cyrilzakka/clinical-trials huggingface dataset:
Pulsed-Field-Ablation to Treat Atrial fiBRillation With a novEl multimodalIty Generator

In this first-in-human clinical trial a novel generator (INTELLAPULSE), designed and built by Stockert, which supports highly flexible PFA protocols as well as RF interventions will be used. For 12 months and follow-up for 12 months, after a 3-months blanking period 50 consecutive paroxysmal AF patients, eligible for catheter ablation, will be enrolled.

The principal safety and efficacy of PFA have been established in previous studies, showing low compli¬cation rates, short procedure times, and non-inferior/ superior efficiency compared to thermal abla¬tion.18, 19 However, current generators available for clinical practice are not generally designed to allow both non-thermal and thermal ablation in single shot settings. Moreover, modification of PFA sequences is not supported in commercially available systems. Flexible, multi-modal generators that allow one to conduct PFA or RF ablation using one and the same catheter would be highly desirable, from a clinical point of view, to allow for on-the-fly decision-making in view of individual patient requirements.

In this first-in-human clinical trial a novel generator (INTELLAPULSE), designed and built by Stockert, which supports highly flexible PFA protocols as well as RF interventions will be used. This generator will be CE marked in Q3/24. Upon completion of the ethical approval process in Q2/25, the 'first in human' study, exploring safety of the Stockert PFA generator will be started.

The trial will be a prospective single arm study at the UHZ Freiburg · Bad Krozingen and will recruit for 12 months and follow-up for 12 months, after a 3-months blanking period. 50 consecutive paroxysmal AF patients, eligible for catheter ablation, will be enrolled. Exclusion criteria will be age \<18 years, previous left atrial ablation, and lack or withdrawal of written informed consent. Data acquisition will use an electronic case report form (RedCap Database). Procedures will be performed using standard operating procedures (SOP).

In short: ablations will be performed under deep analgo-sedation and/or general anaesthesia. Trans¬oesophageal echocardiography will be performed if patients present with either AF or atrial tachycardia (to exclude intracardiac thrombi) or in sinus rhythm (in patients with interrupted oral anticoagulation and CHA2DS2-VASc-Score ≥2). Atrial transseptal puncture will be performed for access to pulmonary veins (PV), using a fixed curve transseptal sheath and transseptal needle according to standard SOP. PFA catheters (FARAWAVE™, Boston Scientific) will be utilized, as in prior work with a commercial PFA system (FARAPULSE™, Boston Scientific) at the UHZ. At every PV antrum, 8 PFA-pulses will be delivered in 'flower' and 'basket' configurations (delivery of additional PFA-pulses will be at operator's discretion).

Eligibility Criteria:
Inclusion Criteria:

* new onset atrial fibrillation

Exclusion Criteria:

* age \<18 years
* previous left atrial ablation
* lack or withdrawal of written informed consent
* unable to receive ablation therapy
Clinical Performance of 59% Hioxifilcon A vs. Marketed Hydrogel Contact Lenses in Habitual Hydrogel Wearers

The study will compare the short-term clinical performance and wearer and practitioner acceptability of a new-to-market spherical daily disposable (DD) hydrogel soft contact lens to a currently marketed spherical DD hydrogel soft contact lens.

This randomized clinical trial will compare the short-term clinical performance, and wearer acceptability of a new-to-market hioxifilcon A spherical daily DD contact lenses against marketed DD lenses in a short cross-over clinical trial.

The primary outcome variable for this study is overall subjective comfort.

Eligibility Criteria:
Inclusion Criteria:

* Currently wearing hydrogel, spherical DD contact lenses at least 5 days/week
* Vision correctable to 20/30 acuity in each eye with spherical DD contact lenses
* No ocular or systemic disease that contra-indicates soft contact lens wear

Exclusion Criteria:

* Currently wearing silicone hydrogel DD contact lenses
* Currently wearing 1-DAY ACUVUE® MOIST (comparator) contact lenses
* Currently using rewetting drops with habitual contact lenses
* Vision not correctable to 20/30
* Participating in another clinical trial
Trail Evaluating Carbon Ion Radiotherapy for Locally Recurrent Nasopharyngeal Carcinoma

The purpose of this study is to determine the maximal tolerated dose (MTD) of re-irradiation using carbon ion radiotherapy (CIRT) in the treatment of locally recurrent nasopharyngeal cancer (NPC) and to evaluate the efficacy of such treatment at the MTD. Participants will be treated with CIRT with escalating dose regimens to evaluate the maximal tolerated dose (MTD) in terms of acute and subactue toxicity observed during and within 4 months after the completion of CIRT. Once the MTD for locally recurrent NPC is determined, the MTD will be used as the recommended dose to patients fulfilling the inclusion criteria in the Phase II part of the trial.

