cyrilzakka/clinical-trials huggingface dataset:
Post-transplantation Benadamustine and Cyclophosphamide in Patients With Refractory Myeloid Malignancies

Prognosis of patients undergoing salvage allogeneic stem cell transplantation for refractory leukemia or other refractory myeloid malignanies is poor. One of the approaches to augment graft-versus-leukemia effect the use of post-transplantation bendamustine in graft-versus-host disease prophylaxis. Despite high frequency of responses and durable remissions after this approach majority of patients develop a serious complication - cytokine release syndrome, which can be life-threatening in some patients. On the other hand post-transplantation cyclophocphamide was reported to abort cytokine release syndrome that sometimes occurs after graft transfusion in patients after haploidentical graft transfusion. The aim of this study is to evaluate if the combination of post-transplantation bendamustine (PTB) and post-transplantation cyclophosphamide (PTCY) facilitates comparable graft-versus leukemia effect to PTB, but with better safety profile and reduced incidence of severe cytokine release syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Patients with indication for allogeneic hematopoietic stem cell transplantation
* Patients with 5-10/10 HLA-matched related or unrelated donor available. The donor and recipient must be identical by the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1.
* Peripheral blood stem cells or bone marrow as a graft source
* Diagnosis:

Acute myeloid leukemia Chronic myeloid leukemia, Ph+ Myelodysplastic Syndromes Myeloprolipherative neoplasms

* Salvage hematopoietic stem cell transplantation defined as:
* Acute myeloid leukemia: \>5% of clonal blasts despite adequate previous induction therapy or allogeneic stem cell transplantation Myelodysplastic Syndrome: \>10% of blasts despite previous therapy with -7 or complex karyotype, or p53 mutation Chronic myeloid leukemia: blast crisis or acceleration phase despite at least 3 previous lines of TKIs Myeloprolipherative neoplasms : high tumor burden despite previous therapy, including \>20 000 WBC/ ul or splenomegaly \>15 cm
* No severe concurrent illness

Exclusion Criteria:

* Moderate or severe cardiac dysfunction, left ventricular ejection fraction \<50%
* Moderate or severe decrease in pulmonary function, FEV1 \<70% or DLCO\<70% of predicted
* Respiratory distress \>grade I
* Severe organ dysfunction: AST or ALT \>5 upper normal limits, bilirubin \>1.5 upper normal limits, creatinine \>2 upper normal limits
* Creatinine clearance \< 60 mL/min
* Uncontrolled bacterial or fungal infection at the time of enrollment
* Requirement for vasopressor support at the time of enrollment
* Karnofsky index \<30%
* Pregnancy
* Somatic or psychiatric disorder making the patient unable to sign informed consent
Bacterial Intestinal Gut Modification Around Cancer Surgery (BIG MACS) Diet

The long-term study objective is to develop optimized nutritional therapies for surgery and test them in clinical practice. This pilot study will test a microbiome-optimization diet in colorectal cancer surgery patients. The study hypothesizes that the Bacterial Intestinal Gut Modification Around Cancer Surgery (BIG MACS) Diet will provide participants with increased microbiota accessible carbohydrates (MACs) to support the microbiome and improve outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Age 25-70 years
* Primary diagnosis of colon cancer, stages 1-3.
* Able and willing to provide informed consent.
* English-speaking.
* Willingness to return to the study site for specified study visits at D7 and D30.
* Able to comply with study measures.

Exclusion Criteria:

* Age ≤ 25 years or ≥70 years
* If surgery is being performed for any reason other than resection of colon cancer. Neoadjuvant therapy, or if surgery is not the initial approach for the patient's colon cancer treatment
* Significant anemia (hemoglobin 1.0 g/dL or more below normal range) or history of coagulopathy: any personal history of hereditary or acquired bleeding disorder, or thrombocytopenia with platelets under 100,000.
* Serum creatinine greater than 1.5 mg/dL.
* Serum total bilirubin greater than the upper limit of normal in the absence of Gilbert's syndrome or alkaline phosphatase or ALT or AST greater than 2.5 times the upper limit of normal. Elevated INR (1.5 or above).
* Alcohol intake more than one drink or greater than 20 grams per day for women or 30 grams per day for men.
* History of gastrointestinal surgery including stomach, small bowel or colon resection, pancreatic surgery, bile duct or gallbladder surgery, or splenectomy, or gastric bypass.
* History of intra-abdominal sepsis.
* Previous organ transplantation.
* Self-reported HIV-positive status, active tuberculosis, active malaria, chronic hepatitis B or C, cirrhosis, or inflammatory bowel disease.
* Currently pregnant or nursing.
* History of alcohol, drug, or opioid dependency (excluding nicotine) in the past five years.
* Active psychosocial or psychiatric problem that is likely to interfere with adherence to the protocol.
* Depression: A CES-D score more than 16 and a psychologist determining that the patient is not a good fit for surgery.
* Body mass index (BMI) \&lt;20 or \&gt; 40 kilograms per meter squared:

