cyrilzakka/clinical-trials huggingface dataset:
The Effects of Compression Stockings on Pressure Parameters in Patients With Chronic Venous Insufficiency

The main objective of this study is to obtain data to determine, in each individual with and without wearing compression stockings of different strengths and during different postures, the relationship between interface pressure and the area and circumference of the great saphenous vein and posterior tibial veins in the calf and ankle.


Eligibility Criteria:
Inclusion Criteria:

* The participant must have given his/her informed and signed consent
* The participant must be insured or beneficiary of a health insurance plan

Inclusion criteria for patients in the venous insufficiency group:

* CEAP (Clinical-Etiology-Anatomy-Pathophysiology) Classification : C1S, C3 or C5

Inclusion criteria for healthy volunteers

* general good health
* subgroups including:
* sedentary volunteers (\< 2hours of physical activity per week)
* active volunteers (between 2 and 6 hours of physical activity per week)
* athletic volunteers (over 6 hours of physical activity per week for at least 1 year)

Exclusion Criteria:

* The participant is participating in another study, except the "volumetric" counterpart to the present study
* The participant is in an exclusion period determined by a previous study
* The participant is under judicial protection, under tutorship or curatorship
* The participant refuses to sign the consent
* It is impossible to correctly inform the participant
* The participant is pregnant, parturient, or breastfeeding
* Arterial vascular disease, heart, lymph, renal, hepatic, oncologic, metabolic or endocrine or any other condition that may cause or exaggerate edema

Exclusion criteria for healthy volunteers:

* Risk for abnormal bleeding (hemophilia, anticoagulation or antiplatelet)
* Taking diuretics or corticoids
Evaluation of Brain Plasticity in Premature Infants at School Age After Cognitive Remediation

Infantile brain plasticity is still a poorly known phenomenon. However, neuropsychological disorders and behavioral deficits are common disorders that can have serious consequences for school enrollment, family and social adjustment, as well as repercussions on future adult lives.

In addition, generally very premature infants (TGP) have identifiable executive function disorders (EF), particularly those involving attentional processes such as working memory (WM).

The main objective of the study is to evaluate the effects of cognitive remediation (CR) strategies on the brain plasticity of the cortical areas involved in the management of WM in school-aged TGP children (8 years).

The secondary objective of the study is to evaluate the action of CR on the development of cortical areas concerned

It is a monocentric, prospective and comparative study of the exposed type (to cognitive remediation) - unexposed. Recruitment and data collection are carried out prospectively, in connection with the original study (EPIREMED). Included patients will be explored by Magnetic Resonance Imaging (MRI) 3 resting state Tesla.

The main hypothesis is that CR strategies have a beneficial effect on the cognitive processing of visual-spatial executive functions, but also on the cortical areas involved in brain plasticity in general (indirect benefits); not to mention the psychological benefits ad hoc to such studies (self-esteem, increased concentration, new stress management strategies put in place).

The ultimate objective of this study is to better understand the mechanisms of cerebral plasticity concerning higher executive functions. Moreover, this study should make it possible to confirm the improvement of the overall fate of the child by better understanding the neuropsychological and anatomical origins of his disorders. Interventions taking into account the environment of the very premature baby are necessary because it is closely linked to the developmental future.


Eligibility Criteria:
Inclusion Criteria:

* Children born between 24 and 34 weeks of amenorrhea and living in the Provence region
* Possessing an intelligence quotient (IQ) greater than 70

Exclusion Criteria:

* Child not understanding French
* Child who did not have all the interventions in the EPIREMED study
Everolimus and Tacrolimus Combination for Regression of Left Ventricular Hypertrophy in Renal Transplants

Clinical study with two parallel group to compare the efficacy of everolimus combination + tacrolimus in regression of left ventricular hypertrophy vs tacrolimus + mycophenolate mofetil in renal transplant patients in the maintenance phase.

A single-center, randomized, open-label, 12 months study, with two parallel group to compare the efficacy of everolimus combination + tacrolimus in regression of left ventricular hypertrophy vs tacrolimus + mycophenolate mofetil in renal transplant patients in the maintenance phase.

