cyrilzakka/clinical-trials huggingface dataset:
A Study of the Onset and Offset of Antiplatelet Effects Comparing Ticagrelor, Clopidogrel, and Placebo With Aspirin

The purpose of this study is to see how Ticagrelor, a new oral reversible anti-platelet medication, affects platelets. Anti-platelet agents are medications that block the formation of blood clots by preventing the clumping of platelets. Blood clots prevent us from bleeding, but when they form inside the arteries their formation is linked to a risk of medical problems such as heart attack and stroke. This study investigated how long it takes for Ticagrelor to begin working and how long it takes for it to stop working after the last dose of drug. Ticagrelor will be compared to clopidogrel, an established anti-platelet treatment for preventing blood clots, and placebo plus Aspirin.


Eligibility Criteria:
Inclusion Criteria:

* Documented stable Coronary Artery Disease (stable angina, previous MI history, previous history of revascularization);
* Females of child bearing potential must have a negative pregnancy test prior to receiving study drug and be willing to use a hormonal contraceptive in addition to double barrier contraception

Exclusion Criteria:

* History of Acute Coronary Syndromes within 12 months of screening or need for revascularization (angioplasty or Coronary Artery Bypass Graft (CABG))
* History of liver or kidney disease
* Have increased bleeding risk, eg, recent gastrointestinal bleed, uncontrolled high blood pressure, low platelet count, recent major trauma
* History of intolerance or allergy to Aspirin or clopidogrel
Study of Pant Type Absorbing Urinary Incontinence Products

Pre-market feasibility clinical investigation designed to evaluate the clinical performance and safety of the investigational product in its intended target population

The clinical clinical investigation is prospective, cross-over, interventional, multicentre and pre-market. The investigation aims to demonstrate the performance and safety of a new absorbing hygiene product (medical device) when used as intended in subjects affected with light to medium urinary incontinence compared to a reference (control) product representing standard of care.

The study participants will be randomly assigned to one of 4 groups. Each group will receive a predefined pair of investigational and reference products (variants: either high waist or low waist) to be used in a predefined order (crossover design: investigational or reference product to be used first). Hence, each study subject will use two products (one investigational product and a corresponding reference product of the same variant) and act as its own control. The study subjects will use one product for 5 days and then switch to use the other product for 5 days.

The primary endpoint for the investigation is the comparison in leakage performance of the investigation product with the reference product. There are also secondary endpoints regarding safety and product satisfaction and product preference.

Eligibility Criteria:
Inclusion Criteria:

* Adult women between age 45 and 75.
* Be willing and able to provide informed consent.
* Capability and willingness to follow the protocol.
* Experience incontinence daily or at least two times a week.
* Uses some sort of protection for the incontinence daily or at least two times a week.
* Uses five or more pieces of protection per week.
* Is currently using protective underwear; a pull-up (pant) product made for incontinence.
* Is able to wear a pant product of size M.
* Is currently using TENA Silhouette or Always Discreet Boutique product.
* Should be affiliate to the social security system.

Exclusion Criteria:

* Is pregnant or nursing.
* Known allergies or intolerances to one or several components of the investigational products.
* Be dependent on either alcohol or recreational drugs.
* Participation in an investigational study of a drug, biologic, or device within 30 days prior to entering the clinical investigation or planned during the course of the clinical investigation.
* Being under safeguard and protection of justice
* Having cognitive impairments.
* Any other condition that may make participation in the clinical investigation inappropriate, as judged by investigator.
Auto-administered Questionnaire by Screening of Disorder of the Haemostasis in Preoperative

The main objective of this study is to determine the capacity of a questionnaire to predict a normal balance sheet of haemostasis.

Recent recommendations formalized by experts of the French society of anaesthesiology on systematic pre-interventional examinations recommend assessing the risk of bleeding from personal and family history of bleeding diathesis and after physical examination . They recommend not to prescribe a systematic hemostasis laboratory tests in patients with a history and physical examination do not suspect a disorder of hemostasis.

However, there is currently no validated questionnaire in the general population to assess the preoperative bleeding risk allowing a reliable assessment of the personal and family bleeding diathesis.

