A Double-Blind, Placebo-Controlled, Double-Dummy Study of Donanemab and RG6289 in PSEN1 E280A Mutation Carriers, and in Non-Randomized, Placebo-Treated Non-Carriers From the Same Kindred, to Evaluate the Efficacy and Safety of Donanemab, RG6289, or the Combination of Donanemab and RG6289, in the Treatment of Autosomal-Dominant Alzheimer's Disease

The study will be conducted in 2 blinded parts (Part 1 and Part 2). In Part 1, study participants who are mutation carriers will receive active donanemab and non-mutation carriers will receive placebo-donanemab for up to 18 months (76 weeks), with a minimum treatment period of 9 months. Amyloid PET scans will be conducted at screening, 9, and 18 months in Part 1. Participants who are at or below 11 CL at screening or reach complete amyloid plaque clearance as measured by florbetapir F18 PET (defined as ≤11 CL) at 9 months will initiate Part 2. Participants who are ≤11 CL at screening may delay their entry into Part 2 for up to 6 months at the discretion of the Investigator. All remaining participants will start Part 2 after completing 18 months (76 weeks) in Part 1 independent of amyloid results. Non-carriers will receive placebo in both Parts 1 and 2.
In Part 2, study participants who are mutation carriers will be randomized 1:1:1:1 in a full factorial design to receive either RG6289 + placebo-donanemab (RG6289 alone group), donanemab + placebo-RG6289 (donanemab alone group), the combination of RG6289 and donanemab (combination group), or placebo-RG6289 and placebo-donanemab (placebo group). All non-carriers will be assigned to the placebo group. CDR-GS at the end of Part 1 and the amyloid level using the last completed amyloid PET scan in Part 1 will be used for stratification. All study participants will participate in a double-dummy design for the duration of Part 2 receiving both an intravenous (IV) infusion at the required interval for the donanemab or matching placebo as well as a daily oral treatment of RG6289 or matching placebo.
An exploratory outcome of Part 1 is a comparison of the amyloid clearance between this ADAD cohort and historical controls using propensity score matching. The primary outcome in Part 2 is change from the start of Part 2 through the end of Part 2 in brain amyloid load in PSEN1 E280A mutation carriers as measured by amyloid PET imaging. Other endpoints will include fluid and imaging biomarkers and measures of cognition and functioning. The maximum study duration for any individual participant will be 3 years, not including the screening or follow-up periods

开始日期2026-01-15

申办/合作机构

Banner Health

[+2]

NCT07239141

/ Not yet recruitingN/AIIT

Estimation of the Non-Inferiority of the Laringocel® Videolaryngoscope Compared With the C-MAC D-BLADE (Karl Storz®) for First-Attempt Intubation in Adult Patients Undergoing Elective Surgery

This study will test two video laryngoscopes that help doctors place a breathing tube during surgery. A breathing tube is needed for people who receive general anesthesia so they can breathe safely. Video laryngoscopes use a small camera to give a better view of the throat and vocal cords, which may help the tube go in on the first try.
The purpose of this research is to find out if a Colombian device called Laringocel® works as well as the widely used international device C-MAC D-Blade® (Karl Storz). If Laringocel® performs similarly, it could be a more affordable option for hospitals with limited resources.
252 adults (126 in each group) who need elective surgery at Alma Máter Hospital de Antioquia (Medellín, Colombia) will take part. Each participant will be randomly assigned, like flipping a coin, to have their breathing tube placed with either Laringocel® or C-MAC D-Blade®. Only trained anesthesiologists will perform the procedure.
The study will look at:
Main goal: how often the tube goes in correctly on the first attempt.
Other goals: overall success within 3 attempts, how well the airway is seen, how long the intubation takes, how satisfied the doctor is with the device, and possible side effects such as sore throat, dental injury, or oral injury.
Participation will not change the usual care people receive during anesthesia. Both devices are already approved for clinical use. Risks are the same as with any standard intubation, and participants will be checked after surgery for any problems.
By comparing these two devices, researchers hope to learn if Laringocel® can provide safe and effective intubation at lower cost, improving access to advanced airway tools.

开始日期2025-12-31

申办/合作机构

Universidad de Antíoquia

NCT06822478

/ Not yet recruiting临床3期IIT

Randomized Blinded Clinical Trial to Evaluate the Safety and Efficacy of Arnica Tincture in the Topical Treatment of Cutaneous Leishmaniasis.

