cyrilzakka/clinical-trials huggingface dataset:
Efficacy of 0.38% and 0.18% Sodium Hyaluronate Ocular Lubricants for Dry Eye in Adult Gazan Participants

The goal of this completed clinical trial was to determine if 0.38% and 0.18% sodium hyaluronate (SH) lubricant eye drops improve symptoms of moderate to severe dry eye disease (DED) in adult Gazan participants. The main questions it aimed to answer were:

1. Did 0.38% and 0.18% SH eye drops improve Arab-Ocular Surface Disease Index (Arab-OSDI) scores?
2. Did these eye drops improve tear break-up time (TBUT), corneal fluorescein staining (CFS), and lissamine green conjunctival staining (LGS)?
3. Did 0.38% SH provide greater benefits in evaporative dry eye (EDE) compared to 0.18% SH and normal saline?
4. Researchers compared 0.38% SH, 0.18% SH, and normal saline eye drops to evaluate their effectiveness in symptom relief and clinical improvements.

Participants:

1. Applied their assigned eye drops three times daily for six weeks Used normal saline eye drops for the first week before starting their assigned treatment
2. Underwent clinical assessments at weeks 1, 3, and 6, including Arab-OSDI scoring, TBUT, CFS, and LGS tests
3. The study began on October 30, 2022, and was completed on February 3, 2023, with 45 participants each completing a 6-week trial period.


Eligibility Criteria:
Inclusion Criteria:

* Participants aged 18 to 40 years.
* Residents of South Gaza Strip.
* Diagnosed with moderate to severe dry eye disease (DED) based on Arab-OSDI score (≥ 23).

Exclusion Criteria:

* History of systemic diseases (e.g., rheumatoid arthritis, Sjögren syndrome, thyroid disorders).
* Previous punctal plugs or punctal cautery treatment for ocular surface pathologies.
* Presence of pterygium, evident lid/orbital disease with lagophthalmos, or history of punctal cautery.
* Contact lens (CL) users who always need to wear CLs.
* History of ocular surgeries within 6 months or LASIK within 12 months.
* Use of medications that could affect study results (e.g., antihistamines, antidepressants, aspirin, anticholinergics, corticosteroids) or recent use of central nervous system or hormonal medications within 30 days.
* Current use of ocular medications or those planning to start new medications during the study.
* Pregnant participants or those with ocular pathologies beyond DED and refractive errors.
Impact of Giving Birth During the Covid 19 Pandemia on Postnatal Women's Depression

Postnatal depression is an important problematic in French population with approximatively 10 -20% of women who suffer from postnatal depression. This pathology may have strong negative impact on both women and neonate's health.

The women's satisfaction degree in front of childbirth is an important factor associated with postnatal depression since women unsatisfied of their childbirth and/or women with a complicated childbirth are more encline to suffer from postnatal depression.

It is likely that the actual context of Covid 19 pandemia and the change in obstetrical cares organization may have a negative impact on women's satisfaction about their childbirth and so a negative impact on the risk of postnatal depression.


Eligibility Criteria:
Inclusion Criteria:

* women older than 18 years
* women who deliver of a singleton, term neonate in cephalic presentation

Exclusion Criteria:

* women younger than 18 years
* women who deliver of a baby in non cephalic presentation
* women with pre term Birth
* women without any internet access
* women with psychiatric disorders
* women who do not understand french language
* women who refuse to be aware of the results of the postnatal depression screening and who refuse that her doctor be ware of the results
Effect of COVID-19 Pandemic on Vaccination Compliance

1- Evaluate the impact of the COVID-19 pandemic on pediatric vaccinations compliance among children attending to Assiut University Children Hospital ,assess the general health profile of studied children.