The establishment of a structured questionnaire, the patient could filled before surgery consultation to guide the possible prescription of a balance sheet, could meet the new recommendations.

It seems therefore important to establish this type of questionnaire in order to optimize the operation of the structure, and to limit the requirements of routine hemostasis balance sheets. To do this, the investigator wants to carry out a preliminary study to ensure the interest of the established questionnaire.

The questionnaire assessed in this study is drawn from existing specialized questionnaires, the description of hemostasis disorders described factor for deficits from the doctor in charge of hemophilia expertise center and expertise of a psychologist, to refine best.

Eligibility Criteria:
Inclusion Criteria:

* All adults addressed in programmed anesthesia consultation, regardless of whether surgery and consultation site

Exclusion Criteria:

* Patients minors
* Physical or mental disability in Patient to agree and complete the questionnaire
* Major patients undergoing a protective measure
* Refusal of participation
Videoocular Assessment of Eye Movement Activity in an Ataxia Telangiectasia

Ataxia-telangiectasia (A-T) is a multisystem auto-somal recessive disorder linked to the A-T mutated gene (ATM) on chromosome 11q22-23, and characterized by progressive neural degeneration, immunodeficiency, and progressive ocular motor dysfunction. In previous studies, the quantitative description of the ocular motor deficits from clinical examination was limited to various defects in saccade and gaze control, dysmetric saccades, impairments of smooth pursuit, gaze holding, convergence, vestibular and optokinetic nystagmus slow phases, and cancellation of the vestibulo-ocular reflex. The aim of our research is to add existing findings with quantitative description of oculomotor patterns in A-T patients using videooculography (VOG).


Eligibility Criteria:
Inclusion Criteria:

* confirmed diagnosis of ataxia telangiectasia,
* informed consent,
* stay at the Clinical Research Rehabilitation Center "Russkoe Pole" for 14 days.

Exclusion Criteria:

* epilepsy,
* poor visual acuity, inability to percept from a computer monitor,
* inability to hold head and posture satisfactory to perform the tasks,
* difficulty to obtain adequate recordings due to corrective lenses,
* visual field defects.
PEPPER : PErcePtion of Pre-anesthesia Visit With or Without Robot

Pre-anesthesia visit for scheduled surgery is mandatory by law in France. During this visit, patients should be informed of the different available technics of anesthesia (i.e. general or loco-regional) and of their own risks .

Nowadays, many informations are given through written paper and leaflets, just before the consultation. In addition, patients need usually to wait for the doctor. This time may be used to give information, and new information's support, such as videos, may be used.

The aim of this study is to evaluated if a robot (PEPPER), who is able to answer to patients and to give informations, may increase the satisfaction of patients having a pre anesthesia visit for a scheduled surgery.

Before- after observational study.

All adult patients (age≥18 yrs) coming for a pre-anesthesia visit will be proposed to fulfill a questionnaire regarding their satisfaction and the quality of information they received.

* in the first period, patients will receive paper informations before the anesthesia visit.
* in the second period, they will have the same paper informations but a robot PEPPER will also stand in the waiting room and propose to the patients to give them informations about anesthesia, patients journey, risks, blood transfusion etc...

Eligibility Criteria:
Inclusion Criteria:

* Adult patients scheduled for a pre-Anesthesia visit during the study period

Exclusion Criteria:

* Refusal to answer the questionnaire
* unable to answer the questionnaire (not speaking french...)
Lymphatic Morphology of Fontan Patients

The Fontan procedure has revolutionized the treatment of patients born with a congenital univentricular heart defect. However, over time, it is associated with severe lymphatic complications such as plastic bronchitis, protein-losing enteropathy (PLE) and peripheral edema.

The hypothesis is that patients with a univentricular circulation have a changed morphology which may be associated with both the degree of lymphatic complications and their physical capacity.

The morphology will be described using T2-weighted non-contrast MRI.

The Fontan procedure has revolutionized the treatment of patients born with a congenital univentricular heart defect. However, over time, it is associated with severe lymphatic complications such as plastic bronchitis, protein-losing enteropathy (PLE) and peripheral edema. It has been proposed that these complications arise due to a elevated central venous pressure of the changed circulation.

