cyrilzakka/clinical-trials huggingface dataset:
Safety and Electrical Performance Evaluation of INVICTA Leads Models Equipped With DF4 Connector

The primary objective of this study is to assess the safety and key electrical performance of the INVICTA leads equipped with DF4 connector: ACTIVE fixation type models (single and dual coil: INVICTA 1CR, INVICTA 2CR) and PASSIVE fixation type models (single and dual coil: INVICTA 1CT, INVICTA 2CT).

FRIENDS study is a pre-market approval (INVICTA leads - devices under investigation - are not CE marked), interventional, prospective, longitudinal, international (European), multicenter, single arm study.

The devices under investigation, the INVICTA defibrillation leads, are new quadripolar leads, to be used with Implantable Cardiac Defibrillators and Cardiac Resynchronization Therapy Defibrillators (ICD/CRT-D).

This clinical study intends to demonstrate safety and electrical performances of the INVICTA leads among the different models: active fixation either single coil (model 1CR) or dual coil (model 2CR) and passive fixation, either single coil (model 1CT) or dual coil (model 2CT) leads models. The clinical data will be used to support the application to CE marking of INVICTA leads.

The primary endpoints will be evaluated at 3 months post-implantation; secondary endpoints will be evaluated up to 2 years post-implantation.

A maximum number of 224 patients will be enrolled in the study, in up to 60 centers in Europe.

The follow-up visits are scheduled at hospital discharge, at 1 month, at 3 months, at 6 months, at 12 months, at 18 months and at 24 months, post-implant .

Eligibility Criteria:
Inclusion Criteria:

1. Any patient presenting an ICD or CRT-D indication as detailed in the latest European Society of Cardiology (ESC) guidelines
2. Scheduled for a primary implant of an ICD / CRT-D, manufactured by MicroPort CRM and equipped with a RV DF4 connector
3. Signed and dated informed consent

Exclusion Criteria:

1. Tricuspid valvular disease or tricuspid replacement heart valve (mechanical or tissue)
2. Transient tachyarrhythmias due to reversible causes (such as drug intoxication, electrolyte imbalance, sepsis, hypoxia or other factors as myocardial infarction or electric shock)
3. Contraindication to a maximum single dose of 330 µg dexamethasone sodium phosphate (DSP)
4. Active myocarditis
5. Already included in another clinical study that could confound the results of this study
6. Inability to understand the purpose of the study or to meet follow-up visits at the implanting centre as defined in the investigational plan
7. Patient less than 18 years old or under guardianship or kept in detention
8. Known pregnancy, women in breastfeeding or in childbearing age without an adequate contraceptive method
9. Drug addiction or abuse
Cryoablation System FIM/CE Mark Study

Multi-center, open label, prospective clinical study to establish the acute safety and performance of the Cryterion Cardiac Cryoablation System

This is a single-arm, open-label clinical study using a cryoablation balloon device to isolate pulmonary veins during an atrial fibrillation ablation procedure. Cryo is a scientifically proven energy source used to create a thermal injury during endocardial ablation. The investigational device uses current technology with minor design modifications and will be studied to validate similarities in the safety and performance parameters compared to literature.

Eligibility Criteria:
Main Inclusion Criteria:

* Currently scheduled for a de novo ablation of atrial fibrillation (AF) defined as AF with self-terminating episodes lasting no longer than 7 continuous days (PAF)

Main Exclusion Criteria:

* In the opinion of the Investigator, any known contraindication to an AF ablation, Transesophageal Echocardiogram (TEE). or anticoagulation
* Any duration of continuous AF lasting longer than 7 days
* History of previous left atrial ablation or surgical treatment for Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia (AF/AFL/AT)
* More than four (4) electrical cardioversions in the year prior to enrollment excluding cardioversions performed within 24 hours of arrhythmia onset.
* Significant structural heart disease or implanted cardiac devices
Ascending-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics of DC371739 Single-Dose Treatment in Healthy Subjects

This study is to evaluate the safety, tolerability, pharmacokinetics of DC371739 after a single-dose oral administration in healthy Chinese subjects, and to explore the maximum tolerated dose, also the pharmacokinetics of urine and feces.

