This study is only enrolling at Baylor College of Medicine. The other research locations listed serve to support data analysis only.
This research study is to investigate the use of technology called Deep Brain Stimulation (DBS) to potentially improve Treatment-Resistant Bipolar Depression (TRBD) symptoms in patients with severe cases. DBS involves the surgical implantation of leads and electrodes into specific areas of the brain, which are thought to influence the disease. A pack implanted in the chest, called the neurotransmitter, keeps the electrical current coursing to the brain through a wire that connects the neurotransmitter and electrodes. It is believed DBS may restore balance to dysfunctional brain circuitry implicated in TRBD. The goal of this study is to enhance current approaches to DBS targeting in the brain and to use a novel approach to find a better and more reliable system for TRBD treatment.
Its important for participants to understand that this is an investigational study where there could be a lack of effectiveness in improving TRBD symptoms. There may be no directly benefit from taking part in this study.
This study is expected to last 20 months and involves 3 main steps.
1. Medical, psychiatric, and cognitive evaluations.
2. Implantation of a brain stimulation system.
3. Follow up after implantation of device, including programming, recording, and psychiatric testing.
There are risks and benefits to this study which need to be considered when deciding to participate or not. Some of the risks are from surgery, the DBS device and programming, the tests involved, and potential loss of confidentiality, as well as other unknown risks.
Some of the more serious risks involved in this study and the percentage that they occur:
1. Bleeding inside the Brain (1 to 2 percent).
2. Infection from the procedures (3 percent)
3. Seizure caused from the procedures (1.2 percent)
However, the benefit of this study is that it may help relieve or decrease TRBD symptoms. This form of treatment has shown to reduce symptom severity in other cases. This could potentially improve quality of life and activities in daily routines. There is also a potential benefit to society in that the data the investigators will obtain from this study may help increase the understanding of the mechanisms underlying TRBD symptoms, as well as enhanced Deep Brain Stimulation techniques.
Study participation is expected to last 20 months from the time the DBS device is activated and should include approximately 23 visits. These visits also include 8 separate, 24 hour stays at the Menninger NeuroBehvaioral Monitoring Unit (NBU). These 24-hour sessions will occur at multiple points throughout the study (1 week prior to surgery, the week preceding device activation, the week following activation, then after 2 weeks, 4 weeks, 6 months, 9 months, and 12 months). Participants will need to stay locally for the week of the NBU stay (typically Monday through Friday).
Study visits will include clinician administered assessments and questionnaires, subject reported assessments, neuropsychological testing, and mobile behavioral assessments which will occur around 23 visits over the course of 20 months.

Start Date01 Nov 2024

Sponsor / Collaborator

Baylor College of Medicine

[+4]

NCT06435286 / Not yet recruitingPhase 2IIT

Effectiveness and Performance of a Mobile, Automated, Optical Biopsy Technology for Esophageal Cancer Screening: A Clinical Study in Brazil and the United States

In a previous clinical trial in China and the United States (US), the investigators developed and validated a mobile, high-resolution microendoscope (mHRME) for screening and surveillance of esophageal squamous cell neoplasia (ESCN). The trial revealed higher specificity for qualitative (visual) interpretation by experts but not the novice and in the surveillance arm (100% vs. 19%, p <0.05). In the screening arm, diagnostic yield (neoplastic biopsies/total biopsies) increased 3.6 times (8 to 29%); 16% of patients were correctly spared any biopsy, and 18% had a change in clinical plan. In a pilot study in Brazil, the investigators tested a software-assisted mHRME with deep-learning software algorithms to aid in the detection of neoplastic images and determine the performance, efficiency, and impact of the AI-mHRME when to Lugol's chromoendoscopy (LCE) alone and when using AI-mHRME with LCE. In this clinical trial, the investigators will build on the Brazil pilot trial data to optimize an artificial intelligence (AI) mHRME and evaluate its clinical impact and implementation potential in ethnically and socioeconomically diverse populations in the US and Brazil.

