cyrilzakka/clinical-trials huggingface dataset:
POCUS Screening for TAA in Hypertensive Patients in the ED

The investigators are going to recruit hypertensive patients in the emergency department of Prince of Wales Hospital. Point-of-care ultrasound of the aorta and measurements of the aortic diameter will be obtained. Other relevant clinical data will also be obtained for analysis. The primary outcome is the number of patients with a maximum aortic diameter of ≥ 4.5 cm and/or ≥ 50% localized enlarged diameter relative to the adjacent normal segment as indicated by POCUS.

Investigators trained with point-of-care ultrasound (POCUS) will recruit hypertensive patients in the emergency department (ED) of Prince of Wales Hospital. POCUS will be performed using a handheld ultrasound device to visualise the aortic root, ascending aorta, aortic arch and descending aorta. Measurements of the diameter will be obtained from different segments of the thoracic aorta for analysis. The definition of aortic aneurysm is a maximum aortic diameter of ≥ 4.5 cm and/or ≥ 50% localized enlarged diameter relative to the adjacent normal segment as indicated by POCUS. The primary outcome is the prevalence of thoracic aortic aneurysm (TAA) in hypertensive patients in the ED. The secondary outcomes include the number of patients with confirmed TAA as verified by CTA, BMI for all participants, the number of CTA scans conducted for TAA confirmation, the number of surgical interventions performed among TAA patients, the ICU admission rate, ICU length of stay, hospital length of stay and mortality, proportion of adequate visualisation of POCUS studies obtained, agreement of aortic diameter measurement between CTA and POCUS, and signs and symptoms of TAA patients presenting to the ED. In addition, the investigators will assess the 28-day all-cause mortality and any advanced imaging done outside the ED.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged ≥ 18 years attending the ED during the study period
* Known history of hypertension or newly diagnosed hypertension in the ED

Exclusion Criteria:

* Known history of aortic aneurysm or dissection
* Previous thoracic aortic interventions or endovascular stenting
* Patients in cardiopulmonary resuscitation
* Traumatic patients
* Patients refuse to participate the study
Latinos CARES (Colorectal Cancer Awareness, Research, Education and Screening)

The purpose of this study is to conduct 4 focus groups and recruit for 12 participants per focus group to explore community members' views about colorectal cancer screening (CRCS) processes and perceived benefits and impediments, what information they believe should be communicated, communication preferences (style, tone) and perceptions of screenings.


Eligibility Criteria:
Inclusion Criteria:

* Men and women, age 50-75 years
* Self-identify as Hispanic/Latino
* Able to understand, read, and speak Spanish
* Prefer to receive health information in Spanish
* Previously screened or not screened
Safety and Efficacy of Workflows of High Volume Single Operators in a LAAO Device Implant Procedural Day

SAFE HV is an observational, prospective, multi-center, non-randomized study evaluating real-world clinical experience of centers where a single procedural physician schedules eight or more left atrial appendage occlusion (LAAO) device implant procedures in a single calendar day.

Since 2009, Watchman FLX™ and its predecessor, Watchman™ have provided a safe and effective alternative to oral anticoagulation for over 200,000 patients in the United States and Europe. Advancements in the design of the Watchman FLX™ have made the device available to a wider range of patients. As more patients qualify for the device, more implant procedures are necessary to provide them with this life-changing treatment option.

Some Watchman FLX™ implanters perform high volumes of implant procedures on certain days. While performing a high-volume of implant procedures is desirable for many reasons, it must be determined that cases performed under such circumstances are comparable in safety and efficacy to implant procedures performed at lower volumes. While there has been no differentiation between high and low volume cases in previous studies, data obtained in this study will be compared to overall safety and efficacy data available from the PINNACLE FLX clinical trial and the SURPASS analysis to ensure that safety and efficacy outcomes are comparable.

