cyrilzakka/clinical-trials huggingface dataset:
The Effect of Folic Acid Supplementation and Pregnancy on the Folate Forms in Red Blood Cells

The purpose of this cross-sectional study was to examine whether or not physical changes or adaptations occur in response pregnancy or to the higher intakes of folic acid from supplementation typically consumed during the reproductive period.

Higher folate requirements during pregnancy to support growth and development are well established but it is unknown what metabolic changes occur in 1-carbon metabolism to provide sufficient nucleotides for DNA/RNA synthesis. Periconceptual folic acid (FA) supplementation and fortification of the food supply have been shown to reduce the risk of pregnancies with neural tube defects but conversely expose women to high FA intakes for extended periods of time. The purpose of this cross-sectional study is to establish if physiological adaptations occur in folate metabolism in response to pregnancy or higher intakes of FA typically consumed among women during the reproductive period. A convenience sample of thirty-two women (n=8/group) were recruited to compare the total concentrations and forms of folate (tetrahydrofolate \[THF\], 5-methylTHF, 5-formylTHF and 5, 10-methenylTHF) in red blood cells in four groups: a) pregnant women (PW, 30-36 weeks gestation) taking 1.0 mg of FA b) non-pregnant women (NPW) taking 0 mg of FA c) NPW taking 1.0 mg FA and d) NPW taking 5.0 mg FA. Blood samples were taken at a single time point and compared across groups. Total red blood cell concentrations were measured using both microbiological assay and liquid chromatography/tandem mass spectrometry (LC/MS/MS) analysis. LC/MS/MS analysis was used to determine folate form concentrations.

Eligibility Criteria:
Inclusion Criteria:

1. pregnant women-

   * between 30 to 36 weeks gestation
   * taking 1 mg folic acid in a multisupplement
2. non-pregnant women-

   * not pregnant
   * taking either 0, 1 or 5 mg folic acid in a multisupplement

Exclusion Criteria:

* Taking any medications known to interfere with folate absorption at the time of sampling (ie. Antibiotics \[ can be enrolled into study if they will be off them at least two weeks prior to study commencement\], methotrexate, aminopterin)
* Those with a history of any disorders or conditions that could interfere with folate absorption or metabolism from either dietary or supplement sources such as the history/presence clinically significant gastrointestinal disease (chronic diarrhea, inflammatory bowel disease, partial gastrectomy), unresolved GI symptoms(diarrhea/vomiting), steatorrhea or other conditions that interfere with absorption, distribution, metabolism or excretion of folic acid.
* Those with preexisting conditions (pre-existing maternal diabetes; insulin-dependent diabetes; previous child with neural tube disorder (NTD), cleft-lip/palate or heart defect; epilepsy and/or seizure disorders) that can increase the risk of pregnancy complicated by NTD.
Outcome Following Truncation of Asparaginase

This study aimed to investigate the outcome of patients who had their asparaginase treatment truncated in the NOPHO ALL2008 protocol.

Overall survival for children with ALL is now above 90% in several protocols, but asparaginase associated toxicities still constitutes a significant problem as they, besides causing acute morbidity and mortality, can cause truncation of treatment with a subsequent increased risk of relapse.

The most frequent toxicities causing asparaginase truncations are hypersensitivity, pancreatitis and thrombosis. Especially hypersensitivity constitutes a problem due to silencing antibodies, not only in patients with clinical hypersensitivity but also in patients without clinical symptoms (silent inactivation).

In the NOPHO ALL2008 protocol asparaginase associated toxicities and truncation of asparaginase have been registered since the protocol opened in 2008. In addition asparaginase enzyme activity measurements have been done before every asparaginase administration and analyzed retrospectively.

The primary aim of this study was to investigate if patients with truncation of asparaginase or lack of asparaginase enzyme activity had a different risk of relapse compared to patients who received full asparaginase treatment. Secondary we aimed to explore if patients who received less than 50% of their planned asparaginase dosages had a different risk of relapse compared to those who received 50% or more.

