cyrilzakka/clinical-trials huggingface dataset:
Refractive Disorders and Seric Vitamin D Level in Children With Disabilities

The investigator want to determine the refractive status of 80 children with disabilities and of 81 healthy children from a witness group. The vitamin D level of the children will be dosed for making different correlations with visual acuity status.

Refraction measurement will be done by the investigator in all 161 children. Visual acuity is checked, initial and after correction with proper correction. Vitamin D level is dosed from all the children in order to make correlations with the visual acuity, refractive status and risk for visual impairment.

Eligibility Criteria:
Inclusion Criteria:

* children with disabilities and healthy children

Exclusion Criteria:

* children diagnosed with another chronic diseases
Removal of Surgical Staples After Cesarean Delivery. Randomized Control Trial.

The optimal choice of skin closure at cesarean delivery has not yet been determined. This study aim to study the wound complications and scar healing after Surgical staples removal at postoperative day 4 and day 8 .

A randomized control trial.

A randomized controlled trial in which pregnant women undergoing a scheduled Elective cesarean delivery were assigned to skin closure with surgical staples and were randomly assigned to the day of removal of surgical staples. Postoperative day 4 VS. Postoperative day 8 .

Outcome assessors were blinded to group allocation. Scars will be evaluated after 8 weeks. Primary outcome measures is Patient and Observer Scar Assessment Scale (POSAS) scores. Secondary outcome measures are complications of surgical site infection (SSI) or wound disruption (hematoma or seroma).

A group of 104 women is needed in order to achieve a clinically signiﬁcant effect with a power of 80%.

Eligibility Criteria:
Inclusion Criteria:

* elective cesarean delivery
* previous cesarean delivery performed using the Pfannenstiel method
* 36-41 weeks of gestation based on first trimester ultrasound and a viable fetus.

Exclusion Criteria:

* emergency cesarean delivery
* clinical signs of infection at the time of CD, uncontrolled
* vunblanaced diabetes mellitus
* history of keloids
An Exploration of the Neuroplasticity of Endogenous Analgesia in Health and Chronic Pain

Transcranial magnetic stimulation (TMS) is a neurophysiological tool for studying cortical functions, and in addition, has an analgesic therapeutic effect whose underlying mechanism is unknown. The proposed research will use TMS in conjunction with brain imaging and electrophysiology to examine cortical plasticity and connectivity modifications induced by repetitive TMS (rTMS) targeted to affect cortical regions associated with endogenous analgesia (EA). This will be carried out in both healthy and chronic pain (fibromyalgia) states. rTMS analgesic intervention, targeted to the motor cortex (M1) will be preceded and followed by structural and functional magnetic resonance imaging (fMRI), and Diffusion Tensor Imaging (DTI). This will be done in order to examine alterations of cortical and brainstem mechanisms involved in EA and to investigate connectivity changes between cortical and sub-cortical regions of the EA networks. The latter as well as EA efficiency and pain-related personality variables will be used to assess individual differences in neuroplasticity within the EA systems in both healthy subjects and chronic pain patients.

Transcranial magnetic stimulation (TMS) is a neurophysiological tool for studying cortical functions, and in addition, has an analgesic therapeutic effect whose underlying mechanism is unknown. The proposed research will use TMS in conjunction with brain imaging and electrophysiology to examine cortical plasticity and connectivity modifications induced by repetitive TMS (rTMS) targeted to affect cortical regions associated with endogenous analgesia (EA). This will be carried out in both healthy and chronic pain (fibromyalgia) states. rTMS analgesic intervention, targeted to the motor cortex (M1) will be preceded and followed by structural and functional magnetic resonance imaging (fMRI), and Diffusion Tensor Imaging (DTI). This will be done in order to examine alterations of cortical and brainstem mechanisms involved in EA and to investigate connectivity changes between cortical and sub-cortical regions of the EA networks. The latter as well as EA efficiency and pain-related personality variables will be used to assess individual differences in neuroplasticity within the EA systems in both healthy subjects and chronic pain patients .

