cyrilzakka/clinical-trials huggingface dataset:
Eosinophilic Esophagitis Clinical Therapy Comparison Trial

Eosinophilic Esophagitis (EoE) is a disorder in which a type of white blood cell (eosinophil) involved in allergic reactions, enter and cover the walls of the esophagus (food pipe). As a result, the esophagus becomes swollen and blocked making it difficult to swallow, and this leads to heartburn. In severe cases it can lead to food getting stuck in the esophagus and poor growth or weight loss in children

The main purpose of this research study is to compare the effectiveness of two different types of treatment for EoE:

1. Oral viscous budesonide- which is a steroid medication that has been used to treat asthma. Recently, it has been used as a therapy to treat the eosinophilic inflammation in EoE, and
2. Specific food elimination.

The study will also be looking to see if a blood test is useful in following the progression of EoE. Currently the only way to follow EoE is by repeating endoscopy, which is a more "invasive test."

This study is a open label, randomized, prospective clinical trial comparing the efficacy of a topical steroid preparation to an antigen (food) elimination diet.

A total of 40 participants will be recruited for this study that are positive for food allergens. Study participants will be randomly assigned to treatments as described below, and the duration of each treatment phase will be 16 weeks.

The subjects will be randomized to group A and B. Subject and study team will NOT be blinded to the group assignments.

Group A will receive oral viscous budesonide at a dose of 1 or 2 mg daily depending on the height.

Group B will receive an elimination diet (elimination of the foods the subject is allergic to).

Eligibility Criteria:
Inclusion Criteria

1. Signed written informed consent and assent if applicable prior to performing any study specific procedure.
2. Male or female subjects aged 3-17 years old.
3. Diagnosis of EoE within 2 months of enrollment (greater than or equal to 15 eosinophils per high powered field in both proximal or distal esophageal specimens).
4. Subjects who have failed at least a two month trial of proton pump inhibitor.
5. A female subject of childbearing potential who is or may become sexually active agrees to routinely use contraception from the time of signing informed consent and assent until 30 days from end of study.
6. Positive allergy testing on prick and/or patch testing.

Exclusion Criteria

1. Subjects who are responsive to at least a two month trial of a proton pump inhibitor.
2. Diagnosis of Inflammatory Bowel Disease or static encephalopathy.
3. Prior abdominal surgery and other organ disorder not including atopic diseases.
4. Previous esophageal surgical procedure.
5. Previous esophageal congenital disorders such as tracheal esophageal fistula and esophageal atresia.
6. Positive for pregnancy.
7. Previous therapy within 6 weeks with oral or swallowed steroids or strict dietary elimination of major allergens
8. Presence of increased eosinophils in the stomach, small intestine, large intestine, and colon based on Debrosse et al.
Cohort Study on Internet Game and Smart Phone Addiction

The aim of this cohort study is to observe the prevalence, incidence, relapse, and remission rates of online and/or smartphone game addiction among elementary and secondary school students in Korea. In addition the investigators are going to identify risk and protective factors, to determine whether online and/or smart phone game addiction is a primary or secondary problem, and to identify outcomes for individuals who become or stop being online and smart phone game addiction.

Participants:

Total 3,000 children will be enrolled the cohort and followed up for 4 years.

Procedures:

These students will be surveyed annually between 2015 and 2019. Surveys were conducted in classrooms by trained interviewer who had been trained by the research team assisted by the teachers.

Measurements

* usage and frequency of internet, internet game, and smartphone game etc.
* interpersional relationship; with family members, peer group, and teacher etc.
* personal characteristics; self esteem, social support, depression, anxiety, hyperactivity etc.
* Socio-demographic factors

Eligibility Criteria:
Inclusion Criteria:

* 3rd, 4th, and 7th grade students of selected 15 elementary and secondary schools who provide consent both the students and their parents

Exclusion Criteria:

* does not provide consent
Nalbuphine Versus Morphine for Mucositis Pain in Pediatric Cancer Patients

Evaluation of safety and efficacy of Nalbuphine versus Morphine patient controlled analgesia (PCA) for mucositis pain in pediatric cancer patients

