263 Clinical Trials for Various Conditions
The goal of this project is to learn about the potential impact of tobacco regulations that could affect the availability of tobacco products among adults who smoke nondaily and daily. Nondaily smoking is increasingly common and tobacco regulation research should consider how FDA actions may impact this group. Participants will be asked to complete online surveys and tests, online shopping sessions in a simulated Experimental Tobacco Marketplace. Reactions and decisions of adults who smoke nondaily and daily will be compared.
The aim of this study is to evaluate the relative efficacy of an experimental dentifrice containing 1150 parts per million (ppm) fluoride (as sodium fluoride \[NaF\]) to remineralize early stage caries type lesions in an in situ model compared to a negative control and a reference dentifrice.
Tooth bleaching is widely used to treat the colors of teeth. This study compares the efficiency of two experimental bleaching gels, with and without nanoparticles, and with and without light activation versus two commercial bleaching products of low and high concentrations. The objective is to evaluate tooth color change, sensitivity, and patient satisfaction in patients with moderate yellowing of their teeth. Methods: This is a randomized controlled trial that will include 120 participants aged 18-65 years. Participants will be randomly assigned to one of 12 treatment groups: Gel A (with or without nanoparticles, with or without light), Gel B (with or without nanoparticles, with or without light), Whiteness HP 35% (with or without light) and Whiteness Automixx 6% (with or without light). The primary outcome is tooth color change, measured using a commercially-available equipment. Secondary outcomes will include tooth sensitivity and patient satisfaction. Randomization will be computer-generated. Results: The study is expected to show differences in color change between the experimental and commercial gels. Tooth sensitivity and patient satisfaction will be evaluated to determine the overall effectiveness and safety of the treatments. Conclusions: This trial will provide information into the whitening efficacy of two experimental gels compared to two widely used commercial products.
This quasi-experimental study involves teachers divided into an experimental group and a control group. Teachers in the experimental group will receive SISI training to support the sign language development of deaf children, while those in the control group will continue with "business-as-usual" teaching methods. Pre- and post-assessments will be conducted for all deaf children at the beginning and end of the school year.
The primary objective of the study is to evaluate the onset of analgesia following administration of a single oral dose of PF614 (50 mg or 100 mg) or placebo in healthy male subjects in an experimental pain model (cold pressor test \[CPT\]).
The purpose of the study is to better understand the effects of cannabis in relation to mental and physical states including its relationship with mood, cognition, perception including the experience of temperature and pain, and heart rate. We expect that participants will be in this research study for approximately one week. The total amount of time that participants will spend completing study tasks will be about 2.5 hours across two separate in-person visits.
Pressure Pain Threshold (PPT) is defined as the minimum force applied to an area that is perceived as pain. PPT is considered an objective measurement tool to assess pain levels. Studies have assessed the difference in pain levels between clear aligners and fixed appliances using subjective pain scales. No study has utilized PPT to evaluate the difference in pain between aligners and fixed braces at different time points. This study will aim to compare the self- reported and experimental pain perception between the clear aligner and fixed appliance therapies during the phase of crown alignment and to assess how long pain is perceived in the following five days from the adjustment of the appliance.
The regulation of human body weight and fatness is not fully understood. Although some models of regulation have been proposed (set point, dual-intervention point, others), no studies have been designed to test their predictions. In this pilot and feasibility study, the investigators will implement an experimental approach to test the predictions of models of body weight regulation in humans. Men and women with either low body weight or obesity will be exposed to a 2-day fasting followed by a 2-day ad-libitum refeeding. During the entire fasting-refeeding period, energy intake and expenditure will be accurately measured within metabolic chambers. The investigators will therefore determine the compensatory responses to fasting elicited to prevent weight loss. The results will serve to design and power future studies to better understand body weight regulation.
This is a multicenter, global study of the effects of a single systemic dose of SRP-9003 on beta-sarcoglycan (β-SG) gene expression in participants with limb-girdle muscular dystrophy, type 2E/R4 (LGMD2E/R4). This study will consist of both ambulatory participants (Cohort 1) and non-ambulatory participants (Cohort 2).
The purpose of this study is to investigate the ability of an experimental dentifrice containing 1150 parts per million (ppm) fluoride to remineralize acid-softened dental enamel and help prevent further demineralization compared to a 0 ppm fluoride placebo dentifrice and a marketed, fluoride-containing dentifrice (Reference Dentifrice).
