cyrilzakka/clinical-trials huggingface dataset:
Factor IX as Adjunctive Therapy to Emicizumab (EMIX)

This trial will enroll patients with severe hemophilia A. Experiments will be run in vitro by spiking patients' blood with different molecules (currently used and theoretically proposed as adjunctive therapy to emicizumab), therefore no more than minimal direct risk to patients is expected. This is a pilot preclinical study.

The study aims to determine the hemostatic effect of different Factor IX (FIX) concentrates when added to the plasma of patients on emicizumab prophylaxis and compare it to the hemostatic effect obtained with the addition of bypassing agents (activated prothrombin complex aPCC, and recombinant VIIa rVIIA, recombinant porcine FVIII).

The investigators will study the hemostatic effect using Thrombin Generation assay (CAT) in the presence of different concentrations of FIX concentrates. The investigators will compare the hemostatic effect of added FIX to the effect of added bypassing agents (activated prothrombin complex aPCC, and recombinant VIIa rVIIA, recombinant porcine FVIII)

Plasma will be collected from patients with hemophilia A and inhibitors treated with Emicizumab, a group of plasma samples will be spiked with different concentrations of Factor IX. Thrombin generation profiles will be obtained using CAT.

Another group of plasma samples will be spiked with different concentrations of by passing agents (activated prothrombin complex aPCC, and recombinant VIIa rVIIA, recombinant porcine FVIII). Thrombin generation profiles will be obtained using CAT.

Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent/Assent Form
* Male patients, Age 12 years and older at time of signing Informed Consent Form
* Ability to comply with the study protocol, in the investigator's judgment
* Diagnosis of severe hemophilia A and are receiving emicizumab prophylaxis, on a weekly maintenance regimen

Exclusion Criteria:

* Not able to sign consent
* Not willing to provide extra blood for the experiments.
* Patients carrying the diagnoses of other coagulopathies in addition to hemophilia A
* Patients that have received any hemostatic agent within 5 half-lives of the blood draw. This applies to any agent that might have been used for any reason prior to the blood draw and might affect the global hemostasis.
Study of Dehydroepiandrosterone (DHEA) in Respiratory Pulmonary Hypertension in Adults

DHEA prevents and reverses chronic hypoxic pulmonary hypertension in a chronic hypoxic-pulmonary hypertension model in the rat. However, no study has been performed in human. The purpose of this study is to determine if DHEA is effective in the treatment of respiratory pulmonary hypertension in adults with Chronic Obstructive Pulmonary Disease (COPD) on exercise capacity and haemodynamic variables. Patients will receive after randomisation either 25 mg/day or 200mg/day oral DHEA over a one-year period. Evaluation concerns clinical parameters, echocardiography and right catheterization after and before treatment. Primary end-point is the six-minute walk test. This is a prospective double blind, randomised, placebo controlled study which will be realized in four university hospitals in France : Bordeaux, Strasbourg, Toulouse and Limoges.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old and ≤ 75 years old
* Chronic Obstructive Pulmonary Disease with FEVs/VC \< 70% (\*)
* Respiratory pulmonary hypertension with mean pulmonary arterial pressure ≥ 20 mmHg (\*) related to normal pulmonary capillar pressure assessed by catheterization of the right side of the heart (pulmonary capillary wedge pressure ≤12mmHg)
* PO2 ≤ 70 mmHg assessed by arterial gasometry at ease
* If oxygenotherapy then oxygenotherapy more than 6 months before pre-screening
* Written informed consent

(\*) Criteria assessed from last health check or the last exams for COPD diagnosis

Exclusion Criteria:

* clinical instability and/or respiratory exacerbation dangerous for catheterization
* Pregnancy (ßHCG \> 20 UI /l) or breastfeeding on going
* General corticotherapy \> 0,5 mg/kg/day prednisolon equivalent
* Hepatic insufficiency (TP \< 50%) or renal insufficiency (creatininemia \> 130 µmol/l) or diabetes mellitus type I or II (treated by oral antidiabetic or insulin)
* Left-heart failure (coronary heart disease and/or left valvulopathy)
* High level of prostatic specific antigen (PSA) (\> 7ng/ml)
* Cancer antecedent or treatment on going
Assessment of the 90-day Mortality Risk Score After VATS Lobectomy

A five classes (A-E) aggregate risk score predicting 90-day mortality after video-assisted thoracoscopic lobectomy for lung cancer, including as independent factors male sex (3 points), carbon monoxide lung diffusion capacity \<60% (1 point) and operative time \>150 minutes (1 point), has been recently published. This study aims to assess the effectiveness and reliability of this risk model in a large, independent cohort of patients, in order to confirm its generalizability.

