cyrilzakka/clinical-trials huggingface dataset:
18791 - Sun Protection Factor Assay

To evaluate the Sun Protection Factor (SPF) efficacy on human skin.


Eligibility Criteria:
Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF
* Signed and dated Informed Consent Form
* Signed and dated HIPAA Form
* An unbmbiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose)

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been dianoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma. diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.
Feasibility of Mindfulness Meditation Training and Home Practice in Persons With Spinal Cord Injury

The purpose of this study is to evaluate the feasibility and acceptability of a 6-week app-guided Mindfulness meditation training (MM) intervention and health education (active control) condition in people with spinal cord injury (SCI) who have chronic pain and to examine the feasibility of data collection procedures

Our multidisciplinary, interinstitutional team of investigators proposes to randomize 60 SCI patients experiencing chronic pain to practice audio-guided MM for ≥ 10 minutes daily for 6 weeks using the free app "Mindfulness Coach" developed by the Department of Veteran Affairs, or to listen or view health education presentations (active control) ≥ 10 minutes daily for 6 weeks on the free TED app (active control). Primary outcomes are the feasibility and acceptability of proposed interventions in people with SCI and chronic pain. Secondary outcomes include the feasibility of collecting patient-reported outcomes of pain, anxiety, depression, mindfulness, quality of life, stress, fatigue and sleep disturbance.

Eligibility Criteria:
Inclusion Criteria:

* Traumatic SCI of at least 6 months duration
* Chronic pain \[defined as pain lasting at least 3 months with a pain intensity rating of 4 or higher on a 10-point visual analog scale\]
* Understand spoken and written English sufficiently to provide informed consent
* participate in the intervention and complete study surveys

Exclusion Criteria:

* Lack of daily access to the internet using a smart phone or smart tablet
* Cognitive impairment (determined by their inability to demonstrate comprehension of informed consent by correctly answering 4 out of 5 questions pertaining to the study)
* Significant visual/hearing impairment that does not allow use of the MM app's audiovisual presentations or health education presentations on Ted-talk
* Use of any kind of meditation more than once a week in the last 3 months
* Inability to provide or obtain an email address for communication with study staff
* Inability to operate the app download or study related survey using a smartphone.
Comparison of Psyllium and Microcrystalline Cellulose on Glycemic Measures in Subjects With Impaired Fasting Glucose

The Purpose of this study is to compare the effects of 2 types of dietary fiber, psyllium and microcrystalline cellulose (MCC), on glycemic measures in subjects with impaired fasting glucose.

This study will be conducted at a single study center. Approximately 40 subjects with pre-type 2 diabetes will be enrolled and randomized in this study.

This 22-week study consists of 3 periods: an 8-week treatment period (Visits 2-4), a 6-week washout period, and an 8-week treatment period (Visits 5-7).

Eligibility Criteria:
Inclusion Criteria:

* be male or female,
* at least 18 years of age
* in generally good health for the pre-type 2 diabetes population;
* if female, be postmenopausal or if of child-bearing capacity agree to use an adequate form of contraception
* have not used any psyllium containing products within the past 3 months;
* be willing to refrain from taking any psyllium containing products during the study;
* be willing to maintain a lifestyle habits for the duration of the study;
* have a fasting serum glucose of 110 - 125 mg/dL

Exclusion Criteria:

* if female, are pregnant or nursing (lactating);
* have a history of diabetes (diagnosis) or is currently taking medications for diabetes
* participated in a clinical drug study or used investigational drug during the previous 30 days;
* have symptoms and signs suggestive of significant underlying disease, or acute onset of new symptoms and signs of major organ disease, that could become unstable during the trial requiring urgent medical intervention
* have evidence of or treatment history of malignancy within the previous 5 years;
* currently alcohol dependent;
* used anti-psychotics in the previous 3 months;
* used systemic steroidal agents within the last 30 days;
* had used oral or systemic antibiotics or any over-the-counter (OTC) bactericidal medication (eg, bismuth salts) within the last 30 days;
* has been taking any medication that may affect blood glucose or GI motility (eg, calcium channel blockers, beta blockers, antimuscarinics, salicylates etc.) for less than 30 days or 5 times the half life of the drug (need to be stable on the medication);
* have evidence of immunodeficiency including subjects currently taking systemic corticosteroids or immunosuppressive drugs
* have a major psychiatric disorder, including major depression, psychoses, alcohol or substance abuse within the past 2 years;
* has a known sensitivity or allergy to any components of study products, including psyllium and aspartame (see Section 3.5.3);
* were previously screened (ie, Visit 1 procedures) for participation in this study and failed to meet entry criteria;
* have difficulty swallowing
Cervical Cancer Screening Study in Brazil

