cyrilzakka/clinical-trials huggingface dataset:
Driver Ablation of Persistent Atrial Fibrillation With Severe Atrial Fibrosis.

This is an open label, randomized parallel control clinical trial, to demonstrate the role of driver mechanism in maintenance substrate of persistent atrial fibrillation with severe atrial fibrosis, and evaluate the clinical outcomes of driver mapping and ablation strategy in patients with persistent atrial fibrillation with severe atrial fibrosis.

This is an open label, randomized parallel control clinical trial. Patients with persistent atrial fibrillation with severe atrial fibrosis are 1:1:1 randomized into group A (circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + driver ablation), group B (circumferential pulmonary vein isolation + linear ablation + posterior wall box isolation) and group C (circumferential pulmonary vein isolation + linear ablation + vein of Marshall ethanol infusion). Postoperative recurrence rate and other indicators are analyzed to demonstrate the role of driver mechanism in maintenance substrate of persistent atrial fibrillation with severe atrial fibrosis and evaluate the clinical outcomes of driver mapping and ablation strategy in patients with persistent atrial fibrillation with severe atrial fibrosis.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 to 80 years old;
2. Persistent AF with severe atrial fibrosis;
3. Nonresponse or intolerance to ≥1 antiarrhythmic drug.

Exclusion Criteria:

1. With uncontrolled congestive heart failure;
2. Having significant valvular disease;
3. With myocardial infarction or stroke within 6 months of screening;
4. With Significant congenital heart disease;
5. Ejection fraction was \<40% measured by echocardiography;
6. Allergic to contrast media;
7. Contraindication to anticoagulation medications;
8. Severe pulmonary disease e.g. restrictive pulmonary disease, chronic obstructive disease (COPD);
9. Left atrial (LA) thrombus;
10. Having any contraindication to right or left sided heart catheterization; 11. Previous atrial fibrillation ablation;

12. Presence of an implanted cardioverter-defibrillator; 13. Previous history of cardiac surgery; 14. Poor general health; 15. Life expectancy less than 6 months.
Post Pancreatitis Complications Study (Based on a Prospective Data Base)

The purpose of this observational epidemiological study is to investigate the management and the complications associated with pancreatitis. Datas will be analysed to answer pre-defined scientific projects and to improve management of these conditions.

Anonymous datas will be collected by study coordinators in a secured e-database.

Cross audit will be performed to check datas.

Eligibility Criteria:
Inclusion Criteria:

* pancreatitis

Exclusion Criteria:

* consent withdrawal
Validation of a Pharmacokinetic Pharmacodynamic Model to Administer Propofol in Obese Patients

The purpose of this study is to validate an integrated pharmacokinetic-pharmacodynamic model to administer propofol in obese patients.

Our hypothesis is that pharmacokinetic and pharmacodynamic changes occur with increasing weight and that mathematical models to administer drugs in obese patients can be developed to accurately predict dose schemes in this population.

Propofol is the most frequently used IV anesthetic today. Propofol TCI is commonly used for induction and maintenance of general anaesthesia in obese and non obese patients. However, current propofol PK models, used in TCI devices, were derived from studies that did not include obese patients. A controversial issue for propofol dose adjustment in this population has been the selection of an adequate size descriptor to scale PK parameters, as drug administration based on total body weight can result in overdose, and conversely, administration based on ideal body weight can result in a sub-therapeutic dose. In a previous study from our group, we developed a PK model capable of characterizing the influence of obesity on propofol disposition. The purpose of this study is to validate this model to administer propofol in obese patients.

Eligibility Criteria:
Inclusion Criteria:

* IMC \> 35 kg m-2
* Scheduled for laparoscopic bariatric surgery
* ASA I-II patients
* Between 18 and 60 yr of age.

