Clinical trials: Adaptive Trial
Bloodstream Infection, Gram-Negative Infections
The Impact of Fast Antimicrobial Sensitivity Testing Tools on Stewardship Antibiotic and Clinical Outcome (ACT-FAST)
The ACT-FAST study aims to compare commercially available Rapid Antimicrobial Susceptibility Testing (R-AST) tools with the current standard of care for patients with Bloodstream Infections (BSI).
- Conditions
- Bloodstream Infection, Gram-Negative Infections, Gram-Positive Infections, Bacteremia Sepsis
- Trial name
- ACT-FAST (NCT07491419)
- Testing
- Diagnostic Test: Rapid Antimicrobial Susceptibility Testing (R-AST) guided Stewardship, Standard of Care (SOC)
- Where
- Italy
- Volunteers
- 400 people
- Sponsor
- Istituto Clinico Humanitas
Contrast-Induced Acute Kidney Injury
ImproviNg rEnal Outcomes Following Coronary angiograPhy and/or percuTaneoUs coroNary intErventions
The NEPTUNE triple-blind, active-placebo, adaptive, pragmatic, randomized trial aims to evaluate the effectiveness of a new intra-venous hydration strategy guided by left ventricular end-diastolic pressure (LVEDP), amount of…
- Trial name
- NEPTUNE (NCT04936607)
- Testing
- Personalized hydration strategy, Standard of care
- Where
- Canada
- Volunteers
- 1,158 people
- Sponsor
- Montreal Heart Institute
COVID-19
COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80
A multi-center adaptive randomized placebo-controlled platform trial evaluating the efficacy and safety of anti-thrombotic strategies in COVID-19 adults not requiring hospitalization at time of diagnosis
- Trial name
- NCT04498273
- Testing
- Apixaban 2.5 MG, Apixaban 5MG, Aspirin
- Where
- 71 sites in United States
- Volunteers
- 657 people
- Sponsor
- Frank C Sciurba
Ventilator Lung
I-ASV in Cardiac Surgery
'POStoperative INTELLiVENT-adaptive support VEntilation in cardiac surgery patients II (POSITiVE II) is an investigator-initiated, international, multicenter, parallel, randomized clinical trial in patients after cardiac surgery.
- Trial name
- POSITiVE II (NCT06178510)
- Testing
- INTELLiVENT-ASV.
- Where
- Austria
- Volunteers
- 328 people
- Sponsor
- Medical University of Vienna
HIV, Organ Transplantation
Bringing Optimised COVID-19 Vaccine Schedules To ImmunoCompromised Populations (BOOST-IC): an Adaptive Randomised Controlled Clinical Trial
Despite the greater risk of adverse COVID-19 outcomes, antibody and cell-mediated immune responses to COVID-19 vaccines vary amongst immunocompromised (IC) people and are poorly defined.
- Conditions
- HIV, Organ Transplantation, Lymphoma, Non-Hodgkin, Chronic Lymphocytic Leukemia
- Trial name
- BOOST-IC (NCT05556720)
- Testing
- Pfizer Bivalent COVID-19 Vaccine, Moderna Bivalent mRNA vaccine
- Where
- 13 sites in Australia
- Volunteers
- 960 people
- Sponsor
- Monash University
COVID-19, SARS-CoV-2
To Evaluate SCTA01 Treatment of High-risk Outpatients With COVID-19
The study is a multicenter, adaptive, randomized, double-blinded and placebo-controlled Phase II/III clinical trial. It will be conducted at selected investigational sites globally. The study is comprised of 2 parts.
- Trial name
- MAOP3 (NCT04709328)
- Testing
- SCTA01
- Volunteers
- 690 people
- Sponsor
- Sinocelltech Ltd.
Head and Neck Cancer, Xerostomia Due to Radiotherapy
MRI - Guided Adaptive RadioTHerapy for Reducing XerostomiA in Head and Neck Cancer (MARTHA-trial)
Radiotherapy is the main treatment for locally advanced squamous cell carcinoma of the head and neck (SCCHN). Many advances regarding tumor control and patient survival have been made over the past decades.
