cyrilzakka/clinical-trials huggingface dataset:
A Post-marketing Study Evaluating Eslicarbazepine Acetate (ESL) as Adjunctive Treatment in Partial-Onset Seizures (Study E2093-E044-404) (EPOS)

This was a Non-interventional Prospective Study. Centres enrolled adult patients with partial-onset seizures with or without secondary generalisation for whom the clinician had decided to initiate Eslicarbazepine Acetate (ESL) as an adjunctive therapy prior to the decision to take part in this study. Patients enrolled into the study were not sufficiently controlled with one drug licensed for the use as monotherapy in partial-onset seizures. Patients were seen at baseline and then during normal clinical visits at intervals. Patients in this study were assessed for efficacy and tolerability at baseline and then at least 3 and 6 months after the baseline.


Eligibility Criteria:
Inclusion Criteria:

* The decision to prescribe ESL was made by the physician before and independently of his/her decision to include the patient in the study
* Patients treated with one drug licensed for monotherapy in partial onset seizures
* Based on the physician's clinical judgment, the patient seizure activity was not controlled sufficiently with a current monotherapy and it was in the patient's best interest to be prescribed adjunctive ESL
* Patient was prescribed ESL no longer than 2 weeks before the baseline
* Treatment with ESL was to be commenced in line with the drug's license and Eslicarbazepine Acetate (ESL) Summary of Product Characteristics (SPC)
* Aged 18 years or older
* Signed written informed consent

Exclusion Criteria:

* Patients that had started ESL outside the approved SPC at enrolment
* Simultaneous participation in an interventional clinical trial
Rotational Atherectomy Prior to Taxus Stent

The primary purpose of this study is to evaluate the long term effects of the polymer-based slow-release paclitaxel-eluting stent (TAXUS; Boston Scientific), with or without prior rotablation, in an angiographically well defined group of patients with complex calcified coronary lesions.

Calcification is an essential part of all atherosclerotic plaques. Its extent increases with the progression of atherosclerotic disease. Heavily calcified lesions form a particular threat to DES; both damage to the polymer coating during vigorous advancement and inadequate diffusion of the drug to the subintima through extensive calcium arcs could contribute to the ineffectiveness of DES when implanted into such lesions, or may lead to primary stent delivery or expansion failure. Rotational atherectomy can effectively ablate calcified plaques. In the DES era, data concerning rotational atherectomy are scarce. DES implantation following rotablation seems a rational combination, but is only poorly supported by controlled studies. In the present study, we are using the polymer-based slow-release paclitaxel-eluting stent (TAXUS; Boston Scientific), with or without prior rotablation, in an angiographically well defined group of patients with complex calcified coronary lesions. This prospective, randomized, controlled study aims at evaluating the long term effects of both strategies in this complex cohort of patients.

Eligibility Criteria:
Inclusion Criteria:

* Angiographically proven coronary artery disease
* Angina II-IV° following the Canadian Cardiovascular Society Classification criteria and/or reproducible ischemia in the target area by ECG or scintigraphy
* The patient signing an informed written consent

From the following angiographic criteria, lesions must fulfil all first degree criteria and at least one second-degree criterion to be eligible for inclusion.

First degree criteria

* De-novo lesion in a native coronary artery
* Target reference vessel diameter between 2.5 and 4.0 mm by visual estimation
* Luminal diameter reduction of 70-99% by visual estimation
* Moderate to severe calcification of the target lesion (clearly defined)

Second degree criteria

* Ostial location
* Bifurcational lesions
* Long lesions (≥ 15mm)

Exclusion Criteria:

* Myocardial infarction within 4 weeks
* Left ventricular ejection fraction \< 30%
* Limited long term prognosis due to other conditions

Angiographic exclusion criteria:

* Unprotected left main lesions
* Coronary artery bypass graft stenoses
* In-stent restenoses
* Chronic total occlusions
* Target vessel thrombus
* Target vessel dissection
Telerehabilitation in Individuals With Rheumatic Disease

increasing the prevalence of exercise models designed in accordance with the biopsychosocial model is very important in terms of ensuring the sustainability of these models with telerehabilitation in periods such as epidemics and pandemics. The aim of this study was to investigate the effects of a biopsychosocial exercise model provided via telerehabilitation in individuals with rheumatic diseases during the COVID-19 pandemic.