This is a randomized, double-blind , placebo-controlled, single-dose study in 43 male healthy subjects assigned to one of the six dose groups (30mg、50mg、100mg、 200mg、400mg and 600mg). 30mg dose group is the pilot group with 3 subjects. Each of the other dose groups will include 8 subjects (7 for DC371739 and 1 for placebo). Subjects will be admitted for treatment on day -1 and receive a single dose of study drug or placebo on day 1. Subjects from different dose groups were enrolled in turn, the next dose group was conducted on the premise that the D6 safety evaluation was completed after the administration of the previous dose group with the result was tolerance. Blood samples will be collected for each group after administration for pharmacokinetic data analysis. Urine and feces were collected in three dose groups of 100 mg, 200 mg and 400 mg respectively to explore the pharmacokinetic characteristics of urine and feces.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-40 years, inclusive, male;
2. Weight≥50kg; body mass index of 19 to 26 kg/m2, inclusive;
3. Based on the medical history, physical examination, clinical laboratory examination, 12-lead ECG and vital signs results, subjects with no evidence of active or chronic diseases, or clinically significant abnormalities;

Exclusion Criteria:

1. Subjects with a history of allergy to study drug ingredients or similar drug, with a history of allergic disease or allergic constitution
2. Presence of symptoms or related history of any major disease, including but not limited to heart, liver, kidney diseases or other acute and chronic digestive tract diseases, respiratory diseases, bone and joint diseases, as well as blood, endocrine, nerve, mental and other systemic disease, or any other diseases or physiological conditions that could interfere with the results;
3. Any surgical condition or condition that may significantly affect the metabolism and excretion of drug absorption and distribution, or that may pose a hazard to the subjects participating in the study; Any surgical condition or condition that may significantly affect the absorption, distribution, metabolism, and excretion of the study drug, or any surgical condition or condition that may harm to the subjects participating in the study;
4. Subjects who donated blood or lost 400 ml of blood within 3 months prior to screening;

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Ischaemic PReconditioning in Non Cardiac SurgEry

Several randomized trials suggested a cardioprotective beneficial effect (eg reduction in cardiac troponin release) of remote ischemic preconditioning in cardiac surgery.

Remote ischemic preconditioning by brief episodes of ischemia and reperfusion in a remote organ or vascular territory provides protection from injury by myocardial ischemia and reperfusion. In the translation of remote ischemic preconditioning from bench to bedside, the first proof of principle and small randomized controlled trials have shown a decreased release of myocardial biomarkers after aortic, congenital cardiac, adult valve and coronary artery by-pass graft surgery. This reduction in cardiac biomarkers release translated into better survival in a recent randomized trial performed in cardiac surgery. No clinical trial on remote ischemic preconditioning in non-cardiac surgery setting has been performed so far.

The investigators study wants to test, for the first time, the hypothesis that remote ischaemic preconditioning is effective in reducing cardiac damage in high risk patients undergoing non-cardiac surgery. Remote ischaemic preconditioning will be achieved by inflation of a blood-pressure cuff to 200 mm Hg to the upper arm for 5 minutes, followed by 5 minutes reperfusion while the cuff will be deflated. General anesthesia will be induced and maintained without using propofol in both groups. Cardiac troponin will be used as marker of cardiac damage. If the results of a reduction in postoperative cardiac troponin release and perioperative cardiac ischaemic events will be confirmed in a non-cardiac surgery setting, the investigators could improve a strategy to prevent perioperative cardiac complication easy to apply, safe and low cost.


