cyrilzakka/clinical-trials huggingface dataset:
Bingo Drug-eluting Balloon Versus a Drug-eluting Stent for Coronary Bifurcation Lesions

Bingo drug-eluting balloon versus a drug-eluting stent for coronary bifurcation lesions: a prospective, multi-center, randomized, non-inferiority trial


Eligibility Criteria:
Clinical Inclusion Criteria:

1. Age 18 to 80
2. Patients with chronic stable coronary artery disease, or unstable angina, or NSTEMI (Grace score\<140), or STEMI more than one week
3. Subjects suitable for PCI
4. Subjects understand the trial purpose, volunteer to participate and sign informed consent form

Angiographic Inclusion Criteria (by visual):

1. One coronary de novo bifurcation lesion (including Medina classification: 1,1,1 / 1,0,1 / 0,1,1, which need to be treated for both main and side branches)
2. The reference vessel diameter of main branch is between 2.5 to 4.0 mm, length ≤ 30 mm. Before lesion preparation, lesion diameter stenosis shall be ≥70%, or ≥50% with evidence of myocardial ischemia
3. The reference vessel diameter of side branch is ≥2.0 mm, length \<20 mm. Before lesion preparation, lesion diameter stenosis shall be ≥70%
4. No more than 3 lesions on the non-target vessel in the same operation, and shall be successfully treated before the target vessel
5. No more than 1 non-target lesion on the target vessel in the same operation, and shall be successfully prepared before the target lesion (successful preparation of non-target lesion is defined as residual stenosis ≤30% and TIMI flow 3). After randomization, the non-target lesion shall be treated according to the assigned group, for the experimental group, using the experimental DCB is recommended; for the control group, using DES is recommended; Independent lesion on the same coronary artery is defined as interval \>5 mm
6. The target lesions of main and side branches must be successfully prepared (successful preparation is defined as: residual stenosis ≤30% , without NHLBI type C or above dissection, and TIMI flow 3)

Clinical Exclusion Criteria:

1. Severe heart failure (NYHA IV), cardiogenic shock or severe valvular heart disease
2. Left ventricular ejection fraction ≤35%
3. Severe renal insufficiency (eGFR \<30 ml/min)
4. Severe liver insufficiency (glutamate transaminase (ALT) or glutamate transaminase (AST) \>3 times the upper limit of normal)
5. Pregnant women or planned pregnancy
6. With a known allergy to heparin, contrast agent, paclitaxel and everolimus
7. Unable to receive antiplatelet agents and anticoagulants, bleeding tendency or coagulopathy
8. Life expectancy does not exceed 1 year
9. Participating in other drug or device clinical trials without reaching the primary endpoint
10. Subjects who had undergone coronary revascularization in the last 6 months
11. Subjects not eligible by the investigator for other reasons

Angiographic Exclusion Criteria (by visual):

1. In-stent restenosis lesion
2. Left main bifurcation lesion
3. Chronic total occlusive lesion
4. Target vessel is severely distorted, angulated or calcified, which is anticipated difficult to cross for balloon or stent
5. Target lesion remains significant residual thrombus after preparation
Determining the Clinical Relevance of the inTeraction Between AprepitaNt aNd EtoposiDe

Rationale: In pharmacokinetic studies, aprepitant was shown to be a moderate inhibitor of CYP3A4 activity. Etoposide is metabolised by CYP3A4.

Objective: to investigate the absence of a clinical relevant interaction between aprepitant and etoposide in TC patients treated with (B)EP.

Study design: A single centre, prospective, paired observational pharmacokinetic study in 12 patients with TC who are treated with etoposide during 5 days in combination with cisplatin with or without bleomycin conform the standard BEP or EP-protocol and who will be treated with aprepitant from day 3 until day 7 according to the routine antiemetic protocol. The effect of aprepitant on etoposide will be investigated within the same patient. In this study the patient will serve as its own control.