Additionally, this study will collect data on the workflows of these high-volume implanters that will help determine which factors contribute to the successful performance of high volumes of Watchman FLX™ implants in a single day. In the future this information may be used to help other implanters optimize workflows to increase their volume of daily implants and hence, provide more opportunities for patients to access this transformative device.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older
2. Able and willing to participate in baseline and follow up evaluations for the full length of the study
3. Clinically qualified, in the opinion of the Investigator, to receive a LAAO device
4. Receiving a Watchman FLX™ or Watchman FLX Pro™ LAAO device as part of their plan of care
5. Having their LAAO device implant procedure scheduled on a qualifying high-volume\* procedure day as assessed within 2 days (≤ 2 calendar days) prior to the planned procedure date

   \*high-volume - a calendar day in which the single implanting physician schedules ≥ 8 LAAO device implant procedures, regardless of the device manufacturer
6. Willing and able to provide informed consent

Exclusion Criteria:

1. Enrolled in an investigational drug or device clinical trial, or any trial that dictates the treatment plan
2. In the opinion of the Investigator, any known contraindication to a LAAO device or implant procedure
3. Having their LAAO device implant procedure scheduled on a day in which the single implanting physician scheduled \< 8 LAAO device implant procedures as assessed within 2 days (≤ 2 calendar days) prior to the planned procedure date
EPIC US Feasibility Study: Use of the FiberNet® Emboli Protection Device in Carotid Artery Stenting

Multicenter, prospective, feasibility study designed to demonstrate the performance and safety of the Lumen Biomedical, Inc. FiberNet™ Embolic Protection System as an adjunctive device during carotid artery percutaneous intervention using the Guidant Acculink carotid stent in high surgical risk patients.


Eligibility Criteria:
Inclusion Criteria:

* One or more of the high surgical risk criteria.
* Candidate for percutaneous stenting with target lesion located within common or internal carotid artery.
* Symptomatic with atherosclerotic stenosis ≥ 50% or asymptomatic with atherosclerotic stenosis ≥ 70% of the carotid artery by NASCET Criteria.

Exclusion Criteria:

* Allergy to Heparin.
* Myocardial infarction within the last 14 days.
* Angioplasty or PTCA/PTA procedure within the past 48 hours.
* Cardiac surgery within the past 60 days.
* Planned invasive surgical procedure within 30 days.
* Stroke within the past 14 days.
* Transient ischemic neurological attack (TIA) or amaurosis fugax within the past 48 hours.
* Intracranial stenosis that exceeded the severity of an extracranial stenosis.
* Peripheral vascular disease of sufficient severity to prevent vascular access to the target lesion.
* Total occlusion of the target vessel.
* Lesion within 2cm of the ostium of the common carotid artery.
* A stenosis that is known to be unsuitable for stenting because of one or more of:

  1. Tortuous or calcified anatomy proximal or distal to the stenosis
  2. Presence of visual thrombus
  3. Pseudo occlusion ('string sign')
* Serial lesions that requires more then one stent to cover entire lesion.
* Procedural complication prior to introduction of the FiberNet device into the body.
Progressive Muscle Relaxation Effect on Sleep Quality, Depression and Stress in People With Multiple Sclerosis

Objective: Evaluate the effects of Progressive Muscle Relaxation on sleep quality and on stress and depression levels of individuals with multiple sclerosis.

Introduction: Multiple sclerosis is a chronic, autoimmune disease, characterized by demyelination and neurodegeneration of the central nervous system. The progressive course of this disease may cause individuals to develop extreme dependency and create serious difficulties both to the individuals themselves and family members and caregivers, since the disease brings a number of physical, emotional, psychological and social symptoms. Therefore, it is essential to offer healthcare practices that go beyond the usually fragmenting, dehumanized care services that focus on the disease bodily processes.

Objective: Evaluate the effects of Progressive Muscle Relaxation on sleep quality and on stress and depression levels of individuals with multiple sclerosis.

Methodology: This is randomized clinical test. The sample was made up of 40 individuals with multiple sclerosis (20 in control group and 20 in the experimental group) in outpatient follow-up. The progressive muscle relaxation technique was employed. In order to collect the data, we adopted the interview with form filling technique, using the Pittsburgh Sleep Quality Index, Perceived Stress Scale and Beck Depression Inventory. Blood pressure, heart rate and respiratory rate of experimental group were measured before and after the progressive muscle relaxation intervention. In order to treat statistical data, we used Statistical Package for Social Sciences, version 19.0.