Corona virus disease (COVID-19) is a disease caused by a new corona virus called Severe Acute Respiratory Syndrome Corona virus 2 (SARS-CoV-2). On March 11, the WHO Director-General declared COVID-19 a pandemic1. The first outbreak occurred in Wuhan, China. 2,3 COVID-19 pandemic has severely affected global health services.4 It is important not to overlook the value of some public health preventive interventions which cannot be postponed, such as vaccinations.5 As reported by WHO, the disruption of immunization services, even for brief periods, will result in increased numbers of susceptible individuals, raising the risks of an upsurge in outbreak-prone VPDs.6 The reduction of vaccination coverage could cause an increase in morbidity and mortality among children. Consequently, a greater burden could be placed on health systems. Examples from previous large epidemics (e.g. diphtheria in the former Soviet Union in 1990-1996 and in Venezuela in 2017-2018) show that, when vaccination coverage falls or vaccinations are disrupted, cases of infectious diseases that have disappeared can quickly re-emerge.7-8 Egypt declared a national state of emergency to control COVID-19 pandemic and implemented a stay-at-home order. Such strategies might result in decreased accessibility to routine immunization services, leaving children at risk for vaccine-preventable diseases and their complications.9 Great efforts are needed for rapid catch-up of children not up-to-date with routine vaccines. Parental concerns about potentially exposing their children to COVID-19 during vaccination visits might contribute to incompalince.10 Reminding parents of the vital need to protect their children against serious vaccine-preventable diseases is critical.

Eligibility Criteria:
Inclusion Criteria:

* Children from 12 to 24 months who admitted in Assiut University Children Hospital or attending the outpatient clinics

Exclusion Criteria:

* : Immunodeficiency (e.g chemotherapy, long term immunosuppressive therapy, hematologic tumor).
Extended Duration Nicotine Replacement Therapy and Bupropion in Smokers With Schizophrenia

After successfully quitting smoking, smokers with schizophrenia are vulnerable to relapse shortly after discontinuation of treatment. The purpose of this study was to assess the feasibility and effectiveness of a 12-month relapse prevention intervention in recently abstinent smokers with schizophrenia. Subjects participated in a 12-week smoking cessation phase, where they received nicotine replacement therapy, bupropion SR 150mg bid, and cognitive behavioral therapy. If, at the end of the 12 weeks, they were able to demonstrate 1 week of abstinence, they continued in the relapse prevention phase of the study, where they continued to receive nicotine replacement therapy, bupropion SR 150mg bid, and cognitive behavioral therapy.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with schizophrenia or schizoaffective disorder by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria
* Reported smoking 10 or more cigarettes per day for at least the prior year
* Expressed a desire to quit smoking and a willingness to set a smoking cessation date within 4 weeks of enrollment
* Were psychiatrically stable on a fixed dose of an antipsychotic for the past 30 days or more
* Reported no active substance use disorder other than nicotine or caffeine within 6 months of enrollment

Exclusion Criteria:

* Participants with neurologic risk factors for bupropion treatment were excluded from receiving bupropion but were eligible to participate and receive short- and long-acting NRT and CBT only.
Discovering Patterns in the Gut Microbiota Associated With the Risk of Stroke and the Outcome After a Stroke and Integration of These Data With Genomic Information to Find New Drug Targets and New Treatments to Improve Neurological Evolution and Functional Status of Stroke Patients.

The composition of the intestinal microbiota is associated with the risk of stroke and with post-stroke neurological evolution. At the same time, the genetics and epigenetics of each patient are associated with the composition of the intestinal microbiota. The study of the microbiome in stroke patients will allow finding new therapeutic targets for the treatment of stroke patients.

For the study, samples will be collected from those patients with ischemic stroke who come to the hospital while the study is being carried out, taking into account certain criteria: the patients must be over 18 years of age, have suffered an ischemic stroke (demonstrated by resonance or head CT), not have any additional serious illness or unstable medical condition, and not be included in clinical trials with neuroprotective drugs. On the other hand, the control group will be asymptomatic, and will be made up of people who have not previously suffered a stroke or a cardiovascular event and who do not have diseases that affect the digestive tract.

The main variables of the study are the risk of stroke and disability after a cerebrovascular accident (measured by mRS at 3rd month). Microbiota, genetic and epigenetic variables are also taken into account, such as the presence and levels of bacteria, dysbiosis, genetic polymorphisms and levels of methylation in CpG islands.


Eligibility Criteria:
Inclusion Criteria:

* Patients with ischemic stroke (demonstrated by resonance or head CT).