Objectives:

Primary Objective: To perform a pilot clinical study to test multi-modal optical imaging for detection of cervical neoplasia in Brazil.

Secondary Objective: Analyze clinical data to establish the imaging modes which demonstrate the highest degree of correlation with disease state.

Wide-field and high-resolution images of precancerous cervical lesions and normal uterine cervix will be obtained by imaging 357 patients, recruited from women presenting for colposcopic evaluation from the Prevention Department at Barretos Cancer Hospital, a MDACC Sister Institution, in Barretos, Brazil. Barretos Cancer Hospital will serve as the lead site for the study

Initial wide-field white light images will be acquired in unpolarized and cross-polarized modes before application of 3-6% acetic acid. Routine colposcopy involves visual inspection of the cervix for aceto-whitening and will be followed by a second pair of white-light images in each polarization mode. The clinician will identify all sites required for biopsy according to clinical impression, marking each location on the recorded unpolarized white light image. Topical application of 0.01% proflavine solution will then be applied for 1 minute, after which wide-field imaging in fluorescence mode will be performed. The clinician will then select up to 2 additional sites for biopsy based on the appearance of this wide-field fluorescence image, recording the location of each. The high-resolution microendoscope will then be used to acquire images at all sites selected for biopsy, followed by collection of biopsy specimens.

The entire imaging procedure should add less than 10 minutes to the standard colposcopy procedure.

Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing colposcopy
2. 18 years of age or older
3. Negative pregnancy test
4. Subjects must be willing and able to provide informed consent

Exclusion Criteria:

1. Patients under 18 years of age
2. Positive pregnancy test
3. Subjects unwilling and unable to provide informed consent
Validation of Ventriject Determined Maximal Oxygen Uptake

This study aims to validate the use of the Ventriject product to estimate VO2 max, through a non-physically active test using ECG, echoseismography and echosonography.

this study will be composed of the following tests:

* blood sample for measurement of blood values
* blood pressure measurement to rule out risks affiliated with maximal effort testing
* DXA body composition scanning
* Measurement on ECG, echosonography and echoseismography with accelerometer, microphone and ECG wires
* Measurements with phone (iPhone)
* VO2 max assessment by maximal oxygen uptake testing on a training bike, using online oxygenmeasurement equipment
* Hand-grip strength assessment

Eligibility Criteria:
Inclusion Criteria:

- healthy adults between 18 and 45 years of age

Exclusion Criteria:

* current or previous cardiovascular disease
* chronic use of medicine
* pregnancy
* illnesses which prohibits the testing of maximal oxygen uptake
Evaluation of Helmet Technology and Head Impact Exposure

The purpose of the study is to monitor longitudinal changes in brain structure and function between the preseason and postseason, in a population of football playing athletes grouped by helmet make and model. Secondly, the purpose is to determine the protection of the helmet make and model relative to amount and magnitude of sustained head impacts.

Sports-related traumatic brain injury (sTBI) is common in competitive sports and recreational activities, with 1.6 to 3.8 million reported annually in the U.S. Children, adolescents and young adults are at the highest risk for sustaining mild TBI. There is scarce high-level prospective, objective evidence indicating that any recent helmet design can prevent sTBI. While helmets were developed for, and are effective in, preventing skull fractures and intracranial hematomas, it is unclear if they afford protection against forces inside the cranium.

