cyrilzakka/clinical-trials huggingface dataset:
A Study of the Effectiveness And Safety Of Lidoderm® As Add-On Treatment in Patients With Postherpetic Neuralgia, Diabetic Neuropathy, or Low Back Pain

Patients with a diagnosis of postherpetic neuralgia (PHN), diabetic neuropathy (DN), or low back pain (LBP) who were currently receiving an analgesic regimen that contained gabapentin participated in a Phase IV clinical trial to assess the effectiveness of Lidoderm® administered once daily (q24h) after 14 day in the treatment of PHN, DN, or LBP in patients who had a partial response to a regimen containing gabapentin.


Eligibility Criteria:
Inclusion Criteria:

* Were currently receiving an analgesic regimen that contained gabapentin
* Had been on a stable dose of gabapentin for at least 14 days (same dose ±10% for 14 days)
* Had a partial response to a gabapentin-containing analgesic regimen defined as an average daily pain intensity score of \>4 on a ) to 10 scale, with 0 being no pain and 10 being pain as bas as the patients have ever imagined (Question 5 of the Brief Pain Inventory \[BPI\] within 24 hours prior to the screening visit
* For diabetic patients, had a hemoglobin A1c level \<0.13 (normal range, 0.047-0.064)

Exclusion Criteria:

* Had a neurological condition other than that associated with their pain diagnosis that, in the opinion of the investigator, would have interfered with their ability to participate in the study
* Had received an epidural steroid/local anesthetic injection within 14 days prior to study entry
* Had received trigger point injections within 14 days prior to study entry
* Had received Botox injections within 3 months prior to study entry
* Were taking a lidocaine-containing product that could not be discontinued while receiving Lidoderm
* Were taking Class 1 anti-arrhythmic drugs (e.g., mexiletine, tocainide)
Vulnerability of the Fetus/Infant to PAH, PM2.5 AND ETS.

The goal of this study is to examine the effects of in utero and postnatal exposure to environmental pollutants in a cohort of pregnant women and their newborns in Krakow, Poland

There is growing concern about adverse developmental effects in infants and young children from prenatal exposure to environmental air pollutants, including polycyclic aromatic hydrocarbons (PAH), particulate matter (PM2.5), and environmental tobacco smoke (ETS). The proposed study combines expertise in molecular epidemiology and biomarkers, state-of- the-art pollutant monitoring techniques, and a strong theoretical framework to guide assessment of the impacts of these pollutants on fetal and child growth and development. The specific aims are: 1. To test the hypothesis that prenatal exposure to airborne polycyclic aromatic hydrocarbons (PAH) adversely affects fetal growth and early childhood growth and development, after controlling for non-PAH components of PM2.5, ETS, nutritional status (essential fatty acids and antioxidants) and other potential confounders; 2. To explore whether non-PAH components of PM2.5, and ETS have an independent effect on birth outcomes and childhood growth and development, after controlling for PAH, and to explore possible interactions between PAH, PM2.5 and ETS; and 3. To estimate the relative contribution of ambient PAH pollution vs. ETS and other indoor PAH sources to a) personal PAH exposure and PAH-DNA adducts and b) impairment of fetal growth and early child development. To achieve these aims, the international team of researchers will carry out a prospective cohort study of 400 nonsmoking pregnant women living in Krakow, Poland, and will follow their newborns for 12 months postnatally. Fetal growth will be assessed at birth by weight, length, head circumference, and size for gestational age. Childhood growth and developmental outcomes will be measured using the Fagan Test and the Bayley Scales. Strengths of the research include the combination of personal inhalation monitoring of PAH and PM2.5 with biomarkers (umbilical cord blood levels of PAH-DNA adducts, cotinine, essential fatty acids, antioxidants and lead) to estimate in utero exposure to the pollutants of interest and potential confounders. The Polish cohort provides a valuable model for study since emissions from coal burning and traffic are relatively high. However, the results will be broadly applicable since exposures to PAH, ETS and PM2.5 during pregnancy are common in virtually all industrialized regions of the world. It is anticipated that this research will provide relevant data to policymakers concerned with protecting the health of young children.

