Clinical trials: Adaptive Trial
Castration-resistant Prostate Cancer Patients with Oligometastases
Management of Castration-Resistant Prostate Cancer with Oligometastases
This adaptive phase II/III randomized trial is designed to demonstrate that eradication of oligometastases by SBRT is a promising and emerging way to delay disease progression and postpone second line systemic therapies in…
- Trial name
- PCS IX (NCT02685397)
- Testing
- Leuprolide Acetate, Goserelin Acetate, Triptorelin
- Where
- 11 sites in Canada
- Volunteers
- 102 people
- Sponsor
- Sir Mortimer B. Davis - Jewish General Hospital
HIV, Substance Abuse Disorder
JomCare Study - A Harm Reduction Study
Chemsex, the use of psychoactive drugs before or during sexual activity, is a growing public health concern associated with striking increases in HIV, particularly among men who have sex with men (MSM).
- Trial name
- JomCare (NCT06794840)
- Testing
- JomCare is a smartphone-based just-in-time adaptive intervention (JITAI) for chemsex-related harm reduction.
- Where
- Malaysia
- Volunteers
- 482 people, healthy volunteers welcome
- Sponsor
- University of Connecticut
Breast Cancer Patients, Breast Cancer Early Stage Breast Cancer (Stage 1-3)
Hormonal Receptor (HR)-Positive HER2 Negative Breast Cancer Patients Treated With Preoperative ELacestrant and PULSAR Radiotherapy
This is a proof-of-concept phase II trial to assess the safety (as primary endpoint) and clinical efficacy of neoadjuvant therapy with Elacestrant and PULSAR.
- Conditions
- Breast Cancer Patients, Breast Cancer Early Stage Breast Cancer (Stage 1-3), HR+/HER2- Breast Cancer, Radiation Therapy
- Trial name
- HELP (NCT07005882)
- Testing
- Elacestrant, PULSAR
- Where
- Italy
- Volunteers
- 21 people
- Sponsor
- Azienda Ospedaliero-Universitaria Careggi
Healthy Subject, Immunity
The Effect of the Consumption of 4 Botanical Extracts on Immunity in Healthy Adults (B-4-Immune)
This study will evaluate the capacity of botanical extracts to modulate immune mechanisms compared to a placebo group in healthy volunteers.
- Trial name
- B-4-Immune (NCT05117385)
- Testing
- Botanical extract
- Where
- France
- Volunteers
- 115 people, healthy volunteers welcome
- Sponsor
- Givaudan France Naturals
Anesthesia, Hip Fractures
Anesthesia and Perioperative Neurocognitive Disorders in the Elderly Patients Undergoing Hip Fracture Surgery Platform Trial (ANDES Platform Trial)
The ANDES Platform Trial is a pragmatic, multicenter, adaptive randomized controlled platform trial in patients aged 65 years or older undergoing surgery for hip fracture.
- Conditions
- Anesthesia, Hip Fractures, Dementia, Cognitive Impairment
- Trial name
- ANDES platform (NCT06452147)
- Testing
- Nerve block, Standard anesthesia care, Bupivacaine liposome
- Where
- 13 sites in China
- Volunteers
- 1,860 people, healthy volunteers welcome
- Sponsor
- Second Affiliated Hospital of Wenzhou Medical University
Methamphetamine Addiction
Efficacy of Adaptive, Gamified Digital Therapeutics Intervention for Individuals With Methamphetamine Use Disorder in Community Rehabilitation
This study evaluates the efficacy of a comprehensive, adaptive digital therapeutics (DTx) smartphone application compared to treatment as usual (TAu) for individuals with Methamphetamine Use Disorder (MUD) receiving…
- Trial name
- NCT07319325
- Testing
- WonderLab Harbor+ (Adaptive DTx), Standard Community Counseling
- Where
- China
- Volunteers
- 360 people
- Sponsor
- Adai Technology (Beijing) Co., Ltd.
