cyrilzakka/clinical-trials huggingface dataset:
RF Lesion Monitoring With 8mm IntellaTip MiFi XP

Abnormal heart rhythms or arrhythmias are often managed by a procedure in which a catheter is introduced into the heart. These catheters can then cauterize abnormally functioning portions of the heart muscle with the hope of returning the heart to a more effective rhythm. In the process of performing such a procedure, called a catheter ablation, an operator must be able to accurately sense electrical activity displayed on computer screens in different parts of the heart, provide sufficient localized energy to the abnormally behaving tissue (ideally without damaging uninvolved heart structures), and accurately reassess the electrical activity of the heart to ensure the spot in the heart has been cauterized.

When sensing electrical activity of the heart, specialized catheters produce recordings on a computer screen known as electrograms (EGM). To produce this recording conventional catheters commonly use a positive and negative electrode, from which the difference between the two provides the EGM. The distance between the two electrodes varies from device to device. The greater the distance between them, the less accurate the measurement of local electrical activity becomes. This may result in poorly localized or excessive use of energy that could be damaging to normal heart structures or put the patient at risk for the return or development of additional arrhythmias. The IntellaTip MiFi catheter has been constructed with a specialized sensing tip that uses "microelectrodes" that are relatively close in proximity (\<1 mm apart) with the hope of improving the sensing capability of the device.

This study will analyze the signals obtained from this FDA-approved catheter in people undergoing a catheter ablation procedure. The study will examine signals after the procedure is finished and will not prolong or differ the process from a standard ablation procedure. The goal of this study is to determine the ability of the microelectrodes to distinguish ablated, or cauterized versus non-cauterized tissue.

This trial is an operator-blinded, acute, single-visit observational trial in humans. Enrollment will include 25 patients undergoing a radiofrequency ablation procedure in which ablation of the cavotricuspid isthmus is planned. Electrogram characteristics of the small, imbedded pin electrodes will be compared to standard bipolar EGMs utilizing the ablation tip electrode and ring. Absolute voltage, voltage reduction, and frequency spectra will be examined before, during, and after ablation. EGM characteristics of standard and "ultra-local" recordings will be compared in their ability to accurately identify an effective RF lesion as defined below.

Eligibility Criteria:
Inclusion Criteria:

* Any adult undergoing an atrial flutter ablation

Exclusion Criteria:

-
The Reported Frequency of FP Visits and Family Difficulties Should Alert FPs and Help Them to Prevent Severe Outcomes in Multimorbid Outpatients

The European General Practitioners Research Network (EGPRN) designed and validated a comprehensive definition of multimorbidity using a systematic literature review and qualitative research throughout Europe. This definition was tested as a model to assess decompensation in multimorbid outpatients.

The objective is to assess which criteria in the EGPRN concept of multimorbidity could detect decompensating outpatients in a primary care cohort at a 6-month follow-up and to assess whether a large scale cohort with FPs would be feasible.

Method: Family Physicians included a random sample of multimorbid patients who attended appointments in their offices from July to December 2014. Inclusion criteria were those of the EGPRN definition of Multimorbidity. Exclusion criteria were patients under legal protection and those unable to complete the 2-year follow-up. Decompensation was defined as the occurrence of death or hospitalization for more than seven days. Statistical analysis was undertaken with uni- and multivariate analysis at a 6-month follow-up using a combination of approaches including both automatic classification and expert decision making. A Multiple Correspondence Analysis (MCA) confirmed results consistency and completed the process with a projection of illustrative variables. A logistic regression was finally performed in order to identify and quantify risk factors for decompensation.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria were patients meeting the criteria for the definition of multimorbidity according to the EGPRN definition: any combination of chronic disease with at least one other disease (acute or chronic) or a bio psychosocial factor (associated or not) or a somatic risk factor.

Exclusion Criteria:

* Exclusion criteria were patients not meeting the criteria of the definition of multimorbidity, the inability to follow the study over time (known to be leaving the practice in the following months), patients under legal protection, outpatients in palliative care for whom survival was estimated by the FPs at less than three months.
Laser Therapy on Tension-type Cephalea and Orofacial Pain in Post-covid-19 Patients

Considering the auxiliary potential effect of photobiomodulation in controlling persistent CTT and TMD-related pain in patients who have been diagnosed with COVID-19, and are recovered from the viral infection, we intend to conduct a clinical trial comparing two modalities of therapeutic laser application: local application and transcutaneous application in the radial artery.

