cyrilzakka/clinical-trials huggingface dataset:
Understanding Clinician Utilization of Corus CAD (Age/Sex/Gene Expression Score - ASGES) in Clinical Decision Making

The purpose of this study is to understand the use of Corus CAD also known as Age/Sex/Gene Expression score (ASGES) in the clinical decision making process of patients who underwent the evaluation of chest pain or anginal equivalent symptoms. Specifically, to better understand whether the use of the assay in clinical decision making resulted in changes in noninvasive diagnostic test ordering or diagnostic yield of additional tests ordered and/or invasive angiography.

The UCU-CARD (Understanding Clinician Utility-Cardiology) study is a retrospective, matched-cohort evaluation of diagnostic testing in a community-based cardiology practice setting that used a personalized age, sex, and gene expression test during early work-up of patients with symptoms suggestive of obstructive CAD (http://www.clinicaltrials.gov, NCT02223286). The study measured the rates of advanced cardiac diagnostic testing after initial work-up, including stress testing with imaging, CTA, or ICA. Rates of advanced diagnostic testing for patients who received the age, sex, and gene expression test (ASGES) were compared with testing rates for matched historical controls (usual care). The study hypothesis was that incorporating the age, sex, and gene expression testing early in the diagnostic work-up pathway would permit the identification of patients for whom advanced diagnostic testing was not required, thereby avoiding unnecessary testing and enabling cardiologists to focus their diagnostic resources more efficiently.

This single-center study was conducted at the North Phoenix Heart Center (Phoenix, AZ), a community-based group cardiology practice that receives patients on referral from primary care physicians and other specialists in the surrounding area. The practice incorporated age, sex, and gene expression testing into its diagnostic protocol beginning in June 2011. Data collection was completed in December 2013. Institutional Review Board (IRB) approval of the study protocol was granted by Quorum Review. Informed consent waivers were granted as data collection was retrospective and all data were de-identified.

Eligibility Criteria:
Inclusion Criteria:

1. Symptoms suggestive of CAD, according to the opinion of the site clinician
2. Age \>= 21 years

Exclusion Criteria:

1. History of myocardial infarction (MI)
2. History of high risk unstable angina, systemic infections or systemic inflammatory conditions
3. Current MI or acute coronary syndrome
4. Current New York Heart Association (NYHA) class III or IV congestive heart failure symptoms
5. Known/documented CAD
6. History/current Diabetes Mellitus
7. Taking steroids, immunosuppressive agents, or chemotherapeutic agents, at time of chest pain presentation
Mechanisms of Refractory Hypertension (Carvedilol)

The purpose of this protocol is test whether patients with hypertension refractory to antihypertensive treatment have evidence of excessive sympathetic (i.e., nervous system) activity.

Refractory hypertension refers to high blood pressure that is failing conventional antihypertensive therapies. In a retrospective assessment of such patients in our clinic we observed that resting clinic heart rates were higher in patients with refractory hypertension compared to patients with controlled hypertension. This observation has led to the hypothesis that refractory hypertension is caused by excessive sympathetic output. This protocol is designed to test this hypothesis by comparing the BP response to carvedilol verses chlorthalidone in patients with refractory hypertension. If their extreme treatment resistance is neurogenic is etiology, a significantly larger BP response to carvedilol should occur compared to chlorthalidone.

Eligibility Criteria:
Inclusion Criteria:

* Uncontrolled clinic BP (\>140/90 mmHg)
* Receiving 5 or more antihypertensive agents including an ACE inhibitor or ARB, calcium channel blocker, and chlorthalidone 25 mg

Exclusion Criteria:

* Current use of an alpha or beta or combined alpha-beta antagonist
* Known allergy to alpha-beta antagonists
* CKD (eGFR \<40 ml/min/m2)
* MI, stroke or episode of CHF exacerbation within 3 months
* Bradycardia \<50 bpm; history of 2nd or 3rd degree heart block unless treated by a pacemaker
* Pregnant or breast-feeding women
* Known hypersensitivity to chlorthalidone or other sulfonamide-derived drugs
Study of REGN6569 and Cemiplimab in Adult Patients With Advanced Solid Tumor Malignancies

There are two main goals of this study: The first is to find the highest safe dose of REGN6569 when given with cemiplimab. The second is to get some initial information about how well the REGN6569 in combination with cemiplimab may help shrink certain types of cancer.

