cyrilzakka/clinical-trials huggingface dataset:
Follow up of Diabetic Macular Edema Treated by Aflibercept (Eylea®) With OCT-Angiography

This is a non-interventional, longitudinal, retrospective and prospective, non-controlled, single arm study in naive or non-naive patients with diabetic macular edema for which aflibercept (EYLEA®) therapy is indicated.


Eligibility Criteria:
Inclusion Criteria:

* Man or woman aged 18 years and more under reliable method of contraception for woman with childbearing potential (hormonal or any intrauterine devices).
* Patients with type I or II diabetes (as defined by criteria of American diabetes association ADA or world health organization WHO) with an glycosylated hemoglobin rate (HbA1c) \< 10.0%, at initial visit (First EYLEA® injection).
* Patients with diabetes treatment unchanged within the last 3 months prior to initial visit (First EYLEA® injection).
* Patients showing a visual lost due to a diabetic macular edema (DME) in the central region and not for another reason, assessed by the investigateur. The visual acuity of the fellow eye is not an exclusion criteria.
* Patient to whom a treatment by aflibercept is indicated and OCT-angiography is performed at each injection visit.
* Patients affiliated to social security system.
* Patient who has been given appropriate information about the study objectives and instructions who has given his/her non-opposition prior to conduct any study-related procedures and examination.

Non iclusion Criteria:

* Treatment with an anti VEGF (EYLEA®, LUCENTIS® or AVASTIN®) administrated by intravitreal injection within 3 months prior to initial visit in the study eye
* Treatment with Ozurdex® administrated by intravitreal injection within 6 months prior to initial visit (First EYLEA® injection) in the study eye
* History of or active ocular /intraocular inflammation (Uveitis) at initial visit (First EYLEA® injection), in either eye
* Intra-ocular pressure ≥ 25 mmHg
* Patient with neocascular glaucoma history
* Patient with foveolar exsudat that interfere with images analysis.
* History or current evidence of hypersentivity to mydriatic eye drops
* Vitreomacular traction in the study eye
* Panretinal coagulation within 3 months prior to initial visit (First EYLEA® injection), in the study eye.
* Cataract surgery in the study eye within the 6 months prior to initial visit (First EYLEA® injection)
* History of vitretectomy in the study eye
* Treatment with systemic anti VEGF medications for cancer
* History of cerebrovascular accident within 3 months prior to initial visit (First EYLEA® injection), renal failure, uncontrolled arterial hypertension (PAS\>160 mm Hg and/ or PAD\>100 mm Hg)
* Patient who does not meet the local indication criteria for Eylea® treatment. Contraindications listed in the SmPCs must be taken into account
* Participation in any investigational study with exclusion period in progress at the initial visit (First EYLEA® injection)
* Patients under guardianship
* Pregnant or breastfeeding woman.
Safety, Tolerability & PK of AZD0328 in Caucasian & Japanese

This study will be performed to evaluate the safety, tolerability and pharmacokinetics of single and multiple doses of AZD0328 when administered to Japanese and Caucasian healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

* first generation Japanese (both parents and grandparents are Japanese, the subject is born in Japan and left Japan less than 10 years ago) or Caucasian subjects.
* Clinically normal physical findings, laboratory values, vital signs and resting ECG as judged by the investigator.

Exclusion Criteria:

* History of clinically significant cardio- or cerebrovascular, pulmonary, renal, hepatic, neurological, mental or gastrointestinal disorder or any other major disorder that may interfere with the study.
* Participation in another study within 12 weeks before the first administration of the investigational product.
* Intake of any prescribed medicine or herbal remedies based on St John's Wort, except for occasional paracetamol and nasal adrenergic anticongestants, within 3 weeks before the first administration of the investigational product.
Quality of Life in Italian Visually Impaired Patients

Clinical register of visual rehabilitation activity and observational study on the validation of the VA LV VFQ questionnaire in the Italian context


Eligibility Criteria:
Inclusion Criteria:

* Subjects aged 18 years or older, suffering from any visual pathology, who are admitted to specialised visual rehabilitation centres for visual rehabilitation.
* Ability to understand and sign the informed consent for participation in the study.

