Clinical trials: Integrated Assessment
Advanced/Metastatic Clear Cell Renal Cell Carcinoma, Recurrence
AB-2100, an Integrated Circuit T Cell Therapy in Patients With Recurrent Clear-cell Renal Cell Carcinoma (ccRCC)
This is a multi-center, open-label phase 1/2 trial evaluating the safety and efficacy of AB-2100 cell product. The study may enroll approximately 60 patients in phase 1 and approximately 70 patients in phase 2.
- Trial name
- NCT06245915
- Testing
- AB-2100
- Where
- 9 sites in United States
- Volunteers
- 37 people
- Sponsor
- Arsenal Biosciences, Inc.
Multiple Myeloma
Efficacy and Safety Evaluation of PD1-BCMA-CART
This trial aims to evaluate the safety and efficacy of PD1-BCMA-CART in treating patients with relapsed or refractory multiple myeloma.
- Trial name
- NCT05308875
- Testing
- PD1-BCMA-CART
- Where
- China
- Volunteers
- 9 people
- Sponsor
- Bioray Laboratories
Type II Diabetes Mellitus
A Study Evaluating the Efficacy and the Benefit of Integrated Personalized Diabetes Management (PDM) for Diabetic Patients.
This study is a German, prospective, multicenter, controlled, cluster-randomized, interventional comparative study evaluating the efficacy and benefits of integrated PDM care by measuring HbA1c levels in patients with Type 2…
- Trial name
- PDMProValueDSP (NCT02156349)
- Testing
- Accu-Chek Smart Pix Software, Accu-Chek Smart Pix readout Device
- Where
- 50 sites in Germany
- Volunteers
- 558 people
- Sponsor
- Hoffmann-La Roche
Peripheral Arterial Disease, Intermittent Claudication
Study to Evaluate the Lower Extremity Intervention With Integrated Embolic Protection Using the Vanguard IEP System
The ENTRAP Study is a prospective, multi-center, non-randomized, single-arm, study with follow-up to 30 days to determine the acute safety, acute device performance and clinical performance of the Vanguard IEP Peripheral Balloon…
- Conditions
- Peripheral Arterial Disease, Intermittent Claudication, Atherosclerosis of Femoral Artery
- Trial name
- ENTRAP (NCT03271710)
- Testing
- peripheral balloon angioplasty
- Where
- 9 sites in Belgium, Germany
- Volunteers
- 113 people
- Sponsor
- Contego Medical, Inc.
Alzheimer Disease
A Study to Evaluate the Safety, Tolerability, and Efficacy of TML-6 in Participants With Early Alzheimer's Disease
The primary purpose of the study is to assess if treatment with TML-6 for 52 weeks will be effective in slowing, stopping, or improving cognitive and functional decline in participants with early Alzheimer's Disease (AD) as…
- Trial name
- NCT07612150
- Testing
- TML-6
- Volunteers
- 210 people
- Sponsor
- Merry Life Biomedical Co., Ltd.
Tooth Extraction, Tooth Fractures
Efficacy and Safety Evaluation Study of Implants With Periodontal Ligament
The goal of this clinical trial is to evaluate the efficacy and safety of periodontal ligament-integrated implants placed via residual periodontal ligament tissue in extraction sockets in adult patients (aged 18 and older)…
- Conditions
- Tooth Extraction, Tooth Fractures, Dental Caries, Tooth Dislocation
- Trial name
- NCT07302581
- Testing
- Periodontal Ligament-Integrated Implant
- Where
- 2 sites in Japan
- Volunteers
- 6 people
- Sponsor
- OrganTech, Inc.
Essential Hypertension
An Integrated Assessment of the Safety and Effectiveness of Bexagliflozin for the Management of Essential Hypertension
This integrated assessment consists of two studies, 603A and 603B, to be carried out sequentially in a common study population. Participating subjects informed of the trial design and their consent to participate in both studies…
- Trial name
- NCT03514641
- Testing
- Bexagliflozin
- Where
- 87 sites in United States
- Volunteers
- 673 people
- Sponsor
- Theracos
Diabetes Mellitus, Type 2
Evaluation of the Integrated Radio Frequency Denervation System to Improve Glycemic Control in Type 2 Diabetic Subjects
The objective of this early feasibility study is to evaluate the safety and performance of intravascular hepatic denervation using the Metavention Integrated Radio Frequency Denervation System (iRF System) to improve glycemic…
- Trial name
- DeLIVER (NCT04285554)
- Testing
- iRF System Hepatic Denervation
- Where
- 8 sites in United States
- Volunteers
- 15 people
- Sponsor
- Metavention
Atrial Fibrillation, Heart Failure
Diagnostic Device Risk Management of Atrial Fibrillation and Heart Failure
The purpose of this study is to characterize the feasibility and impact of a diagnostic tool that may help clinicians identify when patients are at higher risk of visiting the hospital for a heart failure event.
- Trial name
- IDENTIFY-HF (NCT01486316)
- Testing
- Reveal XT® Insertable Cardiac Monitor, Heart Failure Risk Status Diagnostic
- Where
- 11 sites in United States
- Volunteers
- 24 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Carotid Artery Stenosis
Evaluation of the 3-in-1 Neuroguard IEP System for Carotid Artery Stenosis
The Neuroguard IEP System is a 3-in-1 carotid stent delivery system consisting of an angioplasty balloon, an integrated embolic protection device and a nitinol self-expanding stent loaded over the balloon and constrained by an…
- Trial name
- PERFORMANCE (NCT04142541)
- Testing
- Neuroguard® IEP 3-in-1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System)
- Where
- 6 sites in Germany, Italy
- Volunteers
- 67 people
- Sponsor
- Contego Medical, Inc.
