cyrilzakka/clinical-trials huggingface dataset:
Alleviating Effects Against Dry Eye by Oral Intake of Cordyceps Cicadae Mycelia

Cordyceps cicadae mycelia was tested for amelioration of dry eye symptoms through dietary supplementation. Its efficacy in relief of human dry eye status was assessed by randomized, double-blinded tests, including multiple assessments. The results were compared between the placebo group and the experimental group.

Former animal studies had shown that Cordyceps cicadae mycelia can effectively ameliorate UVB-induced dry eye symptoms. This study further investigated its efficacy in human dry eye status by randomized, double-blinded tests, including dry eye questionnaires, blood tests, salivary tests, tear volume test, intra-ocular pressure assessments, ocular surface photography, corneal fluorescein stain, tear film breakup time test, fundus photography, and cornea impression cytology. All tests were performed again after 3 months of dietary supplement of either samples or placebo. A total of 97 participants completed the trial. The data were analyzed by paired-t test and compared between the placebo and the experimental groups.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged from 20 to 60 with dry eye symptoms confirmed by ophthalmologists, and without chronic diseases.

Exclusion Criteria:

* Those vulnerable to damages or loss of self-conscious, or behavior capacity, or with major illness or with critical diseases.
Triple Versus Quadruple Therapy for the Eradication of Helicobacter Pylori

The study aimed to compare the efficacy and safety of 7-day and 14-day vonoprazan-amoxicillin-tetracycline triple therapy with 14-day vonoprazan-amoxicillin-tetracycline-bismuth quadruple therapy for the eradication of Helicobacter pylori. Subjects were randomized to receive the intervention and were reviewed by 13C-urea breath test after 6 weeks. The eradication rates, adverse reaction rates and patient adherence were calculated.

H. pylori-positive patients without eradication history were recruited according to inclusion and exclusion criteria and randomized to the intervention:

14-day quadruple regimen: Vonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid + Bismuth 220mg bid for 14 days 14-day triple regimen: Vonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid 14 days 7-day triple regimen: Vonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid 7 days Subjects were asked to record adverse events and 6 weeks after treatment, 13C-urea breath test was tested for confirmation. The eradication rates, adverse reaction rates and patient adherence were calculated and analysed, and the results were analysed to provide more information for eradication regimens of H. pylori.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 18-70 years old;
2. Patients with H.pylori infection (positive rapid urease test, 13C/14C-urea breath test);
3. Patients without previous treatment for H. pylori eradication.

Exclusion Criteria:

1. Patients with serious underlying diseases, such as liver insufficiency (Aspartate aminotransferase or alanine aminotransferase greater than the normal value), renal insufficiency (Cr≥2.0mg/dL or glomerular filtration rate \<50 ml/min), immunosuppression, malignant tumors, Coronary heart disease or coronary artery stenosis ≥75%;
2. Patients with active gastrointestinal bleeding;
3. Patients with a history of upper gastrointestinal surgery;
4. Patients allergic to treatment drugs;
5. Patients with medication history of bismuth, antibiotics within 4 weeks, or proton pump inhibitor within 2 weeks;
6. Patients who are pregnant or lactating or unwilling to take contraceptive measures during the trial;
7. Patients with other behaviors that may increase the risk of illness, such as alcohol and drug abuse;
8. Patients who are unwilling or incapable to provide informed consents.
Relieving Burden of Hypophosphatasia in Adults With Functional Impairment Due to Chronic Disease

The study will evaluate safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of 2 different doses (approved dose and lower dose) of asfotase alfa in adult participants with pediatric-onset hypophosphatasia (HPP).