Exclusion Criteria:

* Less than 18 years of age.
* Cognitive impairment that, in the opinion of the investigator, limits understanding of the informed consent or the questionnaire.
The Impact of a Smartphone App on the Quality of Pediatric Colonoscopy Preparations

The investigators developed a smartphone app that guides pediatric patients and their families through colonoscopy prep in an attempt to see if an app could improve the colonoscopy process.

The investigators created a smartphone app designed for pediatric patients and their families that informs patients about their colonoscopy procedure, alerts them when to take their medications throughout the hours-long colonoscopy prep process and tells them when to arrive to the endoscopy suite. The investigators designed a study to determine if this app will yield improved colonoscopy cleanouts, better patient understanding of the procedure, fewer calls to the GI service and more punctual arrival times to the endoscopy suite compared to patients who receive written instructions that do not actively interact with the patient before, during or after their colonoscopy prep.

Eligibility Criteria:
Inclusion Criteria:

- Aged 5-18 years scheduled to undergo a diagnostic and/or therapeutic colonoscopy

Exclusion Criteria:

* Patients who had undergone a colonoscopy within the past one year
* Patients admitted for a nasogastric (NG) cleanout
* Patients requiring colonoscopy preparation medication other than Polyethylene Glycol
* Patients with poor understanding of English.
Characterization of Epicardial and Pericardial Adipose Tissue in Coronary Artery Disease

Human epicardial fat is the true visceral fat depot of the heart, and its regional distribution and physiology is of growing scientific and clinical interest. This study aims to characterize the expression profile and function of the epicardial and pericardial adipose tissue compartments of the heart (EAT and PAT). EAT and PAT adipose biopsies will be obtained from patients undergoing coronary artery bypass graft surgery (CABG) or valve replacement surgery.

The epicardial adipose tissue (EAT) stretches from the myocardium to the visceral layer of the pericardium. Adipose located on the outside of the visceral pericardium to the external site of the pericardium is called the pericardial adipose tissue (PAT), and is of a separate origin than EAT. Therefore, this study aims to investigate the global expression profile of the EAT and PAT compartments, in addition to characterizing the function, structure, metabolic and inflammatory profile. Furthermore, this study will determine whether CABG and valve replacement patients display different EAT and PAT characteristics

Eligibility Criteria:
Inclusion Criteria:

* Age \<80 years
* Patients undergoing elective heart surgery either for coronary bypass grafting or for other purposes

Exclusion Criteria:

* Inability of the patient to provide informed consent
* Severe kidney failure, GFR\<30
* Previous cardio-thoracic surgery
* There are no other specific exclusion criteria, as long as the patient is considered eligible for surgery by the clinicians
Virtual Reality Distraction in Pediatric Patients.

The aim of this study is to evaluate the effect of virtual reality distraction on pain and anxiety during infiltration anesthesia in pediatric patients.

Proper pain control and discomfort reduction during dental treatment, especially among children, can maximize a child's cooperation, overall satisfaction, build a good dentist-patient relationship, and enhance patient compliance. Psychological and pharmaceutical methods, and their combinations have tried to address this pain. Pharmaceutical approaches include the application of topical anesthetics. Psychological and behavioral modification methods including active distractions, deep breathing, Witaul and eye movement distractions. Passive distraction methods, such as audiovisual glasses and video distraction. Other methods, such as precooling the injection site, warming the local anesthesia, and camouflaging the syringe, have also been suggested.

A range of fear management techniques have been described in the literature and American Academy of Pediatric Dentistry (AAPD) has described some concepts as basic behavior guidance such as communication, tell show do, voice control, nonverbal communication, positive reinforcement, distraction and parental absence/presence, and advanced behavior guidance such as protective stabilization, sedation and general anesthesia.

Distraction as a behavior guidance technique is defined by the American Academy of Pediatric Dentistry (AAPD) as the technique of diverting the patient's attention from what may be perceived as an unpleasant procedure.

Audiovisual distraction techniques are used in dental clinics and have shown great results in managing anxious pediatric patients.

