cyrilzakka/clinical-trials huggingface dataset:
Intergroup Randomized Trial for Children or Adolescents With B-Cell Non Hodgkin Lymphoma or B-Acute Leukemia: Rituximab Evaluation in High Risk Patients

The aim of the trial is to test whether adding 6 injections of rituximab to standard "Lymphome malin B" LMB chemotherapy regimen improves the Event Free Survival (EFS) compared with LMB chemotherapy alone in children / adolescents with advanced stage B-cell Non-Hodgkin Lymphoma (NHL) / B-Acute Leukemia (B-AL)(stage III and LDH \> Nx2, any stage IV or B-AL).


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically proven B-cell malignancies, either Burkitt lymphoma or B-AL (=Burkitt leukaemia = L3-AL) or diffuse large B-cell NHL or aggressive mature B-cell NHL non other specified or specifiable.
* Stage III with elevated LDH level ("B-high"), \[LDH \> twice the institutional upper limit of the adult normal values (\> Nx2)\] or any stage IV or B-AL.
* 6 months to less than 18 years of age at the time of consent.
* Males and females of reproductive potential must agree to use an effective contraceptive method during the treatment, and after the end of treatment: during twelve months for women, taking into account the characteristics of rituximab and during five months for men, taking into account the characteristics of methotrexate.
* Complete initial work-up within 8 days prior to treatment that allows definite staging.
* Able to comply with scheduled follow-up and with management of toxicity.
* Signed informed consent from patients and/or their parents or legal guardians

Exclusion Criteria:

* Follicular lymphoma, MALT and nodular marginal zone are not included into this therapeutic study
* Patients with congenital immunodeficiency, chromosomal breakage syndrome, prior organ transplantation, previous malignancy of any type, or known positive HIV serology.
* Evidence of pregnancy or lactation period.
* There will be no exclusion criteria based on organ function.
* Past or current anti-cancer treatment except corticosteroids during less than one week.
* Tumor cell negative for CD20
* Prior exposure to rituximab.
* Severe active viral infection, especially hepatitis B.
* Hepatitis B carrier status history of HBV or positive serology.
* Participation in another investigational drug clinical trial.
* Patients who, for any reason, are not able to comply with the national legislation.
Ophthalmological Screening and Follow-up of Optic Pathway Gliomas in Children With Neurofibromatosis Type 1.

The goal of this project is to get more insight into the (neuro)ophthalmological characteristics of children with neurofibromatosis type 1. This way investigators would like to update the current guidelines for follow up and treatment of optic pathway gliomas. Clinical findings will be compared with the results of Optical coherence tomography (OCT) and MRI (magnetic resonance imaging).


Eligibility Criteria:
Inclusion Criteria:

* neurofibromatosis type 1

Exclusion Criteria:

* no neurofibromatosis type 1
Unmasking the dynAmic Component in functionaL mitraL rEGuRgitatiOn in Chronic Heart Failure

Background:

Chronic heart failure (HF) is frequently accompanied by functional mitral regurgitation (FMR) caused by left ventricular (LV) remodeling and subsequent papillary muscle displacement resulting in mitral valve (MV) leaflet tethering, dilatation and flattening of the mitral annulus and reduced closing forces. Up to moderate FMR affects the majority of patients with systolic heart failure - roughly 80% - still independently increasing mortality. Every fifth patient with chronic heart failure experiences a progression of FMR during the first three years of follow up despite guideline directed heart failure therapy, which is independently associated with a poor prognosis. Furthermore, MR is well known to have a strong dynamic component not only during the cardiac cycle at rest and with exercise.

Aims of the study:

The investigators therefore aim to assess whether stress tests in patients with functional mitral regurgitation unmasks significant dynamic mitral regurgitation or might aid to identify patients at risk of FMR progression in patients with functional mitral regurgitation in heart failure with reduced ejection fraction (HFrEF) under guideline directed medical therapy.

Study design:

The investigators will prospectively perform stress tests in all patients with non-severe FMR that are routinely seen in the heart failure outpatient clinic.

Study patients:

Patients with stable chronic heart failure on optimal medical therapy, who undergo routine ambulatory clinical control visits in the heart failure outpatient ward of the Medical University of Vienna, will be included in the present study. A written informed consent will be obtained before inclusion. Inclusion criteria will be a non-severe FMR, an age of at least 18 years and stable heart failure related medical therapy in the last 3 months.