Eligibility Criteria:
Inclusion Criteria:

* written informed consent
* intermedial and high risk non cardiac surgery
* general anesthesia
* ongoing or recently suspended antiplatelet therapy

Exclusion Criteria:

* pregnancy
* planned locoregional anesthesia without general anesthesia
* unstable or ongoing angina
* recent (\< 1 month) or ongoing acute myocardial infarction
* inclusion in other randomised controlled studies in the previous 30 days
* peripheral vascular disease affecting the upper limbs
* cardiac surgery
Application and Clinical Evaluation of Longitudinal Chromatic Aberration Technique in Ophthalmology

Our study aims to delve into the effects of shifting the focal point of blue light from video or text displayed on a terminal screen forward on the axial length of the eye, ocular blood flow, visual fatigue, and visual function, that is, its relationship with Video Display Terminal (VDT) syndrome and myopia. By examining the decoding ability of the adult subjects' retina to the clarity of the signal, we will attempt to develop a novel, non-invasive strategy to curb the elongation of the eyeball associated with myopia. Concurrently, we will also focus on the pathophysiological mechanisms underlying VDT syndrome and explore its potential link to the progression of myopia, providing new scientific evidence for the prevention and treatment of this ocular condition. This research is expected to provide robust support for addressing the global issue of myopia and the health challenges posed by VDT syndrome. Ultimately, by integrating global eye health issues with the challenges brought about by VDT syndrome, we will propose intervention and prevention strategies, offering new insights for the advancement of ophthalmology and public health sectors, thereby promoting visual acuity and ocular health for the population.


Eligibility Criteria:
Inclusion Criteria:

1. Adult population, regardless of gender
2. Refractive error is less than or equal to -2.5D and both eyes achieve corrected visual acuity of 0.8 or higher.
3. Normal intraocular pressure with no organic pathology.
4. No apparent symptoms of dry eye.
5. Willing to cooperate to complete all the tests.
6. Voluntarily signing the informed consent form.

Exclusion Criteria:

1. Individuals with strabismus and amblyopia exist.
2. Suffering from congenital eye conditions such as congenital cataracts or congenital retinal diseases.
3. Those who have undergone intraocular surgery (such as cataract removal, intraocular lens implantation, etc.).
4. Individuals with refractive media opacity (such as corneal lesions, lens opacity, etc.).
5. Abnormal intraocular pressure (IOP) (IOP \< 10 mmHg or IOP \> 21 mmHg, or a bilateral IOP difference of ≥5 mmHg).
6. Only one eye meets the inclusion criteria.
7. Active corneal infections such as bacterial, fungal, viral, or other acute or chronic anterior segment inflammations.
8. Currently using medications that may lead to dry eye or affect vision and corneal curvature.
9. Other ocular conditions, such as dacryocystitis, eyelid disorders and abnormalities, abnormal intraocular pressure, and glaucoma.
10. Unable to undergo regular eye examinations.
Incorporation of Muscle Qualities in Biomechanical Models of the Upper Limbs

Development of a non-invasive method for the determination of the position of optimal muscle length in the different muscles of the shoulder.

Analysis of the adaptation of the muscle to a new optimal length in patients with a shoulder prosthesis.


Eligibility Criteria:
Inclusion Criteria:

* Shoulder prosthesis

Exclusion Criteria:

-
Prevention Program for Problem Behaviors in Girls in Foster Care

This study will determine the efficacy of a parent-involved intervention in preventing problem behavior in middle school girls who are currently in foster care.

The transition from elementary school to middle school presents a complex set of challenges for adolescents. These include increased expectations for time management and self-monitoring, renegotiation of rules and boundaries with parents, increased peer influence, and pubertal changes. For children in foster care, this transition is further complicated by issues such as a possible history of maltreatment, unpredictable changes in their living situations, and difficulty explaining their foster care background to peers and teachers. Such issues may be more serious for girls in foster care. Social problems for these girls in middle school can lead to a number of negative effects, including delinquency, substance abuse, poor school performance, mental health problems, and participation in risky sexual behavior. Despite such risks, adolescent girls are less likely to receive specialty mental health or school-based services than their male counterparts. This study is aimed at determining the effectiveness of a preventive intervention for preadolescent girls living in foster/kinship care. The intervention targets include preventing delinquency, initiation of substance use, participation in risky sexual behavior, school truancy and failure, and mental health problems.

