cyrilzakka/clinical-trials huggingface dataset:
Simultaneous Integrated Boost Radiotherapy and Concurrent Nimotuzumab or Chemotherapy for Esophageal Carcinoma

This prospective, non-randomized phase II study aims to compare radiotherapy and concurrent nimotuzumab with concurrent chemoradiotherapy to obtain a non-inferior pCR rate and pathological lymph node metastases rate in premise of lower toxicities in locally advanced esophageal cancer.

In the era of IMRT and concurrent chemoradiotherapy, the 5-year overall survival of esophageal cancer increase from 10% to about 20%-40%, recurrence rate decrease from 80% to 50%-60%, and local recurrence remains to be the most important type of failure. What called for is to enhance local control without increasing toxicity to improve survival. The investigators have found effective and safe regimen of simultaneously integrated boost radiotherapy in previous study, which can achieve high dose in tumor area with avoid of normal tissues. However, a recent prospective study reported that neoadjuvant chemoradiotherapy resulted in much higher toxicities compares to neoadjuvant chemotherapy (46% vs. 15%, p= 0.04). Although chemoradiotherapy reached a higher pCR rate (28% vs. 9%, p=0.002), patients did not differ in survival in two groups.

Nimotuzumab is an humanized monoclonal antibody against EGFR. Radiotherapy combines Nimotuzumab reveals synergistic effect in head and neck cancers with lower toxicities as compared to concurrent chemoradiotherapy. Our previous study showed that EGFR expression rate were similar in esophageal cancer and head and neck cancers. Based on above results, the investigators design this study which aims to obtain a non-inferior pCR rate and pathological lymph node metastases rate in premise of lower toxicities.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of clinical stage T1-4aN0-1M1a untreated squamous esophageal carcinoma
* KPS≥70
* Adequate organ function
* No known history of drug allergy

Exclusion Criteria:

* Known drug allergy
* Insufficient hepatorenal function
* Severe cardiovascular diseases, diabetes with uncontrolled blood sugar, mental disorders, uncontrolled severe infection, active ulceration which need intervention.
Usefulness of Cardiovascular Disease (CVD) Management Solution

We previously developed the smartphone app (Heart4U) which is coupled with electronic medical record system in Seoul National University Bundang Hospital. In this study, we aim to evaluate clinical usefulness of smartphone app regarding the control of conventional risk factors in patients with history of cardiovascular disease.


Eligibility Criteria:
Inclusion Criteria:

* Patients with atherosclerotic cardiovascular diseae

  1. history of cardiovascular disease (acute myocardial infarction, unstable angina, stable angina)
  2. history of revascularization including percutaneous coronary intervention, peripheral angioplasty or bypass surgery
  3. history of stroke
  4. history of peripheral arterial disease presumed to be of atherosclerotic origin
* Patients who have smartphone and can use app by themselves
* Patients who can speak and read Korean language

Exclusion Criteria:

* Patients with evidences of delirium, confusion or impaired consciousness
* Patients who are not familiar to smartphone or app
* Patients who are not supposed to follow the study protocol adequately.
"Hepatic Substrate Flux Rates in Type 2 Diabetes"

Investigation of the effects of redox shuttle inhibition by metformin on gluconeogenic flux rates of lactate and glycerol in humans with type 2 diabetes

Type 2 diabetes (T2D) is characterized by insulin resistance and relative insulin deficiency leading to hyperglycemia. Enhanced endogenous glucose production during fasting is a key feature of hepatic insulin resistance and a major contributor to deterioration of glycemia. Metformin reduces fasting gluconeogenesis (GNG); the underlying mechanisms are still not fully understood, but involve the inhibition of complexes of the electron transport chain and thus the redox shuttle.

The investigators have previously provided evidence for abnormal hepatic ATP synthesis and mitochondrial efficiency in T2D, but it remains unknown, how and which substrate fluxes account for excessive GNG in T2D. For this reason, this proposal aims at investigating hepatic glucose and energy fluxes in T2D with focus on gluconeogenic contribution of lactate and glycerol to hepatic mitochondrial substrate flux, mitochondrial ATP synthase flux and the activity of the redox shuttle, also after metformin intake, by using a novel combination of positional isotopomer nuclear magnetic resonance (NMR) analysis (PINTA) with multinuclei magnetic resonance spectroscopy (MRS).

