cyrilzakka/clinical-trials huggingface dataset:
Multimodal Physician Intervention to Detect Amblyopia

Current research shows low rates of quantitative vision screening at preschool ages in the medical home. This study targets providers (PCPs) to evaluate the effectiveness of a web-based intervention to improve knowledge about strabismus, amblyopia and preschool vision screening, to increase preschool vision screening rates, and to improve rates of diagnosis of strabismus and amblyopia by eye specialists.

Despite decades of research showing adverse neural consequences of abnormal vision, little has changed for amblyopic children. Over the past 40 years, data have shown that most children with amblyopia are detected late. In our health care system, primary care physicians play a pivotal role in translating findings about amblyopia into practice. But, our experience with the Maternal and Child Health Bureau (MCHB) / NEI expert panel on Vision Screening in the Preschool Child and the MCHB/ American Academy of Pediatrics (AAP) Project Universal Preschool Vision Screening revealed that primary care physicians get very little training about amblyopia and risk factors. Consequently, many do not screen aggressively for these conditions.

The University of Alabama Departments of Optometry, Pediatrics and Continuing Medical Education, in collaboration Medicaid Agencies in Alabama, South Carolina and Illinois, have developed a novel, internet-based, multi-modal strategy to increase the understanding and recognition of amblyopia and its risk factors by pediatricians and primary care physicians in office based settings. We have designed a cluster-randomized, controlled clinical trial to test whether our intervention results in improved performance by "intervention" physicians compared to control physicians (exposed to a web-based intervention for pediatric blood pressure screening and adolescent chlamydia screening). Our design, along with pre / post-intervention and control / intervention performance measures, will evaluate changes in practice attributable to the intervention versus those occurring from other sources over time. Our final analysis will show whether preschool patients of intervention physicians are more likely to be identified with strabismus or amblyopia. This research forges a critical link between the truly phenomenal body of amblyopia research fostered by the NEI and the health care offered to American children.

Eligibility Criteria:
Inclusion Criteria:

* files Medicaid claims for at least 8 well child visits for children aged 3 or 4 years during one year,
* files claims under individual name,
* has internet access.

Exclusion Criteria:

* files fewer than 8 Medicaid claims for well child visits for children aged 3 or 4 years old during one year,
* files claims under a clinic name,
* does not have internet access.
Investigate the Aerosol Particle Distribution During Aerosol Generating Procedures

Massive number of clinicians were infected during the outbreak of COVID-19, which raised the concerns of utilizing "aerosol generating procedures", particularly the use of high-flow nasal cannula, noninvasive ventilation, intubation, bronchoscopy examination and pulmonary function test. There appears to be a trend to avoid those treatments. Instead, aggressive intubation might cause shortage of medical devices and add extra workload. Therefore, we aimed to do a clinical observational study to evaluate the aerosol generation in these procedures and explore the potential measures to reduce the aerosol generation or dispersion.

The intent is to monitor exhaled aerosol produced by COVID-19 patients pre and post aerosol generating procedures. Monitoring will occur at a distance of 1 and 3 feet from the subject's airway. This observational study will be conducted in standard patient hospital rooms (standard or negative pressure room).

Eligibility Criteria:
Inclusion Criteria:

• Adult patients who are diagnosed as COVID-19 infection in ICU or Adult patients are indicated for pulmonary function tests

Exclusion Criteria:

• No need for any respiratory therapy
Portal Hypertension Using Magnetic Resonance Elastography

This prospective study was conducted in a tertiary university hospital. The investigators researched the correlation between MRE-assessed stiffness of the liver and spleen and the Hepatic venous pressure gradient (HVPG) values. Furthermore, the investigator evaluated whether MRE-assessed stiffness reflected changes in portal hypertension (PH) after administering non-selective beta-blockers (NSBBs).