Telerehabilitation was applied to the group with rheumatism in 3 sessions a week for 24 weeks via a social texting program. The intervention sessions consisted of 10 minutes of dance therapy-authentic movement, 40 minutes of exercises, and 10 more minutes of dance therapy. This exercise content was based on a biopsychosocial model, named the Cognitive Exercise Therapy Approach (BETY) which was used in the study, and it was a method that patients already practiced before the pandemic. At the beginning, at the 12th week and 24th week, the Health Assessment Questionnaire (HAQ), the Hospital Anxiety and Depression Scale (HADS), the BETY Biopsychosocial Questionnaire (BETY-BQ) were applied.

Eligibility Criteria:
Inclusion Criteria:

members of an exercise group before the pandemic at the physiotherapy and rehabilitation department of a university.

Exclusion Criteria:

* Individuals who had difficulty in cooperation
Evolution of Intestinal Microbiota in Patients With Juvenile Spondylarthropathy According to Typology of Treatment

Idiopathic juvenile arthritis includes 20% of patients with arthritis with enthesitis or juvenile spondyloarthropathy. This is treated with anti-inflammatory drugs and then followed by biotherapy with DMARDs (Drugs Modifying the Activity of Rheumatic Disease) if the former are insufficient. Methotrexate (MTX) may also be used before these biotherapies. Recently, in adults, a particular profile of intestinal microbiota has been shown to alter the availability of MTX making it in efficient. Knowing that pediatric patients with juvenile spondyloarthropathy have an imbalance of their intestinal flora (dysbiosis) the investigators wanted to explore whether DMARDs could have a similar impact on the microbiota of these young patients and alter the response to treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged over 8 and under 17 years old (included).
* Patients diagnosed with arthritis with juvenile enthesitis according to the International League of Associations for Rheumatology (ILAR) criteria.
* Patients who haven't been treated by Methotrexate or biotherapy for at least 3 months.
* Patients who haven't been treated by cortisone for over a month.
* Patients whose parents have given written informed consent.
* Patients for whom the consent form has been signed by their legal guardian.
* Patients covered by the Social Security System or benefitting from private health insurance.

Exclusion Criteria:

* Patients enrolled in another category 1 study or who have already taken part in a category 1 study within 3 months prior to inclusion.
* Patients who are within an exclusion period determined by another study.
The BuKoBc Project: Building a Deeper Knowledge on Breast Milk Composition

Breast milk is considered the gold standard for infant nutrition thanks to its ability to provide adequate nutrition and a high amount of protective factors for the baby's health. According to the guidelines of the World Health Organization (WHO), exclusive feeding with breast milk should be conducted until the end of 6 months of life and should be continued in the following months with the simultaneous introduction of complementary foods. Several evidence demonstrates that breast milk intake is associated with positive health outcomes, both during infancy and later in the life. Given the protective role of breast milk for the health of the child and the future adult, studying its content is of fundamental importance to have an integrated vision of the biological effects of its components on the child health, and of the factors that are able to modulate its composition. The "Building a Deeper Knowledge on Breast Milk Composition" (BuKoBc) project was designed to study the content of human milk in its entirety and at different times during the feeding and day, also in relation to environmental factors capable of modulating its composition. The results of this study may provide data on optimal reference ranges for nutrient intake in breastfed infants and may provide guidance for defining optimal nutrient intake for infants who cannot be breastfed. Furthermore, the in-depth study of the environmental factors capable of influencing the composition of breast milk will allow the development of nutritional intervention strategies for the breastfeeding mother in order to positively modulate the composition of her milk.


Eligibility Criteria:
Inclusion Criteria:

* Italian women aged between 20 and 40 years who exclusively breastfeed children born at term from normal pregnancy
* Written informed consent

Exclusion Criteria:

* Non-Italian women;
* Age \<20 and \>40 years;
* Mothers of children born preterm;
* Non-exclusive breastfeeding;
* Mothers suffering from chronic diseases:
* malignancies;
* immunodeficiencies;
* chronic infections;
* autoimmune diseases;
* chronic inflammatory intestinal diseases;
* celiac disease;
* genetic-metabolic diseases;
* cystic fibrosis;
* chronic lung diseases;
* malformations of the cardiovascular/respiratory/gastrointestinal system;
* neuropsychiatric disorders;
* neurological diseases.
Growth Hormone in Neuroendocrine Dysfunction With Severe Fibromyalgia Syndrome

The purpose of this study is to evaluate the efficacy of recombinant human growth hormone (r-hGH) treatment in severe fibromyalgia subjects with growth axis dysfunction.


