cyrilzakka/clinical-trials huggingface dataset:
Attachment Style and Mentalization Impact Among Women Victims of Domestic Violence

Attachment and mentalization with a population of domestic violence victims Domestic violence is one of the most common forms of domestic violence. Multiform and complex, it affects all backgrounds and all ages. According to a survey instituted by the government of Emmanuel Macron, 219,000 women were recognized as victims of domestic violence in 2017. This phenomenon is not without questioning the scientific scene. Also, this study focus on the quality of the attachment because if this bond is insecure, it can constitute a point of vulnerability in self-construction and impact on future relational modalities.

The security of the bond of attachment depends on the capacity of the maternal figure, or her substitute, to understand and respond in an adapted and consistent manner to her baby. In addition, it has also been established that when disruptions occur in the security of attachment bond, the quality of mentalization is impacted. But, mentalization is the quality and quantity of psychic representations available to allow someone understanding and thinking about his links to others and to himself. This is an essential asset in the release of situations of violence and in overcoming trauma because it participates in psychic development. That's why this research focuses on early relationships and the quality of mentalization with a cohort of thirty women victims of domestic violence, consultant within the Legal Medicine department of the CHU of Besançon. This research focuses on two groups of subjects: women who managed to get out of violent relationship (15 subjects) and others who did not (15 subjects). The research methodology includes several tools: two projective tests (Rorschach and TAT), ten self-questionnaires (which assess attachment, stress, social support, relational quality with the main attachment figures, the image of the Self-body, quality of mentalization), a clinical research interview and presentation of the AAI. The observation of this population will highlight the impact of the early environment in the psychic construction of the subject and the victim's destiny. Moreover, this study will look at the role of psychotherapeutic follow-up in the quality of mentalization.

Eligibility Criteria:
Inclusion Criteria:

* Women over 20 years old, victims of domestic violence
* With european culture
* Separated from their abusive partner
* Consulting the Legal Medicine Department in Besançon University Hospital

Exclusion Criteria:

* Refusal to participate
Comparison of Sternal Wound Infiltration With Liposomal Bupivacaine v. Bupivacaine Hydrochloride

The aim of this study is to evaluate the analgesic efficacy and safety of wound infiltration with liposomal bupivacaine (LB) in patients undergoing cardiac surgery with sternotomy and cardiopulmonary bypass (CPB) and compare it with bupivacaine hydrochloride infiltration

There are no studies to date on the use of LB infiltration and its analgesic efficacy in cardiac surgery done through sternotomy, even though the majority of cardiac surgeries utilize this approach. Moderate to severe pain is common in patients undergoing these surgeries and is usually inadequately treated. Other various pain treatment modalities such as opioid and neuraxial anesthesia are avoided due to potentially dangerous side effects in this cohort. The efficacy of local anesthesia techniques, such as bupivacaine, are limited due to short duration of action and increased incidence of wound infection. On the other hand, slow release liposomal bupivacaine may last up to 72 hours, indicating it's potential for more adequate analgesia compared to bupivacaine.

Eligibility Criteria:
Inclusion Criteria:

* Open cardiac surgery through sternotomy approach (eg. coronary artery bypass graft, valvular heart procedures, as well as other open cardiac procedures along with coronary artery bypass)
* Surgery with the use of cardiopulmonary bypass

Exclusion Criteria:

* Minimally invasive heart surgery through thoracotomy approach
* Patient undergoing procedures under deep hypothermic circulatory arrest
* Patients with active infections such as infective endocarditis
* Emergency surgery
* Patients undergoing transplantations and ventricular assist device insertion
* Patients on any mechanical circulatory support preoperatively
* Patient's refusal
* End stage liver or renal disease
* Allergy to bupivacaine
* Patient who cannot understand the study procedure or refuse to participate
* Redo-sternotomy
* Participation in another study
* Patients with severe right or left ventricular dysfunction (EF\< 25%)
* Patients requiring chronic opioids for chronic pain condition
Study of Postoperative Nutritional Support in Cardiac Surgery.

The purpose of this study is to determine whether postoperative nutritional support improves postoperative outcomes in cardiac patients with malnutrition .