Cutaneous leishmaniasis (CL) is a parasitic disease caused by more than 20 different species of the protozoan parasite Leishmania. CL usually begins with a papule at the site of the sandfly bite, which enlarges to form a nodule that progresses to an ulceration, or a scaly or warty plaque, over a period of 1 to 3 months.
The exact incidence of CL is not known. An estimated 1.2 million cases/year in approximately 100 countries worldwide suffer from different forms of CL. More than 90% of CL cases occur in the Americas and Eastern Mediterranean regions. Afghanistan, Algeria, Brazil, Colombia, Iraq, Pakistan, and Syria report more than 80% of new CL cases worldwide. Since 2010, the World Health Organization has insisted on the need to work on products that become alternatives for the treatment of LC, especially in products that can be applied topically because with them the probability of systemic toxicity is lower, increasing patient safety.
Currently, it is recommended to apply local treatments for patients with localized LC, either with pentavalent antimonials administered intralesionally or with thermotherapy. Among the options for topical treatment are natural products that have been, are and will be of utmost importance as sources of medicinal agents. In addition to natural products that have found direct medicinal applications as pharmaceutical entities, many others can serve as chemical models or templates for the design, synthesis and semi-synthesis of novel substances for the treatment of human diseases.
Arnica montana L. is a plant with anti-emollient, healing, anti-inflammatory, analgesic and antineuralgic properties; it is included in the Colombian vademecum of medicinal plants.
In a randomized phase Ib/II clinical trial conducted in patients with localized LC in Colombia, 100% (per protocol analysis) and 92% (intention-to-treat analysis) efficacy was demonstrated, with no adverse effects other than those expected such as erythema, burning, pain or itching.
By demonstrating that arnica tincture is effective and safe, and that A. montana flower extracts in different preparations (topical solutions, tinctures, liniments, ointments or gels) are approved by the European Medicines Agency and are included in the vademecum of Colombian plants issued by the Ministry of Social Protection of Colombia in 2008, the present study aims to establish the safety and efficacy of arnica tincture as an alternative for the topical treatment of localized LC compared to a currently available local therapeutic alternative: intralesional pentavalent antimonials.

开始日期2025-10-01

申办/合作机构

Universidad de Antíoquia

[+1]

100 项与 Universidad de Antíoquia 相关的临床结果

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0 项与 Universidad de Antíoquia 相关的专利（医药）

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7,366

项与 Universidad de Antíoquia 相关的文献（医药）

2026-01-01·MEAT SCIENCE

Evaluation of portable, low-cost techniques for discriminating the DFD (dark, firm, dry) condition in beef

Article

作者: Angulo-Arizala, Joaquín ; Hernández-Hernández, Leonardo ; Barragán-Hernández, Wilson ; Mahecha-Ledesma, Liliana

This study evaluated the effectiveness of portable, low-cost techniques, specifically colorimetry and visible spectroscopy for discriminating dark, firm, and dry (DFD) beef carcasses during processing in a certified slaughterhouse. Portable, low-cost devices were used for real-time assessments. A total of 523 chilled carcasses were analyzed, of which 449 were classified as normal and 74 as DFD, based on pH measurements (≥5.8 for DFD). Colorimetric variables (L*, a*, b*, chroma, and hue) were consistently higher in normal carcasses compared to DFD. Supervised classification models were used to predict DFD status using the evaluated detection techniques. Given the class imbalance, the Synthetic Minority Over-sampling Technique (SMOTE) was applied, significantly improving the performance of machine learning models. Portable spectroscopy showed superior performance, especially when combined with preprocessing techniques such as multiplicative scatter correction and second-order derivatives, achieving 96.77 % sensitivity and 98.06 % specificity with the Random Forest model. Although colorimetry proved effective, spectroscopy yielded greater reliability for real-time DFD detection. These findings highlight the potential of these techniques as cost-effective alternatives to traditional methods, supporting their applicability in rapid and objective meat quality assessments under industrial conditions.

2026-01-01·JOURNAL OF HYPERTENSION

Circulatory phenotypes in hypertension identified by 24-h ambulatory blood pressure monitoring

Article

作者: Gallo-Villegas, Jaime ; Álvarez-Montoya, Diego ; Aristizábal-Ocampo, Dagnovar ; Fernández-Ruiz, Ricardo ; Madrid-Muñoz, Camilo

Background::

Although 24-h ambulatory blood-pressure monitoring (ABPM) is widely available, its diagnostic potential beyond confirming different types of hypertension remains under-utilized.

Objective::

To derive and externally validate against echocardiographic hemodynamic indices a purely ABPM-based classification of circulatory phenotypes that extends conventional blood-pressure staging.

