PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT03802604: Combination of Talimogene Laherparepvec With Atezolizumab in Early Breast Cancer
Official title: Combination of Talimogene Laherparepvec With Atezolizumab in Patients With Residual Breast Cancer After Standard Neoadjuvant Multi-agent Chemotherapy (PROMETEO TRIAL)
Conditions: Breast Cancer
Summary: PROMETEO is a window opportunity, single arm, exploratory study to evaluate the effect of T- VEC combined with Atezolizumab in women with operable early breast cancer who present residual disease after Neoadjuvant Chemotherapy (NAC). Other eligibility criteria include TNBC or LumB like primary tumor sized at least 1.5 cm, ECOG PS 0-1 and evaluable diagnostic tumor sample.
Interventions:
description: Talimogene laherparepvec will be given via intra-tumoral injection at an initial dose of 10^6 PFU/mL. On week 3 (i.e. 21 days [± 2] days), a second talimogene laherparepvec injection will be administered at a dose of 10^8 PFU/mL. Third, fourth and fifth injections will be administered every 2 weeks (every 14 [± 2] days). The maximum volume for each injection will be 4.0 mL.
name: Talimogene laherparepvec
other_name: Imlygic
T-VEC
type: Biological
description: Atezolizumab 840 mg will be administered by IV infusion on Day1 week 3, then every 2 weeks (every 14 [± 2] days), for a total of 4 treatment courses.
name: Atezolizumab
other_name: Tecentric
type: Drug
Study arms:
design_group_description: 1. Talimogene laherparepvec: Cycle 1 - 10^6 PFU/mL. Cycle 2, 3, 4 & 5 - 10^8 PFU/mL.<br/>2. Atezolizumab 840 mg
design_group_title: Talimogene laherparepvec + Atezolizumab
design_group_type: Experimental
Sponsor: Grupo SOLTI
Collaborators: Roche Pharma AG
Amgen, Inc.
Drug name mappings:
name: 阿替利珠单抗
lang: CN
name: Atezolizumab
lang: EN
name: アテゾリズマブ（遺伝子組換え）
lang: JP
name: Talimogene laherparepvec
lang: EN
Clinical trial NCT03291379: Vandetanib-eluting Radiopaque Embolic Beads in Patients With Resectable Liver Malignancies
Official title: VEROnA: A Window of Opportunity Study of Vandetanib-eluting Radiopaque Embolic Beads (BTG-002814) in Patients With Resectable Liver Malignancies
Conditions: Carcinoma, Hepatocellular
Metastatic Colorectal Cancer
Summary: This is a pilot, open label single arm phase 0 window of opportunity study of vandetanib-eluting radiopaque beads in patients with resectable liver malignancies.
Interventions:
description: BTG-002814 containing 100 mg vandetanib
name: BTG-002814
other_name: vandetanib-eluting radiopaque beads
type: Drug
Study arms:
design_group_description: Single arm: BTG-002814 (vandetanib-eluting radiopaque beads)
design_group_title: BTG-002814
design_group_type: Experimental
Sponsor: Boston Scientific Corp.
Collaborators: Biocompatibles UK Ltd.
Drug name mappings:
name: 凡德他尼
lang: CN
name: Vandetanib
lang: EN
name: バンデタニブ
lang: JP
Clinical trial NCT03237689: Effects of Glucocorticoids on Cognition in HIV-infected Women
Official title: Effects of Glucocorticoids on Cognition in HIV-infected Women
Conditions: Hiv
Summary: Despite treatment with antiretroviral therapy, women living with HIV continue to experience cognitive impairment. Psychological risk factors, including stress, impair cognition more in HIV-infected women than HIV-uninfected women. This study plans to examine a novel intervention for cognitive dysfunction that targets the mechanisms by which stress negatively affects cognitive functioning.