Eligibility Criteria:
Inclusion Criteria:

* diagnosed liver cirrhosis
* requiring prophylactic treatment of esophageal varices

Exclusion Criteria:

* the coexistence of hepatocellular carcinoma
* refractory ascites who regularly underwent large-volume paracentesis
* the use of selective beta-blocker or carvedilol therapy for at least 4 weeks
* undergoing liver transplantation
* contraindication with magnetic resonance imaging
Seasonal Differences in Home Dialysis Uptake and Initiating Dialysis in the Hospital

This study will investigate whether home dialysis uptake varies by the season of year. We will also investigate whether hospitalizations around the time of dialysis also vary by season of year and whether hospitalizations are associated with reduced home dialysis starts and sustained home dialysis uptake.


Eligibility Criteria:
Inclusion Criteria:

* Started dialysis in the USA for end-stage kidney disease from 12/1/2007-11/30/2017
* No transplant or death prior to day 90 of dialysis
* Medicare Parts A/B as primary payer 30 days prior to starting dialysis
* Valid Medicare Evidence Form (Form 2728)

Exclusion Criteria:

* As above
Association Between Trimethylamine-N-oxide and Gestational Diabetes Mellitus

Background: The microbiota-dependent metabolite trimethylamine-N-oxide (TMAO) has been reported as a novel and independent risk factor for the development of cardiovascular and metabolic diseases, but the association with gestational diabetes mellitus (GDM) remains unclear.

Objective: To investigate the association between plasma TMAO concentration and GDM in a two-phase study.

Design: The initial discovery phase included 866 pregnant women (433 GDM cases and 433 matched controls) in Wuhan China. Study participants were recruited from pregnant women who attended the outpatient clinics of the Department of Endocrinology, Tongji Hospital, to screen for GDM between August 2012 and April 2015, or pregnant women who visited the Hubei Maternal and Child Health Hospital or the Central Hospital of Wuhan for a routine antenatal checkup from May 2014 to November 2016. The inclusion criteria of participants were: age ≥ 20 years, gestational age between 24 and 32 weeks, no history of a diagnosis of diabetes or gestational diabetes, and no history of receiving pharmacological treatment known to affect glucose metabolism. An independent replication phase study was nested within an ongoing prospective cohort study, namely the Tongji Maternal and Child Health Cohort (TMCHC). Beginning in January 2013, women receiving prenatal care prior to 16 weeks of gestation were invited to join the TMCHC. Exclusion criteria included pre-pregnancy diabetes, clinically significant neurological, endocrinological or other systemic diseases and multiple pregnancies. All enrolled pregnant women received a regular prenatal checkup in hospital and underwent an oral glucose tolerance test (OGTT) during 24-32 weeks of gestation to screen for GDM. 276 members who developed GDM before May 2016 and had fasting blood collected before 20 weeks'gestation were included as cases in this analysis. Two controls were individually matched to each case from among women without GDM. These two studies were approved by the ethics committee of Tongji Medical College. All the participants gave informed written consent before they were included in the study. Plasma TMAO concentrations were determined by stable isotope dilution liquid chromatography with online electrospray ionization tandem mass spectrometry.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 20 years;
* Screened for GDM during 24-32 weeks of gestation;
* With fasting blood samples collected before 20 weeks of gestation (only for nested case-control subjects).

Exclusion Criteria:

* History of a diagnosis of diabetes or gestational diabetes;
* History of receiving pharmacological treatment known to affect glucose metabolism;
* Clinically significant neurological, endocrinological or other systemic diseases and multiple pregnancies.
Prognostic Value of Lactates in ICU

he aim of this prospective, analytic trial was to evaluate the accuracy of blood lactates levels in predicting mortality in ICU patients.

In this study, conducted over o 12 months period, arterial blood lactates levels were measured in ICU patients at admission (H0), every 6 hours during the first day and and H48.

This trial included traumatic, medical and surgical patients requiring ICU stay for a predictive period \> to 24 hours.

Blood lactates were evaluated as a prognostic parameter in predicting ICU mortality and compared to classic prognostic scores such as: SOFA score, IGS II and APACHE II.

The primary end point was ICU mortality.

