cyrilzakka/clinical-trials huggingface dataset:
Effect of Helicobacter Pylori Eradication After Subtotal Gastrectomy on Survival Rate of Gastric Cancer Patients: Retrospective Study

In this study, we will observe the long-term survival rate, overall mortality rate, gastric cancer specific mortality rate, and the incidence rate of metachronous cancer in patients who received subtotal gastrectomy, with or without Helicobacter pylori eradication.

In this study, we will observe the long-term survival rate, overall mortality rate, gastric cancer specific mortality rate, and the incidence rate of metachronous cancer in patients who received subtotal gastrectomy, with or without Helicobacter pylori eradication. In addition, we will analyze the correlation between the incidence and survival rate of this type of stomach cancer by comparing smoking, gastric cancer direct family history, disease stage (TNM staging), the histologic type of stomach cancer (intestinal, diffuse, mixed), and the surgical method (Billoth I, Billoth II) as well as the infection and eradication status of H. pylori.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with gastric cancer and received surgery (partial, distal, subtotal gastrectomy), and tested Helicobacter pylori status

Exclusion Criteria:

* Patients with other severe diseases (other primary cancer, severe cardiovascular, cerebral, renal, hepatic diseases)
* Patients received palliative treatment
Correlation Between Central Sensitization Inventory and Posturographic Data

To investigate the use of balance as a screening tool for Central Sensitization, a condition of the nervous system that is associated with the development and maintenance of chronic pain. This is done by comparing the scores of a gold standard screening tool (the Central Sensitization Inventory) with balance data.

First, subjects will be asked to answer a brief medical questionnaire pertaining their general health status: since some of the subjects will be self-assessed to be "healthy" (no medical examination will be conducted to determine if this is indeed the case), the questionnaire will be used to determine if there are any possible known causes of poor balance performance. The questionnaire will not constitute an inclusion/exclusion criterion, it just has a classification purpose.

Subjects will then be asked to fill in the Central Sensitization Inventory (CSI), scoring each of the 25 items on a scale from 0 (never) to 4 (always).

Then, subjects will stand for 2 minutes on a compliant surface (a 4" tall foam cushion of known mechanical properties) to "learn" how to stand on it. Afterward, they will undergo posturography testing using the extended modified Clinical Testing of Sensory Integration in Balance (ext_mCTSIB) protocol: the subjects will be required to stand on a hard or compliant surface in a comfortable posture, feet shoulder width, with eyes open or closed, arms to the side and free to move, gazing forward, and breathing normally, with head straight, turned right or left, flexed or extended.

Eligibility Criteria:
Inclusion Criteria:

* Adults, self assessed to be in good health, or medically diagnosed with any of the following pathologies: Chronic nonspecific low back pain (CNSLBP), Fibromyalgia (FM), Cervicogenic Headche (CH), Chronic Tension Type Headache (CTT), Irritable Bowel Syndrome (IBS), Whiplash Associated Disorder (WAD), Temporomandibular Disorder (TMD)

Exclusion Criteria:

* Pregnant women will be excluded, as will be minors
A Study of Once-Monthly Intravenous Mircera in Hemodialysis Patients With Chronic Renal Anemia.

This single arm study will assess the long-term maintenance of hemoglobin levels, safety and tolerability of once-monthly intravenous administration of Mircera in hemodialysis patients with chronic renal anemia. Patients currently receiving darboepoetin alfa or epoetin alfa maintenance treatment will receive intravenous Mircera at a starting dose of 120, 200 or 360 micrograms/4 weeks (based on the ESA dose administered on week-1). Subsequent doses will be adjusted to maintain hemoglobin levels within the target range of 10.5-12.5g/dL. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* chronic renal anemia;
* regular long-term hemodialysis therapy with the same mode of dialysis for \>=3 months;
* continuous iv or sc maintenance ESA treatment during previous 2 months.

Exclusion Criteria:

* transfusion of red blood cells during previous 2 months;
* significant acute or chronic bleeding, such as overt gastrointestinal bleeding;
* active malignant disease (except non-melanoma skin cancer).
Photoplethysmography (PPG) Algorithm with Smartwatch in Evaluation of Atrial Fibrillation Burden After Catheter Ablation

The purpose of this study is to evaluate the effectiveness of a smart electrocardiogram watch based on the PPG algorithm in monitoring the atrial fibrillation burden of patients after catheter ablation.


