cyrilzakka/clinical-trials huggingface dataset:
Study of the Impact of Everolimus Treatment on Lymphocytes NK (Natural Killer) Development and Functions for Patients With a Metastatic Breast Cancer (HR+ / HER2/Neu Negative)

NK (Natural Killer) cells are important in the fight against tumor, especially for the control of cancer metastasis. The purpose of this prospective study is to evaluate the impact on lymphocytes NK functions and development of an everolimus treatment in women treated for a metastatic breast cancer. In particular, the study of lymphocytes NK functions and development under everolimus treatment could permit to validate an early biomarker of the impact of everolimus on these NK cells.


Eligibility Criteria:
Inclusion Criteria:

* Women \> 18 years old
* Metastatic breast cancer HR+ (Hormone Receptor positive), HER2/neu negative (Human Epidermal Growth Factor Receptor-2)
* ECOG PS (Eastern Cooperative Oncology Group Performance Status) ≤2
* Eligible to an hormonotherapy treatment combined to an mTOR (mammalian Target Of Rapamycin) inhibitor (i.e. SPC (Summary of Product Characteristics) modalities)
* Measurable disease according to RECIST 1.1 (Response Evaluation Criteria In Solid Tumors)
* Not receiving the non-authorized concomitant treatments
* Patient should understand, sign, and date the written voluntary informed consent form at the screening visit prior to any protocol-specific procedures performed.
* Patients must be covered by a medical insurance

Exclusion Criteria:

* BMI\>30
* All dysimmune disease, history of transplantation or immunosuppressive therapy or corticotherapy
* All chronic inflammatory diseases
* Last chemotherapy \< 6 months
* Corticotherapy \<1 year and more than 1 month
* Restrictive diet ≤3 months before inclusion
Cohort of Twin Pregnancy and the Offspring

Twin pregnancy increases the risk of maternal and fetal complications, which include gestational hypertension, premature labor, twin-to-twin transfusion syndrome, intrauterine growth restriction, anemia, amniotic fluid abnormalities. Comprehensively understanding the molecular mechanisms of the disease and identification of markers contribute to development of novel therapeutic approaches. In addition, the twin pregnancy, especially the monochorionic, is an essential model of "experiments of nature". This model can be applied to distinguish the epigenetic differences of twins in utero and after birth in the same genomic context. The aim of the study is to constitute a prospective cohort of twin pregnancies and the offspring.

Data are collected regarding the pregnancy data of the mother, and mental, physical and sociodemographic information of the offspring. The periods span from diagnosis of twins to 3 years old of the offspring. Biological samples would be collected including maternal blood, placental tissues, cord blood, urine, and stool from the pregnant women or the offspring at the specific time.

The total estimated duration of the study is 6 years, of which the first 2.5 years will correspond to the recruitment period of the participants.

Eligibility Criteria:
Inclusion Criteria:

1. Maternal age \>18 years old.
2. Twin pregnancy.

Exclusion Criteria:

1. Fetal chromosomal or congenital abnormalities.
2. Stillbirth.
Respiratory Muscle Strength, Exercise Capacity and Physical Activity Levels in Children Primary Ciliary Dyskinesia

Primary ciliary dyskinesia is an autosomal recessive disorder characterized by abnormal ciliary movement and disrupted mucociliary clearance. In uncleaned airways, microorganisms and respiratory irritants cause inflammation and infection. Permanent rhinitis and chronic sputum cough are typical features in primary ciliary dyskinesia patients. Primary ciliary dyskinesia is a disease that threatens lung function from pre-school age. One of the main causes of respiratory muscle weakness in chronic lung diseases diseases is worsening of lung function. Such a weakness causes alveolar hypoventilation, microatelectasis, reduction of the cough strength .The cough strength is important for airway cleaning.

Exercise capacity is affected in chronic lung diseases. Assessment of exercise capacity in chronic lung diseases is prognostically important. Reduced exercise capacity and pulmonary function in PCD cause decrease in physical activity level. PCD patients have low quality of life and early recognition has been found to affect the quality of life positively. Children with chronic illness have higher level of depression than healthy children.

