cyrilzakka/clinical-trials huggingface dataset:
Effects of Environmental Heat Exposure on Human Multiple Organ Function

This is a randomized controlled human exposure crossover study. Investigators aims to assess the acute effects of high temperature exposure and the underlying mechanisms.

The objective of this study is to study changes in functions of multiple organs under heat exposure, which mainly include changes of cardiac function and lung function. In addition, biological samples such as blood samples, nasal fluid, and urine, etc were collected to explore changes in biomarkers such as complete blood count, liver function, kidney function, and inflammatory indicators, etc. Biochemical analysis and omics analysis were conducted to study the changes of human physiological function caused by heat exposure.

Eligibility Criteria:
Inclusion Criteria:

1. Chinese nationality（aged 18-30 years healthy males and females）;
2. With ability to read and understand Chinese smoothly;
3. Living in Jinan during the study period;
4. Body mass index ≥ 18.5 and ≤ 28;
5. Normal resting ECG；
6. Normal lung function: i. Forced vital capacity (FVC)≥80% of that predicted for gender, ethnicity, age and height; ii. Forced expiratory volume in one second (FEV1) ≥80% of that predicted for gender, ethnicity, age and height; iii. FEV1/FVC ratio≥80% of predicted values.

Exclusion Criteria:

1. Medications or dietary supplements intake that may alter body temperature during the study period;
2. Individuals who have unspecified illnesses, which in the judgment of the investigators might increase the risk associated with heat exposure will be a basis for exclusion;
3. Subjects with anemia, needle fainting and other signs unsuitable for blood drawing；
4. Subjects with cardiovascular diseases or other chronic medical condition, such as congenital heart disease, pulmonary heart disease, and hypertension, etc;
5. Subjects with a history of major cardio-vascular, respiratory, or nervous system surgery, etc;
6. Subjects with neurologic disorders, such as stroke, traumatic brain injury, epilepsy, and depression;
7. Subjects with allergic diseases, such as allergic rhinitis and allergic asthma, etc;
8. Subjects are pregnant, attempting to become pregnant or breastfeeding;
9. Subjects who are currently smoking (including vaping, hookah and e-cigarette) or have smoking history within 1 year of study (defined as more than 1 pk/yr in the past year) or have a greater than equal to a 5 pack year smoking history;
10. Subjects living with a smoker who smokes inside the house;
11. Subjects who are current drinking or have frequent alcohol use (defined as at least 1 time per week) in the past 6 months;
12. Provisional exclusion criteria, such as acute infection in the past two weeks or taking antibiotics. (Subjects can be enrolled after 2 weeks)
Pigment Dispersion Syndrome With and Without Glaucoma

To compare patients having PDS without and with OH or GL by documenting and following the clinical features and course of their disease and evaluating the patient's performance on a variety of diagnostic tests.

Pigment dispersion syndrome (PDS) is not an uncommon ocular condition and is frequently associated with myopia. There is loss of pigment from the posterior iris, seen clinically in most cases as iris transillumination with pigment deposited on the corneal endothelium, iris surface and on the angle structures overlying Schlemm's canal. In a subset of patients ocular hypertension or glaucoma may develop.

Ocular hypertension is defined as 3 separate measurements of the intraocular pressure greater than 22 mm/Hg in the absence of visual field loss. Glaucoma is defined as the presence of a characteristic field defect (Bjerrum scotoma, nasal step or arcuate scotomas) with intraocular pressures greater than 22 mm/Hg measured sometime during a diurnal curve testing.

The etiology of this condition is not known. Hypotheses include developmental abnormalities of the iris dilator muscle or mechanical rubbing of zonules against the iris, resulting in pigment dispersion in the anterior chamber and pressure elevation. PDS is then viewed as a variant of primary open-angle glaucoma or may be secondary to pigment deposited in the angle structures with secondary damage to the trabecular meshwork. A hereditary component does appear to play a role in the PDS syndrome and may also predispose to the development of glaucoma.

The purpose of this study is to evaluate and determine the risk factors that differentiate patients with PDS, PDS+OH, or PDS+GL by documenting the ophthalmic findings and following their clinical course. In order to do this, diagnostic tests including intraocular pressure and visual fields will be performed. This data may make it possible to determine the risk of patients having PDS of developing OH, GL or other possibly associated findings such as retinal detachment or cataract. In addition, patients with "pigmentary glaucoma (PG)" will be compared to those with the known characteristics of primary open-angle glaucoma (POAG) to determine whether PG is different than or a variant of POAG. When possible, family members will be examined to investigate the inheritance pattern of this syndrome and its relationship to POAG.

Eligibility Criteria:
Entrance into the study will depend upon clinical evidence of black pigment deposition on trabecular meshwork at the site of Schlemm's canal and at least one of the following: Kruckenberg spindle, pigment deposition on iris surface, or mid-stromal iris transillumination.

