72 Clinical Trials for Various Conditions
The main objectives are to determine sweat sodium concentration \[Na+\], whole body sweat rate (WBSR) and rate of sweat sodium loss (RSSL) in female athletes aged 13 and above during their normal planned training session across various sports (basketball, soccer, volleyball, cheer, flag football and softball).
The purpose of this study is to examine effects of laser therapy on blood flow and sweating responses in burn-injured skin.
The main objectives are to determine the validity of a Smart Cap in measuring fluid intake during running and fitness exercise and the validity of a Smart Sweat Patch in measuring sweat rate and sweat chloride concentration during outdoor cycling, running, and fitness exercise. A secondary objective is to compare regional sweating rate and sweat electrolyte concentrations (sodium, chloride, and potassium) on contralateral arms with vs. without tattoos.
Individuals with lower limb amputation often complain about uncomfortable residual limb skin temperatures and the accumulation of sweat inside their prostheses. It doesn't take long before the presence of sweat on the residual limb leads to a lack of confidence in the security of their prosthetic suspension. Some circumstances allow the wearer to doff the prosthesis before it falls off, wipe it and the residual limb dry, and then don it again. Another option is to simply reduce the intensity of activities before sweat becomes a problem. However, the Warfighter amputee may not be afforded such accommodations. For these service personnel, inadequate moisture management can significantly limit or inhibit their mobility. The objective of the proposed research is to provide lower limb amputees who work in demanding environments with a prosthesis that remains secure despite profuse residual limb sweating without compromising residual limb health and comfort. The aim of this research is to compare three different, lower limb prosthetic suspension systems and identify which is most effective at maintaining a secure adherence when worn in conditions that result in profuse sweating. The investigators also aim to compare how the three study prostheses effect residual limb skin health and comfort when participants pursue their usual activities in the home, work, and community environments. To achieve these aims, the investigators will to recruit 25 below-knee amputees. Each subject will be asked to be asked to wear: (1) their as-prescribed prosthesis, (2) a prosthesis with a perforated elastomeric liner that allows sweat to flow away from the skin, and (3) a prosthesis that has a battery and body-weight activated pump to flow air between the prosthesis and the residual limb skin, allowing expulsion of any accumulated sweat. Subjects will wear each of these prostheses in the home, work, and community environments for two weeks, after which the investigators will measure their residual limb health and comfort. Subjects will then walk on a treadmill in a room whose climate will be set to Middle East-like conditions: 35 °C (95 °F) and 50% relative humidity. After 30 minutes, the investigators will measure any slippage of their prosthesis relative to their limb and how much sweat is expelled. The investigators hypothesize there will be differences in the amount of slippage, residual limb health, and comfort between the three prostheses.
This pilot clinical trial will explore the accuracy and acceptability of a non-invasive, wearable glucose sensor in patients living with DM. This study will compare needleless glucose sensor readings from sweat with glucometer measurements from patients with any type of diabetes at fasting, and after a meal.
This is a multicenter, cross-sectional, cohort study which will collect contemporary sweat chloride (SC) values from approximately 5000 Cystic Fibrosis (CF) patients prescribed and currently receiving commercially approved Cystic Fibrosis transmembrane conductance regulator (CFTR) modulator therapies.
The study consists of measurement of antidepressant-induced excessive sweating and its treatment with an experimental medication, glycopyrrolate (approved to treat ulcers), which will be added to the antidepressant. This is an open-label study (no placebo group or concealment of the nature of the treatment) that will last 8 weeks, including two weeks of baseline measurement without treatment with the study medication followed by six weeks of treatment with the study medication. The study is pilot study by Dr. Rajnish Mago that is based on the hypothesis that glycopyrrolate will be effective in reducing the severity of excessive sweating caused by antidepressant treatment, and will have minimal side-effects.
The purpose of this study is to compare the effectiveness of two methods in the treatment of excessive underarm sweating (axillary hyperhidrosis): suction-curettage and Botox injections. Suction-curettage is a method in which the doctor will insert a suction tool into two small incisions in order to suction out the sweat-producing glands. It is similar to liposuction, but instead of suctioning out fat, the doctor suctions out the layer of the deep skin where the sweat glands are located. This method has been shown in some studies to effectively reduce underarm sweating for months at a time. Botox is a Food and Drug Administration (FDA) approved drug that in small doses, paralyses muscles. It is most commonly and famously used in the treatment of facial wrinkles. However, it has also been approved to treat excessive sweating. When injected in areas that sweat excessively, sweating can be significantly reduced in that area for months at a time. This study is a pilot study designed to determine feasibility of these procedures.
