cyrilzakka/clinical-trials huggingface dataset:
Bilateral Surgical Resection of Carotid Bodies in Patients With Systolic Heart Failure

The primary aim of the study is to determine safety, tolerability and feasibility of bilateral carotid body resection in patients with systolic heart failure and peripheral chemoreceptor hypersensitivity. The secondary aim is to assess potential efficacy of bilateral carotid body resection.


Eligibility Criteria:
Inclusion Criteria:

* History of heart failure class II-III according to NYHA within at least 6 months prior to inclusion
* Stable clinical state within at least 4 weeks prior to inclusion
* Subject \>= 18 years old
* Left ventricular ejection fraction ≤ 45% evaluated by transthoracic echocardiography (Simpson's method)
* Carotid body present in computer cervical angiotomography
* History of exacerbated peripheral chemoreceptor sensitivity determined as \>0.6L/min/%SpO2
* Able and willing to give written informed consent

Exclusion Criteria:

* Unstable angina pectoris, coronary attack, coronary revascularization, exacerbation of heart-failure requiring hospitalization, clinically significant infection, surgery under general anesthesia within 3 months prior to inclusion
* History of stroke, transient ischemic attack (TIA), or clinically significant chronic neurological disorder
* History of heart transplant
* Pregnancy or anticipation of pregnancy
* Hemodialysis or peritoneal dialysis patients
* Obstructive carotid atherosclerotic disease with \>50% stenosis
* COPD stage III and IV according to GOLD 2007
* Unable to perform the spiroergometric assessment
* Any significant anomaly in additional investigation which may increase the risk of study procedure
Myocardial Bridging in Obstructive Hypertrophic Cardiomyopathy

This study investigated the impact of myocardial bridging (MB) and its characteristics on preoperative atrial fibrillation and survival in patients with obstructive hypertrophic cardiomyopathy (oHCM). We recruited 968 consecutive patients with oHCM who underwent myectomy at our institution between January 2015 and December 2019, including 144 patients with MB and 824 patients without MB. All patients received angiography before surgery. The diagnosis of preoperative atrial fibrillation was based on 12-lead electrocardiography, 24-hour Holter electrocardiography, or in-hospital electrocardiogram monitoring, which was extracted from patients' medical records. Surgical details and follow-up data were also collected.


Eligibility Criteria:
Inclusion Criteria:I(i) age ≥ 18 years and (ii) diagnosis of oHCM based on clinical and echocardiographic evaluation.

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Exclusion Criteria: (i) a history of heart surgery (ii) Patients who had coronary atherosclerosis or myocardial infraction; (iii) Patients who had no angiography records.

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Multimodal Cardiovascular and Hepatic Population Imaging

Medical imaging is increasingly important for understanding diseases, detecting them early, and personalizing treatments. New imaging techniques, which can measure processes in the body without surgery, are opening the door to a more precise approach to medicine. Instead of relying on general probabilities, this technology allows us to analyze specific factors in a person's health, leading to better predictions and targeted treatments. One key challenge in medicine today is reducing "residual individual risk"-the remaining health risks that current treatments don't fully address. This involves understanding how factors like age, sex, genetics, and environment affect our health, particularly when it comes to conditions like heart and liver disease. By using imaging to distinguish between normal aging and disease, we can better assess individual health risks.

The current project will create a large collection of medical images linked with health data from a broad population across France. Using advanced, non-invasive techniques such as MRI and ultrasound, researchers will analyze the heart, blood vessels, and liver in detail, considering factors like gender and health risk profiles. This will help improve our understanding of these diseases, which are often silent and not well understood, providing direct benefits to the participants. Ultimately, the goal is to optimize imaging technologies for large-scale studies, which will help enhance early detection and prevention for everyone.


