Clinical trials: Clinical High-risk
High Risk Percutaneous Coronary Intervention
HeartMate PHP™ CE Mark Clinical Investigation Plan
The HeartMate PHP is a catheter-based pump designed to provide partial left heart circulatory support. The study will assess the safety and performance of the HeartMate PHP in supporting patients who are hemodynamically unstable…
- Trial name
- HM PHP CE Mark (NCT02156609)
- Testing
- Percutaneous ventricular support with the HeartMate PHP
- Where
- 7 sites in Colombia, Netherlands and 2 more
- Volunteers
- 50 people
- Sponsor
- Abbott Medical Devices
Triple Negative Breast Cancer, Non-small Cell Lung Cancer
A Biomarker Screening Protocol for Participants With Solid Tumors
Biomarker Screening Protocol for Preliminary Eligibility Determination for Adoptive T-cell Therapy Trials:This is a decentralized, multi-site, US-based biomarker screening study to identify participants who have specific disease…
- Conditions
- Triple Negative Breast Cancer, Non-small Cell Lung Cancer, Non Small Cell Lung Cancer, Non Small Cell Lung Cancer Metastatic
- Trial name
- START (NCT05891197)
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Lyell Immunopharma, Inc.
MSI-H Solid Malignant Tumor
A Clinical Study to Evaluate HLX10 Monotherapy for the Treatment of MSI-H or dMMR Solid Tumors That Failed to Respond to Standard Therapy
It is a single-arm, open-label, multicenter, phase II clinical study to evaluate the clinical efficacy and safety of HLX10 monotherapy for the treatment of patients with unresectable or metastatic MSI-H or dMMR solid tumors who…
- Trial name
- NCT03941574
- Testing
- HLX10
- Where
- 33 sites in China
- Volunteers
- 108 people
- Sponsor
- Shanghai Henlius Biotech
Lung Cancer
Implementing Fragmentomics Into Real World Screening IntervenTions to Evaluate Clinical Utility Among Individuals With Elevated Risk for Lung Cancer
The purpose of this study is to determine whether availability of DNA Evaluation of Fragments for Early Interception (DELFI) Lung Cancer Screening Test, FirstLook™ to practicing physicians affects overall lung cancer screening…
- Trial name
- FIRSTLUNG (NCT06145750)
- Testing
- Ability to order FirstLook™, Continuing Medical Education for Lung Cancer
- Where
- 3 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Delfi Diagnostics Inc.
Pneumonia
Study Comparing the Clinical Efficacy and Health Outcomes of Outpatients With Mild to Moderate Community-Acquired Pneumonia (CAP) Treated With Either Telithromycin Once Daily for 7 Days, or Azithromycin Once Daily for 5 Days
A multinational, multicenter, randomized, double-blind, study in areas of high pneumococcal resistance comparing the clinical efficacy and health outcomes of outpatients with mild to moderate Community-Acquired Pneumonia (CAP)…
- Trial name
- COBRA II (NCT00237445)
- Testing
- telithromycin, azithromycin
- Where
- United States
- Volunteers
- 110 people
- Sponsor
- Sanofi
Dyslipidemia
Dyslipidemia in Cardiovascular Disease
A multi-center, randomized, double-blinded equivalence clinical trial to evaluate efficacy and safety of LipiLou 20 mg versus Lipitor 20 mg in hypercholesterolemic patients with higher risk cardiovascular disease in Korea.
- Trial name
- KoLipilou (NCT01029522)
- Testing
- Atorvastatin (Lipilou), Atorvastatin (Lipitor)
- Volunteers
- 244 people
- Sponsor
- Chong Kun Dang Pharmaceutical
Myelodysplastic Syndromes(MDS)
A Phase 3 Clinical Study to Evaluate Lemzoparlimab for Injection in Combination With Azacitidine (AZA) Versus AZA Monotherapy in Treatment-naïve Patients With Higher-risk Myelodysplastic Syndrome (MDS)
This phase3 study is a randomized, controlled, open-label, multicenter study to evaluate the efficacy and safety of Lemzoparlimab for injection in combination with AZA versus AZA monotherapy as first-line therapy in…
- Trial name
- NCT05709093
- Testing
- Lemzoparlimab+Azacitidine (AZA), Azacitidine (AZA)
- Where
- 44 sites in China
- Volunteers
- 10 people
- Sponsor
- TJ Biopharma Co., Ltd.