Eligibility Criteria:
Inclusion Criteria:

* Patient's signed informed consent prior to any study-related procedure.
* Adult patients (\> 18 years), renal transplant recipients of more than 1 year of evolution.
* Patients receiving maintenance immunosuppression with tacrolimus delayed release (Envarsus®) and MMF / MPA.
* Patients with Left Ventricular Hypertrophy detected by Cardio-NMR.
* Subjects with glomerular filtration rate \>30 ml/min (calculated by CKD-EPI) and stable in the last two analytical determinations (variation \<20%).
* No known contraindications to the use of Mtor inhibitors (previous intolerance, deep vein thrombosis , pulmonary embolism, proteinuria \> 0.5 g/day)
* Patients with Hb levels ≥ 11 gr/dl.
* Patients with blood pressure \<140/90 mmHg in the hospital visits or \<135/85 mmHg at home.

Exclusion Criteria:

* Patient's signed informed consent prior to any study-related procedure.
* Adult patients (\> 18 years), renal transplant recipients of more than 1 year of evolution.
* Patients receiving maintenance immunosuppression with tacrolimus delayed release (Envarsus®) and MMF / MPA.
* Patients with Left Ventricular Hypertrophy detected by Cardio-NMR.
* Subjects with glomerular filtration rate \>30 ml/min (calculated by CKD-EPI) and stable in the last two analytical determinations (variation \<20%).
* No known contraindications to the use of Mtor inhibitors (previous intolerance, deep vein thrombosis , pulmonary embolism, proteinuria \> 0.5 g/day)
* Patients with Hb levels ≥ 11 gr/dl.
* Patients with blood pressure \<140/90 mmHg in the hospital visits or \<135/85 mmHg at home.
An Open Prospective Longitudinal Pulmonary-cardiovascular Cohort Study

This is an observational study aiming to identify and validate biomarkers (including imaging and clinical descriptors) for chronic obstructive pulmonary disease (COPD), cardiovascular disease (CVD) and lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* 45-75 years
An Open Label Trial of Afatinib (Giotrif) in Treatment-naive (1st Line) or Chemotherapy Pre-treated Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Harboring EGFR Mutation(s)

To evaluate the safety and tolerability of afatinib (Giotrif) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR mutation(s) and have never been treated with an EGFR-TKI


Eligibility Criteria:
Inclusion criteria:

Patients with:

* locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC)
* Epidermal Growth Factor Receptor (EGFR) mutation-positive result per the institution's testing methodology.
* Adequate organ function, defined as all of the following:

  1. Absolute Neutrophil Count (ANC) \> 1500/mm3. (ANC \>1000/mm3 may be considered in special circumstances such as benign cyclical neutropenia as judged by the investigator and in discussion with the sponsor).
  2. Platelet count \>75,000/mm3
  3. Serum creatinine \< 1.5 times of the upper limit of normal
  4. Total Bilirubin \< 1.5 times upper limit of (institutional) normal (Patients with Gilbert's syndrome total bilirubin must be \<4 times institutional upper limit of normal).
  5. Aspartate Amino Transferase (AST) or Alanine Amino Transferase (ALT) \< three times the upper limit of (institutional) normal (ULN) (if related to liver metastases \< five times ULN).
* Eastern Cooperative Oncology Group (ECOG) score between 0 - 2
* written informed consent by patient or guardian prior to admission into the trial that is consistent with International Conference on Harmonisation (ICH)- Good Clinical Practice (GCP) guidelines and local law.

