cyrilzakka/clinical-trials huggingface dataset:
Injection Molding Technique: a Minimally Invasive Management for Enamel Hypoplasia Affecting Permanent Anterior Teeth in Children

This study aims to evaluate and compare the clinical performance of the injectable giomer restoration versus an injectable composite resin restoration using the injection molding technique for veneering hypoplastic permanent maxillary and mandibular anterior teeth using the FDI criteria. Follow up will be done every 6 months for 2 years.

The aim of this study is to evaluate and compare the two-year clinical performance of injectable giomer restoration to an injectable composite resin restoration using the injection molding technique for veneering permanent maxillary and mandibular anterior teeth affected with enamel hypoplasia in children using the FDI criteria.

Injection molding technique using injectable composite resin restoration and injectable giomer restoration will be implemented for the esthetic management of permanent anterior teeth affected with enamel hypoplasia in children after removal of the defective enamel, its etching and bonding. Evaluation of their performance will be done using FDI criteria and will be followed up for 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Healthy patients: Class I according to the American Society of Anaesthesiologists (ASA class I).
* Teeth scored code 3 according to Modified Developmental Defects of enamel (mDDE) index.
* Maxillary and mandibular permanent anterior teeth

Exclusion Criteria:

* Refusal of the parents to sign the informed consent.
* Signs and symptoms of reversible or irreversible pulpitis, as well as necrosis affecting the permanent anterior teeth.
* Enamel hypomineralization
Zinc and Diabetes in Patients With Thalassemia: a Pilot Study

The primary aim of this study is to measure zinc status and related proteins in patients with Thalassemia who have or do not have diabetes. The secondary aim will be to explore the effect of zinc supplementation on glucose metabolism in patients with thalassemia.

Patients with Thalassemia major (Thal) require frequent blood transfusions and are at risk for iron overload. High tissue iron increases the risk of various endocrinopathies, including diabetes, as well as cardiovascular disease, and infections due to the formation of free radicals. This systemic condition of oxidative stress elicits an antioxidant response to reduce tissue damage. Zinc is an important component of that response because it can compete with iron for multiple cellular binding sites and, therefore, reduce the redox-cycling of iron and minimize iron-mediated oxidation of lipids, proteins, and DNA.

In Thal patients with chronic hepatic iron overload, tissue zinc redistribution is likely to be persistent. This could create an unbalanced tissue zinc distribution with excessive amounts in the liver and deficient levels in other tissues altering zinc-dependent functions, such as growth, skeletal development, immunity, and glucose regulation. There is a rich body of literature focused on the 'diabetogenic effects' of altered zinc status which will be reviewed herein. Our group has recently shown that supplementation with 25 mg/d of zinc can improve bone density in patients with Thal. This provides evidence for a functional zinc deficiency, which may also affect other whole body zinc functions, such as insulin secretion and glucose homeostasis.

Our hypothesis is that hepatic iron overload induces a sub-clinical inflammatory response that alters the expression of MT and zinc-transport proteins leading to hepatic zinc sequestration, and an associated zinc-depletion in other tissues. Marginal zinc depletion in turn leads to increased oxidative stress, cellular apoptosis and altered glucose homeostasis and insulin secretion. This proposal will focus on cross-sectional differences in markers of glucose homeostasis and zinc status in diabetic and non-diabetic Thal patients, combined with a short- term zinc supplementation to explore the effect on glucose and insulin homeostasis.

Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with transfusion dependent thalassemia
* \> 12 years of age

Exclusion Criteria (for both cross-sectional and interventional studies)

* patients who are pregnant
* patients who are on growth hormone therapy

Exclusion criteria (for intervention study only)

* patients who currently have diabetes (therefore cannot have an oral glucose tolerance test)
Assessment of Postoperative Delirium With CAM ICU Score in Patients Treated With Serotoninergic Reuptake (SSRI) Inhibitors and Undergoing Intervention of Heart Surgery on Pump

The study aims to observe the presence of postoperative delirium in patients undergoing elective cardiac surgery, without changing the pharmacological prescriptions of the enrolled patients and the procedures carried out by normal clinical practice.


