cyrilzakka/clinical-trials huggingface dataset:
Left Atrial Isolation by Catheter Ablation in Persistent Atrial Fibrillation With Severe Atrial Fibrosis

This is a single-arm clinical trial evaluating the efficacy and safety of left atrial isolation achieved by catheter ablation in patients with persistent atrial fibrillation with severe atrial fibrosis.

This is a single-arm clinical trial. Patients with persistent atrial fibrillation with severe atrial fibrosis are enrolled as subjects to conduct left atrial isolation by catheter ablation. Postoperative recurrence rate and other indicators are analyzed to evaluate the efficacy and safety of left atrial isolation achieved by catheter ablation 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 and left atrial anterioposterior diameter \> 50mm
3. Nonresponse or intolerance to ≥1 antiarrhythmic drug
4. CHA2DS2-VASc ≥ 3 and HAS-BLED \< 3

Exclusion Criteria:

1. With uncontrolled congestive heart failure;
2. Having significant valvular disease;
3. Having moderate-to-severe pulmonary hypertension;
4. With myocardial infarction or stroke within 6 months of screening;
5. With Significant congenital heart disease;
6. Ejection fraction was \<40% measured by echocardiography;
7. Allergic to contrast media;
8. Contraindication to anticoagulation medications;
9. Severe pulmonary disease e.g. restrictive pulmonary disease, chronic obstructive disease (COPD);
10. Left atrial thrombus;
11. Having any contraindication to right or left sided heart catheterization
A Randomized Comparison of AmnioClear™ Human Allograft Amniotic Membrane vs. Moist Wound Dressing in the Treatment of Diabetic Wounds

This research project is testing a product called AmnioClear™ which is an amniotic membrane graft processed for Liventa Bioscience formerly AFCell Medical. AmnioClear™ allograft human amniotic membrane is regulated solely under section 361 of the Public Health Service Act.

The purpose of the study is to see if this treatment works to accelerate the healing time of chronic wounds.


Eligibility Criteria:
Inclusion Criteria:

* Stable Type I or II diabetes mellitus
* At least one chronic diabetic ulcer
* Full-thickness ulcer size from 1-8 cm2.

Exclusion Criteria:

* Concurrent use of corticosteroids, NSAIDs immuno-suppressive or cytotoxic agents
* Bleeding disorders
* Ulcer with muscle, tendon, capsule or bone involvement
Cine-magnetic Resonance Imaging (MRI) Detecting Intra Abdominal Adhesions

Official title:

Sensitivity and predictive value of functional cine magnetic resonance imaging (MRI) detecting intra-abdominal adhesions

Background:

Adhesions are a frequent problem in abdominal surgery. The formation of adhesions is part of a normal wound healing. However in some patients adhesions cause severe complications such as chronic pain, obstruction and strangulation of the bowel. Adhesions can also obstruct access to the peritoneal cavity and complicate reoperations. Accurate imaging of adhesions would be of benefit avoiding adhesion related complications at repeated laparotomy or laparoscopy. At present no validated diagnostic tool mapping adhesions exists.

Purpose:

To define the sensitivity and specificity of functional cineMRI in detecting and mapping adhesions in patients undergoing reoperation.

Design:

Prospective multicenter observational trial

Primary outcome:

Sensitivity and specificity of functional MRI detecting adhesions to the abdominal wall

Secondary outcome:

Sensitivity and specificity of functional MRI detecting organ-to-organ adhesions.

Estimated enrollment: 100

Estimated study completion date: dec 2019

Estimated primary completion date: dec 2019


Eligibility Criteria:
Inclusion Criteria:

* Patients with a median abdominal scar due to a previous open abdominal surgical procedures with a length of at least 10 cm and have given written consent.

Exclusion Criteria:

* Severe claustrophobia.
* No MRI allowed
PK Intravenous Lidocaine Infusion

To determine safe concentration level of lidocaine infusion in children.

This study will address the working hypothesis that intravenous lidocaine may be administered as a bolus followed by an infusion with reliable and safe blood levels of lidocaine. Serial blood draws will be obtained to determine safety of lidocaine doses used in this study by measuring blood levels of lidocaine and its metabolites.