Eligibility Criteria:
Inclusion Criteria:

* All adults admissions in ICU with a predicted length of stay \> 24 hours

Exclusion Criteria:

* Patients who died during the first 24 hours after ICU admission
Effects of Replacing Diet Beverages With Water on Weight Loss and Plasma Glucose Control in Type 2 Diabetes

The purpose of the present study is to evaluate the effect of replacing diet beverages with water on weight loss and biochemical indicators for insulin sensitivity and cardiometabolic risk factors of diabetic obese and overweight female adults when they are in a multidisciplinary weight loss plan.


Eligibility Criteria:
Inclusion Criteria:

* Diabetic female patient with 6.5\<H1AC\<7.2.
* Monotherapy with Metformin.
* 18-45 years of age.
* Body mass index (BMI) between 27-35 kg/ m².
* Consume DBs regularly during their habitual diet.
* Must be able to have moderate exercise.
* Must be interested to have weight loss.

Exclusion Criteria:

* Participating in a research project involving weight loss or physical activity in the previous six months.
* Pregnancy or lactation during the previous 6 months, or planned pregnancy in the next six months.
* Taking medication that could affect metabolism or change body weight.
* Report heart problems, chest pain, and cancer within the last five years.
* Unwilling to change intake of beverages during the study period.
Comparison of the Complications in Multiple Myeloma Patients Who Received Autologous Stem Cell Transplantation Between in HEPA-filtered Room and Non-HEPA-filtered Room

The goal of this observational study is to comparison of the complications in multiple myeloma patients who received autologous stem cell transplantation between in HEPA-filtered room and non-HEPA-filtered room. The main questions it aims to answer are:

* The incidence of febrile neutropenia, infection, and duration of hospital stay
* 2-year progression free survival Participants will be collected the data of baseline diagnosis, treatment, treatment results and complications during admission and follow-up visits from hospital medical record.


Eligibility Criteria:
Inclusion Criteria:

* aged 18 - 65 years old
* Patients with multiple myeloma undergoing treatment with autologous stem cell transplantation and having a Hematopoietic Cell Transplantation-Specific Comorbidity Index (HCT-CI) score less than or equal to 2
* Patients must provide signed consent to participate in the research if they undergo ASCT after the study has been approved.
* If patients undergo ASCT before the study approval, retrospective data will be collected.

Exclusion Criteria:

* Patients with concomitant other types of cancer
* Patients who refuse to participate in the study.
Strategies to Improve Prescribing in Heart Failure Patients

The purpose of the study is to assess whether primary care physicians may uptitrate recommended drug therapies in stable heart failure patients if educational material and specialist support including phone or mail consultation are provided

Heart failure is highly prevalent, particularly in elderly subjects, and costly, mainly because of the high rate of recurrent hospital admissions. Although guideline-recommended treatments, such as beta-blockers and renin-angiotensin inhibitors, are effective on both mortality and morbidity, these drugs are very often underprescribed or used at lower doses than those shown to be beneficial in clinical trials, particularly in the primary care setting, for fear of adverse events. Although referral to specialist services may improve prescription of recommended drugs and doses achieved, frequent consultations may be unfeasible and costly.The study is designed to assess whether active specialist support and educational material improve the prescription process for heart failure patients in primary care

Eligibility Criteria:
Inclusion Criteria:

* a confirmed diagnosis of heart failure wih depressed systolic function (left ventricular ejection fraction \<40% in the previous 6 months).
* stable NYHA class II-III
* a clinical indication to implement drug therapy with betablockers and/or renin-angiotensin system inhibitors and current dose \<50% of the target dose

Exclusion Criteria:

* NYHA class IV or clinically unstable
* cardiac surgery or cardiac resynchronization therapy planned within the following 6 months
* discharged to a rehabilitation unit refusal or impossibility to present to outpatient visits
An Immunity Persistence Study of Sabin Inactivated Poliovirus Vaccine(Vero Cell) After Four Doses

This is an open and observational follow-up clinical trial based on the previous Phase III clinical trial of Sabin Inactivated Poliovirus Vaccine manufactured by Sinovac Biotech Co. , the purpose of this study is to evaluate the immunity persistence of sIPV in infants after 4 doses of vaccination.

