cyrilzakka/clinical-trials huggingface dataset:
Identification of Heritable CTEPH

Some patients who have blood clots come down with a life-threatening condition known as Chronic Thromboembolic Pulmonary Hypertension (CTEPH), which is high blood pressure only in the arteries of the lungs. This study seeks to understand more about the genetics causes of CTEPH by obtaining blood samples and examining family histories.

This project proposes to identify a cohort of Utah patients with CTEPH, and to perform a comprehensive analysis of family history and CTEPH risk factors in these patients, and in controls with acute pulmonary embolism (PE) and pulmonary arterial hypertension (PAH). Detailed family history interviews will be performed with all patients, and all enrolled patients will provide a blood sample for thrombophilia testing and for gene sequencing with the goal of identifying novel genetic variants that contribute to CTEPH risk.

Eligibility Criteria:
Inclusion Criteria:

* CTEPH cohort:

  1. Confirmed CTEPH based on having undergone PEA surgery.
  2. Strongly suspected CTEPH based on right heart catheterization data showing mPAP\>26 and PCWP\<15, and imaging demonstrating chronic thromboembolic disease (either ventilation/perfusion scan, CT pulmonary angiography, or conventional pulmonary angiography).
* PE cohort:

  1. PE diagnosed by CT pulmonary angiography or ventilation/perfusion scan within the preceding 24 months.
  2. No evidence of PH at the time of enrollment (based on absence of dyspnea, exertional chest pain, or exertional presyncope on history, lack of physical exam findings of PH or right heart failure, and lack of signs of PH on objective data including echocardiography and/or right heart catheterization).
  3. No evidence of chronic thromboembolic disease at the time of enrollment (based on chronic appearing thrombus on CT pulmonary angiography or conventional pulmonary angiography, or based on prior high probability ventilation/perfusion scan showing a similar pattern of perfusion defects).
* PAH cohort:

  1. Diagnosis of group 1 PAH.
  2. Prior normal or low probability ventilation/perfusion scan.
  3. No reported history of prior VTE events.
  4. If available, all prior evaluations for VTE (including CT pulmonary angiography and Doppler ultrasound exams) must also be negative.

Exclusion Criteria:

* Under the age of 18
Ambispective Clinical Evaluation of Sophono™

Study to accumulate post-market clinical evidence for the safety and effectiveness of the Sophono Alpha 2 and Alpha 2 Maximum Power Output (MPO) systems in subjects diagnosed with conductive hearing loss, single-sided deafness and mixed hearing loss who currently have or have had the Sophono implant.


Eligibility Criteria:
Inclusion Criteria:

* Any subject who currently has or who has had the Sophono implant (including those who have been explanted)
* Has or has had Sophono implant for 3 months or longer

Exclusion Criteria:

* Subject has implant but is unable or unwilling to perform audiologic testing
* Subject is currently participating in another clinical study and has not been approved for concurrent enrollment by the Study Sponsor
Comparison of CTrach, Intubating Laryngeal Mask Airway (ILMA) and I-gel for Tracheal Intubation

Various supraglottic airways may be used as a dedicated airway for insertion of intubating fibrescope and tracheal intubation in the patients with difficult to manage airways (Difficult Airway Society Guidelines).

The investigators aim to compare three different types of supraglottic device as a conduit for tracheal intubation - CTrach optical laryngeal mask, Intubating laryngeal mask airway and I-gel supraglottic airway. Null hypothesis for this study is that all three devices will perform without statistical difference in the means of success rate and time needed for their insertion and tracheal intubation.

Supraglottic airway devices such as I-LMa, Igel and LMA Ctrach are designed to create a "dedicated" airway which safely allows both spontaneous and controlled ventilation. The use of supraglottic airways can allow planned fibreoptic intubations in expected difficult cases and can provide an emergency airway in cases of unexpected difficult airway.

The ILMA (Intavent Orthofix Ltd.,Wokingham, UK) has been designed for either blind or fibrescope-guided tracheal intubation, in patients with expected and unexpected difficult airway. Since its development in 1997, it has been used for both blind and fibrescope-guided tracheal intubations in the patients with difficult airway. The ILMA is currently a 'gold standard' in supraglottic airways used for tracheal intubation.