Cancer
Re-Engaging AYA Survivors in Cancer-Related Healthcare
The goal of this clinical trial is to test the efficacy (how well they work) of different digital interventions that deliver information to adolescent and young adult (AYA) survivors of childhood cancer to promote re-engagement…
- Trial name
- REACH:SMART (NCT07138040)
- Testing
- Stage 1 Written Information, Stage 1 Low Touch Intervention, Stage 2 Written Information
- Where
- 3 sites in United States
- Volunteers
- 530 people
- Sponsor
- Children's Hospital of Philadelphia
Cancer-associated Cachexia
Visugromab in Cachexia International Trial
A study of how well and safely a new drug called visugromab works in people with certain kinds of cancer (including lung and bowel cancer) and unintended weight loss known as cachexia.
- Trial name
- VINCIT (NCT07112196)
- Testing
- Visugromab (CTL-002)
- Where
- 74 sites in United States, Bulgaria and 10 more
- Volunteers
- 518 people
- Sponsor
- CatalYm GmbH
Emotional Disorders, Anxiety
Efficacy of a Personalized, Response-based Transdiagnostic Intervention for Emotional Disorders Delivered Via the Internet: A Protocol for an Adaptive Randomized Controlled Trial
This adaptive randomized controlled trial evaluates the efficacy of a transdiagnostic, internet-delivered psychological intervention for emotional disorders, tailored to patient´s early clinical response.
- Conditions
- Emotional Disorders, Anxiety, Depression, Unipolar
- Trial name
- NCT07051148
- Testing
- UJI Online Transdiagnostic Protocol, UJI On Line Transdiagnostic Hibrid Protocol
- Volunteers
- 366 people
- Sponsor
- Universitat Jaume I
Chinese Medicine, Stable Coronary Heart Disease
Xuefu-Zhuyu Capsule for the Treatment of "Qizhi Xueyu Zheng" (Qi Stagnation and Blood Stasis Syndrome)
"Xuefu-Zhuyu capsule" (XFZY) is made from a classic Fangji "Xuefu-Zhuyu Decoction" in an ancient Chinese medical book "Yi Lin Gai Cuo" by Chinese physician Wang Qingren, which is the most representative formula for the treatment…
- Conditions
- Chinese Medicine, Stable Coronary Heart Disease, Chronic Insomnia, Headache
- Trial name
- NCT04218487
- Testing
- Xuefu-Zhuyu Capsule, conventional therapy
- Where
- 12 sites in China
- Volunteers
- 720 people
- Sponsor
- Zhong Wang
Amyotrophic Lateral Sclerosis
Fecal Microbiota Transplantation Effect on Amyotrophic Lateral Sclerosis Patients
Given the role of adaptive immunity in ALS, the pathogenicity of some clostridial strains on motorneurons, the putative role of cyanobacteria in ALS development, and the increasing interest for microbiota in neurodegenerative…
- Trial name
- FETR-ALS (NCT03766321)
- Testing
- Fecal microbiota transplantation
- Where
- 5 sites in Italy
- Volunteers
- 42 people
- Sponsor
- Azienda Ospedaliero-Universitaria di Modena
Hepatocellular Carcinoma (HCC)
AI-Guided Surveillance and Curative Salvage of Recurrence After Hepatocellular Carcinoma Resection or Ablation
Hepatocellular carcinoma, the most common type of primary liver cancer, can recur after liver resection or thermal ablation performed with curative intent.
- Trial name
- HCC-AI-RECLAIM (NCT07732504)
- Testing
- Artificial Intelligence-Guided Risk-Adapted Surveillance, Fixed-Interval Surveillance
- Where
- China
- Volunteers
- 2,000 people
- Sponsor
- Tongji Hospital
Extracorporeal Membrane Oxygenation Complication, ARDS (Acute Respiratory Distress Syndrome)
RECOMMEND Platform Trial
The goal of this platform trial is to determine the efficacy, safety and cost-effectiveness of various interventions in patients with acute cardiorespiratory failure requiring extracorporeal membrane oxygenation (ECMO) The main…
- Conditions
- Extracorporeal Membrane Oxygenation Complication, ARDS (Acute Respiratory Distress Syndrome), Intensive Care Medicine, Cardiac Arrest (CA)
- Trial name
- RECOMMEND (NCT06526533)
- Testing
- Liberal RBC Transfusion, Restrictive RBC Transfusion
- Where
- 3 sites in Australia
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Australian and New Zealand Intensive Care Research Centre
Obesity
Continuous Wearable Biometric Monitoring in Adults Undergoing Obesity Treatment (SMART-BMI)
The goal of this clinical trial is to learn if a smart ring that tracks health signals can help adults lose weight and improve their health during obesity treatment.