Suspected Grade III and IV Gliomas Requiring Surgical Intervention, Neurosurgical Procedure
Leica Microsystems Sponsored PMCF Study to Collect and Confirm Clinical Data on the Performance of the GLOW400 Device When Used in Accordance With Its Intended Use
This post-market clinical follow-up (PMCF) study aims to confirm the safety and performance of the GLOW400 surgical microscope accessory when used in conjunction with the ARveo8x surgical microscope.
- Conditions
- Suspected Grade III and IV Gliomas Requiring Surgical Intervention, Neurosurgical Procedure, Glioma, Glioblastoma (GBM)
- Trial name
- IMED-GLOW400 (NCT07366892)
- Testing
- GLOW400 is a digital surgical microscope accessory used in fluorescent visualization of suspected grade III or IV gliomas during neurosurgery.
- Where
- 2 sites in Portugal, Switzerland
- Volunteers
- 37 people
- Sponsor
- Leica Microsystems (Schweiz) AG
Renal Failure, Acute Renal Failure
Premarket Clinical Safety Assessment of the ELISIO™-HX
The primary safety objective of this study is to evaluate the safety of the use of the high-permeability hemodialyzer series ELISIO™-HX, by showing that the pre-dialysis albumin levels are not affected using the investigational…
- Conditions
- Renal Failure, Acute Renal Failure, Chronic Renal Failure, Chronic Kidney Diseases
- Trial name
- NCT07058909
- Testing
- ELISIO™-HX Dialyzer
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- Nipro Medical Corporation
Osteosarcoma
A Clinical Study of PD-L1 Antibody ZKAB001(Drug Code) in Limited Stage of High-grade Osteosarcoma
This is a Phase 1+2, open-label, dose-escalation, and multidose study, aiming to investigate the safety, tolerability and pharmacokinetics of ZKAB001 (a fully human monoclonal antibody targeting the Programmed Death - Ligand 1…
- Trial name
- NCT03676985
- Testing
- ZKAB001 5mg/kg, ZKAB001 10mg/kg, ZKAB001 15mg/kg
- Where
- China
- Volunteers
- 15 people
- Sponsor
- Lee's Pharmaceutical Limited
High-volume, Metastatic, Hormone-sensitive Prostate Cancer (mHSPC)
Dalpiciclib Isethionate Tablets Combined With Abiraterone Acetate Tablets (I) and Prednisone Tablets (AA-P) Versus Placebo Combined With AA-P in Treatment of High-volume, Metastatic, Hormone-sensitive Prostate Cancer (mHSPC)
This study was to evaluate the safety and efficacy of dalcilide tablets in combination with AA-P in the treatment of subjects with high tumor burden mHSPC and to determine the second stage starting dose and progression-free…
- Trial name
- NCT06099990
- Testing
- dalpiciclib isethionate tablets; abiraterone acetate tablets; prednisone tablets
- Volunteers
- 660 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Hemorrhagic Complications, Hematoma
Safety and Efficiency of the PacePress to Prevent Hemorrhagic Complications in Patients Undergoing CIED Implantation.
PacePress medical device, by ensuring constant compression force and the ability to optimize it in the pocket area prevents/significantly reduces the risk of hemorrhagic complications, including but not limited to the operation…
- Conditions
- Hemorrhagic Complications, Hematoma, Hemorrhage, Pathologic Processes
- Trial name
- PacePress (NCT05292326)
- Testing
- PacePress, standard compression band
- Where
- 7 sites in Poland
- Volunteers
- 122 people
- Sponsor
- Medinice S.A.
Non Muscle Invasive Bladder Cancer, High-grade Ta/ T1 Papillary Disease Bladder Cancer
Study of Cretostimogene Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin
This study aims to evaluate the efficacy and safety of Cretostimogene in patients with BCG-unresponsive high-risk non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without Ta/T1 papillary tumors.