Eligibility Criteria:
Inclusion Criteria:

* male or female children 3-15 years of age
* ASA physical status 1-3
* scheduled for colorectal surgery with abdominal incision

Exclusion Criteria:

* ASA physical status \> 3
* postoperative intubation planned ahead of surgery
* history of chronic use of opioid (use longer than 3 months)
* history of hepatic, renal, or cardiac failure
* history of significant liver disease including liver failure, acute or chronic hepatitis, hepatomegaly, portal hypertension and elevated liver enzymes
* history of organ transplant
* BMI \> 30
* history of cardiac arrhythmia
* history of long QT syndrome
* history of allergic reaction to lidocaine or similar agents
* history of seizure disorder
* patient without PICC or other central access with contraindication to inhalation induction
* family history or known patient susceptibility to malignant hyperthermia
Evaluation of Small Vessel Disease by 3D-rotational Angiography

This study is aimed to elucidate the factors affecting the remodeling process of arteriolosclerosis under current practice recommendations. Such knowledge may improve the understanding of cerebral small vessel disease (cSVD) mechanism, define pharmacological therapy and suggest treatment target.

Around 68 patients who have acute cerebral ischemic symptoms attributed by cSVD will be recruited. Stroke etiology will be determined by Neurologists based on clinical syndrome, vascular imaging features and concurrent cardiovascular risks. The time window for recruitment is 4 weeks from the qualifying stroke.

After an informed consent for the study, potential candidates will undergo a cranial MRI and MR angiography. Patients who are found to have acute or subacute lacunar infarcts (defined as an infarct diameter \< 15mm) in the territories supplied by the lateral lenticulostriate arteries, i.e. internal capsule, putamen, external capsular or corona radiata, will proceed to a 3-Dimensional rotational angiography (3DRA) at baseline and in 12 months. All recruited patients will receive single antiplatelet agents and statin. Their cognition, mobility and treat cardiovascular risk factors based on 4 pre-specified goals (as elaborated in Study Procedures) will also be regularly reviewed.

Eligibility Criteria:
Inclusion Criteria:

1. Patient is Chinese ONLY
2. Patient is 30 to 85 years of age, inclusive.
3. Patients who have an acute lacunar infarct in diffusion-weighted MRI compatible with small vessel disease in territories supplied by the lateral lenticulostriate arteries without relevant intracranial atherosclerotic stenosis ≥60%.
4. Patient who has no contra-indication for the proposed imaging tests.
5. Patient who understands the purpose and requirements of the study, and has an informed consent.
6. Patient who has Modified Functional Ambulation Classification 4 or above.

Exclusion Criteria:

1. Stroke etiology uncertain or unrelated to small vessel disease, such as cardioembolism, Moyamoya disease, ICAD or primary angiitis of CNS.
2. Bleeding propensity: active peptic ulcer disease, major systemic hemorrhage within 30 days, thrombocytopenia (platelets \<100 x 109/L), coagulopathy (INR \>1.5).
3. A medical condition that would not allow the patient to adhere to the protocol or complete the study.
4. Patients with severe renal impairment.
5. Patients who are taking warfarin and non-vitamin K antagonist oral anticoagulants would also be excluded.
Hypotension Prediction 2 Study in Cardiac Surgery and Postoperative ICU Admission

This trial registration serves as an amendment incorporating the IPD Sharing Statement.

This study already has a trial registration (2021 April 30) in the Netherlands Trial Registry (Reference number NL9449, https://trialsearch.who.int/). However, the NTR register is subject to a merger with another Dutch register. This means that existing registrations are still visible, but can no longer be adjusted.

Study summary:

Hypotension in the operating room (OR) and during post-operative ICU admission is common in surgical patients and even more prevalent in cardiac surgery patients. It is associated with adverse outcomes and while these events are preventable, current management is predominantly reactive. Edwards Lifesciences (Irvine, CA) has developed the Hypotension Prediction Index (HPI), an early warning system that predicts an hypotensive event, defined as MAP below 65 mmHg, with high accuracy minutes before it occurs. At the time of writing the protocol this model has not been tested in a clinical trial in cardiac surgery patients or ICU admitted patients. The aim of the HYPE-2 trial is to assess whether the HPI-algorithm can reduce the time-weighted average (TWA) of intra- and postoperative hypotension in elective on-pump coronary artery bypass graft (CABG) surgery patients.

