cyrilzakka/clinical-trials huggingface dataset:
Nutriomics and Artificial Intelligence Nutrition Obesity Cohort

The purpose of this study is to establish a prospective cohort. From registration to the 5th year, basic investigation, specific examinations for cardiovascular and metabolic disease, basic blood tests, collection of human material samples, and clinical event follow-up are conducted yearly. The obese group will be examined yearly, and telephone follow-up will be conducted if necessary. The control group will participate in the baseline survey once enrollment and clinical event follow-up by phone will be conducted annually thereafter. From the 6th year, only clinical event follow-up will be conducted.

The obese group will enroll 500 people within 1 year of study initiation and follow-up annually. The control group will enroll 30 patients a year for 5 years.

Eligibility Criteria:
Inclusion criteria for the obese group

1. Adults 19 years of age or older
2. Obese patients with chronic diseases such as cardiovascular disease, hypertension, diabetes, and metabolic syndrome (BMI ≥ 25 kg/m2, \[BMI ≥ 30 kg/m2, including 10% or more\])

Inclusion criteria for the control group

1. Adults 19 years of age or older
2. Those with BMI 18.5\~24.9 kg/m2

Exclusion criteria for the obese group

1. Serious non-cardiovascular disease with life expectancy less than 6 months
2. Pregnant or suspected of being pregnant or are lactating
3. Patients within 3 months of organ transplantation
4. Patients currently being treated for acute transplant rejection
5. Patients treated for acute coronary syndrome (myocardial infarction, unstable angina) and discharged within 6 months
6. Patients with acute cerebral infarction within 6 months of being hospitalized and discharged
7. Type 1 Diabetes
8. Patients taking steroids, female hormones
9. Those who have difficulty using smartphones

Exclusion criteria for the control group

1. Serious non-cardiovascular disease with life expectancy less than 6 months
2. Pregnant or suspected of being pregnant or are lactating
3. Persons who are continuously taking medications prescribed by a doctor due to chronic diseases excluding hypertension and dyslipidemia
4. Within 5 years of diagnosis of malignant tumor
5. Those who have difficulty using smartphones
ENDOvascular Interventions With AngioMAX: The ENDOMAX Trial

The primary objective of the study is to test whether anticoagulation with bivalirudin results in fewer major bleeding complications compared with unfractionated heparin (UFH) in participants undergoing peripheral endovascular interventions (PEI). The secondary objective is to test whether there were potential benefits from bivalirudin therapy on other clinically important events such as death, myocardial infarction (MI), stroke and/or transient ischemic attack (TIA), amputation, unplanned repeat revascularization (URV), and minor bleeding, as well as potential economic benefits that may result from improved clinical outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Participants ≥ 18 years of age
* Must be undergoing one of the following PEI procedures:

  * Carotid artery stenting
  * Lower Extremity Interventions (LEI) for Critical Limb Ischemia
  * LEI for claudication
* Provide written informed consent prior to any study-specific procedure being performed

Exclusion Criteria:

* Any known contra-indication to the use of bivalirudin or UFH
* Acute limb ischemia
* Planned amputation regardless of the outcome of the PEI
* Dialysis dependent
* Weight less than 38 kg or more than 202 kg
* History of any bleeding diathesis or severe hematological disease
* History of intra-cranial: mass, aneurysm, arteriovenous malformation or hemorrhage
* Gastrointestinal or genitourinary bleeding within the 30 days prior to randomization
* Any surgery (excluding punch or shave skin biopsy) within the 30 days prior to randomization
* Concomitant percutaneous coronary intervention
* Any percutaneous coronary, endovascular, or structural heart disease procedure within 30 days prior to randomization
* International normalized ratio \>1.7 within 24 h prior to the index procedure
* Administration of therapeutic doses of UFH within 30 min prior to the index procedure (a low dose \[≤2000 U\] of heparin is permitted during the diagnostic angiogram prior to the intervention)
* Administration of enoxaparin within 8 h; other low molecular weight heparins or fondaparinux within 24 h; any oral anti-Xa or antithrombin agent within 48 h; or thrombolytics, glycoprotein inhibitors, or warfarin within 72 h prior to the index procedure
* Severe contrast allergy that cannot be pre-medicated
* Procedures performed by radial access when they are intended as the primary access site for the index procedure
* Known or suspected pregnant women or nursing mothers
* Previous enrollment in this study (MDCO-BIV-12-03)
* Participation in other investigational drug or device trials within 30 days prior to randomization
* Participants who, for any reason, are deemed by the investigator to be inappropriate for this study
Detection of Immunotoxic Gluten Peptides in Feces