Eligibility Criteria:
Inclusion Criteria:

* Women aged greater than or equal (\>=) 18 years
* Fibromyalgia diagnosed at least one year before
* History of generalized pain and at least 16 positive tender points (1990 American College of Rheumatology \[ACR\] criteria)
* Body Mass Index (BMI) less than or equal to(=\<) 32
* Normal GH stimulation test (insulin)
* Stable (\>= 3 months unchanged) standard treatment with amitriptyline (10-50 milligram per day \[mg/day\]) plus selective serotonin reuptake inhibitor (10-40 mg/day) plus tramadol (25-400 mg/day)
* Active rehabilitation program during the previous year (at least 30 minutes/day)
* Fibromyalgia Impact Questionnaire (FIQ) score \>=75
* IGF-1 serum level =\< 150 nanogram/milliliter (ng/mL) otherwise =\< 2 SD of the local lab normality)
* Normal response to IGF-1 generation test
* Chronic Fatigue Symptoms (Multidimensional Assessment of Fatigue \[MAF\])
* Effective anti-conception
* Willingness to comply with the protocol
* Written Informed consent

Exclusion Criteria:

* Major psychiatric condition
* Rheumatic disease, including systemic lupus erythematosus (SLE)
* Previous or current malignancies, active or inactive
* Clinical history intracranial space occupying lesion
* Reactive or secondary (rheumatoid arthritis \[RA\], osteoarthritis) fibromyalgia syndrome (FMS)
* Antinuclear antibody (ANA) greater than or equal 1:80
* Abnormal Creatine phosphokinase (CPK) or aldolase serum levels
* Not controlled thyroid disease in the last 3 months (free Thyroxine \[T4\] and Thyrotrophin-stimulating hormone \[TSH\] serum levels)
* Diabetes mellitus
* Adrenal gland disease (any abnormal cortisolemia, will be confirmed by 24-hour cortisoluria)
* Pregnancy or breast feeding
* Known to be hypersensitive to somatotropin or any of the excipients
Examining an Emergency Room Intervention for the Prevention of Post Traumatic Stress Disorder (PTSD)

PTSD is a common and distressing possible outcome following exposure to a traumatic event. Recent studies show that memory processes may be central to the development of the disorder, and interrupting the consolidation of traumatic memories may prevent the disorder from developing. Specifically the use of a visual spatial task has been shown to reduce a key characteristic of PTSD, intrusions, in non-clinical populations. This study aims to administer a visual spatial task to recent trauma survivors in the Emergency Room, and compare PTSD and symptoms development in these patients as compared to a control group who did not carry out the task. The study hypothesizes that the task will result in less PTSD, lower levels of intrusions, dissociation and pain.


Eligibility Criteria:
Inclusion Criteria:

* age 18-65,
* no loss of consciousness,
* ability to understand study procedures and give informed consent,
* Hebrew as first language,
* experienced a potentially traumatic event as defined in DSM (objective danger and subjective feeling of fear).

Exclusion Criteria:

* current or past psychiatric treatment,
* current or past PTSD.
Safety and Toleration of PEP005 Topical Gel When Applied to a Treatment Area of up to 100cm2

Study Hypothesis: Safety and Tolerability will differ when treating multiple contiguous 25 cm2 treatment areas, as compared to individual 25 cm2 treatment areas.


Eligibility Criteria:
Inclusion Criteria:

* Must be male and at least 18 years of age.
* A 100 cm2 contiguous treatment area on each of the right and left extensor (dorsal aspect) forearms, each containing a minimum of 5 AK lesions.

