cyrilzakka/clinical-trials huggingface dataset:
Siewert Type I-II: CT, PET-CT, EUS Sensitivity/Specificity for the Assessment of Lymph Node Metastases

In Siewert type I/II EAC, sensitivity/specificity of CT, PET-CT, EUS for assessment of N descriptor in defined groups of lymph nodes were investigated.

Esophageal adenocarcinoma (EAC) is a disease with poor overall prognosis and rising incidence in western countries. In patients without organ metastases, therapy is currently based on surgery with or without neoadjuvant therapy; indication for primary surgery is reserved to clinical TNM stages 0-IIa, whereas a multimodality approach is more suitable for clinical TNM stages IIb-III. The operation comprises the resection of distal esophagus and proximal or total gastrectomy. Two field lymphadenectomy is generally recommended, but the extent of lymphadenectomy is among the controversial issues, as extensive removal of nodes may cause significant morbidity and its effect on survival in addition to neoadjuvant therapy is not clear. Current guidelines are based on the 7th edition of AJCC \& UICC TNM classification, which stages lymph node status (N) according to the number of metastatic nodes, but do not consider the specific anatomic stations of regional nodes. EAC subtypes are known to demonstrate different metastatic nodal patterns of spread. They may be classified with the Siewert's classification according to the position of the tumor with respect to the esophago-gastric junction (EGJ), or according to histologic parameters like the presence/absence of intestinal metaplasia in the esophagus and stomach. Siewert Type I EAC, which fairly corresponds to the Barret's like type according to the presence absence of intestinal metaplasia, spreads more likely to the thoracic nodal stations, while Siewert Type II and the pyloric like type, do spread more frequently to the perigastric and celiac stations. Therefore, an increasing interest is emerging for preoperative mapping of lymph nodes metastases in order to tailor surgery according to metastatic patterns.

The majority of studies aiming to assess the accuracy of N staging with clinical methods generally refer to the global evaluation of regional nodes according to the 7th edition of staging descriptors. Studies reporting specific data on the clinical staging assessment of specific thoracic and abdominal lymph nodal stations are few, diagnostic tests and results are not uniform, interpretation and comparison of data within reports is not immediate.

Eligibility Criteria:
Inclusion Criteria:

* Siewert type I-II adenocarcinoma \> 18 year submitted to primary surgery

Exclusion Criteria:

* Siewert type I-II adenocarcinoma submitted to neoadjuvant therapy.
* Siewert type III adenocarcinoma Squamous Carcinoma
Coronavirus Pediatric Serological Study

The Coronavirus Pediatric Serological Study's aim is to provide a better insight of children's immune response after SARS-CoV-2 infection.

Serological tests were conducted on blood samples taken 3 to 5 months after the children's viral infection.

The study was performed in collaboration with the Institute of Medical Immunology, were antibody levels were measured and immunoglobulin subclasses profiles were studied.

The hospital laboratory provided us the list of children under 15 years old tested for SARS-CoV-2 in Saint-Pierre Hospital (Brussels) by PCR on nasopharyngeal swab between March 1 2020 and December 31 2020.

The medical files of all children that were tested positive for SARS-CoV-2 were reviewed and clinical information was collected.

For each positive child, the family was contacted by phone 3 months after the proven viral infection in order to ask permission to take a single blood test.

Covid19 serologies were performed in the hospital laboratory, and blood samples were then sent to the Institute of Medical Immunology, were antibody levels and immunoglobulin subclasses were studied.

Eligibility Criteria:
Inclusion Criteria:

- Tested positive for SARS-CoV-2 by PCR on naso-pharyngeal swab performed in Saint-Pierre Hospital (Brussels) between March 1 2020 and December 31 2020

Exclusion Criteria:

* /
Exploratory Study of Apple Watch Electrocardiographic Diagnostic Performance Enhanced by an Artificial Intelligence Algorithm

This observational exploratory prospective study will evaluate the performance on an Artificial Intelligence (AI) solution interpreting ECG (electrocardiogram) collected from an Apple Watch (AI-AW) in the detection of Atrial Fibrillation (AF)