Eligibility Criteria:
Inclusion Criteria:

* Absolute lymphocyte count \< 1500
* Albumin \<35 g/L
* Body mass index\<21 kg/m2
* "B" class of nutritional status according to Subjective Global Assessment

Exclusion Criteria:

* Hepatitis B, C
* Total circulatory arrest
* Absence of informed consent signed
* Chronic liver diseases
* Gastric resection in patient's history
* Physical limitations of normal feeding
Fecal Microbiota and Monocyte Trained Immunity in CHD Patients With Different hsCRP

This single-center study enrolled patients aged 35-75 years who were diagnosed with unstable angina (UA), and had at least one of the three major coronary arteries with a ≥ 50% reduction in lumen diameter by angiographic visual estimation. Patients were all recruited at the Department of Cardiology, Union Hospital, Wuhan, Hubei Province, China. Feces and blood samples were collected on admission were used promptly for ex vivo studies.

This single-center study enrolled patients aged 35-75 years who were diagnosed with unstable angina (UA), and had at least one of the three major coronary arteries with a ≥ 50% reduction in lumen diameter by angiographic visual estimation. Patients were all recruited at the Department of Cardiology, Union Hospital, Wuhan, Hubei Province, China. Exclusion criteria included acute myocardial infarction, prior myocardial infarction, malignancies, auto-immune or auto-inflammatory diseases, or ongoing infection. Feces and blood samples were collected on admission were used promptly for ex vivo studies.

the aim of the study is to investigate whether the fecal microbiota and peripheral blood monocytes in patients with coronary heart disease at different levels of inflammation are associated with the level of inflammation.

Eligibility Criteria:
Inclusion Criteria:

1. Age \>35 and \<75 years
2. Admitted for UA and had at least one of the three major coronary arteries with ≥50% reduction in lumen diameter by angiographic visual estimation
3. Informed consent obtained

Exclusion Criteria:

1. Prior myocardial infarction
2. Left ventricular ejection fraction ≤ 40% on echocardiography
3. Have a history of malignancies, auto-immune, auto-inflammatory disease or on immunomodulatory medication
4. Ongoing acute, chronic, or concurrent infectious disease
5. Surgery 3 months before sample collection
6. Immunization with a vaccine within 4 weeks before sample collection
7. Pregnancy, or breast feeding
8. History of primary or secondary immunodeficiency
9. Renal failure with estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73m2
10. Active liver disease with alanine aminotransferase (ALT \>80 U/L) or aspartate aminotransferase (AST \> 80 U/L)
11. History of chronic obstructive pulmonary disease (COPD)
12. Refuse to provide written consent
13. Any other circumstances in which the investigator judges that the patient is not suitable
Effect of Caffeine on Fetal Growth

The purpose of this study is to determine whether caffeine has any effect on birth weight.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant
* Consumption of at least 3 cups of coffee/day at recruitment

Exclusion Criteria:

* Gestational age more than 20 weeks at recruitment
* Chronic kidney disease
* Epilepsy
* Insulin dependent diabetes
* Metabolic disorder
* Previous low birth weight delivery
* Previous preterm delivery
Xpress Digital Mammography System Images for Computer Aided Detection Development

The primary objective of this study is to acquire digital mammography images produced by the Xpress Digital Mammography System in order to develop Computer Aided Detection software and systems.

The proposed study is an image acquisition study of mammograms produced by the investigational digital system. Women who meet the selection criteria and who agree to participate in the study will be imaged with the Xpress Digital Mammography System at the clinical sites. These images will be provided to CAD development companies to conduct their own development and testing. The CAD development companies will be responsible for submitting their results to the FDA for marketing approval of their CAD systems.

Patients will be drawn primarily from those women scheduled for breast biopsy since this population has an enhanced probability of cancer. The intent is to enroll patients until at least 107 women with biopsy proven cancers, and at least 330 women who have negative mammograms are enrolled. All cancers found will be used in the study. It is anticipated that approximately 720 patients undergoing diagnostic mammography will need to be enrolled to yield 107 proven cancer cases. In addition, approximately 330 cases will be drawn from a screening population. The negative status of the screening cases will be established by selecting only cases classified as BIRADS 1 or 2, and have a negative mammogram at one year follow-up. All images collected will be utilized to develop and test the CAD systems, and may be used for further product development.