Eligibility Criteria:
Inclusion Criteria:

* Participation to the Constances cohort
* Age ≥ 20 years
* No overt cardiovascular or hepatic disease or related symptoms
* No known family or personal genetic disease
* Affiliation with a social security scheme or beneficiary of such a scheme.
* Agreement to sign the consent

Exclusion Criteria:

* Renal function impairment with GFR \< 60 mL/min/1.73m2
* Deprived of liberty or persons subject to a legal protection measure (under guardianship or trusteeship)
* People with contraindications to MRI (claustrophobia, presence of metallic elements...)
* Pregnant or breastfeeding woman (pregnancy urinary test before inclusion for women of childbearing age).
Intensive Versus Regular Dosage For PD In AKI.

This is a multicenter, pilot RCT study, aiming to compare intensive dosage and regular dosage of PD for AKI patients with indications for dialysis.

Aims of the study are to:

Examine the feasibility of the study, which aims to determine the efficacy and safety of intensive PD dose for AKI patients as compared to regular PD dose.

Establish the appropriate workflow for PD treatment for AKI patients.

The incidence of acute kidney injury (AKI) is rapidly increasing worldwide, which partly due to greater recognition of AKI, more exposure to various nephrotoxins and an ageing population with increased burden of non-infectious chronic disease. Intermittent hemodialysis (IHD) or continuous renal replacement therapy (CRRT) (i.e. venous-venous HD or hemofiltration) are the most-commonly modalities applied for acute kidney injury (AKI) patients in both developed and developing countries. By contrast, the use of peritoneal dialysis (PD) has been rare. There are no consensus on the ideal dosage and target of adequacy for PD in AKI. Therefore, we are to perform a multicenter, pilot RCT study, aiming to compare intensive dosage and regular dosage of PD for AKI patients with indications for dialysis. If successful, this strategy is expected to enhance the remedy rate of AKF patients, especially in developing regions/countries.

Eligibility Criteria:
Inclusion Criteria:

* Age older than 14 years;
* Be diagnosed as AKI according to KDIGO recommendation;
* Having indications for renal replacement therapy.

Exclusion Criteria:

* Having contraindications to peritoneal dialysis;
* Functional azotemia;
* Hypercatabolic status;
* Previous CKD history (baseline eGFR\<60ml/min/1.73m2 or proteinuria);
* Psychological disorder or communication barrier;
* Pregnancy;
* Refusing to receive dialysis therapy.
* receiving mechanical ventilation.
Coffee and Real-time Atrial and Ventricular Ectopy

Atrial fibrillation (AF) and heart failure (HF) are morbid, costly, and incompletely understood diseases that have reached epidemic proportions worldwide. A dose-dependent relationship exists between premature atrial and ventricular contractions (PACs and PVCs) and development of AF and HF, respectively. Identifying and understanding the mechanisms of additional modifiable risk factors for ectopy has the potential to markedly reduce the healthcare burden of these diseases. In considering how to modify the prevalence of these ectopic beats, the investigators believe common exposures in daily life are prime candidates. Current guidelines suggest that caffeine may be an important trigger for frequent ectopy, although large population-based studies have not demonstrated an association between caffeine consumption and development of clinically significant arrhythmias. No study has employed an actual randomization intervention to assess the effects of caffeine on cardiac ectopy. Utilizing the Eureka platform, the investigators plan to utilize the N-of-1 strategy to rigorously investigate the real-time effect of caffeine intake on ectopy.

This study is designed as a N to 1 randomized trial, where each participant will be randomized to consume or abstain from coffee each day of a 14 day monitoring period. Participants will wear an automatically recording electrocardiographic monitor (ZIO® XT Patch), continuous glucose monitor (Dexcom G6), and a fitness tracker (Fitbit INSPIRE) while utilizing Eureka-a mobile application. We will compare participant self-report of caffeine consumption, glucose monitoring, fitness levels, sleep health, and heart rhythm data in order to better understand the relationship between acute caffeine consumption and heart rhythm changes. Participants will also be genotyped for caffeine metabolism-related SNPs. A total of 100 participants will be enrolled at the UCSF study site.

