cyrilzakka/clinical-trials huggingface dataset:
Adequacy of Pain Management for Upper Extremity Fracture After Discharge From a Pediatric Emergency Depart

Pain is a common cause for children seeking care in the Emergency Department (ED). Children with orthopedic injuries often require pain control when seeking emergency care. Despite the high prevalence of ED visits requiring pain control, pain is often poorly assessed and treated in ED settings. Currently, no standard of care exists for the management of this fracture-related pain in children discharged from the ED. Furthermore, discrepancies in analgesia administration to patients of various racial groups seeking emergency care have been documented but are poorly understood. No research currently exists comparing pain severity between upper extremity fractures requiring simple splinting to those treated with sedated reduction and splinting. Furthermore, there is no research regarding the prevalence of significant post-discharge pain nor the differences among ethnic and age groups treated in the ED.

Research Questions:

What is the prevalence of significant post-discharge pain in children treated for upper extremity fractures?

Is there a difference in severity between those children requiring reduction versus simple splinting?

Is there a difference in pain severity noted among different ethnic or age groups?

Design This is a prospective, un-blinded, observational study that will include patients seeking treatment for an upper extremity fracture.


Eligibility Criteria:
Inclusion Criteria:

* Parents/guardians of patients presenting to the ED will be included if:
* The patient is younger than 18 years old
* The patient has an isolated upper extremity fracture (including clavicle, humerus, forearm, wrist) undergoing ED splinting with or without reduction
* The parent/guardian is English, Spanish, Somali, or Hmong-speaking
* The parent/guardian lives with the child
* He/she has a working telephone number

Exclusion Criteria:

* Potential subjects presenting to the ED will be excluded from study participation if:
* There is suspicion of child abuse or neglect
* The parent/guardian is not English, Spanish, Somali, or Hmong-speaking
* The patient is critically ill
* The fracture requires operative reduction/treatment
* The patient is medically complex
* The patient has a pre-existing bone disease or chronic pain syndrome
Sacubitril/Valsartan Treated Adult Patients With Chronic Heart Failure

This study evaluated changes in healthcare resource utilization (HCRU) and costs of care within 12 months following initiation of sacubitril/valsartan (sac/val) in commercially insured and Medicare Advantage (MA) lives in the U.S among adult patients with heart failure with reduced ejection fraction (HFrEF) (cohort 1) and adult patients with chronic heart failure (CHF) (cohort 2).

This was a non-interventional, retrospective cohort study using secondary data sources from the Optum Clinformatics® Data Mart (CDM) and 100% files of the CMS Medicare RIFs.

Two study cohorts were constructed to include adult Heart Failure with reduced ejection fraction (HFrEF) patients who newly initiated sacubitril/valsartan (Cohort 1) and adult Chronic Heart Failure (CHF) patients who newly initiated sacubitril/valsartan (Cohort 2).

The date of first prescription fill for sacubitril/valsartan during the cohort identification period was defined as index date. A 12-month washout period was employed to ascertain the "new user" status. The Healthcare Resource Utilization (HCRU) and costs of care outcomes will be measured within both the 12 months post-index period and the 12 months pre-index period.

Eligibility Criteria:
Inclusion Criteria:

Cohort 1 - Adult HFrEF patients

* Newly initiated sacubitril/valsartan during the cohort identification period;
* Presence of an International Classification of Diseases, Tenth revision (ICD-10) diagnosis code for systolic HF (I50.1x, I50.2x, I50.4x) on one inpatient hospital claim or two outpatient medical claims during the cohort identification period;
* That are ≥ 18 years old at index date;
* That are treated with sacubitril/valsartan continuously for a minimum of 90-days following treatment initiation;
* That are continuously enrolled in medical and prescription pharmacy benefits in both the pre-index and post-index period, with any gap in coverage of \<45 days allowed.

