cyrilzakka/clinical-trials huggingface dataset:
Executive Functions and Preterm Children in 3 to 4 Year Old

Preterm children have a high risk for neurodevelopmental impairments. The impact on motor functions and neurosensory functions is demonstrated but the incidenceof executive functions is not described for preterm infants.

It is an epidemiologic, observational, prospective study. All patients, included in the LIFT cohort, in 3 to 4 year old during the period study, are contacted by mail. Patientswith congenital anomalies or genetic syndromes are excluded. Children with parents who do not speak French are excluded. Antenatal and postnatal criteria known to be associated with disorders of executive functions are collected as, gestational age, sex, multiple pregnancy, intrauterine growth retardation, antenatal or postnatal steroid use, breastfeeding, cerebral injuries and socio-economic status. After a couple of weeks, parents are contacted by a study manager, by phone call, to collect parental consent and answer parental questions. After consent collect, BRIEF questionnaires are sending. If they wish, parents could give the BRIEF teacher questionnaire to the mean teacher. Teachers send by themselves their response. An informatic version is available with a personal link given especially by mail for each child. All data are anonymous. BRIEF questionnaire is composed of 63 items, exploring 2 main domains: behavior and metacognition. Twenty minutes are necessary to complete questionnaire. In case of no questionnaire return after one month, parents are contacted by phone. The investigators hypothesize a lost to follow-up at 0.25 and no response at 0.35. The response expected is 300 questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* patient in 3 to 4 year old, included in LIFT cohort

Exclusion Criteria:

* Congenital abnormalities including nervous system malformations; genetic diseases; incomplete understanding of written and oral French by parents
Mesenchymal Stem Cells Transplantation for Ischemic-type Biliary Lesions

Ischemic-type biliary lesions (ITBLs) are a major cause of graft loss and mortality after orthotopic liver transplantation (OLT). For now, there are still lacking effective treatment for ITBLs. The purpose of this study is to confirm whether human umbilical cord mesenchymal stem cells are effective in the treatment,or prevention of Ischemic-type Biliary Lesions after liver transplantation.

Advances in organ preservation techniques, immunosuppressive regimens, and surgical techniques have resulted in reduced rates of infection, acute rejection and vascular complications after orthotopic liver transplantation (OLT). However, ischemic-type biliary lesions (ITBLs) are still one of the most serious complications after OLT, with a usual reported incidence of 5-15%, and an incidence of up to 26% in some studies. 46% patients with ITBLs require re-transplantation after 2 years of OLT.

Mesenchymal stem cells (MSCs),a kind of pluripotent stem cells,can differentiate into vascular endothelial cells, which participate in angiogenesis in ischemic tissue. MSCs can also stimulate the proliferation and migration of mature endothelial cells via paracrine.Furthermore, MSCs secret a variety of cytokines and growth factors, such as vascular endothelial growth factor, human basic fibroblast growth factor, hepatocyte growth factor, interleukin-1 and interleukin-8, etc., which also induce angiogenesis.

Participants in the study will be randomly assigned to one of two treatment arms:

* Arm A: Participants will receive 6 months of standard regular treatment for ITBLs plus huc-MSCs treatment.
* Arm B: Participants will receive 6 months of standard regular treatment for ITBLs plus placebo.

huc-MSCs will be prepared according to standard procedures and is collected in plastic bags containing anti coagulant. MSCs are given via i.v. After huc-MSCs transfusion, patients are followed up once per week(in the first months,\<1M),once per 2 week(1-3M)and once per month(3-6M), and the evaluation of liver function and biliary blood supply was performed.

Eligibility Criteria:
Inclusion Criteria:

* benign end-stage liver disease patients with liver transplantation.
* ages of 18 and 60 years.
* first liver transplant.
* gamma-glutamyltransferase \> 300 U/L for 2 weeks, and there was no or low enhancement of the wall of the hilar bile duct in arterial phase via contrast-enhanced ultrasonography.
* Written informed consent.

Exclusion Criteria:

* second or combined organ transplant recipient.
* vital organs failure (Cardiac, Renal or Respiratory, et al).
* clinically active bacterial, fungal, viral or parasitic infection.
* other candidates who are judged to be not applicable to this study by investigators.
Effect of Agaricus Blazei (Murrill) ss. Heinemann (Sun Mushroom)

The aim of the study was to verify the influence of Agaricus blazei (Murrill) ss. Heinemann (A. blazei) on the evolution of nutritional state and liver function in hepatitis C patients.

