Clinical trials: High-risk Patients
Osteopenia, Osteoporosis
Exercise and Fall Prevention
Osteoporosis represents a major public health concern, particularly among older adults, due to its association with an increased risk of fragility fractures, functional limitations, and loss of independence.
- Conditions
- Osteopenia, Osteoporosis, High Fall Risk
- Trial name
- OsteoApp (NCT07897929)
- Testing
- Guideline-based home exercise training
- Where
- Germany
- Volunteers
- 72 people
- Sponsor
- Wolfgang Kemmler, PhD
High-Risk Prostate Cancer
A Single-Arm Phase II Study of Neoadjuvant Intensified Androgen Deprivation (Leuprolide and Abiraterone Acetate) in Combination With AKT Inhibition (Capivasertib) for High-Risk Localized Prostate Cancer With PTEN Loss
The purpose of this study is to learn about how an investigational drug intervention completed before doing prostate surgery (specifically, radical prostatectomy with lymph node dissection) may help in treatment of high risk…
- Trial name
- SNARE (NCT05593497)
- Testing
- Capivasertib, abiraterone acetate
- Where
- 9 sites in United States
- Volunteers
- 30 people
- Sponsor
- VA Office of Research and Development
High-Risk Neuroblastoma
A Safety and Efficacy Study of hu14 in High-Risk Neuroblastoma Patients
Neuroblastoma is the most common type of solid cancer found outside the brain in young children. Generally, it affects children younger than 5 years old, with the average age when it is found being just 2 years.
- Trial name
- SHINE (NCT07549321)
- Testing
- hu1418K322A + Temozolomide + Irinotecan
- Where
- 18 sites in United States, Canada and 5 more
- Volunteers
- 144 people
- Sponsor
- Renaissance Pharma Ltd.
Prostate Cancer (Adenocarcinoma), Adenocarcinoma of the Prostate
RYZ711 Diagnostic Platform Study
This is a Phase 1/2 multicenter, multi-cohort imaging study to evaluate the safety, tolerability, and diagnostic performance of RYZ711 positron emission tomography/computed tomography (PET/CT) in men with histologically confirmed…
- Conditions
- Prostate Cancer (Adenocarcinoma), Adenocarcinoma of the Prostate, Metastatic Castration-resistant Prostate Cancer (mCRPC), Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
- Trial name
- NCT07862582
- Testing
- RYZ711, PSMA PET/CT
- Where
- United States
- Volunteers
- 116 people
- Sponsor
- RayzeBio, Inc.
High-risk Non-muscle Invasive Bladder Cancer
Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC) (MK-3475-676/KEYNOTE-676)
Researchers are looking for new ways to treat high-risk non muscle invasive bladder cancer (HR NMIBC). NMIBC is cancer in the tissue that lines the inside of the bladder but has not spread to the bladder muscle or outside of the…
- Trial name
- NCT03711032
- Testing
- Pembrolizumab, BCG
- Where
- 209 sites in United States, Australia and 28 more
- Volunteers
- 1,397 people
- Sponsor
- Merck Sharp & Dohme LLC
Patients With Ultra High Risk of Psychotic Transition
Evaluation of Membrane Phospholipid and Energy Metabolism in Subjects at High Risk of Psychotic Transition
The management of schizophrenia is a major public health issue, due to its particularly disabling psychotic symptoms and their onset at an early age, typically in adolescents or young adults.
- Trial name
- MR7T-UHR (NCT05865652)
- Testing
- Cerebral MRI with Phosphorus 31 Magnetic Resonance Spectroscopy
- Where
- France
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Centre Hospitalier Henri Laborit
Pregnancy Related, Pregnancy Complications
Resources, Inspiration, Support and Empowerment (RISE) for Black Pregnant Women
Perinatal Mood and Anxiety Disorders (PMADs) encompass a range of mental health disorders that occur during pregnancy and up to one year postpartum. Approximately 13% of women experience PMADs.