Cohort 2 - Adult CHF patients

* Newly initiated sacubitril/valsartan during the cohort identification period;
* Presence of ICD-10 diagnosis code for systolic HF or diastolic HF (I50.1x, I50.2x, I50.3x, I50.4x) on one inpatient hospital claim or two outpatient medical claims during the cohort identification period;
* That are ≥ 18 years old at index date;
* That are treated with sacubitril/valsartan continuously for a minimum of 90-days following treatment initiation;
* That are continuously enrolled in medical and prescription pharmacy benefits in both the pre-index and post-index period, with any gap in coverage of \<45 days allowed.

Exclusion Criteria:

- Patients who died during the post-index period will be excluded.
Evaluation of a Physical Activity Referral Scheme

The study will evaluate the effectiveness of a co-developed exercise referral scheme. Participants will be recruited to one of three groups 1. Co-developed exercise referral scheme, 2. Usual care exercise referral scheme, 3. No treatment control (no intervention). The study will measure effectiveness by observing change in cardiorespiratory fitness at 12 weeks. Intervention cost-effectiveness will also be evaluated at 3 months follow-up using objective physical activity data.

Evidence of effectiveness for UK exercise referral is unclear. This representation has been deemed an unfair assessment of its potential to impact public health. This is due to systematic review evidence that reports evaluations of exercise referral interventions that are not evidence-based or underpinned by behaviour change theory.

This evaluation is the third phase of a project that aims to co-develop (Phase 1), pilot (phase 2) and evaluate (phase 3) an evidence-based exercise referral scheme. This approach is underpinned by the Medical Research Council guidance for complex interventions.

Through co-development work with a multidisciplinary group of researchers and local stakeholders and subsequent pilot work, it is hypothesised that the co-developed, evidence-based intervention will have improved chances of implementation success, and therefore, clinical effectiveness.

Eligibility Criteria:
Inclusion Criteria:

• 18 years or older and have a health-related risk factor (e.g. high blood pressure, hyperglycaemia, obesity etc.) or a health condition (diabetes, cardiovascular disease, anxiety, depression etc.) that may be alleviated by increasing current PA levels.

Exclusion Criteria:

* Uncontrolled health-conditions (Cardiac, metabolic, respiratory etc.) and/or any recent traumatic events (e.g. myocardial infarction).
* Unstable angina or aortic stenosis.
* Severe psychological or neurological conditions.
* Participation in an ERS at any location other than the research centres (at the time of recruitment).
Three-dimensional Analysis of EMMPRIN on Conjunctival Epithelial Cells Surface in Severe Dry Eye Syndrome (ALTESSE)

Modifications of cell surface markers (including EMMPRIN) were observed in conjunctival epithelial cells during dry eye syndrome ; this study aims to describe the modifications of the repartition of these cell surface markers before and after initiation of a treatment.


Eligibility Criteria:
Patients:

Inclusion criteria

* 18 years and over
* Severe eye dryness (grade 3 or 4) as defined by the International Dry Eye Work Shop (2007): Frequent symptoms, Impregnation of fluorescein at the conjunctival level, marked fluorescein staining at the corneal level, Tear Break Up Time ≤ 5 seconds (fluorescein test) Schirmer's test score without anesthesia ≤ 5mm at 5 minutes

Exclusion criteria

* Treatment with topical ciclosporin
* Autologous serum treatment
* Wearer of scleral lenses
* Known pregnancy or breastfeeding

Control subjects:

Inclusion criteria

* 18 years and over
* Tear Break Up Time \> 5 seconds (fluorescein test)

Exclusion criteria

* Wearer of contact lenses
* Functional ocular signs
* Anomalies of the ocular surface observed during examination with the slit lamp
* Fluorescein staining of the ocular surface (cornea, conjunctiva)
* Topical ocular treatment
* Known pregnancy or breastfeeding
Uncemented Total Elbow Arthroplasty Data Collection

The purpose of this study is to document the performance and clinical outcomes of uncemented total elbow replacements involving the press-fit technique performed at the Vanderbilt Hand Center. The press-fit use technique is often used because of complications with cement loosening.

