cyrilzakka/clinical-trials huggingface dataset:
Comparing Remote Interpreter Modalities in the Pediatric Emergency Department

Professional interpretation improves quality of care for patients with limited English proficiency (LEP). However, many health care settings lack access to professional interpreters, and even in locations with good access, logistical factors and perceived barriers have limited their widespread use. Remote methods of professional interpretation, including telephone and video, hold great promise for expanding access, but only limited data exist on the relative impacts of these modalities on patient care and provider uptake. Comparing how these modalities impact multiple aspects of health care quality, including family comprehension, provider communication, and consistency of provider interpreter use will inform dissemination of strategies for delivery of safe, efficient, and equitable care to LEP families.

Aim 1: To determine whether randomly assigned remote interpreter modality (telephone versus video) impacts parent-reported quality of communication and interpretation, diagnosis comprehension, and length of stay (LOS) among LEP Spanish-speaking families seen in a pediatric Emergency Department (ED).

Hypothesis 1: Parent-reported quality of communication and interpretation and parent diagnosis comprehension will be higher among families assigned to video interpretation compared to telephone interpretation.

Hypothesis 2: LOS will not differ between families assigned to video and telephone interpretation.

Aim 2: To determine whether assigned interpreter modality is associated with provider decision to communicate without professional interpretation.

Hypothesis 3: Parent-reported provider communication without professional interpretation (e.g. using the patient or a family member to interpret for some part of the visit) will be lower for families assigned to video interpretation compared to telephone interpretation.


Eligibility Criteria:
Inclusion Criteria:

* Preferred language for medical care of Spanish
* At least one primary caregiver requires interpretation
* Presenting to Seattle Children's ED during recruiting hours

Exclusion Criteria:

* Triage level 1 (life-threatening illness)
* No parent or legal guardian present
* Reason for visit is concern for abuse
* reason for visit is primary behavioral or psychiatric complaint
A Pilot Study to Increase Utilization of GDMT in Patients With HFrEF

The purpose of this study is to test a clinical decision support (CDS) tool that provides clinicians (cardiologists and nurse practitioners) medication recommendations regarding guideline directed medical therapy (GDMT) in patients with heart failure and reduced ejection fraction (HFrEF).

The purpose of our study is to test whether home blood pressure monitoring (HBPM) with clinical-decision support (CDS) will optimize the use of GDMT in patients with HFrEF. HBPM allows cardiologists and NPs to monitor patients outside the clinical setting so that GDMT can be safely initiated and up-titrated. The CDS employs HBPM and electronic medical record (EMR) data to implement the ACC/AHA HF guidelines and provides cardiologists and NPs with GDMT recommendations.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of HFrEF (left ejection fraction \< 40%, assessed by transthoracic echo, cardiac MRI, cardiac SPECT) within the past year.
* New York Heart Association (NYHA) class II-III at most recent screening assessment.
* GDMT composite score of less than or equal to 50% at baseline

Exclusion Criteria:

* Previous contraindication to beta blockers, ACE inhibitors, and/or ARB.
* Baseline creatinine \> 2 mg/dl or potassium level at baseline \> 5 mEq/L or eGFR \<30 mL/min/1.73 m2.
* Baseline systolic blood pressure \< 100 mmHg.
* Concomitant use of ACE, ARB, and/or ARNI
* Polycystic kidney disease
* History of angioedema
* History of or currently on a transplant list
* Left ventricular assist device
* Uncontrolled asthma
* Severe COPD
* Cirrhosis
* Currently receiving hospice or comfort care
* Patient not proficient with written and spoken English
* Patient has diminished decision making capability
* History of non-compliance
The Expression of CD24 "do-not-eat-me" Signal in Cholangiocarcinoma

The investigators found an inverse relationship between CD24 and MiR-122 levels. Then the investigators found that CD24 that goes up with MiR-122 down makes macrophages unable to engulf the tumor cells. All this in mice. the investigators are interested in confirming this result in humans. Details of the preliminary results are attached to the submission of the research documents. the investigators will compare Cholangiocarcinoma tumors with other solid tumors, including liver tissue. The need to deepen understanding the investigators will also make a comparison between cancerous tissue and "normal" tissue adjacent to the tumor.