Eligibility Criteria:
Inclusion Criteria:

1. Are age 18 or older
2. Have a smartphone
3. Are able to use the Eureka mobile application
4. Are willing to provide a saliva sample for genetic processing
5. Drink coffee or coffee-based products at least once a year
6. Are willing to abstain from coffee, caffeinated products, or minimally caffeinated products (decaffeinated coffee) for at least 2 days when instructed

Exclusion Criteria:

1. Have a history of atrial fibrillation, heart failure
2. Have an ICD or pacemaker
3. Have treatment with beta blockers, non-dihydropyridine calcium channel blockers, or Vaughn-Williams class 1 or 3 antiarrhythmic medications
4. Have a medical reason to avoid coffee
Monitoring in Congestive Heart Failure Study

This is a multi-center, non-randomized study designed to develop an external monitor for CHF patients.

Heart failure patients will be externally monitored. The collected information will be used to assess patient status.

Eligibility Criteria:
Inclusion Criteria:

18 years of age or older
CT Scan Guide Percutaneous Biopsy of Lytic Bone Metastases of Lung Cancer : Contribution in Pathology Diagnosis and Molecular Biology

In case of primary lung cancer, bone metastases biopsy can be done in initial diagnosis or follow-up.

Nevertheless, any study focus on rentability and biopsy complications of lytic bone lesion for the context of lung cancer.

This study aims to demonstrate that CT scan guide percutaneous biopsy of lytic bone lesion help to anatomopathologic diagnosis and molecular biology with a low complication rate inasmuch a lung cancer is suspected.

This study is observational, retrospective, one center

Current progress in thoracic oncology require to be able to carry out analysis by molecular biology. So biopsies are done several times during cancer progression. But risk is high for a lung biopsy with enough sample, so a CT scan guide percutaneous biopsy of lytic bone metastases of lung cancer can be an alternative.

In case of primary lung cancer, bone metastases biopsy can be done in initial diagnosis or follow-up. But this contribution in diagnostic (anatomopathologic an molecular biology) is poorly understood. It is demonstrated that to sample on lytic bone lesion have a failure rate lower than on calcified osseous lesion. Nevertheless, any study focus on rentability and biopsy complications of lytic bone lesion for the context of lung cancer.

this study aims to demonstrate that CT scan guide percutaneous biopsy of lytic bone lesion help to anatomopathologic diagnosis and molecular biology with a low complication rate inasmuch a lung cancer is suspected.

This study is observational, retrospective, descriptive, one-center Patient's records selection will be done by keyword search on the CHU Grenoble Alpes radiology software. Only records with bone biopsy register between January 2010 and June 2017 will be included.

Eligibility Criteria:
Inclusion Criteria:

* CT scan guide percutaneous biopsy of lytic bone metastases
* register on CHU Grenoble Alpes radiology software between January 2010 and June 2017
* Patient who have a clinical context of lung cancer with bone metastases

Exclusion Criteria:

* Person deprived of liberty by judicial order
* Opposition expressed by patient
ZIMURA in Combination With LUCENTIS in Patients With Neovascular Age Related Macular Degeneration (NVAMD)

To assess the safety of intravitreal Zimura™ (complement factor C5 inhibitor) administered in combination with Lucentis® 0.5 mg in treatment naïve subjects with neovascular age related macular degeneration (NVAMD)


Eligibility Criteria:
Inclusion Criteria:

* Active subfoveal NVAMD

Exclusion Criteria:

* History or evidence of severe cardiac disease
* Any major surgical procedure within one month of trial entry
* Subjects with a clinically significant laboratory value
* Any treatment with an investigational agent in the past 60 days for any condition
* Women who are pregnant or nursing
* Known serious allergies to the fluorescein dye used in angiography, povidone iodine, to the components of the ranibizumab formulation, or to the components of the Zimura formulation
* Any prior treatment for AMD other than oral supplements of vitamins and minerals
Effects of Nicorandil on Angina Symptoms in Patients With Coronary Slow Flow

