Clinical trials: Safety Plan
Advanced HR+ HER2 Negative Breast Carcinoma
H (Trastuzumab or Biosimilar) Combined With CDK4/6 Inhibitor + AI±OFS in the Treatment of HR+HER2+ Advanced Breast Cancer Efficacy and Safety: a Chinese Multi-center Real World Study
This study is a multi-center prospective real-world clinical study, mainly evaluating the efficacy and safety of H combined with CDK4/6 inhibitor + AI in the treatment of HR+/HER2+ advanced breast cancer; exploring potential…
- Trial name
- NCT05167643
- Testing
- Enituzumab injection+Abesili tablets+Anastrozole tablets
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
Neuropathic Pain
Safety And Efficacy In Long Term Use Of Lyrica (Regulatory Post Marketing Commitment Plan)
The objective of this investigation is to evaluate the safety and efficacy of long term use with Lyrica in medical practice. Also, occurrence of unknown and known adverse drug reactions (ADRs) in subjects treated with Lyrica will…
- Trial name
- RAINBOW-L (NCT01279850)
- Testing
- Pregabalin (Lyrica) capsule
- Volunteers
- 891 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Ileus, Gastro-Intestinal Disorder
A Study to Evaluate LB1148 for Return of Bowel Function in Subjects Undergoing Bowel Resection
The purpose of this study is to evaluate the safety and efficacy of LB1148 in subjects undergoing planned bowel resection.
- Trial name
- INTEGRITY (NCT05470387)
- Testing
- LB1148
- Where
- 23 sites in United States
- Volunteers
- 23 people
- Sponsor
- Palisade Bio
Autism Spectrum Disorder, Suicidal Ideation
Adapted Visual Safety Plan for Autistic Youth (VSP-AY) to Address Self-harm, Suicidal Ideation, and Suicide Behaviors
This pilot randomized controlled trial will recruit 90 autistic adolescents aged 13-18 years with recent suicidal thoughts or behaviors from Geha Mental Health Center in Israel.
- Conditions
- Autism Spectrum Disorder, Suicidal Ideation, Suicidal Behavior, Self-Injurious Behavior
- Trial name
- VSP-AY (NCT07333014)
- Testing
- Adapted Visual Safety Plan for Autistic Youth (VSP-AY) to Address Self-harm, Suicidal Ideation, and Suicide Behaviors
- Where
- Israel
- Volunteers
- 90 people
- Sponsor
- College of Management Academic Studies
Breast Cancer, Postsurgical Acquired Absence of Organ
Non-contrast Magnetic Resonance Angiography in Deep Inferior Epigastric Perforator Flap Breast Reconstruction Planning
The aim of this study is to evaluate the efficacy and safety of contrast-free magnetic resonance angiography (MRA) for deep inferior epigastric perforator flap planning.
- Trial name
- NCT06061835
- Testing
- Non-contrast MRA in preoperative perforator vessels mapping for deep inferior epigastric perforator (DIEP) flap breast reconstruction planning., CTA with iodine contrast in preoperative perforator vessels mapping for deep inferior epigastric perforator (DIEP) flap breast reconstruction planning.
- Where
- 2 sites in Russia
- Volunteers
- 135 people
- Sponsor
- I.M. Sechenov First Moscow State Medical University
NSCLC, Stage I
Combining SBRT and Immunotherapy in Early Stage NSCLC Patients Planned for Surgery
This study aims to evaluate the safety and mechanisms of action of the trimodality treatment (radiotherapy, immunotherapy and surgery) in early-stage non-small cell lung cancer.
- Trial name
- NCT03446911
- Testing
- SABR, SABR + pembrolizumab
- Volunteers
- 20 people
- Sponsor
- Amsterdam UMC, location VUmc
Coronary Disease
Study of Otamixaban Versus Unfractionated Heparin (UFH) and Eptifibatide in Non-ST Elevation Acute Coronary Syndrome
Primary objective: To demonstrate the clinical efficacy of otamixaban (dose effect via 5 intravenous [IV] regimens) in patients with moderate-to-high-risk non-ST elevation acute coronary syndromes (ACS) and planned early invasive…
- Trial name
- SEPIA-ACS1 (NCT00317395)
- Testing
- Otamixaban (XRP0673), unfractionated heparin, eptifibatide
- Where
- 36 sites in United States, Argentina and 34 more
- Volunteers
- 3,241 people
- Sponsor
- Sanofi
Infantile Neuroaxonal Dystrophy
A Study to Assess Efficacy and Safety of RT001 in Subjects With Infantile Neuroaxonal Dystrophy
The purpose of this study is to evaluate the efficacy and safety of RT001 in patients with Infantile Neuroaxonal Dystrophy (INAD).
- Trial name
- NCT03570931
- Testing
- RT001
- Where
- 2 sites in United States
- Volunteers
- 19 people
- Sponsor
- Biojiva LLC
Suicide
Emergency Department Safety Assessment and Follow-up Evaluation 2
Many patients at risk for suicide are discharged from the ED with little or no intervention. Evidence-based suicide prevention interventions, like universal screening and safety planning should be adopted in clinical practice to…
- Trial name
- ED-SAFE-2 (NCT02453243)
- Testing
- Safety Planning, A Lean Implementation Strategy
- Where
- 8 sites in United States
- Volunteers
- 14,250 people
- Sponsor
- University of Massachusetts, Worcester
Suicide
Rapid Personalization of Safety Plans for Psychiatrically Hospitalized Veterans at High-Risk for Suicide
Veterans psychiatrically hospitalized face significantly elevated suicide risk, particularly in the three months post-discharge.
