38 Clinical Trials for Various Conditions
The purpose of the study is to evaluate the usability of PerioMonitor™ in a medical clinic environment and to evaluate the effectiveness of a referral system from physicians to dentists for patients identified with high oral inflammation. PerioMonitor™ is an In Vitro Diagnostic (IVD) device intended as an aid in the detection of oral inflammation in individuals of 18 years and older. This test is intended for use at point-of-care (POC) sites by health care professionals (e.g., physicians, nurses, medical assistants, dentists, dental hygienists, and dental assistants).
Subjects who are in need of extraction of a posterior tooth will be recruited for this study. Prior to extraction, periodontal clinical markers of inflammation, body-mass index and dental radiographs will be measured/taken. The posterior tooth will be atraumatically extracted and a small soft tissue biopsy of the extraction site will be taken. At the two week follow-up, sutures will be removed and another small biopsy of soft tissue will be taken. Subjects will be seen again at 3 months for a final collection of clinical data and radiographs.
These are ethnomedicine studies of plants used by rural and indigenous peoples for pain and oral inflammation relief.
The specific aim of this study will be to determine the safety of TRAUMEEL S for mucositis in head and neck cancer patients undergoing radiation therapy.
COHESION is a randomized trial targeting reduction of systemic inflammation through an oral hygiene regimen incorporating a plaque-disclosing toothpaste and a control toothpaste.
The purpose of this study is to explore the efficacy of Iocide oral rinse in a human clinical trial of gingivitis. Iocide oral rinse will be evaluated against a placebo rinse. Indices for gingivitis, plaque and bleeding will be scored and blood tests will be performed to determine the effect of the antimicrobial oral rinse on relative levels of biological markers of inflammation.
The objective is to determine, in a small number of participants, the protective effects of UV-induced skin erythema (reddening or "sunburn") following oral administration of sulforaphane, curcumin, or a combination of the two plant (diet)-based supplements. The investigators will be using the over-the-counter nutritional supplements Crucera-SGS and Meriva-SF to deliver the biologically stable sulforaphane precursor and a highly bioavailable formulation of curcumin. Volunteers will be challenged with UV irradiation at 2-times the minimum erythematous dose (M.E.D.) on discrete 2 cm diameter circles on the upper buttocks. Skin redness will be monitored daily using a chromometer. Biomarkers will then be evaluated in blood, urine, and skin biopsies.
Background: People with alcohol use disorder (AUD) have a higher rate of dental and gum disease. Poor oral health can increase the risk of other diseases, such as diabetes and stroke. Researchers want to learn more about how to identify developing inflammation in the mouth. They also want to know how improved oral health education and behaviors can affect inflammation in people with AUD. Objective: This study has 2 goals: (1) to test the usefulness of a new questionnaire about oral health and (2) to learn more about how oral health behaviors affect inflammation in people with AUD. Eligibility: People aged 18 years and older who are staying on an inpatient unit being treated for AUD. Healthy volunteers are also needed. Design: The study is divided into 2 parts: People will participate in either one part or the other. In part 1, participants will have 1 visit. They will have a physical exam. They will answer 18 questions for a survey about how they care for their teeth. In part 2, participants with AUD will have a physical exam. They will provide saliva and blood samples. They will have a dental exam with X-rays. They will fill out questionnaires about their health, mental health, social habits, diet, and sleep. They will keep a diary of their nicotine use for 4 weeks while inpatient. Healthy volunteers will have 1 visit. They will have a physical exam and provide blood and saliva samples. They will have a dental exam with X-rays. They will fill out questionnaires.
