cyrilzakka/clinical-trials huggingface dataset:
Bioenergetics and Metabolism in Pediatric Populations

The investigators want to learn more about obesity, the development of insulin resistance, and Type 2 Diabetes in children. The investigators will do this through collecting information about children's health and conducting experiments on a variety of samples.


Eligibility Criteria:
Inclusion Criteria:

* Age 5-9 years and Tanner stage as reported by parent no greater than stage 1 OR Age 5 years - 17 years 5 months, diagnosed with type 2 diabetes mellitus or insulin resistance
* Either healthy lean (BMI≥ 5th percentile and \<85th percentile for age/sex) or obese (BMI ≥ 95th percentile for age/sex)
* For those with BMI≥ 95th percentile for age/sex, parental verbal confirmation will be obtained that the child had a history of BMI≥ 95th percentile for age/sex for at least six months prior to study enrollment

Exclusion criteria:

* Genetic or physical conditions impacting mobility over past year as determined by the Principal Investigator (PI)
* Having known chronic illnesses/disorders that may independently affect study outcome measures: type 1 diabetes mellitus, neurologic (e.g. epilepsy), developmental (developmental delay, autism spectrum disorder), endocrine (thyroid, Cushing's), hepatic, autoimmune, cardiac and renal disorders. Also, chronic lung disorders except well controlled asthma that does not require permanent use of inhaled/oral steroids
* Taking any of the following medications that can affect study outcome: antipsychotics, thyroid hormone replacement therapy, inhaled/oral steroids, insulin, anabolic drugs (growth hormone replacement therapy and oxandrolone) and stimulants
* BMI\<5th percentile for age/sex (classified as underweight based on Centers for Disease Control and Prevention growth charts)
* Subjects determined ineligible by the PI.
Complex Post-traumatic Stress Disorder: What Symptomatological Specificities

A better understanding of the Complex Post-Traumatic Stress Disorder would allow a management as close as possible to the specificities of this one, but also a better training of professionals and adapted therapeutic indications.

Post-Traumatic Stress Disorder manifests itself in a multitude of symptoms and self-regulation difficulties in various domains (somatization and biological balance, attention and consciousness, regulation of affects and impulses, interpersonal relationships and relational capacities, perception of the aggressor and of the aggression, self-perception and identity, sense and belief system) as well as profound changes in personality and various comorbidities .In addition, dissociation, the origin and the resulting disorders also have some similarities to Complex Post-Traumatic Stress Disorder. Indeed, dissociation is thought to have a traumatic origin and the symptomatology (eg hyperesthesia, dissociative amnesia, anesthesia) is included in Complex Post-Traumatic Stress Disorder. We can then ask ourselves the following questions: is Complex Post-Traumatic Stress Disorder a dissociative disorder in its own right causing difficulties with self-regulation? What is the share of dissociation in Complex Post-Traumatic Stress Disorder?

Eligibility Criteria:
Inclusion Criteria:

For clinical population;

* Age between 18 and 65 years old;
* Having experienced repeated and prolonged traumatic exposure;
* Able to understand and answer self-questionnaires;
* Having expressed their free and informed consent
* Affiliated with a social security scheme

For general population:

* Student volunteers from the University of Lille;
* Aged between 18 and 65 years old;
* Able to understand and answer self-questionnaires;
* Having expressed their free and informed consent.

Exclusion Criteria:

For clinical population;

* People with difficulties in answering the self-questionnaires (e.g. incomprehension of items, emotional difficulties);
* Persons under tutorship or curatorship;
* Persons deprived of their liberty.

For general population:

* People with difficulties in answering the self-questionnaires (e.g. incomprehension of items, emotional difficulties);
* Persons under tutorship or curatorship;
* Persons deprived of their liberty;
* Persons having a link of subordination with the investigative team.
Quantification of Myocardial Blood Flow by Positron Emission Tomography in Healthy Volunteers

To establish quantitative values of myocardial blood flow (MBF) in normal, healthy volunteers .

