cyrilzakka/clinical-trials huggingface dataset:
Nodal Status in Adenocarcinoma of the Esophagus an Cardia

Adenocarcinoma of the distal esophagus and cardia are grouped among the thoracic tumors according to the TNM 7th ed., however controversy is pending on the unique or dual pathogenesis (GERD or gastric-like cancerogenesis). It has been shown that biological patterns differ according to the presence (+) or absence (-) of Barrett's epithelium (BIM) and gastric intestinal metaplasia (GIM) in the fundus and antrum. Lymphatic metastatic spreading may differ according to the type of tumor. The investigators retrospectively investigated the pathways of lymphatic spreading in 194 consecutive patients who received radical surgery for adenocarcinoma of the esophagus and cardia with or without BIM and GIM.

The assumption that adenocarcinoma of the esophagus and cardia (ADEC) originates only from the sequence intestinal metaplasia followed by dysplasia and cancer is controversial. It has been shown that biological patterns differ according to the presence (+) absence (-) of Barrett's epithelium (BIM) and of gastric intestinal metaplasia (GIM) in the fundus and antrum. Lymphatic metastatic spreading may differ according to the type of tumor.

Preoperatively patients underwent histological search for Barrett's esophagus (BIM) in mucosa surrounding (ADEC) and intestinal metaplasia in the gastric corpus and antrum mucosa (GIM). Patients in which BIM was documented underwent sub total esophagectomy and gastric pull up (group 1), others underwent esophagectomy at the azygos vein + total gastrectomy with Roux Y esophagojejunostomy (group 2). Radical lymphadenectomy was identical in both procedures except for the greater curvature station.

Eligibility Criteria:
Inclusion Criteria:

* preoperative diagnosis of adenocarcinoma of the distal esophagus and cardia
* preoperative from local to locally advanced disease
* absence of neoadjuvant therapy

Exclusion Criteria:

* neoadjuvant therapy
* metastatic disease
* unfit for surgery
China Medical University Hospital (CMUH) Triapin Listing

The objective of this study is to compare the reduction in office seated systolic blood pressure (BP) following a 8 weeks regimen of ramipril 5mg plus felodipine 5mg versus ramipril 10mg.

To compare the response rate (defined as office systolic blood pressure (SBP) / Diastolic blood pressure (DBP) reduce more than 10mmHg from baseline), and BP controlled rate (defined as SBP\<140mmHg and/or DBP\<90mmHg) and as SBP \< 130 mmHg and /or DBP \< 80 mmHg in diabetes,chronic kidney disease, known Coronary Arterial Disease (CAD) or CAD equivalent, or 10-year Framingham risk score \> 10%.

To ascertain the safety and tolerability of ramipril/felodipine versus ramipril in Taiwanese population.

To compare compliance with fixed dose combination of ramipril/felodipine versus ramipril treatment.


Eligibility Criteria:
Inclusion criteria:

* Uncontrolled essential hypertension defined by office SBP/DBP \> 140/90 or \> 130/80 mmHg for compelling indications (diabetes mellitus, chronic kidney disease, known CAD or CAD equivalent or 10-year Framingham risk score \> 10%)
* Previously untreated, or previously treated with a single antihypertensive therapy at usual dose during the last 4 weeks

Exclusion criteria:

* Female who are pregnant or breast feeding
* Office DBP\> 110mmHg or office SBP \>180mmHg
* Hypersensitivity to ramipril, felodipine or to any of the excipients
* Bilateral stenosis of the renal arteries, or unilateral stenosis in the single kidney
* History of intolerance to any ACE inhibitor
* History of significant renal diseases including: serum creatinine \>3.0 mg/dl, or creatinine clearance \<30 ml/min
* History of hereditary and/or idiopathic angioedema; or angioedema associated with previous ACEI
* Significant cardiovascular diseases, multiple drug allergies, bronchospastic disease or other malignancies requiring current medication
* Hepatic disease as indicated by any of the following: Serum Glutamooxaloacetate Transferase (SGOT) or Serum Glutamopyruvate Transferase (SGPT)\>3 x upper limit of normal, or serum bilirubin \> 2 x upper limit of normal
* Any other condition or therapy that, in the investigator's opinion, or as indicated in the product(s) label may pose a risk to the patient or interfere with the study objective.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Cyberbullying, Empathy, and Storytelling in Adolescents