The study is also looking at:

* Side effects that may be experienced by people taking REGN6569 alone and with cemiplimab
* How REGN6569 and cemiplimab work in the body
* How much REGN6569 and cemiplimab is in your blood
* To see if REGN6569 can lower the number of Treg cells in tumors
* To see if REGN6569 and cemiplimab can shrink tumors when given together


Eligibility Criteria:
Key Inclusion Criteria:

1. Dose escalation cohorts: Advanced stage (unresectable or metastatic) solid tumor malignancy, confirmed histologically or cytologically as defined in the protocol
2. Dose expansion cohorts: Advanced stage (unresectable or metastatic) head and neck squamous cell carcinoma (HNSCC), confirmed histologically or cytologically. Patients must have evidence of progression on anti-Programmed death-1 (receptor)/Programmed death ligand 1 (PD-1/PD-L1) blockade either as monotherapy or in combination with other therapies, as defined in the protocol
3. Mandatory biopsies: Able and willing to provide tumor tissue at baseline and while on treatment, with at least 1 soft tissue lesion amenable to biopsy by ultrasound or computed tomography (CT)-guided biopsy or under direct visualization as defined in the protocol

Key Exclusion Criteria:

1. Has previously received GITR-targeted therapy
2. Has received any previous systemic biologic therapy within 5 half-lives of first dose of study therapy as defined in the protocol
3. Has any condition that requires ongoing/continuous corticosteroid therapy (\>10 mg prednisone/day or anti-inflammatory equivalent) within 14 days prior to the first dose of study therapy
4. Has ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments as defined in the protocol
5. Has a known history of, or any evidence of, interstitial lung disease, or active, non-infectious pneumonitis in the past 5 years. A history of radiation pneumonitis in the radiation field is permitted as long as pneumonitis resolved ≥6 months prior to first dose of study therapy
6. Has uncontrolled infection with human immunodeficiency virus, hepatitis B or hepatitis C infection, or diagnosis of immunodeficiency
7. Has received a live vaccine within 4 weeks of planned start of study medication. For dose escalation only: Has received a COVID-19 vaccination within 1 week of planned start of study medication or for which the planned COVID-19 vaccinations would not be completed 1 week prior to start of study.
8. Has had prior allogeneic stem cell transplantation or received organ transplants at any time, or autologous stem cell transplantation
9. Has a history of malignancy within 2 years of date of first planned dose on study as defined in the protocol

Note: Other protocol-defined Inclusion/ Exclusion criteria apply
Multifocal Electroretinography Before and After Silicone Oil Removal

This is a prospective observational study to investigate the changes in multifocal electroretinogram signal before and after silicone oil removal in silicone-filled eyes.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age or older who underwent pars plana vitrectomy for the repair of rhegmatogenous retinal detachment (RRD) and received silicone oil as an intraocular tamponade.

Exclusion Criteria:

* Patients will be excluded if they have a significant corneal opacity, uncontrolled intraocular pressure, a confounding macular pathology or optic nerve pathology or if silicone oil has been in the eye for longer than 6 months.
Skin Irritation Test of LEO 80185 Gel in Healthy Japanese Subjects

The purpose of the study is to investigate skin irritation of LEO 80185 gel, gel vehicle and Liquid Paraffin in healthy Japanese male subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent has been obtained.
2. Healthy Japanese male subjects.
3. Aged 20 to 40 years inclusive.
4. Subjects without signs of skin irritation/disease/disorders/symptoms or blemishes on test sites (e.g. erythema, dryness, roughness, scaling, scars, moles, sunburn).
5. Subjects without a significant abnormality, as judged by the (sub)investigator

Exclusion Criteria:

1. Body Mass Index outside the range 18-25 kg/m²
2. History of alcohol or drug abuse.
3. History of allergic reaction to any medications.
4. Any disease that could in any way confound assessment of the test sites.
5. Known or suspected hypersensitivity to any component of LEO 80185 gel.
6. Known or suspected hepatic, renal or cardiac disorders.
7. Known or suspected disorders of calcium metabolism associated with hypercalcaemia or albumin-corrected serum calcium above the reference range from the sample taken during screening.
8. Subjects suspected of infection based on the infection testing results from the sample taken during screening (Hepatitis B surface antigen, HCV antibody, HIV antigen/antibody, serological test for syphilis).
9. Use of systemic, locally injected or inhaled corticosteroids within 4 weeks of Day 1.
10. Use of vitamin D or calcium supplements, or systemic vitamin D analogues within 4 weeks of Day 1.
11. Use of any medication (systemic or topical) within 2 weeks of Day 1.
12. Subjects who have received treatment with any non-marketed drug substance (i.e. an agent which has not yet been made available for clinical use following registration) within 4 weeks or 5 half-lives of Day 1, whichever is longest.
13. Current participation in any other interventional clinical trial.
14. Previously enrolled in this clinical trial.
15. Previous or current photo-induced or photo-aggravated disease (e.g. abnormal response to sunlight).
16. Exposure to excessive or chronic ultraviolet radiation (e.g. sunlight, sun lamps, tanning booths or photo-therapy) within 4 weeks of Day 1.
17. Subjects (or their partner) not using an adequate method of contraception during the trial (Day 1-4).
18. In the opinion of the (sub)investigator, participation in the trial is inappropriate.
Impact of a Diabetes Education Mobile Web Application on Patients With Uncontrolled Type 2 Diabetes

The goal of this clinical trial is to evaluate the use and effectiveness of a mobile web application (app) that is designed to educate and allow patients to manage diabetes and make sustainable lifestyle changes, and to study the impact of the app on clinical outcomes of diabetes (HA1C) and educational outcomes (Self-Efficacy for Diabetes Scale). The main question to answer is: Does the use of the Diabetes Application significantly affect clinical outcomes of diabetes and cardiometabolic risk factors (BMI and Blood Pressure)? Patients will be enrolled in one of two available arms of the study.

Participants in the 'intervention arm' will use the app to view educational information presented as videos in the following areas: Healthy Coping, Healthy Eating, Staying Active, Medications (Use and Safety), Problem Solving in Diabetes and Disease Pathophysiology. They will continue routine follow-up care with their primary care physicians during the study.

Participants in the 'control arm' will continue with their primary care physician in routine follow-up care, as normally scheduled.

Researchers will compare the intervention arm participants to the control arm participants to find out about and compare changes in HA1C, systolic blood pressure, diastolic blood pressure, and body mass index. Groups will also be compared on the basis of self-perceived confidence of managing their diabetes by way of the Diabetes Self Efficacy Scale.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Diagnosis of Type 2 Diabetes with HA1c \>8.0
* Current patients of the Family Healthcare Center, Reading Hospital Tower health.

Exclusion Criteria:

* Identified special populations (pregnancy or individuals currently incarcerated)
* Patients without access to their own smart phone
* Any patient who is unable to provide their own informed consent to participate in the study
VRH Pain Reduction During Burn Wound Care and Physical Therapy

Using Virtual Reality Hypnosis to relief pain and anxiety for burn patients.

The purpose of the study is to examine whether there is more effective relief of pain and anxiety during wound care procedures in burn-injured patients that are treated with Virtual Reality Hypnosis with post-hypnotic suggestion.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 7 years
* Able to complete subjective evaluations of pain
* English-speaking
* Not demonstrating delirium, psychosis, or any form of Organic Brain Disorder
* Able to communicate orally

Exclusion Criteria:

* Age less than 7 years
* Incapable of indicating subjective evaluation of pain
* Non-English-speaking
* Demonstrating delirium, psychosis, or Organic Brain Disorder
* Unable to communicate verbally
* Significant developmental disability
* Extreme susceptibility to motion sickness
Pilot Feasibility of Rice Bran Supplementation in Nicaraguan Children

The purpose is to assess feasibility of rice bran consumption in weaning children and collect pilot data on gut microbiome and metabolome modulation with rice bran intake for diarrheal prevention.

Rice bran is a globally accessible, underutilized food ingredient with an array of beneficial nutrients (e.g. phytochemicals and prebiotics) that promote health and potentially prevent diseases. The investigators will determine if dietary rice bran intake can modulate the infant gut microbiome and metabolome to promote gut immunity for the benefit of preventing diarrheal diseases that increase risk for malnutrition and stunting.