In literature, no study investigated respiratory muscle strength, exercise capacity and physical activity PCD patients. Therefore, the investigators aimed to compare aforementioned outcomes in PCD patients and healthy controls.

According to sample size calculation 26 diagnosed primary ciliary dyskinesia patients and 26 healthy individuals will be included. Respiratory muscle strength, anaerobic and aerobic exercise capacity, physical activity, pulmonary functions, peripheral muscle strength, cough strength, respiratory muscle endurance, activity dyspnea perception, quality of life and depression will be evaluated. Primary outcome measurements are respiratory muscle strength, exercise capacity, physical activity; secondary outcomes are pulmonary functions, peripheral muscle strength, cough strength, respiratory muscle endurance, activity dyspnea perception, quality of life and depression.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed primary ciliary dyskinesia patients,
* 6-18 years of age,
* under standard medications,
* stable patients without exacerbation or infection

Exclusion Criteria:

* having cognitive disorder,
* orthopedic or neurological disease with a potential to affect functional capacity,
* acute infections or pneumonia,
* problems which may prevent evaluating such as visual problems
Opiate Sparing Versus Opiate Based Following Shoulder Arthroplasty

To investigate the difference between an opiate sparing pain management protocol versus a standard opiate-based protocol following shoulder arthroplasty in the ninety day postoperative period regarding visual analog scores and oral morphine equivalents.

This is a single center, investigator initiated, prospective, randomized, controlled trial conducted among patients who have given voluntary consent to participate. Participation will last until the completion of the twelve weeks standard of care follow up visit.

Eligibility Criteria:
Inclusion Criteria:

* Primary shoulder arthroplasty
* 18-85 years of age
* Body Mass Index greater than or equal to 45
* Willing and able to provide written informed consent
* Willing and able to cooperative in the required postoperative therapy
* Willing and able to complete scheduled follow-up evaluations
* Fluent in verbal and written English

Exclusion Criteria:

* Less than 18 years or over 85 years of age
* Unable to provide written informed consent, cooperate with postoperative therapy, or complete follow-up evaluations
* Known sensitivity, allergy, or intolerance to medications with protocols
* Renal disease as defined by active or impending dialysis within six months or kidney transplant
* Concomitant ipsilateral upper extremity injury or condition other than shoulder that compromises function
* Chronic pain syndrome
* Five consecutive days of opiate use with the previous ninety days
* Worker's compensation claim
* Women who are pregnant, planning to become to become pregnant, or breastfeeding
Study To Assess Efficacy and Safety of Oglemilast in Patients With Chronic Obstructive Pulmonary Disease (COPD)

This study will assess the safety and efficacy of a range of oglemilast doses. The study will be 14 weeks in duration. All patients meeting the eligibility criteria will be randomized to one of three doses of oglemilast or placebo.


Eligibility Criteria:
Inclusion Criteria:

* Presence of COPD as defined by GOLD criteria (2006); post-bronchodilator FEV1/FVC \<70%, and post-bronchodilator FEV1 \>30% and \< 80% predicted
* Current or former cigarette smoker

Exclusion Criteria:

* Long-term oxygen use of \> 15 hours a day
* Symptoms consistent with a significant asthmatic component (e.g. atopic disease, allergic symptoms)
* Any COPD exacerbations within 30 days prior to study entry or during run-in
* History of chronic or recurrent gastrointestinal disorder associated with bleeding in previous 12 months
* Presence of clinical significant pulmonary disease other than COPD
Adherence and Understanding of a Therapeutic Education Program for Patients With Central Venous Access (EDUVVC)

The aim of this project is to evaluate, in a prospective cohort of PICC line patients, adherence to the project and understanding of the messages.

The transmission of knowledge and the acquisition of skills by patients with this type of invasive device will enable them to play an active role in their own care, and could help to reduce the frequency of risks.

This project is part of a collaborative approach that includes the creation of a mobile application for therapeutic education and monitoring (application under development). The evaluation of the device will be the subject of a national PHRC with national structures (SPIADI and PRIMO). The aim is to create a city-hospital collaboration to improve risk management.

