cyrilzakka/clinical-trials huggingface dataset:
Validation Of TBI Detection System For Head Injured Patients

A prospective, non-randomized trial to validate the database of brain electrical activity recordings and clinical information collected from patients who present to the ED following closed head injury.

The objective of this study is to validate the clinical utility of the BrainScope technology for the acute identification of structural brain injuries in a TBI population presenting to the ED with mild symptoms, following closed head injury.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who are admitted to the ED and are suspected of a traumatic, closed head injury within 72 hours. The patient will have a GCS 12-15 upon arrival to the ED even if GCS was lower prior to arrival to the ED (e.g., at the time of injury).

Exclusion Criteria:

* Subjects will be excluded who have forehead, scalp, or skull abnormalities or other conditions that would prevent correct application of the electrode headset on the skin.
* In addition,

  * subjects with dementia,
  * Parkinson's Disease,
  * multiple sclerosis,
  * seizure disorder,
  * brain tumors,
  * history of brain surgery,
  * evidence of acute psychosis,
  * substance dependence,
  * history of TIA or stroke within the last year,
  * currently receiving dialysis or in end-stage renal disease,
  * active fever defined as greater than 100 degrees F or 37.7 degrees C,
  * current condition is "critical" in the opinion of the investigator,
  * subject is suffering from an open head injury,
  * subject requires advanced airway management (i.e. mechanical ventilation),
  * currently receiving procedural sedation medications.
* Subjects below the age of 18 years, and prisoners will not be eligible for study.
Comparison of Two Protocols to Prevent the Acquisition of Methicillin-Resistant Staphylococcus Aureus.

Nosocomial infections is a major problem in intensive care units due to both growing incidence and pathogens implicated which become increasingly resistant to antibiotics. According to the Center for Disease Control (USA), Staphylococcus aureus is responsible for approximately 10% of cases. In Europe, 79% of the S.aureus strains are resistant to methicillin, a routinely used antibiotic. Recommendations for the prevention of transmission of these resistant bacteria are rarely based on controlled trials. Therefore the aim of our study is to evaluate two protocols to prevent the acquisition of methicillin-resistant S. Aureus in intensive care units: either a reinforced isolation precautions protocol or a standard precautions protocol.

Recommendations for the prevention of transmission of resistant bacteria in intensive care units (ICU) are rarely based on controlled trials. For this reason, we compared a reinforced isolation precautions protocol (RIPP) with a standard precautions protocol (SPP) for the acquisition of methicillin-resistant Staphylococcus aureus (MRSA) in 2 intensive care units.

Evaluation: the risk for MRSA carriage was defined on admission if 1 of 3 criteria were met: hospitalization in the past year, transfer with prior length of stay ≥2 days, prior history of MRSA in the 5 past years.

Intervention: Randomization 1/1 of a total of 500 patients to either protocol; MRSA screening was performed at the sites of carriage and colonization at inclusion, every week and at ICU discharge in all patients; the results were given to the clinicians only for the patients of the RIPP group.

Protocols: the SPP was consistent with the CDC recommendations and included transmission-based isolation precautions to patients with clinical samples involving resistant bacteria (including MRSA) or highly transmissible organisms. The RIPP included the extension of isolation precautions (1) to patients at risk for MRSA on admission until screening results proved negative and (2) to MRSA-positive patients on screening or clinical samples until further negative samples, in whom nasal mupirocin decontamination was added. Compliance with the recommendations of each protocol was controlled by an audit.

The efficacy is assessed on the proportion of patients who acquired MRSA at any site.

Eligibility Criteria:
Inclusion Criteria:

* Adults over 18 years
* Expected length of stay \> 48h in intensive care unit
* Informed written consent

Exclusion Criteria:

* Cerebral death
* Care limitation
* Neutropenia
* Documented MRSA on admission
* Patients receiving antistaphylococcal topical antibiotics on admission
Evaluation of MyoStrain™ in Clinical Practice

Evaluate MyoStrain cardiac MRI pulse sequence in Clinical practice

Evaluate MyoStrain cardiac MRI pulse sequence in Clinical practice to determine how the use may alter treatment decisions and clinical outcomes in patients who are undergoing cardiac MRI.