The purpose of this study is to determine the maximal tolerated dose (MTD) of re-irradiation using carbon ion radiotherapy (CIRT) in the treatment of locally recurrent nasopharyngeal cancer (NPC) and to evaluate the efficacy of such treatment at the MTD. Participants will be treated with CIRT with escalating dose starting from 55GyE (2.5GyE/daily fraction) to potentially 65GyE (2.5GyE/daily fraction) to evaluate the maximal tolerated dose (MTD) in terms of acute and subactue toxicity observed during and within 4 months after the completion of CIRT. Time-to-event continual reassessment method (TITE-CRM) is used for the phase I dose escalating part of the trial and approximately 25 patients will be accrued. Once the MTD for locally recurrent NPC is determined, the MTD will be used as the recommended dose to patients fulfilling the inclusion criteria in the Phase II part of the trial. The Phase II part of the trial will be a single phase single arm study.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed NPC
* Completed a definitive course of intensity-modulated photon radiation therapy (IMXT) to a total dose of ≥ 66 Gy
* Recurrence diagnosed more than 12 months after the initial course of IMXT
* Age ≥ 14 and \< 70 years of age
* Karnofsky Performance Score ≥70
* Willing to accept adequate contraception for women with childbearing potential
* Ability to understand character and individual consequences of the clinical trial
* Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial

Exclusion Criteria:

* Local recurrence of NPC diagnosed within 12 months from the completion of previous course of radiation therapy
* Presence of distant metastasis
* Technology used other than IMXT (including brachytherapy following IMXT) for the treatment of initial diagnosis of NPC
* Pregnant or lactating women
* Patients who have not yet recovered from acute toxicities of prior therapies
* A diagnosis of malignancy other than CIS of the cervix, BCC and SCC of the skin within the past 5 years
* Refusal of the patient to participate into the study
Depth of Sedation and Its Impact on Cerebrovascular Reactivity in Acute Respiratory Distress Syndrome: a Pilot Analysis

Investigation of the feasibility of monitoring processed transcutaneous electroencephalography (EEG), a method of interpreting brain activity, and near-infrared spectroscopy (NIRS), a method of determining levels of tissue oxygenation (StO2) in the brain, for patients with acute respiratory distress syndrome (ARDS) in the ICU.

The aim of this study is to determine the feasibility of using Masimo SedLine processed EEG monitoring and Masimo O3 NIRS to monitor optimal depth of sedation for patients with ARDS in the ICU.

To achieve this, non-invasive devices will be applied to the participant to measure processed EEG signal and StO2. Cerebrovascular reactivity will be determined using the following two values:

1. SEDopt: The optimal depth of sedation that minimizes correlation between StO2 and processed EEG monitoring.
2. MAPopt: The optimal blood pressure that minimizes correlation between StO2 and MAP.

Demographic information (age, sex, height, weight), past medical history, etiology of ARDS, Disease severity, routine bloodwork, and dose of sedation will also be documented.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient admitted to the ICU
* ARDS confirmed according to the Berlin Definition
* Invasive mechanical ventilation
* Deep sedation and/or neuromuscular blockade required for ARDS treatment at the discretion of the treating medical team
* Application of monitoring devices feasible

Exclusion Criteria:

* More than 24 hours elapsed since ICU admission
* Death is deemed imminent and inevitable during the next 24 hours
* Known allergy to a textile component of the device
* Consent declined from patient or authorized third party
* The treating clinician believes that participation in the study would not be in the best interest of the patient
Evaluation of the Efficacy and Tolerability of Detralex in Patients With Chronic Venous Edema in Real Clinical Practice

The VAP-PRO-C3 is a multicenter observational program, which is carried out in the frame of routine consultations and follow-up of patients. The program includes patients with chronic venous diseases (CVDs) of CEAP class C3. It is scheduled in Russia for 2018-2019. The program is expected to enroll 90 phlebologists from 60 cities of Russia. The planned number of patients is 900

The study is aimed at evaluating the efficacy and safety of systemic pharmacotherapy (Detralex) as a part of combination treatment, and its influence on the general outcomes of treatment of patients with chronic venous edema (CEAP class C3) in real clinical practice.