The ever-increasing use of central venous lines, including PICC lines, and the shift in medical practice towards ambulatory care, are making it increasingly complex to prevent the infectious and non-infectious risks associated with their use.

The involvement of numerous healthcare professionals within and outside the hospital, with varying levels of training, exposes patients to numerous complications, the incidence of which, depending on the device, ranges from 6 to 16%, and occur at the time of insertion (hematoma, pneumothorax, necrosis) or during use (infection, thrombosis, extravasation).

The transmission of knowledge and the acquisition of skills by patients wearing this type of invasive device helps to make the patient a player in his or her own care, and could help to reduce the frequency of risks. As part of a therapeutic education program, we aim to validate the communication tools and messages identified by a panel of French experts. These messages, together with the article published by Petit et al, have enabled us to draw up a skills reference framework for patients with a PICC line.

The aim of this project is to evaluate adherence to the project and understanding of the messages on a prospective cohort of patients.

This project is part of a collaborative approach that includes the creation of a mobile application for therapeutic education and monitoring (application under development). The evaluation of the device will be the subject of a national PHRC with national structures (SPIADI and PRIMO). The aim is to create a city-hospital collaboration to improve risk management.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients over 18 years of age
2. Patients requiring a PICC line
3. Patients with a means of communication with an Internet connection (computer or cell phone) or an alternative solution (landline telephone)
4. Patients with a predicted life expectancy of more than 6 weeks

Exclusion Criteria:

1. Patient opposed to participating in the study
2. Patient does not understand French
3. Patient not affiliated to a French social security scheme
4. Patient under guardianship or curatorship
5. Patient under court protection
68Ga-FAPI PET/CT Imaging for Diagnosis, Grading, and Efficacy Evaluation of Myelofibrosis.

To evaluate the diagnostic efficacy of 68Ga FAPI PET/CT in myelofibrosis and to identify fibrosis grades.

To evaluate the diagnostic efficacy of 68Ga FAPIPET/CT imaging in patients with myelofibrosis, compared with conventional CT.

This study uses bone marrow biopsy as a gold standard or reference standard to evaluate the diagnostic efficacy (Sensitivity, Specificity, Positive prediction rate, Negative prediction rate) of 68Ga FAPI PET/CT in myelofibrosis and to identify fibrosis grades.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years old;
2. Cohort 1: Patients with suspected or confirmed myelofibrosis; Cohort 2: Patients with primary/secondary myelofibrosis who were not treated with ruxolitinib.
3. The expected survival time is over 3 months
4. Voluntarily sign informed consent.
5. Willing and able to follow the research protocol;
6. The subject must be able to lie on the scanning bed for 20 minutes;

Exclusion Criteria:

1. Known allergic history to 68Ga FAPI or its excipients;
2. Patients who can not tolerate intravenous drug administration (such as needle fainting and blood fainting history);
3. Those who are not suitable for or unable to complete imaging tests such as PET due to special reasons, including claustrophobia and radiophobia;
4. pregnant and lactating women;
5. Workers who are exposed to radiation for a long period of time;
6. Serious diseases of the heart, kidney, lung, blood vessel, nervous system, mental system, immune deficiency diseases and hepatitis/cirrhosis;
7. Participating in other interventional clinical trials within 1 month before screening;
8. Patients undergoing chemotherapy, immunotherapy or molecular targeted therapy due to other cancers;
9. There are other circumstances that the researcher thinks are not suitable for participating in this study;
CsDCS on Functional Mobility in Parkinsons Disease