From the Italian VATS Group Database, we selected patients who underwent video-assisted thoracoscopic lobectomy for non-small cell lung cancer. We calculated the aggregate risk score and the corresponding class of 90-day mortality risk for each patient. The correlation between risk classes and mortality rates was tested by Spearman's rho-test. Model calibration was evaluated by Hosmer-Lemeshow goodness-of-fit test.

Eligibility Criteria:
Inclusion Criteria:

- Patients undergoing VATS lobectomy for non-small cell lung cancer

Exclusion Criteria:

* Incomplete data for risk score calculation
* Tumor size \>5 cm
* Follow-up \<3 months
* Patients undergoing neoadjuvant treatment
* Patients undergoing extended resection
New Fabric Attenuation Device in Endovascular Interventional Radiology (PREFER)

The PREFER Trial primary objective of the trial is to show how much radiation attenuation is provided by XPF in absolute and relative terms.

The PREFER Trial has three main objectives. The primary objective of the trial is to show how much radiation attenuation is provided by XPF in absolute and relative terms. The secondary objective of the study is to measure and compare the amount of radiation that interventional radiologists are exposed to per case in an interventional suite setting using FDA approved XPF thyroid collars or standard 0.5 mm Pb equivalent thyroid collars. The third objective is to assess the operator comfort wearing the XPF protection devices. In order to achieve these objectives, measurements will be performed in 60 consecutive endovascular procedures requiring C-arm fluoroscopy performed at BCVI. Participants will be asked to wear an XPF cap (weighing approximately 100 grams) in every study procedure. Furthermore, a prospective randomization will be performed, assigning participants to wear their own standard 0.5 mm Pb equivalent thyroid collar or to wear the FDA approved XPF thyroid collar. Radiation exposure will be monitored with 4 radiation detectors (TLDs, 2 attached to the cap, 2 attached to the collar) which the participant is required to wear. After each procedure the participant will be asked to rate the comfort of wearing the devices on a scale from 1 to 100.

Eligibility Criteria:
Inclusion Criteria:

* Interventional Radiologists practicing in Baptist Cardiac \& Vascular Institute
* consecutive endovascular procedure requiring C-arm fluoroscopy

Exclusion Criteria:

* Interventional Neuroradiologists and Interventional Cardiologists will not be included in this study.
Impact of a Telemonitoring Device on the Occurever at Home in Children at Risk of Chemotherapy-Induced Neutropenia

The goal of this clinical trial is to evaluate the feasibility of the study, measured by the acceptability rate of patients to be recruited in a study proposing temperature monitoring at home, by a remote monitoring device or by the visit of an IDE at home (in association with the usual educational sessions), to children at risk of febrile neutropenia, from families with psycho-social vulnerabilities.

The main questions it aims to answer are:

* Will participants adhere to the telemonitoring system?
* Is the intervention feasible, in terms of the device's failure to record temperature data?
* Will parents behave appropriately when using the device?
* How satisfied will parents and caregivers be?
* What will be the physical tolerance of the device?
* On an exploratory basis, will the remote monitoring system be effective for months?

Researchers will compare :

* patients using the telemonitoring device for continuous temperature monitoring at home, in combination with education sessions on temperature monitoring and the device
* with patient with temperature monitoring at home by a nurse, 2 times a day, in combination with education sessions on temperature monitoring (without the telemonitoring device at home)


Eligibility Criteria:
Inclusion Criteria:

patient

* Aged 0 to 17 inclusive
* Followed in the Pediatric Onco-Hematology Department
* Primo-diagnosed with solid or hematological cancer (incident case)
* Having received a first cycle of chemotherapy
* Whose family has psycho-social vulnerabilities assessed by the Froger et al. tool, indicating a need for an IDE to support the family in monitoring the patient.