This study will investigate the relationship between potential changes in brain structure and function pre and post season compared to helmet make and model and head impact exposure in high school and college athletes playing a collision sport such as football. The use of helmets/headgear during such a high-risk sport will allow for collision measurement devices to be affixed to the athlete under the helmet and will not affect play or fit of equipment. By the nature of the sport selected, it is likely this study will primarily include males, however if any female meets inclusion criteria on the team selected, the participant will be included in this investigation. All participants will be outfitted with an accelerometer which will measure the magnitude of every impact to the head sustained by the athlete. Effectiveness of the helmet model will be determined via differences in longitudinal brain imaging and functional testing following competitive football participation. A subset of athletes who report a diagnosed concussion will also receive additional brain neuroanatomical and neurophysiological testing within a week following the diagnosed concussive event. The investigators will also enroll a group of athletes involved in a non-contact sport (such as cross country) to act as controls.

Eligibility Criteria:
Inclusion Criteria:

* Normal healthy volunteer
* Able to provide written consent
* Must be 13 years or older and a participant on a high school or collegiate team

Exclusion Criteria:

* Unable to provide written consent
* Not medically cleared to participate on a high school or collegiate team
MRI QSM Imaging for Iron Overload

The overall goal of this project is to develop and validate a novel technique for Magnetic Resonance Imaging (MRI)-based Quantitative Susceptibility Mapping (QSM) of the abdomen, for non-invasive assessment of liver iron deposition. In this work, study team will develop and optimize advanced data acquisition and image reconstruction methods to enable QSM of the abdomen. Further, investigators will determine the accuracy, repeatability, and reproducibility of abdominal QSM for iron quantification in patients with liver iron overload.

Excessive accumulation of iron in various organs, including the liver, which affects both adult and pediatric populations, is toxic and requires treatment aimed at reducing body iron stores. Accurate assessment of liver iron concentration is critical for the detection and staging of iron overload as well as for longitudinal monitoring during treatment.

In summary, this project will develop a novel MRI-based QSM technique designed for the abdomen and will validate it in pediatric and adult patients with liver iron overload. Upon successful validation, QSM will provide accurate, repeatable, and reproducible quantification of LIC based on a fundamental property of tissue.


Eligibility Criteria:
Inclusion Criteria:

* Ages 10 years or older at University of Wisconsin - Madison
* Age 5 years or older at Stanford
* Known or suspected iron overload

Exclusion Criteria:

* Patients with contraindication to MRI (e.g. pacemaker, contraindicated metallic implants, etc)
* Pregnant or trying to become pregnant (as determined by self-report during MRI safety screening)
* Patients requiring intravenous (IV) conscious sedation for imaging are not eligible; patients requiring mild, oral anxiolytics for the MRI will be allowed to participate as long as the following criteria are met:

  * The subject has their own prescription for the medication.
  * The informed consent process is conducted prior to the self-administration of this medication
  * They come to the research visit with a driver
Effect of Adding Dexmedetomidine As Adjuvant to Bupivacaine in US Guided ESPB for Post MRM Pain Management

The aim of the study is to assess the effect of adding dexmedetomidine to bupivacaine in US guided erector spinae plane block in modified radical mastectomy surgeries , Using visual analogue score and post-operative narcotics consumption.

Peripheral nerve blocks are effective adjuvant options for pain management in breast surgeries. The use of Erector spinae plane block (ESPB) has been proven to be very effective in controlling pain and minimizing narcotic consumption after modified radical mastectomy surgeries.

Many adjuvants to local anaesthetics were used to improve the duration and intensity of the peripheral nerve block.

Breast cancer is one of the most important medical problems in the female gender, since among every eight women, one will suffer from breast cancer during her lifetime.

Acute post-operative pain is very common after breast surgeries which requires adequate pain management. Different peripheral nerve blocks such as paravertebral block had been used as an analgesic option for breast surgeries.

Erector spinae plane block is a newer interfascial plane block first described in 2016 who used it for treating thoracic neuropathic pain by injecting a local anesthetic deep into the erector spinae muscle at the level of T5. Moreover, ESPB is a reasonable option, with clearly identifiable sonographic landmarks and LA needle insertion and injection locations.

