cyrilzakka/clinical-trials huggingface dataset:
Highlighting the Benefits of a Screening Protocol Delivered by Orthoptists to Identify Visual Impairment in Children Aged 3 to 4

Visual developmental abnormalities affect 10 to 15% of the population under 6 years of age and leads to amblyopia in 30% of cases if left untreated. Untreated amblyopia in adulthood has consequences on the quality of life of individuals but will also represent a cost to society due to the increased risk of visual impairment.

The screening protocol for this study recommends that a screening examination for amblyopia and amblyogenic factors be routinely performed by an orthoptist in children between 3 and 4 year old. This examination should include, as a minimum, a standardised measurement of visual acuity, a cover test and a measurement of refraction by photoscreener. In the event of a positive screening, the child must then be referred to an ophthalmologist so as to complete an ophthalmological examination.

The aim of this protocol is to propose screening tests usually performed with a high specificity, in order to avoid congestion of ophthalmological services (i.e. by avoiding excessive or unnecessary referral of children to the ophthalmologist) without losing sensitivity by combining several tests.

The orthoptists' role in this screening protocol is to facilitate an extensive screening coverage of the population in this age group, as they are more easily accessed by the patients and more equitably spread in the community than ophthalmologists.

Therefore, by initially screening and then referring less children to the ophthalmologist, the aim is to reduce waiting times in the access of ophthalmological services which could be detrimental in terms of treatment success rates for patients acutely needing care.

Based on the referral of children between 3 and 4 years of age by the orthoptist to an ophthalmologist, the analysis of the data from the standard screening protocol used in our centre will enable us to validate it scientifically. The referral thresholds can thus be secondarily adjusted for each test if the initial objectives are not achieved (specificity \> 90% and sensitivity \> 87%). The aim of this study is also to observe a change in the patient flow by reducing the volume of consultations with the ophthalmologist currently required based on the present referral rate. The efficiency of the screening protocol by calculating the probable economic gain linked to the modification of the screening circuit will be secondarily studying in this protocol


Eligibility Criteria:
Inclusion Criteria:

* Children from 3 to 4 years old consulting for a screening of visual disorders,
* Patients registered with French social security scheme,
* Not participating in any other clinical study,
* Consent obtained from one of the two parents or the legal representative.

Exclusion Criteria:

* Children whose parent or legal representative is vulnerable according to article L1121-6 of the CSP,
* Children whose parent or legal guardian is under guardianship or trusteeship or under legal protection,
* Children, whose parent or legal guardian is unable to give consent, or is protected by law.
Interactions Between Diet, Intestinal Microbiota and Metabolomics

It is widely known that the quality of the diet is able to modify the expression of many bacterial genes populating the intestine of the host, as well as the type of bacteria themselves. This is also expressed with a more or less evident and troublesome after meals symptomatology that many patients complain to the health care staff.

A good composition of the microbiota is crucial for the health of the individual, both at the intestinal level as well as at the systemic level because, depending on the type of food substrate available at the intestinal level, metabolites will be produced capable of positively or negatively affect the health of the individual.

In fact, scientific evidence shows the existence of the causal link between the health of the microbiota and the genesis of inflammatory diseases not only intestinal, but also systemic, and even of cancer, obesity, metabolic syndrome and atherosclerosis.

The recent diffusion of gene sequencing techniques has brought significant developments in the study of the human and bacterial genome, which allow to produce enormous quantities of sequences at a lower cost and at a higher speed than previous techniques.

Therefore the clinical Nutrition Clinic of the IRCCS De Bellis in Castellana Grotte (BA) proposes to check if changes in the intestinal microbiota correlate, not only with anthropometric and clinical-laboratory parameters, but also with the typical symptoms of irritable bowel syndrome (IBS), a functional pathology very widespread with the advent of the modern era, in which, a diet rich in sugars and proteins of animal origin and poor in plant foods, is unfortunately common also in the areas of the Mediterranean basin.


