cyrilzakka/clinical-trials huggingface dataset:
The Visiting Child and His Family in ICU

According to literature, it's difficult to evaluate the impact of the visit of the child in ICU. Currently, no recommendations are available regarding welcome and accompany children who visit their relative hospitalized in ICU. Collaboration between humanities and medical sciences brings to this question a complementary look. Majority of studies investigated the question of the impact of young child ICU visit in a unidirectional linear causality scheme visit = psychopathological impact. The visit of the child in ICU should not be considered as an isolated event whose objective characteristics would be alone vectors of trauma. Contrary, the child visit must be apprehended in relation to the quality of the supports on which the child can count. The investigators hypothesize that children can overcome the visit of a kin hospitalized in ICU if accompanying people can support the child and contain, before and after the visit, the emotions of the child.


Eligibility Criteria:
Inclusion Criteria:

* family groups in which at least one child aged 6 to 14 years having expressed the wish to visit his/her hospitalized relative
* family groups in which the non-hospitalized parent has expressed the wish to accompany his/her child during the visit
* parent hospitalized in ICU is at least 18 years old
* informed consent of children, non-hospitalized and/or hospitalized relatives
* informed consent of the accompanying caregiver

Exclusion Criteria:

* moribund patient
* child unaccompanied by his/her parent/relative during the visit
* non-hospitalized non-French-speaking parent/relative (need to be able to answer the questionnaires)
* child benefiting from a psychological follow-up prior to the hospitalization of his/her parent
* non French-speaking child
* child under 6 years old or older than 14
* hospitalized relative who died before the proposed interview with the child (particular attention will be carry out to the interview conditions. The loss of the hospitalized parent will not allow for an interview on the experience of the visit).
Somatic Diseases in Autistic Children

For many reasons, medical monitoring in autistic patients is very difficult. This study is designed to determine the prevalence of comorbid diseases (neurological, cardiac, digestive, dental diseases...) in patients suffering from ASD to prevent them or diagnose them earlier.

Mean goal : to determine the prevalence of comorbid diseases (neurological, cardiac, digestive, dental diseases...) in patients suffering from ASD to prevent them or diagnose them earlier.

Secondary goals :

* to obtain an objective assessment of the "general" monitoring in these patients (vaccinations, growth...)
* to assess their habits (food, sleep, screen exposition)
* to determine, in this monitoring and the habits, vigilance points which will need a specific pediatric consultation.

Eligibility Criteria:
Inclusion criteria:

- consultation after psychiatric evaluation

Exclusion criteria:

* age \> 18 years
* Impossibility to obtain the consent of parents / legal representatives.
Efficacy and Safety of Esflurbiprofen Hydrogel Patch in the Treatment of Local Acute Pain

Objective of this study is:

to determine efficacy and safety of a Esflurbiprofen Hydrogel Patch compared to placebo in patients with acute strains, sprains or bruises of the extremities following blunt trauma, e.g. sports injuries.

to demonstrate that the Esflurbiprofen Hydrogel Patch is superior to placebo, and that the patch has acceptable local tolerability.

Study Design Randomized (1:1) (stratified by center and 2 subgroups), controlled, double-blind, multi-centric study in parallel groups. Patient Population/Sample size/Study Sites

The clinical trial population will consist of male or female patients, 18 - 60 years suffering from acute; strains, sprains or bruises of the extremities following blunt trauma, and meeting all clinical trial entry criteria.

200 patients will be enrolled (assumes a drop-out-rate of ≤10%).

The study will be performed in Germany in 3 sites

Eligibility Criteria:
Inclusion criteria

1. acute sports-related soft-tissue injury/contusion (strains, sprains, bruises) of the upper or lower limb
2. location of injury such that pain-on-movement (POM) is elicited on by specified exercises
3. enrollment within 6 hours of the injury
4. baseline VAS score for POM of injured extremity \> 50 mm on a 100 mm VAS
5. size of injury, as assessed by investigator, ≥ 25 cm2 and ≤ 120 cm2
6. adult male or female patients
7. age 18 to 60 years
8. having given written informed consent
9. satisfactory health as determined by the Investigator based on medical history and physical examination.

