cyrilzakka/clinical-trials huggingface dataset:
Interventions to Decrease Heat Stress Among Latinx Farmworkers in Idaho

The goal of this study is to collaborate with farmworker, community organizations, and labor contractors/employers to develop workplace- and individual-level interventions, and evaluate the efficacy of those interventions in decreasing physiological and perceived heat stress among Latinx farmworkers in Idaho.

Occupational heat exposure presents one of the clearest acute and long-term health threats to farmworkers and will continue to worsen under climate change. Exposure to extreme heat can lead to Heat-Related Illnesses (HRI), a continuum of diseases that can range from mild symptoms (e.g., dizziness, fatigue, vomiting) to severe and life-threatening conditions including convulsions, coma, and even death. It is becoming increasingly urgent to identify effective strategies to prevent the health impacts of heat exposure among farmworkers as climate change increases the frequency, intensity, and duration of heat waves. The few studies that have examined this topic have identified some beneficial impacts of increasing access to cold water and shade at the workplace, however studies to date have been limited by their investigation of individual- and workplace- interventions in isolation and research teams that do not engage farmworkers and community-based organizations. Further, the studies that have been conducted have taken place primarily in states with regulations that prohibit work over a specific heat index, and it is important to examine the impacts of interventions to decrease heat stress in states without these regulations, such as Idaho. The aims of this study are to collaborate with farmworkers, farmworker employers, and community organizations to develop and evaluate the efficacy of multi-level interventions in mitigating physiological and perceived heat strain among Latinx farmworkers in Idaho. The investigators further aim to examine the efficacy of educational programs (e.g., training in identifying and preventing personal and occupational risk factors for heat stress) on knowledge, behaviors, and perceptions. Leveraging our existing and well-established relationships with multiple community partners, the investigators will disseminate the research findings and promote the implementation of health-protective heat interventions to farmworkers, farmworker employers, and stakeholders across Idaho and the Mountain West. This study was motivated by concerns voiced by participants in a previous study of Latinx farmworkers led by the current team of researchers and community organizations. Here, the investigators aim to respond directly to their stated concerns regarding occupational heat exposure.

Eligibility Criteria:
Inclusion Criteria:

* Identify as Hispanic/Latinx, currently working in an agricultural field in Idaho

Exclusion Criteria:

* Under age 18 years
LOC387715/HTRA1 Variants in Polypoidal Choroidal Vasculopathy in a Korean Population

This study is to investigate whether variants in the LOC387715 locus and the HtrA serine peptidase 1 (HTRA1) gene within the 10q26 locus are associated with polypoidal choroidal vasculopathy and whether they are associated with clinical patterns including angiographic phenotype in a Korean population.

This is a cross-sectional case-control study. One hundred Korean patients with polypoidal choroidal vasculopathy and 100 control subjects were genotyped for the LOC387715 (rs10490924) and the HTRA1 gene polymorphism (rs11200638)

Eligibility Criteria:
Polypoidal choroidal vasculopathy group

Inclusion Criteria:

* patients older than 60 years of age at onset
* polyp-like terminal aneurysmal dilations with or without branching vascular networks in indocyanine green angiography and subretinal reddish-orange protrusions corresponding to polyp-like lesions

Exclusion Criteria:

* eyes with pathologic myopia, angioid streaks, central serous chorioretinopathy, and other retinal or choroidal diseases

Control group

Inclusion Criteria:

* individuals without retinal diseases and without any signs of polypoidal choroidal vasculopathy or age-related macular degeneration on the bases of comprehensive ophthalmic examination results
Review of Descending Aortic Flow Reversal in Total Anomalous Pulmonary Venous Connection

This is a retrospective review of charts and echocardiograms of our patients with Total Anomalous Pulmonary Venous Connection (TAPVC). The Children's Surgical and non-invasive Echo databases will be used to determine all TAPVC patients. Children's Healthcare of Atlanta and Sibley Heart Center Cardiology charts and echocardiograms of the TAPVC patients between January 1, 2002 and November 26, 2006 will be reviewed. We anticipate approximately 40 patients.

We hypothesize that the presence of descending aortic flow reversal correlates with a higher morbidity and mortality in TAPVC.

Total anomalous pulmonary venous connection (TAPVC) is a congenital cardiac anomaly in which the pulmonary veins fail to connect to the usual anatomic location, the left atrium. This may lead to critical cardio-pulmonary failure and extreme cyanosis. This condition usually requires urgent surgical repair. In many cases, the pulmonary veins may be obstructed leading to severe pulmonary hypertension and low cardiac output which may be acutely life-threatening. In these cases, emergent surgical repair is undertaken in the newborn period. Patients with TAPVC may have poor prognosis which may be difficult to predict.

