoadjuvant Chemotherapy
Official title: Palbociclib in Combination With Letrozole in Patients With Hormone Receptor (HR) Positive/Human Epidermal Growth Factor Receptor 2 (HER2) Negative Residual Disease After Standard Neoadjuvant Chemotherapy (PROMETEO II)
Conditions: Breast Cancer
Summary: PROMETEO II is a single-arm window of opportunity trial to evaluate biologic and anti-proliferative effects of palbociclib and letrozole in HR+/HER2-negative operable breast cancer (BC) patients with residual disease after neoadjuvant chemotherapy (NAC) and help to identify biomarkers for better patient selection.
Interventions:
description: Palbociclib 125 mg once daily, day 1 to day 21, followed by 7 days off treatment in a 28-day cycle
name: Palbociclib
other_name: Ibrance
type: Drug
description: Letrozole: oral, 2.5 mg per day continuously. during the 28-day cycle.
name: Letrozole
type: Drug
Study arms:
design_group_description: Palbociclib 125 mg once daily, day 1 to day 21, followed by 7 days off treatment in a 28-day cycle Letrozole: oral, 2.5 mg per day continuously. during the 28-day cycle.<br/>If the patient is pre-menopausal, ovarian suppression with luteinizing hormone-releasing hormone (LHRH) analogues (ie, triptorelin 3.75 mg intra-muscular (IM) or Goserelin 3,6 mg SC) must be initiated at least 2 weeks before palbociclib plus letrozole administration.
design_group_title: Palbociclib + Letrozole
design_group_type: Experimental
Sponsor: Grupo SOLTI
Collaborators: Pfizer Inc.
Drug name mappings:
name: 来曲唑
lang: CN
name: Letrozole
lang: EN
name: レトロゾール
lang: JP
name: 哌柏西利
lang: CN
name: Palbociclib
lang: EN
name: パルボシクリブ
lang: JP
Clinical trial NCT03910842: Treatment of Children CD19+ Leukemia and Non-Hodgkin Lymphoma With CD19-TriCAR-T/SILK Cell Therapy
Official title: Adoptive Immunotherapy for Children CD19+ Leukemia and Non-Hodgkin Lymphoma With CD19-TriCAR-T/SILK Cell
Conditions: Non-Hodgkin Lymphoma of Intestine
Leukemia
Summary: This is a single arm, open-label, early phase Ⅰ study, to determine the safety and efficacy of CD19-TriCAR-T and CD19-TriCAR-SILK cell therapy in Children CD19+ Leukemia Non-Hodgkin lymphoma treatment.
Interventions:
description: A conditioning chemotherapy regimen of fludarabine and cyclophosphamide may be administered, followed by a single infusion of CD19-TriCAR-T cells or 4 repeat infusions of CD19-TriCAR-SILK cells.
name: CD19-TriCAR-T/SILK
type: Biological
Study arms:
design_group_description: CD19-TriCAR-T/SILK cells will be administered intravenously
design_group_title: CD19-TriCAR-T/NK（SILK）
design_group_type: Experimental
Sponsor: Timmune
Collaborators: Hunan Provincial People's Hospital
Drug name mappings:
name: CD19-TriCAR SILK cell therapy (Timmune Biotech)
lang: EN
Clinical trial NCT04587791: Cannabidiol in Opioid Use Disorder and Chronic Pain
Official title: Cannabidiol Pharmacotherapy for Co-occurring Opioid Use Disorder and Chronic Pain
Conditions: Chronic Pain
Opioid Use Disorder
Summary: This is a randomized, placebo-controlled, crossover human laboratory study investigating the dose-dependent safety and acute effects of Cannabidiol (CBD) on measures of pain and opioid craving in outpatients with opioid use disorder (OUD) receiving medication-assisted treatment with methadone or buprenorphine. With a duration of approximately 4 weeks, participants will come to the testing site for a total of five times: one initial screening session, and four experimental sessions where study medication, CBD, will be administered, separated by at least 72 hours to limit carryover effects.