The investigators will collect samples from the tissue bank. All materials will be kept in refrigerators at minus 80, except for the sections of the paraffin blocks at room temperature. The source of some of the biological samples and the information accompanying them in this study is Midgem - the Israeli repository for biological samples for research. Midgem is a non-profit association that operates within the Ministry of Health as an infrastructure for the promotion of bioresearch - Medical and industrial in Israel. The donors to Midgem are patients with malignant diseases, Non-malignant diseases as well as healthy volunteers. In Midgem, residues are collected from tissues already removed during surgery/taking a biopsy and/or samples from blood/saliva/urine/other body fluids donations and the accompanying medical information required for use in legally approved studies.There is no risk to the donors as a result of the donation of the samples and information and their use, since the donation is transferred to Midgem only after it has been ascertained beyond any doubt that the ability of the diagnosis and/or treatment of the donors will not be harmed. All the information transferred to the researchers is coded, in such a way that the investigators do not allow the identification of the donors' details. Since the donors to Midgem have signed a consent form for the collection and storage of samples and information for use in any legally approved study, the investigators request an exemption from signing a dedicated informed consent form for this study. The samples and information transferred to this study are donated in accordance with what is detailed in the inclusion criteria for the experiment.

Eligibility Criteria:
Inclusion Criteria:

\* Donors with cholangiocarcinoma samples

Exclusion Criteria:

\* Donors who do not have cholangiocarcinoma samples
Neulasta® in Subjects With Advanced Non-Small-Cell Lung Cancer (NSCLC) During Chemotherapy

The purpose of this study is to estimate the relationship between patient reported outcomes (PROs) and neutropenia (or its complications) in NSCLC subjects receiving chemotherapy with or without Neulasta® (pegfilgrastim).


Eligibility Criteria:
Inclusion Criteria: - Non-small cell lung cancer, not previously treated with chemotherapy or radiotherapy - ECOG performance status 0 or 1 - ANC greater than or equal to 2.0 x 10\^9/L Exclusion Criteria: - Cancer other than NSCLC within 5 years of enrollment, with the exception of surgically cured basal cell carcinoma or in situ carcinoma of the cervix - Treatment less than or equal to 30 days prior with any experimental agent - Subjects with symptomatic brain metastases - Subject is currently enrolled or has not yet completed at least 30 days since ending other investigational device or drug trial(s) or is receiving other investigational agent(s)
Non-acute Coronary occlusIon Treated By Everolimus ELuting Stent

Chronic total coronary occlusions (CTO) have an especially high risk of angiographic restenosis, and need for new revascularization procedures. Drug-eluting coronary stents (DES) have demonstrated to significantly reduce the risk of restenosis and new revascularization procedures in comparison with bare-metal stents.

Most data on the efficacy of DES come from the sirolimus-eluting coronary stent Cypher (Cordis corp.), and paclitaxel-eluting coronary stent Taxus (Boston Sci.), and the Cypher stent is the only DES that has been randomly tested in CTO. Among second-generation DES, everolimus-eluting stent (EES) has shown excellent angiographic and clinical results, but this DES has not been studied in unfavourable scenario (such as CTO).

The aim of the CIBELES trial is to demonstrate the hypothesis that EES are equally effective in comparison with sirolimus-eluting stents in the treatment of CTO, in terms of angiographic efficacy considered as in-stent late lumen loss.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 year-old.
* A total occlusion (TIMI 0-1) with an estimated time of occlusion \> 2 weeks.
* Symptomatic or silent ischaemia, or viable myocardium.
* The occlusion is suitable for percutaneous coronary intervention.
* The guidewire has crossed the occlusion, and the occlusion has been dilated with balloon or other device.

Exclusion Criteria:

* Acute myocardial infarction in the myocardial area supplied by the target vessel within 2 weeks before the inclusion in the study.
* The lesion can not be crossed with the guidewire and balloon angioplasty.
* The vessel has been previously treated percutaneously.
* The lesion is not suitable for a 2.25-3.5 coronary stent implantation.
* The patient is not willing to undergo an angiographic follow-up.
* The patient has contraindications for prolonged double (aspirin plus clopidogrel) anti-platelet therapy (e.g. allergy to aspirin, need for chronic oral anti-coagulation, or scheduled surgical intervention within 12 months.
* Pregnancy or absence of pregnancy test in women of childbearing age.
* Chronic renal failure (creatinine plasmatic values \> 3.0 mg/dl).
* Plasmatic platelet count \< 100.000 mm-3 or \> 700.000 mm-3.
* The patient has a severe non-cardiac disease that limits his/her life expectancy to \< 1 year.
* The patient is currently included in other randomized trial.
Broad Validation Study of a Management Algorithm Mild Head Injury in Children

Head injury is a frequent reason for consultation with pediatric emergencies, over 95% are mild head injury defined by a Glasgow score greater than or equal to 13. In October 2009, the Pediatric Emergency Care Applied Research Network has published a rule clinical decision support of mild head injury of the child with the aim to identify children at very low risk for clinically severe intracranial lesions in order to avoid the use of CT and unnecessary exposure to radiation ionizing. This clinical decision rule constructed from a multicenter prospective cohort 42,412 American children allows on anamnestic and clinical elements to guide medical decision for conducting brain imaging, hospital monitoring or discharge home placing the child in three levels of risk of clinically severe intracranial lesions.

