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Oral Ulcer clinical trials

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NCT ID: NCT03239834 Completed - Clinical trials for Oropharyngeal Neoplasms

Clinical Evaluation of the OncAlert RAPID in Subjects Presenting for Evaluation and/or Initial Biopsy; Impact on Decision-Making

Start date: September 7, 2017
Phase:
Study type: Observational

Objectives Validate the OncAlert® RAPID Test by demonstrating that NPV > (1 -prevalence). Evaluate the independent and associated contribution of readily available clinical variables including age, race, gender, HPV status, socioeconomic level, tobacco, and alcohol use with the biopsy and test results. Evaluate OncAlert® RAPID Test results in patients without immediate biopsy, both at baseline and scheduled follow-up visit (approximately 1-3 months±14 days), to assess impact on outcome. Planned Number of Subjects A total enrollment of up to 1000 individuals is projected with 600 as the minimum accrued. Patients in the primary cohort (1a and 1b) will be followed until pathology of clinically directed incisional / diagnostic biopsy pathology report is received. Up to 200 'non-biopsy subjects' will be followed during a 1-3 month ±14 days clinic visit. Patient Population Cohorts 1a and 1b: Subjects with a clinical suspicion of oral potentially malignant disorders, oral or oropharyngeal cancer, or both based in part on clinical examination, symptoms, clinical history, suspicious lesion(s) in mouth without history of a prior positive biopsy. Even if the suspicion is low for cancer or precancer, the patient is eligible if a biopsy is performed, in part, to rule this out. For example, if a subject has findings on imaging, or worrisome localizing symptoms in the oral cavity or oropharynx, they would be eligible. In addition, subjects with papillomas or other findings where there is a low level of concern, but cancer is still in the differential, are also eligible. - Cohort 1a: oral cavity - Cohort 1b: oropharynx Cohort 2: Subjects are enrolled with a clinical suspicion of oral potentially malignant disorders, oral or oropharyngeal cancer, or both based in part on clinical examination, symptoms, clinical history, suspicious lesion(s) in mouth without history of a prior positive biopsy; however, based on clinical impression and or patient related issues no immediate biopsy is obtained. Screen Fail Rate: A 20% Screen Fail Rate is anticipated. Investigational Product Name: OncAlert Oral Cancer RAPID Test (OncAlert RAPID) Methodology Overview Prospectively collect 5cc of normal saline after a combination of swish, gargle and spit into the provided collection specimen cup. Specimens will be collected at baseline (time of biopsy) as per standard practice at each site. The OncAlert RAPID Test cassette is inserted into the specimen cup and read directly from the cassette in 10 minutes. In addition, comprehensive clinical - pathology and patient demographic features including age, gender, race, ethnicity, and all pathology biopsy results will be collected. Any pertinent additional clinical data including HPV status, socioeconomic status, smoking, drinking history, and pertinent features related to oral health will be obtained. A central pathology review for all biopsy results will be performed and incorporated into the final analyses.

NCT ID: NCT03167632 Completed - Oral Ulcer Clinical Trials

Oral Ulcer Prevalence: Hospital-based Cross-sectional Study

Start date: August 10, 2015
Phase: N/A
Study type: Observational

Oral Ulcers have serious effect on patients' lives. Due to absence of any information about its prevalence, risk factors and effect on patients' lives, this study has been held. The investigators recruited patients from the outpatient dental clinic of the faculty of oral and dental medicine, Cairo University, screened them clinically for oral ulcers. All patients filled questionnaires about the risk factors of oral ulcers. Furthermore, oral ulcer patients filled questionnaires about their Quality of life, previous treatments used, previous physicians visited and their Quality of life after using previous treatments.

NCT ID: NCT02769494 Withdrawn - Crohn's Disease Clinical Trials

The Efficacy of Topical Mesalazine Sustained-Release Tablets in Crohn's Disease Patients With Oral Ulcer

Start date: March 2016
Phase: Phase 3
Study type: Interventional

This study aims at evaluating efficacy and safety of topical using Mesalazine Sustained-Release Tablets in in the treatment of oral ulcers in patients with Crohn's disease.

NCT ID: NCT01307540 Completed - Oral Mucositis Clinical Trials

Phototherapy for the Management of Oral Ulcers in Bone Marrow Recipients

Start date: February 2007
Phase: N/A
Study type: Interventional

Study hypothesis: light therapy may prevent oral ulcers in bone marrow recipients. Methods: patients will be treated with either active light-emitting device or inactive light-emitting device. Daily treatment with light therapy will start at the beginning of the conditioning regimen and will last until day 21 post-transplant. Each daily treatment last about 5 minutes. Patients will be evaluated for oral mucositis and oral pain level on a weekly basis.

NCT ID: NCT01039051 Recruiting - Anemia Clinical Trials

Diet and Lifestyle Intervention Study in Postpartum Women in China

Start date: June 2009
Phase: Phase 2/Phase 3
Study type: Interventional

Previous studies have shown "Doing the month", a traditional practice for postpartum women in China and other Asian countries, may be associated with higher prevalence of postpartum problems. The current multicenter randomized controlled trial (RCT) aims to evaluate outcomes of diet and lifestyle interventions in Chinese postpartum women.

NCT ID: NCT00333749 Completed - Oral Ulcer Clinical Trials

The Effectiveness of Pasteurized Goat Milk in the Treatment of Childhood Oral Ulcer Diseases

Start date: January 2006
Phase: Phase 1
Study type: Interventional

Children with acute diseases with oral ulcers (not included PRESENTATIONS OF SLE, IBD or IMMUNOCOMPRMIZED STATES)will receive several doses (drinking or mouth rinsing) of either pasteurized goat milk or cow milk. Children will than be followed for length of the disease - signs and symptoms.

NCT ID: NCT00281723 Suspended - Ulcer, Aphthous Clinical Trials

Efficacy of Adhesive Tablets in Treating Oral Ulcers (Aphthous)

Start date: n/a
Phase: Phase 2
Study type: Interventional

Recurrent Aphthous Stomatitis (RAS) of the oral mucosa is a common and painful condition. Despite advances in therapeutic means there is still necessary to find a way to alleviate the local pain and discomfort induced by the mucosal ulceration. The hypothesis was to study the effectiveness and acceptance of a herbal adhesive tablets in the treatment of RAS. Participants in the study will be examined for oral lesions, will be instructed how to apply the oral-tablet, and will be interviewed during the follow-up period up to one week after the application.

NCT ID: NCT00200837 Completed - Oral Tumors Clinical Trials

Ethnopharmacological Studies in Oral Medicine

Start date: March 2002
Phase: N/A
Study type: Observational

These are ethnomedicine studies of plants used by rural and indigenous peoples for pain and oral inflammation relief.