cyrilzakka/clinical-trials huggingface dataset:
Study of I-125 Brachytherapy Versus Intensity-modulated Radiation Therapy to Treat Inoperable Salivary Gland Cancer

* To compare the efficacy of Iodine-125 radioactive seeds implantation versus IMRT to treat inoperable salivary gland carcinoma.
* To compare the safety of Iodine-125 radioactive seeds implantation versus IMRT to treat inoperable salivary gland carcinoma.

The target population are those patients with inoperable salivary gland derived primary or recurrent cancer, including local advanced primary salivary gland cancer which could not be resected completely; recurrent salivary gland cancer which could not be resected completely; T3/T4 tumor which could not tolerate surgery due to severe combined disease. The subjects would be divided into Iodine-125 radioactive seeds permanent interstitial implantation brachytherapy and intensity-modulated radiation therapy randomly. During the follow-up period, the efficacy and the safety index would be monitored.

Eligibility Criteria:
Inclusion Criteria:

* Patients are diagnosed histologically as primary or recurrent salivary gland cancers that may occur in either major salivary glands or minor salivary glands.
* The inoperable circumstance include: Primary or recurrent salivary gland cancers that could not be resected completely or could not get negative incision.
* T3/T4 tumor patients with severe medical comorbidities could not accept the high risk of perioperative complications.
* At least one measurable tumor or focus (according to RESIST 1.1 Standard).
* Karnofsky score\> 60.
* Survival time predicted ≥ 3months;
* HGB≥9 g/dL, WBC≥3.0×10\^9/L, NEUT≥1.5×10\^9/L, platelet count (PLT)≥ 100×10\^9/L; TBIL≤1.5 upper limit of normal, Alanine aminotransferase (ALT)/AST≤3 upper limit of normal; Cera≤1.5 upper limit of normal.
* Male or female with fertility in the experiment are willing to take contraceptive measures.

Exclusion Criteria:

* Radioactive therapy history of head and neck.
* Suffering from other malignant tumor in recent five years, except skin basal cell carcinoma or carcinoma in situs of cervix.
* Chemotherapy history.
* Receiving other effective therapy.
* Distant metastases.
* Pathologic result as squamous cell carcinoma.
* Neurological or mental abnormalities which affect cognitive ability.
* Severe cardiovascular and cerebrovascular diseases, such as heart failure (NYHA III-IV class), uncontrolled coronary heart disease, cardiomyopathy, uncontrolled arrhythmias, uncontrolled hypertension, myocardial infarction or cerebral infarction within past six months.
* Active serious clinical infections :\> Class 2 NCI-Common Toxicity Criteria for Adverse Effects (CTCAE) Version 4.0 within 14 days before randomization, including active tuberculosis.
* HIV infection or active hepatitis B or hepatitis C.
* Uncontrolled systemic diseases, such as poorly controlled diabetes mellitus.
* Medical history of interstitial lung disease, such as interstitial pneumonia, pulmonary fibrosis, or baseline chest X-ray / CT showed evidence of interstitial lung disease;
* Pregnancy (via urine β-human chorionic gonadotropin test to determine) or breastfeeding.
Safety, Tolerability and Pharmacokinetic Profile of M108 Monoclonal Antibody in Patients With Advanced Unresectable Solid Tumors in China

M108 is a monoclonal antibody specific for gastric and gastroesophageal adenocarcinomas. The aim of this phase I study is to establish safety and Tolerability of different Dosage regimen in patients With Advanced Unresectable Solid Tumors in China.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent.
2. Advanced Unresectable solid tumors proven by histology
3. At least 1 measurable site of the disease according RECIST 1.1 criteria
4. ECOG performance status (PS) 0-1
5. Life expectancy \> 3 months
6. Age ≥ 18 years and ≤75 years
7. Adequate haematological function; absolute neutrophil count ≥1.5 x 109/L; white blood cell count ≥3.0 x 109/L; platelets ≥100 x 109/L; haemoglobin ≥9 g/dL.
8. Adequate coagulation function; international normalized ratio ( INR) ≤ 1.5 x upper limit of normal (ULN), or activated partial thromboplastin time (APTT) ≤ 1.5 x ULN.
9. Adequate hepatic function; bilirubin ≤1.5 x ULN, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) ≤2.5 x ULN.
10. Adequate renal function; creatinine ≤1.5 x ULN, or reatinine clearance rate ≥60 mL/minute calculated.

