Open Label Trial to Evaluate the Adhesion of TK-254RX in Healthy Volunteers.
HealthyThis study is a multi center, multiple dose, open label trial to evaluate the adhesion of TK-254RX in healthy volunteers. The primary purpose of this study is to evaluate the adhesion of TK-254RX. Secondary purpose is to show TK-254RX is safe and to explore and compare adhesion assessment methods.
Clinical Study on a Novel Anti-adhesion Barrier Film
Intrauterine AdhesionThe aim of this clinical study was to verify the effectiveness and safety of the anti-adhesion diaphragm in preventing intrauterine adhesions.
PMCF Study for ADEPT® in LaparoscopicGynecologic Surgery
AdhesionPostoperative adhesions develop in most patients after gynecologic surgery, likely resulting in significant morbidity, complications, and considerable increases in healthcare costs. Good surgical techniques, including a minimally invasive approach, may reduce adhesions and minimize the abovementioned complications. The agents for prevention or reduction of adhesion formation are placed inside the abdominal cavity, and especially in the pelvic cavity, which contains the female reproductive organs. ADEPT Adhesion Reduction Solution, hereinafter referred to as ADEPT, is intended for use as an intraperitoneal instillate for the reduction of adhesions following gynecological laparoscopic surgeries. The objective of this study is to evaluate the effectiveness and safety of ADEPT by detecting the incidence of adhesion-related morbidities (adhesion-related readmissions, including reoperations) after laparoscopic gynecologic surgery through a single-arm, retrospective, chart review with a patient questionnaire intended to supplement the patient chart.
Influence of Operator Factors on Succes and Survival of Indirect Restorations
Partial Indirect RestorationClinical Study4 moreBackground: Nowadays, tissue preserving, aesthetically high-quality and sustainable dentistry is more and more becoming the standard way of treatment. To reach those standards, one of the treatment options is applying a partial indirect restoration made by glass ceramics using immediate dental sealing (IDS). Using IDS, a protocol is followed to applicate a dentin bonding agent to freshly cut dentin when it is exposed during tooth preparation for indirect restorations (inlays/onlays, crowns). The preparation made for partial restorations is minimal invasive. Glass ceramic restorations have very high survival rates (90 to 100% after five years) (Morimoto et al., 2016) and glass ceramic mimics the color and structure of the tooth very well. This kind of treatment is gaining interest and increasingly applied however little information is available on the long-term effects when multiple general practitioners apply these restorations. Objectives: The main goal of this study is to evaluate partial posterior ceramic restorations with the application of an immediate dentin sealing (IDS) performed by various practitioners. Study design and population: Twenty dental practitioners, who followed a course on making ceramic partial restorations using IDS, will be asked to include patients for this study. The dental practitioners are being asked to share their data (occlusal light photo's, impression and x-rays) of twenty-five restorations they make after having the course. Restorations of individuals with a minimum age of 18 will be included. The information from pictures and impressions will be evaluated. Items to evaluate The practitioners will be interviewed to get to know in what circumstances they do their treatment. Items that are discussed are: using rubber dam; using magnification by means of loupes/microscope; scheduled time for the treatment; number of restorations after following the course. Initial data (gathered directly after treatment) will be evaluated looking at: surface of preparation after IDS; size of the prepared surface; color. Follow up data will be evaluated looking at: tooth extraction fracture restoration fracture tooth secondairy caries de-bonding endodontic problems Outcome: Failures (fracture, de-bonding, secondairy cariës, endodontic problems) are the main outcome measurements. Description and estimation of the load and risk for the subjects: No extra intervention is performed. The dental practitioners will provide their data (i.e. impressions, occlusal light photo's) and these will be evaluated by the researchers. Follow up data will be gathered from X-rays already made for periodical oral examination (taking the caries risk into account). Summarizing, there is no extra load or risk for the patients. Studie design Prospective practice-based research, multicenter.
Safety of Anticoagulant Therapy After Tissue Glue for Gastric Varices
Anticoagulants and Bleeding DisordersTissue Adhesion1 moreThis study aimed to clarify the safety of anticoagulant therapy after glue injection for cirrhotic variceal bleeding patients with portal vein thrombosis.