After being informed about the study, participants hospitalized for ablation or cardioversion or having a cardiac rhythm consultation at the investigational center will have Apple Watch ECG recordings done simultaneously with 12-lead ECG measurements performed in accordance with the existing in-stay subject monitoring protocol. AI-AW will be compared to standard manual 12-lead ECG reviewed by cardiologists for AF detection.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged 22 or older, able and willing to participate in the study
* Patient admitted to hospital for ablation, cardioversion or cardiac electrophysiological exploration or who come for regular rhythmology consultations
* Patient who has read the information note and has given his or her consent before any procedure related to the study
* Patient affiliated to social security

Exclusion Criteria:

* Pregnant or breastfeeding women
* Patient with a pacemaker, implantable defibrillator or cardiac resynchronisation therapy device.
* Subject related to the investigator or any other staff member directly involved in the conduct of the study
* Patient incapable of giving consent, minor or adult patient protected by law
Effect of Music Therapy on Pain

The aim of study is to assess the effects of this new music therapy technique on pain treatment, anxiety and depression and on medicinal consumption.

The "U" technique is a music therapy method of recent use developed by taking into account recommendations of the scientific literature. The objective of the study is to evaluate this method on chronic painful patients presenting a lumbago, a fibromyalgia, an inflammatory or neurological pathology. During the hospitalization, the intervention group benefited from at least 2 daily sessions of music therapy between day 0 and day 10, and continued the musicotherapy at home until day 60. The evaluated criteria are pain, depression and anxiety and their evolution after 60 days of treatment (since the inclusion). The evaluation at day 90 allows to test the persistence of the effect of the music therapy 90 days later.

Eligibility Criteria:
Inclusion Criteria:

* Have a pain for more than 6 months
* Pain of neurological origin (fibromyalgia, algodystrophies), or skeletal musculous (back, sciatic nerve)
* Speak and read French fluently
* Wrote consent of patients
* Benefit from the standard treatment : Intravenous treatment (tranquillizer, antidepressive) the first 5 days, 2 time by day (in the morning and evening), followed by the intermediary orally up to the exit (prescribed doses and at request)

Exclusion Criteria:

* Time of hospitalization \< 8 days
* Reflex epilepsy history
* Major insufficiency of auditory function
* Patient with a strong possibility of not compliance to the protocol or of abandon in the course of study
* Presence of an illness threatening vital forecast during period envisaged for the study
Expanded Access of Ruxolitinib Cream to Treat a Single Patient With cGVHD

To provide ruxolitinib through an expanded access to treat a single patient with cGVHD


Eligibility Criteria:
Endoscopic Versus Surgical Treatment for T1 Colorectal Cancer

The implementation of population screening programs for colorectal cancer (CRC) has led to a considerable increase in the prevalence T1 CRC originating on polyps amenable by endoscopy. The benefits of secondary oncological surgery in terms of disease free survival are not well established.

Hypothesis: The characteristics of the individuals and the polyp (endoscopic, histological) should allow us to discriminate T1 CRCs that may benefit from secondary surgery from those that only require local treatment. With the current criteria, the management of patients with T1 CRC is suboptimal since a high proportion of patients are refered for unnecessary surgeries without a clear benefit in terms of survival. Molecular signatures can help to discriminate those patients with good prognosis that do not require secondary surgery nor cancer related follow up.

The primary objective of the study is to compare the effect of oncological surgery versus local treatment for the management of polyps with T1 CRC in relation to disease-free survival and morbi-mortality of the therapeutic procedure. We will also validate molecular signatures in endoscopic samples for the prediction of lymph node metastasis and survival. Methodology: Clinical Study: Retrospective population-based cohort study that will include baseline clinical and follow up data of more than 1400 T1 CRCs in at least 10 Spanish autonomous communities from 2007 to 2017. A centralized pathological review will be carried out by a group of expert pathologists. Inter and intraobserver variability for histological staging will be assessed. A predictive model will be created to discriminate individuals with high probability of receiving surgical and local treatment. For those patients who have a similar probability range, the results in progression-free survival and adverse events will be compared. Translational phase: A 5miRNAs and 8mRNA signature predictive of lymph node metastasis will be assessed in 200 endoscopic samples and related with prognosis.