We have made the unusual and previously unreported observation by echocardiography of flow reversal in the upper descending aorta, indicating extremely reduced left ventricular output in patients with TAPVC, some of whom have had a poor outcome. This has led to the hypothesis that descending aortic flow reversal portends a poor prognosis in TAPVC.

The patients with TAPVC will be divided into two groups by the presence or absence of descending aortic flow reversal. We, also, would evaluate the presence of other associated cardiac anomalies.

The second step of the study would be to review the clinical charts of the above patients to evaluate for serious co-morbidities and mortality. Outcome measures would include mortality, chronic lung disease, continued oxygen requirement, recurrent respiratory infections, listing for transplantation, cardiopulmonary arrest or requirement for ECMO.

Eligibility Criteria:
Inclusion Criteria:

* Children's Healthcare of Atlanta and Sibley Heart Center Cardiology charts and echocardiograms of the TAPVC patients between January 1, 2002 and November 26, 2006 will be reviewed. We anticipate approximately 40 patients.

The patients with TAPVC will be divided into two groups by the presence or absence of descending aortic flow reversal.

Exclusion Criteria:

* those who do not fall under the Inclusion Criteria
A Phase 3 Study in Participants With Moderate to Severe Psoriasis (UNCOVER-2)

This study will assess the safety and efficacy of ixekizumab (LY2439821) compared to etanercept and placebo in participants with moderate to severe chronic plaque psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* Present with chronic plaque psoriasis based on a confirmed diagnosis of chronic plaque psoriasis for at least 6 months prior to first dose of study drug
* At least 10% Body Surface Area (BSA) of psoriasis at screening and at first dose of study drug
* Static Physician Global Assessment (sPGA) score of at least 3 and Psoriasis Area and Severity Index (PASI) score of at least 12 at screening and at first dose of study drug
* Candidate for phototherapy and/or systemic therapy
* Men must agree to use a reliable method of birth control or remain abstinent during the study
* Women must agree to use reliable birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment

Exclusion Criteria:

* Pustular, erythrodermic, and/or guttate forms of psoriasis
* History of drug-induced psoriasis
* Prior use of etanercept
* Clinically significant flare of psoriasis during the 12 weeks prior to randomization
* Concurrent or recent use of any biologic agent
* Received non-biologic systemic psoriasis therapy or phototherapy (including psoralens and ultraviolet A \[PUVA\], ultraviolet B \[UVB\]) within the previous 4 weeks; or had topical psoriasis treatment within the previous 2 weeks prior to randomization
* Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to randomization and during the study
* Have participated in any study with interleukin 17 (IL-17) antagonists, including ixekizumab
* Serious disorder or illness other than plaque psoriasis
* Serious infection within the last 3 months
* Breastfeeding or nursing (lactating) women
The GORE VBX FORWARD Clinical Study: A Comparison of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis to Bare Metal Stenting for Patients With Complex Iliac Occlusive Disease

The objective of this prospective, multicenter, randomized, controlled clinical trial is to demonstrate the superiority of the VBX Device for primary patency when compared to bare metal stenting in complex iliac occlusive disease.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years at time of informed consent signature
* Informed Consent Form (ICF) is signed by the subject
* Subject can comply with protocol requirements, including follow-up
* Patient has symptomatic claudication, rest pain, or minor tissue loss (Rutherford Category 2-5)
* Patient has de novo or restenotic lesion(s) found in the common and/or external iliac artery(ies)
* Patient has: Unilateral or bilateral single or multiple lesions (\>50% stenosis or chronic total occlusion) each between 4 and 11 cm in length
* Patient has a target vessel diameter visually estimated to be approximately between 5 mm and 13 mm
* Patient has a sufficient (\<50% stenotic) common femoral artery and at least one sufficient (\<50% stenotic) femoral artery (deep or superficial).
* Patient has at least one sufficient (\<50% stenotic) infrapopliteal run-off vessel.

Exclusion Criteria:

* Life expectancy \<1 year
* Patient is pregnant at time of informed consent.
* Patient has a known allergy to stent or stent graft components (including nitinol, stainless steel, or heparin).
* Patient has severe chronic renal insufficiency (serum creatinine level \> 2.5mg/dL) and not undergoing hemodialysis.
* Patient has evidence of a systemic infection.
* Patient has a known intolerance to antithrombotic medications that prevent compliance with study or control device Instructions for Use.
* Patient has had vascular catheterization of the lower extremities within 30 days of randomization (excluding diagnostic angiograms for the study procedure).
* Patient has previous stenting in the iliac arteries.
* Patient has previous surgical bypass in the target limb.
* Patient is currently participating in another investigative clinical study unless received written approval by the sponsor.
* Patient has a lesion requiring drug-coated balloon angioplasty, atherectomy, lithotripsy, or any ablative device to facilitate stent delivery.
* Patient has an abdominal aortic artery lesion or aneurysm.
* Patient has a lesion that requires stent placement within 2 cm of the inguinal ligament.
* Patient has isolated common iliac artery stenosis that can be treated with a single device (i.e., common iliac artery stenosis that does not require kissing stents or extend into the external iliac artery).
* Patient has outflow disease that requires concomitant interventions (i.e. common femoral endarterectomy or femoral / tibial revascularization).
Identification of Critical Outcomes in Sarcopenia

