cyrilzakka/clinical-trials huggingface dataset:
Rate of Tissue Temperature Reduction Between Wetted Ice and Game Ready

This study compares the tissue temperature decrease between a wetted ice bag (ice and water) with an elastic wrap to the Game Ready® treatment. The goal is to determine which one decreases the temperature the most and the fastest, which is important in immediate care treatments of a musculoskeletal injury.

The purpose of this study will be to determine which cryotherapy method, wetted ice bag and elastic wrap or Game Ready® set at medium pressure, decreases tissue temperature the most during a 30-minute treatment. Due to the convenience of Game Ready®, it is being used as an immediate care intervention. Findings in the literature have indicated wetted ice cools tissue temperature more than cubed or crushed ice based on the assumption that colder is better. Conversely, research on Game Ready® has revealed ice bags and slush buckets cause a greater reduction in tissue temperature compared to Game Ready®. However, no study exists comparing the effects of Game Ready® versus wetted ice on intramuscular tissue temperature reduction as immediate care interventions. Based on the results, this study may help contribute to the existing literature on tissue temperature reduction of both Game Ready® and wetted ice to determine the better modality to use for immediate care. The research questions guiding this study will be:

1. Which cryotherapy method, Game Ready® or wetted ice with elastic wrap, will be the most effective at decreasing intramuscular tissue temperature during a 30-minute application in patients aged 18-40 years old?
2. Which cryotherapy method, Game Ready® or wetted ice with elastic wrap, will achieve an intramuscular tissue temperature reduction the fastest?

Eligibility Criteria:
Inclusion Criteria:

* Subjects will be both male and female.
* Subjects will be between 18 and 40 years of age.
* Subjects will have no prior injury to the dominant lower leg within the past 6 months.
* Subjects will be able to speak English.
* Subjects will have less than 1 cm of adipose over the medial gastrocnemius muscle.

Exclusion Criteria:

* any current lower extremity injury, or any lower extremity injuries within the past 6 months.
* any previous history of surgery in the lower leg
* any contraindications to cryotherapy such as Raynaud's phenomenon, cold-induced urticaria, previous frostbite to the lower leg, open wounds, peripheral vascular disease, lupus, circulatory insufficiency, mayocardial ischemia, or skin infections.
* any abnormalities seen in the muscle as determined by diagnostic ultrasound.
* any allergies or sensitivities to Betadine.
* greater than 1.0cm of adipose over the medial gastrocnemius muscle (calf).
Late-Onset Treatment Study Extension Protocol

Pompe disease (also known as glycogen storage disease Type II) is caused by a deficiency of a critical enzyme in the body called acid alpha-glucosidase (GAA). Normally, GAA is used by the body's cells to break down glycogen (a stored form of sugar) within specialized structures called lysosomes. In patients with Pompe disease, an excessive amount of glycogen accumulates and is stored in various tissues, especially heart and skeletal muscle, which prevents their normal function. The objective of this extension study is to assess the long-term safety and efficacy of alglucosidase alfa treatment in patients with Late-Onset Pompe Disease who were previously treated under the placebo-controlled, double-blind study AGLU02704 (NCT00158600).


Eligibility Criteria:
Inclusion Criteria:

* Patient must have completed protocol AGLU02704 (NCT00158600)
* Patient must provide signed, informed consent prior to performing any study-related procedures
* Patient (and patient's legal guardian if patient is under 18 years of age) must have the ability to comply with the clinical protocol
* A female patient of childbearing potential must have a negative pregnancy test at Baseline. (note: all female patients of childbearing potential and sexually mature males must use a medically accepted method of contraception throughout the study.)

Exclusion Criteria:

* The patient has a medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, would preclude treatment with alglucosidase alfa.
A Prospective Observational Study of the Breath Responsive Variable Bolus Oxygen Conserving Device

* Evaluate subjects in an prospective observational study
* Subjects will be administered scientifically validated questionnaires
* Evaluate Quality Improvement and Oxygen Utilization Improvements.

