cyrilzakka/clinical-trials huggingface dataset:
Clinical and Healthcare Economic OutcoMes From ReAl-worlD Use in Europe of an AI Software During AF Ablation

The goal of this Observational Prospective Multi-center Study is to observe the acute and long-term safety and performance outcomes after spatiotemporal dispersion-based AF/AT ablation utilizing the Volta Medical AI software in "real-life" clinical practice, without any imposed clinical workflow. Moreover, this study will allow to collect medico-economic data related to the tailored ablation strategy guided by the Volta Medical AI software.

All patients enrolled are treated for atrial fibrillation/tachycardia via a catheter ablation procedure using Volta Medical AI software during the mapping phase to identify areas of interest specific to the patient. The ablation approach is free and chosen by the operator according to standard practice. Intraoperative and postoperative follow-up will be performed as in routine clinical practice during AF ablation procedures: hospitalization for ablation procedure and standard postoperative quarterly visits (at 3 months, at 6 months and/or 9 months as per the study investigator's Standard Of Care) then annual visits up to 24 months post-ablation. Adverse Events, recurrences of atrial arrhythmia and AF related symptoms (EHRA score) are collected from the patient's enrollment until the patient's study termination. A quality-of-life questionnaire related to general health (EQ-5D-3L) is collected during the preoperative visit and at least during annual follow-up visits. The patient's study-termination corresponds to the last annual visit at 24 months post-ablation index.

Eligibility Criteria:
Inclusion Criteria:

1. Patient aged 18 years or older.
2. Patient candidate for catheter ablation to treat paroxysmal or persistent atrial fibrillation, atrial tachycardia, de novo or after one or several previous ablation procedures, and for which the investigator considers using VX1 or Volta AF-Xplorer or Volta AF-Xplorer II.
3. Patient able and willing to provide written informed consent to participate in the study.
4. Only for France: Patient affiliated to the French social security system.

Exclusion Criteria:

1. Contraindication to AF/AT catheter ablation.
2. Patient who is or could potentially be pregnant.
3. Person deprived of liberty or under guardianship.
4. Person unable to undergo a medical monitoring for geographical, social or psychological reasons.
5. Patient\&amp;#39;s refusal to participate in the study.
6. Enrollment in an investigational study evaluating another device, biologic, or drug.
Satisfaction of HIV-infected Patients Treated With Cabotegravir-rilpivirine Injectable Dual Therapy

Question arises as to whether this new treatment "Cabotegravir-rilpivirineactually" improves patient satisfaction and whether it is well suited to everyone, especially those with a history of irregular follow-up. Also, inconvenience of two intramuscular injections every two months and constraint of care organization could represent a barrier to treatment for some patients.

Cabotegravir-rilpivirine prolonged-release injectable dual therapy antiretroviral treatment recently obtained marketing authorization in France to treat human immunodeficiency virus (HIV) infection. It would meet the demand of patients for less frequent treatment to overcome constraints associated with daily drug intake such as stigma due to HIV, weight of daily pill recalling disease or difficulties in compliance. This authorization follows the results of FLAIR and ATLAS phase III clinical trials, which showed non-inferiority of monthly injectable treatment in terms of virological control compared to conventional oral triple therapy. 1-4 ATLAS-trial 2M showed non-inferiority of injectable treatment every two months compared to every month.5 Main risk factors for virological failure highlighted were a low residual plasma concentration of rilpivirine, viral subtype A1/A6, existence of archived resistance mutations to rilpivirine and obesity (BMI \> 30 kg/ m²).6 Discontinuation rate of injectable treatment at one year was 9% in FLAIR trial and 8% in ATLAS versus 8% and 6% respectively for control group under oral treatment. Most treatment discontinuations were due to adverse effects.

Most commonly reported adverse reactions were injection site reactions (up to 84%), headache (up to 12%) and fever (10%). In these studies, patient satisfaction was assessed through multiple scales or questionnaires. Results of these evaluations did not make it possible to conclude on the impact of injectable treatment on patients quality of life.