Eligibility Criteria:
Inclusion Criteria:

* Patients already scheduled for diagnostic testing with commercially available imaging modality (cardiac MRI)
* The patient population will include (but not limited to), those being evaluated for heart disease and heart failure that may be related to vascular disease (coronary artery disease), drug related heart failure (chemotherapy, alcohol), inflammatory systemic conditions (sarcoidosis, amyloidosis, lupus), myocarditis, and/or infectious etiologies
* Provided written informed consent

Exclusion Criteria:

* Contraindication to Magnetic Resonance Imaging
Topical-RAPA Use in Inflammation Reversal and Re-setting the Epigenetic Clock

Topical Rapamycin ointment will be applied to participant forearms to test whether epigenetic changes in the skin are elicited.

Rapamycin 8% ointment will be applied topically to one of the participant's forearms and matching placebo to the opposite forearm daily for a total of 6 months. After consenting, screening and randomization of arms, the participants will be monitored at monthly visits until study completion.

Eligibility Criteria:
Inclusion Criteria:

* 65-95 years of age.
* Good health with all chronic diseases (hypertension, coronary artery disease, etc.) clinically stable.
* Selected subjects will be in good health (Per the World Health Organization, good health will be defined as complete physical, mental, and social well-being and not merely the absence of disease or infirmity).
* All diseases or infirmities will be clinically stable whether managed by medications or not.
* CLOX score of 10 or greater
* Women will be postmenopausal
* Postmenopausal women taking hormone replacement will be included if they have been on a stable dose for ≥6 months
* Live within a 20 mile drive of the UTHSA campus (7703 Floyd Curl Drive, San Antonio, TX)

Exclusion Criteria:

* Diabetes.
* History of skin ulcers or poor wound healing, or keloid formers.
* Smoking.
* Liver disease.
* Coumadin anti-coagulation.
* Treatment with drugs known to affect cytochrome P450 3A (diltiazem, erythromycin, etc. - due to role in rapamycin metabolism).
* Treatment with an immunosuppressant (prednisone, etc.) within 6 months.
* History of recent (within 6 months) Myocardial Infarction or active Coronary Disease.
* Hypersensitivity to rapamycin or petrolatum (ointment vehicle)
* Arm tattoos or scars in application area
Internet-Based and Established Dyspnea Self-Management Programs in Chronic Obstructive Pulmonary Disease (COPD) Patients

The overall goal of this study is to compare the impact of a new Internet Dyspnea Self-Management Program (eDSMP) with an established face-to-face Dyspnea Self-Management Program (DSMP) in patients with COPD. The primary aim of the study is to test the following two hypotheses: 1. The eDSMP and the DSMP will have comparable improvements in the primary outcomes of shortness of breath (dyspnea) with activities of daily living (ADL), exercise adherence and performance, and pulmonary exacerbations (frequency and duration) at 3 and 6 months. 2. The eDSMP and the DSMP will have comparable improvements in the secondary outcomes of perception of support, self-efficacy for exercise and managing dyspnea, and health resource utilization at 3 and 6 months. This study is a randomized, longitudinal, repeated measures design with measurement times at 0, 3, and 6 months.

Despite optimal medical treatment, people with chronic obstructive pulmonary disease (COPD) continue to experience dyspnea or shortness of breath. This study will evaluate two different ways to provide education and support to help patients manage their shortness of breath. One program will be conducted in a face-to-face setting and a second through the Internet. The main difference between the two programs is the way they are administered. The education, exercise, and monitoring components are the same. The overall goal of this study is to find out whether the two programs are comparable in their effect on shortness of breath (dyspnea) with activities of daily living, exercise adherence and performance, and pulmonary exacerbations (frequency and duration) at 3 and 6 months. Perception of support, self-efficacy for exercise and managing dyspnea, and health resource utilization will also be measured at 3 and 6 months. This study is a randomized, longitudinal, repeated measures design with measurement times at 0, 3, and 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of COPD, clinically stable for 1 month;
* Spirometry results showing at least mild disease (FEV1/FVC \< 70% and FEV1 \< 80% predicted after bronchodilator);
* ADL limited by dyspnea;
* Ability to speak English and sign consent form;
* Actively use computer and the Internet;
* Maintain O2 saturation \> 85% on \< 6 L/min of nasal oxygen during the six minute walk;
* Understands and is able to rate shortness of breath during exercise