The purpose of this study is to monitor of gluten-free diet compliance in celiac patients by assessment of gliadin 33-mer equivalent epitopes in feces.

Certain immunotoxic peptides from gluten are resistant to gastrointestinal digestion and can interact with celiac patient factors to trigger immunological response. Gluten-free diet (GFD) is the only effective treatment for celiac disease (CD) and its compliance should be monitored to avoid accumulative damage. However, practical methods to monitor diet compliance and to detect the origin of an outbreak of celiac clinical symptoms are not available.

This study assesses the capacity to determine the gluten ingestion, and to monitor the GFD compliance in celiac patients by detection of gluten and gliadin 33-mer equivalent peptidic epitopes in human feces.

Eligibility Criteria:
Inclusion Criteria:

* Celiac patient
* 1-12 years old
* Written informed consent

Exclusion Criteria:

* Known inflammatory bowel diseases
* Participation in any other studies involving investigational concomitantly or within two weeks prior to entry into the study and during the course of the study
Subjective Ageing in Fibromyalgia

Subjective age or felt age is the term used for how the person feels; one can feel same, younger or older than their actual age. Feeling younger or feeling older may be associated with depression, anxiety, fatigue, sleep, quality of life or cognitive function.

In this cross-sectional study, the investigators hypothesized that fibromyalgia patients mostly feel older than their actual age and this felt age may be associated with depression, anxiety, fatigue, sleep, quality of life or cognition. After power analysis, study sample calculated as 262 patients, the present study will use 2016 revised American College of Rheumatology criteria to diagnose fibromyalgia.

Eligibility Criteria:
Inclusion Criteria:

* Fibromyalgia diagnosis using 2016 revised American College of Rheumatology
* aged \>18 years old
* Widespread pain more than 3 months

Exclusion Criteria:

* Any disease that can cause depression, anxiety, fatigue, poor sleep quality or poor cognitive function except from fibromyalgia.
EF5 to Evaluate Tumor Hypoxia in Patients With High-Grade Soft Tissue Sarcoma or Mouth Cancer

This laboratory study is using EF5 to evaluate tumor hypoxia in patients with high-grade soft tissue sarcoma or mouth cancer. Using the drug EF5 to measure the oxygen level in tumor cells may help in planning cancer treatment

PRIMARY OBJECTIVES:

I. Determine biologically-relevant hypoxia by imaging and cellular analysis of EF5 binding in patients with high-grade soft tissue sarcoma of the trunk or extremity or squamous cell carcinoma of the oral cavity.

II. Determine the spatial relationships between EF5 binding and various tumor tissue markers, pathological processes, and serum plasminogen activator inhibitor-1 in these patients.

III. Correlate EF5 binding with Eppendorf electrode measurement and patient-related factors in these patients.

IV. Determine the adjusted and unadjusted associations between clinical outcome and optimal measures of EF5 binding, patient/tumor characteristics, and biological markers in these patients.