Population studied:

All adult patients undergoing elective on-pump CABG surgery or CABG with additional single heart valve surgery (e.g. valve repair or replacement), requiring a radial arterial line and an intended target MAP of 65 mmHg or above during both surgery (excluding cardiopulmonary bypass pump time (CBP)) and during mechanically ventilated phase of duration of ICU admission.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older at inclusion
* Planned for elective on-pump CABG surgery or CABG with additional single heart valve surgery (e.g. valve repair or replacement)
* Planned to receive standard monitoring for cardiac surgery
* Target MAP of 65 mmHg or above during surgery
* Target MAP of 65 mmHg or above during the mechanically ventilated phase of ICU admission

Exclusion Criteria:

* Known cardiac shunts (significant)
* Severe cardiac arrhythmias (including but not limited to persistent atrial fibrillation prior to surgery)
* Expected to receive an hemodynamic assist device (e.g. intra-aortic balloon pump) during surgery
* Dialysis dependent kidney failure prior to surgery
* Planned to receive Perioperative Goal Directed Therapy (PGDT) other than standard intraoperative care
* Previous cardiac surgery in medical history
Effect of Timi3 Ultrasound on Myocardial Blow Flow in the Hibernating Myocardium

The purpose of this study is to evaluate whether the use application of low frequency ultrasound, administered by the Timi3 ultrasound device, increases myocardial blood flow to the heart, in subjects with reduced myocardial blood flow at rest (hibernating myocardium). The primary endpoint of the trial is to assess the increase in myocardial blood flow from baseline to post Timi3 Ultrasound treatment in a hypoperfused region of myocardium. Positron emission tomography (PET) imaging will be used to noninvasively evaluate cardiac blood flow. The hypothesis is that ultrasound increases blood flow in hibernating myocardium.


Eligibility Criteria:
Inclusion Criteria:

* \>/= 18 years
* Must have reversible resting ischemia, resting non-reversible blood flow defect, or stress-induced ischemia.
* Females with childbearing potential must not be pregnant at the time of the study
* Must provide written informed consent

Exclusion Criteria:

* Unable or unwilling to cooperate with study procedures
* Currently enrolled in another clinical study for which the follow-up period is not complete
Volunteering and Cardiovascular Risk in Adolescents

This study tested whether getting youth engaged in helping others (volunteering) would benefit youth's physical health. 106 predominantly minority and low socioeconomic status (SES) youth were randomized to either volunteer weekly with elementary school children in after school programs or to a wait-list control group. The investigators hypothesized that cardiovascular risk markers of C-reactive protein (CRP), interleukin-6 (IL-6), total cholesterol, and body mass index (BMI) would be lower at post-intervention (4 months after baseline) in the volunteer group compared to the control group. The investigators also hypothesized that the intervention might work through pathways such as reducing negative mood, improving self esteem, and increasing prosocial behaviors (empathy, altruism).


Eligibility Criteria:
Inclusion Criteria:

* 10th grade high school student
* English speaking
* No chronic illnesses

Exclusion Criteria:

* Chronic medical illness
Study of the Efficacy and Safety of Ferrlecit in the Maintenance Dosing in Hemodialysis Patients.

This is a phase 4 clinical investigation of the efficacy and safety of Ferrlecit in the maintenance of iron stores and serum hemoglobin concentration in hemodialysis patients receiving Erythropoietin.

A Multi-Center, Open-Label, Parallel Group Study of the efficacy and safety of Ferrlecit in the Maintenance of Iron Stores and Serum Hemoglobin Concentration in Hemodialysis Patients Receiving Erythropoietin. Patients with normal iron indices receive one of two doses of Ferrlecit administered weekly throughout the treatment period. Efficacy was assesses at designated timepoints throughout the study and after the last Ferrlecit dose.