Start Date01 Nov 2024

Sponsor / Collaborator

Baylor College of Medicine

[+3]

NCT05949047 / RecruitingNot ApplicableIIT

Biobehavioral Mechanisms of Smartphone-based Cognitive Emotion Regulation Training for Unpaid Primary Caregivers of Persons With Alzheimer's Disease

Alzheimer's Disease (AD) and Alzheimer's Disease-Related Dementias (ADRD) not only exact a heavy toll on patients, they also impose an enormous emotional, physical, and financial burden on unpaid, often family, caregivers. The strain of providing care for a loved one diagnosed with AD, often across several years, is associated with elevated depression risk and poorer overall health. Emotion regulation skills represent an ideal target for psychological intervention to promote healthy coping in ADRD caregivers. The project seeks to use an experimental medicine approach to test the efficacy and biobehavioral mechanisms of a novel, relatively brief, targeted, scalable, smartphone-based cognitive emotion regulation intervention aimed at improving psychological outcomes (i.e., reducing perceived stress, caregiver burden, and depressive symptoms) in ADRD unpaid primary caregivers as well as examine potential benefits of the caregiver intervention on quality of life in care recipients. Cognitive reappraisal is the ability to modify the trajectory of an emotional response by thinking about and appraising emotional information in an alternative, more adaptive way. Reappraisal can be operationalized via two primary tactics: psychological distancing (i.e. appraising an emotional stimulus as an objective, impartial observer) and reinterpretation (i.e., imagining a better outcome than what initially seemed apparent). The project will investigate the efficacy and underlying biobehavioral mechanisms of a novel, one-week cognitive reappraisal intervention in this population, with follow-up assessments at 2 weeks, 4 weeks, and 3 months. ADRD unpaid primary caregivers will be randomly assigned to receive training in either distancing, reinterpretation, or a no regulation natural history control condition, with ecological momentary assessments of self-reported positive and negative affect, remotely- collected psychophysiological health-related biomarkers (i.e., heart rate variability data) using pre-mailed Polar H10 chest bands, and health-related questionnaire reports. Distancing training is expected to result in longitudinal reductions in self-reported negative affect, longitudinal increases in positive affect, and longitudinal increases in HRV that are larger than those attributable to reinterpretation training and no-regulation control training.

Start Date14 Sep 2023

Sponsor / Collaborator

William Marsh Rice University

[+1]

100 Clinical Results associated with William Marsh Rice University

0 Patents (Medical) associated with William Marsh Rice University

33,069

Literatures (Medical) associated with William Marsh Rice University

01 Jan 2025·WATER RESEARCH

Metagenomic insights into microalgae-bacterium-virus interactions and viral functions in phycosphere facing environmental fluctuations

Article

Author: Qi, Huiyuan ; Lv, Jiahui ; Tao, Yi ; Alvarez, Pedro J.J. ; Yu, Pingfeng ; Ren, Yong ; Wang, Dongsheng ; Liao, Jingqiu ; Alvarez, Pedro J J ; Jin, Junhao

Despite the ecological and biotechnological significance of microalgae-bacterium symbionts, the response of host-virus interactions to external environmental fluctuations and the role of viruses in phycosphere remain largely unexplored. Herein, we employed algal-bacterial granular sludge (ABGS) with varying light intensity and organic carbon loading to investigate the mechanisms of microalgae-bacterium-virus symbionts in response to environmental fluctuations. Metagenomics revealed that enhanced light intensity decreased the diversity of microalgae, so did the diversity of symbiotic bacteria and viruses. As carbon sources decreased, bacteria prompted horizontal gene transfer in phycosphere by 12.76 %-157.40 %, increased the proportion of oligotrophs as keystone species (0.00 % vs 14.29 %) as well as viruses using oligotrophs as hosts (18.52 % vs 25.00 %). Furthermore, virus-carried auxiliary metabolic genes (AMGs) and biosynthetic gene clusters (BGCs) encoding vitamin B₁₂ synthesis (e.g., cobS), antioxidation (e.g., queC), and microbial aggregation (e.g., cysE). Additionally, phylogenetic and similarity analysis further revealed the evolutionary origin and potential horizontal transfer of the AMGs and BGCs, which could potentially enhance the adaptability of bacteria and eukaryotic microalgae. Overall, our research demonstrates that environmental fluctuations have cascading effects on the microalgae-bacteria-virus interactions, and emphasizes the important role of viruses in maintaining the stability of the phycosphere symbiotic community.