Eligibility Criteria:
Inclusion Criteria:

- Children treated according to the NOPHO ALL2008 protocol from the 1st of July 2008 - 28th of February 2016.

Exclusion Criteria:

* Bilineage ALL
* Pre-treatment with glucocorticosteroids or other antileukemic agents for more than 1 week
* ALL predisposition syndromes
* Previous cancer
* Off protocol administration of additional chemotherapy during induction therapy
* Sexually active females not using contraception
Chronic Subdural Hematoma - Reduction of Recurrence by Treatment With Angiotensin Converting Enzyme Inhibitors

The project aims at investigating if treatment with the Angiotensin Converting Enzyme inhibitor Coversyl (perindopril) for 3 months after surgery for chronic subdural hematoma will decrease the risc of recurrence.

Previous studies have indicated that treatment with ACE inhibitors can reduce the risk of recurrence of CSDH after surgical evacuation. This randomized clinical trial was designed to investigate this

Eligibility Criteria:
Inclusion Criteria:

1. Patients with chronic subdural hematoma that needs surgical evacuation
2. Age \> 18 year

Exclusion Criteria:

1. Lack of compliance
2. Kidney artery stenosis
3. Stenosis of the aorta
4. Severely decreased kidney function
5. Allergy or intolerance/contraindications toward ACE inhibitors
6. Already in ACE inhibitor treatment
7. Coagulopathies
8. Malignant disorders
9. Fertile women
10. Other neurological disorders
11. Treatment with pharmaceuticals contraindicating treatment with ACE inhibitors
Genetic Variants in Nicotinamide Adenine Dinucleotide (NAD) Synthesis Pathway

Researchers are trying to identify versions of genes as well as factors in subjects blood associated with certain types of congenital malformations(CMs). This study will help the researchers to better understand family traits that contribute to CMs.


Eligibility Criteria:
Inclusion Criteria:

1. Adults with confirmed or putative diagnosis of VACTERL association;
2. Families (mother, father, biological offspring) with a history of VACTERL-associated malformations
3. Gravid or non-gravid women with a history of miscarriage and/or offspring with non-VACTERL-associated malformations
4. Willingness to abstain from red meat, meat products, chicken, peanuts, or brewer's yeast (including beer) at least 24 hours prior to blood and urine collection

Exclusion Criteria:

1) Parents of non-biological children 3) Children with congenital malformations associated with an identifiable environmental or lifestyle exposure 4) Children with congenital malformations associated with confirmed chromosomal disorders 5) Failure to abstain from red meat, meat products, chicken, peanuts, or brewer's yeast (including beer) at least 24 hours prior to blood and urine collection.
Preventive Effect of Pitavastatin on Contrast-Induced Nephropathy in Patients With Renal Dysfunction

Contrast-induced nephropathy (CIN) is a well-recognized complication of radiographic contrast administration and is associated with increased short- and long-term mortality. Previous strategies including forced diuresis with diuretics or mannitol, intravenous administration of fenoldopam or dobutamine, and postprocedure hemodialysis to prevent CIN have been largely unsuccessful. In addition, the use of N-acetylcysteine to prevent CIN has yielded conflicting outcomes.

A review of a large insurance database and retrospective study have shown that statins therapy is associated with a lower incidence of CIN after percutaneous coronary intervention. The preventive effect of statins on CIN may be attributed to direct pleiotropic effects on the vascular wall such as improvement of endothelial dysfunction, anti-inflammatory or anti-oxidative effect. However, recent randomized trial could not demonstrate the preventive effect of statin on CIN in patients with chronic kidney disease.