Eligibility Criteria:
Inclusion Criteria:

* Male of female, 18 years old or older.
* Have been receiving chronic hemodialysis therapy
* On stable EPO dosing regimen.
* Have signed patient informed consent.
* Predetermined serum ferritin and TSAT levels.
* Clinical instability - inability to achieve adequate dialysis, abnormal serum albumin and serum glucose.
* Pregnant or lactating.
* A known sensitivity to Ferrlecit

Exclusion Criteria:

* Scheduled for renal transplant.
* A serious concomitant medical disorders incompatible with participation in the study.
* Unable to cooperate or comply with the protocol.
* Use of any investigation agent within 30 days prior to study or during the course of the study.
* Judged by the investigator as unsuitable for enrollment for any reason.
Benefit of Hemostatic Sealant in Preservation of Ovarian Reserve

Introduction : The most common technique used for ovarian cystectomy is the stripping technique. After stripping the cyst wall, the subsequent bleeding of the ovarian stromal wound is usually controlled by bipolar coagulation or/and by suturing. However, hemostasis achieved with bipolar coagulation could result in damage to the ovarian reserve. To avoid damage to healthy ovarian tissue, hemostasis using various topical hemostatic agents has been introduced to control post- cystectomy ovarian wound bleeding. Among these, FloSeal (Baxter Healthcare Corporation, Deer- field, IL, USA) is a hemostatic sealant composed of a gelatin-based matrix and thrombin solution.

Aim: The aim of the study is to evaluate the impact of topical hemostatic sealants and bipolar coagulation during laparoscopic ovarian benign cyst resection on ovarian reserve by comparing the rates of decrease in anti- Müllerian hormone (AMH).

Methods: A randomized prospective data collection was made on women aged 18-45 years who planned to have laparoscopic ovarian cystectomy at one of two institutions (n = 80), Montpellier University Hospital and Nimes University Hospital, France. Patients were randomly divided into two groups treated with either a topical hemostatic sealant (Floseal) or bipolar coagulation for hemostasis. Preoperative, 3-month and 6-month postoperative AMH levels were checked and the rates of decrease of AMH were compared.


Eligibility Criteria:
Inclusion Criteria:

* Cyst diameter between 3 and 10cm
* Preoperative AMH level \>0,5ng/ml
* Understanding and acceptance of the protocol

Exclusion Criteria:

* Post-menopausal status
* Any suspicious finding of malignant ovarian disease
* Change of contraception method leading to AMH variation
* Allergy to bovine products found before inclusion
* Pregnancy
* Patient who has already participated in the protocol
* Person deprived of liberty by judicial or administrative decision
* Person protected by law, under tutorship or curatorship
* Patient participating in another interventional research on the human person in progress
* Refusal of participation after a period of reflection
* Patient not affiliated or beneficiary of a national health insurance system
Characterization of Non-canonical Way in Inflammasome Monocytes of Patients With Severe Sepsis

Activation of caspase-4 and human caspase-5 (orthologs of caspase-11 in mice) in innate immune cells.

Lipopolysaccharide (LPS) of the wall of Gram-negative bacteria is one of pathogen associated molecular patterns (PAMPs), which are recognized by cells of the innate immune system via Toll-like receptor 4 (TLR4) . The LPS / TLR4 interaction induces the secretion of a variety of proinflammatory cytokines. Among them, interleukin-1β (IL-1β) is a major cytokine, and alterations to its secretion has been associated with various diseases, such as periodic syndrome associated cryopyrin (CAPS), gout, rheumatoid arthritis or multiple sclerosis.

The release of IL-1β is controlled by a molecular platform protein, known as the inflammasome name. The canonical protein (that is to say conserved in evolution) of the inflammasome NLRP3 are NLRC4 and that engages the ASC adapter protein to activate caspase-1, which promotes the cleavage of interleukin IL-1β. Gram-negative bacteria such as Escherichia coli cause non-canonical activation of caspase-1, caspase-11In involving more NLRP3 and AUC. In mouse, caspase-11 is essential to the immune response to gram-negative bacteria, but bacterial PAMPs that are responsible for triggering of the non-canonical inflammasome remain to be identified. It has recently been shown that caspase-11 is involved in the death of the mice subjected to septic shock. The mouse model requires caspase-11-dependent mechanism, caspase-independent -1 since the CASP1 - / - mouses are also susceptible to LPS as wild type mice. A key question to be answered is whether LPS triggers similar events in human cells. If this is the case, this knowledge may be useful in drug development for treatment of sepsis.

