cyrilzakka/clinical-trials huggingface dataset:
Changes in the Immunomodulatory Properties of Adipose Stromal Cells Due to Hemarthrosis After Knee Injury

The goal of this observational study is to gain insight in the natural course of pro-inflammatory factors and hemarthrosis in patients older than 18 with a recent knee trauma. The main question\[s\] it aims to answer are:

* What is the natural course of pro-inflammatory factors and hemarthrosis in knee trauma?
* What are the effects of inflammation and hemarthrosis on the anti-inflammatory potential of ASC's in order to better determine eligible patients and circumstances for ASC's therapy?

Participants will:

* undergo blood withdrawal
* undergo knee arthrocentesis for synovial fluid sample collection
* physical examination
* fill out a questionnaire on knee complaints

Recent studies have found an amelioration of post-traumatic osteoarthritis by the use of adipose-derived stromal cells (ASC's) in an experimental animal model. This amelioration was only seen under inflammatory conditions. The presence of hemarthrosis has not been taken into account in the before mentioned animal model, and might have cytotoxic effects on ASC's and aggravate the inflammatory response. The objective of this study is to gain insight in the natural course of pro-inflammatory factors and hemarthrosis and its effects on the anti-inflammatory potential of ASC's in order to better determine eligible patients and circumstances for ASC's therapy.

Therefore the investigators designed a pilot study with exploratory analyses in and with synovial fluid in a longitudinal cohort.

Our study population will consist of 20 patients, older than 18 years, who sustained a recent knee trauma and are presented to the emergency department.The investigators will gather synovial fluid and blood samples for laboratory analysis perform and physical examination and provide questionnaires for clinical follow-up.

The main study endpoint are the anti-inflammatory capacities of ASC's in synovial fluid that contains blood as a result of hemarthrosis after knee injury.

Eligibility Criteria:
Inclusion Criteria:

* Recently suffered an injury of the index knee (rotational or hyperextension)
* A swollen joint
* Inability to mobilise

Exclusion Criteria:

* Patients with an active inflammatory or infectious comorbid disease (including rheumatic diseases)
* Patients using systemic immunosuppressant medication
* Patients with a contra-indication for undergoing a MRI-scan (non-compatible implants or claustrophobia for example)
* Patients with knee prosthesis
* Patients with coagulation disorders
* Patients with a history of a cruciate ligament or meniscal injury of the index knee
* Patients with a tibiofemoral fracture of the index knee due to current distortion
* In case the inclusion of the required amount of patient is reached in one the patient groups, additional patients belonging in the same patient group will not be included in the study
Alterations of Functional Activities and Leg Stiffness After Hamstring Lengthening in Cerebral Palsy Children

Cerebral palsy (CP) is the most prevalent physical disabilities originating in childhood. Crouch gait is a common gait abnormality in patients with cerebral palsy, which is common treated with hamstring lengthening. This surgery can alter mechanical property of lower limb and affected ability of generating force in hamstring, leading changes in functional activities. Therefore, the first aim of this study is to investigate the effects of hamstring lengthening on pelvis and hip control while performing functional activity, including level walking and sit-to-stand.

Cerebral palsy (CP) is the most prevalent physical disabilities originating in childhood. Crouch gait is a common gait abnormality in patients with cerebral palsy, which is common treated with hamstring lengthening. This surgery can alter mechanical property of lower limb and affected ability of generating force in hamstring, leading changes in functional activities. Therefore, the first aim of this study is to investigate the effects of hamstring lengthening on pelvis and hip control while performing functional activity, including level walking and sit-to-stand.

Gait or motion analysis has been used widely in the diagnosis of patients with locomotor pathology and the subsequent planning and assessment of treatment. Ten subjects diagnosed with spastic diplegic cerebral palsy and crouch gait will be recruited and ten healthy controls will be recruited in this study with inform consents. Detailed physical examination and motion analysis experiments will be performed in normal group and in spastic diplegic patients before the hamstring lengthening and follow ip after six months. The subjects would be asked to perform level walking with self-selected pace and sit-to-stand from an armless chair. For each test, subjects would repeat at least 5 times, with their kinematic, kinetic and EMG data collected simultaneously. With thorough analysis and comparison of these data, it is hoped that a reference in clinical decision of hamstring lengthening can be established, and a complete knowledge of the effects after hamstring lengthening, which will be helpful for future clinical rehabilitation.