01 Jan 2025·COGNITION

The primacy of taxonomic semantic organization over thematic semantic organization during picture naming

Article

Author: Zhai, Mingjun ; Qu, Qingqing ; Feng, Chen ; Fischer-Baum, Simon

Different organizational structures have been argued to underlie semantic knowledge about concepts; taxonomic organization, based on shared features, and thematic organization based on co-occurrence in common scenes and scenarios. The goal of the current study is to examine which of the two organizational systems are more engaged in the semantic context of a picture naming task. To address this question, we examined the representational structure underlying the semantic space in different picture naming tasks by applying representational similarity analysis (RSA) to electroencephalography (EEG) datasets. In a series of experiments, EEG signals were collected while participants named pictures under different semantic contexts. Study 1 reanalyzes existing data from semantic contexts directing attention to taxonomic organization and semantic contexts that are not biased towards either taxonomic or thematic organization. In Study 2 we keep the stimuli the same and vary semantic contexts to draw attention to either taxonomic or thematic organization. The RSA approach allows us to examine the pairwise similarity in scalp-recorded amplitude patterns at each time point following the onset of the picture and relate it to theoretical taxonomic and thematic measures derived from computational models of semantics. Across all tasks, the similarity structure of scalp-recorded neural activity correlated better with taxonomic than thematic measures, in time windows associated with semantic processing. Most strikingly, we found that the scalp-recorded patterns of neural activity between taxonomically related items were more similar to each other than the scalp-recorded patterns of neural activity for thematically related or unrelated items, even in tasks that makes thematic information more salient. These results suggest that the principle semantic organization of these concepts during picture naming is taxonomic, at least in the context of picture naming.

01 Jan 2025·ULTRASOUND IN MEDICINE AND BIOLOGY

A Bioengineered Cathepsin B-sensitive Gas Vesicle Nanosystem That Responds With Increased Gray-level Intensity of Ultrasound Biomicroscopic Images

Article

Author: Pacheco, Ana Beatriz F ; Lu, George J ; Garrute, Felipe Vianna ; Machado, João Carlos

OBJECTIVE:

This work aimed to promote the interaction of a modified gas vesicle (GV) with cathepsin B (CTSB) protease and analysed their backscattered signal by ultrasound (US).

METHODS:

We modified the sequence of the gene coding for GvpC to contain a CTSB cleavage and expressed the protein in an Escherichia coli recombinant system. The protein was purified and added to GVs preparations in which the original GvpC was removed (ΔGV), constituting the modified GV (GV*). Western blot testing was used to compare GVs with GvpC and engineered GvpC at starting (T0) and after 24 h (T24) reacting with CTSB. A 21 MHz US B-mode and non-linear contrast mode (5% total power) imaged US phantoms having samples of GVwt, ΔGV (stripped GV), GV* and CTSB + GV*. Also, a 21 MHz US B-mode imaged US phantoms having a tumour cell line extracellular fraction (TCEF) and the TCEF + GV* sample. A 100% total US power was applied to collapse the GV structure.

RESULTS:

On Western blotting, we detected a decrease in engineered GvpC levels 24 h after the incubation of GV* with CTSB, compared with the concentration at T0, suggesting that CTSB cleaved the engineered GvpC. Regions-of-interest over image of phantom cross-sections were determined and the B-mode image mean grey-level intensity resulted in a significant (p < 0.05) increase comparing CTSB + GV* with PBS (control), GVwt, ΔGV and GV*. Non-linear mode image grey-level intensity from CTSB + GV* increased by 11.79, 7.86 and 14.75 dB from samples containing GVwt, ΔGV and GV*, respectively. GV preparations incubated with TCEF and the TCEF + GV* sample showed an increase of 81% in signal compared with TCEF + GVwt.