The three parts of this study will be:

Retrospective Chart Review-

A chart review will be completed on all patients that have had an uncemented total elbow arthroplasty using the press-fit technique at Vanderbilt Hand \& Upper Extremity Center. The chart review will include:

* A historical data form
* An operative data form
* A radiographic assessment form

Questionnaire Mailing- We will mail prospective study patients a DASH (Disabilities of the Arm, Shoulder and Hand) questionnaire to complete with a mailing letter explaining the request for this information. The DASH will be modified to ask patients regarding their pre-operative time as well.

Clinical Data Collection-

We will enroll patients who have already had/or will be having a uncemented total elbow arthroplasty using the press-fit technique. If the patient already has a file completed through the chart review we will not complete the historical data form, operative form, or previous radiograph assessments. If the patient does not have a file completed through the chart review the data collection will include:

* An Informed Consent Document
* A historical data form
* An operative data form
* A radiographic assessment form
* Patient-completed DASH questionnaire
* Elbow Assessment Form

Eligibility Criteria:
Inclusion Criteria:

* Any patient who has had a total elbow arthroplasty using a press-fit technique at the Vanderbilt Hand \& Upper Extremity Center

Exclusion Criteria:

* Patients less than 18 years old
* For chart review and post-operative enrollment the patients must have adequate radiographs.
Community Health Workers and Diabetes Education

The aim of this study is to evaluate the effect of a diabetes education program delivered to CHW in improving the metabolic control of patients with type 2 DM.

The study is a randomized controlled trial conducted in a primary care unit. Eight CHW, providing care for 118 patients, are randomized in two groups to receive a one-month diabetes education program (intervention group, patients n= 62) or an education course in other health issues (control group, patients n= 56).

Background: In Brazil, community health workers (CHW) are members of the community hired by the government to provide education and care for patients for a broad range of health issues, including diabetes mellitus (DM). However, few CHW are trained for diabetes education and little is known about the effectiveness of their interventions. The aim of this study is to evaluate the effect of a diabetes education program delivered to CHW in improving the metabolic control of patients with type 2 DM.

Materials and methods: the study is a randomized controlled trial conducted in a primary care unit. Eight CHW, providing care for 118 patients, are randomized in two groups to receive a one-month diabetes education program (intervention group, patients n= 62) or an education course in other health issues (control group, patients n= 56). Each CHW is responsible for transmitting the acquired knowledge to patients from their respective working areas. The primary outcome is change in HbA1C three months after intervention.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with diabetes mellitus who live in the community of the health care unit and who agree to participate the study.

Exclusion Criteria:

* None.
Validation of the BREATHE Asthma Intervention Trial

The overall goal of this study to preliminarily validate a novel intervention delivered by primary care providers (PCPs) to their Black adult patients with uncontrolled asthma in federally qualified health centers (FQHCs).

Nearly every asthma related hospitalization and death could be prevented with appropriate self-management that achieves and maintains disease control. However, as many as 64% of adults have uncontrolled asthma; minorities are disproportionately represented within that population. While inhaled corticosteroids (ICS) are a safe and effective treatment for uncontrolled asthma, relative to Whites, Blacks have lower rates of ICS adherence.

Black adults with uncontrolled asthma experience profound health disparities. Despite data that point to the critical need for enhanced asthma self-management, rates of controlled asthma are well below Healthy People 2020 targets, particularly among vulnerable populations. This Brief Evaluation of Asthma Therapy (BREATHE) intervention has the potential to offer a new avenue to asthma control via shared decision-making that supports ICS adherence.

Eligibility Criteria:
PROVIDER RECRUITMENT

Inclusion Criteria:

* PCPs (MDs and Nurse Practitioners (NPs)/Physician Assistants (PAs)) working in family, primary or internal medicine care services
* Who have at least 40 adult patients with persistent asthma (defined as having been prescribed ICS) on their patient panel

Exclusion Criteria:

* PCPs whose primary focus is outside of adult health services (family, primary or internal medicine), such as behavioral health, pediatrics and Obstetrics and Gynaecology (OB-GYN)

PATIENT RECRUITMENT

Inclusion Criteria:

