cyrilzakka/clinical-trials huggingface dataset:
Augmenting Growth Hormone to Ameliorate Nonalcoholic Fatty Liver Disease in Adolescents

Fatty liver disease is an increasing problem in overweight and obese young adults. The purpose of this study is to test the effect of growth hormone on liver fat in obese young adults ages 18-29y with increased liver fat.

Non-alcoholic fatty liver disease (NAFLD) is a significant health problem in obese adolescents. Obese children and adolescents have significant reductions in growth hormone secretion, and we hypothesize that augmenting growth hormone in this population will decrease liver fat. Growth hormone inhibits hepatic de novo lipogenesis, which is an important source of hepatic lipid. Patients with pituitary GH deficiency have a higher prevalence of NAFLD and non-alcoholic steatohepatitis (NASH) than the general population, and replacement of GH in these individuals reduces signs of liver damage. The purpose of this study is to test the hypothesis that growth hormone treatment will decrease liver fat quantity in young adults who begin the trial with more than 5% liver fat measured by magnetic resonance spectroscopy.

Eligibility Criteria:
Inclusion criteria:

1. Males and Females ages 18-29yo
2. BMI ≥95th percentile and/or ≥30kg/m\^2
3. Hepatic fat ≥5% by hydrogen magnetic resonance spectroscopy (1H-MRS)
4. IGF-1 standard deviation score (SDS) \< 0

Exclusion criteria:

1. Alcohol consumption of \>14 drinks per week (Females) or \>21 drinks per week (Males)
2. Use of insulin or oral anti-diabetic medications, or hemoglobin A1c (HbA1c) \>7% or fasting glucose ≥126mg/dL
3. Use of corticosteroid, gonadal steroids, or methotrexate ≤ 3 months prior to baseline visit
4. Known diagnosis of alpha-1 antitrypsin deficiency, Wilson's disease, hemochromatosis, or autoimmune hepatitis
5. hemoglobin \< 11.0 g/dL or weight \< 50kg
6. aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>2.5x upper limit of normal (ULN), total bilirubin \> ULN, positive hepatitis B surface antigen (sAg), or positive hepatitis C antibody
7. Routine magnetic resonance imaging (MRI) exclusion criteria (including weight \>450 pounds)
8. Use of weight-loss medications or previous weight loss surgery
9. Pregnant or breastfeeding, or, for sexually-active females, unwillingness to use an appropriate form of contraception during the study
10. Known cirrhosis or clinical evidence of cirrhosis or portal hypertension on imaging or exam
11. Use of growth hormone (GH) or growth hormone releasing hormone within the past 1 year
12. Change in lipid lowering or anti-hypertensive medications within 3 months of screening
13. Change in vitamin E or ursodiol \<6 months before screen; subjects on stable doses of Vitamin E and/or Ursodiol for ≥6 months will be eligible.
14. History of malignancy or active malignancy
15. History of hypopituitarism, head irradiation or any other condition or chronic illness known to affect the GH axis
The CINCH-FMR Post-Market Registry: Percutaneous Repair in Functional Mitral Regurgitation

This is a retrospective and prospective, multi-center, post-market observational registry study. The primary objective of this post market registry is to continue to evaluate the long term safety and performance of the Carillon® Mitral Contour System® (CMCS) in a commercial (post market) setting.

There are more than 22 million people worldwide with heart failure, including 5.3 million in the United States . Functional mitral regurgitation (MR), leakage of the mitral valve due to dilation of the left ventricle and annulus, occurs as a consequence of Heart Failure. Cardiac Dimensions has developed proprietary technology designed to address functional mitral regurgitation in a minimally invasive manner.

Previous studies have established that the Carillon® therapy has caused a significant reduction in functional MR. This reduction in MR results in clinically significant improvements in exercise tolerance, quality of life, and thus overall function in a symptomatic heart failure population.

To supplement the findings from these previous studies, Cardiac Dimensions is conducting this post-market registry of the Carillon® Mitral Contour System® (CMCS) in patients with functional mitral regurgitation. This registry is a retrospective and prospective, multi-center, clinical registry designed to further characterize the acute and long-term safety and performance profile of the CMCS. Up to 250 implanted patients will be enrolled at up to 40 centers located in the European Union and countries that recognize the CE-mark as a valid marketing authorization.

