cyrilzakka/clinical-trials huggingface dataset:
Ventriculo-arterial Coupling Modification Evaluated by PRAM During TAVI Procedure

Calcified aortic stenosis is the most frequent valvulopathy in Europe and North America. Aortic stenosis is an obstacle to the ejection of blood from the left ventricle to the aorta and leads to morphological changes in the left ventricle and hemodynamic modifications.

Intrinsic ventricular performance can be characterized using three parameters:

* Ventricular elastance (Ees for End Systolic Elastance) which represents the index of ventricular contractility independently of the load.
* Arterial elastance (Ea for Arterial Elastance) which represents the post-load
* The ventriculo-arterial coupling index (Ees / Ea) which represents energy efficiency.

For patients with high surgical risk (EuroSCORE II\> 6), TAVI (Transcatheter Aortic Valve Implantation) is recommended for aortic valve replacement. Many complications may occur after TAVI (haemorrhagic, embolic, renal, myocardial ischemia). Post-TAVI complications may also be cardiac decompensation of the underlying cardiac disease to cardiogenic shock. However, literature on left ventricular performance after aortic valvular replacement is poor because of the difficulty and invasiveness of the analysis involved.

Cardiac energy analysis plays an additional role in understanding the clinical patients conditions. On this point, cardiac energy modifications, based on ventriculo-arterial coupling, could be indicators of cardiac function. Two methods (ultrasound and pulse contour) are used to understand and explore the ventriculo-arterial coupling, preload, postload, contractility and hemodynamic changes interactions.

Echocardiography allows the Ees / Ea and SW / PVA (Stoke work/ pressure-volume area) ratios mesurements. PRAM (Pressure Recording Analytical Method) through the MostCare® monitor, gives common hemodynamic parameters and more specific parameters such as arterial elastance (Ea) cardiac cycle efficiency (CCE), dP / dt. Cardiac cycle efficiency (CCE) is an exclusive variable that describes the hemodynamic performance in terms of energy expenditure in the patient being followed.

TAVI procedure is an acute model of ventriculo-arterial coupling modification by treatment of the ventricular ejection obstacle. The PRAM method evaluates the ventriculo-arterial coupling. The aim of our study is to evaluate by PRAM the changes in cardiac energy variables before and after aortic valve replacement by TAVI


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* elective TAVI intervention with femoral access
* consent

Exclusion Criteria:

* permanent arrhythmias
* pacemaker dependency
* moderate to severe mitral or tricuspid valve regurgitation
* intracardiac shunt
Phase 3 Study - Safety and Efficacy of PTK 0796 in Patients With Complicated Skin and Skin Structure Infection (CSSSI)

A Phase III trial to demonstrate the safety and efficacy of PTK 0796 in the treatment of complicated skin and skin structure infections (cSSSI).

The pharmacologic profile of PTK 0796 in humans suggests that it has the potential to be used safely and effectively for this indication. Data from in vitro and animal studies support this hypothesis.

In PTK 0796-CSSI-0805 the safety and efficacy of PTK 0796 in the treatment of cSSSI will be compared to an antibiotic approved for this indication by the FDA. Initial treatment will be administered intravenously with the option for subsequent oral treatment.

Eligibility Criteria:
Inclusion Criteria:

* Has and acute complicated skin and skin structure infection with findings of systemic inflammatory response
* Patients, ages 18 years or older
* Is expected to require greater than or equal to 4 days antibiotic therapy
* Female patients must not be pregnant at the time of enrollment and must agree to a reliable method of birth control during the study and for 30 days following the last dose of study drug

Exclusion Criteria:

* Has received an investigational drug within the past 1 month
* Has been previously enrolled in this protocol
* Has received \>48hr of potentially effective systemic antibiotic immediately prior to study drug
* Is nursing
Traditional Blind Versus Ultrasound-guided Peribulbar Blockade