Exclusion criteria

1. significant concomitant injury in association with the index acute sports-related soft- tissue injury/contusion; e.g. fracture, nerve injury, ligament disruption, tear of muscle or cartilage, or open wound
2. excessively hairy skin at application site, cutting the hair in the injured site prior to patch application will qualify for inclusion
3. current skin disorder or shaving hair at application site
4. history of excessive sweating/hyperhidrosis inclusive of application site
5. intake of NSAIDs or analgesics within 36 hours, opioids within 7 days, or corticosteroids within 60 days of inclusion in the study
6. intake of long-acting NSAIDs or application of topical medication since the injury (RICE allowed)
7. participation in a clinical study within 30 days before inclusion in the study or concomitantly
8. drug or alcohol abuse in the opinion of the investigator
9. Pregnant and lactating women
10. Women of child-bearing potential (defined as all women physiologically capable of becoming pregnant) who are not using an acceptable method of contraception defined as:

    * Surgical sterilization
    * Hormonal contraception
    * Intra Uterine Device
    * Double barrier method
    * Total abstinence throughout the study at the discretion of the Investigator.
Immunological Follow-up After SARS CoV2 Vaccination in Kidney Transplant Recipients

The investigators goal is to assess the vaccine response of kidney transplant patients following vaccination against SARS-CoV-2.

The study population will be derived from cohorts of kidney transplant patients who have been transplanted for more than 3 months and have no contraindications to vaccination. These patients will be vaccinated as part of routine care with a CoV-2 SARS vaccine licensed in France.

In this cohort, the investigators wish to study the post-vaccination humoral response by assaying neutralizing antibodies against SARS CoV-2 and the specific cellular response of SARS Cov-2 by quantiferon and in vitro lymphocyte stimulation assays.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18 years of age or older
* Patient vaccinated against SARS-CoV-2 as part of routine care
* Kidney or pancreatic kidney transplant
* Transplantation for more than 3 months
* Subject affiliated to a social protection health insurance
* Subject able to understand the objectives and risks of the research and to give signed and dated informed consent

Exclusion Criteria:

* History of anaphylactic shock or known allergy to PEG
* Known history of COVID or positive Covid serology in the 3 months prior to vaccination
* Contraindication to an intramuscular injection
* Impossibility to give informed information about the subject (subject in an emergency situation, difficulties in understanding the subject, ...)
* Subject under safeguard of justice
* Subject under guardianship
Botulinum Toxin for Treatment of Seborrhic Dermatitis in Parkinsonian Patients

There's high incidence of seborrhic dermatitis among patients suffering from Parkinson's disease. Seborrhic dermatitis is caused by increased exertion of sebaceous glands. Previous studies have shown an increase of sebum excretion rate in parkinsonian pateints. Other studies demonstrated improvement in seborrhic dermatitis after anticholinergic treatment. From these studies we concluded that there might be hyperactivity of the parasympathetic system among PD patients, that cause increased exertion of sebum, therefore local injection of botulinium toxin, which inhibitis acetyl choline realese, might improve the rash of seborrhic dermatitis.

40 patients suffering from Parkinson disease or other parkinsonian disorders will participate in this study.

Before treating the patients with botulinium toxin, we will measure the sebum exertion with the sebumeter device and make clinical evaluation of the rash. We will also take a picture of the rash.

Then Botulinium toxin (60- 100 units) will be locally injected to the rash area.

Two weeks after the injection the patients will be called and evaluated clinicly and by the sebumeter. Then they will be checked again after 3 weeks, after a month and after two, three and four month's.

Exclusion criteria:

* Dementia
* Renal or liver failure
* Pregnancy or breast feeding
* History of allergy to botolinium toxin
* Motor neuron disease or any other disease that insult the neuromuscular junction
* Treatment with Amynoglycoside antibiotic. This study will include only patients that can give informed concent.

