cyrilzakka/clinical-trials huggingface dataset:
P11-4 and Nanosilver Fluoride Varnish in Treatment of White Spot Carious Lesions

Background: Great efforts have been undertaken for dental caries prevention. Among the recent remineralizing materials, Nano silver fluoride varnish products which are based on nanotechnology have been proposed for "repairing" enamel . Regenerative medicine-based approaches for caries treatment focus on biomimetic remineralization of initial carious lesions as a minimal invasive therapy using Self-Assembling Peptide P11-4 (Curodont Repair) which enhances remineralization of white spot lesions. Purpose of the Study: The aim of this study is to compare clinically and microbiologically the therapeutic effect of Self Assembling Peptide P11-4 (Curodont Repair), nano silver fluoride varnish and 5% fluoride varnish (Duraflor) on remineralization of enamel White Spot Lesions in permanent teeth of adults.

The study will be a randomized controlled double-blinded study conducted on participants aged 10 to 24 years satisfying the inclusion criteria with visible active white spot lesions on buccal surfaces of permanent teeth. Sixty six patients will be randomly allocated into 3 groups of the three materials: study group 1: one application of Curodont Repair, study group 2: one application of Nano-silver fluoride varnish and Control group twice application of Fluoride Varnish (Duraflor).

Eligibility Criteria:
Inclusion Criteria:

1- An age range of 10-24 years ( age of young adolescents and youth as described by the WHO was selected (WHO, 2019). 2. The presence of at least one visible WSL in the buccal surface of permanent teeth with ICDAS II score of 1, or 2. 3. Completion of an informed consent to participate in the study

Exclusion Criteria:

* 1. Patients receiving the following medications: tetracyclines, any other medication known to stain teeth or any medication causing dry mouth and/or limiting salivary flow. 2. Patients receiving any antibiotic within 1 month prior to each saliva sample collection 3. Selected tooth with microcavities or dentinal involvement due to loss of enamel tissues. 4. Selected tooth with a restoration adjacent to the lesions to avoid false- positive readings. 5. Selected tooth with fluoride application \&lt; 3 months prior to study treatment. 6. Selected tooth with discolouration, enamel hypoplasia or fluorosis. 7. Patients with multiple cavitations to avoid variability in microbiological analysis.
A Study of Lumigan® in Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)

This is an observational study of Lumigan® 0.01% (bimatoprost) treatment in clinical practice for patients with Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with primary open angle glaucoma or ocular hypertension
* Prescribed Lumigan®

Exclusion Criteria:

* None
Validation Study of the Simplified Seizure Classification Algorithm

An algorithm has been developed for simplified classification of epileptic seizures, in order to optimize choice of antiepileptic drugs.

The objective of this study was to clinically validate the algorithm.

Optimal choice of antiepileptic drugs (AEDs) depend on the patients´ seizure-types. Over the last four decades, several classification systems have been proposed for epileptic seizures. The recent position paper of the International League Against Epilepsy defines 63 seizure-types. While this complex system might be useful for detailed phenotyping, currently there is no evidence that each of these seizure-types needs different clinical management strategy, and many clinicians find it difficult to implement.

To help physicians with optimizing the choice of AEDs, the investigators developed a simplified seizure classification, consisting of the minimal number of seizure-types, necessary for choice of AEDs, and the investigators developed an algorithm that identifies the patient´s seizure-type, based on a set of 10 simple questions, that can be answered by physicians even without extensive training in epilepsy. The current form of the algorithm was developed for patients whose seizures started in adolescence or adulthood (at the age of 10 years or older).

In this study, the investigators aim to validate the diagnostic algorithm, by comparing the seizure-type identified by the algorithm with the diagnosis and seizure-type as defined by trained experts, in the clinical workup of the patients.