Interventions:
description: Participants will receive 400 mg CBD
name: 400 mg Cannabidiol
other_name: CBD
Epidiolex
type: Drug
description: Participants will receive 800 mg CBD
name: 800 mg Cannabidiol
other_name: CBD
Epidiolex
type: Drug
description: Participants will receive 1200 mg CBD
name: 1200 mg Cannabidiol
other_name: CBD
Epidiolex
type: Drug
description: Participants will receive beta carotene oral solution without CBD (placebo)
name: Beta carotene oral solution without CBD
other_name: Placebo
type: Drug
Study arms:
design_group_description: CBD 400 mg
design_group_title: CBD 400 mg
design_group_type: Active Comparator
design_group_description: CBD 800mg
design_group_title: CBD 800 mg
design_group_type: Active Comparator
design_group_description: CBD 1200 mg
design_group_title: CBD 1200 mg
design_group_type: Active Comparator
design_group_description: Beta carotene oral solution without CBD
design_group_title: Beta carotene oral solution
design_group_type: Placebo Comparator
Sponsor: Yale University
Collaborators: National Institute on Drug Abuse
Drug name mappings:
name: 大麻二酚
lang: CN
name: Cannabidiol
lang: EN
Clinical trial NCT05715606: Safety and Efficacy of Metabolically Armed CD19 CAR-T Cells (Meta10-19) in the Treatment of r/r DLBCL Clinical Research
Official title: Safety and Efficacy of Metabolically Armed CD19 CAR-T Cells (Meta10-19) in the Treatment of r/r DLBCL Clinical Research
Conditions: Diffuse Large B-cell Lymphoma
Summary: A Study of Metabolically Armed CD19 CAR-T Cells Therapy for Patients With Relapsed and/or Refractory Diffuse Large B-Cell Lymphoma
Interventions:
description: Each subject receive metabolically armed CD19 CAR-T cells by intravenous infusion
name: Metabolically Armed CD19 CAR-T cells
other_name: Meta10-19
type: Drug
Study arms:
design_group_description: Patients undergo leukapheresis. Patients will receive a lymphodepletion chemotherapy with cyclophosphamide and fludarabine before CAR-T cells infusion. A dose of metabolically armed CD19 CAR-T cells will be infused on day 0.
design_group_title: Administration of Metabolically Armed CD19 CAR-T cells
design_group_type: Experimental
Sponsor: Anhui Provincial Hospital
Collaborators: Leman Biotech Co., Ltd.
Drug name mappings:
name: Metabolically Armed CD19 CAR-T cells(Leman Biotech )
lang: EN
Clinical trial NCT03771612: Inflammation and Daily Life Study
Official title: Inflammation and Daily Life Study
Conditions: Inflammation
Summary: UCLA researchers looking for healthy individuals (age 45-60) to participate in a study investigating whether an anti-inflammatory medication can impact daily life experiences.
Everyday for two weeks, participants will take either an anti-inflammatory medication (naproxen) twice daily, or a placebo pill twice daily. Participants will also answer daily questions during the 2-week period. Participants will also fill out questionnaires and complete a few tasks on the computer: once prior to the 2-week period and once immediately after the 2-week period, both during online study sessions.
Interventions:
description: Half of the participants will be randomly assigned to receive naproxen twice daily (400 mg total daily; 200 mg 2x a day)
name: Naproxen
type: Drug
description: Half of the participants will be randomly assigned to receive a placebo pill twice daily
name: Placebos
type: Drug
Study arms:
design_group_title: Naproxen
design_group_type: Active Comparator
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: University of California, Los Angeles
Collaborators: National Institute on Aging
Drug name mappings:
name: 萘普生
lang: CN
name: Naproxen
lang: EN
name: ナプロキセン
lang: JP
Clinical trial NCT06171282: A Clinical Study on Oncolytic Virus Injection (R130) for the Treatment of Advanced Bone and Soft Tissue Tumors
Official title: A Clinical Safety and Efficacy Study on Oncolytic Virus Injection (R130) for the Treatment of Advanced Bone and Soft Tissue Tumors
Conditions: Osteosarcoma
Sarcoma
Soft Tissue Sarcoma
Bone Tumor
Summary: 9 participants are expected to be enrolled for this open，Single-armed clinical trial to evaluate the safety and efficacy of the recombinant herpes simplex virus Ⅰ, R130 in patients with advanced bone and soft tissue tumors.