Exclusion Criteria:

1. Previous received or planned to be vaccinated with 2019-nCoV vaccine or other vaccines within 3 months prior to the start of study treatment or during the study or within 3 months after the end of the study;
2. Previous radiotherapy within 4 weeks prior to the start of study treatment. (if palliative radiotherapy was given to bone metastatic side peripherally and the patient recovered from acute toxicity was allowed).
3. Previous anti-tumor therapy within 4 weeks prior to the start of study treatment.
4. Previous major operation within 8 weeks prior to the start of study treatment.
5. Prior severe allergic reaction or intolerance to a monoclonal antibody, including humanised or chimeric antibodies.
6. Symptomatic cerebral metastases.
7. Uncontrolled or severe illness.
8. Known human immunodeficiency virus infection or known symptomatic hepatitis
9. Other clinically significant disease which may have adversely affected the safe delivery of treatment within this study
Comparison Between Bare Scleral Technique and Conjunctival Auto-graft on Corneal Topography After Pterygium Surgery

Aim of the work:

To study the corneal topographic pattern changes in patients who have pterygium excision by two surgical techniques (bare sclera, conjunctival autograft).

Pterygium is one of the common ocular surface disorders , it's is an elastotic triangular fibro-vascular tissue covered by conjunctival epithelium that spreads over the cornea. Pterygium causes differences in curvature \& power across the cornea .

The prevalence of pterygium varies from 1.1% to 53% globally in different environmental conditions. Risk factors include;UV radiation, geographical latitude near to the equator, outdoor activity , aging, male, and dusty environment.

Pterygium excision is important in patients suffering from blurred vision due to astigmatism . Surgical techniques include ; bare sclera excision, conjunctival autograft, conjunctival transpositional flap, and amniotic membrane grafting. Pterygium excision increases in the mean central corneal curvature \& reduces astigmatism that leads to improvement in visual acuity.

Corneal topography is a gold standard in corneal pathology follow-up. Corneal topography is a computer assisted diagnostic tool that creates a three-dimensional map of the surface curvature of the cornea. Corneal topography produces a detailed, visual description of the shape and power of the cornea.

In this study , corneal topography is used to detect how does corneal curvature change after excision of pterygium .

Eligibility Criteria:
Inclusion Criteria:-

* Patients with pterygium not associated with other pathologies (suitable for excision).
* Nasal pterygium extended to the cornea.

Exclusion Criteria: -

* Associated pathologies such as glaucoma, and cataract.
* Corneal opacities or irregularities, scars, dystrophy or ectasia.
* Patients who underwent previous corneal surgery (including refractive surgery)
* Pseudo-pterygium.
Cognitive Rehabilitation in Pediatric Acquired Brain Injury

Acquired brain injury (e.g., traumatic brain injury, brain tumour, brain infections) is one of the leading causes of death and disability for children and adolescents. Importantly, injuries affecting the brain in childhood or adolescence appear during a time of development when the brain is particularly vulnerable. Thus, pediatric acquired brain injury does not only impact cognitive functions at the time of injury or onset of disease, but also cognitive functions that are yet to develop. Changes in cognitive function, and in particular executive dysfunction due to acquired brain injury, cause significant real-life disability, yet solid evidence in support of executive functioning interventions for children and adolescents is lacking. In the present study different group-based cognitive rehabilitation interventions will be compared. The aim of the study is to investigate if a group-based "brain training" intervention is able to improve executive function in children and adolescents after acquired brain injury. Efficacy will be assessed immediately after intervention, but also six months after the intervention. The project is in line with international research efforts aimed at establishing more knowledge about how children and adolescents with brain injuries respond to cognitive rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed with traumatic brain injury, brain tumor or damage by inflammation in the brain
* more than 12 months since injury/illness or more than 12 months since ended cancer therapy
* evidence of executive dysfunction in everyday life

