Actinic Keratosis

Researchers are studying the use of a 2,910 nm mid-infrared Fiber Laser (UltraClear, Acclaro Medical) to treat advanced perioral lines and wrinkles. The goal is to assess the laser's effectiveness for skin rejuvenation by using both superficial epidermis ablation and deeper skin layers' ablative and coagulative effects. The study also aims to evaluate safety and participant satisfaction with this resurfacing treatment for photodamaged skin and wrinkles. Participants will receive up to two treatments with the UltraClear laser, spaced 6 to 8 weeks apart. These treatments focus on improving the appearance of perioral lines and wrinkles using the laser's combined superficial and deep skin effects. Following treatments, participants will have follow-up visits at 1 month and 3 months to evaluate the results and any side effects. Throughout the study, researchers will measure improvements using multiple scales, including the Fitzpatrick Wrinkling and Degree of Elastosis Scale, Physician Global Aesthetic Improvement Scale, and assessments by independent photographic reviewers. Participants will also report their own perceptions of aesthetic improvement and satisfaction. Safety and overall aesthetic outcomes will be monitored during follow-ups, with the total participation lasting through the 3 months after the final treatment.

Researchers are evaluating noninvasive imaging methods to study the appearance of skin and mucosal lesions to improve diagnostic accuracy before a biopsy is needed and to help guide treatment planning. This study involves creating an Image Repository to store these images for clinical practice, teaching, training, and future research. It uses a high-resolution Optical Coherence Tomography (OCT) device called ApolloVueae S100 Image System that provides detailed cross-sectional and en-face images with cellular information. Participants with muco-cutaneous lesions, including normal skin, benign lesions, or neoplastic conditions, identified during routine clinical care will undergo various non-invasive imaging tests. These include dermoscopic imaging, 3-dimensional total body photography, confocal microscopy, OCT imaging, ultrasound, hyperspectral imaging, electrical impedance spectroscopy, and patient self-imaging using mobile phone technology with dermatoscope attachments. Images will be collected of untreated and treated lesions over a period of 7 years. Participants will have their lesions imaged using these non-invasive tools, with images collected and stored in the Image Repository. Assessments include capturing detailed images using specialized devices to evaluate lesion morphology, depth, vascular features, and biochemical information. Researchers will monitor the imaging data to support clinical decisions, teaching, and future research. Participation may involve multiple imaging sessions over time, and safety monitoring includes ensuring no allergic reactions to imaging materials. The study welcomes healthy volunteers and all ages, with informed consent or parental consent and patient assent as applicable.

This research aims to find a new way to treat actinic keratoses, which are rough, scaly skin spots caused by long-term sun exposure. These spots are common in adults under 50 with chronically sun-damaged skin and can sometimes develop into skin cancer if untreated. The study is exploring whether adding aluminum chloride hexahydrate to a standard cream treatment improves the reduction of these skin spots. Participants will apply one of two treatments to their affected skin areas: either the standard 5% 5-fluorouracil cream alone or a combination of 5% 5-fluorouracil cream plus 15% aluminum chloride hexahydrate cream. The treatment is applied twice daily for one week on either the scalp or forearms. The study uses a split-area approach where one half receives the investigational treatment and the other half receives standard care, with the assignment randomized and blinded. Participants will be examined before treatment, shortly after the one-week treatment ends, and about eight weeks later. During these visits, a dermatologist will count the number of actinic keratoses and take photographs to monitor changes. Researchers will also assess skin redness, itchiness, and pain at the treatment sites. The study will measure how well each treatment reduces the number of skin spots over time and monitor participant safety.