Eligibility Criteria:
Inclusion Criteria:

1. Atrial fibrillation patients diagnosed by electrocardiogram
2. Received catheter ablation procedure
3. Willing to use long-range electrocardiogram monitoring equipment

Exclusion Criteria:

1.Patients who are allergic to electronic devices or unable to wear watches
Artificial Intelligence-Supported Mobile Application for Diabetes Self-Management

Patients in the AI-supported mobile application group will be able to log in with a username and password that will be defined specifically for them. Patients will be informed about how the application is used during their first interview. They will enter their personal and disease characteristics (age, gender, height, weight, HbA1C, HDL, LDL) into the application at the entrance. Other sections of the application will include exercise, nutrition, medication tracking, complication tracking and diabetic foot care sections. The person will be asked to enter relevant information in these fields according to their own life and condition (for example; how many times do you use insulin per day, what are your medication times, how do you spend your day in terms of exercise, how many meals do you eat, what is your diet, do you urinate frequently, are you extremely thirsty, are you hungry often, do you have numbness in your hands and feet, etc.). After the patient enters the necessary information, they will also be asked to enter their daily blood sugar measurement values into the system. Thus, the individual\&amp;#39;s hypo/hyperglycemia risk, risk analysis, nutrition recommendations, medication reminder system, exercise reminder and incentive warnings will be communicated to the individual thanks to the AI-based mobile application. The aim of this application is to reduce the risk of complications and improve the individual\&amp;#39;s quality of life by providing personalized recommendations for all the needs of the individual, including alarms and reminders, and to support patients to continue their diabetes education and disease management more actively.

pre-test post-test control group design

Eligibility Criteria:
Inclusion Criteria:

* Having been diagnosed with diabetes for at least 1 year
* Being between the ages of 18-65
* Being open to verbal communication
* Being able to read and write and speak Turkish
* Having a smart android phone and being able to use mobile applications
* Being willing to participate in the study

Exclusion Criteria:

* Having a perception disorder and psychiatric disorder that prevents the patient from communicating,
* Having a condition that prevents them from using a smart phone (advanced retinopathy and neuropathy, internet problems)
* Being on intensive insulin treatment
* Having a condition that prevents them from continuing the application phase of the study
* Wanting to leave the study
Collection of Bone Marrow Aspirate From Volunteer Donors

The purpose of this study is to collect bone marrow cells for research purposes.

This study is designed to provide bone marrow cells for other research studies. The research is being done because there are ongoing experiments in a number of National Institute on Aging (NIA) laboratories that require access to normal human bone marrow aspirate for their studies of the immune system. These studies are done to understand how blood cells are formed and how they function. Samples will be used to study problems such as the immune system in bone marrow failure and related conditions. Cells will be used in laboratory research and may be banked for future laboratory studies

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers age 18 and over

Exclusion Criteria:

* Significant abnormalities on health history questionnaire or in the results of blood tests
* Pregnant or nursing mother
* Participation in another research study within the past six weeks that is felt by the Principal Investigator to be incompatible with this study
* Severe infection in the past two months
* Immune disorder, or use of any medication that can alter immune system function
* A medical or mental health finding showing inability to go through the procedure
* Body mass index (BMI) greater than 29%
* Chronic back pain, sciatica, or a compression fracture of the spine
* Positive test results for viral infections: Hepatitis B, Hepatitis C, or HIV (AIDS)
Incidence and Risk Factors for Delirium in Severely Injured Patients

Delirium is very common in intensive care unit (ICU) patients and leads to poor outcomes. There is little information on delirium in injured patients however. This study determined the incidence and risk factors for delirium in severely injured patients.

This study was a prospective cohort study that reviewed the medical records of 179 trauma patients who were admitted to Asan Medical Center from January 01, 2013 to December 31, 2014. The investigators included all patients who had an Injury Severity Score (ISS) of more than 15 and excluded patients younger than 15 years old. This study was approved by the Asan Medical Center Institutional Review Board (2014-0344).

Patient delirium was checked using the Confusion Assessment Method in Intensive Care Unit (CAM-ICU) three times every day. The CAM-ICU includes four features that assess acute changes in or the fluctuating course of mental status, inattention, altered level of consciousness, and disorganized thinking. If a patient has a Richmond Agitation Sedation Scale (RASS) score of -3 or more with acute changes in mental status, inattention, and disorganized thinking or altered level of consciousness, a diagnosis of delirium can be made. The investigators considered patients to be delirious when CAM-ICU was positive for more than 24 h.