SEBUMETER SM 810- this is the device we will use to measure sebum exertion before and after injecting botulinium toxin. The measurement is based on grease-spot photometry. A special tape becomes transparent in contact with the sebum on the skin surface. For the determination of the sebum, the measuring head of the cassette is inserted into the aperture of the device, where the transparency is measured by a light source sending light through the tape which is reflected by a little mirror behind the tape. A photocell measures the transparency. The light transmission represents the sebum content on the surface of the measuring area. A microprocessor calculates the result, which is shown on the display in µg sebum/cm² of the skin.

Eligibility Criteria:
Inclusion Criteria:

* Parkinson disease patients that have seborrhic dermatits

Exclusion Criteria:

* Dementia
* Renal or liver failure
* Pregnancy or breast feeding
* History of allergy to botolinum toxin
* Motor neuron disease or any other disease that insult the neuromuscular junction
* Treatment with Aminoglycoside antibiotic.
Clinical Validation of ColonAiQ (a Blood-based Assay Targeting ctDNA Methylation) for Colorectal Cancer Detection

The DNA methylation targets in preoperative plasma samples of the subjects will be detected by the multi-gene methylation test (ColonAiQ), and the test accuracy will be evaluated by compared with the clinical diagnosis evidence.

The accuracy of ColonAiQ test in clinical testing will be evaluated in the multicenter, prospective study. Patients with colorectal cancer, intestinal polyps, adenomas and other non-neoplastic diseases of the digestive system, and patients with non-colorectal cancer such as gastric cancer, esophageal cancer, breast cancer and lung cancer will be enrolled. In this study, all cfDNA will be tested by fluorescence quantitative PCR, and some samples will be tested by NGS to verify the effectiveness of ColonAiQ test. Clinical diagnosis reports and methylation test results will be blinded to the lab tester and clinician respectively.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years old, gender is not limited;
2. meet one of the following conditions: 1) Suspected colorectal cancer (CRC); 2) Diagnosed with CRC according to clinical diagnostic criteria; 3) Do not have CRC and have interfering diseases:

   1. Confirmed non-CRC digestive tract cases: colorectal polyps, adenomas, and other benign diseases of the digestive system;
   2. Confirmed cases of other cancers other than CRC: gastric, esophageal, breast, and lung cancer;
   3. diseases where the same gene methylation may be present (non-rheumatoid arthritis, etc.);
3. The subject or his/her guardian is able to understand the purpose of the study, demonstrate sufficient adherence to the study protocol, and sign the informed consent.

Exclusion Criteria:

1. People who cannot tolerate relevant tests for clinical diagnosis;
2. Pregnant women;
3. Patients who have previously received colorectal cancer surgery, tumor drug therapy, neoadjuvant therapy, or radiotherapy;
4. Other conditions deemed unsuitable for inclusion by the investigator.
Exercise for Patients With HIV Infections

The investigators will evaluate the effects of an endurance exercise program on the physical performance, the well being, and indicators of metabolic function in patients with an HIV infection.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 65
* HIV infection
* Antiviral therapy
* Understanding of written German

Exclusion Criteria:

* Diabetes mellitus
* All conditions which can be aggravated by exercise
ASCENT: Androgen Independent Prostate Cancer Study of Calcitriol Enhancing Taxotere

The purposes of this study are to determine if DN-101 plus Taxotere lowers PSA levels, delays or limits disease progression and is safe with minimal side effects.

DN-101 is an investigational drug that has not been approved by the U.S. Food and Drug Administration (FDA). It is a newly formulated pill that contains high amounts of calcitriol, a naturally occurring hormone and the biologically active form of vitamin D. Administration of DN-101 results in much higher blood levels of calcitriol than the body can produce from dietary vitamin D or vitamin D supplements. These higher levels of calcitriol are associated with anti-cancer effects in laboratory models of human cancer. Laboratory models also indicate that calcitriol has synergy with many commonly used chemotherapeutic agents used to treat cancer.

