cyrilzakka/clinical-trials huggingface dataset:
Urinary Aquaporin 2 Excretion After Methylprednisolone in Fasting Healthy Humans

We wanted to test the hypotheses that methylprednisolone up regulates u-AQP-2 in fasting healthy humans


Eligibility Criteria:
Inclusion Criteria:

* (1) Genders; both mal and female
* (2) Age; 18- 65 years old
* (3) BMI; below 30
* (4) Females had to bee in oral contraceptive treatment

Exclusion Criteria:

* (1) Clinical signs or history of disease in the heart, lungs, kidneys or endocrine organs
* (2) Abnormal laboratory test (blood haemoglobin, white cell count, platelets, plasma sodium, plasma potassium, plasma creatinine, plasma albumin, plasma bilirubin, plasma alanine aminotransferase, plasma cholesterol and blood glucose)
* (3) Albuminuria or glucosuria
* (4) Cancer
* (5) Arterial hypertension
* (6) Alcohol abuse
* (7) Use of tobacco
* (8) Medical treatment, except oral contraceptives
* (9) Pregnancy or breast feeding
* (10) Medicine abuse
* (11) Donation of blood less than 1 month before the study.
Study on Correlated Factors of Barrier and Immune Function in Stress Related Mucosal Disease (SRMD)

To study the changes of barrier and immune function in Stress Related Mucosal Disease (SRMD).

38 patients admitted to ICU and 15 healthy volunteers were successively enrolled in this study.The healthy volunteers were treated with endoscopy and biopsy .The 38 patients were treated with bedside gastroscopy and diagnosed with SRMD due to illness. The acute physiology and chronic health evaluation（APACHE）II score were evaluated, malondialdehyde (MDA) as an index of oxygen radical-lipid peroxidation was assessed in the serum. Transforming growth factor(TGF)β1,claudin3, interleukin (IL) 1 and interleukin（IL）10 levels in the gastric mucosa and plasma level of superoxide dismutase(SOD)，Ischemic modified albumin(IMA)and C-reactive protein（CRP）were evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Occurrence time: ≤72h.
* With complete clinical data.
* Patients admitted to ICU were treated with bedside endoscopy and diagnosed with SRMD.

Exclusion Criteria:

* Primary digestive tract diseases included stomach cancer, gastric ulcer, cirrhosis with esophagus fundus ventricularis varices and esophageal cancer.
* Patients were complicated with gastric perforation.
* Nonsteroidal anti-inflammatory drugs and antiplatelet agents had been used recently, or with the history of major surgery.
Investigation in Integrated Perspective of Radiculomyelopathy Patients

Cervical radiculopathy and myelopathy are common degenerative disorders, which can create a large amount of social and medical burden. The aims of this study are(1) to investigate the functional outcomes progression before and after surgery, (2) to evaluate the biomechanical change and compensatory patterns of patients with or without decompression surgery, and (3) to design innovation intervention for the patients with cervical myelopathy and radiculopathy.

Neck pain, which is common in population recently, is causing the huge burden in the global medical service system. Cervical myelopathy, that is induced by disc degeneration, is turning to be an alarming public health issue. The clinical manifestations of cervical myelopathy include neck/shoulder pain, numbness/weakness of four limbs, sensorimotor impairment, and sociopsychological dysfunction. However, most of the previous studies tend to justify patients, prognosis in a single dimension. The investigators realized that no standard protocol for management in patients with the variety of manifestation and severity of signs and symptoms.This study is purposed to integrate and analyze the finding in surgery selection, clinical manifestation, psychological consultation, compensatory patterns in the neuromusculoskeletal system, postural control, home exercise and biomechanical features. Then, the investigators will develop a complementary model in assessment and prediction of prognosis, and also an applicable standard guideline in the clinical setting. To achieve the expected target, the principal investigator will play the role as the main coordinator in the team. The 3-year plan is listed as below:

1. In the first year, the patients will be recruited for projects from different co-investigators. The recruited participants will be allocated to different study group after assessment to ensure the most suitable intervention are offered to the participants.
2. In the second year, the participants' recruitment will be continuing. The effectiveness previous treatment will be assessed. The study procedure will be adjusted based on pilot results.