The investigators will compare between using of PCA Morphine (Group A) and using of PCA Nalbuphine (Group B) in the following items over the first 7 days of initiation:

1. Pain intensity VAS every 12 hours and during the performing of mouth care for each patient over the first 7 days.
2. Total opioid consumptions for each patient every 24 hours and the total consumption of the entire 7 days since initiation.
3. Number of active and total pushes of PCA buttons every 24 hours and the sum up of the active and total pushes of PCA buttons for each patient over the 7 days.
4. Patient satisfaction at the end of the 7 days. Patient satisfaction score PSS was assessed using a linear scale where 0=very satisfied; 10=very dissatisfied (14).
5. Serious adverse events. (Nausea and vomiting, pruritus, respiratory depression, urinary retention, sedation, bradycardia, hypotension).

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed Primary AML or HSCT and ALL with oral mucositis grade III OR IV presenting in the study period.
* Age above 5 year and below 18 years
* Written Informed Consent from parents/guardian

Exclusion Criteria:

* History of mental retardation
* known or suspected allergy to any narcotics
* Presence of any other co-morbidity:
* kidney (Crcl \<50)
* liver (liver enzymes more than 10 folds)
* chest (SPO2 \<92% on room air)
* cardiac disease (ejection fraction \<40%)
* terminal patients who scheduled for palliative care
Hepatic Artery Infusion Chemotherapy Plus Donafenib in Patients With Hepatocellular Carcinoma After Surgery

This is an open-label，multi-center ，non-randomized ，single arm exploratory study . This clinical study is an investigator-initiated clinical trial（IIT ）. The objective of this study is to evaluate if the addition of hepatic artery infusion chemotherapy (HAIC) and Donafenib after curative resection for hepatocellular carcinoma patients with a solitary tumor≥5 cm and microvascular invasion （MVI） will prevent or delay the recurrence of the disease.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-75 years, male or female;
2. Naive patients with hepatocellular carcinoma pathologically diagnosed who have Underwent radical hepatectomy 4-8 weeks before enrollment;
3. HCC patients with a solitary tumor≥5 cm and Microvascular invasion;
4. Child-Pugh score A/B(≤7);
5. ECOG PS score 0-1;
6. No residual tumor lesions were confirmed on imaging more than 4 weeks after surgery;
7. The main organ functions meet the following criteria within 14 days before enrollment; (1)Hemoglobin(HB)≥100 g/L (2)neutrophils(ANC)≥1.5×10\^9 /L, (3)platelet count(PLT)≥75×10\^9/L; (4)ALB≥28g/L (5)alanine aminotransferase(ALT), aspartate aminotransferase(AST)\<5×ULN (6)Total bilirubin (TBIL)\<1.5×ULN (7)Plasma creatinine ≤1.5×ULN with a creatinine clearance≥50mL/min (8)Activation Partial Thrombin Activation Time (APTT) and International Normalized Ratio (INR)≤1.5×ULN
8. Subjects voluntarily enrolled in the study, signed an informed consent form, followed well and cooperated with the follow-up

Exclusion Criteria:

1. Patients who have received any hepatocellular carcinoma-related systemic therapy before enrollment; including targeted therapy such as sorafenib, lenvatinib, and regorafenib, or immunomodulators such as anti-PD-1, anti-PD-L1, and anti-CTLA-4 Treatment, excluding antiviral treatment; if the patient has used traditional Chinese medicine with anti-tumor indications, it must be\> 2 weeks or 5 drug half-lives (whichever is longer). Patients whose adverse events caused by treatment have not recovered to ≤ CTCAE Grade 1;
2. Patients who have received other adjuvant treatments (except antiviral therapy) after radical hepatectomy, including adjuvant local treatments (such as transarterial chemoembolization \[TACE\]);
3. Hepatic veins, portal veins, bile ducts, or inferior vena cava can be visually or microscopically seen with tumor thrombi
4. Diagnosed with lymph node invasion or extrahepatic metastasis;
5. Number of tumors≥2;
6. A history of other malignant tumours within the last five years, except for cured skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ or other carcinoma in situ;
7. Pregnant or breastfeeding women; males or females of childbearing age who are unwilling or unable to take effective contraceptive measures
8. Known history of alcohol, psychotropic drug or other drug abuse within 6 months before entry into the study 9.Those the researcher deems inappropriate for inclusion.
PET Adapted Treatment of Patients With Limited Stage DLBCL and no Risk Factors

Prospective, multicenter, phase IV study, of real-life evidence destined to evaluate the feasibility and efficacy of performing a treatment adapted to PET-CT in patients with stage I and II DLBCL, without poor prognostic factors.

