cyrilzakka/clinical-trials huggingface dataset:
Study of Relationship Between Vedolizumab Therapeutic Drug Monitoring, Biomarkers of Inflammation and Clinical Outcomes

The purpose of this study is to determine if a relationship exists between Week 6 vedolizumab therapeutic drug monitoring (TDM) and Week 30 Faecal calprotectin (FCP).

This is a non-interventional, retrospective, and longitudinal study of participants with IBD (UC or CD) receiving vedolizumab between years 2015 and 2020. The study will determine the real-world evidence of vedolizumab, its relationship with TDM, biomarkers of inflammation, and its effect on clinical outcomes in a real-world setting.

This study will enroll approximately 5,500 participants. Participants will be enrolled in 2 cohorts: TDM Cohort and Historical Cohort. The study will have a retrospective data collection of the participants from PSP between the years 2015 and 2020. The study will include longitudinal analysis of data collected in a subset of Takeda Canada PSP, specifically for those participants on vedolizumab, some of which received biomarker testing and TDM at pre-specified intervals during their treatment.

This multi-center trial will be conducted in Canada. The overall time for data collection in the study will be approximately 5 years.

Eligibility Criteria:
Inclusion Criteria:

1. The participant or, when applicable, the participant's legally acceptable representative signed and dated a written, informed consent form, which specified secondary use of their data, and any required privacy authorization as part of their enrollment in Takeda Canada's PSP.
2. Received or receiving vedolizumab between the years 2015 and 2020.

Exclusion Criteria:

No exclusion criteria will be applied.
Modifying Nutrition to Modify Delivery in Nulliparous Women

In France, around 20% of women exceed the term of 41 weeks' amenorrhoea (SA). Maternal and foetal morbidity and mortality are increased when the term is exceeded, which justifies inducing labour. However, induction also increases maternal and foetal morbidity.

According to several studies, regular consumption of dates during the last month of pregnancy may increase the rate of spontaneous labour and natural childbirth.

Single-centre, randomised, open-label, 3-arm study :

Experimental group n°1: 'dietary advice + food provided'. Advice to eat 7 dates a day from 37 weeks' gestation until delivery. The quantity of dates required will be provided to the women.

Experimental group 2: 'dietary advice alone'. Advice to eat 7 dates a day from 37 weeks' gestation until delivery. The food will not be provided.

Control group: no specific dietary advice. Routine care group.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women
* Age ≥ 18 years
* Nulliparous
* Single pregnancy with fetus in cephalic presentation
* Pregnancy with physiological course
* Gestational age ≥ 34 and ⩽ 37 SA
* Membership of a social security scheme (CMU accepted)
* Signed informed consent

Exclusion Criteria:

* Any contraindication to vaginal delivery
* Presence of a foetal malformation
* Diabetes of any type (1, 2 or gestational)
* Food allergy contraindicating participation in the study
* Illiterate or non-French-speaking women
* Women under guardianship or trusteeship
Health Consequences of the Burden of Atrial Fibrillation

The Swiss-AF-BURDEN study will be embedded in the follow-up visits of the Swiss-AF cohort study. The research question of the current atrial fibrillation burden will be answered by using 7-day Holter-ECG recordings and continuous implanted loop recorder recording, whereas cardiac MRI examination will give results about cardiac dimensions and function. The 7-day Holter ECG will be repeated after one year. The cMRI will be performed separately or directly after the brain MRI to minimize the additional burden for the patients. Only a subsample of 100 patients will additionally receive ILR for 2 years.


Eligibility Criteria:
Inclusion Criteria:

* Swiss-AF study patient
* Paroxysmal or persistent AF

Exclusion Criteria:

* Permanent AF
* Swiss-AF patients not willing or able to undergo 7-day Holter monitoring
* Specifically for cMRI: Pregnant women or women of child-bearing age without a prior negative pregnancy test
Autologous Fresh Whole Blood and Coagulation Following Cardiopulmonary Bypass in Infants

