cyrilzakka/clinical-trials huggingface dataset:
Nutrition Education Module for Preschooler Children

This study evaluates the knowledge of preschooler children before and after intervention of nutrition education using nutrition education module for preschooler children. The teachers will be given training regarding the module and deliver it in the class during the intervention.

A nutrition education module for preschooler children had been developed in the previous study. The module consists of 3 topics of nutrition (my meal plate, fruits and vegetables, healthy snacks). Each topic consists of 4 activities engaging children and teachers. A total of 12 activities will be delivered on 4 consecutive school day every week.

The teacher will deliver the nutrition education which trained prior to the study.

Eligibility Criteria:
Inclusion Criteria:

* children registered in selected public kindergarten
* grade/class B kindergarten
* willing to follow the study

Exclusion Criteria:

-
Cross-sectional Study to Assess Prevalence and Burden of CKD-associated Pruritus in Haemodialysis Patients

Vifor International Inc. is seeking real-world evidence (RWE) to better understand the epidemiology, patient characteristics, and management of CKD-aP in the real-world clinical setting.

This is a non-interventional, cross-sectional, multicentre, and multinational (European) study. The non-interventional study (NIS) design allows the observation of patients in large haemodialysis (HD) centres reflecting routine clinical practice. All decisions on therapeutic or diagnostic procedures, treatments, management of the disease, or resource utilisation will be at the full discretion of the treating physician without interference by the sponsor or study protocol. All treatment decisions will follow the real-life treatment behaviour.

The CENSUS-EU represents a cross-sectional study design of a representative selection of patients undergoing HD at 113 large dialysis centres across 7 countries in Europe. Prot. v.2.0, 9 May 2023

Eligibility Criteria:
Inclusion Criteria:

* Male or female adult patients with CKD (≥18 years) receiving HD for at least 3 months prior to signing informed consent
* Signed informed consent
* Able and willing to fill in questionnaires

Exclusion Criteria:

* Patients performing HD at home or both home and centre
An Online-platform to Improve Patient-centered Care During the COVID-19 Pandemic: a GIMEMA Surveillance Program in Hematologic Malignancies

This is a national multicenter prospective observational study led by the GIMEMA. The GIMEMA-ALLIANCE Platform is also an online monitoring system for patients with hematologic malignancies aiming at helping hematologists in the early recognition and timely management of problems of their patients. Based on patient's rating of specific items (i.e. on the presence of clinically relevant problems or problems with adherence to therapy or risk of SARS-CoV-2 infection), the Platform will automatically send alerts to the treating hematologist (and/or appointed members of the local Team). Physicians will be free to make any action they feel appropriate for the best care of their patients.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of any hematologic malignancy according to 2016 WHO classification
* Adult Patients (≥18 years).
* Written informed consent

Exclusion Criteria:

* Major cognitive deficits or psychiatric problems hampering a self-reported evaluation.
* Not able to read and understand local language
Study to Evaluate Hemodynamic Response to to a Sublingual Dose of Glyceryl Trinitrate in Subjects Receiving TA-1790, Sildenafil Citrate, and Placebo

The objective of this study is to evaluate the hemodynamic response to a sublingual dose of glyceryl trinitrate in subjects receiving oral TA-1790, sildenafil citrate, and placebo.


Eligibility Criteria:
Inclusion Criteria:

* Provide written informed consent
* Willing to comply with all study requirements and clinic schedules
* Male between 30 to 60 years of age
* Non-smoker
* No history of alcohol abuse
* Normal screening laboratory values

Exclusion Criteria:

* Allergy or hypersensitive to PDE5 inhibitors
* Evidence of clinically significant disease
* Supine systolic/diastolic blood pressure level
* History of cardiovascular disease
* Previously participated in TA-1790 within the past 30 days
Upper Extremity Dysfunction in Patients With Cervical Radiculopathy

