cyrilzakka/clinical-trials huggingface dataset:
Brain Changes by Rivastigmine According to Butyrylcholinesterase Alleles

Butyrylcholinesterase (BuChE) activity is increasing in Alzheimer Disease (AD) process (Lane et al., 2006). BuChE wild type has stronger butyrylcholine esterase activity than BuChE K variant allele and this strong activity can affect AD brain negatively by choline depletion. Rivastigmine has unique dual action - acetylcholine esterase inhibition and butyrylcholine esterase inhibition. Therefore, rivastigmine can lower serum butyrylcholine esterase activity and delay functional decrease of Fluorodeoxyglucose positron emission tomography (FDG PET) images in AD patients with BuChE wild type allele by strong BuChE inhibition.

It suggests that rivastigmine can affect brain function differently by BuChE genotype in AD. Therefore, we will try to find the different changes of serum butyrylcholine esterase activity by ELISA and functional and structural changes of brain between BuChE wild type and K-variant type by FDG PET and MRI pre and post images after 12 month use of rivastigmine.

1. Primary objective:

   1. the mean changes of Standardized Uptake Values (SUVmean) in PET imaging
   2. the mean changes of serum BuChE activity between BuChE wild type and K-variant type.
2. Secondary objectives:

   1. the mean changes of cortical thickness in brain MRI
   2. the cognitive changes in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog)
   3. the cognitive changes in Mini-Mental State Exam (MMSE)
   4. the daily function changes by Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)
   5. the behavioural changes by Caregiver-Administered Neuropsychiatric Inventory (NPI)
   6. the disease severity changes by Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) between BuChE wild type and K-variant type.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Alzheimer's Disease (NINCD-ADRDA and MMSE between 10 \~26)
* Who didn't take Cholinesterase Inhibitor on liver within 3 months

Exclusion Criteria:

* diagnosed with diseases other than AD that affect brain atrophy according to Brain MRI
* Diagnosed with diseases other than AD which affect cognitive functions (i.g. Schizophrenia, Major Depression, Mental Retardation, encephalopathy, etc.)
* Didn't suspect of drug or alcohol addictions within last decade
* Unable to participate the study due to poor sight and hearing
* Who aren't suitable to participate according to the researchers' judgement
Role of Glycation and Inflammation in Acute Ischemic Heart Disease

This study requires the consecutive enrollment of 60 patients following the first event of acute myocardial infarction, evaluating B-Cell Activating Factor (BAFF) and methylglyoxal (MGO) levels in the acute setting (pre-reperfusion) and 3 months after reperfusion.

This study requires the consecutive enrollment of 60 patients at admission for first acute myocardial infarction. At enrollment, before reperfusion, a blood sample is obtained to measure B-Cell Activating Factor (BAFF) and methylglyoxal (MGO) levels in the acute setting. This measure is then repeated at follow-up visit 3 months after reperfusion. The aim of the study is to identify specific subsets of patients and evaluate biomarkers variations.

Eligibility Criteria:
Inclusion Criteria:

* hospitalization for first myocardial infarction (STEMI or NSTEMI)
* age between 18 and 80

Exclusion Criteria:

* uncompensated T2DM (HbA1c \>53mmol/mol)
* use of anti-CD20 treatment
* chronic anti-inflammatory treatment for autoimmune disease (i.e. DMARDs, high dose FANS, cortisonic drugs)
A Single Center Diagnostic, Cross-sectional Study of Coronary Microvascular Dysfunction

Among patients with stable ischemic heart disease who are referred for coronary angiography, a substantial proportion have non-obstructive coronary artery disease (CAD). Ischemia based on symptoms or stress testing may be due to coronary microvascular dysfunction in up to 40% of these patients. However, the mechanisms and optimal treatment of coronary microvascular dysfunction are unknown. Aberrant platelet activity and inflammation have been hypothesized as mechanisms of microvascular dysfunction. Investigators plan to evaluate association between platelet activity, inflammation, and coronary microvascular dysfunction in stable women referred for coronary angiography, and to identify non-invasive correlates of coronary microvascular dysfunction in these patients.

The objectives of this study are to

1. Investigate platelet activity and inflammation in patients with and without coronary microvascular disease who are referred for coronary angiography for the evaluation of stable ischemic heart disease and are found to have non-obstructuve epicardial CAD
2. To identify correlates of coronary microvascular dysfunction in non coronary microvascular beds that can be characterized in vivo.