Eye surgeries are traditionally performed under local anaesthesia with a peribulbar block. This is a blind technique where local anaesthetic is injected into the back of the eye to make the eye numb and motionless for surgery. This is a blind injection and can be associated with complications such as bleeding, rupture of eye globe, blindness, increasing the pressure of the eye etc. It also has a high failure rate resulting in need for additional injections, further exposing the patient to possible complications. The investigators propose to perform the peribulbar block with ultrasound to guide the block needle placement and injection. The investigators hypothesize that ultrasound guided peribulbar blocks would have higher success rate (less need for additional injections) and that the total amount of local anaesthetics used would be decreased.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing vitrectomy surgery

Exclusion Criteria:

* Lack of informed consent
* Coagulopathic disorder, anticoagulated with INR (international normalized ratio) \> 1.5 or platelet count less than 75 x 10\^9/L
* Pathological myopia. Inability of patient to lie down for 2 hours for the operation -Local infection at site of needle entry
Evaluation of an Intra Auricular Device as a Treatment for Painful Temporo-Mandibular Disorders

Background: An innovative, non-invasive, and reversible Intra Auricular Device (IAD) has recently been introduced to treat temporomandibular muscle and joint disorders.Aim: To evaluate the effects of the IAD on pain, psychosocial domain and Pressure Pain Threshold (PPT) of masticatory muscles in patients with TMD pain. Methods: Ten subjects with TMD pain and with pain intensity higher than 30 mm on a VAS scale were included in the study. Patients received the IAD and counselling. Assessments included questionnaires of the DC/TMD Axis II questionnaires (Characteristic Pain Index, Interference, Jaw Functional Limitation Scale, Patient Health Questionnaire 9, Patient Health Questionnaire 15, Generalized Anxiety Disorder scale, Oral Behavior Checklist and Oral Health Impact Profile-22, Axis I clinical examination and PPTs at baseline (T0), after one month (T1), three months (T2) and six months (T3) from the first use of the device. PPTs were measured at anterior temporalis muscles, masseter muscles and right thenar as a control site.The Shapiro-Wilk test was used for the normal distribution of data. The difference among the longitudinal timepoints for variable was analysed with ANOVA. Statistical significance was accepted at p \< 0.05.

The goal of ths study is to evaluate the effects of a new intra auricular device, the IAD, on pain, psychosocial domain and Pressure Pain Threshold (PPT) of facial muscles in patients with diagnosis of TMD pain according to the Diagnostic Criteria of Temporomandibular Disorders

Eligibility Criteria:
Inclusion Criteria:

* age \>18
* TMD-pain diagnosed according to the DC/TMD (myalgia, myofascial pain, arthralgia, headache attributable to TMD)
* disc displacement with reduction

Exclusion Criteria:

* disc displacement without reduction
* intermittent locking
* degenerative TMJ disorder
* craniofacial anomaly
* history of prior TMJ
* orthognathic surgery
* recent (within the past six months) trauma to the face or jaw
* current, active orthodontic treatment
* severe mental health disorder
Adaptive CT Acquisition for Personalised Thoracic Imaging

In this trial, Respiratory Motion Guided (RMG) 4DCBCT will be implemented for the first time on lung cancer patients. RMG-4DCBCT adapts the image acquisition as the patient's breathing changes (i.e. if the patient breathes faster, imaging data is acquired faster).

By adapting the acquisition to the dynamic patient, personalised images of a patients lungs are able to be acquired for radiotherapy treatments.

Four dimensional cone beam computed tomography (4DCBCT) continues to play a pivotal role in the safe delivery of radiotherapy treatments for lung cancer patients. 4DCBCT meets exacting tumour localisation requirements by allowing radiation therapists to measure the tumour as a patient breathes (4D=volumetric images plus respiratory induced tumour motion). Despite the success of 4DCBCT to date, it suffers from relatively poor image quality, very long scan times (4min) and higher imaging doses than are necessary. The primary reason for these problems is that although the purpose of 4DCBCT is to acquire information about tumour motion due to respiration, there is no feedback from the patients breathing signal to adapt and optimise the image acquisition process. This clinical trial is a phase 1 first in human's pilot study and the aim is therefore to prove feasibility of RMG-4DCBCT, not necessarily efficacy. As such, patient scans will be acquired across a broad range of patient breathing conditions to optimise the RMG-4DCBCT technique and also to plan a hypothesis driven clinical trial to follow.

