cyrilzakka/clinical-trials huggingface dataset:
Role of MRI in Breast Cancer Subtypes

efficacy of MRI in detection of breast cancer molecular subtypes instead of biopsy and immunohistochemistry

2.4.4 -Study tools (in detail, e.g., lab methods, instruments, steps, chemicals, ...): Patient with breast cancer (malignant breast mass) will do MRI breast and molecular subtypes will be assessed

MRI imaging studies will performed on a 1.5 T scanner , The patient is placed in the prone position with both breasts placed adequately in a double breast coil (four-channel phased array coil), MRI sequences are:

1. Axial T1WI. 2. Axial T2WI. 3. Axial STIR. 4. DCE-MRI with post-processing subtraction images 5- Axial DWI at b value( 0, 400, 800 and 1000 mm\^2 per second) and ADC map will performed 6. MRI spectroscopy MRI acquisition protocol MRI protocols includes

* Axial T2-weighted fast spin echo sequence: TR=3840 ms, TE=81 ms, slice thickness=3.5 mm, and matrix=448×448.
* Coronal T2-weighted fast spin echo sequence: TR=3840 ms, TE=81 ms, slice thickness=3.5 mm, and matrix=448×448.s
* Short tau inversion recovery - axial: TR=8540 ms, TE=59 ms, TI=170 ms, slice thickness=3.5 mm, and matrix=320×314.4.
* The standard dynamic protocol commenced with a coronal three-dimensional rapid Field echo (thrive) sense non-enhanced T1-weighted sequence.
* A gadolinium containing contrast was administered at a dose of 0.2 ml/ kg by power injection at a speed of 2.0 ml/s and flushed with 20 ml of saline solution at the same rate.
* Dynamic imaging was then done in five consecutive series at 90-s intervals. Standard subtraction images were obtained by subtracting precontract images from the early peak postcontrast image.

Eligibility Criteria:
Inclusion Criteria:

a. patients with breast cancer confirmed by histopathology,

Exclusion Criteria:

1. breast implants
2. general Contraindication of MRI as claustrophobia
Telomere Length in Human Polar Body and Telomere Length in Cumulus Cells: A Clinical Validation Study

To investigate whether telomere length (TL) of the first Polar body (PB) correlates with TL in Cumulus cells (CC)

With the present study we want to analyze, as a primary objective, whether telomere length (TL) in the first Polar Body (PB) correlates with TL in the corresponding Cumulus cells (CC). As a secondary objective, a possible correlation between TL in PBs and blastocyst TL and ploidy will be evaluated.

To our best knowledge, there are no studies evaluating TL in CC and TL in PBs of the corresponding oocyte. With the present prospective study, we sought to investigate whether there is a correlation between CC-TL and PB-TL. If a correlation exists, CC-TL assessment would serve as a valuable non-invasive technique to gain information about oocyte competence.

Eligibility Criteria:
Inclusion Criteria:

* BMI 18- 30kg/m2
* Expected normo/high responders
* Normal female/male karyotype
* Antagonist protocol with agonist trigger.
* PGT-A: NGS in blastocysts
* Fresh autologous ejaculates (≥5 mill/ml)
* Primary and secondary infertility
* Only ICSI as insemination technique

Exclusion Criteria:

• PCOS patients according to International evidence-based guideline for the assessment and management of polycystic ovarian syndrome 2018.
Long-term Outcomes of Conduction System Pacing: a National Multicenter Observational Study - NORMAND'HIS / STIMU'HIS

This prospective multicenter registry will evaluate the long-term electrical, echocardiographic, and clinical outcomes of conduction system pacing (CSP). There is currently limited data in the literature regarding the long-term results and benefits of CSP. The long-term maintenance of conduction system (His bundle or Left Bundle Branch) capture and physiological ventricular activation is an essential prerequisite for the expected benefits of this technique.