Patients will be recruited on each site according to inclusion criteria. Participants willing to participate will received an information sheet and a consent form. After given their consent to participate, they will receive a questionnaire composed of 13 choice questions. In this DCE, patients will be asked to choose which one of two hypothetical patients (Patient A and Patient B) suffering from sarcopenia with different levels of outcomes deserves the most the treatment. After completion of the choice tasks, respondents will be asked how difficult they found the choice tasks on a seven-point scale and to questions on their socio-economic and disease characteristics.

The participants will first receive an information letter and consent form. Participants will be free to ask any questions to the doctor/researcher. Once the consent form signed, participants will receive the questionnaire and will be asked to complete it. Explanation of the task and an example choice task should be provided by a doctor or a researcher but the questionnaire is intended to be self-administered. Nevertheless, some level of support can be brought if necessary.

The questionnaire is composed by a general explanation of the purpose of the study followed by a definition of sarcopenia and a clear description of the DCE task. The attributes and levels are carefully explained in the introduction part of the questionnaire and an example of a completed choice set is provided. Each patient will then receive 13 choice sets. After completion of the choice tasks, respondents will be asked how difficult they found the choice tasks on a seven-point scale. Participants who graded the level of difficulty as "extremely difficult" will be removed from the analyses. The DCE task is presented in Appendix 1. The questionnaire also asks questions on patients' characteristics.

The questionnaire has been created with experts during the phase of "Identification and prioritization of important outcomes of sarcopenia". Five attributes and different levels of consequences have been identified by the panel.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Diagnosis of sarcopenia :
* Muscle mass
* Muscle strength and physical performance should be measured

Exclusion Criteria:

* Problem of Cognitive function
* Diagnosis of dementia
* unability to understand the study and the the questionnaire
* unability to fill in the questionnaire
* major depression
Prebiotic Fructans on the Incidence of Acute Infectious Diseases in Children

The study aims to explore whether prophylactic dietary supplementation with prebiotic inulin-type fructans is able to influence the intestinal microbiota and the frequency of infectious disease episodes in kindergarten children during a winter period.


Eligibility Criteria:
Inclusion Criteria:

* Subject is healthy at the time of pre-examination
* Subject is aged 3-6 years at the time of pre-examination
* Subject attends a kindergarten at the time of pre-examination

Exclusion Criteria:

* congenital disease or malformation influencing the gastrointestinal System
* children with congenital or acquired immunodeficiency
* children with food intolerance, food allergy or metabolic disorder requiring special diet
* children who regularly (more than 3 times per week) consumed products or food supplements containing prebiotics or probiotics
* children who consumed antibiotics or laxatives within 14 days
* children who had any infectious disease within 14 days at the time of pre-examination
The Effect of Tinnitus Retraining Therapy on Subjective and Objective Measures of Chronic Tinnitus

The objective of this study is to examine the efficacy of tinnitus retraining therapy (TRT) as a treatment of chronic tinnitus in people with limited hearing loss. The study design is prospective, randomized, double-blind, with repeated measures. The null hypothesis states there will be no difference in subjective measures of tinnitus severity between subjects treated with standard TRT and subjects treated with sham TRT.

The specific aims of the study are to:

* Evaluate the efficacy of TRT in reducing the objective magnitude of tinnitus.
* Evaluate the efficacy of TRT in reducing the subjective awareness and impact of tinnitus.
* Determine the therapeutic time course of improvement in tinnitus.
* Determine the long-term improvement in tinnitus derived from TRT.

Eligibility Criteria:
Inclusion Criteria:

* Chronic non-pulsatile tinnitus

Exclusion Criteria:

* Hyperacusis
* Subjective hearing loss
* Objective hearing loss with pure tone average greater than 35 dB sound pressure level (SPL)
* Evidence of significant depression or suicidal ideation
The Risk of Surgical Cancellation in Adult Patients Assessed by Telephone Versus In-person for Scheduled Non-cardiac Elective Surgery.