Interventions:
description: Low dose hydrocortisone (10mg)
name: Hydrocortisone
type: Drug
description: capsules of starch 1500 powder
name: Placebo Oral Tablet
type: Drug
Study arms:
design_group_description: Low dose hydrocortisone (10mg orally)
design_group_title: Hydrocortisone
design_group_type: Experimental
design_group_description: Placebo tablets, made of starch 1500 powder
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: The Johns Hopkins University
Collaborators: National Institute of Mental Health
Drug name mappings:
name: 醋酸氢化可的松
lang: CN
name: Hydrocortisone Acetate
lang: EN
Clinical trial NCT05856643: Single-arm, Open-label Clinical Study of SZ011 in the Treatment of Ovarian Epithelial Carcinoma
Official title: Single-arm, Open-label Clinical Study of SZ011 in the Treatment of Ovarian Epithelial
Conditions: Ovarian Epithelial Carcinoma
Summary: This study was a single-center, open-label, investigator-initiated clinical trial (IIT) to observe and investigate the clinical safety and efficacy of SZ011 in the treatment of ovarian epithelial carcinoma
Interventions:
description: In the escalation study, the minimum initial dose was 5.0×10^6 cells, then increased to 1.0×10^8, 2.0×10^8and 5.0×10^8 cells. The infusion is given every 2 weeks.
name: SZ011 CAR-NK
type: Drug
Study arms:
design_group_title: SZ011 CAR-NK
design_group_type: Experimental
Sponsor: Shantou University
Collaborators: Guangdong ProCapZoom Biosciences Co., Ltd.
Drug name mappings:
name: SZ-011
lang: EN
Clinical trial NCT06445465: Study to Evaluate a Potential PET Radioligand for Imaging Alpha-synuclein Deposits in the Brain
Official title: Phase 1 Study to Evaluate [18F]MNI-1216 ([18F]ACI-12589) as a Potential PET Radioligand for Imaging Alpha-synuclein Deposits in the Brain of Patients With Suspected Alpha-synuclein Pathology Compared With Healthy Volunteers
Conditions: Alpha-Synucleinopathy
Parkinson's Disease
Dementia With Lewy Bodies
Multisystem Atrophy
Summary: The overall goal of this protocol is to evaluate [18F]MNI-1216 (also known as [18F]ACI-12589) as an α-synuclein targeted radiopharmaceutical in 3 parts as follows:
* Part 1: first in human (FiH) imaging
* Optional Part 2: expansion of FiH imaging
* Optional Part 3: retest imaging
A total of up to 30 participants may be enrolled and participate in the study. Part 1 of the study will include up to 10 participants (target of up to 5 healthy volunteers and up to 5 participants with idiopathic Parkinson's Disease). There will be an ongoing review of study data in Part 1 to evaluate the characteristics of tracer binding and safety. If the study results are deemed adequate in Part 1, Part 2 and/or Part 3 may be initiated. The decision to initiate Part 3 may also include a review of data from Part 2, if Part 2 is performed and the data are available. If performed, Part 2 will include up to 20 participants, including health volunteers and participants with α-synucleinopathies to acquire additional tracer-related data. If performed, Part 3 will include up to 10 participants from in Part 1 and/or Part 2 (including health volunteers and participants with α-synucleinopathies) to evaluate the reliability of [18F]MNI-1216 ([18F]ACI-12589) Positron Emission Tomography (PET) imaging.
Interventions:
description: [18F]MNI-1216 is an intravenously administered radioactive imaging agent being studied as a potential positron emitting radiopharmaceutical for in vivo imaging of α-synuclein deposits.
name: [18F]MNI-1216
other_name: [18F]ACI-12589
type: Drug
Study arms:
design_group_description: The study population will be composed of participants with α-synucleinopathies.
design_group_title: Participants with α-synucleinopathies.
design_group_type: Experimental
design_group_description: The study population will be composed of health volunteers.
design_group_title: Healthy volunteers
design_group_type: Active Comparator
Sponsor: Invicro LLC
Collaborators: AC Immune SA
Drug name mappings:
name: ACI-12589
lang: EN
Clinical trial NCT07348250: Open-label Study to Evaluate Brain α-Synuclein Deposition Using PET and [18F]MK-0947 in Parkinson's Disease
Official title: An Open-label Study to Evaluate Brain α-Synuclein Deposition Using Positron Emission Tomography (PET) and [18F]MK-0947 in Patients With Parkinson's Disease
Conditions: Parkinson's Disease (PD)
Parkinson's Disease
Parkinson's Disease (Disorder)
Summary: This clinical study is being conducted to learn more about a new imaging drug called [18F]MK-0947, which is designed to help doctors see changes in the brain related to Parkinson's disease (PD). PD is a condition that affects movement, balance, and thinking. The drug works with a type of scan called PET (Positron Emission Tomography) to show areas of the brain where a protein called α-synuclein builds up. This buildup is linked to PD and other brain disorders.
The main goal of this study is to find out if [18F]MK-0947 is safe for people and if it works well to show α-synuclein in the brain. The study will also look at how the drug moves through the body and how much radiation it gives off. Researchers hope this information will help develop better tools for diagnosing PD and tracking how it changes over time.