Eligibility Criteria:
Inclusion Criteria:

* Have the ability to give informed consent
* A diagnosis of lung cancer with an indication for radiotherapy either curative or palliative
* Radiotherapy treatment involving the routine acquisition of CBCT for patient setup provided that 4DCBCT is to be acquired during the course of treatment.
* At least two radiotherapy fractions during the course of treatment.

Exclusion Criteria:

* Pregnant women.
* Patient who in the opinion of the treating physician could not tolerate the extra time on the treatment couch for two days of treatment.
Infant Medical Records: Case Report Proposal

Infants with congenital long QT syndrome (LQTS) and 2:1 atrioventricular block (AVB) have been recognized as a clinical subset of children with LQTS.

The purpose of this study is to describe the clinical course and outcome of a patient with congenital long QT syndrome (LQTS).

It has been previously reported that 2:1 AVB in neonatal LQTS seems preferentially associated with HERG mutations . It has also been reported in association with the SCN5A gene. We report on a neonate with congenital LQTS and congenital complete heart block who experienced frequent episodes of torades des pointe and ventricular tachycardia, which, over the first 2 days of life, was recalcitrant to traditional therapy of beta-blockers and other antiarrhythmics. Eventually hypotension necessitated the use of an epinephrine infusion, which halted the ventricular tachyarrhythmias. A pacemaker was implanted once the infant was stable and, currently, he is thriving. Genetic analysis revealed a HERG mutation.

For this study, we will need access to the infant's inpatient and outpatient medical records at Children's Healthcare of Atlanta at Egleston Children's Hospital and Sibley Heart Center Cardiology to include his age, date of birth, medical record number, inpatient labs, inpatient echo reports, outpatient echo reports, inpatient and outpatient EKG's, inpatient pharmacy records, the results of his genetic analysis, his history and physical, transfer notes, daily progress notes, consultation reports and operative reports from his admission beginning 9/30/04.

Eligibility Criteria:
Inclusion Criteria:

* Congenital long QT Syndrome single case report

Exclusion Criteria:

* Single case report
Efficacy of TTMPB in Adult Cardiac Surgery

The goal of this clinical trial is to compare the efficacy of Transversus Thoracic Muscle Plane Block (TTMPB) integrated in a modern multimodal analgesia protocol, following the ERAS® recommendations, in adult patients undergoing planned open heart surgery.

The main study question is:

Does the addition of TTMPB to a standard analgesic protocol significantly improve analgesia following elective open heart surgery?

The investigators will primarily compare postoperative opioid consumption and pain scores in patients who will be randomly allocated to one of two groups:

The control group will receive standard analgesia per institutional Intensive Care Unit protocol.

The intervention group will receive the same standard of care plus a TTMP block (40ml of bupivacaine 0.375%, total dose of 150 mg).

The investigators will also study the impact of group allocation on secondary outcomes, such as the rate of early mobilization.


Eligibility Criteria:
Inclusion Criteria:

* Direct informed consent as documented by signature
* Major adult (≥ 18 years old) with body weight ≥ 50 kg. For the record, fifty kilograms is the minimal weight to ensure that participants remain safely away from maximal doses of LA (3 mg/kg)
* Planned and primary cardiac surgery via a sternotomy approach
* Planned for ultra-fast-track procedure (i.e. postoperative extubation time of maximum two hours)

Exclusion Criteria:

* Participation in another study with investigational drug within the 30 days preceding and during the present study
* Refusal and/or inability to understand or sign the informed consent
* Emergent cardiac surgery
* Previous cardiac surgery
* Known hypersensitivity or true allergy to bupivacaine and other amide-class LA
* Chronic pain history
* Substance abuse history
* Inability to follow the procedures of the study (e.g. due to language problems, psychological / psychiatric disorders, dementia)
* Clinically significant concomitant diseases: severe cardiac dysfunction (i.e. LVEF ≤ 35%); severe chronic obstructive pulmonary disease (i.e. FEV \< 50%); severe hepatic disease.
* Severe obesity (BMI \> 35kg/m2)
Safety, Tolerability and Pharmacokinetics of LNZ101 and LNZ100 Ophthalmic Solutions in Healthy Adult Chinese With Presbyopia

Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of LNZ101 and LNZ100 Ophthalmic Solutions in Chinese Healthy Adult Subjects with Presbyopia

A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of LNZ101 and LNZ100 Ophthalmic Solutions in Chinese Healthy Adult Subjects with Presbyopia

Eligibility Criteria:
Inclusion Criteria

1. Be able and willing to provide written informed consent prior to any study procedure being performed.
2. Be able to and willing to use investigational products per study requirements and attend all study assessments, including admission to and stay in the CRU on required study days.
3. Be Chinese healthy male or female subjects aged 45-75 years (inclusive) at screening.
4. Be diagnosed and documented to have presbyopia by the investigator at the screening visit.

Exclusion Criteria:

1. Have known contraindications or sensitivity to the use of any of the investigational products or its components, or any other medications required by the protocol.
2. Have any active systemic or ocular disorder that has a potential risk to or impact on subject safety, study process or study results other than refractive disorder.
3. Have presence of any abnormality of the lids, ocular surface, or lacrimal duct system that in the investigator's opinion could affect ophthalmic solution absorption in either eye.
4. Have prior (within 14 days of the first dose), current or anticipated use of any contact lenses during study participation.
5. Be ineligible for this trial in the opinion of the investigator.
Hemorrhagic Myocardial Infarction Detection by Biomarkers

Pilot trial to determine diagnostic efficacy of post-reperfusion troponin kinetics in detection of hemorrhagic myocardial infarction


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Index STEMI
3. Coronary angiogram with PCI to occur irrespective of the onset of the symptoms.
4. Ability to provide informed consent for themselves

Exclusion Criteria:

1. History of prior myocardial infarction,
2. Cardiogenic shock,
3. Patients who present with current cardiac arrest
4. Any contraindication to cardiac CMR (claustrophobia, pacemaker or cardiac defibrillator, known allergy to gadolinium),
5. Presence of permanent atrial fibrillation,
6. Unconscious patient,
7. Severe renal insufficiency (creatinine clearance ≤ 30 ml/min/m2 or renal replacement therapy),
8. Women who are pregnant or breastfeeding. Women of reproductive potential must have a negative pregnancy test.
IntErnational Long-term Follow-up Study of Patients With Uncontrolled HyperTensioN

The purpose of this post market clinical investigation is to further evaluate the safety and performance of the EnligHTN™ Renal Denervation System in the treatment of patients with uncontrolled hypertension.

This is a post market, prospective, multicenter, non-randomized, single arm study of the EnligHTN™ Renal Denervation System. Approximately 500 subjects with uncontrolled hypertension will undergo renal artery ablation at approximately 40 investigational sites located internationally and will be followed up to five years post procedure.

Eligibility Criteria:
Inclusion Criteria:

* Subject is ≥ 18 years of age at time of consent
* Subject must be able and willing to provide written informed consent
* Subject must be able and willing to comply with the required follow-up schedule
* Subject has office Systolic Blood Pressure ≥ 140 mmHg at confirmatory visit
* Subject has a daytime mean Systolic Ambulatory Blood Pressure \> 135 mmHg within 90 days prior to procedure
* Subject has established hypertension (diagnosed ≥12 month prior to baseline) and is on a guideline based drug regimen at a stable and fully tolerated dose consisting of ≥ 3 anti-hypertensive medications (including 1 diuretic) or subject has a documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.

Exclusion Criteria:

* Subject has significant renovascular abnormalities such as renal artery stenosis \> 30%
* Subject has undergone prior renal angioplasty, renal denervation, indwelling renal stents, and/or abdominal aortic stent grafts
* Subject has hemodynamically significant valvular heart disease as determined by study investigator
* Subject has a life expectancy less than 12 months, as determined by the Investigator
* Subject is participating in another clinical study which has the potential to impact their hypertension management (pharmaceutical/device/homeopathic)
* Subject is pregnant, nursing, or of childbearing potential and is not using adequate contraceptive methods
* Subject has active systemic infection
* Subject has renal arteries with diameter(s) \< 4 mm in diameter
* Subject has an estimated GFR \<15 mL/min per 1.73 m\^2 using the MDRD formula
* Subject had a renal transplant or is awaiting a renal transplant
* Subject has blood clotting abnormalities
A Study of Enhancing Drug Prophylaxis of Venous Thromboembolism in Chinese Colorectal Cancer Surgery