Participants were randomly assigned to receive either the preventive intervention or usual foster care services in the summer before entering middle school (typically sixth grade). The preventive intervention consisted of weekly training and support sessions for both participants and their foster or kin parents. The sessions began at study start and continued throughout participants' first year in middle school. Participants' relationship development, delinquency, school behavior and performance, sexual behavior, and substance use were assessed through questionnaires. Parenting practices were assessed through interviews. Assessments were conducted at study entry and at Months 6, 12, and 24, and 36. A new, follow-up assessment on the girls' decision making was conducted at age 14-16.

Eligibility Criteria:
Inclusion Criteria:

* Living in a foster home or receiving kinship care
* Are about to enter middle school
* Oregon resident
* Guardian willing to provide informed consent
* Female

Exclusion Criteria:

* male
* not in foster care
* not living in Oregon
Introducer Curving Technique for Tilt of Transfemoral Günther Tulip Inferior Vena Cava Filter

It has been demonstrated that implantation of inferior vena cava filter was safe and effective in the prevention or reduction of fatal pulmonary thromboembolism in numerous clinical researches. When acute deep venous thrombosis need transcatheter thrombolysis, transfemoral Günther Tulip Filter implantation could avoid catheter across the Günther Tulip Filter. Although incidence of significant filter tilting (\>10°) is not high (13%-16%), severe tilting of the Günther Tulip Filter may be associated with difficulty or sometimes impossibility of retrieval. It has been reported that a simple technique of keeping tension of the delivery system may prevent significant tilting of the transjugular Günther Tulip Filter in an in-vitro study. But no clinical study of prevention transfemoral Günther Tulip Filter from tilting has been reported. The investigators conducted a randomized, controlled study to test whether the introducer curving technique is useful to decrease the extent of tilting of transfemoral Günther Tulip Filter.

The study was designed as a double-blind randomized controlled trial, with research assessors and patients intended to be blind to the intervention status. The staff members performing the assessment were not involved in implementing any aspect of the intervention. 108 patients were randomized to accept curving introducer Günther Tulip Filter and transcatheter thrombolysis or straight introducer Günther Tulip Filter and transcatheter thrombolysis. The assessments include the tilting angle between the axes of inferior vena cava and Günther Tulip Filter after implantation; the tilting angle between the axes of inferior vena cava and Günther Tulip Filter before retrieval; the fluoroscopy time of Günther Tulip Filter retrieval; the rate of retrieval hook adhering vascular wall; the success rate of retrieval.

Eligibility Criteria:
Inclusion Criteria:

* acute lower extremity deep vein thrombosis, diagnosed by vascular ultrasound and clinical history

Exclusion Criteria:

* both lower extremities deep vein thrombosis
* Inferior Vena Cava thrombosis
* refractory hypertension (blood pressure \> 180/110mmHg)
* contraindication of thrombolysis
* the diameter of Inferior Vena Cava \> 35mm or \< 14mm
* Inferior Vena Cava venous anomalies
Anesthetic Management in Fetoscopic Surgery and Incidence of Complications

Fetoscopic surgery has been acknowledged to be a reliable procedure to correct several congenital anomalies e.g. shunt insertion in fetal bladder outlet obstruction, laser ablation of vessels in twin-twin transfusion syndrome (TTTS), balloon occlusion in congenital diaphragmatic hernia etc. The technique involves an introduction of small-caliber instruments into the amniotic cavity under ultrasound guidance. This procedure can be successfully done under either general anesthesia, regional anesthesia or local anesthesia with sedation. Each technique has both advantages and drawbacks.

Several complications related to anesthetic after fetoscopic surgery can occur. For instance, pulmonary edema which is caused by intravenous fluid loading, irrigation fluid absorption or fluid flow through myometrium venous channel. Besides, maternal hypotension intraoperatively can arise from spinal anesthesia.

The aim of the study is to report choice of anesthesia using in fetoscopic surgery in the tertiary care institute (Siriraj hospital) and incidence of complications which may relate to different anesthetic techniques.

The quantity and types of medications using in different anesthetic technique will be gathered including opioid, benzodiazepine, propofol, detail of drugs making fetal paralysis, amount of local anesthetic drug in spinal anesthesia etc. Tocolytic drug will also be recorded eg. terbutaline, nifedipine or magnesium sulfate. These drugs have been generally known that may cause hypotension or pulmonary edema.