Eligibility Criteria:
Inclusion Criteria:

* To be diagnosed with Multiple Sclerosis for at least 6 months
* To be diagnosed with relapsing-remitting multiple sclerosis
* To have Expanded Disability Status Scale score \< 5.0
* To not have had any attacks during the 3-month period preceding enrollment in the study
* To have audio at home
* To be residing in the Metropolitan region of Vitória-Espirito Santo-Brazil.
* To be 18-65 years of age
* Treatment with an immunomodulator

Exclusion Criteria:

* Being hospitalized at the time of data collection or outbreak at the time of data collection
* Have physical and / or mental changes that prevent the collection of data, such as motor or cognitive deficits
* Experiencing relapse and/or corticosteroid use within the last month, diagnosed with progressive MS (primary or secondary)
* Use of psychotropic drugs (antidepressants, benzodiazepines, antipsychotic and cannabis, or other stimulants),
* Practice of other relaxation techniques (yoga, pilates, meditation, psychotherapy)
Passive Versus Active Educational Interventions for Melanoma Recognition

This study evaluates the efficacy of a passive versus an active educational intervention in increasing the ability of laypersons at low risk for melanoma development, in recognizing atypical skin melanocytic lesions. Patients will be randomized (1:1) to receive the active or the passive intervention.

Almost 60-70% of primary melanomas are first detected by patients or their relatives and not by physicians. Then, it appears imperative to promote public campaigns in order to increase the awareness of laypersons on the most important rules for early identification of atypical skin lesions. The two main clinical rules are:

1. ABCD rule. According to this rule, lesions characterized by one of more of the following features: Asymmetry, irregular Borders, Color variegation and Diameter larger than 6 mm, should be considered at risk for malignancy. In order to evaluate Evolution, monitoring strategies have been implemented;
2. "ugly duckling" sign. According to this rule, a suspicious lesion tends to be different from the general nevus pattern of a given patient.

The passive intervention will consist in the administration of a booklet containing the explanation of this two previous clinical rules for early detection of atypical melanocytic lesions. In the active intervention a standardized explanation will be given to the patient by a dermatologist, together with the administration of the booklet.

Efficacy will be evaluated through the completion of a specific test before, immediately after and after one month the administration of the educational intervention.

Eligibility Criteria:
Inclusion Criteria:

* no personal or family history for melanoma;
* first visit for skin examination

Exclusion Criteria:

* patients referring to know and to be already confident in the use of at least one of the tested rules.
Prevalence and Risk Factors for Pain and Related Adverse Reactions Among Breast Cancer Survivors on Aromatase Inhibitors

We obtained the occurrence of pain sensation, pain mood, sleep, etc. during endocrine therapy in breast cancer patients through telephone follow-up, and analyzed risk factors through artificial intelligence


Eligibility Criteria:
Inclusion Criteria:

- Breast cancer survivors on aromatase inhibitors

Exclusion Criteria:

* Advanced breast cancer
Piloting a Motivational Interviewing Shame-Resilience Training

The purpose of this study is to evaluate the shame resilience theory in a pilot context to assess its feasibility in a potential full scale clinical trial. Shame resilience was developed through qualitative methods but currently has little quantitative backing. Continued research is needed to assess shame-resilience as a potential intervention for shame which little is known to combat prevalent negative health outcomes associated with shame.

Shame is an emotion that can have significant negative impacts on health outcomes, including engagement in care. Feelings of shame are commonly experienced with stigmatized behaviors, such as substance misuse, and may be particularly strong among pregnant women who misuse substances. Rates of opioid misuse during pregnancy are dramatically rising, particularly in New Mexico, leading to negative health outcomes for mothers and fetuses. Shame has been found to decrease these patients' willingness to attend and engage in care. Although a theoretical model is available to guide interventions to reduce shame, it has not been tested empirically. In the current study, investigators seek to evaluate the preliminary effectiveness and feasibility of a brief Shame Resilience Intervention among women seeking care in UNM's Milagro program, a prenatal medical clinic for opioid using pregnant women. This research has the potential to significantly improve public health by generating a tool to reduce barriers to care.