Methods::

We retrospectively analyzed 29 743 consecutive adults who underwent 24-h ABPM. After excluding anyone previously treated for hypertension, 12 876 de-novo participants (50.2 ± 13.6 years; 51.4% men; 24.7% obese) were included, 9195 of whom were hypertensive. Pearson correlation matrices identified diastolic blood pressure (DBP), pulse pressure (PP) and heart rate (HR) as the least-collinear variables. These were z -standardized and submitted to K-means clustering.

Results::

Four reproducible phenotypes were yielded: cardiogenic – elevated HR and cardiac output (CO) without arterial dysfunction (ΔHR = +10.5 bpm vs. normotensives, 95% CI 10.0–10.9); vaso-resistive – raised DBP with reduced HR, resulting in a higher DBP/HR index (ΔDBP/HR = +0.23 mmHg bpm −1 , 95% CI 0.22–0.24); mixed – simultaneously increased HR and DBP, giving the highest DBP/HR index ( P < 0.001 vs. normotensives); arterial-stiffness – widened PP with lower DBP, reflected in an elevated PP/DBP index (ΔPP/DBP = +0.16, 95% CI 0.15–0.17). Cluster-derived proxies of CO, systemic vascular resistance, and arterial stiffness showed good agreement with echocardiographic measurements, confirming their physiological validity.

Conclusions::

A simple, unsupervised cluster analysis of routine ABPM data uncovers four reproducible circulatory phenotypes that enrich traditional blood pressure staging. Incorporating these phenotypes into clinical practice could refine risk stratification and enable mechanism-targeted antihypertensive therapy.

2025-12-31·Hospital practice (1995)

Direct costs of severe hypoglycemia events in individuals with diabetes mellitus: a perspective from the Colombian health system - a single-center study

Article

作者: Rojas-Henao, Natalia A. ; Garcia-Rivera, Michael ; Díaz-Giraldo, Juliana ; Hernandez-Herrera, Ana C. ; Builes-Montaño, Carlos E.

BACKGROUND AND AIMS:

Diabetes mellitus is one of the more prevalent chronic diseases globally, and healthcare expenditures for diabetes care are on the rise. Intensive diabetes treatment has been associated with reducing the risk of chronic complications. However, hypoglycemia, the most common adverse effect, poses a significant risk to individuals' lives and is linked to high costs for healthcare systems.

METHODS:

We conducted a retrospective cross-sectional study to determine direct costs by identifying emergency room visits due to hypoglycemia events using diagnostic codes during January 2017 to June 2019. Direct costs were calculated using billed data from the payer and information on outpatient treatment regimens. Differences in median costs were estimated based on length of stay and type of outpatient treatment.

RESULTS:

Data from 101 patients and the same number of events were included. Women represented (62.4%) of the patients, the median age was 70 (IQR 59.5-80). Blood glucose levels at admission ranged from 12 mg/dL to 67 mg/dL. Most patients were on insulin for outpatient treatment. The median cost of care per hypoglycemia episode was US $345.35 (IQR US $202-727.8), and the cost per episode was higher in patients treated with regimens that included sulfonylureas.

CONCLUSIONS:

The management of patients admitted to the emergency department with a diagnosis of hypoglycemia places a significant burden on the Colombian healthcare system, primarily due to the associated hospitalization costs. Patients treated with regimens that included sulfonylureas incurred higher costs per episode. Prevention, patient education, and individualized treatment approaches could help alleviate the burden of hypoglycemia on both patients and the healthcare system.

项与 Universidad de Antíoquia 相关的新闻（医药）

2025-12-02

·Business Wire

Unravel Biosciences Announces Approval by Colombian Health Regulatory Authority to Initiate RVL-001 Clinical Studies for Rett Syndrome and Pitt Hopkins Syndrome