CONCLUSION:

The increased US backscattered signal intensity suggests GVs as a potential biosensor for protease activity, possibly aiding the detection of protease-rich tissue regions.

199

News (Medical) associated with William Marsh Rice University

08 Nov 2024

·www.echemi.com

U.S. Department of Defense Funds 17 Biomanufacturing Projects with a Total of $26.9 Million

BioMADE, a Biomanufacturing innovation institute initiated and founded by the U.S. Department of Defense, recently announced 17 selected projects with the goal of further promoting the scale development and commercialization of biomanufacturing products in the United States. These projects cover a wide range of areas, including biodegradable bioplastics, bio-aviation fuel, waste upcycling, and innovative technologies such as cell-free systems. The selected projects were submitted by teams from 30 different member organizations across 18 U.S. states, from New York to Texas. Participating member organizations include private enterprises, non-profit organizations, academic research institutions and community colleges, reflecting the breadth of cross-sectoral collaboration. "U.S. leadership in scientific research must be matched by leadership in production processes and scale-up capabilities," emphasized Arati Prabhakar, assistant to the U.S. Department of Science and Technology and director of the White House Office of Science and Technology Policy. She believes that through such project support, the United States can ensure overall leadership in the field of biofuturing. It is worth noting that the last batch of selected BioMADE projects was announced in September 2023, when a total of nine projects were selected. The 17 projects announced this time will undoubtedly bring more innovation and business opportunities to the U.S. biofutrition field. To support the development of these projects, the United States government will provide $13.9 million in federal funds, while project participants will also contribute $13 million in non-federal cost-sharing, bringing the total support funding to $26.9 million. This funding will provide strong support for these innovative projects to make breakthroughs in the field of biofabration. Member Team Project Name Field Involved Lygos Achieving Greener Chemistry through Pilot-Scale Process Integration and Intensification Bio-based Succinic Acid Invizyne Technologies, University of Georgia Protein Production via Cell-Free Biomanufacturing: Applicable for Sustainable Aviation Fuel Cell-Free Methods Manufacturing Biofuel Isobutanol Johns Hopkins University Whiting School of Engineering, Technology Holding, CleanJoule Upcycling Waste to Carboxylic Acids through Integrated Fermentation and Separation Organic Waste to Medium-Chain Carboxylic Acids (MCCA) Manus, University of Texas at Austin Engineering Yeast Lysis to Enhance Intracellular Product Recovery Improved Intracellular Product Recovery in Yeast Systems Mango Materials, University of California Davis, Black & Veatch Gas Fermentation for Decentralized Local Biomaterials Manufacturing Producing Polyhydroxyalkanoates (PHA) from Methane Bluestem Biosciences, ideaCHEM, Iowa State University, Southeast Community College Achieving Sustainable Bioacrylic and Organic Acid Separation through New Technologies 3-Hydroxypropionic Acid (3-HP) NCERC at SIUE, University of Hawaii at Hilo Establishing a Tropical Sustainability Center through Collaboration Converting Hawaiian Feedstocks to Cellulosic Sugars for Ethanol Production Binghamton University, NCERC at SIUE Biomanufacturing Project Management Certificate Program One Core Course, Two Electives University of Minnesota, Georgia Tech Security and Safety Impacts of Cell-Free Systems on Biomanufacturing Development of Cell-Free Systems Rice University Genetic Toolkit for Non-Model Organisms Developing a Genetic Toolkit for Three Environmental Bacteria Tandem Repeat Technologies, ARCTOS Technology Solutions, University of Georgia Biomanufacturing Methods for Producing Sustainable Textile Fibers from Waste Yeast Converting Waste Yeast Biomass to Textile Feedstock Industrial Microbes, Georgia Tech University, FERMWORX Sustainable Carbon Fiber from Waste Producing Bio-based Carbon Fiber from Ethanol and Carbon Dioxide Capra Biosciences, Virginia Tech Continuous Biomanufacturing of High-Value Products from Food Waste Inhibiting Anaerobic Digestion to Advance Food Waste Recovery Tega Therapeutics, Advanced Regenerative Manufacturing Institute (ARMI) Domestic Supply of Heparin Production of Recombinant Heparin Montana State University Technology Status Study Biomaterials in Arctic Environments Purdue University Enzymes and Cell Transformations Tufts University Bio-preservatives