Eligibility Criteria:
Inclusion Criteria:

* Study participants will be Milagro patients
* Engaged in medication assisted treatment
* At least 18 years of age
* Can read and speak English
* Are willing to be contacted for follow-up \\
* Are not incarcerated
* Are within the first or second trimester of pregnancy

Exclusion Criteria:

* The study will not enroll non-English speaking Milagro patients
* Patients with obvious cognitive impairments
* Patients with the inability to provide informed consent.
The Efficacy of 3% Kanuka Oil Versus 1% Hydrocortisone Cream in Patients With Atopic Dermatitis

Atopic dermatitis is a common disease affecting millions worldwide. A common associated symptom in this population is pruritus. We seek to investigate the use of an natural, over-the-counter cosmeceutical to help this population

There are many treatment options available for atopic dermatitis yet many patients still suffer from the underlying symptomatology. It is important to explore other treatment alternatives to help this population.

Eligibility Criteria:
Inclusion Criteria:

* age greater than 12 years, diagnosis of atopic dermatitis for longer than 2 years, investigator's static global assessment score of either 2 or 3, and initial worst itch numerical rating scale (WI-NRS) for itch greater than 4.

Exclusion Criteria:

* the use of topical or systemic corticosteroids within 28 days of entering the study, the use of any other non-emollient therapy within 28 days of entering the study,nursing, and pregnancy
Vitamin C and Tyrosine Kinase Inhibitor in Lung Cancer Patients With Epidermal Growth Factor Receptor Mutations

This trial was to explore whether intravenous vitamin C can prolong resistance time of Tyrosine Kinase Inhibitor(TKI) on lung adenocarcinoma patients with Epidermal Growth Factor Receptor(EGFR) mutations, and can benefit NSCLC patients.

The effects of vitamin C in combination with tyrosine kinase inhibitor on tumor size, tumor markers, inflammatory factor levels, quality of life, duration of resistance, progression-free survival, and overall survival time were evaluated.

This trial is a low risk treatment, and has developed the appropriate safety measures and contingency plans to ensure patients' safety in the whole process.

Patients will be followed up after the end of the trial, and follow-up observations will be performed every month during the first year. Followed every 3 months in the second year for 3 years.

Eligibility Criteria:
Inclusion Criteria:

* Primary non-small cell lung cancer (adenocarcinoma) with EGFR mutations on exons 19 and 21.
* 18 years old to 75 years old.
* During the trial, patients were prescribed TKI drugs(received initial treatment within 2 months, or change medication within 2 months) and did not receive chemotherapy or radiotherapy at the same time.
* Eastern Cooperative Oncology Group (ECOG) performance status are 0 to 2.
* Expected survival over 3 months.
* Household registration is Guangdong Province.

Exclusion Criteria:

* Co-morbid conditions that affect survival: end stage congestive heart failure, unstable angina, myocardial infarction (within the past 6 weeks), and uncontrolled blood sugars of greater than 300 mg/dL, known chronic active hepatitis or cirrhosis.
* Glucose-6-phosphate dehydrogenase deficiency (G6PD) (a relative contraindication).
* Patients who are allergic to vitamin C.
* Patients with HIV and other infectious diseases.
* Patients who are taking anticoagulants and have coagulopathy;
* Combine dysfunction of important organs such as heart, lung, liver and kidney;
* Patients with impaired renal function (serum creatinine content \> 1.2 mg/dL)
* Compromised liver function with evidence of Serum total bilirubin content, Serum alanine aminotransferase(ALT) and aspartate transaminase(AST)\> 2 times normal reference value.
* Pregnant or lactating female.
* Smoking and alcohol abuse patients;
* Anti-infective treatment is required for systemic or localized serious infections;
* Patients with hyperuricacidemia (normal: 91-456 μmol / 24h (8-40mg / 24h));
* Wilson's disease.
* Evidence of significant psychiatric disorder by history or examination that would prevent completion of the study or preclude informed consent.
* Any condition that impairs the patients' ability to swallow, which impairs drug absorption or drug kinetic parameters, including any kind of gastrointestinal resection or surgery;
* History of surgery of visceral organs within 6 weeks before the study.
Expanded NIPT for Pregnancy Complications

