cyrilzakka/clinical-trials huggingface dataset:
Study on the Prognosis and Effect of Anti-diabetic Drugs on Type-2 Diabetes Mellitus With Coronary Artery Disease

The purpose of this study is to explore the recurrence risk of cardiovascular events in patients with type 2 diabetes mellitus and coronary heart disease after different antidiabetic drug therapy (glipizide or metformin) by using an double-blind, randomized, parallel control and prospective study

The end point of this study is:

1. follow up 3yr
2. recurrence of cardiovascular event
3. death caused by other reasons such as stroke, uremia, blindness and amputation


Eligibility Criteria:
Inclusion Criteria:

* Coronary heart disease
* Type 2 diabetes

Exclusion Criteria:

* Severe organ dysfunction, psychopathy, infection, neutropenia
* Congenital heart disease, rheumatic heart disease, severe arrhythmia, myocardiopathy
Gastric Emptying Time After Turkish Breakfast

DETERMINING GASTRIC EMPTYING TIME IN ELDERLY USING ULTRASOUND ASSOCIATED WITH PREOPERATIVE FASTING TIME

Background:

Gastric contents aspiration is the most crucial complication of general anaesthesia. There are limited studies to assess the gastric volume ultrasound to clarify an appropriate fasting time before surgery. Gastric content will examine after a traditional Turkish breakfast with ultrasound.

Methods:

After the first ultrasound examination by asking 8 hours fasting ,gastric emptying time(GET) was determined by serial gastric ultrasound examinations with two ultrasonographers and GET identified by real time USG evaluations in every 1 hour.

All ultrasound assessments on volunteers will made both in the supine position and right lateral decubitus (RLD) from the epigastric area by using a convex probe.

This study is the first one which examine gastric emptying time after a standard Turkish breakfast in over 65 years Turkish population by measuring antral cross section area (CSA) using noninvasive ultrasound.

Preoperative fasting has always been problematic in preoperative patients because of the pulmonary aspiration hazard and discomfort of prolonged fasting. Although stomach scintigraphy has been accepted as a gold standard for imaging method of evaluating gastric content; recently, ultrasound is being a simple, efficient, available and non invasive alternative. Preoperative fasting is especially difficult in elderly because of comorbidities, dehydration, drug therapies. Therefore, in this study gastric emptying time will be identified after a standard Turkish breakfast in over 65 years old Turkish population to clarify fasting time, measuring antral cross section area (CSA) by using non invasive ultrasound for the first time. Ultrasound assessments on volunteers will be made both in the supine position and right lateral decubitus (RLD) from the epigastric area by using a convex probe. After visualization of gastric antrum according to landmarks such as abdominal aorta, superior mesenteric artery and the left lobe of liver; antrum will measured in two sagittal planes: craniocaudal (CC) and anteroposterior(AP) diameters. Gastric emptying time will be identify by real time usg done by 1 hour intervals.This is the first study with ultrasound evaluation of gastric emptying time in Turkish population after a traditional Turkish breakfast.

Eligibility Criteria:
Inclusion Criteria:

* over 65 years of age who have not any comorbidities

Exclusion Criteria:

* gastrointestinal and functional disorders, previous oesophageal or upper abdomen surgery.
A Prospective Evaluation of Pain After Non-complex Ventral Hernia Repair

The study aims to evaluate outcomes relating to pain and QOL after robotic-assisted or laparoscopic non-complex ventral hernia repair.