Exclusion criteria:

Patients who or with:

* prior treatment with an EGFR tyrosine kinase inhibitor (TKI)
* anti-cancer treatment within 2 weeks prior to start of trial treatment (continued use of anti-androgens and/or gonadorelin analogues for treatment of prostate cancer permitted)
* radiotherapy within 14 days prior to drug administration, except as follows:

  1. Palliative radiation to organs other than chest may be allowed up to 2 weeks prior to drug administration, and
  2. Single dose palliative treatment for symptomatic metastasis outside above allowance to be discussed with sponsor prior to enrolling.
* previous or concomitant malignancies at other sites, except effectively treated non-melanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ or effectively treated malignancy that has been in remission for more than 3 years and is considered to be cured.
* known pre-existing interstitial lung disease
* meningeal carcinomatosis and symptomatic brain metastases (patients with asymptomatic brain metastases, who were previously treated, are eligible provided they have had Stable Disease (SD) for at least 4 weeks on stable doses of medication)
Assessment of Shared Decision Making Aids in Asthma

The purpose of this study is to determine whether the use of shared decision making aids is more effective than usual care in improving asthma knowledge, lessening decisional conflict, and enhancing adherence to treatments and asthma control in adult patients with mild to severe asthma.


Eligibility Criteria:
Inclusion Criteria:

1. Men or women, aged 18 to 65 years;
2. Current diagnosis of mild to severe asthma; 2.1) Asthma diagnosis will be made upon one of the following criteria: 2.1.1) Forced expiratory volume in one second (FEV1) increases by at least 12% after the use of a bronchodilator (and a minimum ≥ 200 mL); 2.1.2) Current asthma symptoms and a positive methacholine challenge test (20% fall in FEV1 after inhalation of a provocative dose of methacholine 16 mg/mL); 2.1.3) A respirologist's current diagnosis of asthma found in the patient's medical report. 2.2) Severity of asthma will be assessed according to prescribed pharmacotherapy, as suggested by the 2012 Canadian Thoracic Society Guidelines: 2.2.1) Patients with mild asthma using SABA as well as low doses (≤250 mcg/day beclomethasone or equivalent) of inhaled glucocorticosteroids; 2.2.2) Patients with moderate asthma using SABA as well as low to moderate doses (250mcg/day \< dose ≤500 mcg/day beclomethasone or equivalent) of inhaled glucocorticosteroids, with or without additional therapy (LABA or LTRA); 2.2.3) Patients with severe asthma using high doses (\>500 mcg/day beclomethasone or equivalent) of inhaled glucocorticosteroids, and additional pharmacotherapy (LABA, LTRA, or Prednisone), and SABA.

Exclusion Criteria:

1. Chronic obstructive pulmonary disease (COPD);
2. Education on asthma in the last 6 months.
Effects of Peer-based Education on Adolescent Oral Health Literacy

This project aims to identify whether an oral health peer education strategy can influence the level of functional literacy and oral health attitudes of adolescents aged 15 to 19 years. An experimental study will be carried out, a non-randomized controlled community trial, with two groups of educational strategy in oral health: peer education (experimental group) and conventional education (control group). For data collection, three questionnaires will be applied: for socioeconomic, demographic and dental data; assessment of oral health literacy (BOHL-AQ); and assessment of oral health attitudes; the last two being applied before and after the intervention.

This project aims to identify whether an oral health peer education strategy can influence the level of functional literacy and oral health attitudes of adolescents aged 15 to 19 years. An experimental study will be carried out, a non-randomized controlled community trial, carried out in the municipality of Araruna-PB, with two groups of educational strategy in oral health: peer education (experimental group) and conventional education (control group). For data collection, three questionnaires will be applied: for socioeconomic, demographic and dental data; assessment of oral health literacy (BOHL-AQ); and assessment of oral health attitudes; the last two being applied before and after the intervention. Descriptive analysis will be performed and a test will be applied to assess the normality of the data. The psychometric properties of the BOHL-AQ with adolescents will be evaluated using factor analysis. For literacy and attitude data, a comparison of means before and after the intervention will be performed using the intragroup paired and unpaired Student t test. All analyzes will be performed using the Statistical Package for the Social Sciences (SPSS) 25.0, considering a significance level of p \< 0.05.

Eligibility Criteria:
Inclusion Criteria:

* Adolescents aged 15 to 19 years old, who obtain consent from their parents/guardians (for those under 18 years of age), voluntarily accept to participate in the study and are present on the day the questionnaires are administered.

