cyrilzakka/clinical-trials huggingface dataset:
High in Front-of-package Label Pretest

The goal of this trial is to understand which of five "High In" front-of-package label designs is most effective at helping consumers identify the healthiest products (i.e., products that are high in the fewest number of nutrients of concern: added sugar, sodium, and saturated fat).

The objective of this aim is to assess which of five "High In" front-of-package label (FOPL) designs is most effective at helping consumers identify the healthiest products (i.e., products that are high in the fewest number of nutrients of concern: added sugar, sodium, and saturated fat). The investigators will use a between-subjects randomized experiment to assess the primary outcome. Participants will be randomized to one of five label conditions modeled after the U.S. Food and Drug Administration's draft "High In" FOPL designs: 1) No Icon; 2) Magnifying Glass; 3) Exclamation Mark; 4) Exclamation Mark with multiple labels; 5) Exclamation Mark with Black Background.

The primary outcome is correct identification of the healthiest product, defined as the product that is high in the fewest nutrients of concern, including added sugars, sodium, and saturated fat (percent correct for each condition). Secondary outcomes include correct identification of which product is least healthy; which product(s) are high in added sugars, saturated fat, and sodium (3 separate questions); and perceived message effectiveness (PME) of the different labels.

Logit models will be used to compare proportions in each condition that correctly identified the items (each condition compared to every other condition). For continuous outcomes (e.g., knowledge, PME scale), the investigators will use linear regression models regressing the outcome on an indicator for experimental condition. A critical alpha 0.05 will be used, and statistical tests will be two-tailed. The Bonferroni Holm correction will be used for analyses comparing conditions 2-5 to each other for each outcome (6 comparisons).

The investigators will also measure nutrition literacy, and assess moderation on the primary outcome by nutrition literacy (continuous) and highest education attainment (Bachelor's Degree or higher vs. less than Bachelor's Degree).

Eligibility Criteria:
Inclusion Criteria:

* Equal or greater than 18 years of age
* Less than 100 years of age
* English-speaking
* U.S. residents
* Participants will reflect the U.S. Census Bureau's 2021 American Community Survey 5-year estimates for gender, race/ethnicity, educational attainment, and age

Exclusion Criteria:

* Failing the attention check question
* Completing the survey in less than 33% of the median completion time
A Registry of Subjects With Primary Indeterminate Lesions or Choroidal Melanoma

The purpose of this observational research study is to follow participants who have been treated with either bel-sar or received alternate treatment (sham, standard of care therapy, etc.) while participating in a previous Aura Biosciences clinical research study to assess the long-term safety and effectiveness in these subjects. This study will collect information from procedures conducted as part of routine follow-up eye care and cancer care. Additionally, the registry will collect all adverse events, information about pregnancy and symptomatic overdose.

This is a multi-center long-term observational Registry of subjects with Primary Indeterminate Lesions or Choroidal Melanoma.

The Registry will initially be open to subjects who have previously participated in an Aura Biosciences bel-sar sponsored clinical trial for their primary Choroidal Melanoma or Indeterminate Lesions.

All subjects will be followed for a minimum of 5 years (including time enrolled in an Aura sponsored clinical trial), until withdrawal of consent, or until death whichever comes first.

No interventions will be required as part of the Registry. Data collection will be based on IL or CM information anticipated to be available based on the standard of care for subjects with CM or IL.

Eligibility Criteria:
Inclusion Criteria:

* Have been clinically diagnosed with primary IL or CM at the time of entry to a previous Aura Biosciences sponsored clinical trial.
* Have received AU-011 bel-sar or assigned to a different cohort or treatment arm (sham, SoC, etc.) an observation cohort in a previous Aura sponsored clinical trial.

Exclusion Criteria:

- None
Neuroinflammation, Serotonin, Impulsivity and Suicide

Suicide is a major health problem that causes annually a million death worlwide. In the stress-vulnerability model, suicidal behavior (SB) results from the interaction between an individual's predisposition (personality, family history of SB...) and stressful conditions (early life adversity).

Studies show that suicide ideations could favour inflammation and that depression is associated with an elevated inflammation.

Recent evidences also suggest that inflammatory mediators play a critical role in SB.

The aim of the study is to evaluate the inflammatory markers rate on depressed patients with or without personal history of SB.

In the second part of the study, the relations between the rates of inflammatory markers and characteristics of SB, impulsivity, psychological pain, childhood abuse and gene expression of 5HT2B receptor will be investigated.

Over one year, we will recruit 280 patients suffering from a major depressive episode with (n=140) and without any history of suicide attempt (n=140), from a specialized clinic for mood disorders and SB.

First visit : clinical, biological and neuropsychological assessment

Second visit, at 6 month : Follow-up visit in the department or interview by telephone in order to assess suicidal ideations or suicide attempts since the inclusion.