Virtual reality (VR) distraction, defined as a human-computer interface that enables the user to interact dynamically with the computer- generated environment is a new method in the medical field with the aim of aiding in patient behavior management. It offers the advantage of an immersive virtual experience blocking out external stimuli that may provoke a negative attitude, especially in young patients.

Distraction using VR provided favorable outcomes for adult and pediatric patients during various dental procedures, ranging from simple anesthesia to periodontal, restorative, and pulpal therapy .

Eligibility Criteria:
Inclusion Criteria:

1. Healthy children with no systemic illness.
2. Cooperative child with frankels behavior rating scale positive or definitely positive.
3. Patient requiring infiltration LA for dental treatment.
4. Children with proper parental consent.
5. Patients who needed non-urgent dental treatment.

Exclusion Criteria:

1. Medical disability such as history of seizures, convulsion disorder, vertigo, eye problems and autism.
2. Children below 5 years of age.
Ovitex in Paraesophageal and Large Hiatal Hernia Repair

The purpose of the study is to evaluate the success of hiatal hernia repairs in patients with large (\>5cm) or paraesophageal hernias when Ovitex LPR mesh used during the repair.

This is an investigator initiated, single site, single arm study investigating the recurrence rate of hiatal hernia and safety using Ovitex LPR in patients undergoing hiatal hernia repair.

Ovitex LPR mesh is a reinforced tissue matrix, comprised of a fine non-absorbable polymer suture interwoven through layers of absorbable biologic material in a "lockstitch" pattern.The biologic material in OviTex, derived from ovine rumen (sheep stomach), serves as the natural building block and is optimized to reduce foreign body response, enable functional tissue remodeling and promote a more natural hernia repair. The interwoven polymer fibers provide additional reinforcement, along with improved handling and load-sharing capability. The permanent polymer fiber (polypropylene) is a standard surgical suture material that is used in hiatal hernia surgery and comprises less than 5% of the final product.

Preop details, quality of life questionnaires and surgery details will be collected along with post op GERD (gastro esophageal reflux disease) quality of life questionnaires and barium swallow esophagrams to objectively examine recurrence of hiatal hernia at 1, 3, and 5 years post op. Data will be carefully collected and reviewed for discrepancies and verified with source prior to analysis.

Eligibility Criteria:
Inclusion Criteria:

* 18-85 year old with PEH and appropriate surgical indication for repair

Exclusion Criteria:

* Under 22 years of age.
* In need of an emergency procedure.
* Currently being treated with another investigational drug or device.
* Have had prior gastric or esophageal surgery.
* Have had any previous intervention for GERD.
* Are suspected or confirmed to have esophageal or gastric cancer.
* Have a Body Mass Index (BMI) greater than 45.
* Cannot understand trial requirements or are unable to comply with follow-up schedule.
* Are pregnant, nursing, or plan to become pregnant.
* Have a mental health disorder that would interfere with your ability to follow study instructions.
* Have suspected or known allergies to Ovitex
* Have an illness that may cause you to be unable to meet the protocol requirements or is associated with shortened life expectancy.
Effects of Consuming Sugar-Sweetened Beverages With Meals for 10 Weeks

The purpose of this study is compare the effects of consuming glucose- and fructose-sweetened beverages on appetite, body weight, body fat, and the amount of energy the body burns as well as effects on blood pressure, hormones, blood triglycerides and cholesterol, and the body's sensitivity to the insulin.

The study is designed as a prospective, blinded diet intervention study during which the participants consume either fructose- or glucose-sweetened beverages (25% of energy) with meals. Experimental procedures, including 24-hour serial blood sampling, 26-h stable isotoped infusions, post-heparin blood collection, gluteal biopsies, metabolic rate monitoring, computed tomography scans of the abdomen, and Oral Glucose Tolerance and Disposal Tests, are performed during baseline and at the end of a 10-week intervention period at the UC Davis School of Medicine/Sacramento Veterans Affairs Medical Center Clinical Research Center (CCRC). During the 2-week inpatient baseline period, subjects are served energy balanced diets containing 15% of energy as protein, 30% as fat, and 55% as complex carbohydrate. Following the baseline period, the subjects reside at home for 8 weeks and consume their usual ad libitum diet along with 25% of energy requirements as fructose- or glucose-sweetened beverages. Subjects then return to the CCRC for the 2-week inpatient intervention period at the end of the study and are served energy-balanced diets containing 15% of energy as protein, 30% as fat, 30% as complex carbohydrate and 25% of energy as fructose- or glucose-sweetened beverage.