Eligibility Criteria:
Inhibitors of serotoninergic reuptake on

Inclusion Criteria:

* patients over 18 years old
* patients undergoing elective cardiac surgery
* patients diagnosed with depressive syndrome requiring treatment with Inhibitors of serotoninergic reuptake excluding neurodegenerative diseases
* patients on antidepressant therapy for more than 3 months at the time of enrollment

Exclusion Criteria:

* absence of written informed consent to the study
* patients undergoing non-elective and emergency cardiac surgery
* patients undergoing off pump surgery
* patients with depression not on therapy
* patients with existing malignancies
* patients with acute infections in progress
* patients with previous stroke, cerebral haemorrhage with relics
* patients with acquired and congenital metabolic pathologies with CNS alterations
* Patients with acute and / or chronic renal failure according to RIFLE score (exclude only F-L-E)
* Patients with acute and / or chronic hepatic insufficiency according to Child - Pugh score \<6 (but without encephalopathy);
* Patients with neurodegenerative diseases (dementias of all types both organic and vascular, parkinson's and ongoing delirium);
* Patients with previous or current drug and / or alcohol abuse
* pregnant or postpartum period patients (6 months after delivery)

Inhibitors of serotoninergic reuptake off

Inclusion Criteria:

* patients over 18 years old
* patients undergoing elective cardiac surgery
* patients without a diagnosis of depressive and psychiatric illness requiring treatment with psychoactive drugs to the exclusion of neurodegenerative diseases

Exclusion Criteria:

* absence of written informed consent to the study
* patients undergoing non-elective and emergency cardiac surgery
* patients undergoing off pump surgery
* patients with depression not on therapy
* patients with existing malignancies
* patients with acute infections in progress
* patients with previous stroke, cerebral haemorrhage with relics
* patients with acquired and congenital metabolic pathologies with CNS alterations
* Patients with acute and / or chronic renal failure according to RIFLE score (exclude only F-L-E)
* Patients with acute and / or chronic hepatic insufficiency according to Child - Pugh score \<6 (but without encephalopathy);
* Patients with neurodegenerative diseases (dementias of all types both organic and vascular, parkinson's and ongoing delirium);
* Patients with previous or current drug and / or alcohol abuse
* pregnant or postpartum period patients (6 months after delivery)
Interactive Effects of Mindfulness and Slow-paced Breathing

The purpose of this study is to better understand specific stress-management practices on mood, sleep, and physiology. Participants will be assigned to one of three interventions (they all active interventions - none are a "wait-list"). Each intervention asks participants to engage in a daily practice of 20 minutes per day for 8 weeks. Questionnaires and measures of heart rate and blood pressure will be collected at the start and end of the 8 weeks, including a virtual laboratory visit.

Slow-paced breathing (SPB), mindfulness (M), and their combination (SPB+M) in the form of yoga, yogic breathing, Tai Chi, Qigong, and other practices are considered distinct forms of intervention, yet are often considered inextricably linked and overlapping in their effects on the autonomic nervous system. Although the scientific community continues to build understanding of autonomic mechanisms that might be unique to SPB, M, and their interaction (SPB+M), no studies we are aware of have attempted to directly compare these three forms of intervention in a controlled fashion that enables a 'dismantling' framework of interpretation.

The goal of this pilot project is to compare the separate and combined effects of SPB and M on autonomic function. We will test the feasibility of a three-arm intervention trial (N=5 per group), involving 20-min daily practice for 8 weeks, with multimodal ambulatory autonomic measurement before and after intervention. We will first focus on a healthy young adult population to then inform translation to hypertension, insomnia, and other clinical groups.

Aim 1: Distinguish SPB, M, and SPB+M training in terms of breathing rate and subjective mindfulness.

Aim 2: Obtain pilot data comparing the three interventions in terms of autonomic regulation using both conventional metrics and non-linear dynamics.

Aim 3: Develop methods to examine relationships across domains of autonomic regulation, stress, and sleep for the three interventions.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-24 years.