This study will examine how cervical radiculopathy (a pinched nerve in the neck) affects function in both arms, not just the symptomatic side. The investigators will evaluate 42 patients with different cervical nerve root involvement (C4-5, C5-6, or C6-7) and compare them to 16 control subjects with non-specific neck pain. The assessments will measure muscle strength, sensory function, hand performance, pain levels, and psychological factors. These evaluations may contribute to the development of rehabilitation programs for cervical radiculopathy.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years
* Clinical diagnosis of unilateral cervical radiculopathy at C4-5, C5-6, or C6-7 level
* Diagnosis confirmed by clinical examination and MRI
* Symptoms present for at least 4 weeks prior to enrollment
* Ability to understand and follow study instructions
* Ability to provide informed consent for participation
* For control group: non-specific neck pain without radiculopathy
* Ability to complete required assessments

Exclusion Criteria:

* Systemic disorders
* Neurological disorders (excluding CR)
* Previous spinal surgery
* Acute trauma
* Fracture
* Malignancy
* Osteoporosis
* Rheumatic disease
* Ongoing pharmacological treatment for chronic neck pain
Optimizing Bronchopulmonary Cancer Screening

The aim of this study is to evaluate the feasibility of performing a first screening for bronchopulmonary cancer by thoracic scanner in a French cohort within a dedicated, effective and structured network in the pilot centers participating in the study.

The organization of bronchopulmonary cancer screening in the Ile de France region, within the Mutualists and its affiliated health centers, is based on a clear, simple and functional process:

* Definition of eligibility criteria for screening, based on those of the NELSON study,
* Referral and consultation by a health center physician trained in these criteria,
* Referral and performance of a chest Computer Tomography Scanner (CTscan) according to the same recommendations,
* Structured centralized reading and interpretation of CTscan images,
* Referral to a multidisciplinary team (CITT), if bronchopulmonary cancer is suspected,
* Referral to a tobacco unit in a health center for smokers who have not stopped smoking,
* Organization of follow-up and continuation of the screening program.

Eligibility Criteria:
Inclusion Criteria:

* Participant aged 50 to 74.
* Resident in the Île-de-France region.
* Active smoker or quit smoker for 10 years or less:

  1. more than 10 cigarettes a day for more than 30 years,
  2. more than 15 cigarettes a day for more than 25 years.
* The participant has been informed and has signed the consent form.
* Social Security System affiliation.
* Willingness to participate in a smoking cessation program, if currently smoking.

Exclusion Criteria:

* Active cancer or a history of cancer in remission for less than 5 years (except basal cell carcinoma of th skin or epithelioma in situ of the uterine cervix).
* Presence of symptoms suggestive of bronchopulmonary cancer. Participants with these symptoms require immediate diagnostic investigations and are therefore not eligible for screening.
* Weight \>= 140 kg.
* Severe comorbidity contraindicating therapeutic options or invasive thoracic diagnostic investigations.
* Inability to climb two flights of stairs without stopping.
* A thoracic CTscan performed within the previous year.
* Persons deprived of liberty or under guardianship.
* Impossibility to undergo the medical monitoring of the trial for geographical, social or psychological reasons.
Effect of Itopride, on Symptoms of Functional Dyspepsia, Such as Indigestion, Bloating, Inability to Finish a Meal

Itopride is a new compound that is already marketed in Japan and in some countries of Eastern Europe under the name of Ganaton. It is used to treat symptoms of functional dyspepsia. Patients suffering from this condition have difficulties digesting food. They feel full after eating a few bites; they feel bloated and their stomachs hurt. The goal of this study is to see if itopride helps to relieve the symptoms of functional dyspepsia.

The study lasts approximately 10 weeks. Patients may either receive the real itopride, or a sugar pill called placebo. They have equal chances of receiving either treatment. After having completed this study, patients may be eligible to continue treatment for a longer period. At that point, all patients receive itopride.