Exclusion Criteria:

* Active symptomatic illness other than COPD;
* Formal pulmonary rehabilitation training in the past 6 months
Training in the 21st Century: Using Virtual Role-Plays to Improve Nurse Communication for Medication Adherence

This study will utilize a three-phase approach that is informed by a theory-driven implementation framework to: 1) conduct a needs analysis in order to identify individual-, health care team-, and practice-level barriers and facilitators to conducting adherence counseling in safety-net primary care practices; 2) develop a virtual communication simulation designed to improve the quality of adherence counseling by allowing nurses repeated opportunities to practice discussing medication adherence with virtual patients; and 3) conduct a pilot study to evaluate the feasibility, acceptability and preliminary efficacy of the simulation on changes in: a) nurses' collaborative communication skills, b) medication adherence, and c) reduction in BP in a sample of 20 patients with uncontrolled hypertension (HTN) who are non-adherent to their medications.


Eligibility Criteria:
Inclusion Criteria:

* PCPs and nurses will be enrolled if they fulfill the following criteria:

  1. male or female healthcare provider (MD/DO, NP, and Registered Nurse) practicing at the clinic
  2. age 18 years or older.

No exclusions will be made based on provider race/ethnic origin. We will oversample males to examine differential communication skills based on gender.

* Patient eligibility criteria include:

  1. receiving care at the participating clinic
  2. having uncontrolled HTN (BP\>140/90 mmHg) at two visits in the past year
  3. being prescribed at least one antihypertensive medication and are non-adherent
  4. are ≥age 18 years
  5. fluent in English

Exclusion Criteria:

* Unable to give consent
* Have a diagnosis of cognitive dysfunction or significant psychiatric comorbidity,
* Participating in another HTN-related study.
Effectiveness of Hortitherapy on the Immediate Well-being of Elderly People With Alzheimer's Disease or Related in Day Care

Currently, there are an estimated 47 million people with dementia worldwide, with approximately 10 million new cases diagnosed each year. This figure is expected to triple to 130 million in 2050.

In France, the number of dementia cases is estimated at 754,000 and could reach 1,813,000 in 2050.

In a recent literature review, researchers highlighted the many benefits of horticultural therapy and garden environments for people with Alzheimer's or cognitive disorders. They include: alleviating pain, improving attention, decreasing stress, relieving agitation, decreasing the use of medications, such as antipsychotics, as well as reducing falls.

Gardening offers a non-pharmacological approach to achieving these goals and could improve the quality of life for people with Alzheimer's disease or another dementia. As part of a care solution, support services that include social activities, such as gardening, reduce the need for more intrusive and expensive care solutions.

The objective of this research is to evaluate the impact of horticultural

This research is an interventional study involving the human person of category 2 involving only minimal risks and constraints, it is prospective, multicenter and non-randomized.

The study will take place with users of the Lépine Versailles day care centre, the La Porte Verte hospital and the Les Magnolias Geriatric Center, living with cognitive disorders. For the purposes of this study, understanding the instructions is required.

The people welcomed will participate in their usual day supervised by the day reception team.

Part of the group having agreed to participate in the study will carry out the horticultural workshop while the other group will benefit from the workshop usually offered. The study will be done with 52 users with the participation of a supervisor to animate the workshops of the different groups.

Each site will have a workshop that will take place in the morning from 11 a.m. to 12 p.m. and one in the afternoon from 2:30 p.m. to 3:30 p.m. This will make it possible to compare the well-being of users according to the time of the workshop.

Eligibility Criteria:
Inclusion Criteria:

* Patient having signed an informed and written consent,
* Patient aged over 60,
* Patient with Alzheimer's or related disease,
* Patient benefiting from day care,
* Patient under guardianship or curatorship.