Telemedicine has been regulated in Colombia since 2006, with applications in anesthesia being explored since 2004 to improve accessibility and reduce costs. Although Decree 538 of 2020 expanded telemedicine's medical applications, challenges such as connectivity issues and the need for training remain. Telemedicine has shown promise in rural areas of Colombia, particularly for managing chronic diseases. However, further evidence is needed regarding the effectiveness of telephone pre-anesthetic evaluations.

This study aims to investigate the implementation of telephone assessments for non-cardiac surgery and their impact on surgical cancellations compared to in-person pre-anesthetic evaluations. The primary question we seek to answer is:

Does telephone pre-anesthetic assessment in non-cardiac surgical patients carry a higher risk of surgical cancellations compared to in-person evaluations?

To address this question, we will evaluate patients' medical records in two hospitals where patients were assessed using both telephone and in-person modalities.

The COVID-19 pandemic accelerated the adoption of telemedicine, including its application in preoperative anesthesia evaluations. While the use of telephone assessments in anesthesiology is increasing, there is ongoing debate about their accuracy in identifying medical risks and predicting potential post-surgical outcomes. Preanesthetic evaluations are essential for determining patient suitability for surgery and for classifying surgical risk.

Despite the benefits of increased accessibility and cost reduction associated with telephone assessments, concerns persist regarding their ability to match the thoroughness of in-person evaluations. This is particularly relevant given the potential for higher surgical cancellation rates.

In Colombia, telephone preanesthetic evaluations for non-cardiac elective surgeries are a recent development, potentially optimising resource use and enhancing patient satisfaction. However, it is crucial to investigate whether they result in a cancellation rate comparable to in-person assessments, as this could be a significant barrier to widespread implementation. This study examines the effectiveness of telephone assessments for non-cardiac surgeries and their impact on surgical cancellations compared to in-person preanesthetic evaluations. A secondary objective of the study is to evaluate the incidence of perioperative complications, including cardiovascular issues, pulmonary complications, bleeding, unexpected ICU admissions, and non-anticipated difficult airways.

Eligibility Criteria:
Inclusion Criteria:

- Patients who were scheduled for elective non-cardiac surgery.

Exclusion Criteria:

* Pregnant patients.
* More than three months between the pre-anesthetic evaluation and the scheduled surgery.
Reliability and Validity of The Turkish Version of the Functional Assessment of Chronic Illness Therapy - Treatment Satisfaction - General Questionnaire

In the evaluation of the services provided in hospitals in recent years, importance has been given to the measurements based on the perception of the patients. Today, the most frequently used criteria for this purpose are quality of life and patient satisfaction. The general opinion of the experts is that the information obtained with these criteria is valid and reliable.The researchers pointed out that patients who are dissatisfied with the health service provided comply with the recommendations of the healthcare personnel less and thus the primary and secondary preventive services are adversely affected.Although treatment satisfaction is a very important factor in terms of patient adherence to treatment, there is no valid and reliable scale in Turkish to evaluate this factor. This study was carried out to investigate the validity and reliability of The Turkish version of the Functional Assessment of Chronic Illness Therapy - Treatment Satisfaction - General Questionnaire in the patients receiving health care.


Eligibility Criteria:
Inclusion Criteria:

Getting at least 3 sessions of physiotherapy and rehabilitation services, To be at the cooperative level to understand and answer the surveys. Volunteering to participate in the study.

Exclusion Criteria:
Identifying Novel Variants in the DPYD Gene in Patients of Non-Western Descent

This is a observational, multicenter study to identify novel variants of the DPYD gene which are possible deleterious in patients of non-Western descent.

Research has shown that DPYD-guided dose-individualization based on 4 DPYD variants (DPYD\*2A, c.1236G\>A, c.2846A\>T and c.1679T\>G) can significantly reduce severe fluoropyrimidine-related toxicity. However, these 4 variants are most likely not predictive for toxicity in patients of non-Western descent. In this study the DPYD gene of patients of non-Western descent will be sequenced to identify novel variants that could be associated with a reduced DPD enzyme activity and an increased risk of developing severe fluoropyrimdine-related toxicity. Additionally, the ability to predict if a DPYD variant is possibly deleterious by a recombinant model systen (DPYD-varifier) will be studied.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed malignancy for which treatment with a fluoropyrimidine is considered to be in the patient's best interest
* Patients need to be self-declared non-Western
* Age 18 years and older
* Able and willing to give written informed consent
* WHO performance status of 0, 1 or 2
* Life expectancy of at least 12 weeks
* Able and willing to undergo blood sampling for study related analysis
* Adequate baseline patient characteristics (complete blood count, hepatic function which involves serum bilirubin, ASAT, ALAT, and renal function)

Exclusion Criteria:

* Prior treatment with fluoropyrimidines
* Patients with known substance abuse, psychotic disorders, and/or other diseases expected to interfere with study or the patient's safety