OUTLINE:

Approximately 24-48 hours prior to surgical resection or biopsy, patients receive EF5 IV over no more than 2½ hours. Tissue samples are analyzed by immunohistochemistry for EF5 binding. Blood samples are analyzed for genetic markers and cytokines associated with hypoxia and EF5 concentration.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed high-grade soft tissue sarcoma (STS) of the trunk or extremity or squamous cell carcinoma of the oral cavity for which surgical biopsy or resection is standard initial therapy

  * Clinical imaging of mass that is likely to be STS or squamous cell carcinoma of the head and neck allowed if surgery is indicated prior to definitive diagnosis
* Planned resection and standard oncologic treatment
* No known distant metastatic disease
* ECOG 0-2
* WBC at least 2,000/mm\^3
* Platelet count at least 100,000/mm\^3
* Bilirubin less than 2.0 mg/dL
* Creatinine less than 2.0 mg/dL OR creatinine clearance at least 50 mL/min
* No significant cardiac condition that would preclude study compliance
* Weight no greater than 130 kg
* No grade III or IV peripheral neuropathy
* No other medical condition that would preclude study compliance
* Not pregnant or nursing
* Fertile patients must use effective contraception
* See Disease Characteristics
* No chemotherapy within 3 months before planned surgery
* Preoperative radiotherapy allowed for STS
* No radiotherapy within 3 months before planned surgery
* No other concurrent investigational agents
Study of Early Stage Endometrial Cancer Based on Molecular Classification and Traditional Risk Stratification to Guide Adjuvant Radiotherapy Decisions

The purpose of this study is to compare the efficacy and toxicity of early stage endometrial cancer based on molecular classification and conventional risk stratification adjuvant therapy decision-making, and to provide high-quality evidence-based medical evidence for individualized adjuvant therapy selection under the guidance of fine stratification system of endometrial cancer.

This is an investigator-initiated prospective, national multicentre, phase III, randomised, open, non-inferiority clinical study. The study hypothesis is that adjuvant radiotherapy decision for early-stage endometrial cancer which is based on molecular classification can achieve de-escalation of adjuvant treatment without reducing local tumour control and survival, thereby potentially further reducing radiotherapy-related toxicity and improving quality of life, compared to using conventional risk stratification. The primary endpoint of this study is the 3-year local recurrence rate.

Eligibility Criteria:
Inclusion Criteria:

1. Women aged 18-75.
2. Patients with newly histologically confirmed Endometrioid adenocarcinoma.
3. ECOG score 0-2
4. Surgery consisting of a total hysterectomy and bilateral salpingo-oophorectomy, pelvic lymphadenectomy or sentinel lymph node biopsy, with or without para-aortic lymphadenectomy, oophorectomy
5. Patients with FIGO staging(2009 edition) I or II and meet one of the following conditions:

   1. Stage IA G1-2 with massive LVSI+ or age ≥ 60 years
   2. Stage IA G3, regardless of LVSI status
   3. Stage IB G1-3, regardless of LVSI status
   4. Stage II, regardless of tumor grade and LVSI status
6. Patients can understand the study protocol and voluntarily participate in the study, and give written informed consent before treatment.

Exclusion Criteria:

1. Not FIGO stage I-II.
2. Residual tumor or positive margin.
3. Mixed carcinoma, sarcoma or carcinosarcoma
4. Previous history of malignant tumor
5. Previous history of pelvic radiotherapy
6. The interval between surgery and radiotherapy is more than 12 weeks.
7. With serious medical complications, such as heart disease, lung disease and other diseases that cannot tolerate the whole course of radiotherapy
Assessment of the Analgesic Effects of PF-05089771 and Pregabalin in Healthy Volunteers Using Evoked Pain Endpoints

This study will examine the activity of PF-05089771 and pregabalin, alone and in combination on a panel of evoked pain tests carried out from 0.5 to 10 hours following oral dosing in healthy male subjects


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG or clinical laboratory tests. •Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs). •Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study. •Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing). •Any condition possibly affecting drug absorption (eg, gastrectomy). •A positive urine drug screen
Treatment of Failing Blebs With Ranibizumab

This study was designed to evaluate the efficacy and safety in the use of Ranibizumab, an effective vascular endothelial growth factor (VGEF) inhibitor, in treating patients with a failing bleb, characterized by increased fibrosis and vascularization of the conjuctiva, following trabeculectomy. Six subjects from one site will be enrolled in this study.


Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written informed consent and comply with study assessments for the full duration of the study
* Age \> 40 years
* Patients with Open-angle Glaucoma who have had trabeculectomy
* Patients determined to have failing bleb with presence of superficial bleb vascularity and IOP increase on 3 successive visits without topical medication
* Patients whose intraocular pressure (IOP) is above goal IOP after suture lysis and digital compression have been attempted

Exclusion Criteria:

* Pregnancy (positive pregnancy test) or lactation.
* Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.
* Current infection or inflammation in either eye
* Any abnormality preventing reliable applanation tonometry in either eye
* Other non-glaucomatous disease affecting visual field, (pituitary lesions, demyelinating disease, congenital optic nerve anomaly, prior retinal and optic nerve vascular occlusive disease, retinal dystrophy and degeneration, diabetes and HIV and AIDS infection)
* Strabismus, nystagmus, monocular patient
* Prior enrollment in the study
* Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
* Participation in another simultaneous medical investigation or trial
Influence of Different Physical Education Pedagogical Approaches on the Health and Development of 5-6 Year Old Children

The Skill Acquisition Methods underpinning Pedagogy for LEarning in Physical Education (SAMPLE-PE) project aims to investigate the influence of different pedagogical approaches to teaching and learning in physical education (PE) on 5-6 year old children's health and development. Schools from deprived areas are invited to take part in the project and will be randomly assigned to either: (1) linear pedagogy PE curriculum programme, (2) nonlinear pedagogy PE curriculum programme or (3) carry on as normal. The linear and nonlinear pedagogy PE programmes will be underpinned by different and contrasting theories of skill acquisition and are delivered by trained coaches over 15 weeks. Children will be measured to assess their physical, psychological, cognitive, and emotional health and development, and their physical activity levels at the start of the study, immediately after the 15 week PE programme, and again after 12 months. It is expected that children taking part in the linear and nonlinear PE programmes will demonstrate greater physical development than children attending schools that carry on as normal. Furthermore, it is also anticipated that children taking part in the nonlinear PE programme will show greater gains in psychological, cognitive and emotional outcomes than the linear and usual practice programmes.


Eligibility Criteria:
Inclusion Criteria:

* Children aged 5-6 years attending Liverpool primary schools.

Exclusion Criteria:

* From the details given in participant's Child Medical Form, any child diagnosed with health or co-ordination issues that could affect motor competency will be excluded from analyses.
Safety and Efficacy of Cyclosporine Ophthalmic Emulsion in Patients With Primary Pterygium

This study will evaluate the safety and efficacy of Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®) in patients with primary pterygium (abnormal growth on surface of eye).


Eligibility Criteria:
Inclusion Criteria:

* Have a pterygium in at least one eye that has not been previously removed with surgery

Exclusion Criteria:

* Uncontrolled systemic disease
* Active eye disease
* Current or anticipated use of topical eye medications other than artificial tears.
* Anticipated wearing of contact lenses
Accuracy of Infrared Thermography for Detecting Febrile Critically Ill Patients

Accurate determination of critically ill patient of being febrile or not is an essential part of management critically ill patients as it prompt investigating the underlying cause and initiating therapeutic action.

Pulmonary artery catheter thermistor is considered the gold standard for temperature measurement . Central non-vascular thermometer such as esophageal, bladder and rectal thermometer showed excellent correlation and agreement with pulmonary artery catheter thermistor and has been accepted as alternative methods for core body temperature assessment. However, those methods are invasive and cannot be tolerated in conscious patients. Peripheral thermometer such as oral, axillary and tympanic membrane thermometer are either impractical in unconscious patient and/or carry the risk of trauma and infection.