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged ≥ 18 years at the time of signing the informed consent form
* Clinical diagnosis of pediatric-onset HPP based on signs and symptoms consistent with HPP
* Past medical history that includes at least one nonvertebral fracture (or pseudofracture) incurred without evidence of significant trauma.
* The presence of a current fracture is not necessary, but for participants with current unhealed fracture(s) or pseudofracture(s) of the lower extremity(ies) (that is, femoral, tibial, fibular, metatarsal) documentation must be provided of the presence of these fractures for at least 3 months prior to screening (with or without surgical intervention)

Exclusion Criteria:

* Medical condition, serious concurrent or recurrent illness and/or injury, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance or the assessment of study endpoints, including all protocol required evaluations and follow up activities, or may put the patient at risk
* Primary or secondary hyperparathyroidism or hypoparathyroidism
* History of hypersensitivity to any ingredient contained in asfotase alfa
* Oral bisphosphonate use within 6 to 12 months (depending on the half-life of the drug as assessed by the investigator) and intravenous (IV) bisphosphonate use within 12 months prior to screening
* Denosumab use within 18 months prior to screening
* Asfotase alfa use within 6 months prior to screening
* Teriparatide/parathyroid hormone analog use within 2 months prior to screening
* Treatment with strontium or sclerostin inhibitors within 6 months prior to the first dose of study drug
* Vitamin B6 use for at least 2 weeks prior to screening
* Serum 25-hydroxy (25-OH) vitamin D below 20 nanogram (ng)/milliliter (mL), with repletion and recheck allowed at screening (results from local laboratory may be used if within 4 weeks of screening)
* Female patients who are pregnant, planning to become pregnant, or breastfeeding
Sublingual Fentanyl and Procedural Burn Pain

The purpose of this study is to examine the efficacy and safety of sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement) in patients with burn injury.

The purpose of this study is to examine the efficacy and safety of sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement) in patients with burn injury. It will be compared with a standard treatment regimen of oral morphine. The hypothesis is that the fentanyl spray will be more effective for the treatment of procedural pain in patients with burn injury.

Eligibility Criteria:
Inclusion Criteria:

* Subject capable of giving consent
* Age 18-65
* Total burn surface area greater than or equal to 5%
* Opioid tolerant
* BMI less than or equal to 35

Exclusion Criteria:

* Subjects with cognitive or psychiatric impairment that would preclude study participation or compliance with protocol
* Allergy to fentanyl, morphine, naloxone
* Pregnancy, intent to become pregnant or lactating
* Evidence of burn injury to oral mucosa
* Active illicit drug use or illicit drug abuse history
HealtheRx Survey for Pulmonary Research Registry Recruitment

The purpose of this research is to study the utility of using the HealtheRx as a tool to recruit eligible patients into the Pulmonary Research Registry (PRR) (IRB 15543B) at the University of Chicago. HealtheRx is an example of a potential recruitment tool that has high reach in populations typically underrepresented in research studies, uses a high tech infrastructure that allows matching of research opportunities to patient characteristics, but that delivers information in a low-tech, patient-centered mode using the printed HealtheRx prescription.

1. Patients living in one of 16 zip codes of the South and West Sides of Chicago who present for care at one or more of 30 clinical sites receive a personalized HealtheRx prescription with programs and services in the community from their health care provider. The HealtheRx is printed and delivered to the patient at the end of the visit.
2. Patients age 18+ with a diagnosis of asthma and/or COPD will receive a HealtheRx with programs/services to help manage their condition, as well as an advertisement to participate in a phone survey.
3. Patients interested in completing the phone survey can call or text the Lindau Lab at the University of Chicago.
4. An experienced survey researcher will first read the consent script and if oral consent is received, continue with the phone survey (The survey includes items pertaining to program participants' receipt of the HealtheRx, use of community services provided on the HealtheRx, thoughts about participation in clinical research.
5. Participants who choose to complete the survey will receive a $10 check delivered via U.S. mail to their home address. Patients interested in joining the PRR will receive the PRR consent form with their $25 check.
6. Participants with interest in joining the PRR will also receive, via mail, a $5 bill as thanks for reading, signing and returning the consent form. Participants will be randomized to receive the $5 bill at 2 different time points.
7. Once the signed consent form is received, a member of the Asthma and COPD Center research staff will contact the participant by phone and complete the PRR case report form by phone.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of asthma/COPD
* receipt of HealtheRx

Exclusion Criteria:

-
Incentives for Adherence in Adolescent Asthma

Financial incentives have been suggested as a possible means for increasing adherence to asthma medications. This study will evaluate an incentive strategy (daily small reward for adherence) in maintaining high levels of adherence as tracked by adherence sensors in adolescents with asthma.