Dilution of blood caused by cardiopulmonary bypass (the heart-lung machine) during open heart surgery is associated with decreased concentrations in the blood of coagulation factors. This can be extreme in infants because of their small blood volumes and can lead to impairment of the normal blood clotting mechanism and excessive bleeding after the operation. Transfusion of fresh whole blood has been shown to be an effective treatment because fresh blood is rich in coagulation factors. However, it is difficult to obtain truly fresh blood from a blood bank. We hypothesized that fresh blood drawn from the patient and given back after cardiopulmonary bypass would improve the clotting mechanism. In our study, the infants in the treatment group have some of their own fresh blood removed after they are anesthetized for the operation and before they are placed on cardiopulmonary bypass. This blood is then given back to them after completion of cardiopulmonary bypass. Infants in the control group will not have their own blood removed but will undergo cardiopulmonary bypass. We will compare the two groups by drawing blood samples that measure coagulation tests.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing non-complex open heart surgery
* Diagnosis of congenital heart disease
* No previous open heart surgery
* Weight 15 kg or less
High Definition Versus Chromoendoscopy for Dysplasia Detection in Ulcerative Colitis (UC)

Patients with ulcerative colitis (UC) have an increased risk for colorectal cancer (CRC) compared to the general population. Regular screening by colonoscopy is an internationally recommended cancer prevention strategy. Random sampling of the mucosa throughout the colon has been the mainstay of conventional surveillance practice to detect abnormalities, known as dysplasia which can progress to CRC. This requires multiple biopsies, to be taken and processed, a practice which is is tedious, expensive, time consuming and has a low pickup rate. Dysplasia in UC is typically flat and patchy and can be easily overlooked with standard conventional white light colonoscopy (WLC).

Detection can be improved by the application of dyes which highlight more subtle abnormalities. This practice, known as chromoendoscopy (CE) is better than WLC at dysplasia detection but more time consuming for the patient and cannot guarantee that the whole colon is covered. CE has only been compared in clinical trials with standard definition endoscopy rather than the recently available high definition endoscopes with better resolution and picture. High definition (HD) endoscopy uses a high definition onitor and a high resolution CCD (charge coupled device) providing much better images than standard video endoscopy. HD colonoscopy promises therefore to provide an alternative to CE in UC surveillance without the need for the extra time and experience required for dye spraying for both endoscopists and nursing staff.

The investigators plan to do a randomized trial to assess HD colonoscopy alone compared to chromoendoscopy (with HD colonoscopies) for dysplasia detection during surveillance for ulcerative colitis. There have been no trials comparing these two modalities and the investigators hope to provide evidence that the additional benefit of CE over HD colonoscopy would be marginal and therefore CE would be reserved for procedures using standard definition scopes.


Eligibility Criteria:
Inclusion Criteria:

* Patients with longstanding (more than 10 years), extensive (extending proximal to the splenic flexure) colitis attending for surveillance colonoscopy.
* Patients over 18 years of age

Exclusion Criteria:

* Pregnancy
* Unwilling or unable to give informed consent
* Severe active colitis (as assessed by the endoscopist)
Norepinephrine Infusion Combined With Goal-directed Fluid Therapy in Patients Undergoing Kidney Transplantations

Delayed graft function (DGF), delineated by the necessity for dialytic intervention within the initial week post-transplantation, afflicts approximately 20%-50% of recipients. The primary objective of this study is to investigate the potential efficacy of norepinephrine infusion in conjunction with goal-directed fluid therapy (GDFT) in mitigating the occurrence of DGF among individuals undergoing kidney transplantations. The findings of this investigation have the potential to advance the field of perioperative care in kidney transplantations by providing insights into optimized management strategies.

Chronic kidney disease (CKD) presents a formidable challenge to global healthcare systems. With ongoing advancements in surgical techniques, kidney transplantation has emerged as a principal therapeutic modality for individuals afflicted with end stage renal disease (ESRD), markedly enhancing their long-term prognosis and overall quality of life postoperatively. Nevertheless, the occurrence of delayed graft function (DGF) represents a prevalent early complication following kidney transplantations, mainly stemming from the ischemia-reperfusion injury incurred by the transplanted kidneys and the utilization of extended criteria donor organs. The manifestation of DGF can precipitate primary allograft nonfunction, acute rejection episodes, and potentially fatal outcomes. Vigilant attention to perioperative fluid management emerges as a cornerstone in mitigating the risk of DGF. Recent strides in goal-directed fluid therapy (GDFT) have garnered substantial attention within critical care contexts, with empirical evidence underscoring its favorable impact on postoperative outcomes in critically ill cohorts. However, the efficacy of GDFT specifically in the context of kidney transplantation remains a subject of ongoing debate and scrutiny. Hence, the imperative arises to investigate potential strategies aimed at attenuating the incidence of DGF in this patient demographic.