Who can join? Adults who have PD or who are healthy may be able to take part. Participants will have screening tests to make sure they qualify.
What does participation involve? People in the study will have PET scans, blood tests, and other safety checks. Some participants will also have an MRI scan. The study is divided into two parts: Part 1 looks at how the drug works in the brain of PD patients and healthy elderly participants, and Part 2 measures radiation levels in healthy participants.
Why is this important? There is currently no cure for PD, and better imaging tools could help researchers develop new treatments. By joining this study, participants will help advance research that may improve care for people with PD and similar conditions in the future.
Interventions:
description: PET radiopharmaceutical selective for α-synuclein, administered IV at doses up to 10 mCi.
name: [18F]MK-0947
other_name: MK-0947
type: Drug
Study arms:
design_group_description: Participants receive [18F]MK-0947 for PET imaging of the brain.
design_group_title: Part 1 - Brain Imaging
design_group_type: Experimental
design_group_description: Healthy participants receive [18F]MK-0947 for whole-body dosimetry.
design_group_title: Part 2 - Dosimetry
design_group_type: Experimental
Sponsor: Invicro LLC
Collaborators: Merck Sharp & Dohme LLC
Drug name mappings:
name: [18F]MK-0947
lang: EN
Clinical trial NCT02714439: Low-Cost Imaging for Cervical Cancer Prevention in the Texas Lower Rio Grande Valley
Official title: Low-Cost Imaging for Cervical Cancer Prevention in the Texas Lower Rio Grande Valley
Conditions: Malignant Neoplasms of Female Genital Organs
Summary: The purpose of this study is to evaluate a different type of medical equipment called "High-Resolution Microendoscope" (HRME) for the diagnosis of cervical pre-cancerous lesions and cervical cancer. The investigators want to compare patients' clinical findings using the current equipment used in clinic with the clinical findings using new equipment we are testing on this research project. If the new equipment is proven to give comparable findings with current equipment being used, doctors might be able to offer a diagnosis and treat cervical lesions in one visit. It might not be necessary to wait for cervical biopsies to come back before women would receive the indicated treatment. Study subjects are being asked to participate because they have been diagnosed with an abnormal Papanicolaou (Pap) PAP smear, positive human papillomavirus (HPV) test or history of cervical dysplasia and need to have a colposcopic examination to determine the reason for abnormal results and receive treatment.
Interventions:
description: Proflavine 0.01% applied to the cervix before high-resolution microendoscopy imaging procedure performed.
name: Proflavine
other_name: Proflavine hemisulfate
type: Drug
description: High-resolution microendoscopy imaging procedure performed after colposcopy exam. Standard colposcopy procedure will then continue. Entire HRME imaging procedure should add less than 10 minutes to the standard colposcopy exam.
name: High-Resolution Microendoscopy (HRME)
type: Procedure
Study arms:
design_group_description: After standard colposcopy examination performed, participants undergo a high-resolution microendoscopy imaging procedure. Proflavine 0.01% is applied to the cervix, then high-resolution microendoscopy imaging procedure performed. Standard colposcopy procedure will then continue.
design_group_title: High-Resolution Microendoscopy (HRME)
design_group_type: Experimental
Sponsor: University of Texas Medical Branch
Collaborators: William Marsh Rice University
The University of Texas Health Science Center at Houston
The University of Texas MD Anderson Cancer Center
Drug name mappings:
name: 原黄素
lang: CN
name: Proflavine
lang: EN
Clinical trial NCT06229678: Ketones, SGLT2, HFrEF
Official title: Ketones, Muscle Metabolism, and SGLT2 Inhibitors
Conditions: Type2diabetes
Heart Failure With Reduced Ejection Fraction
Summary: The study team will examine the effects of elevated plasma ketone levels following initiation of SGLT2 inhibitor therapy in high-risk type 2 diabetes mellitus (T2DM) individuals with heart failure (HF) with reduced ejection fraction (HFrEF) providing an energy-rich fuel that is taken up with great avidity by the myocardium, to measure change in Left Ventricle diastolic and systolic function
Interventions:
description: Empagliflozin 25MG will be administered orally once per day for 3 months
name: Empagliflozin 25 MG Oral Tablet
other_name: jardiance
type: Drug
description: The placebo will be administered orally once per day for 3 months
name: Placebo
type: Drug
description: subjects will be started on acipimox 250mg every 6 hours for 8 days while on continued empagliflozin/placebo therapy. This will be added at the end of 3 months after they finished baseline studies
name: Acipimox 250 Mg Oral Capsule
type: Drug
Study arms:
design_group_description: Subjects will be randomized 2:1 to receive empagliflozin, 25mg/day for 3 months
design_group_title: Empagliflozin Group
design_group_type: Experimental
design_group_description: Subjects will be randomized to receive the empagliflozin placebo for 3 months
design_group_title: Placebo group
design_group_type: Placebo Comparator
Sponsor: University of Texas Health Science Center At San Antonio
Collaborators: National Institute of Diabetes & Digestive & Kidney Diseases
Drug name mappings:
name: 阿昔莫司
lang: CN
name: Acipimox
lang: EN
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 NCT04731818: An Exploratory Study of ZB-06 as a Vaginal Contraceptive Film
Official title: An Exploratory Phase 1 Mechanism-of-action Study of ZB-06, a Vaginal Film Containing HC4-N, an Anti-sperm Monoclonal Antibody.