Since March 2012, the French Emergency Medicine Society recommends for the treatment of mild head trauma the child's use of the clinical decision rule provided that it is the subject of a validation study externally. Indeed, after the construction phase and before its daily application, a clinical decision rule must be subject to an broad validation process so that its predictive performance can be definitively established.

The investigators' work aims to conduct this broad validation study prospective multicenter way in a French pediatric population, as recommended by the French Emergency Medicine Society, in order to confirm or deny its predictive performance and allow its application and generalization. The investigators will check and if the Rule Clinical Decision is adapted or not to the management of mild head injuries in the French pediatric population.


Eligibility Criteria:
Inclusion Criteria:

* Children under 16 years admitted to an emergency room for mild head injury (Glasgow Coma Scale score ≥14) in the previous 24 hours
* Children who have agreed to participate in the study (if age\> 8 years)
* Patient Parents have accepted the participation of their child in the study

Exclusion Criteria:

* Children with bleeding disorders
* Ventricular shunt Presence
* Benin mechanism of trauma (fall of the height of the child or impact against an object while walking / running with no sign that the scalp dermabrasion)
* Penetrating trauma
* Known brain tumor
* Previously known neurological disorders
* Evaluation scanographic in another hospital before emergency review
Knotless Suture in Revision Total Joint Arthroplasty

Barbed suture has been demonstrated to be safe in primary hip and knee surgery and retrospective data suggests barbed suture represents no increased complications in the revision setting. Barbed suture may represent a faster, more effective way to perform revision arthroplasty closures. There are no Level I studies comparing traditional and barbed suture closure. The purpose of this study is to assess the surgical complexities of closures using closure time without sacrificing cosmesis or wound complications between the traditional closure and barbed closure.


Eligibility Criteria:
Inclusion Criteria:

1. Patients ≥ 18 years of age
2. Surgical candidates undergoing revision total knee or total hip arthroplasty for one of the following indications second stage of two stage reimplantation for infection, mechanical loosening, instability, polyethylene wear, stiffness, or periprosthetic fracture

Exclusion Criteria:

1. Patient is ≤ 18 years of age
2. Patient is unable to provide written consent
3. Patient has active infections in the operative leg/joint
4. Known Allergy to Suture material
5. Underlying Dermatological diseases affecting surgical site including dermatitis, eczema, or psoriasis; connective tissue or vascular disorders or diseases that would adversely affect wound healing; metastatic cancer; renal insufficiency (dialysis); steroid dependence; malnourishment; and other disease processes resulting in an immunocompromised state. Diabetes, smoking and obesity will be allowed as they are frequent comorbidities in our revision joint population
6. Anterior total hip replacement
7. Stage 1 of two stage revision for infection
8. Closure performed by plastic surgeon, including flap coverage

Vulnerable populations will not be enrolled in this study.

Withdrawal Criteria

1. Failure to attend regularly scheduled follow up appointments
2. Deviation from closure protocol
Breast Cancer Treatment Based on Organ-like Culture

Based on the breast cancer organ platform, this experiment establishes a drug sensitivity test method that is closer to the body tumor in breast cancer, provides a basis for the accurate treatment of breast cancer, and discusses the possible mechanism of breast cancer drug resistance.


Eligibility Criteria:
Inclusion Criteria:

Patients with breast cancer and the largest tumor diameter ≥ 3cm No previous chemotherapy regimen age 18-65 years old Can obtain the tumor tissue specimens required for culture Heart, liver, kidney and bone marrow hematopoietic function is good Know and sign the informed consent form

Exclusion Criteria:

Pregnant or lactating women Also suffering from other cancer patients There are serious uncontrolled medical diseases or acute infections Those who are known to be allergic to this study drug or a variety of previous drugs The patient cannot understand the purpose of the study or disagree with the requirements of the study.

Other investigators believe that patients who are not suitable for this study group
Technology Assisted Motivational Interviewing

Building on our successful pilot work to develop a Motivational Interviewing (MI)-capable chatbot and cessation coach, the investigators propose to address the problems of intrinsic motivation and social barriers to smoking cessation by evaluating a highly scalable and easily accessible digital-coaching intervention that 1) promotes readiness to change using a technology-assisted MI (TAMI) chatbot, 2) provides compelling and accessible multilingual education about smoking cessation tools, and 3) develops a tailored quit plan addressing social barriers to treatment initiation and sustainment.


Eligibility Criteria:
Inclusion Criteria:

* A current Primary Care Provider patient
* Age 18 or older
* Smoke at least 1 cigarette per day for the past 7 consecutive days (and at least 100 lifetime)
* Have a digital device (phone, laptop, tablet)
* Moderately proficient in English
* Able to participate for 6-month trial

Exclusion Criteria:

* Current participation in a smoking cessation program
* Current use of Nicotine Replacement Therapy or smoking cessation pharmacotherapy
* Cognitive impairment that would preclude informed consent
Extended Follow-Up Study for Subjects Who Participated in 2010 Study

This study is being performed to follow up on subjects who participated in the initial study (ZA10-001) in 2010.