Eligibility Criteria:
Inclusion criteria:

* Pregnant women between 18 and 40 years old
* Resided for at least 1 year within proximity to air monitoring station

Exclusion criteria:

* Smoking/ illicit drugs
* Hypertension
* Diabetes
* Occupational exposure
Study in High Risk Patients Switched From Higher Doses of Other Statins to Crestor on the Percentage of Patients Reaching the New LDL-C Target Goal

The purpose of this study is to determine the efficacy of Crestor in high risk patients switched from higher doses of other statins in obtaining the new European Atherosclerosis Society (EAS) low-density lipoprotein cholesterol (LDL-C) guidelines.


Eligibility Criteria:
Inclusion Criteria:

* High risk patients
* High doses of other statins
* LDL-C known, starts with Crestor 10 mg
* Permission to use patient data by AstraZeneca (AZ)
Reduced Visit Frequency in the Treatment of Uncomplicated Severe Acute Malnutrition: Evaluation of Operational Feasibility and Safety

Community-based management of severe acute malnutrition (SAM) has been shown to be safe and cost-effective, but program coverage remains low. New treatment models that maintain high levels of clinical effectiveness but allow for increased coverage are still needed. A reduced schedule of follow-up, in which children receive clinical follow-up and therapeutic foods on a monthly rather than weekly or biweekly basis, may be one alternative. This study aims to describe the safety and feasibility of a monthly distribution of ready-to-use therapeutic food in the treatment of uncomplicated SAM, in terms of clinical response to treatment and household ready-to-use therapeutic food (RUTF) utilization. This is a non-randomized pilot intervention study in which 115 children eligible for the outpatient treatment of SAM were provided a monthly ration of RUTF. Anthropometric measurements were taken on a weekly basis for 4 weeks to monitor treatment response defined as weight gain, (mid-upper arm circumference) MUAC gain, weight loss \> 5%, and the development of edema. Unannounced household spot checks were conducted over 4 weeks to assess household utilization of RUTF and storage practices.


Eligibility Criteria:
Inclusion Criteria:

* a) being eligible for new admission to treatment of uncomplicated SAM
* b) being resident within 15 km of the study health center

Exclusion Criteria:

* previously default from previous SAM treatment (e.g. missed 2 consecutive weekly visits)
* considered a relapse case (e.g. re-admitted within three months of previous discharge)
Perioperative Risk Factors for Postoperative Delirium in Children

Despite recent advances in postoperative delirium research, the proportion of children with postoperative delirium is still high. Although postoperative delirium is a frequent complication and is associated with the need for more inpatient hospital care and longer length of hospital stay, little is known about risk factors for recovery room delirium (RRD) occurred in postanaesthesia care unit. The aim of the study was to determine pre- and intraoperative risk factors for the development of RRD among children undergoing non cardiovascular surgery.

Recovery room delirium (RRD) defined as delirium occurred in PACU was diagnosed according to RASS-PAEDS criteria. Pre-, intra-, and postoperative data of patients undergoing elective non cardiovascular surgery were prospectively collected, univariate and multivariate logistic regression were performed to find the risk factors related to postoperative delirium.

Eligibility Criteria:
Inclusion Criteria:

* between 3 to 12 years old
* elective non-cardiovascular surgery
* general anesthesia

Exclusion Criteria:

* under regional anaesthesia
* instable vital sign
* without consent form
* underwent neurosurgery
* history of primary neurologic diseases
* stayed less than 10min in PACU
* received general anaesthesia but recovered in locations outside the recovery room
Daily Self-weighing and Holiday-associated Weight Gain in Adults

Background: Previous studies report 0.4-1.5kg of weight gain during the holiday season, which may contribute to annual weight gain.

Purpose: To test whether daily self-weighing (DSW) can prevent holiday weight gain.

