PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT05904743: INHALE-3: Afrezza® Combined With Insulin Degludec Versus Usual Care in Adults With Type 1 Diabetes
Official title: INHALE-3: A 17-Week Randomized Trial and a 13-Week Extension, Evaluating the Efficacy and Safety of Inhaled Insulin (Afrezza) Combined With Insulin Degludec Versus Usual Care in Adults With Type 1 Diabetes
Conditions: Diabetes Mellitus, Type 1
Summary: INHALE-3 is a Phase 4, randomized controlled trial (RCT) that will randomly assign participants ≥18 years of age with type 1 diabetes (T1D) using multiple daily injections (MDI), an automated insulin delivery (AID) system, or a pump without automation, and continuous glucose monitoring (CGM) 1:1 to an insulin regimen of insulin degludec plus inhaled insulin (Afrezza) and CGM or continuation of usual care. The primary outcome of the RCT is at 17 weeks. The RCT will be followed by a 13-week extension phase in which participants in both groups will use the degludec-inhaled insulin regimen.
Interventions:
description: Pharmaceutical form: powder Route of administration: inhalation
name: Afrezza
other_name: Technosphere Insulin
type: Biological
description: Pharmaceutical form: solution for injection Route of administration: subcutaneous
name: insulin degludec
type: Biological
description: Pharmaceutical form: clear and colorless solution for injection Route of administration: subcutaneous
name: Rapid-acting Insulin Analog
other_name: any FDA approved Rapid-acting Insulin Analog
type: Biological
description: Pharmaceutical form: clear and colorless solution for injection Route of administration: subcutaneous
name: Basal Insulin
other_name: any FDA approved Basal Insulin
type: Biological
Study arms:
design_group_description: The Afrezza-Degludec group will inhale Afrezza at meals and corrections and will inject insulin degludec once a day for the 17 weeks of the RCT Phase. Dexcom Continuous Glucose Monitoring (CGM) will be provided. The Afrezza-Degludec group will continue to use Afrezza and insulin degludec for an additional 13 weeks in the Extension Phase.
design_group_title: Afrezza (Technosphere Insulin) + insulin degludec
design_group_type: Experimental
design_group_description: The Usual Care group will continue to receive insulin as they did before the study. This could be by multiple daily injections (MDI) or by using an insulin pump with or without automation for the 17 weeks of the randomized controlled trial (RCT) Phase. Participants will continue to use their personal continuous glucose monitor (CGM) as they did before the study. The Usual Care group will then use Afrezza and insulin degludec for 13 weeks in the Extension Phase. Dexcom CGM will be provided during the Extension Phase.
design_group_title: Usual Care: Insulin delivery with either MDI, a pump without automation, or an AID system and CGM
design_group_type: Active Comparator
Sponsor: MannKind Corp.
Collaborators: Jaeb Center For Health Research Foundation, Inc.
Drug name mappings:
name: 德谷胰岛素
lang: CN
name: Insulin degludec
lang: EN
name: インスリン デグルデク (遺伝子組換え)
lang: JP
name: 人胰岛素
lang: CN
name: Insulin Recombinant Human(MannKind)
lang: EN
Clinical trial NCT02476409: Tolvaptan For Worsening Outpatient Heart Failure: Role of Copeptin In Identifying Responders
Official title: Tolvaptan Treatment to Reverse Worsening Outpatient Heart Failure: Possible Role of Copeptin In Identifying Responders (TROUPER)
Conditions: Congestive Heart Failure
Summary: Patients who present to clinic or in the outpatient setting with worsening heart failure represent a unique opportunity for novel approaches to decongestion (removing fluid) that may more rapidly improve fluid status and symptoms as well as reduce the risk of hospitalization.
In these patients with less severe congestion (fluid overload), combining the vasopressin antagonist tolvaptan with loop diuretics (or fluid pills like furosemide/bumetanide/torsemide) may represent a more effective strategy for decongestion. In addition, looking at patients' copeptin levels may help identify those who are more likely to respond to tolvaptan.