Patients need to come to the clinic for evaluations 4 times during the trial. Various evaluations are done at these visits, such as a physical exam, lab tests, evaluation of the heart condition, and questionnaires need to be completed by the patient to see if the drug helps them in relieving their symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from functional dyspepsia according to Rome II criteria

  * 18-65 years old
  * Absence of, or infrequent heartburn (one episode per week or less)
  * Helicobacter pylori (H. pylori) negative
  * Normal upper endoscopy
Complementary Testing to Evaluate Immunogenicity of Human Papillomavirus (HPV) Vaccine (580299) in Healthy Female Subjects Aged >/= 26 Years

Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Indeed, certain oncogenic types of HPV can infect the cervix (part of the uterus or womb). This infection may go away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. This study will supplement an ongoing study evaluating the safety, efficacy and immunogenicity of the vaccine in women aged 26 years and above. This study will therefore assess additional immunogenicity parameters of the vaccine in women from selected investigative sites.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


Eligibility Criteria:
Inclusion Criteria:

* A female enrolled in study 104820 and who received three doses of study vaccine/control.
* Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
* Written informed consent obtained from the subject prior to enrolment in this ancillary study.

Exclusion Criteria:

* Pregnancy.
* Administration of any HPV vaccine other than that foreseen by the study protocol.
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine since study start.
* Chronic administration of immunosuppressants or other immune-modifying drugs since study start.
* Administration of immunoglobulins and/or any blood products within 90 days preceding a blood sampling.
Decreased Tongue Strength is Related to Skeletal Muscle Mass in COPD Subjects

Background:

Dysphagia is frequently observed in subjects with chronic obstructive pulmonary disease (COPD). But tongue strength has not been investigated yet in COPD subjects. The investigators hypothesized that tongue strength is weaker in COPD subjects compared to normal subjects.

Methods:

This was a single-centre, observational, and cross-sectional study. Twenty-seven subjects with COPD and twenty-four age-matched control subjects were enrolled in this study. Isometric tongue strength was measured using a device fitted with a disposable oral balloon probe. The investigators also evaluated handgrip strength, gait speed, and appendicular skeletal muscle mass (ASM) to define participants as having sarcopenia. ASM, fat free mass index (FFMI), and skeletal muscle mass index (SMI) were measured by bioelectrical impedance analysis. Gait speed was measured using the 6-meter walking test. The eating assessment test-10 (EAT-10) was used to diagnose dysphagia.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of stable COPD.
* Age-matched control subjects who did not have any pulmonary disease.

Exclusion Criteria:

* Participants with metallic implants.
* History of stroke disease.
* History of neuromuscular disease.
* Participants who did not have their front teeth.
Comparison of Oral Sodium Phosphate and Sennoside A+B Calcium Lavage for Colonoscopy Preparation

The aim of the investigators study is to assess the bowel cleansing effects of two different agents and to compare their safety of application, ease of usage and effects on serum electrolytes.

Colorectal cancer is a leading cause of death from cancer. Because colonic cancer begins as a small adenoma that , evolves into carcinoma over a decade or more pre-emptive colonoscopic polypectomy can prevent this malignancy. For a good colonoscopic examination ideally the colon should be cleansed of all fecal material because poor bowel preparation before colonoscopy often leads to inability to reach the cecum or poor visualization of the mucosa . Thus , pathology may be missed, repeat examinations may be scheduled at earlier intervals than planned and the procedure is more difficult and time consuming. In addition , poor bowel preparation can increase the risk of significant complications. Perforations resulting from maneuvers has greater consequences in the setting of inadequate bowel preparation.