Exclusion Criteria:

* Patients under 18 years of age.
* Additional serious illness or unstable medical condition.
* Inclusion in clinical trials with neuroprotective drugs.
The Effect of Position Change on Pain and Cerebral Oxygen Saturation

This study is a randomized controlled experimental study to investigate the effect of position change on pain and cerebral oxygen saturation after endotracheal aspiration in pediatric patients.

This study is a randomized controlled experimental study to investigate the effect of position change on pain and cerebral oxygen saturation after endotracheal aspiration in pediatric patients. The study sample consisted of 70 pediatric patients (35 in the control group and 35 in the intervention group) who met the inclusion criteria and whose parents gave informed consent. The research data were collected using the "Child Identification Form" and the "Behavioral Pain Scale". SPSS 24 program was used to analyze the data obtained in the study. Children in the experimental group were given 30 minutes of wrapping and 30 minutes of fetal position after aspiration. Children in the control group did not receive any treatment.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients whose consent form is signed by their legal guardian
* Intubated pediatric patients receiving mechanical ventilation support
* Non-sedatized pediatric patients
* Pediatric patients who have received only paracetamol and whose duration of action has exceeded 4-6 hours

Exclusion Criteria:

* Unconscious pediatric patients
* Pediatric patients receiving pharmacologic drugs other than paracetamol
* Unstable pediatric patients
* Pediatric patients with painful procedures during the procedure
Oxford - Fibrates in Aortic Stenosis

Aortic stenosis (AS) is characterised by left ventricular (LV) hypertrophy and altered myocardial substrate metabolism. Peroxisome proliferator-activated receptor (PPARα), a regulator of lipid metabolism is deactivated in pressure overload hypertrophy such as in AS and can lead to dysregulation of fatty acid oxidation, myocardial triglyceride accumulation (steatosis) and lipotoxicity. The investigators propose a proof-of-concept study to investigate the effect of altering myocardial triglyceride (MTG) using a PPARα agonist, fenofibrate on cardiac physiology in patients with asymptomatic moderate-severe AS. The primary endpoint is a change in MTG assessed by magnetic resonance spectroscopy at baseline and after 6 months of treatment. Exploratory endpoints are changes in cardiac physiology including myocardial deformation (strain) as assessed by cardiac magnetic resonance imaging. The investigators hypothesise that pharmacological reduction of MTG with a PPARα agonist will result in steatosis regression and changes in cardiac physiology.

This is a single-centre, proof-of-concept study to investigate the effect of altering MTG content using fenofibrate on cardiac physiology in patients with asymptomatic moderate-severe AS. All patients will participate in a randomised, double-blind, placebo- controlled design for 6 months. AS will be graded according to the British Society of Echocardiography's transthoracic echocardiography guidelines. Sixty two eligible patients will be recruited in total, of which forty nine patients will be randomised to receive 200 mg daily oral fenofibrate and thirteen patients will receive matching placebo for 6 months. All patients will undergo 1H-MRS to assess MTG, 31P-MRS to assess myocardial energetic (Phosphocreatine-to-ATP ratio - PCr/ATP), standard cardiac magnetic resonance imaging to assess LV strain, LV mass, late gadolinium enhancement (fibrosis), physiological exercise assessments to measure maximum oxygen consumption (VO2 max) and 6-minute walking distance. Bloods will be drawn for cholesterol, renal and liver function, glucose and free fatty acids. All tests will be done at baseline and after 6 months' treatment with fenofibrate/placebo.

Eligibility Criteria:
Inclusion Criteria:

* Asymptomatic moderate to severe AS (with at least two of the following: aortic valve area \<1.5 cm2, peak pressure gradient \>36 mmHg or mean pressure gradient \>25 mmHg)
* Not planned aortic valve replacement or transcatheter aortic valve implantation (TAVI)
* Age \>18
* No other significant valvular pathology
* No contraindication to magnetic resonance imaging.