Interventions:
description: R130, a modified herpes simplex virus-Ⅰ (HSV-1) containing the gene coding for anti-CD3 scFv/CD86/PD1/HSV2-US11
name: Recombinant oncolytic herpes simplex virus type Ⅰ (R130)
other_name: Oncolytic virus Injection
type: Drug
Study arms:
design_group_description: Every 7-14 days,1-2 ml R130 （concentration of 1x10^8 plaque-forming Units/mL,PFU/mL）will be injected intratumoral in patients with relapsed/refractory bone and soft tissue tumors.
design_group_title: Experimental: R130 Treatment Group
design_group_type: Experimental
Sponsor: Shanghai Yunying Medical Technology Co., Ltd.
Collaborators: Shanghai First People's Hospital
Drug name mappings:
name: Recombinant oncolytic herpes simplex virus type 1(Shanghai Yunying Medical Technology)
lang: EN
Clinical trial NCT05871320: Novel 99mTc-labeled Somatostatin Antaginosts in the Diagnostic Algotithm of Neuroendocrine Neoplasms
Official title: Novel 99mTc-labeled Somatostatin Antaginosts in the Diagnostic Algotithm of Neuroendocrine Neoplasms - a Feasibility Study
Conditions: Neuroendocrine Tumors
Summary: The main goal of the study is to expand cancer preclinical research results on the usefulness of SSTR2-Antagonist [99mTc]Tc-TECANT1 in clinical practice. Detection of NEN and monitoring of response to therapy is still challenging due to their cellular heterogeneity. Initial preclinical studies suggest that NEN imaging with the use of SSTR2-Antagonist may be advantageous in comparison to the widely used SSTR2-Agonists.
Recently, novel radiopharmaceuticals, based on SSTR2-Antagonists, were shown to provide superior SSTR2 visualisation than currently used agonists. The need for molecular imaging of NEN is expected to grow significantly in the near future due to their increasing incidence and prevalence. Although a persistent trend to shift the molecular imaging of NEN from conventional SPECT/CT gamma cameras to PET/CT has been observed in the last decade, labelling the compound with Tc-99m offers significant advantages by its extremely wide availability, low cost and low radiation exposure to patients. Effective and accessible molecular imaging methods as an integral part of personalised patient management are needed to optimise selection and follow-up of available therapeutic modalities. The Tc-99m-labeled SSTR2-Antagonist [99mTc]Tc-TECANT1 is expected to be an effective, widely available compound for quantitative assessment of SSTR2 NEN status, allowing a personalised therapeutic approach.
Interventions:
description: only one arm - the administration of [99mTC]-Tc-TECANT1 in all patients included
name: [99mTc]Tc-TECANT1
type: Drug
Study arms:
design_group_description: The injection volume will be up to 5 mL over 20 seconds with an activity of 10 MBq/kg body weight (range between min. 500 and max. 800 MBq). To ensure application of the complete activity additionally 10 mL of 0.9% saline will be infused via the same system.
design_group_title: [99mTc]Tc-TECANT1
design_group_type: Experimental
Sponsor: Uniwersytet Jagiellonski
Collaborators: Medical University of Innsbruck
University of Ljubljana
UMC Ljubljana
Drug name mappings:
name: [99mTc]Tc-TECANT1
lang: EN
Clinical trial NCT05105867: CD19 Targeted Universal Chimeric Antigen Receptor T Cells Injection for CD19+ Refractory/Relapsed B-cell Malignancies
Official title: A Single-Arm, Open-Label Study to Evaluate the Efficacy and Safety of Anti-CD19 Universal CAR-T Cells in the Treatment of CD19+ Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia and Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
Conditions: Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia
Relapsed or Refractory B-cell Non-hodgkin Lymphoma
Summary: It is a single-arm, open-label clinical study to assess the safety and efficacy of the Anti-CD19 Universal CAR-T Cells injection for patients with CD19+ refractory/relapsed B cell acute lymphoblastic leukemia and B cell non-Hodgkin lymphoma.
