cyrilzakka/clinical-trials huggingface dataset:
Physiopathologic Study of Induced by Thoracotomy / Thoracoscopy Neuropathy Mechanism

Pulmonary surgery, performed routinely by thoracotomy or thoracoscopy, can cause significant and frequent chronic postoperative pain, most often neuropathic. The role of trauma intraoperative intercostal nerve is evoked to explain the genesis of the neuropathy. Treatments proposed in the indication of neuropathic pain in a broad sense, are exposed to many cases of failures. It is supposed that these failures are due to a mismatch between the selected drug (which is specific to the target) and the real pathology because neuropathy encompasses many different pathophysiological syndromes which are sometimes intricated.

The main objective of this project is to study the clinical, psychophysical and electrophysiological (noninvasively) intercostal nerve affected by the surgery at the second postoperative month, by comparing the results with similar observations made shortly before the intervention.

This study will be proposed to patients undergoing thoracotomy or thoracoscopy for partial or total lung resection in the service of Thoracic Surgery of Centre Jean Perrin, the objective is to recruit 120 patients (for 100 evaluable patients) over a period of 18 months of inclusion.

The other objective of the project is to provide a treatment algorithm for patients in pain, and to compare the efficacy of this treatment with the pre-treatment observations data.

Exploratory study, including additional examinations and visits. Biomedical research.

Eligibility Criteria:
Inclusion criteria :

* patients undergoing lateral or posterolateral thoracotomy scheduled lung surgery, regardless of indication, or lung or pleural scheduled surgery (treatment of recurrent pneumothorax) by thoracoscopy;
* 18 to 80 years
* Informed consent to the trial
* Protected by the French health welfare

Exclusion Criteria:

* Refusal of the patient;
* Preexisting neuropathy ;
* Treatment of active substance known on neuropathic pain: gabapentin, pregabalin, amitryptyline, duloxetine, venlafaxine, tricyclic antidepressants, topical lidocaine or capsaicin;
* Emergency surgery;
* Specific clinical contexts including terminal or palliative neoplasia;
* Deficit psychiatric pathology and dementia.
Tolerance and Pharmacokinetics Study of MNTX Tablets

This is a double-blind, randomized, placebo-controlled, phase I study in normal healthy volunteers. Study treatment includes single doses of MNTX and placebo. In addition, half of each active treatment group is further randomized to a second, replicate dose of MNTX, and the placebo group receives an additional placebo dose.


Eligibility Criteria:
Inclusion Criteria:

1. Weight between 55 and 85 kg
2. In good health with no evidence of a clinically significant chronic medical condition
3. Non-Smokers.

Exclusion Criteria:

1. History of asthma, allergic skin rash, significant allergy or other immunologic disorder
2. Known or suspected hypersensitivity to opioids or opioid antagonists
3. History or suspicion of alcohol or drug abuse.
Metabolic Features Effects on FAST Score in MASLD Patients

The goal of this observational cross-sectional study is to evaluate the effect of metabolic features on Fibroscan-AST (FAST) score stratification in metabolic dysfunction-associated steatotic liver disease (MASLD) patients in Egypt.

Researchers will identify the metabolic risk factors in patients with MASLD. evaluate the effect of metabolic features on stratifying MASLD patients by predicting higher FAST score.

Participants will be subjected to history taking, clinical examination, laboratory investigations, abdominal ultrasonography, and transient elastography (Fibroscan) to measure liver stiffness (LSM) and controlled attenuation parameter (CAP). The Non-alcoholic fatty liver disease (NAFLD) fibrosis score and FAST score will be calculated.


Eligibility Criteria:
Inclusion Criteria:

* All patients with MASLD who had steatosis detected by (VCTE-CAP) elastography

Exclusion Criteria:

* Patients with a history of significant alcohol consumption more than 30 g/day in men and \> 20 g/day in women.
* Patients with positive hepatitis B or C virus markers.
* Patients with autoimmune hepatitis.
* Patients with any other metabolic liver disease.
* Patients with hepatic focal lesions.
Safety and Pk Study in 1- to 3- Month-Old Children With Bronchiolitis (0476-297)

The purpose of this study is to look at the preliminary safety profile of an investigational drug in children 1 to \< 3 months of age with bronchiolitis.