Eligibility Criteria:
Inclusion Criteria:

* patients with sepsis severe (bacterial infection associated with deterioration of at least one vital function) defined according to the criteria consensus conference
* patients whose diagnosis is made within 24 hours of the opening hours of Pasteur Research Laboratory
* patients with arterial catheter (not to impose an additional puncture to the patient) will be recruited in the intensive care unit of the Hospital St. Joseph. Arterial blood (20 ml) will be charged within 24 hours of the onset of severe sepsis criteria, during working hours of the laboratory of the Pasteur Institute, using vacuum tubes under heparin (Vacutainer), sent by a courier within 2 hours following the removal (to ensure that the cells are sufficiently "fresh" during processing in the laboratory)

Exclusion Criteria:

* none
Application of Esketamine in Anesthesia of Autism Children

Autism Spectrum Disorder (ASD) is a group of serious neurodevelopmental disorders. Autistic children appear with significant frequency for medical services, lots of which requiring procedural sedation or anaesthesia. Autistic children have often been described as difficult to sedate or anesthetize due to a variety of ASD symptoms. It is a challenging task to provide safe and effective sedation during the procedure of colonic TET for FMT in autism children. The investigators intend to explore an optimum anesthetic regimen for autism children undergoing endoscopic procedures.

Autistic children appear with significant frequency for medical services, lots of which requiring procedural sedation or anaesthesia. The participants have often been described as difficult to sedate or anesthetize due to a variety of ASD symptoms. It is a challenging task to provide safe and effective sedation during the procedure of colonic TET for FMT in autism children. The primary objective was to compare the clinical efficacy and safety of propofol-esketamine (PE) with propofol-sufentanil (PS) for deep sedation in the procedure of colonic TET in ASD children. A secondary objective was to compare adverse events (AEs) and recovery in those children during/after either PE or PS sedation.

Eligibility Criteria:
Inclusion Criteria:

* (1) aged 2-12 years;
* (2) diagnosed with ASD by pediatric psychiatrists in accordance with the criteria in the Fifth Edition of Diagnostic and Statistical Manual of Mental Disorders (DSM-V);
* (3) evaluated as American Society of Anesthesiologists (ASA) physical status I-II;
* (4) scheduled for colonic TET procedure.

Exclusion Criteria:

* (1) oral sedation (premedication) before intravenous catheter placement;
* (2) any contraindication to study medications;
* (3) other circumstances in which the investigator determined that a patient was not suitable for participation in the clinical trial.
Ranibizumab Treatment for Age-Related Macular Degeneretion

To establish the correlation between visual acuity improvement and QOL measurement after ranibizumab treatment for AMD patients.


Eligibility Criteria:
Inclusion Criteria:

* Active primary or recurrent subfoveal choroidal neovascularization lesion due to AMD
* Subjects of either gender age 50 years or older
* Visual acuity better than 0.05 decimal( 20/400 Snellen)
* Signed informed consent form

Exclusion Criteria:

* Prior treatment for neovascular AMD in the study eye, for example, PDT or anti-VEGF therapy
* Patients whose lesion site evaluated by FA examination is more than 12DA in subject eye
* Patients with treatment of triamcinolone intravitreal injection within 6 months in subject eye
* Patients with a history of intraocular surgical operation(including cataract)within 3 months in subject eye
* Patients with serious allergic history to such as fluorescein, indocyanine green, iodophors
* The pregnant or lactating woman
A Phase II Study of Continuous Versus Syncopated Dosing of CC-5013 for the Treatment of Refractory Multiple Myeloma

To evaluate the response rate, response duration, and survival of patients treated with CC-5013 in a chronic dosing schedule versus a syncopated dosing schedule.


Eligibility Criteria:
* History of histologically documented multiple myeloma with relapsed or resistant disease
* Pregnant or nursing women may not participate. Women of childbearing potential must have a negative pregnancy documented within one week of registration. Women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
* Signed written informed consent and willingness to meet follow-up schedule and study procedure obligations