Interventions:
description: Study will test the addition of tolvaptan to augmentation of loop diuretic as standard of care for outpatients presenting with worsening heart failure.
name: tolvaptan
other_name: Samsca
type: Drug
description: Placebo for tolvaptan
name: Placebo
type: Other
Study arms:
design_group_description: Augmentation of current dose of loop diuretic + 30 mg of oral tolvaptan daily
design_group_title: Tolvaptan
design_group_type: Experimental
design_group_description: Augmentation of current dose of loop diuretic
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: The University of North Carolina at Chapel Hill
Collaborators: Otsuka America Pharmaceutical, Inc.
Drug name mappings:
name: 托伐普坦
lang: CN
name: Tolvaptan
lang: EN
name: トルバプタン
lang: JP
Clinical trial NCT07177417: Characterizing the Human Airway Immune Response to FluMist Vaccination
Official title: EVax-3: Human Upper and Lower Airway Mucosal Immune Response to FluMist Vaccination
Conditions: Healthy Young Adults
Influenza Vaccines
Influenza Vaccine Response
Summary: The goal of this clinical trial is to measure the immune response in the blood, nose, and lungs after participants receive either the FDA-approved inactivated influenza vaccine or the FDA-approved intranasal FluMist vaccine. The study will evaluate immune responses in groups of healthy, non-pregnant, volunteers between the ages of 18 and 40. The main purpose of the study is to measure the change in influenza vaccine-specific antibodies in the lower lungs and nose between vaccination and 14 days after participants receive the vaccine. All participants will be randomized to receive one of the two seasonal flu vaccines and will have blood and back of the nose swabs collected throughout the study. Some study participants will choose to undergo optional bronchoscopy procedures and will be included in the part of the study looking at lower lung immune responses.
Interventions:
description: intranasal administered live attenuated influenza vaccine
name: FluMist
type: Biological
description: intramuscular administered inactivated influenza vaccine
name: inactivated influenza vaccine
other_name: FLUARIX
type: Biological
description: bronchoscopy with bronchoalveolar lavage and endobronchial biopsy sampling
name: bronchoscopy
type: Procedure
Study arms:
design_group_description: Individuals who undergo all bronchoscopy procedures randomized to receive FluMist vaccine
design_group_title: FluMist bronchoscopy group
design_group_type: Experimental
design_group_description: Individuals who do not complete day 14 or day 90 bronchoscopy procedures randomized to receive FluMist vaccine
design_group_title: FluMist no bronchoscopy group
design_group_type: Experimental
design_group_description: Individuals who undergo all bronchoscopy procedures randomized to receive inactivated influenza vaccine
design_group_title: inactivated influenza vaccine bronchoscopy group
design_group_type: Active Comparator
design_group_description: Individuals who do not complete day 14 or day 90 bronchoscopy procedures randomized to receive inactivated influenza vaccine
design_group_title: inactivated influenza vaccine no bronchoscopy group
design_group_type: Active Comparator
Sponsor: Washington University School of Medicine
Collaborators: AstraZeneca PLC
Drug name mappings:
name: Influenza virus vaccine live intranasal (quadrivalent)(MedImmune LLC)
lang: EN
name: 経鼻弱毒生インフルエンザワクチン
lang: JP
Clinical trial NCT04790305: Effect of Huaier Granule on Adjuvant Treatment for High-risk Early-stage Triple-negative Breast Cancer
Official title: Effect of Huaier Granule on Postoperative Adjuvant Treatment for High-risk Early-stage Triple-negative Invasive Ductal Carcinoma: a Prospective, Multicenter, Randomized, Controlled, Open-label Study
Conditions: Carcinoma Breast
Triple-negative Breast Cancer
Invasive Ductal Carcinoma, Breast
Summary: This is a prospective, multicenter, randomized, parallel controlled, open-label study. The primary purpose of this study is to evaluate the efficacy of Huaier Granule on postoperative adjuvant therapy of high-risk early-stage triple-negative invasive ductal carcinoma. The Secondary purposes are to evaluate the safety of long-term use of Huaier granules as postoperative adjuvant treatment of high-risk early-stage triple-negative invasive ductal carcinoma, and the changes of quality of life score after treatment with Huaier granule.