Hypothesis: We hypothesized that daily self-weighing would effectively prevent weight and fat gain, and that individuals with overweight and obesity would respond most favorably to DSW.

A single-blinded randomized control trial:

Adults (age 18-75y, BMI ≥ 18.5kg/m2) were randomized to either a control or daily self-weighing (DSW) group. There were 3 testing visits: pre-holiday (v1: within 7d before Thanksgiving), post-holiday (v2: within 7d after New Year's Day), and a follow-up (v3: 14 weeks after v2). The DSW group were given Wi-Fi scales that provide graphical feedback of daily weight. They were instructed to perform DSW during the holidays and to try not to gain weight above baseline weights. Anthropometrics were measured at each visit.

Eligibility Criteria:
Inclusion Criteria:

* BMI of at least 18.5 kg/m2
* Recognizing or celebrating at least two holidays between November and January
* Access to WiFi

Exclusion Criteria:

* Current eating disorder, history of an eating disorder
* Involvement in a current weight loss and/or exercise program
* Pregnancy or nursing
* Any medications or chronic diseases affecting metabolism or body weight
Comparing Hypertension Remote Monitoring Evaluation Redesign

The goal of this clinical trial is to compare the effectiveness of evidence-based, adapted, and tailored, patient-focused and clinic-focused strategies to improve blood pressure (BP) control in English- and Spanish-speaking patients with hypertension (HTN).


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Any sex/gender
* Any race or ethnicity
* Have hypertension or high blood pressure (BP) (BP \>=140/90 mmHg at least twice in the previous 18 months)
* Can read and write English or Spanish
* Be able to provide consent

Exclusion Criteria:

• We will exclude individuals with conditions that might have severe self-management limitations due to a disability or medical condition or might complicate remote BP monitoring, such as self-reported:

* Pregnancy
* Lactating/nursing
* Dialysis
Dispervise Ophthalmic Viscoelastic as an Agent to Ensure Watertight Wound Closure After Clear Corneal Cataract Incisions

The purpose of this study is to look at the ability of Viscoat to ensure proper wound closure.


Eligibility Criteria:
Inclusion Criteria:

* Ability to provide informed consent, complete questionnaires, and likely to complete all visits
* Subject must be male or female, of any race, and at least 21 years old
* Undergoing uncomplicated cataract surgery with clear corneal incisions

Exclusion Criteria:

* Subjects with known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course
* Acute or chronic disease or illness that would increase risk or confound study results (e.g., uncontrolled diabetes mellitus, immunocompromised,etc.)
* Uncontrolled systemic disease
* Corneal abnormalities (e.g., stromal, epithelial or endothelial dystrophies)
* Subjects who use concurrent topical or systemic medications that may impair healing, including but not limited to:antimetabolites,isotretinoin (Accutane) within 6 months of treatment, and amiodarone hydrochloride (Cordarone) within 12 months of treatment
* Subjects with a history of any of the following medical conditions, or any other condition that could affect wound healing: collagen vascular disease, autoimmune disease, immunodeficiency diseases, ocular herpes zoster or simplex, endocrine disorders (including but not limited to unstable thyroid disorders and diabetes), lupus, and rheumatoid arthritis
* Concurrent participation or participation in the last 30 days in any other clinical trial
A Dispensing Clinical of Fanfilcon A Lens Against Lotrafilcon B Lens Over 1 Month Wear Per Lens

This is a study to evaluate the performance of fanfilcon A lens when worn on a daily wear modality over approximately 1 month in comparison to the lotrafilcon B lens.

This is a 45 subject, 1-month dispensing, crossover, double-masked, randomized, bilateral study comparing the test lens against the control lens. Both test and control lenses will be used in a daily wear modality for 1 month each.