Eligibility Criteria:
Inclusion criteria:

* type 2 diabetes (duration \<7 years),
* age (18-75 years)
* BMI \<40 kg/m2
* HbA1c 6-15%

Exclusion criteria:

* uncontrolled hyperglycaemia (\>340 mg/dl)
* diabetes types other than type 2 diabetes (ADA criteria)
* thiazolidinedione use during the preceding 6 months
* clinically relevant angiopathy, restrictive or obstructive lung diseases
* other acute or chronic diseases including wounds and the use of pharmacological agents known to affect insulin sensitivity, lipid metabolism or immunological function.
A Retrospective Review - Anti-HLA Antibodies

Transplant rejection following organ transplant occurs because the recipient's immune system attacks the transplanted organ. The recipients immune system recognizes the transplanted organ as foreign tissue and attempts to destroy it in the similar way that it attempts to destroy infectious agents such as bacteria and viruses. The human leukocyte antigen (HLA) system is a set of genes that is responsible for controlling an individuals' ability to tell the difference between an infectious agent and self tissue.

Differences in HLA genes between donors and recipients play a major part in influencing the rejection or acceptance of foreign tissue (i.e. transplanted organs). Due to time limitations in heart transplantation, HLA matching is not considered. It is unclear how individual HLA differences affect the recovery and expected lifespan of pediatric heart transplant recipients.

This study is designed to look at the donor-recipient matching and mismatching to determine if mismatching leads to more complications, shorter graft survival and, therefore, increased risk of death following pediatric heart transplantation.

It is generally thought that immunologic mismatching in solid organ transplant will lead to increased rates of graft failure due to acute rejection in the short term and chronic rejection, or coronary vasculopathy in the longterm. Many studies in renal, pancreas and lung transplantation suggest favorable outcomes when HLA matching occurs and unfavorable outcomes when HLA mismatching occurs and circulating donor-specific antibodies are produced.

However, in heart transplantation this association is less clear. Advances in recognition and identification of HLA antibodies have resulted in more specific information regarding HLA mismatching and outcomes. This study is aimed at analyzing outcomes in pediatric heart transplant based on recipient-donor HLA incompatibility and the post-transplant production of donor-specific HLA antibodies.

Hypothesis:

1. HLA systems' genes class I \& II matching results in a survival/rejection benefit in pediatric heart transplant recipients.
2. Mismatched transplants with donor-specific HLA antibodies have decreased overall survival.

A Multivariate Analysis of data will be performed by both Emory and Children's investigators and research support staff.

Eligibility Criteria:
Inclusion Criteria:

* heart transplants at Childrens Healthcare of Atlanta, Egleston Hospital
* transplants between July 1, 1988 through and including January 31, 2007
* complete HLA data
* survived more than 30 days after transplant

Exclusion Criteria:

* subjects undergoing retransplant
Endoscopic Band Ligation (EBL) Versus Propranolol for Primary Prophylaxis of Variceal Bleeding

This study is performed to compare the efficacy and safety of EBL, propranolol, and EBL combined with propranolol in patients with medium or large varices.

Current guidelines recommend prophylactic treatment with propranolol or endoscopic band ligation (EBL) to prevent variceal bleeding in patients with medium or large varices. However, it is unclear which treatment is more useful in regard to prevention of variceal bleeding as well as safety. In addition, the efficacy and safety of the combination of EBL and propranolol is not still defined. This study is performed to compare the efficacy and safety of EBL, propranolol, and EBL combined with propranolol in patients with medium or large varices.

Eligibility Criteria:
Inclusion Criteria:

* Liver cirrhosis
* Age between 18 and 70 years
* Esophageal varices with high bleeding risk: more than F2 and red color sign
* No previous history of upper gastrointestinal bleeding
* No previous history of endoscopic, radiologic, or surgical therapy for varices or ascites
* Do not take beta-blocker, ACE inhibitor, or nitrate
* Child-Pugh score \<12

Exclusion Criteria:

* Patients with systolic blood pressure \<100 mmHg or basal heart rate \<60/min
* Portal vein thrombosis
* Uncontrolled ascites or hepatic encephalopathy
* Severe coagulation disorder: prothrombin time \<40% (or INR \>1.7) or platelet count \<30,000/mm3
* Medium or large sized gastric or duodenal varices
* Coexisting malignancy
* Severe cardiovascular disorder, renal failure, peritonitis, sepsis
* Severe erosive esophagitis, severe esophageal stricture, active gastric or duodenal ulcer
* Contraindication to beta-blocker
* Pregnancy
* Refusal to give consent to participate in the trial
Relation Between Atherogenic Index of COVID-19 and Upcoming Cardiac Morbidity and Mortality in Non-Cardiac Patients