No patients with other ocular disease or disorders (uveitis, trauma, pseudoexfoliation, ICE syndrome, etc.)
Maveric Magnetic Resonance Imaging Used to Study Detailed Bone Apposition and Fixation of the Stryker Trident II Tritanium System

The study aims to describe bone apposition and fixation of the Trident and Trident II Tritatnium acetabular system in patients 1 year status post total hip replacement. We will be studying this by comparing magnetic resonance imaging (MRI)s taken 1 year s/p total hip replacement with a Trident II cup with MRI's taken of patients with the Trident Cup who had MRIs done at 1 year post-op.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who had a primary total hip replacement with a Stryker Trident II acetabular cup that have one year or more follow up.
2. Patients that are willing able able to have an MRI at their one year follow up visit.
3. Patients entered into the CORRe database (our HSS institutional joint replacement registry).

Exclusion Criteria:

1. Patients who have not been consented as part of the CORRe database.
2. Patients who are unable or refuse to have an MRI at their 1 year follow up.
Validation/Dissemination Of A Temporal Bone Dissection Simulator

Designed to test the efficacy of a computer based virtual simulation for teaching ear surgery.

This research is designed to test the efficacy of a computer based virtual simulation for teaching ear surgery. Subjects will be randomized to training in the usual fashion and training in the simulation environment. Subjects performance will be tested in a standard fashion by dissecting cadaveric temporal bones (human ears) before and after training. The subjects will also perform a dissection in the virtual environment before and after training. The results will be tabulated to compare the different training arms. There is minimal risk associated with the projects and is limited to exposure to cadaveric material. Current training techniques utilize cadaveric material so exposure to this type of material is already a part of the standard training process and this study should not constitute an increased risk beyond what is encountered during their regular training. Demographic information will be obtained for each of the study subject on age, sex, information regarding previous otologic training, year of training and prior experience using computers. The anticipated benefits to society will be that future otologic surgeons can obtain operative experience in a controlled and non threatening environment. They will have access to a greater number of variations in pathology. This will allow each novice surgeon to obtain significantly more experience outside the operating room prior to working with live patients. This will result in less risk to the patient and better trained ear surgeons.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in residency for ear, nose and throat training or medical student interested in ear, nose and throat training.

Exclusion Criteria:

* Not enrolled in ENT training program or interest in ENT training.
The Influence of Warm Bupivacaine on Supraclavicular Plexus Block Characteristics

Despite PH adjustment of local anesthetic solution improves the quality of the block in all respects with special advantage of early onset of sensory and motor block, adequate level of analgesia, and prolongation of duration of block, the effect of warmed bupivacaine should have the same effect which have not been evaluated on supraclavicular plexus block for upper limb surgery.

The warmed bupivacaine used in supraclavicular plexus block may reduce sensory and motor block onset and prolong the duration of analgesia when compared to bupivacaine at operating room temperature.

The aim of this study is to compare the effect of warm bupivacaine 0.5% at 37◦C versus bupivacaine 0.5% at operating room temperature at 23◦C on ultrasound-guided supraclavicular plexus block characteristics as regard sensory block onset time, motor block onset time, duration of sensory and motor block , effective duration of analgesia, total analgesics requirement, complications and side effects.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical class I or II

Exclusion Criteria:

* Patient refusal.
* Pregnancy
* Neuromuscular diseases (as myopathies, myasthenia gravies...)
* Hematological diseases
* Bleeding disorders
* Coagulation abnormality.
* Psychiatric diseases.
* Local skin infection
* Sepsis at site of the block.
* Known intolerance to the study drugs.
* Body Mass Index \> 40 Kg/m2.
* Bilateral upper limb injury to be performed at the same procedure.
Etomidate to Improve Outcome in Elderly Patients

Elderly patients have high mortality and postoperative complications rate after surgery, especially postoperative cardiac complications. A meta-analysis revealed haemodynamic intraoperative events significantly increased the risk of postoperative cardiac complications.To limit the risk, optimize the intraoperative management of circulation is essential. Anesthetic drug may effect on the haemodynamic intraoperative, reduction of postoperative complications should aimed at choosing the optimal anesthetic drug with minimal effect on haemodynamic.So this study is to explore the comparative efficacy and safety of anesthetic drug (etomidate or propofol) in elderly patients


Eligibility Criteria:
Inclusion Criteria:

* Aged between 65 and 80 years old.
* Patients scheduled for elective gastrointestinal surgery under general anesthesia.