We seek to establish quantitative values of myocardial blood flow in 20 normal, healthy volunteers using our existing 2D PET camera (Positron Attrius) and invasively validated software package (HeartSee) in order to 1) establish institutional values for which clinical patients can be compared to and 2) add to the collective data of the scientific community. Values to be measured will be resting myocardial blood flow (MBF), stress MBF and coronary flow reserve.

Eligibility Criteria:
Inclusion Criteria:

* Adults ≥18 and \<40 years old
* Participants must be able to give informed consent.
* Ability to abstain from caffeine for 48 hours

Exclusion Criteria:

* Any chronic cardiac disease or condition (e.g. hypertension, hyperlipidemia)
* Any chronic systemic disease or condition (e.g. diabetes, systemic lupus, rheumatoid arthritis)
* Tobacco use
* Family history in a first degree relative with clinical coronary artery disease (history of myocardial infarctio, percutaneous intervention or coronary artery bypass grafting) in men \<55 years old or women \<65 years old
* Severe claustrophobia
* Positive urine pregnancy test
* Inability to give informed consent
Phase IIIB Subcutaneous Abatacept Monotherapy Study

To evaluate safety and immunogenicity of abatacept when used with or without methotrexate in the absence of an IV loading dose of abatacept


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Rheumatoid Arthritis
* Subjects Global Disease Assessment of greater than equal to 20 mm on a visual analog scale
* Discontinue all Biologics and Disease-modifying antirheumatic drugs (DMARDS) except for methotrexate

Exclusion Criteria:

* Received treatment with rituximab
* Subjects who have received treatment with immunoadsorbtion columns (such as Prosorba columns), mycophenolate mofetil (Cellcept®), cyclosporine A or other calcineurin inhibitors, or D-Penicillamine
Surgical Stress and Intracorporeal Anastomosis

The short-term advantages of minimally invasive colon resection have been well established in several randomized trials. A major factor in the development of morbidity is the surgical stress response with subsequent increased demand on the patient's reserves and immune competence. Although the advantage in term of stress response of laparoscopic surgery over open surgery has been widely reported, little is known about the role of Intracorporeal anastomosis.

In an attempt to evaluate the surgical stress response after totally laparoscopic right colectomy a comparative study has been designed.

Two surgical procedures will be evaluated:

* Totally laparoscopic right colectomy with intracorporeal anastomosis (Experimental group)
* Laparoscopic assisted right colectomy with extracorporeal anastomosis (Control group).


Eligibility Criteria:
Inclusion Criteria:

All elective laparoscopic right colectomy for cancer

Exclusion Criteria:

Urgent procedures Immune depressant therapy Immune depressant disease Post-operative Complications
Neurological Complications at Stroke Patients With Diabetes Mellitus

It is to be investigated if a correlation exist between the development of the HbA1c value and the complication rate is following a stroke.

The immediate objective of the study is to find out if a correlation between blood sugar control in diabetics and the incidence of complications after a stroke exists.

The study has a high practical importance because any consequences in the treatment of diabetes mellitus can be implemented without affecting costs.

Eligibility Criteria:
Inclusion Criteria:

* Stroke patients on the Stroke Unit with hyperglycemia with cerebral ischemia within the last 24 hours

Exclusion Criteria:

* Patients with intracerebral hemorrhage
* Pregnant patients
* Patients with sensory aphasia
Short-term Effects of Oxytocin Nasal Spray on Chronic Tinnitus

The study compares the short-term tinnitus reduction following a single oxytocin intervention with a placebo control condition.


Eligibility Criteria:
Inclusion Criteria:

* chronic tinnitus with a duration \> 6 months
* medical examination by an ENT specialist
* sufficient knowledge of the Portuguese language to follow the instructions and answer the questionnaires
* VAS score \>4 points

Exclusion Criteria:

* vascular tinnitus
* muscular tinnitus
* conductive hearing loss
* previous experience with oxytocin nasal spray
* additional medications during the intervention
Pelvic Ring Fractures: New Analysis Method and Treatment Decision Algorithm

Pelvic ring fractures are common and often the result of high energy trauma but also sometimes of lower energy trauma in older patients. A good classification and description of the fracture is essential to the choice of treatment.