Exclusion Criteria:

* Patients with allergy to study drugs
* Uncontrolled hypertension
* Heart block greater than first degree
* Take any drug acting in the central nervous system within 24 hrs before surgery.
Efficacy and Safety of AQX-1125 in IC/BPS

The primary objective of this study is to evaluate the effect of 6 weeks of treatment with once daily administration of AQX-1125 compared to placebo on average daily pain in subjects with interstitial cystitis/bladder pain syndrome (IC/BPS), during and after treatment, using a standardized 11-point numerical rating scale (NRS) pain score recorded by electronic diary


Eligibility Criteria:
Inclusion Criteria:

* Be females, ≥18 and ≤75 years of age, who have consistently had symptoms of bladder pain in addition to urinary urgency and/or urinary frequency for more than 12 months
* Have had the diagnosis of interstitial cystitis for \> 6 months (pain for at least 12 months) but ≤15 years
* Have average daily pain score of at least 5 out of 10 on the 11-point Numerical Rating Scale \[NRS\] pain scale in the 9 days prior to baseline
* Have undergone a cystoscopy and have documented visible signs of bladder bleeding, lesions or glomerulation within the last 36 months prior to baseline.
* Subjects if of child bearing potential, must agree to avoid pregnancy and use medically acceptable method of contraception from screening visit and throughout the study.
* Must be capable of voiding independently

Exclusion Criteria:

* Pelvic floor pain (\>5 out of 10 on the 11-point NRS pain scale following a pelvic pain assessment)
* Have a body mass index \[BMI\] of \<18 kg/m2 or \>39 kg/m2
* Have had a urinary tract infection including bacterial cystitis within the past 30 days.
* Have greater than 1+ hematuria on dipstick test at screening from an unknown cause
* History of previous procedure(s) (augmentation cystoplasty, cystectomy, or cystolysis) that has affected bladder function
The Effect of Virtual Simulation Training in Mastoidectomy

The purpose of this study is to investigate the effect of virtual simulation training on mastoidectomy dissection performance of otorhinolaryngology trainees, to explore performance assessment using a final-product analysis approach and to explore the role of cognitive load.

Traditional dissection training in temporal bone surgery is not evidence-based yet gold standard. In the recent years the Visible Ear Simulator has been used as an introduction to mastoidectomy in the Danish temporal bone course curriculum before letting the participants move on to dissection training in order to maximize the yield from the dissection training. Instructors have the impression that participants perform better in dissection after the simulator training session has been introduced. Our pilot study suggests that participants perform better in the simulator compared to traditional dissection training. This could be due to a reduction of the cognitive load in the virtual simulator.

These observations lead to the hypothesis that virtual simulation training of mastoidectomy provides an effect that improves performance in traditional dissection training.

Eligibility Criteria:
Inclusion Criteria:

* Resident in otorhinolaryngology postgraduate year 2-5
* Informed written consent

Exclusion Criteria:

* Previous participation in formal mastoidectomy training in a virtual simulator
Impact of Monthly High Dose Oral Cholecalciferol on Serum 25 Hydroxy Vitamin D Levels in Bariatric Surgery Subjects

Vitamin D deficiency is common after bariatric surgery. This study is designed to determine if a high dose monthly supplement of vitamin D 3 will be effective in helping improve vitamin D status after surgery such as gastric bypass. Bariatric surgery subjects taking monthly high dose cholecalciferol supplements in addition to the standard vitamin D protocol will have a significant rise in serum vitamin D levels compared to the subjects taking only the usual vitamin D protocol.


Eligibility Criteria:
Inclusion Criteria:

* morbidly obese meeting criteria for gastric bypass over age 18

Exclusion Criteria:

* taking medications that affect vitamin D status, elevated serum hydroxy vit D or calcium
A Two-Week Crossover Dispensing Evaluation Of Orion Daily Wear Soft Contact Lens

The primary objective of the study is to evaluate the clinical performance of test lens (Orion) in comparison with control lens (Gemini) over a period of two weeks of wear.

The primary objective of the study is to evaluate the clinical performance of test lens (Orion) in comparison with control lens (Gemini) over a period of two weeks of wear. This is a double-masked, randomized, bilateral, two-week crossover, dispensing study.