22 Oct 2024

·www.prnewswire.com

Rice launches RBL LLC to rapidly create biotech startups focused on delivering breakthrough therapies to patients

Venture creation studio situated in the Texas Medical Center Helix Park HOUSTON, Oct. 22, 2024 /PRNewswire/ -- In a bold move to transform patient care, Rice University has launched RBL LLC, a pioneering biotech venture creation studio designed to rapidly build companies based on life-saving medical technologies developed out of the Rice Biotech Launch Pad, the university's biotech innovation accelerator. The Rice Biotech Launch Pad, established last year, will continue to provide RBL with fully developed and de-risked technologies from Rice's life sciences portfolio, serving as a steady pipeline of innovation for new ventures. RBL's mission is to fast-track the journey "from bench to bedside" by leveraging a large portfolio of over 100 patents from Rice faculty, bringing together world-class scientists and engineers with experienced business executives to launch multiple companies in a thriving biotech innovation environment. Located in Houston's Texas Medical Center Helix Park, RBL bridges the gap between academic biotech discoveries and the clinical care market. RBL's location within the TMC provides greater opportunity to collaborate with premier clinical centers, corporate partners and global investors — all within the same complex — to rapidly bring groundbreaking therapies to patients by directly transforming Rice's most promising life science technology into high impact ventures, company leaders said. RBL was co-founded by an elite team of scientists, engineers, entrepreneurs and investors including Paul Wotton, executive director of the Rice Biotech Launch Pad; Omid Veiseh, Rice professor of bioengineering and faculty director of the Rice Biotech Launch Pad; Jacob Robinson, Rice professor of electrical and computer engineering; and Dr. Rima Chakrabarti, a physician scientist and venture capital investor with KdT Ventures. "This is a pivotal moment for Houston and beyond," said Wotton, RBL's managing partner. "Houston has rapidly emerged as a global life sciences powerhouse, blending cutting-edge research with early clinical applications at Rice and the city's world-renowned hospital systems. Investors from across the nation are recognizing Houston's potential, and with RBL, we're building on that momentum. We'll not only amplify the work of the Rice Biotech Launch Pad but expand our reach across Texas, creating opportunities for biotech ventures statewide and driving growth for the biotech industry as a whole." Rice President Reginald DesRoches highlighted the far-reaching impact of RBL, saying the company opens a "new chapter" in how universities engage with the biotech industry. "By forging a direct pipeline between our world-class research with clinical and commercial experts, we're at the forefront of life sciences innovation," DesRoches said. "RBL will enable us to tackle some of the most pressing health care challenges globally by working with our partners in the Texas Medical Center to make therapeutics more accessible and affordable, while strengthening our leadership in Houston's dynamic biotech innovation ecosystem." William McKeon, president and CEO of the TMC, expressed enthusiasm for the collaboration, calling the launch of RBL a "critical step forward" for Houston's life sciences ecosystem. "Leveraging Rice University's Biotech Launch Pad breakthroughs and pairing it with the world-class translational infrastructure of TMC Helix Park well positions RBL to drive unprecedented advances in patient care," McKeon said. "This partnership between academia, industry and health care is exactly what's needed to transform medical discoveries into real-world solutions that improve lives globally." The creation of RBL from Rice was spearheaded by Paul Cherukuri, Rice's chief innovation officer, and Veiseh, who recognized the need for launching a commercial entity to create multiple startup companies faster from newly developed biotechnology. "RBL is a game-changer for Rice, Houston and the global biotech community," Cherukuri said. "This venture not only accelerates the commercialization of our innovations but also sets a blueprint for other universities looking to maximize the real-world impact of their discoveries. By combining scientific expertise with entrepreneurial support from Day Zero together with strategic clinical partnerships in the TMC, we're creating a model for driving large-scale biotech innovation that universities everywhere should aspire to replicate." "RBL provides a powerful platform to translate high-impact scientific discoveries into therapies that will dramatically improve patient outcomes," Veiseh said. "Our goal is to rapidly bring Rice's pioneering research into the clinic, delivering life-saving solutions to patients around the world." The formation of RBL LLC was guided by Hogan Lovells US LLP with Houston partner Barry Burgdorf, representing Rice, playing a key role in its design and rollout, while Goodwin Procter LLP, representing RBL, ensured the transition from concept to execution. About RBL LLC: RBL LLC is a pioneering biotech venture creation studio based in Houston that is dedicated to accelerating the development of breakthrough medical technologies and therapies through company formation. RBL provides entrepreneurs, researchers and innovators with the infrastructure, financial support and strategic guidance as well as access to laboratory space and shared resources in the Texas Medical Center Helix Park. For more information, please visit . Media Contact: Russo Partners David Schull or Liz Phillips (347) 956-7697 [email protected] [email protected] SOURCE RBL LLC WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