obesity is known to impact the microbiome and immune system and the occurrence of anastomotic leak, and extreme obesity may confound interpretation of these factors in association to leak. Inferences may be made by matching participants with less severe obesity (BMI \&lt;40).

* Presence of any type of non-MRI compatible implant, including cardiac pacemakers or defibrillators, neurostimulators, cochlear implants, or other metallic hardware
* Self-reported history of claustrophobia.
* Incarceration
* Inability to adhere to the study protocol, procedures, and diet
* Exclusions may also be made at the discretion of the attending physician.
Evaluation of Phlebotomy as a Treatment for Non-alcoholic Fatty Liver Disease

The purpose of this study is to evaluate the use of phlebotomy (blood taking)as a treatment for patients with non-alcoholic fatty liver disease.

In this study phlebotomy will be evaluated as a therapy for non-alcoholic fatty liver disease (NAFLD), a common and important cause of liver disease. Phlebotomy has been used for many years in the treatment of disorders of iron overload such as hemochromatosis, where it is well tolerated and improves symptoms and survival. There is some evidence that it is also effective in treating NAFLD. However, previous studies have not evaluated whether phlebotomy improves liver biopsy findings. We will measure the severity disease in NAFLD patients prior to phlebotomy therapy and again at the end of treatment. This will allow us to accurately determine the benefit of this therapy in these patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18y or older
* Diagnosis of Non-alcoholic Fatty Liver Disease

Exclusion Criteria:

* Unable or unwilling to provide informed consent
* Alcohol consumption of \>10g/day for women and \>20g/day for men
Prospective Clinical Evaluation of the FilmArray® NGDS Warrior Panel

This study will evaluate the clinical specificity of the FilmArray NGDS Warrior Panel.


Eligibility Criteria:
Inclusion Criteria:

* Whole blood (prospectively collected via informed consent):
* Adult subject has a recorded or self-reported fever within the previous 24 hours
* Subject provides informed consent prior to enrollment and specimen collection
* Subject has not previously provided a whole blood specimen for this study

Whole blood (residual)

* Whole blood (in EDTA) submitted to laboratory for standard of care testing
* Specimen is not from an individual with a specimen previously enrolled in the study

Positive Blood Culture:

* Culture was detected as positive by an automated blood culture system
* Culture is not from a patient previously enrolled in the study

Negative Blood Culture:

* Culture not detected as positive by an automated blood culture system
* Culture is not from a patient previously enrolled in the study

Sputum:

* Specimen was accepted for testing by the respective site's microbiology laboratory
* Specimen is not from an individual that has a sputum already enrolled in the study
The Effects of Immunotherapy in the Nose

Allergic rhinitis might be caused by decreased resistance of nasal barrier to allergens and other environmental insults. About 20 % of the European population suffers from pollen allergies. Birch pollen allergic rhinitis is the most common allergic disease in the Scandinavia and it exists widely also in the Central Europe. Suffering and high costs of pollen allergies may be reduced by understanding the molecular biology of the nasal barriers during allergic response. Our aim is to observe the effect of season and birch pollen immunotherapy on the molecular biology of nasal epithelium and the microbiome.