Eligibility Criteria:
Inclusion Criteria:

* Is at least 18 years of age and has full legal capacity to volunteer.
* Is no greater than 55 years of age.
* Has read and understood the information consent letter.
* Is willing and able to follow instructions and maintain the appointment schedule.
* Is an adapted soft contact lens wearer having worn lenses for a minimum of 4 weeks prior to the study.
* Has spectacle cylinder ≤1.00D in both eyes.
* Has spherical contact lens power requirement between -1.00D and -6.00D in both eyes.
* Has manifest refraction visual acuities (VA) equal to or better than logMAR equivalent of 20/20 in each eye.
* Wears CLs in both eyes (monovision acceptable, but not monofit)
* Has clear corneas and no active ocular disease.
* Has not worn lenses for at least 12 hours before the examination.
* Is willing to wear the study contact lenses for a minimum 8 hours per day/6 days per week

Exclusion Criteria:

* Has never worn contact lenses before.
* Has any systemic disease affecting ocular health.
* Is using any systemic or topical medications that will affect ocular health.
* Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
* Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
* Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
* Is aphakic.
* Has strabismus/amblyopia.
* Has undergone corneal refractive surgery.
* Is pregnant, lactating or planning a pregnancy.
* Is participating in any concurrent clinical or research study.
A Randomized, Single-blind, Controlled Clinical Study of Cardiomyopeptidin on Improving Ischemia-reperfusion Injury in Patients With Acute ST-segment Elevation Myocardial Infarction After Primary PCI

This study aim to investigate the myocardium protection effect of cardiomyopeptidin in patients undergoing primary PCI for ST-elevation myocardial infarction through myocardial enhanced MRI.

Investigators will enroll 160 patients with STEMI who were admitted to the Chinese PLA General Hospital between March 2022 and Marchr 2024，the investigators randomly assign eligible patients in a 1:1 ratio to either cardiomyopeptidin intervention group or control group befor primary PCI. The cardiomyopeptidin intervention group patients received intravenous infusion 3 mg/(kg·d) of cardiomyopeptidin during the PCI until 3 days after operation. Primary end point of the study was the area of infarct size measured by cardiac magnetic resonance (CMR). and secondary endpoints include slow flow/no-reflow incidence, corrected TIMI frame count (cTFC), ST-segment fall rate of ECG, cardiac enzymes and troponin, area of myocardial edema, microvascular obstruction, left ventricular ejection fraction, and composite cardiovascular events during the study period: all-cause death, cardiovascular death, unplanned hospitalization for heart failure, and revascularization. All adverse clinical events as well as study end points were monitored and adjudicated by the independent event committee.

Eligibility Criteria:
Inclusion Criteria:

* STEMI patients: typical chest pain lasting 30 min within the previous 12 h, a clear ST-segment elevation of N0.1 mV in ≥2 contiguous electrocardiographic leads, and elevated blood levels of troponin T
* patients were scheduled to undergo diagnostic cardiac angiography or percutaneous coronary interventions

Exclusion Criteria:

* had once treated by ivabradine
* history of myocardial infarction
* mechanical complications
* Unable to perform myocardial MRI
* liver and kidney failure
* malignant tumor
* unconscious
* Patients with other significant abnormal signs, laboratory tests and clinical disease are unsuitable for participation in the study accessed by clinicians.
PRP for Treatment of Peyronie's Disease

The purpose of this study is to learn about the effects of Platelet-Rich Plasma (PRP) injection in men with Peyronie's Disease (PyD).


Eligibility Criteria:
Inclusion Criteria:

1. Be Male
2. Be 18 to 75 years of age (inclusive).
3. Be able to provide written informed consent
4. Have a diagnosis of PD with evidence of active or stable disease as determined by the investigator
5. Penile curvature deformity of \>30° to \<120°
6. Agree to comply with all study related tests/procedures.

Exclusion Criteria:

1. Previous penile surgery of any kind (except circumcision and condyloma removal), such as penile lengthening, penile cancer surgery, penile plication, grafting.
2. Previous intralesional injection therapy (such as Xiaflex) for PD.
3. Previous history of priapism or penile fracture
4. PD characterized by a ventral plaque
5. Severe erectile dysfunction as characterized with an International Index of Erectile Function (IIEF) score ≤ 16
6. Actively on anticoagulation during time frame of injections (aspirin 81 mg will be eligible for therapy)
7. Hour-glass deformity
8. Unwilling to participate
9. Medically unfit for sexual intercourse as deemed by the principal investigator
10. Patients scheduled to undergo an elective medical procedure during the investigation timeframe that will interfere with autologous PRP injection therapy.
11. Have a serious comorbid illness/condition/behavior that, in the opinion of the investigator, may compromise the safety or compliance of the subject or preclude successful completion of the study.
CO2 Field Saturating Alternative Techniques Comparison