Eligibility Criteria:
Inclusion Criteria:

* Self-report of stable body weight
* Women were post-menopausal based on a self-report of no menstruation for at least one year

Exclusion Criteria:

* evidence of diabetes
* renal or hepatic disease
* fasting serum TG concentrations \>400 mg/dl
* hypertension (\>140/90 mg Hg)
* surgery for weight loss
* individuals who smoked
* reported exercise of more than 3.5 hours/week at a level more vigorous than walking
* having used thyroid, lipid-lowering, glucose-lowering, anti-hypertensive, anti-depressant, or weight loss medications
* habitual ingestion of more than one sugar-sweetened beverage/day or more than two alcoholic beverages/day
Effects of Aerobic Exercise Training on Nurses' Sleep Quality, Fatigue, Attention and Cortisol Profile

Shift work in nursing has been found to result in sleep disruption and sleep deprivation, and in sleepiness or fatigue at work. Slow reaction, insufficient attention and poor judgement often come with increased fatigue, which contributes to a high risk of accident and patient safety. Studies have shown that aerobic exercise is helpful in promoting high sleep quality. The study is conducted a prospective parallel randomized trial is performed to 60 nurses with low sleep quality. The subjects are randomly assigned to: (i) the experimental group, in which aerobic exercise training is given; (ii) the control group, in which the subjects kept their original lifestyles. The study aims to investigate the effects of aerobic exercise training on nurses' sleep quality, fatigue, attention and cortisol profile.

When work shifts and lifestyles change, the synchronous relationship between the body's biological clock and the environment, i.e., circadian rhythms, is disrupted, resulting in insufficient sleep and insomnia. Shift work in nursing has been found to result in sleep disruption and sleep deprivation, and in sleepiness or fatigue at work. Slow reaction, insufficient attention and poor judgement often come with increased fatigue, which contributes to a high risk of accident and patient safety. Studies have shown that aerobic exercise is helpful in promoting high sleep quality, whereas few researchers have argued over how aerobic exercise training improves sleep quality in nurses. The study is conducted in two stages. Previous stage, we conducted with a cross-sectional study design with convenience sampled 200 participants to fill out the Chinese Pittsburgh Sleep Quality Index (CPSQI) questionnaire for screen the low sleep quality (CPSQI \> 5) participants. A total of 200 nurses were recruited, and 199 valid samples were collected, 108 participants were found to have low sleep quality (CPSQI \> 5). The study will adopt a prospective, longitudinal, parallel-group comparative study, randomly sample from previously screen low sleep quality participants, then random assign to experimental (aerobic exercise) and control (routine activity) groups, and actigraphy sleep recording, saliva samples and attention data will be collected.

The study aims to investigate the effects of aerobic exercise training on nurses' sleep quality, fatigue, attention and cortisol profile. The findings of the study could provide guidelines on improving nurses' fitness and sleep quality.

Eligibility Criteria:
Inclusion Criteria:

* Full-time
* Female nursing staff members
* Worked 8 hours per shift
* Had at least 1 year of work experience.

Exclusion Criteria:

* Had used sedatives, hypnotics, antihistamines, or hormonal drugs within the 4 weeks before commencing the study
* Pregnant
* Were diagnosed as having sleep or stress disorders, or experienced sleep problems owing to concurrent insomnia or sleep apnea.
Clinical Performance of Restorative Materials in Primary Teeth

The purpose of this study is to evaluate and compare the clinical performance of dental restorative materials in Class II cavities of primary molar teeth

Restorations will be placed on four primary molar teeth with proximal caries, in a split mouth design. 100 patients will be included in the study. The teeth will be randomized into four groups according to the restorative materials.