BOSTON--(BUSINESS WIRE)--Unravel Biosciences, Inc., (“Unravel”), a clinical-stage therapeutics company established to advance drugs for complex diseases through its Predictable Medicine™ platform, today announced the approval to initiate Unravel’s RVL-001 clinical trials for Rett syndrome (“RTT”) and Pitt Hopkins syndrome (“PTHS”) in Colombia by the Colombian Health Regulatory Agency (“INVIMA”). Today’s announcement is a validation of Unravel's efficient approach towards rapid clinical testing of promising therapeutics for rare and complex disorders, conditions that afflict nearly 10% of the world’s population. Unravel's proprietary data and BioNAV™ discovery engine established dynamic transcriptome network profiles, called “Living Molecular Twins,” to identify RVL-001 as a potentially promising therapeutic drug for RTT and PTHS. RVL-001 targets a novel therapeutic mechanism, which will be clinically evaluated for the first time in these studies. In addition to Unravel’s RVL-001 program for RTT and PTHS, the company has also initiated development of RVL-002, a first-in-class novel molecule for RTT syndrome. INVIMA approval allows both programs to commence recruiting immediately, with first patient dosing anticipated in January 2026 at the Universidad de Antioquia’s Center for Technological Development (“PECET”), a clinical study center of excellence and designated INVIMA clinical trial site in Medellin, Colombia. Both RVL-001 proof of concept studies are placebo-controlled, “n-of-1” trials with a target enrollment of 15 RTT patients and 5 PTHS patients. More information can be found at https://clinicaltrials.gov/study/NCT07150013 and https://clinicaltrials.gov/study/NCT07150026 "We are thrilled to commence both clinical trials as a critical milestone in our patient-driven, platform-developed therapeutics programs,” said Richard Novak, Ph.D., Unravel Co-Founder and CEO. "Today’s announcement is a validation of our efficient approach towards rapid clinical testing of promising therapeutics for rare and complex disorders, conditions that afflict nearly 10% of the world’s population." RTT and PTHS are both rare neurogenetic disorders starting in early childhood that lead to debilitating cognitive, motor and autonomic disability. Despite one approved treatment for RTT, there remains a significant unmet need for novel treatments having meaningful efficacy and acceptable safety and tolerability. There are no known treatments for PTHS. About Unravel Biosciences Unravel Biosciences is a clinical-stage therapeutics company that integrates AI systems biology computation with rapid clinical validation of discovered targets, leading to four clinical trials starting in 2026. Unravel leverages its proprietary BioNAV™ platform and primary transcriptomics data to create Living Molecular Twins of real patients that can be used to predict therapeutic response. This enables target and drug discovery, preclinical screening, patient stratification, and clinical validation to find treatments for complex diseases using a systematic, data-driven approach called Predictable Medicine™. Unravel's platform discovered RVL002, a first-in-class small molecule that targets mitochondrial metabolism and has multiple clinical applications, including neurodegenerative and metabolic disorders, and identified RVL069, a molecule that targets a novel mechanism to treat dystonias. The rareSHIFT™ program provides platform and proprietary datamine access to foundation and biotech partners to accelerate and clinically derisk therapeutics. www.unravel.bio and www.rareshift.org

临床研究

2025-04-29

·PRNewswire

Unravel Biosciences Announces Submission of RVL-001 Clinical Study Applications for Rett Syndrome and Pitt Hopkins Syndrome to Colombian Health Regulatory Authority

Submissions follow Ethics Committee Approvals for Both Studies Received Earlier This Month and Have Been Accepted for INVIMA Priority Review Under Fast Track Program for Rare Disease BOSTON, April 29, 2025 /PRNewswire/ -- Unravel Biosciences, Inc., ("Unravel"), an AI-enabled therapeutics company established to advance drugs for complex diseases, today announced the submission of clinical study applications for Unravel's RVL-001 proof of concept clinical trials for Rett syndrome ("RTT") and Pitt Hopkins syndrome ("PTHS") in Colombia. Both applications have been submitted under a pilot program by the Colombian Health Regulatory Agency ("INVIMA"), allowing for priority review and fast track approval for orphan and high unmet need diseases. Unravel anticipates study initiation in the early summer for both programs at the Universidad de Antioquia's Center for Technological Development ("PECET"), a clinical study center of excellence and designated INVIMA clinical trial site in Medellin, Colombia. Both RVL-001 proof of concept studies are designed as placebo-controlled, "n-of-1" trials with a target enrollment of 15 patients with RTT and 5 patients with PTHS. "Today's announcement represents an important milestone towards Unravel's evolution into a clinical-stage company," said Richard Novak, Ph.D., Unravel Co-Founder and CEO. "We look forward to INVIMA's expedited review of our study applications and are prepared to start patient dosing soon after we receive INVIMA approval." RTT and PTHS are both rare neurogenetic disorders starting in early childhood that lead to debilitating cognitive, motor and autonomic disability. Despite one approved treatment for RTT, there remains a significant unmet need for novel treatments having meaningful efficacy and acceptable safety and tolerability. There are no known treatments for PTHS. Unravel's proprietary BioNAV™ drug discovery platform identified RVL-001 as a potentially promising therapeutic drug for Rett Syndrome and PTHS. In addition to Unravel's RVL-001 program for RTT and PTHS, the company has also initiated development work on RVL-002, a first-in-class novel molecule for Rett syndrome. "The Rett and Pitt Hopkins Syndrome communities, including families, caregivers and treating physicians, have been eagerly awaiting the opportunity to participate in meaningful clinical research to find potentially beneficial therapeutics for their loved ones." said Dr. Carolina Lesmes, Pediatric Neurologist and Principal Investigator of the RVL-001 studies. "We are ready to initiate these two important studies to assess the safety and potential efficacy of RVL-001." About Unravel Biosciences Unravel Biosciences is a therapeutics company founded on the principle that biological networks inform clinical outcomes. By using primary patient data with AI systems biology computation, rapid in vivo screening, and clinical validation of discovered targets, Unravel enables drug development with unprecedented efficiency. Unravel leverages its proprietary BioNAV™ platform combining target and drug prediction with patient stratification by efficacy and toxicity response to find treatments for complex diseases. Unravel's platform has led to two clinical trials starting in 2025. Unravel's platform developed RVL002, a first-in-class new small molecule targeting mitochondrial metabolism, and RVL027 and RVL068, molecules targeting two novel mechanisms to treat dystonias. The rareSHIFT™ program provides platform access to foundation and biotech partners to accelerate and clinically derisk therapeutics. and SOURCE Unravel Biosciences, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床研究快速通道优先审批