Methods:

All patients that are willing to participate will undergo stress testing (i.e. volume challenge and low dose dobutamine stress) to determine whether patients display severe dynamic FMR under stress conditions. Within the registry patients will be followed-up during routine ambulatory visits for three years. Patients with severe dynamic functional mitral regurgitation will be compared to patients without severe dynamic FMR. Record of clinical events during the FUP will be performed. Routine laboratory parameters, have been measured at inclusion. Additionally, neurohormone patterns will be measured at baseline and at peak stress.

Sample size:

Expecting a prevalence of severe dynamic FMR of 20%, the investigators would include a total of 150 chronic heart failure patients taking also into account a study-dropouts of 20% ( loss of follow-up and mortality).


Eligibility Criteria:
Inclusion Criteria:

* non-severe FMR,
* age of at least 18 years,
* stable heart failure related medical therapy in the last 3 months.

Exclusion criteria

* non-willing to participate
* myocardial infarction,
* cardiac decompensation within the last 3 months,
* pregnancy,
* life expectancy of less than 1 year for non cardiac reasons.
The Very Large Database of Lipids (VLDL)

Closer examination of granular lipid data in a large population offers numerous opportunities to generate new knowledge, ranging from studies examining concordance between commonly used lipid parameters to phenotypic characterization of rare or extreme disorders of lipid metabolism, opening possibilities to better personalize future treatment of abnormal blood lipids.

STUDY POPULATION:

The Very Large Database of Lipids (VLDL) includes adults and children who were clinically referred for a Vertical Auto Profile (VAP). Patient samples originated predominantly from outpatient primary care clinics in the U.S. (85%), along with specialty clinics and inpatient settings.

LIPID MEASUREMENTS:

The VAP test (VAP Diagnostics Lab, Birmingham, Alabama, USA) directly measures cholesterol concentrations of low density lipoprotein, very low density lipoprotein, intermediate density lipoprotein, high density lipoprotein, their subfractions, and lipoprotein(a). Triglycerides in the database are directly measured using the Abbott ARCHITECT C-8000 system (Abbott Park, Illinois, USA). Lipid distributions in the database closely match those from the population-representative National Health and Nutrition Examination Survey (NHANES).

STUDY PROCEDURES:

This database was investigator-initiated. Only de-identified data reach the investigational site. The master database is housed at The Johns Hopkins Hospital in Baltimore, Maryland, and maintained by Drs. Jones and Martin. The current database (2nd harvest) includes 5,051,467 patients whose laboratory samples were collected from October 1, 2015 and June 30, 2019. Only electronic data, and not blood samples, are sent to Hopkins. The academic investigators have unrestricted access to study data, take responsibility for the accuracy of analyses, and have authority over manuscript preparation and submission.

VARIABLES:

The variables currently in the VLDL database are testing date, age, sex, fasting/nonfasting, and components of the VAP test. From these primary variables, many additional variables were derived for inclusion in the master database. Other analytes measured by validated assays in subsets of the VLDL database include apolipoprotein B (apoB), apolipoprotein A1 (apoAI), high-sensitivity C-reactive protein (hsCRP), homocysteine, uric acid, insulin, hemoglobin A1c, 25-hydroxy vitamin D, cystatin C, lipoprotein-associated phosphatase (Lp-PLA2), thyroid stimulating hormone (TSH), free T3 and T4, pro-brain natriuretic peptide (pBNP), direct bilirubin, creatine phosphokinase (CPK), creatinine and other components of the comprehensive metabolic panel, magnesium, and phosphate.