Exclusion Criteria:

* cognitive, sensory, physical, or language impairment affecting the capacity to attend mainstream school and/or complete the training program
* pre-injury neurological disease or psychiatric disorder
* recently detected brain tumor relapse
* unfit for evaluation of outcome (independent evaluation by 2 investigators)
* not fluent in Norwegian language
Flavanol-Rich Cocoa and Cerebral Blood Flow

The purpose of the study is to learn whether or not cocoa has a beneficial effect on blood flow to the brain in older subjects with diabetes mellitus or hypertension (high blood pressure). We hypothesize that cocoa, which contains flavanols (a type of polyphenol), may help to promote blood flow to the brain in older people with diabetes or hypertension.


Eligibility Criteria:
Inclusion Criteria:

* diabetes and/or hypertension

Exclusion Criteria:

* alzheimers disease, dementia, stroke, recent angina or heart attack
Cerebral Artery Stenosis, Coronary Artery Disease and Arrhythmia

There are many reports about the association of coronary artery disease (CAD) and cerebral artery stenosis (CAS), which had been proved to induce stroke and cognition decline after the revascularization including coronary bypass surgery (CABG) or percutaneous coronary intervention. Perfusion defect on nuclear brain scan is also noted to correlate with these neurological complications. On the other hand, the perioperative arrhythmia and following cerebral embolism was also attributed to be one factor inducing such neurological hazards.

In the patients with coexistent CAD and CAS (1st group), and also the patients scheduled for CABG or percutaneous coronary intervention (PCI) (2nd group), we, the researchers at Far Eastern Memorial Hospital, attempted to integrate all the parameters mention above, including angiography of coronary and cerebral system, quantitative analysis of nuclear brain scan, biochemical profile, and signals of a new ambulatory device which could record the electrocardiograph (ECG) and electroencephalograph (EEG) simultaneously, in order to define the correlation between them. A chorological relation between EEG signals and ECG signals is our first target to be worked out. Thereafter, we hope to establish a regression model of all involved parameters according to the relation. Such a model, we believe, is essential not only to explain the post-CABG neurological complications, but to prevent them.

Furthermore, for the undetermined ischemic stroke patients who had no obvious culprit artery or embolism source, the paroxysmal arrhythmia had long been regarded as the cause. Whether a paroxysmal atrial fibrillation, which had not been disclosed by routine ECG, could induce most of such a stroke is still not known. With this new ambulatory device which could record the electrocardiograph (ECG) and electroencephalograph (EEG) simultaneously, we want to answer the question.


Eligibility Criteria:
Inclusion Criteria:

* Coronary artery stenosis \>50% and either carotid or brain artery stenosis \> 50%

Exclusion Criteria:

* Creatinine \> 2.0 mg/dL
* Co-morbidity
* ER
* A letter of authorization is not given
Metabolic Causes of Thrombosis in Type 2 Diabetes - Question 4

Hypoglycemia (low blood glucose level) occurs frequently in intensively treated patients with diabetes. Although hypoglycemia was thought to occur almost exclusively in T1DM, with the advent of improved metabolic control in T2DM, the incidence of hypoglycemia is rising in these patients. Therefore in this application, we will test the novel hypothesis that prior hypoglycemia will result in (cardiovascular complications) during subsequent hypoglycemia.

This study will test the hypothesis that 1) hypoglycemia causes a prothrombotic state and defective endothelial function and 2) episodes of repeated hypoglycemia will result in greater impairments of endothelial function and an increased prothrombotic tendency. Preliminary data in healthy men demonstrates that hypoglycemia can dramatically increase PAI-1 levels and the PAI-1 to tPA ratio, thereby creating a prothrombotic state. Whether this also occurs in type 2 DM patients is unknown. Furthermore, the effects of hypoglycemia on endothelial function in T2DM are also unknown.