The hypothesis of the study is that patients with a univentricular circulation have a changed morphology which may be associated with both the degree of lymphatic complications and their physical capacity.

The morphology will be described using T2-weighted non-contrast MRI. The main lymphatic vessel, the thoracic duct, will be rendered and measured using 3D software, and the lymphatic changes characterized by Dr. Yoav Dori (CHOP, Pennsylvania, USA), using a newly published grading system. The above will be correlated with the amount of complications experienced by the patients, and their physical capacity measured by both IPAQ questionaire and CPX test.

The study population consists of patients with a Fontan circulation operated at InCor Heart Institute, São Paulo, Brasil and Hospital das Clínicas, Ribeirão Preto, Brasil. Exclusion criteria were mental illness, genetic syndromes and age \<18 years. The patient group will be compared with age, gender and weight matched healthy controls.

Eligibility Criteria:
Inclusion Criteria:

- Fontan Circulation

Exclusion Criteria:

* Age \<18 years
* Mental illness
* Genetic syndromes
Study of Dalpiciclib Combined With Letrozole in the Maintenance Treatment of HR Positive and HER2 Negative Metastatic Breast Cancer After First-line Chemotherapy

This study aimed to evaluate the efficacy and safety of Dalpiciclib combined with Letrozole in the maintenance treatment of HR positive and HER2 negative metastatic breast cancer after first-line chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

1. Has the pathologically-confirmed diagnosis of locally recurrent or metastatic, hormone-receptor positive, HER2 negative Breast Cancer.
2. Age: 18 - 75 years old
3. Eastern Cooperative Oncology Group performance status (ECOG PS)=0\~1
4. Functions of liver and kidney is normal
5. Agreed to take contraceptive measures during treatment

Exclusion Criteria:

1. Confirmed diagnosis of HER2 positive disease.
2. Central nervous system metastasis
3. Patients who received prior treatment with any CDK4/6 inhibitor.
4. Clinically significant cardiovascular and cerebrovascular diseases,including but not limited to severe acute myocardial infarction within 6 months before enrollment, unstable or severe angina, Congestive heart failure (New York heart association (NYHA) class \> 2), or ventricular arrhythmia which need medical intervention；
5. Researchers believe that is not suitable for the study
Observational Study on Inappropriate Therapies

The purpose of the study is to assess the incidence of inappropriate shocks at 2 years, in a population of patients undergoing a generator replacement (VR/DR/CRT) or upgrade from a previously implanted ICD (VR/DR)

All subjects will be included during an inclusion visit (within 7 days post generator replacement or upgrade), and followed up at a post replacement visit (1 - 6 months post replacement or upgrade), at 12, 18 and 24 months post replacement or upgrade. These follow-up visits will be performed in-clinic except for the 18 months post replacement or upgrade visit, which could be performed through device remote monitoring.

Additional follow-ups can be performed at physician's discretion. Data on reportable adverse events will be collected throughout the study. All study data will be collected using an EDC system.

All delivered anti-tachycardia therapies (shock or ATP) will be reviewed by an independent board of experts in order to evaluate appropriateness.

The programming of the device parameters is at physician's discretion (suggested settings is slow VT monitoring zone 150 - 185 bpm with 30 cycles persistence, VT zone 185 - 230 bpm with 16 cycles persistence, remote monitoring activated).

Eligibility Criteria:
Inclusion Criteria:

1. Any subject that had an ICD/CRT-D replacement/upgrade according to the latest relevant clinical guidelines with a MicroPort CRM ICD / CRT-D for less than 7 days
2. Signed and dated the informed consent form

Exclusion Criteria:

1. RV lead replacement
2. Previous ICD/CRT-D inactivated or already explanted
3. Active myocarditis
4. Primary prevention for Arrhythmogenic Ventricular Cardiomyopathy, Ion channelopathies, Hypertrophic Cardiomyopathy and Infiltrative or Inherited Cardiomyopathy.
5. Heart transplant (done or on waiting list) or implanted with a ventricular assist device (VAD)
6. Already included in an Interventional study that could confound the results of this study
7. Inability to understand the purpose of the study or to meet follow-up visits as defined in the investigational plan
8. Minor age (\<18 years) or under guardianship or kept in detention
9. Ongoing drug or alcohol addiction or abuse which would interfere with the subject's ability to be compliant with the study.
10. Life expectancy less than 1 year
11. Pregnant or breast feeding
A Study Investigating the Safety and Performance of DV3395, a New Concept Device for the Delivery of Medicine.