This study is an open and observational follow-up clinical trial based on the previous Phase III clinical trial of Sabin Inactivated Poliovirus Vaccine.The purpose of this study is to evaluate the immunity persistence of sIPV in infants after 4 doses of vaccination.A total of at least 450 subjects who have received 4 doses of the experimental vaccine or control vaccine will be enrolled,about 3.0ml of venous blood will be collected from each enrolled subject at the age of 4 years (48 to 54 months) and 5 years (78 to 84 months) after the last vaccination, respectively,and the serum will be separated for neutralizing antibody detection.The antibody levels of the experimental vaccine group and the control vaccine group will be compared to evaluate the immunity persistence of sIPV.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who have received 4 doses of experimental vaccine or control vaccine in phase Ⅲ clinical trials

Exclusion Criteria:

* History of vaccination of other vaccine with poliovirus antigenic components except that of phaseⅢ clinical trial.
To Determine the Fasting Bioequivalence of Reformulated OXY Tablets and Original OxyContin® (OXY) Tablets

The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (40 mg) relative to the original OxyContin® (OXY) formulation (40 mg) in the fasted state.

Oxycodone hydrochloride (oxycodone) is a semi-synthetic opioid analgesic that is effective in the relief of moderate to severe malignant and non-malignant pain.

Eligibility Criteria:
Inclusion Criteria:

* Males and females aged 18 to 50, inclusive.
* Body weight ranging from 50 to 100 kg and a BMI ≥18 and ≤34 (kg/m2).
* Healthy and free of significant abnormal findings as determined by medical history, physical examination, vital signs, and ECG.
* Females of child-bearing potential must be using an adequate and reliable method of contraception.

Exclusion Criteria:

* Females who are pregnant or lactating.
* Any history of or current drug or alcohol abuse for 5 years.
* History of or any current conditions that might interfere with drug absorption, distribution, metabolism or excretion.
* Use of an opioid-containing medication in the past 30 days.
* History of known sensitivity to oxycodone, naltrexone, or related compounds.
* Any history of frequent nausea or emesis regardless of etiology.
* Any history of seizures or head trauma with current sequelae.
* Participation in a clinical drug study during the 30 days preceding the initial dose in this study.
* Any significant illness during the 30 days preceding the initial dose in this study.
* Use of any medication including thyroid hormone replacement therapy (hormonal contraception is allowed), vitamins, herbal, and/or mineral supplements, during the 7 days preceding the initial dose.
* Refusal to abstain from food for 4 hours following administration of the study drugs and to abstain from caffeine or xanthine entirely during each confinement.
* Consumption of alcoholic beverages within forty-eight (48) hours of initial study drug administration (Day 1) or anytime following initial study drug administration.
* History of smoking or use of nicotine products within 45 days of study drug administration or a positive urine cotinine test.
* Blood or blood products donated within 30 days prior to administration of the study drugs or anytime during the study, except as required by this protocol.
* Positive results for urine drug screen or alcohol screen at Check-in of each period, and HBsAg, HBsAb (unless immunized), anti-HCV.
* Positive Naloxone HCl challenge test.
* Presence of Gilbert's Syndrome or any known hepatobiliary abnormalities.
Carotid Revascularization With MicroNet Covered Stent Comparing Early Neurological Outcomes With Distal Versus Proximal EPS

The SIBERIA study demonstrated a clear advantage of CGuard stent implantation over the existing classical stent when using a distal anti-embolic device. At the same time, there is no Level 1 evidence for a difference between the proximal and distal anti-embolic device for the CGuard stent.