Eligibility Criteria:
Inclusion Criteria:

* Adult women age ≥18 years referred for coronary angiography
* Stable ischemic heart disease, defined by ischemic symptoms and/or myocardial ischemia by stress testing
* Administration of aspirin therapy prior to cardiac catheterization

Exclusion Criteria:

Pre-Cath Exclusion criteria:

* Active bleeding and/or bleeding diathesis
* Anemia (hemoglobin \<9 mg/dl)
* Known thrombocytosis (platelet count \>500,000)
* Know thrombocytopenia (platelet count \<100,000)
* NSAIDs (e.g., ibuprofen, naproxen) within 3 days
* Platelet antagonists other than aspirin and thienopyridines, within 7 days
* Prior percutaneous coronary intervention or coronary artery bypass grafting
* Acute myocardial infarction within 3 months
* Severe valvular heart disease
* Cardiogenic shock or mechanical circulatory support
* New York Heart Association (NYHA) Functional Class III or IV heart failure
* Ejection Fraction \<40%
* Hypertrophic obstructive cardiomyopathy or severe left ventricular hypertrophy
* Pregnancy
* Contraindication to intravenous infusion of adenosine during coronary angiography, due to known hypersensitivity to adenosine, known or suspected bronchoconstrictive or bronchospastic lung disease (severe asthma), second- or third-degree AV block (except in patients with a functioning artificial pacemaker), or sinus node disease, such as sick sinus syndrome or symptomatic bradycardia,

Angiographic Exclusion criteria:

* Obstructive CAD (≥50% luminal obstruction in ≥1 major epicardial coronary arteries by invasive coronary angiography)
* Unfavorable coronary artery anatomy for guidewire positioning (as determined by the angiographer or PI)
Limb Girdle Muscular Dystrophy Type 2E Recruitment Study

This study is to recruit and establish baseline measurements for potential subjects that may be eligible for a gene therapy trial. Specifically, this trial is recruiting individuals who are suspected or have been confirmed to have Limb Girdle Muscular Dystrophy type 2E (LGMD2E).

This is a longitudinal observational study. It is a 24-month study with the possibility of extending the data time points. Visits will occur monthly. However, at the discretion of the PI, subjects may not be required to return monthly. These subjects may return at intervals ranging from 2 months to a max of 6 months apart.

In the situation that the subjects would fall out of the inclusion criteria or not be eligible for the LGMD2E gene therapy trial, they will be given the opportunity to roll over into the Natural History for LGMD (IRB17-01086). If a subject is invited to screen for the gene therapy trial they will discontinue this trial. By being in this study, it is not a guarantee that subjects will be invited to screen for the LGMD2E gene therapy trial.

Eligibility Criteria:
Inclusion Criteria:

* Age 3-15 inclusive
* Males or females of any ethnic group
* SGCB DNA gene mutations at both alleles or suspected to have LGMD2E based on family and medical history. If suspected, genetic testing will be performed to confirm diagnosis.
* Weakness demonstrated based on history of difficulty running, jumping and climbing stairs
* Ability to complete 100MW timed test within 30-90% predicted
* Perform assessments to the best of their ability with reliable results as deemed by the evaluator.
* Ability to attend scheduled appointments
* Ability to provide informed consent (or assent for ages 9-15)

Exclusion Criteria:

* Confirmed diagnosis of neuromuscular disorder other than LGMD2E
* Has a medical condition or extenuating circumstance that, in the opinion of the investigator, might compromise the subject's ability to comply with the protocol required testing or procedures or compromise the subject's wellbeing, safety, or clinical interpretability
* Subjects with AAVrh74 binding antibody titers \> 1:400 as determined by ELISA immunoassay. If endpoint titer is positive at screening, testing may be repeated in 1 month. Antibody testing will be performed on a separate study (IRB17-01101).
* Diagnosis of (or ongoing treatment for) an autoimmune disease
Analysis of Hospitalization Data From ZOC

The real-world electronic health records (EHR) were derived from the hospitalization of Zhongshan Ophthalmic Center (ZOC) of Sun Yat-sen University from 1998-2020 to investigate the ophthalmology diagnosis and treatment activities.