2. In the third year, the study finding of all co-investigators and results of the biomechanical analysis will be integrated to establish the model of prognosis prediction and clinical management guideline. This study will provide a complete clinical management guideline in cervical myelopathy, which is expected to be globally leading reference in the management of cervical myelopathy.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as cervical myelopathy or radiculopathy based on imaging results

Exclusion Criteria:

* With spondylolisthesis, rheumatoid arthritis, multiple sclerosis
* With cancer/tumor
* With neurological or psychological disorder
* Not suitable for cervical decompression surgery or physical therapy
Kids Diabetes Telemedicine Study (KITES)

Randomised prospective single-center clinical trial evaluating the outcomes of children with type 1 diabetes followed up by remote telemedicine check-ups without their personal present at the outpatient clinic.

At the first study visit (visit Month 0), after obtaining the written informed consent from the parents, 50 children with type 1 diabetes will be randomised to two groups of equal size.

The first group will have regular visits with their diabetologist to our outpatient clinic every 3 months (visits Month 3 and Month 6), the second group will have a remote control by email only instead of regular visits (visits Month 3 and Month 6). The CGM data and inzulin dose will be evaluated through cloud systems (Diasend, Carelink) at every control by diabetologist. The patients would be instructed about the reccomendation during the "live" control or by email according the group. The final meeting (visit Month 9) will take place at our outpatient clinic for both of the study groups. The CGM data, HbA1c, and the questionaire evaluating the quality of the controls will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of type 1 diabetes
* Age 1-18 years
* Type 1 diabetes duration at least 12 months
* Using continuous glucose monitoring for at least previous 6 months
* Willingness to use continuous glucose monitoring for the whole study
* Signed informed consent by the legal representatives

Exclusion Criteria:

* Change of the type 1 treatment modalitry (from insulin pens to insulin pump or vice versa, start the treatment with hybrid closed loop, start of the treatment with the drug affecting the glucose metabolism) in 3 months prior to the study or planning to change the treatment modality during the study
* Concomitant psychiatric diagnosis diagnosed by the psychiatrist
* Hospitalisation for severe hypoglycaemia and/or diabetic ketoacidosis in 1 year prior to the study initiation
* Glycated hemoglobin concentration \>90 mmol/mol in 1 year prior to the study or substantially bad co-operation of the patient/parent
Study of Quemliclustat and Chemotherapy Versus Placebo and Chemotherapy in Patients With Metastatic Pancreatic Ductal Adenocarcinoma

The purpose of this study is to compare overall survival of quemliclustat, nab-paclitaxel and gemcitabine versus placebo, nab-paclitaxel and gemcitabine in all randomized patients.


Eligibility Criteria:
Inclusion Criteria:

* Have histologically or cytologically confirmed PDAC that is metastatic.
* Have not been previously treated for PDAC in the metastatic setting.

  1. Prior neoadjuvant and/or adjuvant therapy for PDAC is permitted if completed at least 12 months before randomization.
  2. Prior palliative radiotherapy is allowed if completed at least 2 weeks prior to randomization and AEs have resolved to Grade 1 or less before randomization.
  3. Prior and/or placement of a biliary stent/tube is permitted if any treatment-related AEs have improved to Grade ≤ 1 and the patient is not exhibiting any signs/symptoms of biliary obstruction.
* Eastern Cooperative Oncology Group PS of 0 to 1.
* At least 1 target lesion measurable by computed tomography (CT)/magnetic resonance imaging (MRI) per RECIST v1.1. not within a field of prior radiation therapy.

Exclusion Criteria:

* Previously treated for locally advanced, unresectable PDAC.
* History of brain metastases or leptomeningeal metastases.
* Prior treatment with a CD73 antagonist or inhibitor.
* Underlying medical conditions that, in the investigator or sponsor's opinion, will make the administration of study-specified therapy hazardous

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Adults With Rheumatoid Arthritis

The primary objective of this study is to evaluate the long-term safety and tolerability of filgotinib in participants who have completed one of the parent studies of filgotinib in rheumatoid arthritis (RA).