Calcitriol, at very low doses, is currently approved for use in patients with chronic kidney failure. DN-101 was specifically designed for cancer and contains 30 times the amount of calcitriol found in the calcitriol pill commercially available today. In order to take an amount of calcitriol equivalent to 1 DN-101 pill, cancer patients would need to swallow 30 pills of the approved, low dose formulation. DN-101 represents a breakthrough in the use of calcitriol in the clinic, because it contains high concentrations of calcitriol and makes it more feasible for patients to stay on regimen.

Eligibility Criteria:
* Three rising PSA measurements OR a new metastatic lesion
* Adequate liver and kidney function
* Ongoing hormonal therapy
* No hospitalization for angina, heart attack or congestive heart failure within the last 12 months
* No kidney stones in the last 5 years
Relationship of EBV-positive Gastric Cancer and Multiple Genes Associated With Gastric Carcinogenesis

The data of 460 gastric cancer patients who underwent curative gastrectomy with D2 lymph node dissection between January 2017 and February 2022 were analyzed. The clinicopathological features and prognosis of the patients with EBV-positive gastric cancers were compared with those of EBV-negative gastric cancers. Immunohistochemistry for epidermal growth factor receptor (EGFR), C-erb B2, Ki-67, and p53 was performed. Additionally, in situ hybridization was conducted to detect EBV, and microsatellite instability (MSI) analysis was used to assess the deficiency in mismatch repair (MMR) genes.

This study collected consecutively the data of 463 patients with gastric adenocarcinomas who underwent curative gastrectomy with lymphadenectomy at our institution between January 2017 and February 2022. The Institutional Review Board of St. Vincent's Hospital, The Catholic University of Korea approved this study (VC22RISI0177). Informed consent of the patients was waived because of the retrospective nature of the study. The inclusion criteria were: (1) gastric adenocarcinoma; (2) R0 resection; (3) formalin-fixed paraffin-embedded tissue (FFPE) blocks available for analysis. Patients who had undergone previous surgery, palliative resection, chemotherapy, or radiation therapy were excluded. All patients underwent gastrectomy with lymphadenectomy based on the Korean Practice Guideline for Gastric Cancer 2018 \[18\]. After the surgery, clinical follow-up data were collected every 6 months during the first year and then every year thereafter. Disease-free survival (DFS) was defined as the length of time from curative surgery to the first tumor recurrence or distant metastasis. Overall survival (OS) was defined as the time from curative surgery to death from any cause.

Eligibility Criteria:
Inclusion Criteria:

* (1) gastric adenocarcinoma; (2) R0 resection; (3) formalin-fixed paraffin-embedded tissue (FFPE) blocks available for analysis.

Exclusion Criteria:

* Patients who had undergone previous surgery, palliative resection, chemotherapy, or radiation therapy were excluded.
Deuterium Metabolic Imaging in People with Multiple Sclerosis

The goal of this case-control study is to investigate glucose brain metabolism in people with multiple sclerosis and age- and sex-matched healthy controls. The main questions it aims to answer are:

* How does brain glucose metabolism in people with multiple sclerosis compare to age- and sex-matched healthy controls?
* How is the brain glucose metabolism of people with multiple sclerosis associated with disease severity?

Participants will come in for testing lasting approximately three hours and undergo deuterium metabolic imaging, physical function test, cognitive function test, and answer survey.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18-60 years.
* Definite Relapsing remitting multiple sclerosis diagnosis according to the most recent diagnostic criteria

Exclusion Criteria:

* Contraindications for MRI:

Pacemaker, neurostimulator or cholera implant. Metal foreign bodies such as fragments and irremovable piercings. Unsafe medical implants (safety of heart valves, hips and the like must be confirmed).