Eligibility Criteria:
Inclusion Criteria:

- All patients diagnosed with pT1 CRC will be included, regardless of endoscopic features, treatment received and lymph node staging

Exclusion Criteria:

* CRC with other histology than adenocarcinoma
* Patients with hereditary syndromes of CRC (Lynch syndrome, classical familial adenomatous polyposis) or inflammatory bowel disease.
* Synchronous CRC
* Metachronous CRC in the previous 5 years
* Patients with metastatic neoplastic disease at the time of diagnosis
Simvastatin as a Neuroprotective Treatment for Moderate Parkinson's Disease

Participants are randomly allocated to one of two treatment groups. In one group, participants are given capsules of simvastatin to take orally (by mouth) for 24 months. In the other group, participants are given placebo (dummy) capsules to take orally for 24 months. At the start of the study, when they receive their medication, participants complete a number of questionnaires and motor (movement) tests (a walking test and a finger tapping test). Participants in both groups also attend a further 6 clinic visits after 1, 6, 12, 18 and 24 and 26 months, where they are asked about their health and any medication they are taking, as well as repeating the questionnaires and motor tests. For 4 of the clinic visits, the participants will be asked to attend in the 'OFF medication' state (having omitted their usual PD medication) so that the researchers can get a true picture of their disease without it being masked by their normal medication.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of idiopathic PD
* Modified Hoehn and Yahr stage ≤ 3.0 in the ON medication state
* Age 40-90 years
* On dopaminergic treatment with wearing-off phenomenon
* Able to comply with study protocol and willing to attend necessary study visits

Exclusion Criteria:

* Diagnosis or suspicion of other cause for parkinsonism
* Known abnormality on CT or MRI brain imaging considered to be causing symptoms or signs of neurological dysfunction, or considered likely to compromise compliance with study protocol
* Concurrent dementia defined by MoCA score \<21
* Concurrent severe depression defined by MADRS score \>31
* Prior intracerebral surgical intervention for PD including deep brain stimulation, lesional surgery, growth factor administration, gene therapy or cell transplantation
* Already actively participating in a research study that might conflict with this trial
* Prior or current use of statins as a lipid lowering therapy
* Intolerance to statins
* Untreated hypothyroidism
* End stage renal disease (creatinine clearance \<30 mL/min) or history of severe cardiac disease (angina, myocardial infarction or cardiac surgery in preceding two years)
* eGFR \<30 mL/min
* History of alcoholism or liver impairment
* Creatine kinase (CK) \>1.1 x upper limit of normal (ULN)
* Aspartate transaminase (AST) or alanine transaminase (ALT) \>1.1 x ULN
* Females who are pregnant or breast feeding or of child-bearing potential and unwilling to use appropriate contraception methods whilst on trial treatment
* Currently taking any medication contraindicated with simvastatin use (Appendix 2)
* Any requirement for statin use
* Regular participation in endurance or high-impact sports
* Unable to abstain from consumption of grapefruit-based products
Safety and Immunogenicity of a Booster Dose of -H5N1 Influenza Vaccine

To assess persistence of antibody titers 17-18 months after primary immunization with two 0.5mL intramuscular (IM) doses of H5N1 influenza vaccine containing H5N1 influenza antigen, as measured by Hemagglutination Inhibition (HI), Single Radial Hemolysis (SRH), and Microneutralization (MN) test


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects who previously participated in study V87P1, but did not receive the booster dose on day 202

Exclusion Criteria:

* Pregnant or breastfeeding
* Receipt of another vaccine or any investigational agent within the past 4 weeks
* Surgery planned during the study period
Skin Sensitisation (Modified Draize-95 Test)

Skin Sensitization Test (Modified Draize-95) to Support a Low Dermatitis Potential Claim for a Powder Free Polychloroprene Surgical Gloves, Sterile. To evaluate whether residual chemical additives at a level on the gloves that may induce type IV allergy to the unsensitized general user population when using polychloroprene based surgical gloves

1. To evaluate whether residual chemical additives at a level that may induce Type IV allergy in the unsensitized general user population are present in a finished Polychloroprene Rubber Containing Medical Device, Powder Free Polychloroprene Surgical Gloves, Sterile. (CR-SG-140-AF-WH)
2. To meet requirements for claim: This product demonstrated reduced potential for sensitizing users to chemical additives as described in Guidance for Industry and FDA Staff- Medical Glove Guidance Manual. Supporting Test Data: A negative skin sensitization test (Modified Draize-95 Test) on a minimum of 200 non-sensitized human subjects.