Eligibility Criteria:
Inclusion Criteria

Cases selected for the study must meet all of the following criteria:

* Female
* Scheduled for a routine screening mammography or routine breast biopsy for non-palpable findings
* Any ethnic origin

Exclusion Criteria

Patients meeting any of the following criteria will be excluded from the study:

* Any contraindication to mammography
* Pregnant or suspicion of being pregnant, or nursing
* Patients with palpable lesions
* Patients with internal breast markers in the region of interest
* Breast implants, without displaced views
* Significant recent breast trauma/acute mastitis
* Patient has previously undergone an excisional breast biopsy
* Patients with a history of breast cancer
* Unable or unwilling to give consent
Movement Pattern in Patients With Hip Dysplasia

The purpose of this study is to examine the movement pattern in patients with hip dysplasia preoperative, six and 12 month after minimally invasive approach for Periacetabular osteotomy (PAO). Secondary to examine the movement pattern in patients compared to healthy controls and historical data.

Congenital hip dysplasia is a disease characterised by pathological changes in the hip joint. Hip dysplasia is a normal disease with a prevalence of 4.3% in men and 3.6 in woman. Untreated hip dysplasia is a known cause of developing osteoarthritis early in life and symptoms as pain, hip instability together with a changed gait pattern are normal. Symptomatic hip dysplasia is seen in patients between 15 and 55 years and can be unilateral as well as bilateral. Causes of hip dysplasia are described as genetic, mechanic or hormonal.

Today patients with hip dysplasia are offered a hip conserving surgery before the osteoarthritis has developed. In 2003 a minimally invasive approach for periacetabular osteotomy (PAO) was introduced at Aarhus University Hospital. An advantage of minimally invasive approach compared to the classical Bernese periacetabular osteotomy is minimal impact of the soft tissues in the hip region.

Hip pain and activity limitations highly affect quality of life and physical function. The gait distance is reduced and patients have to compensate to relieve the pressure on the hip joint. Knowledge about the dynamics of the gait and running pattern in patients with dysplasia is important to understand the consequences of the dysplastic hip joint. Furthermore knowledge about gait compensations is relevant for the clinicians in the management and treatment of patients with hip dysplasia.

Today, gait and running compensation is unknown after minimally invasive approach The purpose of this study is, therefore, to examine the movement pattern in patients with hip dysplasia preoperative, six and 12 month after minimally invasive approach for Peri-acetabular osteotomy (PAO). Secondary to examine the movement pattern in patients compared to healthy controls and historical data.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with hip dysplasia
* Patients in the age of 18-60 years
* Patients, who can speak, understand and read Danish

Exclusion Criteria:

* Persons with hip dysplasia secondary to other hip conditions such as Calvé Perthes and epiphysiolysis.
* Persons who have had alloplastic surgery in the hip, knee or ankle.
* Persons with diseases that affect the gait pattern.
* Persons with serious hip, knee, ankle or back pain.
Safety and Efficacy of SGN-LIV1A Plus Pembrolizumab for Patients With Locally-Advanced or Metastatic Triple-Negative Breast Cancer

This trial studies ladiratuzumab vedotin (LV) with pembrolizumab in patients with triple-negative breast cancer. It will find out what side effects happen when participants get these two drugs. A side effect is anything the drugs do besides treating cancer. Pembrolizumab is a drug that can be used to treat triple-negative breast cancer. The trial will also find out if these drugs work to treat this type of cancer. Participants in this study have metastatic breast cancer. This means the cancer has spread to other parts of the body.

The primary goal of this study is to evaluate the combination of LV, which targets LIV-1- expressing tumor cells, with the checkpoint inhibitor pembrolizumab for patients with unresectable locally-advanced or metastatic triple-negative breast cancer. These two drugs act through distinct and possibly complementary modes of action.