Patients must be

1. adults (\> or = 18 years of age) who self-report race as Black or African American
2. with PCP-diagnosed persistent asthma
3. prescribed ICS
4. receiving asthma care at participating FQHCs
5. who have uncontrolled asthma
6. have erroneous personal health and/or negative ICS beliefs

Exclusion Criteria:

1. participation in Phase 1 (Part 1) of the BREATHE trial (focus groups)
2. non-English speaking
3. serious mental health conditions (e.g., psychosis) that preclude completion of study procedures or confound analyses
Study of Motexafin Gadolinium and Docetaxel for Advanced Solid Tumors

The primary purpose of this study is to evaluate the safety, toxicities, and dosage for investigational drug Motexafin Gadolinium administered with docetaxel to patients with advanced solid tumors. Secondly, tumor response to the combined treatment will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old
* Histologically or cytologically confirmed diagnosis of cancer (i.e., Unresectable locally advanced or metastatic non-small-cell lung carcinoma (NSCLC) that had progressed during or after one or more chemotherapy regimens; Metastatic breast cancer; Hormone-refractory prostate cancer; Recurrent or refractory ovarian cancer; Sarcoma)
* ECOG performance status score either 0 or 1
* Willing and able to provide written informed consent

Exclusion Criteria:

Laboratory Values of:

* Absolute neutrophil count \< 2000/µL
* Platelet count \< 100,00/µL
* AST or ALT \> 1.5 x the upper limit of normal
* Alkaline phosphatase \> 5 x the upper limit of normal
* Bilirubin \> ULN
* Creatinine \> 2.0 mg/dL

and

* Peripheral neuropathy NCI CTC Grade 3 or higher
* Chemotherapy, radiation therapy, immunotherapy, or systemic biologic
* anticancer therapy within 21 days before beginning study treatment
* Known history of brain metastases or spinal cord compression
* Uncontrolled hypertension
* Myocardial infarction within 6 months before beginning study treatment
* Unstable angina pectoris, uncontrolled congestive heart failure, or uncontrolled serious arrhythmias
* Known sensitivity to or intolerable adverse effects from taxanes or polysorbate 80
* Known history of porphyria (testing not required at screening)
* Known history of glucose-6-phosphate dehydrogenase (G6PD) deficiency (testing not required at screening)
* Known history of HIV infection (testing not required at screening)
* Female who is pregnant or lactating (pregnancy test is required for all female patients of childbearing potential)
* Female of childbearing potential or sexually active male unwilling to use adequate contraceptive protection
* Physical or mental condition that makes patient unable to complete specified follow-up assessments
Inflammatory Stress and Periodontal Tissue Destruction

Metabolic syndrome and periodontitis are diseases that lower the quality of life and their incidence rates are increasing. Since both of these diseases are associated with systemic inflammation and insulin resistance, they may be comorbid. The aim of this study was to evaluate the effect of interleukin-20 (IL-20) on periodontal destruction in individuals with metabolic syndrome while considering the relationship between metabolic syndrome and periodontitis.

This study included a total of 80 individuals who were systemically and periodontally healthy (CG, n=20), were systemically healthy and had periodontitis (PG, n=20), had metabolic syndrome and were periodontally healthy (MG, n=20), or had both metabolic syndrome and periodontitis (MPG, n=20). Gingival crevicular fluid (GCF) and serum samples were collected from all participants for biochemical analyses.


Eligibility Criteria:
Study groups were created based on the guidelines of the 2017 Classification of Periodontal Diseases and the 2005 Metabolic Syndrome Diagnostic Criteria of the Endocrinology and Metabolic Society of Turkey

Inclusion Criteria:

* all participants were required to have at least 20 teeth and be between the ages of 20 and 65 years

Exclusion Criteria:

* Smokers, patients who had used antibiotics or anti-inflammatory and antioxidant drugs in the last 6 months, patients who were pregnant or lactating, those who had cancer or autoimmune diseases, and those who had undergone any periodontal treatment in the last 6 months
Neural Mechanisms of Cognitive Assessment and Rehabilitation for Cognitive Decline

This study investigates the neural mechanisms of cognitive function decline, cognitive assessment methods for subjects with mild cognitive dysfunction (Mild cognitive impairment, MCI, or cognitive decline milder than MCI), and the approaches used to improve and restore cognitive function.