One of the main advantages of auxiliary techniques in pain control is the decrease of the use of drugs for analgesia, avoiding side effects and tolerance caused by them, and promoting an improvement in the individual's quality of life.

Orofacial pain and tensional cephalea were symptoms commonly reported in COVID-19 patients, even after recovery, and were considered chronic pain in these cases. The pain control, in these cases, is mostly accomplished with the use of analgesic and anti-inflammatory drugs. However, there are auxiliary treatments that can reduce the amount of pharmacological intake and improve the quality of life of compromised individuals, one of them is photobiomodulation. Using lasers for treatments to control inflammation and pain is successfully performed, but the parameters and the ways of application are not yet strongly established. The aim of this research is to evaluate the effect of the application of photobiomodulation with red and infrared lasers applied locally and systemically. For this purpose, individuals who have been diagnosed with COVID-19 and have had a tension headache and/or orofacial pain for more than 3 months will be selected by convenience. The participants will be divided into two different groups: G1- photobiomodulation with red and infrared laser with local application on the pain points (808 nm and 660 nm,100 mW, 6J per point) and G2 -photobiomodulation with red laser with transcutaneous application on the radial artery (660 nm, 100mW, 30 minutes). All participants will be treated for a period of 4 weeks, with 8 application sessions. The effects will be measured by means of blood lactate level, Brief Pain Inventory, Visual Analog Scale (VAS), and Cephalea Impact Test.

Eligibility Criteria:
Inclusion Criteria:

* Individuals of both sexes, between the ages of 19 and 65, complaining of persistent orofacial pain or functional-type cephalea, for more than 3 months.
* Individuals diagnosed with COVID-19, confirmed by RT-PCR for SARS-CoV-2 already recovered, at least 30 days after infection.

Exclusion Criteria:

* Individuals with diagnoses of neuropathies and headaches other than tension-type headache
* Physical or intellectual incapacity to answer the survey questionnaires; illiterate; diabetics, pacemakers, and pregnant women.
* Individuals who report photosensitivity to laser.
Clinical Performance Evaluation of AMH Assay

The Access AMH Assay is an in vitro diagnostic assay intended as an aid for fertility assessment. The purpose of the study is to evaluate the clinical performance of the Access AMH Assay in the intended use population.

same as brief summary

Eligibility Criteria:
Inclusion Criteria:

* ≥ 21 and \< 46 years of age
* Regular menstrual cycle
* Both ovaries present

Exclusion Criteria:

* Evidence of PCOS
* Confirmed ovarian endometrioma
* Ovarian surgery prior to enrollment
* Being treated for cancer
* Hormonal contraceptive use prior to enrollment
* Currently pregnant
Biological Monitoring of Nano Sized Particles in the Airways of Asthmatic Children

Background Ambient airborne particulate material (PM) is defined according the aerodynamic diameter into coarse, fine, and ultrafine or "nano" sized particles ranging between 2.5-10 µm (coarse), \<2.5 µm (fine), and \<0.1 µm (nano(. Many studies have examined particle effect on respiratory health in children, mainly by environmental monitoring of coarse and fine particles. Biological assessment of individual exposure to nano sized particles in correlation to adverse health effect was not previously studied.

Hypothesis individual exposure to nano sized particles in children is associated with reduction in forced expiratory volume at one second.


Eligibility Criteria:
Inclusion Criteria:

* age 6-18 years
* living in the Tel Aviv area
* referred to the pulmonology lab for respiratory function evaluation

Exclusion Criteria:

* Exposure to cigarette smoke
* Respiratory infection in the 4 weeks prior to recruitment and testing
A New Exogenous Marker for Diagnosis of Oxidative Stress During Laproscopic Surgery

Recently, a new synthetic marker was developed, based on a molecule that is composed of Amino Acids and Linoleic Acid and Neucleic Acid, which is capable of detecting even minor changes of oxidative stress.