Conditions: Contraception
Summary: This is an early Phase 1 study to establish proof-of-concept by determining whether an intravaginal film containing a human contraceptive antibody (ZB-06) shows promise to provide contraceptive efficacy using the post-coital test, a surrogate measure of efficacy. The study will also evaluate the safety and pharmacokinetics of ZB-06.
Interventions:
description: ZB-06 is a polyvinyl alcohol-based film containing 20 mg of human contraceptive antibody (HCA) for topical intravaginal administration.
name: ZB-06
type: Biological
Study arms:
design_group_description: All participants will receive a single ZB-06 film for intravaginal administration prior to intercourse.
design_group_title: ZB-06
design_group_type: Experimental
Sponsor: KBio Inc.
Collaborators: Eastern Virginia Medical School
Drug name mappings:
name: ZB-06
lang: EN
Clinical trial NCT00263185: High Dose Vit D Musculoskeletal Symptoms & Bone Density in Anastrozole-Treated Breast Cancer With Marginal Vit D Status
Official title: A Double-Blind, Randomized, Placebo Controlled Trial of High Dose Vitamin D Therapy On Musculoskeletal Symptoms and Bone Mineral Density in Anastrozole-Treated Early Stage Breast Cancer Patients With Marginal Vitamin D Status
Conditions: Breast Neoplasms
Summary: The purpose of this study is to determine whether Vitamin D supplementation reduces the symptoms of muscle stiffness and joint tenderness that some patients may develop after starting therapy with Anastrozole for breast cancer.
Interventions:
name: Vitamin D
type: Dietary Supplement
name: Calcium carbonate
type: Dietary Supplement
name: Vitamin D
type: Drug
name: Placebo
type: Other
Study arms:
design_group_description: Patients with baseline 25OH vitamin D level of 10-19 ng/ml.<br/>* Calcium carbonate 1000 mg/day<br/>* Vitamin D 400 units daily.<br/>* Vitamin 50,000 IU/wk x 16 weeks and then once a month for a total of 6 months.<br/>Patients with baseline 25OH vitamin D level of 20-29 ng/ml.<br/>* Calcium carbonate 1000 mg/day<br/>* Vitamin D 400 units daily.<br/>* Vitamin 50,000 IU/wk x 8 weeks and then once a month for a total of 6 months.
design_group_title: Active Treatment Group
design_group_type: Experimental
design_group_description: Patients with baseline 25OH vitamin D level of 10-19 ng/ml.<br/>* Calcium carbonate 1000 mg/day<br/>* Vitamin D 400 units daily.<br/>* Placebo once per week x 16 weeks and then once a month for a total of 6 months.<br/>Patients with baseline 25OH vitamin D level of 20-29 ng/ml.<br/>* Calcium carbonate 1000 mg/day<br/>* Vitamin D 400 units daily.<br/>* Placebo once per week x 8 weeks and then once a month for a total of 6 months.
design_group_title: Control Group
design_group_type: Placebo Comparator
design_group_description: Patients with a baseline Vitamin D level below 10 ng/ml.<br/>* Calcium carbonate 1000 mg/day<br/>* Vitamin D 400 units daily.
