cyrilzakka/clinical-trials huggingface dataset:
Chronic Non-inflammatory Pains in Rheumatopediatrics

The purpose of this study is to determine the frequency of chronic pain in adolescent with juvenile idiopathic arthritis, especially when the disease is inactive or with minimal activity.

Secondary objectives are, first to determine intensity of pain and its repercussion in daily life and second to determine risk factor of chronic pain.

Juvenile idiopathic arthritis is the most frequent pathology in paediatric rheumatology clinic. Pain is an important symptom in paediatric rheumatology. It is actually poorly studied and is not evaluate in disease activity score like the Juvenile Arthritis Disease Activity Score (JADAS). It is source of handicap, social and psychological distress and greatly contribute to poor quality of life. Chronic pain is frequently multifactorial, even in inflammatory disease. In adult population, rheumatologists have shown an association between inflammatory disease like spondylarthritis or rheumatology polyarthritis and fibromyalgia.

There is no specific data on chronic pain in juvenile idiopathic arthritis. Pain is mostly evaluated by the Visual Analogue Scale (VAS) with no evaluation of pain repercussion on daily life or its chronicity. This study's primary objective is to determine the frequency of chronic pain and its relationship with disease activity. Secondaries objectives are to determine repercussion of pain in daily life, and risk factor of chronic pain.

To responded to this objective, we will conduct a transversal study in a paediatric rheumatology refence centre in Necker-Enfants malades Hospital. We will include all patients between 12 and 18 years old followed in our centre for any type of juvenile idiopathic arthritis.

Patients will be evaluated as usual by their paediatrics rheumatologist during a follow-up consultation or hospitalisation with the used of the clinical JADAS. Patient accepting to participate the study will be given a paper questionnaire evaluating chronic pain, its repercussion, anxiety (by the used of the Revised Children's Manifest Anxiety Scale (RCMAS score)), depression (by the used of the Children's Depression Inventory (CDI score)), Sleepiness (by the used of the Pediatric Daytime Sleepiness Scale (PDSS score)) and quality of life (by the used of the measurement model for the Pediatric Quality of Life inventory (PedQL score)).

Eligibility Criteria:
Inclusion Criteria:

* Child from 12 to 17 years old
* Follow-up to Necker Hospital by a rheumatologist at the reference center for juvenile idiopathic arthritis (RAISE), regardless of the form
* Not opposed to participating in the study

Exclusion Criteria:

No exclusion criteria
Preventing Burnout Among Caregivers Through Physical Activity

The purpose of this study is to evaluate the impact of an adaptive physical activity programme to prevent the risk of burnout at the end of the programme (10 weeks after the start of the intervention).

The PACA trial is a pilot, prospective, comparative, randomised (2 arms), controlled, single-centre study.

The study population consisted of adult healthcare professionals at the Clinique de la Sauvegarde with a low to moderate level of physical activity and no contraindications to physical activity.

Participants will be randomised into two arms (ratio 1:1):

* Arm A (intervention): Participants will benefit from an adaptive physical activity programme supervised by a physical activity professional over a 9-week period.
* Arm B (control): Participants will receive the recommendations of the world health organisation for physical activity.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years ;
* Non-physician health professionals at the Clinique de la Sauvegarde ;
* Low or moderate level of physical activity, as assessed by the questionnaire International Physical Activity Questionnaire. In fact, work-related physical activity is not associated with a reduction in burnout ;
* Absence of serious chronic pathology incompatible with the physical activity of the protocol ;
* Willing and available to commit to the project for the duration of the study ;
* Using a personal smartphone or tablet and with an Internet connection ;
* Able to read, write and understand French ;
* Membership of a social security scheme.

Exclusion Criteria:

* High level of physical activity (not including work-related physical activity) ;
* Contraindication to physical activity (uncontrolled hypertension, uncontrolled heart disease...) ;
* Concurrent participation in another physical activity study ;
* Pregnant or likely to be pregnant ;
* Unable to be monitored for medical, social, family, geographical or psychological reasons for the duration of the study ;
* Persons deprived of their liberty by judicial or adm inistrative decision, or adults protected by law.
Safety and Efficacy of OSTEOFORM (rhPTH [1-34]) in Increasing Bone Mineral Density in Osteoporosis

OSTEOFORM, containing recombinant (rhPTH \[1-34\]), enhances bone mineral density and reduces risk for vertebral fracture. This study evaluates the safety and efficacy of OSTEOFORM in the treatment of osteoporosis in post-menopausal women.