The I-gel (Intersurgical Ltd., Wokingham, UK) is a newer dedicated airway device, which with its wide bore allows direct passage of a tracheal tube.

The CTrach (The Laryngeal Mask Company,Singapore) is a newer device for airway management. It has special optical fibres built-in inside its bowl and a liquid crystal display which allows views of the larynx while the endotracheal tube is being placed.

With reference to these supraglottic airway devices, only a small number of case reports detail tracheal intubation through an I-gel in patients with difficult airways. There have been manikin studies comparing ILMA and CTrach, and some descriptive studies on the use of CTrach in patients with predicted difficult airways- but no studies comparing the performance of these devices in clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-III patients
* Age 18-89 years, males and females
* Elective surgical patients needing tracheal intubation

Exclusion Criteria:

* ASA IV or V patients
* Emergency surgical procedures
* Patients at increased risk of aspiration
Safety and Preliminary Performance of Xtrac O.S. System for Lead Extraction.

This is an open label, interventional, feasibility, prospective, multicenter, clinical trial of lead extraction. The Xtrac O.S. system is intended for transvenous removal of pacing or defibrillator leads, having an inner lumen, through a superior approach.

A total of 15 patients, who are scheduled for CIED lead extraction, will be recruited in order to ensure a total of at least 10 patients finishing the study procedures and follow up.


Eligibility Criteria:
Inclusion Criteria:

1. Men or Female patients, 18-85 years old.
2. Patients must understand the procedures and methods of this study and be willing to sign the informed consent form and to complete the trial in strict accordance with clinical trial protocol.
3. Scheduled for a CIED lead extraction upon current guidelines.
4. Lead implant duration more than 1 year and less than 5 years.
5. Patient must be SARS-CoV-2 negative and without Covid-19 signs and symptoms, prior to enrollment.
6. Patients are classified as ASA II/III.
7. Leads with external diameter of 7Fr-9Fr.

Exclusion Criteria:

1. Patient age \> 85 years old.
2. Hemodynamic instability.
3. Class IV NYHA heart failure.
4. Contrast allergy.
5. Patients felt to be high risk due to degree of acute illness or systemic comorbidities.
6. Patients who are placed on a heparin bridge, and are felt to be high risk for even brief discontinuation of anticoagulation
7. Pregnant or lactating.
8. Participating in another clinical study.

Eligibility will be determined by the PI and investigators based on the exclusion/inclusion criteria, current medical status and evaluation of the procedure risks mitigation.
Audiological and Quality of Life Outcomes of Anatomy Based Fitting in Patients Implanted by Robot Assisted Cochlear Implant Surgery (RACIS)

Severe to profound hearing loss affects 0,8% of the global population. For these people, a conventional hearing aid often does not provide sufficient benefit. However, these people can benefit from a cochlear implant (CI). A CI needs to be individually programmed (fitted) for each recipient. A fitting "map" is defined as a set of electrical parameters that are individually adapted to a recipient's needs to achieve optimal sound perception. At present, most CI recipients are fitted with a default frequency allocation map that doesn't take individual variability in size and shape of the cochlea into account. In this study, a fitting strategy based on the post-operative CT scan, that will allow the audiologist to set a frequency-band distribution for CI fitting that may be more closely aligned to the natural tonotopic frequency distribution of a normal hearing cochlea, will be evaluated. This study will focus on patients that are already implanted with the HEARO robotic system.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Post-lingual onset of severe to profound sensory-neural hearing loss in the implanted ear(s)
* Subject implanted by Robot Assisted Cochlear Implant Surgery (RACIS)
* Subject implanted with MED-EL cochlear implant(s) with Flex28, Flex 26 or FlexSoft electrode to obtain maximum cochlear coverage
* Subject planned to receive a MED-EL SONNET 2 or RONDO 3 audio processor on the newly implanted side
* Subject is either a user with unilateral implantation, bilateral implantation or a bimodal CI user (unilateral CI user with contralateral ear adequately fitted with a hearing aid)
* Pre- operative and post-operative CT scan of the temporal bone available
* Pre-operative result of pure-tone audiometry, speech test in quiet and in noise available
* Audio processor not yet activated on the newly implanted side
* Minimum of 10 active channels can be activated
* Fluent in the language of the test centre (Dutch or French)
* Signed and dated ICF before the start of any study-specific procedure

Exclusion Criteria:

* Subject is a Single-Sided Deafness (SSD) CI user
* Subject is an Electric Acoustic Stimulation (EAS) user (with an EAS audio processor)
* Lack of compliance with any inclusion criteria
* Anything that, in the opinion of the Investigator, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study
Efficacy of Re-treatment With Cimzia® in Subject With Chronic Plaque Psoriasis

The primary objective is to assess differences in PASI scores between Week 12 of Study C87040 \[NCT00245765\] and Week 12 of re-treatment in this study.