Eligibility Criteria:
Inclusion Criteria

* 14 (7 female/ 7 male) Type 2 diabetic patients age 18-60 yrs
* 14 (7 female/ 7 male) Non-diabetic controls age and weight matched
* Body mass index \>20 kg/m2
* Normal results of routine blood test to screen for hepatic, renal, and hematological abnormalities
* Female volunteers of childbearing potential: negative HCG pregnancy test
* Volunteers over 40 years old: normal baseline cardiac stress test
* For those with type 2 diabetes: HBA1C \>5.5%
* For those with type 2 diabetes: diabetes \< 20 years
* For those with type 2 diabetes: C-peptide \>0.2 nmol (1.1-4.4 ng/ml). If c-peptide is abnormal or there is a clinical suspicion of type 1 diabetes, MODY, or LADA, Anti-Islet cell (negative) and Glutamic Acid Decarboxylase (GAD) antibody negative (0.0-1.5 U/ml) will be performed

Exclusion Criteria

* Uncontrolled hypertension
* History of cerebrovascular incidents
* Pregnancy
* Subjects unable to give voluntary informed consent
* Subjects with a recent medical illness
* Subjects on anticoagulant drugs, anemic, or with known bleeding diseases
* Tobacco Use

Physical Exam Exclusion Criteria

* Blood Pressure greater than 150/95
* Clinically significant Cardiac Abnormalities (e.g. Heart Failure, Arrhythmias, ischemic tachycardia, S-T segment deviations, ect.) from history or from cardiac stress testing
* Pneumonia
* Hepatic Failure/Jaundice
* Renal Failure
* Acute Cerebrovascular/ Neurological deficit
* Fever greater than 38.0 C

Screening blood tests exclusions according to protocol
Genetics of Familial and Sporadic ALS

We are collecting blood samples, clinical and family information from ALS (amyotrophic lateral sclerosis) patients and their families to identify causes of ALS and ALS/dementia.

The investigators' long term goals are to improve diagnosis and develop effective treatments that arrest or ameliorate symptoms of ALS, and possibly delay or prevent disease onset in individuals at risk for developing familial ALS (FALS). In order to do this one must understand how disease develops at a molecular level. Identification of genes that increase risk for developing all types of ALS will reveal the pathways of molecular events that are involved in ALS.

The investigators are collecting blood samples, family and medical histories of patients with all types of ALS, (familial and sporadic, with and without frontotemporal dementia, and primary lateral sclerosis and particular family members. Samples are coded to maintain confidentiality. Travel is not necessary.

As well as seeking to identify new genes implicated in ALS, the investigators continue our study of families with known genetic mutations to more fully characterize that disease mechanism.

Linkage analysis and affected relative pair analysis will be used to identify causative FALS genes and disequilibrium analysis and association studies are being done for sporadic ALS.

Results from these studies will provide insight into the underlying disease mechanisms of ALS and provide targets for therapeutic interventions.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Amyotrophic Lateral Sclerosis or ALS and frontotemporal dementia
* Selected family members, generally brothers and sisters of an ALS patient, the patient's parents

Exclusion Criteria:

* Under 18 years old
Monitoring of Exhaled Carbon Monoxide to Promote Pre-operative Smoking Cessation

Smoking causes 90% of all lung cancer deaths among men and 80% of lung cancer deaths in women. Surgery is a great opportunity to help patients quit smoking. Smokers are at increased risk for heart, lung, and wound complications around the time of surgery. Even a brief abstinence from smoking can produce benefits. Surgery can also motivate smokers to quit spontaneously. If the investigators can take advantage of this great opportunity, they may be able to help many smokers quit using simple means. However, currently most smokers continue to smoke cigarette on the morning before surgery, as shown by the measurement of exhaled carbon monoxide (CO) on the morning of surgery. CO is one of the many poisons in cigarette smoke. It only stays in the body for a few hours. By asking smokers to blow into a small machine, the investigators can test the CO level in the smokers' body and thus know if they have just smoked within the past few hours. The goal of this study is to determine the role of carbon monoxide monitoring as a means to decrease cigarette smoking before surgery. The investigators will identify a group of smokers who are scheduled for surgery and invite them to participate. One or two days before surgery, half of the patients will receive a brief advice about quit smoking. The other half of patients will be told that their CO will be checked before surgery, in addition to the brief advice. On the morning of surgery, the investigators will then check their CO level to determine if they have followed the advice. In order to have a better understanding about the factors influencing patients' intent to quit smoking, the investigators will ask all study participants to fill out a questionnaire. The questionnaire is constructed according to behavioral theories which provide good framework for studying people's intent and behavior. If the investigators are successful, they will determine how much of an impact the message of CO testing has on smoking before surgery. The investigators will also gain insights into facilitators and barriers to smoking cessation around the time of surgery. The brief intervention evaluated in this study has potential to be disseminated and to promote the long term health of surgical patients.