207 post-menopausal women were enrolled for screening at 6 centres, and supplemented with daily 1000 mg elemental calcium and 500 IU of vitamin D for 45 days. 82 eligible women with osteoporosis were randomly received daily either calcium and vitamin D alone (control group) or Osteoform 20 µg subcutaneously with calcium and vitamin D (drug group) for 12 months. End points such as percentage of increase in bone mineral density and, changes in bone biomarkers (serum osteocalcin, bone specific alkaline phosphatase, and urinary DPD) were evaluated at baseline, and 6 and 12 months after supplementation. Besides, safety parameters and adverse events were monitored through out the study period.

Eligibility Criteria:
Inclusion Criteria:

Postmenopausal women with osteoporosis (Lumbar spine or femoral neck BMD or total hip T-score less than or equal to-2.5)

Exclusion Criteria:

1. Women with vertebral (L1-L4) abnormalities that preclude accurate measurement by DEXA.
2. Women on medications that are known to affect bone for more than 7 days in the past 6 months.
3. Currently taking systemic prednisone, inhaled steroids, anticoagulants, anticonvulsants.
4. History of rhPTH use or known hypersensitivity to study drug.
5. Vitamin D3 deficiency (Vitamin D3 \< 20 ng/ml).
6. Abnormal thyroid function.
7. History of kidney disease.
8. Any history of hypercalciuria, hypercalcemia or hyperparathyroidism.
9. History of active or treated tuberculosis or significant liver disease or gastrointestinal disease or cancer.
Assessment of a Vaginal Ring With Meloxicam in the Treatment of Dysmenorrhea

The investigators propose that the sustained administration of a vaginal ring would have a better response with respect to pain and a better safety profile than the oral administration of a non-steroidal anti-inflammatory drug.

To assess the relief of the symptoms associated with dysmenorrhea, a specific survey was elaborated that also includes a Visual Analog Scale (VAS) to objectify and measure dysmenorrhea as is the case with McGill's Pain Questionnaire (MPQ).


Eligibility Criteria:
Inclusion Criteria:

* Regular menstrual cycles on previous 3 months (24-35 days),
* Primary dysmenorrhea on 3 previous months,
* With tubal ligation or users of condom for contraception,
* Hemoglobin of at least 11 g/dl,
* Safety blood analysis in normal levels

Exclusion Criteria:

* Secondary dysmenorrhea,
* Users of hormonal contraceptives (2 months prior to the study) or intrauterine devices (IUDs) (1 month prior the study).
* Allergy to any anti-inflammatory drug including meloxicam or diclofenac.
* Allergy to silicon.
* Pregnant or in lactation.
* Women with untreated or decompensated endocrine disorders
Neural and Antidepressant Effects of Propofol

This study will compare the antidepressant effects of propofol at two different doses while measuring potential treatment-related biomarkers.

Aim 1: Compare the clinical antidepressant effects of high-dose versus low-dose propofol.

Aim 2: Characterize the dose-dependent effects of propofol on brain function and gene expression

Eligibility Criteria:
Inclusion Criteria:

Age 18-55 years Diagnosis of major depressive disorder or bipolar disorder Current moderate-to-severe depressive episode Episode duration more than 2 months and less than 5 years Failure of at least 2 adequate antidepressant medication trials within the past 2 years 16-item Quick Inventory of Depressive Symptomatology, self-rated (QIDS) \> 10 24-item Hamilton Depression Rating Scale (HDRS) \> 18

Exclusion Criteria:

Contraindication to propofol, egg lecithin, soybean oil, or other study drugs Lifetime history of a serious suicide attempt(Gvion and Levi-Belz, 2018) Recent suicidal behavior(past 3 months) Body mass index \> 40 kg/m2 Daily use of benzodiazepine, opioid, ACE inhibitor, or ARB medication Symptomatic coronary artery disease or heart failure Poorly controlled hypertension or diabetes Abnormal kidney or liver function Pregnant or breast feeding Traumatic brain injury or significant neurologic signs (past year) Substance use disorder, moderate-to-severe(past 3 months) Obsessive compulsive disorder (past month) Post-traumatic stress disorder (past month) Schizophrenia-spectrum disorder (lifetime) Neurocognitive disorder (past year) Personality disorder as a current focus of treatment ECT within the past 3months Inappropriate for ECT, or poor response to ECT within the past 5 years Incompetent to provide consent
Impact of Mode of Anesthesia on Ischemia Modified Albumin in Patients With Traumatic Brain Injury

In the current study the investigators intend to evaluate the mode of anesthesia on ischemia modified albumin and outcome in patients with traumatic brain injury undergoing emergency craniotomy

After obtaining Institutional Ethical Committee approval and written informed consent from legally acceptable representative relatives, patients with traumatic brain injury, aged from 18- 60 years old, ASA from (I-III), GCS more than 8 undergoing emergency craniotomy surgery will be selected for this prospective randomized Study.