There is currently no prospective study evaluating the preservation of CSP during long-term follow-up. The design of the present study will allow reliable evaluation of CSP maintenance at 2 years follow-up. The prospective collection of electrical data (pacing thresholds, impedance, R wave sensing) during pacemaker follow-up visits will confirm thresholds stability over the long term. The incidence of atrial fibrillation episodes will also be precisely evaluated and will provide new information. Although pathophysiological studies have demonstrated less impairment of left atrial function with conduction system pacing, there is currently no data on the incidence of atrial fibrillation in patients implanted with a CSP pacemaker.

Echocardiographic data will be prospectively collected in order to analyse the evolution of left ventricular ejection fraction (LVEF) after CSP. This systematic follow-up is rarely found in CSP studies, often retrospective, with significant missing echocardiographic data. The hypothesis is that patients benefiting from CSP will not develop the deleterious effects demonstrated with conventional right ventricular pacing, such as left ventricular dilation and LVEF impairment. Inter- and intraventricular asynchrony criteria will also be systematically evaluated during follow-up echocardiography.Finally, this prospective cohort will also systematically collect clinical follow-up data (hospitalizations for heart failure and NYHA stage).


Eligibility Criteria:
Inclusion Criteria:

* Patient who had undergone conduction system pacing attempt
* Age \> 18 yo
* Capacity to understand the nature of the study, legal ability and willingness to give informed consent

Exclusion Criteria:

* Patient under guardianship, trusteeship, or legal protection.
* Pregnant woman (positive urine pregnancy test) or breastfeeding or lack of proven effective contraception (according to the WHO definition) or menopausal without confirmed diagnosis (non-medically induced amenorrhea for at least 12 months before the inclusion visit).
RECOVERY: A Transdiagnostic Intervention for Anxiety and Depression

To investigate the efficacy and acceptability of a guided internet delivered transdiagnostic intervention, targeting mild to moderate clinical symptoms of anxiety and depression and emphasizing the changes taking place at the level of the structures of the self.

The effectiveness of a Transdiagnostic Cognitive-Behavioral Treatment will be compared with an improved version of it, in which new intervention techniques were added, pointing out the importance of improving some self-concept dimensions in reducing symptoms of anxiety and depression. In order to prove this, the study design will include two active intervention groups; a standard transdiagnostic intervention protocol will be delivered to one group and an improved version of the same transdiagnostic protocol will be delivered to the other group. The new added techniques targets some self-concepts, namely self-compassion, unconditional self-acceptance and self-esteem. The main goal of the study is to concurrently test effectiveness of these two transdiagnostic approaches in reducing symptoms of anxiety and depression and improving the above-mentioned self-concepts. This non-inferiority trial has the power to detect an effect size larger than Cohen's d = .40 (including 20% attrition at post-test and 6 month follow-up)

Eligibility Criteria:
Inclusion Criteria:

1. be fluent in Romanian,
2. be at least 18 years of age,
3. have at least a clinical diagnosis of major depressive disorder/dysthymia, and/or generalized anxiety disorder, and/or social anxiety disorder, panic anxiety disorder and/or Agoraphobia, specific phobia or any combination of these conditions on Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders 5 (SCID-I 5)

Exclusion Criteria:

1. suicidal plans,
2. changes in the dosage if psychotropic medication during the last month (if present),
3. have bipolar disorder or psychosis (according to medication status),
4. have an alcohol/substance abuse and/or dependence disorder,
5. currently take part in other psychological treatment,
6. obvious obstacle to participation (i.e., no current Internet access, long travel plans during the treatment period etc.)
CVD Nutrition Modules Tailored to Low Literacy Skills

To develop cardiovascular disease nutrition modules tailored to subjects with low literacy skills.

BACKGROUND:

The study was part of an NHLBI initiative on "CVD Nutrition Education for Low Literacy Skills". The initiative originated within the Prevention and Demonstration Branch of the DECA, was approved by the September 1988 National Heart, Lung, and Blood Advisory Council, and released in July 1990.