Cognitive assessment tools are used to assess cognitive function of subjects in different cities. Functional and structural MRI and EEG are applied to investigate the neural mechanisms of cognitive function decline and effects of methods to improve and restore cognitive function.

Eligibility Criteria:
Inclusion Criteria:

* Adults being able to walk at least a block, and
* Adults with subjective cognitive decline (SCD), or
* Adults with mild cognitive impairment (MCI), or
* Adults with normal cognitive function

Exclusion Criteria:

* Clinical diagnosis of dementia
* Adults who cannot follow the protocal
LiquID Guide Catheter Extension Safety Study

Single arm, open label, historically controlled, multicenter study evaluating the primary safety and performance of the LiquID Guide Catheter Extension

The study will consist of evaluating the safety and performance of the LiquID Guide Catheter Extension (GCE) compared to historical data. The safety measures will consist of procedural Major Adverse Cardiac Events (MACE) while performance measures will include Device Oriented Clinical Outcomes.

Eligibility Criteria:
Inclusion Criteria - participants must be:

1. scheduled for non-emergent, percutaneous coronary procedure in which the use of a guide catheter extension is anticipated
2. able to provide informed consent to participate in the study

Exclusion Criteria - participants must not have:

1. evidence of ongoing ST-elevation myocardial infarction (STEMI) or STEMI treatment for late presentation STEMI with index admission (stabilized acute coronary syndrome allowed)
2. left ventricular ejection fraction \<20%
3. required intervention in a saphenous vein graft
4. an intolerance or known allergy to medications/contrast expected to be used during the procedure or during hospital stay
5. had a cardiac intervention within two weeks of the procedure
6. renal insufficiency (serum creatinine of \> 2.3 mg/dl)
7. active gastrointestinal bleeding
8. an active infection or fever (\>37.8º C) that may be due to infection
9. significant anemia (hemoglobin \< 8.0 mg / dl)
10. severe uncontrolled systemic hypertension (systolic press. \> 240 mm Hg within the past month)
11. a severe electrolyte imbalance
12. congestive heart failure (NYHA Class IV)
13. presented with an acute coronary syndrome where serum troponin concentrations have not been demonstrated to be declining prior to the scheduled procedure (within the past two weeks)
14. uncontrolled diabetes (\> 2 serum glucose concentrations of \> 350 mg/dl within the past 7 days)
15. participation in an investigational protocol
16. unwillingness or inability to comply with any protocol requirements
17. angina, or ischemia caused by occluded artery
18. other clinical conditions, that in the opinion of the investigator significantly compromise the ability to perform a safe and/or effective procedure

Vulnerable Population Exclusion - participants must not be:

1. under 18 years old
2. pregnant or nursing
3. immuno-compromised
4. over 89 years old
5. incapacitated, mentally compromised or otherwise incapable of understanding and/or providing informed consent (including emergency situations)
All-cause and Diseases-specific Mortality of High-risk HPV Infection

The corresponding prevention strategies and treatment routes of HPV infection can be provided through investigating causes of death due to HPV infection and specialized diseases.

Anxiety and panic about HPV infection have become common phenomena in tumor screening. Transitional and useless diagnosis and treatment caused by HPV infection are also common, affecting women's physical and mental health and health economic level. If the investigators can understand the causes of death related to HPV infection and specialized diseases, the investigators can provide corresponding prevention strategies and treatment routes from the level of health policies and individual methods and mechanisms, and also alleviate the related panic caused by HPV infection.

Eligibility Criteria:
Inclusion Criteria:

1. Female participate in at least once cervical cancer screening with clear information of HPV DNA test results;
2. Having clear identification (ID number or others) that can be retrieved in the cause of death database.

Exclusion Criteria:

Cases that do not fully meet all inclusion criteria are used as exclusion criteria.