Perspiration or sweating is a normal physiological response to increased body temperature, environmental heat and humidity, emotions, nervousness, or physical exertion. Perspiration occurs when sweat is secreted from sweat glands, travels through sweat ducts and exits sweat pores to coat the skin's surface. The evaporation of sweat from the skin dissipates heat and is the primary thermoregulatory mechanism used by humans and primates. Excessive sweating beyond what is required for maintaining body temperature homeostasis is termed hyperhidrosis. Primary hyperhidrosis is idiopathic affecting the palmar, plantar, axillary, or craniofacial regions bilaterally, while secondary hyperhidrosis is less common and is often a side effect of medication or an underlying pathology. Primary hyperhidrosis may affect up to 4.8% of the US population, yet it is widely underreported and undertreated. Hyperhidrosis can negatively impact daily activities, cause significant stress, limit social interactions, and reduce the quality of life for patients. In particular, excessive palmar sweating interferes with professional activities (e.g., shaking hands, working with tools, or wearing exam gloves) and degrades sports performance. Hyperhidrosis (HH) is especially difficult to treat on the hands and feet, with clinical care beginning with prescription strength topical aluminum chloride hexahydrate antiperspirants such as DrySol or Secret Clinical, and OTC products (e.g., Carpe). However, prescription strength aluminum chloride antiperspirants are often ineffective, can be irritating and leave a residue that degrades skin texture and grip. Currently, iontophoresis is the only medical device approved for treating palmar and plantar HH, but these devices are expensive (\~$1,500), uncomfortable to use and are time consuming (30 minutes sessions, 3-4 times a week for several months). Oral anticholinergic medicines such as oxybutynin are often prescribed but they have unwanted side effects including blurred vision, dry mouth, and headache. Topical anticholinergic wipes have shown promise, but they are expensive, take weeks to relieve symptoms and have unpleasant side effects in \>18% of patients. Finally, invasive procedures such as Botox™ injections and endoscopic thoracic sympathectomy are used to treat the most severe palmar/plantar HH cases but these treatments are expensive, invasive, painful and can have significant adverse effects including persistent muscle weakness and compensatory sweating. Thus, a high unmet need exists for topical treatments that are fast-acting, safe, and effective. Cyanoacrylate (CA) tissue adhesives have been used for decades to close wounds, stop bleeding, and prevent infection. CA tissue adhesives bond to the skin through Michael's addition reactions to tissue amines, forming durable but flexible films. Despite CA being used for various medical applications, no CA-based antiperspirants are currently clinically approved or commercially available. Topical cyanoacrylate (TCA) is based on medical grade cyanoacrylate adhesives with decades of demonstrated safety clinical applications. TCA is cheap to produce which will improve affordability and treatment adoption. In addition, prototypical TCA formulations eliminate surface moisture within seconds and occlude eccrine sweat pores, anticipating a strong antiperspirant effect compared to current treatments which typically reduce sweating with variable efficacy. TCA is innovative because it is fast acting (acts within seconds) and does not degrade the surface of the skin or grip function. Current hyperhidrosis treatments typically require days to weeks to achieve clinical results, have a variety of undesirable side effects, and can negatively affect the surface feel of the skin. Aside from topical antiperspirants, Botox injections and anticholinergic agents are the only drugs approved by the FDA for treating hyperhidrosis. Due to their rapid polymerization and strong adhesion and low toxicity, n-Butyl and 2-Octly cyanoacrylate are widely used in thoracic, gastrointestinal, neurologic, cardiovascular, ophthalmologic, and vascular surgery. Although n-Butyl and 2-Octyl cyanoacrylate are considered safe, allergic contact dermatitis can occur after surgical wounds closure at an incident rate of 2.7% for 2-Octyl cyanoacrylate and 2.2% for n-Butyl cyanoacrylate, but risks are presumably lower for topical application on intact glabrous skin. Thus, a significant unmet need exists for fast-acting, cheap, effective, and safe treatments that leave the skin with a desirable surface feel and improve grip security. In this pilot study described in this proposal, investigators will evaluate the safety and efficacy of a topical application of generic cyanoacrylate (TCA, equivalent to FDA cleared GluStich® medical adhesive or Marathon No Sting Liquid Skin Protectant) to inhibit palmar perspiration.
