cyrilzakka/clinical-trials huggingface dataset:
Interest of Whole-body MRI Correlated to Spreading Sequences for Staging Neuroendocrine Tumors

The diagnosis and the follow-up of neuroendocrine tumors can be difficult to assess, especially in the detection of metastasis as they can grow in different organs such as liver, lungs, bones or lymph nodes. Nowadays, the diagnosis is made with two main imaging techniques which are the thoraco-abdomino-pelvic CT-scan and a scintigraphic method (Octreoscan and sometimes a TEP-scan). The use of a whole-body MRI is more and more often used for the detection and evaluation of tumors and metastases; therefore, it could be used for neuroendocrine tumors. The MRI would allow to replace the two imaging techniques and to avoid the use of irradiation but also to have a better detection of metastases. This purpose of the study was to evaluate this statement by assessing the consistency between the routine techniques and the MRI and finally to update the recommendation if the study is positive.

The main metastatic sites of neuroendocrine tumors can be the liver, the bones, the lungs and lymph nodes. According to the French recommendations (" Thesaurus national de cancérologie digestive "), the initial assessment includes a thoraco-abdomino-pelvic CT-scan and a scintigraphic method (Octreoscan and TEP-scan if Octreoscan negative). The aim is to detect metastases and tumoral progression to offer the appropriate treatment, such as surgery. Due to its high contrast resolution, its absence of irradiation, and diffusion sequences, the MRI is more and more used to detect tumor progression. The recent literature shows better results with the diffusion sequences than the T2-weighted sequences and, potentially, than the contrast-enhanced sequences to detect liver metastasis. The whole-body diffusion-weighted MRI seems promising for the staging and the following of some cancers. Only two publications have evaluated the diagnostic value of diffusion sequences to detect pancreatic neuroendocrine tumors and liver metastasis. Yet, no publication has assessed the diagnostic value of whole-body diffusion-weighted MRI in the patients with neuroendocrine tumors.

Eligibility Criteria:
Inclusion Criteria:

* Patients with moderately to well-differentiated neuroendocrine tumors with stage ≥ 3 according to the classification ENETS, regardless the tumor site and the OMS
* Patients who signed the informed consent
* Patients followed in one of the participating center

Exclusion Criteria:

-
Evaluation and Treatment of Heart Disease in Patients Not Participating in Research

There is an important need to maintain clinical skills, provide quality training and expertise, and provide an environment that stimulates ideas for clinical research.

This study permits inpatient evaluation and management of patients with heart disease who do not qualify to participate in studies currently being conducted by the Cardiology Branch of the National Heart, Lung, and Blood Institute.

There is an important need to maintain clinical skills, to ensure adequate training and expertise, and provide an environment that stimulates ideas for clinical research. This protocol permits inpatient evaluation and management of patients with heart disease who do not fulfill criteria for participation in existing Cardiology Branch research protocols.

Eligibility Criteria:
Patients with signs or symptoms of heart disease.

Patients selected because of either medical or research interest to the Principal Investigator.

Patients must not have unstable angina pectoris, unstable course following recent (within one month) myocardial infarction.

Must not be in New York Heart Association functional class IV heart failure.

A positive pregnancy test will obviate any cardiovascular testing requiring ionizing radiation.
Comparative Analysis of Two Therapeutic Strategies in Patients With Spondyloarthritis Treated With Anti-tnf Biologics

The objective of the study is to evaluate two therapeutic strategies: "early switch" or "therapeutic intensification" in patients with spondyloarthritis in case of secondary treatment failure suspicion to a first monoclonal antibodies anti-TNF definite by increase of ASDAS and positivity to ADAb.

