cyrilzakka/clinical-trials huggingface dataset:
Immune Response Post Pry Vaccination of 2 Formulations of DTPw-HBV Vaccine Given With Rotavirus Vaccine to Infants

To compare the two formulations of GSK Biologicals' DTPw-HBV vaccine to concomitant administration of CSL's DTPw vaccine and GSK Biologicals' HBV with respect to the antibody response to the diphtheria antigen after a three-dose primary vaccination course.

Randomized study with five groups to receive one of the following vaccination regimens:

One of the two formulations of GSK Biologicals' DTPw-HBV + GSK Biologicals' HRV One of the two formulations of GSK Biologicals' DTPw-HBV + Placebo CSL's DTPw + GSK Biologicals' HBV

Eligibility Criteria:
Inclusion criteria:

* Subjects who the investigator believes that their parent/guardian can and will comply with the requirements of the protocol.
* Administration of one dose of hepatitis B vaccine at birth.
* A male or female between, and including, 11 and 17 weeks of age at the time of the first DTPw vaccination.
* Free of obvious health problems as established by medical history and clinical examination before entering into the study.

Exclusion criteria:

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) 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 since birth.
* Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days before the first vaccine dose or planned administration during the study period with the exception of oral polio vaccine.
* Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required)
* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Effectiveness of Digital Cognitive Behavioral Therapy for the Treatment of Depression: a Real-world Study

The project proposes to develop a digital product based on cognitive behavioral therapy for the assisted treatment of depression. The digital cognitive behavioral therapy in this study is conducted based on a self-developed mobile applet. The therapy is developed by psychotherapists, which is conducted for a total of 8 weeks, with weekly sessions including AI-guided course work and homework. This study aims to evaluate the therapeutic effects of CBT-based digital products for depression in patients through a real-world study, and to explore its genetic and neuroimaging mechanisms.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 14-60 years (including 14 and 60), no gender restriction;
2. HAMD \>= 17;
3. Written informed consent obtained from the patient; written informed consent obtained from the guardian for minors.

Exclusion Criteria:

* Persons with severe suicidal tendencies (item 10 of the MADRS scale ≥ 5).
Dialectical Behavior Therapy Skills Group Pilot Evaluation

Uncontrolled pilot study examines feasibility, acceptability, and preliminary efficacy of Dialectical Behavior Therapy skills group for Veterans with suicidal ideation and emotion dysregulation.

Uncontrolled pilot study to examine feasibility, acceptability, and preliminary efficacy of Dialectical Behavior Therapy skills group for Veterans with suicidal ideation and emotion dysregulation. Outcome measures will occur at pre-treatment, mid, end, and follow-up.

Eligibility Criteria:
Inclusion Criteria:

1. Veterans at VACHS who are referred or self-referred to DBT Skills Group
2. Ages 18-65
3. Able to understand written and spoken English
4. DERS score 105 or greater
5. Suicidal ideation within past 3 months
6. Seeing an individual mental health provider at VACHS at least monthly
7. Willing to create or review a Mental Health Safety Plan, and stated willingness to use this plan to maintain safety
8. Consent to participate in study assessments
9. Consent to recording of group sessions

Exclusion Criteria:

1. Inability to understand written or spoken English
2. Diagnosis of schizophrenia, schizoaffective disorder, bipolar I, antisocial personality disorder, or thought disorder in CPRS problem list and confirmed by current mental health provider
Cholinergic Status and the Metabolic Syndrome

The investigators aims in the current study are to examine whether the cholinergic status should be considered as another risk factor for the metabolic syndrome and it's co-morbidities and to test the effect of a hypocaloric high complex carbohydrates diet on the cholinergic status of overweight and obese adults with and without the metabolic syndrome.

Intervention studies have demonstrated that the autonomic disturbances of the metabolic syndrome may be reversible. A reduction in body weight induced by a hypocaloric diet exerts a marked reduction in sympathetic activity in obese people with or without metabolic syndrome. Incorporation of regular, moderate intensity aerobic exercise training during a dietary weight loss program does not confer additional benefits on resting sympathetic neural activity, compared with weight loss by diet alone. A new method has been developed to examine the sympathetic-parasympathetic status of an individual - the cholinergic status. Cholinergic Status represents the total soluble circulation capacity for acetylcholine hydrolysis. Higher cholinergic status means the individual is more sympathetic .

