Clinical trials: High-risk
Acute Myeloid Leukemia (AML), High-risk Myelodysplastic Syndrome
Safety and Efficacy of RVU120 for Treatment of Relapsed/Refractory AML
The goal of this study is to assess the safety, tolerability, anti-tumor activity (efficacy), pharmacokinetics (PK), and pharmacodynamics (PD) of the agent RVU120 when administered to adult patients with relapsed or refractory…
- Trial name
- RIVER-52 (NCT06268574)
- Testing
- RVU120
- Where
- 41 sites in France, Italy and 2 more
- Volunteers
- 62 people
- Sponsor
- Ryvu Therapeutics SA
Severe Hypertriglyceridemia With a High Risk of Acute Pancreatitis
Phase II Clinical Trial Evaluating the Efficacy and Safety of HRS-7249 and SHR-1918 in Patients With Severe Hypertriglyceridemia at High Risk of Acute Pancreatitis
Phase II clinical trial evaluating the efficacy and safety of HRS-7249 and SHR-1918 in patients with severe hypertriglyceridemia at high risk of acute pancreatitis
- Trial name
- NCT07308392
- Testing
- HRS-7249 injection set, SHR-1918 injection set
- Where
- China
- Volunteers
- 119 people
- Sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
Prostate Cancer, High-risk Biochemical Recurrence
Evaluation of Xaluritamig in High-Risk, Biochemically Recurrent, Non-metastatic Castrate-sensitive Prostate Cancer
The main objective of this study is to evaluate the safety and tolerability of xaluritamig monotherapy in adult participants with high-risk biochemical recurrent (BCR) nonmetastatic castration-sensitive prostate cancer (nmCSPC).
- Conditions
- Prostate Cancer, High-risk Biochemical Recurrence, High Risk Biochemical Recurrence of Non-metastatic Castration-sensitive Prostate Cancer, Non-metastatic Castration-sensitive Prostate Cancer
- Trial name
- NCT06555796
- Testing
- Xaluritamig
- Where
- 11 sites in United States, Australia
- Volunteers
- 50 people
- Sponsor
- Amgen
High-risk Non-muscle-invasive Bladder Cancer
A Study of HS-10566 in Patients With High-risk Non-muscle-invasive Bladder Cancer Who Are Ineligible for or Refuse Radical Cystectomy
This is a multicenter, open-label, Phase I/II clinical study evaluating the safety, efficacy, tolerability, and pharmacokinetic/pharmacodynamic (PK/PD) profiles of HS-10566 in patients with high-risk non-muscle-invasive bladder…
- Trial name
- NCT07468851
- Testing
- HS-10566
- Where
- 2 sites in China
- Volunteers
- 180 people
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
High-Risk Non-Muscle-Invasive Bladder Cancer
Phase 2 Study to Evaluate Safety and Efficacy of Cretostimogene Grenadenorepvec in High-Risk NMIBC
This is a Phase 2, Multi-Arm, Multi-Cohort, Open-Label Study to Evaluate the Safety and Efficacy of Cretostimogene Grenadenorepvec in Participants with High-Risk Non-Muscle-Invasive Bladder Cancer.
- Trial name
- NCT06567743
- Testing
- Cretostimogene Grenadenorepvec
- Where
- 80 sites in United States, Canada
- Volunteers
- 325 people
- Sponsor
- CG Oncology, Inc.
Oral Health, Child
Guardians Receiving Information Through Navigators
A multi-arm study, experimental and control groups, to explore the impact of an online training program to help community health workers conduct effective outreach to support the dental health of high-risk youth via their…
- Conditions
- Oral Health, Child, Adolescent, High-risk
- Trial name
- GRIN (NCT07147244)
- Testing
- Treatment 1: Full GRIN course (Lessons 1-8), Treatment 2: Part 1 of GRIN (Lessons 1-4), Treatment 3: Part 2 of GRIN (Lesson 1, 5-8)
- Where
- United States
- Volunteers
- 455 people, healthy volunteers welcome
- Sponsor
- KDH Research & Communication
Non-Muscle Invasive Bladder Cancer, NMIBC
Sample Collection for Ongoing Research and Product Evaluation Study - Non-muscle Invasive Bladder Cancer (SCORE-NMIBC)
The SCORE-NMIBC study is a prospective, multi-center, study designed to collect data and biological samples from participants diagnosed with non-muscle Invasive Bladder Cancer (NMIBC).
- Conditions
- Non-Muscle Invasive Bladder Cancer, NMIBC, High-risk Non-Muscle Invasive Bladder Cancer
- Trial name
- SCORE-NMIBC (NCT07763197)
- Where
- United States
- Volunteers
- 400 people
- Sponsor
- Natera, Inc.