Eligibility Criteria:
Inclusion Criteria:

* cerebral palsy
* couch gait

Exclusion Criteria:

-
Physiological Responses to Maximal 4-s Sprint Interval Cycling

The optimal recovery duration depends on the intensity of exercise and in the present study the intensity was maximal power for 4-s while cycling an 'Inertial Load' ergometer (ILE). Recovery duration of 15, 30 and 45-s were given between 30 successive sprints.

All subjects completed an informed consent for this study that was approved by the Institutional Review Board of the University of Texas at Austin.

Study Overview. A randomized, cross-over experimental design was conducted. Each participant visited the laboratory on four occasions which were separated by two to five days. Measurement of body mass, familiarization with experimental procedures and cycling peak oxygen consumption test (VO2peak) were performed on the first visit. Participants took part in inertial-load exercise (ILE) on the remaining test days. On each separate session, a different inter-sprint recovery duration was employed (i.e. 15, 30 or 45-s). Cycling power output, pulmonary gas exchange, vastus lateralis de-oxygenation status, heart rate and blood lactate were measured.

Eligibility Criteria:
Inclusion Criteria:

* healthy participants

Exclusion Criteria:

* unhealthy
ECALMIST Versus InSurE in Preterm Infant < 32 Weeks,Multicenter, Multinational RCT

Minimally invasive surfactant therapy via a small vascular catheter - ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant Therapy) versus InSurE (Intubate, Surfactant Extubate) in preterm infants with Respiratory Distress Syndrome (RDS): A prospective randomized clinical trial.

After meeting all the inclusion criteria, eligible infants will be randomized to receive surfactant either through the ECALMIST or the InSurE methods. The attending neonatologist or neonatal team will have full discretion to decide when to intubate and when to extubate or wean the infant off the ventilator or NCPAP.

General guidelines for reintubation include persistent pH\<7.20, PaCO2 \> 65 mmHg, very frequent apnea (\>2-3/hour of apneic or bradycardic spells not responsive to corrective therapy), frequent desaturations \>3/hour not responding to increase in FiO2 or increase in FiO2 to 100%), or apneas requiring prolonged PPV. For the purpose of the study a successful outcome for the primary objective will have occurred if the infant has not been reintubated and ventilated during the initial 3 days of life.

Eligibility Criteria:
Inclusion Criteria:

All should apply:

* Newborn less than 32 weeks gestation at birth
* Postnatal age \< 24 hrs of life
* Clinical diagnosis of RDS
* Spontaneously breathing on NCPAP
* Clinical decision to give surfactant.

Exclusion Criteria:

* Lack of parental consent.
* Need for mechanical ventilation
* Major congenital malformation
Fecal Calprotectin in Cystic Fibrosis

Elevated fecal calprotectin is a biomarker for intestinal inflammation in cystic fibrosis


Eligibility Criteria:
Inclusion Criteria:

* All patients

Exclusion Criteria:

* Informed consent/assent not obtained
Effect of Curcumin on Iron Metabolism in Healthy Volunteer

The purpose of this study is to determine the impact of curcumin, administrated orally, on iron metabolism in healthy volunteers. Iron metabolism will be describe by hepcidin expression that the investigators observed in vitro and serum hepcidin levels.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index between 18 et 25 Kg/m²
* Non smoker
* No swallowing disorders
* Normal clinical exam
* Normal ECG
* Normal values for routine biological tests : serum iron, transferrin saturation,, hemogram ferritin, C Reactive Protein, AST, ALT, HDL and LDL cholesterol, triglycerides
* No C282Y mutation within the HFE gene
* Affiliation to social security
* Written informed consent obtained

Exclusion Criteria:

* Chronic or evolutive disease
* Infection during the 7 days before each sequence
* Drug or alcohol (\>30g) abuse
* Current treatment
* Known food allergy
* stay at altitude (\> 1500m) in 2 months
* Positive serology for hepatitis B or C virus or HIV.
* Transfusion or blood donation during the last three months.
* Exclusion period on the healthy volunteer National File.
Efficacy of Pantoprazole 20/40 mg Once Daily (od) in Patients Older Than 12 Years Who Have Gastrointestinal Symptoms of Reflux Disease

The aim of this study was to evaluate the effect of 14 days treatment with Pantoprazole 40 mg and 20 mg on gastroesophageal reflux disease (GERD) related symptoms in a large patient population.