This is a prospective, observational, study across robotic-assisted and laparoscopic primary (non-recurrent) umbilical and incisional hernia repair. The study aims to evaluate pain and QOL outcomes through 30 days. During the post-operative period through 30 days, pain medication intake, subject reported pain and quality of life and incidence of intra-operative and post-operative adverse events related to the ventral hernia repair will be collected.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is between 18 and 80 years of age.
2. Subject is a candidate for an elective primary (non-recurrent) ventral hernia repair.
3. Ventral hernia repair that will require mesh placement

Exclusion Criteria:

1. Subject is contraindicated for general anesthesia or surgery.
2. Subject with a ventral hernia that will require retromuscular mesh placement or employ a technique, including (but not limited to) external oblique release, Rives- Stoppa, eTEP Rives-Stoppa, transversus abdominis release, other component separation techniques (i.e. anterior component separation) or eTEP transversus abdominis release.
3. Subject has a recurrent hernia.
4. Subject who will have an emergent hernia repair.
5. Subject with a history of chronic pain and/or taking daily pain medications for \>6 weeks.
6. Subject with a history of substance abuse (excluding marijuana) and/or current (within 30 days) narcotic use.
7. Current marijuana use that the subject is unwilling to discontinue within the 14 days prior to surgery.
8. Subject with a history of MRSA infection.
9. Subject with HbA1c level \> 8.5%.
10. Use of Exparel during the surgical procedure.
11. Subject who will undergo a concomitant hernia repair or any other concomitant procedure.
12. Current nicotine use (including vaping) within the past 30 days.
13. Subject has a known bleeding or clotting disorder.
14. Pregnant or suspected pregnancy.
15. Subject is mentally handicapped or has a psychological disorder or severe systemic illness that would preclude compliance with study requirements or ability to provide informed consent.
16. Subject belonging to other vulnerable population, e.g, prisoner or ward of the state.
17. Subject is currently participating in another interventional or investigational research study.
Prospective Longitudinal Monocentric Study to Evaluate the Syde® Digital Endpoint in Patients With Multiple Sclerosis

The study aims to assess the validity of real-world activity monitoring by the Syde® wearable device in subjects with multiple slclerosis. The Syde® collected data will be compared to on-site conventional clinical endpoints for MS pathology (EDSS, FSS and T25FWT). Subjects with multiple sclerosis will be assessed every 6 months for 2 years.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subject aged from 18 to 65 years old.
2. Signed informed consent and ability to comply with study and follow-up.
3. Diagnosed with MS base on 2017 McDonald criterion
4. EDSS ≤ 5.5
5. No clinical or radiological relapse within the last 3 months
6. For patient under treatment, the molecule and its dose should be stable about 2 months before inclusion
7. Subject willing and able to comply to all study procedures including the Syde® related ones

Exclusion Criteria:

1. Patient with a cognitive or communicational disorder disturbing the understanding of the tasks or data collection
2. Previous or current disorder with an impact on current ambulation or motor function
3. Patient who have had surgery or traumatic injury in upper or lower limb within the last 6 months before the inclusion or patients who have had major surgery or trauma within the last 6 months before the inclusion
Digital Holographic Microscopy: Evaluation of Histological Disease Activity in Patients With Ulcerative Colitis

Ulcerative colitis (UC) belongs to the group of inflammatory bowel disease (IBD) and is characterized by a chronic relapsing disease course. As uncontrolled intestinal inflammation can lead to severe disease complications, treatment of UC has evolved from sole treatment of symptoms up to histological remission which is marked by the absence of histological inflammation. To correctly assess and quantify the degree of histological inflammation in IBD patients remains difficult.

Digital holographic microscopy (DHM) is a new imaging technique belonging to quantitative phase contrast imaging. It is based on the detection of optical path-length delays in a stain-free manner, thereby providing a refractive index which directly correlates to tissue density.

This study aims to evaluate the role of DHM for quantifying the degree of histological inflammation in endoscopically acquired biopsies of UC patients in a prospective clinical trial. From 28 UC patients, the investigators will obtain endoscopically acquired colonic biopsies. The investigators will assess the degree of inflammation in these biopsies using DHM and in addition to this an experienced histopathologist will determine the degree of inflammation in these biopsies using a histological scoring system (Nancy-Score = goldstandard). Finally, the investigators will directly correlate the results from DHM analysis to the histological analysis using the Nancy-Score.