This study investigates how safe the study device DV3395-C1 is when swallowed by healthy men and women. By the use of X-ray the device will be followed from the mouth, through the food pipe to the stomach and then into the gut. It will be checked if the device activates itself in the stomach as planned. Participants will be admitted to the clinic research center on day -1 and will receive the device on day 1 after 6 hours fast. The X-ray session will take up to 5 hours ending with administration of a small amount of contrast agent for better visualisation. The participants will stay at the clinic research center for up to 6 days until the device has been excreted. A follow-up phone call will take place 1 week after the device has been excreted.


Eligibility Criteria:
Inclusion criteria:

* Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
* Body mass index between 18.5 and 29.9 kg/m\^2 (both inclusive).

Exclusion criteria:

* Presence of any known or suspected clinically significant gastrointestinal disease or gastrointestinal disorder (including functional and structural disorders) as judged by the investigator.
* History of clinically significant gastrointestinal or abdominal surgery (including gynaecological/obstetrical and urological procedures) as judged by the investigator.
* History of radiotherapy of the neck, thorax or abdomen.
* Exposure to ionizing radiation from diagnostic or interventional procedures of greater than 0.1 mSv within 1 year prior to V2 pre-administration, a radiation burden of greater than 1.1 mSv within 2 years prior to V2 pre-administration, a radiation burden of greater than 2.1 mSv within 3 years prior to V2 pre administration, etc. (add 1 year per 1 mSv).
* Known or suspected hypersensitivity to any component of DV3395 C1 or to any iodine based contrast agent.
* Female for whom any of the below applies:

  * pregnant as determined by a positive laboratory pregnancy test at screening or at V2 pre administration
  * breast-feeding
  * of child-bearing potential and not using an adequate contraceptive method for 28 days or more prior to screening or between screening and V2 pre-administration, and not willing to maintain use of adequate contraception during the study period (adequate contraceptive measures as required by local regulation or practice)
  * wish to become pregnant within 6 months after the study
Role of MRI in Assessment of the Urinary Bladder Wall Post Transurethral Tumor Resection

To study the feasibility of using magnetic resonance imaging (MRI) in evaluation UB wall thickening after transurethral resection (TUR) of bladder cancer.

Urinary bladder carcinoma is the second most common tumour of the urinary tract and 70% of such carcinomas are non-muscle-invasive (superficial) at presentation. Transurethral resection (TUR) is the standard treatment; however, recurrence of the tumour is not uncommon so such patients require long-term close supervision.

Staging is based on TNM system. Ta tumors are treated with transurethral resection of bladder tumor (TUR-BT). T1 and carcinoma in situ (Tis) tumors have risk of progression and intravesical immunotherapy with Bacillus-Calmette-Guerin (BCG) instillations is used to obtain local control and organ preservation. Invasive bladder cancer (MIBC) is an aggressive disease and standard treatment is radical cystectomy (RC), accompanied by pelvic lymph node dissection (PLND). In addition to radical surgery, neoadjuvant chemotherapy (NAC) has been demonstrated to increase overall survival in MIBC and is recommended by consensus guidelines.

Compared to contrast enhanced CT, MRI has better soft tissue contrast which may improve local tumor evaluation.

