cyrilzakka/clinical-trials huggingface dataset:
Predicting Breast Cancer with the BRAVE System

Breast cancer predominates among cancer diagnoses in Canadian women. It accounts for around 25% of new cases and contributes to 13% of all cancer-related deaths. In 2020, almost 27,400 Canadian women were diagnosed with breast cancer and 5,000 of them died from it.

Mammography is still the preferred method for screening for breast cancer. Although progress has been made over the years, mammography does have its drawbacks. These include physical discomfort for patients, exposure to X-rays and reduced effectiveness in dense breasts. The study team is therefore interested in developing a new breast cancer detection method, the BRAVE method.

The BRAVE method, short for "BRA-based Visco-Elastography", uses the high contrast of elastic stiffness in malignant breast tumors to detect possible cancer cases without the need for X-rays or breast compression.

The first phase, carried out on a small scale pilot study, aimed to assess the method's ability to distinguish a breast with no abnormalities from one with confirmed cancer. The second phase (current phase), carried out on a larger scale, aims to confirm the sensitivity and specificity of the method in detecting malignant lesions, i.e. to determine whether the method is capable of distinguishing between several types of breast masses.

This study has two objectives, which will be studied in two separate groups.

1. To measure the sensitivity and specificity of BRAVE in identifying malignant lesions in a cohort of 300 women.
2. To assess the impact of breast density on the ability of BRAVE to discriminate malignant breast lesions.

The research team aim to recruit 300 women requiring follow-up imaging. Half will have lower breast density (categories A or B) and the other half will have higher breast density (categories C or D).

Participants will need to attend a single visit lasting approximately 75 minutes, where they will be asked to wear the study's bra and complete the examination process.

Other data will also be collected in the medical file to enable the team to confirm: the density of the breast, and the results and dates of mammography imaging or other tests related to breast cancer.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old
* Able and willing to provide signed informed consent in French or English
* Recent mammogram (\< 6 months)
* Breast mass newly identified by palpation, mammography, sonography, or MRI and have been referred for additional imaging or evaluation.

Specific inclusion Criteria:

Group 1 - Normal Mammographic Breast Density (NMBD): Breast density A or B Group 2 - Elevated Mammographic Breast Density (EMBD): Breast density C or D

Exclusion Criteria:

* Pregnant or breast-feeding women
* Breast implants or prior surgery/biopsy to breasts
* Any disease or condition limiting the capacity to complete the examination process
* Any previous or prescribed treatment against cancer
HNFO With or Without Helmet NIV for Oxygenation Support in Acute Respiratory Failure Pilot RCT

This Randomized Control Trial will directly compare helmet non-invasive ventilation (NIV) combined with high flow nasal oxygen (HFNO) versus HFNO alone in patients with Acute Hypoxemic Respiratory Failure (AHRF).

This is a pilot multicentre, concealed, stratified, permuted block randomized controlled trial enrolling patients with AHRF who are admitted to the intensive care unit. Patients with imminent need for intubation, or a contraindication to study interventions will be excluded. Patients will be randomized to receive either (1) sessions of at least 12 hours per day of helmet NIV oxygen interspersed with HFNO or (2) HFNO alone over at least 2 calendar days. Participants will be followed to hospital discharge or 60 days, with an additional quality of life assessment via telephone interview 6 months after enrolment.

Eligibility Criteria:
Inclusion Criteria:

1. Intensive care unit admission (orders written)
2. Age ≥18 years
3. Hypoxemic acute respiratory failure for at least 1 hour and still present at time of screening for eligibility (symptom onset during last 14 days) with the following:

   1. Respiratory rate \>21bpm or clinical evidence of increased work of breathing and
   2. Documented Hypoxemia defined as any one of:

   i. PaO2:FiO2 \< 300 ii. If no arterial blood gas available, then SpO2:FiO2 \< 315 iii. Oxygen saturation \<98% on FiO2 \>= 0.4 or higher by Venturi mask, TAVISH mask 10 Litres / minute, or any non-invasive oxygenation strategy
4. Not already intubated or with tracheostomy