This is a single-arm, open-label, multicenter trial. Patients given LV and pembrolizumab during dose escalation will be monitored for frequency of dose-limiting toxicities to determine a recommended doses for expansion cohorts. In addition to safety measures, objective response rate, progression-free survival, overall survival, and other efficacy outcomes will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Metastatic or locally-advanced, histologically documented TNBC (absence of HER2, ER, and PR expression)

  * Part D only: Tumor tissue PD-L1 Combined Positive Score \<10 expression.
* Have not previously received cytotoxic therapy for the treatment of unresectable locally-advanced breast cancer or metastatic breast cancer
* At least 6 months since prior treatment with curative intent and recurrence
* At least 1 tumor 10mm in diameter or greater OR lymph node of at least 15 mm in short axis
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Able to provide biopsy tissue for biomarker analysis
* Meet baseline laboratory data criteria

Exclusion Criteria:

* Prior immune-oncology therapy
* Pre-existing neuropathy of at least Grade 2
* History of carcinomatous meningitis or active central nervous system (CNS) metastases. Patients are eligible if CNS metastases are adequately treated and patients have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 4 weeks prior to enrollment. Patients must be off corticosteroids.
* Received prior radiotherapy within 2 weeks of start of study treatment or have not adequately recovered from prior radiotherapy
* Active autoimmune disease requiring systemic treatment within the past 2 years
* History of interstitial lung disease
* Current pneumonitis or history of pneumonitis requiring steroids
Evaluation of the GORE PV1 Device in Patients With Pulmonary Valve Dysfunction

This study will assess the safety and performance of the GORE PV1 Device for replacement of the pulmonary valve and reconstruction of the Right Ventricular Outflow Tract (RVOT).


Eligibility Criteria:
Inclusion Criteria:

1. A symptomatic or appropriate asymptomatic subject with a native or repaired right ventricular outflow tract requiring reconstruction with a valved conduit
2. Age ≥5 years at the time of informed consent signature.

Note: Additional Inclusion Criteria may apply

Exclusion Criteria:

1. An artificial valve at another position or will need an artificial valve at another position (i.e. replacement at the time of index procedure or anticipated within 3 years).
2. Subjects with previously implanted pacemaker (including defibrillators).
3. Major or progressive non-cardiac disease (liver failure, renal failure, cancer) that has a life expectancy of less than one year.

Note: Additional Exclusion Criteria may apply
Ultrasound Detection of Radiographically Negative Fractures of Elbow in Children

Fractures of an elbow are common in children. Accurate initial diagnosis is crucial for the management of the fractures of an elbow. In young children the fractures may be suspected clinically but missed on x-rays due to mostly non-ossified cartilage that is not visible on a regular x-ray. We propose that every x-ray negative, but clinically suspicious elbow trauma in children can be additionally evaluated using high resolution US.


Eligibility Criteria:
Inclusion Criteria:

* Signing Informed consent

Exclusion Criteria:

* Unwillingness to sign informed consent.
* Any fracture of the same hand or forearm before or after an avaluated event.
Effectiveness of a Wheelchair Skills Training Program for Power Mobility Users: A Randomized Controlled Trial

This is a 3-year multi-centre, single-blinded, randomized controlled trial (RCT) to test the hypothesis that wheelchair skills training (using a systematic training program called the Wheelchair Skills Training Program) improves wheelchair skills and safety of 144 powered wheelchair users. A second objective is to assess the effects of age, sex, training centre, and participant experience on outcomes, assessing the retention of benefits and assessing the impact of training on other important outcomes.


Eligibility Criteria:
Inclusion Criteria:

* new or experienced powered wheelchair users
* use or are expected to use powered wheelchairs for at least 4 hrs/week
* have access to a powered wheelchair with a suitable range of controller settings (i.e. able to climb a 5cm level change) for testing and training
* equal or greater than 18 years of age
* able to follow directions in either French or English (whichever is in use at the participating site)
* have the potential to operate their powered wheelchairs independently
* have room for improvement (in the opinion of the potential participant's clinician)
* requires no more than minimal assistance for communication and auditory comprehension (in the opinion of the potential participant's clinician)
* able to follow 2-step commands
* demonstrate the ability to attend training sessions during the intake session
* competent to provide their own informed consent
* able to be comfortably seated in the powered wheelchairs that will be used for the study (if not their own).