Eligibility Criteria:
Inclusion Criteria :

* Active bronchiolitis and a history of bronchiolitis and asthma-like symptoms.

Exclusion Criteria :

* Anemia or history of any significant illness that will pose additional risk to the patient.
[Study Evaluating the Efficacy and Safety of a Digital Therapeutic as an Adjunct to TAU in Postpartum Depression]

This study evaluates the efficacy of two digital therapeutics, WB001 and ED001, on depressive symptoms among women diagnosed with postpartum depression.

This randomized, double-blind, controlled trial evaluates the efficacy and safety of 8 weeks of treatment of two digital therapeutics in a population of women with mild to moderate postpartum depression. Patients will be referred by an obstetrician, pediatrician, or other healthcare professional, or by other digital and site based recruitment methods and, if interested, will complete the pre-screening process. Those confirmed as eligible will be scheduled to attend a screening/baseline onsite visit. Eligible participants will be randomized to one of the two groups and will receive instructions on downloading and using the smartphone application to which they were randomized. Participants will use the app as instructed and will attend telehealth visits to complete assessments for the primary and safety endpoints at Weeks 4 and 8 (EOT).

Eligibility Criteria:
Inclusion Criteria:

1. Must have primary residence in the United States
2. Must be ≤ 92 days postpartum
3. Must be women aged 22-45 years who had onset of a major depressive episode any time during pregnancy or within 4 weeks following delivery
4. Must own or have regular access to a smartphone (Android or iOS smartphone with a recent, supported operating system), and has reliable Wi-Fi access or sufficient data plan to engage with assigned treatment condition for the duration of the study
5. Participants must have current mild-moderate depression as measured by the HAMD-6 score \>7 and \<13 at screening
6. Participant must have a form of TAU, defined as clinician supervised outpatient care management and includes follow-up visits, medication, psychotherapy, or some combination thereof
7. TAU must be regularly scheduled or stable for at least 4 weeks prior to baseline (BL) visit

Exclusion Criteria:

1. Gestation less than 28 weeks
2. HAMD-6 score ≤7 or ≥13 (severe depression) at screening
3. Currently pregnant or plans to become pregnant within the next 8 weeks
4. History of drug and/or alcohol use disorder within the past 12 months
5. Lifetime history of suicide attempt or ideation with a plan and intent to harm oneself during the current episode of PPD
6. Current or lifetime psychosis
7. Current or lifetime history of schizophrenia, schizoaffective disorder, bipolar disorder, and/or homicidal or infanticidal ideation
8. History of antidepressant treatment with ketamine/esketamine, electroconvulsive therapy, vagal nerve stimulation, or a deep brain stimulation device
9. History of treatment-resistant depression (TRD)
10. Fetal demise within the past 18 months
Estrogen and Microvascular Function

The goal of this study is to learn how long-term use of estrogen affects blood vessels in healthy adults who were assigned male at birth.

Participants will:

* give one blood draw of 5 mL
* have a camera placed under the tongue to take pictures of blood vessels
* have 2 laser Doppler microdialysis catheters placed on the forearm to monitor blood vessels before and after local drug infusion

Researchers will compare blood vessel function of those who take estrogen supplements to those who do not.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18-60 years
* Identify as assigned male at birth (AMAB) +/- continuous estrogen treatment for a minimum of 1 year.
* Blood pressure \<140/ \< 90 mmHg
* No more than 1 cardiovascular risk factor

Exclusion Criteria:

* BMI \>35
* Medications that could alter cardiovascular control
* Rash, skin disease, or pigmentation disorders
* Anemia
* Kidney Disease
* Known skin allergies
* Smoking or tobacco use within last 6 months
* Coronary Artery Disease
* \> 1 cardiovascular risk factor
* Hypertension
* Diabetes
* Hypercholesterolemia
* Hyperlipidemia
* Bleeding disorders
* Use of anti-coagulants
* Allergies to study drugs
* Erectile dysfunction medication in the past 6 months
* Use of topical/non-topical steroids in last 6 months
* Internal mouth sores
Prevention of Pneumonia Comparing Ceftriaxone With Subglottic Aspiration

The primary purpose of the trial is to compare the efficacy and safety of two measures which claim to prevent early-onset ventilator-associated pneumonia.