Eligibility Criteria:
Inclusion Criteria:

1. Recipients aged 18 years or older
2. Scheduled to undergo kidney transplantations under general anesthesia
3. Cadaveric kidney transplantations
4. Sign the informed consent form

Exclusion Criteria:

1. Donors aged under 18 years
2. Donor kidneys classified as Maastricht category I or II
3. Contraindications to radial artery catheterization
4. Pregnancy
5. Cardiac dysfunction (exercise tolerance less than 4 METS)
6. Severe liver dysfunction (Child Pugh C-grade)
7. Respiratory diseases with tidal volume intolerance exceeding 8ml/kg
8. Severe arrhythmias, including atrial fibrillation, frequent atrial or ventricular premature beats, moderate or severe aortic and mitral regurgitation
9. Double-kidney transplantations
10. Simultaneous organ or additional surgeries during kidney transplantations
11. Repeat kidney transplantations
12. Concurrent participation in other clinical trials
13. Patients deemed ineligible by researchers
Clinical Validation of Cervical Cancer Screening Methods

This single-institution cross-sectional non-inferiority validation study evaluates alternative techniques and tests for primary cervical cancer screening programs in Russia, particularly: local cytology staining techniques, local HPV tests.

Cervical cytology practices are different across the world. While the Pap test became the cornerstone of the highly-effective cervical cancer screening in the countries that initially implemented population-based programs in the 60s and the 70s, alternative staining techniques were implemented in the Soviet Union. The tradition to apply other staining techniques than conventional Pap test remained unchanged in the national screening program implemented in the 2010s in Russia. As a new alternative option HPV testing showed effectiveness in screening women older than 30. The acceptable sensitivity and specificity of a screening test are crucial in population-based screening, that is why validation against "the gold standard" should be the first step in the process of program implementation. The objective of this study is to evaluate alternative techniques and tests for primary cervical cancer screening programs in Russia, particularly: local cytology staining techniques, local HPV tests in the population of 25-65 yo women without prior history of malignancy referred to colposcopy enriched with a population sample of women from several primary healthcare facilities referred to a primary screening test.

Eligibility Criteria:
Inclusion Criteria:

Age between 25 and 65 years old Referral to colposcopy or to a primary screening test Signed informed consent

Exclusion Criteria:

Prior history of malignancy or cervical dysplasia Prior history of cervical dysplasia
A Pilot With Interactive Computer-assisted Screening for Mental Health in Primary Care

The current protocol pertains to the evaluation of the interactive computer-assisted screening (iCAS) tool through a pilot randomized control trial. The purpose of this evaluation is to determine the efficacy of the iCAS tool in improving clinician's detection of common mental health conditions (i.e. major depression/generalized anxiety/post-traumatic stress disorder/alcohol dependence), and patients' discussion on mental health.

The iCAS tool is a health-risk assessment survey that is completed by adult patients using touch-screen iPad device in their waiting time before seeing their clinician (family physician or nurse practitioner). The computer program generates tailored risk-report for the clinician and a simple recommendation sheet for the patient, with community resources and health information, at the point of care. The iCAS tool currently includes validated screening scales for depression, generalized anxiety, posttraumatic stress disorder and alcohol abuse. There are some questions on the social determinants of mental health as well. The current versions of the tool are in English and Spanish; a Chinese language version will also be developed.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Speak/read Spanish
* Speak/read English
* Visiting the consenting clinician

Exclusion Criteria:

* Patient accompanied by a family member for interpretation
* New patients coming for first visit
* Patients feeling unwell (self-report)
* Inability of the research staff to offer study details in privacy
Comparison of Robotic Arm-assisted PET/CT-guided Lung Biopsy With PET Fused CT- Fluoroscopy-guided Lung Biopsy