Ten patients were studied (5 - GI - not taking A. blazei - and 5 - G2 - taking A. blazei), from both sexes, with positive Anti-VHC and a healthy nutritional state, admitted into in the viral hepatitis ward. Diagnosis and treatment for hepatitis C concurred with the regulations of the Ministry of Health and nutritional evaluation was performed in 3 moments according to anthropometrical, bioimpedance, biochemical and dietary standards, with duration of 6 months. The consumption of A. blazei (10g/day) in dehydrated powder was concomitant with antiviral therapy (conventional or pegylated interferon associated with ribavirin) with duration of 5 months.

Eligibility Criteria:
Inclusion Criteria:

* To have been informed and signed adequately the free and clarified assent
* Initiating the anti-viral treatment (interferon or pegylated interferon associate the ribavirin)
* Age: 24-70 years
* Gender :both the gender
* Race : all races
* To present serology positive to the anti-VHC ELISA
* To present genotype type 1,2,or 3
* Body mass index- \>18,5 e \< 35kg /m2
* Conditions full to the ORAL ingestion

Exclusion Criteria:

* Don't agree to the project or don't have signed the term of clarified free assent
* Restriction for oral ingestion
* The existence of surface of antigen of the hepatitis B virus(Ag HBs)
* The existence of antibody for the human immunodeficiency virus
* To be enclosed in another project of research or form of treatment
* Pregnant women
* Suckles
* Cirrhosis
* Patients with hepatitis auto-imune.
Safety and Efficacy of Hormone Therapy With Letrozole in Postmenopausal Women With Breast Cancer

The aim of this study is to assess the safety and efficacy of neoadjuvant hormone therapy with letrozole in postmenopausal women with estrogen- and/or progesterone-receptor positive primary breast cancer on tumour regression to permit breast conserving surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Postmenopausal women able to comply with the protocol requirements with confirmed primary invasive breast cancer whose tumours are estrogen-and/or progesterone-receptor positive
2. Clinical stage T2 or \>T2 tumours which in the investigators' opinion would not be eligible for breast-conserving surgery. The nodal status will be evaluated by palpation and/or ultrasound.
3. Postmenopausal status defined by one of the following:

   * Women with an intact uterus AND

     * ≥ 55 years of age, OR
     * \< 55 years of age without menses for the last 5 years, OR
     * \< 55 years of age and have not had menses for at least the last 12 months (but have had menses in the last 5 years) and have postmenopausal levels of follicle-stimulating hormone.
   * Women without an intact uterus AND

     * ≥ 55 years of age, OR
     * \< 55 years of age and postmenopausal levels of follicle-stimulating hormone
   * Both ovaries removed (prior to the diagnosis of breast cancer).
4. Tumour measurable by clinical examination, mammography and ultrasound
5. Adequate bone marrow function as shown by:

   * WBC ≥ 3.5 x 10\^9/L
   * ANC ≥ 1.5 x 10\^9/L
   * Platelets ≥ LLN
   * Hb \> 10 g/dL

Exclusion Criteria:

1. Multifocal disease (cancer that starts in several different sites)
2. Patients with bilateral breast tumours.
3. Patients who are eligible for breast conserving surgery.
4. Evidence of inflammatory breast cancer or distant metastasis.
5. Simultaneous anti-cancer treatments such as chemotherapy, immunotherapy/biological response modifiers, endocrine therapy (including steroids), bisphosphonate therapy and radiotherapy. NOTE: Bisphosphonate therapy for osteoporosis is NOT excluded, and can be continued. Patients who have received hormone replacement therapy will NOT be excluded if it is discontinued at least 2 weeks before starting the study.

The following additional treatments are NOT allowed during the treatment phase of the study:

* Any other anti-cancer therapy
* Hormone replacement therapy.
* Estrogen cream (including any intra-vaginal preparation).
* Steroids other than creams or inhalers.
* Megestrol acetate for the treatment of hot flushes.
* Radiation therapy.