High Risk Non-muscle Invasive Bladder Cancer
A Phase I/II Study of JL19001 Injection Alone or in Combination With BCG in Subjects With High Risk Non-Muscle Invasive Bladder Cancer.
Phase Ia, an open-label, sequential, dose escalation study to evaluate the tolerability and safety of JL19001 Injection alone in subjects with high risk NMIBC.
- Trial name
- JL19001-NMIBC (NCT07483970)
- Testing
- JL19001 Injection
- Where
- China
- Volunteers
- 18 people
- Sponsor
- Jecho Biopharmaceuticals Co., Ltd.
Acute Myeloid Leukemia, Diffuse Large B Cell Lymphoma (DLBCL)
GRACE: A Phase 1/2a Study of VTRU200 in Relapsed/Refractory AML, High-risk MDS, DLBCL Post CART Failure and Advanced Solid Tumors
About this study This is the first study of VTRU200 in people. The main purpose of this study is to find a safe dose of VTRU200 and learn how the medicine behaves in the body.
- Conditions
- Acute Myeloid Leukemia, Diffuse Large B Cell Lymphoma (DLBCL), High Risk Myelodysplastic Syndrome, Solid Tumor Malignancies
- Trial name
- NCT07749976
- Testing
- VTRU200
- Volunteers
- 108 people
- Sponsor
- Vitruviae
High Risk PCI, Coronary Arterial Disease (CAD)
Prospective Evaluation for Receiving SynFlow 3.0 Interventional Circulatory Support in High-risk PCI: A Randomized Controlled Trial
This study is conducted to compare the effectiveness of a new percutaneous mechanical circulatory support device called SynFlow 3.0 with VA-ECMO in high-risk percutaneous coronary intervetnion(PCI) patients.
- Trial name
- PERSIST Ⅲ (NCT06853470)
- Testing
- VA-ECMO circulatory support, SynFlow 3.0 circulatory support, percutaneous coronary intervention
- Where
- China
- Volunteers
- 222 people
- Sponsor
- ForQaly Medical (Shanghai) Co., Ltd
HPV Infection, HPV 16 Infection
Evaluation of the Q-Pad hrHPV Test System for Identifying Precancer
The EQUIP Study is testing whether high-risk human papillomavirus (hrHPV), the virus that causes most cervical cancers, can be accurately detected from menstrual blood collected at home.
- Conditions
- HPV Infection, HPV 16 Infection, High Risk HPV, Cervical Cancer Screening
- Trial name
- EQUIP (NCT07281599)
- Testing
- Q-Pad hrHPV Test System
- Where
- 3 sites in United States
- Volunteers
- 450 people, healthy volunteers welcome
- Sponsor
- Qurasense
High-risk Muscle Invasive Urothelial Carcinoma
An Open-label Study to Investigate the Efficacy and Safety of Dato-DXd + Rilvegostomig vs SoC in Adult Participants With High-risk MIUC
Purpose: to assess efficacy and safety of Dato-DXd + rilvegostomig as adjuvant therapy versus SoC in MIUC participants with high-risk residual disease after radical resection.
- Trial name
- TU-04 (NCT07720284)
- Testing
- Dato-DXd, Rilvegostomig, Durvalumab
- Where
- 160 sites in United States, Australia and 14 more
- Volunteers
- 915 people
- Sponsor
- AstraZeneca
High-risk Cardiac Patients
Registry Study for the Evaluation of High-risk Cardiac Patients by WILLEM AI-based ECG Platform
The WILLEM Registry is a large-scale, single-group, observational, registry study to collect continuous clinical evidence of Willem in real-world settings.
- Trial name
- WILLEMRegistry (NCT07333547)
- Testing
- Willem AI ECG assessment
- Where
- 5 sites in United States, Ecuador and 1 more
- Volunteers
- 200,000 people, healthy volunteers welcome
- Sponsor
- Idoven 1903 S.L.