Eligibility Criteria:
Main inclusion criteria:

* Outpatients with gastroesophageal reflux disease (GERD)

Main exclusion criteria:

* Criteria as defined in the Summary of Product Characteristics
Clinical Trial on Personalized Neoantigen Vaccine for Pancreatic Tumor

This clinical trial is to evaluate the safety and impact on prognosis of personalized neoantigen peptide-based vaccines, which are based on next-generation sequencing and major histocompatibility complex affinity prediction algorithm, in patients with pancreatic ductal adenocarcinoma. The hypothesis of this study is that personalized neoantigen vaccines will be safe and can systemically elicit measurable neoantigen-specific immunologic responses in patients. Participants will receive complete macroscopic resection of primary tumor, standard adjuvant chemotherapy and subsequently personalized neoantigen vaccines.

This is a single-center, open-label Phase Ib clinical trial. In this trial, adult subjects with pancreatic ductal adenocarcinoma who have completed resection of the primary tumor and who have not undergone preoperative chemotherapy will be enrolled in the study. Eligible enrolled patients all will undergo tumor resection and all receive adjuvant chemotherapy prior to preparation of the personalized neoantigen vaccine. After the chemotherapy finish, subsequently patients will receive a priming immunization with five doses of the personalized neoantigen vaccine over one month and a boosting immunization with two doses three months later. This clinical trial will examine the safety and effect of the personalized neoantigen vaccine when given at several different time points and will examine the participant's peripheral blood cells for signs that the vaccine induces immunologic responses. Finally we will establish the typical flow to assess efficiency and safety of vaccines according to the different reactivity of patients, as a result, to explore the most suitable practical approaches for applying personalized pancreatic tumor vaccines.

Eligibility Criteria:
Inclusion Criteria:

1. Pathologic diagnosis of pancreatic ductal adenocarcinoma
2. Aged ≥20 and ≤75
3. Male or not pregnant women
4. Undergone radical resection (R0 status of resection margins \[no cancer cells within 1 mm of all resection margins\])
5. No serious underlying disease, Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
6. No chemotherapy or radiotherapy before resection surgery
7. No significant cardiac, lung, liver, kidney, and bone marrow insufficiency
8. No HIV or syphilis infection
9. Signing informed consent

Exclusion Criteria:

1. Poor postoperative situation
2. Obvious organ dysfunction
3. Radiographically confirmed recurrence or metastasis within 180 days after the surgery
4. Unstable angina pectoris, symptomatic congestive heart failure, severe arrhythmias, Myocardial infarction in the past 6 months, and prolonged QT interval (\> 450ms)
5. Previous malignant tumors other than pancreatic cancer
6. Cannot be follow up
7. Participating in other clinical trials
8. Without chemotherapy after resection surgery

Exit criteria:

1. Missed within one month after surgery or not follow-up as required
2. Patient's own willingness to withdraw
3. Concurrent disease or severe adverse events
4. Protocol violations
5. Administrative reasons
Blood Components Changes by Using of Ringer's Lactated as Detergent In Autologous Blood Cell Transfusion

Placenta accreta spectrum (PAS) disorders are associated with increased maternal morbidity and mortality related to life-threatening hemorrhage, and greater potential need for blood transfusion. Clinical evidences have confirmed that the use of autologous blood cell transfusion is safe and effective for patients with obstetric haemorrhage. Normal saline is the solution recommended for red cell washing, administration and salvage. However, there is growing concern that normal saline is more toxic than balanced, buffered crystalloids such as Lactated Ringer's and Plasma-Lyte. The purpose of this study is to evaluate the blood components using of Ringer's Lactated by a prospective, single-center, open, and single-arm clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 45 years old
* Without health problem nor disease requiring regular medical treatment

Exclusion Criteria:

* subject with contraindication for drawing blood
* Subject with physical or mental disability or restriction of liberty that would prevent autotransfusion
Influence of Therapeutic Education in Patients With Joint Inflammation Treated With a Biological Treatment

To describe, with a patient reported score (BIOSECURE), the influence of an approved therapeutic education program (TEP) in patients with joint inflammation requiring a biological treatment initiation.