A cross sectional study that took place in Tel Aviv Sorasky medical center and included 632 participants found that the cholinergic status is related to metabolic syndrome parameters in a dose response manner and that it correlates significantly with glucose,HbA1c, lipid profile and hs-CRP.

Eligibility Criteria:
Inclusion Criteria:

* BMI ≥ 25kg/m2
* Stable weight (±1kg)in the previous six months
* Non smokers

Exclusion Criteria:

* Type II diabetes
* Hypertension pharmacologically treated
* Cardiovascular disease
* Renal disease
* Cirrhosis and end-stage liver failure
* Thyroid disease
* Cerebrovascular disease
* Cancer
* Autoimmune disease
* Chronic inflammatory disease
* Surgery or heart catheterization in the previous six months
* Use of drugs known to affect measured parameters
Determination of Anatomic Variations of the Internal Jugular and Femoral Veins Using Ultrasound in the Emergency Department

Central venous catheterization is a common and important procedure done in the emergency department. The internal jugular vein (IJV), subclavian vein (SV) and femoral vein (FV) are commonly used for central venous access. Unfortunately, this procedure has high-risk complications.

Traditionally, physicians have relied on the use of anatomic landmarks and physical manipulation such as moving the head or rotating the leg in order to place central catheters; however, studies have demonstrated that significant anatomic variations exist within large percentages of study populations. In addition, although studies have demonstrated that the use of ultrasonography for placement of femoral catheters leads to lower rates of complications, no previous studies have specifically determined anatomic variations in the femoral triangle. Therefore, this study will examine the anatomic variation of the IJV vs. carotid artery and the femoral vein vs. femoral artery in the emergency room setting. The investigators will study the variation as a function of sex, age, race, body habitus and degree of head rotation (measured using a goniometer) and in doing so, the investigators will demonstrate the utility of using ultrasound to place central lines in order to decrease morbidity.


Eligibility Criteria:
Inclusion Criteria:

* Patients being cared for in the Tampa General Hospital Emergency Department
* 18 yrs or older
* male or female
* have the anatomy that will be examined (lateral neck and femoral regions)
* speak either English or Spanish
* alert and oriented to person, place, time and situation
* stable vital signs

Exclusion Criteria:

* under 18 yrs
* incarcerated individuals
* those with acute changes in mental status (intoxicated, encephalopathy, psychosis)
* those from whom consent could not be obtained
* those requiring intensive care monitoring
* persons having pathologies that would interfere with the ultrasound investigation
* persons who do not speak English or Spanish
* persons with acute or severe mental or cognitive disabilities
* individuals in a sedated, traumatized or crisis state
Efficacy of Adjuvant Cytokine-induced Killer Cells in Colon Cancer

It has been reported that the immune status of patients with cancer were suppressed, especially those after surgery and adjuvant chemotherapy. Thus, immunotherapy may decrease the recurrence rate after surgery. CIK cells transfusion has been reported as an effect therapy in advanced cancers. In another retrospective study, investigators found that adjuvant CIK therapy would prolong the disease-free survival (DFS) for colorectal cancer patients.

The purpose of this study is to determine wether adjuvant immunotherapy with CIK cells in patients with colon cancer after operation will prolong DFS, and overall survival (OS).