Other protocol-defined inclusion/exclusion criteria may apply.
Study of Epigallocatechin-3-gallate (EGCG) for Supportive and Symptomatic Management in Patients With Esophageal Cancer

The main symptom of patients with advanced esophageal cancer is eating obstruction. In clinical practice, patients need to wait for a long time before anti-tumor treatment, which will lead to a rapid decline in the quality of life and nutritional status of patients, and severe patients sometimes need to place nasointestinal feeding tubes or endoscopic stents. EGCG has been shown to have antioxidant, anti-inflammatory and anti-tumor effects . The complex effects of EGCG may improve esophageal obstruction during the waiting period before antineoplastic therapy. The purpose of this phase I study was to explore the safety, recommended dose and preliminary efficacy of EGCG solution in the treatment of esophageal obstruction.


Eligibility Criteria:
Inclusion Criteria:

* confirmed pathological esophageal squamous cell carcinoma
* ≥18 years old
* the Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1
* no previous anti-tumor treatment
* no esophageal bleeding or fistula
* adequate hemocyte count, normal hepatic and renal functions
* Esophageal obstruction classified as grade 2 or grade 3 according to Stooler's dysphagia score

Exclusion Criteria:

* lactating or pregnant women
* known hypersensitivity or allergy to any kind green tea extract
* placement of small intestinal feeding tube or endoscopic stent treatment
* unable or refusing to take oral liquids
Does Mindfulness Enhance BMI in Obese Adolescents Enrolled in the Bright Bodies Weight Management Program?

Participants will be randomized to an evidence-based healthy lifestyle program alone or a healthy lifestyle program with mindfulness meditation added. The purpose of the study will be to determine if mindfulness improves BMI outcomes more than the program alone due to the stress-reduction benefits of mindfulness.

The study will randomize 44 adolescents (aged 11-17 yo) with BMI \>95th percentile to traditional Bright Bodies Healthy Lifestyle Program or Lifestyle Program plus mindfulness meditation (6 sessions within the 12-week program) (22 per group). The traditional program includes exercise two evenings per week and nutrition/behavior modification one evening per week for 12 weeks. Mindfulness session topics include breathing meditation, body scan meditation, mindful eating techniques, and identification of hunger verses satiation. The primary outcome measure with be (1) BMI, while secondary outcomes include changes in (2) percent body fat, (3) perceived stress scale (questionnaire), (4) physical stress (saliva cortisol levels), and (5) overall caloric intake (pre and post food records). After the 3 month intervention, participants will engage in post measures and be asked to return 6 months later (9 months) for longer-term follow-up measures.

Eligibility Criteria:
Inclusion Criteria:

* BMI \>95th percentile for gender \& age
* English-speaking subject and parent/caregiver
* Parent/caregiver willing to participate in weight mgt program

Exclusion Criteria:

* BMI \>40 \<27
* Psychiatric disorder or medical condition that precludes participation in program
* Currently taking medication that causes weight gain or loss
* Involvement in co-existing weight management program
* A positive pregnancy test
* Plans on moving out of the Greater New Haven area within 9 months
Randomized Study Evaluating the Efficacy of Low Intensity Transcranial Electrical Stimulation (Tdcs) for the Relief of Dyspnea

Nearly half (47%) of patients with mechanical ventilation in the intensive care unit report having dyspnea. This respiratory distress, with a feeling of "thirst for air", often reaches unbearable limits and is a major factor in the deterioration of the quality of life and the prognosis of patients. Physiopathological mechanisms of dyspnea are beginning better understood and have analogies with those of pain. Like pain, dyspnea often persists despite appropriate treatment of the cause, because of perceptual dysfunction related to changes in cortical excitability and neuronal plasticity and requires specific treatments. Studies have shown that Transcranial Stimulation by low Current (tDCS) was able to modulate the perception of acute pain induced and chronic pain. The tDCS modulates the functioning of a whole set of brain structures including the anterior cingulate gyrus, the prefrontal cortex, the thalamus and the brain stem, some of which have an established role in the central integration of pain and dyspnea. The investigators have recently demonstrated that the application of tDCS on the primary cortical motor area reduces the excitability of the central neurological pathways dedicated to the respiratory muscles in healthy subjects. The investigators therefore hypothesize that tDCS could relieve dyspnea in intensive care. In this research project, the investigators propose to evaluate the efficiency of tDCS on dyspnea in patients admitted to intensive care unit, having sepsis and mechanically ventilated.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient, hospitalized in intensive care unit, presenting a sepsis, having required a mechanical ventilation since at least 24h.
* Non-sedated or showing good wake up (Richmond Agitation-Sedation Scale score (RASS)\> -3 at inclusion (Sessler et al., 2002)) within 48 hours after cessation of sedation
* Patient able to answer by "yes" or "no" to simple questions
* Showing significant dyspnea (level ≥ 4) on the A1 sub-scale of the Multidimensional Dyspnea Profile (MPD-A1 ≥ 4).
* Signature of informed consent by the patient or his relative.