Parkinsons disease is a progressive neurological disorder marked by a decline in the efficacy of dopaminergic synapses in the nigrostriatal pathway, causing motor disturbances. Resting tremor, bradykinesia, and muscle rigidity are the most prominent motor features. These factors result in gait impairments, including slowness and freezing. The primary treatment for the disease is medication. However, while medication does reduce motor symptoms, prolonged usage may lead to an increase of dyskinesias and a worsening of a patients clinical condition. Thus, alternative therapies, such as cerebellospinal direct current stimulation (csDCS), have gained popularity. Studies suggest that csDCS may be an effective approach to mitigate gait disorders in this patient population. Kinesiotherapy is an established therapeutic method that has been demonstrated to promote functional mobility and improve gait. To date, the combination of kinesiotherapy and csDCS has not been tested, thus the purpose of this study is to evaluate the effectiveness of this combined therapy for enhancing functional mobility in Parkinsons disease patients. The goal of this study is to assess the efficacy of blending csDCS and kinesiotherapy for improving patients functional mobility in Parkinsons disease. Two groups of volunteers will be assigned: i) actual csDCS + kinesiotherapy, and ii) sham csDCS + kinesiotherapy. The full procedure involves 10 therapy sessions conducted across two weeks.


Eligibility Criteria:
Inclusion Criteria:

* a clinical diagnosis of PD provided by a neurologist
* regular dopaminergic drug treatment (at least three months of use)
* aged 40 years or over
* staging I to IV on the modified Hoehn and Yahr scale

Exclusion Criteria:

* other neurological disorders, postural hypotension, vestibular, musculoskeletal or visual disorders that compromise performance in the proposed tests
* other osteoarticular diseases in the lower limbs that interfere with performance and locomotion
* a Montreal Cognitive Assessment (MoCA) score of less than 21 points
* have undergone previous surgery for PD
Creation of a Syncope Channel for Patients Admitted to the Emergency Department for Loss of Consciousness and Not Hospitalized: Etiological Predictivity (Before/After Study)

The main aim of this study is to assess the value of creating a "syncope pathway" to optimize diagnostic performance in patients admitted to the emergency department for syncope and not hospitalized, compared with the previous pre-syncope pathway situation.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 and over;
* Consultant at the emergency department of the Centre Hospitalier de V ersailles
* For a confirmed diagnosis:
* of recurrent syncope with low-risk criteria according to ESC 2018 (1,2) Or
* of syncope recurrent or not, not fulfilling low-risk or high-risk criteria according to the ESC 2018 definition (1,2). These patients are those with minor high-risk criteria without aggravating circumstances:

  * With no personal history of loss of consciousness whose clinical features strongly suggest syncope of rhythmic origin;
  * No structural heart disease or abnormal ECG.
* Outpatient (returning home after emergency);
* Beneficiary or beneficiary of a social security scheme (excluding AME).

Exclusion Criteria:

* Etiology of syncope identified as early as the emergency department visit;
* High-risk syncope according to ESC 2018 criteria (1,3);
* First and only episode of low-risk syncope according to ESC 2018 criteria (1,3);
* Syncope of any risk category requiring hospitalization at the discretion of the emergency physician and cardiologist;
* Legal protection by guardianship ;
* Language barrier or condition incompatible with the patient's understanding or informed adherence to the protocol;
* Opposition to the use of their pseudonymized data (for retrospective inclusions);
* Patient's refusal to give consent to participate in the study (for prospective inclusions);
Influence of Cytochrome CYP3A4-induction by St. John's Wort on the Steady State Pharmacokinetics of Ambrisentan

The aim of the present study is to assess the impact of CYP3A4-induction by SJW on steady state ambrisentan and the impact of the cytochrome P450 2C19 (CYP2C19) genotype (\*2 and \*3 allele vs. wild type; \~2-5% poor metabolisers in Caucasian population) on the pharmacokinetics of ambrisentan in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Good state of health (physically and mentally)
* Able to communicate well with the investigator, to understand and comply with the requirements of the study
* Voluntarily signed informed consent after full explanation of the study to the participant.
* No clinically relevant findings in any of the investigations of the pre-study examination, especially aminotransferase elevations ≥ 3 × upper limit of normal (ULN). Minor deviations of other laboratory values from normal range may be acceptable, if judged by the investigator to be of no clinical relevance.
* Known genotype for CYP2C19 polymorphism.
* Agreement to abstain from alcoholic beverages during the time of the study.
* Females must agree to use a reliable contraception (Pearl Index \<1%), e.g. double barrier method.