Background: In a previous double-blind, placebo-controlled, randomized trial we found that a 3-day-course of ceftriaxone significantly reduced the incidence of early-onset ventilator-associated pneumonia (EOP). Continuous aspiration of secretions accumulating in the subglottic space above the cuff of the endotracheal tube has also been shown to prevent EOP.

Objective: To compare the effect of both preventive measures on the incidence of EOP.

Design: Randomized, multicenter.

Setting: Three general intensive care units at university hospitals in Spain. Patients: Patients without signs of infection and no concomitant systemic antibiotics were included if expected to require endotracheal intubation exceeding 2 days.

Intervention: All patients were intubated with an endotracheal tube equipped with a port for aspiration of subglottic secretions and subsequently randomized to receive a three day course of 2 gram/day iv ceftriaxone without aspiration of subglottic secretions or continuous aspiration of subglottic secretions.

Measurements: All ICU-acquired infections, antibiotic therapy, colonization and infection with 3rd-generation cephalosporin-resistant microorganisms, duration of intubation and ICU-stay and-mortality.

Eligibility Criteria:
Inclusion Criteria:

* Endotracheal intubation with endotracheal tube equipped with port for aspirations of subglottic contents and expected to exceed 48 hors.
* Absence of infection.
* 18 years or older.
* Informed Consent.

Exclusion Criteria:

* Endotracheal intubation prior to admission to hospital.
* Allergic to beta-lactam antibiotics.
* Formal indication for systemic antibiotic therapy.
Prediction of Patient Deterioration Using Machine Learning

This is a retrospective observational study drawing on data from the Brigham and Women's Home Hospital database. Sociodemographic and clinic data from a training cohort were used to train a machine learning algorithm to predict patient deterioration throughout a patient's admission. This algorithm was then validated in a validation cohort.


Eligibility Criteria:
Inclusion Criteria:

Cared for in the Brigham and Women's Home Hospital study

Exclusion Criteria:

Incomplete continuous monitoring data
Online Cognitive Behavioral Therapy Targeting Cardiac Anxiety

The purpose of the present study is to evaluate an internet-delivered exposure-based cognitive behavioral therapy (CBT) protocol tailored for patients following myocardial infaction (MI) to increase Quality of Life (Qol) and physical activity by reducing cardiac anxiety.

In the present research project, the investigators have tailored a CBT protocol to target the hypothesized mechanisms of how cardiac anxiety affects the clinical course of MI; by using exposure therapy to reduce fear, hypervigilance, and misinterpretations of cardiac symptoms to reduce MI-related avoidance and increasing physical activity.

Participants (estimated N=100) are randomized to internet-delivered CBT for 8 weeks or to a waitlist offered treatment as usual. Patients in the control arm will be crossed over to CBT treatment 3 months after the experimental group has completed treatment. Assessments will be conducted pre-treatment, post-treatment, 3 months (primary endpoint), 1-, 2 - and 5 years after treatment. These measurement points will also include the control group as it is crossed over to CBT after the 3-month follow-up

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria:
* Myocardial infarction ≥ 6 months before assessment (type 1 STEMI/NSTEMI)
* Age 18-80 years;
* Clinically significant cardiac anxiety that leads to severe distress and/or interferes with daily life
* On adequate medical treatment(21); (E) Able to read and write in Swedish.