DESIGN NARRATIVE:

The study had three phases. The goal of Phase I was to develop two innovative care modules that used demographic, psycho-social, nutritional, and behavioral information to individually tailor nutrition treatment programs for southern patients with less than ninth grade reading skills. Counselor Directed innovative care consisted of a structured assessment and intervention package of simply written, graphically-oriented printed materials to guide the patient and health counselor (nutritionist, health educator, nurse, or physician). Computer Assisted innovative care used a user-friendly, interactive, computer assisted program permitting more sophisticated tailoring to individual needs, conveying nutrition information in a vivid, understandable format, and extending the services of the health counselor. The investigators used focus groups of patients with low literacy skills to aid in concept development and refinement of intervention delivery strategies. Reliable and valid assessments of readability and comprehension helped further refine the materials.

In Phase II, a randomized trial was conducted to determine if the innovative modules produced a meaningful reduction in cholesterol and overall cardiovascular risk compared to standard care. Subjects with high cholesterol and low literacy skills served by four community health centers were randomly assigned to one of four groups: Innovative Care-Counselor Directed, Innovative Care-Computer Assisted, Standard Care, and Usual Care for dietary treatment of cholesterol, obesity, and hypertension. Standard Care involved the same amount of time and health counselor exposure as Innovative Care, but used currently available materials. Usual Care patients were referred to their usual provider for treatment. After four months and again at one year, changes in lipids, blood pressure, and weight were assessed..

Phase Ill consisted of a feasibility study to test the ability of both innovative care modules to reach low literacy adults through county health departments, worksites, and churches. Results of the feasibility assessment helped refine a dissemination strategy using the state health department as a centralized coordinating agency, and county health departments to implement the interventions at the community level.

Eligibility Criteria:
Must have high cholesterol; Low-literacy skills; Must be patient at one of 9 community health centers recruited for study
Reducing Fetal Exposure to Maternal Depression to Improve Infant Risk Mechanisms

This study evaluates Interpersonal Therapy (IPT) in the treatment of depression among pregnant women with elevated depressive symptoms. Half of the women will be randomized to receive IPT, and the other half will get Treat As Usual, provided via behavioral health in the hospital.

Exposure to maternal depressive symptoms is one of the most well established risk factors for the development of later child psychopathology. Accumulating evidence from naturalistic observational studies documents that fetal exposure to maternal depressive symptoms is associated with risk for later child mental health problems. Maternal depression is one of the most common prenatal complications with approximately 40% of women experiencing elevated levels of depressive symptoms. The majority of past research has been correlational, so potential causal conclusions have been limited. This project will break new ground by testing the hypothesis that manipulating maternal depressive symptoms will benefit infant outcomes. In this project, maternal depressive symptoms will be reduced using brief interpersonal therapy (IPT), a well-established and efficacious treatment, and testing whether this reduction leads to an improvement in the development of infant mechanisms associated with risk for later psychopathology. The investigators propose to assess 300 pregnant women who report elevated levels of depressive symptoms and their infants. Prior to the intervention, maternal measures of depressive symptoms will be collected. Then half of the women will be randomized to receive IPT and the other half will receive enhanced usual care (TAU). After completion of the intervention, maternal measures will be collected longitudinally through 14 months postpartum. Infants will be evaluated at birth and two other times. Infants will be assessed across four units of analysis (brain structure and function, physiology, behavior, and maternal-report).

Eligibility Criteria:
Inclusion Criteria:

* Adult women (over 18 years of age)
* A singleton intrauterine pregnancy
* English speaking
* Elevated depressive symptoms based on screening with the Edinburgh Postnatal Depression Scale (EPDS) with score \> 9

Exclusion Criteria:

* Bipolar disorder and psychosis based on the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-NP)
* Current psychotropic medication use or current CBT/IPT usage
* An HPA axis or an endocrine disorder
* Maternal substance use \[assessed using maternal report and urine toxicology
* Corticosteroid medication use during this pregnancy
* Invitto fertilization
* Presence of cervical or uterine abnormalities
Pregnancy Exposure Registry for Vumerity (Diroximel Fumarate)

The primary objectives of the study are to estimate the risk of major congenital malformations (MCMs) in infants born to women with multiple sclerosis (MS) who were exposed to diroximel fumarate (DRF) at any time from 2 weeks after the first day of their last menstrual period (LMP) up through the first trimester of pregnancy and to comparatively evaluate pregnancy outcomes with MCMs in women with MS who were exposed to DRF at any time from 2 weeks after the first day of their LMP through the first trimester of pregnancy with the following: i) women with MS who were unexposed to disease modifying therapies (DMTs) and, ii) women with MS who were exposed to other DMTs (e.g., Avonex and Tysabri Pregnancy Registries).

