cyrilzakka/clinical-trials huggingface dataset:
HEmorrhoidAl Disease in Inflammatory Bowel Disease: a Multicenter Prospective Cohort Study

Patients who will undergo surgery for HD after the diagnosis of IBD over a 12-month period will be enrolled across Europe.

Primary objective of this study is to determine the safety and effectiveness of surgical treatments for HD in a large multicenter cohort of IBD patients.

Secondary aim is to identify factors that may affect clinical and surgical outcomes.

To date, there is no consensus in the scientific literature regarding the exact indications for surgery for hemorrhoidal disease (HD) in patients with inflammatory bowel disease (IBD). The HEAD-IBD-II study is a multicenter, prospective cohort designed to evaluate the safety and effectiveness of surgical treatments for hemorrhoidal disease (HD) in patients with inflammatory bowel disease (IBD). This study aims to collect contemporary, real-world data from multiple hospitals across various countries, focusing on the surgical management of HD in this unique patient population. The study will include adult patients with a confirmed diagnosis of Crohn's disease or ulcerative colitis who undergo surgery for HD.

The data collection process will involve detailed records of patient demographics, pre-operative status, operative techniques, and post-operative outcomes, with a specific focus on short-, medium-, and long-term surgical and clinical results. The study will track outcomes such as postoperative complications, recurrence of symptoms, IBD flare-ups, and anal continence.

In addition, factors such as surgical volume, techniques employed, and individual patient characteristics will be analyzed to identify variables that may impact the outcomes. The study is designed to generate hypotheses and explore variability in current practices, thereby highlighting areas in need of further investigation through randomized controlled trials.

All patient data will be collected anonymously through a secure electronic case report form (eCRF), and results will be disseminated according to the STROBE guidelines for observational studies. Ethical approval will be obtained from participating institutions, and all patients will provide informed consent prior to inclusion. The study is expected to improve the understanding of surgical approaches to HD in IBD patients and potentially guide future clinical recommendations.

Eligibility Criteria:
Inclusion Criteria:

* age of 18 years and above;
* established diagnosis of Crohn's disease or ulcerative colitis at the time of surgery for hemorrhoidal disease;
* planned surgery for hemorrhoidal disease during the study period, including hemorrhoidectomy (open, close or submucosal), transanal hemorrhoidal dearterialization, hemorrhoidal laser procedure, stapled hemorrhoidopexy).

Exclusion Criteria:

* previous surgery for hemorrhoidal disease other than office-based treatments (e.g., sclerotherapy injection, rubber band ligation);
* active perianal disease at the time of surgical intervention.
Very Small Embryonic-like Stem Cells for Facial Skin Antiaging

The aim of this study is the safety and efficacy of autologous very small embryonic-like stem cells(VSELs) to facial skin antiaging.

VSELs come from the patient's peripheral blood, and will be injected in left preauricular area, followed by skin pathology to compare the improvement of skin aging. Two 0.5 × 1 cm fragments of skin and subcutaneous tissue was removed from bilateral preauricular areas for morphologic analysis by optical and electron microscopy. Histologic analysis of skin biopsy specimens was performed by hematoxylin and eosin, picrosirius red (for visualization of collagen), and orcein (for visualization of elastic fibers) staining.

Eligibility Criteria:
Inclusion Criteria:

• Healthy volunteers with anti-aging willingness

Exclusion Criteria:

* Metabolic and systemic diseases such as diabetes and atherosclerosis
* Facial skin diseases such as herpes, eczema, skin rash, systemic lupus erythematosus, dermatomyositis, connective tissue disease
* Endocrine disorders and cancer patients Blood disease patients, thrombocytopenia or dysfunction, hypofibrinemia or anticoagulant therapy, long-term use of aspirin
Genetic Analysis of Childhood Obesity

Identify news genetic causes of different type of obesity (syndromic, familial or isolated obesity) by highlighting new mutations or new implied genes


Eligibility Criteria:
Inclusion criteria:

* BMI \> curve of IOTF 30 (International Obesity Task Force)
* Age: between 6 months old and 18 years old
* Child presenting syndromic, isolated or familial obesity.