  1. Functional capability, dyspnea, oxygen saturation as primary endpoints
  1. Baseline Dyspnea Index (BDI)
  2. Transitional Dyspnea Index (TDI)
  3. Chronic Respiratory Disease Questionnaire (CRQ)
  4. Six minute walk distance (6MWD)
  5. Oxygen saturation using pulse oximeter
* The secondary endpoints:

  1. Portable oxygen source utilization
  2. Health care utilization (emergency room encounters, hospital admissions)

Evaluate subjects in an prospective observational study in which subjects will be screened and administered scientifically validated questionnaires at study entry and during the observation period at specified intervals to determine Quality Improvements through using the Breath Responsive Variable Bolus Oxygen Conserving Device with a Portable/Ambulatory Oxygen Source on improvements in functional capability, dyspnea, oxygen saturation, quality of life as primary endpoints, and portable oxygen source utilization, health care utilization as secondary endpoints.

Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of chronic obstructive pulmonary disease (COPD)
* Clinically stable disease at the time of consent
* Current prescription of oxygen 24 hours a day
* Previous or current oximetry desaturation at rest or activity (≤88% on one occasion)
* Highest measured FEV1, 70% predicted; and
* Highest measured FEV1/FVC, 70% predicted
* Capable of giving informed consent
* Currently using a portable oxygen source that is a portable tank
* Mobility without a walker, cane or rollator
* Spo2 ≥ 90% on portable oxygen source at rest and activity
* Non-smoker at time of consent

Exclusion Criteria:

* Cardiovascular disease - New York Heart Association Functional Class III
* Degenerative bone or joint disease with limited functional ability
* Current homeless persons
* Active drug/alcohol dependence
* Recent drug or alcohol abuse history within the past two years
* Clinically unstable at the time of consent
* Currently a tobacco smoker
Bread Structure and Postprandial Metabolic Responses

The structural properties of bread are considered one of the most important factors that can affect its digestibility, glucose homeostasis and postprandial metabolic responses. The purpose of this study is to examine the effects of consumption of less processed whole grain bread products (wheat and fortified with legumes) in comparison with finely milled whole grain bread products on postprandial glycaemic response and appetite regulation.

Postprandial glucose response caused by bread products of different degree of processing, as well as their appetite regulating properties will be evaluated. In the intervention there are totally four samples, the reference (white wheat bread), the less processed whole wheat bread, the whole wheat bread fortified with finely milled legumes (chickpeas), the whole wheat bread fortified with less processed legumes (chickpeas). The volunteers that will be enrolled in the study should be apparently healthy subjects (women and men) with normal body weight. Certain effects related to the structure of the different products on glycemic and insulinemic responses, subjective appetite ratings and other parameters will be examined.

Eligibility Criteria:
Inclusion Criteria:

* normal exercise and dietary habbits
* weight stable for at least 3 months before enrollment

Exclusion Criteria:

* pregnancy and lactation
* diabetes
* chronic medical illness
* regular intense exercise (\>5 hrs/week)
* alcohol consumption \>2 drinks/day
Vibratory Perturbation-based Pinch Task Training for Stroke Patients

The investigator assumed that perturbed-event-induced vibrotactile cueing enable more precision arm movement adjustment, sensory function and dexterity improvement in the spastic arm. Thus the specific aim of the study was to develop a vibrotactile therapy system that can provide vibrotactile feedback through the pinch performance of the hand when countering mechanically induced perturbations and also analyzed training effects of the perturbation-based pinch task training system on the sensorimotor performance of the hands for stroke patients.


Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of unilateral cerebral infarction or hemorrhage
2. Be able to perform a pinch task with the thumb and index finger
3. With premorbid right-handedness

Exclusion Criteria:

1. Subject has a uncontrolled hypertension
2. Subject has major cognitive-perceptual deficits
3. Subject has other brain disease
Environmental Exposures, Genetics, and Exhaled Nitric Oxide in Pediatric Asthma

Asthma is one of the most common childhood diseases. It is chronic and often severely disabling. The amount of nitric oxide that is exhaled while breathing increases with airway inflammation, a symptom of asthma. This study will examine the results from a previous study, the Cincinnati Asthma Prevention (CAP) study, to evaluate the effects of environmental and genetic factors on exhaled nitric oxide (eNO) levels and to determine the relationship between eNO and asthma severity.

Nitric oxide is a naturally occurring gas that plays a role in many body functions. Levels of eNO increase with airway inflammation, a symptom of asthma. Researchers have proposed using eNO as a noninvasive measure to guide physicians in the treatment and medical management of asthma in children. However, more information about eNO is needed before this can happen. This study will perform a secondary analysis of the results from its parent study, the CAP study, which evaluated the effectiveness of preventing asthma in children who had been exposed to environmental tobacco smoke.

This study will not enroll any new participants. Previously collected data from the CAP study will be reevaluated in this study to determine the longitudinal effects of environmental and genetic factors on eNO levels. In addition, the data will be evaluated to determine the relationship between eNO levels and asthma severity. No new data will be collected in this study.

Eligibility Criteria:
Inclusion Criteria:

* Participated in the Cincinnati Asthma Prevention Study
* Diagnosis of asthma
* Lives with someone that smokes at least 5 cigarettes a day

Exclusion Criteria:

* No additional neuromuscular or respiratory disorder that may interfere with safe participation in the parent study
* Does not have electricity
* Plans to move within 1 year of entry into the parent study
To Evaluate the Effectiveness of a Virtual and Telephone Intervention for the Prevention of Postpartum Depression in Women at Risk

Women's perinatal mental health problems can create a cascade of short- and long-term negative influences for the mother, child, and the family as a whole. To prevent these impacts, preventive online and telephone interventions exist, but need to be tested and improved to develop this type of support to women in Quebec. The Parents \& Babies program, which is a distance learning course, followed during pregnancy and accompanied by telephone follow-up, aims to improve the mental health of future parents.The investigators seek to evaluate the effect of the intervention of the Parents \& Babies program offered with telephone support compared to the course offered without telephone follow-up.

The Parents \& Babies intervention to be evaluated is an adaptation of the existing, evidence-based Mothers \& Babies program which has shown efficacy in four clinical trials for the prevention of postpartum depression through in-person (group or individual) counseling

The Parents \& Babies program was adapted to be virtual and include: 1) specific modules for the mother-partner dyad; 2) third-wave cognitive behavioral therapy (CBT) strategies targeting well-being, relaxation, mindfulness, self-compassion, and gratitude; 3) confinement and social distancing related material. Participants follow the program online or with a paper workbook and are called weekly by a member of the intervention team.

Participants will fill out three questionnaires (online or by telephone) at 12-25 weeks' gestation, 3 months' postpartum and 6-months postpartum to assess baseline values and trial outcomes, respectively.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women (12-25 weeks' gestation)
* subclinical and clinical levels of depression (Edinburgh Postnatal Depression Scale (EPDS) scores 8-16)
* ability to read and understand French.

Exclusion Criteria:

* EPDS score in the clinical range (≥ 17) or no symptoms (EPDS \< 8)
* Positive screening of psychotic symptoms using the Psychosis Screening Questionnaire (PSQ)
* self-reported substance abuse problems.
Physical Activity Scale in Individuals With Spinal Cord Injury