The hypothesis is that patients attending the TEP will display better cognitive and adaptation competences than patients with no TEP.

Patient's reported quality of life, disease related stress management, treatment adherence, socio-demographic factors, biological home administration modalities and if the biologic treatment is maintained at 12 months, will also be described.


Eligibility Criteria:
Inclusion Criteria:

* Non-radiological spondyloarthritis diagnosis (ASAS criteria)
* Anti-TNFalpha biological treatment initiation required
* Adult patient (age\>18years)
* Capacity to understand self-questionnaires and address questions
* Patient accepting to attend a therapeutic education program (TEP)

Exclusion Criteria:

* Previous Anti-TNFalpha biological treatment
* Previous attendance to a TEP concerning biological or spondyloarthritis
* Contraindication to Anti-TNFalpha treatment
* Associated and unbalanced diseases
Individualized Molecular Profiling for Allocation to Clinical Trials (IMPACT) Project

This study aims to screen tumor molecular profile for better selection of anticancer treatment, in particular, allocation to clinical trials if available.

Molecular profiling will be performed on archival tumor tissue or freshly collected tumor tissue from re-biopsy. Blood, pleural fluid, FNA, and/or saliva may be collected to study the genetic makeup and also to compare the tumor molecular profile. Personalized therapy will be given based on molecular profile.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed histological diagnosis of solid tumor
* Suitable for systematic treatment and clinical trials
* ECOG (Eastern cooperative oncology group) performance status \< 2
* Able to provide tumor tissue for molecular profiling
* Able to understand and sign the informed consent form

Exclusion Criteria:

* None
Identification of Biomarkers of Attention Deficit Disorder With or Without Hyperactivity (ADHD) by a Metabolomic Approach in Children

Attention-deficit with or without hyperactivity disorder (ADHD) is a real health public concern. No easy-use diagnosis tool are available. Metabolomic approaches has brought very usefull data in others neurological diseases like amyotrophic lateral sclerosis or autism spectrum disorder, as we had shown in previous studies. Targeting on neurotransmitter pathways involving in ADHD, metabolomic screening could help to enhance our diagnosis power to better help numerus of children. We propose to study the phenylalanine and the tyrosine pathways with a multimodal metabolomic approach, in easy-available biological fluid (blood and urine), in child or adolescent suspected of ADHD. Our objectives are: 1- to determine a specific metabolomic signature of ADHD 2- to compare the diagnostic value of this metabolomic signature with the reference methodology for ADHD diagnosis, as now practiced in our reference center for learning troubles.


Eligibility Criteria:
Inclusion Criteria:

* Child or adolescent with symptoms of attention disorders and / or hyperactivity
* aged from 6 to 15 years old

Exclusion Criteria:

* Failure or refusal of all or part of the multidisciplinary evaluation (medical and / or neuropsychological assessments and / or biological assessments)
* Identification of an intercurrent condition likely to have an impact on metabolomic analyzes (acute infection, fever, etc.)
* Parents or legal guardians opposed to data processing
Effects of Malnutrition on Colon Cancer Patients With Abdominal Surgery

The prevalence of malnutrition in patients with colorectal cancer is recorded. We want to find out, if a malnourished patient has more complications after the elective surgery.

All patients attending elective colorectal surgery are screened for malnutrition in advance. Their length of stay in the hospital and the complications are recorded.

