cyrilzakka/clinical-trials huggingface dataset:
North Health in Intellectual Disability

Intellectual disability (ID) is a diagnosis characterized by significant limitations both in intellectual functioning and in adaptive behavior as expressed in conceptual, social and practical adaptive skills. The disability originates before age 18 years. People with IDs will often require health- and social services throughout their lifetimes. Studies report worse health among people with IDs compared to the general population, in addition to more unmet healthcare needs and more difficulty accessing healthcare. There are also concerns about low levels of physical activity in this population.

In general health surveys in Norway do not include people with intellectual disabilities, and studies of health indicators in this group are largely lacking. Further, the unique organization of services for this group in Norway calls for specific research efforts. This project will use multinational health indicators for youths and adults with IDs in a biopsychosocial context in attempt to identify unmet health care needs to improve services. In addition to a description of the health indicators, the objective of this project is delimited to assess the health determinant physical activity level in association with body mass index (BMI) and functioning.

People with IDs are experiencing more illnesses and approximately 80% of adults 50 years or older have multimorbidities. To improve services, information about health care provision should be complemented with knowledge about the health situation and functioning in a community-based setting.

The main objectives of this study are to describe health indicators in a Norwegian population of youths and adults with IDs in relation to age, and to assess the associations between the health determinant physical activity and body mass index, physical function, activities and social participation in youths and adults with IDs.

Assessments of physical and mental health indicators, and aspects of activities and social participation according to International Classification of Functioning, Disability and Health (ICF), in relation to health determinants and unmet healthcare needs in a cross-sectional health screening survey.

The prevalence of suitable health indicators will be compared to studies in this area and from the following Norwegians population based studies: the "Tromsø-study", the "HUNT" study and the "NORSE study".

The following articles will be published as part of this project:

1. A feasibility study of the use of tests like the Short Physical Performance Battery.
2. An overview of the health indicators among youths and adults with intellectual disabilities in Norway, in relation to age groups.
3. Presentation of levels and predictors for physical activity, as well as body mass index, in youths and adults with IDs.
4. Presentation of functioning (daily activities and work) in association to levels of physical activity.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of intellectual disability
* Age 16 or older and providing consent to participate.

Exclusion Criteria:

-
Efficacy and Safety of Enteric-Coated Mycophenolate Sodium (EC-MPS) in de Novo Kidney Transplant Recipients

At present, imitation EC-MPS have just come on the market, no clinical studies have confirmed the efficacy and safety of using imitation EC-MPS for immunosuppressive therapy after kidney transplantation. Therefore, there is an urgent need to conduct a multicenter study in China to provide further guidance for the use of imitated mycophenol sodium enteric-coated tablets in kidney transplant patients. Therefore, this study will analyze whether the anti-rejection effect of generic EC-MPS in the treatment of renal transplantation in Chinese population is equivalent to that of the original EC-MPS, in order to provide reference for clinical rational drug use.

Under the premise that tacrolimus is used as basic immunosuppressant, to explore the efficacy and safety of imitation mecophenol sodium enteric-coated tablets (EC-MPS) compared with the original preparation agent (Miv) in Chinese kidney transplant patients.

This study was divided into experimental group and control group. The experimental group was imitation mycophenol sodium enteric-coated tablets, and the control group was original mycophenol sodium enteric-coated tablets. Both groups were treated with the triple immunosuppressive regimen of "Mycopherol sodium enteric-coated tablets (EC-MPS) + tacrolimus (TAC) + glucocorticoid" immediately after transplantation for at least 12 months. Tacrolimus, glucocorticoid and antibody induction can be treated according to the clinical routine diagnosis and treatment path, and no specific restrictions were made in this study

Eligibility Criteria:
Inclusion Criteria:

1. Male and female, aged 18-65;
2. Patients with end-stage renal disease who received live/cadaveric kidney transplantation for the first time;
3. After kidney transplantation, patients were subjected to a routine triple immunosuppressive regimen, namely "mecophenol sodium enteric-coated tablets (EC-MPS) + tacrolimus (TAC) + glucocorticoid" regimen;
4. The patients signed informed consent, were able to follow up regularly and fully collect information related to this study.