The anesthesia will be induced with 2mcg/kg fentanyl and 2 mg/kg propofol. Muscle relaxation will be achieved with 0.5 mg/kg atracurium.

Anesthesia will be maintained with:

* Group I, isoflurane (mac\<1) mixed with oxygen 40% and fentanyl 1mcg/kg hourly.
* Group PD, propofol infusion(100-150mcg/kg/min) and dexmedetomedine 0.3mcg/kg /h.

Parameters will be assessed Preoperative period

* Ischemia modified albumin level from venous sample.
* Basal Systolic blood pressure, diastolic blood pressure. Mean arterial blood pressure, oxygen saturation, heart rate.
* GCS. Intraoperative period
* Systolic blood pressure, diastolic blood pressure. Mean arterial blood pressure, oxygen saturation, heart rate after intubation, 5,15,30,60,90min and after extubation.
* Need for resuscitation with vasoactive drugs.
* Brain relaxation score at dural opening and closure.
* ICP
* Intraoperative blood loss.
* Amount of fluid and blood transfusion. Postoperative period
* Ischemia modified albumin immediately postoperatively, after 6h and after 24 hours.
* Type of surgery.
* Duration of surgery.
* Extubation time.
* Recovery scores (Ramsay sedation score and modified Alderte score).
* GCS immediately postoperatively, after 6h, after 24h and after 48 hours.
* Total analgesic requirement during the first 24 hours.
* Need for ICU admission.
* Length of ICU stay.
* Complications.
* 28 day mortality.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-60 years old of both sex .
2. Isolated traumatic brain injury undergoing emergency craniotomy.
3. G.C.S more than 8.
4. ASA grade (I-III).

Exclusion Criteria:

1. Non traumatic brain injury.
2. Poly trauma patient.
3. Coagulation disorder.
4. Drug( alcohol, opiods, tranquilizers) addiction.
5. Liver and kidney dysfunction.
6. Severe diseases such as severe hypertension, cardiovascular disease, malignant tumor, autoimmune disease, mental disorders.
7. Diabetes mellitus with poor blood glucose control.
8. Previous drug allergy.
9. Currently lactating.
Cancer Survival in Reunion Island , 1998-2008 (SUCRE)

Cancer survival is important to determine prognostic of patients and evaluate care and prevention health strategies. Sucre is the first study to describe cancer survival in Reunion Island. Sucre aims at evaluating five year cancer prognostic in Reunion Island by cancer site and gender. Sucre is a retrospective cohort study of cancer diagnosed between 01/01/1998 and 31/12/2008.

Data are extracted from Reunion Island Cancer Registry.

Eligibility Criteria:
Inclusion Criteria:

* Patients domiciled in Reunion Island at diagnosis
* Patients with at least 15 years of age at diagnosis
* Patients with cancer diagnosis between 01/01/1998 and 31/12/2008

Exclusion Criteria:

* Cutaneous malignant cancer expected melanoma
Evaluation The Effect of NB-UVB and Methotrexate on The Level of Serum Gelsolin in Psoriatic Patients

Psoriasis is a common chronic, immune-mediated, skin disease with a significantly negative impact on patients' quality of life. It is one of papulosquamous diseases defined by erythematous plaques with silvery scales.

The interplay among cytokines released by dendritic, Th1, Th2, and Th17 cells leads to the clinical manifestations seen in psoriasis. Although discovering novel biomarkers for psoriasis is challenging step., it may play an essential role in diagnosis, severity assessment and prediction of treatment outcome and prognosis of the disease

The protein expression of gelsolin- which is an actin scavenger controlling cytoskeletal remodeling, cell morphology, differentiation, movement, and apoptosis- has been found to be significantly decreased in several pathological conditions including neurodegenerative diseases, inflammatory disorders, and cancers.