Eligibility Criteria:
Inclusion Criteria:

A person is eligible for inclusion in the study if he/she:

* Is at least 17 years of age and has full legal capacity to volunteer;
* Has read and signed an information consent letter;
* Is willing and able to follow instructions and maintain the appointment schedule;
* Is correctable to a visual acuity of 20/30 or better (in each eye) with their habitual correction and the assigned study lenses;
* Is an adapted soft contact lens wearer (For the purpose of this study: Current lens wear at least 3 days per week, 8 hours each day);
* Demonstrates an acceptable fit with the study lenses.

Exclusion Criteria:

A person will be excluded from the study if he/she:

* Is participating in any concurrent clinical or research study;
* Is a habitual wearer of lotrafilcon B or enfilcon A lenses.
* Has any known active\* ocular disease and/or infection;
* Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
* Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
* Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
* Is pregnant, lactating or planning a pregnancy at the time of enrollment; (by verbal confirmation at the Screening Visit)
* Is aphakic;
* Has undergone refractive error surgery;

  * For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
Memantine in Patients With Chronic Glaucoma

Randomized double-masked clinical trial of memantine in patients with glaucoma


Eligibility Criteria:
Inclusion Criteria:

* Glaucoma damage on examination of visual field and optic disc
* Good visual acuity (with glasses if needed)
Influence of Simple Renal Cysts on Renal Function

This is a prospective, cohort, randomized clinical trial examining the effect of simple renal cysts on renal function.

This study is planned to include patients from S.I. Spasokukotskiy Citi Clinical Hospital with simple renal accidentally discovered cyst.

The aim of the study is to evaluate the impact of simple renal cysts on renal function and explore the correlation between cyst's size, parenchymal atrophy, and renal function.

After receiving the results, the analysis of the data obtained is carried out.

1. The symmetry of the function of both kidneys is analyzed
2. The relationship between the presence of a simple kidney cyst and a decrease in its function in comparison with a healthy kidney is analyzed.
3. The relationship between the maximum size of a kidney cyst and a decrease in its function in comparison with a healthy kidney is analyzed.
4. The relationship between the volume of the atrophied kidney parenchyma and a decrease in its function as compared with a healthy kidney is analyzed.
5. Correspondence of GFR indices obtained by scintigraphy and by calculation using the Schwartz formula

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with simple kidney cyst Bosniak 1-2
* Normal blood creatinine values

Exclusion Criteria:

* Impossibility of performing CT with intravenous contrast enhancement.
* Bosniak 3-4
* CKD
* Bilateral cysts
* Multiple renal cysts
* Sinus cysts
* Cysts with a max size less than 2 cm.
* Single kidney
* Chronic kidney disease and conditions associated with the potential decrease of kidney function
* Glomerulonephritis
* Chronic pyelonephritis
* Amyloidosis
* Diabetes
* Autoimmune diseases
* Urolithiasis
* Kidney and upper urinary tract surgery
* Anomalies of the kidneys and upper urinary tract with impaired outflow
* Calcification of the renal arteries
* Renal artery stenosis
* Hypertensive nephropathy
* Severe concomitant diseases requiring
* Chemotherapy
* Long-term (more than 10 days) antibiotic therapy in the last month
* Long-term (more than 7 days) use of NSAIDs in the last month
* Diagnostic and therapeutic manipulations accompanied by the introduction of X-ray contrast agents
* Secondarily shriveled or non-functioning kidney
* Kidney hypoplasia
* Accessory kidney
* a decrease in GFR below normal values for a kidney without a cyst (as determined by nephroscintigraphy)
Factors That Impact the Relationship Between Pulmonary Status and Actual Electronic Cigarette Use

Secondary data analysis will be performed as our approach to complete the study. A nationally representative dataset (BRFSS, 2017) will be used to answer the above hypotheses.