Exclusion Criteria:

1. Multi-organ recipients, such as those with heart, lung, liver and other organ transplants;
2. ABO incompatible kidney transplant recipients;
3. HLA antibodies or past/current population reactive antibody level (PRA) \> 25% were preexisting in the recipient before renal transplantation;
4. Allergic to EC-MPS or preparation components (hypersensitivity);
5. Women with fertility potential who are pregnant, lactating or planning to become pregnant;
6. Severe/uncontrolled concomitant infections or other serious medical problems;
7. Active bacterial, viral or fungal infections;
8. Neutropenia (ANC\<1.3×103/µL)
9. Patients judged by the investigator to be unsuitable for inclusion in this study for other reasons.
P3 Study Brodalumab in Treatment of Moderate to Severe Plaque Psoriasis

The purpose of this study is to assess the safety and efficacy of brodalumab at two different doses

.The purpose of this study is to assess the safety and efficacy of brodalumab at two different doses compared with placebo in participants with moderate to severe plaque psoriasis. A second purpose of this study is to assess the safety and efficacy brodalumab at two different doses compared with ustekinumab in participants with moderate to severe plaque psoriasis. A third purpose of this study is to assess the safety and efficacy of 4 maintenance regimens of brodalumab.

Eligibility Criteria:
Inclusion Criteria:

* Subject has had stable moderate to severe plaque psoriasis for at least 6 months
* Subject has involved body surface area (BSA) ≥ 10%, PASI ≥ 12, and sPGA ≥ 3 at screening and at baseline

Exclusion Criteria:

* Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, or other skin conditions at (eg, eczema) that would interfere with study evaluations
* Subject has known history of Crohn's disease
* Subject has any other significant concurrent medical condition or laboratory abnormalities, as defined in the study protocol
* Subject has not stopped using certain psoriasis therapies as defined in the study protocol
* Subject has previously used ustekinumab or any anti-IL-17 biologic therapy
* Subject is pregnant or breastfeeding, or planning to become pregnant while enrolled in the study
* Female subject is unwilling to use highly effective methods of birth control unless 2 years post-menopausal or surgically sterile
A Study to Evaluate the Safety and Efficacy of Humia Inj. in Patients With Symptomatic Osteoarthritis of the Knee

A Multi-Centre, Parallel, Double-Blind, Active comparator, Randomised phase III Clinical Trial


Eligibility Criteria:
Inclusion Criteria:

* Primary knee osteoarthritis confirmed clinically and radiologically according to American College of Rheumatology criteria have joint pain
* Kellgren-Lawrence Grade Ⅰ to Ⅲ confirmed radiologically within 6 months
* Knee pain under weight-bearing pain(100mm-VAS) greater than 40mm
* Able to walk without assistive devices
* Patients willing and able to provide signed informed consent after the nature of the study has been explained

Exclusion criteria:

* Body Mass Index (BMI) \> 32
* History of rheumatoid arthritis or other inflammatory arthritis in knee articular cavity
* Systemic Intravenous Steroid injection within 1 month, intra-articular corticosteroid injection within 3 months or hyaluronate injection within 6 months
* Has clinically severe tense effusion of the target knee diagnosed Positive according to Patella tap test
* Undergo Knee Replacement Surgery of the target knee
Evaluating Refractive and Visual Outcomes With the Alcon Toric ReSTOR +2.5 and +3.0 Models

The study will evaluate visual acuity and visual function with a 'blended' ReSTOR Toric intraocular lens (IOL) implantation after cataract surgery.

The objective is to provide a normative standard for refractive and visual outcomes in eyes with significant corneal astigmatism undergoing cataract surgery with the Alcon Toric ReSTOR lens. Patients will be bilaterally implanted, with the Toric ReSTOR +2.5D model implanted in the dominant eye and the Toric ReSTOR +3.0D model implanted in the non-dominant eye.

Eligibility Criteria:
Inclusion Criteria:

* Subjects are eligible for the study if they meet the following criteria:

Note: Ocular criteria must be met in the eligible eye.

* Bilateral visually-significant cataracts
* Willing and able to provide written informed consent for participation in the study.
* Willing and able to comply with scheduled visits and other study procedures.
* have good ocular health, with no pathology that compromises visual acuity (outside of residual refractive error and cataract)
* Regular corneal astigmatism of 1.00D to 2.50D in both eyes
* Potential postoperative acuity of 20/25 or better

Exclusion Criteria:

* If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.

  * Irregular astigmatism (e.g. keratoconus)
  * Corneal pathology (e.g. opacities, epithelial basement membrane dystrophy (EBMD), Fuch's dystrophy, etc.)
  * Monocular status (e.g. amblyopia)
  * Previous radial keratotomy, corneal refractive surgery or other corneal surgery (e.g. corneal transplant, Descemet Stripping Automated Endothelial Keratoplasty (DSAEK), lamellar keratoplasty)
  * Previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy)
  * Moderate-to-advanced glaucoma
  * Strabismus
  * Use of arcuate incisions for astigmatism management at the time of surgery
  * Diabetic retinopathy
  * Macular pathology (e.g. age-related macular degeneration, epiretinal membrane, etc.)
  * History of retinal detachment
  * Subjects who have an acute or chronic disease or illness that would confound the results of this investigation (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, and any other such disease or illness), that are known to affect postoperative visual acuity.
  * Participation in (or current participation) any investigational drug or device trial within the previous 30 days prior to the start date of this trial.