The investigators would like to assess the usefulness of this marker during positive pressure pneumoperitoneum, during laproscopic surgery, with or without intenstinal resection (ischemia induced by intra-abdominal pressure and vascualr compromise).


Eligibility Criteria:
Inclusion Criteria:

* Healthy patients undergoing elective laproscopic cholecystectomy and patients undergoing operation for tumer of large intenstine.

Exclusion Criteria:

* Patients suffering from Cardio Pulmonory and renal diseases
Utility of Contrast-Enhanced Sonography and Shear Wave Elastography

Our overall hypothesis is that Contrast-enhanced ultrasound (CEUS) and Shear Wave Elastography (SWE) will allow for high diagnostic accuracy of benign and malignant thyroid nodules, which will correlate with and complement the ACR TI-RADS classification system, allowing for more accurate diagnosis of benign and malignant thyroid nodules.

Thyroid nodules are an exceedingly common clinical entity, however, only a small percentage of nodules are malignant. Conventional ultrasound is the current standard for the initial evaluation of thyroid nodules, yet due to several overlapping characteristics between benign and malignant nodules its utility in diagnosis has been limited, leading to a high rate of negative biopsies. To overcome these challenges the American College of Radiology has proposed a Thyroid Imaging Reporting and Data System (TI-RADS) in an effort to decrease unnecessary biopsies \[5\]. While these efforts have shown encouraging results, further work is still needed. Contrast-enhanced ultrasound (CEUS) and Shear Wave Elastography (SWE) are two emerging non-invasive imaging techniques which have shown promising results in the evaluation of thyroid nodules. However, data is limited and how these imaging modalities could potentially compliment ACR TI-RADS is unknown.

Eligibility Criteria:
Inclusion Criteria:

* - Patients over the age of 18 with one or more thyroid nodules diagnosed on conventional ultrasound within the last 6 months.
* Patients referred for standard of care thyroid nodule biopsy, ordered at the discretion of the treating physician and/or radiologists.
* Patients must demonstrate ability to understand and express willingness to sign a written informed consent to undergo SWE and CEUS imaging prior to their thyroid nodule biopsy.

Exclusion Criteria:

* Patients who are pregnant, nursing, or less than 18 years of age
* Thyroid nodules ≤1 cm
Assessing the Acute Effects of Diagonal Mobilization

Investigating the acute effects of mobilization on these parameters offers innovative insights for the practitioner community and sheds light on the strategy's potential effectiveness in mitigating injury risk. Therefore, this study aims to assess the immediate effects of mobilization on static and dynamic balance in young male and female soccer players using a randomized, double-blinded study design.

Participants underwent assessment twice: once before the intervention and again afterward. Tests included the single leg lend and hold test and the single leg standing test, measured using force plates.

Eligibility Criteria:
Inclusion Criteria:

* age between 14 to 16 years old, with regular soccer practice;
* absence of lower limb and lumbar spine surgery or injuries within the last 6 months (hip, knee, ankle), no current pain in the hip, knee, or ankle joints, no hypermobility of the lower limb joints, and no history of neurological or connective tissue disorders;
* availability for both assessment time points

Exclusion Criteria:

-
The Efficacy of the Acupuncture in the Treatment of Systemic Arterial Hypertension

There are few studies in the treatment of hypertension employing acupuncture as a blood pressure regulating technique. The Ministry of Health synthesized the inclusion of integrative and complementary practices within the Unique Health System, such as acupuncture. Our objective is to verify the effect of the acupuncture session on hypertensive patients, measured through ambulatory blood pressure monitoring (ABPM). In this way two groups of patients will be selected in a randomized clinical trial. In the first group, Chinese traditional acupuncture will be applied and in the second group the acupuncture sham will be applied.