Eligibility Criteria:
Inclusion Criteria:

* patients referred to the participating centers on suspicion of epilepsy

Exclusion Criteria:

* none
Study of Vanadis® NIPT for Non-invasive Prenatal Screening of Trisomies (T21, T18 and T13)

This study will assess the feasibility of Vanadis NIPT for screening of T21, T18 and T13. The results obtained from Vanadis NIPT will be compared with the study site's current prenatal screening methods. The primary objectives are: 1) To assess the feasibility of Vanadis NIPT for screening of T21, T18 and T13 in the maternal healthcare setting, 2) To assess preliminary performance of Vanadis NIPT for screening of T21 in comparison to site's routine screening methods i.e. combined and integrated tests, and 3) To evaluate preliminary cost effectiveness of Vanadis NIPT use in different models. The secondary objective is to assess the feasibility of Vanadis NIPT regarding determination of fetal sex.


Eligibility Criteria:
Inclusion Criteria:

* between the age of 18 and 55 years (inclusive)
* ≥ 10+0 weeks gestation

Exclusion Criteria:

* Pregnant woman undergoing amniocentesis without any screening test result
* Pregnant woman with previous severe hypotension episodes or other conditions that may complicate the blood sampling
* Known maternal aneuploidy
* Known maternal cancer
* Invasive test (chorionic villus sampling or amniocentesis) performed before blood sampling for NIPT
Safety And Tolerability Of Multiple Doses Of PF-04950615 (RN316) In Subjects With Hypercholesterolemia

The primary objective of this study is to evaluate the safety and tolerability of repeated doses of PF-04950615 (RN316) in study volunteers with hypercholesterolemia. PF-04950615 is an investigational drug that is currently being studied as a lipid lowering agent.


Eligibility Criteria:
Inclusion Criteria:

* LDL-C must be greater or equal to 130 mg/dl
* BMI must be between 18.5 and 40 kg/m2
* Japanese volunteers must have 4 Japanese grand parents born in Japan

Exclusion Criteria:

* History of cardiovascular or cerebrovascular event during the past year.
* Poorly controlled type 1 or type 2 diabetes mellitus
* Subjects who have taken lipid lowering therapies within the last 3 months of screening.
Posterior Cingulate Function in Persons With Risk Factors for Alzheimer's Disease

The purpose of this study is to use fMRI techniques to explore a certain part of the brain associated with Alzheimer's disease known as the posterior cingulate. Determining the functionality of this brain region may help us diagnose AD more accurately, thus allowing earlier treatment.

The posterior cingulate is a key brain region suggested by recent studies to be affected in people at risk for Alzheimer's Disease (AD). Because the PC is affected very early in the course of AD and the region may have reduced function even prior to the onset of symptoms, further understanding of its functional role and its relationship to other brain regions may be helpful in detecting AD earlier and in monitoring disease progression and treatment. This project examines the role of the PC and its connections to other brain regions using functional magnetic resonance imaging (fMRI), a technique that allows us to examine the brain at work during tests of memory and decision-making. The main goal is to see if functional connections between brain regions are modulated by risk for AD.

Eligibility Criteria:
Inclusion Criteria:

* Cognitively healthy
* (Controls Only) Parents survived past age 70 and did/do not have memory problems.

Exclusion Criteria:

* Claustrophobia
* Metallic or electronic implants
A Study for Pre-diabetic Patients With Cholesterol Lowering Drugs

The purpose of this research study is to examine if a combination of a cholesterol lowering-drug, simvastatin, with a sugar-lowering drug called rosiglitazone is more effective in improving vascular inflammation (irritation of the vessels that transport your blood) and other cardiovascular risk factors than the taking of simvastatin alone.

Age 21-75 years Metabolic syndrome (must have 3 of the 5 components) elevated waist circumference \>40inches in men, \>35 inches in women elevated triglycerides \>150mg/dL reduced HDL \<40mg/dL in men\<50 in women elevated blood pressure \>130mmHg systolic, or \>85mmHg diastolic elevated fasting glucose \>100mg/dL

Eligibility Criteria:
Inclusion Criteria:

* 21-75 years
* Metabolic syndrome (3 of the 5 components)
* Elevated waist circumference \>40inches in men, \>35inches in women
* Elevated triglycerides \>150mg/dL
* Reduced HDL \<40mg/dL in men, \<50mg/dL in women
* Elevated blood pressure \>130mmHg systolic, \>85mmHg diastolic
* Elevated fasting glucose \>100mg/dL

Exclusion Criteria:

* Diabetes mellitus
* Stage 3 hypertension \>180mmHg systolic, \>110mmHg diastolic office blood pressure
* History of non-diabetic kidney disease
* Myocardial infarction of unstable angina within the past 6 months
* History of liver disease
* History of malignancy
* History of drug or alcohol abuse
* Treatment with corticosteroids
* Pregnancy or lactating women of women of child bearing potential who are not willing to use reliable contraception method during the study
Study of Peripheral Blood Non-coding RNAs as Diagnosis and Prognosis Biomarker for Acute Pancreatitis

It is important to identify patients with acute pancreatitis who are at risk for developing persistent organ failure early in the course of disease. The investigators evaluated whether peripheral blood non-coding RNAs, including microRNAs and long noncoding RNA (lncRNA), could serve as a good marker for detection of acute pancreatitis with persistent organ failure at early phase.

Acute pancreatitis is a sudden inflammation of the pancreas. It can have severe complications and high mortality despite treatment. While mild cases are often successfully treated with conservative measures, such as fasting and aggressive intravenous fluid rehydration, severe cases may require admission to the intensive care unit or even surgery to deal with complications of the disease process. The diagnosis of severe acute pancreatitis at an early phase remain a major challenge for clinicians.

Therefore, many biologic markers have been studied in an effort to improve the diagnostic rate and determine the severity of acute pancreatitis but with disappointing results. Non-coding RNAs, including microRNAs and long noncoding RNA (lncRNA), have recently been validated to stably exist in peripheral blood. Several publications showed that it may serve as potential markers for various diseases, including cancer and inflammation. Our current study evaluated whether and which kind of non-coding RNAs could serve as good markers for severe acute pancreatitis.

Eligibility Criteria:
Inclusion Criteria:

* Patients who was diagnosed acute pancreatitis
* Male or female
* 18 Years and older
* written informed consent

Exclusion Criteria:

* Symptoms of acute pancreatitis present for more than 72 hours
* Age under 18 years
* Pregnancy
* patients unable to consent
Sleep Management in Cancer Survivors

The pilot project will investigate three short-term intervention programs for sleep management in cancer survivors in a randomized controlled clinical study. Three programs to be examined in the study are:

1. the mind-body bridging program (MBBP),
2. mindfulness meditation program (MMP), and
3. sleep education program (SEP).

This pilot randomized study investigates whether the two awareness training programs (ATP), MBBP and MMP are effective in improving sleep disturbance and in reducing stress in post-treatment cancer patients. The two experimental conditions and the SEP control will each comprise 3 sessions of 2 hr. duration and conducted over 3 consecutive weeks (Week 1-3).

Eligibility Criteria:
Inclusion Criteria:

1. Selection of subjects will be based on their exhibiting sleep disturbance as assessed by a validated sleep questionnaire (MOS Sleep Scale, Hayes et al, 2005).
2. Participant is willing to be randomized to any one of the three interventions, will be willing to attend all three classes, complete self-report questionnaires and collect saliva samples, at pre- and post- treatment, weekly intervals and 2-3 months follow-up.
3. Participant must be English speaking and comprehend information presented during the course of study, including the consent form.

Exclusion Criteria:

1. Underlying psychiatric illness, such as severe or untreated psychopathology (e.g. schizophrenia), or cognitive impairments, neurologic disorders, or dementia.
2. Use of psychotropic medication for any of the above, and for any other unspecified condition.
3. Has had previous exposure to MBBP or MBSR/MMP.
4. Incidence of metastatic cancer
5. Currently taking immuno-suppressants and/or corticosteroids.
6. Compromised physical health, in which individual has impaired mobility: unable to carry out movement exercises, cannot lie down on the floor, kneel, get up from the floor to a standing position.
7. Individuals who are considered at the 'end-of-life' stage of their cancer.
Gut Organoid Study

The study will compare basic properties of gut epithelia of hypertensive and normotensive reference subjects. The study will determine if there are fundamental differences in the gut epithelium in hypertension compared to normotension.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion/exclusion criteria for hypertension participants
* Ages: 18-80 years old with a weight greater than or equal to 110 lbs
* Diagnosis of hypertension or without hypertension for the reference cohort. 2017 ACC/AHA (American College of Cardiology/American Heart Association) definition for hypertension (systolic blood pressure ≥130 mmHg and/or diastolic BP ≥80 mmHg) will be used.
* Scheduled elective colonoscopy