Exclusion Criteria:

* Common obesity
* Impossibility for blood sampling
* Impossibility to receive information
* Participation refusal of one of the parents
* Refusal to sign the informed consent
* Neither Healthcare coverage nor insurance
Monitoring Asthma Treatment Using Exhaled Nitric Oxide

Asthma is a chronic inflammatory condition in which the airways develop increased responsiveness to various stimuli such as exposure to an allergen, cold air or exercise. It is characterized by airway hyper-responsiveness, inflammation, increased mucus production, and airway obstruction. Since inflammation is an important feature of asthma, the use of non-invasive tests to measure lung inflammation to monitor asthma are of interest.The purpose of the study is to relate costs associated with healthcare utilization and loss of work and school time to the primary health outcome of cumulative number of symptom-free days. This will enable the researchers to determine whether the costs of monitoring exhaled NO to regular management strategy in recently diagnosed asthma will be offset by reductions in other costs of asthma-related care, and, if not, whether the additional costs are likely to be acceptable in terms of the improvement in health outcomes as measured by the additional number of symptom-free days.


Eligibility Criteria:
Inclusion Criteria:

* Male or female children, aged 6-14 years
* A documented history of asthma for a period of at least 6 months
* Mild to severe persistent asthma according to GINA guidelines
* A documented history of allergic sensitization (positive skin prick test or specific IgE
* Subject's guardian/parent should be able to complete a symptom score on behalf of the subject.
* Subject's guardian/parent should be able to send a symptom score weekly by sms
* Both parents have to give written informed consent to participate in the study

Exclusion Criteria:

* Received any investigational study medication in the 4 weeks prior to screening Visit
* Significant comorbidity such as concurrent infection, history of prematurity, history of bronchopulmonary dysplasia, cystic fibrosis, other chronic lung diseases, and other severe chronic diseases
* Acute asthma exacerbation within 4 weeks of screening visit
* Hospitalization within 12 weeks of screening visit
* Systemic corticosteroids within 12 weeks of screening visit
* Oral corticosteroid dependence
Evaluation of the Prognostic Impact of a Neuro-vascular Examination Associated with Cerebral MRI in the Acute Phase of Infectious Endocarditis

Infectious endocarditis (IE) is a serious condition with an annual incidence of 3 to 10 per 100,000 people. Brain infarctions complicate approximately 20-40% of endocarditis.

Brain MRI can detect the presence of recent ischemic lesions and asymptomatic microbleeds. Preoperative brain imaging is part of the recommended assessment in the management of IEs, but the type of imaging and sequences are not codified and the impact of cerebral and vascular imaging findings on the therapeutic decision remains uncertain.

The level of evidence of the recommendations remains low, especially for complicated IEs of stroke. There is very little neurological clinical data on patients with IEs. Similarly, neurologists do not systematically participate in multidisciplinary meetings during the management of an IE. It therefore seems interesting to carry out a neurological cohort of this population and to evaluate what would be the contribution of vascular neurologists in the management of infectious endocarditis.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* Certain infectious endocarditis according to Dukes Criteria
* Signed informed consent

Exclusion Criteria:

* Hospital admission due to neurovascular emergency
* MRI contraindications
* Pregnant or women of childbearing age who were not using contraception (oral diagnosis),
* Patient without health coverage,
* Patient under legal protection.
Food Effect And Relative Bioavailability Study Of Oxycodone in Healthy Volunteers

To estimate the effects of food on oxycodone pharmacokinetics after administration of 40 mg doses of PF-00345439 Formulation K and to estimate its relative bioavailability compared to PF-00345439 Formulation X in the fasted state in healthy volunteers

This study will estimate the effect of food (standard high-fat breakfast) on the pharmacokineticsand relative bioavailability of oxycodone following oral administration of single 40 mg doses of PF-00345439 Formulation K in healthy volunteers.

Additionally, the study will estimate the pharmacokinetics and relative bioavailability of oxycodone following oral administration of single 40 mg doses of the test PF-00345439 Formulation K compared with the reference PF-00345439 Formulation X under fasted conditions in healthy volunteers and assess the single-dose safety and tolerability of oxycodone in PF-00345439 formulations in healthy volunteers when administered under a naltrexone block.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects between 18 and 55 years of age (inclusive).