The type of this study is a randomized controlled experimental study. The aim of this study is to determine the effect of storytelling method on cyberbullying and empathy level in adolescents. The population of the study consisted of 5th and 6th grade middle school students. The sample of the study will consist of students involved in cyberbullying. The sample will be selected through randomization and stratified selection will be made according to gender. The students in the intervention group will receive 4 sessions of storytelling intervention. The active control group will receive 4 sessions of cyberbullying training. Questions that the research aims to answer:

Is there a difference between the intervention group and the control group in terms of cyberbullying level? Is there a difference between the intervention groups and the control group in terms of empathy level?

Participants:

The intervention group will participate in 4 sessions of storytelling intervention.

The control group will participate in 4 sessions of cyberbullying training.


Eligibility Criteria:
Inclusion Criteria:

* Family approval
* Volunteering to participate in the study.
* Being a 5th and 6th grade student
* Engaging in cyberbullying behavior

Exclusion Criteria:

* Having a diagnosis of any mental illness
* Having at least one of vision, speech and hearing disabilities
* Foreign nationality
* Being a 7th and 8th grade student
* Not engaging in cyberbullying behavior
COVID-19 In-vitro Diagnostic Test and Androgen Receptor Gene Expression

This research study will evaluate the association of Androgen Receptor (AR) gene expression and COVID-19 disease severity and mortality. The research procedure involves collection of a single saliva sample which will be mailed to the participants by the study team. This saliva will be used in a COVID-19 Androgen Sensitivity Test (CoVAST) which will detect AR gene expression. Eligible participants are males, at least 18 years or older, and have tested positive for COVID-19.


Eligibility Criteria:
Inclusion Criteria:

* Male over the age of 18
* Laboratory confirmed SARS-CoV-2 infection
* Able to give verbal informed consent

Exclusion Criteria:

* Unable to give informed consent
* Diagnosed with an additional respiratory co-infection
* XXY males
Balneotherapy and Anxiety During SARS-CoV-2 Pandemic

Investigators will measure the level of anxiety and fear of Covid during the balneological treatment in patients. They are interested in the effect of general trust and resilience on the level of anxiety state.

Investigators will measure the level of anxiety and fear of SARS-CoV-2 virus during the balneological treatment in patients. They are interested in the effect of general trust and resilience on the level of anxiety state.

A number of between 300 and 800 inpatients are expected to get involved in the study. They suffer from cardiovascular disease, osteoarthritis, respiratory diseases and many others.

Eligibility Criteria:
Inclusion Criteria:

* enrolled in balneological treatment

Exclusion Criteria:

* not enrolled in the balneological treatment
Throwing Device Tracker for Youth Injury Prevention

The primary objective of this study is to collect motion-capture data on movements common to baseball play in order to develop an algorithm for a wearable device for the prevention and rehabilitation of sports-related overuse injuries. Secondary objectives include evaluating the feasibility of wearing the throwing device during simulated baseball play.

With the rise in competitive sports participation in pediatric and adolescent populations, there has also been an increase in overuse injuries. Current methods of overuse injury prevention, such as pitch-counting, fail to account for differing techniques or effort and often ignore the elevated risk for children participating in two or more sports emphasizing the same body part. This wearable device seeks to more accurately monitor overuse to prevent and aid rehabilitation of overuse injuries.

Subjects will be asked to fill out a short survey about their athletic activities. They will wear a prototype of a minimal risk throwing device during simulated baseball play in a sports medicine session or at the Human Motion Laboratory. Various motion data from the device and from the Motion Lab analysis will be collected to create and refine an algorithm to quantify workload and throwing movements.

The primary endpoint of this study is to quantify motion capture data on movements common to baseball play. The secondary endpoints include quantifying injury associated with different baseball movement using the proposed system, development of algorithms to quantify workloads associated with injury during common baseball movements and validation of basic device measurements (Pilot Phase).