Two groups will be enrolled. The control group will have mediation monitoring sensors placed on their controller inhalers. The treatment group will also have the monitoring sensors placed on their medications, however they will be paid up to $1 per day for perfect adherence for 3 months. Both groups will be monitored for 4 months. 10 subjects will be chosen from each group to complete semi-structured phone interviews

Eligibility Criteria:
Inclusion Criteria:

* physician diagnosed asthma
* on at least one inhaled controller medication

Exclusion Criteria:

* language other than English or Spanish (these are the only languages supported by the adherence monitoring application)
* other severe chronic lung disease including tracheostomy/ventilator dependence, interstitial lung disease or cystic fibrosis, or significant developmental delay.
The Impact of a Diagnosis of Parkinson's on Work

Parkinson's disease leads to loss of employment on average within less than 10 years of disease onset and has been found to be associated with an increased absence from work. This combined with hospitalisation; use of secondary health services; drug usage; and caregivers needing to give up work contributed to the costs associated with the conditions. It has been estimated that early support for working age newly diagnosed would cost the government about 1.5 million Euro in the UK but might lead to a potential cost saving of over half a billion over 5 years.

The study will explore the impact of a Parkinson diagnosis on employment. The study will be survey based and will include demographic questions: age, age at diagnosis of PD, educational level, and Nationality; questions pertaining to employment type, history, and reasons for leaving if this happened; and also general health.


Eligibility Criteria:
Inclusion Criteria:

Diagnosis of Parkinson

Exclusion Criteria:

None
Nutraceutical Supplement in the Management of Hypertension

The purpose of this study is to evaluate the efficacy and safety of a proprietary nutraceutical supplement in capsule form over 4 months in treating blood pressure in a group of chronic hypertensive subjects that are not receiving any pharmaceutical anti-hypertensive agents or other nutraceutical supplements.


Eligibility Criteria:
Inclusion Criteria

* Diagnosed with chronic hypertension: Blood pressure at study entry must be greater than or equal to systolic blood pressure of 140 mm Hg but less than 180 mm Hg or diastolic blood pressure greater than or equal to 90 mm Hg but less than 105 mm Hg
* Subjects are not taking any prescription anti-hypertensive drugs.
* Subjects must be off all nutraceutical supplements for at least 30 days prior to entry into the study.

Exclusion Criteria

* Myocardial infarction, PTCA , stent, CABG within 5 years, known clinical CHD or clinical angina.
* History of cerebrovascular accident (CVA).
* Creatinine over 2.5 mg/dL.
* Known allergy or sensitivity to any components of the study blood pressure supplement.
* Chronic liver disease with AST, ALT, alkaline phosphatase over 1.5 x normal lab values.
* Known cancer within 2 years.
* Clinical congestive heart failure ( systolic or diastolic CHF)
* Pregnant and nursing women and women.
* Women of child bearing age not on approved contraception control.
* Type 1 and Type 2 diabetes mellitus on medications.
* If the study subjects develop BP over 180 mm Hg systolic or 110 mm Hg diastolic during the study, they will be discontinued from the study and the investigator will immediately start rescue drug therapy for BP control.
Creating Digital Dental Plaque Scoring

It is aimed to compare dental plaque area measured on images obtained in the clinic by using dental photography and intraoral scanner and to evaluate the correlation of this area with clinical plaque scores.

Clinical dental plaque scoring was measured according to the "Turesky Modified Quigley Hein Plaque Index" after applying a plaque staining agent (Tri Plaque ID Gel, GC Corp., Tokyo, Japan) to evaluate the oral hygiene of 20 patients who applied to the university clinic. Following clinical scoring, intraoral photographs of the patients were taken using dental photography equipment of the same standards (EOS700D, Canon; 100mm lens, Canon; twin flash, Yong Nuo) and scan images were taken with an intraoral scanner (iTero Element Flex, Align Tech., USA). In the data obtained, dental plaque area on the buccal surface of 66 lower and upper jaw anterior teeth were measured with Image J (National Institute for Health, Bethesda, USA) software, and the ratio of dental plaque area to the visible surface area of the tooth was measured.