The goal of this clinical trial is to learn if Nicotinamide adenine dinucleotide (NAD+) can influence cognition and biomarkers in healthy, cognitively intact women who identify as Latina and are between the ages of 40-80. The main questions it aims to answer are: Will executive function change in response to NAD+? Will inflammatory markers and serum indicators of neurodegeneration change in response to NAD+? Researchers will compare individuals receiving the NAD+ to see if the results differ from those receiving the placebo. Participants will: Complete an online questionnaire, Visit the lab for computerized cognitive testing and a blood draw, Take NAD+ or a placebo every day for 4 weeks, Visit the lab for computerized cognitive testing and a blood draw
This study aims to evaluate the efficacy of BioNatureHealth's Eye Empower supplement in supporting vision and eye health. It is a virtual, single-group trial lasting 3 weeks. Participants will take three capsules of the supplement daily and complete questionnaires at Baseline, Week 1, Week 2, and Week 3 to assess visual clarity, dryness, symptoms of inflammation, and sensitivity to blue light.
The purpose of this study is to evaluate how supplementation will alter the skin and the gut barrier and inflammation in those with rosacea.
The study is a 56-day (8-week), randomized, controlled, examiner-blinded, parallel-design study of patients with existing Stage II or Stage III periodontitis. After eligibility determination, subjects will be randomized to the following groups: * Group 1: Full mouth periodontal debridement + Emanate Tray (treatment group) * Group 2: Full mouth periodontal debridement alone (control group) Patients will be evaluated at Baseline and on Days 14, 28, and 56 for primary endpoint and at baseline and on day 56 post-treatment for secondary (efficacy) endpoints.
The investigators propose to determine the impact of high-protein beverages on protein status and inflammation markers among CKD patients undergoing hemodialysis. A 12-week double-blind randomized cross-over trial will be used in which participants (n=22) will consume a 4-ounce high protein supplement with either whey (20 g total protein) or soy (20 g total protein). Outcomes of interest include serum urea nitrogen and inflammation markers (CRP and IL-6). The findings will contribute to the knowledge gap regarding the effect of different protein types in CKD populations which can be translated to the development of affordable supplements to prevent malnutrition in adults with non-communicable diseases.
This study is a randomized, placebo-controlled, double-blind, two-arm trial of N=94 apparently healthy men and women to be recruited at a single investigational center in Northeast Ohio. Subjects will attend three study visits. During Visit 1, subjects will be screened for participation (i.e., medical history, physical exam, routine blood work, background baseline diet). Over the next 12 weeks, subjects will attend Visits 2 (baseline) and 3 (week 12), wherein assessments of body weight, waist circumference, urinary ketones, serum glucose, insulin, liver enzymes as well as other biomarkers of metabolic health, quality of life (SF-36 questionnaire), and various visual analog scales (VAS) for appetite, satiety, and cravings will be made.
The purpose of this multicenter, prospective, single arm Study is to evaluate the efficacy and safety of PerioMonitor as an aid to the presumptive detection of oral inflammation associated with periodontal diseases. PerioMonitor is an IVD device for the rapid, semi-quantitative detection of PMN in oral samples. This test is intended for prescription use at Point-of-Care ("POC") settings by health care professionals.
This phase II/III trial compares the side effects and activity of oral azacitidine in combination with the standard drug therapy (reduced dose rituximab-cyclophosphamide, doxorubicin, vincristine, and prednisone \[R-miniCHOP\]) versus R-miniCHOP alone in treating patients 75 years or older with newly diagnosed diffuse large B cell lymphoma. R-miniCHOP includes a monoclonal antibody (a type of protein), called rituximab, which attaches to the lymphoma cells and may help the immune system kill these cells. R-miniCHOP also includes prednisone which is an anti-inflammatory medication and a combination of 3 chemotherapy drugs, cyclophosphamide, doxorubicin, and vincristine. These 3 chemotherapy drugs, as well as oral azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Combining oral azacitidine with R-miniCHOP may shrink the cancer or extend the time without disease symptoms coming back or extend patient's survival when compared to R-miniCHOP alone.