Eligibility Criteria:
Inclusion Criteria:

* Patients with TC who will start or already started treatment with (B)EP
* Age of at least 18 years
* Patients from whom it is possible to collect blood samples
* Patients who are able and willing to give written informed consent prior to screening

Exclusion Criteria:

* Patients who are co-treated with drugs that could interfere with the metabolism of etoposide (including drugs classified as a weak, moderate or strong CYP3A4 inhibitor OR weak, moderate and strong inducers of CYP3A4 according to the table based on the Flockhart table (Appendix 1) less than 30 days prior to study or during the study.
* Creatininclearance \<40 ml/min
* Severe liver dysfunction (bilirubin\>ULN)
Sudden Death Stratification

Sudden cardiac death (SCD) risk stratification is a challenge in non-ischemic cardiomyopathy (NICM). The underlying mechanism of monomorphic ventricular tachycardia (VT) is mostly scar related. While electrophysiological mechanisms underlying ventricular arrhythmia are well known, late gadolinium enhanced (LGE) cardiac MRI-3D reconstructions are now able to guide VT ablation procedures. Such exam may help in identifying specific properties of scar at risk of malignant arrhythmia.


Eligibility Criteria:
Inclusion Criteria:

* Adult with NICM
* Previous history of ventricular tachycardia (VT) and no previous history of VT

Exclusion Criteria:

* Inherited cardiomyopathies
* Previous history of myocarditis WITHOUT oedema/scar at the MRI
HOME Study: a Combination Support Package to Increase Uptake of PrEP and HIV/STI Testing

Home HIV self-testing has been FDA approved and allows users to read their own HIV test results at home, while home sexually transmitted infection (STI) test self-collection allows men to use a swab at home and mail it in for testing. The purpose of this study is to learn how Men who have Sex with Men (MSM) use these new testing options, a set of online support tools, and the option to test with someone to support them (a testing "buddy").

We will also evaluate whether the online tools help these men to connect with HIV prevention services such as Pre-Exposure Prophylaxis (PrEP) if they test HIV negative, and to HIV care services if they test HIV positive.

Participants will be randomized 2:1 after enrollment to the intervention and control condition. Data obtained from this study will be used to inform the further tailoring and distribution of an intervention for young Black and Latino MSM to increase utilization of home HIV self-testing and linkage to HIV treatment and Pre-Exposure Prophylaxis (PrEP).

Eligibility Criteria:
Inclusion Criteria:

* Self-identify as Black or Latino.
* Report anal sex with at least one male sex partner in the prior 12 months.
* HIV negative by self-report.
* Currently own a cell phone.
* Willing and able to provide written informed consent.

Exclusion Criteria:

* Inadequate contact information for follow-up.
* In a mutually monogamous sexual relationship for the past 12 months.
* Currently taking PrEP.
* Does not have reliable access to the Internet.
* Does not live, work, or play in the San Francisco Bay Area.
* Planning to move out of the Bay Area during the 9 month study period.
* Previously participated in the HOME Pilot study.
* Any medical, psychiatric, or social condition, or occupational, or other responsibility that, in the judgment of the investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
Pain Relief for Birth Control Implants Insertion

The aim of our study is to compare the analgesic effect of topical application of lidocaine-prilocaine cream and lidocaine infiltration during insertion of birth control implants


Eligibility Criteria:
Inclusion Criteria:

* female want use subcutaneous birth control

Exclusion Criteria:

* previous scar at side of insertion
Pediatric Early Autism Recognition System: PEARS

The goal of the study is to assess a new autism evaluation model that would include the addition of a Level-2 autism screener, the Rapid Interactive Screening Test for Autism in Toddlers (RITA-T), to the developmental screening already done by the child's pediatrician.

The study hypotheses:

1. The PEARS intervention will show high feasibility to primary care physicians (PCPs) and patient families.
2. The PEARS intervention will lead to increased parent activation around autism diagnosis.


Eligibility Criteria:
Inclusion Criteria- Child:

* Increased risk for Autism Spectrum Disorder (ASD) defined as:

  * positive Modified Checklist for Autism in Toddlers-Revised (MCHAT) (score greater than 3);
  * OR having a sibling or parent with ASD;
  * OR history of prematurity (gestational age less or equal 34 weeks);
  * OR other provider or parent concern for ASD.
* Child age 18-36 months

Exclusion Criteria- Child:

* previous ASD diagnosis
* previous negative ASD evaluation
* known seizure disorder
* vision impairment
* hearing impairment

Inclusion Criteria- Parent

- Parent or legal guardian of the children

Exclusion Criteria- Parent

- Not a Parent or legal guardian of the child
Influence of Sex Hormones Variation During Third Trimester of Pregnancy and Post-partum on QT Interval Duration

QT interval prolongation, corrected for heart rate (QTc), either spontaneous or drug-induced, is associated with an increased risk of torsades de pointes and sudden death. Women are at higher risk of torsades de pointes, particularly during post-partum and the follicular phase.