The aim of this study was to improve the cultural adaptation and Turkish version of the The Physical Activity Scale for Individuals With Physical Disabilities (PASIPD) and to investigate the validity and reliability of the Turkish version of PASIPD in individuals with spinal cord injury. PASIPD, which consists of 13 questions, will be adapted to Turkish by translation and back translation method. The study included 47 wheelchair-dependent patients over the age of 18 who were able to read and write Turkish (26 females, 21 males). In order to determine the reliability and internal consistency of PASIPD, item-total correlation, if item deleted cronbach alpha coefficient and cronbach alpha coefficient of the whole scale will be calculated. Test-retest method will be used for the stability of the scale. In the test-retest method, the scale will be re-applied to the same people with 7-day intervals. Pearson correlation analysis will be performed between the first test and the second test total and sub-parameters after 1 week. Test-retest reliability will be determined using the intraclass correlation coefficient (ICC). In the validity test of PASIPD; construct validity and criterion validity will be used. Test of construct validity; factor analysis and convergent and discriminant validity methods. The Barthel Index of Activities of Daily Living and Functional Independence Measure (FIM); World Health Organization Quality of Life Scale Abbreviated Version (WHOQOL-BREF), Nottingham Health Profile (NHP) and Craig Handicap Assessment and Reporting Technique (CHART-SF) will be used to convergent and discriminant validity. Manual Wheelchair Propulsion Tests will be used to demonstrate criterion validity.


Eligibility Criteria:
Inclusion Criteria:

* Classified as group A, B, C or D according to American Spinal Injury Association (diagnosed with spinal cord injury),
* Fully or partially wheelchair dependent
* Over 18 years old
* Willing to research,
* Can read and write and read and write in Turkish
* Patients without cognitive impairment.
* Having the upper extremity muscle strength required for wheelchair use

Exclusion Criteria:

* Reluctant and unwilling to research,
* Having any progressive discomfort
* Bed dependent,
* Patients with severe cognitive impairment.
Human Intervention Study to Increase 25-hydroxyvitamin D Levels

The interventional study will evaluate effectiveness and potential of a regularly consumption of wheat germ oil (UV treated) vs. wheat germ oil (UV untreated) to increase plasma vitamin D levels ín humans.

The interventional study in parallel design will evaluate the effectiveness and potential of a daily consumption of wheat germ oil (UV treated vs. untreated) to increase plasma vitamin D levels in humans.

Wheat germ oil is naturally rich in vitamin D precursors (ergosterol and 7-dehydrocholesterol), which are converted into vitamin D2 and vitamin D3 by a defined UV light irradiation for the present study.

Half of the participants will consume UV-treated wheat germ oil (intervention) and the other part will consume traditional wheat germ oil (untreated, control). The subjects will consume 10 ml of wheat germ oil per day over an entire period of 6 weeks (no follow-up).

On the basis of the planned human intervention study (randomized, single-blind, parallel design) it will be investigated to what extent a regular consumption of wheat germ oil (UV-treated) can contribute to the increase of plasma 25 (OH) D levels.

The comparison is made against the intake of traditional (untreated) wheat germ oil (control).

The study fits with the strategy of the Competence Cluster for Nutrition and Cardiovascular Health (nutriCARD), Halle-Jena-Leipzig, Germany (www.nutriCARD.de) and the study collaborators are active members of the nutriCARD cluster.

Eligibility Criteria:
Inclusion Criteria:

* healthy subjects
* plasma 25(OH) vitamin D \< 50 nmol/l
* nutritional habits: western diet

Exclusion Criteria:

* intake of lipid-lowering medications
* gastrointestinal diseases, diabetes mellitus type I and II
* intake of supplements (vitamin D supplements, fish oil capsules, vitamins and minerals) 3 months before and during the study
* relevant food allergies / intolerances
* visit to the solarium (within 4 weeks before beginning of the study and during the study)
* stay in the mountains / skiing (within 4 weeks before beginning of studies and during the study)
Multicenter Trial of Daily Chlorhexidine Bathing to Reduce Nosocomial Infections

To determine if daily bathing with chlorhexidine impregnated washcloths will reduce the incidence of MRSA and VRE within an Intensive Care Unit (ICU) or ward setting.