- Trial name
- MARTHA (NCT03972072)
- Testing
- Pre-defined MR-linac based IGRT and plan adaptation protocol, salivary flow measurements
- Where
- Switzerland
- Volunteers
- 49 people
- Sponsor
- Panagiotis Balermpas
Breast Cancer
A Study of Ridaforolimus (MK-8669) in Combination With Dalotuzumab (MK-0646) Compared to Standard of Care Treatment in Estrogen Receptor Positive Breast Cancer Patients (MK-8669-041 AM3)
This is a two-part study that will determine, if: 1) the combination of ridaforolimus and dalotuzumab will improve progression-free survival compared to exemestane; and 2) the combination of ridaforolimus and dalotuzumab will…
- Trial name
- NCT01234857
- Testing
- ridaforolimus + dalotuzumab, exemestane, ridaforolimus
- Volunteers
- 115 people
- Sponsor
- Merck Sharp & Dohme LLC
Sickle Cell Disease, Cognitive Impairment
Cognitive Remediation Intervention to Prepare for Transition of Care
Randomized Controlled Trial (RTC) testing the efficacy of a telehealth adaptation of the Cognitive-Remediation of Executive and Adaptive Deficits in Youth (C-READY) intervention to prepare adolescents with sickle cell disease for…
- Conditions
- Sickle Cell Disease, Cognitive Impairment, Adolescent Behavior, Self Efficacy
- Trial name
- NCT05336201
- Testing
- CREADY (Cognitive-Remediation of Executive and Adaptive Deficits in Youth)
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- University of Alabama at Birmingham
Acute Myeloid Leukemia (AML)
Phase 1 Study of UniCAR02-T-CD123 in Patients With Selected CD123 Positive Hematologic Malignancies
This dose-escalating phase I trial assesses for the first time the safety, the side effects and the harmlessness, as well as the therapeutical benefit of the new study drug UniCAR02-T-CD123 in patients with hematologic and…
- Trial name
- NCT04230265
- Testing
- Cyclophosphamide (Non-IMP), Fludarabine (Non-IMP), TM123 (IMP)
- Where
- 10 sites in Germany, Netherlands
- Volunteers
- 32 people
- Sponsor
- AvenCell Europe GmbH
Dental Caries
Building Adaptive School-based Interventions for Caries
Dental caries (tooth decay) is the world's most prevalent noncommunicable disease. Current preventive and therapeutic treatments are available that can be provided in a school-based health service environment.
- Trial name
- BASICS (NCT07265830)
- Testing
- Silver Diamine Fluoride (38%), Glass Ionomer Sealant, Fluoride Varnishes
- Where
- United States
- Volunteers
- 1,200 people, healthy volunteers welcome
- Sponsor
- University of Pennsylvania
Ovarian Cancer, Relapsed Ovarian Cancer
Adaptive ChemoTherapy for Ovarian Cancer in Patients With Replased Platinum-sensitive High Grade Serous or High Grade Endometrioid Ovarian Cancer
ACTOv will compare standard 3-weekly carboplatin (AUC5), to carboplatin delivered according to an AT regimen. The AT regimen will modify carboplatin dose according to changes in the clinical-standard serum biomarker CA125 as a…
- Conditions
- Ovarian Cancer, Relapsed Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
- Trial name
- ACTOv (NCT05080556)
- Testing
- Carboplatin
- Where
- United Kingdom
- Volunteers
- 80 people
- Sponsor
- University College, London
SARS-CoV-2
PROTECT-APT 1: Early Treatment and Post-Exposure Prophylaxis of COVID-19
This study is an adaptive, randomized, double blind, platform trial evaluating promising investigational products (IP) for safety and efficacy as early outpatient treatment and post-exposure prophylaxis for Severe Acute…
- Trial name
- PROTECT-APT 1 (NCT05954286)
- Testing
- Upamostat
- Where
- 6 sites in United States, South Africa and 2 more
- Volunteers
- 92 people, healthy volunteers welcome
- Sponsor
- Henry M. Jackson Foundation for the Advancement of Military Medicine
Lupus Nephritis
Study of Efficacy and Safety of LNP023 in Participants With Active Lupus Nephritis Class III-IV, +/- V
The overall purpose of this two-part study is to evaluate the efficacy, safety and tolerability of iptacopan (LNP023) in addition to standard of care treatment.