Exclusion Criteria:

* Patient in period of adaptation in day care,
* Patient in temporary care at day care,
* Patient having participated in less than 4 horticultural workshops during the cycle,
* Patient with severe asthma and/or an allergy that does not allow workshops to be carried out,
* Patient with major behavioral problems that make it impossible to carry out the workshops.
Study to Evaluate the Use of Direct Oral Anticoagulants in UK Clinical Practice For Patients With a First Stroke Attributable to Nonvalvular Atrial Fibrillation

National Institute of Health and Care Excellence (NICE) guidance recommends anticoagulation for stroke prevention in high risk patients with nonvalvular atrial fibrillation (AF).

Early evidence suggest that patients with atrial fibrillation (AF) who do not receive anticoagulation are more likely to experience a stroke. However, the characteristics of patients experiencing a first AF-related stroke in real-world settings, who have not been receiving anticoagulation, have not been well documented.

It is unclear how the direct anti-FXa oral anticoagulants have been used within real world practice since the introduction of edoxaban in 2015.

This non-interventional study will focus specifically on the patient characteristics, management pathways, and patient reported experiences associated with real world use of three direct anti-FXa oral anticoagulants (DOAC) commonly used within United Kingdom clinical practice; apixaban, rivaroxaban and edoxaban.

The primary objective will describe the demographics, clinical characteristics and medical history of patients presenting with a first ischaemic stroke with AF who have not received anticoagulation (for any reason) in the 12 months prior to stroke, by type of anticoagulant treatment subsequently prescribed for secondary prophylaxis of stroke.

Secondary objectives of the study will describe management pathways of patients initiated on DOACs (apixaban, edoxaban or rivaroxaban) for secondary prophylaxis of stroke, including timing and reasons for any dose changes or treatment switches to alternative anticoagulants; describe hospital resource use and clinical assessments associated with DOAC treatment for secondary prophylaxis of stroke; describe real world patient-reported adherence to DOACs for secondary prophylaxis of stroke; and describe patient experience and treatment satisfaction for patients receiving DOAC therapy for secondary prophylaxis of stroke.

Eligibility Criteria:
Inclusion Criteria:

- For all patients:

* Participants presenting to the study centre with a first ischaemic stroke which is, in the clinician's opinion, attributable to nonvalvular AF
* Participants aged 18 years or over at time of first stroke

For group 2 patients:

\* Participants initiated on apixaban, edoxaban or rivaroxaban after their first stroke

Exclusion Criteria:

* For all patients:

  * Participants prescribed any anticoagulant for any purpose in the 12 months prior to stroke diagnosis
  * Participants with haemorrhagic stroke
  * Participants with diagnosis of transient ischemic attack
  * Participants with severe cognitive or emotive deficit
  * Participants whose medical records are not available for review
  * Participant unwilling or unable to give written informed consent
* For group 2 patients:

  * Participant unwilling or unable to complete the patient-reported questionnaires
Study on Dietary Intake Levels of Iodine for 3-6 Years Old Pre-school Children

Iodine as an essential trace element for human, both excessive and insufficient intake would be harmful for human health. As susceptible population, children will be more sensitive to adverse effects caused by inadequate intake of iodine since they are at the peak of growth and development. Meanwhile, there are few direct evidence to establish dietary intakes levels of iodine for 3-6 years old pre-school children.

This study plan to conduct iodine balance experiment by providing devised diet consist of different iodine contents, in order to simulate iodine equilibrium of iodine deficiency to iodine excess in children and find the lowest iodine requirement of iodine for pre-school children, then aim to provide data to establish recommend nutrient intake of iodine for 3-6-year-old pre-school children. On the other hand, this study will make use of natural geographic environment with high water iodine in China. The investigators will conduct big-scale epidemiologic study in areas with high water iodine levels in Shandong and areas with adequate iodine in Tianjin, to enroll pre-school children with various iodine intake levels. The investigators will collect 24-hour urine samples as well as dietary records to evaluate iodine intake levels, and detect thyroid volume and thyroglobulin to evaluate the effects of various iodine intake on pre-school children, aiming to find the lowest safe intake level of iodine and then establish the tolerable upper intake level (UL) of iodine for 3-6-year-old pre-school children. This study aims to define the RNI and UL of iodine for 3-6-year-old pre-school children, to provide data for revision of Chinese dietary intake levels of iodine, and to guide children safe and scientifical iodine fortification.