Exclusion Criteria:

* Evidence or history of clinically significant disease
* Positive urine drug test
Coronary Artery Disease (CAD) in Women Marathon Runners

The aim of this study is to determine the effects of extreme fitness in women. The incidence of coronary artery disease observed via multislice computed tomography (MSCT) angiogram will be compared with age and risk-matched controls from both sedentary and fitness activity groups who have never been significant runners. Life style, training volume and risk factors will be assessed.

Single-center, non-randomized, prospective, observational study. The study population will be up to 100 female athletes who are competitive long distance runners, and have been so for a minimum of 10 years. Multi-slice computed tomography (MSCT) will be used to characterize the amount, severity and type of atherosclerotic lesions. MSCTA will be performed per usual practice using a minimum X-ray dose protocol.

The study will determine whether moderate to high intensity, long term athletic training and competition is associated with enhanced coronary artery disease in women. Each participant will complete a life-style, training volume and risk factor questionnaire. These participants will be compared to an age, gender and risk factor matched cohort.

Eligibility Criteria:
Inclusion Criteria:

* Female athletes who have run marathons competitively for a minimum of 10 years.
* Age \> 40 years old
* Agree to participate and sign an informed consent form

Exclusion Criteria:

* Allergy to X-ray contrast
* Creatinine ≥ 2.0
* Pregnant Female
* Has run a marathon within the past 2 weeks
Focal Accumulation of Iron in Cerebral Regions in Early ALS (Amyotrophic Lateral Sclerosis) Patients

The FAIR-ALS study is to investigate the safety and efficacy of a scavenger treatment of iron deferiprone, which would reduce the brain iron to limit the development of amyotrophic lateral sclerosis.

It has been shown an excess of iron in the central nervous system carrying a sporadic ALS patients. Iron overload associated with a loss of motor neurons may explain the signs of the disease (atrophy).

The investigators discuss the hypothesis that reducing excess iron, the investigators can reduce the loss of neurons and thus the progression of signs of the disease.

At the end of the study, it will propose to continue the usual quarterly patient follow up, as recommended by the French ALS centers.

Deferiprone can be administered as part of a compassionate use, for patients who want it and who do not have hypoxemia.

We therefore plan a treatment period compassionate relatively short and less than 3 years.

Eligibility Criteria:
Inclusion Criteria:

* Amyotrophic lateral sclerosis defined in accordance to the El Escorial criteria (possible, probable or defined)
* 18 to 85 years old patient, male or female
* Patient with social security cover

Exclusion Criteria:

* Achieved respiratory defined by a FVC \<70%
* Evolution of more than 24 months
* Demented subject
* Severe malnutrition
* Patients with treatment potentially at risk of agranulocytosis and neutropenia
* Patients with a history of agranulocytosis or iatrogenic under haematological disease
* Incapable of giving consent
* Indication against MRI
* Indication against lumbar puncture
* Patient refused lumbar puncture
* Hypersensitivity to iron chelators
* Concomitant treatment with antacids containing aluminum
* Presence of another serious illness to life-threatening or disabling cons to the use of the treatment mixture of oxygen and nitrous oxide equally
AlloSure Guided Immuno-Optimization for COVID-19: An Early Experience

The utilization of AlloSure to help guide immunosuppression management in solid organ transplant recipients diagnosed with COVID-19

An observational case series of patients with solid organ transplants who have been admitted with suspected COVID-19 utilizing AlloSure dd-cf DNA to help guide immunosuppression management balancing the treatment of sepsis and avoiding allograft rejection.

Eligibility Criteria:
Inclusion Criteria:

* Liver, Heart, Lung or Kidney organ transplant recipient with a suspected or confirmed diagnosis of COVID-19

Exclusion Criteria:
Effects of Electroconvulsive Therapy (ECT) in Bipolar Depression

The primary purpose of this study is to use magnetic resonance spectroscopy (MRS) to measure the levels of several brain chemicals including, but not limited to, glutamate, glutamine, and N-acetylaspartate, before and after treatment with ECT. In addition to MRS, the investigators will use several other MRI techniques including structural MRI, resting state functional MRI (fMRI), and diffusion tensor imaging (DTI) to measure how the structure and function of the brain changes with ECT.