Eligibility Criteria:
Inclusion Criteria:

* Colon cancer in stage III or stage II with high risk after R0 resection
* Eastern Cooperative Oncology Group (ECOG) performance status was 0 - 1;
* Life expectancy of at least 3 months;
* Normal bone marrow, liver, renal, heart and lung function;
* Age between 18-80;
* Patients who provided written informed consent for this study

Exclusion Criteria:

* With uncontrolled other malignant tumors;
* With uncontrolled infection or tubercle bacillus (TB) or underlying diseases that were severe or life threatening;
* Patients who need to treat with radiotherapy;
* Patients who accepted other immunotherapy
* With sever mental disease or disease with central nervous system (CNS);
* With the history of organ transplantation, including bone marrow transplantation or stem cell transplantation;
* Patients with auto immune diseases;
* pregnant or lactating.
CT Coronary Angiography After Arterial Switch Operation

The purpose of this study is to find a non-invasive alternative (with using ECG gated 64-slice CT angiography) to invasive coronary angiography for detecting coronary lesions in patients who had undergone arterial switch operation for transposition of the great arteries

Objectives To find a non-invasive alternative (with using ECG-gated 64-slice CT angiography) to invasive coronary angiography for detecting coronary lesions in children who had undergone arterial switch operation for transposition of the great arteries.

Background Assessment of the integrity of reimplanted coronary arteries is crucial for long-term outcome after arterial switch operation for transposition of the great arteries. Non-invasive tests have limited accuracy for detecting coronary lesions, and invasive coronary angiography is usually required in this setting.

Materials and methods Patients (age 4 to 30 years old) who undergone arterial switch operation in neonate period are potentially eligible. They will be prospectively included in the study. They will have both examinations, their routine invasive coronary angiography and ECG-gated 64-slice CT angiography. The ability of CT to detect lesions of the ostia and proximal segments of the reimplanted coronary arteries was analyzed by blinded comparison to invasive coronary angiogram.

Expected results and clinical implications We expect to demonstrate that ECG-gated 64-slice CT angiography is safe and accurate for the detection of coronary lesions with a high sensitivity (expected sensitivity\>95%) as compared to invasive angiography. In that condition, ECG-gated 64-slice CT angiography could replace the invasive coronary angiography for the follow-up of patients with reimplanted coronary arteries after arterial switch operation for transposition of the great arteries.

Eligibility Criteria:
Inclusion criteria :

* patients, age 4 to 30 years old, who had undergone arterial switch operation for transposition of the great arteries, are eligible.

Exclusion criteria :

* No consent
* Allergy to contrast agent (iodine contrast)
* Severe renal failure (clearance \< 80ml/min/1.73m²)
* Severe arrhythmias
* Absence of medical care insurance
* Pregnancy
* Contre-indication to beta-blockers
Specificity Study of Diagnostic for Chagas Disease

This study assesses the specificity of Chagas Detect™ Plus (CDP) rapid test versus standard reference tests (e.g. RIPA or IFA) for Chagas diagnosis in the US.

The Chagas Detect™ Plus Rapid Test is a rapid immunochromotagraphic strip assay for the qualitative detection of antibodies to Trypanosoma cruzi (T. cruzi) in human serum or whole blood samples. Reactive assay results are presumptive evidence of Chagas infection.

This study will enroll males and females 18-70 years of age from areas non-endemic for Chagas infection. A fingerprick blood sample and a venous blood sample (for processing to serum) will be collected from each subject. Subject age, gender, and symptoms will be recorded. For this study, samples will have no personally identifiable information.

CDP and reference tests will be performed by different operators who are laboratory staff members. These staff members, blinded to each other's results, will evaluate the samples from each method independently.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female subjects 18 to 70 years of age
2. Subjects must be able to answer questions concerning:

   1. Clinical symptoms
   2. Blood transfusions
   3. Organ transplants
   4. Travel or residence in Chagas endemic areas

Exclusion Criteria:

1. Any subject who knows that they have positive serology for Chagas disease
2. Subjects who are unable to understand verbal of written or oral language of the consent, or require a legal authorized representative for consent.
Comparative Effects of Aerobic Exercises and Progressive Muscle Relaxation Exercises on Pain and Quality of Life

Premenstrual syndrome is the clinical condition in which reproductive age females suffer from emotional and physical symptoms not related to any disease, starting usually 5 days before the menstrual cycle for 3 consecutive cycles.