Gelsolin (GSN) is a member of the GSN protein family, the main function of it is to cut and seal actin filaments to regulate the cytoskeleton and participate in a variety of biological functions.

Low serum gelsolin levels are linked to the severity of psoriasis, suggesting that gelsolin may help in assessing the severity of the disease and how it responds to treatment.

Methotrexate (MTX) is the first-choice drug when phototherapy or retinoid treatment are not effective in psoriatic patients.

It is a cytotoxic drug with powerful anti-proliferative and anti-inflammatory effects that has gained prominence in treating inflammatory diseases one of them is psoriasis.

Narrowband (NB) UVB phototherapy is a common line of treatment in psoriasis. It was proven to be more effective than broadband UVB and safer and/or more practicable than psoralen_UVA in treatment of psoriasis

Eligibility Criteria:
Inclusion Criteria:

* Patients with moderate to severe plaque psoriasis.
* No restriction of age, race nor occupation.

Exclusion Criteria:

* History of psoriasis treatment with systemic and biological agents prior to the study for at least 3 months.
* Pregnancy and lactation.
* Infections.
* Patients with chronic diseases: hepatic disorders, hematologic diseases, chronic renal failure or cancer.
Reconfiguring the Patient Room to Increase Patient Stability

Despite decades of research into patient falls, falls and the injuries incurred continue to be a serious threat to patient safety. Fall rates continue to be unacceptably high. The purpose of this project is to increase the safety of a hospital room for patient mobility, using innovative simulation strategies and patient-centric design.

Despite decades of research into patient falls, falls and the injuries incurred continue to be a serious threat to patient safety. Fall rates continue to be unacceptably high. The purpose of this project is to increase the safety of a hospital room for patient mobility, using innovative simulation strategies and patient-centric design.

An innovative simulation environment will be built to enable rapid assessment of room layout and fixture positioning and patient stability. The results from multiple simulations will be used to fabricate a prototype room layout that will be tested by patients with Parkinson disease and reviewed and updated with input from other relevant stakeholders. A final room prototype will be built and tested. Results will be translated and shared with all stakeholders and disseminated for implementation.

Eligibility Criteria:
Inclusion Criteria:

* Frail elderly, impaired gait

Exclusion Criteria:

* Use of walking aid
Sperm DNA Fragmentation Effects on Blastocyst Morphology Grading, Pregnancy Rate and Implantation Rate

Retrospective cohort study for 189 couples assigned to normal and abnormal Sperm DNA fragmentation (SDF) groups.To determine the effect of SDF on blastocyst's trophectoderm (TE), Inner cell mass (ICM) morphology grading, and implantation rate. Semen in both groups was processed by density gradient (DG).

Purpose: to determine if sperm DNA fragmentation (SDF) has a correlation with Blastocyst's trophectoderm (TE) and Inner cell mass (ICM) grading, or with the implantation rate?

Method: Retrospective cohort study for 189 couples, assigned to normal SDF group (121 cases), and abnormal SDF group (68 cases). Semen in both groups was processed by double layer density gradient (DG).

Statistical analysis done using SPSS version 22.

Eligibility Criteria:
Inclusion Criteria:

* All cases in this study have to reach the blastocyst stage.
* Female age ≤37 years old.
* Male sperm count ≥ 5 million.

Exclusion Criteria:

* Usage of sperm selection techniques.
* Testicular aspiration or testicular biopsies.
* Oocyte or sperm donation.
Bridging Animal and Human Models of Exercise-induced Visual Rehabilitation

This study will determine whether blood biomarker changes predict sight-saving benefits of exercise.

Investigators of the Atlanta VA Center for Visual and Neurocognitive Rehabilitation (CVNR) find a very high prevalence of blinding diseases in the aging Veteran population. There are few treatments for the disorders that threaten our Veterans' eyesight. The work proposed here is the first step in determining whether exercise can be used by aging Veterans as an inexpensive and self-controlled therapy for vision loss. In order to translate exercise therapy for vision into the clinic, the investigators need to identify biomarkers that can be used to predict visual benefits.

Though human and animal studies show that aerobic exercise is beneficial to specific central and peripheral nervous system functions, effects on the retina and vision were unknown until the investigators recently discovered that treadmill exercise directly protects retinal neurons in mice undergoing light-induced retinal degeneration (LIRD). The investigators found that exercise increased levels of brain-derived neurotrophic factor (BDNF) a blood protein in the blood, brain and eyes, whereas treatment of mice with a BDNF inhibitor prevented the protective effects of exercise.