Interventions:
description: Anti-CD19 Universal CAR-T Cells injection will be administered by vein after lymphodepletion.
name: Anti-CD19 Universal CAR-T Cells injection
type: Biological
Study arms:
design_group_description: Anti-CD19 Universal CAR-T Cells injection will be administered by vein after lymphodepletion .
design_group_title: Anti-CD19 Universal CAR-T Cells injection
design_group_type: Experimental
Sponsor: 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Collaborators: Gracell Biotechnologies (Shanghai) Co., Ltd.
Drug name mappings:
name: GC007g
lang: EN
Clinical trial NCT01672255: Hypoglycemia Associated Autonomic Failure in Type 1 Diabetes Mellitus (DM)
Official title: Hypoglycemia Associated Autonomic Failure in Type 1 DM, SSRI and Exercise
Conditions: Type 1 Diabetes
Hypoglycemia Associated Autonomic Failure
Summary: Exercise is a cornerstone of diabetes management. It helps reduce blood pressure, promote weight loss, lower insulin resistance and improve glucose and lipid (triglyceride and HDL-cholesterol) profiles. Unfortunately, the benefits of exercise are often not embraced by diabetic individuals because of the fear of low blood sugar (hypoglycemia). My laboratory has demonstrated that Autonomic nervous system (ANS) counterregulatory failure plays an important role in exercise associated hypoglycemia in Type 1 DM. ANS responses are significantly reduced in Type 1 DM and are further blunted by antecedent episodes of hypoglycemia. Furthermore, there is a large sexual dimorphism of reduced ANS responses during submaximal exercise in both Type 1 DM and healthy individuals that is unexplained. Accumulating data are demonstrating that serotonergic pathways can regulate ANS discharge. Generally, serotonergic pathways are inhibitory but both single and longer term administration of selective serotonin reuptake inhibitors (SSRI's) such as Prozac has been demonstrated to increase basal epinephrine levels and enhance baroreflex control of Sympathetic nervous system (SNS) activity. What is unknown is whether fluoxetine can also enhance SNS responses and also override the large ANS sexual dimorphism present during sub maximal exercise. Therefore, the purpose of this study is to determine if the SSRI fluoxetine (Prozac) can improve SNS responses during exercise.
Interventions:
description: 20 mg week 1, 40 mg week 2, 60 mg week 3, 80 mg week 4-6
name: Fluoxetine
other_name: Prozac
type: Drug
description: 20 mg Week 1, 40 mg Week 2, 60 mg Week 3, 80 mg Week 4-6
name: Placebo control
type: Drug
Study arms:
design_group_description: 90 minute exercise baseline with 6 weeks treatment with SSRI (Prozac). Repeat 90 minute exercise after 6 week treatment.
design_group_title: Trial 1-SSRI
design_group_type: Active Comparator
design_group_description: 90 minute exercise at baseline with 6 weeks treatment with placebo. Repeat 90 minute exercise after 6 weeks treatment of placebo.
design_group_title: Trial 2-Placebo
design_group_type: Placebo Comparator
Sponsor: University of Maryland Baltimore
Collaborators: National Heart, Lung & Blood Institute
Drug name mappings:
name: 盐酸氟西汀
lang: CN
name: Fluoxetine Hydrochloride
lang: EN
Clinical trial NCT02728830: A Study of Pembrolizumab on the Tumoral Immunoprofile of Gynecologic Cancers
Official title: A Pilot Study Investigating the Effect of Pembrolizumab on the Tumoral Immunoprofile of Gynecologic Cancers of Mullerian Origin
Conditions: Gynecologic Neoplasms
Epithelial Ovarian Cancer
Uterine Endometrial Cancer
Fallopian Tube Cancer
Peritoneal Cancer
Summary: The ultimate goal of the study is to identify potential biomarkers, immune gene expression signatures, and co-stimulatory pathways that may be used to understand the effect of immune checkpoint inhibitors on gynecologic cancers.