The classifications used to describe these fractures are numerous (Tile modified AO, Young and Burgess, Letournel, Rommens) and of a descriptive order more or less depending on the lesion mechanism allowing some to orient the surgical reduction technique. However, none of them helps with the choice of surgical or functional treatment, which is currently based on obvious notions of instability and / or displacement of lesions and, by habit, all different services.

In addition, the complexity of these classifications leads to poor reproducibility of these.

A new method for analyzing unitary lesions has been developed in the Orthopedic Surgery department of the Paris Saint-Joseph Hospital Group with a rating system which determines the indication according to the score.

Teaching this new method of analyzing pelvic ring fractures would simplify decision making between surgical and functional treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged\> 18 years
* Patient treated or followed within the Orthopedic Surgery service of the GHPSJ for a pelvic ring fracture
* complete initial imaging patient record (scanner)
* French speaking patient

Exclusion Criteria:

* Patients under guardianship or curatorship
* Patients deprived of their liberty
* Patients objecting to the use of their data for this research
* Patient with isolated sacral or acetabular fracture
* Absence of scanner during the initial assessment
Imaging Retinal Vasculature in Infant Eyes

Retinopathy of prematurity is a leading cause of childhood blindness worldwide. The fovea, a critical location in the retina determining visual acuity and visual function, and the blood vessels around it, are abnormally developed in infants with retinopathy of prematurity. However, how these blood vessels form during development of the human fovea remains unclear. This research will advance our understanding of the fundamental knowledge of how the blood vessels around the fovea form in infants, and how they change in diseased states such as preterm birth or retinopathy of prematurity.


Eligibility Criteria:
Inclusion Criteria:

* Health care provider, knowledgeable of protocol, agrees that study personnel could contact the Parent/Legal guardian
* Parent/Legal Guardian is able and willing to consent to study participation for the infant
* Infant meets the American Association of Pediatrics eligibility of ROP screening, and is age less than 34 6/7 weeks postmenstrual age at first visit

Exclusion Criteria:

* Participant or Parent/Legal Guardian unwilling or unable to provide consent
* Infant has a health or eye condition that preclude eye examination or retinal imaging (e.g. corneal opacity such as with Peter's anomaly or cataract)
* Infant has a health condition, other than prematurity, that has a profound impact on brain development (e.g. anencephaly)
Cetuximab-IRDye 800CW in Detecting Tumors in Patients With Malignant Glioma Undergoing Surgery

This study is a phase 1-2 trial that evaluates the best dose of cetuximab-IRDye 800CW and how well it works in detecting tumors in patients with malignant glioma who are undergoing surgery. Cetuximab-IRDye 800CW is an optical imaging agent that may help detect tumor cells when a special camera is used.

This is a dose-escalation study of cetuximab-IRDye 800CW. Patients are assigned to 1 of 2 cohorts.

COHORT I: Patients receive cetuximab intravenously (IV) over 30 minutes and a lower dose of cetuximab IRDye800 IV over 30 minutes to 1 hour on day 0.

COHORT II: Patients receive cetuximab IV over 30 minutes and a higher dose of cetuximab IRDye800 IV over 30 minutes to 1 hour on day 0.

All patients undergo standard of care surgical resection of tumor on days 2-5.

After completion of study, patients are followed up at days 10 and 30.

PRIMARY OBJECTIVE:

Determine the efficacy of cetuximab-IRDye 800CW (cetuximab IRDye800) in intraoperatively identifying malignant glioma compared to surrounding normal central nervous system tissue, as measured by tumor-to-background ratio.

SECONDARY OBJECTIVE:

Determine the tolerability of the cetuximab IRDye800 as an imaging agent in subjects undergoing resection of malignant glioma.