design_group_title: Observational Group
design_group_type: Other
Sponsor: Washington University School of Medicine
Collaborators: AstraZeneca PLC
Drug name mappings:
name: 碳酸钙
lang: CN
name: Calcium carbonate
lang: EN
name: 沈降炭酸カルシウム
lang: JP
Clinical trial NCT02872519: PET Imaging of Ovarian Carcinoma With 18F-FSPG
Official title: PET Imaging of Ovarian Carcinoma With 18F-FSPG
Conditions: Stage IIIA Fallopian Tube Cancer
Stage IIIA Ovarian Cancer
Stage IIIA Primary Peritoneal Cancer
Stage IIIB Fallopian Tube Cancer
Stage IIIB Ovarian Cancer
Stage IIIB Primary Peritoneal Cancer
Stage IIIC Fallopian Tube Cancer
Stage IIIC Ovarian Cancer
Stage IIIC Primary Peritoneal Cancer
Stage IV Fallopian Tube Cancer
Stage IV Ovarian Cancer
Stage IV Primary Peritoneal Cancer
Summary: This clinical trial studies positron emission tomography (PET) imaging utilizing 18F-FSPG [(S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid], a glutamic acid derivative, to image patients with ovarian cancer before undergoing surgery or transplant. Diagnostic procedures, such as 18F-FSPG PET, may help find and diagnose ovarian cancer and find out how far the disease has spread.
Interventions:
description: Given by IV
name: (S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid (18F-FSPG)
type: Drug
description: Undergo scan
name: Positron Emission Tomography
type: Procedure
description: Laboratory Biomarker Analysis
name: Laboratory Biomarker Analysis
type: Other
Study arms:
design_group_description: Patients receive (S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid (18F-FSPG) PET scans. Patients undergo PET imaging scans during 0-45 minutes, 60-75 minutes, and 105-120 minutes after injection and within 4 weeks prior to surgery (Cohort A) or within 4 weeks of SOC imaging at diagnosis and prior to subsequent treatment (Cohort B).
design_group_title: Experimental
design_group_type: Experimental
Sponsor: The Vanderbilt-Ingram Cancer Center
Collaborators: National Cancer Institute
Drug name mappings:
name: BAY-94-9392
lang: EN
Clinical trial NCT04076540: A Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD4041 in Healthy Volunteers
Official title: A Phase I Randomized, Double-blind Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD4041 Following Single Ascending Dose Administration to Healthy Volunteers
Conditions: Smoking Cessation
Summary: This is a Phase I, first-in-human (FIH), single-center, randomized, double-blind, placebo controlled, single ascending dose, sequential group study in healthy vasectomized male and female subjects of non-childbearing potential, aged 18 to 65 years.
Interventions:
description: Administration by Oral syringe
name: AZD4041
type: Drug
description: Administration by Oral syringe
name: Placebo
type: Drug
Study arms:
design_group_title: AZD4041
design_group_type: Experimental
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: AstraZeneca PLC
Collaborators: Eolas Therapeutics, Inc.
National Institutes of Health
Drug name mappings:
name: AZD-4041
lang: EN
Clinical trial NCT02152007: Topical Sirolimus for the Treatment of Pachyonychia Congenita (PC)
Official title: Phase 1b Clinical Trial Using Topical Sirolimus for the Treatment of Pachyonychia Congenita
Conditions: Pachyonychia Congenita
Summary: A study to evaluate safety and efficacy of topical sirolimus to treat plantar keratoderma in adults with PC. Subjects may receive either placebo or treatment with at least 1 foot receiving topical sirolimus at some time. For certain phases of the study treatment assignment to the right and left foot will be randomized in a double blind fashion. Blood levels will test systemic absorption of sirolimus. Other safety and efficacy measures will be taken through the 39-week study duration. Funding Source - FDA OOPD
Interventions:
description: 1% sirolimus cream (TD201 1%)
name: 1% sirolimus cream (TD201 1%)
type: Drug
Study arms:
design_group_description: This is a split-body design. Subjects will self-administer 1% topical sirolimus cream or placebo cream (no drug, vehicle control) on the plantar surface of each foot. At least one foot will be treated with topical sirolimus at some time during the study. Application will be one time daily for a total of 26 weeks. There will be an additional follow-up visit 3 months after the last application of study drug. The total duration of the study is 39 weeks.
design_group_title: Split-body 1% sirolimus cream (TD201 1%)
design_group_type: Experimental
Sponsor: Transderm, Inc.
Collaborators: Pachyonychia Congenita Project
Drug name mappings:
name: 西罗莫司
lang: CN
name: Sirolimus
lang: EN
name: シロリムス
lang: JP