Exclusion Criteria:

* heart failure with severe systolic dysfunction (ejection fraction ≤ 35%)
* Significant valvular disease
* Planned coronary artery bypass surgery or percutaneous interventions
* Any medical restriction to physical exercise
* Severe medical illness
* Grade 3 hypertension (i.e., blood pressure ≥ 180 systolic and/or 110 diastolic)
* Severe psychiatric disorder or risk of suicide
* Alcohol dependency
* Ongoing psychological treatment.
Non-Invasive Cerenkov Luminescence Imaging of Lymphoma, Leukemia and Metastatic Lymph Nodes

The purpose of this study is to see if a new way of imaging called the Cerenkov luminescence or effect that is used with a standard clinical PET/CT and/or investigation scans can be done in order to capture tumor sizes. The investigators believe endoscopies and surgical procedures could benefit from this type of imaging in the future. The Cerenkov imaging could be used as a guide for surgical resections.

The purpose of this study is to use the Cerenkov light from FDG, Iodine-131 tracer sand/or other investigational tracers to image tumors and its sizes in the head, neck, breast, axillary and pelvic regions with a highly sensitive camera. The investigators will be trying to see if we can get another picture of the tumor using the Cerenkov light as part of the standard clinical scan or therapy.


Eligibility Criteria:
Inclusion Criteria:

* Participant is 18 years of age or older.
* Participant is scheduled for standard clinical and/or investigational PET/CT scan or 131I therapy within the Nuclear Medicine Service at Main Hospital.
* Patients must have had pathologic lymph node metastases in the neck, axillary or inguinal area (do not need to be biopsy proven) from either leukemias, lymphomas: , Head and Neck cancers (e.g. tonsillar, nasopharynx, tongue carcinoma, breast cancer or melanoma;or lymphoma or tonsillar or squamous cell carcinoma with metastases in the neck region for PET/CT imaging, or thyroid cancer for thyroid ablation therapy. Any other more infrequent cancer metastasizing with nodal metastasis in the neck, axilla and inguinal regions to cervical lymph nodes is eligible as well as the primary goal is to image pathological (i.e. hypermetabolic) lymph nodes.
* Patients with hypermetabolic activity and uptake in the neck,axilla, breast and inguinal region on scan, defined visually as significant lesion suspicious for malignancy by a nuclear medicine physician or trainee. (We will include a subset of patients with normal lymph nodes during screening. This subset of patients will be imaged as a negative control for this study.)

Exclusion Criteria:

* Patients imaged for Cerenkov luminescence are going to be required to be in a darkened enclosure for at least 10 minutes and sit still during image acquisition, potentially covered by a dark cloth in case that the ambient light level remains too high for the ultra-sensitive camera. Any conditions that would prevent this will exclude the patients.
* There are any other past medical, physiological or demographic concerns. This includes any patients with skin blemishes that are present at the dermis over the tumor, as these are of particular interest for use of this technique.
Study of the Blood and Skin Immunological Profile of Patients With Recessive Dystrophic Epidermolysis Bullosa: in Vivo Analysis and the Impact of Placental Stem Cells in Vitro

Patients with recessive dystrophic epidermolysis bullosa (RDEB) suffer from acute and chronic post-bullous wounds along with impaired skin healing. These issues are attributed not only to mucocutaneous fragility and abnormal healing directly related to quantitative and/or qualitative constitutional abnormalities of collagen VII but also to a contingent cutaneous and systemic inflammatory component. This inflammatory aspect contributes to the perpetuation of skin lesions and delayed healing. Our primary objective is to define the systemic immunological/inflammatory signature of patients with RDEB with an aim to develop a strategy that involves using stem cells with high immunomodulatory/anti-inflammatory capacity such as allogeneic placental stem cells (WJ-MSCs and trophoblasts).


Eligibility Criteria:
Inclusion Criteria:

EBDR patients :

* Patients aged 18 to 80 years old
* Clinically, histologically, and/or genetically confirmed intermediate, reversed or generalized, moderate to severe EBDR

Healthy controls :

* Adults aged 18 to 80 years old
* PBMC healthy donors: subjects who have donated blood to the EFS according to the indication criteria who have consented to the use of their samples for research purposes.
* Healthy skin biopsy donors: subjects undergoing abdominoplasty scheduled in plastic surgery and who have given their consent for the collection of a skin biopsy from post-operative abdominoplasty skin remnants.
* Healthy donors of bandages soiled with exudates from cutaneous wounds: subject consulting a plastic surgery department as part of their usual post-operative follow-up, who have given their consent for the collection of one of their dressings during their usual during their usual renewal.