Exclusion Criteria:

Patient:

* with a dermatosis contraindicating the use of the device
* Refusing to participate in the study
Optimize Pediatric OCT Imaging

Handheld optical coherence tomography (OCT) has become an important imaging modality to evaluate the pediatric retina. The objective of this pilot study is to compare a new contact OCT system (Theia Imaging) with an investigational noncontact OCT system (Duke Biomedical Engineering) to assess their ability to image the pediatric retina.

The investigators hypothesize that the contact OCT system is superior in imaging larger areas of the retina (larger field-of-view), while it has similar resolution to image the retina substructures (non-inferior image quality).

Handheld optical coherence tomography (OCT) has become an important imaging modality to evaluate the pediatric retina. The objective of this pilot study is to compare a new contact OCT system (Theia Imaging) with an investigational noncontact OCT system (Duke Biomedical Engineering) to assess their ability to image the pediatric retina.

The investigators plan to enroll 10 healthy adult volunteers and 20 pediatric patients in clinic or undergoing examination under anesthesia. This is an observational study. There are no known risks associated with handheld OCT imaging and no adverse events identified imaging with our prior investigational imaging with the same system. There is a risk of corneal abrasion with the contact imaging system (Theia imaging), however, this system is used in the setting of other contact imaging systems (such as RetCam fundus photography).

Imaging data will be downloaded to a secure server for protocol image processing, segmentation, and analysis per protocol in the Duke Advanced Research in SD/SSOCT Imaging (DARSI) Laboratory.

Eligibility Criteria:
Inclusion Criteria:

* Group 1 - Healthy adult volunteers
* Subject is able and willing to consent to study participation
* Subject is more than 18 years of age
* Healthy adult volunteers without known ocular issues other than refractive error
* Pregnancy Reasonably Excluded Guide (PREG) evaluation on women of childbearing potential
* Group 2 - Pediatric participants
* Health care provider, knowledgeable of protocol, agrees that study personnel could contact the parent/legal guardian
* Parent/legal guardian is able and willing to consent to study participation
* Pediatric patient less than 18 years of age in Duke Eye Center ophthalmology clinics or undergoing clinically-indicated examination under anesthesia at Duke Eye Center

Exclusion Criteria:

* Group 1 - Healthy adult volunteers
* Students or employees under direct supervision of the investigators
* Subjects with prior problems with pupil dilation
* Pregnant woman if receiving dilating drops
* Group 2 - Pediatric participants
* Parent/legal guardian unwilling or unable to provide consent
* Participant has a health or eye condition that preclude eye examination or retinal imaging (such as corneal opacity or cataract)
Scripted Sexual Health Informational Intervention in Improving Sexual Function in Patients With Gynecologic Cancer

This randomized pilot clinical trial studies the feasibility of a pre-operative and/or post-operative scripted sexual health informational intervention and how well it works in improving sexual function in patients with gynecologic cancer. Discussing sexual outcomes and counseling options with patients may help improve sexual outcomes and/or anxiety after primary gynecologic cancer treatment.

PRIMARY OBJECTIVES:

I. To evaluate the feasibility of patient recruitment, including time required to consent, enroll and retain the necessary number of participants.

II. To determine the distribution of candidate primary patient-reported outcome measures, including time to resumption of sexual activity, global satisfaction with sex life, sexual function and anxiety in this particular population.

III. To establish the prevalence of patient recall of the intervention to determine the most effective time at which to deliver the intervention.

OUTLINE: Patients are randomized to 1 of 4 treatment arms.

ARM I: Patients receive standard counseling at both the pre-operative and 2-4 week post-operative visit.

ARM II: Patients receive standard counseling at the pre-operative visit and the scripted sexual health intervention at the 2-4 week post-operative visit.

ARM III: Patients receive standard counseling and the scripted sexual health intervention at the pre-operative visit and standard counseling at the 2-4 week post-operative visit.

