cyrilzakka/clinical-trials huggingface dataset:
Comparison of the Efficacy and Safety of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes Insufficiently Controlled With Non-insulin Antidiabetic Therapy

Primary Objective:

To compare the efficacy of insulin glargine (U300) and Lantus in terms of change of glycated hemoglobin A1c (HbA1c) from baseline to endpoint (scheduled at Month 6, Week 26) in patients with type 2 diabetes mellitus.

Secondary Objectives:

* To compare insulin glargine (U300) and Lantus in terms of occurrence of hypoglycemia and nocturnal hypoglycemia.
* To compare insulin glargine (U300) and Lantus in terms of reaching target HbA1c values (all and reaching target without hypoglycemia).
* To compare insulin glargine (U300) and Lantus in terms of controlled plasma glucose (all and reaching target without hypoglycemia).
* To compare the frequency of occurrence and diurnal distribution of hypoglycemia by category of hypoglycemia (documented symptomatic, asymptomatic, nocturnal, severe, probable and relative).
* To assess the safety and tolerability of insulin glargine (U300).
* To assess the development of anti-insulin glargine antibodies (AIA).

The total maximum study duration per patient will be 29 weeks that will consist of a 2-week screening period, 26-week treatment period, and a 2-day post-treatment safety follow-up period.

Eligibility Criteria:
Inclusion criteria :

* Adult patients with type 2 diabetes mellitus inadequately controlled with non-insulin antihyperglycemic drug(s).
* Signed written informed consent.

Exclusion criteria:

* Age \< legal age of adulthood.
* HbA1c \<7.0% (\<53 mmol/mol) or \>11% (\>97 mmol/mol) (at screening).
* History of type 2 diabetes mellitus for less than 1 year before screening.
* Less than 6 months before screening with non-insulin antihyperglycemic treatment.
* Change in dose of non-insulin antihyperglycemic treatment in the last 3 month before screening.
* Initiation of new glucose-lowering medications and/or weight loss drug in the last 3 months before screening visit and/or initiation of glucagon like peptide-1(GLP-1) receptor agonist in the last 6 months before screening visit.
* Patients receiving only non-insulin antihyperglycemic drugs not approved for combination with insulin according to local labeling (Note: non-insulin antihyperglycemic drugs not approved for combination with insulin are to be discontinued at randomization).
* Current or previous insulin use except for a maximum of 10 consecutive days (eg, acute illness, surgery) during the last one year prior to screening.
* Severe hypoglycemia resulting in coma/seizures, and/or hospitalization for diabetic ketoacidosis in the last 6 months before screening visit.
* Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (eg, laser, surgical treatment or injectable drugs) during the study period.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Implementation of a Teacher Classroom Program to Support Preschool Children with Autism or Developmental Problems

The Incredible Years® "Helping Preschool Children with Autism" (IY-HPCA) program is designed for teachers of children aged 2 to 5 years who have students with autism in their classrooms. The program provides tools to support children with autism.

The primary aim of this pilot study is to examine the feasibility of implementing the IY-HPCA intervention among teachers of preschool children (typically aged 2 to 5 years) working in mainstream schools. Specifically, we aim to assess teachers' engagement, acceptability, and satisfaction with the program. Secondarily, we aim to gather preliminary evidence on the program's effectiveness in improving teachers' use of strategies, teacher self-efficacy, and in reducing burnout.

We will conduct an exploratory randomized controlled pilot trial. We aim to recruit approximately 40 teachers, and they will be randomly assigned to either an intervention or control group.

The intervention consists of six weekly sessions lasting 3 hours each, delivered by clinical psychologists and child psychiatrists specialized in developmental disorders at Hospital Sant Joan de Déu, in Barcelona. Two intervention face-to-face groups will be conducted at Hospital Sant Joan de Déu.

Feasibility outcomes include program attendance, acceptability, and satisfaction (assessed using the Incredible Years Teacher Workshop Evaluations and the Teacher Satisfaction Questionnaire), as well as fidelity to the intervention delivery (measured with the Leader Checklist). After the intervention, individual interviews with teachers and group leaders will qualitatively assess satisfaction and experiences with the program.