Later studies have shown that ESPB can provide effective analgesia in breast surgeries.

ESPB is achieved by injecting the local anesthetics locally deep to erector spinae muscle surface, as a part of multimodal analgesia. Given that erector spinae muscles anatomically situate along the thoracolumbar spine, ESPB promotes an extensive craniocaudal spread.

Ultrasound is a non-invasive visualization technology that helps in capturing the anatomical structure of target tissues, it can help to guide the direction and depth of anesthesia puncture needles, thus reducing the risk of complications .

Adjuvants to local anesthetics, such as opioids, alpha 2 agonists, magnesium and dexamethasone may improve the duration and intensity of peripheral nerve blocks effect.

Eligibility Criteria:
Inclusion Criteria:

* Age:30-65years.
* Physical status: ASA I,II.
* BMI\<35.
* Localized breast cancer

Exclusion Criteria:

* Age:\<30 and \>65 years.
* Refusal of procedure or participation in the study by the patient.
* Physical status: ASA III or above.
* History of allergy to the study drug.
* BMI\>35.
* Bleeding disorders and coagulopathy.
* Psychiatric illness that may interfere with the study.
* Metastatic breast cancer.
Effect of a Dietary Fatty Acid Supplementation on Symptoms and Bronchial Inflammation in Patients With Asthma

The proposed study will investigate the effect of a polyunsaturated fatty acid / lipid mixture (LCPUFAs) on the clinical symptoms, bronchial inflammation and lung function in allergic asthma in a bronchial allergen provocation (BAP) model. For this purpose, patients with stable episodic asthma and dust mite allergy will underwent BAP before and after supplementation with LCPUFAs. The clinical symptoms, bronchial inflammation, exhaled NO increase and lung function decline (FEV1) will be analyzed.

Asthma is a chronic lung disease, which is characterized by recurrent obstruction, a hypersensitivity and a chronic inflammation of the airway. It is known that LCPUVAs could reduce the production of inflammatory mediators. In addition, LCPUVAs can improve pulmonary function, with a concurrent reduction in bronchodilator use in patients with asthma. Subjects suffering from episodic asthma and house dust mite (HDM) allergy usually have a normal lung function testing at rest and show a decrease in lung function when they are exposed to HDM. Bronchial allergen provocation models are well established in asthma research and allow the evaluation of anti-allergic and anti-asthmatic agents in relatively small sample sizes. In a previous study the investigators could show, that LCPUVAs could reduce exhaled NO after repeated BAP with HDM.

In this study the investigators will investigate the protective effect of LCPUVAs in a repeated BAP model. Clinical symptoms (nasal and bronchial), exhaled NO, decrease in lung function the early asthmatic reaction (EAR), the late asthmatic reaction (LAR) and blood parameters (Triglyceride and Cholesterin and mircro RNAs) will be measured before and after LCPUVA supplementation.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent

  * Patients: aged ≥18 and 45 years
  * known allergen induced asthma and HDM-Allergy
  * basic lung function FVC ≥ 80%, FEV1 ≥ 75%
  * decrease in FEV1 after BAP ≥ 20%
  * 30% increase of NO after BAP

Exclusion Criteria:

* lung function Forced vital capacity (FVC) \<80% and Forced expiratory volume in 1 second (FEV1) \<75%
* chronic diseases or infections (e.g. HIV, Tbc)
* pregnancy
* systemic corticosteroid-treatment
* inhalative corticosteroid therapy or leukotriene antagonists
* alcohol, substance or drug abuse
* current smokers
* inability to capture extend and consequences of the study
Requirements of Propofol With Target Controlled Infusions for Supraglottic Airway Devices

to evaluate and compare the effect-site concentration of propofol with the TCI system for second-generation SGA device insertion between the I-gel™, Supreme™, ProSeal™ and Laryngeal Tube Suction II™.

to determine the hemodynamic changes during insertion of supraglottic devices in patients undergoing elective surgery and any complications after device insertion.