The (h1) hypothesis of this study was that dental plaque scores measured through digital camera and intraoral scanner images can replace clinical visual scoring. This study aimed to compare dental plaque areas measured on images taken by digital camera and intraoral scanner and to evaluate these areas with clinical plaque scores with the help of a software program and provide a novel plaque index to score dental plaque on the taken intraoral images.

Study Design The tooth arches of the volunteers were stained with a plaque-disclosing solution (Tri Plaque ID Gel, GC Corporation, Tokyo, Japan). The Turesky Modified Quigley Hein Plaque Index (TMQHPI) of anterior teeth of the volunteers' was recorded using clinical visual examination.

Intraoral photographs of the volunteers were taken by using a digital camera (Canon EOS 700D; 100 mm macrolens, Canon Inc., Tokyo, Japan), and 3D images were recorded by an intraoral scanner (iTero Element Flex, Align Technologies, San Jose, California, USA). Photograph and intraoral scanner images were overlapped and pixel-synchronized using the Keynote program.

After synchronization, all taken images were transferred to the Image J V1.53 (National Institute for Health, Bethesda, USA) program. The plaque-covered area and the total surface area of the teeth were marked in the manual mode of the program and the areas were measured in square pixels. Measurements were made on a total of 66 teeth, which can be easily seen on the images. Intraoral scanner plaque area/ tooth surface area ratio and intraoral photograph plaque area/ tooth surface area ratio were calculated and recorded for each tooth.

Eligibility Criteria:
Inclusion Criteria:

* Patients without orthodontic brackets, fixed or implant restorations and without severe tooth crowding were included in the study.

Exclusion Criteria:

* Among the patients with orthodontic brackets, severe tooth crowding that could not be visually verified on images, fixed or implant restorations were excluded in the study.
Neuropsychological and Behavioral Testing in Younger Patients With Cancer

This research trial studies neuropsychological (learning, remembering or thinking) and behavioral outcomes in children and adolescents with cancer by collecting information over time from a series of tests.

PRIMARY OBJECTIVES:

I. To institute procedures to ensure a consistent, streamlined, and efficient administration of the neuropsychological/behavioral tests in a cooperative group setting in order to maximize compliance with a standardized assessment battery conducted at 3 standardized time points.

OUTLINE:

Parent and child participants complete the COG Standard Neuropsychological and Behavioral Battery at approximately 9, 30, and 60 months post-diagnosis in a 1-2 hour testing session conducted by a neuropsychologist or psychologist. The Battery consists of measures of intelligence, processing speed, attention, memory, language preference, behavioral/social/emotional function, executive function, adaptive function, and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* The patient must be currently be enrolled or plan to be enrolled on a COG therapeutic study that aims to examine neuropsychological, social, emotional, and/or behavioral functioning
* The patient must have receptive and expressive language skills in English, French, or Spanish; if a patient meets these criteria but the parent/guardian speaks a language other than English, French, or Spanish, the patient may still be enrolled and tested, and the parent-report measures should be omitted
* All patients and/or their parents or legal guardians must sign a written informed consent
* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Exclusion Criteria:

* Patients with a history of moderate to profound intellectual disability (i.e. intelligence quotient \[IQ\] =\< 55) are not eligible for enrollment; PLEASE NOTE: Children with a prior history of attention deficit hyperactivity disorder (ADHD) or a specific learning disability (e.g., dyslexia) are eligible for this study
Diagnostic Value of Weight Bearing CT for Detecting Meniscal Tears

This observational study will compare the clinical value of weight-bearing CT arthrography (WBCTa) with that for MRI in evaluating meniscal and cartilage lesions of the knee joint. The MRI Osteoarthritis Knee Score (MOAKS) and modified MOAKS for WBCTa will be used to compare findings between MRI and WBCTa of the knee while comparing with surgical measurements using the ICRS scoring system.

The study hypothesis is that meniscal and cartilage lesions may be missed by non-weight-bearing MRI, but detected by WBCTa.

Study Objectives:

Aim 1 Establish the accuracy of WBCTa and MRI for diagnosing knee cartilage and meniscal lesions in both surgical and non-surgical participants.