Claustrophobia. Largest circumference including arms \&gt; 160 cm

* Pregnancy
* Competing neurological, psychiatric, or systemic diseases including diabetes (except prior TIA, unspecific brain MRI findings, hypertension, atherosclerosis and hyperlipidemia/cholesterolemia which are allowed).
* Participating in other clinical trials with investigational medical products or drugs.
Recent Techniques for Diagnosing Central Venous Catheter-related Bloodstream Infections in Children

Removal of a central venous catheter (CVC) is often useful to prove its responsibility in a bloodstream infection. To avoid unnecessary removal of CVC, some catheter-spearing diagnostic methods have been recently developed. The aim of the study is to evaluate three catheter-spearing diagnostic methods in critically ill children: 1) the measurement of the differential time to positivity between a blood culture drawn from a peripherical vein and another one drawn through the CVC; 2) the exam of a blood sample drawn for the CVC and stained by acridine orange leucocyte cytospin test; 3) the semi-quantitative skin culture of the area around the insertion site of the CVC.

Samples for the three techniques described above will be collected from the children admitted in Pediatric Intensive Care Unit with a CVC for more than 48 hours and with clinical or biological signs of systemic infection. Any investigation required to determine the origin of the infection will be performed, according to physician's judgement. If the CVC is removed or changed on a guide wire, a quantitative culture of the distal segment will be performed.

All the patients with a bloodstream infection and sampled according to the protocol will be included for statistical analysis. The physician and an independent medical expert will analyse if the bloodstream infection is CVC-related or not, according to the reference standard, by analysis of the clinical and bacteriological data, blinded towards the three studied techniques. The most optimal threshold will be determined and the sensibility, the specificity, the positive and negative predictable value of the three techniques will be calculated. Then sensibility of these three techniques will be compared.

Eligibility Criteria:
Inclusion Criteria:

* age between 0 and 18 years.
* Presence of a Central Venous Catheter for more than 48h (excepted umbilical catheter or peripherally inserted central catheters)
* Presence of at least one clinical or biological sign of systemic infection
* Parents are informed of the protocol and don't refuse the inclusion
* Prior inclusion in this study for the same bloodstream infection

Exclusion Criteria:
Online Support for Outpatient Peripheral Arterial Disease Self-management

This study looks to examine whether an online patient tool to monitor factors affecting patients peripheral artery disease can lead to improvements in patients' disease and slow its progression.

The objective of this project is to implement a program involving a new online patient-centred approach to assist in peripheral arterial disease (PAD) self-management in home and work environments, in collaboration with patient circles of care (patients, care-givers, physicians, and allied healthcare professionals). This program involves online modules tailored to the needs of specific patients and diseases, oriented to education, training, monitoring, and continuing support for lifestyle changes (smoking cessation, exercise, healthy diets, weight loss, etc.) and psycho-social needs such as social isolation and loneliness. The investigators have tested an online desk-top version for over 30 out-patients with PAD at St. Michael's Hospital in Toronto. The investigators propose to test its ability for improved outcomes and healthcare quality of life through a multi-centre randomized controlled trial for PAD and a frequently co-occurring chronic illness, high blood pressure.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18 years
* diagnosed with peripheral artery disease (ABI\<0.9)

Exclusion Criteria:

* unable to communicate in English
* unwilling to participate
* patients with dementia or other cognitive impairment
Expanded Access to ABBV-CLS-484

This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to ABBV-CLS-484 prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.


Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

-
The Relationship Between Morbid Obesity and Carotid Artery Stenosis

The correlation between metabolic syndrome and carotid artery stenosis is well established. The purpose of this study is to evaluate the relationship between morbid obesity and carotid artery stenosis.

The investigators hypothesis is that there is a direct relationship between morbid obesity and carotid artery stenosis. The investigators hypothesize that metabolic/Bariatric surgery improves the stenosis in the carotid artery.

This is a prospective comparative study on the candidates for metabolic/Bariatric surgery in the bariatric center, Emek Medical Center, Afula, Israel. The investigators will compare the candidate for metabolic surgery with metabolic syndrome risk factors to the ones without metabolic syndrome risk factors.

The assessment of the carotid artery will be done by Ultrasound Doppler before surgery and 6, 12 and 24 month post surgery.

Eligibility Criteria:
Inclusion Criteria:

• Candidates for first bariatric surgery

Exclusion Criteria:

* Smokers or past smokers
* Patients who are post carotid artery intervention