Patients with suspicious lung lesions were undertaken for PET/CT directed under CT fluoroscopy lung biopsy or robotic-assisted biopsy. The biopsy planning including patient positioning was done after F18-FDG PET/CT whole body or regional imaging of the patient. Written consent was obtained and the patient will be prepared for the biopsy. Lung biopsies were done using a semi-automatic biopsy gun under the imaging guidance (PET fused CT fluoroscopy) following aseptic precautions. Follow-up CT scans were taken post-biopsy. The time consumed for the procedure, radiation exposure to the interventionist, complications and diagnostic yield in both the arms were compared.

Patients with clinical suspicion of lung lesions were recruited for FDG PET/CT. Based on the PET/CT findings and clinical details a PET/CT guided biopsy was planned. The patients were assigned to the two arms. In the first arm, participants underwent a robotic-assisted biopsy. In the second arm, participants underwent PET/CT-directed CT fluoroscopy-guided lung biopsy. The biopsy planning including patient positioning was done after F18-FDG PET/CT whole body or regional imaging of the patient. Written consent was obtained and the patient will be prepared for the biopsy. Lung biopsies were done using a semi-automatic biopsy gun under the imaging guidance (PET fused CT fluoroscopy) following aseptic precautions. Follow-up CT scans were taken post-biopsy. The time consumed for the procedure, radiation exposure to the interventionist, complications and diagnostic yield in both the arms were compared.

Eligibility Criteria:
Inclusion Criteria:

1. Age \>/= 18 years
2. FDG avid amenable lung lesion
3. INR \< 1.2 and Platelet counts \> 80,000/mm3

Exclusion Criteria:

1. Participants with pre-existing bleeding diathesis like hemophilia, coagulopathy defined by INR ≥ 1.2 and Platelet counts ≤ 80,000/mm3
2. Participants who refuse to provide the written informed consent
3. Signs of hypoperfusion like cyanosis, hypotension etc.
4. Presence of hypoxemia (SpO2 \< 95% -measured in a pulse oximeter)
5. Pregnant/Lactating females participants
6. Non-cooperative participants
7. Inaccessible lesions (based on the decision made on pre-biopsy planning)
8. CoVID-19 positive participants
Acute Coronary Syndrome CardioFlux TM Study (ACCMED)

Approximately 16.5 million people suffer from coronary artery disease (CAD) and about 10 million present each year to emergency departments with symptoms like chest pain and shortness of breath, commonly suggestive of acute coronary syndrome (ACS). To clinically assess ACS risk in these patients, there are typically 2-6 hours of emergency room evaluation, followed by 6-42 hours of an observation period prior to discharge. The clinical pathway includes: 1) 1-3 ECG's; 2) serial troponins (1 and 3 hours vs 1 and 6 hours); and 3) other pertinent diagnostic information, including but not limited to echocardiography, stress testing and/or CT Angiography. Patients who are evaluated, have presented with a low risk for ACS, and maintain negative diagnostic results can potentially be discharged within 6 hours. However, 20%-40% of patients who fall into indeterminate diagnostic categories will require longer observation periods or admission of 12-48 hours which result in the use of expensive imaging and provocative testing, such as stress testing. The purpose of ACCMED is to measure the efficacy of Magnetocardiography (MCG) as a diagnostic tool to rule-in/rule-out myocardial ischemia in patients with suspicion of an acute coronary syndrome who have a HEART Score \> 2 and to allow safe and timely disposition of the patient to an appropriate level of care.


Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years of age at the time of enrollment.
2. Patient presenting acutely with signs and symptoms suggestive of ACS.
3. Informed Consent Form signed by subject or LAR.
4. HEART Score of \>2.
5. Patient consented within 4 hours of the beginning of the clinical assessment (exclusive of any screening examination) for suspected ACS by an appropriately credentialed clinician.