Eligibility Criteria:
Inclusion Criteria:

Pilot Phase:

1. Males or females age 8 to 14 years
2. Presenting to the Children's Hospital of Philadelphia (CHOP) Physical Therapy Clinic for rehabilitation of injury that does not impede their ability to perform basic throwing movements.

Phase 1:

1. Males or females age 8 to 14 years
2. Involved in official baseball team and primarily plays as the pitcher

Exclusion Criteria:

Pilot Phase

1. Injury of any aspect of the throwing arm
2. Unwillingness to perform all requested motions
3. Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study procedures.

Phase 1

1. Injury or disability impeding ability to perform normal baseball-related movements
2. Inability/unwillingness to schedule and/or travel to the Human Motion Laboratory
3. Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
Fructose Consumption and Metabolic Dysregulation

High fructose intake is increasingly recognized as causative in development of prediabetes, metabolic syndrome and cardiovascular disease (CVD). The mechanisms underlying fructose-induced metabolic disturbances are unclear but are beginning to be unraveled. In contrast to metabolism of glucose, the breakdown of fructose leads to the generation of metabolites that stimulate hepatic de novo lipogenesis (DNL) and increased levels of both fasting and postprandial triglycerides. The key lipogenic transcription factor seems to be activated by fructose independently of insulin. However, it is still controversial whether fructose consumption increases DNL in man to the extent that it induces metabolic disturbances. Animal studies have shown that also the adipose tissue is responsive to fructose feeding fructose, and that high fructose-feeding induces insulin resistance and inflammation in the adipose tissue. The role of intestinal insulin resistance in fructose-induced dysmetabolism has not been studied in detail. The critical question is whether the metabolic disturbances are induced by calorie excess or by fructose per se.

Detailed description: Study subjects will participate to studies 1-4 before and 3 m after fructose diet:

1. An oral fat load or a kinetic study with stable isotopes combined with an oral fat load.
2. Determination of liver, subcutaneous and intra-abdominal fat. (Proton magnetic resonance spectroscopy )
3. Lipolytic enzymes, advanced lipid analysis, fat biopsies and genetic studies and gut microbiota profiling
4. Oral glucose tolerance test and analysis of incretins and inflammatory biomarkers.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index 27-40
* Waist \> 96 cm
* Age 20-60 years
* Male

Exclusion Criteria:

* Smoking
* Active health problems
* Contraindications to MRI scanning
* Bleeding tendency
* Abnormal liver or renal function tests
* Type 2 diabetes
* Evidence of metabolic or viral liver disease
* Alcohol intake \> 21 units per week
* Chronic medication except ones needed for stable hypertension
Treating Schizophrenia by Correcting Abnormal Brain Development

The purpose of this study is to determine whether treatment with tiagabine (Gabitril) during the early course of schizophrenia can fundamentally correct the brain deficits associated with the disease.

This study is funded by the National Institutes of Health.

It is hypothesized that enhancement of GABA neurotransmission during the early course of the illness by tiagabine (Gabitril), a GABA transporter GAT-1-specific inhibitor and a FDA-approved anticonvulsant, will improve both clinical symptoms and working memory in schizophrenia. This improvement is postulated to be the result of tiagabine-mediated modification of the developmental synaptic pruning of prefrontal cortical circuitry. The occurrence of circuitry modification after tiagabine treatment will be assessed by the following independent methodologic approaches: MRI morphometric analysis of prefrontal gray matter volume and fMRI measurements of brain activity patterns during performance of tasks that probe working memory.

Eligibility Criteria:
Inclusion Criteria:

* Meets criteria for the diagnosis of schizophrenia, with onset of psychotic symptoms within the past 3 years.
* Currently on second-generation antipsychotics for at least 3 months.
* Age 18-25, otherwise healthy.