This is a controlled study with an intervention arm, and a control group of healthy volunteers. The population is composed of nonsmoking healthy adults and patients having birch or timothy pollen allergy with rhinoconjuctivitis symptoms and without other diseases. The diagnosis of pollen allergy is verified with positive history, skin prick test, and allergen specific IgE antibodies. Subjects undergo a spirometry with a bronchodilatator test and a histamine challenge. Quality of life and patient history data is collected by questionnaires. Four peripheral blood samples, as well as nasal cell swabs from nasal mucosa without local anesthesia are collected from each patient; in spring and winter before the group of the intervention arm starts with birch pollen subcutaneous immunotherapy; and during the first spring and winter when a subgroups has received the birch pollen immunotherapy. We plan to perform the following analyses for the nasal specimens: transcriptomics and their regulators, sequencing of 16SrRNA and RT-qPCR for assessing mucosal microbiome, mass spectrometry for analyses of proteins and protein-protein complexes, immunohistochemistry for tissue level localization and quantitation of proteins, in silico analyses for the data mining, integration and display. In addition we observe the alterations in inflammatory mediators after in vitro allergen activation of purified peripheral blood leukocytes by ELISA and real time qPCR.

Eligibility Criteria:
Inclusion Criteria:

* allergic rhinoconjunctivitis of birch pollen OR healthy controls

Exclusion Criteria:

* smoking, asthma, any other disease than allergic rhinoconjunctivitis, requiring constant medication
Quality of Life and Efficacy Evaluation of Patient Self-monitoring Their Oral Anticoagulation Therapy

The purpose of this study is to determine whether self-management of oral anticoagulation therapy with warfarin has an effect on patient's quality of life following a specific training program led by pharmacists.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 years and over followed at the Montreal Heart Institute's Anticoagulation clinic
* Warfarin treatment planned for at least 4 months after inclusion in the study
* Warfarin treatment initiated for at least 6 months
* Last 2 INRs between 1.5 and 4 if target INR is between 2 and 3
* Last 2 INRS between 2 and 4 if target INR is between 2.5 and 3.5
* Provide a signed informed consent

Exclusion Criteria:

* Patient unable to understand (spoken and written) French or English
* Patient refuses or is unable to attend the required training sessions
* Targeted INR other than 2 to 3 or 2.5 to 3.5
* Handicap or physical limitation compromising the patient's ability to initiate self-monitoring in the absence of a proxy helper
* Moderate to severe cognitive impairment or important comprehension problems
* Active neoplasm
* Concurrent chemotherapy
* Hypercoagulable conditions
* Life expectancy of less than 1 year documented in the medical chart
* Inclusion (at time of inclusion or 30 days prior to inclusion) in another research project involving a drug
* Patient anticoagulated with nicoumalone
* Pregnancy or breastfeeding
* Active bleeding (except for menses)
* Recent major bleeding (less than 3 months before inclusion)
* Stroke, acute coronary syndrome, percutaneous coronary intervention, coronary artery bypass graft, cardiac valve replacement, deep veinous thrombosis or pulmonary embolism in the 3 months prior to inclusion
* Any other condition that, in the opinion of the investigators, of the treating physician or of the healthcare professionals working at the anticoagulation clinic could make self-management by the patient impossible
Alcohol Challenge On Liver and Gut Measured by Liver Vein Catheterization. A Pathophysiological Intervention Trial

To investigate the effects of acute alcohol challenge on the gut and liver axis.

To study the role of acute alcohol challenge on the intestine permeability and inflow of bacterial products to the liver in participants with alcoholic liver disease, non-alcoholic steatohepatitis and healthy controls.

Eligibility Criteria:
Inclusion Criteria:

* Alcoholic liver fibrosis, non-alcoholic steatohepatitis or liver-healthy individuals

And all of following:

* Bodymass \> 50 kg
* Able to be fasting and abstinent on the day of intervention
* international ratio \<1.5 and platelets \>100 x 10\^9, 7 days before the intervention day
* Informed consent

Exclusion Criteria:

* Antibiotics during the last 4 weeks
* Total alcohol abstinence
* Desire of total alcohol abstinence
* Other causes of liver disease suspected (viral, autoimmune, haemochromatosis, Wilsons diseases, alfa 1 antitrypsin deficiency or drug induced)
* Cirrhosis
* Insulin dependent diabetes mellitus
* Incapable to follow the protocol instructions
* Pregnancy
* Primary or secondary liver cancer
* Severe comorbidity
* Allergic to the contrast media iohexol
Same Day Discharge

This study is to assess if subjects receiving a clinically indicated implanted cardiac pacemaker or defibrillator can be safely discharge home the same day of the procedure.