Secondary (effectiveness) outcomes include teachers' use of strategies (Teacher Strategies Questionnaire for Children with Autism), self-efficacy (Teacher Sense of Efficacy Scale), and burnout (Maslach Burnout Inventory-Educators Survey).

This study will provide pioneering insights into the implementation of this program within the public mental health and education systems in Spain. This will allow the potential implementation of a wider randomized controlled trial in the future at a larger scale.


Eligibility Criteria:
Inclusion Criteria:

* Teachers working at mainstream schools near the catchment area of Hospital Sant Joan de Déu Barcelona.
* Teachers working at mainstream schools with specific programs for children with special needs.
* Teachers of pre-school children.
* Teachers willing to participate in the study and signing the inform consent.

Exclusion Criteria:

- Teachers working at special education centers instead of mainstream schools.
Blue-Blocking IOLs in Combined Surgery

Although commonly used in cataract surgery, the use of the blue light-filter IOLs in vitrectomy combined with cataract surgery has not been reported yet. A prospective controlled clinical trial was designed to evaluate the effect of the blue light-filter IOL on the surgeon's ability to perform specific vitreoretinal procedures and on the patients' outcome.

Sixty patients were randomly assigned to receive a UV-filter IOL (transparent IOL group) or a blue light-filter IOL (yellow IOL group) combined with a vitreoretinal procedure.

Outcome measures were intraoperative conditions for the surgeon, complication rates, the functional outcome and vitreoretinal diagnoses.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis vitreoretinal pathology (diabetic vitreous hemorrhage, macular hole, epiretinal membrane or persisting macula edema)
* Coexisting significant cataract
* The need for combined surgery ( pars plana vitrectomy, phacoemulsification and IOL implantation)
* Age over 50 years.

Exclusion Criteria:

* Pseudophakia on the non-study eye
* The need for silicone oil tamponade
* Optic atrophy.
A Registry Study on Xiyanping(a Chinese Medicine Injection) Used in Fifty Hospitals

This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences in October 2011.

It was funded by China major scientific and technological specialized project for 'significant new formulation of new drugs'.

Xiyanping is kind of Chinese Medicine injection used for treating viral pneumonia 、bronchitis、amygdalitis、infantile diarrhea、bacillary dysentery 、virus hepatitis、and Children acute hot diseases in many Chinese hospitals.

The purpose of this study is to determine adverse drug events or adverse drug reaction in large sample size 20,000 patients.

It is very common that Chinese Medicine Injection used in hospitals in mainland China. However safety problems rose in recent years. There could be many uncertain factors influence Chinese Medicine Injection in clinical practice.

In order to ensure the safety of public drug use and lower drug-induced risks, a registry study for Xiyanping injection safety surveillance with 20000 patients will be conducted from Jan.2012 to Dec.2015.

Eligibility criteria Patients who will use Xiyanping injection in selected hospitals.

Eligibility Criteria:
Inclusion Criteria:

* Xiyanping injection from 2012 to 2014
Stereotaxis Computed Tomography (CT) Co-Registration Study

The Stereotaxis Niobe® II Magnetic Navigation System (MNS) is designed to direct and digitally control catheter and guidewire based therapeutic and diagnostic devices along complex trajectories within the heart and coronary vasculature.

Navigation using vectors acquired from the CT Co-registration feature of Navigant™ provides clinical benefits for percutaneous coronary intervention (PCI) by decreasing the amount of contrast used during complex PCI procedures.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be between 18-80 years of age
* Willing and able to provide prior written informed consent
* Patients present with a single bifurcated lesion or single non-CTO complex lesion requiring PCI.
* Able to be safely exposed to magnetic fields, such as magnetic resonance imaging (MRI)
* CT angiography performed prior to cardiac catheterization (must be performed \>48 hours prior to procedure to limit peri-procedural contrast use, but \<12 months prior to the procedure)

Exclusion Criteria:

* Patients with a creatinine greater than 2.0 mg/dL
* Exclude patients whom in the Investigator's opinion, are hemodynamically unstable on the day of the procedure.
* Untreatable allergy to contrast media
* Patients who have undergone CT angiography within 48 hours of index PCI procedure
* Patients with chronic total occlusions (CTOs) requiring intervention.
* Patients requiring treatment for lesions other than the single bifurcated or single non-CTO complex lesion.
The Effect of a Multistrain Probiotic on Metformin Tolerance and Efficacy With Microbiota and Stool Metabolome in Insulin-resistant Women - a 12-week Randomized, Placebo-controlled, Double-blind Study

The goal of this study is to evaluate the efficacy of metformin on insulin sensitivity and vascular endothelial function with respect to gut microbiota and metabolome in women with established insulin resistance and its tolerance after 12 weeks of probiotic therapy.

The hypothesis is probiotic therapy in women with established insulin resistance undergoing metformin treatment increases the drug's efficacy to improve insulin sensitivity and intestinal endothelial function, and reduces gastrointestinal side effects.

Study participants will be randomly assigned to 2 groups, taking a probiotic (GS) or a placebo (GP). The randomization scheme will be computer-generated using permuted blocks of block size 4.


Eligibility Criteria:
Inclusion Criteria:

* women 25-45 years old, menstruating, BMI 25-32.9 kg / m2, insulin resistance based on the HOMA-IR index (cut-off point 2.5

Exclusion Criteria:

* type 1 and 2 diabetes,
* poorly controlled arterial hypertension (mean SBP values\> 140mmHg and / or mean DBP values\> 90mmHg) within the last month and / or the need to modify pharmacological treatment,
* 2nd degree obesity, BMI\> 35 kg / m2,
* lipid disorders requiring pharmacological treatment in the last 3 months before the start of observation or during observation,
* positive history of ischemic heart disease, carotid and / or lower limb atherosclerosis,
* features of heart failure on physical examination and / or additional examinations (chest X-ray, echocardiography),
* clinically significant arrhythmias or conduction disturbances,
* chronic kidney disease with creatinine clearance \<60mL / min / 1.73m2,
* clinically significant impairment of liver function (transaminase values 3 times the normal range),
* acute or chronic, clinically evident inflammatory process (diseases of connective tissue and joints, inflammatory processes of the respiratory tract, inflammatory processes of the genitourinary system, inflammation of the head and neck),
* acute infection in the last month,
* Cancer,
* alcohol abuse, drug addiction,
* taking medications that may interfere with test results,
* Taking antibiotics, steroids, antifungal and antiparasitic agents 4 weeks before the examination (not applicable to topical antifungal agents).
* taking pre - and / or probiotics in the last 12 weeks before the test
* travel to tropical countries in the last 4 weeks prior to the survey
* other conditions that may pose any risk to the patient during the follow-up.
An Observational Study on Sarilumab-exposed Pregnancies

Primary Objective:

To evaluate the relative risk of major structural birth defects, specifically a pattern of anomalies, in sarilumab-exposed pregnancies compared to disease-matched unexposed pregnancies.

Secondary Objective:

To evaluate the risk for sarilumab-exposure relative to the group of healthy pregnant women, and the effect of exposure on other adverse pregnancy and infants outcomes.

Pregnant women enrolled in the study will participate for the duration of that pregnancy. Those who deliver at least one live born infant and the infants will participate for 1 year after delivery of that infant.

Eligibility Criteria:
Inclusion criteria:

* Cohort 1: Sarilumab-Exposed Cohort
* Currently pregnant, exposed to Kevzara (sarilumab) for approved indication
* Cohort 2: Disease-matched Comparison Cohort
* Currently pregnant, diagnosed with Kevzara (sarilumab) approved indication
* Cohort 3: Non-diseased Comparison Cohort
* Currently pregnant, not diagnosed with a Kevzara (sarilumab) indication and unexposed to Kevzara

Exclusion criteria:

First contact the Registry after prenatal diagnosis of any major structural defect or after pregnancy outcome is known (retrospective data).