Patients and Methods:

Multicentric randomized prospective study. Duration of inclusion 30 months. Duration of follow-up 24 months. 104 patients with spondyloarthritis treated with infliximab or adalimumab will be included if their ADAb dosage is positive, and they will be randomized (1:1) in two groups : "early switch" where treatment will be change to another anti-TNF, or "therapeutic intensification" where interval between two injections will be shortened. Patients will be evaluated clinically (ASDAS) and biologically (ADAb) at 12 weeks then at 24 weeks. Principal outcome will be the variation of ASDAS between baseline and end of the study. Number of patients to be included has been determined statistically from a preliminary study (power \>98% for ASDAS variation of 20% on week 24).

Expected results:

On week 24, we expect a better response and a greater proportion of patients in remission in the "early switch" arm compare to the "therapeutic intensification" arm.


Eligibility Criteria:
Inclusion Criteria:

* Spondyloarthritis positive for the ASAS criteria, treated with a first biologic : infliximab ( 5mg/kg intravenously every 8 weeks) or adalimumab (40mg subcutaneously every 2 weeks)
* Active spondyloarthritis definite by ASDAS-CRP \> 2.1 at two successive evaluations while patient was previously responder (ASDAS\<2.1 at least once in the 6th months after beginning of treatment)
* Positivity to anti-drug antibodies (ADAb)
* Consent of the patient
* No contra-indication to another anti-tnf biologic
* affiliation to health insurance
* woman of childbearing age must use an appropriate mean of contraception

Exclusion Criteria:

* Pregnant or breastfeeding woman
* contra-indication to anti-tnf biologic
* patient with known hypersensitivity to any of the excipients
* Severe and uncontrolled opportunistic infection , includins septicemia, tuberculosis, abcess and opportunistic infection
* Evolutive infection, including chronic or localised infection
* Patient with moderate to severe heart failure (NYHA class III/IV)
Dim Light at Night in Patients With Obstructive Sleep Apnea

With the advent of electricity, light at night has become a ubiquitous part of our society.

The main purpose of this study is to determine whether sleeping with dim light (40 lux), the brightness of a night light) in your bedroom for 5 consecutive nights will result in increased markers of inflammation in the blood compared to sleeping in darkness during the night in patients with obstructive sleep apnea (OSA).

A secondary aim is to examine the effects on insulin sensitivity, other blood proteins, and RNA molecules as a result of sleeping with dim light. RNA molecules are substances in blood that dictate what type of proteins the body should make.

The primary objective of this study is to determine whether sleeping with dLAN (40 lux) for 5 consecutive nights will result in increased markers of inflammation compared to sleeping in darkness (\< 1 lux) during the night in patients with OSA. A secondary aim is to examine the effects on insulin sensitivity, adipokines, and RNA molecules.

The risks associated with this study are minimal compared to the potential benefits. Knowledge about the effects of sleeping with dim light on inflammation in patients with OSA is important and would guide future recommendations about proper sleep hygiene. This research may also guide future recommendations about light conditions in other environments such as hospital bedrooms.

Eligibility Criteria:
Inclusion Criteria:

* • 18 -60 years of age.

  * Willing and able to give informed consent
  * AHI \>10 episodes per hour based on a prior PSG.
  * Patients who have been started on treatment for OSA with either Continuous Positive Airway Pressure (CPAP) or dental device will be eligible for the study as long as they have been compliant with treatment for at least 30 days.

Exclusion Criteria:

* • Incapable of giving informed consent

  * Under the age of 18
  * Currently sleeping with lights on in the bedroom
  * Excessive alcohol consumption

    * Excessive alcohol use is defined as:
    * More than 3 glasses of wine a day
    * More than 3 beers a day
    * More than 60 mL of hard liquor a day
  * Room air oxyhemoglobin saturation \< 88%
  * Use of home oxygen
  * Use of corticosteroids and other immunosuppressive medications.
  * Diagnosis of: HIV, Connective Tissue Disease (Lupus, Rheumatoid arthritis), Inflammatory Bowel Disease.
Estimated Glomerular Filtration Rate After Kidney Transplantation - the Formula MDRD, CKD-EPI or Cockroft-Gault?