The secondary objective of the study is to evaluate pregnancy outcomes in women with DRF exposure at any time from 2 weeks after the first day of their LMP through the end of pregnancy compared with the following: i) women with MS who were unexposed to DMTs, ii) women with dimethyl fumarate (DMF) exposure, iii) women with MS who were exposed to other DMTs (e.g., Avonex and Tysabri Pregnancy Registries), and iv) women without MS (e.g., women from external, general population comparators).


Eligibility Criteria:
Key Inclusion Criteria:

* Participant must have a diagnosis of MS
* Documentation that the participant was one of the following:

  1. exposed to DRF at any time from 2 weeks after the first day of their LMP (i.e., conception date) up through any time during pregnancy. (If exact exposure dates are unknown, the reporter must be able to specify or estimate trimester of exposure).
  2. unexposed to any DMT during pregnancy, defined as having never received DMT therapy; discontinued treatment with DRF at least 1 day before 2 weeks after the first day of their LMP (i.e., conception date); or discontinued a non Registry-specified MS DMT more than 5 times its half-life prior to 2 weeks after the first day of their LMP (i.e., conception date)
* Participants with knowledge of the outcome of the pregnancy (e.g., pregnancy loss or live birth)

Key Exclusion Criteria:

- None

NOTE: Other protocol defined Inclusion criteria may apply
Clariance ErYs Registry

International, prospective, single arm, multicenter and observational Post-Market Clinical Follow-up (PMCF).

The overall objective of this study is to collect preoperative, intraoperative and postoperative (at 9 weeks, 6 months, 1 year and 2 years) data on the clinical complications and functional outcomes of the study devices to demonstrate safety and performance in a real-world setting.

The primary objective is to demonstrate that the use of the study devices is safe.

The secondary objective is to demonstrate that the use of the study devices decreases the pain, and improves the quality of life and the daily activities of the subjects.


Eligibility Criteria:
Inclusion Criteria:

* Considered as adult in the respective geography (18 years old or older for France and 21 years old or older for United-States).
* Indicated for treatment with one or more commercially available sponsor spine device included into the study.
* For France only, affiliated with or beneficiary of a social security scheme.

Exclusion Criteria:

* Subjects who are not able to comply with the study procedures based on the judgment of the investigator (e.g., inability to comprehend study related questions, inability to keep scheduled assessment times).
* Subjects who are considered as vulnerable: minor, pregnant woman or people under legal protection (guardianship or curatorship).
* Contraindicated for spine surgery utilizing a commercially available sponsor spine device.
Electroclinical Features of Sudden Unexpected Death in Epilepsy (SUDEP) : a Multi-center Observational Study

Sudden unexpected death in epilepsy (SUDEP) is regarded as a leading cause of premature death in epilepsy patients. We aim to capture the whole process of SUDEP and near-SUDEP occurrence in patients with epilepsy, and expolre video-electroencephalograph (V-EEG) changes and marker. A Chinese multicenter study was carried out to determine electroencephalo-graph marker related to SUDEP to provide a scientific basis for the prevention of SUDEP in patients with epilepsy.


Eligibility Criteria:
Inclusion Criteria:

* Patients with epilepsy who meet SUDEP or near-SUDEP diagnosis,
* Giving written informed consent to participate in the study from relatives or caregivers.

Exclusion Criteria:

* Refusing to recruitment from relatives or caregivers.
Use of Exome Sequence Analysis and Circulating Tumour in Assessing Tumour Heterogeneity in BRAF Mutant Melanoma

Despite recent advances in cancer treatment, little impact has been made on curing as opposed to controlling cancers over the last several decades. Part of the problem is that investigators have an incomplete understanding of how tumours behave as they evolve and in response to treatment. In this trial, the investigators hope to better understand the evolution of BRAF melanoma in response to drugs a patient may have received such as vemurafenib or dabrafenib. Importantly, the investigators want to understand how the tumours evolve resistance to these drugs and whether this can be predicted through blood tests, in particular of the circulating tumour DNA.