Exclusion Criteria:

* Known coronary artery disease, history of angina, myocardial infarction or presence of regional wall motion abnormalities
* Other underlying cardiomyopathy
* Left ventricular ejection fraction\<50%
* Uncontrolled hypertension
* Diabetes Mellitus
* Liver impairment
* Pregnancy and lactation
* Body mass index \>35 kg/m2
* Renal impairment (eGFR\<30 ml/min)
* Intolerance to or concurrent use of fibrates or PPARα agonists.
Comparison of Dermatoscopy X400 Interpreted by 6 Non-dermatologists and an Artificial Intelligence Software Skin Artificial Intelligence Versus Dermatoscopy x 20

Pigmented lesions of the genital mucosa are common, affecting between 10% and 20% of the population. The clinical appearance is sometimes confusing. They are often extensive, irregular, and inhomogeneous in color, which can make them look suspicious. Moreover, dermatoscopic imaging is often complex to interpret, as shown by the many different patterns reported in the literature.

Thus, preliminary work in confocal microscopy has shown that it is possible to simplify diagnosis by using microscopic, in vivo, non-invasive imaging. However, CIM cameras are rare, very expensive and difficult to access.

Conversely, digital dermatoscopes with 400x magnification are much less expensive and can also allow, in a certain number of cases, an examination at the cellular level of tumors, with, in our opinion, the advantage of being easy to learn. In the context of the pooling of resources within medical centers in particular, their dissemination should accelerate. Furthermore, x400 dermatoscopy can provide similar information to IVCM for the most frequent black genital tumors.

The hypothesis that motivates this work is that X400 dermatoscopy in the hands of non-experts would allow a fast increase in their diagnostic capacity by identifying the main genital pigmented tumor, namely melanosis, and thus improve the use of expert centers relieved of the care of benign tumors.

Eligibility Criteria:
Inclusion Criteria:

* Men and women with a pigmented lesion of the genital mucosa, having benefited from a mucosal consultation at the University Hospital of Saint-Etienne, with Professor Perrot.
* The patient's clinical file must contain clinical images, dermatoscopy images x 20 and at least 1 dermatoscopy image x 400.

Exclusion Criteria:

- None
The Role of Psychosocial and Other Quality of Life Parameters in Evaluating Functional Changes Prior to and Following Laser In-situ Keratomileusis (LASIK)Changes Laser In-situ Keratomileusis (LASIK)

To evaluate the changes in quality of life parameters after LASIK surgery.

Our purpose is to evaluate the changes in quality of life parameters after LASIK surgery. We intend to create a questionnaire to delineate the changes that occur in LASIK patients at the pre-operative visit and at the 1-month and 3-month post-operative visits. Additional questionnaires will be administered to demonstrate the validity of the new questionnaire. The approximate time the patient will be required to spend in clinic will be approximately 45 minutes at each of the three visits.

Eligibility Criteria:
Inclusion Criteria: All refractive surgery patients with otherwise normal eyes undergoing routine LASIK as a primary refractive procedure for myopia, hyperopia or astigmatism.

-

Exclusion Criteria: Patients who elect to perform alternative refractive surgery such as PRK, RK, or Intacts™.

-
Strawberries and Risk of Diabetes in Adults

Strawberries can be categorized as a functional food based on results from several clinical trials in improving cardiometabolic health beyond providing nutrition. Recent studies identify the role of strawberries in improving insulin resistance and risks of type 2 diabetes which urgently warrants further investigation, keeping in view the huge public health burden of diabetes in the US. In this study, the investigators propose to investigate the effects of a dietary achievable dose of strawberries on glycemic control, insulin resistance, and HbA1c (primary variables) and biomarkers of inflammation and endothelial function in a 28- week controlled crossover study.