In the past two decades , various bowel preparation methods have been proposed including castor oil, anthraquinones, phenolphtalein and magnesium citrate, in combination with low residue diet4-7. Along these agents , cleansing enemas formed the traditional bowel preparation. Oral sodium phosphate (Fleet Phospo-soda, C.B Fleet Co, Inc., Lynchburg, Va.)(NaP) a preparation containing dibasic and monobasic sodium phosphate was proven to be cost effective and has since been used worldwide8,9. NaP osmotically draws plasma water into the bowel lumen to promote bowel cleansing. NaP must be accompanied by significant oral fluid to prevent dehydration. Patients with compromised renal function, dehydration, hypercalcemia or hypertension with the use of angiotensin converting enzyme inhibitors have experienced phosphate nephropathy after use of oral NaP solutions.

Senna laxatives containing sennosides activated by colonic bacteria have a direct effect on intestinal mucosa increasing the rate of colonic motility , enhancing colonic transit, and inhibiting water and electrolyte secretion10. Sennosides may result in hypokalemia and atonic colon.

The aim of our study is to assess the bowel cleansing effects of two different agents and to compare their safety of application, ease of usage and effects on serum electrolytes.

Eligibility Criteria:
Inclusion Criteria:

* Patients requiring diagnostic outpatient colonoscopy.
* Over the age of 18 and giving informed consent by their will.

Exclusion Criteria:

* Patients unable to give informed consent
* Those younger than 18 years old
* Those with a known history of chronic renal failure
* Pregnant women and those with a known history of bowel resection were excluded
Crestor Versus Placebo in Subjects With Heart Failure

The purpose of the study is to investigate if rosuvastatin, added on top of all other medicines prescribed to subjects with symptomatic systolic heart failure, reduces the combined endpoint of cardiovascular death or non-fatal myocardial infarction or non-fatal stroke (time to first event)


Eligibility Criteria:
Inclusion Criteria:

* Chronic symptomatic systolic heart failure of ischaemic aetiology as judged by the investigator, optimal therapy for chronic symptomatic systolic heart failure according to the investigator

Exclusion Criteria:

* Acute myocardial infarction within 6 months before randomization
* Treatment with any statin or other lipid lowering drug; or a medical condition that in the opinion of the investigator requires treatment with a statin or other lipid lowering drug
Genetics Study of Tissue Collected From Patients With Acute Myeloid Leukemia

RATIONALE: Collecting and storing samples of tissue and blood from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.

PURPOSE: This laboratory study is looking at changes in the DNA of tissue samples that were collected from patients with acute myeloid leukemia.

OBJECTIVES:

* Validate, on the larger number of patients with karyotypically normal acute myeloid leukemia (AML) treated uniformly on CALGB-19808, preliminary results from CALGB-9621 showing that BAALC and ERG overexpression and microarray gene-expression signatures can stratify the patients prognostically.
* Establish whether microRNAs are differentially expressed in subsets of patients with AML and normal cytogenetics, and, if so, attempt to identify a signature that stratifies patients prognostically.
* Explore the relative contribution in predicting clinical outcome of patients with cytogenetically normal AML using genetic markers such as BAALC, ERG, and EVI1 overexpression, MLL partial tandem duplication, FLT3 internal tandem duplication, NPM1 and CEBPA mutations, and microarray gene expression microRNA signatures.

OUTLINE: This is a multicenter, pilot study.

Peripheral blood and bone marrow samples are analyzed to assess gene expression using polymerase chain reaction (PCR) or reverse transcriptase-PCR assays and microarray assays. Genes to be studied include BAALC, ERB, EVI1, MLL, FLT3, NPM1, and CEBPA.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of acute myeloid leukemia

  * Normal karyotype
* Bone marrow and/or peripheral blood samples from patients treated on CALGB-19808 and registered on CALGB-9665 required

  * No additional samples required
Retrospective, Uncontrolled Cohort Study on the Therapy of Chronic Megalon

The aim of this retrospective cohort study is to analyze all available data of patients with chronic megacolon in three clinical centers with respect of conservative and surgical therapies.