Study population: BRAF mutant melanoma patients

Pre-mortem bloods will be taken from the patient on three occasions at one to thirty days apart from each other, with the first blood draw taking place on the patient's first clinic visit. Six 7 ml EDTA and one 6 ml SST vacutainers of blood (a total of approx. 50 ml of blood) will be taken from the patient.

When death is expected within the next 48-72 hours, the Medical Oncologist/ Radiation Oncologist/ Hematologist OR delegate will revisit the RAP process with the patient and/or family/substitute decision maker to ensure that they are still in agreement. The patient and the families will also be provided with an additional consent form for participation including blood sampling.

Eligibility Criteria:
Inclusion Criteria:

UHN adult patient with BRAF mutant melanoma

Exclusion Criteria:

Non BRAF mutant melanoma patient Pediatric patient Non-UHN patient
Study to Determine the Impact of Multiple Doses of Rifampin on Single-dose Pharmacokinetics of HCV-796

An open label, 2-period, sequential study to determine the impact of multiple doses of rifampin on single-dose pharmacokinetics of HCV-796


Eligibility Criteria:
Inclusion Criteria:

* Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG).
Waitlist-Control Trial of Smartphone CBT for Major Depressive Disorder (MDD)

The investigators are testing the efficacy of Smartphone-delivered cognitive behavioral therapy (CBT) treatment for major depressive disorder (MDD). The investigators hypothesize that participants receiving app-CBT will have greater improvement in SIGH-D scores than those in the waitlist condition at treatment endpoint (week 8).

The primary aims of this study are to test the efficacy of a Smartphone-based CBT treatment for adults with MDD recruited nationally. Eligible subjects (N=112) will be randomly assigned to 8 weeks of Smartphone-delivered CBT for MDD either immediately, or after a 8-week long waiting period (50-50 chance). The investigators hypothesize that Smartphone-delivered CBT for MDD will be feasible and acceptable to individuals with MDD, and that it will lead to greater reductions in MDD symptom severity compared to the passage of time (waitlist control).

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Current diagnosis of primary DSM-5 MDD, based on MINI
* Currently living in the United States

Exclusion Criteria:

* Psychotropic medication changes within 2 months prior to enrollment (Participants taking psychotropic medication must have been on a stable dose for at least 2 months prior to enrollment and not change medication during study period)
* Past participation in ≥ 4 sessions of CBT for depression
* Current severe substance use disorder
* Lifetime bipolar disorder or psychosis
* Acute, active suicidal ideation as indicated by clinical judgment and/or a score ≥ 2 on the suicidal ideation subscale of the C-SSRS
* Concurrent psychological treatment
* Does not own a supported mobile Smartphone with a data plan
* Lack of technology literacy that would interfere with ability to engage with smartphone treatment
PLACE OF THE 18F-FDG-PET/CT IN THE DIAGNOSTIC WORKUP IN PATIENTS WITH CLASSICAL FEVER OF UNKNOWN ORIGIN (FUO)

Objective : To explore the diagnostic contribution of the 18F-FDG-PET/CT in a population of patients with classical fever of unknown origin (FUO), to precise its place in the diagnostic decision tree in a real-life setting and to identify factors associated with a diagnostic 18F-FDG-PET/CT.

Methods: All adult patients (age≥18 years) with a diagnosis of classical FUO who underwent a 18F-FDG-PET/CT in the University Hospital of Montpellier (France) between April 2012 and December 2017 were included. True positive 18F-FDG-PET/CT which evidenced a specific disease causing FUO were considered to be contributive.


Eligibility Criteria:
Inclusion Criteria:

* age≥18 years
* a diagnosis of classical FUO who underwent a 18F-FDG-PET/CT

Exclusion Criteria:

-refusal to participate-