This study evaluates the utility of expanded panel non-invasive prenatal testing (NIPT) in detecting confined placental mosaicism of rare autosomal trisomies among pregnancies with placentally-mediated complications, including fetal growth restriction and severe preeclampsia.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of early onset (\< 34 weeks) severe fetal growth restriction, defined as estimated fetal weight less than 10th percentile with abnormal umbilical artery Dopplers OR estimated fetal weight less than 5th percentile alone OR biometric size at least 14 days behind expected dates

Exclusion Criteria:

* Maternal age \< 18 years
* Multifetal gestation
* Chronic hypertension require use of pharmacotherapy
* Tobacco or drug use
* Major congenital malformations
Prognosis of Low-grade Endometrial Stromal Sarcoma

This study is to investigate the survival outcomes and fertility outcomes in patients with uterine low-grade endometrial stromal sarcoma (LGESS) treated in Peking Union Medical College Hospital. All primary and recurrent LGESS patients will be enrolled. The study will collect retrospectively data consisting of epidemiological characteristics, surgical, medical treatment and adjuvant therapy. Details about recurrence, mortality, pregnancy and obstetrical outcomes are also followed as primary endpoints. Fertility-sparing procedures, including uterine-sparing and ovary-sparing surgeries will be recorded specifically.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* Confirmed of LGESS
* Acceptance of surgical treatment for LGESS
* With detailed follow-up outcomes

Exclusion Criteria:

- Not meeting all of the inclusion criteria
Experimental Exposure to Air Pollutants and Sympathetic Nerve Activity in Human Subjects

The primary hypothesis of the study is that in healthy elderly subjects experimental exposure to air pollutants increases sympathetic nervous system activity compared with sham (clean air) exposure. The secondary hypothesis of the study is that combined experimental exposure to air pollutants (particles + ozone) increases sympathetic nervous system activity to a greater extent than does the exposure to particles alone.

In a randomized, double-blind, and cross-over fashion, the participants will be exposed to clean air, ultrafine particles, or ultrafine particles and ozone in an exposure chamber. The investigators will determine blood pressure, heart rate, respiration as well as cardiac output and directly record sympathetic vasomotor tone using the microneurography technique. To elucidate the underlying mechanisms through which particles and ozone affect the autonomic nervous system, the investigators will assess the local and systemic inflammatory response as well as the changes in neurotrophic factors in sputum and blood. In addition, the activation of inflammatory cells in sputum and blood will be analyzed at different points in time after exposures. Changes in sympathetic activity will be correlated with the degree of airway inflammation and oxidative stress assessed in induced sputum and blood. This study will provide important insight in the mechanisms through which air pollution, particularly ultrafine particle exposure, increases cardiovascular risk in human subjects and generate a human model for mechanistic and therapeutic studies.

Eligibility Criteria:
Inclusion Criteria:

* Elderly man or postmenopausal woman older than 50 years of age.
* Signed written informed consent.

Exclusion Criteria:

* Smoker.
* Cardiovascular and/or pulmonary disease.
* Medication with relevant impact on autonomic system function, e. g. norepinephrine reuptake inhibitors. Stable medication with slight to moderate autonomic effects is tolerable.
* Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.
* Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
* Subject unlikely to comply with protocol, e. g. uncooperative attitude or unlikelihood of completing the study.
* Known hypersensitivity to ozone.
* History of drug or alcohol abuse. Particles Study - Protocol version: October 19, 2012 14
* Blood donation of more than 500 mL during the previous 3 months.