The study included 300 patients who are post-kidney transplantation (\> 3 months and \<10 years). An analysis of body composition using bioelectrical impedance, calculated BMI and serum creatinine was determined. Glomerular filtration rate (GFR) was calculated using the formula CKD-EPI, Modification of Diet in Renal Disease (MDRD) and Cockroft-Gault.


Eligibility Criteria:
Inclusion Criteria:

* give voluntary consent to participate in the study
* functioning graft longer than 3 months to 10 years
* no clinical cardiovascular disease during the 6 months preceding entry
* stable graft function- glomerular filtration rate \> 30 ml/min/1.73 m2, creatinine concentration \<2.5 mg/dl

Exclusion Criteria:

* not meet the above criteria
* episode of illness (for example: infection)
* pregnancy
Ceramide Level as Apredictor of Outcomes in Patients of Anterior Myocardial Infarction Undergoing Primary Coronary Intervention

Ceramide level as a predictor of outcomes in patients of anterior myocardial infarction undergoing primary Coronary intervention

Ceramides are a family of lipid molecules that are found in high concentrations within cell membranes and play a key role in a variety of physiological functions including apoptosis, cell growth, cell adhesion and plasma membrane integrity maintenance.(1)

All tissues can synthesize ceramides de novo from saturated fats and sphingosine.(2) the ( LDL ) Present in atherosclerotic plaque is rich in ceramide and contain 10 - 50 fold higher content of ceramide when compared with plasma LDL .(3)

Ceramide (d18:1/16:0) is associated with the fraction of necrotic core tissue and lipid core burden in coronary atherosclerosis.(4) Previous clinical research found that circulating ceramides are elevated in patients with hypertension,(5) obesity (6 - 7) and type II diabetes mellitus.

Previous clinical research found that elevated ceramide plasma concentrations are associated with coronary plaque vulnerability evaluated by intravascular ultrasound .

virtual Recent studies showed targeted profiling of ceramides predicted short-term and long-term major adverse cardiac events.

Plasma ceramide level is also positively associated with the levels of total cholesterol. \[8 - 9\] The plasma ceramides that have been studied as high-risk factors are Cer (d18:1/16:0), Cer (d18:1/18:0) and Cer (d18:1/24:1) and the ratios of these ceramides to Cer (d18:1/24:0) \[10 - 11\].

However, it is tempting to speculate that ceramides are associated with plaque vulnerability as they are known to fuel many central atherosclerosis processes including lipoprotein aggregation and uptake, inflammation, superoxide anion production, andapoptosis 12 - 13 - 14

Eligibility Criteria:
Inclusion Criteria:

* 1- Subjects with anterior STEMI according to ESC guidelines 2017 . 2. Subjects undergoing PPCI

Exclusion Criteria:

* Patients with previous PCI. Patients with previous CABG. Patients with TIMI flow less than II. Patients with residual stenosis more than 70 % in major artery. Cardiogenic shock.
Evaluation of Heart Rate Variability in Third Lower Molars Surgeries

The purpose of this study is to use heart rate variability as a monitor of cardiovascular safety during third molar surgeries, using the Polar heart rate-meter.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Patients (ASA I)
* Need to remove one of Lower Third Molar.

Exclusion Criteria:

* smoking
* pregnant
Molecular Targets for the Treatment of Histiocytosis

The primary objective: to develop technical and operating procedures for detection mutations of histiocytosis during clinical practice of no-specialized molecular platforms, for diagnosis and follow-up of the disease.

The secondary objectives: to describe therapeutic target mutations in histiocytosis patients, and to develop the cellular tests to evaluate in vitro the sensibility of these mutations drive to inhibitors.

The study is ancillary of the French "Gene Histio" cohort (patients already included) and "HISTIO target 2020" cohort (patients recruited since may 2020).