Eligibility Criteria:
Inclusion Criteria:

* have retrospective inpatient records of ZOC from 1998 to 2020

Exclusion Criteria:

* Demographic data missing
* Diagnosis data missing
Docetaxel, Irinotecan, and Carboplatin in Extensive Stage Non-Small Cell Lung Cancer

Primary Objective: To determine the maximum tolerated dose of docetaxel when given with Irinotecan and Carboplatin for the treatment of inoperable lung cancer.

Secondary Objective: To evaluate the dose-related toxicities of this triple regimen in patients with inoperable lung cancer.

A phase I/II dose escalating study to determine the maximum tolerated dose of docetaxel when given with Irinotecan and Carboplatin for the treatment of inoperable lung cancer.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older unresectable lung cancer measurable or evaluable lesions Karnofsky PS greater than or equal to 60%

Exclusion Criteria:

* untreated CNS metastases
Noninvasive Perioperative Monitoring of Arterial Stiffness, Volume and Nutritional Status in Stable Renal Transplant Recipients

Central blood pressure and pulse wave velocity were measured using a BR 102 Plus PWA device in perioperative time after kidney transplantation


Eligibility Criteria:
Inclusion Criteria:

* give voluntary consent to participate in the study
* no clinical cardiovascular disease during the 6 months preceding entry

Exclusion Criteria:

* not meet the above criteria
Study of T Specific Immune Response Against Delta-CD20 Peptide in Hematological Malignancies B

Cancer-specific splice variants gain significant interest as they generate neo-antigens, that could be targeted by immune cells. CD20, a membrane antigen broadly expressed in mature B cell lymphomas, is subject to an alternative splicing named Delta-CD20 leading to loss of membrane expression of the spliced isoform.

The investigators group would now determine if it's possible, in patients with lymphoproliferative B, to detect the presence of a specific memory response to delta-CD20 peptides.

If this memory response exists, it will confirm the interest of this antigen as a target for tumor immunotherapy.


Eligibility Criteria:
Inclusion Criteria:

* For all patient :

  •Written informed consent
* For Cohort A :

  * Patient with hematological malignancy of high grade phenotype B (non Hodgkin's lymphoma diffuse large cell) or low grade (mantle cell lymphoma, follicular lymphoma, marginal zone lymphoma or Waldenstrom disease), regardless the initial extension stage.
  * Histologically or cytologically and immunophenotypical confirmed
  * Patient candidate to a second-line or more therapy
  * First-line treatment with rituximab
* For Cohort B :

  * Absence of prior treatment with an anti-CD20 antibody
  * Histologically or cytologically and immunophenotypical confirmed

Exclusion Criteria:

* For all patients :

  * Patient with any medical or psychiatric condition or disease,
  * Patient under guardianship, curatorship or under the protection of justice and pregnant women
* For Cohort A :

  * Patient with chronic lymphocytic leukemia
  * Patient with indolent lymphoma relapsed more than 1 year after treatment with Rituximab
  * Patient allogeneic hematopoietic cells
  * Patient with linked lymphoproliferative syndrome with congenital immunosuppression (eg SCID, XLP ...) or acquired (post-transplant lymphoma)
Improving the Safety of Fluoropyrimidine-based Chemotherapy

In this study it will be determined whether the rate of severe toxicity associated with fluoropyrimidine treatment (capecitabine or 5-fluorouracil) can be significantly diminished by individualized dosing of fluoropyrimidines based on upfront phenotypic assessment of dihydropyrimidine dehydrogenase (DPD) deficiency.

In this study a phenotypic approach will be studied to determine the additional value of pretreatment uracil level-guided dose individualization in wildtype patients. Patients with a pretreatment serum uracil concentration above 16 ng/ml will be treated with a 50% reduced fluoropyrimidine starting dose. The pretreatment serum uracil levels in DPYD variant carriers will be assessed retrospectively and non-interventional. Additionally, the effect of a higher dose reduction in c.1236G\>A and c.2846A\>T DPYD variants carriers (50% instead of 25%) will be studied.