Vasomotor Symptoms Caused by Adjuvant Endocrine Therapy in Women With, or at High Risk for Developing Hormone-receptor Positive Breast Cancer, Hot Flashes
A Study to Learn More About How Well Elinzanetant Works and How Safe it is Compared to Placebo for the Treatment of Hot Flashes Caused by Anti-cancer Therapy in Women With, or at High Risk for Developing Hormone-receptor Positive Breast Cancer
Researchers are looking for a better way to treat women with, or at high risk for developing hormone-receptor positive breast cancer, who have vasomotor symptoms (VMS), a condition of having hot flashes caused by anti-cancer…
- Trial name
- OASIS-4 (NCT05587296)
- Testing
- Elinzanetant (BAY3427080)
- Where
- 102 sites in Austria, Belgium and 14 more
- Volunteers
- 474 people
- Sponsor
- Bayer
Moderate to High-risk Noncardiac Surgery
SMART TRENDS Study
A multicenter, interventional, feasibility comparison with historical controls
- Trial name
- NCT05957406
- Testing
- Acumen HPI Smart Alerts and Smart Trends Software, The HemoSphere advanced monitoring platform with Acumen HPI software, and Acumen IQ sensor and Acumen IQ cuff
- Where
- 8 sites in United States
- Volunteers
- 296 people
- Sponsor
- Becton, Dickinson and Company
Intensive Care Unit, Coronary Artery Bypass Grafting (CABG)
Intravenous Fish Oil Based Lipid Emulsion to Enhance Recovery in High-Risk Cardiac Surgery Patients
The MODIFY CSX study is a prospective, randomized, placebo-controlled trial conducted in heart centers in Germany and Italy. A total of 550 high-risk cardiac surgery patients will receive either 0.20 g fish oil/kg body weight…
- Conditions
- Intensive Care Unit, Coronary Artery Bypass Grafting (CABG), High Risk Patients, Cardiopulmonary Bypass
- Trial name
- MODIFY CSX (NCT06279793)
- Testing
- Fish Oil, Intravenous 0.9% Sodium Chloride
- Where
- 10 sites in Germany
- Volunteers
- 550 people
- Sponsor
- GCP-Service International West GmbH
High-Risk Multidisciplinary Care, Clinical Decision Support
ANCHOR Validation Trial in High-Risk Multidisciplinary Care
This pre-registered, pragmatic, three-arm (1:1:1) patient-level randomized controlled trial with mixed-effects analysis at the encounter level tests two questions in real high-risk multidisciplinary clinical encounters at the…
- Conditions
- High-Risk Multidisciplinary Care, Clinical Decision Support, Artificial Intelligence-Assisted Care, Telemedicine
- Trial name
- NCT07597499
- Testing
- Gemini 3.1 Pro with Safety Prompt, ANCHOR Clinical AI Verification Layer (with Gemini 3.1 Pro)
- Where
- United States
- Volunteers
- 240 people
- Sponsor
- Waymark
Resectable Hepatocellular Carcinoma With Intermediate or High Recurrence Risk
A Trial of SHR-8068 Combined With Adebrelimab and Apatinib in Perioperative Treatment of Resectable Hepatocellular Carcinoma
This study is conducted to evaluate the efficacy and safety of SHR-8068 combined with Adebrelimab and Apatinib compared with Adebrelimab combined with Apatinib in perioperative treatment of resectable hepatocellular carcinoma…
- Trial name
- NCT07682272
- Testing
- SHR-8068 Injection, Adebrelimab Injection, Apatinib Mesylate Tablets
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Post Partum Haemorrhage, Maternal Care Patterns
Pivotal, Prospective, Multi-centre, Single-arm Study to Evaluate the Safety and Effectiveness of Oli for Identification of Patients, During the Intrapartum Period, Who Are at Higher Risk of Developing Abnormal Postpartum Uterine Bleeding, Including Postpartum Haemorrhage
Oli is a predictive, non-invasive device, intended to be placed on the participant's maternal abdomen during the intrapartum period, which can alert healthcare professionals of an impending cumulative blood loss of ≥500 ml…
- Conditions
- Post Partum Haemorrhage, Maternal Care Patterns, High Risk Pregnancy
- Trial name
- NCT06655207
- Testing
- Oli is a non-invasive, wearable device, designed to provide clinicians with an early indication if the participant is at a higher risk of developing abnormal postpartum uterine bleeding
- Where
- 7 sites in United States, Australia
- Volunteers
- 1,000 people
- Sponsor
- Baymatob Operations Pty Ltd
SCLC, Malignant Melanoma
GD2-SADA:177Lu-DOTA Complex in Patients With Solid Tumors Known to Express GD2
Patients with Small Cell Lung Cancer, High Risk Neuroblastoma, Sarcoma and Malignant Melanoma will be treated with GD2-SADA:177Lu-DOTA complex(The IMP is a two-step radioimmunotherapy, delivered as two separate products GD2-SADA…
- Conditions
- SCLC, Malignant Melanoma, Sarcoma, High Risk Neuroblastoma
- Trial name
- NCT05130255
- Testing
- GD2-SADA (0.3 mg/kg) and 177Lu-DOTA (30 mCi), GD2-SADA (3 mg/kg) 177Lu-DOTA (30 mCi), GD2-SADA (0.3 mg/kg) 177Lu-DOTA (200 mCi)
- Where
- 8 sites in United States
- Volunteers
- 23 people
- Sponsor
- Y-mAbs Therapeutics