cyrilzakka/clinical-trials huggingface dataset:
Immunological Characteristics of Preclinical IBD

The purpose of this study is to evaluate disease progression, in terms of development of symptomatic disease and complications associated with IBD (e.g. fistula, abscess, stricture).

This is a prospective, observational, multicenter, collaborative research project that will explore the earlier stages of IBD, before the onset of the first symptoms of the disease. This novel approach constitutes an innovative strategy on the research on the natural history of the disease. The study will be carried out based on colorectal cancer screening colonoscopies, recruiting all patients with a new diagnosis of IBD in this setting. These patients will undergo follow-up visits every 6 months for 10 years and the clinical information will be enriched with longitudinal multi-omic analyses.

Two additional control groups will be identified, including patients with new-onset symptomatic IBD in the last 3 months and healthy controls (with normal screening colonoscopy).

Eligibility Criteria:
Inclusion criteria

Patients from cohort A will be included if they fulfill all the following inclusion criteria:

* Male or female ≥18 years of age at baseline.
* New diagnosis of IBD during a CRC screening colonoscopy, based on the criteria from the European Crohn's and Colitis Organization (33, 34).
* Presence of a chronic inflammatory infiltrate and histological diagnosis compatible with IBD.
* The patient must be asymptomatic at diagnosis and without previous symptoms suggestive of IBD.
* Time interval between the index colonoscopy and the baseline visit up to 3 months.

Patients from cohort B will be included if they fulfill all the following inclusion criteria:

* Male or female ≥18 years of age at baseline.
* Recent diagnosis of IBD, with \<3 months from symptoms onset.
* Time interval between the index colonoscopy and the baseline visit up to 3 months.

Patients from cohort C will be included if they fulfill all the following inclusion criteria:

* Male or female ≥18 years of age at baseline.
* No endoscopic signs of IBD after a complete ileo-colonoscopy within the CRC screening program.
* Time interval between the index colonoscopy and the baseline visit up to 3 months.

Exclusion criteria

Patients from cohort A will be excluded if they fulfill any the following exclusion criteria:

* Identification of any enteropathogen in the stool culture.
* Isolated findings of acute inflammatory infiltrate without signs of chronicity.
* Previous or current diagnosis of microscopic colitis.
* Alteration in biomarkers in blood or stool will not constitute an exclusion criterion.

Patients from cohort B will be excluded if they fulfill any the following exclusion criteria:

- Previous use of immunomodulators or biologics for any condition.

Patients from cohort C will be excluded if they fulfill any the following exclusion criteria:

* Any gastrointestinal symptoms at baseline.
* Previous use of immunomodulators or biologics for any condition.
The Impact of a Patient Education Intervention for Ambulatory Oncology Patients

This study will test the impact of newly created and available symptom management patient education brochures on symptom burden \[measured via the Edmonton Symptom Assessment System (ESAS)\], health-related quality of life \[measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30)\], patient satisfaction with care \[measured by the Princess Margaret Hospital Patient Satisfaction Questionnaire (PMH/PSQ-MD 29) and the European Organisation for Research and Treatment of Cancer Patient Satisfaction with Radiation or Chemotherapy (EORTC PatSat35 RT/CT)\], self-efficacy, and knowledge at Sunnybrook Health Sciences Centre in Toronto, Canada. These brochures are designed for oncology patients in order to provide a response to symptom screening and are now a standard part of care. Symptom screening occurs at each visit as patients are required to fill out ESAS, that asks about their experience with the occurence and severity of symptoms. The intent of the patient brochures are to acknowledge the screen, validate the symptom and provide knowledge of self-management strategies for symptoms. The brochures also provide information to patients about when and how to seek further help from their oncology team. The hope is that patients will experience a useful response to their screen with all levels of symptoms-from 0-10 in severity

It is hypothesized that the addition of patient education symptom management pamphlets on 7 of the symptoms measured by ESAS (appetite, nausea and vomiting, depression, anxiety, fatigue, dyspnea and pain) will provide new and meaningful information which will build knowledge, validate the patient's experience of the symptom, lead to increased satisfaction with care, improved self efficacy in managing and accessing help for the symptom and therefore improved health related quality of life.