- Trial name
- NCT07283835
- Testing
- Cretostimogene Grenadenorepvec, n-dodecyl-B-D-maltoside
- Where
- 14 sites in China
- Volunteers
- 16 people
- Sponsor
- Lepu Biopharma Co., Ltd.
Presence of High Intracranial Pressure
An Evaluation of Non-invasive ICP Monitoring in Patients Undergoing Invasive ICP Monitoring Via an External Ventricular Drainage (EVD) Device
Invasive intracranial pressure (ICP) monitoring is highly effective, but involves risks. HS-1000 measures ICP non-invasively by assessing the acoustic properties of the patient's head.
- Trial name
- NCT02284217
- Testing
- EVD
- Where
- 7 sites in United States, Germany
- Volunteers
- 100 people
- Sponsor
- HeadSense Medical
High Blood Sugar, Metabolic Syndrome
Effect of ANKASCIN 568-P Products on Decreasing HbA1c and Regulating Blood Glucose
This study is a randomized, double-blind, placebo-controlled, parallel-controlled trial (24 weeks in total), divided into three periods (screening, treatment, and discontinuation follow-up)
- Trial name
- NCT05737342
- Testing
- ANKASCIN 568-P Red yeast rice capsules
- Where
- Taiwan
- Volunteers
- 80 people
- Sponsor
- SunWay Biotech Co., LTD.
Various Advanced Cancer
An Investigational Immuno-therapy Study of Nivolumab, Compared to Placebo, in Patients With Bladder or Upper Urinary Tract Cancer, Following Surgery to Remove the Cancer
The purpose of this study is to determine the effectiveness and safety of Nivolumab compared to placebo in participants who have undergone radical surgery for invasive urothelial cancer.
- Trial name
- CheckMate 274 (NCT02632409)
- Testing
- Nivolumab
- Where
- 188 sites in United States, Argentina and 28 more
- Volunteers
- 709 people
- Sponsor
- Bristol-Myers Squibb
High-risk PCI
Evaluate the Effectiveness and Safety of the OmniHeart 4.0 Percutaneous Ventricular Assist Device in Providing Hemodynamic Support for Patients Undergoing High-risk Percutaneous Coronary Intervention (PCI).
The objective of this clinical trial is to understand the effectiveness and safety of the OmniHeart 4.0 percutaneous ventricular assist device produced by ShanghaiDynaheart Medical Technology Co., Ltd.
- Trial name
- NCT07622446
- Testing
- OmniHeart 4.0 Percutaneous Ventricular Assist Device, ECMO
- Where
- 2 sites in China
- Volunteers
- 254 people
- Sponsor
- Shanghai Dynaheart Medtech Co., Ltd.
Myelofibrosis
A Clinical Trial of TQ05105 Tablets Combined With TQB3909 Tablets in the Treatment of Myelofibrosis (MF)
This is an open, single-arm, multi-center clinical study designed to evaluate the efficacy and safety of TQ05105 tablets combined with TQB3909 tablets in patients with moderate- and high-risk Myelofibrosis.
- Trial name
- NCT06245941
- Testing
- TQ05105 tablets, TQB3909 tablets
- Where
- 5 sites in China
- Volunteers
- 21 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Leukemia, Myeloid
γδ T Cell Therapy for Relapse Prevention in High-Risk AML Post-Transplant
This is a prospective, double-arm, single-center, randomized controlled single-blind clinical study
- Conditions
- Leukemia, Myeloid, Acute
- Trial name
- NCT07123662
- Testing
- Gamma-Delta T cell injection, Standard prophylactic treatment
- Sponsor
- Guangzhou Bio-gene Technology Co., Ltd
Cervical Carcinoma
Clinical Validation of Molecular Triage in HR-HPV Positive Women
Women accessing the HPV-based screening programme for primary screening, will undergo cervical sampling and clinical data recording.
- Trial name
- VALTRIHP (NCT05193669)
- Where
- Italy
- Volunteers
- 23,941 people
- Sponsor
- Hiantis Srl