Each investigator is planned to include in the program 10 patients fulfilling the inclusion criteria. The treatment will be carried out in accordance to the routine clinical practice, instructions for the medical use of drugs, and a specific clinical situation. To assess changes in edema, the method of truncated cones and duplex ultrasound scanning (DUS) will be used.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years old or above
* Written informed consent
* Patient did not receive treatment with venoactive drugs within the past 4 weeks prior to the inclusion in the study
* Diagnosis of chronic venous disease of class C3 (CEAP)
* Decision of an attending physician to prescribe Detralex.

Exclusion Criteria:

* Age below 18 years old
* Written informed consent is not obtained
* History of alcohol or drug abuse or use of narcotic drugs
* History of allergic reaction to diosmin or any other venoactive agent, or their intolerance
* History of allergic reaction to anesthetics and/or sclerosing agents
* Chronic venous disease of СЕАР class C0-С2 or class С4-С6
* Lymphatic edema of the lower extremities
* Secondary varicose veins, angiodysplasia, or neoplasia
* Arterial disease (ankle-brachial index \<0.9)
* Infection within the past 6 weeks
* Any of the following concomitant diseases, which can affect the results:

  * Connective tissue disease (including rheumatoid arthritis), arthritis
  * Heart failure
  * Intermittent claudication (peripheral artery disease)
  * Diseases of the bones or joints of the lower extremities
  * Malignancy
* Treatment with drugs potentially causing leg edema (calcium channel blockers, hormonal drugs, NSAIDs, etc.)
* History of deep vein thrombosis (within the past year)
* History of superficial thrombophlebitis (within the past 3 months)
* Patient cannot walk (regardless of the cause)
* Obesity or body mass index \[BMI\] \>30 kg/m2 \[BMI = body mass (kg)/height (m)2\]
* Predictable poor adherence to treatment
* Participation of the patient in the intervention study within the previous 3 months
* For women: pregnancy or breastfeeding, the desire to become pregnant within at least 2 months after the study
* Patient cannot attend a follow-up visit
* Patients with a contraindication to diosmin-containing agents, including Detralex
Magnesium Sulfate in the Prevention of Post-ERCP Pancreatitis.

MagPEP is a multi-centre, randomized, phase III, double blind, placebo controlled, parallel group trial. It evaluates magnesium sulfate for the prevention of post-ERCP pancreatitis. Adult patients with a medical indication for ERCP are to be randomized (1:1 ratio) to receive either magnesium sulfate or placebo (NaCl 0,9%) 60 min before and 6 hours after ERCP.

Title: prospective, randomized, placebo controlled, phase III trial to evaluate the efficacy of magnesium sulfate for the prevention of post-ERCP pancreatitis

Study drug: Magnesium sulfate

Indication: post-ERCP pancreatitis

Study design: multi-centre, randomized, phase III, double blind, placebo controlled, parallel group

Patient population: adult patients with a medical indication for ERCP

Number of patients: 1376 randomized to two equal groups

Treatment: patients receive 2 infusions of 500 ml NaCl 0,9%: the first one 60 min before ERCP and the second one 6 hours after ERCP. To the infusions 10 ml of either magnesium sulfate or placebo (NaCl 0,9%) will be added.