Eligibility Criteria:
Inclusion Criteria:

* a prior FMS diagnosis by a rheumatologist or pain specialist based on American College of Rheumatology (ACR) preliminary diagnostic criteria for fibromyalgia
* healthy subjects - no pain/psychiatry/neurological diseases

Exclusion Criteria:

* other chronic pain, psychiatric or neurological diseases. All will be asked to withdraw from any pain-relieving medications for 24h before the testing.
A Trial Investigating the Concentration in the Blood of NN1250 in Children, Adolescents and Adults With Type 1 Diabetes

This trial was conducted in Europe. The aim of this clinical trial was to look into the concentration of NN1250 (insulin degludec/insulin 454) in the blood after one injection of NN1250 in children, adolescents and adults with type 1 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 6-65 years (both inclusive)
* Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
* Body mass index for children: 15.0-20.0 kg/m\^2 (both inclusive), for adolescents: 18.0-28.0 kg/m\^2 (both inclusive) and for adults maximum 30.0 kg/m\^2

Exclusion Criteria:

* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
* Not able or willing to refrain from smoking during the inpatient period
* Female of childbearing potential who is pregnant, breast-feeding or intends to become pregnant or is not using adequate contraceptive methods
Evaluation of the Recovery Experienced by Patients After an Ankle Sprain Treated in the Emergency Department of Nantes University Hospital

To evaluate the recovery experienced by patients with ankle sprains treated in the adult emergency department of Nantes University Hospital.

The aim of this study is therefore to establish the current situation by describing the practices of doctors working in the adult emergency department of the Nantes University Hospital regarding the initial treatment of ankle sprains, and to assess the rate of recovery experienced by patients one month after their trauma. This preliminary study may be pursued in the future, with a view to proposing new recommendations for the management of ankle sprains in the emergency department.

Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years of age
* Presenting an isolated ankle sprain
* Visiting Nantes CHU emergency department for this reason
* Patient able to read and speak French
* Patient covered by a social security scheme

Exclusion Criteria:

* Patient \> 70 years old
* Patients requiring hospitalization following a visit to the emergency department
* Any intercurrent pathology that may affect the management of the ankle sprain
* Associated ankle fracture
* Patients under legal protection.
[18F] LBT-999 PET Compared to [123I]-FP/CIT SPECT to Distinguish Between Parkinson's Diseases and Essential Tremor

Clinical study to demonstrate an at least equivalent performance of a new PET molecular Imaging radiopharmaceutical named \[18F\] LBT-999 in brain imaging compared to the SPECT reference method named \[123I\]-FP-CIT to establish the differential diagnosis between Parkinson's Disease and Essential Tremor.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 35 to 80 (male or female)
* Patients:

  * suffering from an essential tremor as defined by Elble's criteria from 2000 (excluding head tremor in decubitus and compatible with the study by the investigator)
  * or with Parkinson's disease as defined by the United Kingdom Parkinson's Disease Society Brain Bank (UKPDSBB)
* Patients diagnosed over 18 months ago
* Women of childbearing potential who must have effective contraception at baseline and up to 30 days after the last administration of the radiopharmaceutical (investigational medicinal product or comparator)
* Patients affiliated with or receiving a social security scheme
* Patients who have been fully informed about the organization of the research and who have signed their informed consent

Exclusion Criteria:

* Patients with atypical non-idiopathic Parkinson's syndrome (multi system atrophy, progressive supranuclear palsy, etc.)
* Patients treated with deep brain stimulation
* Patients with functional psychogenic movements
* Patients with severe and progressive psychiatric disorders
* Patients with disabling dyskinesia or essential tremor that are incompatible with imaging studies
* Patients who have had an ionizing radiation examination on the brain within the last 3 months
* Individuals with a contraindication to PET or SPECT imaging:

  * Patients with claustrophobia
  * Patients refusing to be informed in case of abnormalities detected during imaging tests
  * Patients treated with amphetamines, benzatropine, amfebutamone, cocaine, mazindol, methylphenidate, phentermine or sertraline
  * Individuals with a known allergy to the active substance or one of the excipients of the product under investigation or to the reference product or to or to thyroid treatment
* Woman of childbearing age without effective contraception in the opinion of the investigator
* Any other serious unstabilized chronic condition deemed incompatible with the study by the investigator
* Patients unable to sign the informed consent
* Patients participating in a protocol or in a period of exclusion from a protocol
* Patients who received compensation of more than 6000 € in the last 12 months prior to enrollment in clinical studies
* Patients in a period of exclusion from the national volunteer database during which they cannot participate in another clinical study
* Patients not affiliated with a social security scheme
* Patients refusing to participate
* Individuals referred to in articles L. 1121-5 to L. 1121-8 and L1122-2 of the French Public Health Code
Efficacy and Safety of Rebamipide in Subjects With Dry Eye Syndrome

The purpose of this study is to evaluate the efficacy and safety of rebamipide ophthalmic suspension in subjects with dry eye syndrome.


Eligibility Criteria:
Inclusion Criteria:

* History of dry eye-related ocular symptoms for at least 20 months.
* Meet protocol-defined criteria for corneal and conjunctival staining.
* Meet protocol-defined criteria for ocular discomfort.

Exclusion Criteria:

* Active anterior segment ocular disease other than dry eye syndrome.
* Inability to suspend the use of topical ophthalmic medications throughout the duration of the study.
* Inability to suspend the use of contact lenses for the duration of the study.
* Judged by the investigator to be ineligible for the study because of a past or concurrent systemic disease, or safety concerns.
* Received any other investigational product within 4 months before the screening visit.
Quality of Life Measures in Patients With Retinal Degeneration

Inherited retinal degeneration (IRD) is a major cause of blindness and partial loss of vision cases in the UK and starts at an early age. The purpose of this observational study is to use the results of two questionnaires and a computerised test testing contrast sensitivity, to assess the impact of IRD on quality of life. This study will involve collecting data from patients with IRD, but also collecting data from normal controls.

IRD presents a significant burden on the NHS as well as on the individual and families. IRDs are particularly difficult in a family situation due to guilt and other complex emotions related to inheritance patterns. Poorer mental health has been reported in patients with retinitis pigmentosa, manifesting in a range of ways including stress, depression and anxiety, particularly as the disease progresses. This is most probably caused by the uncertainty of the disease process and the progressive nature of the degeneration.

Recent work has reported that quality of life significantly deteriorates with a drop in visual field diameter of 20 degrees or a drop in visual acuity lower then LogMAR 0.3 (equivalent to 6/12). Contrast sensitivity is often used in conjunction with VA to assess visual capabilities. It is a measure of the ability to see reduced contrast and has a major impact on utility of vision. Relating contrast sensitivity function to quality of life will provide valuable information about whether this aspect of vision is a critical measure for patient health. This is especially important as novel treatments are being developed for the treatment of IRDs.

Eligibility Criteria:
Inclusion Criteria:

* Participant is willing \& able to give informed consent for participation in the study.
* Male or female, aged 18 - 85.
* A clinical or genetic diagnosis of retinal degeneration or normal age and sex-matched controls without known retinal disease.
* Able to participate in visual function testing.

Exclusion Criteria:

* The participant may not enter the study if any of the following apply:

  * 1) they have a pre-existing amblyopia or squint;
  * 2) they have any other retinal problems that may confound the measures assessed.
A Study on the Mechanism of Cough Hypersensitivity

The aim of this study is described as follows,

1. To establish a validated method to test cough reflex sensitivity conducted by transient receptor potential vanilloid 1(TRPV1).
2. To observe the variance of cough reflex sensitivity conducted by transient receptor potential ankyrin 1(TRPA1) of chronic patients and the relationship between cough reflex sensitivity conducted by TRPA1 and conducted by TRPV1.
3. To study the distribution of TRPA1 and TRPV1 channels and their relationship to cough reflex sensitivity.

This study is divided into two major part, Firstly,to observe the variance of cough reflex sensitivity of chronic cough patients and the relationship between it and airway inflammation.

1. Recruit chronic cough patients and healthy volunteers as subjects.
2. Help subjects to complete detailed history,physical examination,Hull airway reflux questionnaire,chest x-rays,induced sputum,blood routine test,pulmonary ventilation function test and histamine provocation test before they enter this study.
3. Complete allyl isothiocynate(AITC) cough provocation test the day subjects enter the study,then complete capsaicin（CAP）cough provocation test after 3 days.
4. To detect the substance P(SP),calcitonin gene-related peptide(CGRP),prostaglandin E2(PGE2),et al level in sputum supernatants.