Eligibility Criteria:
Inclusion Criteria:

* No major comorbidities with a life expectancy less than 12 months;
* BMI between 29 and 33 kg/m2
* Serum cholesterol 200-260 mg/dl
* Serum triglycerides \> 150 mg/dl

Exclusion Criteria:

* Antibiotics or prebiotics in the 3 months before the enrollment;
* Use of statins or other medications for lowering cholesterol;
* Menopause;
* Previous history of cancer.
The Effect of Heat on Blood and Oxygen Flow Readings Part 2

This is the second part of a research study in order to determine if using a specialized pulse oximetry probe with external heat pack will help obtain oxygen saturation (SaO2) and heart rate (HR) during monitoring for patients with peripheral vascular disease (PVD), vasoconstriction, and hypothermic extremities. The inability to obtain accurate SaO2 and pulse readings can lead to misdiagnosis, incorrect treatment, or procedures to be canceled. SaO2 and pulse readings are important to maintain patient stability during diagnostic testing, surgical procedures and monitoring while in critical care areas. Changes in SaO2 and pulse are important to monitor in order to be able to compensate for any decrease in patient oxygen saturations during hemodynamic monitoring.

The primary aim of this study is to determine if using a specialized pulse oximetry probe with external heat pack will improve oxygenation readings in order to obtain SaO2 and pulse readings in patients with PVD, vasoconstriction, and hypothermic extremities as compared to readings obtained from an arterial blood gas.

The hypothesis is using a specialized pulse oximetry probe with external heat pack will help obtain more accurate pulse oximetry readings consistent with values obtained with an arterial blood gas.

150 patients will be approached in order to ensure 110 patients will be enrolled in this study total. 30 patients will have peripheral vascular disease (PVD), vasoconstriction, or hypothermic extremities and 80 patients with no blood flow issues will be enrolled. The patients will serve as their own controls. Each patient will have a specialized pulse oximetry probe with external heat pack added to their extremity while measuring pulse oximetry. These SaO2 readings will be compared to SaO2 readings obtained from an arterial blood gas obtained during the course of the study.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years
2. Able to give informed consent
3. Patients must be able to read and understand English.
4. Patients scheduled to enter the VA Pittsburgh Healthcare System catheterization lab

Arm 2 of the study:

1. The PI will determine if patients have poor circulation due to obstruction of the large arteries in their arms and legs (peripheral vascular disease (PVD), narrowing of their blood vessels (vasoconstriction), or extremities (arms, legs, etc) that are at least 3 degrees Fahrenheit below their normal body temperature. If patients do have any of the following they will be considered for arm 2. If they do not they will be considered for arm 1.

Exclusion Criteria:

In addition to the exclusions mentioned above, patients with the following conditions will be excluded from the trial:

1. Inability or unwillingness to sign informed consent with free will and sound mind, as determined by a score of \<11 on the Evaluation to Sign Consent Form.
Effect of Low-dose vs. High-dose Pitavastatin on In-stent Restenosis

To compare low dose (1mg) pitavastatin and high dose (4mg) pitavastatin on neointimal hyperplasia and atherosclerosis progression by using optical coherence tomography (OCT) and near-infrared spectroscopy (NIRS) at 12 months follow-up and on clinical adverse cardiovascular events during 3-year follow-up.

* Patients with non-ST elevation ACS will be randomized into pitavastatin 1mg or 4mg after everolimus-eluting stent implantation with OCT and NIRS study.
* 12 months follow-up coronary angiography with OCT and NIRS will be performed to compare neointimal hyperplasia and atherosclerosis progression.
* 36 months clinical follow-up for major adverse cardiovascular events (cardiac death, all-cause death, myocardial infarction, stroke, target lesion revascularization) will be compared.
* Safety issues such as bleeding rates, abnormal liver function will be compared

Eligibility Criteria:
Inclusion Criteria:

1. Provision of informed consent prior to any study specific procedures
2. Patients between the age of 30 to 79
3. Non-ST elevation Acute coronary syndrome with successful everolimus eluting stent implantation (with TIMI flow grade 3 after the procedure)

Exclusion Criteria:

1. Hypersensitivity to pitavastatin
2. Unable to perform OCT and NIRS
3. Serum creatinine \> 2.0 mg/dL.
4. Steroid or hormone replacement therapy
5. Hemoglobin A1c \>9%
6. Type 1 diabetes
7. Decreased serum platelet level (\< 100,000/uL)
8. Need for chronic oral anticoagulant therapy or chronic low-molecular-weight heparin
9. Life expectancy less than a year
10. Renal failure requiring dialysis or anticipated need for dialysis during the course of the study
11. Any condition which in the opinion of the investigator would make it unsafe or unsuitable for the patient to participate in this study
12. Involvement in the planning and/or conduct of the study
13. Left ventricular ejection fraction \< 40%
14. Hepatic dysfunction (aspartate aminotransferase or alanine aminotransferase \> twice the upper limit)
15. Gastrointestinal disorder such as Crohn's disease
16. Alcohol abuse
17. Known pregnancy, breast-feeding, or intend to become pregnant during the study period
Deep Brain Stimulation (DBS) for the Treatment of Refractory Alcohol Use Disorder (AUD): Pilot Trial

This is a phase I, non-blinded, non-randomized, pilot trial for safety and efficacy of DBS for AUD. Patients who meet inclusion and exclusion criteria will be identified and recruited from the practices of Sunnybrook psychiatrists. Five (5) to ten (10) subjects will be enrolled and study duration for each patient will be of one (1) year. Our primary objective is to establish the safety of DBS in a patient population with treatment refractory AUD. In addition to demonstrating safety, our second primary objective will be to evaluate if DBS-targeted nucleus accumbens in alcoholism is efficacious in the treatment-refractory patients with AUD. This will be measured by various outcome measures that will include validated scales to assess addiction and craving behaviours.


Eligibility Criteria:
Inclusion criteria

1. Female or Male patients between age 18-70
2. Diagnosis of alcohol use disorder (AUD) as defined by the Diagnostic and Statistical Manual fifth edition (DSM-5).
3. History of AUD for at least 2 years, with evidence of repeated failure to respond to evidence-based AUD treatments (psychosocial treatments plus pharmacotherapies such as disulfiram, naltrexone and acamprosate).
4. Alcohol Use Disorders Identification Test (AUDIT) Scale Score \>8
5. Ability to provide informed consent and comply with all testing, follow-ups and study appointments and protocols

Exclusion criteria

1. Any past or current evidence of psychosis or mania
2. Current suicidal or homicidal ideation
3. Active neurologic disease, such as epilepsy
4. Visible brain damage or atrophy in CT or MRI scan
5. Any contraindication to MRI or positron emission tomography (PET) scanning
6. Likely to relocate or move during the study's one year duration
7. Presence of clinical and/or neurological conditions that may significantly increase the risk of the surgical procedure.
8. Patients with renal dysfunction (GFR\<60)
9. Pregnant or lactating
Autism in Adult Patients and the Effects on Caregivers

Background: The number of adults with autism is expected to rise significantly in the near future, due to two main reasons: First, a dramatic increase in the estimates of the prevalence of autism starting in the mid 1980s; Second, the clinical diagnosis of autism was first introduced during the 1950s, and those diagnosed with autism back then are only now entering middle age. Few studies, however, have focused on the outcomes of adult autistic individuals, and very little is known about the course of autism in adulthood and on the familial burden resulting from caring for an autistic adult. We therefore propose to study adult outcomes in autism, and to examine the influence of raising an autistic individual on the parents.

Working hypothesis and aims: The primary objectives of the study are:

1. Determine clinical status and functioning of autistic adults.
2. Study the influence of raising and caring for an individual with autism on the well-being of the parents.


Eligibility Criteria:
Inclusion Criteria:

* Autism or autism spectrum disorder
* Understands the informed consent
* Hebrew Speaker

Exclusion Criteria:

* Severe acute or chronic illness
* Substance abuse
* In control subjects: Autism or autism spectrum disorder in subject or siblings
* In control subjects: participating sibling
Registry to Evaluate the ROX COUPLER in Patients With Resistant or Uncontrolled Hypertension

The purpose of this registry is to evaluate the safety and performance of the ROX COUPLER in patients with treatment-resistant or uncontrolled hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of resistant or uncontrolled hypertension must be made on the basis of current findings, medical history, and physical examination.

Exclusion Criteria:

* Any serious medical condition that may adversely affect the patient's safety, limit the subject's ability to participate in the registry, comply with follow-up requirements, or impact the scientific integrity of the study.
Evaluation of Prostate Cancer Margins

Pathological assessment of prostate tissue


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with prostate cancer
* Subject must be scheduled for robotic-assisted radical prostatectomy at the clinical site.