Eligibility Criteria:
INCLUSION CRITERIA

* Suspected brain tumors to undergo removal (surgical resection) as standard of care, as assessed by the operating surgeon
* Life expectancy of \> 12 weeks
* Karnofsky performance status of at least 70% or Eastern Cooperative Oncology Group (ECOG)/Zubrod level 1
* Hemoglobin ≥ 9 gm/dL
* Platelet count ≥ 100,000/mm³
* Magnesium, potassium and calcium \> the lower limit of normal per institution normal lab values
* Thyroid-stimulating hormone (TSH) \< 13 micro international units/mL

EXCLUSION CRITERIA

* Received an investigational drug within 30 days prior to first dose of cetuximab IRDye800
* Within 6 months prior to enrollment, myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina
* History of infusion reactions to cetuximab or other monoclonal antibody therapies
* Evidence of QT prolongation on pretreatment electrocardiogram (ECG) (greater than 440 ms in males or greater than 450 ms in females)
* Receiving class IA (quinidine, procainamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
* Pregnant or breastfeeding
Group Versus Individual Acupuncture for Cancer Pain

Typically, in North America, acupuncture is performed on an individual basis. However, community acupuncture, also known as group acupuncture, is an emerging method of treating patients. Cancer patients, post-treatments were given acupuncture treatments to help alleviate pain, in a two-arm randomized trial.

Typically, in North America, acupuncture is performed on an individual basis. However, community acupuncture, also known as group acupuncture, is an emerging method of treating patients. Although the practice can vary, community acupuncture is performed in a group setting, typically with reclining chairs dispersed around a large room, and one practitioner treating up to six people per session.

The outcomes of this this randomized controlled trial will allow the researchers to assess whether group acupuncture is a viable treatment option for people with cancer who are suffering from pain, especially those who are either resistant to or looking to avoid the side effects of opioids.

Objectives Examine the efficacy of community acupuncture for alleviating cancer pain, fatigue, sleep disturbances and distress when compared to individual acupuncture.

Evaluate the cost-effectiveness of community acupuncture compared to individual acupuncture.

Eligibility Criteria:
Inclusion Criteria:

1. Adult cancer patients (≥18 years old), both male and female.
2. Experiencing pain with a minimum worst pain score (in the previous week) ≥3 on the 10-point Brief Pain Inventory (BPI).
3. All tumor groups, including metastatic patients.
4. Participant's pain can originate from any source, including postoperative, malignancy related, and neuropathic pain.
5. Must be willing to be randomized into either group, and must be able to attend a minimum of nine treatment sessions within a six-week period.

Exclusion Criteria:

1. Use of acupuncture within the previous six months.
2. Currently on or within one-month of active treatment (chemotherapy or radiation).
Safety and Efficacy of Drug Combinations Against Trichuris Trichiura

This randomised, controlled, double-blinded clinical study investigates the safety and efficacy of albendazole (ALB), mebendazole (MBD) and ivermectin (IVM) separately, and ALB and MBD each in combination with IVM in the treatment of Trichuris trichiura in children aged 5-14 years.


Eligibility Criteria:
Inclusion Criteria:

* Those who are enrolled in class one to six
* Are infected with T. trichiura
* Whose parent consent and who are willing to participate

Exclusion Criteria:

* Those with acute and chronic diseases other than T. trichiura
* Those with a history of any serious adverse drug reactions
Potential Pharmacokinetic Interaction Between Selexipag and Midazolam in Healthy Male Subjects

The primary purpose of this study is to evaluate the effect of repeated doses of selexipag on the pharmacokinetics of a single oral dose of midazolam (i.e., how long and how much midazolam is present in the blood)

In order to exclude an inductive effect of selexipag in the gastrointestinal tract, this study aims at investigating the effect of selexipag on the PK of midazolam, a sensitive substrate of both hepatic and intestinal cytochrome P450 3A4 (CYP3A4).