The aim of this study is to explore if QTc duration is prolonged during post-partum as compared to the 3rd trimester of pregnancy

Sex steroid hormones are known to influence heart repolarization. Overall, estradiol is considered to promote QTc lengthening while progesterone and testosterone shorten QTc. New findings suggest more complex regulation of QTc by sex steroid hormones involving also follicle-stimulating hormone, which is associated to prolongation of QTc. Another important aim of this study is to study the influence of sex hormones on QTc duration.

Eligibility Criteria:
Inclusion Criteria:

* Adult (\>18 yo) pregnant women in their third trimester
* Able to give her consent

Exclusion Criteria:

* Concomitant intake of QTcF prolonging drugs
* Past medical history of cardiovascular or endocrino-metabolic conditions (except hypertension or diabetes)
* QRS \>120 msec on electrocardiogram
Enhancing Spatial Navigation Using Non-Invasive Brain Stimulation

Remembering how to travel from one location to another is critical in everyday life, yet this vital ability declines with normal aging and can be further affected by conditions that disproportionately affect the elderly, such as vision loss or progressive dementia. Human and animal research has shown that two distinct memory systems interact during navigation. The first, referred to as allocentric navigation, is very flexible and uses spatial knowledge of key features or landmarks to develop and use a mental map of the environment. This approach involves brain regions that are critical for new learning and memory but that decline with age. The second, referred to as egocentric navigation, is inflexible and relies on "habit" memories that link specific features with specific directions. This approach relies on brain regions that are critical for "automatic" responses and that are relatively unaffected by age.

The main problem is that allocentric navigation declines with age and is accompanied increased dependence on egocentric navigation. This change increases the risk of becoming disoriented or "lost" when traveling in unfamiliar areas or even when traveling new routes in familiar areas. Therefore, the main goal of this project is to examine whether non-invasive brain stimulation, specifically transcranial direct current stimulation, can improve allocentric navigation in healthy older adults and patients with mild cognitive impairment.

Participants will complete two functional magnetic resonance imaging sessions while learning new environments. Before one of these sessions, participants will receive active brain stimulation over the parietal cortex. Before the other session, participants will receive sham brain stimulation over the parietal cortex. The effects of this stimulation will be evaluated using both an allocentric and an egocentric memory test. Physiologic effects will be evaluated using both task-based and resting-state MRI.


Eligibility Criteria:
Inclusion Criteria:

General inclusion criteria (all participants):

* All medications stable for approximately 1-2 months;
* No history of severe mental illness;
* No current untreated alcohol or substance abuse/dependence;
* English as native and preferred language;
* MRI-compatible if taking part in fMRI studies
* Able to give informed consent.

MCI Inclusion Criteria:

* Diagnosis of amnestic MCI based on criteria set forth by Petersen (2004). Additionally, other potential causes of cognitive deficit ruled out by the referring physician;

Healthy older adults

* intact cognitive functioning as measured by neuropsychological testing

Exclusion Criteria:

* History of neurological disease or injury
* History of severe mental illness
* Current untreated alcohol or substance abuse
* Other conditions may exclude; please discuss with contact
A Dose-Ranging Study Evaluating the Safety and Efficacy of IDP-108 in Patients With Onychomycosis

The purpose of this study is to assess the safety and effectiveness of two concentrations of IDP-108 in treating patients with onychomycosis


Eligibility Criteria:
Inclusion Criteria:

* Presence of onychomycosis of the target toenail
* A positive fungal culture from the target toenail

Exclusion Criteria:

* Any disease or condition that might cause nail abnormalities or may interfere with clinical evaluations
* Presence of tinea pedis (athletes foot)
* Female subjects who are pregnant, nursing, planning a pregnancy, or become pregnant during the study
Comparative Study of the Propagation of Uterine Electrical Activity (EHG) in Pregnant Women During Pregnancy and During Labour

The original aspect of the methodology proposed for this study concerns the use of as many as 16 electrodes to study the propagation and coordination (or synchronization) of uterine contraction. Over the last two years, the Compiègne University of Technology and the University of Reykjavik (Iceland) teams have developed the tools required to obtain good quality signals during electrohysterography and have worked on filtering and mapping of uterine electrical activity derived from these signals.