Eligibility Criteria:
Inclusion Criteria:

* Subject having responded to treatment at Week 12 in study C87040 and having relapsed during the follow-up period
* Female subjects either postmenopausal for at least one year, surgically incapable of childbearing, or effectively practising an acceptable method of contraception.Subjects agreed to continue using adequate contraception during the study and for 12 weeks after the last dose of CDP870

Exclusion Criteria:

* Subjects with erythrodermic, guttate, generalized pustular form of psoriasis
* Any recent serious or life-threatening infection or any current sign or symptom that may indicate an infection (e.g., fever, cough)
* Positive hepatitis B surface antigen test and /or hepatitis C antibody test results
* Positive human immunodeficiency virus (HIV) test result
* White blood cell counts less than 4000 per cubic millimeter or more than 20000 per cubic millimeter
* Suspected or diagnosed demyelinating disease of the central nervous system (e.g. multiple sclerosis or optic neuritis)
* Systemic Lupus Erythematosus
* Participation in a clinical study within the past 3 months except Study C87040
* Any other condition, which in the Investigator's judgment would make the subject unsuitable for inclusion in the study
Viral Epidemiology of Bronchiolitis After Nirsevimab Implementation and Respiratory Evolution in Infants

Acute bronchiolitis in infants, mainly caused by the Respiratory Syncytial Virus (RSV), is a public health issue, in terms of morbidity and hospital costs.

Nirsevimab, a long-acting antibody against RSV available for all infants under 12 months, could profoundly modify the epidemiology of the next epidemic seasons, with the increase of the frequency of the other respiratory viruses (endemic Coronaviruses, Metapneumovirus, etc) Monitoring viral ecology is important, as the impact of respiratory infections on morbidity in the short, medium and long term, but also in economic terms.

Infants under the age 12 months with a first episode of bronchiolitis and consulting the emergency pediatric department will be included. A nasopharyngeal swab will be performed as routine care, and clinical data will be collected.

Multiplex Polymerase Chain Reaction will be performed to identify respiratory virus(es) responsible for the bronchiolitis. In hospitalized infants with RSV or rhinovirus positive Polymerase Chain Reaction (PCR), daily nasal washes will be collected to perform viral loads with specific quantitative PCR (nasal washes biobank), associated with daily clinical data. A 12-month follow-up is planned for every infant included, consisting with 4 phone calls, to identify factors associated with the onset of preschool wheezing.

The main objective is to describe the viral epidemiology associated with acute bronchiolitis leading to a pediatric emergency department visit the implementation of Nirsevimab.


Eligibility Criteria:
Inclusion Criteria:

* Infant aged 12 months or less
* Admitted to the pediatric emergencies services during one of the three epidemic years: 2024-2025, 2025-2026 and 2026-2027
* With clinical diagnosis of first episode of acute bronchiolitis by the emergency pediatrician
* With nasopharyngeal swab for virological diagnosis

Exclusion Criteria:

* Refusal of one or more of the infants parents to participate in the study
* Infants parents refused to be called back for follow-up
* No nasopharyngeal swab taken
A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Patients With Presumed Nonalcoholic Steatohepatitis (NASH)

This phase 1b, Open-Label Study is to assess the safety, efficacy of miricorilant in patients with presumed Nonalcoholic Steatohepatitis (NASH)

This phase 1b, Open-Label Study will assess the safety, efficacy and pharmacokinetics (PK) of miricorilant in patients with presumed Nonalcoholic Steatohepatitis (NASH).