Exclusion Criteria:

* None
Olfactory and Taste Changes During Fasting Mimicking Diet (FMD)

Literature experiences demonstrated the impact of medically-assisted pulsed fasting on olfactory behavior in both the animal and human models and - conversely - the lack of homogeneous results linked - up to now - to administrations of pulsed fasting which are not widely codified.

Thus, objective of this study protocol is to evaluate the olfactory-gustatory aspects and blood patterns of a group of subjects suffering from obesity / overweight after a 6-month period of Fasting Mimicking Diet (FMD) (Group A) - consisting of a caloric restriction regimen - compared to a group of homogeneous subjects observing their own eating habits (Group B) which - according to a "cross-over" model - will undergo FMD in the following semester during which the subjects belonging to Group A will observe their eating habits.

A group of obese and/or overweighted patients who did not pass screening criteria (BMI andor neuropsychological testing) to undergo surgical procedure aimed at reducing weight (grastrectomy, bypass, other...) will follow a 6-month period of FMD followed by 6-month period of routinary eating behaviour (Group A) or viceversa (Group B).

All the patients will undergo - before and after the administration of FMD or the routinary diet habit - a battery of:

* Olfactory test (sniffin' stick test)
* Taste Test (Taste strips)
* Blood Samples including: IGF-1, IGFBP1/3, VEGF, insulin, adiponectin, c reactive protein, plasma ghrelin, serum glucose, alanine aminotransferase (ALT) and aspartate aminotransferase (AST), total cholesterol, triglycerides (TGs), high density lipoprotein (HDL) cholesterol and low-density lipoprotein (LDL) cholesterol, erythrocyte sedimentation rate (ESR), conjugated and unconjugated bilirubin, uraemia, serum creatinine and leptin.
* anthropometeric measures, including height and body weight, BMI, waist circumference (WC), estimation of fat mass (FM, in % and Kg), skeletal muscle mass (MM, in % and Kg) and grade of visceral fat (VF level)

Eligibility Criteria:
Inclusion Criteria:

* subjects excluded from bariatric surgical treatment for failing to neuropsychological tests or for co-morbidities that would excessively increase the intra-operative and/or
* non-responders to any previous dietary / nutritional treatment
* BMI \> 25

Exclusion Criteria:

* Subjects under the age of 18 and over 75 years.
* Subjects already undergoing bariatric surgical treatment
* Women who are pregnant or breastfeeding
* Hormonal therapies and / or chemotherapy in place
* Active mental or psychiatric illness
* Addiction to drugs of abuse or alcohol
* other acute or chronic systemic disorders
* Severe hypertension (systolic blood pressure\> 200 mm Hg and / or diastolic blood pressure\> 105 mm Hg)
* Visual impairment (for completion of neuropsychological tests)
* Inability to complete home FMD
Are Audiovisual Materials Superior to Printed Materials in Improving Awareness Among Type 2 Diabetic Patients?

This research evaluates the effectiveness of video educations against patients fixed believes and knowledge that either not precise or overestimated, and compare with classic educational method such as Brochure. As many researches indicates the difficulties to initiate insulin therapy for type 2 diabetic patients due to overestimated barriers such as needle anxiety, feelings of guilt and failure, concerns about hypoglycemia, sense of loss of control over one's life and reduced quality of life. This research will introduce different educational tools to evaluate their effectiveness in breaking psychological insulin barriers.

Introduction This research evaluates the effectiveness of video educations against patients fixed believes and knowledge that either not precise or overestimated, and compare with classic educational method such as Brochure. As many researches indicates the difficulties to initiate insulin therapy for type 2 diabetic patients due to overestimated barriers such as needle anxiety, feelings of guilt and failure, concerns about hypoglycemia, sense of loss of control over one's life and reduced quality of life. This research will introduce different educational tools to evaluate their effectiveness in breaking psychological insulin barriers.

Methodology It's a randomized controlled trial. Validated questionnaire (ITAS) was used to evaluate the psychological insulin barriers, video and Brochures were devolved as educational materials contain same contents and validated. Study conducted in King Abdulaziz city housing with total sample size of 126. They were divided into intervention group (video group) and controlled group (Brochure group). Both group filled the same questionnaire before the intervention. And then immediately after the intervention. Six weeks later, both groups filled the same questionnaire to measure the long-term effects.