- Trial name
- SMART-BMI (NCT07736729)
- Testing
- Biometric-informed care, Control Arm: Standard Care
- Where
- United States
- Volunteers
- 260 people
- Sponsor
- Jeff Reeves
Sleep and Circadian Problems
Optimisation and Evaluation of a Just-in-time Adaptive Intervention (JITAI) for Sleep and Circadian Problems (Phase III)
The JITAI approach holds considerable promise for addressing current challenges in mHealth, including the limitations in supporting real-time monitoring, timely intervention, and poor adherence.
- Trial name
- NCT07277049
- Testing
- Optimised just-in-time adaptive intervention (JITAI) based on TranS-C (GoodShleep+)
- Where
- Hong Kong
- Volunteers
- 80 people
- Sponsor
- Chinese University of Hong Kong
Septic Shock
Selepressin Evaluation Programme for Sepsis-Induced Shock - Adaptive Clinical Trial
This is a double-blind, randomised, placebo-controlled, two-part adaptive clinical trial. The trial is designed to investigate the efficacy and safety of multiple dosing regimens of selepressin and to confirm the efficacy and…
- Trial name
- SEPSIS-ACT (NCT02508649)
- Testing
- selepressin
- Where
- 21 sites in United States, Belgium and 3 more
- Volunteers
- 868 people
- Sponsor
- Ferring Pharmaceuticals
Major Depressive Disorder (MDD), Breast Cancer Survivor
Moving on After Breast Cancer Trial for Depressed Breast Cancer Survivors in Pakistan
Breast cancer is the most common cancer among women worldwide, and many survivors experience comorbid mental health conditions such as depression and anxiety, which can significantly worsen health outcomes and increase mortality.
- Trial name
- Moving On ABC (NCT07015944)
- Testing
- Non-specialist delivered Low intensity guided self-help (Khushi and Khatoon), Moving on After Breast Cancer (ABC) plus, Standardised pharmacological treatment (antidepressants)
- Where
- Pakistan
- Volunteers
- 26,376 people
- Sponsor
- Pakistan Institute of Living and Learning
Epilepsy
A Single-blind, Placebo-controlled, Outpatient Trial to Assess the Effects of Single Oral Tablet Dose of OPC-214870
Despite availability of several antiepileptic drugs (AEDs), in one-third of patients, epilepsy remains uncontrolled with AEDs. There is a need to develop new approaches to improve the existing medications to relieve patients'…
- Trial name
- NCT04241965
- Testing
- OPC-214870
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Lung Non-Small Cell Carcinoma, Stage IIIB Lung Cancer AJCC v8
Immunotherapy Biomarkers to Predict First-line PD(L)1-based Immunotherapy Response and Selection of Second-line Treatment in Stage IIIB-IV Non-small Cell Lung Cancer, IMMUNO-BIOMAP Trial
This phase II trial tests the impact of biomarkers in predicting initial treatment (first-line) PD1 or PD-L1 (PD[L]-1)-based immunotherapy response and in selecting second-line treatment in patients with stage IIIB-IV non-small…
- Conditions
- Lung Non-Small Cell Carcinoma, Stage IIIB Lung Cancer AJCC v8, Stage IV Lung Cancer AJCC v8
- Trial name
- NCT07288034
- Testing
- Adagrasib, Anti-PD-L1 Monoclonal Antibody, Anti-PD1 Monoclonal Antibody
- Where
- 13 sites in United States
- Volunteers
- 535 people
- Sponsor
- City of Hope Medical Center
Impaired Glucose Tolerance, Obesity
Enhancing Fitness in Older Pre-diabetic Veterans
This study targets older adults (ages 60 and over) who are overweight (body mass index 25-40) with impaired fasting glucose (100 - 125).
- Conditions
- Impaired Glucose Tolerance, Obesity, Diabetes
- Trial name
- NCT00594399
- Testing
- Physical Activity Counseling
- Where
- United States
- Volunteers
- 302 people
- Sponsor
- US Department of Veterans Affairs