Eligibility Criteria:
Inclusion Criteria:

* receiving treatment at the Odette Cancer Centre or Breast Cancer Centre at Sunnybrook Hospital
* over the age of 18
* English-speaking and able to read and complete a survey in English

Exclusion Criteria (patients will be withdrawn from study in the event that...):

* The patient is thought to be at risk to self or others, or be in need of immediate psychiatric assessment, in which case the patient will be referred urgently for assessment with psychosocial oncology or department of psychiatry
* The patient wishes to discontinue the study
* The patient is noted to be cognitively impaired during the course of the study such that he cannot complete a questionnaire reliably or physically impaired such that it is too burdensome
Prevalence of Sexually Transmitted Infections (STIs) and Coinfections in the General Population

Prevalence of Sexually Transmitted Infections (STIs) and co-infections in the general population


Eligibility Criteria:
Inclusion Criteria:

* Subject, male or female, 18 years of age or older
* Subject capable of understanding the purpose of the research having given their free and informed written consent
* Subject presenting to the laboratory for a biological examination
* Affiliated subject or beneficiary of a social security scheme

Exclusion Criteria:

- Protected subject: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
Safety and Efficacy Study of EGT0001442 in Subjects With Type 2 Diabetes Mellitus

The purpose of this study was to assess the effect of EGT0001442 on fasting plasma glucose after 28 days of treatment in subjects with type 2 diabetes.

The study also assessed the pharmacokinetics, safety and tolerability of EGT0001442, the effect on weight and HbA1c as well as the effect EGT0001442 has on the amount of glucose produced in the body by the urine.

This was a phase 2 study to evaluate the efficacy of

EGT0001442. The study included two segments:

Segment 1 was a single center, open labeled, ascending dose study in 4 groups of 5 diabetic subjects per group who received 5, 10, 20, or 50 mg of EGT0001442 capsules orally once daily for 28 days. The subjects were in clinic for the first 3 days for safety and PK evaluation.

Segment 2 was a multi-center, double-blind, placebo-controlled parallel group study. One hundred and thirty one subjects in 5 parallel groups of approximately 25 diabetic subjects per group were randomly assigned to receive oral EGT0001442 at 5, 10, 20, or 50 mg/day or placebo once daily for 28 days in an outpatient setting.

Eligibility Criteria:
Inclusion Criteria:

* Male or female between the ages of 18 and 70 years diagnosed with type 2 diabetes.
* Body mass index (BMI) between 18 kg/m2 and 37 kg/m2 (inclusive).
* HbA1c levels between 6.5 and 9.5 (inclusive) where the upper limit of normal for the HbA1c assay is 6.4% or HbA1c levels between 6.2 and 9.5% (inclusive) where the upper limit of normal for the HbA1c assay is 6.1%.
* Fasting plasma glucose levels between 126 and 270 mg/dL (7 - 15 mmol/L, inclusive) while on diabetic medications.
* Treatment naïve subjects with HbA1c between 6.5 and 9.5 and fasting plasma glucose between 126 and 270 mg/dL (7 - 15 mmol/L).
* If taking drugs for diabetes, must be medically able and willing to discontinue diabetic medications for the duration of the study.
* Female subjects must be surgically sterilized or postmenopausal.

Exclusion Criteria:

* Type 1 diabetes or diabetes treated with insulin injection.
* Insulin therapy or oral antidiabetic medication other than metformin, sitagliptin, saxagliptin, a sulfonylurea or combination of these.
* Sitting blood pressure above 150/95 mmHg on two evaluations at least 10 minutes apart at screening.
* Positive results on screen for drugs of abuse.
* Previous treatment with an investigational drug within 30 days or 7 half-lives, whichever is longer.
* Previous treatment with EGT0001474 or EGT0001442.
Simplification of Low Level Internal Dosimetry

This is a pilot study with the primary aim being to identify the minimum number of scans and measurements necessary to determine accurately the absorbed radiation doses delivered from internal sources of radiation administered for diagnostic nuclear medicine procedures.

A study to develop practical methods of accurate low radiation absorbed dose measurement in patients referred for nuclear medicine scans.