The goal of this project is to look at the effect of proposed tobacco product regulations in Appalachian Kentucky. Appalachian Kentucky is a diverse and underserved rural area that would benefit from more tobacco regulation research. Researchers will study the effects of three proposed tobacco product regulations among users of tobacco products in Appalachian KY. Researchers will also study how degree of rurality effects how those regulations impact behavior. Participants will be asked to complete online surveys and tests, online shopping sessions in a simulated Experimental Tobacco Marketplace, and track their tobacco product use throughout the 9-week experiment.
This phase I/II trial tests the safety, side effects, best dose, and effectiveness of iberdomide in combination with belantamab mafodotin and dexamethasone in treating patients with multiple myeloma (MM) that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). Multiple myeloma is a cancer that affects white blood cells called plasma cells, which are made in the bone marrow and are part of the immune system. Multiple myeloma cells have a protein on their surface called B-cell maturation antigen (BCMA) that allows the cancer cells to survive and grow. Immunotherapy with iberdomide, may induce changes in body's immune system and may interfere with the ability of cancer cells to grow and spread. Belantamab mafodotin has been designed to attach to the BCMA protein, which may cause the myeloma cell to become damaged and die. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Iberdomide plus belantamab mafodotin may help slow or stop the growth of cancer in patients with multiple myeloma.
The main aim of this study is to investigate the ability of an experimental dentifrice containing 5 percent (%) potassium nitrate (KNO3), 1% alumina and 5% sodium tripolyphosphate (STP), to maintain tooth color and reduce extrinsic dental stain accumulation following peroxide tooth bleaching compared to a regular fluoride dentifrice.
This study is a mechanistic randomized controlled trial that investigates whether inhibition of tumor necrosis factor signaling via intravenous infusion of infliximab improves psychomotor speed and executive functioning in depressed individuals who exhibit an inflammatory phenotype.
This controlled clinical trial will assess clinically, immunologically, and microbiologically the healing of experimental peri-implant mucositis (PIM) lesions in implants treated previously with implantoplasty (IP) compared to those treated without IP.
The goal of this clinical trial is to compare the control of oral malodor between an investigational lozenge with the enzyme polyphenol oxidase plus green coffee extract or an investigational lozenge with color and flavor along with the enzyme polyphenol oxidase plus green coffee extract in generally healthy subjects. Safety will be evaluated also. Subjects will be randomly assigned to one of four study groups (group code: A, B, C or D): * Experimental lozenge with the enzyme Polyphenol oxidase and green coffee extract * Experimental lozenge with the enzyme Polyphenol oxidase, green coffee extract and flavor * Placebo lozenge control (sorbitol only) * No product control Subjects will be asked to allow their assigned lozenge to dissolve in the mouth while placed on the dorsal surface of the tongue. Subjects can suck on the lozenge and press the lozenge against the palate; however, the lozenge should not be moved around in the mouth or placed on the buccal mucosa. Subjects should avoid biting or chewing the lozenge and talking while dissolving the lozenge. After the lozenge has completely dissolved, the subject will be instructed to swallow the remaining solution. Immediately (no later than 5 minutes) after subjects use their assigned lozenge product or no product, subjects will receive organoleptic assessments (OI) by the 4-5 trained judges and VSC readings (OralChroma readings). Organoleptic measurements (OI) will be repeated at 30 minutes, 1, 2, 3, and 4 hours following test product use or no test product use. OralChroma measurements will be performed again after 30 minutes, 1, 2, 3, and 4 hours after test product use or no test product. Subjects will complete a post-product performance questionnaire after the 1-hour OI and OralChroma assessments have been administered. Following the 4-hour OralChroma assessment, each subject will receive a final oral soft and hard tissue exam for safety.
This project tests the role of the human hippocampus in providing online representation of episodic content and providing the top-down signals to brain networks for visuospatial attention and visual processing needed to drive visual sampling for the formation of coherent episodic memories. This hypothesis will be tested in several experiments that measure and manipulate hippocampal activity within eye-tracking tasks designed to isolate the interplay between memory and visual sampling during memory formation. These experiments will be performed in individuals with epilepsy undergoing neurosurgical procedures as part of clinical care, as this provides invasive recordings of neural activity (intracranial electroencephalography, or "iEEG") from the hippocampus and other regions of interest with temporal resolution that matches the rapid pace of eye movements. The temporal resolution of iEEG is key to addressing the hypotheses concerning how the hippocampus drives visual sampling, in addition to responding to it. Direct electrical stimulation through the iEEG electrodes will also be used to test the necessary role of hippocampal processing in driving active visual sampling. By rigorously testing the role of hippocampus in interaction with large-scale networks during the process of memory formation that occurs via active sampling, this project aims to better understand mechanisms relevant to the disruptions of memory formation that occur in neurological and psychiatric disorders.