Eligibility Criteria:
Key Inclusion Criteria:

* Males or females who may benefit from filgotinib as judged by the investigator AND who completed a Gilead sponsored filgotinib parent study for RA as outlined below:

  * Have completed GS-US-417-0301, GS-US-417-0302 or GS-US-417-0303 on study drug

    * OR
  * Have completed GS-US-417-0302 on standard of care therapy due to RA non-responder status
* Females of childbearing potential must have a negative pregnancy test prior to first dose of study drug in the long term extension (LTE)
* Females of childbearing potential who engage in heterosexual intercourse must agree to protocol-approved methods of contraception

Key Exclusion Criteria:

* Diagnosis of an autoimmune or inflammatory joint disease other than RA, which would put the participant at risk by participating in the study or would interfere with study assessments/data interpretation, per judgment of the investigator
* Known hypersensitivity to the study drug or its excipients
* Any medical condition which would put the participant at risk by participating in the study or would interfere with study assessments/data interpretation, per judgment of the investigator

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Real-time fMRI Neurofeedback Training on the Anterior Insula Based on Interoceptive Processing

The main aim of the study is to investigate whether subjects can learn self control of activity of the anterior insula via real-time functional magnetic resonance imaging (fMRI) neurofeedback training based on a regulation strategy of interoceptive processing.

A double-blinded, placebo-controled, between-subject design is employed in this study. In a randomized order, a total of 90 healthy subjects will be recruited and assigned into the experimental group (EG; N=33), which receives real feedback from the left anterior insula, or the control group (CG; N=33) which receives sham feedback from a whole slice of top brain, or the control group 2 (CG2; N=33) wich receives sham feedback from the middle temporal gyrus. Neurofeedback training consists of 4 training sessions with real-time feedback and 1 transfer session without feedback. A heartbeat detection task pre- and post-training was used to determine interoceptive accuracy changes induced by neurofeedback training. A pre-training empathy task before training was used to localise the anterior insula and as a baseline of empathic response. A post-training empathy task was used to determine the effects of neurofeedback training on empathic response by comparing with the pre-training one. Behavioral and fMRI data are collected during the empathy tasks and the neurofeedback task. Personality traits of subjects are assessed using validated Chinese version questionnaires, including the Toronto Alexithymia Scale (TAS), Multidimensional Assessment of Interoceptive Awareness (MAIA), Interoceptive Confusion Questionnaire (ICQ), Beck Depression Inventory (BDI), State-Trait Anxiety Inventory (STAI), Autism Spectrum Quotient (ASQ), Empathy Quotient (EQ). Subjects are asked to complete Positive and Negative Affect Schedule (PANAS) twice before and after the neurofeedback training task.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects without any past or present psychiatric or neurological disorders

Exclusion Criteria:

* History of brain injury Medical or mental illness
The Role of Vitamin D in Corneal Epithelial Barrier Function, Ocular Microbiome, Ocular Inflammation, and Visual Acuity of Children With Allergic Conjunctivitis

A double-blind study to evaluate the role of vitamin D in corneal epithelial barrier function, ocular microbiome, ocular inflammation, and visual acuity of children with allergic conjunctivitis.

The prevalence of allergic conjunctivitis (AC) has rapidly increased in recent decades, resulting in a significant global public health concern. The ocular surface is a unique mucosal immune compartment in which immunological features act in concert to foster a tolerant microenvironment (immune privilege). The corneal epithelial barrier is the first line of defense that forms a protective barrier against pathogens, pollutants, and allergens. The ocular microbiota has a role in maintaining the homeostasis of the ocular surface and preservation of barrier function. Vitamin D functions as enforcing intercellular junctions and maintaining intestinal epithelial barrier integrity; metabolites from the gut microbiota may also regulate expression of vitamin D receptor (VDR). Low serum vitamin D levels have been shown to predispose to a variety of allergic disorders. A recent study shows that corneas contain vitamin D and VDR; vitamin D enhances corneal epithelial barrier function. However, research data of the role of vitamin D in ocular microenvironment of AC are insufficient and controversial. In recent research, the investigators found allergic inflammation of ocular surface weakened corneal epithelial barrier, modulated the signal pathway of retinal pigment epithelial cells, and enhanced scleral tissue remodeling, resulting in myopia in progression. However, there are few studies available to investigate the role of vitamin D in ocular surface microenvironment, ocular inflammation, and visual acuity in AC. Moreover, understanding the interaction of vitamin D, ocular microbiota, and ocular inflammation may provide a new target for the development of therapeutic interventions of ocular allergy and restore visual function.