There is currently very little information on and therefore understanding of the effects of exposure to low levels of radiation on patients or radiation workers. Assumptions are largely based on evidence from high radiation doses following nuclear incidents which may not be applicable to medical procedures. Underestimation of the radiation effects incurs greater risk to patients than is currently assumed, while overestimation can prevent more informative scans that would be obtained from higher administered activities. This research study answers an invitation from the Department of Health Policy research programme to improve our understanding of those low radiation dose risks.

Over 600,000 patients have nuclear medicine scans in the UK each year, presenting an opportunity to accurately measure low radiation doses and follow up the effects on a large number of patients. This study will develop practical methods to measure accurately the radiation doses delivered to patients referred for nuclear medicine positron emission tomography (PET) and single photon emission computed tomography (SPECT) scans.

Five patients referred for each of 7 diagnostic nuclear medicine procedures will undergo up to 7 quantitative PET/SPECT scans and up to 10 whole body radiation retention measurements over the course of 1-2 days to enable the absorbed radiation doses to be calculated accurately. Analysis of subsets of these measurements will be performed to identify the timing and minimum number of measurements necessary for accurate dose estimates.

The longer term aim is that these methods and results will subsequently be used to inform a national epidemiological (epidemiology is the study of factors affecting the health and illness of populations) study on the effects of low doses of radiation.

Eligibility Criteria:
Inclusion Criteria:

\* All patients able to undergo the procedures necessary to acquire sufficient data for dosimetry, consisting of up 7 nuclear medicine scans and 10 external radiation retention measurements over a time period of up to 24 hours

Exclusion Criteria:

* Patients unable or unwilling to undergo further procedures that may include scans and external retention measurements.
* Paediatric patients 18 years of age and under.
* Pregnant patients.
Patient Ambulation in Post-Op Recovery

The purpose of this study is to create a platform that accurately measures and reports patient physical activity before a procedure, during the hospital stay, and after discharge from the hospital.

Early ambulation in post-operative patients has shown benefits including shorter length of stay and/or fewer complications. Accelerometers have been found as useful instruments in encouraging ambulation in patients. Accelerometers are non-invasive devices that can evaluate changes in movement, gait, and ambulatory activity. Although these devices can be beneficial, little research exists on the best way to engage patients in ambulation, how to develop a standard ambulation protocol, and the best algorithms to measure ambulation post-operation. This study seeks to develop a standardized activity tracker and program that will encourage patient ambulation and allow patients and healthcare providers to view the progress of daily walking goals.

A total of 3,000 patients will be asked if they would like to participate in this study. A healthcare provider will explain to the patient the benefits of getting out of bed, sitting, and walking after an invasive procedure. Patients who decide to participate will be given an accelerometer during their pre-operation visit or after their surgery while still in the hospital. Patients will be asked to wear the accelerometer continuously during waking hours. The accelerometer will provide patients with daily walking goals, reminders of when it is time to walk, track step count, record time of walk, and duration of walk. Patients will be asked to wear the accelerometer until their post-op visit (about 30 days).

The following data points will be analyzed:

* Relationship between ambulation and patient outcomes
* Relationship between ambulation and other health factors
* Effectiveness of prototype platform to motivate and monitor patient activity

Eligibility Criteria:
Inclusion Criteria:

* Patients of physician study investigators

Exclusion Criteria:

* Patients whose physicians find they are unfit to participate in a walking program
Lifestyle Intervention for Patients With Impaired Glucose Regulation

Impaired glucose regulation (IGR) is closely related to overweight/obesity. By studying different dietary patterns (energy-limited diet vs. low-carbohydrate diet) and intensive lifestyle interventions combined with blood glucose monitoring, glucose regulation of overweight/obesity is affected. To improve the blood glucose and related metabolic indexes of patients with impaired (IGR), establish 1-2 clinical intervention programs for impaired glucose regulation.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years old ② Fasting blood glucose is between 5.6-6.9 mmol/L (100-125mg/dL) or oral glucose tolerance test (OGTT) 2h plasma glucose (2h-PG) is 7.8-11.1 mmol/L (140-200 mg/dL)

  * 24 kg/m2 ≤ BMI ≤ 35 kg/m2

    * Those who are willing to accept assessment and sign informed consent.