Eligibility Criteria:
Inclusion Criteria:

* The test subjects are normal volunteers who have documented informed consent and have not participated in other voluntary testing for at least 30 days.
* Age of the test subjects ranged from 18 to 65 years.
* Efforts are made to provide racial and gender diversity of the test subjects that reasonably reflects the general user population in the US

Exclusion Criteria:

* The test subjects with any visible skin disease that might be confused with skin reactions caused by the test material.
* The test subjects with any indication of existing Type I allergy to natural rubber proteins.
* The test subjects who have used corticosteroids, either systemically or topically on the potential test site, two weeks before testing.
* Test subjects who have received endogenous or exogenous immunosuppressive treatments (or prolonged sun exposure).
* All subjects who are pregnant or become pregnant during the study.
* All lactating women,
The Pharmaco-genetic and Brain Mechanisms Associated With Cannabis- Induced Psychosis

There is growing evidence of high rates of substance use disorders among individuals with psychotic disorders especially in young people with predisposition for psychosis. There is some genetic evidence that carriers of the valine158 allele of the catechol-O-methyltransferase (COMT) gene had increased risk to exhibit psychotic symptoms and to develop schizophrenia if they used cannabis by the age of 18. It was also shown that carriers of the COMT val/val genotype were most sensitive to THC-induced psychotic experiences but this was conditional on pre-existing susceptibility to psychosis. The investigators propose to use brain-imaging and molecular genetics to investigate whether genetic factors may contribute to the THC-induced dopamine release and possibly to cannabis- induced psychosis.

Genetic association study will be performed in 100 young cannabis users (age 18-26 years) for genes that are related to the neurotransmitters dopamine (D2, DAT, COMT), GABA, glutamate and the cannabinoid receptor CB1. Out of this cohort, 24 male subjects without history of cannabis or drug-induced psychosis will undergo brain imaging procedure in order to measure THC-induced dopamine release using \[11C\] Raclopride in PET imaging. Carriers of high activity COMT158Val allele are expected to show higher meso-limbic DA release than carriers of low activity COMT 158Met homozygotes and after smoking a cigarette with THC which in turn are thought to underlie the risk for THC-induced psychotic symptoms. The aim of the present study is to evaluate the relationship between the COMT genotype and cannabis-induced meso-limbic dopamine release as measured by D2 occupancy. In addition, the association between predisposition to psychosis, age of onset of cannabis dependence, and genotype of COMT and other neurotransmitters-related genes will be evaluated. Such finding could provide novel pharmaco-genetic explanation for the psychogenic effects of cannabis in vulnerable individuals.

Eligibility Criteria:
Inclusion Criteria:

* age 18-26 meeting DSM-IV-TR (American Psychiatric Association, 1994) diagnosis of THC dependence will be recruited from the general population by advertisement in the newspapers.

Exclusion Criteria:

* dependence on other substances or alcoholism
* a history of CNS disease
* a history of infection that might affect CNS (HIV, syphilis, cytomegalovirus, herpes)
* a history of head injury with loss of consciousness and pregnancy
Tea Components, Mental Stress and Blood Pressure

Assess the effects of adding theanine to a caffeinated beverage on changes in blood pressure during acute mental stress.

Caffeine and (mental) stress can increase blood pressure. In a typical everyday and/or work environment they commonly coincide. Tea has the reputation of being a relaxing drink. L-theanine is an amino acid found almost exclusively in tea. In a previous study it was shown that caffeine increased blood pressure, while theanine antagonised these effects. In the current study the effect of theanine to a placebo on blood pressure are directly compared.