- Conditions
- Pregnancy Related, Pregnancy Complications, Pregnancy, High Risk, Depression
- Trial name
- RISE (NCT05552053)
- Testing
- MWSH plus Candlelit Care, MWSH
- Where
- United States
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Cedars-Sinai Medical Center
Clinical High Risk for Psychosis (CHR), Suicidal Ideation
Developing a Recovery-Oriented Suicide Prevention Program for Young People at Clinical High Risk for Psychosis
Young people at clinical high risk for psychosis are more likely to experience suicide thoughts than the general population, but there are few suicide prevention programs designed specifically for them.
- Conditions
- Clinical High Risk for Psychosis (CHR), Suicidal Ideation, Psychosis, Suicidal Behavior
- Trial name
- NCT07756567
- Testing
- Suicide Prevention Intervention, Standard Care (in control arm)
- Where
- 2 sites in United States
- Volunteers
- 108 people
- Sponsor
- University of California, San Diego
High Risk Smoldering Multiple Myeloma (HR-SMM)
A Study to Compare Linvoseltamab and Daratumumab Treatment in High-Risk Smoldering Multiple Myeloma (HR-SMM)
This study is researching an experimental drug called linvoseltamab (also called "study drug") compared to another drug called daratumumab, in participants with Smoldering Multiple Myeloma (SMM), who are at a High Risk (HR) of…
- Trial name
- LINKER-SMM2 (NCT07393282)
- Testing
- Linvoseltamab, Daratumumab
- Where
- 27 sites in United States, Japan and 3 more
- Volunteers
- 270 people
- Sponsor
- Regeneron Pharmaceuticals
Development Delay, Motor Skills Disorders
Effect of a Telerehabilitation-Supported, Family-Centered Early Intervention Program on Neurodevelopmental and Parental Outcomes in Infants at Mild-to-Moderate Risk
The goal of this pilot randomized controlled trial is to learn whether a family-centered early intervention program, delivered remotely to parents and carried out at home, can support the development of infants who were treated…
- Conditions
- Development Delay, Motor Skills Disorders, Neurodevelomental Disorders, High Risk Infant
- Trial name
- NCT07878819
- Testing
- Remote Family-Centered Early Intervention Program, Standard Information and Routine Follow-up
- Where
- Turkey (Türkiye)
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Bengisu Boz Gürboğa
Myelodysplastic Syndromes, High Risk
Sonrotoclax Plus Azacitidine in Patients With MDS-IB2
This study will evaluate the safety and preliminary effectiveness of sonrotoclax combined with azacitidine in adults aged 18-70 years with newly diagnosed myelodysplastic neoplasms with increased blasts-2 (MDS-IB2).
- Trial name
- NCT07885397
- Testing
- Sonrotoclax, Azacitidine (AZA)
- Where
- 6 sites in China
- Volunteers
- 60 people
- Sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
Total Marrow and Lymphoid Irradiation as Conditioning Regimen Before Hematopoietic Cell Transplantation in Patients With Myelodysplastic Syndrome or Acute Leukemia
This phase II trial studies how well total marrow and lymphoid irradiation works as a conditioning regimen before hematopoietic cell transplantation in patients with myelodysplastic syndrome or acute leukemia.
- Conditions
- Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, High Risk Myelodysplastic Syndrome, Myelodysplastic Syndrome
- Trial name
- NCT04262843
- Testing
- Cyclophosphamide, Fludarabine, Fludarabine Phosphate
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- City of Hope Medical Center
Human Papilloma Virus (HPV), High-risk Human Papillomavirus Infection
A Study of the Preliminary Efficacy of DARE-HPV to Treat High-risk Persistent Human Papillomavirus (hrHPV)
The goal of this clinical study is to learn if DARE-HPV can treat persistent high-risk human papillomavirus (hrHPV). The primary outcome will be if the genital infection clears following treatment in 30, 60 or 90 days.
- Trial name
- NCT07601074
- Testing
- Lopinavir / ritonavir
- Where
- 8 sites in United States
- Volunteers
- 118 people
- Sponsor
- Daré Bioscience, Inc.
Coronary Artery Disease, High Risk Percutaneous Coronary Intervention
Pivotal Study of the SUpira System in Patients Undergoing High-Risk Percutaneous COronaRy InTervention (HRPCI)
The objective of this study is to assess the safety and efficacy of the Supira System in providing temporary cardiovascular hemodynamic support in patients undergoing HRPCI.