Thus, we will investigate the preventive effect of pitavastatin on CIN in patient with renal dysfunction undergoing coronary angiography or intervention.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 19 years
* Need for coronary angiography or intervention in patients with typical symptoms for angina or myocardial infarction, or documented myocardial ischemia at non-invasive studies including ECG, treadmill ECG test, heart spect or coronary CT angiography
* Estimated glomerular filtration rate ≤60 mL/min
* Informed consent

Exclusion Criteria:

* Need for primary percutaneous coronary intervention or emergent intervention in patients with myocardial infarction
* Allergic reaction for contrast agent (Visipaque) or statin
* Contraindication for contrast agent (Visipaque) or statin
* Shock status fron any cause including cardiogenic shock
* Statin use before enrollment (Enrollment after 2 weeks of wash-out period)
* Exposure of contrast agent within 7 days before enrollment
* Pregnancy or Expectation for pregnancy in women of childbearing age
* Heart failure (NYHA class ≥3 or left ventricular ejection fraction \< 40%)
* Acute renal injury
* Dialysis therapy
* Mechanical ventilator
* Life expectancy \< 6 months
* Non-steroidal anti-inflammatory drug, dopamine, mannitol or N-acetylcysteine, ascorbic acid within 48 hours before and after coronary angiography/intervention
* Severe hepatic dysfunction
* Eisenmenger syndrome or idiopathic pulmonary hypertension
* Renal artery angioplasty within 6 months
* Single functioning kidney
* Kidney transplantation
Seasonal Trends of Respiratory Morbidity in Diabetic Patients

Type 2 diabetes mellitus (T2DM) poses a significant burden on the patients and the health care system. The increasing number of surgery performed in elderly population results in an increased number of perioperative T2DM-related adverse effects. T2DM has a prevalence of 30-40% in a population undergoing cardiovascular surgery. Cardiac surgery, especially cardiopulmonary bypass (CPB) is also known to deteriorate respiratory mechanics.

Therefore, the study is aimed at a retrospective analysis of seasonal trends in respiratory consequences of T2DM, i.e.: i: distribution of patients with and without T2DM presenting for elective cardiac surgery during the two-year examination period; ii: characterization of respiratory co-morbidities in the patients, iii: exploring whether the respiratory mechanics at presentation and those caused by cardiac surgery exhibit different trends in T2DM and control patients.

Our study is a retrospective analysis of patient records from all patients undergoing elective cardiac surgery between January 2007 to December 2018 at the Second Department of Internal Medicine and Cardiology Centre Cardiac Surgical Unit, University of Szeged.

Electronic and paper documentation will be examined and anonymously analysed for the following information:

1. date of cardiac surgery,
2. type of cardiac surgery procedure,
3. demographic data (age, height, weight),
4. presence of T2DM (previous diagnosis, fasting plasma glucose level, glycated haemoglobin \[HbA1C\]),
5. presence of respiratory co-morbidities (e.g. asthma, COPD, etc.),
6. presence of other circulatory co-mobidities (e.g. hypertension, previous stroke, vascular stenosis)

6. respiratory mechanical parameters before and after cardiac surgery, 7. presence of perioperative respiratory complications, 8. history of smoking 9. blood gas measurements before, during and after surgery

Time series statistical analysis of all data will be carried out to discover the presence of seasonal trends in both diabetic and control patients. Analysis of variance (ANOVA) will be carried out to explore global differences between diabetic and control patients.

Eligibility Criteria:
Inclusion Criteria:

* all patients undergoing cardiac surgery with or without diabetes mellitus, age between 18-85 years during the time period January 2007 to December 2018

Exclusion Criteria:

* patients older than 85 years
* patients younger than 18 years
Protocole Advanced RadioTherapy ORL

The purpose of this study is to do health economic evaluation of tomotherapy and dynamic arctherapy (2 techniques exist: RapidArc and Vmat).

This study evaluate also local disease control after 18 months in patients with an ENT epidermoid carcinoma and treated by tomotherapy orarctherapy .

The number of patients required in this study is: 300:

* Number of patients treated with tomotherapy: 120
* Number of patients treated with dynamic arctherapy RapidArc: 120
* Number of patients treated with dynamic arctherapy Vmat: 60

This is a prospective; multicentric and non randomized study.


Eligibility Criteria:
Inclusion Criteria:

* PS \<= 2
* Age \>= 18 years
* Histologically proven carcinoma
* Cavum Epidermoïd or undifferentiated carcinoma; or oropharynx epidermoïd carcinoma; or oral cavity epidermoïd carcinoma
* Stade T1 to T4
* M0
* Patient with no surgery ( except laser partial surgery and ganglionic cleaning out)
* Bilateral ganlionic cervical area irradiation
* Covered by a medical insurance.