Eligibility Criteria:
Patients with age and lipid data are included in the master database. Eligibility criteria are specific to each individual study.
Quality of Life in Asthma and Rhinitis Allergic With Singulair (0476-365)

Allow physicians not familiar with anti-leukotriene based therapy to test it


Eligibility Criteria:
Inclusion Criteria:

* Establish diagnosis of mild to moderate chronic asthma and/or allergic rhinitis currently on treatment
* Voluntary acceptance to participate in the study

Exclusion Criteria:

* Patients with cystic fibrosis
* Patients with known hypersensitivity to singulair or any of its components
* Patients with severe chronic asthma
Maternal Characteristics Associated With Child Growth and Adiposity

The goal of this observational study is to investigate the concentrations of leptin, insulin, liver expressed antimicrobial peptide 2 (LEAP2), and cortisol in plasma and breast milk and their relationship with eating behavior, growth, adiposity and with the levels of these hormones in infants, comparing mothers with normal weight and with pre-pregnancy overweight/obesity. The main question\[s\] it aims to answer are:

* Are maternal hormones associated with child growth and adiposity
* Are maternal hormone receptors associated with child growth and adiposity
* Are infant hormones and their receptors associated with child growth and adiposity Participants will provide milk and blood samples. Researchers will compare mothers with normal weight and with pre-pregnancy overweight/obesity to see if there are differences in child growth and adiposity .


Eligibility Criteria:
Inclusion Criteria:

* Lactating women with pre-pregnancy normal weight and overweight or obesity as described by the World Health Organization.

Exclusion Criteria:

* Diabetes (Type I or II or gestational)
* Multiple pregnancy
* Hypertensive disorders during pregnancy
* Delivery of pre-term infant (\<37 weeks).
Connected Pens for Diabetes Study

The objective of the study is to evaluate the impact of a wireless smart insulin pen and smartphone-based bolus advisor on clinical and psychosocial outcomes in insulin-treated diabetes mellitus patients after 3 months of use.

The study is a prospective, randomized, controlled treatment design. The study device will be used for multiple daily injection (MDI) therapy of insulin. The participant will interact with the study device in the uncontrolled environment of the participant's daily life. The study protocol is designed to yield meaningful data to determine clinical and psychosocial benefits of using the study device. The study will evaluate the study device as an intervention versus a control group.

Eligibility Criteria:
Inclusion Criteria:

1. The participant is ≥ 18 years of age
2. The participant has Type 1 OR Type 2 diabetes and is being treated with intensive insulin therapy via injection for ≥ 3 months. Intensive insulin therapy is defined as at least one long acting insulin dose and two or more short acting insulin doses per day.
3. Glycated hemoglobin (HbA1c) ≥ 7.5%).
4. The participant is a current iPhone user for over 30 days.
5. Participant adjusts meal insulin doses based on carbohydrate content of meals.
6. The participant is fluent in the English language.
7. The participant and the investigator understand participant obligations and agree that the participant is willing and able to complete the study visits.
8. Patients prandial insulin need must be \<30 U per meal.

Exclusion Criteria:

1. The participant has been using unblinded CGM for less than 6 months.
2. The participant uses pre-mixed insulin.
3. Current use of a smart insulin pen.
4. Use of sliding scale insulin therapy that determines insulin dosages based exclusively on specific blood glucose results
5. Used systemic oral or inhaled steroids for more than 7 days within the last 3 months
6. Oral anti-diabetic agents, with the exception of metformin
7. Injectable anti-diabetic agents other than insulin
8. The participant is legally blind or has below specified best-corrected vision level.
9. Diagnosed with any clinically significant infectious disease or major organ system disease, such as gastroparesis or renal disease (at Investigator's discretion)
10. The participant is pregnant, lactating, or plans to become pregnant in the next 6 months.
11. The participant is currently participating in another clinical study that may preclude the participant from meeting the obligations of this study.
12. The participant has any additional condition(s) (medical, social, or psychosocial) that in the investigator's opinion would warrant exclusion from the study or prevent the participant from completing or complying with the study requirements.
Food Concentrates Supplementation to Alleviate Asthma in Children

The purpose of this study is to determine whether food concentrates supplementation (vegetable plus fruit, fish, probiotics) are effective to alleviate drug used, asthma symptoms and lung function in children due to asthma.