Exclusion Criteria:

* Patients diagnosed with diabetes or undergoing diabetes treatment;

  * Receiving drugs or surgery for weight loss at present or in the past 3 months;

    * Receiving corticosteroid or thyroid hormone treatment;

      * Secondary obesity caused by endocrine, genetic, metabolic and central nervous system diseases;

        * Patients with abnormal liver function (alanine aminotransferase or/and aspartate aminotransferase exceeding the upper limit of normal value 3 times); patients with abnormal renal function (serum creatinine exceeding the upper limit of normal value); suffering from kidney disease and other diseases that need to control protein intake;

          * Diseases affecting the digestion and absorption of food (such as chronic diarrhea, constipation, severe gastrointestinal inflammation, active gastrointestinal ulcer, gastrointestinal resection, cholecystitis/cholecystectomy, etc.); ⑦ Suffering from cardiovascular and cerebrovascular diseases, grade 3 hypertension, chronic hepatitis, malignant tumors, anemia, mental illness and memory disorders, epilepsy and other diseases; ⑧ Suffering from infectious diseases such as active tuberculosis and AIDS; ⑨ During pregnancy or lactation; ⑩Patients with physical disabilities and clinicians think it is not suitable to participate in the study (for example, have a serious disease not included in the discharge criteria) or are unwilling to participate in this study.
Efficacy of Reslizumab Dose Escalation in Patients With Severe Asthma

Dose escalation of reslizumab can ameliorate sputum eosinophilia in severe asthmatics who have persistent sputum eosinophilia despite treatment with reslizumab at the standard dose.

Monoclonal antibody therapies targeting the interleukin-5 (IL-5) pathway, critical for maintaining eosinophil homeostasis, have been developed as adjunct therapy for severe asthma with an eosinophilic phenotype. Reslizumab/Cinqair is an approved/marketed product administered monthly by intravenous to severe eosinophilic asthmatics at 3mg/kg. However some patients do exhibit sputum eosinophilia at this dosage. We are investigating whether those that receive 3mg/kg that have persistent sputum eosinophils would benefit at a higher dose of 4mg/kg and those that still exhibit sputum eosinophils at this elevated dose would show improvement at 5mg/kg.

The overall aim of this study is to determine whether dose escalation of reslizumab can ameliorate sputum eosinophilia in severe asthmatics who have persistent sputum eosinophilia despite treatment with reslizumab at the standard dose.

Eligibility Criteria:
Inclusion Criteria:

1. Asthma confirmed within the past 2 years by:

   a. A ≥12% improvement in forced expiratory volume in 1 second (FEV1) after use of a beta agonist, or a methacholine challenge test showing a ≥20% reduction in FEV1 after a concentration of ≤8 mg/mL of methacholine
2. Blood eosinophils ≥400 cells/µL and/or sputum eosinophils ≥3% (or presence of moderate-to-many free eosinophil granules) at the time of study enrollment
3. Treated with an inhaled corticosteroid at a dose of ≥1500 µg of fluticasone propionate (or equivalent) and a long-acting beta agonist with or without oral corticosteroids
4. Ability to provide informed consent

Exclusion Criteria:

1. Current smokers, ex-smokers with greater than 20 pack-year history or ex-smokers who have smoked within the past 6 months
2. Any comorbidity that the investigator believes is a contraindication including but not limited to any respiratory (e.g., chronic obstructive pulmonary disease, allergic bronchopulmonary aspergillosis, pulmonary fibrosis), cardiovascular (e.g., congestive cardiac failure, pulmonary hypertension), hematological, gastrointestinal, immunological, musculoskeletal, infectious, or neoplastic disease
3. Currently treated with another biologic agent (excluding denosumab for osteoporosis)
4. Use of anti-IL-5 (other than reslizumab) or anti-IgE mAb use within the past one month
5. Use of a systemic immunosuppressive or immunomodulatory agent within 6 months prior to study entry
6. Suspected of abusing drugs or alcohol
7. Pregnancy or lactation
Diet Intervention, Head and Neck Cancer, Feasibility

This study will examine the effects of a dietary intervention in post-treatment head and neck cancer survivors on the ability to function physically, tiredness, and quality of life, as well as on changing markers in the blood that are associated with better recurrence and survival.


