208 Clinical Trials for Various Conditions
This clinical trial will assess the whether fish oil supplementation can modulate brown fat activation, shivering, thermal comfort and skin blood flow during cold exposure.
The purpose of this study is to see if cold liquids improve the swallowing mechanisms in premature infants with swallowing difficulties (dysphagia). The only way to objectively diagnose dysphagia is by having that infant undergo a Video Fluoroscopic Swallow Study (VFSS), which allows direct visualization of the liquid bolus (barium) in real time. Infants suspected of having dysphagia and who are referred for a VFSS will be recruited for this study. Once consented, the infant will undergo a standard VFSS. If that infant is diagnosed with dysphagia, the study protocol will begin by keeping the infant the same position and feeding them cold liquid barium from an identical bottle. A total of 5 swallows will be visualized, which adds approximately 5-10 seconds to the study. Both the standard swallows and the study swallows will be recorded for analysis and comparison. It is hypothesized that the study swallows will have less deficits than the standard swallows. If an infant's standard VFSS does not indicate dysphagia, that infant will no longer be eligible for this study.
The purpose of this research study is to determine whether a functional fiber, galactooligosaccharide, can help maintain immune strength and digestive health in free-living older adults. It is hypothesized that older adults consuming the fiber daily for 24 weeks over cold and flu season will have more healthy days due to a proliferation of beneficial bacteria within the colon which alters cytokine production and enhances natural killer cell function. Immune and gastrointestinal health will be evaluated via daily questionnaires obtained from 80 participants and from the collection of blood and fecal samples.
Assesses the efficacy of treatment with montelukast 10 mg PO QD x 5 days versus placebo for the treatment of viral-induced upper respiratory infection in healthy adults aged 18-50 years.
The goal of this randomized clinical trial is to learn if a combination of hot and cold EMR technique is associated with a lower risk of polyp recurrence without increasing the risk of complication when removing large polyps. Participants will undergo EMR and return for a follow-up endoscopy in 3-6 months to check for polyp recurrence.
Ear infections are common in young children with cold symptoms, but they can be difficult to diagnose due to small ear canals, child movement, and limited viewing time. In this study, investigators will take photos of the eardrums of children 6-24 months of age with upper respiratory symptoms. The photos will be reviewed by imaging software enhanced with artificial intelligence (AI app) to determine whether the AI app changes how ear infections are diagnosed and treated. The AI app has undergone rigorous study and was found to be highly accurate; but how using this technology affects the diagnosis and treatment by clinicians has not been studied. This research may help improve diagnostic accuracy for ear infections and ensure antibiotics are prescribed only for those children who have definite ear infections.
Individuals who operate in cold weather are at risk of developing cold injuries, for example, frostbite. They also often experience a loss of hand function and joint mobility due to a decrease in skin temperature and blood flow. In addition, the risk of getting a cold injury is higher in the Black population compared to other racial and ethnic groups. Increases in oxidant compounds can cause the blood vessels in the skin to narrow and decrease skin temperature in the cold. However, it is unknown whether the higher risk of cold injury in Black individuals is because of a greater amount of oxidant compounds in the blood vessels. The purpose of this research is to see if an antioxidant supplement called MitoQ can help to improve skin temperature and blood flow in the cold and if the improvement is greater in Black individuals.
The goal of this clinical trial is to evaluate the effectiveness of Neural Ice for pain management associated with knee osteoarthritis in adults aged 22-80 years. Participants will attend study visits and complete subject diaries. Participants will be followed for 6 months after study procedure.
The purpose of this clinical trial is to explore the effects of a 4 week cold-water immersion (CWI) intervention on measures of immune function, sleep quality, mental health and well-being, and muscular strength. The main questions it aims to answer are: * Does a 4 week CWI intervention improve measures of immune function, sleep quality, mental health and well-being, and muscular strength? * Are there any differences in these measures when comparing cold tubs versus cold showers? Researchers will compare chronic use of cold tubs to cold showers to see if cold water immersion may improve overall immune health and well-being. Participants will: * Undergo 4 weeks of Cold Tub or Cold Shower interventions at a frequency of 3 times a week for 4 minutes, if placed in the CWI intervention groups * Undergo testing measures at the two pre- and post- intervention time points, if placed in the healthy control group or the CWI intervention groups
An interest in cold-water immersion (CWI) to elicit diverse physiological effects has been prevalent for centuries. CWI typically consists of bodily exposure to water at temperatures ranging from 5-10º C for various durations. CWI has profound cultural significance in different areas of the world, such as in Scandinavian countries, and has emerged as a popular modality for its purported health-promoting effects. Individuals on social media have repeatedly advocated for CWI as a method to improve muscular recovery, enhance sleep, and increase immune and cognitive function. Because of this, companies that specialize in cold tub production have become popularized; however, individuals who are seeking a more cost-effective option are drawn toward cold showers for their preferred method of cold exposure. Despite the scarcity of rigorous research investigating the difference in effects of cold tub versus cold shower CWI, individuals on social media promoting CWI via a shower continue to praise its comparable benefits to that of a tub. Therefore, investigations of chronic CWI (utilizing both a cold tub and a cold shower) is vital. Thus, the purpose of the proposed study is to explore the varying effects of chronic CWI on neural and cognitive function using a cold tub and a cold shower. Further, the study aims to investigate performance measures and immune measures to create a comprehensive understanding of CWI's implications on human physiology over time. The investigators hypothesize measures relating to mental performance and health will improve after 4-weeks of CWI, and there will be no difference between tub and shower immersion groups.