Slow coronary flow is an angiographically diagnosed phenomenon defined as delayed opacification of epicardial arteries in the absence of significant arterial narrowing and blockade. Endothelial dysfunction at the level of microarteries have been proposed as the main pathological mechanism in this regard. Available evidence suggest that standard anti-angina medications (e.g. nitroglycerin) that solely target large coronary trunks might not provide adequate symptomatic relief in patients with slow coronary flow phenomenon. It is hypothesized that anti-angina medications which exert vasodilatory effects in large coronary arteries as well as small dividing branches might be superior to nitroglycerin in amelioration of angina symptoms. The present randomized clinical trial was thus designed and conducted to compare the short-term efficacy of nicorandil (a dual-acting anti-angina medication with effects on both large and small coronary vessels) with nitroglycerin in a group of patients with slow coronary flow presented with frequent angina episodes.


Eligibility Criteria:
Inclusion Criteria:

* on coronary angiographic studies, arterial narrowing did not exceed 50% in any of the three main coronary arteries; (
* a delayed opacification in at least one of the main coronary arteries was documented. Delayed opacification was defines as corrected TIMI frame count \> 23 fps

Exclusion Criteria:

* comorbid cardiovascular condition other than mild coronary atherosclerosis and coronary slow flow
* refusal to participate
* discontinuation of treatment
* not returning for the follow up visit
Allogenomic Mismatch Score (AMS) Applied to Haplo-identical Donor/Recipient Pairs in Haematopoietic Stem Cell Transplantation

The occurrence of acute and/or chronic GVH (Graf Versus Host disease) for recipients undergoing HSCT (haematopoietic stem cell transplantation) with a geno-identical donor suggests the implication of other systems or genes than those involved in HLA (Human Leukocyte Antigen) compatibility.

In kidney transplantation, it has been shown that the AMS (allogenomic mismatch score) is correlated with the probability of survival of the graft. This AMS reflects the degree of differences between the immunopeptidomes of the recipient and his donor as it is a continuous variable based on the number of nsSNP (non synonymous Single Nucletotide Polymorphism) between the donor and the recipient. Roughly, the exome of the donor is aligned to the exome of the recipient, allowing to count the number of variations that will generate a peptide present in the recipient but absent in in the donor. In this case, peptide presented by the recipient's cells is not part of the donor's immunopeptidome, leading to an activation of the donor's immunocompetent cells toward this antigen, i.e. to alloreactivity that may cause GVL (Graft Versus Leukemia) and/or GVH.

This study aims to highlight significant correlations between the occurrence of acute and/or chronic GVH after haplo-identical stem cell transplantation and the AMS.

This would allow to use the AMS as a predictive factor of acute or chronic GVH, which could be employed to select the best donor for one particular recipient and/or personalize the immunotherapies after transplantation


Eligibility Criteria:
Inclusion Criteria:

* - Recipients who underwent haplo-identical stem cell transplantation in CHRU (Centre Hospitalier Régional et Universitaire) de Nancy
* Recipients transplanted between 03/01/2015 et 01/01/2020
* Recipient older than 18 years old at time of transplant
* Available DNA for the recipient and his donor.

Exclusion Criteria:

* Recipient died within the 6 months following the transplantation without acute GVH (unknown status for one of the measured outcomes)
Effect of Music Over the Tolerance to Colonoscopy.

This study will evaluate the efficacy of music (a very well selected list of songs)on improving the tolerance to the colonoscopy. The patients will be randomly assigned to receive music or not. The authors hypothesis is that music is able to improve the tolerance to colonoscopy evaluated as a reduction on the level of anxiety, on the intensity of pain experimented during the procedure and a reduction of the administered dose of midazolam during the colonoscopy.