Megacolon may be defined as dilatation of the abdominal colon with a minimum of 9 cm in diameter and the absence of mechanical obstruction. Chronic megacolon in adults is an acquired uncommon condition that generally is associated with constipation. It has to be distinguished from other forms of megacolon such as acute toxic megacolon, acute non-toxic megacolon (Ogilvie´s-syndrome) and congenital megacolon (Hirschsprung disease). Regardless of concomitant diseases and causes, most patients with chronic megacolon were treated by laxative measures. Less is known about the optimal conservative therapy . If conservative measures fail, there are several surgical options, depending upon anorectal function. However, less in known about the optimal surgical therapy of patients with chronic megacolon. The aim of this retrospective cohort study is to analyze all available data of patients with chronic megacolon in three clinical centers with respect of conservative and surgical therapies.

Eligibility Criteria:
Inclusion Criteria:

* Chronic megacolon (colon diameter \> 90 mm)

Exclusion Criteria:

* Toxic megacolon
* Ogilvie-syndrome
* Hirschsprung disease
* Mechanical colorectal obstruction
Transplantation of Bone Marrow Mesenchymal Stem Cell in Crohn's Disease

This study is a prospective, randomized, parallel, phase 1 trial to assess the safety and feasibility of the transplantation of bone marrow derived mesenchymal stem cells (MSCs) in fistulizing Crohn's disease.

In this study all eligible patients were randomly allocated into two study groups by a permuted block randomization method: group A receives only autologous MSCs suspended in fibrin glue, group B receives autologous MSCs+ Fibroblasts. Both groups receive 4 injections inside the wall and lumen of the fistula. Injections will be repeated every month.

Eligibility Criteria:
Inclusion Criteria:

* 1- Poor response to routine treatments in refractory Crohn's disease with fistula.

  2- CDAI\>220 3- Age 18 to 60 years 4- GFR\>30, Cr\<2 5- The presence of perinea fistula.

Exclusion Criteria:

* pregnancy
Prenatal Iodine Supplementation and Early Childhood Neurodevelopment

A randomized controlled trial to determine the effect of reducing iodine from vitamin and mineral supplements for pregnant women who have adequate iodine intakes (\>165 μg/d from food alone) on cognitive development of children at 24 months of age.

It is known that severe iodine deficiency during pregnancy leads to profound intellectual disabilities in the child. Following results of a 2004 national survey of school-aged children showing that mild iodine deficiency had re-emerged in the south-eastern parts of Australia, the Australian government mandated the addition of iodine to salt used in bread making to increase population iodine intake. It is also recommended that all pregnant and lactating women take an additional iodine supplement containing 150 µg/d of iodine.

Since this time, further evidence has emerged from cohort studies that children born to women with high iodine intake (as well as low iodine intake) have poorer neurodevelopmental scores, suggesting that more tailored supplementation may be a better strategy. Our PoppiE trial will determine if limiting iodine supplementation in women who already consume adequate iodine from food, improves cognitive scores in early childhood.

A total of 754 pregnant women from around Australia who are ≤13 weeks of gestation will be enrolled and randomised to receive a standard prenatal vitamin and mineral supplement with a reduced amount of iodine (20 μg - intervention) or a standard prenatal vitamin and mineral supplement with 200 μg of iodine (control). The control supplement contains a level of iodine to match the amount in most commonly used vitamin and mineral supplements sold in Australia. Infant neurodevelopment at 24 months of age will be assessed using the Bayley-IV and conducted at participating centres or a location convenient to the family.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women ≤13 weeks of gestation.
* Consume greater than 165 µg/d of iodine from food alone based on our validated Iodine Specific Food Frequency Questionnaire (I-FFQ).
* English is main language spoken at home as child will need to understand and take instruction in English to participate in the neurodevelopmental assessment.
* Able to give informed consent.

Exclusion Criteria:

* Known history of thyroid disease.
* Previous child diagnosed with thyroid dysfunction.
* Carrying a fetus with a known or suspected congenital abnormality.