Exclusion Criteria:

1. Already on HFNO or other non-invasive ventilation strategy at FiO2\>=0.4 for the last 24 hours in the ICU.
2. Immediate need for intubation (e.g., inadequate airway protection or refractory hypoxemia or cardiopulmonary arrest, massive hemoptysis, etc)
3. Extubated in the ICU within past 72 hours
4. Clinician deems that face mask NIV is indicated to treat a primary diagnosis of hypercapnic respiratory failure or acute congestive heart failure
5. Known neuromuscular disease
6. Patients being transitioned to Palliative care or unlikely to survive more than 24 hours
7. ICU discharge is planned or anticipated on the day of screening
8. Previously enrolled in this trial
9. Trauma patients who remain in a cervical spine collar at the time of recruitment or who have upper limb/torso fractures that would preclude them from safe application of the helmet
10. Clinician decision that positive pressure to face and/or nasal pharynx is a contraindication (eg. Transphenoidal surgery, basal skull fracture etc.)
Evaluation of the Sacroiliac Joints of People With Chronic Low Back Pain From a Chiropractic Perspective

Low back pain is a musculoskeletal problem that we commonly encounter in the clinic,which negatively affects the quality of life, reduces productivity and limits the ability to perform activities of daily living.

The most common causes of low back pain are disc lesions and soft tissue injuries due to trauma, rheumatological disorders such as spondylosis, spinal stenosis and spondylolisthesis, ankylosing spondylitis and rheumatoid arthritis due to degenerative changes; osteoporosis, root disorders, and sacroiliac joint dysfunction

Eligibility Criteria:
Inclusion criteria;

* Volunteer
* Not undergoing surgery related to the lumbar region
* Cases without lumbar steroid injection in the last 3 months
* Not having visual and hearing loss
* Having low back pain
* Cases without neurological problems
* Cases without tumor and infection in the lumbar region
* Cases in which communication and cooperation are provided Exclusion criteria;
* Not having a musculoskeletal or neuromuscular disease that limits mobility,
* No upper extremity sequelae,
* Not volunteering
Assessment of Pharmacokinetics of Single Dose Odanacatib (MK-0822) in Participants With Moderate Hepatic Insufficiency (MK-0822-070)

This open-label, non-randomized study was designed to compare pharmacokinetics of a single 50 milligram (mg) dose of MK-0822 in participants with and without moderate hepatic insufficiency (abnormal liver function) in order to determine to what degree hepatic dysfunction may impact therapeutic blood levels of MK-0822. The primary hypothesis is that plasma AUC0-∞ of odanacatib in participants with moderate hepatic insufficiency is similar to that in matched healthy participants following a single 50 mg oral dose.


Eligibility Criteria:
Inclusion Criteria:

* Not currently pregnant, nursing or planning to be pregnant through-out the course of the study; agree to use specified contraception per protocol requirement
* Body Mass Index (BMI) of ≤ 39 kg/m\^2 (not obese)
* Judged to be in good health (for healthy participant population)
* Non-smoker for the past 6-months; social smokers (smoke less than 10 cigarettes within the past 3 months; or per discretion of the study Investigator, quit smoking within the past 3 months.
* Diagnosed with chronic (more than 6 months), stable (no acute episodes of illness within the previous 2 months) hepatic insufficiency (liver dysfunction) with features of cirrhosis due to any cause (for the moderate hepatic insufficiency participant population)
* Possess the ability to understand the study, grant voluntary informed consent and willingly comply with all study requirements

Exclusion Criteria:

* Does not meet the age requirement, is mentally or legally incapacitated, has or is expected to have significant emotional problems, or a history of a clinically significant psychiatric disorder
* Has been diagnosed with a disease or medical condition which may pose a risk to the participant or may confound the study results
* Compromised renal (kidney) function, significant organ system disease(s) or cancer(s)
* Unable to refrain from or anticipates the use of any new medication, including prescription and non-prescription drugs or herbal remedies
* Meets the requirements of the study in regard to current medication profile including: prescribed medications, caffeine, alcohol, over-the-counter drugs, herbals and nutritional products; with expected non-use of recreational (illicit) drugs associated with misuse, abuse and/or addiction
* Had surgery, donated 1 unit of blood or received another investigational study medication within 4 weeks prior to the study's first dose of investigational product
* History of multiple and/or severe allergies, or has had a life-threatening reaction or inability to tolerate prescription or non-prescription drugs or food
Comparison of Apixaban Versus Enoxaparin

The goal of this randomized trial is to compare bladder cancer patient experiences taking prophylactic anticoagulation at home after surgery to remove their bladder. The main questions it aims to answer are:

* Are patients equally adherent to apixaban as they are enoxaparin? Why or why not?
* Do patients prefer apixaban or enoxaparin?
* What is the typical patient cost to take apixaban vs enoxaparin after surgery?

Participants will be randomized to receive a prescription for either enoxaparin or apixaban which they will then fill themselves and self-administer at home until post-operative day 30. They will receive phone calls from study coordinators at days 30 and 90 to complete questionaries over the phone to assess trial outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Able to communicate in English over the phone
4. Male or female, age \>18 years
5. Diagnosed with biopsy-proven, urothelial cell carcinoma (any T stage, N0-1, M0) with plan for radical cystectomy with urinary diversion and concurrent pelvic lymph node dissection as treatment

Exclusion Criteria:

1. Preoperative use of a therapeutic dose of anticoagulant (this notably does not exclude patients taking antiplatelet agents)
2. Failure to undergo radical cystectomy with concurrent urinary diversion and pelvic lymph node dissection
3. Failure to be discharged by post-operative day 14
4. Failure to receive a script for enoxaparin or apixaban.
5. Any medical condition which precludes treatment with either enoxaparin or apixaban (including dialysis, hemophilia or any other bleeding diathesis)
Maternal Physical Activity and Pregnancy Outcome

The aim of this study is to investigate the impact of maternal physical activity during pregnancy on pregnancy outcome. Primary, fetal growth during pregnancy abd birth weight will be examined.

During this study, the information on maternal physical activity will be collected and the impact on delivery and pregnancy complications as well as on neonatal complications will be evaluated. From the first visit at maternal care center, the information on socioeconomical and maternal characteristics will be collected. During pregnancy, fetal growth will be estimated by ultrasound. Physical activity will be measured using free app for measuring steps that mothers make during pregnancy. Using logistic regression, the impact of physical activity on pregnancy outcomes will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

Healthy women with singleton pregnancies

-

Exclusion Criteria:

* Twins pregnancies. Mothers with preexisting conditions. Malformations.
The Effect of Low Furanocoumarin Grapefruit Hybrid Juice Consumption on Midazolam Pharmacokinetics

Grapefruit (GF) contains furanocoumarin (FC) which is known to irreversibly inhibit the activity of cytochrome P450-3A (CYP3A) enzymes in the human gastrointestinal tract (PAINE 2005). Because CYP3A enzymes are integral in the metabolism of some drugs, co-ingesting GF or GF Juice (GFJ), which inhibits CYP3A, along with drugs reliant on CYP3A for metabolism can significantly alter the drugs kinetic properties and result in elevated plasma drug concentrations which may be toxic. The Citrus Research and Education Center at the University of Florida has developed a new GF hybrid (GFH) which contains low FC content and which may not inhibit CYP3A enzyme activity, and therefore may be safe to co-ingest with drugs that require CYP3A activity for metabolism. The investigators hypothesize that low FC GFHJ will not inhibit CYP3A to the degree that regular GFJ does, and will not significantly affect midazolam kinetics compared with regular GFJ. Midazolam is an FDA approved probe drug for CYP3A activity and has been used previously to establish an interaction between GFJ and midazolam. This study will evaluate the concomitant administration of midazolam and low FC GFHJ, regular GFJ, or water to evaluate the significance of this interaction.