Exclusion Criteria:

* Expected duration of surgery \< 1 or \>4 hours
* American Society of Anesthesiologists status \>III
* Body Mass Index \< 18 kg/m2 or\> 25 kg/m2
* Cerebrovascular accident occurred within the previous 3 months,such as stroke or transient ischemic attack
* Unstable angina and myocardial infarction occurred within the previous 3 months
* Patients with serious hepatic dysfunction ( the serum level of alanine transaminase, conjugated bilirubin, aspartate transaminase, alkaline phosphatase or total bilirubin is 2 folds more than upper normal limit) or renal dysfunction(creatinine clearance rate less than 30 milliliter per minute).
* Diabetic patients with complication (diabetic ketoacidosis, hyperosmotic coma,all kinds of infection, macroangiopathy, diabetic nephropathy, retinopathy, diabetic cardiomyopathy, diabetic neuropathy, diabetic foot).
* Preoperative blood pressure more than or equal to 180/110 mmHg
* Confirmed or suspected of narcotic analgesics abusing or long term using
* Taking corticosteroids or immunosuppressive agents for more than 10 days with the previous 6 months or had history of adrenal suppression or immune system disease.
* Patients with thyroid hypofunction.
* Patients with history of asthma.
* Patients with history of surgery within previous 3 months.
* Patients allergic or contraindicated to propofol or etomidate
* Patients participated in other study within the last 30 days
Celiac Disease: Nutrition Education in Primary School

Celiac disease is a chronic immune-based intestinal pathology. Its prevalence is 1% and its incidence has increased in recent years. This disease usually causes gastrointestinal and/or extraintestinal symptoms, which can only be reduced by following a strict, lifelong gluten-free diet. In addition, the social life of people with celiac disease is impaired due to the impact of the gluten-free diet on daily activities.

An adequate Nutrition Education program can improve the physical and social health of these people. Moreover, considering the high impact this disease has on the people close to the celiac patient, and due to the important role that general population has in the care and inclusion of persons with celiac disease, education should be directed to general population.

Therefore, the purpose of ZELIAKIDE program is to promote Nutrition Education in general population. In particular, the specific aims are 1) to promote the social inclusion of people with celiac disease by raising awareness among the general population, and 2) to promote a balanced diet and an interest in science and research among children.

ZELIAKIDE is an intervention aimed at children and focused on the school environment, and is based on Inquiry Based Learning (IBL) methodology. Inquiry-based Teaching-Learning Sequence (TLS) has been created to internalize and integrate competences related to celiac disease, gluten, gluten-free diet, balanced diet and healthy lifestyle.

In addition, this TLS aims to develop scientific competence through activities that promote science and the research process.

Although nutrition education programs for children have proven to be effective, it has been observed that children's interest in science has decreased. The investigators therefore aim to implement a nutrition education programme based on previous experiences that promotes science skills and stimulates children's interest in science.


Eligibility Criteria:
Inclusion Criteria:

* School must show interest in participating in the project.
* Children study in a primary school that must be used to project based learning.
* Have at least one class in grades 5th and 6th level of primary school.

Exclusion Criteria:

* Family or closed relationship with school students.
Standard Versus High-Dose Trivalent Inactivated Flu Vaccine in Pediatric Acute Lymphoblastic Leukemia Patients

This is a phase I safety and immunogenicity trial comparing high-dose (HD)trivalent inactivated influenza vaccine (TIV) to standard dose (SD) TIV in pediatric patients with Acute Lymphoblastic Leukemia.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients with standard or high risk Acute Lymphoblastic Leukemia.
* Must be in 1st complete remission.
* Must be 4 weeks into maintenance therapy.
* 17 years of age, inclusive.
* Available for duration of study.

Exclusion Criteria:

* History of hypersensitivity to previous influenza vaccination or hypersensitivity to eggs/egg protein.
* History of Guillain-Barre syndrome.
* Evidence of relapsed disease.
* Have any condition that would, in the opinion of the site investigator, place them at an unacceptable risk of injury or render them unable to meet the requirements of the protocol.
* Have any condition that the investigator believes may interfere with successful completion of the study.
* History of receiving 2010 - 2011 influenza vaccine.
* Pregnant female.
* History of proven influenza disease after September 1, 2010.
Comparison of Vascular Function in Emergency Service Professionals

Emergency Service Professionals have an increased risk of death from heart attacks when compared to the general public. All the emergency professions share similar responsibilities such as emergency call-outs and shift work. Heart disease is the commonest cause of on-duty death amongst fire-fighters accounting for 45% and compared with 22% in police officers and 15% in the general population. The unique risk to fire-fighters is likely to reflect a combination of factors including extreme physical exertion, mental stress, heat and pollutant exposure.

In this study the investigators will assess healthy career fire-fighters and age-matched healthy police officer control subjects following a sedentary period. The investigators will take blood samples to measure platelet activity (platelets are the particles in blood that help blood clot) and will examine how blood clots outside of the body. The investigators will then perform studies placing small needles in the arm to assess how the blood vessels respond following these duties. The investigators hypothesise that fire-fighters do not have pre-existing impairment of heart, blood or blood vessel function as a cumulative effect of their occupation, but rather these are acute and transitory effects following distinct fire-fighter duties. We therefore expect similar results in both occupational groups.