The prevalence of asthma is increasing in Taiwan and worldwide. This could be related to dietary factors and their interactions with genes and the environment. Ample evidence from cross-sectional and case-control observational studies suggested that consumption level of fruits, vegetables, and potentially vitamins A, C, E from foods have negative association with asthma risk, and positive association with lung function. However, single nutrient supplementation neither improved asthma symptoms and lung function, nor reduced inflammatory mediators. Some studies had shown probiotics could regulate human immunity. A number of trials have suggested that fish oil supplement improves lung function and reduces inflammatory mediator. The potential interactions among multiple components in foods have been neglected in the past. Recently, observational studies on dietary pattern analyses or intervention trials modifying the overall dietary composition have caught tremendous scientific attentions. Therefore, the investigators will design an intervention trial with food-based principle to investigate the the joint effect of several beneficial dietary components on asthma symptoms. For practicality and efficiency, vegetable plus fruit concentrates, fish oil, and probiotic concentrate are considered as supplements to asthmatic children. The investigators hope that the study can provided a direction for dietary modification in asthma children.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of asthma

Exclusion Criteria:

* subjects received immunotherapy over the past 6 months
* Long-term used oral corticosteroids
* have other diseases such as heart disease, kidney disease, liver abnormalities
* have been supplement fish oil, probiotics, and high levels of vitamin supplements in the past three months
* vegetarian
* subjects have hemorrhagic disease
Surgical Site Infection in Perforated Appendicitis After Peritoneal Lavage With Super-oxidised Solution

This study is to evaluate the effectiveness of peritoneal lavage with super-oxidised solution in reducing surgical site infection after open surgery for perforated appendicitis.

Open appendicectomy for perforated appendicitis is associated with significant morbidity from surgical site infection. The standard practice is to perform peritoneal and wound lavage using normal saline solution. The investigators propose the use of superoxidized solution for peritoneal and wound lavage to decrease the incidence of surgical site infection.

Superoxidized solutions contain hypochlorous acid (HOCl) which has bactericidal properties. The reactive oxygen species that is produces damages cell wall membrane of unicellular organisms, however remains safe when in contact with human or animal tissue. It is commonly used for topical treatment of wounds.

Eligibility Criteria:
Inclusion Criteria:

1. Patients between the age 13 and 70 years
2. Diagnosed with perforated appendicitis intra-operatively
3. Undergo open appendicectomy via Lanz incision

Exclusion Criteria:

1. Surgical technique: Laparoscopic appendicectomy or mid-line laparotomy
2. Patients on steroid treatment and immunosuppressant therapy.
Prone Positioning and High-flow Nasal Cannula in COVID-19 Induced ARDS

Prone position (PP) has been proved to be effective in severe ARDS patients. On the other hand, High flow nasal cannula (HFNC) may prevent intubation in hypoxemic Acute respiratory failure (ARF) patients.

Our hypothesis is that the combination of PP and HFNC in patients with COVID19 induced ARDS may decrease the need of mechanical ventilation.

Primary outcome: Therapeutic failure within 28 days of randomization (death or intubation). Secondary outcomes: to analyze PP feasibility and safety in HFNC patients and to analyze effectiveness in terms of oxygenation.

Methods: multicentric randomized study including patients with COVID19 induced ARDS supported with HFNC. Experimental group will received HFNC and PP whereas observation group will received standard care.

Optimization of non-invasive respiratory management of COVID19 induced ARDS patients may decrease the need of invasive mechanical ventilation and subsequently ICU and hospital length of stay.


Eligibility Criteria:
Inclusion Criteria:

* COVID-19 pneumonia according to the diagnostic criteria in effect at the time of inclusion or very strongly suspected.
* Patient treated by nasal high flow.
* Moderate or severe ARDS: bilateral radiological opacities not explained entirely by effusions, atelectasis or nodules; acute hypoxemia with worsening within the 7 previous days, not entirely explained by left ventricular failure; PaO2 / FiO2 ratio \<300 mmHg (or SpO2 / FiO2 equivalent).
* Informed consent.
* Beneficiary or affiliated to a social security scheme.

Exclusion Criteria:

* Indication of immediate tracheal intubation
* Significant acute progressive circulatory insufficiency
* Impaired alertness, confusion, restlessness
* Body mass index\> 40 kg / m2
* Chest trauma or other contraindication to prone position
* Pneumothorax
* Vulnerable person: safeguard of justice
* Pregnant or lactating woman
Five Fractions of Radiotherapy Followed by Full Dose FOLFOX Chemotherapy as Preoperative Treatment for Rectal Cancer

To determine if short course radiotherapy followed by chemotherapy can maintain morbidity at or below levels reported with concurrent 5FU, oxaliplatin, and radiotherapy, while maintaining response rates comparable to what would be expected with radiotherapy and concurrent chemotherapy.