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 \[CPT\]).
In this study, the investigators will examine the effect of cold-water immersion (CWI) on objective and subjective recovery metrics, as well as simple performance metrics, in National Collegiate Athletics Association (NCAA) Division I Men's and Women's Volleyball players, Men's Football players, and Men's and Women's Cross Country runners. This is a cohort cross-over study that will take place over the course of four weeks during an intensive training cycle. Participants will wear a WHOOP monitoring device on their wrists at all times during the study period. The two-week intervention will consist of ten minutes of CWI to take place within one hour of the completion of the last training session of the day. The target water temperature will be 55 degrees Fahrenheit, and each participant will complete five sessions of CWI per week (for a total of ten sessions over the two-week intervention phase). Objective recovery measures will include heart rate variability, resting heart rate, total sleep time, slow wave sleep time, sleep consistency, blood oxygenation, and nocturnal skin temperature, all of which will be collected continuously by the WHOOP monitoring device. Subjective recovery measures will include three surveys to be completed daily, including the Likert Scale of Muscle Soreness, the Total Quality Recovery Scale, and the Single-Item Sleep Questionnaire. Performance measures will include a counter-movement jump to be completed two times per week, an isometric mid-thigh pull to be completed once per week, and a drop jump to be completed once per week. These outcome measures will similarly be collected during the two-week control period, during which participants will not have access to CWI following training sessions.
The study will compare the use of cold snare piecemeal resection (CSPR) vs cold endoscopic mucosal resection (Cold EMR). The study will include two cohorts: one cohort for conventional adenomas 10-19mm in size and one cohort for serrated lesions 10mm or larger.
This study aimed to assess the effect of the supplementation with grape seed extract (GSE) on blood pressure during static handgrip exercise and muscle metaboreflex in individuals with elevated and state 1 hypertension.
Currently, there is a lack of evidence-based prevention strategies for respiratory infection and management of these conditions can be costly to the public. Airway nitric oxide provides a first line of defense against pathogens, and beetroot juice, a source of dietary nitrate, has been shown to elevate nitric oxide. The main objective of this project is to demonstrate that one week of supplementation with beetroot juice elevates airway nitric oxide during stressful periods in young adults and thereby can protect against respiratory viral infections.
Patients undergoing an endobronchial ultrasound and biopsy can experience bleeding during the biopsy. These biopsies are read in real time by pathologists who travel to the endoscopy unit during the procedure. Often, when this happens, the blood contaminates the pathology slides making the slide unreadable. This then requires more biopsies to be performed, thus prolonging the procedure, and increasing anesthesia time. One innovative way to reduce bleeding may be to irrigate the bronchial wall with cold saline, where the biopsy is to be taken, immediately before biopsy, thus causing vasoconstriction and possibly resulting in less blood contamination on the biopsy slides. The current study will evaluate this prophylactic irrigation with saline to control bleeding, thus resulting in a quicker diagnostic result of the biopsies.
The primary objective of this study is to determine if a sphenopalatine ganglion (SPG) block, performed through intranasal atomization of 4% lidocaine, is able to prevent cold induced cephalgia ("Brain Freeze"). Secondary objectives will be to determine the degree of decreased pain/duration of brain freeze after sphenopalatine ganglion block
The objective of this feasibility study is to evaluate continuous temperature monitoring, oxygen (O2) concentration and ventilation with positive end expiratory pressure (PEEP) to keep lungs cooled at 4-8 degrees Celsius, with continuous O2 concentration of 100% and inflated with a PEEP of 8-10 during the entire cold ischemic period.
Assess the effect of skin rewarming during lower body negative pressure upon arterial blood pressure and tolerance to simulated blood loss after exercise in the cold.
This study will recruit 112 medically healthy adults (aged 18-65) currently experiencing depressive symptoms to be randomized to receive either a single Whole Body Hyperthermia (heat therapy) treatment or a Whole Body Hyperthermia treatment followed by a cold water plunge. Participants will complete a baseline assessment of their depressive symptoms as well as 1-week and 2-week post-treatment followup assessments.