22 Oct 2024

·endpts.com

MacroGenics sells rights to breast cancer drug; Rice’s new biotech accelerator

Plus, news about Annexon, Passkey Therapeutics, XOMA Royalty and Twist Bioscience: MacroGenics sells breast cancer drug rights for up to $75 million: The company is handing over Margenza’s rights to TerSera Therapeutics in exchange for $40 million when the deal closes and up to $35 million in sales milestones. The treatment, which is administered with chemotherapy for some patients with metastatic HER2-positive breast cancer, was approved by the FDA in 2020. — Jaimy Lee Rice University launches biotech accelerator: RBL LLC is looking to speed up the journey of biotech startups with medical tech developed out of the Rice Biotech Launch Pad, the university’s innovation accelerator. RBL will use patents from university faculty and bring together executives and scientists to launch “multiple” companies, according to RBL . — Katherine Lewin Annexon reports more data from Phase 2 eye drug trial: The company is back with positive secondary endpoint data from a mid-stage trial. Last year, it said its complement inhibitor didn’t prove statistically significant in the primary endpoint of reducing lesion eye growth. On Tuesday, it said the drug, ANX007, showed “enhanced protection of vision and greater preservation of central photoreceptor cells” in a subpopulation of patients in the trial that had less advanced geographic atrophy. It expects to share data from a pivotal Phase 3 trial in the second half of 2026. — Katherine Lewin Passkey emerges from stealth with $20M in seed funding: The raise will go toward developing a new class of single-drug therapies that the company is calling synergistic multifunctional therapeutics, which will be designed to “modulate rare combinations of proteins that work together.” Breakout Ventures, Innovation Endeavors and Bison Ventures led the funding round. — Katherine Lewin XOMA’s new royalty deal with Twist: The company will get $15 million upfront in cash in exchange for one-half of milestones and royalties from agreements that Twist is already engaged in. — Jaimy Lee

Phase 2Drug Approval

100 Deals associated with William Marsh Rice University

100 Translational Medicine associated with William Marsh Rice University

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Pipeline Snapshot as of 02 Dec 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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Drug(Targets)	Indications	Global Highest Phase

MMUT CRISPR/Cas9 gene therapy (CRISPR Therapeutics/ National Institutes of Health/Rice University/Baylor College of Medicine)	Methylmalonic Acidemia More	Preclinical
WBZ-7 ( c-Kit )	Neoplasms More	Pending

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