Exclusion Criteria:

1. \< 18 years of age.
2. STEMI.
3. Unable to fit into device.
4. Non-ambulatory patients.
5. Positive response on MCG metal checklist.
6. Deemed hemodynamically unstable by treating physician, regardless of cause.
7. Unable to lie supine for up to 5 minutes.
8. Poor candidate for follow-up (e.g., no access to phone).
9. Prisoners.
10. Repeat participants.
Study of Circulating Microparticles in Giant Cell Arteritis

To demonstrate that microparticles (MPs), having a powerful procoagulant potential, are in larger amounts in the blood of patients with histologically proven giant cell arteritis (GCA), compared with patients matched for age, sex and with or without inflammatory syndrome.


Eligibility Criteria:
For GCA group:

Inclusion Criteria:

* Men and women ≥ 18 years of age Patient affiliated to social security regimen
* Informed and having signed the consent form to take part in the study.
* Diagnosis of GCA, meeting at least 3 of the following 5 American College of Rheumatology (ACR) criteria for the diagnosis of GCA, including inflammatory syndrome and having

  * Either temporal artery biopsy showing characteristic GCA abnormality
  * Or inflammatory arteritis on imaging examination

Exclusion Criteria:

* Persons under protection of the court or guardianship
* Inability to understand or to follow study procedures
* Dementia
* cancer diagnosed within the previous 5 years (except for non-melanoma skin cancer or in situ carcinoma of the cervix)non-contributory or inconclusive temporal artery biopsy
* Any conditions that might interfere with MPs level: diabetes, recent endo-arterial gesture, current treatment with corticosteroids.
* Participation in another ongoing clinical trial Current anticoagulant therapy
* Active infectious disease
The Effect of Brushing With Fluoride Toothpaste on Dental Plague Control for Elementary School Students

The purpose of this study is to evaluate the effect of correct tooth cleaning and use of fluoride toothpaste after school lunch and before going to bed on primary school children's plaque reduction and tooth cleaning skills.

Taking the school as a unit, the participants are children in grades three to six of elementary schools under the jurisdiction of Chiayi County, with a total expected sample size of 400 people.

Through class teaching, the Shelley method of brushing teeth is taught, and flossing instruction is added to senior grades to improve students' teeth cleaning skills. They also use fluoride toothpaste with a concentration of more than 1000PPM to clean teeth after lunch at school and before going home to go to bed. School children were tested for plaque before and after using fluoride toothpaste, collected plaque control index, filled out a self-administered tooth cleaning skills and self-efficacy questionnaire, and tracked changes in the six weeks after use.

Professional dentists and researchers will go to school to conduct dental plaque testing and fill out the first questionnaire for students. They will also use fluoride toothpaste after lunch at school and before going home to go to bed. Together with correct tooth cleaning methods, at 6 weeks Afterwards, the dental plaque test will be carried out again and the second questionnaire will be filled out. Each filling in of the questionnaire will take about ten minutes.

Eligibility Criteria:
Inclusion Criteria:

* Chiayi County has jurisdiction over elementary school students in grades three to six

Exclusion Criteria:

- 1. Students with disability certificates. 2. School children with congenital serious oral diseases (such as cleft lip and palate).

3. Children who are unable to operate the Bates tooth brushing method (such as students who are still unable to complete the operation after being guided by teachers and researchers).
Inspiratory Muscle Training in Ventilator Dependent Patients

The purpose of this study is to determine if inspiratory muscle strength training will increase the proportion of ventilator dependent patients weaned versus Sham treated patients.

The inspiratory muscle strength training consists of 4 sets of 6-10 breaths through a threshold inspiratory muscle strength training device, 5 days per week. The inspiratory muscle training is conducted at the highest pressure setting tolerated by the patients. The Sham groups uses an inspiratory muscle trainer that does not increase inspiratory muscle strength. Both the treated and Sham groups participate in progressively lengthening periods of breathing without ventilator as tolerated. Patients are considered weaned when they can breathe for 72 consecutive hours without any ventilator support.

Eligibility Criteria:
Inclusion Criteria:

* Failure to wean patients in the medial, surgical and intermediate respiratory care units at Shands Hospital
* medically stable
* able to initiate spontaneous breaths
* able to provide informed consent
* able to follow simple instructions

Exclusion Criteria:

* life expectancy \< 12 months due to malignancy
* damaged phrenic nerves
* neuromuscular diseases
* heart or lung transplant