Eligibility Criteria:
Inclusion Criteria:

* Colorectal Carcinoma
* Elective surgery
* Informed consent

Exclusion Criteria:

* Survival \< 4 weeks
European Registry on Rare Neurological Diseases

The recent implementation of European Reference Networks for Rare Diseases (ERNs) is an unprecedented move to improve the care of patients suffering from rare health disorders by transnational collaboration. ERN-RND, the ERN for Rare Neurological Diseases, oversees more than 35,000 patients in 31 specialist centers in 13 countries. The ERN-RND registry aims to gather information on patient cohorts in the multiple specialist centers and to provide an overview on patient numbers principally accessible for translational studies.

The ERN-RND (European Reference Network on Rare Neurological Diseases) Registry aims to establish a demographic platform for collection of relevant core patient information. This will be accomplished by the construction and implementation of a single data base encompassing all rare neurological diseases in pediatric and adult patients (the ERN-RND Registry), which will collect information according to the "Set of common data elements for Rare Diseases Registration" as it has been defined by the European Commission.

The ERN-RND network covers the following six disease groups in patients of all age groups: (i) Ataxia and Hereditary Spastic Spinal Paralysis (HSP), (ii) Leukodystrophies, (iii) Frontotemporal Dementia, (iv) Dystonia, Paroxysmal Disorders and Neurodegeneration with Brain Iron Accumulation (NBIA), (v) Atypical Parkinsonism and (vi) Huntington's Disease \& Choreas.

Eligibility Criteria:
Inclusion Criteria:

Patients suffering of one of the rare neurological diseases indicated below or probands who are at risk to develop such a disease since they are first degree relatives of patients affected by a RND including:

* Ataxia and HSP
* Leukodystrophies
* Frontotemporal Dementia
* Dystonia, Paroxysmal Disorders and Neurodegeneration with Brain Iron Accumulation (NBIA)
* Atypical Parkinsonism
* Huntington's Disease \& Choreas

Exclusion Criteria:

• Missing informed consent of the patient and/ or their parents
Does Duloxetine Reduce Chronic Pain After Total Knee Arthroplasty?

Range from 24% to 44%, with a prevalence of neuropathic-type pain from 6% to 20%-cause impairment in quality of life and functional capacity after total knee arthroplasty(TKA). Duloxetine (cymbalta) is a selective serotonin and nor-epinephrine reuptake inhibitor shown to be effective in treating chronic pain. Serotonin and norepinephrine in the brain and spinal cord are believed to both mediate core mood symptoms and help regulate the perception of pain. Its effects on depression and anxiety symptoms, as well as its effect on pain perception, may be due to increasing the activity of serotonin and norepinephrine in the central nervous system. Approved for the acute and maintenance treatment of major depressive disorder, the acute treatment of generalized anxiety disorder, the management of diabetic peripheral neuropathic pain and the management of fibromyalgia, all in adults (18+).

Investigators will compare the neuropathic pain following TKA in duloxetine group (n=84) with those in non-duloxetine group (n=84). Investigators will classify the participants in to 2 groups (duloxetine and non-duloxetine group) randomly, and primarily evaluate the degree of neuropathic pain using the S-LANSS pain scale (preoperatively and postoperatively 3 and 6 months). All participants will receive postoperative pain control after TKA using the same pain control regimen except duloxetine.

Both groups of participants will receive pain control regimens as follows:

Preemptive analgesia : celebrex celecoxib, Patient controlled analgesia (postoperation 28 hours), During admission : celebrex BP or vimovo BP +ultracet ER BP, targin HS, Discharge medication: celebrex BP or vimovo BP, ultracet ER BP(PRN)

Drug generic names: celecoxib (celebrex), naproxen/esomeprazole (vimovo), acetaminophen/tramadol (ultracet ER), oxycodone/naloxone (targin)

Eligibility Criteria:
Inclusion Criteria:

* Osteoarthritis of knee requiring TKA

Exclusion Criteria:

* Rheumatoid arthritis
* Other inflammatory arthritis
* Neuropsychiatric patients
* Hepatic insufficiency
* Renal insufficiency
* Patients older than 75
* Allergy or intolerance to study medications
* Patients with an ASA of IV (angina, congestive heart failure, dementia, cerebrovascular accident)
* Chronic gabapentin or pregabalin use (regular use for longer than 3 months)
* Chronic opioid use (taking opioids for longer than 3 months)