Prospective Randomized study comparing three strategy of deairing (NO CO2 insufflation, CO2 insufflation with non specific cannula, CO2 insufflation with commercial dedicated diffuser) as regarding Time to Complete Deairing measured from declamping via TEE Echo and Neurological Events at Wake Up

The impact of air bubbles into the cerebral circulation after open heart surgery has been a topic of discussion since the introduction of the heart-lung machine, and flooding the surgical field with CO2, which is heavier than Azote and Oxygen but over ten times more soluble seems a promising technique to minimize the presence of air microemboli. However very few studies have been conducted to ascertain what is the most efficient way to administer this treatment, or even of this treatment really impacts deairing time and clinical neurological events.

This study aims at comparing the use of CO2 (administered in two different ways: a simple cannula, which might be prone to emulsioning air and CO2 not reaching a complete CO2 saturation and a specific commercial diffuser which states promises complete filed saturation) to the no-CO2 standard approach.

The primary end point will be Time to Complete deairing as measured by intraoperative transesophageal echo while the secondary end point will be the incidence of clinical neurological events the day after the operation.

Eligibility Criteria:
Inclusion Criteria:

Isolated, Elective Aortic Valve Replacement or combined AVR and CABG

-

Exclusion Criteria:

* any other kind of operation
* Urgency
To Evaluate the Performance of Total 30 (Lehifilcon A) Contact Lenses in Patients Using Digital Devices for Greater Than 8 Hours Per Day 5 Days Per Week Based on Subjective Reported Data.

To evaluate the performance of Total 30® (lehfilcon A) contact lenses in patients using digital devices for greater than 8 hours per day 5 days per week based on subjective reported data.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged 18-40 of any sex and any race.
* Reports habitually using digital device usage (phone, Ipad, computer, social media, video streaming) for 8 hours or more per day 5 days per week with plans to continue the habit throughout the study.
* Wearing contact lenses for at least 13 hours daily 5 days per week.
* Spherical refractive error between -11.00 D and +6.00D with \< -0.75 D of astigmatism.
* Willing to comply with the protocol instructions.
* Has read (or has had read to), understood, and signed an Informed Consent.
* Willing to not use any artificial tears, rewetting drops or dry eye treatments during the study.

Exclusion Criteria:

* Active ocular infection or ocular inflammatory disease.
* Presbyopic or pre-presbyopic that have a measured add power for reading.
* Current Total 30 contact lens wearer.
* Anterior basement membrane dystrophy or history of recurrent erosion syndrome or topographical abnormalities that might indicate ectasia or other corneal degenerative conditions.
* Current or previous diagnosis of dry eye disease; currently using a dry eye treatment including but not limited to artificial tears, rewetting drops or prescription treatments.
* History of severe / serious ocular pathology or other medical conditions that could result in an inability to safely complete the study.
* Participation by the patient in any other investigational study within the past 30 days.
* Unlikely to comply with protocol instructions for any reason (confusion, substance abuse, etc.). The Principal Investigator or the Medical Monitor reserves the right to declare a patient ineligible based on medical evidence that indicates the patient is unsuitable for the study.
* Inability to utilize Clear Care Cleaning solution.
* Pregnancy
Effects of Dexmedetomidine on Respiratory Function and Inflammatory Responses in Patient With Sepsis Undergoing Cleaning Focus of Infection

The purpose of this study is to assess the efficacy of dexmedetomidine on lung protection in patient with sepsis undergoing cleaning focus of infection.

Sepsis is one of the most common, life-threatening medical conditions and is frequently complicated by organ failures, especially lung injury. It is well accepted that inflammatory reaction is the major cause of lung injury. Dexmedetomidine (Dex) is a novel α2-adrenoceptor agonist that is primarily used in surgical anesthesia and conscious-sedation. Recently, animal studies have shown that Dex plays an anti-inflammatory role, while it is not known whether Dex possesses any lung protective functions in patients with sepsis. Therefore, the aim of this study is to investigate the efficacy of Dex on lung protection in patient with sepsis undergoing cleaning focus of infection.

Eligibility Criteria:
Inclusion Criteria:

* The patients with sepsis requiring abdominal cleaning focus of infection
* older than 18 years
* American Society of Anesthesiologists (ASA) physical status II-IV.