To select the music that will be administered on this trial we will performed as the first part of the study, a two fase pilot study. In the first part, five song belonging to different musical styles (Rock, Bosa Nova, Classical Music, Popular chilean music and New age) will be heard by 40 persons and the main emotion produced by every song will be registered (chosen among a previously defined list of emotions) and then rated using a visual analog scale. Thus, we will be able to select the musical style that with more frequency produce "tranquility and/or peace". Once this musical style will be selected we generate a set of songs belonging to this style. This set of songs will be validated using again a similar methodology in the second part of the pilot study to be sure that is able to produce the same emotion that the song previously evaluated. The validated set of songs will be the music that will be administered to the patients participating on a multicentric randomized controlled trial where the effect of the selected music over the tolerance to colonoscopy will be evaluated measuring the level of anxiety, the administered dose of midazolam and the intensity of pain experimented during the procedure among another variables on the experimental and the control groups, including 150 patients on each arm.

Eligibility Criteria:
Inclusion Criteria:

* Adults (over 18 years)
* Diagnostic colonoscopy
* Signed informed consent

Exclusion Criteria:

* Hypoacusia
* Significant cognitive impairment
* Hypotension
* Signs of digestive haemorrhage (other than a small amount of rectorrhagia)
* More than moderate intensity of pain before the colonoscopy.
* Previous colorectal surgery
* allergy to midazolam or pethidine
A Study to Evaluate the Efficacy and Safety of HLX15-IV Versus DARZALEX® in Combination with Lenalidomide-Dexamethasone (Rd) in Transplant-ineligible Patients with Newly Diagnosed Multiple Myeloma

This is a randomized, double-blind, parallel-controlled, multicenter, phase III study to compare the efficacy and safety of HLX15-IV in combination with Rd (HLX15-IV-Rd) versus DARZALEX® in combination with Rd (D-Rd) in patients with NDMM who are ineligible for autologous stem cell transplantation (ASCT).


Eligibility Criteria:
Inclusion Criteria:

1. Capable to understand and sign the ICF.
2. Patients aged ≥ 18 years .
3. Patient must have documented multiple myeloma (MM) satisfying the International Myeloma Working Group (IMWG) diagnostic criteria for MM.
4. Newly diagnosed, untreated and not considered candidate for autologous stem cell transplantation (ASCT).
5. Patient must have an ECOG performance status score of 0.
6. Patient must have pretreatment clinical laboratory values.
7. Contraceptive use by men or women should be consistent with local regulations.
8. A WOCBP must have a negative serum pregnancy test at screening within 72 hours prior to randomization.

Exclusion Criteria:

1. Patient has a diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), Waldenström's disease, or other conditions in which IgM M-protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions.
2. Patient has plasma cell leukemia or POEMS syndrome .
3. Patient has prior or current systemic therapy or ASCT for MM before randomization.
4. Patient has peripheral neuropathy or neuropathic pain Grade 2 or higher.
5. Patient has a history of malignancy (other than MM) within 3 years before randomization .
6. Patient has clinical signs of meningeal involvement of MM.
7. Patient has known COPD, persistent asthma, or a history of asthma within the last 2 years.
8. Patient is known to be seropositive for history of human immunodeficiency virus (HIV) or known to have treponema pallidum antibodies (Anti-TP).
9. Patient is known to have active hepatitis B or C.
10. Patient has any concurrent medical or psychiatric condition or disease that is likely to interfere with the study procedures or results.
11. Patient has clinically significant cardiac disease.
12. Patient has known allergies, hypersensitivity, or intolerance to treatment drugs.
13. Patient has history of drug abuse or substance abuse.
14. Patient is a woman who is pregnant, or breast-feeding, or planning to become pregnant or donate eggs (ova, oocytes).
15. Patient had radiation therapy within 14 days of randomization.
16. Patient had plasmapheresis within 28 days of randomization.
17. Patient had major surgery within 28 days before randomization.
18. Patient in clinical trials of any other drug or device within 3 months before randomization.
19. Patient has any condition could prevent, limit, or confound the protocol-specified assessments.