Plasma lipids levels were estimated and the Atherogenic Index of Plasma (AIP) was computed in 302 COVID confirmed patients. Patients were evaluated using the COVID-GRAM (CG) critical illness score and during a hospital stay the rates of admission to intensive care unit (ICU), development of cardiac insults, and need for admission to cardiac ICU (CCU) and its outcome were determined.

All patients were admitted to the quarantine department at Tanta University hospital and quarantine hospitals at Al-Gharbia governorate with a diagnosis of SERS-CoV-19 infection that was confirmed by having positive nasopharyngeal swab for SARS-CoV-2 using reverse transcriptase-polymerase chain reaction (RT-PCR). The study protocol was approved by the Local Ethical Committee according to instructions of the Ministry of Health and written informed consents were signed by all enrolled patients or their nearest relative.

Using the strict personal protective equipment, patients were clinically examined for collection of the demographic data age, sex, weight and height, history taking especially past and/or present history of diabetes mellitus (DM), hypertension, cardiac diseases, hypercoagulability events, chest, liver or kidney diseases or endocrinopathy. BMI was calculated in kg/m2 as weight (kg)/height (m2) (14) and was graded according to the guidelines of WHO (15). The chest was examined clinically and CT imaging was performed to assess the disease severity.

Clinical parameters

1. COVID-19 disease severity grading
2. COVID-GRAM Critical Illness Risk Score
3. Atherogenic index of plasma (AIP)

Laboratory investigations A- Routine lab investigations included estimation of random blood glucose, complete blood count and serum levels of urea, creatinine, liver enzymes, and total and direct bilirubin B- Investigations for evaluation of SARS-CoV-2 infection severity including estimation of serum C-reactive protein, interleukin-6, lactate dehydrogenase, D-dimer levels.

C- Estimation of a plasma lipid profile

Eligibility Criteria:
Inclusion Criteria:

* Only non-cardiac patients with confirmed COVID-19 disease who had mild-to-severe COVID disease according to the guidelines of the National Institutes of Health admitted to quarantine hospitals and free of exclusion criteria were enrolled in the study. Patients were categorized according to disease severity into mild, moderate, and severe.

Exclusion Criteria:

* Patients presented by COVID disease of critical severity that necessitated admission to ICU at time of hospital attendance, admission to ICU for any other indication, presence of a history of cardiac diseases, previous cardiothoracic or chest surgery for any indication, BMI of ≥35 kg/m2, presence of endocrinopathy, preexisting autoimmune diseases, current maintenance on immunosuppressive drugs, malignancy elsewhere in body organs, refusal to sign the written consent to receive the study protocol or death just on admission or before completion of the diagnostic protocol.
Cardiovascular Risk Reduction Study (Reduction in Recurrent Major CV Disease Events)

Main Study (CACZ885M2301): The purpose of the pivotal phase of this trial was to test the hypothesis that canakinumab treatment of patients with myocardial infarction (MI) at least one month prior to study entry and elevated hsCRP could prevent recurrent cardiovascular events.

The purpose of the extension phase of the main study is to collect additional long-term safety data on continued exposure to canakinumab in patients who participated in the pivotal phase.

Sub-study 1 (CACZ885M2301S1): The purpose of this sub-study was to evaluate the effect of quarterly subcutaneous canakinumab treatment for 24 months comparted with placebo on the carotid plaque burden measured by integrated vascular MRI in patients enrolled in the CACZ885M2301 study (CANTOS).

Sub-study 2 (CACZ885M2301S2): The purpose of this CANTOS sub-study was to determine whether, in patients with type 2 diabetes participating in the CANTOS main study, canakinumab compared to placebo, on top of standard of care could increase insulin secretion and insulin sensitivity.

Sub-study 1 and 2 were terminated prior to data collection from subjects. However, there is an ongoing extension trial where patients are receiving open-drug label.