2024-12-02

·mobihealthnews

GE HealthCare acquires remaining stake of Nihon Medi-Physics from Sumitomo Chemical

GE HealthCare announced it acquired the remaining 50% stake in Nihon Medi-Physics (NMP) from Sumitomo Chemical, giving it full ownership of NMP. GE HealthCare has had a 50% stake in NMP since acquiring Amersham plc in 2004 for $9.5 billion. Amersham specialized in medical imaging agents and life sciences. In a statement, NMP said it can now expand on its expertise developing and manufacturing proprietary and in-licensed radiopharmaceuticals that are used in single photon emission computed tomography (SPECT) and positron emission tomography (PET) molecular imaging procedures to detect and diagnose disease. NMP’s product line includes GE HealthCare radiopharmaceuticals that are used to allow clinical images across neurology, cardiology and oncology procedures. Besides its 13 manufacturing facilities, NMP concentrates on research and development, such as nonclinical and clinical development of radiotracers and theranostics research. "As the third largest pharmaceutical market in the world and amongst the leading countries by number of cyclotrons, Japan is on a path to becoming a leader in the $7 billion molecular imaging global market and a center of excellence for Asian markets," Kevin O’Neill, president and CEO of the pharmaceutical diagnostics (PDx) segment of GE HealthCare, said in a statement. "NMP will play a key role in that journey, including bringing its deep expertise and scale to global innovators looking to bring novel products to the Japan market and beyond. This will strengthen our precision care strategy in Asia and our existing footprint in Japan, where our contrast media and medical devices are used every day to enable imaging procedures across the country." Hiroshi Ueda, executive vice president, Sumitomo Chemical, said the company is proud of its 50-year relationship with NMP and its partnership with GE HealthCare. "At a time of exciting developments in the industry, following its discussions with Sumitomo Chemical, we believe GE HealthCare is the best owner to enable NMP to continue its successful growth journey," Udea said in a statement. The deal between Sumitomo and GE HealthCare is expected to close in early 2025. THE LARGER TREND GE HealthCare exhibited more than 40 innovations, including several key AI-enabled technologies to optimize patient care and increase operational efficiencies at the Radiological Society of North America’s (RSNA) 2024 Annual Meeting in Chicago. Among them, workflow efficiency technologies are being showcased at RSNA, including Clarify DL, a bone-image reconstruction algorithm powered by AI that is designed to enhance bone SPECT image quality performance, a key factor in increasing diagnostic confidence. Additionally, Command Lite by IONIC Health empowers radiology staff to concentrate on patient care, while accessing support through remote collaboration and scan assistance. In November, GE HealthCare announced the Pristina Via mammography system designed to increase the screening experience for both technologists and patients. The system, which debuted at the RSNA 2024 Annual Meeting, provides mammography technologists with a suite of sophisticated tools that balance the demands of diagnostic accuracy and fast-paced workflows to facilitate more patient-centered breast care. GE HealthCare also announced additional clinical applications as part of the OEC 3D mobile CBCT C-arm portfolio to help enable precise and effective imaging during endoscopic bronchoscopy procedures.

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100 项与 Universidad de Antíoquia 相关的转化医学

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