Exclusion Criteria:

* Prior history of other malignancies in the last 5 years(except non evolutive ENT cancer or squamous cell carcinoma )
* Re-irradiation indication
* Unilateral cervical area irradiation
* Post-operative radiotherapy
* Patient treated by amifostine
* Impossible follow-up
Low Voltage Electrical Stimulation for Depression in Parkinson's Patients

The goal of this clinical trial is to determine the relative efficacy of fMRI model guided Transcranial Direct Current Stimulation (mgTDCS) in improving the depressive symptoms of patients with Parkinson's Disease (PD). The main questions it aims to answer are: 1) Can the use of mgTDCS significantly improve the self-reported level of depression and apathy in patients with PD from pre-intervention to post-intervention compared to a sham control? 2) Can the use of mgTDCS significantly normalize the cortical eeg alpha asymmetry so commonly seen in depressed patients compared to sham mgTDCS? 3) Can the use of mgTDCS significantly improve scores on neuropsychological tests of working memory?

This study seeks to expand the growing body of literature on the use of a particular type of low voltage electrical stimulation known as Transcranial Direct Current Stimulation (TDCS) to reduce the symptoms of Parkinson's Disease (PD). One common disorder that can result from, and/or be exacerbated by PD is Major Depressive Disorder. In particular, apathy has been noted as a common and detrimental component for those with PD. While many studies have been performed on PD patients using TDCS, the consensus in the literature is that results are widely variable.

Participants will:

* complete self-report measures and neuropsychological tests
* undergo eeg recording pre and post intervention
* participate in 15, 46 minute sessions (2 13 minute stimulation sessions with 20 minutes of rest between) of mgTDCS over the course of 4-5 weeks Researchers will compare active mgTDCS to Sham mgTDCS to see if active mgTDCS is more effective. A non Parkinson's group of depressed controls who are age-matched to the PD patients will serve to determine if treatment effects are specific to PD or generalize to depression more generally.

Eligibility Criteria:
Inclusion Criteria:

* 19 to 65 years in age.
* Parkinson's Group must have a physician dx of Parkinson's Disease
* Must meet exhibit elevated levels of depression on the Beck Depression Inventory (scores of 20 or above).
* Must be willing and able to travel of the Psychology Department for EEG and tDCS sessions.
* Participants who have undergone surgery for Deep Brain Stimulation implantation may be enrolled if advised to and monitored by their physician.
* Read and understand spoken English.

Exclusion Criteria:

* No history of or being treated for epilepsy or other seizure disorders.
* No history of penetrating head wounds or TBI greater than mild TBI.
* No history of atypical Parkinson's
Thrombin Generation in Beta-thalassemia Major

This study aims to evaluate the persistence of a hypercoagulable state in chronically-transfused patients with beta thalassemia major, by using the thrombin generation test (performed in whole blood and plasma). Patients will be compared with 2 control groups: 1/ healthy volunteers and 2/ carriers of beta-thalassemia trait


Eligibility Criteria:
Inclusion Criteria:

* Patient with de Beta-thalassemia major
* Patient with regular blood transfusion regimen (every 4 - 6 weeks)
* informed and signed consent
* weight \> 30kg
* Hemoglobin \> 7g/dL

Exclusion Criteria:

* Emergency situation
* Patients receiving antithrombotic drugs (anticoagulants such as Vitamin K antagonism, heparin or direct oral anticoagulant) or antiplatelet drugs;
* women of childbearing age without contraception
* pregnancy
* deprivation of liberty
* no consent
Celiac Disease in Children

The aim is to study the clinical, serological, endoscopic and histopathological characteristics and treatment outcome of children diagnosed with celiac disease in Sohag University Hospital

Celiac disease (CD), or gluten-sensitive enteropathy, is an immune-mediated enteropathy triggered by the ingestion of gluten-containing cereals (wheat, barley, and rye) in genetically susceptible individuals. Undiagnosed CD may cause intestinal (e.g. chronic diarrhea, failure to thrive) and/or extra intestinal (e.g. anemia, osteoporosis, dermatitis herpetiformis) manifestations.