Acupuncture as therapy is the subject of conflicting opinions on its effectiveness in scientific means, because in spite of its long existence as a therapeutic tool, raises doubts on the standards of Western science model. In addition, there are few studies in the treatment of hypertension employing Acupuncture as a blood pressure regulating technique. The Ministry of Health synthesized the inclusion of integrative and complementary practices within the Unique Health System, such as Acupuncture. The World Health Organization (WHO) recognizes its effectiveness, having its own concept in the energy imbalance that alter the organic, mental and emotional part addressing a current issue proposing to groundbreaking research. The objective is to verify the effect of the acupuncture session on hypertensive patients, measured through ambulatory blood pressure monitoring (ABPM). In this way two groups of patients will be selected in a randomized clinical trial. In the first group, Chinese traditional acupuncture will be applied and in the second group the acupuncture sham will be applied.

Eligibility Criteria:
Inclusion Criteria:

* patients enrolled in stage I to III of systemic arterial hypertension
* signing the free and informed consent term

Exclusion Criteria:

* patients who do not agree to participate in the study
* patients with systolic pressure values greater than 180 mmHg or diastolic pressure above 110 mmHg
* patients with important comorbidities
Emotional Prosody Recognition and Decision Making Inf fMRI and Vulnerability to Suicide

Suicide is known to be frequent in depression, and in most of the psychiatric diseases. But as it can occur in patients with no psychiatric illness and doesn't occur in every patients with psychiatric illness, it has to be considered henceforth as a specific vulnerability.

This trial will study two fMRI paradigms, emotional prosody recognition and decision making, in order to characterize emotional and cognitive trait factors in a population of patients vulnerable to suicide. Four different groups will be constituted : depressed suicide attempters, depressed patients with past history of suicidal acts, depressed patients with no history of suicidal acts and healthy controls.

The main goal will be to correlate fMRI activation during the two paradigms in subjects vulnerable to suicide. The secondary goals will be to characterize emotional and cognitive trait factors in these subjects, to demonstrate that those characteristics are independent from depression and to correlate these trait factors with socio-demographic and clinical features with fMRI activations.


Eligibility Criteria:
Inclusion Criteria:

* Right-handed,
* Depressed suicide attempters for the first group,
* Depressed patients with past history of suicidal acts for the second group,
* Depressed patients with no history of suicidal acts for the third group,
* Healthy controls for the fourth group.

Exclusion Criteria:

* Another psychiatric trouble than depression,
* Another psychotrope treatment than SSRI/SNRI and/or benzodiazepine at inclusion and/or one month before,
* For the first and secand groups : more than fous suicidals acts within the past 3 years,
* Deficits that do not allow test realisation (visual audition troubles, cognitif deficits,
* Prosopagnosia,
* Pregnancy,
* Severe central nervous system disease or somatic disease,
* MRI contra-indication,
* Major benefiting from a legal protective measure,
* No coverage care.
Early Outcome of Mechanochemical Endovenous Ablation

More than 25 percent of the general population suffers from varicose veins, which has a considerable impact on quality of life. Nowadays endovenous treatment modalities for great saphenous incompetence are widely accepted. Mechanochemical endovenous ablation is a new tumescent-less technique, that combines mechanical endothelial damage using a rotating wire with the infusion of a liquid sclerosant. The current study aims at evaluating short and long term outcome after mechanochemical endovenous ablation.


Eligibility Criteria:
Inclusion Criteria:

* Insufficiency of the GSV
* Ultrasound criteria for endovenous treatment have been met:
* Diameter GSV between 3-12 mm
* No thrombus present at the GSV part to be treated
* Signed informed consent
* Patient willing to present at follow-up visits
* Age \> 18 jaar

Exclusion Criteria:

* Patient is unable to give informed consent
* Patient unable to present at all follow-up visits
* Other treatment is more suitable for the treatment of the varicose veins than mechano-chemical ablation
* Pregnancy and breast feeding
* Known allergy/ contra indication for sclerotherapy
* Previous ipsilateral surgical treatment of varicose veins
* Deep venous vein thrombosis in medical history
* Anticoagulant therapy
Ultrasound Contrast-Enhanced Accurate Diagnosis of Preoperative Staging of Bladder Cancer