Exclusion Criteria:

* Bradycardia
* Atrioventricular block
* Allergic to the drugs
* A history of respiratory disease
* Pregnancy or breast-feeding women
A Pilot Study of Mitoxantrone for the Treatment of Recurrent Neuromyelitis Optica (Devic's Disease)

Neuromyelitis optica (NMO) is a severe demyelinating disease that selectively involves the optic nerves and the spinal cord but usually spares the brain. NMO is considered to have a B cell induced pathogenesis. Mitoxantrone (MITO, Novantrone®), a synthetic anthracenedione approved for worsening relapsing-remitting multiple sclerosis (MS) and secondary progressive MS, has been shown to primarily suppress the humoral response. We conducted a prospective 2-year study to evaluate the benefit of MITO in five relapsing NMO patients.

The treatment protocol consisted of monthly 12 mg/m2 MITO intravenous infusions for 6 months followed by 3 additional treatments every 3 months. Neurological assessment including the determination of the Expanded Disability Status Scale (EDSS) score was performed every 3 months and during relapses. Orbital, brain and spinal cord MRI was performed at baseline, 3, 6, 12, 18, and 24 months. Visual evoked potentials and ophthalmologic evaluations were performed at baseline and annually.

Eligibility Criteria:
Inclusion Criteria:

* Recurrent longitudinal myelitis (\>3 segments of spinal cord involvement by MRI) with or without recurrent ON (unilateral or bilateral) but with normal brain MRI.
* Patients with recurrent longitudinally extensive myelitis without optic neuritis have an underlying pathology and serology similar to NMO and it is appropriate to consider this a form of NMO10.
* Cerebrospinal fluid required no intrathecal IgG synthesis or oligoclonal bands.
* Age was required to be 18-55 years
* Extended Disability Status Score ≤ 7.

Exclusion Criteria:

* Cardiac risk factors (e.g history of congestive heart failure and left ventricular ejection fraction (LVEF) \< 50%
* Systemic diseases such as lupus, Sjogren's syndrome, anti-phospholipid antibody syndrome, sarcoidosis, rheumatoid arthritis, or vitamin B12 deficiency
* Previous treatment with mitoxantrone or anthracyclines
A Living Tissue Bank of Patient-Derived Organoids From Glioma Tumors

There is a high medical need to improve treatment outcome for high-grade and low-grade glioma since no curative treatment is available. To achieve this goal, a broader understanding is needed of the causes of inter-and intratumoral heterogeneity; glioma dedifferentiation and invasion; the major determinants of malignancy and treatment failure in glioma patients. Patient-derived organoid (PDOs) of high-grade gliomas and low-grade gliomas will be used to identify the mechanisms that underlie this malignant behaviour and treatment resistance. This insight may be used to develop patient avatars to simultaneously test multiple new treatment modalities that are predictive for survival and quality of life of glioma patients.

To establish primary patient-derived three-dimensional organoid cultures from low grade and high-grade gliomas to study the mechanisms that contribute to i.e.

resistance to radiotherapy and/or chemotherapy and immunotherapy, dedifferentiation, tumor invasion among others, in primary and recurrent tumors.

Primary Objectives:

1. Establishment of primary patient-derived organoids (PDO) of 'de novo' and recurrent high-grade glioma (HGG) and low-grade glioma (LGG)
2. Phenotypic, genetic, epigenetic and transcriptomic characterization of HGG and LGG organoids and resemblance to the parental tumor (i.e. characterization of specific cell populations and genomic and transcriptomic profiles of PDOs)
3. Investigation of combinations of new or standard glioma systemic treatments (i.e immunotherapy, chemotherapy) with or without radiation (i.e. protons, photons).

Secondary objectives

1. Establishment of co-cultures of HGG and LGG organoids with immune cells.
2. Investigation of radiation-triggered cell death mechanisms on PDOs after irradiation with photons and protons.
3. Investigation of dedifferentiation mechanisms of LGG to HGG in the context of radiation w/wo immunotherapy.

Eligibility Criteria:
Inclusion Criteria:

* MRI diagnosis of low grade glioma (LGG) or high grade glioma (HGG)
* Age 18 years or older
* Patient is eligible for a resection of the tumor

Exclusion Criteria:

* Contra-inidication for neurosurgical resection of the tumor.
* Incapacitated patient, unable to give informed consent.