The investigators hypothesize that the Gln/Glu ratio is increased in the anterior cingulate cortex (ACC), but not the parieto-occipital cortex (POC), following the first ECT treatment.


Eligibility Criteria:
Inclusion Criteria:

* Male or female age 18-55
* Meets DSM-IV criteria for Bipolar Disorder Type I, II, or NOS with current episode depressed
* Has been scheduled to be evaluated by an ECT consultant from the McLean Hospital ECT service
* Current score of greater than or equal to 24 on the Montgomery-Asberg Depression Rating Scale (MADRS)

Exclusion Criteria:

* Unwillingness or inability to provide informed consent
* Lifetime history of schizophrenia
* DSM-IV diagnosis of alcohol or substance dependence, with the exception of nicotine dependence, within three months prior to screening
* Positive urine toxicology screen at screening (NOTE: Participants with a positive urine toxicology screen who are prescribed benzodiazepine, stimulant, or opiate medications by their physician will be permitted to enroll in the study as long as they do not meet abuse or dependence criteria for these substances)
* Female participants with a positive urine pregnancy test at screening
* Pregnancy. Females of childbearing potential must be using an effective contraceptive method (e.g., abstinence, prescription oral contraceptives, contraceptive injections, MRI-safe intrauterine device, double-barrier method, male partner sterilization)
* Any contraindications to having an MRI scan, including cardiac pacemakers, metal vascular clips or stents, artificial heart valves, certain kinds of prostheses, brain stimulator devices, implanted drug pumps, ear implants, eye implants or known metal fragments in eyes, exposure to shrapnel or metal filings (wounded in military combat, sheetmetal workers, welders, and others), transdermal drug delivery systems, and certain tattoos with metallic ink. NOTE: Participants will be screened for these conditions at screening, and will be required to fill out a standard MRI screening form at the Brain Imaging Center, which will be reviewed by an MRI technician prior to each MRI scan
* Scheduled to receive first ECT treatment on a Friday
Patients Characteristics, Treatment Pattern & Outcomes of Patients With Advanced, Recurrent or Metastatic Endometrial Carcinoma

This is a national observational retrospective multi-site chart review study of patients with advanced, recurrent or metastatic endometrial carcinoma.


Eligibility Criteria:
Inclusion Criteria:

1. Adult women ≥ 18 years at index date.
2. Documented diagnosis of advanced recurrent or metastatic endometrial cancer not eligible to primary complete surgery. Patients with interval surgery after primary CT may be eligible.
3. Index date should represent at least the first\* or second line\*\* chemotherapy systemic treatment and occur between, 1, January 2019 and 31, December 2019.
4. do not express refusal to her personal data processing or did not express her refusal for deceased patients.

Exclusion Criteria:

1. No clinical records for tumor imaging or administration of anti-cancer therapy.
2. Patients with active malignancy other than EC cancer which contribute significantly to the clinical impairment of the patient during the study period, according to investigator opinion.
3. Patients lost to follow-up, defined as patients whose last follow-up information occurs less than two years after index date (unless the patient is deceased).
4. Patient did not receive chemotherapy systemic treatment.
5. Patient undergo treatment by pembrolizumab or another immunotherapy in first line (cohort 1) or second line (cohort 2) during the eligibity (inclusion) period.
Real Time 3D Navigation and Traditional US to Identify Epidural Space Depth in Obese Pregnant

The aim of this study is to assess the accuracy of the Accuro Ultrasound Device in estimating the epidural space depth compared to the Standard Ultrasound Examination and with the measured needle depth during epidural and spinal insertion in pregnant obese patients

SpineNav3DTM technology facilitates image interpretation of individual 2D lumbar spine scans by automating spinal bone landmark detection and depth measurements and providing a real-time assessment of scan plane orientation in 3D.

All the subjects will have their lumbar area scanned for the measurements of the depth of the epidural space (recorded in cm) by two blinded anesthesiologists, one using standard ultrasounds and the other the Accuro Device.