Eligibility Criteria:
Main Study Inclusion Criteria:

* Written informed consent
* Male, or Female of non-child-bearing potential
* Age ≥ 18 years.
* Spontaneous MI at least 30 days before randomization. hsCRP ≥ 2 mg/L

Substudy 1 Inclusion:

* All Inclusion from Main Study
* Acquisition of evaluable baseline MRI images of bilateral carotid arteries by the imaging core laboratory

Substudy 2 Inclusion:

* All inclusion from Main Study
* T2D at baseline per Main protocol criteria and be on a stable anti-hyperglycemic medication for at least 4 weeks prior to the baseline OGTT test
* Willing to have the OGTT assessment started before 10 am

Main Study Exclusion Criteria:

* Pregnant or nursing (lactating) women
* Women of child-bearing potential
* Any of the following concomitant diseases
* Planned coronary revascularization (PCI or CABG)
* Major non-cardiac surgical or endoscopic procedure within past 6 months
* Multi-vessel CABG surgery within the past 3 years
* Symptomatic patients with Class IV heart failure (HF) (New York Heart Association \[NYHA\].
* Uncontrolled hypertension
* Uncontrolled diabetes
* History or evidence of active tuberculosis (TB) infection Substudy 1 Exclusion
* All Main exclusion
* Patients with prior history of carotid angioplasty, stenting, or carotid atherectomy
* Patients with contraindications to MRI examination (brain aneurysm clip, implanted neural stimulator, implanted cardiac pacemaker, pacemaker wires or defibrillator, prosthetic heart valves, cochlear implant, ocular foreign body or other implanted body, tattoos, implanted insulin pump, metal shrapnel or bullet)
* Patients prone to claustrophobia or known anxiety disorders
* BMI \> 40 kg/m2 Substudy 2 Exclusion
* This sub-study does not have any additional exclusion criteria.
The Influence of Autophagy on Fatty Liver

Non-alcoholic fatty liver disease (NAFLD) is one of the most common causes of chronic liver disease worldwide. It is not known why only some obese subjects develop NAFLD. In recent years, a growing body of evidence showed a crucial role of autophagy in in the regulation of liver fat storage. The purpose of this study is to determine whether autophagy pathway-related genetic polymorphisms affect NAFLD.

The investigators will perform a prospective comparison of the genotype distribution of autophagy pathway-related genetic polymorphisms between those with and without NAFLD in a cohort of obese children and adolescents.

\[Subjects\] Obesity is defined as the BMI value \> 95 percentile by different age- and gender groups according to the standards of the Department of Health in Taiwan.

\[Data collection\] The following data were obtained for each subject: age, gender, BMI, waist and hip circumference. The investigators will measure total serum bilirubin, alanine aminotransferase, aspartate aminotransferase, γ-glutamyltransferase fasting glucose, triglyceride, total cholesterol, and high-density lipoprotein cholesterol, insulin, glucose, and adiponectin.

\[Liver ultrasonography\] All participants will receive an ultrasonographic study of the liver. NAFLD is defined as the presence of an ultrasonographic pattern consistent with the following criteria: liver-kidney echo discrepancy, attenuated echo penetration and visibility of diaphragm, and obscure hepatic vessel structures.

\[Genotyping\] Genomic DNA will be extracted from 3 cc venous blood from each participant. After extraction, the genomic DNA will be immediately stored at -80°C. The TaqMan genotyping assays will be performed for selected SNPs genotyping on ABI 7300 Real-Time PCR System (Applied Biosystems).

\[Sample size\] Sample size was estimated by Epi InfoTM 7 (CDC, USA) program. Because there was no previous data regarding to the effect of autophagy related gene on NAFLD, the investigators estimate the odds ratio to vary between 60-80%. The investigators used a confidence level of 95%, power of 80%, the ratio of controls to NAFLD cases of 25%, percent of controls exposed of 25-35%, the samples size required would be a total of 291-872 subjects.

Eligibility Criteria:
Inclusion criteria:

* Age 6-18 years old
* Obesity definition: BMI \> 95% according to the age- and gender-specific standard by National Health Institute in Taiwan
* Willing to give written informed consent

Exclusion criteria:

* Alcohol consumption
* Chronic liver diseases, including hepatitis B, hepatitis C, Wilson disease and autoimmune hepatitis
* Major systemic diseases, including cardiopulmonary disease, renal failure, cancer, and psychotic disorder
Assess Differences in Pain Following Cryo and Radiofrequency Atrial Fibrillation Ablation

The primary objective is to assess any differences in patient quality of life between Cryo Balloon ablation and Radiofrequency ablation in the treatment of atrial fibrillation. The study will also assess any differences in the amount and duration of pain medication required after the ablation.