Exclusion Criteria:

* Active infection/disease
* Current untreated mental or physical health condition deemed likely to interfere with ability to complete study procedures (determined by study staff consensus)
* Current use of medications with known effects on stress physiology (antidepressants \[SSRI, SNSI, NDRI, atypical, TCA, MAOI\], anitpsychotics, benzodiazepines, non-benzodiazepine receptor agonists, melatonin and melatonin receptor agonists, orexin/hypocretin receptor antagonists, barbiturates, mood stabilizers, anticonvulsants, anticholinergics, first generation antihistamines, and stimulants including NRI, antihypertensives, opioids, or systemic corticosteroids)
* Moderate/substantial prior meditation, yoga, or other mind-body practice self-reported as a self-rating of 5 or higher on a scale of 0-10 asking "How experienced are you with meditation, yoga, or other mind-body interventions?"
Cardiac Resynchronization Therapy Efficacy Enhancements

The purpose of this study is to demonstrate that the amount of effective CRT (Cardiac Resynchronization Therapy) pacing during AF (atrial fibrillation) when CAFRPlus (Conducted AF Response Plus) is applied is not inferior to the amount of effective CRT pacing during AF when CAFR (Conducted AF Response) is applied.

The CRTee study is an IDE, prospective, multi-center, randomized, controlled, crossover clinical study, conducted worldwide and designed to demonstrate that the amount of effective CRT pacing during AF (atrial fibrillation) when CAFRPlus (Conducted AF Response Plus) is applied is not inferior to the amount of effective CRT pacing during AF when CAFR (Conducted AF Response) is applied.

The study will be conducted at up to 30 centers located in the United States, Europe and Middle East and Africa (MEA).

Eligibility Criteria:
Inclusion Criteria:

* Subject is willing to sign and date the study patient Informed Consent form.
* Subject is at least 18 years of age (or older, if required by local law).
* Subject is expected to remain available after enrollment to complete follow-up visits in both arms of the study
* Subject has had a Medtronic Viva or Brava CRT-D device implanted at least 30 days prior to enrollment.
* Subject has history of AF burden, of at least 6 days of at least 4 hours of AF over any 4 week period within the last 90 days as documented in device diagnostic data OR if subject has no atrial lead (therefore no device diagnostic data) but clinical evidence of high AF burden.
* Subject has demonstrated history of being able to complete Left Ventricular Capture Management (LVCM) documented in device data.
* Subject has a documented % V pacing during AF of less than or equal to 97% within 90 days prior to enrollment or within 10 days after enrollment.

Exclusion Criteria:

* Subject has undergone AV node ablation for treatment of AF.
* Subject has complete or 3rd degree AV block.
* Subject has had an MI within 30 days.
* Subject has medical conditions that limit study participation (per physician discretion).
* Subject is enrolled in one or more concurrent studies that could confound the study results as determined by Medtronic.
* Subject has a limited life expectancy for non-cardiac causes that would not allow completion of the study.
* Subject is pregnant (in the US, all women of child-bearing potential must undergo a pregnancy test within seven days prior to CRTee download).
* Subject meets the exclusion criteria required by local law.
Reducing Cognitive Impairment by Management of Heart Failure as a Modifiable Risk Factor

This study will test the feasibility and effectiveness of an innovative model of care for cognitively impaired patients with heart failure. This program aims to improve cognition, reduce dementia risk and cardiovascular events, and will be supported by innovative digital technology for wide scale rollout and implementation. Findings from this research will transform the way healthcare is delivered to cognitively impaired patients with heart disease who have a very high risk of developing dementia.


Eligibility Criteria:
Inclusion Criteria:

1. Hospitalised with HF as primary or secondary diagnosis.
2. At least mild cognitive impairment (CI) based on Montreal Cognitive Assessment (MoCA) on hospital discharge.