Strawberries are popularly consumed fruits in the US and are a rich source of several bioactive compounds with demonstrated health benefits in T2D and cardiovascular disease (CVD). Based on previously reported studies, strawberries have been shown to improve elevated lipid profiles/dyslipidemia, oxidative stress and inflammation in adults with the metabolic syndrome or prediabetes. In a recently reported study, strawberries at a dose of two-and-a-half servings per day for four weeks was shown to significantly reduce insulin resistance and serum adipokines in obese adults. These results conform to only a few reported trials using strawberries in adults with cardiometabolic risks. While these study findings are clinically meaningful, these warrant urgent investigation in trials of longer duration specifically targeting adults with impaired fasting glucose (vs. other features of the metabolic syndrome) as well as adults with diagnosed T2D with poor glycemic control despite taking medications. Furthermore, to the best of our knowledge, only one clinical trial has been reported on the role of strawberries in improving glycemic control, oxidative stress, and inflammation in adults with T2D. While these results are encouraging, they lack generalizability due to the short duration of the study (six weeks) that precludes accurate changes in glycated hemoglobin (HbA1c) as a stable biomarker of glucose control. Based on these gaps in the existing literature, the investigators will examine the effects of strawberry supplementation at a dose of 2.5 servings/day for 12 weeks on glycemic control and related cardiometabolic profiles in prediabetes in a randomized controlled crossover trial.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Waist size greater than 40 inches in men or 35 inches in women
* Blood glucose greater than 100mg/dL but less than 126 mg/dL or glycated hemoglobin less than 6.5%
* Insulin resistance \>1.0
* Not on diabetes medications
* Normal liver and kidney function tests

Exclusion Criteria:

* Allergy to strawberries
* Smoke or drink alcohol on a regular basis
* Pregnant or lactating
Incentive-based Intervention for Smoking Cessation and Prevention in High Schools

The purpose of this study is to design an incentive-based intervention to motivate a tobacco-free lifestyle among high school students and to pilot the intervention in the first academic year in two schools (CT and NY) and examine feasibility and acceptability. Preliminary efficacy of the intervention will be assessed by implementing it in two new schools (CT and NY) in the second academic year and determine an effect size estimate for a larger trial.

The study is intended to assess the number of students joining the program and pledging to be smoke-free and to examine changes in tobacco use rates and attitudes following intervention exposure. We hypothesize that the schools will have lower rates of tobacco use and improvement in attitudes, norms and behavioral control over tobacco use after participating in the program.


Eligibility Criteria:
Inclusion Criteria:

* high school student at school that is invited to participate

Exclusion Criteria:

* no exclusion criteria
Integrated Parent Training for Treating Depression in Mothers of Children With Attention Deficit Hyperactivity Disorder

This study will determine the effectiveness of integrated parent training versus standard behavioral parent training in treating depression and stress in mothers of children with attention deficit hyperactivity disorder (ADHD).

ADHD is one of the most common childhood mental disorders. Children with ADHD have impaired functioning in multiple settings, including home and school, and in relationships with peers. Parenting a child with ADHD can be discouraging and stressful. Research has shown that parent-child interactions are more negative among families with ADHD children. Additionally, families with children with ADHD experience increased parental stress, maternal depression, and marital distress, as compared to families with healthy children. These interactions may exacerbate the child's ADHD symptoms. Behavioral parent training has been used to improve parent-child relationships. This study will determine the effectiveness of integrated parent training versus standard behavioral parent training in treating depression and stress in mothers of children with ADHD.

Individuals interested in participating in this open-label study will first undergo an assessment of their eligibility for inclusion in the study. This session will last between 3 and 4 hours and will involve both the mother and the child. If eligible, mothers will be randomly assigned to receive either standard behavioral parent training or an integrated treatment, involving both behavioral parent training and cognitive-behavioral therapy targeted at coping with stressful parenting situations. The integrated treatment will also include a course on coping with depression. Both groups will meet for 2 hours every Wednesday evening for 14 weeks. Childcare will be provided, as well as free treatment for childrens' ADHD symptoms and mothers' depression. Both the child's and the mother's psychological functioning will be assessed upon study completion and at the 3-month follow-up visit.

Eligibility Criteria:
Inclusion Criteria:

Mothers:

* Scores at least 10 on the Beck Depression Inventory (BDI)-II scale on two occasions approximately 1 week apart
* Does not meet criteria for current substance abuse, psychosis, or bipolar disorder, which would likely warrant other immediate treatment

Children:

* Meets DSM-IV criteria for ADHD according to parent and teacher reports on rating scales and parent diagnostic interviews
* Estimated IQ of at least 70
* Aged between 6 and 12 years
* Lives with mother

Exclusion Criteria:

* Child has current Pervasive Development Disorder
* Mothers and children participating in psychosocial treatment that cannot be suspended