This project intends to conduct a multicenter, prospective, observational cohort study, aiming to explore the impact of the timing of pharmacological thromboprophylaxis initiation on postoperative bleeding risk and the effectiveness of venous thromboembolism (VTE) prevention in Chinese patients after colorectal cancer (CRC) surgery. The research outcomes of this project could provide valuable insights for optimizing the prevention and management of VTE after CRC surgery.


Eligibility Criteria:
Inclusion Criteria:

- 1.Age \> 18 years old; 2.The patient was diagnosed with colorectal cancer, and the cTMN stage was cT1-2, N0 or cT3, N0 or any cT, N1-2； 3.The patient was diagnosed with colorectal cancer and was able to receive radical surgery (laparoscopic or open surgery). The expected operation time was \>45 minutes, and the expected postoperative survival time was \>6 months.

4.The patient or guardian agrees to the study plan and signs the informed consent.

Exclusion Criteria:

* 1.Renal insufficiency (CrCl\<30 mL/min) or hepatic insufficiency (ALT\> 3 times the upper limit of normal); 2.The patient was diagnosed with colorectal cancer with a cTMN stage of cT4 and/or local unresectable lesions. Unresectable local recurrent lesions included: (1) extensive lateral pelvic wall invasion, (2) external iliac vascular involvement, (3) tumor invasion into the great sciatic notch, sciatic nerve invasion, and (4) invasion of the second sacrum level and above.

  3.Known allergy to low molecular weight heparin (LWMH), narcotic drugs or radiocontrast agents; 4.The presence of systemic hemorrhagic disease or bleeding tendency, such as active peptic ulcer, uncontrolled hypertension, cerebral thrombosis, cerebral hemorrhage or neurosurgical history within 6 months; 5.Known brain metastases, endocarditis, or history of heparin-induced thrombocytopenia; 6.VTE occurred within 3 months before surgery; 7.Use heparin or oral anticoagulant therapy within 5 days before surgery; 8.Women who are pregnant or breastfeeding; 9.Any situation in which the investigator determines that the subject is not suitable for anticoagulant therapy.
Effect of Using Nanochitosan Versus Calcium Hydroxide as Disinfectant on Pain and Apical Bone Healing

Effect of Using Nanochitosan versus Calcium Hydroxide as Intracanal Medications on the Postoperative Pain and Apical Bone Healing

PICO approach P (population): maxillary anterior teeth having necrotic pulp with symptomatic apical periodontitis with evidence of apical radiolucency (minimum size 2 mm x 2 mm).

I (intervention):0.2% nanochitosan as intracanal medication. C (control): calcium hydroxide paste intracanal medication.

O (outcome):

Primary outcome: postoperative pain at time interval 4, 12, 24, 48, 72 hours

Secondary outcome:

1. Postoperative pain, swelling, palpation, percussion and mobility at one week, 3, 6, 12 months
2. Number of analgesic tablets used at 4, 12, 24, 48, 72 hours and one week.
3. healing of apical periodontitis using CBCT at 3, 6, 12 months

Eligibility Criteria:
Inclusion criteria:

* Patients in good general health.
* Patient's age ranging between 20-40 years with no sex predilection.
* Maxillary anterior teeth with non-vital pulp and symptomatic apical periodontitis.
* Evidence of apical radiolucency (minimum size 2 mm x 2 mm).
* Patients' acceptance to participate in the study.

Exclusion criteria:

* Medically compromised patients with a severe systemic condition.
* Pregnant female patients.
* Patients who had taken any antibiotic or analgesics during the past 24 hours.
* Presence of a swelling because emergency management may include incision and drainage.
* Retreatment cases.
* Generalized periodontitis (calculus, deep pockets).
* Out of normal variations (open apex- severely curved canal- obstructed canal).