- Trial name
- NCT07507786
- Testing
- Personalized Safety Plans, Safety Plans as Usual + Calls
- Where
- United States
- Volunteers
- 111 people
- Sponsor
- VA Office of Research and Development
HIV, Suicide
Suicide Assessment and Feasible Evidence-based Treatments for Youth Living With HIV in Lilongwe
The overall aim of this study is to determine the feasibility, fidelity, acceptability, and preliminary effectiveness of the Friendship Bench +Safety Planning intervention in reducing suicidal ideation and behaviors (SIBs) and…
- Trial name
- NCT06770101
- Testing
- Behavioral: Enhanced Friendship Bench + Safety Planning, Augmented usual care
- Where
- 4 sites in Malawi
- Volunteers
- 60 people
- Sponsor
- University of Pennsylvania
Male Contraception
Open Label, Dose Escalation, Repeat Dose Study Evaluating YCT-529 in Healthy Males
This is a Phase 1b/2a open-label, dose escalation 3 part-study, 28-day, 90-day or 180 day repeat dose study of YCT-529 in healthy males who have decided to have a vasectomy and are waiting for the procedure and for men who have…
- Trial name
- NCT06542237
- Testing
- YCT-529
- Where
- New Zealand
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- YourChoice Therapeutics, Inc.
Suicidal Ideation, Suicidal Behavior
Integrated Suicide Supports and Safety Planning for Youth
The goal of this clinical trial is to evaluate an app to help keep teens and young adults with suicidal thoughts safe. The app includes a safety plan created by adolescents and healthcare providers, and videos to encourage…
- Trial name
- ISSP (NCT06701006)
- Testing
- Integrated skills and safety planning app
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- University of Washington
Breast Neoplasms, Lung Neoplasms
Benchmarking Large Language Models Against Tumour Boards for Oncology Treatment Recommendations
BEACON (Benchmarking AI for Clinical Oncology decisioNmaking) is a prospective, multicentre, comparative, blinded, non-interventional benchmark comparing the treatment recommendations of six frontier large language models (LLMs)…
- Conditions
- Breast Neoplasms, Lung Neoplasms, Urologic Neoplasms, Prostatic Neoplasms
- Trial name
- BEACON (NCT07739121)
- Testing
- Multidisciplinary tumour boards, Frontier large language models
- Where
- 5 sites in France
- Volunteers
- 100 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Intracranial Metastatic Disease From Any Solid Malignancy
Simulation-Free Hippocampal-Avoidance Whole Brain Radiotherapy Using Diagnostic MRI-Based and Cone Beam Computed Tomography-Guided On-Table Adaptive Planning in a Novel Ring Gantry Radiotherapy Device
Hippocampal-avoidance whole brain radiation therapy (HA-WBRT) limits radiation dose to the hippocampal-avoidance region while still delivering therapeutic doses of radiation to the whole brain.
- Trial name
- NCT05096286
- Testing
- Ethos Therapy
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Washington University School of Medicine
Malnutrition
Pilot Study of the Safety and Efficacy of Oxandrolone in the Prevention and Treatment of Malnutrition in Infants
Oxandrolone is an anabolic steroid, marketed in the United States as an adjunctive therapy to combat weight loss resulting from chronic infection, extensive surgery, severe trauma, protein catabolism associated with prolonged…
- Trial name
- NCT01048632
- Testing
- Oxandrolone
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Utah
Suicide
A System of Safety (SOS)
SOS will identify evidence based best practices consistent with Zero Suicide's six specific recommended clinical actions (A.2.) and use them to develop standardized clinical protocols for each care setting, clinical unit…
- Trial name
- SOS (NCT03104504)
- Testing
- Suicide Risk Screening, Safety Planning, Care transition facilitation
- Where
- United States
- Volunteers
- 493,756 people
- Sponsor
- University of Massachusetts, Worcester
Suicide, Attempted, Suicide Ideation
Preventing Suicidal Behavior With Diverse High-Risk Youth in Acute Care Settings
This multisite randomized controlled trial will compare two brief interventions for youth and young adults ages 12-24 following an acute care visit for suicide risk: the Stanley-Brown Safety Planning Intervention with follow-up…
- Conditions
- Suicide, Attempted, Suicide Ideation, Suicide, Suicide Prevention
- Trial name
- Project HOPE (NCT06151158)
- Testing
- Stanley Brown Safety Planning Intervention and Follow-up Contacts (SPI+), Interpersonal Psychotherapy for Adolescents Ultra Short Crisis Intervention (IPT-A SCI)
- Where
- 6 sites in United States
- Volunteers
- 484 people
- Sponsor
- Johns Hopkins University
Suicide, Attempted
Safety Planning Intervention to Reduce Short Term Risk
This study will determine the efficacy of Safety Planning Intervention (SPI) compared to receiving risk factors and warning sign information (RWI) in recent suicide attempters during the 6 months following an acute care visit on…
- Trial name
- NCT03227991
- Testing
- Safety Planning Intervention, Risk factors and Warning signs
- Where
- 3 sites in United States
- Volunteers
- 422 people
- Sponsor
- New York State Psychiatric Institute
Large Hole Percutaneous Arterial Closure
Safety and Performance Study for Arterial Large Hole Vascular Closure Device
To study will assess safety and performance of the PerQseal Elite Closure Device when used with the 18F PerQseal Elite Introducer to percutaneously close femoral artery punctures and to induce arterial haemostasis in patients…
- Trial name
- ELITE (NCT05951634)
- Testing
- PerQseal ELITE
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Vivasure Medical Limited