The investigators hope to learn about the feasibility of dietary supplementation of heat-stabilized rice bran in weaning children living in regions with increased susceptibility to diarrhea and malnutrition, and whether or not rice bran consumption can modulate the stool microbiome and metabolome.

Eligibility Criteria:
Inclusion Criteria:

* Children between the ages of 4 months and 6 months at beginning of recruitment
* Have received the 3 doses of the rotavirus vaccination (RV5)
* Families willing to feed their infant a daily dose of study-provided heat-stabilized rice bran for 6 months

Exclusion Criteria:

* Have had a diarrheal episode between 4 and 6 months of age
* Have had a prior hospitalization
* Have had an antibiotic or prophylactic treatment within 1 month prior to participation
* Have an ongoing illness, a known immunocompromising condition, or use of medications
Knowledge and Needs of Nursing in Relation to the Treatment Complex Wounds

Study with cross-sectional and descriptive mixed methodology. With questionnaires with likert-type questions (0-10) being the 10 with the highest score, and open questions in relation to knowledge in wound care; include all Corporaciló Sanitària Parc Taulí (CCSPT) nurses who voluntarily want to participate in a pseudo-anonymized surv

INTRODUCTION A complex wound is a skin injury with little or no tendency to heal as long as the cause that produces it is present. Complex wounds that are difficult to heal or develop torpid or refractory to the usual treatments, do not evolve adequately in the expected time (\> 6 weeks).

The clinical practice we find is completely heterogeneous among professionals who care for people with injuries.

OBJECTS Describe the knowledge and training needs perceived by nurses in the approach to people with complex wounds of the CCSPT.

To explore the difficulties and facilitating elements that professionals perceive when dealing with people with complex wounds, from the reference area of the Parc Taulí University Hospital, over a period of 12 months.

Explain tools with scientific evidence for correct continuity of care.

METHODOLOGY:

Study with cross-sectional and descriptive mixed methodology. With questionnaires with likert-type questions and open questions in relation to knowledge in wound care; include all CCSPT nurses who voluntarily want to participate in a pseudo-anonymized survey.

EXPECTED RESULTS:

Current situation of the knowledge, needs, limiting and facilitating elements that nursing professionals have to address people with injuries.

Eligibility Criteria:
Inclusion Criteria:

* Nurses who take care of people with both adult and pediatric injuries.
* Nurses who give their informed consent to participate in the study voluntarily.

Exclusion Criteria:

* Nurses who do not want to participate in the study voluntarily.
* Nurses who do not have healthcare activities (due to workplace, due to long-term illness, absence from work)
Assessing Diagnostic Methods for Invasive Fungal Disease in Lung Transplant Recipients

This study aims to assess the diagnostic performance of different tests, including metagenomic next-generation sequencing (mNGS), real-time PCR, galactomannan assay, and lateral-flow device tests, in detecting invasive fungal disease in lung transplant recipients using bronchoalveolar lavage fluid samples. The study is retrospective and cross-sectional in design.

This retrospective, cross-sectional study evaluates the diagnostic accuracy of various tests in detecting invasive fungal disease (IFD) in lung transplant recipients. The diagnostic methods under assessment include metagenomic next-generation sequencing (mNGS), real-time polymerase chain reaction (PCR), galactomannan (GM) assay, and lateral-flow device (LFD) testing, all performed on bronchoalveolar lavage fluid (BALF) samples. The study analyzes the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of each method for diagnosing invasive pulmonary aspergillosis (IPA) and Pneumocystis jirovecii pneumonia (PJP). The sample cohort consists of 109 lung transplant recipients, with data collected from January 2015 to April 2023

Eligibility Criteria:
Inclusion Criteria:

* Adult lung transplant recipients aged 18 years and older.
* Suspected cases of invasive fungal infection (invasive pulmonary aspergillosis or -Pneumocystis jirovecii pneumonia) based on clinical symptoms, radiological findings, or microbiological evidence.
* Able to provide sufficient bronchoalveolar lavage fluid (BALF) samples for diagnostic testing.