Patients older than 17 years of age, with no upper age limit with a de novo histological diagnosis of DLBCL, in stages I and II and without risk factors, will be included. All patients will have a baseline PET-CT and will undergo 3 cycles of R-CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone). A PET-CT will be performed on day 15-18 of the third cycle that will be centrally reviewed. Those patients with negative PET-CT (Deauville 1, 2 and 3) will receive an additional cycle of R-CHOP and will finish treatment. Patients who have PET-CT with a Deauville 4 score will complete a fourth cycle and then receive radiation therapy to the compromised site. Those patients with a Deauville score of 5 should receive rescue therapy, so they will be outside the protocol.

A standardized follow-up of the patients included with tomographic controls will be carried out, evaluating OS (overall survival) and PFS (progression-free survival) at 3 years as the main objectives.

Eligibility Criteria:
Inclusion Criteria:

* Patients \> 17 years old with no upper age limit.
* Histological diagnosis of DLBCL Stages I or II
* Patients who have signed informed consent.

Exclusion Criteria:

* Patients with elevated LDH (lactate dehydrogenase)
* ECOG (Eastern Cooperative Oncology Group) \> 2
* Stage III or IV
* Bulky mass (\> 7.5 cm)
* Central nervous system involvement
* Testicular lymphoma
* Breast involvement
* Eyeball involvement
* Primary mediastinal lymphoma
* Cutaneous primary lymphoma
* Diffuse large B-cell lymphoma of the leg
* HIV positive patients
* Platelet count \<100,000 / mcl and total leukocyte count \<3,000 / mcl
* Marked impairment of ventricular function (FEy \<50%)
* Moderate / severe renal impairment defined by Cl. Cr. \<50 ml / min
* Severe liver disease: prothrombin rate \<50% and / or bile level. total\> 2.5 times normal value
* Pregnant and breastfeeding
* Previous or concomitant diagnosis of indolent lymphoma
* Patients who have previously received chemotherapy and / or radiotherapy
Immunogenicity and Safety Study of FluarixTM Vaccine in Children Who Have Previously Been Vaccinated With PandemrixTM

This study is designed to assess the immunogenicity, reactogenicity and safety following vaccination with GSK Biologicals' FluarixTM vaccine in children who have previously been vaccinated with one dose of PandemrixTM at the age of 10-17 years.


Eligibility Criteria:
Inclusion Criteria:

* Subjects having previously been immunized with only one single dose of Pandemrix at the age of 10-17 years inclusive.
* Subjects having received Pandemrix at least six months prior to study enrolment.
* Subjects who the investigator believes that subject and/or parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] can and will comply with the requirements of the protocol
* Written informed consent obtained from the subject/ the parent(s)/LAR(s) of the subject.
* Healthy subjects as established by medical history and clinical examination before entering into the study.
* Subjects or Parent(s)/LAR(s) with access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device

Exclusion Criteria:

* Active participation in other clinical trials.
* Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period.
* Planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration.
* Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to enrolment in this study or planned administration during the study period.
* Acute disease and/or fever at the time of enrolment:
* Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.
* Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned use during the study.
* Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination
* Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to any constituent of influenza vaccines; or a history of severe adverse reaction to a previous influenza vaccine.
* History of seizures or progressive neurological disease.
* Subjects having received an H1N1v pandemic vaccine other than Pandemrix or having received the 2010/2011 seasonal influenza vaccine.
* If the subject is female and if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for two months after completion of the vaccination series.
* Child in care.
Semi-quantitative Cough Strength Score (SCSS)

Cough strength score will give true prediction of Extubation outcome

Head trauma patients were evaluated for readiness to be weaned off mechanical ventilation. If they had completed an Spontaneous Breathing Trial (SBT) before extubation. To measure Semiquantitative Cough Strength Score (SCSS), the investigator will put the patients at 30° to 45°, measure SCSS, first. The investigator enhance the patient to cough with as much effort as, when the investigator disconnect the ventilator. The cough strength was scored from 0 to 5 as follows: 0 = no cough on command, 1 = audible movement of air through the endotracheal tube but no audible cough, 2 = weakly (barely) audible cough, 3 = clearly audible cough, 4 = stronger cough and 5 = multiple sequential strong coughs.