Detailed description of device and surgical procedure: During the surgical procedure, the colorectal anastomosis will be created using the C-REX RectoAid Cath (Carpo Novum AB, Halmstad, Sweden). The C-REX devices are CE-marked and used in its intended purpose in this trial. The C-REX RectoAid Cath is a refined anastomotic device that facilitates the construction of an inverted serosa-to-serosa adaptive colorectal anastomosis where the bowel ends are held together by snap-locking a proximal and distal silicone anastomotic ring. The C-REX devices can be used in both open and minimally invasive procedures. The proximal limit for C-REX RectoAid Cath is 25 cm above the anal verge and the distal limit is formed by the anal ring. The anterior resection using the C-REX RectoAid Cath is performed by experienced colorectal surgeons who received training to use the C-REX device from an experienced Clinical Field Trainer from Carpo Novum AB. After bowel resection and measuring of the lumen using the C-REX Test Device, the proximal ring is placed using the C-REX LapAid. This device ensures that the colonic wall is folded around the anastomotic ring. Once this colonic ring is in position, the anvil is connected whereby catheters are placed into the colonic lumen. Subsequently, the C-REX RectoAid can be inserted transanal. In similarity to ordinary stapler devices, a concealed trocar becomes visible by rotating the knob on the base of the handle of the C-REX RectoAid. When possible, the stapler line of the transected proximal rectal stump is invaginated into the distal anastomotic C-REX ring and thus removed at firing of the RectoAid instrument. The trocar and proximal anvil are connected and by turning the knob clockwise, the gap between the anvil and the head of the instrument is closed. After firing the device, the two anastomotic rings are connected and the anastomosis is created. The four integrated catheters will be extracted simultaneous with the RectoAid instrument and can be used to measure the Anastomotic contact pressure (ACP) to validate the anastomosis. These catheters are in direct contact with the anastomotic healing site. When the anastomotic rings detach during the healing process by necrosis, after approximately 10 days, the anastomotic ring loosens from of the intestinal wall and is expelled with the feces.

Skin cancer cases, including both melanoma and non-melanoma types, have been steadily rising over recent decades. This research investigates new imaging technologies to improve the diagnosis of pigmented and non-pigmented skin tumors without needing invasive biopsies. The study evaluates the use of a high-resolution optical coherence tomography (OCT) scanner, the ApolloVueae S100 Image System, which offers detailed skin imaging at the cellular level and combines advantages of existing imaging methods like confocal microscopy and traditional OCT. The study uses the ApolloVueae S100, a CE-certified device that produces two-dimensional, cross-sectional, and en-face images of the skin in real time. This system employs a special light source and camera to create high-speed, high-resolution images, allowing precise examination of skin lesions. Other imaging devices such as confocal microscopy, Vivascopeae, Vivosightae OCT, and dermoscopy with DermLite FotoXae are also used for comparison on a subset of skin lesions. The system's guiding mechanism helps position the probe accurately for detailed scans during the study. Participants with pigmented or non-pigmented skin lesions scheduled for biopsy or excision will undergo imaging assessments using these devices. Researchers will characterize disease features and evaluate diagnostic accuracy over approximately 1.5 years. Data collected includes OCT images, lesion positions, and clinical assessments. This non-invasive imaging study aims to improve skin tumor evaluation while reducing unnecessary biopsies, with no additional treatments given. Participants' progress and skin lesion images will be monitored and recorded throughout the study period.

This research aims to evaluate how artificial intelligence (AI) can help diagnose Helicobacter pylori infection and premalignant gastric lesions by analyzing upper endoscopic images. The study focuses on linking these images with urea breath test results and histopathological findings to improve diagnosis accuracy. The goal is to support clinicians, especially in rural areas, through a telemedicine system that assists in detecting these conditions and potentially links to gastric cancer risk. Participants undergo urea breath tests, upper gastrointestinal endoscopy, and histology examinations. The AI analyzes the correlation between the collected endoscopic images and the test results. This approach will be developed into a telemedicine service to assist healthcare providers in remote locations, such as the Matsu Islands. Throughout the study, researchers collect and review test results, endoscopic images, and histopathological data. They will measure how sensitive the AI is in detecting premalignant gastric lesions over up to five years and assess its ability to accurately exclude these conditions. The study runs until the end of 2026, allowing long-term follow-up and evaluation of the AI system's diagnostic performance.