Eligibility Criteria:
Inclusion Criteria:

* Ages of 18 and 65
* Main diagnosis of major depressive episode (DSM-IV criteria)
* Having signed the informed consent
* Able to understand nature, aims, and methodology of the study

Specifics Inclusion criteria:

* Depressed patients with suicide attempt history :

  * Have done in his lifetime at least one suicide attempt (however the period of time between inclusion and suicide attempt)
* Depressed patients without suicide attempt history :

  * Had never realized suicide attempt in his lifetime

Exclusion Criteria:

* Patients suffering from inflammatories pathology
* Antibiotic or anti-inflammatory current treatment
* Pregnancy
* Participation in another clinical trial with an exclusion period
* Patient on protective measures (guardianship or trusteeship)
A Study to Assess the Effectiveness and Safety of Irinotecan Liposome Injection, 5-fluorouracil/Leucovorin Plus Oxaliplatin in Patients Not Previously Treated for Metastatic Pancreatic Cancer, Compared to Nab-paclitaxel+Gemcitabine Treatment

The purpose of this study is to look at the efficacy and safety of Irinotecan liposome injection in combination with other approved drugs used for cancer therapy, namely 5 fluorouracil/leucovorin (5FU/LV) plus oxaliplatin compared to nab-paclitaxel + gemcitabine treatment in improving the overall survival of patients not previously treated for metastatic pancreatic cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histological or cytologically confirmed adenocarcinoma of the pancreas that has not been previously treated in the metastatic setting.
* Initial diagnosis of metastatic disease must have occurred ≤6 weeks prior to screening.
* Subject has one or more metastatic lesions measurable by computed tomography (CT) scan (or magnetic resonance imaging (MRI), if the subject is allergic to CT contrast media) according to RECIST Version 1.1 criteria.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Subject has adequate biological parameters as demonstrated by the following blood counts:(a) Absolute neutrophil count (ANC) ≥2000/mm3 without the use of hemopoietic growth factors within the last 7 days prior to randomisation (b) Platelet count ≥100,000/mm3 (c) Haemoglobin (Hgb) ≥9 g/dL obtained ≤14 days prior to randomisation.
* Adequate hepatic function as evidenced by: (a) Serum total bilirubin ≤1.5x ULN (biliary drainage is allowed for biliary obstruction), and (b) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5x upper limit of normal (ULN) (≤5x ULN is acceptable if liver metastases are present).
* Adequate renal function as evidenced by creatinine clearance ≥30 mL/min.
* Adequate coagulation studies (obtained ≤14 days prior to randomisation) as demonstrated by prothrombin time and partial thromboplastin time within normal limits (≤1.5xULN ).

Exclusion Criteria:

* Prior treatment of pancreatic cancer in the metastatic setting with surgery, radiotherapy, chemotherapy or investigational therapy
* Prior treatment of pancreatic adenocarcinoma with chemotherapy in the adjuvant setting, except those where at least 12 months have elapsed since completion of the last dose and no persistent treatment-related toxicities are present.
* Subject has only localised advanced disease.
* Documented serum albumin \<3 g/dL
* Known history of central nervous system (CNS) metastases.
* Clinically significant gastrointestinal disorder
* History of any second malignancy in the last 2 years
* Concurrent illnesses that would be a relative contraindication to trial participation
* Use of strong inhibitors or inducers of CYP3A, CYP2C8 and UGT1A1
* Neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma
* Known low or absent dihydropyrimidine dehydrogenase (DPD) activity
Pathophysiology of Inborn Immunodeficiencies

The pathophysiology of primary immunodeficiencies (PID), which encompass a broad range of different diseases with susceptibility to infection and/or a deregulated inflammatory response, is poorly understood. Available treatments are often not specific for a distinct target and might be associated with side effects. To elucidate pathophysiology of different PIDs, stool, urine, blood, tissue biopsies and/or bone marrow will be collected and analysed for anti-microbial activity and inflammatory response. In a second step, targeted treatment for different PIDs might be developed preclinically and ex vivo according to underlying pathophysiology.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of an inborn error of immunity (primary immunodeficiency, PID)
* Clinically healthy (non-age matched) volunteer

Exclusion Criteria:

* exclusion of an inborn error of immunity
* secondary immunodeficiency
* refusal to enter the study
Digital Learning on Competence in Motivational Interviewing

Motivational interviewing is an essential practical skill to promote medication adherence; however, it is rarely emphasised in nursing education. Purposes: 1. To develop a self-regulated digital learning system for motivational interviewing; 2. To evaluate the effectiveness of digital learning of motivational interviewing on mental health nurses' knowledge, skills and self-efficacy (confidence); 3. To compare the effectiveness of self-regulated digital learning, blended learning and treatment as usual learning.