Secondary data analysis will be performed as our approach to complete the study. A nationally representative dataset (BRFSS, 2017) will be used to answer our research questions. Our rationale is that there is insufficient research assessing the relationship between pulmonary status and e-cigarette use and that some factors, such as behavioral variables or psychosocial variables, might influence this relationship. Our expectation is that this study will deepen the understanding of the relationship between pulmonary status and e-cigarette use among U.S. adults. This study will cast light on different factors that influence the relationship between pulmonary status and e-cigarette use. Also, the following secondary outcomes will be tested: Severity of COPD symptoms (COPD group) moderate the relationship between pulmonary status (COPD status) and e-cigarette use, and Severity of asthma symptoms (asthma group) moderate the relationship between pulmonary status (asthma status) and e-cigarette use.

Eligibility Criteria:
This is secondary data analysis, so there is no control over the data (inclusion criteria, and exclusion criteria).

Inclusion Criteria:

Group 1: Pulmonary

* Are 18 years of age or older.
* Reported any of the pulmonary disease (Asthma, COPD). Group 2: Control Group
* Are 18 years of age or older.
* Free from any pulmonary disease (asthma, COPD).

Exclusion Criteria Group 1: Pulmonary

* Are younger than 18 years of age.
* Did not report any of the pulmonary disease (Asthma, COPD). Group 2: Control Group
* Are younger than 18 years of age.
* Reported any pulmonary disease (asthma, COPD

The Behavioral Risk Factor Surveillance System (BRFSS) is health-related telephone surveys that collect state data about United States residents regarding their health-related risk behaviors, chronic health conditions, and use of preventive services. This database contains data to help determine e-cigarette use in individuals with pulmonary disease in the US which little is known.

Note: The Behavioral Risk Factor Surveillance System (BRFSS) is a public dataset, and the data is publicly available online at (https://www.cdc.gov/brfss/annual_data/annual_2017.html)
Primary Prevention Youth Suicide Trial in Colorado High Schools Prevention Among Colorado High School Students

Sources of Strength is an evidence based program for youth suicide that trains student key leaders to strengthen social connectedness and healthy norms school-wide and is listed on the National Registry of Evidence Based Programs and Practices (NREPP). This project will expand the existing evidence base by evaluating Sources of Strength for sexual violence outcomes in a randomized controlled trial (RCT) in twenty-four high schools.

At present few programs systematically address broader social-ecological factors such as school-wide norms and youth-adult connectedness that research identifies as major drivers of sexual violence. To address this gap, this application proposes a large-scale RCT evaluation of Sources of Strength to evaluate for sexual violence perpetration outcomes. Sources of Strength is an evidence based program for youth suicide that trains student key leaders to strengthen social connectedness and healthy norms school-wide and is listed on the National Registry of Evidence Based Programs and Practices (NREPP). This project will expand the existing evidence base by evaluating Sources of Strength for sexual violence outcomes, which has never been done before. Twenty-four high schools will be recruited and stratified (rural or urban) and randomly assigned to one of two conditions: (a) immediate Sources of Strength intervention, (b) wait-list for Sources of Strength Implementation after 16 months.

Eligibility Criteria:
Inclusion Criteria:

* high school student in participating school, parents did not withdraw from study

Exclusion Criteria:

* none
Research on the Role of SLC1A5 in the Development of Esophageal Cancer

To explore the significance of Solute Carrier Family 1 Member 5 (SLC1A5) in the occurrence of esophageal cancer, by comparing the expression of SLC1A5 between esophageal cancer tissues and adjacent tissues.

This will be an observational study. The investigators will aim to enroll 100 male and female adult patients (aged 18 years and over) of all ethnicities/races, who have been referred to the Fourth Affiliated Hospital of Guangxi Medical University for esophageal cancer.

The investigators will be using a standardized data collection form. This is an observational study in which standard of care will be practiced and the patients are not placed at additional risk from participating in this study. However, as the investigators are collecting data prospectively, all participants will sign consent. An attempt will be made to see if there is a correlation between the expression of SLC1A5 with esophageal cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with histologically proven esophageal cancer;
2. Age ≥18 years;
3. All patients must sign consent forms voluntarily;

Exclusion Criteria:

1. Inability to obtain histologic proof of malignancy.
2. Age \<18 years;