Patients who meet the criteria for the study CORT-118335-861 will be enrolled on Day 1 into 1 of 11 cohorts and receive:

* Cohort 1 - a daily dose of 150 mg of miricorilant over 24 weeks.
* Cohort 2 - a daily dose of 150 mg of miricorilant over 12 weeks.
* Cohort 3 - a daily dose of 100 mg of miricorilant over 2 weeks, followed by 10 weeks of dosing at 100 mg miricorilant every Monday, Wednesday and Friday.
* Cohort 4 - a daily dose of 100 mg of miricorilant over 2 weeks, followed by 10 weeks of dosing at 100 mg miricorilant every Monday and Friday.
* Cohort 5 - a thrice weekly dose of 100 mg of miricorilant over 12 weeks every Monday, Wednesday, and Friday.
* Cohort 6 - a twice weekly dose of 100 mg of miricorilant over 12 weeks every Monday and Friday.
* Cohort 7 - a daily dose of 50 mg of miricorilant over 12 weeks.
* Cohort 8 - a daily dose of 100 mg of miricorilant over 12 weeks.
* Cohort 9 - a daily dose of 30 mg of miricorilant over 12 weeks.
* Cohort 10 - a once weekly dose of 200 mg of miricorilant over 12 weeks.
* Cohort 11 - a twice weekly dose of 150 mg miricorilant over 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

Have a diagnosis of NASH based on a biopsy obtained within the last year OR Have a diagnosis of presumed NASH based on blood tests and scans

Exclusion Criteria:

* Have participated in another clinical trial within the last year and received active treatment for NASH
* Have participated in another clinical trial for any other indication within the last 3 months
* Are pregnant or lactating women
* Have a BMI \<18 kg/m2
* Have had liver transplantation or plan to have liver transplantation during the study
* Have type 1 diabetes or poorly controlled type 2 diabetes.
A Multi-center Clinical Longitudinal Study of Neuropathic Pain by Collecting Data

A multi-center clinical longitudinal study of neuropathic pain by collecting data on patients' brain physiology and cognitive function

Using the use of pain visual analog scale (VAS), digital pain grading method (NRS), neuropathic pain assessment scale (DN4), sleep quality (Pittsburgh sleep quality index, Ascens insomnia scale), social support assessment scale (SSQ), Montreal cognitive assessment scale (MoCA), Barrett impulse scale (BIS), anxiety and depression score (GAD-7, PHQ-9), emotional tasks, cognitive function (N-back, time perception, delay-discount), electroencephalogram (EEG), near-infrared brain function imaging (fNIRS) and other indicators to study the dynamic changes of various factors in the process of acute pain.

Eligibility Criteria:
Inclusion Criteria:

1. The subjects voluntarily participated in the study and signed an informed consent form;
2. The age is between 18 years old (inclusive) and 85 years old (inclusive), regardless of gender;
3. Body mass index (BMI) ≤ 45;
4. Clinically clearly diagnosed neuropathological pain (pain VAS score ≥4 or above);
5. Did not participate in the drug/medical device test within 3 months before the test;

Exclusion Criteria:

-
Effects of Stress on Exposure Therapy

This study investigates whether stress can augment exposure therapy outcome in patients with specific phobia (spider phobia).

Stress has been shown to modulate fear extinction. The present study is aimed at investigating whether stress (administered prior to exposure with the socially evaluated cold pressor test) augments exposure therapy outcome in patients with specific phobia (spider phobia). Furthermore, the effects of stress on the generalization of exposure-induced symptom reduction towards untreated fear stimuli (i.e. cockroaches) will be explored.

Participants are randomly assigned to the cold or warm water condition of the socially evaluated cold pressor test (SECPT; Schwabe et al., 2008). Thereafter, participants of both conditions receive 45 minutes of in-vivo exposure to spiders. The effects of stress on exposure-based anxiety reductions toward spiders (treated fear stimulus) and cockroaches (untreated fear stimulus to assess generalization of treatment outcome) are assessed on the behavioral, subjective and physiological level at pretreatment, posttreatment (24 hours after exposure) and follow-up (4 weeks after exposure).