Eligibility Criteria:
Inclusion Criteria:

1. Pathologically confirmed malignancy for which treatment with a fluoropyrimidine is considered to be in the patient's best interest
2. Patient need to be of Western descent
3. Age ≥ 18
4. Able and willing to give written informed consent
5. WHO performance status of 0, 1 or 2
6. Able and willing to undergo extra blood sampling for study related analysis
7. Adequate baseline patient characteristics, in the opinion of the treating physician (complete blood count, hepatic function which involves serum bilirubin, AST, ALT, and renal function)

Exclusion Criteria:

1. Prior treatment with fluoropyrimidines
2. Patients with known substance abuse, psychotic disorders, and/or other diseases expected to interfere with study or the patient's safety in the opinion of the treating physician
3. Patients treated with the combination of a fluoropyrimidine and irinotecan
COVID-19 Convalescent Plasma (CCP) Transfusion

This research study evaluates the safety and effectiveness for the use of convalescent plasma transfusion as a treatment option for novel coronavirus SARS-CoV-2 infection (COVID-19). Donors who have recovered from COVID-19 with high antibody levels to the CoV-2 virus will donate plasma at a Mississippi Blood Services facility. Recipients with COIVD-19 who have severe or life threatening conditions will receive plasma from those persons who have recovered from COVID-19.

The research purpose is to evaluate the safety and clinical effectiveness of transfusing one unit of banked plasma obtained from patients who have recovered from the novel coronavirus SARS-C0V-2 infection with high titers of IgG antibody to this virus transfused into patients with severe or at high risk of progressing to severe coronavirus-induced disease (COVID-19).

The research hypothesis is that COVID-19 convalescent plasma (CCP) transfusion improves outcomes in patients with COVID-19.

The use of CCP to treat serious and life threatening COVID-19 has a sound biological as well as clinical rationale to provide virus-specific immune protection in patients unable to produce and/or maintain antiviral antibodies. This treatment protocol is designed primarily to offer a rescue therapy in patients with severe and life threatening disease and explore use in patients for whom a progression to serious disease is likely. Examining the specific antibody responses to the virus in transfused patients if/when they show signs of recovery and comparing these values with those obtained before the transfusion may provide information to design more extensive trials aimed at identifying the best patient population for future use of CCP.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18
2. Clinician judged serious or life threatening COVID-19 (or at significant risk to develop serious COVID) manifested by at least one of the following:

   1. Laboratory confirmed diagnosis of SARS-CoV-2 infection
   2. Hypoxia (PaO2/FiO2 \<300, Pulse oximetry \<93% at rest
   3. Evidence of pulmonary infiltration
   4. Respiratory failure
   5. Sepsis
   6. Multiple organ dysfunction or failure (assessed by SOFA score)
3. Informed consent provided by the patient or legally authorized representative (LAR)

Exclusion Criteria:

1. Greater than 21 days from confirmed COVID-19 diagnosis
2. Receipt of pooled immunoglobulin transfusion in previous 28 days
3. History of prior reaction to transfused blood products
4. Currently enrolled in other drug trials that preclude investigational treatment with CoV-2 convalescent plasma transfusion
Visualizing Regional Lung Ventilation in Patients With Postacute-COVID-19

In the absence of data on Electric impedance tomography of healthy spontaneous breathing patients that is compared to dyspnoeic patients suffering from postacute COVID-19 syndrome, the investigators contend that electrical impedance tomography provides additional clues to visualize regional lung ventilation and differentiate healthy from sick patients.

When treating patients with dyspnoea, conventional diagnostic tools (computed tomography, spirometry, body plethysmography) often fail to detect pathological changes, making it difficult for the treating physician to choose an appropriate therapeutic approach. Therefore, it would be desirable to have an examination method that reveals the pulmonary changes in postacute Corona-Virus-Disease-2019 (COVID-19) syndrome patients that remain hidden from other diagnostic procedures.

Electrical impedance tomography (EIT) is a non-invasive and radiation-free imaging technique that can show the regional ventilation of the lungs almost "in real-time" based on the changes in the electrical impedance of the thorax during inspiration and expiration. This method is based on the observation that the electrical conductivities of biological tissues vary considerably depending on their nature and functional state. Clinical questions in which the inhomogeneity of lung ventilation is to be analysed (e.g., under- or overinflation of individual lung areas, lung collapse, etc.) can be investigated particularly well with EIT since intrathoracic impedance changes correlate strongly with changes in regional lung ventilation.

Up to now, EIT has mainly been used as a monitoring method in intensive care medicine to adapt ventilation settings and other therapeutic measures to the individual needs of patients. In this field, the method has proven useful for obtaining an overview of the distribution of a respiratory volume in a transverse EIT slice, comparing different lung regions, identifying inhomogeneities and assessing regional ventilation during spontaneous breathing.