Exclusion Criteria:

1. Unable to provide written consent; requiring palliative care; or participating in another RCT
2. Recovery of cognitive function shortly after hospital discharge: to ensure that we only include patients with "true" CI, any patients with a repeated MoCA\>25 at 2 weeks post-discharge will be excluded.
3. Terminal illness (eg. cancer) that may influence 12-month prognosis.
Efficacy and Safety of Insulin Glargine Versus. Neutral Protamine Hagedorn (NPH) Insulin in Children With Type 1 Diabetes Above 6 Years Old.

Primary Objective:

6 To assess the efficacy of insulin glargine given once daily (QD) on glycosylated hemoglobin (HbA1c) levels over a period of 24 weeks in children with type 1 diabetes mellitus (T1DM) aged at least 6 years to less than 18 years.

Secondary Objectives:

* To assess the effects of insulin glargine compared to NPH insulin over 24 weeks on:

  * Percentage of patients reaching International Society of Pediatric and Adolescent Diabetes (ISPAD) recommended target of HbA1c \< 7.5%,
  * Fasting blood glucose (FBG),
  * Nocturnal blood glucose (BG),
  * 24-hour blood glucose profile based on 8-point self-monitoring of blood glucose (SMBG) values,
  * Daily total insulin dose and basal insulin dose,
  * Rates of asymptomatic and/or symptomatic, severe, nocturnal and nocturnal symptomatic hypoglycemia.
* To assess the safety and tolerability of insulin glargine versus NPH insulin based on the occurrence of treatment-emergent adverse events (TEAEs).
* To assess anti-insulin and anti-glargine antibody development in both groups.
* To assess insulin glargine pharmacokinetic(PK) for all patients treated with insulin glargine in selected sites with approximately 45% of insulin glargine population to rule out accumulation tendency of insulin glargine after repeated dosing

The study duration for each patient is 28 weeks +/- 7 day broken down as follows:

* Screening phase: up to 2 weeks
* Run-in phase: 1 week
* Treatment phase: 24 weeks
* Follow-up: 1 week

Eligibility Criteria:
Inclusion criteria:

- Paediatric patients diagnosed with T1DM aged at least 6 years to less than 18 years at screening.

Exclusion criteria:

* Treatment with oral or parenteral glucose-lowering medications other than insulin.
* HbA1c \< 7% or \> 12 % at screening.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
ICF-Based Evaluation of the Upper Extremity in Children With Quadriparetic Cerebral Palsy

Cerebral palsy (CP) is a neurodevelopmental disorder characterized by abnormalities in muscle tone, movement, and motor skills resulting from permanent, non-progressive damage to the developing brain before, during, or after birth. The worldwide prevalence of CP is 2-3 per 1000 live births. Spastic CP accounts for approximately 85% of all CP cases. Among the types of spastic CP, quadriparetic CP (QCP) is the most severe and accounts for 20% of spastic CP cases. Individuals diagnosed with quadriparetic cerebral palsy (QCP) are restricted from participating in daily life activities due to inadequate upper extremity function (spasticity, muscle weakness, inability to perform isolated movements, and limitation of supination movements). In order to correctly evaluate children diagnosed with QCP and determine treatment priorities, it is very important to evaluate them based on the International Classification of Functioning, Disability, and Health (ICF). In the literature, there is no study that evaluates the upper extremity of individuals with isolated QCP based on ICF. The aim of this study is to examine the upper extremity functions of individuals with isolated QCP diagnosis within the framework of ICF.

It is an observational study. Purpose of the study: To examine the upper extremity functions of individuals with an isolated diagnosis of quadriparetic Cerebral Palsy (QCP) within the framework of ICF.

Participants: Children with quadriparetic CP between the ages of 0-17.

Questions:

* What is the relationship between upper extremity spasticity and manual dexterity in children with QCP?
* What is the relationship between manual skills and activities of daily living in children with QCP?

The upper extremities of the patients with QCP will be evaluated within the framework of ICF. Body structure and functions will be evaluated with the Modified Ashworth Scale (MAS), activities with the Manual Ability Classification System (MACS), and participation with the Functional Independence Measure for Children (WeeFIM). The evaluations will be made by physiotherapists experienced in children with CP.