For this study, the investigators will assess visual outcomes and serum biomarkers (e.g, BDNF) in 60 subjects age 18-89 before, during, and after aerobic exercise. Subjects currently enrolled in a 12-week study (under Institutional Review Board (IRB) 56726) examining the effects of aerobic exercise on cognition will have visual testing (ERG, visual acuity, contrast sensitivity, and OCT) and blood collection prior to, during and after the standardized 12-week aerobic exercise regimen to determine whether circulating biomarker levels and visual outcomes are correlated and whether biomarker levels are altered as predicted in animal studies.

This study will determine whether biomarker changes predict sight-saving benefits of exercise. As opposed to surgery or pharmacological treatments, exercise programs provide a means for Veterans to exert some control over their visual disease progression and will increase their overall health.

Eligibility Criteria:
Inclusion Criteria:

* English speaking
* Aged 18 to 89
* Sedentary as defined by \< 120 min/week of aerobic exercise over prior 3 months
* Non-demented (MMSE 24)

Exclusion Criteria:

* Severe diabetes requiring insulin
* Cognitive-executive function deficit (MoCA \< 26)
Storytelling With or Without Social Contextual Information in Children With Autistic Spectrum Disorder and Typical Development

This study was to examine the effects of storytelling with or without contextual information on children with autism spectrum disorder (ASD) and typical development (TD).

This was a 2 x 2 x 2 randomized controlled trial with 52 children (26 with ASD and 26 with TD) recruited in the community and randomized into four groups: 1) ASD Group 1 - storytelling with contextual information; 2) ASD Group 2 - storytelling without contextual information; 3) TD Group 1 - storytelling with contextual information; 4) TD Group 2 - storytelling without contextual information. All stories were photo-based and static in nature. The only difference between Group 1 and Group 2 was that the stories included and did not include social contextual information, respectively. Training was delivered in small groups, with eight sessions across four weeks, two sessions per week, and 30 minutes per session. Participants' total fixation duration (TFD), total visit duration (TVD), and total fixation count (TFC) on human faces from 20 photos and a video were recorded using the Tobii eye tracker.

Eligibility Criteria:
Inclusion Criteria for children with ASD:

* 1) children aged between 6 and 12 years old;
* 2) had a previous diagnosis of ASD from medical professionals;
* 3) studied in mainstream primary school;
* 4) had a composite IQ score of 80 or above

Inclusion Criteria for children with TD:

* 1) children aged between 6 and 12 years old;
* 2) had no developmental disorder or intellectual disability;
* 3) attended primary school.

Exclusion Criteria:

* NA
The Epidemiology of Ventricular Assist Device-Related Infections

Infections often occur after ventricular assist devices (VADs) are placed. These infections can be very serious. The goal of this study is to understand why these infections occur. Bacteria (germs) normally live on our skin and in our noses. After surgery, they can infect the VAD. The investigators will collect cultures of your skin and nose before and after surgery. The investigators will compare these bacteria to bacteria that cause infections. Their genes will be compared to see which ones help the bacteria cause infection.

Infections are one of the most serious of ventricular assist device (VAD) related complications. Many of these infections are associated with significant patient morbidity and mortality. Diagnosis of these infections is often difficult due to the complicated nature of the patient's medical problems, the need for rapid institution of empiric antibiotic therapy and the lack of established criteria that define infection. Staphylococci are among the most common causes of VAD infections. The basis for this high incidence is not well understood but is believed to be in part due to inoculation of staphylococcal commensal flora into wound sites at the time of surgery or thereafter. The goals of this observational study are to develop a better understanding of the pathogenesis and epidemiology of Staphylococcus aureus and epidermidis-VAD infections as well as to develop a set of criteria that can be used to help diagnose the presence or absence of a VAD related infection.

This is a prospective, multi-center, observational study to identify risk factors associated with the development of VAD-related infections. Patients will be followed for up to one year following VAD implantation, time of death or transplantation, whichever comes first. There will be no randomization for this observational study.

Eligibility Criteria:
Inclusion Criteria:

1. Age greater than or equal to 18 years.
2. Approved by the institution's heart failure/transplant committee for VAD implantation, either as a bridge to cardiac transplantation or for destination therapy for end-stage heart failure.
3. Signed informed consent, release of medical information, and HIPAA forms.
4. Expectation of compliance with protocol procedures and study visit schedule.