Cystic fibrosis (CF) is a multisystem autosomal recessive inherited disease affecting approximately 75,000 individuals in USA. The sweat chloride (Cl) test remains the gold standard for diagnosis of CF but still has a number of limitations. The objectives of this study are: 1)To evaluate a skin-interfaced colorimetric bifluidic sweat device with two synchronous channels as a potential low-cost but potentially accurate test to diagnoses cystic fibrosis (CF) and 2) To evaluate measurements of sweat chloride (Cl) using this same system in comparison to the standard clinical laboratory procedures routinely performed in the Clinical Laboratory at Penn State Health Milton S. Hershey Medical Center (PSH-HMC), Hershey, PA for assessment of the diagnosis of CF. This is a single institution study performed solely at PSH-HMC. Study participants will include 1) adults 18 years of age or older capable of providing signed and dated informed consent, 2) subjects with an established known diagnosis of cystic fibrosis (CF) or healthy volunteers, and 3) able to understand and speak English language. Exclusion criteria include: 1) any medical condition or disorder known to potentially interfere with accurate measurements of sweat chloride and 2) inability to understand and speak the English language. Cystic Fibrosis (CF) subjects will be identified from the population of eligible patients receiving medical care at Penn State Health- Milton S. Hershey Medical Center (PSH-HMC). Healthy donor volunteers will be recruited from various members of the PSH-HMC CF clinical care team, members of the Division of Allergy, Pulmonary and Critical Care (both faculty and trainees) at PSH-HMC, and PSU-University Park research team. The total projected number of combined enrolled subjects is 30. This is a single day single time study that will require approximately 60 minutes of subject participation. Potential risks include a) side effects from pilocarpine iontophoresis sweat test collection (pain, skin discomfort, blisters, rarely burns and b) loss of confidentiality. There will be no cost to subjects for study participation. There will be no reimbursement financially for study participation. There is no benefit to subjects for study participation. There is the potential benefit to medical science via identification of improved method to accurately measure sweat chloride for diagnosis of CF.
Subjects will walk on a treadmill at 3 mph and sweat will be collected from both forearms. One arm will be pretreated with topical lidocaine, and the other will act as the control.
The purpose of the study is to evaluate whether sauna use after active-duty firefighting is effective in reducing exposure to certain harmful chemicals called polycyclic aromatic hydrocarbons (PAHs). PAHs are found in soot and several types are known to be carcinogens. This study is a cross-sectional pilot study that will be performed in active-duty firefighters. The firefighters will be subdivided into those who will use a sauna immediately after fighting a fire versus those who will not, the latter of which will serve as a metabolism control group. There will thus be two comparison groups within the study: 1) active-duty firefighters using a sauna after fire suppression (sauna group); 2) active-duty firefighters not using a sauna after fire suppression (metabolism control).
Background: The COVID-19 pandemic has challenged the health systems worldwide. Many tools have been developed in response to the pandemic, but there is no current way to quickly screen multiple people for the disease. Research has shown that people with COVID-19 have higher levels of some proteins involved in the immune response and inflammation. These proteins can be detected in sweat using a special camera. Researchers want to see if analysis of sweat from fingerprints could be used to detect COVID-19 infection in people. Objective: To test a new technology to detect COVID-19 infection based on an analysis of sweat from fingerprints. Eligibility: Adults ages 18 and older who tested positive or negative for COVID-19 within the last 7 days. Design: Participants will visit the NIH Clinical Center for one day within 7 days from COVID-19 testing. The visit will last for 3 to 4 hours. Participants who show symptoms for COVID-19 with a positive test will give blood samples to correlate with the sweat markers. About 1/2 tablespoon of blood will be drawn. For sweat markers, 10 fingers will be imaged by a camera using a touchless system. This will be repeated 3 times. It will take about 15 minutes. Participants will use the device. They will get instructions and watch a short video on how to use the device.
The investigators want to test in this non-randomized clinical trial a new method of administrating Pilocarpine medicine into the skin during the Sweat testing process that does not use any electrical current.
To determine the validity of the Gx Sweat Patch in measuring sweating rate and sweat chloride concentration during moderate-high intensity practice against well-established reference methods in field conditions with basketball athletes
The Sahara Study is a study to evaluate the safety and effectiveness of the N-SWEAT Patch for use in subjects with excessive axillary sweating, or primary focal axillary hyperhidrosis.
To determine the validity of a prototype patch in measuring sweating rate and sweat electrolyte concentration during moderate intensity exercise against well-established reference methods in a controlled laboratory and in field conditions.
The proposed natural history study will enroll male patients with a diagnosis of XLHED, female carriers of XLHED and healthy volunteers. The study protocol will include collection of XLHED questionnaires and clinical outcomes using minimally invasive technologies. Data will be collected both retrospectively and prospectively. Clinical outcome assessments will be performed at the NFED Family Conference on July 11-12, 2019. Study participants will be able to complete XLHED questionnaires electronically ahead of the conference.