Upper respiratory infections (URIs) have long posed a significant burden to the US healthcare system. Well before the coronavirus disease of 2019 (COVID-19) pandemic they have been among the most common acute outpatient illnesses, causing 75-100 million physician visits each year on average, and costing the health care system billions of dollars annually. This double-blind randomized placebo-controlled study tested the efficacy of two anti-inflammatory throat sprays against placebo and against a throat spray taken in conjunction with 325mg of aspirin, a well-known systemically administered cyclooxygenase (COX) inhibitor. Participants having common cold symptoms lasting less than two days were enrolled and given treatment to administer at home. Various common cold symptoms were assessed and measured via clinically validated self-assessment scales. Participants were screened for influenza and COVID-19 before enrollment and were excluded if found positive.
Many Navy diving operations are performed in cold water. Despite technical advances to improve thermal protection for cold water diving, these applications are cumbersome and do not provide complete thermal protection as thermal discomfort is subjectively reported by many Navy divers. Brown adipose tissue is highly thermogenic in humans. Therefore, activation of brown adipose tissue might improve cold water tolerance and lower thermal discomfort during cold water diving operations. Mirabegron is a beta-3-adrenergic receptor agonist that is used to treat overactive bladder. Beta-3-adrenergic receptors are located on the urinary bladder, gallbladder and brown adipose tissue. Recent evidence has demonstrated that acute mirabegron administration increases thermogenesis for \~3 hours in humans. However, it is currently not known which dose of mirabegron can increase thermogenesis for longer durations. It is also not known if mirabegron administration can improve cold water tolerance and thermal discomfort during cold water immersion. Finally, it is not known if mirabegron can increase thermogenesis during sympathetic stimulation. This project will fill these knowledge gaps by determining if acute mirabegron administration will delay the fall in core temperature and the onset of shivering during a progressive cold-water immersion challenge. This study is part of a collection of studies that will show if mirabegron is a potential ergogenic aid that can be used to improve cold water tolerance in Navy divers which will ultimately improve the likelihood of successful missions.
Patients between 4-21 years of age with at least one wart or molluscum lesion are eligible to participate in this study. The duration of the study is a minimum of 4 weeks with the maximum duration of monthly treatments for one year, depending on lesion clearance. The number of lesions will be chosen by the dermatologist. Patients who opt to participate will receive non-thermal, or cold, atmospheric plasma to treat all lesions selected. Safety profile as well as changes in size, pain and appearance will be measured. Photographs and dermatologist impressions will be used to measure treatment response.
Focus Consumer Healthcare has developed Herpecin L. Herpecin L combines many different ingredients hypothesized to promote quick healing and symptom reduction from cold sores.
This is a multinational, multi-center, observational, prospective, longitudinal disease registry designed to collect data on participants with cold agglutinin disease (CAD) or cold agglutinin syndrome (CAS). Among them, a minimum of 30 patients with CAD treated with sutimlimab are expected to take part in the sutimlimab cohort study. Patients with CAD who have been enrolled in previous sutimlimab clinical trials (e.g., BIVV009-01/LTS16214 \[NCT02502903,CAD patients\], BIVV009-03/EFC16215 \[NCT03347396\], and BIVV009-04/EFC16216 \[NCT03347422\]) and who either completed or discontinued the corresponding clinical trial are eligible to participate in the registry.
10-13 patients will be enrolled to receive split face treatment: the control side will be treated with metronidazole cream, the intervention side will be treated with a cold atmospheric plasma device
In cold weather environments, blood flow to the extremities is significantly reduced, which severely impairs hand function and induces thermal discomfort. Prolonged or repeated cold exposure elicits an adaptive habituation response that is characterized by blunted skin vasoconstriction and thus may be an effective strategy to improve peripheral perfusion, reduce thermal discomfort, and maintain hand function during cold weather military operations. Since mission conditions often involve low ambient temperatures, countermeasures that reduce cold-induced decrements in hand function and thermal comfort are important to enhance Warfighter readiness in cold weather battlefield environments. The goals of this study are to 1) evaluate the effectiveness of cold habituation in improving skin blood flow, hand function, and thermal comfort during cold exposure and 2) identify the mechanisms that contribute to improvements in skin blood flow following habituation.
This is a blinded, randomized study in the US to compare the duration response of two different concentrations of Xeomin in healthy female subjects with moderate to severe dynamic glabellar lines on maximum frown.
This study explores the use of transcutaneous auricular vagus nerve stimulation (taVNS), a new form of neuromodulation which stimulates the ear. 24 healthy subjects without a past medical or psychiatric history will be recruited to participate in a phone screen followed by 1 lab visit. During the lab visit, subjects will participate twice in a validated stress induction technique called the cold pressor test, while concurrently receiving either active or sham taVNS. The cold pressor test consists of subjects placing their feet in an ice bath for a short period of time. Researchers will measure participant's heart rate while they receive taVNS (ear stimulation) and participate in the cold pressor test. Assessments of mood, anxiety, and stress will be collected at the beginning and end of the visit.
This trial is being performed to evaluate the feasibility of the study protocol and to test the efficacy and safety of platelets stored at cold conditions (1-6°C) in 100% plasma for 10-14 days (CSP) in cardiac surgery patients who are actively bleeding and require platelet transfusion.