Subjects who are implanted with a clinically indicated implanted cardiac pacemaker or defibrillator will be randomized to standard of care (next day discharge) versus same day discharge post implant. Both groups will under go standard of care assessments prior to discharge. The same day discharge group will receive a phone call the next day to assess for events and will transmit device data electronically. Both groups will be seen 10 - 14 days after implant for further evaluation.

The subjects will also complete questionnaires regarding their knowledge of self care and satisfaction with care.

Eligibility Criteria:
Inclusion Criteria:

1. Scheduled for clinically indicated implant of cardiac pacemaker or defibrillator
2. Willing and able to provide informed consent
3. Appropriate clinical indication for the purpose of this study

   1. Primary prevention implantable cardioverter-defibrillator implant indicated for sudden cardiac death with ejection fraction more than 20%
   2. Sick sinus syndrome, non-high degree heart block as indication for pacemaker implant.
   3. No history of syncope
   4. No documented sudden cardiac death or ventricular arrhythmias requiring shock
4. Adequate social support to be able to comply with protocol.
5. Ability to complete remote monitor transmission

Exclusion Criteria:

1. Determined to be at risk for bleeding or on oral anticoagulation 2. Planned to be implanted with non-Biotronik device 3. Complete heart block as indication for permanent pacemaker 4. Secondary ICD indication 5. Immediate procedural complication requiring prolonged admission such as: pneumothorax, large hematoma, tamponade) determined during the procedure or immediately before discharge.

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Pneumothorax Post CT Lung Biopsy

A CT scan is performed after a lung biopsy in order to detect a Pneumothorax. We postulate that CT is more useful than chest radiography


Eligibility Criteria:
Inclusion Criteria:

* all patients having a lung biopsy

Exclusion Criteria:

* none
Endothelial Function Guided Therapy in Patients With Non-obstructive Coronary Artery Disease

The purpose of this study is to systematically evaluate the clinical application value of vascular endothelial function examination in patients with non-obstructive coronary artery disease.

The study will be carried out in two stages. Phase I is mainly intended to evaluate the effects of vascular EFT on the prescription of doctors and the application rate of mid and long-term secondary prevention medication in patients. If the results are positive, the sample size and observation time will be further expanded in Phase II to evaluate its impact on the cardiovascular events of patients, as well as its cost-effectiveness.

Eligibility Criteria:
Inclusion Criteria:

* 1. Age: 18 years or older;
* 2. Patients with NOCAD defined by CT or CAG results of less than 50% occlusion;
* 3. Having signed their written informed consent.

Exclusion Criteria:

* 1. Left ventricular ejection fraction ≤ 50%;
* 2. Serious endocrine diseases (severe hyperthyroidism, hypothyroidism);
* 3. Severe liver diseases (jaundice hepatitis, liver cirrhosis, liver failure);
* 4. Severe nephropathy (uremia, renal failure);
* 5. Severe inflammatory diseases (severe infection, lupus erythematosus, etc.);
* 6. Malignant tumor;
* 7. Mental disorders or cognitive disorders;
* 8. Participating in other interventional clinical trials;
* 9. There are any other factors that the treating doctors think are not suitable for inclusion or completion of this study.
Impact of [11C]-Methionine PET/MRI in the Detection of Pituitary Adenomas Secreting ACTH and Causing Cushing's Disease

Cushing's disease is characterized by the existence of a benign pituitary tumor developed from corticotropic cells responsible for excessive ACTH secretion. This results in hypercorticism causing high morbidity and mortality and severely impairing quality of life. The etiological diagnosis is based on Magnetic Resonance Imaging (MRI). However, pituitary MRI revealed a pituitary tumor in only 60% of patients. The diagnostic procedure is complicated by the existence of extra pituitary tumors responsible for ACTH ectopic secretion. This rare etiology imposes, in the absence of typical pituitary image, the realization of catheterization of the lower petrosal sinuses. Treatment of Cushing's disease is based on transsphenoidal surgical management, even in the absence of a formal MRI image, if pituitary origin is confirmed by the catheterization. Although pituitary surgery without identified target is part of French recommendations, this surgery is associated with a high risk of failure and morbidity. Optimization of the management of patients' with Cushing's disease thus requires the improvement of the diagnostic methods.