For all subjects :

* Free, informed, written consent, signed by the person and the investigator no later than the day of inclusion and before any examination carried out as part of the study.
* Person affiliated or benefiting from a social security scheme

Exclusion Criteria:

EBDR patients :

* EBH with no definite diagnosis or other than EBDR intermediate, reversed or generalized
* Systemic anti-inflammatory or immunosuppressive therapy for less than one month
* Refusal of skin biopsy

Healthy controls :

* Acute or chronic systemic or cutaneous inflammatory disease at the time of sampling
* Current immunosuppressive anti-inflammatory treatment in the month prior to sampling

For all subjects:

* Persons under guardianship or curatorship, or deprived of their liberty by judicial or administrative decision
* Patients receiving State Medical Aid
* Pregnant or breast-feeding women
RISE Versus Advocacy-based Enhanced Care as Usual for Patients Experiencing IPV

This study aims to improve treatment for Veterans Health Administration (VHA) patients who experience intimate partner violence (IPV). This study will evaluate two brief counseling interventions for VHA patients who have experienced IPV in the past 12 months: Recovering from IPV through Strength and Empowerment (RISE) and advocacy-based Enhanced Care as Usual (ECAU). The RISE intervention includes up to 8 sessions and includes specific topic areas (e.g., social support, health effects, resources). The other intervention, ECAU, includes a single session that includes supportive education about IPV and health effects, discussion of ways to increase safety, and information about resources. This study will test which approach is better for improving self-efficacy and other aspects of health.

Participants will answer surveys about their self-efficacy and other health and safety indicators (e.g., mental health symptoms) right before receiving treatment, approximately 12 weeks later, and then every three months after that for one year. Participation in this research will last about 15 months.


Eligibility Criteria:
Inclusion Criteria:

* patients receiving care at an enrolled site/affiliated Community-Based Outpatient Clinic (CBOC)
* report experience of past-year physical, psychological, and/or sexual IPV on an established screening tool used to detect IPV in VHA, and
* be able to provide informed consent including permission to have intervention sessions recorded

Exclusion Criteria:

* severe cognitive impairment,
* suicide or homicide intent with a specific plan
* untreated or unstable symptoms of mania or psychosis
COVID-19 Seroprevalence Study in ITM Staff

In Belgium, the corona virus disease 2019 (COVID-19) epidemic is in the growing phase of its second wave.

The Belgian crisis cell is balancing between allowing the economy to recover and minimize the disease spread. To decide which containment measures should be maintained, reinstalled or suspended, information on what proportion of people has been infected and on possible risk factors for virus transmission can be helpful.

This study will be conducted on staff members of the ITM. All staff members will be invited to participate. Participants will be asked to have a blood sample drawn for detections of antibodies against SARS-CoV-2 (using one of these two commercial assays: Anti-SARS-CoV-2 ELISA (EUROIMMUN) or WANTAI SARS-CoV-2 Ab ELISA (WANTAI SARS-CoV-2 Diagnostics)) and to complete a questionnaire about their exposure, both within and outside the ITM, to the SARS-CoV-2, and about their health and symptoms. The primary objective is to estimate the occurrence rate of anti-SARS-CoV-2 antibodies or seroprevalence in ITM staff. Secondary objective is to estimate the SARS-CoV-2 seroprevalence in ITM staff member groups, stratified by variables obtained through the questionnaire, such as age, gender, symptoms, exposure to COVID-19 patients/samples, comorbidities, adherence to containment measures.

The study is observational and will be conducted on ITM staff members. All members will be invited to participate.

Eligibility Criteria:
Inclusion Criteria:

* Be an active ITM staff member
* Be willing and able to complete the questionnaire
* Be willing and able to provide informed consent

Exclusion Criteria:

* Doctor of Philosophy (PhD) students, Master students and interns of the ITM