Eligibility Criteria:
Inclusion Criteria:

* The age of the cases is between 0-17,
* They have been diagnosed with quadriparetic CP,
* The participants and parents want to participate in the study voluntarily.

Exclusion Criteria:

* Having different types of CP such as dyskinetic, ataxic and mixed type,
* Having spastic diparetic or hemiparetic type CP,
* Having any history of surgery on the musculoskeletal system,
* Having received Botulinum Toxin injection within the last 6 months.
Macintosh Versus Macgrath for Laryngoscopy in COVID 19 Hypoxemic ICU Patients

In this comparative prospective study, we aim to compare the classic Macintosh laryngoscope and the Mac Grath videolaryncoscope in ICU covid 19 patients recruiting intubation and invasive mechanical ventilation.

patients meeting inclusion criteria were randomized in 2 groups: MacGrath and Macintosh.

we collected anthropometric and intubation data among all patients, and the 2 groups were compared regarding the time for intubation, the need of alternative techniques to intubate and the impact on the oxygenation by recording the lowest SPO2.

In this comparative prospective study, we aim to compare the classic Macintosh laryngoscope and the Mac Grath videolaryncoscope in ICU covid 19 patients recruiting intubation and invasive mechanical ventilation.

All hypoxemic COVID19 patients requiring intubation were enrolled in this trial.

all patients had a preoxygenation with non invasive ventilation with 100% oxygen.

patients meeting inclusion criteria were randomized in 2 groups: MacGrath and Macintosh.

we collected anthropometric and intubation data among all patients, and the 2 groups were compared regarding the time for intubation, the need of alternative techniques to intubate and the impact on the oxygenation by recording the lowest SPO2.

Eligibility Criteria:
Inclusion Criteria:

* All COVID 19 hypoxemic patients requiring tracheal intubation

Exclusion Criteria:

* hypoxemic cardiac arrest before intubation
Study of VX-809 Alone and in Combination With VX-770 in Cystic Fibrosis (CF) Patients Homozygous or Heterozygous for the F508del-CFTR Mutation

The purpose of this study is to evaluate of the safety, efficacy, pharmacokinetics (PK) and pharmacodynamic (PD) effects of lumacaftor (VX-809) alone and when coadministered with ivacaftor (VX-770) in participants with cystic fibrosis, homozygous or heterozygous for the F508del-CFTR mutation.


Eligibility Criteria:
Inclusion Criteria:

* Male or female participants with confirmed diagnosis of CF
* Must have the F508del-CFTR mutation on at least 1 allele.
* FEV1 greater than equal (\>=) 40% of predicted normal for age, gender, and height (Knudson standards)(Cohort 1, 2, and 3); FEV1 40-90% of predicted normal for age, gender, and height (Hankinson standards (Cohort 4)
* Participant of child-bearing potential and who are sexually active must meet the contraception requirements

Exclusion Criteria:

* History of any illness or condition that, in the opinion of the investigator might confound the results of the study or pose an additional risk in administering study drug to the participant (e.g., cirrhosis with portal hypertension).
* An acute illness including acute upper or lower respiratory infection, pulmonary exacerbation or changes in therapy (including antibiotics) for pulmonary disease within 14 days (Cohort 1, 2, and 3) or 28 days (Cohort 4) before receiving the first dose of study drug.
* History of solid organ or hematological transplantation.
* History of alcohol abuse or drug addiction in the past year, including cannabis, cocaine, and opiates.
* Ongoing participation in another therapeutic clinical study, or prior participation in an investigational drug study without appropriate washout
* Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of non-hormonal contraception
* Participants enrolled in Cohort 1 or Cohort 2 will not be eligible for Cohort 3
* Ongoing or prior participation in an investigational drug study within 30 days of the Screening Visit
* Heterozygous participants who participated in Cohort 2 and meet the eligibility criteria for Cohort 4 may participate in Cohort 4
* Evidence of lens opacity or cataract as determined by the ophthalmologic examination (Cohort 4 only)