Eligibility Criteria:
Inclusion Criteria:

1. Type 2 diabetic patients
2. Age group from 30 to 70 years
3. A1c = 8 mg/dL or above
4. Both genders

Exclusion Criteria:

1. Pregnant women
2. Blindness or profound vision loss
3. Severe mental problems e.g. Psychosis
A Study to Investigate the Effect of Probiotics (L. Reuteri ATCC PTA 5289 and L. Reuteri DSM 17938) on Symptoms of Viral Upper Respiratory Tract Infections in Children

This study investigates the effect of Lactobacillus reuteri probiotic strains (ATCC PTA 5289 and DSM 17938) on symptoms of viral upper-respiratory tract infections in children.

Lactobacillus reuteri probiotic strains (ATCC PTA 5289 and DSM 17938) have been shown to significantly reduce the number of febrile days and pain severity in upper respiratory tract infections in children aged six months to 5 years. The investigator's planned study complements this earlier publication by significantly increasing the number of cases and expanding the age range studied including children from 4 to 17 years of age diagnosed with viral upper respiratory-tract infection.

Eligibility Criteria:
Inclusion Criteria:

* Children with symptoms of upper respiratory tract infection (coughing/fever/sneezing/runny or congested nose/pharynx pain)
* Any gender
* Age from 4 years to 17 years
* Signing a informed consent form by at least one parent, foster parent or guardian after patient information and by children aged over 6 years
* Negative Strep test

Exclusion Criteria:

* Use of antibiotics or probiotics in the 10 days prior to study enrolment
* Use of a probiotic other than the test sample during the study
* Eight or more otitis media within 12 months
* Two or more bacterial sinusitis within 12 months
* Two or more pneumonia episodes within 12 months
* History of two or more invasive infections (meningitis, cellulitis, osteomyelitis, septicaemia)
* Chronic diarrhea
* Recurrent deep skin or organ abscesses
* Persistent superficial candidiasis
* Use of antibiotics for two months or more to treat respiratory infections within 12 months
* Gastroesophageal reflux
* Perennial (e.g., dust mite or mold) or current seasonal hay fever allergy
* Primary or secondary ciliary dyskinesia
* Congenital malformations of the respiratory tract
Intrathrombus Thrombolysis Versus Aspiration Thrombectomy During Primary PCI

This is an multicenter, randomized, controlled, parallel group study. ST-Segment Elevation Myocardial Infarction (STEMI) patients with high thrombus burden(HTB) will be allocated to one of the following: intrathrombus thrombolysis or manual aspiration thrombectomy during primary percutaneous coronary intervention(PPCI).

The hypothesis for ATTRACTIVE trial is that the intrathrombus thrombolysis with microcatheter or pierced balloon compared to manual aspiration thrombectomy will reduce the incidence of major adverse cardiovascular events(MACEs), including cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or heart failure rehospitalization, stent thrombosis and target-vessel revascularization at 1 year in STEMI patients with HTB undergoing PPCI.

Eligibility Criteria:
Inclusion Criteria:

1. Patients presenting with:

   * Symptoms of myocardial ischemia lasting for ≥ 30 minutes AND
   * Definite ECG changes indicating STEMI: ST elevation of greater than 0.1 mV in two contiguous limb leads or 0.2 mV in two contiguous precordial leads
2. Referred for PPCI
3. Within 12 hours of symptom onset, or 12-24 hours but still suffered from persistent symptom, hemodynamic instability or fatal arrhythmia
4. High thrombus burden:

   * TIMI thrombus grade 3 or 4 after emergency coronary angiography
   * Or TIMI thrombus grade ≥3 after guidewire crossing or 1.5mm-diameter predilating the culprit lesion if emergency coronary angiography shows TIMI thrombus grade 5
5. Informed consent

Exclusion Criteria:

1. Rescue PCI after systemic thrombolysis
2. Previous CABG history
3. Life expectancy\<1 year
4. Active bleeding in past 6 months, hemorrhagic disorders and prone to bleeding
5. Serious hepatic or kidney dysfunction
6. Pregnancy and lactation
7. Uncontrolled hypertension (\>180/100mmHg)
8. Previous hemorrhagic stroke or ischemic stroke in past 3 months
9. Cardiogenic shock or cardio-pulmonary resuscitation
10. Informed consent cannot be obtained or follow-up cannot be completed