The primary objective of this investigation is to assess the durability of treatment outcomes with the ZELTIQ System.

Eligibility Criteria:
Inclusion Criteria:

1. Subject participated in the ZA10-001 study, and received all study treatments.
2. Subject has read and signed a written informed consent form.

Exclusion Criteria:

1. Subject has had any surgical or aesthetic procedure(s) in or around the abdomen since the completion of the ZA10-001 study treatments.
2. Subject is pregnant.
3. Subject is unable or unwilling to comply with the study requirements.
4. Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
5. Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the integrity of the data.
Effects of Early Stepping Verticalization + FES on CIP

Background: Intensive Care Unit (ICU) survivors often develop an acquired weakness due to a Critical Illness Polyneuropathy (CIP). Early mobilization in ICU, by reducing the bed rest and decreasing the oxidative stress, was shown to represent a valid preventive option.

Purpose: To evaluate whether ICU sessions of stepping verticalization associated with Functional Electrical Stimulation (FES) of the lower limbs are able to reduce the occurrence of CIP in Acquired Brain Injured (ABI) patients.

Methods: all the ABI patients admitted in our Neurorehabilitation Unit from our ICU were retrospectively evaluated. Patients affected by previous peripheral neuropathy, diabetes, cancer, alcoholism, viral hepatitis, AIDS and autoimmune diseases were excluded. They were divided into 3 groups according to the rehabilitation strategy received in ICU: group 1 received conventional physiotherapy + stepping verticalization sessions with Erigo® (Hocoma, Switzerland); group 2 received conventional physiotherapy + stepping verticalization sessions with FES using ErigoPro®; group 3 received only conventional physiotherapy. As for internal protocol, all patients started rehabilitation in the first week from the ABI and performed 60 minutes/day of rehabilitation, 5 days/week. Primary outcome was the evidence of CIP at Neurorehabilitation admission (=ICU discharge), according to neurophysiological criteria. Secondary outcomes were the strength impairment at Neurorehabilitation discharge, measured by the total Motricity Index score and the Functional Ambulation Classification (FAC) score, assessing quality of gait.


Eligibility Criteria:
Inclusion Criteria:

* arriving directly from our acute care facility
* hospitalized in ICU due to an acute brain injury

Exclusion Criteria:

* previous peripheral neuropathies
* diabetes
* cancer
* alcoholism
* viral hepatitis
* AIDS
* autoimmune diseases
* absence of clinical or neurophysiological informations at data collection
Diet Challenge in G6PD Deficient Egyptian Children: A One- Year Prospective Single Center Study With Genotype - Phenotype Correlation

Glucose-6-phosphate dehydrogenase (G6PD) deficiency is prevalent and add a burden on families in Egypt and Middle East due to lifelong diet restriction, non-fava beans diet is main food for most families in the region and parents and doctors consider it as a prohibited food whatever the genetic or clinical phenotypes. The effective management is avoiding a spectrum of food and drugs causing oxidative stress. No data is available about the hazards of consumption of non-fava beans diet.

Investigate the effect of challenge of non-fava beans diet on occurrence of hemolysis in both common and rare mutations causing G6PD deficiency in Egyptian children as well as making a genotype-phenotype correlation. Patients and Methods: The study will include all G6PD deficient children who were regularly followed up in Pediatric Hematology Center, Ain Shams University over last decade from 2004-2014 who stopped eating non fava-bean diet since their diagnosis as G6PD deficient and willing to participate in the diet challenge. They will be enrolled in a one year prospective study involving quantitative analyses for enzymatic activity, and molecular typing of G6PD enzyme using a polymerase chain reaction-amplification refractory mutation system (PCR-ARMS) technique. Patient's medical records will be reviewed as history of blood transfusion and G6PD level at diagnosis. Initial phase will be dietetic challenge with ingestion of non-fava beans taken in small amount (10-20 gm/day for 3 successive days ) for children with haemoglobin level ≥ 11 gm/dl with daily clinical and laboratory monitoring by complete blood count, and markers of hemolysis as well as measurement of malondialdehyde (MDA) level both basal and at study end. A drop of Hb of ≥0.5 gm/dl and / or appearance of hemoglobinuria is considered a significant hemolysis. Patients who will not meet the definition of significant hemolysis will be prospectively followed up for one year with follow up during their chronic exposure by complete blood count and hemolysis markers/ 3 months.

Eligibility Criteria:
Inclusion Criteria:

* All children with proved enzymatic deficiency of G6PD.
* Patients who met the criteria of hemoglobin level at study time ≥ 11 gm/dl

Exclusion Criteria:

* patients with another enzyme deficiency