- Conditions
- Coronary Artery Disease, High Risk Percutaneous Coronary Intervention, Interventional Cardiology, Mechanical Circulatory Support
- Trial name
- SUPPORT II (NCT07296744)
- Testing
- The Supira System, Impella
- Where
- 25 sites in United States
- Volunteers
- 358 people
- Sponsor
- Supira Medical
Gestational Diabetes, Pregnancy, High Risk
Intensive Glycemic Targets in Overweight and Obese Women With Gestational Diabetes
This is a multicenter randomized clinical trial of 828 overweight and obese individuals with gestational diabetes designed to compare standard to intensive glycemic targets.
- Conditions
- Gestational Diabetes, Pregnancy, High Risk, Overweight and Obesity
- Trial name
- iGDM (NCT05124808)
- Testing
- Intensive glycemic targets, Standard glycemic targets
- Where
- 5 sites in United States
- Volunteers
- 828 people
- Sponsor
- Indiana University
Myelofibrosis, Myelofibrosis Due to and Following Polycythemia Vera
Flonoltinib Maleate Oral Regimens in Patients With Myelofibrosis
The goal of this clinical trial is to learn which of three different doses of Flonoltinib Maleate taken by mouth daily works best to treat adult patients with myelofibrosis in whom the most common approved therapy has failed to…
- Conditions
- Myelofibrosis, Myelofibrosis Due to and Following Polycythemia Vera, Myelofibrosis Transformation in Essential Thrombocythemia, Myelofibrosis With High Molecular Risk Mutations
- Trial name
- FM-MF-02 (NCT07750574)
- Testing
- Flonoltinib Maleate orally
- Volunteers
- 105 people
- Sponsor
- Chengdu Zenitar Biomedical Technology Co., Ltd
Anxiety, Pregnancy, High-Risk
Foot Reflexology for Anxiety in Women Hospitalized With High-Risk Pregnancy
The goal of this clinical trial is to learn whether a single foot reflexology session reduces anxiety in pregnant women who are hospitalized in a high-risk pregnancy unit because of maternal or fetal complications.
- Conditions
- Anxiety, Pregnancy, High-Risk, Pregnancy Complications
- Trial name
- NCT07878637
- Testing
- Foot Reflexology
- Where
- Israel
- Volunteers
- 144 people
- Sponsor
- Wolfson Medical Center
High Risk Cardiovascular Disease, Hypertension
Zilebesiran in Patients With Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Cardiovascular Disease
The purpose of this study is to evaluate whether zilebesiran versus placebo reduces the risk of cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, or heart failure (HF) events.
- Conditions
- High Risk Cardiovascular Disease, Hypertension, High Cardiovascular Risk
- Trial name
- ZENITH (NCT07181109)
- Testing
- Zilebesiran
- Where
- 1,190 sites in United States, Argentina and 33 more
- Volunteers
- 11,000 people
- Sponsor
- Alnylam Pharmaceuticals
Acute Myeloid Leukaemia, High Risk Myelodysplastic Syndrome
Phase 1 Open-label Study of AMX-883 Alone in Participants With AML and High-risk MDS and in Combination in Participants With AML
The purpose of the study is to assess the safety, pharmacokinetics, and preliminary efficacy of AMX-883 monotherapy in participants with acute myeloid leukaemia (AML) and high-risk myelodysplastic syndrome (MDS) and in…
- Trial name
- BRAMLIE (NCT07723703)
- Testing
- AMX-883, Posaconazole
- Where
- United States
- Volunteers
- 54 people
- Sponsor
- Amphista Therapeutics Ltd
High Risk Biochemical Recurrence (BCR), Deutenzalutamide Soft Capsules
A Phase 3 Study of Deutenzalutamide in Patients With High-Risk BCR Prostate Cancer
This is a multicenter, randomized, double- blind, placebo-controlled Phase III trial to evaluate the efficacy and safety of Deutenzalutamide plus ADT versus placebo plus ADT in patients with high-risk biochemical recurrence (BCR)…
- Trial name
- NCT07875881
- Testing
- Deutenzalutamide Soft Capsules + ADT
- Where
- 3 sites in China
- Volunteers
- 1,044 people
- Sponsor
- Hinova Pharmaceuticals Inc.