Eligibility Criteria:
Inclusion Criteria:

* Non-smoking healthy firefighters

Exclusion Criteria:

* Current smoker
* History of lung or ischaemic heart disease
* Malignant arrhythmia
* Systolic blood pressure \>190mmHg or \<100mmHg
* Renal or hepatic dysfunction
* Previous history of blood dyscrasia
* Unable to tolerate the supine position
* Blood donation within the last 3 months
* Recent respiratory tract infection within the past 4 weeks
* Routine medication including aspirin and NSAIDs
Controlled Study of Stage 3 Osteonecrosis Treatment by Bone Marrow

In stage 3 Osteonecrosis (ON) of the femoral head, a beneficial effect of bone marrow grafting was reported with a reduction of the functional evolution and the necessity of a total prosthesis placement in a non-controlled retrospective trial. Based on this experience, the investigators would like to start a randomized controlled double blind study on the effect of autologous implantation of autologous bone marrow cells into the necrotic lesion of stage 3 ON of the femoral head.


Eligibility Criteria:
Inclusion Criteria:

1. patients who have a non traumatic ON of the femoral head
2. Stage 3 ON (subchondral fracture).
3. Age \> 18 years
4. Be able and willing to participate in the study

Exclusion Criteria:

1. evidence of malignant disorder in the past five years
2. Patient unable to undergo a MRI.
3. Patient who is positive for an HIV, hepatitis B or C infection.
Impact of Non-magnetic Screen Respiratory Self-guidance During MRI-guided Radiotherapy Sessions for Mobile Lesions

The patients eligible for the study are those treated by radiotherapy on Linac MRI for a mobile cancerous lesion (pancreas, liver, kidneys, adrenals, lung, adenopathy above or below the diaphragm ...).

After signing the consent form, each patient will be randomized to one of two treatment arms:

* Standard arm : Radiotherapy treatment with Linac MRI without non-magnetic shielding
* Experimental arm : radiotherapy treatment with Linac MRI with non-magnetic screen The aim is to evaluate the effect of using a non-magnetic screen visible to the patient in the bunker during radiotherapy sessions delivered by Linac MRI on decreasing the ratio between the actual treatment time and the treatment time predicted by the machine.

The patients eligible for the study are those treated by radiotherapy on Linac MRI for a mobile cancerous lesion (pancreas, liver, kidneys, adrenals, lung, adenopathy above or below the diaphragm ...).

After signing the consent form, each patient will be randomized to one of two treatment arms:

* Standard arm : Radiotherapy treatment with Linac MRI without non-magnetic shielding
* Experimental arm : radiotherapy treatment with Linac MRI with non-magnetic screen

The aim is to compare the effect of the non-magnetic screen on the blocking of the patient's breathing versus the current procedure (the blocking of the breathing is informed by the staff)

The patients will each receive 5 sessions of radiotherapy on Linac MRI. 100 patients are expected to participate in this study

Before each session will be assessed for anxiety and stress. After each session will be evaluated patient satisfaction, pain intensity and respiratory effort.

The duration of the treatment and therefore of the follow-up of the patient in the study is 1 to 2 weeks

Eligibility Criteria:
Inclusion Criteria:

* Patient is at least 18 years old
* Patient starting radiotherapy on Linac MRI for a mobile cancerous lesion most often in the pancreas, liver, kidneys, adrenals, lung, supra or subdiaphragmatic adenopathy
* Patient affiliated to the social security system

Exclusion Criteria:

* Patient with lesions not detected by the device's tracking system
* Patient with visual disturbances
* Contraindications to treatment with Linac MRI (epileptic patients, pregnant or breastfeeding women, metallic prosthesis or pacemaker not compatible with MRI)
* Patients with cognitive disorders
* Persons deprived of liberty or under guardianship (including curatorship)
* Pregnant or nursing woman
* Refusal to participate in the study
Clinical Comparison of Two Daily Disposable Toric Lenses

The purpose of this trial was to compare the performance of two contact lenses commercially available for people with astigmatism.

This trial compared the performance of two commercialized daily disposable contact lenses in Germany.

Eligibility Criteria:
Inclusion Criteria:

* Sign written informed consent.
* Germany: Be of legal age.
* Current monthly or weekly toric soft lens wearer able to be fit in both eyes with soft toric lenses in the study parameters.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Eye injury or surgery within twelve weeks.
* Pre-existing ocular irritation that would preclude contact lens fitting.
* Currently enrolled in an ophthalmic clinical trial.
* Wears contact lenses overnight while sleeping.
* Habitual daily disposable contact lens wearer.
* Monovision correction during the study.
* Other protocol-defined exclusion criteria may apply.