Currently there are several different accepted techniques for performing ablation of atrial fibrillation. The two primary techniques currently in use in our center for atrial fibrillation are Cryo Balloon and Radiofrequency ablation.

Based on personal observation, it is felt that patients undergoing Radiofrequency ablation have a higher incidence of chest discomfort and subsequently a greater requirement for pain medications post procedure as compared to those patients undergoing Cryo ablation.

Eligibility Criteria:
Inclusion Criteria:

* Paroxysmal atrial fibrillation who are advised either Cryoablation or Radiofrequency ablation for treatment.

Exclusion Criteria:

* Persistent atrial fibrillation
* Pregnant
* Taking pain medications for acute or chronic conditions at the time of the procedure.
* Undergo a combination of Cryoablation and Radiofrequency ablation
* Radiofrequency group who undergo ablation beyond pulmonary vein isolation
Soft Tissue Outcomes Of Badly Broken-Down Teeth Treated With Orthodontic Extrusion Compared With Immediate Implant Placement

Many patients suffer from tooth substance loss as a result of fracture or decay of teeth situated in the esthetic zone. This might commonly occur with car accidents, sport injuries, falls or even fistfights.

For those patients, most of the crown is lost and only the root remains, so there is no enough ferrule in order to restore the tooth with a crown.

The most common treatment for those patients is immediate single-tooth implant. However, some problems may arise such as: high treatment expenses, the need for bone augmentation, the refill of the papilla to its normal position may be questionable in some implant cases, young growing patients, apprehensive patients, dental facilities and rural areas lacking cone beam computed tomography (CBCT) machines.

Accordingly, orthodontic extrusion may be an alternative attempt to preserve the tooth by traction of the remaining root to create a sufficient ferrule effect to restore the tooth.


Eligibility Criteria:
Inclusion Criteria:

* Patients at 20-40 years old and have no history of periodontal disease. (periodontally healthy patients).
* Single rooted teeth with adjacent intact or restored neighboring teeth, more than one tooth may be included in the same arch.
* More than 1:1 crown root ratio, so that the C/R is 1:1 after extrusion and restoration.
* Presence of intact adjacent teeth.

Exclusion Criteria:

* Badly broken-down teeth with active signs of infection.
* Teeth with vertical root fracture.
* Teeth with severely tapered roots..
* Diabetic patients, assessed by measuring glycosylated hemoglobin (HbA1c). Patients with an HbA1c level greater than 8 will be excluded.
* Potentially uncooperative patients who are not willing to go through the proposed interventions (patients who will refuse to undergo orthodontic treatment).
* Moderate-to-heavy daily smokers\* (who report consuming at least 11 cigarettes/day).
* Patients with systemic disease that may affect normal healing.
* Psychiatric problems, emotional instability, and unrealistic esthetic demands.
* History of radiation therapy to the head and neck, or bone augmentation to implant site.
* Labial cortical bone fenestration diagnosed from CBCT.
* Bruxism.
Postoperative Respiratory Depression After Cardiac Surgery

Coronary artery bypass graft surgery (CABG) is associated with postoperative respiratory depression. In this study we aimed at investigating perioperative parameters that could predict the nadir of postoperative respiratory function impairment.

Coronary artery bypass graft (CABG) surgery is a principal revascularization option for ischemic heart disease and the principal modality for invasive treatment of coronary artery disease. Postoperative pulmonary complications are the most frequent and significant contributor to length of hospitalization, morbidity and mortality. The objective of this study is to search for perioperative parameters that could predict the degree of impairment of respiratory function after CABG with cardiopulmonary bypass (CPB).

Eligibility Criteria:
Inclusion Criteria:

* patients of both sexes older than 18 years submitted to CABG with CPB, presence of coronary disease confirmed by coronary angiography, use of the left internal thoracic artery and/or saphena, patients who remained in spontaneous ventilation on the first postoperative day, absence of chronic or acute pulmonary disease, and giving written informed consent to participate in the study.

Exclusion Criteria:

* intraoperative change of the surgical technique, surgical complications or complications occurring in the ICU, emergency reoperation, renal failure, failure to agree to continue in the study, presence of other types of heart disease, and presence of pulmonary diseases.