Exclusion Criteria:

* Adolescents with physical and/or mental disabilities that make it impossible to follow the activities proposed in the intervention and respond to the questionnaires.
Fertility and Ovarian Reserve Function in the Patient With Inflammatory Bowel Disease

ECCO consensus, the fertility would decline in activity inflammatory bowel disease(IBD), because of anus lesions and pelvic abscess, or who underwent surgery, especially in patients with ileal pouch anal anastomosis (IPAA) storage.The study on fertility in inflammatory bowel disease were almost epidemiological investigation, the lack of objective evaluation of fertility, and controversial.This study will explore the fertility, ovarian reserve function and the pregnancy outcomes in patients with IBD.


Eligibility Criteria:
Inclusion Criteria:

1. Inflammatory bowel disease
2. 17-40 years old
3. female

Exclusion Criteria:

1. in pregnancy or lactation
2. a drug that has been or is being used known to affect ovarian function, such as cyclophosphamide
3. reproductive system diseases unrelated to disease or treatment of inflammatory bowel disease, such as hysterectomy, pelvic radiotherapy after surgery, after ovariectomy, polycystic ovary syndrome, endometriosis, ovarian granulosa cell tumor
4. other endocrine diseases, such as prolactin, hyperthyroidism, lead to endocrine disorders;
5. malignant tumor
Primitive Immunodeficiency and Pregnancy

The management of patients with primary immune deficiency is increasingly codified, however contraception and pregnancy have not yet extensively studied or codified, and the medical monitoring and the prevention of infectious complications thus remains at the discretion of the practitioner.

The aim the research is to study the obstetric features and outcome of patients with primary immune defects.

Primary immune deficiencies constitute a large group of immune system disorders of genetic origin which can associate, to varying degrees, an increased susceptibility to infections and immunopathological manifestations: allergy, inflammation, autoimmunity, lymphoproliferation, tumors malignant.

Although their prevalence remains underestimated, there has been an increase in the number of cases diagnosed in the past 10 years. The national average prevalence is 8.6 patients per 100,000 inhabitants and the diagnostic incidence is 400 new cases per year in France. Major improvement in the management of primary immunodeficiencies have drastically changed patients outcome. Most patients now reach adulthood and the possibility of carrying out a pregnancy project, that has already reported for patients suffering from hypogammaglobulinemia or variable common immune deficiency, is now increasingly reported for other types of inherited immunodeficiencies. Whereas the management of patients with hereditary immunodeficiencies is increasingly codified, contraception and pregnancy have not yet been the subject of recommendations: medical monitoring and the prevention of infectious complications thus remain at the discretion of the practitioner.

The aim the research is to study the obstetric experiences of patients with a primary immune deficiency, paying particular attention to infectious complications.

Eligibility Criteria:
Inclusion Criteria:

* Adult woman with Hereditary Immune Deficits and entered in the reference Center for Hereditary Immune Deficits (CEREDIH, hospital Necker-Enfants Malades, Paris) register
* Patient having reported at least one pregnancy or attempted pregnancy
* Patient not opposing to participation in research

Exclusion Criteria:

- Refusal to participate of the study
Virtual Reality; the Effect on Pain Reduction During an External Version.

SUMMARY

Rationale: The use of an external cephalic version (ECV) to rotate the fetus from a non-cephalic to cephalic presentation reduces the rate of caesarean section by approximately two-thirds in term pregnancies with breech presentation. Reducing pain during external cephalic version can contribute to an increase in success rate and consequently reduce the number of cesarean sections. Literature about the effectivity of virtual reality (VR) on acute pain reduction seems promising.

Objective: The primary objective of this study is to explore the effect of VR on pain during ECV. Secondary objectives are the rate of successful ECV procedures and to explore tolerability, feasibility and patient satisfaction of VR use.

Study design: The study concerns a non-blinded, single centre, randomised controlled trial.

Study population: Eligible women who fulfill the inclusion criteria and are scheduled for an external cephalic version in the Zuyderland Medical Centre location Heerlen.

Intervention: The study population will be randomly divided into the intervention group (VR-group) or the standard care group. The intervention group can choose for an immersive guided relaxation VR experience or an interactive VR experience during the external version additional to the usual standard care. The participants randomised to the standard care group receive the usual standard care given during external version.