Eligibility Criteria:
Inclusion Criteria:

- Patients with an indication for a colonoscopy

Exclusion Criteria:

* Patients under 18 years, pregnancy
* Inability to have a patient education
* Bad conditions or other reasons prohibiting a colonoscopy
Age-dependency of Thrombin Generation Using a New Standardized Assay

The aim of this study is to establish normal values of thrombin generation assay parameters in pediatrics, according to different age groups. The standardized thrombin generation assay "Genesia™" will be used. Different age groups of healthy children will be recruited : neonates, 1-3 months, 3-6 months, 6-12 months, 1-2 years, 2-6 years, 6-12 years, and 12-15 years old. Adults values will be obtained (healthy adults \> 18 years old).

Materials and Methods Collection of blood samples Blood samples of 240 healthy children will be obtained from the blood that will be collected for the routine coagulation screening (in neonates and in children \< 18 months) or at the time of surgery in children aged \> 18 months. Healthy neonates will be recruited by the neonatologists. Children aged from 1 month to 15 years will be included by anesthesiologists before minor elective surgery such as tonsillectomy, adenoidectomy, phimosis or oral surgery. Additionally, blood from adults referred for thrombophilia testing will be studied. This study was approved by French authorities (ANSM and CPP). Inform consent will be obtained from all participants. Blood will be collected into plastic tubes containing sodium citrate (0.106 M, tubes from "Starstedt"). Platelet poor plasma will be obtained by two centrifugations for 10 minutes at 2500 g at room temperature and stored at - 70°C until further examination.

Statistical analysis Statistical analysis will be performed as 1) a descriptive analysis (frequency and percentage for qualitative data, mean, SD and centiles for quantitative data), and 2) a comparison analysis (student, Mann-Withney, Kruskall- Wallis).

Eligibility Criteria:
Inclusion Criteria:

* Informed consent from parents of children
* Informed consent from patients in the case of adults refered for thrombophilia testing
* Affiliation to the French Health Social System

Exclusion Criteria:

* weight \< 3250 g
* Patients under law protection
Clinical Investigation of the Cardioprotective Effect of Early Administration of SGLT2 in Patients Presented With AMI

This study aims to investigate the effect of early administration of DAPA during ischemia and before pPCI on infarct size, reperfusion injury-related myocardial damage, cardioprotection from HF, and renoprotection from AKI in patients with AMI.

DAPA was approved for HF patients, but there is no sufficient data about its efficacy on patients with AMI and if it can protect from the development of HF after AMI.

the investigators aim to investigate the effect of DAPA on patients who presented with AMI when administered as early as possible before pPCI and to be continued for three months after there.

the effect of DAPA on infarct size, cardiac biomarkers will be assessed during the follow-up period

Eligibility Criteria:
Inclusion Criteria:

1. Patients with ST-elevation myocardial infarction (STEMI).
2. STEMI was defined according to the Fourth Universal Definition of AMI.
3. 18 - 80 years of age.
4. Diabetics or non-diabetics.
5. eGFR \> 45 ml/min/1.73m2.
6. Blood pressure before first drug dosing \>110/70 mmHg.

Exclusion Criteria:

1. Cardiogenic shock.
2. Hypoglycemia.
3. History of diabetic ketoacidosis.
4. Genital and urinary infections.
5. History of AMI.
6. Stent thrombosis.
7. Previous coronary artery bypass surgery.
8. Severe hepatic insufficiency.
9. Advanced cancer patients.
10. Blood pH \< 7.32.
11. Known allergy to SGLT-2 inhibitors.
12. Hemodynamic instability.
13. Females of childbearing potential without adequate contraceptive methods.
14. Patients currently on or have received any SGLT-2 inhibitors.
The Effect of Education Given to Children With Asthma

The aim of this study is to examine the effects of asthma education on asthma knowledge, control and quality of life of school-aged children (7-11 years old) diagnosed with asthma and followed up in the outpatient clinic.