Eligibility Criteria:
Inclusion Criteria:

* psychiatric registered nurse

Exclusion Criteria:

* nursing administrator
* expected to resign within three months
* blended learners who have participated in motivational interviewing
Comparing Methods to Biopsy Pancreas Mass

This study will examine whether there is any difference in number of passes needed to diagnose pancreatic masses during endoscopic ultrasound-guided biopsies using 2 different types of needles.


Eligibility Criteria:
Inclusion Criteria:

* adult
* pancreas mass

Exclusion Criteria:

* coagulopathy
* mass not approachable by endoscopic ultrasound biopsy
Diagnostic Accuracy of Near Infrared Transillumination in Combination With a Dye in the Cavitation Detection

The aim of the study will be to make a comparison in vivo of the following techniques:

DIAGNOcam, DIAGNOcam in combination with indocyanine and bitewing radiography, analyzing the ability to detect cavitation in initial proximal caries in posterior teeth using visual separation with tactile exploration as a gold standard.

Methodology:

During a period of 2 years, patients with initial proximal caries will be evaluated in the facilities of the clinic belonging to the Fundación de la Clínica Universitaria of the Rey Juan Carlos University (Madrid, Spain). Those subjects where a minimum of a proximal carious lesion (E1, E2 or D1) is diagnosed in posterior teeth will be candidates for the study. The exploration of proximal caries will be carried out in four phases: radiographic exploration, exploration with DIAGNOcam, exploration with DIAGNOcam and Indocyanine and visual-tactile exploration with separation. Once the visual-tactile examination with separation has been completed, the caries lesions will be treated. Depending on whether the lesion is cavitated or not, a non-invasive procedure or an operative treatment will be chosen.


Eligibility Criteria:
Inclusion Criteria:

* E1, E2 and D1 proximal carious lesions in permanent posterior teeth (E1: outer half of enamel; E2: inner half of enamel; D1: outer half of dentin)

Exclusion Criteria:

* estructural abnormalities
* visible clinical cavitation
* restorations on the proximal surfaces
* open contact points
* overlapping structures on the X-ray that prevent a clear view of the proximal area
Ventilation Efficacy of Size 3 or Size 4 I-gel in Female Patient Weighing 50 to 60 Kilograms

Currently, the main method for selecting an i-gel® size is based on the body weight recommendation (30-60 kg for size 3 and 50-90 kg for size 4) according to the manufacturer's recommendation. However, there is an overlapping in size selection in people weighing between 50 and 60 kilograms. Laryngeal mask airways are widely used for breast surgery, and this patient cohort is often weighed between 50-60 kilograms in National Taiwan University Hospital. Therefore, in this randomized clinical trial, the investigators will compare the ventilation efficacy of size 3 and size 4 i-gel® in anesthetized, paralyzed female patients weighing 50 to 60 kilograms who undergo breast surgery. Also, the investigators will record any side effects of size 3 and size 4 i-gel® in this cohort.

With the introduction of the laryngeal mask, it has been widely used for the management of airway during general anesthesia. Compared to the endotracheal tube, it has the advantages of easier and faster placing, reducing the proportion of a sore throat and other benefits. The i-gel® is a second-generation of the laryngeal mask. Compared to the classic laryngeal mask, it provides higher sealing pressure and better airway protection to reduce respiratory complications.

Choosing an appropriate size laryngeal mask is an important issue. Trauma during placing or positive ventilation failure may occur if the wrong size is selected. Currently, the main method for selecting an i-gel® size is based on the body weight recommendation (30-60 kg for size 3 and 50-90 kg for size 4) according to the manufacturer's recommendation. However, there is an overlapping in size selection in people weighing between 50 and 60 kilograms. Laryngeal mask airways are widely used for breast surgery, and this patient cohort is often weighed between 50-60 kilograms in National Taiwan University Hospital. Therefore, in this randomized clinical trial, the investigators will compare the ventilation efficacy of size 3 and size 4 i-gel® in anesthetized, paralyzed female patients weighing 50 to 60 kilograms who undergo breast surgery. Also, the investigators will record any side effects of size 3 and size 4 i-gel® in this cohort.

Keywords: Airway management; laryngeal mask airway; breast surgery

Eligibility Criteria:
Inclusion Criteria:

* Age \> 20 years old.
* ASA physical status I and II.
* Elective breast surgery.
* Female with a body weight of 50 - 60 kilograms.