Exclusion Criteria:

* Hypertensive or reference individuals with history of autoimmune disease or other chronic inflammatory conditions.
* Pregnant or have been pregnant in the last six months.
* Antibiotic treatment within two months of study enrollment
* Currently taking a medication (e.g. antibiotic, anti-inflammatory agents, glucocorticoids, other immune modulating medications, antacids or proton pump inhibitor drugs like Prilosec) known to modify gut microbiota.
* Unwilling to discontinue using probiotics for at least two weeks before scheduled biopsy.
* History of intestinal surgery, inflammatory bowel disease, celiac disease, lactose intolerance, chronic pancreatitis or other malabsorption disorder.
* History of blood transfusion within 4 weeks.
* Subjects who, in the opinion of the investigator, will be uncooperative or unable to comply with study procedures
A Study of RO5095932 in Patients With Type 2 Diabetes Mellitus

This randomized, double-blind, placebo-controlled study will assess the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of RO5095932 in patients with type 2 diabetes mellitus. Patients will be randomized to receive either RO5095932 subcutaneously once weekly or placebo for 4 weeks (part 1) or 6 weeks (part 2), in addition to their current stable doses of metformin.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, 18-65 years of age
* females who are either surgically sterile or post-menopausal
* type 2 diabetes treated with a stable dose of metformin
* BMI between 25-39kg/m2
* HbA1c between 7 and 10%
* fasting plasma glucose between 7 and 13.3mmol/L

Exclusion Criteria:

* history of clinically significant cardiovascular disease
* history of clinically significant hepatic or renal disease or impairment
* recent therapy with insulin, thiazolidinedione, glucagon-like peptide-1 analogues, amylin analogues and/or DPP-IV inhibitors
Special Drug Use Investigation for ADOAIR DISKUS COPD (Salmeterol and Fluticasone)

To investigate possible problems or questions in safety and effectiveness of salmeterol and fluticasone in patients with chronic obstructive pulmonary disease (bronchitis chronic / emphysema). In this special drug use investigation, onset of pneumonia shall be handled as the priority investigation item.


Eligibility Criteria:
Inclusion Criteria:

* Must use salmeterol and fluticasone for the first time

Exclusion Criteria:

* Patients with hypersensitivity to salmeterol and fluticasone
* Patients with infection which salmeterol and fluticasone is not effective
* Patients with deep mycosis
Prevelance of Uterine Vein and Uterine Vein System Variations

Contrary to the uterine arterial system, our knowledge about superficial and deep uterine vein prevalence and anatomic variations are limited. The present study aims to deepen and clarify our knowledge on superficial and deep uterine vein anatomy, prevalence and relationship with other neighbouring structures which may be helpful in uterine transplantation and radical hysterectomy operations.

Despite that two veins draining the uterus, superficial and deep, are described, their true anatomy, number, calibers, trajectories, relationships with sympathetic and parasympathetic nerves and internal iliac vasculature and ureters are quite limited. Additionally, variations of these vasculature are much less described. The aim of this study is to increase the our current knowledge about these anatomical information and also to calculate the prevalence of superficial and deep uterine veins which may potentially decrease the possible complications such as bleeding in uterine transplantation surgery and nerve sparing radical hysterectomy for cervical cancer.

Eligibility Criteria:
Inclusion Criteria:

Endometrium and cervical cancer patients that will be operated -

Exclusion Criteria:

Any women in whom uterine vascular anatomy that might be changed for a specific disease such as myomas, uterine infections, etc.

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Identifying Family Members in Need of Support While Caregiving and After Loss

This screening tool will be used to identify significant relations of patients with advanced medical illness or serious hospitalization and family individuals who lost their loved one and who could use professional support in the future. We are interested in enrolling family members or close friends of patients with advanced medical illness as well as family members or close friends who have lost a loved one. Some screening tools to identify family members who might need support do exist, but the investigators are hoping to develop one that is brief and easier for healthcare providers to use. The information learned in this study will help us refine the screening tool. Family member input will be essential in the development of this screening tool.