Eligibility Criteria:
Inclusion Criteria:

* for children with mild malnutrition: hemoglobin \<110g / L, or weight for age \<P50 according to the Chinese 2009 child growth and development reference standard, or BMI z score \<-1 according to the WHO Child Growth Assessment Software (version 3.2.2 ) ; have not been treated for thyroid disease; have not used amiodarone and other drugs (including iodine supplements) during the investigation; have no major diseases ,chronic diseases and family history.
* for children with good nutritional status: healthy,-1 \<BMI z score \<1; have not been treated for thyroid disease; have not used amiodarone and other drugs (including iodine supplements) during the investigation; have no major diseases ,chronic diseases and family history;

Exclusion Criteria:

long-term low-protein; long-term low-heat energy malnutrition
Calculating of Correlations Between ADR, PDR, MAP

The aim of our study is to compare MAP (mean adenoma per colonoscopy) with ADR (adenoma detection rate) and PDR (polyp detection rate) of all colonoscopists in our department

ADR (adenoma detection rate) is generally accepted quality indicator. For possible gaming with ADR other indicators are needed. MAP (mean adenoma per colonoscopy) reflects the quality of examination of entire colon and is considered to be the most objective quality indicator. The aim of our study is to compare MAP with ADR and PDR (polyp detection rate) of all colonoscopists in our department.

We want to retrospectively assess the quality indicators of all colonoscopies from January 2013 to December 2017. We want to calculate ADR, PDR and MAP of all our endoscopists for all colonoscopies in patients over 50 years of age excluding therapeutic, IBD, management of complications and sigmoidoscopies (screening, surveillance, diagnostic) and separately only for screening colonoscopies. Correlations between MAP/ADR and MAP/PDR will be performed using Pearson´s correlation coefficient.

Eligibility Criteria:
Inclusion Criteria:

* people over 50 years of age coming for colonoscopic examination (screening, surveillance, diagnostic)

Exclusion Criteria:

* age under 50 years
* indication for colonoscopy: therapeutic, IBD, management of complications and sigmoidoscopies
Comparison of EMR-P With Conventional EMR

Colorectal cancer is the third most common cancer in men and the second most common cancer in women.There are about 14 million cases of colonoscopy in the United States every year. In recent years, the incidence of colorectal cancer in China has risen sharply, becoming a serious threat to people's health.For small(≤ 9mm) lesions, endoscopic biopsy forceps and cold snare polypectomy can be used to remove.For larger lesions, especially laterally spreading tumor,endoscopic mucosal resection is a classic method of treatment.With the increasing diameter of the lesion size(\> 20mm),we also need to adopt endoscopic piecemeal mucosal resection or endoscopic submucosal dissection.

As IT, Hook knife, BB, and other devices appear constantly, foreign researchers recently adopted a variation of conventional EMR（CEMR）, namely endoscopic mucosal resection with circumferential precutting(EMR - P).The technology is superior to conventional EMR for 10 to 20 mm polyps.Moreover, preliminary studies suggest that it has good safety and efficacy, and may be a better method for treatment of 10-20mm polyps under colonoscopy.

This clinical trial is being conducted to compare the efficacy and safety of two methods of polypectomy, CEMR and EMR-P, for 10-20mm colorectal polyps.


Eligibility Criteria:
Inclusion Criteria:

* One polyp or lesion of 10-20mm at the most proximal of colorectal
* Adult patients (≥18 years old)
* Polyps other than pedicled polyps

Exclusion Criteria:

* There was submucosal infiltration under endoscope
* Residual lesions after endoscopic resection
* Inflammatory bowel disease, familial polyps, electrolyte abnormalities, coagulation disorders, or severe organ failure
* Pregnant or nursing
* No informed consent has been signed
* Patients taking NSAIDs or other anticoagulants
* sedated colonoscopy