Eligibility Criteria:
Inclusion Criteria:

* The study included 80 adult male and female patients' their ages between 18-65 years admitted to trauma ICU with head trauma, on mechanical ventilation more than 24 hours and was ready to be weaned off from mechanical ventilation after successful spontaneous breathing trial and Glasgow Coma Scale (GCS) score \> 8 before extubation

Exclusion Criteria:

• Patients who had undergone tracheostomy before extubation, GCS ≤ 8, chest trauma (ribs fracture and lung contusion) and patients with chronic chest disease (Chronic obstructive pulmonary disease, tuberculosis and cancer lung) were excluded from the study.
Evaluation of Body Iron Stores in Overweight Healthy Volunteers

Normal body iron store value in overweight subjects is currently not described in literature. The comparison of this value with body iron levels in patients suffering from dysmetabolic iron overload syndrome (DIOS) could allow to quantify iron overload in this condition. The purpose of the study is to determine iron levels in healthy overweight volunteers, and to compare them to DIOS patients treated with phlebotomy.

Normal body iron store value in overweight subjects is currently not described in literature. The comparison of this value with body iron levels in patients suffering from dysmetabolic iron overload syndrome (DIOS) could allow to quantify iron overload in this condition.

DIOS is the leading cause of hyperferritinemia and mainly affects men between 45 and 60 years. It is characterized by unexplained hyperferritinemia associated to metabolic disorders (including overweight) and iron overload, objectified by MRI or liver biopsy.

Some authors suggest that hyperferritinemia associated to metabolic disorders is the expression of an inflammatory syndrome caused by insulin resistance and steatohepatitis, and not the manifestation of real iron overload.

The debate surrounding iron overload in DIOS is related to the limits of the current analysis methods (phlebotomy, liver iron concentration, MRI). At present, phlebotomy is the standard method used to determine body iron stores.

Using this method, the purpose of the study is to determine iron levels in healthy overweight volunteers, and to compare them to DIOS patients treated with phlebotomy included in another ongoing clinical trial (SAIGNEES - ClinicalTrials.gov Identifier: NCT01045525).

Eligibility Criteria:
Inclusion Criteria:

* Male,
* At least 18 years old
* BMI \> 25 Kg/m2
* Serum ferritin level between 100 et 300 µg/L
* Written informed consent

Exclusion Criteria:

* Blood donations in the past two years
* Alcohol consumption more than 30 g/day
* Inflammatory syndrome (CRP \> 10 mg/L)
* Inflammatory, dysimmunitary or cancerous disease
* Hepatic cytolysis
* Transferrin saturation \> 45%
* Person involved in another clinical trial
* Person with a measure of legal protection (guardianship)
* Person who reached the annual limit for compensation provided by biomedical research
* Hemoglobin \< 13 g/dL
* Uncontrolled heart failure or coronary insufficiency
* Abnormal ECG
* Echocardiographic abnormalities contraindicating phlebotomy
* Hepatic, renal or respiratory insufficiency
* Superficial venous network insufficiency
TDCS Combined With CT In Opioid Use Disorder

The aim of the present study is to investigate the effect of prefrontal transcranial Direct Current Stimulation (tDCS) combined with cognitive training on cognitive functions in individuals with Opioid Use Disorder (OUD). The participants will be allocated into active/sham groups (1:1) and will receive a single session of prefrontal tDCS combined with cognitive training. Outcomes of the active and sham groups will be compared.