Exclusion Criteria:

* Cosmetic or therapeutic procedures (e.g., use of liquid nitrogen, surgical excision, curettage, dermabrasion, medium or greater depth chemical peel, laser resurfacing): within 2 weeks and within 2 cm of the selected treatment area(s).
* Treatment with immunomodulators, or interferon/ interferon inducers or systemic medications that suppress the immune system: within 4 weeks.
* Treatment with 5-FU, imiquimod, diclofenac, or photodynamic therapy: within 8 weeks and within 2 cm of the selected treatment area(s).
Phytoestrogens and Breast Cancer - Effects of Phytoestrogens on Markers of Disease Progression and Gene Expression

The aim is to investigate if soy isoflavones and lignans affect markers of disease progression and gene expression among breast cancer patients receiving neo-adjuvant treatment in a three arm, double-blinded, randomized placebo-controlled trial (RCT) comparing: soy isoflavone supplementation, lignan supplementation, and placebo.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with breast cancer at "Brystkirurgisk Afdeling" at Rigshospitalet and Herlev Hospitals (within the last 30 days).
* Advised (and accepted) to receive neo-adjuvant treatment
* Primary unilateral breast cancer
* Treatment is expected to be curative
* Is expected to be able to attend surgery

Exclusion Criteria:

* Allergic to soy
* Celiac disease
* Inflammatory bowel disease
* Not understanding Danish (patient material and questionnaires are in Danish)
* Prior diagnosis of breast cancer
* Use of dietary supplements containing lignans or isoflavones three months prior to diagnosis
Evaluation of Innovative Ultrasonic Techniques for Non-invasive Diagnosis of Liver Fibrosis in Patients With Chronic Viral Hepatitis B or C

The non-invasive assessment of liver fibrosis in chronic viral hepatitis B and C is now entering clinical practice. It is based on blood tests, especially FibroMetre® and Fibrotest® and on elastography with the Fibroscan®. Despite the overall satisfactory diagnostic performance for all of these tests (AUROC ranging from 0.80 to 0.90 depending on the study) for the discrimination of F≤1 versus F≥2, the positive and negative predictive values , however, are far from be perfect in a given patient. With these technique, failures are also possible and the measures do not meet quality standards that increase the risk of misclassification. It would be particularly useful to have new generation techniques with a better diagnostic performance.

In this project, in response to the problems presented above, we propose to evaluate the diagnostic performance of five innovative ultrasonic techniques for the non-invasive diagnosis of fibrosis.


Eligibility Criteria:
Inclusion Criteria:

* patient with an Ac-HCV positive and RNA HCV positive or AgHBs-positive,
* naive to treatment or not receiving treatment for viral eradication in six months,
* patient for whom a liver biopsy size less than 15 mm, regardless of the number of portal tracts present or fragments, is being considered or has been performed between two and one month before inclusion,
* Patient affiliated to social security or similar regime,
* patients who signed consent for participation in the study.

Exclusion Criteria:

* patient with anti-HIV Ac positive (latter result not older than 12 months and in the absence of risk factors)
* chronic liver disease due to other causes than HCV (hemochromatosis, autoimmune hepatitis, autoimmune disease, metabolic liver disease, alcoholic liver disease, alcoholic liver disease, exposure to toxins ...)
* chronic alcohol consumption \>30g/day in men and \>20g/day in women
* history of severe systemic disease,
* HCV treatment with anti-viral or anti-fibrotic referred to within the last 6 months,
* immunosuppressive therapy: corticosteroids, Imurel, cyclosporine, tacrolimus, Cellcep,
* patient with an active implantable medical device,
* protected person referred to in Articles L1121-5 to L1121-8 of the Code of Public Health
A Randomised Trial Evaluating Continuous Subcutaneous Infusion of Formulations of NN1218 and NovoLog® in Subjects With Type 1 Diabetes

This trial is conducted in the United States of America (USA). The aim of the trial is to evaluate continuous subcutaneous infusion of NN1218 formulations and NovoLog® in subjects with type 1 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes mellitus (diagnosed clinically) for at least 12 months prior to the screening visit (Visit 1)
* Treatment with the same insulin analogue by CSII (continuous subcutaneous insulin infusion) for the previous 3 months prior to the screening visit (Visit 1)
* Using a MiniMed Paradigm® pump (515/715, 522/722 or 523/723) for the previous 6 months prior to the screening visit (Visit 1)
* Glycosylated haemoglobin (HbA1c) below or equal to 9.0% by central laboratory
* Body Mass Index (BMI) below or equal to 35.0 kg/m\^2

Exclusion Criteria:

* History of diabetic ketoacidsosis (DKA) episodes requiring hospitalization within 6 months prior to the screening visit (Visit 1)
* History of abscess at the infusion site within 6 months prior to the screening visit (Visit 1)
* Hypoglycaemic unawareness as judged by the Investigator or history of severe hypoglycaemic episodes requiring hospitalization within the last 6 months prior to the screening visit (Visit 1)
Anesthetic Efficacy of 2% Mepivacaine Versus 4% Articaine

The aim of this prospective randomized clinical trial was compare between 2% Mepivacaine and 4% Articaine for inferior alveolar nerve blocks in patients with symptomatic irreversible pulpitis in mandibular molars as regards to their anesthetic efficiency; during access cavity preparation and instrumentation.