Group 1: Adhesive agent+ Compomer (Dyract AP, Dentsply DeTrey, Konstanz,Germany) Group 2: Primer + Resin modified glass ionomer (Vitremer, 3M ESPE, U.S.) Group 3: Adhesive agent + Giomer (Beautifil II, (Shofu Dental, Tokyo, Japan) Group 4: Amalgam (Permite amalgam, SDI Limited, Bayswater, Australia) The restorations will be evaluated at baseline, 3., 6., 12. months for the first year, and at every 6 months for 5 years. The modified US Public Health Service criteria (secondary caries, marginal integrity, marginal discoloration and retention) will be used for clinical evaluation of restorations. The data will be analysed statistically using Wilcoxon test, chi square test and the Kaplan-Meier survival method will be used to estimate survival percentages.

Eligibility Criteria:
Inclusion Criteria:

* Patients and parent of the patients who accept to participate and sign the informed consent
* Patients who have at least four first and/or second primary molars with proximal caries that require class II restorations
* Teeth that have healthy lamina dura and periodontal ligament
* Teeth that have caries lesions extending no more than the outher half of dentin radiographically

Exclusion Criteria:

* Patients and parent of the patients who don't accept to participate and sign the informed consent
* Teeth that are previously restored
* Patients who are uncooperative
* Teeth that doesn't have proximal or occlusal contacts with adjacent healthy teeth
* Patients who have bruxism, skeletal or dental malocclusion
* Teeth that have developmental defects or anomalies
Postoperative Peripheral Nerve Stimulation for Management of Post-amputation Pain

Limb loss is frequently associated with postamputation pain that can be challenging to treat and often involves opioids. Advances in the field of neuromodulation has led to development of an intentionally reversible percutaneous peripheral nerve stimulation (PNS) system that has had promising results when treating chronic postamputation pain. PNS may offer sustained pain relief even after the treatment period has ended. Currently, there is no convincing evidence regarding the role of PNS in the acute postoperative period, which may be a critical time to control pain as those with higher pain appear to be at higher risk for developing persistent post-procedural pain. The investigators of this study aim to evaluate the feasibility and effects of PNS in the acute postoperative period and determine the feasibility of completing a randomized controlled treatment outcome study.

16 patients with new nontraumatic transfemoral or transtibial amputation will be enrolled in the study

Having met inclusion criteria, the patients will be randomized to experimental or control groups

Patients in the experimental group undergo placement of PNS leads within 7 days of amputation surgery

Patients in both groups will be treated with standard pharmacologic and nonpharmacologic pain therapies and evaluated weekly for 8 weeks, then at 3, 6, and 12 months postamputation

Eligibility Criteria:
Inclusion Criteria:

* Nontraumatic transfemoral (above-the-knee) or transtibial (below-the-knee) amputation
* Presence of postamputation pain rated at least 4 or more

Exclusion Criteria:

* Beck Depression Inventory score greater than 20
* Systemic infection
* Immunocompromised or taking immunosuppressive medications
* Implanted electronic device
* Pregnancy
* Previous allergy to skin contact materials and/or anesthetic agent
* Altered mental status
* Inability to provide informed consent
Mind Body Program for Vascular Disease

The purpose of the current study is to conduct a proof-of-concept test regarding the delivery of a Mind Body Program for vascular disease, focusing on support for depression, stress, and adherence, as part of patients' chronic disease management for peripheral artery disease (PAD).


Eligibility Criteria:
Inclusion Criteria:

* Rutherford score 1-4 (mild-severe claudication, or ischemic rest pain)
* Resting ankle-brachial index assessment ≤0.90 or drop in post-exercise ankle pressure ≥20 mmHg or non-compressible ankle-brachial index (≥1.30) or toe brachial index less than 0.70 in the past year
* Positive depression screening result (positive PHQ-9 result ≥10) or high stress screening result (10-item Perceived Stress Scale Score ≥27)

Exclusion Criteria:

* Not speaking either English or Spanish
* Age ≥18 years
* Currently incarcerated
* Current alcohol dependency or other substance use disorder (score ≥ 5 on NM-ASSIST)
* Cognitive impairment (T-MoCA Short \<10)
* Acute suicidal risk (positive screen ASQ Tool)
* History of psychosis or bipolar disorder
* Previously enrolled in the study
* Unable to provide written informed consent