All measurements will be performed either in the sitting or in the supine position at L1/L2, L2/L3 and L3/L4 levels. Neuraxial anesthesia will be performed by using the previously marked interspace by a blinded anesthesiologist who will measure the epidural space depth during epidural or spinal insertion by marking the needle.

Eligibility Criteria:
Inclusion Criteria:

* ASA Status \>III
* obese BMI\>30
* term gestatio \> 37 weeks
* singleton pregnancy
* undergoing elective cesarean section with spinal anesthesia
* requesting epidural labor analgesia

Exclusion Criteria:

* contraindications to neuraxial block
* severe scoliosis
* previous spine surgery
Whole Egg Intake and Choline Concentration in the Aging Brain

By doing this study, researchers hope to learn to see if there is relationship between whole egg consumption and brain choline status. Additionally, researchers also plan to see if there is a relationship between brain choline status and cognition.

Participants will come to the research center for 2 different visits. Visit 1 will include anthropometric measurements, surveys, and a cognitive test. Approximately 7-10 days after visit 1, participants will come back to the research center for visit 2. At visit 2, participants will return surveys and a MRI scan will be performed to measure brain choline status. Potential participants need to be located within the Kansas City metro area.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 60 - 85 years of age
* Good general health with no concomitant diseases
* Cognitively normal as defined as Mini-mental state examination (MMSE) score ≥ 25
* BMI range: 20 - 40 kg/m2

Exclusion Criteria:

* Presence of central neurological disease (e.g., brain tumor, stroke, epilepsy, motor neuron disease, multiple sclerosis, Alzheimer's, Parkinson's)
* Prior major head trauma with loss of consciousness
* Presence of active unstable and life-threatening illness (e.g., cancer)
* Presence of major psychiatric disorder within the past 3 years including depression, anxiety, and alcohol (over 3 drinks per day or total of 18 per week) or drug abuse (DSM-IV criteria; Geriatric Depression Score \> 6)
* Presence of diabetes mellitus or use of anti-diabetic agents
* Use of psychoactive and investigational medications
* Use of hormone replacement therapy
* Tobacco smokers
* Subjects with MRI contraindications
A Cold Physical Treatment to Manage Insulin Resistance

Insulin resistant volunteers will choose to undergo an 8-week cold treatment, 2 hours per day, to selective regions of the body enriched with brown fat including neck, supraclavicular and interscapular regions) in combination with electroacupuncture (EA). Their insulin sensitivity and glucose and lipid homeostasis will be measured. The brown fat activation will be assessed by positron emission tomography and computed tomography (PET/CT)-scans and/or serum marker measurements.


Eligibility Criteria:
Inclusion Criteria:

* BMI: 20-30
* Insulin resistant

Exclusion Criteria:

* uncontrolled hypertension
* insulin dependent diabetics
* heart diseases
* hyperthyroidism
* secondary obesity
* surgical operation within treatment or planned in two months
* pregnancy
* anemia
* liver or kidney failure
* cancer
A Clinical Study Carried Out in Patients Operated With Calcanail®

This study is part of the Post-Market Clinical Follow-up process for the Calcanail medical device; the objective of which is to collect data on the safety and performance of the device after it has been placed on the market.

The primary objective of this study is to evaluate the safety of the device. The secondary objectives are to evaluate the clinical performance and safety of the device.

This is a research not involving the human person: observational study, retrospective, monocentric, non-comparative and national.

84 patients will be included in the study.

The CALCANAIL nail is an osteosynthesis nail intended for the repair of articular fractures of the calcaneus, deformities of the hindfoot and arthrosis of the hindfoot. This study aims to answer specific questions about the clinical performance, efficacy or safety of the medical device when used in accordance with its instructions for use. It will also enable us to better detect rare adverse events if necessary, as well as medium-term results.

Eligibility Criteria:
Inclusion Criteria:

1. Patient operated with the studied device between the 01/01/2012 and 01/01/2020.
2. Patient over 18 years old
3. Patient who has received informed information and does not object to the collection of their data in this study.

Exclusion Criteria:

Patient refusing the use of his data or deceased patient who expressed in writing during his lifetime the non-use of his medical information.