Pilot study of a wearable gas and sweat skin sensor
Subjects with type 1 diabetes will be observed in the diabetes research center clinic following a meal and an insulin injection. Breath and sweat samples will be collected at intervals throughout the visit, with increased frequency during hypoglycemia. Collaborators with the MITRE Corporation will perform analyses on these samples to identify any relationships between volatile organic compounds in breath and sweat and hypoglycemia.
Pilot study of a soft, flexible wearable sweat sensor
Cystic Fibrosis (CF) is a hereditary multi-system disease affecting approximately 30,000n children and adults in the USA. The diagnosis of CF requires biochemical confirmation (either abnormal sweat chloride measurement and/or identification of two CF disease causing mutations) plus clinical symptomatology. Measurements of sweat chloride remain cumbersome and although most common methodology to confirm CF diagnosis with limitations especially in young children less than 6 months of age and in areas that lack ability for the complex testing. The study objectives of this current research proposal include: A) To expand upon previously obtained pilot study data "Evaluation of a fluorescent-based chloride sensor as an optical sweat test to diagnose cystic fibrosis" B) To add the exploratory measurement of sweat Bromide as a first in human assessment observation, C) To Evaluate the development of smartphone based point-of-care technology for chloride and bromide sensor measurements, D) To further expand the class of citrate-based sensors with improved fluorescence and sensing properties for the design of new fluorescence-based analytical and diagnostic solutions based on the automated multi-halide detection system, and E) To develop point-of-care systems that can successfully integrate into clinical settings to improve current practices and facilitate early detection of disease.
To visually evaluate the retention of coverage of the Test Product(s) (TP) on the face after exercise compared to the full coverage observed prior to exercise
The purpose of this study is to see what the differences are in sweat (amount and small molecule content) collected from different sites of the body and by different methods of sweat stimulation. Additionally, the investigators want to know whether the amount and small molecule content of the sweat is the same in an individual over time, and the same across individuals at a given time. Finally, the investigators want to know how consumption of over-the-counter anti-inflammatory drugs such as ibuprofen will affect the inflammatory mediator content of sweat and how that compares to blood. This information will help to better understand the composition and behavior of sweat and assess its potential utility as a routine clinical tool in skin research.
To visually evaluate the retention of coverage of the Test Product(s) (TP) on the face after exercise compared to the full coverage observed prior to exercise.
This study will investigate a new diagnostic technology in order to expand current understanding of inflammatory and neoplastic cutaneous disease processes such as eczema, psoriasis, granuloma annulare, cutaneous lymphoma, squamous cell carcinoma, basal cell carcinoma and melanoma. Protein fragments found in sweat will be collected using a diagnostic skin patch and analyzed with mass spectrometry. The goal of this study is to identify specific protein fragment biomarkers that may further current understanding of cutaneous diseases. The protein expression patterns derived from sweat will be compared to conventional histopathologic, immunohistochemical, flow cytometry, in-situ hybridization, polymerase chain reaction, and mass spectrometry analyses of cutaneous biopsy specimens. The insight gained from this research will be used to promote advances in disease prevention and early diagnosis, identify prognostic indicators and new therapeutic targets.
To evaluate the gravimetric sweat measurements in subjects who meet the subjective criteria for a diagnosis of palmar hyperhidrosis compared to subjects without hyperhidrosis.
This is an observational comparative study to compare the standard-of-care methods for sweat testing used to support diagnosing cystic fibrosis (CF) against a new method of sweat testing called the CF Quantum Sweat Test System. The results of the new device in this study are for comparison ONLY and will NOT be used to diagnose, treat or mitigate the subject's condition.
This study uses an Alizarin Red powder mixture to characterize the sweat distributions in youth during tilt table testing. Patients with a known orthostatic sweat response from a prior clinical tilt table test in the investigators laboratory will be recruited. The Alizarin Red powder will be applied to exposed skin, and quantitative sweat will be measured at the thigh. During tilt testing, serial photos will be taken once the sweat response occurs. Sweat distributions will be compared during syncope (orthostatic sweat), during periods of anxiety (emotional sweat), and in patients with POTS (with and without syncope).
Clinical studies of lumacaftor + ivacaftor (combo therapy) produced better FEV1 (forced expiratory volume in 1 second) improvements than ivacaftor alone, without further improvement in sweat chloride results. To help understand why sweat chloride was unresponsive, the investigators will use a newly developed sweat secretion test that provides accurate, in vivo readout of CFTR (cystic fibrosis transmembrane conductance regulator) function in the sweat gland secretory coil. The investigators devised a protocol to determine if short courses of ivacaftor (3.5 days) will produce significant increases in WT (Wild-Type, i.e. normal) CFTR open probability by measuring CFTR-dependent sweating (C-sweat) in subjects with WT CFTR.