Evaluate Formation of IUAs After Third-generation Endometrial Ablation, With and Without Intrauterine...
Asherman SyndromeIntrauterine AdhesionEvaluate the formation of adhesions after third-generation endometrial ablation, with and without the intrauterine adhesion barrier.
Evaluation of Patients With Immune Function Abnormalities
Chronic Granulomatous Disease (CGD)X-Linked Severe Combined Immune Deficiency (XSCID)2 moreThis study will evaluate patients with abnormal immune function that results in recurrent or unusual infections or chronic inflammation. This may include inherited conditions, such as X-linked severe combined immunodeficiency (XSCID), chronic granulomatous disease (CGD), and leukocyte adhesion deficiency (LAD), or conditions resulting from outside factors, such as graft-versus-host disease (GVHD). The information from this study will be used to establish the pattern and pace of change of the disease and to help develop new treatments. The period of observation and study following enrollment in this study may be for up to one year. In addition these studies may provide the medical information needed to determine eligibility for enrollment in other clinical study protocols and more prolonged follow up. Patients of any age with abnormal immune function who have recurrent or unusual infections, whose blood tests show evidence of immune dysfunction, or who have GVHD, XSCID, CGD or LAD may be eligible for this study. Patients' parents, siblings, grandparents, children, aunts, uncles and first cousins of any age also may be included. Healthy normal volunteers between 18 and 85 years of age are recruited as controls. Normal volunteers undergo a physical examination and provide blood, saliva, and urine samples for immune function studies. Patients' family members provide a medical history, have a physical examination, and give blood and urine samples, and possibly a saliva sample. The samples are used for genetic and routine laboratory studies. Investigators may request tissue samples, such as biopsy specimens, previously removed for medical reasons to be sent to NIH for study. Patients undergo the following tests and procedures: Medical history and physical examination. Blood and urine tests, including analysis for genes involved in immune disorders. Buccal smear (in some patients) for genetic studies. This involves scraping the lining of the mouth near the cheek. Specialized tests to evaluate specific conditions in patients who have an immune disorder that might affect lung function, gum infections or eye problems. These may include chest x-ray, CT scan, breathing function test, dental, eye, and hearing examinations. Follow-up visits of patients with immune problems may occur at 6 months and at one year after the first visit (or more frequently if medically required) to include: Medical history update Physical examination Follow-up on abnormal test results and medical treatments initiated at NIH Collection of blood, saliva, urine, or wound drainage samples for repeat immune function studies Tissue study of specimens removed for medical reasons at other institutions besides NIH
The Efficacy of a Topical Anti-adhesive Film for Decreasing Perihepatic Adhesions in Repeat Hepatic...
AdhesionLiver NeoplasmsThere has been an increase in the need for repeat hepatic surgery, especially for patients with colorectal liver metastasis and hepatocellular carcinoma. Adhesions at the time of repeat surgery can lead to increased operative times, higher blood loss and even increased perioperative morbidity. Not much data exists regarding use of anti-adhesion barriers at the time of index hepatectomy and their effect on adhesions at repeat hepatectomy. This randomized controlled trial aims to evaluate the effectiveness of the use of a hyaluronan and cellulose based antiadhesive topical film at index hepatectomy in reducing perihepatic adhesions at the time of repeat hepatic surgery.
Closure vs Non Closure of Rectus Muscle at Cesarean Section 5 Year Study
Intraperitoneal Adhesions After Rectus Muscles Approximationapproximation of both recti during lower segment cesarean section may be an important step to lower incidence of intraabdominal adhesions . peritoneal adhesions are of major medical importance and are associated with clinical problems such as chronic pain and infertility.
Multicentre Prospective Clinical Database for the Construction of Predictive Models on Risk of Intrauterine...
Database for Intrauterine AdhesionRisk Factors for Intrauterine Adhesion2 more1. To establish a follow-up database for uterine adhesions and a library of biological specimens for Intrauterine Adhesion. 2. using epidemiological surveys and biological analyses to screen risk factors for the development and prognosis of Intrauterine Adhesion. 3. Predictive models based on clinical and biochemical indicators, specimen testing and hysteroscopic images are also combined with statistical analysis and machine learning algorithms to enable patients' risk stratification and prognostic assessment.