Infrared thermography (IRT) is a non-contact and non-invasive imaging approach that enable real-time estimation of body temperature by detecting infrared emission. IRT had been used for screening for mass detection of febrile patients at airport at times of infectious disease outbreak. In adult population, IRT showed good accuracy in detecting febrile patients in emergency department; however, those studies used 37.7⁰ C as the fever threshold and the reference standard was either oral 6 or tympanic membrane thermometer. No studies to the best of our knowledge had evaluated the IRT accuracy in detecting fever in critically ill patients using esophageal thermometer as a reference method.

The enrolled patient will be sedated according to the ICU protocol. A calibrated esophageal thermometer will be inserted by the attending intensivist through the nostril or oral cavity into the lower third of the esophagus to approximately 10-20 cm.

IRT will be performed using FLIR C2 compact thermal camera. The focal length of the thermal camera will be adjusted at 0.5 meter from the patient head. scanning will conducted over a period of 10-seconds. The researcher will record the highest reading obtained from medial canthus. No cold fomentations will be applied to the head nor the axilla of the patient for 30 minutes at least before measuring IRT.

FLIR C2 thermal camera will be calibrated before use to eliminate the effect of the ambient room temperature.

The researcher of will obtain the IRT temperature will be blinded to the esophageal probe reading.

Eligibility Criteria:
Inclusion Criteria:

* Critically ill intubated adult patients (\>18 years)

Exclusion Criteria:

* Patients with condition that preclude the application of esophageal thermometer such as esophageal varices, diverticulum, stenosis and malignancy
* patients with eye pathology as inflammation or malignancy which would interfere with the interpretation of the IRT reading,
* Pregnant women.
Effect of Tirzepatide on Brown Adipose Tissue in Obesity

This study is testing whether a new anti-obesity medicine called tirzepatide can increase the activity of special fat cells in the body that help burn energy. These fat cells are known as brown and beige fat. The study includes women with obesity and will last 24 weeks.

Participants will receive either tirzepatide or a placebo (a look-alike injection with no active drug). Researchers will measure the amount and activity of brown fat using medical imaging (PET/CT, MRI, and thermal camera), and examine fat tissue samples to look for changes in gene activity and structure that show beige fat activation.

The study will also evaluate how these fat changes affect body weight, energy use, hormone levels, blood sugar, and other health markers. The goal is to learn whether tirzepatide helps improve metabolism by increasing energy-burning fat in addition to reducing appetite.


Eligibility Criteria:
Inclusion Criteria:

* Female sex
* Age between 18 and 50 years
* BMI between 30 kg/m² and 40 kg/m² at pre-screening
* Prior comprehensive non-pharmacological and non-surgical management of obesity, including a history of at least 12 months of intensive lifestyle intervention with a maximum weight reduction of less than 5%
* Stable body weight within the three months preceding study enrollment (defined as weight fluctuations within 5%)
* No prior pharmacological or surgical interventions for obesity
* Euthyroid state
* Eumenorrhea or Oligomenorrhea
* Ability to comprehend the study objectives and procedures
* Willingness to provide informed consent and to comply with the study protocol, including the use of highly effective contraception during the study period, with signed consent and agreement provided in duplicate
* Commitment to use highly reliable contraception and absence of plans for pregnancy within the 8 months following enrollment

Exclusion Criteria:

* Pregnancy or lactation
* Postmenopausal
* Amenorea
* Type 2 diabetes
* Reliance on natural contraception methods
* Non-compliance with previous therapeutic regimens
* Personal history of malignancy
* Personal or family history of medullary thyroid carcinoma
* Personal history of pancreatitis
* Personal history of cholelithiasis
* Personal history of major depressive episodes or suicidal ideation
* Personal history of acute coronary events or hemodynamically significant coronary artery disease
* Psychiatric disorders
* Current treatment with sympathomimetics or sympatholytics
* Excessive alcohol consumption