ARM IV: Patients receive standard counseling and the scripted sexual health intervention at both the pre-operative and 2-4 week post-operative visit.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a new suspected or confirmed gynecologic malignancies
* Patients plan to have primary surgery at either the University of Chicago Hospital or the University of Wisconsin Hospital
* Patients must be English speaking

Exclusion Criteria:

* Previous treatment of any cancer excluding skin cancer
* Patients with a suspected benign gynecologic process
* Patients who are prisoners or incarcerated
BF2.649 in Patients With OSA, Still Complaining of EDS and Refusing to be Treated by CPAP.

Multicenter randomized double blind study versus placebo during 12 weeks with at first, an escalating dose period followed by stable dose period at the selected dose.

This double-blind period can be followed by a 9 months open-label period if the patient wishes to continue with the study product.

The first period (12 weeks double blind period) will aim at demonstrating the efficacy and safety of BF2.649 by verifying whether the results of BF2.649 are superior to those of placebo.

The aim of the second period (open label extension phase) will be to assess the long-term tolerance, as well as the maintenance of the BF2.649 efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Patients with OSA still complaining EDS,refusing nCPAP
* ESS score ≥ 12

Exclusion Criteria:

* Patients suffering from insomnia without OSA
* Co-existing narcolepsy
* Patient with sleep debt not due to OSA
* Acute or chronic severe disease
Physiological Studies in Post-COVID-19 Syndrome, and the Association With DNA Methylation

The physiological derangements in subjects suffering from long-term symptoms following a Covid-19 infection (Post-COVID-19 Syndrome) are poorly understood and evaluated. This study will recruit subjects with a clinical diagnosis of Post-Covid-19-syndrome) who are scheduled for either of lung function testing, cardiopulmonary exercise testing or cardiac ultrasound. Patients' symptoms will be correlated to physiological measures and compared to predicted values. In addition, in 20 patients, symptoms and physiological measures will be correlated to epigenetical alterations, or DNA-methylation patterns. In addition, a subset of patients will be examined a year after the baseline testing in order to follow the progress of the disease.

The physiological derangements in subjects suffering from long-term symptoms following a Covid-19 infection (Post-COVID-19 Syndrome) are poorly understood and evaluated. For example, the extent to which subjective symptoms correlate with physiological impairments are not known.

This study will recruit subjects with a clinical diagnosis of Post-Covid-19-syndrome) who are scheduled for either of lung function testing, cardiopulmonary exercise testing or cardiac ultrasound. Patients' symptoms will be correlated to physiological measures and compared to predicted values.

In addition, in 20 patients, symptoms and physiological measures will be correlated to epigenetical alterations, or DNA-methylation patterns. In addition, a subset of patients will be examined a year after the baseline testing in order to follow the progress of the disease.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed or clinically highly suspected Covid19-infection
* Symptom duration at least 12 weeks following first occurence of symptoms
* No other disease that better could explain the symptoms than Covid19

Exclusion Criteria:

* Age \<18 years
* Unability to perform a maximal exercise test
* Unability to understand written or spoken Swedish
A Study Validating the Use of Candin as a Challenge Agent in Healthy Participants - Intervention Specific Appendix 1

The purpose of this study is to characterize the delayed-type hypersensitivity (DTH) response at the site of Candin intradermal injection in the presence of a targeted immune pathway inhibitor.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) between 18 and 30 kilogram per square centimeter (kg/m\^2) (BMI = weight/height\^2), inclusive, and a body weight of no less than 50 kg
* Must be a non-smoker (not smoked for at least 6 months prior to screening) and has not used nicotine-containing products (eg, nicotine patch) for 3 months prior to screening
* Has a negative severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) coronavirus disease 2019 (COVID-19) reverse transcription polymerase chain reaction (RT-PCR) test within 72 hours prior to administration of study intervention
* Are considered eligible according to the following tuberculosis (TB) screening criteria: have no history of latent or active TB prior to screening, have no signs or symptoms suggestive of active TB upon medical history and/or physical examination, and have had no recent close contact with a person with active TB
* Have a negative T-Spot TB test or QuantiFERON-TB test result within 28 days prior to the first administration of study intervention. A negative tuberculin skin test prior to the first study intervention administration is additionally required if the T-Spot test or QuantiFERON-TB test is not approved/registered in that country or the tuberculin skin test is mandated by local health authorities. If the test is positive, the participant will be referred for appropriate follow-up; however, these participants will not be included in the study