Exclusion Criteria:

* use or are expected to use a scooter
* have a rapidly progressive disorder (e.g. amyotrophic lateral sclerosis or terminal cancer)
* have significant visual impairments (legally blind)
* have unstable medical conditions (e.g. angina, seizures)
* have emotional problems (e.g. severe anxiety, depression) that might make participation unsafe or unpleasant
Efficacy of Ramdicivir and Baricitinib for the Treatment of Severe COVID 19 Patients

This study was designed to evaluate the efficacy of Remdesivir and Baricitinib combination therapy for the treatment of severe Acute Respiratory Distress Syndrome (ARDS) caused by Coronavirus disease 2019 (COVID-19). Our aim is to compare the outcome of the "Remdesivir + Baricitinib" combination against "Remdesivir + Tocilizumab" therapy and find the best option for the management of ARDS in COVID-19 patients.


Eligibility Criteria:
Inclusion Criteria:

Severe COVID-19 patients require hospitalization under HDU/ICU. The SARSCoV-2 infection will be confirmed by RT PCR / CT Chest in every case.

Exclusion Criteria:

Participants with uncontrolled clinical status who were hospitalized from the before. Contraindication / possible drug interaction. Participants who have any severe and/or uncontrolled medical conditions like, Severe ischemic heart disease, epilepsy, malignancy, Pulmonary/ renal/hepatic disease, AIDS, Pulmonary TB, pregnancy, Corpulmonale, and etc.
Effectiveness of Reminiscence Therapy Versus Cognitive Stimulation in Older Adults With Cognitive Decline

Although data suggest that non-pharmacologic therapies such as Reminiscence Therapy (RT) and Cognitive Stimulation (CS) can potentially maintain or reverse this trend, cognitive impairment can be a precursor to neurodegenerative processes. This study aimed to assess how an RT and a CS program affected cognition, depressive symptomatology, and quality of life (QoL) in older persons with cognitive decline who attended community support institutions in central Portugal. For seven weeks, a quasi-experimental study with two arms (RT and CS program) was conducted. The intervention was completed by 76 of the 109 older persons who were first screened (50 in the RT program, 26 in the CS program). In both groups, a pre- and post-intervention analysis revealed statistically significant differences in cognition, particularly in older adults' delayed recall ability.


Eligibility Criteria:
Inclusion Criteria:

* Ability to give informed consent before study commencement;
* Ability to participate in group activities for a period between 45 to 60 minutes;
* No pronounced impairment of their visual and auditory abilities;
* Mild to moderate cognitive decline, assessed as a score equal to or below 20 points in the Six-Item Cognitive Impairment Test (6-CIT).

Exclusion Criteria:

* Unstable clinical condition;
* Prescribed with cholinesterase inhibitors and/or antipsychotics during the study period.
Arterial Spin Labeling Perfusion Magnetic Resonance (MR) Imaging in Pediatric Brain Tumors

The purpose of this study is to get information regarding the usefulness and accuracy of this new magnetic resonance imaging (MRI) technique - termed arterial spin labeling (ASL) - in the diagnosis of pediatric brain tumors.

The purpose of this study is to get information regarding the usefulness and accuracy of this new MRI technique - termed arterial spin labeling (ASL) - in the diagnosis of pediatric brain tumors. This technique can non-invasively measure the blood flow to the brain during MRI examination. Because aggressive brain tumors require new blood vessels and a high level of blood supply to support its growth, we believe the tumor blood flow measured using ASL is a reliable indicator of tumor grade. This information may be useful for doctors to make treatment decisions and to monitor patients' response to treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age 0-18 years
* Primary brain tumor (newly diagnosed or recurrent) with measurable disease (at least 1cm2)

Exclusion Criteria:

* Patients with cardiac pacemaker or ferrous metal foreign bodies
* Patients with medical problems contradictive to receiving MRI scans.
* Patients requiring general anesthesia or sedation for their MRI scan.
* Patients with a history of cerebrovascular disorders (stroke, moya moya) that may alter cerebral perfusion.