The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.

Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.
Evaluation of an Organized Consultation "Return Home" of Patients With a Cancer (CREDO)

Prospective, open label, randomized and multicentric study evaluating the efficacy of an organized consultation "return home" compared to a current standard of care in patient hospitalized due to metastatic solid tumor cancer.

Subject will be randomized (1:1) as described below :

• Arm A (standard) : current standard of care ; connection documentation faxed to GP ( General practitioner) on the day of patient's discharge Arm B (experimental) : CREDO standard of care, organized consultation "return home" between patient, GP DESC (diploma of complementary specialized study) and patient's referent GP


Eligibility Criteria:
Inclusion Criteria:

1. Age \> or = 18 years old
2. Subject hospitalized in an oncology dedicated center for administration of the first chemotherapy cycle.
3. Subject with metastatic solid tumor whatever the organ
4. subject planned to be discharged home after chemotherapy administration
5. Affiliated to the French social security system.
6. Subjects must provide written informed consent prior to any study-specific procedure or assessment

Exclusion Criteria:

1. Subject included in another trial evaluating the pathways care
2. Pregnant or breastfeedings women
3. Subject law protected
Cognitive and Brain Development in Adolescents With Gilles de la Tourette Syndrome

In children with neurodevelopmental disorders, adolescence is usually associated with a reshaping of the clinical picture and symptomatology. Tourette syndrome (TS) is a paradigmal neurodevelopmental syndrome characterised by involuntary paroxysmal movements (motor tics) and vocalisation (vocal tics) often associated with various psychiatric disorders. The neuronal and cognitive mechanisms associated with TS symptoms improvement during adolescence, or the persistence in adulthood remains unknown, and this is what we aim to address in this study.

Thus, the aims of the present project is threefold:

Aim 1: To evaluate the maturation of cognitive functions in adolescents with TS compared to typically developing adolescents.

To achieve this aim, three distinct cognitive dimensions will be assessed in all subjects (patients and controls): (i) reward sensitivity and habit formation; (ii) cognitive impulsivity and action control and (iii) self-agency.

Aim 2: To identify neuronal correlates of cognitive function and brain development in health and disease. To achieve this aim, we will use a combined behavioural (as described in Aim 1), (i) neuroimaging and (ii) TMS approaches.

Aim 3: To predict clinical outcome . In this part of the project we aim to identify behavioural, imaging or neurophysiological markers of clinical outcome in patients with TS.

Eligibility Criteria:
Inclusion Criteria:

* Tourette syndrome
* Ages 13 - 18
* Acceptance to perform the Brain MRI
* Acceptance to perform the cognitive testing
* Acceptance to perform the TMS measures

Exclusion Criteria:

* Learning disability
* Incompatibility with MRI procedure (metal body implants, pregnancy)
Efficacy of Topical Treatment With Clobetasol in Symptomatic Oral Lichen Planus.

The investigators want to study the effect of clobetasol in symptomatic oral lichen planus. The investigators will include 90 patients and randomly allocate them in three groups. The first group will receive active treatment both in the morning an evening. Group two receives placebo in the morning and active treatment in the evening. Group three will get placebo both in the morning and in the evening. All Groups will follow the same protocol with rinsing twice daily with test substance in conjunction with antifungal treatment. The patients will be controlled after two weeks and and again after another two weeks. A biopsy will be performed at inclusion and another biopsy will be taken at the end of the test period. Smears for candida will also be evaluated. The patients will be examined for changes in clinical appearance and will answer questions to note changes in symptoms. Our hypotheses: #Patients receiving clobetasol will have a better resolution af symptoms than those who got placebo. #Patients treated with clobetasol twice daily will have a faster relief of symptoms than patients just treated once daily. #The clinical signs of oral lichen planus will diminish more pronounced in the two groups given active treatment. #A majority of the OLP lesions were infected by candida. #Specific histological changes can be seen in the biopsies taken after clobetasol treatment compared to those taken before treatment.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic oral lichen planus
* Age above 40 years

Exclusion Criteria:

* Lichenoid contact lesions
* Graft versus host disease
* Bacteria related lichenoid reaction
* Intraoral vesiculobullous diseases
* Active antibiotic treatment
* Active treatment with steroids or other immunomodulating substance
* Allergy to Clobetasol
* Severe periodontitis
* Bad oral hygiene
* Biopsy not supporting OLP
* Allergy to nystatin
* Not in menopause
* Previous or actual oral malignancy
* Participation in other medical study
Virtual Reality in Awake Surgery : Pilot Study VIRAS

The virtual reality mask is a tool likely to improve the conditions for performing awake surgery:

* by improving tolerance for the patient,
* by improving ergonomics in the operating room.