Exclusion Criteria:

* Diagnosis of schizoaffective disorder.
* Has failed two or more clinically adequate antipsychotic trials.
* History of seizures or any neurologic disorders.
* Pregnant or nursing women.
* Known HIV infection.
* Actively suicidal.
* History of any substance dependence.
* Currently meets criteria for substance abuse/dependence.
* Other MRI exclusion criteria per Radiology Department protocols.
Biomarkers in Samples From Young Patients With Soft Tissue Sarcoma

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

PURPOSE: This research trial is studying biomarkers in samples from young patients with soft tissue sarcoma.

OBJECTIVES:

* To identify the key components of driver pathways of primary and secondary soft tissue sarcomas.
* To perform the next-generation sequencing on primary versus normal on undifferentiated sarcomas.

OUTLINE: Genomic DNA and RNA samples from undifferentiated sarcoma tumors are analyzed by next-generation sequencing for somatic mutations. Normal matched lymphocytes and tissue are also analyzed.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Banked childhood samples from the COG-D9902 soft tissue sarcoma biology and banking study
* Rhabdomyosarcoma, NOS

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Self-administered Acupressure for Knee Osteoarthritis: A Pilot Randomized Controlled Trial

Objectives: To test the feasibility of the study design and clinical effects of self-administered acupressure on relieving knee osteoarthritis (OA) pain.

Hypothesis: self-administered acupressure would have a superior beneficial effect compared to health education control group in terms of pain relief in patients with knee osteoarthritis across the 6-week study period.

Design and subjects: A pilot randomized controlled trial. 36 subjects with knee OA will be recruited; 18 per group. All eligible subjects will be randomized to either self-administered acupressure or health education control group in 1:1 ratio.

Interventions: Subjects in the self-acupressure group will attend two 1.5 hours training sessions to learn self-acupressure and will practice self-acupressure every morning and night for 6 weeks; subjects in the education control group will receive two 1.5 hours training sessions to learn the health information related to knee OA.

Main outcome measures: The primary outcome measure is the numerical rating scale for knee pain. Other measures include Western Ontario and McMaster University Osteoarthritis Index, knees' range of motion (ROM), and SF-6D. Acceptability of the self-acupressure training course will also be evaluated.

Data Analysis: Differences in the questionnaire scores and ROM will be examined using a mixed-effects model. Both completer and intention-to-treat analyses will be conducted. Effect sizes will be computed by dividing the difference in means by the pooled standard deviation.


Eligibility Criteria:
Inclusion Criteria:

* ethnic Chinese;
* aged 50 -70 years
* fulfills any 3 of the following criteria proposed by Altman et al., (1986): ( I. morning stiffness\</= 30 min; ii. crepitus on active joint motion; iii. bone tenderness; iv. bone enlargement; or v. no palpable joint warmth);
* having knee pain for at least 3 months;
* ability to provide informed consent;
* ability to comprehend Chinese; and
* Knee pain ≥3/10 and \</= 7 on a Likert pain scale from 1-10

Exclusion Criteria:

* medical diagnoses or conditions that preclude individuals from active participation (bleeding disorders, alcohol or drug abuse);
* presence of skin lesions or infections at the treatment sites;
* currently participating in other interventional research studies for knee OA;
* cognitive impairment preventing informed consent or understanding of instructions
* body mass index over 25, the obese criteria for Asians (Anuurad et al., 2003);
* knee pain related to other conditions (cancer, fracture, rheumatoid arthritis, rheumatism) as screened according to the red flags for further investigation or referral in the NICE 2014 Guidelines for Osteoarthritis of the knee;
* had previous foot injury or trauma;
* using of steroid for knee pain;
* pregnancy or contemplating pregnancy;
* ever received acupressure for knee OA over the past 6 months.
Reducing Underuse of Early-Stage Breast Cancer Treatment in Minority Communities

The purpose of this study is to determine if a physician-centered intervention will help women with early stage breast cancer receive appropriate treatment.