Spasticity
A Study to Assess the Safety and Efficacy of IPN10200 in Adult Participants With Upper Limb Spasticity.
The purpose of the study is to assess the safety and efficacy of increasing doses of Corabotase (also known as IPN10200) with the aim to evaluate the Pharmacodynamics (PD) profile of Corabotase and to establish the total…
- Trial name
- LANTIMA (NCT04752774)
- Testing
- Corabotase, Dysport
- Where
- 81 sites in United States, Austria and 12 more
- Volunteers
- 240 people
- Sponsor
- Ipsen
Subjects With Clinical Indication for PET/CT
Clinical Evaluation of an Integrated PET/MRI System
The investigational PET/MRI scanner, including attenuation correction method, is capable of producing diagnostic quality images and appropriate device functionality per user feedback.
- Trial name
- PET/MR_ZURICH (NCT02071706)
- Testing
- PET/MRI system
- Where
- Switzerland
- Volunteers
- 62 people
- Sponsor
- GE Healthcare
Non-Squamous Non-Small Cell Lung Cancer
A Study to Compare the Efficacy, Safety, Immunogenicity, and Pharmacokinetic Profile of HLX17 Vs. Keytruda® in the First-Line Treatment of Advanced Non-squamous Non-small Cell Lung Cancer
This is a multicentre, randomized, double-blind, parallel-controlled integrated phase I/III clinical study to evaluate the similarity in efficacy, safety, PK profile, and immunogenicity of HLX17 vs.
- Trial name
- NCT06847334
- Testing
- HLX17, US-sourced Keytruda®, EU-sourced Keytruda®
- Volunteers
- 772 people
- Sponsor
- Shanghai Henlius Biotech
Asthma
A 12-Week Treatment Study to Evaluate the Effectiveness of Albuterol Multidose Dry Powder Inhaler With Integrated Electronic Module Digital System (eMDPI DS) in Participants13 Years or Older With Asthma
This is a 12-week treatment, multicenter, open-label, randomized, parallel group comparison feasibility study to evaluate the effectiveness of the Albuterol eMDPI Digital System (DS), including inhaler, App, digital health…
- Trial name
- CONNECT1 (NCT03890666)
- Testing
- Albuterol eMDPI DS, albuterol
- Where
- 29 sites in United States
- Volunteers
- 333 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Cardiac Disease, Myocardial Dysfunction
Temporary Epicardial Pace Wire With Integrated Sensor for Continuous Postoperative Monitoring of Myocardial Function
Transesophageal echocardiography is used to monitor cardiac wall motion at various time points during open-heart surgery. After surgery, the measurements are made at various time points by transthoracic echocardiography.
- Trial name
- NCT04886934
- Testing
- CS1 System
- Where
- Norway
- Volunteers
- 38 people
- Sponsor
- Cardiaccs AS
Schizophrenia, Major Depressive Disorder
Exploratory Trial to Assess the Functionality of an Integrated Call Center for the Digital Medicine System
This study will assess the helpfulness of the integrated call center in optimizing use of the Digital Medicine System in adult subjects with Schizophrenia, Major Depressive Disorder, or Bipolar Disorder taking oral aripiprazole.
- Conditions
- Schizophrenia, Major Depressive Disorder, Bipolar I Disorder
- Trial name
- NCT02722967
- Testing
- Aripiprazole + IEM (Ingestible Event Marker)
- Where
- 4 sites in United States
- Volunteers
- 49 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Relapsing Remitting Multiple Sclerosis
Study to Evaluate the Usability and Value of Integrated Digital Solutions in Medical Care of Participants With Multiple Sclerosis
The main purpose of this study is to assess the usability and value of the multiple sclerosis (MS) care management platform in terms of improved monitoring of people with MS (pwMS) in clinical practice.
- Trial name
- ILLUMINATE (NCT05949580)
- Testing
- MS Care Platform (icobrain ms and icompanion ms)
- Where
- 7 sites in United States, Germany and 1 more
- Volunteers
- 500 people
- Sponsor
- Hoffmann-La Roche
Menorrhagia
Sonography Guided Transcervical Ablation of Uterine Fibroids
The objective of this study is to establish the safety and effectiveness of the Sonata® System in the treatment of symptomatic uterine fibroids.
- Trial name
- SONATA (NCT02228174)
- Testing
- Intrauterine Ultrasound-Guided Radiofreq. Ablation System
- Where
- 23 sites in United States, Mexico
- Volunteers
- 147 people
- Sponsor
- Gynesonics
Obesity & Overweight, Weight Loss
GLP-1 Medication & Behavioral Health Programs on Weight & Metabolic Outcomes: FLOURISH and THRIVE Prospective Cohort Study
This research program includes two coordinated prospective studies (FLOURISH and THRIVE) evaluating the real-world effectiveness of Noom's digital health programs on weight, cardiometabolic biomarkers, physiological health…
- Conditions
- Obesity & Overweight, Weight Loss, Preventative Health, Body Weight
- Trial name
- FLOURISH (NCT07588984)
- Testing
- Noom Weight, Free Tier, Education-only control
- Where
- United States
- Volunteers
- 2,310 people
- Sponsor
- Noom Inc.
Respiratory Depression, Respiratory Insufficiency
Determination of the Clinical Impact of Continuous Surveillance Monitoring (SM) and Utility of IPI.
Single site prospective observational nested study of bedside CS20p monitor on the GCF impeded into a retrospective review of the frequency of escalation of care with intermittent vitals signs compared to continuous respiratory…
- Trial name
- IPI (NCT03050983)
- Testing
- IPI
- Where
- United States
- Volunteers
- 440 people
- Sponsor
- Medtronic - MITG