Enrolled in this cohort study with a previous pregnancy. Cohort 1: Sarilumab-Exposed Cohort

* Exposed to Kevzara (sarilumab) for an indication other than a currently approved indication.
* Exposure to another biologic during pregnancy or within 10 weeks prior to the first day of LMP.
* Exposed to methotrexate, cyclophosphamide, chlorambucil, or mycophenolate mofetil in pregnancy (ie, at any time after the LMP), or leflunomide within two years prior to pregnancy unless a blood level for leflunomide below 0.02 mcg/mL has been documented prior to LMP before the pregnancy.
* Cohort 2: Disease-matched Comparison Cohort
* Exposure to any Kevzara (sarilumab) during pregnancy or within 10 weeks prior to the first day of the LMP.
* Exposed to methotrexate, cyclophosphamide, chlorambucil, or mycophenolate mofetil in pregnancy (ie, at any time after the LMP), or leflunomide within two years prior to pregnancy unless a blood level for leflunomide below 0.02 mcg/mL has been documented prior to LMP before the pregnancy.
* Cohort 3: Non-diseased Comparison Cohort
* Diagnosed for any serious chronic disease that is thought to adversely impact pregnancy.
* Exposed to a known human teratogen during pregnancy as confirmed by the OTIS Research Center

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
The 28 Day Challenge

The purpose of this study is to determine how a 28 Day Challenge influences mental health and well-being. This is a blinded study. Participants both with and without depression and anxiety, will be included. A moderation analysis will be performed to see whether changes in depression after the intervention are a function of baseline depression and anxiety levels.


Eligibility Criteria:
Inclusion Criteria:

* English Fluency

Exclusion Criteria:

* Severe hearing impairment
The Development and Validation of EMPOWER-UP: a Generic Questionnaire for Measuring Empowerment in Patient-provider Relationships

Empowerment is widely acknowledged as an important approach in long-term care. The concept relates to the individual's ability to manage their own life and make rational decisions. Despite good intentions of working empowerment-based, research has shown that it can be difficult to realize and achieve in everyday practice within the healthcare system. To this date, no measurement instrument (questionnaire) exists that evaluate people's perceptions of whether their relationship with a healthcare provider promotes their empowerment process. The EMPOWER-UP questionnaire was therefore developed to provide such a measure. The EMPOWER-UP study aims to finalize the development process of the questionnaire and to test whether it is a valid and reliable measure.

People at the age of 18 years or above can participate if they have ever been diagnosed with a type of cancer, diabetes, or a mental illness and because of that diagnosis have been in contact with the healthcare system within the past six months.

The study is conducted online and requires participants to fill out an online questionnaire on a single occasion. Participation is expected to take no more than 10-15 minutes.

By participating, people may experience an increased awareness as to the nature of their interactions with healthcare providers. For some, this awareness may be beneficial and may alone enable them to ask for better care, while others may experience it as a burden if they are not able to seek better care.

By participating, people are helping to ensure that EMPOWER-UP will be a good questionnaire that may help raise awareness of the quality of relationships within the healthcare system and in term lead to better care.

The study is led by a team of researchers at the Danish University Hospital Rigshospitalet and the University of Copenhagen, Denmark.

The UK lead of the study is located at King's College London, UK. The Australian lead of the study is located at Deakin University, Melbourne, Australia.

This study is financially supported by the Novo Nordisk Foundation's Steno Collaborative Grant and by the Trygfonden foundation (Denmark)


Eligibility Criteria:
Inclusion Criteria:

* Ever diagnosed with cancer, diabetes, or a mental disorder AND have had an interaction with a healthcare provider concerning their cancer/diabetes/mental disorder diagnosis within the past six months (relating to e.g. treatment or follow-up consultations)

Exclusion Criteria:

* Unable to read and understand Danish (for danish participants) or English (for UK and australian participants)
Fitostimoline Vaginal Pessaries in Women With Hysterectomy. Randomized, Perspective, Monoscentric Study.

Clinical evaluation of Fitostimoline vaginal pessaries in the treatment of hysterectomy. An observational, randomized, perspective study performed on 60 women where 30 women are treated with fitostimoline pessaries and 30 women are treated with the standard of care.