Eligibility Criteria:
Inclusion Criteria

1. Consecutive patients 45-80 years old accepted for CAS following neurological consultation and qualification for the procedure according to center's routine practice.
2. More than 6-month life expectancy
3. Suitable clinical conditions for performing DW-MRI
4. Written Informed consent approved by the Ethics Committee
5. Subject agrees to all required follow-up procedures and visits

Exclusion Criteria:

1. Currently enrolled in another investigational device or drug study that has not completed the study or that clinically interferes with the current study endpoints
2. Recent surgical procedure within 30-days before or planned surgery within 30-days after the stenting procedure
3. Hepatic active disease (bilirubin\> 35 mmol / l) or renal insufficiency (serum creatinine \> 2.5 mg/dL or glomerular filtration rate \<60 ml / min)
4. Recent evolving acute stroke within 30-days of study evaluation
5. Myocardial infarction within 72 hours prior to carotid stenting procedure (CPK-MB \> 3 times normal)
6. Female patients of childbearing potential or known to be pregnant
7. Any known factor for potential stroke other than carotid stenosis, such as atrial fibrillation or atrial flutter (paroxysmal, permanent or persistent) or thrombophilia
8. Patient on VKA or new oral anticoagulants
A Study Comparing Different Dosing Regimens of Ixekizumab (LY2439821) in Participants With Moderate to Severe Plaque Psoriasis

The main purpose of this study is to evaluate the efficacy of ixekizumab dosing regimens in participants with plaque psoriasis.

The purpose of this study is to evaluate both the safety and efficacy of ixekizumab dosing regimens. There are 3 study periods: Screening Period, Blinded Treatment Dosing Period, and Post-Treatment Follow-Up.

Eligibility Criteria:
Inclusion Criteria:

* Present with chronic plaque psoriasis for at least 6 months prior to enrollment
* At least 10% BSA of psoriasis at screening and at enrollment
* sPGA score of at least 3 and PASI score of at least 12 at screening and at enrollment
* Candidates for phototherapy and/or systemic therapy
* Participant must agree to use reliable method of birth control during the study; women must continue using birth control for at least 12 weeks after stopping treatment

Exclusion Criteria:

* Predominant pattern of pustular, erythrodermic, or guttate forms of psoriasis
* History of drug-induced psoriasis
* Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to enrollment and during the study
* Received systemic non-biologic psoriasis therapy or phototherapy within the previous 4 weeks; or had topical psoriasis treatment within the previous 2 weeks prior to enrollment
* Concurrent or recent use of any biologic agent
* Have participated in any study with ixekizumab
* Received a live vaccination within 12 weeks prior to enrollment
* Serious disorder or illness other than psoriasis
* Ongoing or serious infection within the last 12 weeks or evidence of tuberculosis
* Major surgery within 8 weeks of baseline, or will require surgery during the study
* Breastfeeding or nursing (lactating) women
Retinol-induced Dermatitis in Aged Skin

Topical therapy with retinoids is the only proven medical therapy for aged/photoaged human skin. However, topical therapy with retinoids often result in unwanted cutaneous dermatitis, including erythema and scaling. The reseachers intend to investigate the dose, frequency of use, and time dependence of topical retinol-induced dermatitis. The researchers intend to evaluate retinoid-induced dermatitis biochemically, including retinol regulation of retinoid responsive genes that control retinoid metabolism and serve as markers for retinoid bioactivity. The researchers will also investigate the role of EGF receptor pathway in retinoid-induced dermatitis.


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Subject is at least 21 years of age
* Good general health
* No disease states, physical conditions or medications that would impair evaluation of the test sites
* Willingness and ability to follow protocol
* Signed written and witnessed informed consent form
* No use of oral retnoids in the past year
* No use of topical steroids to the treatment area in the past 2 weeks

Exclusion Criteria:

* Has received an experimental drug or used and experimental device in the 14 days prior to admission to the study
* History of keloids
* History of hypersensitivity to lidocaine or epinephrine
* Pregnant or nursing women
* Disease states or physical condition that would impair evaluation of the test sites or compliance with the protocol
* History of chemical peels or laser treatments to the sites evaluated