Exclusion Criteria:

* History of liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic, or mucocutaneous disturbances
* Has or has had a serious infection (eg, sepsis, pneumonia, or pyelonephritis) or has been hospitalized for a serious infection during the 6 months prior to screening
* Has received over-the-counter medications (including vitamins/multivitamins/supplements, corticosteroids, acetaminophen/paracetamol aspirin, decongestants, antihistamines, and other non-steroidal anti-inflammatory drugs), and herbal medication (including, but not limited to, herbal tea and St. John's Wort) within 2 weeks prior to first study treatment administration unless approved by the investigator and sponsor medical monitor
* Has surgery planned within 20 weeks after the study intervention administration
* Has had prior exposure to secukinumab or other interleukin-17 inhibitors, such as ixekizumab, brodalumab, bimekizumab
Exair® Versus Native Tissue Repair for Prolapse

The purpose of this study is to compare safety and effectiveness of the Exair Prolapse Repair System for treatment of pelvic organ prolapse to traditional native tissue repair through 36 months of follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Female at least 18 years of age
* Subject has pelvic organ prolapse with leading edge at or beyond the hymen. At or beyond the hymen is defined as POP-Q scores of Ba ≥0 and Bp ≥0 and C≥ -1/2 tvl
* Subject reports a bothersome bulge they can see or feel per PFDI-20 question 3, response of 2 or higher (i.e. responses of "somewhat", "moderately" or "quite a bit")
* Subject is willing to provide written informed consent
* Subject is willing and able to comply with the follow-up regimen

Exclusion Criteria:

* Subject is pregnant or intends to become pregnant during the study
* Subject has an active or chronic systemic infection including any gynecologic infection, untreated urinary tract infection (UTI), or tissue necrosis
* Subject has a history of pelvic organ cancer (e.g. uterine, ovarian, bladder, or cervical)
* Subject has had prior or is currently undergoing radiation, laser therapy, or chemotherapy in the pelvic area
* Subject has taken systemic steroids (within the last month), or immunosuppressive or immunomodulatory treatment (within the last 3 months)
* Subject has a systemic connective tissue disease (e.g. scleroderma, systemic lupus erythematosus (SLE), Marfan syndrome, Ehlers Danlos, collagenosis, polymyositis or polymyalgia rheumatica)
* Subject has chronic systemic pain that includes the pelvic area or chronic focal pain that involves the pelvis
* Subject has uncontrolled diabetes mellitus (DM)
* Subject has a known neurologic or medical condition affecting bladder function (e.g. multiple sclerosis, spinal cord injury, or stroke with residual neurologic deficit)
* Subject is seeking obliterative vaginal surgery as treatment for pelvic organ prolapse (colpocleisis)
* Subject is not able to conform to the modified dorsal lithotomy position
* Subject is currently participating in or plans to participate in another device or drug study during this study
* Subject has a known sensitivity to polypropylene
* Subject has had previous prolapse repair with mesh in the target compartment(s)
Sustained Ketamine Effectiveness for Suicidal Ideation

As part of the usual clinical activity of the Emergency and Post-Emergency Psychiatric Department, IV ketamine is used to treat suicidal crises in depressed patients hospitalized as an add-on to the treatment of depression. This infusion can be repeated.

Patients are systematically reassessed twice in the month following the last infusion, to ensure that the suicidal crisis is progressing. Psychometric assessments are part of routine care, to ensure systematic evaluation of psychopathology, intensity of depression and suicidality.

Therefore existing data were re-used from the medical records of patients who had received ketamine infusions to assess the effect of ketamine on suicidal ideation and behaviour.


Eligibility Criteria:
Inclusion Criteria:

* Patients treated with IV ketamine in the Psychiatric Emergency and Post-Emergency Department (University Hospital, Montpellier) in context of suicidal crisis
* over 18 y.o

Exclusion Criteria:

* Opposition to data use
* Subject deprived of liberty (by judicial or administrative decision)
* Subject protected by law (guardianship or curatorship)
* Subject not affiliated to a social security system