Exclusion Criteria:

* Patients with confirmed non-fungal infections.
* Patients unable to provide adequate BALF samples for analysis.
* Patients with severe comorbidities that prevent study participation or completion.
The Effect of a Real-time Audiovisual Feedback System on CPR Quality

The investigators will evaluate the effect of a real-time audiovisual feedback system on CPR quality during in-hospital cardiac arrest.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 17 years old who require cardiopulmonary resuscitation in a medical or surgical intensive care units

Exclusion Criteria:

* Patients less than 18 years
* Patients with Do Not Resuscitate order
* Patients who require cardiopulmonary resuscitation outside a medical or surgical intensive care unit
Nitroglycerin Prevents Radial Artery Occlusion

Trans-radial approach (TRA) has becoming popular and widely adopted over the last decade. However, radial artery occlusion (RAO) continues to be one of the limitation of trans-radial access and potentially limits the radial artery as an access site in the future. Several strategies have been used to decrease the incidence of RAO including the use of anticoagulation, maintenance of patency during hemostasis, or shortening the duration of compression. Currently, there is no data whether vasoactive pharmacological therapy such as nitroglycerin administered intra-arterially at the end of the procedure may reduce the incidence of RAO. It is hypothesized that the addition of nitroglycerin (nitric oxide donor) at the end of a TRA procedure may reduce the incidence of RAO.


Eligibility Criteria:
Inclusion Criteria:

* Sequential patients undergoing trans-radial catheterization in the institution will be consented to be randomized to receive either 500 microgram nitroglycerin (Group A) or a placebo (Group B) administered intra-arterially through the sheath at the end of the procedure.

Exclusion Criteria:

* Patients with cardiogenic shock or hemodynamically unstable
* Unable to tolerate nitrates
Influence of Probiotics in Diabetic Cardiopathies With Excessive Weight

Today in Brazil, 6.9% of the population has Diabetes Mellitus 2 (DM2). In the world, there are about 422 million people with DM2. It is a chronic disease of the endocrine system, accounts for 90 to 95% of cases of DM2 and is characterized by defects in insulin action and secretion. Its main cause is linked to obesity and insulin resistance. Obesity is a chronic, multifactorial disease - environmental, nutritional and genetic factors - characterized by excessive accumulation of body fat, and is reaching epidemic proportions, more than 100 million children and 600 million adults worldwide. The number of obese people in Brazil reaches 17.9% of the population.

Rates of obesity and DM2 have increased in the last decades, both diseases being associated with inflammation and specific alterations in the intestinal microbiota. Thus, studies show that the use of probiotics may be associated with reduced body weight and reduced glucose in the bloodstream. Probiotics are living microorganisms that, when administered in suitable dosages, confer benefits to the health of the host. In addition, studies show the relationship of the intestinal microbiota and the emergence of various diseases and demonstrate that probiotics can control inflammatory processes, metabolic dysfunctions, normalization of stress-induced behaviors, regulation of the hypothalamic-pituitary-adrenal axis and neuropsychiatric disorders. Thus, the importance of investigating the ingestion of probiotics in relation to anthropometry, biochemical profile and anxiety in diabetic and overweight individuals with cardiopathy are justified. It is a randomized, double-blind, controlled clinical trial. The study will last 3 months and will occur with 74 adult individuals (between 20 and 60 years) of the SUS outpatient clinic of the Institute of Cardiology of Porto Alegre - RS, of both sexes, with BMI above 25 m² / kg. and less than 40 m² / kg, divided into 2 groups and 37 individuals per group. These patients were: Group A (intervention: n = 37): patient received 1 sachet per day of probiotics Lactobacillus acidophilus, Lactobacillus casei, Lactobacillus lactis, Bifidobacterium lactis and Bifidobacterium bifidum for 90 days and Group B (placebo; n = 37): microcrystalline cellulose, lactose, pregelatinized maize starch. Probiotics will contain a dose of 109 CFU in each strain. The excipients used will be: microcrystalline cellulose.

Probióticos

Eligibility Criteria:
Inclusion Criteria:

* Age between 20 and 60 years;
* BMI greater than 25 m² / kg and less than 40 m² / kg;
* DM2.

Exclusion Criteria:

* Use of antibiotics or medications for weight loss purposes;
* Use of kefir, yacult;
* Lactose intolerance;
* Inflammatory bowel disease;
* Valvar surgery;
* Use of laxative in the last 3 months;
* Patients participating in other clinical studies.