Eligibility Criteria:
Inclusion Criteria:

* medical indication for ERCP
* first ERCP in the Patient
* signed informed consent forms for ERCP and MagPEP trial

Exclusion Criteria:

* privious ERCP
* hypersensitivity to study medication or similar substances
* participation in another clinical trial during the last 4 weeks
* addictive disorders
* women who are pregnant or breastfeeding
* unwillingness or inability to comply with study protocol
* acute pancreatitis
* renal insufficiency of stage 4 or higher
* active hyperthyreosis
* symptomatic bradycardia (\<35/min)
* known history of Myasthenia gravis
* AV bock \> first degree or other bradycardic disorders of conductivity
* liver cirrhosis Child C
* coagulation disorder
* urinary stone diathesis (calcium magnesium ammonium phosphate stones)
* patients who are not able to provide informed consent
* intake of magnesium during the last 14 days
* intake of calcium antagonists
Impact of Endothelial Cell Activation and Modifications of Haemostasis Induced by Infective Endocarditis on the Risk of Embolism

Prospective study including all the consecutive patients admitted at the Department of Cardiology, Timone Hospital wih a definite diagnosis of IE according to the modified Duke criteria. The period of inclusion will be for 24 months. Eighty patients and age-matched control subject will be included. Primary end point are EE occurring during the antimicrobial treatment and secondary end points will be 6-month mortality, vegetation length and the impact of antimicrobial treatment on inflammation-induced procoagulant changes and endothelial cell activation.


Eligibility Criteria:
Inclusion Criteria:

* All the patients presenting certain diagnosis of infectious endocardite according to the criteria of modified Duke

Exclusion Criteria:

* Age \< 18 years
* Pregnancy and feeding
* Health not allowing to give the assent
* Innate abnormalities of the haemostasis
* More than a week before the inclu antibiothérapie adapted begun
Acute Effects of Exercise in Smokers With Schizophrenia

People with schizophrenia have two- to three-times the mortality risk of the general population. This is primarily due to their unusually high rates of cigarette smoking, as well as other cardiovascular risk factors such as physical inactivity, obesity, high blood cholesterol and diabetes. Effective smoking treatments are needed to reduce morbidity and mortality in this population. Over a dozen experimental studies indicate that walking and other forms of exercise acutely reduce cigarette craving, nicotine withdrawal symptoms and smoking behavior in non-psychiatric smokers. However, the effects of acute exercise on smoking measures have not been studied in smokers with schizophrenia. This study will use a within-subjects, repeated-measures design, in which participants will undergo 4 laboratory sessions (order counterbalanced across participants): (1) smoking cues followed by exercise, (2) smoking cues followed by passive activity, (3) neutral cues followed by exercise, (4) neutral cues followed by passive activity. Outcome measures include cigarette craving, nicotine withdrawal symptoms, mood and smoking behavior. If the results of this study indicate that walking acutely reduces craving and smoking in smokers with schizophrenia, the next step in this research would be to test the effectiveness of a smoking cessation intervention that incorporates exercise bouts as a behavioral strategy for improving smoking cessation rates in this population.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of schizophrenia
* smoke at least 20 cigarettes per day
* less than 60 min moderate-intensity exercise per week

Exclusion Criteria:

* medication changes in past 4 weeks
* unable to give informed consent to participate
* alcohol/drug screen
* pregnant or nursing
* receiving or seeking immediate smoking treatment
Online Asthma Self-Management for Children Aged 5-10 and Their Parents

The potential benefits of this research to public health include improved understanding of cultural factors in pediatric asthma self-management, improved self-management skills for children, and better asthma management skills for their parents. This could result in eased suffering and improved quality of life for millions of children and their families, and also reduce the economic burden borne by society in the forms of medical expenditures and lost productivity.

This proposal will create an interactive multimedia (IMM) program designed to support the self-management efforts of asthmatic children aged 5-10 years and their families. This behavior change program will be designed to promote self-management by (a) increasing child and caregiver knowledge about asthma, (b) encouraging compliance with medication protocols and environmental controls, and (c) increasing self-efficacy to create and implement an Asthma Action Plan.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 5-10 with physican-diagnosed asthma and who had been prescribed any type of asthma medication, and one of their parents or primary caregivers. Parents and children needed to have access to an internet- and video-capable computer, and the parent needed to have a valid e-mail address in order to receive study-related correspondence.

Exclusion Criteria:

* Only English-speaking participants were accepted because the program was developed only for English speakers. Children less than 5 years of age and older than 10 were excluded because the program is developed targeted to the developmental abilities and interests of children aged 5-10. There were no exclusions based on race/ethnicity.
Influence of Acute Daily Workload Changes on Low-frequency Fatigue Morning Scores

In recent years, the increased demands of both training and competition have heightened the need of load monitoring among soccer players. However, adopting metrics that comprehensively capture the intricacies of neuromuscular fatigue remains a challenge. Assessing low-frequency fatigue may contribute to fill this gap, as it provides an objective measure to evaluate muscle function readiness. Thus, the aim of this study was to examine whether variability in low-frequency fatigue morning scores are related to training external load acute changes throughout the in-season microcycle.