Eligibility Criteria:
Inclusion Criteria:

1. Children aged 6-18 years with allergic conjunctivitis (AC) diagnosed by ophthalmologists or allergists

Exclusion Criteria:

1. Previous eye surgery
2. Active eye infection
3. Any active inflammatory eye disease except AC
4. Systemic steroid use within 28 days of study
Use of Walkers in Infancy and Musculoskeletal System

The aim of this study was to compare lower extremity muscle strength, posture disorders and physical activity levels of children with and without walker use during infancy. Thirty-nine children aged between 8 and 15 years were included. Demographic data, New York Posture Analysis Questionnaire and Physical Activity Assessment Questionnaire Scale (PAQ-C) were collected. Muscle strength was measured with a digital muscle strength meter.

This study aimed to compare lower extremity muscle strength, postural disorders, and physical activity levels of children who used and did not use a walker during infancy.

The study included 39 children aged between 8 and 15 years. The demographic information of the children, their motor development stages and walker use situations, the age at which they started using it, and the duration of use were questioned. The New York Posture Analysis Questionnaire and Physical Activity Assessment Questionnaire Scale (PAQ-C) were administered to the children. Muscle strength was measured with a digital muscle strength meter.

Eligibility Criteria:
Inclusion Criteria:

* No idiopathic serious orthopedic problems
* No chronic disease
* Children and their parents who volunteered to participate in the study

Exclusion Criteria:

* Presence of neurologic disease.
* Presence of neuromuscular disease.
* Presence of mental retardation.
To Evaluate the Safety and Performance of the AMS ActivHeal Silicone Foam and the ActivHeal Silicone Foam Lite Dressing.

To demonstrate the safety and performance of both AMS ActivHeal Silicone Foam and AMS ActivHeal Silicone Foam Lite dressings to both the patient and clinician in managing both chronic and acute wounds.

This PMCF study has been set up to investigate and assess residual risks in relation to the CE-marked AMS ActivHeal Silicone Foam and Silicone Foam Lite dressing . The purpose of this study is primarily to collect clinical follow-up data on the AMS ActivHeal Silicone Foam and Silicone Foam Lite dressing , as CE-marking was based on equivalence. The data and conclusions obtained from this study will be used to provide clinical evidence of safety and effectiveness for the clinical evaluation process.

Eligibility Criteria:
The patient population of this evaluation will consist of patients with either a chronic or acute wound of various wound types, according to the intended use of both the AMS ActivHeal Silicone Foam and ActivHeal Silicone foam lite dressing, and they meet study eligibility criteria.

Inclusion Criteria:

1. Males or females, age 18 years or above. (Females must not be pregnant and if of reproductive age should be using contraception).
2. Subjects who are able to understand and give informed consent to take part in the evaluation.
3. No local or systemic signs of infection, including new pain or increasing pain, erythema, local warmth, swelling, purulent discharge, pyrexia (in surgical wounds, typically five to seven days after surgery), delayed wound healing, abscess or malodour.
4. None to high levels of exudate

Exclusion Criteria:

1. Patients who decline the invitation to take part.
2. Patients who are known to be non-compliant with medical treatment,
3. Patients who are known to be sensitive to any of the dressing components.
4. Broken/ damaged or prone to blistering peri wound skin.
5. Presence of a clinically infected wound as determined by the presence of three or more of the following clinical signs: peri wound, erythema, pain between dressing changes, malodourous wound, abundant exudate, oedema, abscess, cellulitis, purulent discharge, discolouration, friable granulation tissue which bleeds easily.
6. Patients who have a current illness or condition which may interfere with wound healing in the last 30 days which may interfere with wound healing (carcinoma, connective tissue disease, autoimmune disease or alcohol or drug abuse.)
7. Life expectancy of \<6 months.
Constitution of a Biological Collection to Study the Pathophysiology in Noonan Syndrome

The present study will establish a collection of biological samples from Noonan patients to be used for research purposes only, with due respect for confidentiality.