Efficacious adjuvant treatments such as radiotherapy following breast conserving surgery, and chemo- or hormonal therapy for stage 1b or 2 breast cancer improve disease-free and overall survival. Lower rates of radiotherapy following breast-conserving surgery have been reported among black women. Few data exist about racial disparities in receipt of chemo- or hormonal therapies; however, poorer stage-specific survival rates among blacks and among women with poor or no insurance suggest underuse of these treatments. Despite elimination of racial disparities in rates of mammography screening, the full benefit of screening will not be realized unless underuse of effective treatments for early-stage breast cancer is eliminated. Little is known about reasons for underuse of these treatments or ways to increase treatment rates. Our preliminary work suggests omitted referrals and lack of follow-up tracking account for a majority of underuse particularly among minority patients.

The proposed breast cancer project will measure the extent of underuse of efficacious breast cancer treatments among patients of the hospitals serving East and Central Harlem and other minority communities in lower Manhattan. We will first interview physicians and patients about their reasons for omission of efficacious adjuvant treatments. At the 6 participating hospitals, we will then implement an intervention consisting of: a) computerized reminders to prompt surgeons to refer patients for adjuvant treatment, and b) an individual to track referrals for and receipt of adjuvant treatments. We will assess racial/ethnic differences in rates of underuse and explore racial differences in reasons for underuse.

We will assess the impact of the intervention on reducing underuse of efficacious therapies among 2 years of 695 pre-intervention and 2 years of 695 post-intervention patients. This study will provide new knowledge about racial disparities in treatment for early-stage breast cancer; patient and physician reasons for underuse; and the effectiveness of a simple, sustainable intervention to improve rates of efficacious adjuvant treatments.

Eligibility Criteria:
Inclusion Criteria:

* All patients, who are English or Spanish speaking, with a new primary stage 1 or 2 breast cancer who have undergone either breast conserving surgery or mastectomy and those with tumors \> 1 cm or \< 1 cm and poorly differentiated
* All surgeons performing breast surgery at the participating hospitals

Exclusion Criteria:

* Patients with dementia or those with a poor prognosis due to end-stage organ failure or other concomitant conditions such as those undergoing treatment for other cancers
Immunogenicity and Safety of Imovax Polio in Chinese Infants Compared to Local OPV

This study is intended to support the registration of IMOVAX Polio in China.

The primary objective of this Pase III trial is to compare IMOVAX Polio to the current Chinese standard of care (OPV) that is administered following a schedule of 2-3-4 months. The objective is to demonstrate that after the 3 doses primary series, in terms of seroprotection rates, IMOVAX Polio is not inferior to OPV. The safety of IPV will be assessed after each IPV dose.


Eligibility Criteria:
Inclusion Criteria:

* Aged 2 months (60-70 days) on the day of inclusion into the study
* Born at full term pregnancy ( over 36 weeks) with a birth weight ≥ 2.5 kg 2Ibs) or more
* Parent(s) or legal representative able to understand and give authorization and sign informed consent for participation
* Able to attend all planned clinic appointment and obey and follow all study instructions

Exclusion Criteria:

* Taking part in another clinical trial during the 4 weeks before the first trial vaccination
* Have plans to take part in another clinical trial d during this trial period
* Inborn or acquired decreased body natural defense, undertaking treatment that can reduce body's natural defense such as cancer drugs, radiation in the past six months or long term corticosteroid treatment
* Systemic reaction to any vaccine component or history of life-threatening reaction to study vaccine or any vaccine with the same ingredient(s)
* Prolonged or long time illness that could interfere with study or full participation
* Received blood or blood-derived products since birth
* Received any vaccine in the 4 weeks before the first trial vaccination is given (except BCG and hepatitis B)
* Have plans to receive any vaccine in the 4 weeks after the (or any) study vaccination is given (except DTacP)
* Previous vaccination against the poliomyelitis infection with the trial vaccine or another vaccine
* History of poliomyelitis infection (confirmed either by symptoms, blood or other laboratory test)
* Clinical or serological evidence of systemic illness including hepatitis B, hepatitis C or Human immunodeficiency virus (HIV)
* Bleeding disorder or a low platelet which do not allow vaccination into the muscle
* Had seizures in the past
* Febrile illness (axillary temperature ≥ 37.1°C) or acute illness on the day of inclusion