The etiology of CD is multifactorial, with both genetic and environmental factors involved in disease development. Susceptibility to CD is primarily associated with the human leukocyte antigen HLA-DQ2 allele. The heterodimer DQA1\*0501 and DQB1\*0201 is detected in up to 95% of persons with celiac disease, with the remaining 5% expressing HLA-DQ8 (DQA1\*0301, DQB1\*0302). The frequency of these alleles in the general populations in Western countries is 20% to 30%. Therefore, an individual not carrying DQ2 or DQ8 alleles is extremely unlikely to develop CD.

Celiac disease is associated with a host of autoimmune diseases such as type 1 diabetes mellitus, autoimmune thyroid disease, Addison disease, autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, and immunoglobulin (Ig) A deficiency. There is also an increased prevalence of CD in patients with genetic disorders such as Down syndrome and Turner syndrome.

Serologic testing is recommended as the first step in pursuing a diagnosis of CD, however, small-bowel mucosal biopsy is currently considered the gold standard for diagnosing CD. All serologic tests and small-bowel biopsies need to be performed while the patient is on a gluten-containing diet.

The characteristics of small intestine biopsies from CD include partial or complete villous atrophy, crypt hyperplasia, and intraepithelial lymphocyte infiltration.

According to the modified Marsh classification, the intestinal damage is divided into four stages. Stage 0 intestinal damage is characterized by the lesion invasion in the mucous layer, the increased number of intraepithelial lymphocytes and the presence of lymphocytes in the lamina propria, whereas Stage 1 damage features microscopic enteritis with an increase of intraepithelial lymphocytes. A feature of Stage 2 intestinal damage is crypt hyperplasia along with villous atrophy while Stage 3 is characterized by a complete atrophy of the intestinal villi.

Treatment of CD includes lifelong gluten-free diet. The clinical and histological benefits of a gluten-free diet (GFD) in the management of CD are well recognized showing that the degree of histological recovery is dependent upon how strict the patient adheres to the diet.

Eligibility Criteria:
Inclusion Criteria:

* Children less than 18 years.
* Both sexes.
* Children suffering from manifestations of celiac disease.
* Children previously diagnosed with celiac disease.

Exclusion Criteria:

* cases more than 18 years.
* Children diagnosed with other causes of malabsorption
Training With Elastic Tubing in Cardiopaths: Clinical Trial

Background: Resistance training is effective in cardiac rehabilitation; however, other types of training, such as elastic tubing, are rarely used and may present good therapeutic alternatives. Due to its practicality and cost effectiveness, training using elastic tubing may become an important tool in cardiovascular rehabilitation. Objective: To evaluate muscular strength, functional capacity, aerobic capacity and quality of life in patients with cardiovascular diseases in phase II of rehabilitation, after resistance training with elastic tubing. Methods: patients with cardiovascular diseases performed training with elastic tubing for six weeks, twice a week and the load was progressively increased every 15 days. The following muscle groups were evaluated and trained: shoulder abductors and flexors, elbow flexors, and knee flexors and extensors. Muscular strength was evaluated using a dynamometer; functional capacity with a 6-minute walk test and ergospirometric test; and quality of life using the SF-36 questionnaire. Data normality was assessed using the Shapiro Wilk test. Comparisons before and after training were performed using the paired Student's t test or the Wilcoxon test (p \<5%).


Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes
* Aged between 45-79 years
* Clinical diagnosis of heart disease (coronary artery disease, postoperative myocardial revascularization, acute myocardial infarction)
* In phase II of CRP for at least three months

Exclusion Criteria:

* Patients hemodynamically unstable
* Patients with changes in medication for a minimum of 30 days
* Patients who presented arteriopathies, neurological, muscular or orthopedic disorders, such as rheumatism and unstable heart disease that could be detected by electrocardiogram, and lung diseases.