The primary purpose of this study is to evaluate safety/ reactogenicity of INFLUENZA G1 mini-hemagglutinin stem-derived protein vaccine antigen (mHA), with or without Al(OH)3 adjuvant, in healthy adults greater than or equal to (\>=) 18 to less than or equal to (\<=) 45 years of age.
SLC-391 is a novel, potent and specific small molecule inhibitor of receptor tyrosine kinase AXL with desirable potency and pharmaceutical properties. The study is being done to evaluate the safety and pharmacokinetic (PK) profile of SLC-391 in combination with pembrolizumab in participants with non-small cell lung cancer (NSCLC). Each treatment cycle lasts 21 days. Participants will swallow SLC-391 pills two times every day. Participants will get pembrolizumab intravenously (IV) from the study site staff on the first day of every cycle. This study has 2 parts. The first part will determine the recommended dose of SLC-391 in combination with pembrolizumab. The second part wants to find out if the combination of SLC-391 and pembrolizumab can help stop NSCLC tumours from growing or spreading.
This trial examined how the administration of exogenous testosterone would influence pain tolerance and other endogenous steroids (i.e. estradiol and progesterone).
This study aims to identify spatiotemporal alterations in thalamocortical circuitry functioning in both healthy subjects and patients with chronic pain, combining multimodal neuroimaging.
Microparticles (MPs) as a mode of therapeutic delivery can selectively deliver immunomodulatory treatment to the phagocytic cells, particularly dendritic cells (DCs), inducing their tolerogenic phenotype and function and T regulatory (Treg) cell expansion. The study will characterize the in vitro response of cGAMP immunomodulator incapsulated microparticles on the capacity of DCs and Tregs to regulate the inflammatory response.
The purpose of this study is to understand the safety and effects of an experimental gene therapy called fordadistrogene movaparvovec. We are seeking participants from previous Pfizer interventional studies. We will follow participants' experience in this study for 10 years after the end of their previous study. Participants will have 1 annual onsite visit and a few annual remote visits. The exact number of remote visits will be decided by their study doctor.
Two different groups of healthy volunteers will be chronically treated with GLP-1 drugs PF-07081532 or alternatively Semaglutide. The effect of these GLP-1 drugs on a single dose of the common sedative medication midazolam blood levels will be measured. The effect of chronic PF-07081532 on single doses of the common stomach acid medication omeprazole, and common birth control medication blood levels will also be measured. The hypothesis is that chronic administration of the GLP-1 drugs will minimally affect blood levels from these common medications.
This study will evaluate the safety and effectiveness of a new pain medication in development, clonidine micropellet. Participants will receive a single injection of either clonidine micropellet or sham injection for the treatment of low back and leg pain from sciatica.
The purpose of this study is to investigate the efficacy of an experimental dentifrice, containing 0.454 percent (%) stannous fluoride and 0.3% zinc chloride, to reduce oral malodor, compared to a marketed regular fluoride dentifrice after 3 weeks twice daily brushing in a population of clinically diagnosed gingivitis.
The purpose of this study is to use an intravenous infusion of allogeneic human mesenchymal stem cells (Allo-hMSCs) to treat an acute ischemic stroke condition.
The aim of this study is to investigate the stain removal efficacy of 2 experimental anti-dentin hypersensitivity (DH) dentifrices with four and eight weeks twice daily use. A daily use, regular fluoride dentifrice will be included as a reference dentifrice.
The research team recruited physicians (medical oncologists and specialty palliative care providers) trained in a communication tool called the serious illness conversation guide. Physicians conducted a simulated, telehealth serious illness conversation with an actor playing the role of a patient with advanced cancer. Physicians completed psychologic inventories before and after the encounter, documented the encounter using a template in the electronic medical record, and then participated in a structured interview afterwards discussing what they were feeling during the encounter and how it impacted the encounter. Physicians also wore three heart rate variability sensors during the simulated encounter.
Latex condoms have long been available as contraceptive devices as well as an effective means of preventing the spread of sexually transmitted infections. However, lack of adequate lubrication leads to inconsistent and incorrect condom use. The latex HydroGlyde condom has a hydrophilic coating which maintains its lubricity when in contact with water. Improved lubrication during intercourse may lead to improved user satisfaction and increased condom use which would help prevent the spread of Sexually Transmitted Infections and unwanted pregnancies. The primary objective of this study is to evaluate the preference, performance (breakage, slippage), safety (adverse events) and acceptability of a HydroGlyde prototype condom compared to a commercial latex condom with silicone lubricant. A secondary objective of this study is to compare and evaluate various lubricant activation methods for reliability, usability, and user preference.