Eligibility Criteria:
Inclusion Criteria:

* Women using oral contraceptives (OC)
* Specific phobia (spider phobia)

Exclusion Criteria:

* Body Mass Index (BMI) \< 19 or \> 27
* Pregnancy
* Any acute or chronic mental, somatic, endocrine, or metabolic disease
* Psychological, psychiatric, neurological or pharmacological treatment
* Shift work
* Smoking more than 5 cigarettes per month
* Vaccination in the past 2 month
* Drug or alcohol abuse
Mobile Health For Pacemaker Patientes

Previous studies suggested that most patients with Cardiac Electronic Implantable devices have a perception of describing the lifestyle due to a limitation of daily activities and physical exercise, besides the consequences in the psychological aspects such as anxiety and depression. The MHOL-CEID is a randomized controlled trial that Verifies the effectiveness of the Mobile Health of lifestyle that focuses on aspects of physical functional, psychosocial, and quality of life of patients with Cardiac Electronic Implantable Device.

Cardiovascular diseases represent one of the main causes of death in the Brazilian population, as well as dysfunctions of the heart conduction system. In an attempt to treat and correct heart conduction system dysfunctions, Cardiac Electronic Implantable Device (CEID) was developed. Most people with CEID have a perception of describing the lifestyle due to a limitation of daily activities and physical exercise, besides the consequences in the psychological aspects such as anxiety and depression. These changes in the psychosocial conduct of patients with CEID are due to the lack of knowledge and the lack of effective guidance, being of fundamental importance to elaborate the resources of education in health for patients with CEID. Health promotion through educational intervention is a recognized strategy and an Internet approach to the mobile health proposal is a recognized and promising practice.

This randomized controlled study is been conducted to verify the effectiveness of the Mobile Health of lifestyle that focuses on aspects of physical functional, psychosocial, and quality of life of patients with CEID. The hypothesis is that the use of Mobile Health of lifestyle provides greater physical functional, psychological aspects, and quality of life to patients with CIED.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent prior to randomization and any study procedure;
* Patients with any CIED
* Access to the internet
* Clinical stability in the last 3 weeks
* With left ventricular ejection fraction (LVEF) greater than 40%
* Skill to conduct the self-monitoring of intensity in physical activity
* New York Heart Association classification 1 or 2

Exclusion Criteria:

* Unstable angina
* Uncontrolled systemic arterial hypertension
* Cardiac arrhythmia effort- induced
* People with a musculoskeletal or neurological problem
* Cognitive disability
* Patients opposed to the participation in the research
* Other concomitants cardiovascular disease, including uncontrolled diabetes mellitus (systemic hypertension without target-organ impairment is allowed);
* Moderate or severe chronic obstructive pulmonary disease;
Denosumab Treatment in CKD Patients at High Risk of Fracture

Objective: To verify the efficacy and safety of denosumab in the prevention and treatment of CKD-MBD in CKD patients with high risk of fracture.

Methods: A cohort of CKD patients with high risk of fracture was established and followed up for long periods (≥24 months). Patients with CKD3b-5D stage and fracture risk assessment tool (FRAX) scores at high risk or very high risk of fracture were enrolled. A multicenter, prospective, open-label, randomised controlled, interventional study was conducted. The patients were divided into two groups. The patients in the denosumab group received subcutaneous injection of denosumab 60mg once every 6 months, and the patients in the non-denosumab group received conventional treatment. Bone metabolic markers (serum calcium, phosphorus, vitamin D, parathyroid hormone, alkaline phosphatase, tartrate-resistant acid phosphatase 5b, osteocalcin, total N-terminal propeptide of type I collagen, etc.), bone mineral density (dual-energy X-ray, quantitative CT), and vascular calcification score were regularly monitored. All adverse events (all-cause death, cardiovascular death, cardiac events, fracture, hospitalization, emergency department visits, etc.) were recorded during the follow-up period. Bone mineral density and clinical parameters were compared between the two groups.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old;
* Stage 3b-5D chronic kidney disease;
* The 10-year probability of hip fracture assessed by fracture risk assessment tool (FRAX) was \>5%;
* Voluntarily signed informed consent.

Exclusion Criteria:

* Age \< 18 or ≥100 years;
* Premenopausal women;
* Denosumab was absolutely contraindicated;
* Had received denosumab or bisphosphonates therapy;
* Tertiary hyperparathyroidism;
* Patients with malignant tumor;
* Patients at risk for osteonecrosis of the jaw;
* Estimated follow-up time ≤12 months.