The investigators enrolled ASA physical status I-III patients who were 18-70 years old and scheduled for general anesthesia for elective non-cardiac surgery with SGA devices.Adults with a potentially difficult airway (cervical spine disease, Mallampati classification IV, or a mouth opening less than 2.5 cm.), reactive airway disease, signs of respiratory infection or a plan to remain intubated were excluded from the study. The investigators also excluded patients who had a risk of gastric aspiration or morbid obesity (body mass index \> 35 kg/m2).

Patients were randomized into 4 groups (I-gel™, Supreme™, ProSeal™ and Laryngeal Tube Suction II™ SGAs) according to a computer generated randomization list and patients were allocated consecutively. The sample size of each group required 10 patients.

All patients were pre-oxygenated with 100% oxygen. After the administration of 2 µg/ml intravenous fentanyl for 5 minutes, anesthesia was induced with the Schnider pharmacokinetic TCI system. After equilibration of the plasma-site and effect-site concentrations in propofol TCI, 1 of the 4 types of SGA was randomly inserted by two anesthesiologists (resident trainee and staff doctor) who were unaware of the actual plasma concentration of propofol without the use of a muscle relaxant.

The response of each patient determined the effect-site concentration of propofol of the next patient. "No Response" was defined as Laryngeal Mask Airway Insertion Score = 0 and "Response" was defined as Laryngeal Mask Airway Insertion Score ≥ 1. If the insertion of the supraglottic airway device was successful ("No Response"), then the target effect-site concentration was decreased by a step of 0.4 µg/ml. If the insertion failed ("Response"), the target effect-site concentration was increased by the same dose. The patients' responses to LMA insertion was classified by blinded investigators.

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I-III patients.
* Patients 18-70 years old .
* Patients scheduled for general anesthesia for elective non-cardiac surgery with SGA devices.

Exclusion Criteria:

* Adults with a potentially difficult airway (cervical spine disease, Mallampati classification IV, or a mouth opening less than 2.5 cm.).
* Adults with reactive airway disease.
* Adults with signs of respiratory infection or a plan to remain intubated were excluded from the study.
* Excluded patients who had a risk of gastric aspiration or morbid obesity (body mass index \> 35 kg/m2).
Pexelizumab in Patients Undergoing Coronary Artery Bypass Grafting With Cardiopulmonary Bypass (PRIMO-CABG II)

During a heart bypass procedure, a substance called "complement" is activated by the body. This "complement activation" causes an inflammatory response that can lead to side affects such as chest pain, heart attacks, stroke, heart failure, or death. The purpose of this study is to find out if the study drug (pexelizumab), that blocks "complement activation," can reduce such side effects and be given safely to patients requiring the bypass procedure with the use of the heart-lung machine.


Eligibility Criteria:
Inclusion Criteria:

* be at least 18 years of age;
* have 2 or more of the following risk factors:

  • diabetes mellitus; • repeat CABG; • the need for urgent intervention, defined according to the ACC/AHA guidelines as being patients who are required to stay in the hospital due to medical factors, but may be scheduled and operated on within a normal scheduling routine, excluding patients who have had an MI within 48 hours of CABG; • female; • history of a neurologic event (cerebrovascular accident, transient ischemic attack or carotid endarterectomy); • history of congestive heart failure (NYHA CHF Class III or IV); • history of 2 MIs, or an MI that occurred greater than 48 hours but less than 4 weeks prior to CABG;
* provide Informed Consent.

Exclusion Criteria:

* requires salvage intervention as defined by the ACC/AHA guidelines 10 as being ongoing cardiopulmonary resuscitation on the way to the operating room;
* has current cardiogenic shock, acute left ventricular rupture, acute septal rupture or acute papillary muscle rupture;
* has any active bacterial or other infection which is clinically significant, in the opinion of the Investigator (e.g. evaluate the evidence based on WBC, temperature, cultures etc. as appropriate for the patient);
* has a known or suspected hereditary complement deficiency;
* has participated in any other investigational drug study or was exposed to an investigational agent or device within 30 days of randomization;
* is receiving, or is planning to receive, any other investigational drug or device, or will participate in any other research study within 30 days of randomization;
* is pregnant or breast-feeding.