Main study parameters/endpoints: The primary outcome is pain measured on a numeric rating scale (NRS). A total of 42 patients have to be included in each group. This means that a total of 84 women will have to be included in the study.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Each participating woman is asked to complete a questionnaire after using VR and the degree of pain perception is questioned on the basis of a 0-10 score (NRS). The study population experiences a very small medical risk when participating to this study. They can experience side-effects of VR for example dizziness or nausea and in rare cases epileptic insults.


Eligibility Criteria:
Inclusion Criteria:

* Written and orally given informed consent
* 18 years and older
* Native Dutch speaker
* Singleton pregnancy in breech position
* Scheduled ECV

Exclusion Criteria:

* Contraindication for ECV
* Chronic pain patients defined as 'persistent or recurrent pain lasting longer than 3 months' \[16\]. The pain is not due to an obstetrical problem.
* Chronic use of pain medication (opioids)
* Alcohol or drug abuse
* Known car sickness
* Epileptic insults in previous history
* Psychotically seizures in previous history
* Claustrophobic
* Blindness
* History of mental illness
* Patients in strict isolation (MRSA)
* Age \<18 years
* Twin pregnancy
* No native Dutch speaker
Impact of Exclusion Diet in Addition to Anti-TNF Therapy in Crohn's Disease and Ulcerative Colitis: a Prospective, Double Arm, Open-label Study

This clinical study protocol aims to prospectively compare the efficacy of standard therapy with anti-TNF agents combined with the Crohn's Disease Exclusion Diet (CDED) versus anti-TNF therapy alone in adult patients with active Crohn's disease or ulcerative colitis.

The study will involve patients starting therapy with anti-TNF agents due to active Crohn's disease or ulcerative colitis as per standard clinical practice and in accordance with European (ECCO) guidelines.

One group will receive standard medical therapy only, the other will additionally receive dietary advice on how to adhere on a specific exclusion diet, the CDED.

By prospectively evaluating the impact of this combined approach, the study seeks to provide evidence on whether CDED can improve response to treatment and therefore improve quality of life for patients with Crohn's disease and ulcerative colitis.

This is a prospective interventional, single-center, double-group, open-label study.

Primary objective is to compare the efficacy of CDED in addition to anti-TNF therapy in active CD and UC versus anti-TNF therapy alone.

Secondary objective are:

* Endoscopic response
* Endoscopic remission
* Early and late efficacy and persistence of benefits
* Biochemical response
* Sonographic improvement
* Tolerability and compliance to the Crohn's Disease ExclusionDiet (CDED)
* Quality of life-Safety of the combination of biological therapy and CDED. The subjects considered are adult patients diagnosed with moderate-to-severe Crohn's disease or moderate-to-severe ulcerative colitis who are starting therapy with an approved anti-TNF agent (infliximab and adalimumab for both UC and CD, and golimumab only for UC).

Eligibility Criteria:
Inclusion Criteria:

1. Participant is willing and able to give informed consent forparticipation in the study
2. Males or Females, Adults aged 18 years or older
3. Confirmed diagnosis of moderate-to-severe Crohn's disease orulcerative colitis
4. Patients who are planned to start anti-TNF therapy
5. Ability and willingness to comply with the Crohn's DiseaseExclusion Diet (CDED)

Exclusion Criteria:

1. Patients with undetermined inflammatory bowel disease
2. Patients with metabolic or gastrointestinal conditions that couldinterfere or are incompatible with the study intervention (e.i.celiac disease, diabetes etc)
3. Patients with a body-mass index lower than 17 or greater than30
4. Patients who previously underwent intestinal resectionirrespective of cause
5. Patients currently on exclusive enteral nutrition (EEN)
6. Patients who have previously used or are currently adhering toCDED
7. Pregnant or breastfeeding women
8. Patients with a history of severe allergic reactions orintolerance to any food recommended in CDED
9. Patients with significant comorbidities that may interfere withthe study or pose a risk to the participant
10. Inability or unwillingness to comply with study protocols orfollow-up schedules