Eligibility Criteria:
Inclusion Criteria:

* singleton pregnancy

Exclusion Criteria:

* Minor patient
* twin pregnancy or more
Latin American Real-world Study in Acute Leukemia

The objective of the study is to describe the current epidemiology, treatment patterns, outcomes and healthcare resource use of adult patients diagnosed with relapsed/refractory (R/R) B-cell ALL and de novo AML in 4 Latin American countries.

This is a retrospective multicenter non-interventional study using real-world data collected from medical records of newly diagnosed AML or with relapsed/refractory B-cell ALL diagnosed between 01 January 2015 and 31 December 2019 in 4 Latin American countries: Argentina, Brazil, Chile, and Colombia. In addition, as secondary objectives, the study will also describe molecular profile, cytogenetic risk, clinical outcomes, and healthcare resource utilization of treated B-cell ALL R/R and AML patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥18 years old at diagnosis
* Confirmed diagnosis of relapsed/refractory B-cell ALL or de novo AML diagnosed between 01 January 2015 and 31 December 2019
* At least 1 line of treatment for R/R B-cell ALL or de novo AML within the study period

Exclusion Criteria:

* Patients with no medical chart available
* Patients with unreliable data as per investigator's opinion (e.g. excessive missing data or inconsistence data)
* Patients that have participated in any interventional clinical trial for relapsed/refractory B-cell ALL or AML at any moment
* Patients with secondary AML
* Patients with any concomitant primary malignancy
* Patients with acute promyelocytic leukemia (APL)
Detection and Characterisation of Varicella Zoster Virus From Dermal Lesions of Chickenpox-infected Patients

This study is conducted in order to collect clinical samples from patients who are diagnosed of having chickenpox infection. The results of this study will provide basic scientific information about chickenpox disease.

The study involves NO therapeutic or prophylactic treatment nor further observation of the patients. There is no product to be tested in this study.

Eligibility Criteria:
Pediatric patients who are diagnosed of having varicella and are presenting varicella dermal lesions.
A 12 Week Study to Confirm the Effectiveness of 8mg of Fesoterodine Compared to 4mg of Fesoterodine

This study is designed to confirm if 8mg of fesoterodine is more effective in reducing overactive bladder symptoms than 4mg of fesoterodine. In addition the study is designed to assess if the higher dose reduces the overall effect of overactive bladder on the subject's daily life more than the lower dose. The study also assesses the side effects and safety of the two doses.


Eligibility Criteria:
Inclusion Criteria:

* 6 months overactive bladder symptoms, minimum of 2 urgency urinary incontinence episodes per 24 hours and minimum of 8 micturitions per 24 hours.

Exclusion Criteria:

* Other concurrent and concomitant medication or disease that could put the subjects at additional risk or interfere with the study results.
Grade Analysis of Veins by MRI and CT in Post-Thrombotic Syndrome

The aim is to improve the diagnosis of chronic lower limb venous thrombosis before a lower limb venous recanalization procedure. Additionally, if the MRI scores are comparable to those of the CT, MRI would reduce radiation exposure and limit the need for foot vein punctures that accompany CT use.