Sixty-six patients diagnosed clinically and radiographically with symptomatic irreversible pulpitis in mandibular posterior teeth will received single-visit root canal treatment using ProTaper Universal rotary system for canal preparation, then they will be randomly divided into two groups (n=33) according to the anesthetic solution used, either Group M (3.6 ml Mepivacaine hydrochloride 2% with 1:100000 epinephrine) or Group A (3.4 ml Articaine hydrochloride 4% with 1:100000 epinephrine). The pain will be assessed using numerical rating scale (NRS) during access cavity preparation and instrumentation, then the need for supplemental anesthesia will be also recorded.

Eligibility Criteria:
Inclusion Criteria:

1. Patients in good health (American Society of Anesthesiologists Class II or higher)
2. Patients having symptomatic irreversible pulpitis in one of their mandibular molars.
3. Age range is between 20 and 50 years.
4. Patients who can understand Visual Analogue Scales VAS.
5. Patients able to sign informed consent

Exclusion Criteria:

1. Patients allergic to articaine and/or mepivacaine and/or sulfur
2. Patients having active sites of pathosis in the area of injection.
3. Patients having active pain in more than one molar.
4. Patients who had taken analgesics in the 12 hours preceding the injection.
Lipids and Insulin Sensitivity

Rationale: The investigators hypothesize that a change in dietary fat quality (an increase in unsaturated fatty acids) may modulate fuel partitioning within the type 2 diabetic muscle towards less accumulation of lipid metabolites and an improved insulin sensitivity.

Objective:

1. The contribution of dietary vs endogenous fat sources to lipid overflow in the circulation and to skeletal muscle lipid uptake and storage in obese insulin resistant subjects vs obese insulin sensitive controls.
2. The acute effect of meals with various fatty acid composition ((high saturated (SFA) vs polyunsaturated (PUFA) vs monounsaturated (MUFA)) on skeletal muscle lipid uptake and storage, fatty acid mediated gene expression and postprandial insulin sensitivity in obese insulin resistant subjects.

Study design: single-blind randomized cross-over trial

Study population: obese males (35-70 years) with or without insulin resistance

Intervention:

1. 1 test meal
2. 3 test meals with a different fatty acid composition

Main study parameters/endpoints:

More insight whether dietary fat quality may modulate circulating lipids and skeletal muscle fatty acids handling, and may affect oxidative capacity and lipid storage in parallel to an increased insulin sensitivity.


Eligibility Criteria:
Inclusion Criteria:

* Obese males aged between 35 and 70 years with insulin resistance.

Exclusion Criteria:

* History of type 2 diabetes.
* Liver or kidney failure.
* Diseases in which the live expectation is shorter then 5 years.
* The use of experimental medication.
* Diseases/medication use that may have an influence on the glucose tolerance.
* Not to be able to understand the study information.
* Users of fatty acid supplements including fish oils etc.
* Users of high doses of antioxidant vitamins.
* Athletes.
* People on a diet of people that are planning to lose weight.
Inferior Turbinate Surgery in Rhinoseptoplasty: a Randomized Clinical Trial With Quality of Life Outcomes

The purpose of this study is to determine whether inferior turbinate surgery during rhinoseptoplasty is effective in improving quality of life and acoustic rhinometry outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Older than 15 years old;
* Nasal obstruction and nasal aesthetics complaints;

Exclusion Criteria:

* Previous septoplasty, turbinates intervention and/or rhinoplasty;
* Association of other surgical procedures in the same surgical time, as functional endoscopic sinus surgery, blepharoplasty, mentoplasty or otoplasty;
* Inferior turbinate hypertrophy as the isolated cause of nasal obstruction (no septum deviation or internal valve collapse)