Eligibility Criteria:
Inclusion Criteria:

* patient aged between 35 and 80 years
* patient undergoing hysterectomy
* Willingness to understand the procedures and aims of the study

Exclusion Criteria:

* Anamnestic or clinical data of metabolic or endocrine diseases (such as uncontrolled diabetes mellitus) or any other local and / or systemic pathology potentially able to interfere with the study parameters;
* Concomitant treatment with antibiotics / antiseptics, NSAIDs, analgesics (excl. Paracetamol)
* Non-therapeutic use of psychoactive substances;
* Abuse of drugs and / or alcohol / smoking;
* Neurological disorders or psychiatric conditions potentially capable of affecting the validity of the consent and / or compromising the patient's adherence to the study procedures;
* Known allergy, hypersensitivity or intolerance to the constituents of the preparations under study;
* Any condition, medical or otherwise, that could significantly reduce the possibility of obtaining reliable data, achieving the objectives of the study, perfecting its completion;
* Presumption of poor reliability or collaboration;
* Treatment with any preparation in the last 30 days prior to the start of the study;
* Patients already enrolled in this study;
* Center staff directly involved in the study and close relatives
Macular Hemorrhage in Myopic Eyes

Visual impairment in high myopic eyes is mainly due to the different types of myopic maculopathies, such as diffuse or patchy atrophy, lacquer cracks and choroidal neovascularization. Macular hemorrhage was one of those complications. Despite choroidal neovascularization, simple hemorrhage from rupture of Bruch's membrane and choroidal microcirculation is also the cause of hemorrhage. The prognosis of those eyes with simple hemorrhage is generally good. However, some patients had persistently poor vision after the absorption of the hemorrhage. In the literature, the visual prognosis in those patients was reported to be associated with the microstructure change under the optical coherent tomography (OCT) or the presentation of the autofluorescence. The investigators will collect the patients with high myopia and presenting with macular hemorrhage. High resolution OCT and autofluorescence imaging will be used to analyze the change of the microstructure of retina and its correlation with the visual prognosis.


Eligibility Criteria:
Inclusion Criteria:

* Myopia more than -6D
* Macular hemorrhage inside arcade
* Patients who are willing to visit our clinic and receive examination regularly for at least 1 year

Exclusion Criteria:

* Patients who cannot cooperate.
* Macular hemorrhage unrelated to myopia
Sonographic Assessment of Postural Lung Recruitment in Pediatric Patients Under General Anesthesia

Anesthesia-induced atelectasis is a well-known entity observed in approximately 68-100% of pediatric patients undergoing general anesthesia. The collapse of dependent lung zones starts with anesthesia induction but can persist for hours or even days after surgery.

Lung collapse is a pressure-dependent phenomenon. Each acinus has a critical closing pressure, i.e., the minimum transpulmonary pressure (Ptp) below that the acinus begins to collapse. While airway pressure is homogeneously distributed within all lung units, Pleural pressure increases along the vertical gravitational vector because of the lung's weight. As a consequence, the decreased Ptp in the dependent zones promotes collapse. This means that patients in the supine position suffer from increasing closing pressures in the ventral to dorsal direction.

Alveolar recruitment maneuvers recruit collapsed alveoli, increase gas exchange, and improve arterial oxygenation.

The investigators hypothesized that in children with anesthesia-induced atelectasis, postural changes have recruiting effects and improve lung aeration assessed by lung ultrasound.

Compare lung aeration between two different lung recruitment strategies (recruitment maneuvers in supine position and recruitment maneuvers with postural changes of lateral decubitus with 10 cmH2O level of positive-end expiratory pressure (PEEP) during 180 seconds; in pediatric patients scheduled for surgery under general anesthesia using ultrasound imaging and a four-point-aeration score to assess the lung aeration.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent by parents.
* Patients aged 6 months to 5 years old
* Scheduled for surgery under general anesthesia with tracheal intubation with atelectasis assessed by lung ultrasound after anesthesia induction.
* American Society of Anesthesiologists classification: physical status I-II

Exclusion Criteria:

* Acute airway infection
* Cardiovascular or pulmonary disease
* Previous thoracic procedure