Surveillance strategies for urinary bladder carcinoma recurrence have historically relied on cystoscopy, but this procedure has drawbacks, including its high cost, invasiveness and the fact that it may lead to iatrogenic bladder injury and urinary sepsis. In addition, it cannot diagnose upper tract tumours. The presence of a radiological method that could differentiate between benign and malignant lesions of the bladder would avoid the need for invasive cystoscopy, provided that upper tract tumours were excluded. Diffusion-weighted (DW) MRI is a non-invasive technique measuring the microscopic mobility of water molecules in the tissues without contrast administration. It provides information on perfusion and diffusion simultaneously in any organ, so it can be used to differentiate normal and abnormal structures of tissues, and it might help in the characterization of various abnormalities.

During follow-up of patients after trans-urethral resection (TUR), it is difficult to distinguish residual cancer from fibrotic and inflammatory changes secondary to TUR and intravesical chemotherapy, both of which manifest as bladder wall thickening on T2-weighted MRI.

Eligibility Criteria:
Inclusion Criteria:

-Patients who had a history of TUR of superficial bladder tumors and fit for the MRI examination.

Exclusion Criteria:

* Patients with pacemaker, claustrophobia or metallic prosthesis which are not MRI compatible.
* Patients with contraindications for cystoscopy (unfit for anesthesia or urethral stricture).
* Patients refusing consent for the study.
Sexual Function and Wellbeing in Males With Rectal Cancer

Preoperative radiotherapy and pelvic surgery is recommended to many patients with rectal cancer. For men there are theoretical reasons to believe that the treatment may effect hormone levels, spermatogenesis, sexual function and wellbeing. To address these questions a longitudinal observational study was initiated where measurements of androgen hormone levels, semen samples and sexual function were assessed before treatment (baseline) and during a follow-up period of two years.

Men with rectal cancer stage I to III planned for resection was included in the study. Men treated with preoperative RT were assigned to the exposed group and men treated with surgery alone were assigned to the unexposed group. Eighteen months after start of inclusion, less than 10% of the participants were treated with surgery alone. To increase the sample size of the unexposed group, men with prostate cancer stage I to III and scheduled for robot-assisted prostatectomy were also included.

Participants with rectal cancer were enrolled at two centres in Stockholm (Karolinska University Hospital and Ersta Hospital) between 2010 and 2014. Participants with prostate cancer were enrolled at the Urology department of the Karolinska University Hospital in Stockholm between 2012 and 2013.

Patient data, fasting venous blood samples, semen samples and questionnaires regarding sexual function and well being were collected before start of oncological treatment (baseline), 1 and 2 years after surgery. Men treated with preoperative RT for rectal cancer had an additional venous blood sample during the week before surgery. Men with rectal cancer under 55 years of age were offered semen cryopreservation.

Participants could choose if they wanted to participate in one, two or three of the following parts; hormone analysis, semen analysis and/ or questionnaires regarding sexual function and well being. Semen sampling and cryopreservation was not performed in men with prostate cancer.

Changes in hormone levels, semen measurements and sexual function during follow-up were assessed, and compared between exposed and unexposed participants.

Eligibility Criteria:
Inclusion Criteria:

* Males diagnosed with rectal cancer stadium I-III, planned for surgery with or without preoperative radiotherapy or males with prostate cancer stadium I-III planned for robot-assisted prostatectomy without preoperative radiotherapy.
* Informed consent
* Fluent in Swedish
* Residents of the Stockholm county area

Exclusion Criteria:

* Rectal cancer stadium IV
* Previous radiotherapy to the pelvic region
* History or evidence of a second pelvic malignancy
* Androgen deprivation therapy, Testosterone replacement or Androgen abuse
Epigenetic Biomarkers for Alzheimer's Disease

Alzheimer's disease (AD) is a neurodegenerative disorder with no know cure. The pathogenesis of late onset AD (LOAD) is complex and multifactorial in nature, with multiple susceptibility genes and environmental factors at interplay.

The objective of this study is to improve our understanding of the risk factors of LOAD by conducting an epigenome wide study within patients of LOAD contrasted against their cognitively normal siblings.


Eligibility Criteria:
Inclusion Criteria:

* Sufficient Cantonese competency for cognitive test
* Written informed consent given
* Have at least one gender-matched cognitively normal sibling

Exclusion Criteria:

* Subjects who refuse blood taking procedure
* Do not have a reliable family/caregiver informant (personal contact at least once a month)