Exclusion Criteria:

* Any regular drug treatment within the last two months, except for oral contraceptives in female volunteers and L-thyroxine.
* Any intake of a substance known to induce or inhibit drug metabolising enzymes or drug transporters within a period of less than 10 times the respective elimination half-life or 2 weeks, whatever is longer
* Any participation in a clinical trial within the last month before inclusion
* Any physical disorder which could interfere with the participant's safety during the clinical trial or with the study objectives
* Any acute or chronic illness, or clinically relevant findings in the pre-study examination, especially: a) any condition, which could modify absorption, distribution, metabolism, or excretion of the drug regimen under investigation b) Allergies (except for mild forms of hay fever) or history of hypersensitivity reactions
* Regular smoking
* Blood donation within 6 weeks before first study day
* Excessive alcohol drinking (more than approximately 20 g alcohol per day)
* Inability to communicate well with the investigator due to language problems or poor mental development
* Inability or unwillingness to give written informed consent
* Known or planned pregnancy or breast feeding
* Pre-existing moderate or severe liver impairment
* Contraindication against midazolam, ambrisentan, or SJW or any known intolerance to any of these substances or their additives
Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of MYO-029

This is a multiple dose study assessing the safety, tolerability, pharmacokinetics and pharmacodynamics of an investigational new drug.


Eligibility Criteria:
Inclusion Criteria:

* Men aged 18 to 45 years inclusive on study day 1.
* Elderly men and women aged 65 to 80 years inclusive on study day 1.
* Women must be postmenopausal for \> or = 1 year (with estradiol \< 25 pg/mL and an FSH \> 40 mIU/mL).
* Healthy as determined by the investigator on the basis of medical history, physical examination, vital signs, clinical laboratory test results, and 12-leave electrocardiogram.
* Elderly subjects may have stable, nonclinically significant abnormalities on physical examination, and laboratory evaluation.
* Non-smoker.
Influence of Yogic Breathwork on CSF Circulation

The purpose of this research study is to determine the influence of yoga breathing practices on cerebrospinal fluid (CSF) circulation, and to find out primarily if a regular practice of 8-week yoga breathing would enhance CSF circulation as well as if the intervention would improve participant's quality of life, quality of sleep, and reduce existing stress. Participants will be randomized into two arms for different breathing practices.

The purpose of this research protocol is to determine the influence of an 8-week breathing intervention on cerebrospinal fluid (CSF) circulation among healthy participants using a non-invasive real-time phase-contrast magnetic imaging (RT-PCMRI) technique. This aim will be examined by studying the changes in each participant's pre- and post-intervention CSF flow dynamics using the non-invasive RT-PCMRI technique during two MRI scans (one before and one after the 8-week intervention).

The study protocol consists of 20 healthy participants (two groups; 10 in each group with different breathing practices) undergoing an 8-week intervention, and pre-and post-intervention outcome measures.

The two 8-week interventions will be guided by two separate certified experienced yoga teachers. Both interventions will consist of 60-minute weekly group on-site sessions (1day/week) with a 20-minute daily home sessions (in between on-site sessions; 6 days/week) using home-aid practice materials. Participants' respiration data will be objectively tracked using a wearable respiration tracker device.

Eligibility Criteria:
Inclusion Criteria:

- 18-65 years of age, able to provide their consent to be in the study, available and able to participate in study activities, who can lie in supine, able to walk 15 feet, who have no prior/current mind-body practice inducing breath awareness or training such as yoga, meditation, Ta-Chi, Qi-Gong.

Exclusion Criteria:

- Inability to provide informed consent, MRI contraindications, need for muscle relaxants or anti-anxiety drugs in order to tolerate MRI, history of neurological disorders, head trauma with loss of consciousness, craniospinal disorders, spinal injury, sleep disorders, allergic or respiratory disorders, major or uncontrolled psychiatric illness or major depression, lung and heart problems, any condition requiring the use of medication that acts on the brain like stimulants, sedatives current substance abuse issues, pregnancy or nursing.