Researchers are evaluating a new artificial intelligence (AI) tool designed to assist primary care providers in assessing skin conditions. This AI-powered dermatology image reference app works with a smartphone to provide reference images, helping providers make diagnoses using their medical training. The study aims to compare diagnoses made by primary care providers using the AI tool to those of a panel of dermatologists, considered the gold standard. The research is supported by the Advanced Research Projects Agency for Health (ARPA-H) and focuses on improving diagnostic accuracy and care in real-world clinical settings. The study involves primary care providers using the Belle AI tool, which analyzes images captured via a smartphone app and identifies over 2,000 skin conditions based on a large image database. Providers use the app during patient visits to capture images and receive differential diagnoses, which they review before making final decisions. After the initial visit, participants receive notifications to submit follow-up images using the app over a two-week period. Providers reassess diagnoses based on updated AI analysis, and follow-up visits may be scheduled or canceled depending on results. Providers receive training on the app and give feedback through surveys. Participants present with a primary dermatological complaint and consent to study procedures, including using the smartphone app to submit images. Researchers monitor diagnosis accuracy compared to a dermatology review committee consensus and assess economic impact and provider experience. The study lasts about 14 days per participant, with ongoing documentation in electronic medical records and continuous case review to determine care needs or resolution.

Researchers are studying the use of the AVAVA Device, a 1550nm Non-Ablative Fractional Laser, to treat various dermatologic conditions including acne, acne scars, wrinkles, pigment lesions, and skin texture disorders. The study aims to collect and analyze patient feedback on their overall experience with the device treatment. The primary focus is on responses to post-treatment questionnaires, while secondary measures include evaluations by physicians and patients regarding improvements and side effects. Participants will receive treatment using the AVAVA Device targeting their dermatologic condition. The study includes follow-up periods at 3, 6, and 12 months after the final treatment to assess outcomes. During these times, trained dermatologists will review before and after images, and both physicians and subjects will complete satisfaction and clinical improvement scales. The treatment process involves digital photography and adherence to specific skincare and sun exposure guidelines. Throughout the study, participants will complete questionnaires immediately after treatment and during follow-up visits to report their experience and tolerance of the procedure, including pain levels. Researchers will monitor the skin's response and improvements over time through imaging and clinical assessments. The study requires participants to comply with study instructions, maintain consistent skincare, and attend scheduled visits. The total participation duration spans from initial treatment through 12 months of follow-up.

Researchers are evaluating treatments for actinic keratoses (AK), a skin condition that can benefit from field-directed therapy. This study compares a new combination treatment of 5-fluorouracil (5FU) and calcipotriol (CAL) against the standard 5FU therapy alone. The goal is to find out if a shorter treatment with 5FU-CAL can be as effective as the longer 5FU-only course, while reducing side effects like redness, itching, burning, and crusting that often lead to poor adherence and early treatment stopping. The study involves two treatment groups. One group will apply a combination of topical 5FU and CAL twice daily for 4 or 6 consecutive days, depending on the treatment location. The other group will use topical 5FU alone twice daily for 4 weeks. Treatment areas include the face, ears, scalp, neck, chest, and upper extremities. The study will carefully monitor how these treatments perform over time. Participants will be followed for 12 months after finishing treatment to assess treatment success. Researchers will measure clearance and recurrence of AK lesions, side effects, patient satisfaction, treatment compliance, and quality of life at multiple points before, during, and after treatment. This thorough follow-up aims to understand how well the shorter combination therapy works compared to the standard 4-week 5FU treatment.

Researchers are evaluating the OralViome Cancer Testing System to detect Oral and Throat Cancers early using saliva metatranscriptomic analysis. This observational study aims to assess the design, safety, and effectiveness of this system in identifying cancers such as Oral Squamous Cell Carcinoma (OSCC) and Oropharyngeal Cancer (OPC). Participants include cancer-free individuals, those with potentially malignant oral diseases (OPMD), and patients diagnosed with OSCC or OPC, recruited from clinical care facilities. The study involves collecting saliva samples through kits provided by Viome, which can be used at home or in clinics. Four groups will be studied: cancer-free controls, patients with OPMD, and those with OSCC or OPC. Cancer-free and OPMD participants will have one clinic visit, while OSCC and OPC participants may be followed for up to one year. The OralViome system includes a saliva collection kit, a laboratory process analyzing RNA expression, and software that detects cancer-related signatures. Participants will complete health questionnaires and provide saliva samples during their involvement. The primary outcome is to determine if the system detects OSCC or OPC within one year. The study monitors participant health status without additional treatments, with a focus on safety and data collection. Total participation duration varies based on the group, with some followed for up to a year and others for a single visit.