Asthma is among the most common chronic diseases in childhood. Besides being one of the most common diseases, it is a preventable and controllable disease.In a study analyzing asthma data of children aged 0-17 by the Centers for Disease Control and Prevention (CDC), the prevalence of asthma was 8.7% in 2001, this rate increased to 9.4% in 2010, and decreased to 8.3% in 2016. In the same study, the prevalence of asthma was found to be 9.2% in boys and 7.4% in girls.Asthma is also the leading cause of school absences in children ages 5 to 17, accounting for more than 14 million days of absence from school in 2013.These adverse effects of asthma can be minimized with appropriate education.Studies have found an increase in the quality of life of asthmatic students after asthma education, a decrease in asthma exacerbations, school absences, parental workday loss and medical expenses, and an increase in adherence to treatment, asthma knowledge and correct inhaler use.These findings suggest that asthma management interventions increase children's knowledge about their disease and their self-management skills.Based on this need, the aim of this study is to examine the effects of asthma education given to school-aged children (7-11 years old) diagnosed with asthma and followed up in the outpatient clinic on their asthma knowledge, control and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 7-11,
* Medically diagnosed with asthma and being followed up in the outpatient clinic
* Family and child agreeing to participate in the study
* Ability to use a smartphone, computer or tablet
* Having internet access
* Children who can read and understand Turkish

Exclusion Criteria:

* Children who do not have a medical diagnosis of asthma
* Children who do not agree to participate in the study and their parents
* Children who do not complete the training and tests
Bridging Hemophilia B Experiences, Results and Opportunities Into Solutions (B-HERO-S)

This study is conducted in the United States of America (USA). Tha aim of this study is bridging Hemophilia B Experiences, Results and Opportunities into Solutions (B-HERO-S).


Eligibility Criteria:
Inclusion Criteria:

* Adults aged below or equal to 18 years with hemophilia B (any severity, with or without inhibitors)
* Caregivers of children currently aged below 18 years with hemophilia B (any severity, with or without inhibitors)
* Subjects must have access to the internet, either at home or at a location convenient to them
* Provision of informed consent before the start of any survey-related activities

Exclusion Criteria:

* Inability to understand and comply with written instructions in English
* Previous completion of the B-HERO-S study with receipt of compensation
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
Correlation Between Change of HbA1c, Urinary Glucose Excretion and Other Factors in Patients Treated With Ipragliflozin

The purpose of this study is to examine the correlation between change of HbA1c, urinary glucose excretion and other factors when ipragliflozin is added to preexisting therapy in subjects with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Subject who has written informed consent
* Subjects who are diagnosed as type 2 diabetes mellitus
* Subjects who are 20 to 70 years old
* Subjects on a stable diet and exercise at least 8 weeks prior to the study participation
* Stable doses of the following medications for 8 weeks or more but, HbA1c level of 7.0 to 9.5% (Metformin, Metformin + SU, Metformin + DPP-4 inhibitor, Metformin + TZD, TZD, TZD + SU, TZD + DPP-4 inhibitor, SU, SU + DPP-4 inhibitor, DPP-4 inhibitor)

Exclusion Criteria:

* Type 1 DM
* Gestational DM
* Diabetic ketoacidosis
* CKD stage 3B-5 (eGFR 45)
* Severe infection, serious trauma, or perioperative period
* Known or suspected hypersensitivity to ipragliflozin
* Symptomatic urogenital infection
* Chemotherapy or radiation therapy for malignant tumor or diagnosis of malignant tumor within 5 years (except for thyroid cancer)
* Under the therapeutic intervention and/or another clinical study using IP drug
* Hepatic disease ( 3 times of upper normal limit of AST or ALT)
* Serious voiding difficulty due to neurogenic bladder or prostate hyperplasia
* Drugs not allowed for concomitant use