This is a cluster randomized, crossover-controlled trial with wards as the units of randomization. The trial will predominantly take place in ICU's but may include any acute care ward that has active surveillance for MRSA and or VRE in place (i.e., Bone Marrow transplant units, Oncology wards, etc.) Units will be randomly assigned to utilize two bathing routines in a random order. Each bathing routine will be utilized on all admitted patients to the unit for a six month study period for a total study duration of 12 months. The two bathing routines will include either the use of the Comfort® Bath Washcloth System (control) or the use of 2% Chlorhexidine Gluconate Cloth. Randomized units will either start with 2% Chlorhexidine Gluconate Cloth for six months and then switch to Comfort™ Bath Washcloth for the remaining six month period or the reverse order. Data collection will include all surveillance and clinical cultures for MRSA and or VRE and all bloodstream infections.

Eligibility Criteria:
Inclusion Criteria:

* All patients admitted to study units during the proposed study interval are eligible for inclusion in the study

Exclusion Criteria:

* Patients with known allergies to chlorhexidine gluconate or any other ingredients in the product
* Patients with burns that include a high percentage of disrupted body surface area
* Use in patients undergoing lumbar punctures or contact with the meninges
* Patients with large open skin wounds; and
* Children less than 18 years old
Interleukin 38 as a Biomarker for Metabolic Syndrome in Psoriatic Patients

case control study to compare level of interleukin 38 in patients with psoriasis and patients with metabolic syndrome with healthy control subjects

this case control study will measure plasma level of interleukin 38 in 4 groups of 24 subject, group one will have psoriatic patients, group 2 will have psoriatic patients with metabolic syndrome, group three will have patients with metabolic syndrome only, and group 4 will have healthy control subjects.

Eligibility Criteria:
Inclusion Criteria:

* specific to each group

Exclusion Criteria:

* Patient refusal. Age \<18 years Pregnancy Lactation smoking Infections. Patients with other inflammatory skin disorders use of antioxidant and anti-inflammatory drugs patients on treatment for psoriasis
Regulation of Postprandial Nitric Oxide Bioavailability and Vascular Function By Dairy Fat

Cardiovascular disease (CVD) is the leading cause of death in the United States. Short-term increases in blood sugar, or postprandial hyperglycemia (PPH), affect blood vessel function and increase the risk of CVD. Greater intakes of dairy foods have been associated with a lower risk of CVD, but whether these effects occur directly or indirectly by displacing foods in the diet that might increase CVD risk is unclear. Further controversial is the extent to which dietary fat derived from dairy foods regulate the risk of CVD. The health benefits of dairy on CVD risk are at least partly attributed to its ability to limit PPH and resulting PPH-mediated responses leading to vascular dysfunction. This provides rationale to investigate full-fat containing dairy as a dietary strategy to reduce PPH and risk for heart disease. The objective of this project is to define the extent to which full-fat dairy milk compared to non-fat dairy milk protects against PPH-induced vascular dysfunction by reducing oxidative stress responses that limit nitric oxide bioavailability to the vascular endothelium in adults with prediabetes.

This study consists of three, 3-hour postprandial trials in response to consuming the following dietary treatments: 1. oral glucose challenge, 2. oral glucose challenge in combination with non-fat milk, and 3. oral glucose challenge in combination with whole milk. For three days preceding each trial, participants will be provided all meals to standardize physiologic responses to test meals. On each trial day, vascular function will be assessed and blood samples collected prior to and at 30 minute intervals for 3 hours following test meal ingestion.

Eligibility Criteria:
Inclusion Criteria:

1. hemoglobin A1c 5.7-6.4%
2. non-dietary supplement user
3. no medications affecting vasodilation, inflammation, or energy metabolism
4. no CVD
5. nonsmokers
6. individuals having blood pressure \<140/90 mmHg and total cholesterol \<240 mg/dL

Exclusion Criteria:

1. unstable weight (±2 kg)
2. vegetarian or dairy allergy
3. alcohol intake \>3 drinks/day or \>10 drinks/week
4. ≥ 7 hours/week of aerobic activity