In intraoperative period, the investigators emphasize in the incidence of hypotension and other possible complications such as pulmonary aspiration, failed intubation, maternal desaturation or maternal bradycardia. Volume of intravenous fluid administered and amount of irrigation fluid will also be recorded.

Maternal and fetal outcome in recovery room and in postoperative period will be collected.

Eligibility Criteria:
Inclusion Criteria:

* pregnant women who received intrauterine minimally invasive surgery from the past until 30 Nov 2015

Exclusion Criteria:

* pregnant women who received intrauterine minimally invasive surgery which was not anesthetized by anesthesiologist.
Efficacy of Periorbital Rejuvenation With a 1927 nm Diode Laser Treatment

The purpose of this research project is to investigate the treatment design, therapeutic effects and safety of the 1927 nm laser for the rejuvenation of the skin around the eyes.

The chromophore of the 1927 nm diode laser is mainly water, which can be used for skin rejuvenation. This study intends to use the Solta CLEAR+BRILLIANT Laser System, featuring a 1927 nm diode laser with 5 mJ energy, a treatment spot of 140 μm, a treatment depth of 170 μm, and a treatment coverage of approximately 5% per energy level after four rounds of treatment using the patented Intelligent Optical Tracking® System (IOTs). The purpose of this research project is to investigate the treatment design, therapeutic effects and safety of the 1927 nm laser for the rejuvenation of the skin around the eyes. This is an open-label, single-center clinical trial. Participants will be randomized into treatment groups, including Group A (treatment interval of 2 weeks) or Group B (treatment interval of 4 weeks).

Eligibility Criteria:
Inclusion Criteria:

1. aged between 30 and 65 years old;
2. no significant skin lesions or inflammation on the facial skin;
3. willing and able to comply with study requirements, instructions, and restrictions;
4. signed informed consent form.

Exclusion Criteria:

1. underwent facial active treatment, such as using laser, intense pulsed light, radiofrequency skin tightening, ultrasound skin tightening, botulinum toxin, or dermal fillers injection, within the previous six months;
2. have chronic skin diseases such as atopic dermatitis, psoriasis, chronic urticaria, vitiligo, rosacea, or keloid;
3. pregnant or breastfeeding;
4. suffered from acute illnesses or infections requiring treatment within 14 days before entering the study;
5. have had serious illnesses (such as heart disease, lung disease, brain disease, or liver disease) within the previous three months;
6. allergic to Lidocaine or Prilocaine used in topical anesthetic cream or suffer from methemoglobinemia;
7. used any skin medication on the face within 30 days before the trial, deemed by the principal investigator to affect the study results;
8. deemed unsuitable for the study by the principal investigator.
Association Between the Effect of Glucocorticoid Pulse Therapy on Neuromyelitis Optica (NMO) and Gene Polymorphism

Aims of this study are to observe the correlation between ABCB1、VDR、TBX21、NR3C1 and other gene polymorphisms and the effect of glucocorticoid shock therapy on neuromyelitis optica. Investigators plan to include patients with neuromyelitis optica who will receive glucocorticoid shock therapy prospectively. The patients are divided into glucocorticoid sensitive (GS) group and glucocorticoid resistance (GR) group according to the change of central vision after treatment. Patients' clinical data will be collected and blood samples are needed for single nucleotide polymorphism (SNP) typing test. Through statistical analysis, the data differences between GS group and GR group were compared, and the effects of clinical indexes and gene polymorphisms on the efficacy of glucocorticoid shock therapy in the treatment of neuromyelitis optica should be analyzed.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of neuromyelitis optica
* Chinese Han nationality, gender is unlimited;
* Must be able to accept methylprednisolone pulse therapy

Exclusion Criteria:

* Other optic nerve diseases, such as ischemic, compressive, invasive, traumatic, toxic and nutritional metabolic, hereditary optic neuropathy;
* Visual path and central lesion on optic chiasma;
* Other eye diseases, such as anterior segment lesions, retinopathy, macular lesions, ametropia, glaucoma, etc;
* Non-organic visual impairment;
* Treated with glucocorticoid in two weeks.