Background: An autoimmune disease is one in which the immune system attacks a person s own body. Sjogren's syndrome (SS) is an autoimmune disease. It often involves multiple systems and organs of the body. Researchers are trying to find new, more effective and safe treatments for SS. Objective: To evaluate the safety and tolerance of tofacitinib in people with SS. Eligibility: Adults ages 18-75 with SS. Design: Participants will be screened on a separate protocol. They will undergo: * Medical and dental history * Physical exam * Medicine review * Electrocardiogram to test the heart s electrical activity (Participants will lay on a table. Sticky pads will be placed on their body.) * Eye exam and test for dry eyes * Oral, head, and neck exams * Plaque collection (Dental plaques and tongue and mucosal scrapings will be collected using a small tongue depressor.) * Salivary gland ultrasound * Blood and urine tests * Minor salivary gland biopsy (The lower lip will be numbed. Several tiny salivary glands will be removed through a small incision.) * Saliva collection * Disease assessment. Participants will repeat some of the screening tests during the study. Participants will take capsules of the study drug or a placebo by mouth for 168 days. Participants will have tests to measure blood pressure and the speed of blood flow through the organs. They will also have a test that examines the function and reaction of the blood vessels. For these tests, they will wear blood pressure cuffs and other sensors. Participants will complete questionnaires about their health. Participants will have 9 study visits over 28 weeks. They may be contacted by phone between study visits.
The purpose of the study is to evaluate the efficacy and safety of lyophilized PRIM-DJ2727 capsules given orally in subjects with ulcerative colitis at remission stage. This study will also include longitudinal analyses of recipient's gut microbiota taxonomy and metagenomics to determine potential associations with clinical outcomes in context of active FMT or placebo administration.
This study evaluates the effect of an oral typhoid vaccine on disruption of the intestinal barrier and response of the immune system. Intestinal and whole-body responses will be measured in all participants before and after the vaccine.
The purpose of this study is to evaluate the effects and safety of OPS-2071 (150, 300, or 600 mg twice a day \[BID\]) versus placebo, as add-on therapy in participants with Crohn's disease who show symptoms of active inflammation despite being on ongoing treatment.
This will be a prospective study of cirrhotics and healthy controls comparing their oral microbiota, endotoxemia and systemic inflammation at baseline and at 30 days after clinically indicated systematic oral cleansing and interventions as well as 3-month hospitalizations post-cleaning.
The primary objective is to evaluate the safety of an investigational compound, BLXA4-ME, topically applied as a daily oral rinse in adults with gingivitis. Safety will be assessed by the incidence of adverse events, including mucosal inflammation and irritancy and findings from safety labs. Subjects will be monitored for development of periodontitis, and oral flora will be analyzed to detect an increase in opportunistic organisms. The secondary objective is to assess preliminary efficacy of the oral rinse, by monitoring changes in the plaque index (PI), modified gingival index (MGI), bleeding on probing (BOP) and levels of interleukin -1β (IL-1β) in gingival crevicular fluid (GCF). The study comprises three groups in a randomized, placebo-controlled double-blind clinical trial design. The treatment group (1.0 μM BLXA4-ME oral rinse) and the placebo rinse group will each include 50 subjects. The no-rinse control group will consist of 25 subjects. Subjects in the treatment and placebo rinse groups will receive oral rinse (BLXA4-ME or placebo) to be applied once daily after morning teeth brushing. Safety parameters will be assessed before and after 3, 7, 14, 21, and 28 days of treatment. Efficacy parameters will be assessed before and after 14 and 28 days of treatment.
In recent years, greater emphasis has been placed on the link between oral and systemic health. Obesity, a growing medical problem worldwide, has been associated with multiple chronic inflammatory diseases such as diabetes mellitus and cardiovascular disease. With respect to the effect of obesity on periodontal health, it has been shown that obese subjects exhibit higher inflammation around natural teeth and are at increased risk of tooth loss than individuals with normal weight. Peri-implantitis, an inflammatory condition of bacterial origin that occurs around oral implants and resembles periodontal disease, has become a serious concern for the dental profession given its increasing prevalence and challenging treatment. There is also strong evidence that individuals with a history of periodontitis are also at risk for peri-implantitis. However, knowledge about the pathogenesis and treatment of peri-implantitis is scarce. Hence, it is extremely important to understand the implications of excessive body fat on peri-implant health. Based on the current understanding on the effect of obesity on systemic and local inflammation around natural teeth, the investigators hypothesize that obesity will have a significant impact on peri-implant health by inducing an increased inflammatory response as measured by clinical as well as molecular markers of inflammation.