Exclusion Criteria:

* High risk of aspiration. (defined as history of gastroesophageal reflux, hiatal hernia, previous gastric surgery, and those who take medications for disorders of gastrointestinal motility)
* Previous head \& neck surgery.
* Previous head \& neck concurrent chemoradiotherapy (CCRT)
* Reactive airway disease: chronic obstructive pulmonary disease (COPD), asthma, upper respiratory infection in recent two weeks
* Exposure to tobacco
* Pregnancy
Stereotactic Management of Arrhythmia - Radiosurgery Treatment and Evaluation of Response in Ventricular Tachycardia

Prospective single-arm study investigating the efficacy and safety of non-invasive cardiac radiosurgery for the treatment of ventricular tachycardia (VT) with reduced dose of radiation (20 Gy). The efficacy and safety outcome measures will be compared with historical control - patients treated within the SMART-VT study (NCT04642963) with a single dose of 25 Gy to test the hypothesis that reduced dose of radiation is similarly effective in terms of reduction of VT burden.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Patients with structural heart disease
* Patients with implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy with defibrillation (CRT-D)
* Clinically symptomatic ventricular arrhythmia despite adequate treatment, with episodes of ventricular tachycardia occurring at least 3 times per month
* At least one episode of monomorphic ventricular tachycardia recorded during an electrophysiological examination
* Recurrent VT despite at least one previous failed attempt at percutaneous ablation or disqualification from this treatment method (eg, patients after percutaneous closure of patent foramen ovale, ventricular septal defect).
* Persistent recurrence of VT despite adequate pharmacotherapy.
* Informed consent of the patient to participate in the study.

Exclusion Criteria:

* Premature ventricular contractions
* Cardiac damage requiring inotropic treatment
* Implantation of left ventricular assist device (LVAD)
* Ventricular arrhythmia in the course of channelopathy
* Reversible cause of VT
* New York Heart Association (NYHA) stage IV heart failure
* Myocardial infarction or cardiac surgery in the last 3 months.
* Life expectancy less than 6 months
* Polymorphic ventricular tachycardia
* Pregnancy or breastfeeding
* Substrate location that prevents safe radiotherapy (eg due to location relative to critical organs, or dose given during previous radiotherapy treatments).
* Evidence of an active systemic, pulmonary or pericardial inflammatory process that has required systemic treatment in the past 6 months (eg disease-modifying drugs, steroids, immunosuppressants). Patients treated for sarcoidosis who are currently in remission on chronic immunosuppressive drugs, without current signs of an acute inflammatory process, may be included in the study.
* Active, uncontrolled malignancy and/or chemo/immunotherapy in the past month or planned within the month following radioablation.
* Lack of the informed consent
Paradigm I Clinical Trial: Study of the PFX Closure System in Subjects With Cryptogenic Stroke, Transient Ischemia Attack or Paradoxical Embolism

The primary objective of this study is to demonstrate the safety of the PFX Closure System when utilized for patients with patent foramen ovale (PFO) suffering from cryptogenic stroke, transient ischemic attacks or paradoxical embolism.

Patent Foramen Ovale has been implicated in the etiology of paradoxical embolism, cryptogenic stroke, transient ischemic attack (TIA), and right to left gas embolism in severe decompression illness. An association between patent foramen ovale and severe migraine headaches has also been reported. Several implantable devices are being used for percutaneous closure of patent foramen ovale; we propose to use a non-implantable system to safely effect closure.

Eligibility Criteria:
Inclusion Criteria:

* Subject is between 18 and 65 years old.
* Documented patent foramen ovale as determined by positive micro bubble study demonstrating right to left shunt and/or anatomic detection and functional assessment by pre-operative TCD and peri-operative echocardiography or ultrasound.
* Subjects with a history of cryptogenic stroke, transient ischemic attack or paradoxical embolism due to presumed paradoxical embolism through a PFO.
* Negative pregnancy test in women who are of child-bearing potential.
* Signed Informed Consent form.

Exclusion Criteria:

* Presence of thrombus at the intended site of closure, in left atrial appendage, or documented evidence of venous thrombus in the vessels through which access to the PFO is gained.
* Active endocarditis, or other infections producing a bacteremia.
* Presence of atrial septal defects or fenestrations which allow right-to-left shunting.
* Presence of implanted cardiac valves, pacemaker, implantable cardioverters/defibrillators (ICDs) or vena cava filters.
* Subjects with an intra-cardiac mass, tumor, clot or vegetation.
* Large, redundant atrial septal aneurysm that would prohibit adequate device access to the PFO or closure of the PFO, in the judgment of the investigator. A coexisting redundant atrial septal aneurysm is considered large if it prohibits the ability of the operator to adequately achieve vacuum suction necessary to achieve PFO closure.
* Presence of arrhythmia requiring pharmacologic or electrical therapy intervention or 1st degree block.
* Current enrollment in any investigational trial(s) using devices implanted in the vascular system or enrolled in any experimental drug study(ies) within three months of study entry.
* History of stroke or TIA within the past 14 days.
* Source of stroke other than paradoxical embolization.
* Hemodynamic instability or shock.
* Hypercoagulable disorder.
* Subjects with coagulation disorders who are unable to take antiplatelet or anticoagulant therapy.