Interventions:
description: The subjects in the experimental group will be treated with Huaier Granule continuously for 2 years or until the disease progressed, intolerable toxicity, withdrawal of informed consent form or died for any reason.
name: Huaier Granule
other_name: Z20000109（NMPA Approval Number）
type: Drug
Study arms:
design_group_description: Huaier Granule: oral administration, 20g each time, 3 times a day. The starting time of Huaier granule: from the beginning of adjuvant therapy to the end of adjuvant therapy, and within 60 days after the end of adjuvant therapy is also acceptable.<br/>Conventional Treatment/visit：The postoperative adjuvant therapy and visit of TNBC are based on clinical routine.
design_group_title: Huaier Granule + Conventional Treatment/visit
design_group_type: Experimental
design_group_description: Conventional Treatment/visit：The postoperative adjuvant therapy and visit of TNBC are based on clinical routine.
design_group_title: Conventional Treatment/visit
design_group_type: No Intervention
Sponsor: Fudan University
Collaborators: Huazhong University of Science & Technology
Linkdoc Technology (Beijing) Ltd.
Drug name mappings:
name: 槐耳颗粒
lang: CN
name: Huaier Granule
lang: EN
Clinical trial NCT04661709: Efficacy and Safety of Wen Xin Granules for the Treatment of Unstable Angina Pectoris
Official title: Efficacy and Safety of Chinese Herbal Medicine Wen Xin Granules for the Treatment of Unstable Angina Pectoris With Yang Deficiency and Blood Stasis Syndrome: Study Protocol for a Randomized Controlled Trial
Conditions: Coronary Heart Disease
Unstable Angina
Chinese Herbal Medicine
Summary: This is a double-blind, randomized placebo-controlled trial which aims to evaluate the efficacy and safety of Wen Xin granule in patients with unstable angina pectoris.
Interventions:
description: one dose daily, two times per day.
name: Wen Xin granule
other_name: WXG
type: Drug
description: one tablet daily. (for patients who can't use aspirin)
name: Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet
type: Drug
description: 20 mg tablet, one tablet each night.
name: Atorvastatin Calcium
type: Drug
description: one tablet， twice daily.
name: Isosorbide Mononitrate Tab 20 MG
type: Drug
description: 12.5 mg or 25 mg, two times daily.
name: Metoprolol Tartrate Tab 25 MG
type: Drug
description: 100mg tablet, one tablet daily.
name: Aspirin Enteric-coated Tablets
type: Drug
description: one dose daily, two times per day.
name: WXG placebo
type: Drug
description: 20 mg tablet, one tablet three times daily.
name: Trimetazidine Dihydrochloride Tablets
type: Drug
description: be taken when angina pectoris attacks.
name: glyceryl trinitrate
type: Drug
Study arms:
design_group_description: Patients are given Wen Xin granule by mouth, one dose daily for 2 months & Conventional western medicine, including Aspirin Enteric-coated Tablets 100mg qd, Clopidogrel Hydrogen Sulfate 75 mg qd, Atorvastatin Calcium 20mg qn, Isosorbide Mononitrate Tab 20 mg bid, Metoprolol Tartrate Tab 25mg, Trimetazidine Dihydrochloride Tablets 20mg tid.
design_group_title: Wen Xin granule
design_group_type: Experimental
design_group_description: Patients are given Wen Xin granule placebo by mouth, one dose daily for 2 months & Conventional western medicine, including Aspirin Enteric-coated Tablets 100mg qd, Clopidogrel Hydrogen Sulfate 75 mg qd, Atorvastatin Calcium 20mg qn, Isosorbide Mononitrate Tab 20 mg bid, Metoprolol Tartrate Tab 25mg, Trimetazidine Dihydrochloride Tablets 20mg tid.