In order to control the risks as well as possible, the investigators propose to test the equipment on patients who will undergo orthopedic surgery under local anesthesia at the hospital of Brest: the patients operated in orthopedics under local anesthesia are immobile during the procedure. This target population will allow an immersion of the equipment in the operating room, with an awake patient, during a short time (on average 1 hour of intervention) and for a technically light interventional procedure.


Eligibility Criteria:
Inclusion Criteria :

* Major subject
* Consent for the study
* Patients eligible for orthopedic surgery with local anesthetic block
* Estimated duration of the Orthopedic surgery of minimum 1 hour

Exclusion Criteria :

* Age \< 18 years, Age \> 75 years,
* Known central neurological pathology/cognitive impairment,
* Mini-Mental State examination (MMSe) \< 23 if no school certificate, \< 27 if school certificate,
* History of vertigo,
* Claustrophobia,
* Visual deficit not compatible with the use of the virtual reality mask,
* Contraindication to surgery,
* Outpatient treatment,
* Refusal or inability to consent.
Duloxetine for Postoperative Pain of Laparoscopic Cholecystectomy

Recent studies on the impact of perioperative duloxetine for treatment of acute postoperative pain have yielded positive outcomes with respect to reduction opioid consumption. The aim of the present study is to investigate the role of perioperative duloxetine on the management of postoperative pain in patients undergoing LC.


Eligibility Criteria:
Inclusion Criteria:

* 1. Patients who are scheduled to undergo elective LC

Exclusion Criteria:

1- Patients with acute pancreatitis 2. Patients undergoing chronic pain treatment 3. Patients who received analgesics or sedatives 24 h before scheduled surgery 3. Patients had alcohol or drug addiction 4. Severe hepatic and renal dysfunction 5. Previous allergic response to duloxetine 6. Pregnancy and lactation 7. Patients with communication problems, cognitive dysfunction, or psychological disorders
Re-Evaluation of Systemic Early Neuromuscular Blockade and Transthoracic Ultrasound Assessment of the Diaphragm

ROSETTA is a multi-centre study evaluating the time course of diaphragm thickness and function following exposure to neuromuscular blockade or control in patients with acute respiratory distress. ROSETTA is an ancillary study to the Re-evaluation of Systemic Early Neuromuscular Blockade (ROSE) trial (NCT02509078). It is designed to (1) test the feasibility of a multi-center evaluation of the diaphragm structure and function by ultrasound during mechanical ventilation and (2) determine whether neuromuscular blockade accelerates atrophy and dysfunction of the diaphragm in patients with acute respiratory distress syndrome (ARDS).

A growing body of evidence strongly suggests that mechanical ventilation injures the respiratory muscles, particularly the diaphragm. Due to the deleterious effects of diaphragm inactivity on diaphragm function, there are important concerns about the risk of diaphragm weakness and difficult liberation from mechanical ventilation following neuromuscular blockade. Sonographic measurements of diaphragm thickness provide a potentially useful window for studying diaphragm injury and function during mechanical ventilation.

Patients enrolled in the ROSE trial (randomizing patients with moderate-severe acute respiratory distress syndrome to receive neuromuscular blockade or control for 2 days) will be eligible for participation in this study. Study patients will undergo regular diaphragm ultrasound to assess diaphragm thickness and activity during the first week of the study. Diaphragm function will be assessed by ultrasound on study days 7, 14, 21, and 28.

ROSETTA is designed to:

1. Test the feasibility of a multi-center evaluation of the diaphragm structure and function by ultrasound during mechanical ventilation;
2. Determine whether neuromuscular blockade accelerates atrophy and dysfunction of the diaphragm in patients with acute respiratory distress syndrome; and
3. Evaluate whether patients with greater diaphragm dysfunction exhibit worse functional outcomes compared to patients without diaphragm dysfunction.

Eligibility Criteria:
Inclusion Criteria:

1. Patients enrolled in the ROSE PETAL trial (adult patients with moderate-severe acute respiratory distress syndrome who have received invasive mechanical ventilation for less than 5 days)

Exclusion Criteria:

1. Patients expected to be extubated within 24 hours of screening for eligibility
2. Patients with a contraindication to chest ultrasonography (chest tubes inserted over right lower chest wall; chest wall trauma)