Eligibility Criteria:
Inclusion Criteria:

* HIV-1 infected patient
* Patient over 18 years of age
* Patient for whom dual injectable sustained-release cabotegravir-rilpivirine therapy is implemented according to the decision of the referring physician in the context of care.
* Patient who understands, reads and writes French well

Exclusion Criteria:

* Patient opposing to participate in the study.
* Patient subject to legal protection measures (guardianship, curatorship or safeguard of justice)
Clinical Characteristics of Patients With Leukemia and COVID-19

The purpose of this study is to describe the main clinical characteristics of patients with de novo acute lymphoblastic leukemia treated inside the third level hospitals converted to Coronavirus disease 2019 (COVID-19) attention for the metropolitan area of Mexico City.

Retrospective, observational study in patients with diagnosis of acute lymphoblastic leukemia, according to the criteria of the World Health Organization, from April 2020 to December 2020. Patients was cared for in the hematology department of the Hospital Regional de Alta Especialidad de Ixtapaluca or the Hospital General de México. Both hospitals have been assigned as Coronavirus disease 2019 (COVID-19) hospitals, limiting the access, number of outpatient visits and chemotherapy protocols.

Real-time polymerase chain reaction (RT-PCR) test for Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was performed for patients with respiratory symptoms or history of contact with suspected / confirmed cases of COVID-19 Upon having a positive RT-PCR test, patients were transferred to a respiratory isolation unit to continue their recovery. Support treatment for COVID-19 was based on local considerations.

Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosis of acute lymphoblastic leukemia according to the criteria of the World Health Organization.

Exclusion Criteria:

* Age less than 18 years
* Incomplete medical records
Surveillance Monitoring on General Wards

This is a study to determine if surveillance monitoring of general ward patients can reduce cardio-pulmonary arrest while maintaining an acceptable false alarms rate for nursing workload.

The investigators placed a wired monitoring system (pulse oximetry, heart rate and respiratory rate) on every patient who arrived on a subject general post surgical ward who assented to wear the system. this was the Masimo PSNET system using the Radical 87 monitor and an acoustic respiratory sensor along with a Masimo pulse oximetry probe. Patients were monitored for a minimum of 48 hrs. Heart Rate (HR) parameters were set between 45-130, Respiratory rate was set between 6-20 and pulse oximetrry was 85-100%. Nurses documented in the Electronic Medical Record (EMR) any alarms they responded to as to whether they were false (vital sign not out of range when rechecked) or true and what the response was. Responses ranged from nurse managed to notification of primary service to Rapid Response Activation to Code team activation as well as transfer to a higher level of care (operating room or Intensive Care Unit (ICU)/IMC. Patient and Nursing satisfaction surveys were collected.

Eligibility Criteria:
Inclusion Criteria:

* all post-surgical patients admitted to a post-operative general hospital ward

Exclusion Criteria:

* inability to understand English or provide verbal consent for data analysis
PK/PD Study With G-Pump (Glucagon Infusion) in T1DM Patients

The purpose of the study is to assess the safety, speed of absorption, and onset of action of G-Pump™ (glucagon infusion) at three subcutaneous doses as compared to Novo GlucaGen®, all delivered via an OmniPod® infusion pump to patients with type 1 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Males or females diagnosed with type 1 diabetes mellitus for at least 24 months
* Current usage of subcutaneous insulin pump treatment
* Age 18-65 years
* C-peptide level \< 0.5 ng/ml
* Willingness to follow all study procedures, including attending all clinic visits
* Subject has provided informed consent and has signed and dated an informed consent form before any trial-related activities

Exclusion Criteria:

* Pregnant and/ or Lactating: For women of childbearing potential: there is a requirement for a negative urine pregnancy test and for agreement to use contraception during the study and for at least 1 month after participating in the study.
* HbA1c \>10.0%
* Renal insufficiency (serum creatinine of 1.2 mg/dL or greater)
* Serum ALT or AST equal to or greater than 3 times the upper limit of normal; hepatic synthetic insufficiency as defined as a serum albumin of less than 3.0 g/dL; or serum bilirubin of over 2.0.
* Hematocrit of less than or equal to 34%
* Congestive heart failure, NYHA class II, III or IV
* History of coronary artery disease
* Active foot ulceration
* History of a cerebrovascular accident
* Active alcohol abuse or substance abuse
* Active malignancy, except basal cell or squamous cell skin cancers
* Major surgical operation within 30 days prior to screening
* Seizure disorder
* Current administration of oral or parenteral corticosteroids
* Use of an investigational drug within 30 days prior to screening
* Bleeding disorder, treatment with warfarin, or platelet count below 50,000
* Proliferative or severe non-proliferative retinopathy
* Gastroparesis
* Personal or family history of pheochromocytoma or disorder with increased risk of pheochromocytoma (MEN 2, neurofibromatosis, or Von Hippel-Lindau disease)
* Insulinoma
* Allergies to glucagon or glucagon-like products, or any history of significant hypersensitivity to glucagon or any related products.
* Glycogen storage disease
* Any concurrent illness, other than diabetes, that is not controlled by a stable therapeutic regimen
* Whole blood donation of 1 pint (500 mL) within 8 weeks prior to Screening.
* Any reason the principal investigator deems exclusionary
Sucrosomial Iron and Iron Sulphate to Blood Donors

2 different oral iron supplementations after blood donation are compared.

Iron depletion is common in regular blood donors. During a blood donation the donor loses 200-250 mg iron. The routine at our donor sites is to give donors 20 tablets of iron sulphate (Duroferon®) 100 mg after blood donation.

In this study we will compare two different iron supplementations given after blood donation. 60 donors are given oral sucrosomial Iron (SiderAl Forte®) and 60 donors are given oral iron sulphate (Duroferon®) after 4 successive blood donation.

The primary purpose of this study is to compare the side effects of sucrosomial Iron and iron sulphate and to investigate if the iron balance can be maintained with sucrosomial iron.

After each blood donation the donors are asked to answer a questionary with questions about side effects and symptoms of Restless legs syndrome/Willis-Ekbom (symptoms associated with iron deficiency).

Eligibility Criteria:
Inclusion Criteria:

Blood donors at Uppsala University hospital wo have been donating blood regularly the last two years are eligible to participate in the study.

Exclusion Criteria:

Donors who cannot be accepted for blood donation anymore because they do not fulfill the Swedish criteria for blood donation.
Validation of the SIGAM/VF Mobility Grade

The objective of this study is to demonstrate the validity, the reproducibility and the coherence of the French version of the Special Interest Group in Amputee medicine (SIGAM) mobility scale questionnaire in adults with lower-limb amputations.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 to 80 years
* Patients who have been informed about the research
* Patients with national health insurance cover
* Patients who accepted to take part in the study
* Able to understand simple instructions
* With transtibial, femoral, or bilateral amputation of the lower limb
* Whatever the etiology
* Patients able to do the 2-minute walk test
* Group 1:

  * Patients in the stabilized phase of the definitive prosthesis, with no modification of the prosthesis in the previous 3 months and at more than 6 months after the amputation.
* Group 2:

  * Patients in the initial phase of management (temporary prosthesis, rehabilitation) post trans-tibial unilateral amputation

Exclusion Criteria:

* Patient without national health insurance cover.
* Patients under guardianship.
* Pregnant or breast-feeding women.
* Alteration of executive functions making understanding of and compliance with the research protocol impossible (Mini Mental State Examination\<20)
* Associated chronic motor deficiency, of neurological origin (examples: sequelae of stroke, balance and coordination disorders), or of osteo-articular origin (examples: knee or hip osteoarthritis), or due to secondary functional repercussions making it impossible to walk with a prosthesis.
* Severe medical disorder that significantly impairs functional capacities (severe heart failure, respiratory failure, non-stabilized metabolic disorders such as progressive kidney failure) that is life-threatening in the short or medium term (Progressive neoplastic disease, non-stabilized systemic disease).
* Complications at the stump other than microcirculation that could affect the application of a contact socket/sleeve: haematoma, Cysts, effusion, calcifications of soft tissues, bone spurs, infection (skin, abscess), neuroma, deterioration of the knee of the amputated limb, specifically painful Farabeuf angle (compression between bone and skin), venous thrombosis, abnormal stump shape making it impossible to use a socket (flexion of the knee, "pear-shaped", "deep-scar" stump...)
Safety and Tolerability of IBI355 in Patients With Primary Sjogren's Syndrome

This study aims to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of IBI355 in primary Sjogren's syndrome (pSS) patients. This study also aims to evaluate the anti-Drug antibody after multiple ascending doses of IBI355 in pSS patients.


Eligibility Criteria:
Inclusion Criteria:

1. Understand and sign the informed consent form;
2. Age ≥ 18 years, male or female；
3. Body Mass Index (BMI) within the range of 18.0 to 28.0 kg/m² (inclusive);
4. Meet the 2016 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for Sjögren's Syndrome;
5. Positive for anti-Sjögren's syndrome A autoantibodies (SSA) and/or anti-Sjögren's syndrome B autoantibodies (SSB);
6. Unstimulated whole salivary flow rate \> 0 ml/min;

Exclusion Criteria:

1. Individuals who have had allergic reactions to any components of IBI355, have allergic diseases, or possess an allergic constitution;
2. Those who cannot tolerate frequent venipuncture procedures;
3. Participants diagnosed with secondary Sjögren's syndrome, or whose clinical symptoms (or laboratory abnormalities) require explanation by another connective tissue disease (such as systemic lupus erythematosus, mixed connective tissue disease, etc.).
4. Subjects paticipated in the other clinical trail in 1 month or less than 5 t1/2 since the previous clinical trial (which is longer)；
5. Subjects with an infection requiring systemic medication was present within 30 days prior to randomization;
6. HIV-Ab、RPR、HCV-Ab、HBV、HBeAg or HBcAb, one of them positive;
7. There have a clinical or imaging evidence that the subject with active tuberculosis, or there is evidence that the subject is in the incubation period for tuberculosis;

6.Patients with a history of central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, metabolic disorders and other systemic diseases; 7. Subject with a hcg positive; 8.Patients with a history of neuropsychiatry or who are considered unfit to participate in this clinical trial; 9.Patients with pulmonary interstitial fibrosis, or those requiring combined antifibrotic drug therapy, or those with abnormal lung function that the investigators determined was not suitable for this study; 10. Need to use other drugs that could cause xerostomia during the study.
Efficacy and Safety of Gadobutrol 1.0 Molar (Gadovist) for Breast Magnetic Resonance Imaging (MRI)

The purpose of this study is to look at the efficacy (how does it work) and safety of gadobutrol when used for obtaining MR images of both breasts.Women with a recent diagnosis of breast cancer by mammogram (X-ray examination of the breasts) may benefit from MRI of the breasts as MRI may detect additional breast cancers


Eligibility Criteria:
Inclusion Criteria:

* Recent histologically proven diagnosis of breast cancer after having obtained X-Ray Mammography (XRM) of both breasts (according to American College of Radiology \[ACR\] and performed no longer than 6 weeks prior to enrollment into the study) and has been referred for a contrast-enhanced Magnetic Resonance Mammography (MRM) prior to surgery of the breast.
* if female, a digital XRM is required if any of the following criteria is met:

  * a. patient is younger than 50 years;
  * b. patient has heterogeneously or extremely dense breasts;
  * c. is not post-menopausal (post-menopause defined as at least 12 months prior to inclusion without menstruation).
* if female of childbearing potential, MRM should be performed on the 7-14th day of the menstrual cycle.
* has an estimated glomerular filtration rate (eGFR) value \>/= 60 mL/min/1.73m\^2 derived from a serum creatinine result within 2 weeks prior to study enrollment.