Eligibility Criteria:
Inclusion Criteria:

* As per self-report, 21 years or older
* As per self-report, has a domestic partner or spouse, child (minor or adult), sibling (sister or brother), parent or close friend diagnosed with any advanced medical illness or who was recently (2 months) or is currently hospitalized for life-threatening injuries or conditions related to a traumatic incident (e.g., car accident, overdose, assault) OR
* As per self-report, experienced the recent (within 2 months to 3 years) death of a domestic partner or spouse, child (minor or adult), sibling, parent or close friend.
* Responds "yes" to the question "Can you understand spoken and written English?
* Agrees to be audio-taped during the cognitive interview \[Waves 1 and 2 only\] \* For Part 2 only: In the event that the patient dies prior to a consenting pre-loss family member completing the study questionnaires, the family member will be eligible for participation in the post-loss group after at least 2 months have passed after the loss

Exclusion Criteria:

* Significant psychiatric or cognitive disturbance sufficient, in the investigators' judgment, to preclude the completion of the assessment measures or informed consent (i.e., acute psychiatric or neurological symptoms which require individual treatment)
* Another family member (parent, domestic partner or spouse, sibling, or adult child) has been enrolled in the study
The RATIO: Registry of Infections and Lymphoma in Patients Treated With TNF-a Antagonists

The RATIO registry is a French registry designed by a multidisciplinary group to collect data on opportunistic and severe bacterial infections and lymphoma in patients treated with TNF-a antagonists ( infliximab, etanercept and adalimumab). A total of 486 medical units in metropolitan France participate in the RATIO registry. All diagnosis are retained after validation by 2 qualified infectious disease or haematologist physicians (on the basis of the standardized case report form, the hospitalisation summary, and the microbiological and radiological results). Risk factors for developing these conditions when treated by TNF-a antagonists will be identified in a case control study. Incidence of these diseases will be calculated.


Eligibility Criteria:
Inclusion Criteria for cases:

* past or current treatement with TNF-a antagonists
* either lymphoma severe bacterial infection opportunistic infection

Inclusion Criteria for controls:

* matched with cases by gender, age (+/- 5 years), underlying disease (rheumatoid arthritis, ankylosing spondylitis, Crohn's disease, or psoriasis)
* past or current treatement with TNF-a antagonists
* no lymphoma, severe bacterial infection, opportunistic infection (same as case)

Exclusion Criteria:

* none
Using Personal Mobile Technology to Identify Obstructive Sleep Apnea in Children With Down Syndrome (UPLOAD)

This study aims to see if mobile video clips (smartphone recordings) can be used to screen children with Down syndrome to identify those at highest risk of obstructive sleep apnea (OSA), so they can be prioritized for an earlier sleep study. Parents will be asked to record short video clips of their child sleeping, and then rate whether they think their child has OSA. Later, children will undergo a sleep study to compare to the ratings.

Children with Down syndrome have approximately a 50% chance of developing obstructive sleep apnea (OSA) in their lifetime. OSA is a serious condition where a person stops breathing periodically during sleep; it is associated with high blood pressure, behavioural issues, and lower quality of life. Early diagnosis and treatment is critical, but the best way to diagnose OSA, a 'sleep study', is in short supply. Given the limited resources, this study aims to see if mobile video clips (smartphone recordings) can be used to screen children with Down syndrome to identify those at highest risk of OSA, so they can be prioritized for an earlier sleep study.

Parents of children with Down syndrome, recruited from clinic, will be asked to record short video clips of their child sleeping. Parents will independently rate whether they think their child has OSA and how severe it is, based on the videos, as will two clinicians. Parents will also watch an educational webinar and be asked to re-rate the presence and severity of OSA in their child, to see if the webinar improves their accuracy. Finally, children will undergo a sleep study to compare to the ratings. This study will help determine whether videos can be used to accurately screen for OSA in this high risk population, prioritizing children for earlier diagnosis and treatment.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Down syndrome
* Within the catchment area of the Children's Hospital of Eastern Ontario Down Syndrome clinic

Exclusion Criteria:

* Previous diagnosis of sleep-disordered breathing on polysomnography
* No access to mobile technology to record video clips
* Children unable to cooperate for polysomnography
* Caregiver does not speak French or English