The aim of this case-control study is to use EIT data obtained during routine examinations of post-COVID patients to analyse whether EIT is suitable as a radiation-free, non-invasive imaging technique for assessing regional ventilation of the lung in spontaneously breathing post-COVID patients and whether additional evidence of regional ventilation disorders in these patients can be found by determining lung ventilation using EIT. As there are no reference data from spontaneously breathing lung-healthy patients so far, a reference group will be generated whose EIT data will be compared with those of post-COVID patients.

Eligibility Criteria:
Inclusion Criteria:

* for control group: no lung diseases, no allergic symptoms, non-smokers, over 18 years old
* for patients with postacute COVID-19 syndrome: over 18 years, dyspnoeic symptoms

Exclusion Criteria:

* heart pacemaker
* epilepsy
* BMI over 50
Study of Dietary Patterns and Food Diversity in Russian GERD Patients

The aim of the study is to assess food diversity and dietary patterns in Russian GERD patients

The study of dietary patterns may provide complex vision of an association between consumption of specific foods, or groups of food products and manifestations of gastroesophageal reflux disease (symptoms: heartburn and acid regurgitation; endoscopic findings - oesophagitis). Only limited data on this matter are published to the moment and they predominantly concerns outcomes of gastroesophageal reflux disease (oesophageal adenocarcinoma or Barrett's oesophagus). Taking into the consideration that earlier studies found significant differences in consumption of nutrients in different world regions, new data on food patterns of dietary patterns in Russian GERD patients could partly fill in the gap of knowledge on this particular matter.

Eligibility Criteria:
Inclusion Criteria:

* willingness to participate (signed the informed consent form);
* willingness to follow all the required procedures;

Exclusion Criteria:

* Pregnant or breast-feeding females;
* Neoplasms, current or by the medical history (except local skin cancer successfully treated);
* History of chest or abdominal surgery, except appendectomy and cholecistectomy (in case when no consequences of these operations like adhesive disease of the abdominal cavity are present);
* Co-morbid conditions which can influence or mask the symptoms of GERD (including, but not limited to: ischaemic heart disease, severe pulmonary disease, severe depression or anxiety, etc);
* the use of concomitant medications that may influence on the symptoms or other manifestations of gastroesophageal reflux disease: NSAIDs, corticosteroids (except topic ones for no longer than 2 weeks), any medications directly influencing mood and function of central nervous system (antidepressants, anxiolytics, anti-anxiety agents, anticonvulsant etc) at the moment of enrolment and during a 2 half-life period of the certain drug;
* the use of medications that influence gastric secretion at the time of enrolment and during 2 week before it;
* any condition of the patient which makes the participation of the patient in the study unreasonable or put him at risk of the condition's exacerbation
Use Cord Blood Single Nucleotide Polymorphism to Predict the Later Development of Atopy and Allergy

The aim of our study was firstly to detect in cord bloods the polymorphism of genes related to atopy and allergic diseases and to examine their mutual interaction and their associations with cord blood IgE and cytokines. After that, in the prospective follow-up visits, we liked to investigate if the measurement of cord blood SNPs of genes related to atopy and allergic diseases was helpful in predicting the development of atopy and allergic diseases later in life.


Eligibility Criteria:
Inclusion Criteria:

* Apgar score of 5 minutes not less than 7 gestational age not less than 36 weeks

Exclusion Criteria:

* Apgar score of 5 minutes \< 7 gestational age \< 36 weeks
Vascular Effects of Hesperidin in Metabolic Syndrome

It has been suggested that cardiovascular risk factors either independently or in cluster (metabolic syndrome) increase the risk of both type 2 diabetes (DM2) and cardiovascular diseases (CVD). Consumption of citrus fruits is linked to reduced cardiovascular morbidity and mortality. Hesperidin is a flavanone abundant in citrus fruit with putative vasodilator actions in vitro. While molecular mechanisms of vascular actions of hesperidin begin to be explored, no data on in vivo vascular effect of this flavanone has been ever acquired.


Eligibility Criteria:
Inclusion Criteria:

* Metabolic Syndrome (ATPIII criteria)
* BMI \<35
* Age 20-55

Exclusion Criteria:

* History of cancer.
* History of cardiovascular diseases.
* Any other acute or chronic illness which requires administration of steroids or other drugs able to interfere with glucose or lipid metabolism.