Premenstrual syndrome is the clinical condition in which reproductive age females suffer from emotional and physical symptoms not related to any disease, starting usually five days before the menstrual cycle for three consecutive cycles. As menstrual cycle starts in females these symptoms vanish on 4th day of menstruation. Around 10% to 53% of female adults suffer from this condition. This condition limits activities of daily life and adversely effects the quality of life therefore, the administration of proper medical intervention is very important. Aerobic exercises and progressive muscle relaxation exercises have been effective in the treatment of premenstrual syndrome previously in a few studies. However, these two interventions have never been compared to test their effects on pain, and functional performance.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 to 40 years
* Females in their last week of the luteal phase (1 week before menstruation)
* Females with regular menstrual with equal intervals between 21 and 35 days
* Females with a score of 133 and above after being screened with Premenstrual syndrome scale
* Females suffering from PMS for at least the past six months

Exclusion Criteria:

* Females with the irregular menstrual cycle
* Pregnant females
* Menstruating females or females in the follicular or ovulatory phase
* History of physical exercise in the past three months before the beginning of the study
* Females suffering from other gynecological issues such as endometriosis, PCOS, uterine or cervical cancer
Tucidinostat Plus Etoposide in the Treatment of Neuroblastoma in Childhood.

Neuroblastoma is a malignant tumor that develops in infants and kids. Dysregulation of histone acetylation is associated with a series of malignant tumors. Neuroblastoma is caused by defective neural crest differentiation due to abnormal gene regulation.


Eligibility Criteria:
Inclusion Criteria:

1. Age 3\~18 years old;
2. Patients must have a life expectancy of at least 6 weeks and a Lansky (≤16 years) or Karnofsky (\>16 years) score of at least 50;
3. Histologically confirmed neuroblastoma and/or demonstration of tumor cells in the bone marrow with increased urinary catecholamines;
4. Patients must have a history of high-risk neuroblastoma, at least one measurable lesions according to the RECIST 1.1;
5. Patients who have progressed, recurrent or refractory disease after first-line treatment;
6. The residual disease biopsy must be done, if patiens who have persistent disease obtain incomplete response after first line treatment;
7. Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to study registration；
8. Patients have not received enzyme-induced anticonvulsant therapy;
9. Patients have not received valproic acid within 30 days before admission;
10. ANC ≥ 1.5×10\^9/L, PLT ≥75×10\^9/L;TBIL≤1.5ULN, ALT and AST≤3×ULN（ALT and AST≤5×ULN if liver metastasis）;BUN and Cr≤1.5×ULN 9）LVEF ≥ 50% and QTc≤470 ms.
11. Patients' guardians must be willing and able to understand and comply with the protocol for the duration of the study.

Exclusion Criteria:

1. Patients with severe cardiovascular disease;
2. Patients who have previously received organ transplants;
3. Inability to swallow pills;
4. Female patients during pregnancy and lactation, fertile women with positive baseline pregnancy tests or women of childbearing age who are unwilling to take effective contraceptive measures throughout the trial;
5. Active HIV, hepatitis B or hepatitis C;
6. Researchers believe that patients are unsuitable for any other situation in this study.
Role of Montelukast in the Management of Chronic Rhinosinusitis With Nasal Polyps.

The aim of the work is to examine the efficacy of montelukast as an adjunct to steroid therapy in patients with chronic rhinosinusitis with nasal polyps.

Population and Methods The study will be conducted at the otorhinolaryngology department in Assiut University Hospital.

* Study design: prospective randomized controlled trial.
* .
* Methodology:

After fulfilling all inclusion and exclusion criteria all patients will be subjected to

A. Full history taking including :

1. Personal History
2. History of sinonasal symptoms (nasal obstruction, nasal discharge, headache, hyposmia, sneezing, itching, facial pain...etc)
3. History of nasal surgery.
4. Other ENT symptoms
5. General symptoms suggestive of atopy
6. History of general medical illness.

B. Examination :

* 1. General examination.
* 2. Full ENT examination.
* 3. Nasal endoscopy.

C. Investigations :

Multi-slice computer tomography (MSCT) of nose and paranasal sinuses axial, coronal and sagittal cuts without contrast .