Exclusion Criteria:

* Patient under guardianship,
* Wake up delay, coma (GCS ≤ 8), or severe agitation.
* chronic respiratory pathology
* respiratory pathology, neuromuscular or neuro-sensory disability (auditory or visual).
* Cranioplasty
* Language barrier, refusal to participate in the study or to sign the informed consent,
* Pregnant or nursing woman,
* No affiliation to a social security scheme.
Feasibility Study of a Post-hospitalization Self-rehabilitation Program for Elderly Suffering of Sarcopenia

Loss of autonomy among elderly during and after hospitalisation is a well-known problem. Patient suffering of sarcopenia (decreasing in muscle mass and function) are more likely not to recover their previous autonomy.

Studies have shown that physical exercise, especially resistance exercises, is the most efficient known treatment of sarcopenia. Several institution-based rehabilitation programs had been implemented in this purpose.

On the other hand, some studies have shown that home-based self-rehabilitation can be as efficient as institution-based rehabilitation, for example in stroke, cardiac failure and COPD rehabilitation.

The investigators propose to set up a home-based self-rehabilitation program to fight against sarcopenia and hence increasing autonomy among elderly. This study aimed to establish the feasibility of such a program.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 70 or older
* Non-institutionnalised patients
* Patients suffering of sarcopenia during hospitalisation (assessed by the Short Physical Performance Battery, Bio-Impedance analysis and griptest)
* Patients hospitalised in the service of Internal Medicine of Institut Mutualiste Montsouris
* Patients returning at home after hospitalisation
* Patients who gave their written consent
* Patients who benefits from a social security coverage

Exclusion Criteria:

* Patients suffering from a severe medical condition not allowing them to follow a physical exercise program
* Palliative care patients
* Patients without the musculo-squelettic capacity to follow the program : 4/4 on seated postural stability scale ; no motor deficit on lower limb muscular testing ; quadricipital locking when standing
* Patients with severe cognitive disorders (according to MMSE score adapted to socio-cultural level and age)
* Patients who live more than 150 km away
* Patients following specific physiotherapy
To Evaluate the Response to Glucagon During Hypoglycemia

The purpose of this study is to evaluate the response to Glucagon versus the spontaneous hormonal response to low blood sugar levels in T2DM Patients treated with AZD1656 and Metformin


Eligibility Criteria:
Inclusion Criteria:

* type II diabetes patients, female with non child-bearing potential
* T2DM diagnosis confirmed by C-peptide \>0.3nmol/L and no glutamic acid decarboxylate (GAD) antibodies at enrolment (screening)
* Treatment with metformin alone with a total daily dose not less than 1 000 mg. Stable glycaemic control indicated by unchanged treatment within 3 months prior to enrolment

Exclusion Criteria:

* History of ischemic heart disease, symptomatic heart failure, stroke, transitory ischemic attack or symptomatic peripheral vascular disease
* Signs of diabetic proliferative retinopathy or diabetic maculopathy, at screening or on an ophthalmological examination within 3 months from start of study
* Participating in another clinical study during the last 30 days prior to enrolment
Beta2-adrenergic Agonism and Muscle Remodelling

The study aims to investigate gender-specific adaptations to beta2-adrenoceptor stimulation with selective short- and long-acting beta2-agonist with emphasis on skeletal muscle in relation to performance enhancing effects and anti-doping


Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women, aged 18-45 years
* VO2max \>55 ml/kg/min for men and \>50 ml/kg/min for women (± biologic and techinical variation of 5.6% (Katch et al. 1982)
* Body Mass Index (BMI) \< 26

Exclusion Criteria:

* Chronic user of beta2-agonist or allergy towards study drugs
* Serious adverse side effects of the used study drug
* Chronic disease that by the project physician would affect any of the outcomes of the study
* Smoker
* Chronic use of prescription medication (other than contraceptives for women)
* Pregnancy
Study to Investigate the Absolute Bioavailability of Oral Sylibin

This clinical trial phase I in healthy volunteers is intended to describe the oral bioavailability of the silybin-phosphatidylcholine complex by calculating the area under the curve (AUC0-? and AUC0-12) after administration of the same dose of oral silybin (AUCo) and intravenous silybin (AUC iv).


Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals men who give their written consent to participate in the study, after having received information about the design, the project objectives, the risks and that at any moment they can refuse their cooperation.
* Understand the purpose of the study and be available for performing hospital visits and and admissions.
* Age between 18 and 45 years.
* Healthy subjects, without any organic or psychological pathology
* Clinical history and physical examination within normal limits.
* Lack of clinically relevant abnormalities in blood test (hematology, biochemistry, virology) and urine test
* Vital signs and electrocardiographic recording in the normal range.
* Males with childbearing potential partners must agree to use a highly effective method of contraception (such as surgical sterilization, double barrier method) from the moment of signing the informed consent until 6 months after the end of their participation in the study.

Exclusion Criteria:

* Subjects suffering from organic or psychological pathology. Prior to the inclusion of any volunteer it should be considered all security parameters mentioned in the protocol (biochemical markers of kidney damage and / or liver out of the normal range set by the laboratory).
* Subjects who have received prescription drug treatment in the last 15 days or any medication within 48 hours before receiving study medication.
* Subjects with a BMI that is not between 18 and 30.
* Known hypersensitivity to any drug
* Suspected of drug abuse
* Consumers of alcohol daily and / or acute alcohol poisoning in the last week.
* Subjects smoking.
* Have donated blood in the last three months.
* Participation in any other investigational drug study in the previous 3 months
* Not to be able to follow instructions or collaborate during the course of the study.
Ultra Low Dose CT and Use of Iomeron 400 in PCD-CT

Evaluation of ultra low dose protocols and Iomeron 400 contrast in PCD-CT


Eligibility Criteria:
Inclusion Criteria:

* CT SCAN for pulmonary nodule detection/follow up
* CT SCAN for pneumonia detection/follow up

Exclusion Criteria:

* under 18
* BMI over 30
Radioaerosol Pulmonary Deposition During Asthma Exacerbation Through Noninvasive Ventilation

Despite the physiologic and clinical effects provided by coupling nebulization with noninvasive ventilation in asthma exacerbation, there are few and controversial studies reported in the literature.

Reduced work of breathing, increased oxygenation and increased in expiratory peak flow (EPF) and forced expiratory volume in the first second (FEV1) are benefits of noninvasive ventilation (NV) in the treatment of asthma. Despite these clinical improvements attributed to NV during asthma exacerbations and the well-established effects of nebulization, there are few studies in the literature coupling both therapeutic resources.

In addition to this, no studies on scintigraphic analysis of radioaerosol deposition coupled with NV in asthmatics have published. A previous study was published by our group, but involved healthy subjects.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of moderate to severe asthma (FEV1 \< 60 % of predicted values)
* Breathing rate \> 25 bpm
* History of asthma for at least 1 year
* Duration of current asthma attack of \< 7 days
* Reversibility of FEV1 of at least ≤ 10% after the administration of bronchodilator drugs

Exclusion Criteria:

* Current smoker
* Presence of cardiopulmonary disease (COPD, pneumonia, heart failure, myocardial infarction, pneumothorax)
* Hyperthermia
* Indication of intubation and invasive mechanical ventilation;
* Hemodynamic instability (heart rate \> 150 bpm and systolic blood pressure \< 90 mmHg)
* Cardiac arrhythmia
* Changes in consciousness
* Pregnancy
* Contraindications to use NV
Comparison of High-Dose Methotrexate (HDM) Plus Doxorubicin to HDM Plus Etoposide-Ifosfamide in Osteosarcoma Children

The purpose of this study is to compare two preoperative chemotherapy regimens based on high-dose methotrexate courses given alternately either with doxorubicin or with etoposide-ifosfamide.


Eligibility Criteria:
Inclusion Criteria:

* non metastatic limb osteosarcoma,
* age less than 20 years,
* biopsy proven high-grade osteosarcoma,
* no previous treatment,
* no contraindication to chemotherapy
* no previous malignancy,
* Written informed consent.

Exclusion Criteria:

* juxta-cortical sarcoma and microcellular anaplastic sarcoma,
* previous anticancer treatment
* contraindication to chemotherapy
* previous malignancy,