Exclusion Criteria:

* is a female patient who is pregnant or lactating
* has any contraindication to the MRM examination (e.g. metal implants, phobia) or the use of gadolinium-containing contrast agents.
* has received any contrast agent within 24 hours prior to the study MRM, or is scheduled to receive any contrast agent within 24 hours after the study MRM.
* has severe cardiovascular disease (e.g., known long QT syndrome, acute myocardial infarction \[\< 14 days\], unstable angina, congestive heart failure New York Heart Association class IV) or acute stroke (\< 48 hours)).
* has acute renal insufficiency of any severity due to hepato-renal syndrome or in the peri-operative liver transplantation period or who has acute or chronic moderate or severe renal insufficiency (glomerular filtration rate \< 60 mL/min/1.73m\^2).
* has received chemotherapy or hormonal therapy for breast cancer within 6 months.
* has received hormone replacement therapy within 4 weeks prior to study drug administration.
* is scheduled or likely to require a surgery and/or biopsy in the time period up to 24 hours following study drug application
* has prior excisional biopsy or breast surgery less than 6 months before enrollment and between XRM and study MRM
HEMA-free Universal Adhesives for Restoring Non-carious Cervical Lesions

because of the recent introduction of universal adhesives, little information is currently available about the bond durability of universal adhesives to various substrates. Evaluation of bond durability is important since the stability of the bond between the adhesive and substrates is related to the clinical success of restorations. Because significant hydrolysis of the dentin-resin interface occurs after 6-12 months, a clinical trial of at least 18 months' duration is indicated to more accurately depict the likelihood of long-term clinical success

Cervical restorations are ever challenging because of difficulties in moisture control, caries access, and proximity to the gingival margin. Both mechanical and non-mechanical factors act to hinder the longevity of cervical restoration newer materials are readily introduced in the market with improved chemomechanical properties, longevity, patient safety, and comfort.

The introduction of new-generation adhesive systems has aimed at reducing technique sensitivity and the number of clinical steps required for adhesion. There has been a trend toward the use of less time-consuming options, continuing this trend, universal adhesives have recently been introduced to the profession. However, because of the recent introduction of universal adhesives, little information is currently available about the bond durability of universal adhesives to various substrates. Evaluation of bond durability is important since the stability of the bond between the adhesive and substrates is related to the clinical success of restorations. Although the most reliable conclusions about the performance of adhesives in the oral environment are derived from clinical trials.

To evaluate the effectiveness and clinical performance of adhesive systems, the American Dental Association (ADA) recommends clinical trials on non-carious cervical lesions (NCCLs), as composite resin restorations only remain bonded to these lesions by the micromechanical interlocking produced by the adhesive systems. The immediate, short-term, and long-term bonding performance of adhesive systems are then evaluated by retention, marginal integrity, and marginal discoloration. There are many attempts to improve bonding to substrates, bond strength, and bond durability, one of these attempts is the newly introduced universal adhesive (BeautiBond ).

Eligibility Criteria:
Inclusion Criteria:

* Participants had to be in good general health, be at least 18 years old
* have an acceptable oral hygiene level
* Participants were required to have NCCLs in different teeth preferably anterior or posterior that needed to be restored.
* These lesions had to be noncarious
* deeper than 1 mm
* involve both the enamel and dentin of vital teeth without mobility.

Exclusion Criteria:

* Uncooperative behavior, limits the use of adhesive due to hampering of adequate field or isolation techniques throughout the procedure.
* Patients allergic to the adhesive material. Patients with extremely poor oral hygiene
* severe or chronic periodontitis
* heavy bruxism habits
* Pulp involvement