Eligibility Criteria:
Key Inclusion Criteria:

* Signed informed consent form
* Age from 18 to 45 years (inclusive) at screening
* Body mass index (BMI) from 18.0 to 28.0 kg/m2 (inclusive) at screening
* Healthy on the basis of physical examination, cardiovascular assessments and laboratory tests

Key Exclusion Criteria:

* Any contraindication to the study treatments
* History or clinical evidence of any disease or medical / surgical condition or treatment, which may put the subject at risk of participation in the study or may interfere with the absorption, distribution, metabolism or excretion of the study treatments
* Any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study or compliance with the protocol
Immunogenicity and Safety Study in Infants of GlaxoSmithKline Biologicals' Infanrix Hexa™ (DTPa-HBV-IPV/Hib) Vaccine

This study evaluates the immunogenicity and safety of Infanrix hexa™ (DTPa-HBV-IPV/Hib) when administered as a primary vaccination course to Indian infants according to a 6-10-14 weeks or a 2-4-6 months schedule.


Eligibility Criteria:
Inclusion Criteria:

All subjects must satisfy ALL the following criteria at study entry:

* A male or female between, and including, 6 and 10 weeks of age at the time of the first vaccination
* Documented administration of a hepatitis B vaccine dose at birth
* Subjects who the investigator believes that their parent(s)/legally acceptable representative(s) \[LAR(s)\] can and will comply with the requirements of the protocol
* Written informed consent obtained from the parent(s)/LAR(s) of the subject
* Healthy subjects as established by medical history and clinical examination before entering into the study
* Born after a gestation period of at least 36 weeks

Exclusion Criteria:

The following criteria should be checked at the time of study entry. If ANYexclusion criterion applies, the subject must not be included in the study:

* Child in care
* Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose, or planned use during the study period
* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose
* Administration of a vaccine not foreseen by the study protocol, within 30 days prior to the first study visit, or planned administration during the study period, with the exception of oral human rotavirus (HRV) vaccination which is allowed at any time during the study
* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product
* Evidence of previous diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b (Hib) vaccination or disease, with the exception of a birth dose of hepatitis B vaccine and oral poliovirus vaccine (OPV) as per local standard of care
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
* Family history of congenital or hereditary immunodeficiency
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine
* Major congenital defects or serious chronic illness
* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period
* Acute disease and/or fever at the time of enrolment
Goal Directed Fluid Therapy Versus Liberal Fluid Regimen in Primary Elective Hip Artrhoplasty

Patients undergoing elective primary total hip replacement and spinal anesthesia may encounter significant hemodynamic instability.

The study is a randomized controlled type and is aimed at comparing how perioperatory hypotension and fluid regimen are managed using Clearsight non invasive monitoring system or PAM monitoring.

The primary endpoint is to evaluate total duration of hypotension, defined as a MAP \< 65 mmHg, calculated during all the perioperatory time.

Fifty-eight patients, aged 50-80 years, with an American Society of Anaesthesiologists' (ASA) score I, II and III were enrolled and split in two groups (Clearsight and control group). Patients were monitored both with the EV1000 platform, the Clearsight finger-cuff and MAP monitoring. Depending on the group, the fluid regimen was a goal directed fluid therapy or a liberal fluid regimen.


Eligibility Criteria:
Inclusion Criteria:

* Age 50-80 years
* ASA I, II or III
* primary elective hip arthroplasty

Exclusion Criteria:

* spinal anesthesia contraindications
* periferical vasculopaty
* other diseases which indicates better an invasive monitoring by radial artery cannulation
* atrial fibrillation
* denial or inability to provide informed consent
Retrospective Non-interventional Analysis of Opportunistic Infections in Immunocompromised and Frail Patients

The analysis of a cohort of consecutive non-selected patients from the Strasbourg University Hospital, and therefore representative of the real life, will allow better identifying the risk factors for these infections (by comparison with a cohort of patient with similar conditions of immunosuppression and no infection) and improving the diagnosis and therapeutic management.

The primary objective is to identify prognosis factors affecting survival in patients with opportunistic infections


Eligibility Criteria:
Inclusion criteria:

* Non selected consecutive immunocompromised or frail patients with an opportunistic infection
* Hospitalized in any of the department of the University Hospital of Strasbourg
* For epidemiological study, patients with similar immunodepression of frail condition and no opportunistic infection

Exclusion criteria:

- Opposition of the patient to use his personal data