The data base of the French registry of histiocytoses is held by Dr J. Donadieu, and localized in Trousseau hospital (APHP) 75012 Paris, France, where server and backup are kept.

5 teams contributes to the study with different role: Team 1 is responsible for histology diagnosis, selection of histiocyte- rich areas, extraction of nucleic acids and detection of the BRAF p.V600E mutations. This group is also responsible of the tissue and nucleic acids biobank.

Team 2 is responsible for the collection of clinical data and tissue and blood samples of the children. This group is also responsible of the clinical data base.

Team 3 is responsible for the collection of clinical data and tissue and blood samples of the adult patients.

Team 4 is responsible for the development and validation of the new methods of detection of genetic somatic alterations described in project, and will perform most of the molecular analyses and interpretations.

Team 5 is responsible for regulatory requirements preparation and submissions and takes care of replying to regulatory comments and amendments until getting approvals. The project manager will also take care of the coordination of all activities related to the database setting and utilization, liaising between researchers, doctors and operational team. Team 5 will be in charge of the data management of the database and will ensure collection tools, integration and availability of data at appropriate quality. The data manager ensures that data is collected, validated, complete, and consistent, to provide a high quality and comprehensive database to the statistics team. Team 5 includes also a statistician who will perform data analysis according to a detailed statistical analysis plan to be developed once the project is approved.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven histiocytosis;
* Informed consent form signed by patients (or parents/legal tutors of children) to participate"Gene Histio" or "HISTIO target 2020".

Exclusion Criteria:

- Patient refusal.
Ro 31-7453 in Treating Patients With Metastatic Solid Tumors

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Randomized phase I trial to determine if Ro 31-7453 is more effective with or without food in treating patients who have metastatic solid tumors.

OBJECTIVES: I. Assess the impact of food on the bioavailability of Ro 31-7453 in patients with locally advanced or metastatic solid tumors.

OUTLINE: This is a randomized, crossover study. Patients are randomized to one of two treatment arms. Arm I: Patients receive oral Ro 31-7453 under fasting conditions on day 1. After a 1-week washout period, patients receive oral Ro 31-7453 under fed conditions. Arm II: Patients receive fed treatment as in arm I on day 1. After a 1-week washout period, patients receive fasted treatment as in arm I. Both arms: At the start of week 3, patients may continue to receive oral Ro 31-7453 every 12 hours on days 1-4. Treatment repeats every 3 weeks for at least 24 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed at 7 days.

PROJECTED ACCRUAL: A total of 10 patients (5 per arm) will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed locally advanced or metastatic solid tumor for which no standard therapy is available No CNS metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Hemoglobin at least 9 g/dL WBC at least 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST and ALT no greater than 1.5 times ULN (4 times ULN for liver metastases) Alkaline phosphatase no greater than 2.5 times ULN (4 times ULN for liver or bone metastases) Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No history or clinical signs of significant cardiovascular disease Other: No other serious concurrent illness No greater than grade II neuropathy No evidence of gastrointestinal dysfunction No intolerance to a high-fat meal Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior biologic therapy Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) Endocrine therapy: At least 2 weeks since prior endocrine therapy (except for antiandrogen therapy) Concurrent antiandrogen therapy allowed Concurrent corticosteroids allowed if stable dose for at least 2 weeks prior to study Radiotherapy: At least 3 weeks since prior radiotherapy Surgery: Not specified Other: No prior enrollment in this study At least 4 weeks since prior investigational drugs No other concurrent investigational agents
Optiflow vs. Convential Anesthesia During Pediatric Laryngeal Papilloma Removal

This is a randomized cross over study of high flow oxygen delivery via nasal cannula vs. conventional tubeless anesthesia for patients undergoing dubulking surgery for laryngeal papilloma. Ten patients aged 2-17 with laryngeal papilloma that are eligible for debulking surgery will be consented and enrolled.