Eligibility Criteria:
Inclusion Criteria:

* Apparently healthy males and females
* Women taking the contraceptive pill
* 18-45 years of age
* BMI 20-30 kg/m2
* Normal or corrected vision
* Low caffeine consumers (\<100mg/day)
* Non smokers and having been a non-smoker for \> 6 months
* Fluent English
* Normotensive (\>90/60 \<140/90 mmHg)

Exclusion Criteria:

* Significant current or medical history of cardiovascular disease
* Low or high STAI trait score in the opinion of the PI
* Known sensitivity to caffeine or theanine
* Colour blindness
* Alcohol consumption above 14/21 units female/male resp. per week
* Weight loss diet \> 10% of bodyweight in the previous year
* Anyone with a dependency on PI or staff of Department of Epidemiology and Public Health or being an employee of Unilever
* Reported participation in another biomedical study \< 3 months before screening
Novel Stomal Occlusion Device in Patients With a Brooke Ileostomy

This investigation constitutes an initial evaluation of the stoma occlusion device in humans with a mature permanent Brooke ileostomy. The overall objective of this study is to assess feasibility and initial operating characteristics of a novel stoma occlusion device. The study will recruit 20 patients for placement of the device into the mature Brooke ileostomy and subsequent 2 hour observation period. The device will remain in the ileostomy for up to 2 hours.

An ostomy is a protrusion of part of the intestines extending through the abdominal wall for the purpose of elimination of wastes and may be temporary or permanent depending on the purpose of the initial surgery. The most common reasons for permanent bowel diversion are cancer and ulcerative colitis. Appliances have improved greatly over the last 50 years, but patients continue to experience appliance leakage and skin infections and struggle with the emotional and social impact of an external pouch. This study seeks to answer the opportunity to significantly improve quality of life to a large segment of the global population through optimization of a technology for a stoma occlusion device in patients with permanent stomas. Four pre-clinical animal studies have been conducted. All the animals that completed the study tolerated the device well and had no adverse reactions to device materials. This project will allow a prototype of an artificial stomal occlusion device to be tested in humans.

Eligibility Criteria:
Inclusion Criteria:

* Age range: 18 and older
* Gender: Male and Female
* Target disease or condition: 20 patients with permanent End Ileostomy, specifically Brooke ileostomy for greater than 3 years
* Ability to comply with protocol
* Competent and able to provide written informed consent

Exclusion Criteria:

* Inability to provide consent
* Crohn's Disease
* Koch pouch
* Pregnancy
* If subject's stoma length is less than 4 cm or longer than 8 cm
* Clinically significant medical conditions within the six months before participation with the device that would, in the opinion of the investigators, compromise the safety of the patient.
Femoral Nerve Blockade 7.5 ml of 1% Lidocaine: US Guidance Versus US Guidance With Electrical Stimulation of Peripheral Nerves (Influence of the Femoral Nerve Blockade on the Effectiveness of Small Doses of Local Anesthetic.). (EPBwEPN)

In modern anesthesiology, peripheral nerve blocks are performed using ultrasound control and electrical stimulation of peripheral nerves (PEN), or only ultrasound control or only EPN. The most effective methods are with the use of ultrasound control. Until now, the effectiveness of the femoral nerve blockade, performed only under ultrasound control without EPN, in comparison with the blockade of the femoral nerve performed under ultrasound control with EPN, has not been established.

There is no data on how the effectiveness of the blockade of the femoral nerve with small doses of lidocaine is influenced by the method of performing the blockade: under ultrasound control versus ultrasound control with electrostimulation of the nerve.

Research hypothesis: the blockade of the femoral nerve (7.5 ml 1%lidocaine -Minimum Effective Dose - previously established ) performed only under ultrasound control has the same effectiveness as the blockade performed under the ultrasound control with EPN.


Eligibility Criteria:
Inclusion Criteria:

* indication requiring anesthesia maintenance;
* patient's written consent about the type of anesthesia and possible complications of regional anesthesia

Exclusion Criteria:

* patient's refusal of application for the proposed form of anesthesia;
* patients younger than 18 years;
* patients weighing less than 50 kg;
* a physical status score of more than 3 determined by the American Society of --Anesthesiologists (ASA);
* a history of allergic reactions to the drugs used;
* coagulopathies;
* infections of the skin at the injection site;
* neurological or neuromuscular diseases;
* severe liver diseases or kidney failures;
* an inability to cooperate with the patient.