design_group_title: WXG placebo
design_group_type: Placebo Comparator
Sponsor: Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Collaborators: National Natural Science Foundation of China
Drug name mappings:
name: 阿托伐他汀钙
lang: CN
name: Atorvastatin Calcium
lang: EN
name: アトルバスタチンカルシウム水和物
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
name: 稳心颗粒
lang: CN
name: Wenxin granules
lang: EN
name: 三硝酸酯
lang: CN
name: Trinitrate
lang: EN
name: ニトログリセリン
lang: JP
name: 阿司匹林
lang: CN
name: Aspirin
lang: EN
name: サリチル酸
lang: JP
name: 单硝酸异山梨酯
lang: CN
name: Isosorbide Mononitrate
lang: EN
name: 一硝酸イソソルビド
lang: JP
name: 盐酸曲美他嗪
lang: CN
name: Trimetazidine Hydrochloride
lang: EN
name: トリメタジジン塩酸塩
lang: JP
Clinical trial NCT05684731: Safety and Efficacy of KM1 in Subjects With Recurrent or Refractory Ovarian Cancer
Official title: A Single-Arm, Open-Label Clinical Study to Evaluate the Safety, Tolerance and Preliminary Efficacy of KM1 Oncolytic Vaccinia Virus Injection Combined With Chemotherapy in Subjects With Recurrent or Refractory Ovarian Cancer
Conditions: Ovarian Cancer
Summary: The purpose of this study is to determine if KM1 is well tolerated with anti-tumor activity in patients diagnosed with recurrent or refractory ovarian cancer, and explore the Recommend Phase 2 Dose (RP2D) of KM1 in the treatment of patients with recurrent or refractory ovarian cancer.
Interventions:
description: Administer via intraperitoneal infusion for 3 or 6 doses Q3D.
name: KM1
type: Biological
description: Physician's Choice of carboplatin (preferred) or cisplatin，gemcitabine, taxane (paclitaxel, docetaxel or nab-paclitaxel) or pegylated liposomal doxorubicin，with or without bevacizumab.<br/>Administer beginning in Week 5 or Week 6.
name: Chemotherapy
type: Drug
Study arms:
design_group_description: Biological: KM1 Administer via intraperitoneal infusion for 3 or 6 doses Q3D.<br/>Drug: Chemotherapy: Physician's Choice of carboplatin (preferred) or cisplatin，gemcitabine, taxane (paclitaxel, docetaxel or nab-paclitaxel) or pegylated liposomal doxorubicin，with or without bevacizumab.<br/>Administer beginning in Week 5 or Week 6.
design_group_title: Experimental: KM1 + Chemotherapy
design_group_type: Experimental
Collaborators: Shenzhen Huayao Kangming Biopharmaceutical Co., Ltd.
Qilu Hospital of Shandong University
Drug name mappings:
name: KM1溶瘤痘苗病毒(Shenzhen Huayao Kangming Biopharmaceutical)
lang: CN
name: Oncolytic vaccinia virus (Huayao Kangming)
lang: EN
Clinical trial NCT02792114: T-Cell Therapy for Advanced Breast Cancer
Official title: A Phase I Clinical Trial to Evaluate the Safety and Tolerability of Mesothelin-Specific Chimeric Antigen Receptor-Positive T Cells in Patients With Metastatic Mesothelin-Expressing Breast Cancer
Conditions: Breast Cancer
Metastatic HER2-negative Breast
Summary: The purpose of this study is to test the safety of different doses of specially prepared T cells collected from the blood. The investigators want to find a safe dose of these modified T cells for patients who have metastatic HER2-negative breast cancer.
Interventions:
name: Cyclophosphamide
type: Drug
name: Mesothelin-targeted T cells
type: Biological
name: AP1903
type: Drug
Study arms:
design_group_description: A single blood volume leukapheresis for harvesting of PBMCs will be performed, As the transduced T cells will be frozen, the timing of leukapheresis is not defined & can vary from patient to patient. Subsequently, a single dose of mesothelin-targeted T cells will be infused via intravenous catheter or central line (i.e., mediport). Patients will be monitored in the hospital and discharged home after a minimum of 48 hours. Patients will be monitored closely as outpatients for the next 2 months. Patients will be followed weekly as outpatients for the first 8 weeks after treatment. All patients will be hydrated intravenously, premedicated with acetaminophen & diphenhydramine, & administered cyclophosphamide at 1.5 g/m2 2 to 7 days (Day -7 to Day -2) before administration of mesothelin-targeted T cells.