- Trial name
- NCT05268289
- Testing
- Iptacopan (part 1), Iptacopan (part 2)
- Where
- 74 sites in United States, Argentina and 17 more
- Volunteers
- 81 people
- Sponsor
- Novartis Pharmaceuticals
Pancreas Cancer
Adaptive Approach to Neoadjuvant Therapy to Maximize Resection Rates for Pancreatic Adenocarcinoma
The purpose of this study is to determine if neoadjuvant therapy to increases resection rate for pancreatic adenocarcinoma.
- Trial name
- NCT04594772
- Testing
- Folfirinox, Gemcitabine, radiation therapy
- Where
- 2 sites in United States
- Volunteers
- 32 people
- Sponsor
- University of Cincinnati
Stroke, Intracerebral Hemorrhage
APEX-STROKE CALM-ICH Domain
In this domain of APEX-STROKE, participants with acute intracerebral hemorrhage (ICH) who meet the eligibility criteria for this domain will be randomized in a 1:1 ratio to receive either Angong Niuhuang pills (ANP) or matching…
- Trial name
- CALM-ICH (NCT07752719)
- Testing
- Angong Niuhuang Pills (ANP)
- Volunteers
- 1,100 people
- Sponsor
- Fudan University
Glottic Carcinoma
Volumetric Adaptive SBRT Versus Conventional Accelerated Radiation Therapy for Early-Stage Glottic Cancer
This non-inferiority trial will compare conventional long-course accelerated fractionation radiation therapy (AF-RT) with volumetric adaptive stereotactic body radiation therapy (SBRT) in patients with early-stage (cT1-2N0M0)…
- Trial name
- VOICE (NCT07895745)
- Testing
- Long course accelerated fractionation radiation therapy, Adaptive stereotactic body radiation therapy
- Where
- Canada
- Volunteers
- 150 people
- Sponsor
- University Health Network, Toronto
Oropharyngeal Cancer
PEARL PET-based Adaptive Radiotherapy Clinical Trial
The PEARL study will recruit approximately 50 patients with human papillomavirus (HPV)-positive oropharyngeal squamous cell carcinoma (OPSCC) who are about to undergo primary treatment with concurrent chemo-radiation from South…
- Trial name
- PEARL (NCT03935672)
- Testing
- PET-CT scans, Outlining the biological GTVs (bGTV_P and bGTV_iP), Blood samples for cell-free DNA analysis
- Where
- 3 sites in United Kingdom
- Volunteers
- 50 people
- Sponsor
- Velindre NHS Trust
Cocaine-Related Disorders
Developing Adaptive Interventions for Cocaine Cessation and Relapse Prevention
First, the investigators will determine whether Acceptance and Commitment Therapy in combination with Contingency Management increases initial treatment response rates.
- Trial name
- NCT02896712
- Testing
- Acceptance and Commitment Therapy (ACT), Drug Counseling (DC), Contingency Management (CM)
- Where
- United States
- Volunteers
- 118 people
- Sponsor
- The University of Texas Health Science Center, Houston
Cardiovascular Risk Factor
Precision Assignment of Intervention Messages to Promote Physical Activity - Precision AIM
Our goal is to develop personalized decision rules for selecting the frequency, timing, and content of messages to promote physical activity.
- Trial name
- NCT04972279
- Testing
- Digital message (text + image)
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Penn State University