Hypothesis of our study is that \[11C\] MET MRI-PET may be performed as a first-line MRI for suspected Cushing's disease and may limit indications for catheterization of lower petrosal sinuses. Its localizing value should also make it possible to improve the surgical results with a better identification of the adenoma


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years old or over
* Patient with a diagnosed Cushing's disease according to the French "protocole national de diagnostic et de soins (PNDS)"
* Patient who underwent a MRI pituitary for diagnostic purposes
* Patient who have undergone catheterization of the lower petrosal sinuses (if MRI does not detect pituitary adenoma) and have a result in favor of a central secretion of ACTH
* Patient having an indication of surgical excision of the adenoma
* Patient with a micro-adenoma (less than 1 cm in diameter) if the tumor is visualized on MRI
* Patient for which informed and written consent to participate has been obtained.

Exclusion Criteria:

* - Patient participating in another study
* Patient with a pituitary macro-adenoma with visual impairment
* Patient with ACTH-dependent Cushing's syndrome secondary to ectopic ACTH secretion
* Patient with recurrence and / or history of pituitary adenoma excision
* Patient with a contraindication to pituitary surgery or general anesthesia
* Pregnant woman, breastfeeding or old enough to have children but without effective recognized contraception
* Contra-indication to the realization of an MRI: permanently fixed metal parts (pacemaker, cerebral clip, cephalic end piercing, cochlear implant, pin or screw for recent bone fracture, dental equipment, metal splinters), claustrophobia
DLBCL Treatment in Children and Adolescents

We compared the efficacy and safety of modified NHL-BFM-90 regimen and R-CHOP/CHOP regimen in pediatric (aged 0-14 years) and adolescent（aged 15-18 years）DLBCL patients in a single institution during a 20-year period. we compared the efficacy and safety of modified NHL-BFM-90 regimen and R-CHOP/CHOP regimen in pediatric (aged 0-14 years) and adolescent（aged 15-18 years）DLBCL patients in a single institution during a 20-year period. To our best knowledge, no reports have been previously published regarding the comparison.

Diffuse large B-cell lymphoma (DLBCL) is an aggressive lymphoma that accounts for approximately 10%-20% of pediatric and adolescent non-Hodgkin's lymphomas (NHLs).

The incidence increases with age, with 37% of NHLs patients being adolescents aged. Poor survival has been demonstrated in adolescents and young adults compared to children with DLBCL. However, the Associazione Italiana Ematologia Oncologia Pediatrica (AIEOP) LNH-97 study showed that age was not a poor prognostic factor in children and adolescents with Burkitt lymphoma (BL) and DLBCL. A conclusion as to whether adolescent age is an independent risk factor has not been reached.

At present, the preferred protocols for adolescent DLBCL patients have not been standardized. Adolescents with cancer have been designated as a vulnerable population, positioned between children and the adult population. Treatment strategies differ between adults and pediatric patients. The pediatric strategy for DLBCL was developed in parallel by the Berlin-Frankfurt-Münster (BFM) and French-American-British/Lymphomes Malins B (FAB/LMB) groups. The combination of rituximab plus Cyclophosphamide, Adriamycin, Vincristine, and Prednisone (R-CHOP) or R-CHOP-like chemotherapy regimens are the standard therapy for the treatment of adult patients with DLBCL. There is currently a lack of studies that have compared the treatment outcomes in adolescent patients with DLBCL who were administered pediatric or adult regimens. Hence, we retrospectively analyzed the clinical characteristics and prognostic factors in DLBCL patients, especially the efficacy and safety of the pediatric regimen (modified NHL-BFM-90) and adult regimen (R-CHOP/CHOP), between pediatric and adolescent DLBCL patients.

Eligibility Criteria:
Inclusion Criteria:

1. patients who were pathologically diagnosed with DLBCL
2. patients under 18 years of age.

Exclusion Criteria:

1. Was administered prior chemotherapy;
2. Patients who could not receive chemotherapy due to severe immunodeficiency or other diseases.
3. Patients with primary central nervous system lymphomas.