Endovascular management of post-thrombotic syndrome (PTS) has created new opportunities for patients and interventional radiologists. PTS is the most chronic complication of deep vein thrombosis (DVT), occurring in 20% to 40% of patients despite optimal anticoagulant therapy within the first 1 to 2 years after a lower limb DVT. PTS is characterized by various symptoms lasting more than 6 months after a DVT, including mild pain or swelling, venous claudication, heaviness/fatigue, chronic pain or cramps, venous ulcers, edema, skin discoloration, and venous ectasia. Severe PTS negatively impacts quality of life. Several clinical tools or scales, such as the Villalta scale and CIVIQ-20, are used to diagnose and define PTS. Endovascular treatment of symptomatic chronic iliofemoral vein occlusions has shown good technical and clinical efficacy, with significant clinical benefits and improvements in the Villalta and CIVIQ scores. Proper planning of the recanalization procedure is essential, using CT and MRI imaging to analyze the venous anatomy in the pelvis, abdomen, and lower limbs. The CT is the reference examination for chronic lower limb thrombosis, performed using the Baldt technique to opacify the deep venous network and detect endoluminal adhesions. However, there are risks such as failure to puncture the veins on the back of the foot, pain during puncture, and flow artifacts. MRI is less commonly used due to its availability and long examination times, but its results are promising. The literature on chronic lower limb thrombosis is limited, with no consensus on lesion descriptions, highlighting the need for a descriptive lesion score

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged more than 18 years old,
* patient's oral consent,
* affiliated or beneficiary of health insurance

Exclusion Criteria:

* inability of the patient to understand the nature or risks or significance and implications of the clinical investigation,
* patient under legal protection
Novel Auto-continuous Positive Airway Pressure (CPAP) Validation

This single-blind randomised crossover trial aims to compare the efficacy of a novel Auto-CPAP algorithm (SPAP) to conventional CPAP. Up to 50 patients will be recruited from an OSA population, aged over 18.

Auto-CPAP devices change therapeutic pressure based on the needs of the patient. Algorithms differ from machine to machine. This single-blind randomised crossover trial aims to compare the efficacy of SPAP (a novel Auto-CPAP algorithm) to conventional CPAP.

Up to 50 patients will be recruited from an OSA population, aged over 18. Participants will consist of male and female patients diagnosed with moderate-severe OSA (Apnea Hypopnea Index (AHI) greater than or equal to 15 per hour. Eligible participants, according to the protocol approved by the Northern X Region Ethics Committee, providing written informed consent will be enrolled into the study. Patients will be enrolled sequentially according to the randomisation list. Patients will be randomised to CPAP or SPAP.

The therapeutic pressure will be based on the most recent titration night of each patient. Comparisons between data will be made using a one-tailed t-test for non-inferiority of the SPAP algorithm compared with conventional CPAP therapy.

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥18 years with mild-to-severe OSA (Apnea Hypopnea Index equal to or greater than 5 per hour).

Exclusion Criteria:

* Any medical condition which contraindicates (see Appendix A) the use of CPAP or AutoCPAP.
* Unstable cardiovascular disease (untreated or resistant hypertension acceptable).
* Unstable psychiatric disease.
* Other significant sleep disorder.
* Inability to tolerate CPAP due to nasal obstruction or claustrophobia, as determined by the investigation investigator.
* Any known factor or disease that might interfere with treatment compliance, investigation conduct or interpretation of the results such as psychiatric disease, history of non compliance to medical regimens, or unwillingness to comply with investigational requirements.
* Participation in another clinical trial in the previous month.
* Less than 2 hours recorded sleep in either arm
Promoting Self Care to Prevent Urinary Incontinence (UI): A Four-Year Follow-up

This study examined whether self-efficacy promoted adherence to Pelvic Floor Muscle Training (PFMT) and Bladder Training (BT) in women aged 55 and older.

The study was designed to determine the capacity of self-efficacy to predict maintenance of the practices of PFMT and BT. Women in the treatment arm of the RCT attended a Bladder Health Class (PFMT \& BT) to prevent UI. The class content emphasized self-efficacy. At 3-months post intervention the self-efficacy of participants was measured; these results were collected to analyze for predictive capacity of training adherence. For four years participants in both the treatment and control (no class) arms were followed with both questionnaires and 3-day bladder diaries (2/year) and clinic evaluations of (1/year). In addition, qualitative analyses of the narratives of Bladder Health Class participants identified individual attitudes and strategies that either facilitated or deterred adherence.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 55 years or older who report 5 or fewer episodes of UI / year, no prior treatment for UI, no neurological disease, no difficulties performing activities of daily living

Exclusion Criteria:

* Less than 55 years old, UI episodes greater that 5 per year, score of less than 24 on Mini Mental Status Examination