Determine the benefit of oral vancomycin therapy for Primary Sclerosing Cholangitis.
The purpose of this study is to determine the relationship between lipid-induced inflammation and ovarian androgen secretion in women with polycystic ovary syndrome (PCOS); and to examine the effect of salsalate and polygonum cuspidatum extract (PCE) containing resveratrol on lipid-induced inflammation, ovarian androgen secretion, body composition and ovulation in a subset of normal weight women with PCOS.
The purpose of this study is to determine whether 4 weeks of dosing with senicapoc alleviates exercise induced asthma symptoms.
This research will test whether consuming additional choline before gynecological surgery decreases postoperative pain.
The purpose of this study is to compare the effects of oral versus patch administration of hormonal contraception on hormone sensitive proteins such as lipoproteins, clotting factors and inflammatory proteins as well as blood sugar and insulin levels, antioxidant status and flow-mediated dilation of arm and forearm vessels. The hypothesis is that oral administration of contraceptive hormones will result in higher plasma levels of estrogen sensitive proteins originating from the liver while patch administration of contraceptive hormones will result in greater systemic effects of estrogen on vascular reactivity and antioxidant status.
Tissue inflammation is a major component of the acne disease process. Leukotriene B4 (LTB4) is thought to be a major player in the development of tissue inflammation. Synthesis of LTB4 is controlled by the enzyme 5-lipoxygenase. Zileuton blocks the activity of 5-lipoxygenase. This study will test the safety and efficacy of zileuton in the treatment of facial acne.
This study will evaluate the effects of the anti-inflammatory drug etanercept (Enbrel) on relieving pain and swelling after oral surgery. The Food and Drug Administration has approved Enbrel for treating symptoms of rheumatoid arthritis, including pain. Healthy volunteers 16 to 35 years of age who require third molar (wisdom teeth) extractions may be eligible for this study. Participants must not be allergic to aspirin or to non-steroidal anti-inflammatory drugs (NSAIDs). Candidates will be screened for eligibility with a medical history and oral examination, including X-rays if needed. Participation in the study requires four clinic visits: two for surgery and two for follow-up: Visit 1: Patients will have ultrasound pictures taken to measure cheek size. One hour before surgery, they will receive a dose of either 25 milligrams (mg) of Enbrel; 15 mg of the standard pain medicine Toradol; or a placebo (salt-water) through an arm vein. A local injection of an anesthetic (lidocaine) will be given before surgery to numb the mouth, and a sedative (Versed) will be infused through a vein to induce sleepiness. When the anesthetic takes effect, a small piece of tissue will be removed from the inside of the cheek, and then the upper and lower molars on one side of the mouth will be extracted. After surgery, a small piece of tubing will be placed in the lower extraction site, from which samples will be collected to measure chemicals involved in pain and inflammation. Patients will stay in the clinic for 4 hours after surgery while the anesthetic wears off and will complete pain questionnaires during that time. If, an hour after surgery, patients have pain that is not relieved by the treatment given before surgery, they may receive acetaminophen (Tylenol) and codeine for pain. Another biopsy will be taken (under local anesthetic) from the inside of the cheek when pain occurs or at the end of the 4-hour observation period. The tubing then will be removed and the patient discharged with Tylenol and codeine for pain. Visit 2: Patients will return to the clinic in the morning 48 hours after the oral surgery for a 1- to 2-hour visit. They will fill out questionnaires, undergo ultrasound imaging of both cheeks and have another biopsy taken from the inside of the cheek on the operated side. Visits 3 and 4: Three weeks after the first surgery patients will schedule extraction of the two wisdom teeth on the other side of the mouth, and the procedures for visits 1 and 2 will be repeated.