Noonan syndrome is a rare autosomal dominant genetic disorder characterized by a combination of typical facial features, heart defects, short stature, skeletal abnormalities, mild developmental delay and a predisposition to myeloproliferative disorders. This syndrome is caused by germline mutations in genes encoding components or regulators of the Rat Sarcoma (RAS) / extracellular signal-regulated kinase (ERK) signaling pathway, which is essential for cell cycle differentiation, growth, and senescence.

Patients with Noonan syndrome or related diseases are followed at the children's hospital, Toulouse University Hospital. During regular check-up visits, an extra sample of blood and urine will be collected and stored for research utilisation with the patient's consent. The ultimate objective of this collection is to provide available biological resources to facilitate the development of subsequent studies aimed at better characterizing the multisystemic disorders in Noonan syndrome, to understand the pathophysiology of the disease, and to identify biological factors that predict the severity and progression of the disease. The possibility of having systematically collected biological resources will make it possible to answer certain questions more quickly depending on the progress of research.

Eligibility Criteria:
Inclusion Criteria:

* Children aged at least 3 years old or adult with Noonan syndrome
* Patients affiliated to or beneficiaries of a social security scheme
* Patients able to receive information on the progress of the study and understand the information form to participate in the study. That implies to master the French language and not to be subject to a restriction of rights by the judicial authorities
* Patients or legal representative who have given their consent to participate in the study (expression of no objection)

Exclusion Criteria:

* Patients subject to a legal protection measure (guardianship, curators, or safeguard of justice)
* Pregnant or breastfeeding women
Progesterone in Luteal Phase Deficiency

The main objective of this study will be to assess the efficacy of natural progesterone at a daily dose of 25 mg in restoring a normal luteal phase. The primary end-point will be the ongoing pregnancy rate.

The secondary objectives will be the rate of endometrial biopsy showing an in phase endometrium after 3 months of treatment.

The length of the luteal phase of the menstrual cycle after treatment will also be assessed and compared with the initial duration (from LH peak to onset of menstruation).


Eligibility Criteria:
Inclusion Criteria:

* Women who wish to get pregnant with a previous diagnosis of luteal phase deficiency:
* Able and willing to sign the Subject Consent Form and adhere to the study visit schedule;
* Age: 20-35 years;
* BMI: 18-28 kg/m2;
* Inadequate luteal phase (menstrual period shorter than 21 days);
* Sub-fertile couple: 12 months of trying to conceive without success.
* Normal uterine cavity;
* Basal P4 level (day 3 of a previous cycle) ≤ 3ng/ml;
* Non-smoking;
* Fertile male partner (normal sperm count).

Exclusion Criteria:

* History of recurrent miscarriage;
* Basal P4 level (day 3 of a previous cycle) \> 3ng/ml;
* Severe uterine malformations (including submucosal fibroids, endometrial polyps, and intrauterine adhesions) ;
* Known hypersensitivity to study medication;
* Neoplasias (known or suspected breast or genital tract cancer);
* Severe impairment of hepatic or renal function;
* Use of concomitant medications that might interfere with study evaluations (other hormonal treatment);
* Current vaginal infection;
* Endometriosis;
* PCOS;
* Partially or completed block of fallopian tubes;
* Hydrosalpinx;
* Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events;
* Porphyria;
* A history of idiopathic jaundice, severe pruritus or pemphigoid gestationis during pregnancy;
* Antiphospholipid syndrome;
* Diabetes mellitus;
* Thyroid diseases or autoimmune conditions;
* Hypothalamic dysfunction;
* Hyperprolactinaemia;
* Infertility due to male factor;
* Smokers.