Hypothesis 1: Pre-operative cartilage and meniscal scoring on WBCTa is more accurate than MRI, in comparison with arthroscopic assessment.

Aim 2 Establish the accuracy of WBCTa for detecting persistent and recurrent meniscal root and radial tears not detected by MRI 6 months after meniscal repair (defined by diastasis of the repair or meniscal extrusion ≥3mm).

Hypothesis 2: Six months following meniscal repair, WBCTa detects persistent and recurrent meniscal root and radial re-tears not detected by MRI.

Study Type and Design: This cross-sectional, observational study will compare WBCTa with MRI to evaluate rate of detection of meniscal and cartilage lesions. The inter-rater reliability of WBCTa readings also will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Male or female over 18 years of age with a knee MRI acquired in the previous 10 days to evaluate for suspected meniscal or cartilage pathology.
* Body mass index (BMI) ≤ 45 kg/m2
* Ability to stand with support without moving for at least 2 minutes.

Exclusion Criteria:

* End stage kidney disease
* Allergic to iodinated contrast material.
* Pregnancy
* Skin breakdown or rash at the knee joint which would prevent injection of the contrast.
* Any clinically significant degree of cognitive impairment or other condition, finding, or psychiatric illness at screening which, in the opinion of the investigator, affects their ability to ambulate to a sufficient degree and could compromise patient safety or interfere with the assessment of the safety of the study injection.
* Superficial or deep infection in or around the index knee joint or allergy to iodinated contrast media.
* History of inflammatory arthritis, meniscectomy, or end-stage OA
Sorafenib Versus Best Supportive Care in Egyptian Hepatocellular Carcinoma Patients.

The aim of the study is to evaluate the efficacy of sorafenib, compared to the best supportive care (BSC), in two cohorts of patients who presented with advanced hepatocellular carcinoma (HCC) based on etiology of hepatitis C virus.

In Egypt, chronic hepatitis C virus (HCV) infection occurs in around 10% of the population (about 8 million individuals), and is a leading cause of liver cirrhosis, hepatocellular carcinoma, and mortality. Although HCV genotype 4 constitutes about 20% of HCV infections worldwide, the prevalence in Egypt is more than 90%.(Waked et al., 2016)

In 2014 Omar et al. reviewed 41 patients in a study to evaluate Sorafenib for Egyptian patients with advanced hepatocellular carcinoma at a median follow up period of 13 months, the median PFS for the whole group was 4 months; the median OS for the whole group is 6.25 months.(Abdel-Rahman et al., 2014)

Till current, no studies have evaluated the Sorafenib efficacy in comparison to the best supportive care treatment in HCC patients whose etiology from HCV genotype 4 ( the most prevalent hepatitis C virus genotype in Egypt).

So, The study aims to evaluate the efficacy of sorafenib, compared to the best supportive care (BSC), in two cohorts of patients who presented with advanced hepatocellular carcinoma (HCC) based on etiology of hepatitis C virus.

Eligibility Criteria:
Inclusion Criteria:

1. Patients ≥18 years of age
2. Patients based on etiology of hepatitis C virus.
3. Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less
4. Child-Pugh liver function class A,B
5. A life expectancy of 12 weeks or more
6. adequate hematologic function (platelet count, ≥60×109 per liter; hemoglobin, ≥8.5 g per deciliter; and prothrombin time international normalized ratio, ≤2.3; or prothrombin time, ≤6 seconds above control), adequate hepatic function (albumin, ≥2.8 g per deciliter; total bilirubin, ≤3 mg per deciliter \[51.3 µmol per liter\]; and alanine aminotransferase and aspartate aminotransferase, ≤5 times the upper limit of the normal range), and adequate renal function (serum creatinine, ≤1.5 times the upper limit of the normal range).
7. Patients were required to have at least one untreated target lesion that could be measured in one dimension, according to the Response Evaluation Criteria in Solid Tumors (RECIST)

Exclusion Criteria:

1. Had previously received molecularly targeted therapies or any other systemic treatment.
2. Any co morbid disease that will confuse the assessment of the Quality of life questionnaire scoreFHSI-8 score.