  * Alpha glucosidase inhibitor or meglitinide within 60 days prior to screening
  * Insulin within 60 days prior to screening
  * Systemic steroid use (PO, IV or IM) over 2 weeks within 3 months prior to screening
  * Inhalation or pleural intracavitary injection of steroid known as having high systemic absorption rate
* GLP-1 agonist (except for exenatide) within 60 days prior to screening
* Heart failure (NYHA class III-IV) or uncontrolled arrhythmia within 6 months prior to screening
* Cardiovascular diseases (unstable angina, myocardial infarction, transient ischemic attack, cerebrovascular disease, coronary artery bypass graft, or percutaneous coronary intervention) within 3 months prior to screening
* Subjects who are not eligible to the study according to an investigator's decision
* Inability to read the consent form
* Pregnancy, lactation, or plan to get pregnant during the study period
Effects of Nateglinide vs Acarbose on Postprandial Glucose Fluctuation, Dyslipidemia, and Inflammatory Factors

This study was conducted to demonstrate superiority of nateglinide in postprandial glucose fluctuation, dyslipidemia, and inflammatory status improvement.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed type 2 diabetes mellitus patients
* HbA1c \> 6.5 and \< 9.0%
* Fasting fingertip capillary blood glucose (FCBG) \< 9 mmol/L after 2 weeks diet control

Exclusion Criteria:

* History of acute metabolic complications in the past 3 months or of severe diabetic complications or severe infections or active substance abuse
* Liver disease
* Patients under oral hypoglycemic drugs and/or insulin treatment, or corticosteroid treatment within past 4 weeks

Other protocol-defined inclusion/exclusion criteria applied to the study.
Technology/Digital Media Use and Children's Word Learning Development

The goal of this work is to address increasing concerns about young children's digital media exposure and language outcomes by testing how the times course of word learning unfolds in digital environments and the cascading impact of digital media on vocabulary outcomes. The findings will have important implications for understanding when and where optimal word learning from media can occur.

The goal of the current proposal is to identify how digital media alters the mechanisms of word learning and subsequently impacts the lexical foundation on which a child's vocabulary is built. Specifically, the proposal aims to identify the impact of digital media on 1) the processes underlying real-time word learning, and 2) the processes of language generalization and vocabulary growth. Specific Aim 1 will use a novel word learning task to test children's ability to map and retain new words within and between digital media (2D images on a tablet) and real world objects (3D objects). Specific Aim 2 will probe children's novel label generalization abilities within and between 2D and 3D modalities using a novel noun generalization task. Further, individual differences in a child's prior technology experience will be measured and used to predict overall vocabulary as well as performance within and between each task.

Eligibility Criteria:
Inclusion Criteria:

* between 17-30 months old

Exclusion Criteria:

* diagnosed developmental delay or disorder
* exposure to more than 25% of another language
The Effects of Online Single-Session Interventions on College Student Well-being

This study seeks to investigate the effects of an online single-session intervention on college student mental health and well-being. Undergraduate students from the University of Pennsylvania and Harvard will be randomized to a 30-minute single-session intervention or a study skills control group. Students' depressive symptoms, anxiety symptoms, positive and negative affect, and subjective well-being will be assessed up to 12 weeks post-intervention.

The design of our study is a randomized control trial. After enrollment in the study, participants will randomly assigned to one of two conditions. In each condition, participants will be asked to complete an initial survey of mental health and well-being measures. Following this survey, participants will complete either a well-being skills single-session intervention or control single-session intervention (study skills) depending on which condition they were assigned to. These single-session interventions educate the participant on their focal concept and teach them exercises to improve that skill. Completing the single-session intervention will take approximately 20-30 minutes.

After completing their single-session intervention, all participants will retake the measures of mental health and well-being presented to them at the beginning of the program. Participants will also be asked to complete measures of intervention feasibility, acceptability and appropriateness at this time.

Following this initial intervention, participants will retake the measures of well-being and mental health at 2 weeks, 4 weeks, and 12 weeks after they completed the intervention. This will allow us to fulfill our first objective by determining how long single-session interventions improve undergraduate mental health and well-being.

Eligibility Criteria:
Inclusion Criteria:

* Current undergraduate student at select universities
* Able to access the internet
* Can participate in follow-up surveys for three months post sign-up

Exclusion Criteria:

* Unable to access the internet
* Will not be able to respond to the follow-up surveys post-intervention