The investigators reviewed clinical information for the study patients including age, sex, and underlying disease. Trauma factors reviewed were cause of trauma, ISS, Glasgow Coma Scale (GCS) score, shock, initial lactate level, massive transfusion within 24 h, cardiopulmonary resuscitation rescue, and time taken to the hospital after trauma. Factors related to treatment included use of restraints, mechanical ventilation, and surgery. Clinical outcomes included mortality, ICU stay, mechanical ventilation duration, and hospital stay.

Statistical analysis were done using both univariate (chi-square test and t-test) and multivariate (logistic regression) procedures. Results are reported as mean ± standard deviation. Significance set at a P value of less than .05. For the multivariable logistic regression, the primary outcome variable of interest was the development of delirium after trauma that was classified as either present or absent. Variables were entered for analysis based on the strength of their univariate association with the presence/absence of delirium.

Eligibility Criteria:
Inclusion Criteria:

* trauma patients with Injury Severity Score (ISS) more than 15

Exclusion Criteria:

* age under 15
The Effect of Obesity on Ventilation Tube Insertion

Obesity is associated with increased risk of surgical complications. Ventilation tube insertion is one of the most frequent surgical procedures performed on children. However, the impact of obesity on surgical results or surgical related complication following ventilation tube insertion remains poorly understood. The aim of this study was to investigate the effect of obesity on the surgical results of ventilation tube insertion for otitis media with effusion (OME) in pediatric patients.

OME was diagnosed by the presence of fluid in the middle ear on otoscopy or tympanometry according to clinical practice guidelines . The diagnostic findings of pneumatic otoscopy and otomicroscopy include the tympanic membrane dullness, impaired mobility, and an air-fluid level or bubble. In addition, the type B or C tympanogram was considered positive for OME.

Indication for ventilation tub insertion includes history of OME lasting 3 months or longer, structural damage to tympanic membrane or middle ear and risk for speech, language learning difficulties. Adenoidectomy is also performed when adenoid hypertrophy is founded during preoperative assessment.

Body weight and height were measured before ventilation tube insertion at hospital. Body mass index (BMI) was calculated using the formula weight/ height2 (Kg/m2).

Eligibility Criteria:
Inclusion Criteria:

* Children aged 2-15 years with a diagnosis of OME who underwent ventilation tube insertion

Exclusion Criteria:

* Children with a previous history of ventilation tube insertion
* Use of ventilation tubes other than Paparella type I
* Head and neck anomalies
* Chronic or systemic disease
Multicenter Cohort Study of AAV in Hunan of China

This study aimed to explore the incidence of Anti-neutrophil cytoplasmic antibody (ANCA）-associated vasculitis (AAV) progression and its association with adverse consequences. It will enroll approximately 500 AAV patients in Hunan province of China and follow-up for at least 5 years. Demographic characteristics, clinical and laboratory data will be collected at baseline and every follow-up. The principal clinical outcomes of the study consist of end stage renal disease (ESRD) and death.

The study is a multicenter prospective cohort study, aimed to explore the incidence of AAV and its progression and association with adverse consequences. The study will establish a baseline cohort of 500 AAV patients in Hunan province of China. The follow-up will be conducted for at least 5 years until death or starting renal replacement therapy or dropout. Their demographic characteristics, clinical data, laboratory and imaging examinations will be collected at baseline and every follow-up.

The baseline visit includes the following items: detailed demographics, medical and family history, medication history, health behaviors, physical activity, and anthropometric measures. The laboratory parameters of chemistry test. After the baseline visit, participants will return annually for follow-up visits and evaluation. The evaluating items of follow-up visits are similar to the baseline visit, and sample collection.

The principal clinical outcomes of the study can be broadly categorized as end stage renal disease and death. Death is further clarified as cardiac, infectious, renal, others, or unknown.

Eligibility Criteria:
Inclusion Criteria:

* Fulfill 2012 criteria of ANCA associated vasculitis and agree to sign informed consent

Exclusion Criteria:

* Do not agree to sign informed consent
Azacytidine, Bendamustine, Piamprizumab in Refractory/Relapsed B-cell Non-Hodgkin's Lymphoma

This is an open label, single arm, phase I/II for patients with r/r Non-Hodgkin's Lymphoma

. The purpose is to evaluate the safety and efficacy of the combination with Azacytidine, Bendamustine and Piamprizumab