Secondly,to observe the distribution of TRPA1,TRPV1 channels and the relationship between it and cough reflex sensitivity.

1）Recruit chronic cough patients and healthy volunteers and complete related examinations as mentioned before.

2)Collect mucosa specimens from upper trachea via endobronchial biopsy,and airway epithelial cells from 2nd or 3rd order bronchi via brushing.

3)Evaluate the expression level of TRPA1,TRPV1 of mucosa specimens of subjects by immunofluorescent assay and Image analysis software.

4)Cultivate airway epithelial cells from subjects and evaluate the expression of TRPV1,TRPA1 and functional changes of it.

Eligibility Criteria:
Inclusion Criteria:

chronic cough group:

1. cough lasting ≥ 8 weeks,characterized by irritating dry cough.
2. sensitive to fumes，dust,the odorous and cold air.
3. with normal chest x-rays. 4.17-70 years old.

5.without smoking history. healty controls group: 1.17-70 years old. 2.without smoking hitory or stop smoking for more than 2 years. 3.without chronic cough. 4.without chronic respiratory diseases. 5.without chronic heart, liver, kidney,and autoimmune disease. 6.with normal chest x-rays. 7.with normal pulmonary ventilation function,and histamine challenge test showed negative result.

Exclusion Criteria:

chronic cough group and healty controls group:

1. with respiratory tract infection within 8 weeks.
2. with chronic respiratory diseases or severe heart, liver, kidney,and autoimmune disease.
3. using Angiotensin-Converting Enzyme Inhibitors(ACEI),bronchodilators,glucocorticosteroid,antihistaminics within one week.
4. women during pregnancy or lactation.
5. patients with malignant tumours.
A Randomized Prospective Trial Comparing Low-volume Bowel Preparation Methods

Colonoscopy is a common screening method to detect polyps and CRC. With the early detection of CRC through screening colonoscopy, patients could have better therapeutic effects and outcomes. In population screening programs, an increase in completed colonoscopies is related to a decrease in mortality from CRC. However, the miss rate for detecting colorectal neoplastic polyps of colonoscopy is 5-28%. The reluctance of participants to undergo bowel preparation results in the relatively low rate of detection of polyps and CRC, because poor preparation interferes with successful colon mucosa examination during a colonoscopy.

Low-volume bowel preparations provide equivalent cleansing effect compared with standard 4 liter polyethylene glycol. However, studies comparing the superiority between low-volume bowel preparations are rare, and results are controversial. This study aimed to compare the bowel cleansing quality and tolerability between split-dose sodium picosulfate/magnesium citrate and polyethylene glycol with ascorbic acid.

1. Study design: endoscopist-blinded, prospective, randomized controlled trial
2. Subjects

   1. Entry criteria: Male or female patients, aged between18 and 80 years undergoing elective outpatient colonoscopy were eligible for the study.
   2. Exclusion criteria:

   patients who had chronic kidney disease, severe heart failure(New York Heart Association \[NYHA\] class III or IV), uncontrolled hypertension (systolic pressure ≥170 mm Hg, diastolic pressure ≥100 mm Hg), severe constipation, any bowel resection, significant gastroparesis, or suspected bowel obstruction or perforation.
3. Sampling design: Consecutive recruitment of consenting patients
4. Variables Predictor

   1. group 1 (SPMC 2) received one sachet of SPMC at 7 p.m the evening before colonoscopy and another sachet of SPMC at 5 hours before procedure
   2. group 2 (PEG-Asc) received 1 L solution of PEG-Asc at 7 p.m the evening before colonoscopy and another 1 L solution of PEG-Asc at 5 hours before procedure;
5. Primary Outcome: Quality of bowel preparation (Boston Bowel Preparation Scale, Aronchick scale, bubble score)
6. Secondary Outcome: Tolerability, palatability

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients, aged between18 and 80 years undergoing elective outpatient colonoscopy were eligible for the study

Exclusion Criteria:

* patients who had chronic kidney disease, severe heart failure(New York Heart Association \[NYHA\] class III or IV), uncontrolled hypertension (systolic pressure ≥170 mm Hg, diastolic pressure ≥100 mm Hg), severe constipation, any bowel resection, significant gastroparesis, or suspected bowel obstruction or perforation.
Correlation of LONGterm Wrist ACTigraphy Recorded Physical Performance & 6-minute Walk Distance in Patients With Pulmonary Arterial Hypertension

The objective of the study is to monitor physical activity longitudinally with a wrist activity tracker specifically in PAH patients newly initiating ERA therapy and to assess the correlation with the 6MWD at different time points. Further objectives are to assess the correlation of physical activity measured with the tracker and other parameters for clinical evaluation and right ventricular function assessment (i.e. Biomarkers, WHO Functional class, hospitalization due to PAH, Echochardiography and Quality of Life) as well as sleep efficacy in PAH patients newly initiating ERA therapy.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients with right heart catheter (RHC)-confirmed PAH (WHO PH group I)
* Age ≥18 year
* Not receiving ERA therapy in the 30 days prior to the enrolment visit
* Signed patient informed consent form

Exclusion Criteria:

* Patient with conditions that prevent compliance with the protocol or to adhere to therapy and use of the device
Long-term Effectiveness of a Recombinant Hepatitis E Vaccine

This test-negative study is designed to evaluate the long-term effectiveness of hepatitis E vaccine (Hecolin®) and to explore the prevalence of rat hepatitis E in Dongtai City.

In this negative test study, residual clinical serum will be collected from 13 hospitals in Dongtai, if it was from patients born between 1941-1991 from 11 towns in Dongtai, who tested positive for ALT levels higher than 2.5 times the upper limit of normal (ULN). Detection of HEV IgM, IgG, antigen, RNA will be performed to diagnose hepatitis E (HE) in each individual. In addition, HE vaccination history will be collect. All the information above will be used to evaluate the long-term effectiveness of HE vaccine. Based on the study design, virological and serological detection (IgM, IgG, antigen, and RNA) of hepatitis E virus species C (HEV-C) will be performed to analyze the prevalence of rat hepatitis E infection in Dongtai.

Eligibility Criteria:
Inclusion Criteria:

1. From 11 townships（Anfeng、Fuan、Tangyang、Hougang、Liangduo、Qingdong、Shiyan、Shenzao、Wulie、Xuhe、Xinjie）
2. ALT ≥ 2.5 ULN
3. Born between 1941 and 1991
Study Evaluating the Efficacy of Loco-regional Anaesthesia PECS on Chronic Pain of a Mastectomy

A non-randomized, mono-centric, prospective interventional study that will assess the efficacy of the loco-regional anesthesia PECS on the rate of chronic pain, 6 month after a patient will have either received a mastectomy or a mastectomy associated with axillary nodes dissection, and/or a reconstruction by prosthesis.

The aim of this study is to assess the care given to treat breast cancer while the patient receives a total mastectomy. It is done by evaluating the technique of anesthesia PECS used during this procedure so that the rate of chronic pain can be measured 6 month after the operation.

As well as total mastectomy, patients are also eligible for an axillary lymph node dissection (ALND) and a reconstruction of the breast by prosthesis as options.

Other objectives of the study include:

* Evaluating the effectiveness of the PECS anesthesia technique on the trajectory of acute post-operative pain and on chronic pain after 12 month of the surgery
* Evaluating the type and intensity of the pain
* Evaluating the quality of life
* Study the link between chronic pain and the trajectory of acute pain.

Eligibility Criteria:
Inclusion Criteria:

* Patients with unilateral breast cancer
* Surgery must be a total mastectomy +/- axillary lymph node dissection and +/- reconstruction by prosthesis; unless first surgery was performed more than 5 years prior to total mastectomy without any residual pain
* Age ≥ 18 ans
* Non-opposition of patients

Exclusion Criteria:

* Reconstruction by other than prosthesis
* Previous breast surgery in the last year
* Hypersensitivity or allergy of anaesthetics
* Coagulopathy and local infections
* Pregnant or breastfeeding
* Patients under guardianship