This trial will be a randomized unmasked open-label study of Transnasal humidified high-flow oxygen/air delivery compared to conventional tubeless anesthesia during airway surgery in pediatric patients. This will be a single center study at MEE main campus on 243 Charles St, Boston, MA for the use of the high-flow oxygen delivery device.

Two study arms will be used in this study. Subjects will be treated with both study arms over the course of two study visits. Enrolled patients will be patients that present themselves routinely for removal of laryngeal papilloma. These patients, once enrolled, will be randomized to either receive conventional tubeless anesthesia or standard anesthesia with the addition of transnasal high-flow oxygen/air for their next scheduled anesthetic. Oxygen flows for the high-flow nasal cannula will be titrated down to achieve a FiO2 value of 21% during lasering. The anesthesia method not chosen will be used for the following anesthetic for each patient. Intraoperatively patients will be monitored for number of desaturations below 90 percent, length of these desaturations and severity, number and type of interventions necessary by the anesthesiologist, and number of intubations necessary by the anesthesiologist. Flow rates appropriate for the age of the patient will be used and also be recorded within these cases. Adverse events and complications will also be recorded for both anesthetics.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of laryngeal papilloma via endoscopic exam by a pediatric ENT surgeon. And the expectation that he or she will require multiple debulking surgeries.
2. Age 2-17 years old at time of consent and both surgeries.
3. Parent/guardian consent and patient assent has been given.

Exclusion Criteria:

1. Patients with nasal obstructions or are otherwise not candidates for high flow oxygen delivery via nasal cannula.
2. Patients with underlying complicating pulmonary diseases like severe asthma, pulmonary hypertension, or ongoing pneumonia.
3. Pregnant patients.
4. Absence of parent or legal guardian able to provide written consent.
5. Patients who in the opinion of the investigator would not be good candidates for debulking surgery.
Study of Progression to Progressive Fibrosing Interstitial Lung Disease (PF-ILD) Incidence/Management and Treatment

The primary objective for this trial is to investigate the incidence probability of progression to Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs) in patients with fibrosing ILD other than Idiopathic Pulmonary Fibrosis (IPF) in real-world setting in Japan.

The secondary objective is to investigate the characteristics of procedures for management and treatment in patients with fibrosing ILD other than IPF in real-world setting in Japan.


Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with at least two fibrosing Interstitial Lung Disease (ILD) codes on different dates in the patient identification period
2. Patients aged 18 years and older on the index date
3. Patients for whom data for the 12 months prior to the index date can be extracted as baseline data

Exclusion Criteria:

1. Patients grouped into the underlying disease of Idiopathic Pulmonary Fibrosis (IPF)
2. Patients who have met PF-ILD progression criteria during the baseline period
An European Multi-centre Cohort Study for Unravelling Pharmacokinetic and Genetic Factors Underlying Post-ERCP Pancreatitis

Endoscopic retrograde cholangiopancreatography (ERCP) comes with a risk for post-ERCP pancreatitis (PEP), which accounts for considerable morbidity, high healthcare expenditure, and death. The pathophysiology of PEP and the underpinnings of the preventive effect of rectal NSAID (RN) is poorly understood. Guidelines advise to take preventive measures with a single dose of 100mg RN, peri-ERCP. While NSAID administration reduces the risk with 40%, PEP still occurs after ERCP. In addition, patients with a PEP history have a higher risk to develop recurrence after a subsequent ERCP. This might suggest that an underlying genetic risk may contribute to increasing the incidence of PEP in some patients.

This study is a hypothesis driven and hypothesis free analyses of PEP risk variants. Integrative analysis of NSAID pharmacokinetics and-genetics in PEP patients.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* written informed consent
* Indication to undergo an ERCP

Exclusion Criteria:

* Pancreatic cancer
* Chronic pancreatitis
* Ongoing acute pancreatitis
* Altered anatomy, defined as anatomical variations in which gall and/or pancreatic juices (in case of pancreatic duct interventions) do not enter the duodenum by way of the ampulla of Vater.