design_group_title: T-cell infusion
design_group_type: Experimental
Sponsor: Memorial Sloan Kettering Cancer Center
Collaborators: Defense Language Institute Foreign Language Center
Drug name mappings:
name: ATA-2271
lang: EN
name: 环磷酰胺
lang: CN
name: Cyclophosphamide
lang: EN
name: シクロホスファミド水和物
lang: JP
name: Rimiducid
lang: EN
Clinical trial NCT04015700: Neoantigen-based Personalized DNA Vaccine in Patients With Newly Diagnosed, Unmethylated Glioblastoma
Official title: A Pilot Study to Assess the Safety, Feasibility, and Immunogenicity of a Neoantigen-based Personalized in Patients With Newly Diagnosed, Unmethylated Glioblastoma
Conditions: Glioblastoma
Summary: This is a single institution, open-label, single arm, study assessing the safety, feasibility, and immunogenicity of a personalized neoantigen-based vaccine in subjects with newly diagnosed, unmethylated glioblastoma.
Interventions:
description: -The neoantigen DNA vaccines are also known as DNA plasmid vector expressing tumor-specific antigens.
name: Personalized neoantigen DNA vaccine supplied by Geneos Therapeutics
other_name: GNOS-PV01
Vaccine
type: Biological
description: CELLECTRA® 2000 Device is a system indicated for use to enhance the uptake and expression of plasmid-based biologics in order to enhance vaccine efficacy.
name: CELLECTRA®2000 EP Device supplied by Geneos Therapeutics
type: Device
description: The INO-9012 vials will be supplied by Geneos Therapeutics
name: Plasmid encoded IL-12
other_name: INO-9012
type: Drug
Study arms:
design_group_description: * Standard radiation therapy will be administered per standard of care and is outside the scope of this study.<br/>* GNOS-PV01 + INO-9012 will be given on Days 1, 22, and 43 of Cycle 1 and then on Day 1 of each subsequent cycle beginning with Cycle 2.
design_group_title: Vaccine (GNOS-PV01 + INO-9012)
design_group_type: Experimental
Sponsor: Washington University School of Medicine
Collaborators: National Institute of Neurological Disorders & Stroke
Geneos Therapeutics, Inc.
Barnes-Jewish Hospital Foundation
Drug name mappings:
name: Rocakinogene Sifuplasmid
lang: EN
name: GNOS PV01 + INO 9012
lang: EN
Clinical trial NCT02063555: Phase I Trial of DAR-901
Official title: A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Multiple-Dose, Dose-Ranging Study of the Safety and Immunogenicity of DAR-901, a Killed, Non-Tuberculous Mycobacterial Vaccine, in HIV-negative and HIV-positive Adults Who Have Previously Received BCG
Conditions: Tuberculosis
Summary: This is a Phase 1, randomized, controlled, double-blind, multiple-dose, dose-ranging study of DAR 901, (an inactivated whole cell mycobacterial vaccine) to be conducted in HIV negative and HIV positive adults previously vaccinated with BCG. The goals of the trial are to determine the safety, tolerability, and immunogenicity of multiple doses of the vaccine at different dose levels, ranging from 0.1 to 1 mg.