Eligibility Criteria:
Inclusion Criteria:

1. Patients ≥ 18 yrs. scheduled for elective non-cardiac surgery at Mayo Clinic Rochester;
2. Current smoking, defined as \> 100 cigarettes lifetime consumption and self-report of smoking every day.

Exclusion Criteria:

1. An inability to understand consent procedures;
2. Inability to complete a written questionnaire.
Trial of a Limited Versus Traditional Oxygen Strategy During Resuscitation in Premature Newborns

Preterm infants are born with immature lungs and often require help with breathing shortly after birth. This traditionally involves administering 100% oxygen. Unfortunately, delivery of high oxygen concentrations leads to the production of free radicals that can injure many organ systems. Term and near-term newborns deprived of oxygen during or prior to birth respond as well or better to resuscitation with room air (21% oxygen) compared to 100% oxygen. However, a static concentration of 21% oxygen may be inappropriate for preterm infants with lung disease.Purpose of the study is to investigate if preterm neonates where resuscitation is initiated with 21% fiO2 and adjusted to meet transitional goal saturations (Limited oxygen strategy or LOX) would have less oxidative stress as measured by the oxidative balance ratio of biological antioxidant potential/total hydroperoxide compared to infants where resuscitation is initiated with pure oxygen and titrated for targeted saturations of 85-94% (Traditional oxygen strategy or TOX). Secondary outcomes of interest included need for other delivery room resuscitation measures, respiratory support and ventilation/oxygenation status upon neonatal intensive care unit (NICU) admission, survival to hospital discharge, bronchopulmonary dysplasia and other short-term morbidities.


Eligibility Criteria:
Inclusion Criteria:

* Inborn
* Gestation age 24 0/7 to 34 6/7
* Need for active resuscitation

Exclusion Criteria:

* Prenatally diagnosed cyanotic congenital heart disease
* Non-viable newborns
* Precipitous delivery and resuscitation team not present in the delivery room to initiate resuscitation
Correlation Salivary Cortisol and Free Serum Cortisol to Total Serum Cortisol in MICU Septic Shock

The purpose of the study is:

* to correlate salivary cortisol to free serum cortisol (as salivary cortisol is considered to be almost complete free cortisol) and,
* to correlate free serum cortisol to total serum cortisol levels

Both in patients with septic shock (severe sepsis requiring vasopressors).

We believe that:

* total serum cortisol does not correlate with free serum cortisol in patient with septic shock and,
* that salivary cortisol correlates with free serum cortisol and can be used to determine the level of free serum cortisol.

Free serum cortisol is considered the active hormone.

In patients with septic shock only the total serum cortisol level is available, however, the free cortisol level can be normal despite a low total cortisol level due to changes in the serum protein.

The hormone can be replaced improperly in these patients and contribute to poor outcome in septic shock.

We are studying adult MICU patients with septic shock who are not receiving corticosteroid replacement.

This study does not include any intervention.

In-hospital or 28-day mortality are registered in all the patients.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with septic shock

Exclusion Criteria:

* Corticosteroid replacement
* Blood in mouth
Effect of Hypnosis on Dyspnea

The purpose of this protocol is to test the effect of hypnosis on laboratory dyspnea.

This is a study of permissive suggestion in two laboratory models of dyspnea ("work/effort", "air hunger"). Breathing discomfort rating induced by laboratory models of dyspnea will be assessed before, during and after hypnosis.

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers

Exclusion Criteria:

* pregnancy
* ongoing pain
* respiratory disease
* high levels of depression, panic disorder, or other significant mental health problems
* not fluent in french