D. Management :

Patients will be divided into 2 equal groups. Patients in group A will be treated with fluticasone furoate nasal: (50 micrograms /spray ) 100 micrograms (2 sprays) in each nostril twice daily plus oral montelukast (montelukast 10 mg, once a day) for 3 monthes and oral Prednisolone 40 mg/day for two weeks. Subjects in treatment group B will receive topical and systemic steroids in an identical regimen only.

.

Eligibility Criteria:
Inclusion Criteria:

* - 1- Adult patients (aged 18 years and over)
* 2- Bilateral denovo nasal polyps confirmed by nasal endoscopy and CT scan.

Exclusion Criteria:

* - 1- CRS patients without nasal polyposis.
* 2- Patient with unilateral nasal polyp.
* 3- Revision cases (history of previous surgical treatment).
* 4- Patient with fungal rhinosinusitis..
* 5- Pregnancy and lactation.
* 6- Malignancies.
Study on the Effectiveness of a School-Based Fat Loss Program for Adolescents

The students were divided into an intervention group and a control group. The intervention group attended fat loss exercise classes three times a week and the parents cooperated with us in dietary monitoring and control. Before and after the intervention, questionnaires were completed, physical fitness and body composition were measured, and physical activity measurement bracelets were worn for 4 days. In this study, it is possible to know the mental health state, physical activity habits, body composition and physical fitness of adolescents.


Eligibility Criteria:
Inclusion Criteria:

* Passed PAR-Q questionnaire screening
* No professional sports experience
* Able to understand the test
* Voluntarily participate in the entire testing process

Exclusion Criteria:

* Serious organic pathology of the heart, brain, lungs, kidneys, and locomotor system
* Taking medication for a chronic condition
* Have history of psychiatric disorders
* Inability to complete follow-up visits or poor adherence.
Randomized Trial Comparing Irrisept to Saline Irrigation for Infection Prevention

Early debridement and definitive fixation, at the initial operative setting, historically led to no difference in the infection rates for Gustilo-Anderson type III open tibia fractures. However, Lenarz et al. reported that delaying definitive fixation in open tibia fractures could decrease the deep infection rate. At the University of Missouri, the investigators found that staged procedures, including initial debridement-temporary fixation and delayed definitive fixation, did not statistically decrease the rate of deep infection in Gustilo-Anderson type III fractures, prompting the study that is being proposed here. Antibiotic cement coated intramedullary nails have been used in management of infected long bone fractures. Since external fixation and staged debridement did not decrease type III open tibia infection rate, the investigators wanted to consider using antibiotic cement coated nails to deliver antibiotics locally in the acute open fracture setting to prophylactically decrease associated infection rate. Additionally, Irrisept is a wound irrigant that has been used to lower infection rates in different wound settings. To the investigators' knowledge, there are no robust data showing its effectiveness at lowering infection rates in open tibia fracture management. The purpose of this study is to determine the effects of Irrisept and antibiotic nails on lowering deep infection rates in type III open tibia fractures.


Eligibility Criteria:
Inclusion Criteria:

1. Adult, 18 or over
2. Gustilo-Anderson type III open tibia fracture
3. Able to obtain informed consent from patient

Exclusion Criteria:

1. Minor, under 18
2. Pregnancy
3. Prisoner
4. Allergic to chlorhexidine gluconate
5. Allergic to vancomycin or tobramycin
6. Patient's tibia is unable to accommodate the smallest antibiotic nail
7. Unable to provide informed consent
Adjustment Exploratory Protocols and Functional Evaluation of New Non Invasive Devices in Patient Volunteers

Parameters, sequences or paradigms optimisation in view of data quality and relevancy improvement.

Various tests are needed for methodological optimization of the several devices (per-operative MRI, MEG, EEG, SPECT-CT, motor platform) of the technological platform.

Eligibility Criteria:
Inclusion Criteria:

* Volunteers patient
* Male or female aged over 18 years
* Registered in the French social security scheme
* Signed informed consent

Exclusion Criteria:

* Contraindication to Magnetoencephalography (MEG) and/or Electroencephalography (EEG)
* Contraindication to Magnetic resonance imaging (MRI)
* All categories of protected persons