Our principal objectives in this trial will be to determine if short course radiotherapy followed by chemotherapy can maintain morbidity at or below levels reported with concurrent 5FU (oral capecitabine if 5FU is unavailable), oxaliplatin, and radiotherapy, while maintaining response rates comparable to what would be expected with radiotherapy and concurrent chemotherapy. If we can establish a T stage downstaging rate that is significantly better than 50% and if acute tolerance is acceptable, then we would consider this study as having provided sufficient pilot data to support including this approach as an arm in a multi-institution phase III trial. The long-term goal is improved overall control of disease by delivering better chemotherapy earlier.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven adenocarcinoma of the rectum
* Patient evaluated by surgeon and found to be a potential surgical candidate. Since the primary objectives are response to chemoradiation and acute toxicity, lesions which are initially unresectable are eligible-provided the surgeon feels that, if there is sufficient response, surgery could become feasible.
* Clinical evidence of T3 or T4 disease. This can be by imaging studies (see or by physical findings (tethering on palpation for T3 lesions or invasion of a neighboring organ for T4 lesions)
* Karnofsky Performance Status at \>60
* Laboratory criteria:
* Absolute neutrophil count \>= 1.5 K
* Platelets \>= 100 K
* Total Bilirubin \<= 2.0;
* SGOT and Alkaline Phosphatase \<= 2 x upper limit of normal
* Creatinine \< 2.0
* Hemoglobin \>= 8.0
* Informed consent signed
* Tumor measurable in at least one dimension. This may be, e.g. length and/or width measured endoscopically or on digital rectal examination, and maximum rectal wall thickness determined by imaging studies.
* Estimated longevity at least 12 months
* Patients with distant metastatic disease will be eligible if they satisfy all other conditions

Exclusion Criteria:

* Pregnant women, children \< 18 years, or patients unable to give informed consent
* Patients with a past history of pelvic radiotherapy.
* Patients with any other malignancy within the past 5 years except: skin cancer or in-situ cervical cancer
* Patients with known allergy/intolerance to 5FU, Leucovorin, Oxaliplatin, Capecitabine
* Prior chemotherapy for colorectal cancer.
* Grade \>= 2 peripheral neuropathy
* Any condition which, in the opinion of the treating medical oncologist, renders the patient unfit for 5FU (oral capecitabine if 5FU is unavailable), Leucovorin, Oxaliplatin chemotherapy
Comparing Cytokines, Toxins Adsorbing oXiris Filter to ST150 Filter During CRRT in Patients With Septic Shock

The Oxiris® filter is a registered product for CRRT already safely used in routine care.

In in vitro experiments, the Oxiris® filter has been demonstrated to adsorb endotoxin and cytokines. Compared to conventional filters this may be advantageous in patients with severe sepsis but neither decreased levels of endotoxin and cytokines nor an improved outcome has been demonstrated with clinical use.

But there are so far little clinical data on the oXiris® filter on humans. The oXiris® filter will be investigated in a double blind randomized crossover setting against a traditional filter (ST150). Either filter will be used for 24 hours after which it will be changed to the opposite filter for another 24 hours.

Arterial blood samples will be drawn at start and then 1, 3, 8, 16 and 24 hours after the start of each filter, and analyzed for endotoxin (EAA assay), TNF-α, IL-1β, IL-6 and IL-10 (ELISA) levels. Standard blood tests will be analyzed simultaneously. Data concerning mode and settings of CRRT, heart rate, blood pressure, medication, data concerning ventilatory support and pathogen will be registered.

Primary endpoint: Levels of endotoxin and cytokines will be compared using Student's paired t-test on AUC values for each 24-hour period.


Eligibility Criteria:
Inclusion Criteria:

1. Patients admitted to intensive care unit (ICU) of age \>18 years with decision based on the clinical situation of the patient taken by the physician in charge that continuous renal replacement therapy will be started.
2. Vasoconstrictor and volume dependent septic shock with known Gram-negative infectious agent in blood culture.
3. Vasoconstrictor and volume dependent septic shock suspected to be caused by a Gram-negative agent and with positive plasma endotoxin test.

Exclusion Criteria:

1. Infected with Hepatitis B or C or HIV.
2. Dependence on dialysis treatment before the actual ICU episode.