Interventions:
description: Pembrolizumab 200mg IV
name: Pembrolizumab
other_name: Keytruda
type: Drug
Study arms:
design_group_description: Subjects will receive one dose of 200mg pembrolizumab by IV 14-21 days prior to surgery. Subjects will undergo standard surgical cytoreductive surgery as deemed appropriate by their gynecologic oncologist, followed by standard adjuvant chemotherapy for their cancer as deemed appropriate by their treating physician.<br/>If subject's disease does not get worse following standard of care chemotherapy, they will receive pembrolizumab in the maintenance setting every three weeks for up to a year.<br/>If subject's disease returns after completing a year of pembrolizumab and they have not had adverse reactions to pembrolizumab they may be eligible to continue receiving pembrolizumab for an additional year in the second course phase.
design_group_title: Pembrolizumab
design_group_type: Experimental
Sponsor: Duke University
Collaborators: Merck Sharp & Dohme Corp.
Drug name mappings:
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 NCT00879164: Stellate Ganglion Nerve Block in Treating Women With Hot Flashes
Official title: Pilot Evaluation of a Stellate Ganglion Block for the Treatment of Hot Flashes
Conditions: Hot Flashes
Summary: RATIONALE: A stellate ganglion nerve block may help relieve hot flashes in women.
PURPOSE: This clinical trial is studying how well a stellate ganglion nerve block works in treating women with hot flashes.
Interventions:
name: bupivacaine hydrochloride
type: Drug
name: questionnaire administration
type: Other
Study arms:
Sponsor: Mayo Clinic
Collaborators: National Cancer Institute
Drug name mappings:
name: 盐酸布比卡因
lang: CN
name: Bupivacaine Hydrochloride
lang: EN
name: ブピバカイン塩酸塩水和物
lang: JP
Clinical trial NCT04050410: Autonomic Determinants of POTS - Pilot1
Official title: Autonomic Determinants of Postural Tachycardia Syndrome (Acute Pilot Study 1)
Conditions: Postural Tachycardia Syndrome
Summary: Postural tachycardia syndrome (POTS) is a relatively common condition affecting mostly otherwise healthy young women. It is the cause of significant disability and an impairment in quality of life. These patients have high heart rate and symptoms during standing. Many of these patients are disabled and have a poor quality of life. The sympathetic nerves are part of the nervous system that helps to maintain normal blood pressures and heart rates during activities of daily life. The purpose of this study is to determine the importance of sympathetic activation as a cause of orthostatic symptoms. The investigators will assess the effects of a blood pressure medication (Moxonidine) on the symptoms during standing. Moxonidine lowers sympathetic activity. The investigators believe patients with high resting sympathetic activity might benefit from Moxonidine. It might reduce high heart rate and improve symptoms during standing. This study should help clinicians and the growing population of patients with POTS gain a better understanding of this disorder and find more personalized treatment.
Interventions:
description: active drug given as 1 dose
name: Moxonidine
other_name: Physiotens
type: Drug
description: placebo pill given as 1 dose
name: Placebo
other_name: inactive pill
type: Drug
Study arms:
design_group_description: Patients will receive a single oral dose of moxonidine 0.4 mg.
design_group_title: Moxonidine
design_group_type: Experimental
design_group_description: Patients will receive a single oral dose of placebo.
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: Vanderbilt University Medical Center
Collaborators: National Heart, Lung & Blood Institute
Drug name mappings:
name: 盐酸莫索尼定
lang: CN
name: Moxonidine
lang: EN