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 and ≤80 years
2. Performance status (ECOG) between 0 and 3.
3. Histologically confirmed B-cell non-Hodgkin lymphoma (NHL), including the following types defined by WHO 2016.
4. Refractory disease or relapsed after treatment with ≥2 lines of chemotherapy and either having failed autologous HSCT or being ineligible for or not consenting to autologous HSCT; or not suitable for CAR T treatment or resistance, progression or relapse after CAR T treatment; or CAR T pre-culturing losers can also be enrolled.
5. Adequate organ function.
6. An adequate bone marrow reserve.
7. Measurable or assessable disease according to the"IWG Response Criteria for Malignant Lymphoma"(Cheson 2014). Patients in complete remission (CR) with no evidence of disease were not eligible.
8. Informed consent/assent requiring that all patients have the ability to understand and the willingness to provide written informed consent.
9. Life expectancy \> 12 weeks.
10. Patients with definite involvement of the gastrointestinal tract, and patients with central nervous system (CNS) by PETCT and MRI involvement were allowed to enrolled in this clinical study.

Exclusion Criteria:

1. Pregnant or lactating women.
2. Uncontrolled medical disorders, active bacterial, viral infection or treponema pallidum infection and so on.
3. Requirement for urgent therapy due to tumor mass effects such as respiratory obstruction or blood vessel compression.
4. Current or expected need for systemic corticosteroid therapy.
5. Any organ failure.
6. Patients with a second tumor requiring therapy or intervention.
7. Subjects considered unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation according to the investigator's judgement.
8. Prior organ allograft.
9. Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
Investigation of Docosahexaenoic Acid (DHA) Metabolic Pathway in Human by Using 13C Labeled Molecules

The purpose of this study is to compare three lipidic forms of DHA in their metabolic pathway in human by using 13C labeled molecules.

The circulating form of DHA plays a major role in his cerebral incorporation. The aim of this research is to confirm that some lipidic forms are best carriers for the cerebral incorporation in studying 13C-DHA distribution in plasma lipids and blood cells.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male
* Aged of 60 to 70 years
* Body Mass Index of 20 to 30 kg/m2
* Glycaemic and lipid parameters normal

Exclusion Criteria:

* Smokers more than ten cigarettes/day
* Medical history of personal or family dyslipidemia
* Medication that could interfere with lipid metabolism
Comparison of GSK Measles-mumps-rubella-varicella (MMRV) Vaccine Versus PriorixTM

The purpose of this study is to assess non-inferiority of two different vaccination regimens using GSK Biological's MMRV vaccine (two doses at 9 and 15 months) or Priorix™ (9 months) and one dose of MMRV vaccine (15 months) to the current standard of care which is Priorix™ administered at 9 months of age followed by concomitant administration of Priorix™ with Varilrix™ at 15 months of age in a measles endemic environment such as India.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
* Male or female subjects between and including 9 and 10 months of age at the time of the first vaccination.
* Written informed consent obtained from the the parent or guardian of the subject.
* Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

* Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
* Planned administration/administration of a vaccine not foreseen by the study protocol starting 30 days prior to administration of any dose of the study vaccine, up to 42 days after the vaccine dose with the exception of hepatitis A vaccine and oral poliovirus vaccine .
* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-registered product.
* Previous vaccination against measles, mumps, rubella and varicella.
* History of measles, mumps, rubella and/or varicella diseases.
* Known exposure to measles, mumps, rubella and/or varicella within 30 days prior to the start of the study.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* A family history of congenital or hereditary immunodeficiency.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccines including neomycin.
* Major congenital defects or serious chronic illness.
* History of any neurologic disorders or seizures.
* Acute disease at the time of enrolment.
* Axillary temperature \> 37.5°C (99.5°F) / Rectal temperature \> 38°C (100.4°F).
* Administration of immunoglobulins and/or any blood products during the six months before entering the study or planned administration during the study period.
* Presence of a susceptible high-risk person in the same household during the study period.
Lanreotide Autogel in Patients With Acromegaly Previously Treated With Octreotide LAR

The purpose of this study is to assess the efficacy, safety and patient acceptability of Somatuline Autogel in patients with acromegaly previously treated with octreotide LAR.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of acromegaly
* The patient must have been tested at Week -4 (4 weeks prior to the Baseline visit) and shown to have a GH level \<10 mU/L.
* The patient must have been treated with a stable dose of octreotide LAR for at least four months prior to study entry
* Life expectancy of at least 2 years

Exclusion Criteria:

* Adenectomy within past 6 months, or likely during study period
* Radiotherapy for acromegalic disease within 1 year, or likely during study period
* Unstable concomitant dopamine agonist therapy