Eligibility Criteria:
Inclusion Criteria:

* Being aged between 18-65 years
* being in the maintenance phase of the OUD treatment
* naivety to tDCS
* at least 5 years of education

Exclusion Criteria:

* current diagnosis of major depressive disorder
* current diagnosis or history of bipolar disorders, psychotic disorders, neurocognitive disorders, pervasive developmental disorders, mental retardation, severe neurological disorders,
* common tDCS contraindications
The Effects of Smartphone Addiction on Physical Activity, Fatigue and Sleep Quality of University Students

The increasing rate of usage of smartphones ushers in various health problems and smartphone addiction. In the literature, the research focused mainly on the relationship between smartphone addiction and depression, anxiety and musculoskeletal system problems; however, the number of studies on fatigue was limited. We believe that this paper will be of interest to the readers of your journal because it adds information about the effect of smartphone addiction on physical activity, on sleep quality and especially on fatigue.

This cross-sectional study was conducted with the participation of 322 students attending the Faculty of Health Sciences at Süleyman Demirel University. The participants were given the socio-demographic characteristics form, developed by the researchers according to the literature review. They were also given the evaluation form, which surveys some variables related to smartphones, as well as the short version of the Smartphone Addiction Scale Short Version (SAS-SV), the International Physical Activity Questionnaire-Short Form (IPAQ-SF), the Pittsburgh Sleep Quality Index (PSQI), and the Piper Fatigue Scale (PFS).

Eligibility Criteria:
Inclusion Criteria:

* The students who volunteered to participate in the study after being informed about the aims and procedures of the study.

Exclusion Criteria:

* The students who didnot volunteered to participate in the study after being informed about the aims and procedures of the study.
Pathological Changes in the Cardiovascular System in Valvular Heart Disease

An observational cohort study of patients recruited presenting with valvular heart disease. The specialized investigations will focus on myocardial remodelling and scar formation/regression and extracardiac micro- and macro-vascular sequelae of valvular heart disease (VHD). The aim is to investigate the natural history of VHD and its ensuing cardiac and extracardiac end organ effects, the impact of existing interventions and the long-term outcome. We hope to establish the underlying causative aetiology of known associated conditions (e.g. vascular dementia) and to determine if extracardiac changes may serve as early biomarkers of prognosis in VHD. Participants will attend for two visits at Barts Heart Centre or Chenies Mews Imaging Centre and will undergo a panel of tests including cross-sectional cardiac imaging, point-of-care microvascular assessment and blood tests. Patient outcome will be assessed by data linkage to hospital episode statistic (HES) data and ONS data (via NHS spine). We aim to identify determinants that will help to improve patient selection and timing of valve intervention based on advanced clinical, blood and/or imaging biomarkers.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Able to provide written informed consent
* Mild, moderate or severe valvular heart disease (Natural history cohort), or severe valvular heart disease planned for surgical/transcatheter intervention (Intervention/Heart-Brain axis cohort).

Exclusion Criteria:

* Participants unwilling to consent.
* Needle phobic patients that would preclude blood taking
* Diagnosis of dilated or hypertrophic cardiomyopathy
* Pregnancy/breast feeding
* Inability to complete the protocol, other conditions that would prevent participation in the study.
* In severe VHD, no more than moderate valve disease other than primary lesion (AS / MR / AR)

Exclusion for the Heart-Brain-Axis Study:

• Participants that have more than moderate epicardial coronary disease (by CT or invasive coronary angiography) will be excluded.
Comparative Impact of RAST and TST for Improving Motor Functions in Stroke Patients

This study evaluates the effectiveness of Rhythmic Auditory Stimulation (RAS) therapy versus Task-Specific Training (TST) in enhancing motor function recovery in stroke patients. RAS uses rhythmic cues to aid movement synchronization, while TST focuses on practicing daily tasks to improve functional ability. In a randomized clinical trial, participants were assigned to either RAS or TST groups, with both receiving structured sessions over several weeks.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients diagnosed with stroke
* Age 40-80 years (46)
* Patients having first ever stroke occurrence
* Moderate motor function impairments (47)
* Patients able to follow instruction

Exclusion Criteria:

* Patients with severe motor impairments
* Patients who had cognitive impairments
* Patients having other neurological conditions and musculoskeletal disorders
* Patients having history of surgery