Ultrasound and magnetic resonance imaging (MRI) technologies have become essential tools for the diagnosis and preoperative staging assessment of bladder cancer. However, establishing a precise system suitable for clinical application remains a significant challenge, and accurate prediction of bladder cancer staging is not yet possible. Therefore, exploring a system for the precise diagnosis of preoperative staging of bladder cancer using ultrasound contrast enhancement or a combination of ultrasound contrast enhancement and MRI is of great importance. The applicant has previously demonstrated the accuracy of multimodal data analysis in the diagnosis and prediction of malignant tumors. Preliminary results from this study have shown that ultrasound contrast enhancement has a high diagnostic efficacy for the preoperative staging assessment of bladder cancer, with a high area under the curve (AUC) of 0.88, sensitivity of 83.3%, specificity of 92.5%, and accuracy of 90.8%. In this project, the applicant intends to further expand the sample size and, based on the combination of ultrasound contrast enhancement and MRI, develop a precise diagnostic system for the preoperative staging of bladder cancer to aid clinical treatment decisions.


Eligibility Criteria:
Inclusion Criteria:

* (a) eligible patients should be 18-year-old or older;
* (b) patients should have a histologically or cytologically confirmed diagnosis of primary bladder cancer;
* (c) patients should not have had any surgery, chemotherapy, immunotherapy, or any therapy before CEUS diagnosis.

Exclusion Criteria:

* (a) participants with confirmed to have no carcinoma of the bladder;
* (b) participants with previous pelvic surgery, who had undergone therapy, any bladder surgery, or had received chemotherapy, radiotherapy or immunotherapy;
* (c) participants diagnosed with tumor recurrence or metastasis; (d) participants who were allergic to ultrasound contrast agents or could not tolerate CEUS examination, for instance, with recent myocardial infarction, angina pectoris, cardiac insufficiency, severe cardiac arrhythmia, a right/left cardiac shunt, severe pulmonary hypertension, uncontrolled systemic hypertension, acute respiratory distress syndrome, or chronic obstructive pulmonary disease.
Reliability and Validity of Urdu Version of the King's Health Questionnaire

This study is aimed to translate King's Health Questionnaire into Urdu language and to test its reliability and validity among Pakistani women with urinary incontinence.


Eligibility Criteria:
Inclusion Criteria:

* Having symptoms of Urinary Incontinence
* Age 21 or more than years
* Sufficient literacy to complete questionnaire

Exclusion Criteria:

* Being unable to complete questionnaires due to language and cognitive limitations
* Pelvic organ prolapse
* Concomitant neurological disorders
Early Progressive Mobility in the CVICU: Assessing Current Status

The current study is proposed to assess the frequency and type of progressive mobility procedures currently performed in the CVICU The study will evaluate the type and frequency of progressive mobility orders, whether or not progressive mobility steps are being taken by the nursing teams, define what steps patients are receiving, and record time to first weight bearing. Other outcome measures will be the days of required mechanical ventilation, and current ICU length of stay and cost to treat.

This will be a descriptive 4 month study of standard care practice. Patients who meet the inclusion / exclusion criteria for study will be enrolled (Waiver of informed consent is requested) and followed for a maximum of 28 days. The type and frequency of progressive mobility orders, whether or not progressive mobility steps are being taken by the nursing teams, define what steps patients are receiving, and record time to first weight bearing will be recorded. Weight bearing will be defined as standing for at least 1 minute. ICU LOS, Ventilator Days will be assessed at ICU discharge for study patients. Barriers to PM procedures will also be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Patient is ≥ 18 years old.
* Patient has been admitted to the ICU for less than 3 days prior to study enrollment
* Patients require mechanical ventilation for \>48 hours

Exclusion Criteria:

* Mobilization is contraindicated by Patient's condition. Such as hip fractures or other injury that would impede standing posture.
* Patient weighs less than 70 pounds or more than 440 pounds
* Mobilization is contraindicated by patient's condition or physician's orders exist that prevent the patient from participating in the mobility protocol.
* Patient was unable to walk or stand without assistance prior to ICU admission.
* Patient was cognitively unable to follow verbal commands prior to ICU admission.
* Patients current diagnosis includes acute stroke with neurologic impairment
* Patient's current diagnosis includes drug overdose.
* Patient has "Do not resuscitate" orders and/or is at an end stage terminal disease state.
* Patient requires a specialty bed or mattress.