Interventions:
name: DAR-901
type: Biological
name: BCG
type: Biological
name: Sterile saline
type: Biological
Study arms:
design_group_description: Intradermal administration at 0, 2 and 4 months<br/>Three dose groups in dose escalation: 0.1 mg, 0.3 mg and 1.0 mg, all constituted in 0.1 mL
design_group_title: DAR-901
design_group_type: Experimental
design_group_description: Intradermal injection of 0.1 mL saline at 0 mos, 2 mos, intradermal injection of 0.1 mL BCG at 4 mos
design_group_title: BCG
design_group_type: Active Comparator
design_group_description: Intradermal injection of 0.1 mL sterile saline at 0, 2 and 4 mos
design_group_title: Sterile saline
design_group_type: Placebo Comparator
Sponsor: Dartmouth-Hitchcock Medical Center
Collaborators: Aeras Global TB Vaccine Foundation
Drug name mappings:
name: IMM-201
lang: EN
Clinical trial NCT06249438: A Study of C-CAR168 in the Treatment of Autoimmune Diseases Refractory to Standard Therapy
Official title: An Exploratory Clinical Study of Cluster of Differentiation Antigen 20(CD20)/Anti-B-cell Maturation Antigen(BCMA) Chimeric Antigen Receptor Autologous T Cell Product (C-CAR168) in the Treatment of Autoimmune Diseases Refractory to Standard Therapy
Conditions: Systemic Lupus Erythematosus (SLE)
Immune-mediated Necrotizing Myopathy (IMNM)
Neuromyelitis Optica Spectrum Disorders (NMOSD)
Multiple Sclerosis (MS)
Myasthenia Gravis
Systemic Sclerosis (SSc)
Summary: This is an investigator-initiated, multicenter, open-label study of C-CAR168, an autologous bi-specific CAR-T therapy targeting CD20 and BCMA, for the treatment of adult patients with autoimmune diseases refractory to standard therapy
Interventions:
description: Autologous 2nd generation CD20/BCMA-directed CAR-T cells, single infusion intravenously
name: CD20/BCMA-directed CAR-T cells
other_name: C-CAR168
type: Biological
Study arms:
design_group_description: Autologous C-CAR168 administered by intravenous (IV) infusion
design_group_title: C-CAR168
design_group_type: Experimental
Sponsor: Shanghai Renji Hospital
Collaborators: AbelZeta Pharma, Inc.
Drug name mappings:
name: C-CAR168
lang: EN
Clinical trial NCT03233932: CKD-841 Pharmacokinetic/Pharmacodynamic Study
Official title: Clinical Trial to Investigate the Safety and Pharmacokinetics/Pharmacodynamics of CKD-841 After Subcutaneous Injection in Postmenopausal Female
Conditions: Postmenopausal Disorder
Summary: A randomized, open-label, single dose, parallel design phase I clinical trial to investigate the safety and pharmacokinetic/pharmacodynamics of CKD-841 or Leuplin Inj. 3.75mg after subcutaneous injection in postmenopausal female.
Interventions:
description: Investigational drug(=LeuplinⓡInj)is prescribed single injection dose by subcutaneous to 6 of randomized subjects once.
name: LeuplinⓡInj
type: Drug
description: Investigational drug(=CDK-841) is prescribed single injection dose by subcutaneous to 6 of randomized subjects once.
name: CKD-841
type: Drug
Study arms:
design_group_description: LeuplinⓡInj(=leuprorelin acetate 3.75mg)
design_group_title: LeuplinⓡInj
design_group_type: Active Comparator
design_group_description: CKD-841(=leuprorelin acetate 3.75mg)
design_group_title: CKD-841
design_group_type: Experimental
Sponsor: Chong Kun Dang Pharmaceutical Corp.
Collaborators: Severance Hospital
Drug name mappings:
name: 亮丙瑞林
lang: CN
name: Leuprorelin
lang: EN
Clinical trial NCT01670136: Pharmacokinetics of Sildenafil in Premature Infants
Official title: Pharmacokinetics of Sildenafil in Premature Infants
Conditions: Persistent Pulmonary Hypertension of the Newborn
Summary: The purpose of this study is to learn more about the safety and dosing of sildenafil in infants.
Interventions:
description: A single IV dose of sildenafil will be administered over 90 minutes with no greater than a 15-minute flush. Final dose to be determined based on at least the first 4 participants enrolled in Cohort 1; final dose expected to be a single dose between 0.25 and 0.5 mg/kg.
name: 1 dose of sildenafil
other_name: Revatio
Viagra
type: Drug
Study arms:
design_group_description: Infants receiving sildenafil as standard of care
design_group_title: sildenafil, standard of care
design_group_type: No Intervention
design_group_description: 1 dose of sildenafil administered for study
design_group_title: sildenafil administered for study
design_group_type: Other
Sponsor: The University of North Carolina at Chapel Hill
Collaborators: The Emmes Co. LLC
Duke University
National Institute of Child Health & Human Development
Drug name mappings:
name: 枸橼酸西地那非
lang: CN
name: Sildenaifl Citrate
lang: EN
name: シルデナフィルクエン酸塩
lang: JP