As a participant in this study the following will take place: A pre-study visit will be done which will include a physical exam, pregnancy test if applicable, and a review of your medical history. If you qualify you will then undergo three separate study visits as described below.

While participating in this study, participants will not eat grapefruit or other citrus fruits (oranges, lemons, for example) or drink non-study specific grapefruit juice or other citrus fruit juices, or citrus containing foods (orange marmalade, for example) for 1 week prior to each study visit. In addition, no herbal or other dietary supplements or over the counter medications should be taken for 48 hours before and during the study visits.

During each of the three study visits, separated by at least 2 weeks, one of two different grapefruit juice products (either the low furanocoumarin grapefruit hybrid or regular grapefruit) or water will be provided. The order in which these three drinks will be received will be random, like the toss of a coin. Also, 1 dose of midazolam (a drug normally used to make someone sleepy or relaxed before a medical test) will be given during each visit.

Each study visit will consist of three days, on Days 1 and 2 a drink of 200ml (about 7 ounces) of the assigned grapefruit juice or water will be given.

On Day 3 of each study visit, you will fast (abstain from having anything to eat or drink except water) from 12 a.m. the night before, and report to the clinic for the study day at 8am.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years of age
* non-smokers

Exclusion Criteria:

* Inability to abstain from alcoholic beverages (24 hours),
* Inability to abstain herbal containing supplements/teas/beverages, and
* Inability to abstain from over-the-counter medications (48 hours) prior to the study visits
Comparison of Intravascular Ultrasound With Venography in the Diagnosis and Treatment of Iliac Vein Compression Syndrome

The aim of this study is to compare intravascular ultrasound with venography in the diagnosis and treatment of iliac vein compression syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18 to 90 years
* Willing to participate in and sign the informed consent
* Patients with suspicious iliac vein stenosis or compression presented by preoperative magnetic resonance venography (MRV)
* Patent common femoral vein and/or femoral vein of the study leg
* Undergoing iliofemoral venography with the intend to treat potential iliac vein compression syndrome

Exclusion Criteria:

* Not providing informed consent
* Venous compression caused by pelvic tumors or fibroid uterus
* Previous stent implantation or venovenous bypass surgery of the study leg
* Known metal allergy precluding the possibility of stent implantation
* Known iodine allergy or severe renal insufficient function which are unsuitable for venography
* Pregnant or planning to be pregnant recently
* Acute deep vein thrombosis or tumor thrombus involving the study leg
* Know history of thrombophilia (e.g. protein C or S deficiency, anti-thrombin III deficiency, etc )
* Any concurrent disease, for example, heart failure, might make the patients unsuitable for surgery
A Study to Determine the Risk of Cancer in Rheumatoid Arthritis (RA) Patients Who Use Abatacept and Other Biologic Agents

An observational study to determine the risk of cancer associated with the use of abatacept and other biologic agents among rheumatoid arthritis patients


Eligibility Criteria:
Inclusion Criteria:

* RA patients will be identified using algorithms that require ≥ 1 rheumatologist (physician specialty code: 66) diagnosis codes for RA (at least one of the following ICD9 diagnosis codes: 714.0, 714.2, 714.81) at any time before the first claim for a specific drug (Index date) during the study period and ≥1 physician (affiliated with physician evaluation \& management codes, listed in the appendix 2) diagnosis codes within 12 months before the first claim for a specific drug use. The index date is defined as the date of the first claim for a specific drug use, and the baseline period is defined as 12 months prior to specific drug use
* Naive users of biologics, including abatacept, anti-TNFs (i.e. etanercept, adalimumab, certolizumab, golimumab, infliximab), rituximab, and tocilizumab, will be defined specific to each drug as no claim for that therapy in any time prior to the index date
* Eligible subjects, including cancer patients in SEER and non-cancer beneficiaries from 5% sample, must have been continuously enrolled in Medicare Parts A, B and D and not C at their index date and during baseline

Exclusion Criteria:

* Patients diagnosed with any cancer (ignoring non-melanoma skin cancer, which is not captured within SEER) before the use of biologics under study. Cancer cases will be identified based on the records in SEER
* Patients who were younger than 18 years on the index date
* Patients with claims for other types of auto-immune diseases (e.g. psoriatic arthritis, systemic lupus erythematosus) during baseline
* Month or year of diagnosis of malignancy in SEER was unknown
* Cancer cases who were identified by death certificate or autopsy only in SEER

Other protocol defined inclusion/exclusion criteria could apply
Study to Evaluate Cardiac Hemodynamics and Safety of SLV320 in Subjects With Congestive Heart Failure

The study is a randomized, placebo controlled, multi-center, single dose study to evaluate cardiac hemodynamics and safety of iv SLV320 in 110 subjects with congestive heart failure requiring diuretic treatment. Each subject will receive one dose of SLV320 or placebo or furosemide. The study consists of three visits (or study days when in-subjects are included). Ambulatory subjects will be in hospital for two nights and one day.


Eligibility Criteria:
Inclusion Criteria:

* history of chronic, symptomatic, mild to severe (NYHA Class II-IV) CHF for at least three months requiring treatment with diuretics and with documented systolic dysfunction
* on stable doses of their individually optimized medication regimen for at least one week prior to enrollment

Exclusion Criteria:

* required hospitalization (for cardiovascular disease) or adjustment of background medications for CHF
* orthostatic hypotension or symptomatic orthostasis
* sitting systolic or diastolic blood pressure \< 90 mmHg
* 2nd or 3rd degree atrio-ventricular block or sick sinus syndrome
* heart rate of \< 50 or \> 110 bpm on the ECG
* transplanted heart
* heart failure due to primary valvular disease (unless surgically corrected), obstructive cardiomyopathy, pericardial disease, cor pulmonale or congenital heart disease
* hemodynamically significant left ventricular outflow tract obstruction
Integrating Artificial Intelligence Into Lung Cancer Screening.

Lung cancer (LC) screening using low-dose chest CT (LDCT) has already proven its efficacy.

The mortality reduction associated with LC screening is around 20%, much higher than the reduction in mortality associated with screening for breast, colon or prostate cancers.

Implementing lung cancer screening on a large scale faces two main obstacles:

1. The lack of thoracic radiologists and LDCT necessary for the eligible population (between 1.6 and 2.2 million people in France);
2. The high frequency of false positive screenings: in the NLST trial, more than 20% of the subjects screened were found to have at least one nodule of an indeterminate lung nodule (ILN) whereas less than 3% of ILNs are actually LC.

The gold standard for determining on the benign or malignant nature of a nodule is definitive histology. Otherwise, the evolution of the nodule on serial thoracic imaging is a good alternative. The period of indeterminacy of a nodule can be as long as 24 months in many cases, which can be a source of prolonged and sometimes unjustified anxiety for screening candidates.

The purpose of this randomized controlled study that focuses on LC screening in patients aged 50 to 80 years, who smoked more than 20 packs/ year or stopped smoking less than 15 years ago. Its objective is to determine whether assisting multidisciplinary team (MDT) meetings with an AI-based analysis of screening LDCT accelerates the definitive classification of nodules into malignant or benign.


Eligibility Criteria:
Inclusion Criteria:

* Age between 50 and 80 years old
* active smoker or ex-smoker who quit smoking less than 15 years ago
* smoking history of at least 20 pack-years
* signature of the informed consent
* affiliation to French social security

Exclusion Criteria:

* clinical signs suggestive of cancer
* recent chest scan (\<1 year) for another cause
* radiological abnormality requiring follow-up or additional investigations
* health problem significantly limiting life expectancy from the clinician's point of view
* health problem limiting ability or willingness to undergo lung surgery
* Patients with active neoplasia, except basal cell carcinoma of the skin.
* vulnerable people: adults under guardianship, adults under curatorship medical and/or psychiatric problems of sufficient severity to limit full adherence to the study or expose patients to excessive risk