Eligibility Criteria:
Inclusion Criteria:

Patients will be eligible to participate if they are 1) diagnosed with Stage I - IV oral, hypopharyngeal, nasopharyngeal, oropharyngeal, or laryngeal cancer; 2) age 19+; 3) at least 6 months - 2 years post-treatment; 4) able to consume foods orally; 5) no evidence of disease; 6) English-speaking

Exclusion Criteria:

Patients will not be eligible to participate if they have 1) dementia or organic brain syndrome; 2) severe emotional distress; 3) active schizophrenia; 3) another diagnosis of cancer in the past five years (not including skin or cervical cancer in situ)
Screening of Hereditary Upper Gastrointestinal Cancer in China

Through exploring the specific genetic mutations in the upper gastrointestinal tract tumors with a family history and specific clinical pathological types，we establish a complete family and follow-up system，in order to improve the screening criteria of Chinese hereditary upper gastrointestinal tumors and carry on primary prevention of disease.


Eligibility Criteria:
Inclusion Criteria:

Patients with gastric cancer, esophageal adenocarcinoma, or duodenal adenocarcinoma meet one of the following criteria:

1. age≤30;
2. age≤35，gastric cancer with special pathological types;
3. age≤50，≥one first-degree relative of a malignant tumor;
4. ≥ two first-degree／second-degree relatives of a malignant tumor，and ≥one first-degree relative;
5. have ≥two types of malignancies，and age ≤50 at the first time of diagnosis;
6. MSI or dMMR of tissue specimen;

Patients with esophageal squamous cell carcinomas meet one of the following criteria:

1. ≥ two first-degree／second-degree relatives of a malignant tumor，and ≥one first-degree relative;
2. have ≥two types of malignancies，and age ≤50 at the first time of diagnosis;
3. MSI or dMMR of tissue specimen;

Exclusion Criteria:

* Patients do not meet one of the inclusion criteria;
Predictive Value for Stroke

Patients with a moderate to severe carotid atherosclerotic plaque are at risk for stroke and this risk increases with increasing degree of stenosis. It has been shown that carotid endarterectomy in symptomatic patients with a carotid artery stenosis of 70-99% is highly beneficial. However, the beneficial effect of surgery in patients with symptomatic 30-69% stenosis is not clear yet.A clear beneficial effect of surgery in the 30-69% stenosis group might be found in a sub-group of patients whom are at greater risk for stroke. Definition of this sub-group might be achieved by plaque characterization, since rupture of a vulnerable plaque is the main cause of stroke due to carotid artery stenosis.This study will include patients with a 30-69% carotid artery stenosis, and assess plaque composition by MRI, the degree of plaque inflammation by FDG-PET, and the amount of microembolization by transcranial Doppler ultrasound. The main purpose of this study is to assess whether one or a combination of each of these imaging methods can predict the occurrence of a (recurrent) ischemic stroke.


Eligibility Criteria:
Inclusion Criteria:

* Patients with neurological symptoms due to ischemia in the carotid artery territory and with a carotid stenosis between 30% and 69% as detected by ultrasound examination

Exclusion Criteria:

* Patients with a probable cardiac source of embolism (rhythm disorders, mitral valve stenosis, prolapse or calcification, mechanical cardiac valves, recent myocardial infarction, left ventricular thrombus, atrial myxoma, endocarditis, dilated cardiomyopathy, patent foramen ovale) or a clotting disorder.
* Patients with evident other cause of neurological symptoms than carotid stenosis due to atherosclerotic disease (like demyelinating diseases, epilepsy, congenital brain disorders, aneurysms, fibromuscular dysplasia, etc.).
* Patients already scheduled for carotid endarterectomy or stenting
* Severe co-morbidity, dementia, or pregnancy.
* Standard contra-indications for MRI (ferromagnetic implants like pacemakers or other electronic implants, metallic eye fragments, vascular clips, claustrophobia, documented allergy to contrast media, renal insufficiency, etc).
* Patients who were referred from another hospital to one of the three participating hospitals (to avoid referral bias).
* Patients who had a TIA or minor stroke more than 3 weeks before inclusion
* Patients who had a prior TIA or stroke