Eligibility Criteria:
Inclusion Criteria:

* elite soccer players

Exclusion Criteria:

* injured athletes
Accuracy of Contrast-Enhanced Ultrasound for Hepatocellular Carcinoma Post TACE

The purpose of this research study is to find out if a different type of imaging study called contrast enhanced ultrasound (CEUS) is as good as, or better than CT or MRI in patients diagnosed with hepatocellular carcinoma (HCC) after receiving TACE treatment

This is a prospective trial to determine if contrast enhanced ultrasound (CEUS) is non-inferior to CT or MRI in patients with hepatocellular carcinoma (HCC) following transcatheter arterial chemoembolization(TACE) treatments. All patients will receive standard of care CT/MRI and will also get a contrast ultrasound to directly compare.

Timepoint 0- Our proposed study population includes subjects with diagnosed HCC, who are treated with TACE. Patients will be identified and enrolled at the time of initial TACE.

Timepoint 1- Following initial TACE, patients will receive a CT or MRI, as routinely ordered in the post-TACE setting, to assess for residual or new HCC. At this same imaging follow-up visit, patients will also receive a one-time additional contrast-enhanced ultrasound (CEUS). Timepoint 2- Per standard clinical care, patients typically return for repeat imaging (CT/MRI) within 2-4 months following the first imaging visit.

Eligibility Criteria:
Inclusion Criteria:

* Adult (≥18 years of age) patients with diagnosed HCC (via imaging, biopsy, or combination of imaging and biochemical markers), who are treated with their first round of TACE.
* Sex: male or female
* BMI ≤ 40

Exclusion Criteria:

* Children (\<18), pregnant patients
* Patients who do not speak English
* Patients with a history of hypersensitivity reactions to sulfur hexafluoride lipid microsphere components or to any of the inactive ingredients in Lumason.
* Patients with unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, or serious ventricular arrhythmias)
* Patients who have a prior non-contrast ultrasound, within last 3 months (at time of consent), where the tumor could not be seen - most commonly due to severe steatosis or obesity.
* Pregnant or nursing woman
* Patients who do not plan to get their follow-up CT/MRI at Hershey Medical Center.
Bivalirudin in Elderly Patients With Acute ST-segment Elevation Myocardial Infarction

The study is an investigator-sponsored, prospective, multicenter, randomized, open-label study designed to compare efficacy and safety between bivalirudin and heparin in elderly patients with acute ST-segment elevation myocardial infarction undergoing emergency PCI.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥75 years old;
* Planned emergency (Symptom onset within 24h) PCI for acute STEMI patients;
* Life expectancy ≥ 1 year;
* Provide written informed consent.

Exclusion Criteria:

* Contraindications to angiography or PCI;
* Active bleeding or bleeding constitution, bleeding tendency, including GI or urinary tract hemorrhage (3 months), cerebral hemorrhage (6 months) or cerebral infarction history (3 months), etc;
* Other disease may lead to vascular lesions and secondary bleeding factors (such as active gastric ulcer, active ulcerative colitis, intra-cerebral mass, aneurysm, etc.);
* Severe renal insufficiency (eGFR \< 30 mL/min/ 1.73 m2);
* Elevated AST, ALT level higher than three times of the normal upper limit;
* Advanced heart failure (NYHA classification grading of cardiac function ≥ Ⅲ)
* Complicated with immune system diseases；
* Abnormal hematopoietic system：platelet count \< 100 \* 109 / L or \> 700 \* 109 / L，white blood cell count \< 3 \* 109/L etc;
* Suffering from acute infections ,infectious diseases or other serious diseases, such as malignant tumors;
* Known intolerance, or contraindication to any antithrombotic medication
* Known allergy to the study drugs and instruments (UFH, bivalirudin, aspirin and clopidogrel, stainless steel, contrast agents, etc.), or those allergic constitution.
* Non-cardiac co-morbid conditions are present that may result in protocol non-compliance;
* Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period;
* Patient's inability to fully cooperate with the study protocol