Patients enrolled in the registry have received the Carillon implant and will be assessed to document the long-term safety and performance of the device. These patients will be followed according to routine standard of care post procedure follow up assessments.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with functional mitral regurgitation (i.e., dilated cardiomyopathy), in accordance with CE-mark approved labeling
2. Patients implanted with the Carillon device
3. Patients must be ≥ 18 years old
4. Patients require informed consent prior to inclusion in this registry
5. Minimum baseline data, as described in CINCH Protocol, including:

   * Hemodynamic measures (by echocardiography)
   * Baseline must include the following measurements: MR grade, LVEF (%), LVEDD, LAD, and AP \& ML diameters
   * NYHA Classification
Lidocaine and Dexmedetomidine Infusion and Their Combination on Perioperative Pain in Patients Undergoing Video-Assisted Thoracoscopic Surgery

This study aims to compare lidocaine and dexmedetomidine infusion and their combination on perioperative pain in patients undergoing video-assisted thoracoscopic surgery.

Video-assisted thoracoscopic surgery (VATS) is a minimally invasive procedure allowing the reduction of surgical stress. However, postoperative pain management is crucial for patients undergoing VATS, as inadequate pain control can lead to complications (such as lung atelectasis), prolonged recovery, and decreased patient satisfaction.

Dexmedetomidine has shown positive effects on postoperative pain intensity, opioid consumption and other recovery parameters, such as postoperative nausea and vomiting (PONV), and speed of recovery.

Lidocaine has exhibited an excellent safety profile when administered as a low-dose infusion for cancer or non-cancer chronic pain.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years old.
* Both sexes.
* American Society of Anesthesiologists (ASA) physical status of I, II.
* Patients undergoing video-assisted thoracoscopic surgery (VATS) under general anesthesia.

Exclusion Criteria:

* Hypersensitivity to any of the used drugs.
* Coagulation disorder.
* Body mass index \>35 kg/m2.
* History of chronic pain requiring daily opioids/steroids/clonidine/other α2 agonist/analgesics or any drugs acting on the central nervous system during the previous 2 weeks, and drug/alcohol abuse.
* Contraindication to the use of local anesthetics.
* Cardiovascular disease.
* Severe respiratory, renal or hepatic impairment.
* Insulin-dependent diabetes mellitus.
* Central nervous system or psychiatric disease.
Interest of a Post-operative Ultrasound With Systematic Use of Ultrasonic Contrast in the Follow-up of Aortic Endoprosthesis: Prospective Study at the University Hospital of Nice

This is a prospective study conducted on a population with an aortic endoprosthesis in the context of an abdominal aortic aneurysm. The study's objective is to standardize the ultrasound methodology in the monitoring of aortic endoprosthesis in immediate post-operative care by comparing the results with CT-scan (gold standard). To improve ultrasound methodology, the investigators propose to use the VESMA protocol for ultrasound diameter measurement at four incidences. In addition, the use of ultrasonic contrast agents increases the accuracy of vascular structures, the quality of the ultrasound blood flow image and the duration of signal enhancement. This makes it possible to visualize small gauge vessels and those with slow flows. In this way, the investigators could improve the ultrasound technique for measuring aneurysm bag diameters and endoleak detection. Moreover, the toxicity of iodinated contrast agents is the third cause of acute renal failure in hospitalized patients and is all the more frequent when the investigators increase injections. Improving the quality of ultrasound investigations for the monitoring of aortic endoprosthesis would therefore allow us to reduce the number of CT-scan performed in this population and thus reduce irradiation and the injection of nephrotoxic products. Thereby, the investigators would like to integrate the technique into the systematic follow-up of patients who have benefited from the placement of an aortic endoprosthesis by replacing the CT-scan.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age.
* Abdominal aortic aneurysm treated with aortic stent.
* Signature of informed consent.
* Person affiliated or beneficiary of a social security scheme

Exclusion Criteria:

* Hypersensitivity to sulphur hexafluoride or to these excipients (Macrogol 4000, Distearoylphosphatidylcholine, Dipalmitoylphosphatidylglycerol sodé, Palmitic acid).
* Right-left shunt patient
* Patient with severe pulmonary hypertension (pulmonary blood pressure \> 90 mm Hg),
* Patient with uncontrolled systemic hypertension
* Adult patients with respiratory distress syndrome.
* Dobutamine patient in patients with a pathology suggesting cardiac instability
* Hypercoagulation, recent thromboembolic accident
* Fenestrated aortic stent
* Pregnant or nursing woman.
* Severe heart failure.
* Person deprived of liberty by judicial or administrative decision.
* Person subject to legal protection.
Longitudinal Endodontic Study of Apical Preparation Size

This protocol is for a clinical trial evaluating the clinical success of root canal therapy performed on teeth with chronic apical periodontitis of pulpal origin with either large or small apical root canal preparation techniques.

This randomized clinical trial will compare the clinical success of two commonly used techniques for performing non-surgical endodontic procedures on teeth with chronic apical periodontitis of pulpal origin. The first method, termed the "GT method" uses a commercially available rotary file system to instrument the root canal systems from the crown to the apical portion of the root. After completion of this technique, the apical portion of the root is prepared to the same standardized ISO size #20 in all roots (i.e., 0.2 mm cross-sectional diameter). The second method, termed the "Lightspeed method" uses a different commercially available rotary file system to shape the root canal systems from the apical to the crown portion of the root. After completion of this technique, the apical preparation is often larger in cross-sectional diameter than that observed after the GT method; however, an equally important distinction is that the Lightspeed method customizes the final cross-sectional diameter for each root canal system, and thus each root has a similar enlargement of apical preparation size due to proportionate removal of infected dentin at the end of the root. Although the Lightspeed method may result in reduced bacteria in the apical portion of root canal systems, there is no evidence to date that this effect improves clinical success rates. This study will test the hypothesis that the larger apical preparation size produced by the Lightspeed instrumentation system will produce a higher percentage of clinically successful treatments of teeth with apical periodontitis (AP) as compared to the GT method

Eligibility Criteria:
Inclusion Criteria:

1. Patient must be at least 18 years of age.
2. Clinical indication for Non-Surgical Root Canal Therapy (NSRCT).
3. 1st or 2nd maxillary or mandibular molar.
4. Diagnosis must be Chronic Apical Periodontitis (CAP) with or without symptoms.
5. Intact, mature apices.
6. ASA I or II.

Exclusion Criteria:

1. Failure to meet any of the above
2. Previous NSRCT
3. Previous pulpotomy or pulpectomy
Respiratory Rate Validation Study - HiCardi+ Wearable Patch Device, Mezoo Co., Ltd.

The purpose of this study is to analyze the accuracy of respiratory and breathing patterns generated through impedance changes generated by a patch-type electrocardiogram device (HiCardi+ wearable patch device, Mezoo Co., Ltd.), targeting patients undergoing pulmonary function testing and ventilator application.

Subjects The target number of participants for this study is 211, consisting of 181 patients undergoing pulmonary function testing and 30 patients using a ventilator.

* Spontaneous breathing subjects (181 patients): Assuming that a pulmonary function testing examiner with spontaneous breathing would examine about 50 patients per day, a total of 181 subjects will be targeted, taking into consideration the possibility of refusals.
* Non-Spontaneous breathing subjects (30 patients): In addition, in the case of patients with a Richmond Agitation Sedation Scale of -4 to -5 who use a ventilator and do not have spontaneous breathing, the final 30 subjects will be conducted for the purpose of data collection for about 6 hours.

Focus of the study The tidal volume and respiratory amplitude will be analyzed in detail through pulmonary function tests, and the respiratory rate will be analyzed through ventilator data.

Study method The study method is as follows: In the pulmonary function testing room, consent will be obtained from patients undergoing pulmonary function testing, and a patch-type electrocardiogram device will be attached before the test is conducted. The records of the ECG patch generated during the approximately 30-minute pulmonary function test and the results of the pulmonary function test will be acquired. Based on the impedance obtained from the patch-type electrocardiogram, the pulmonary function test results are extracted as the reference data related to the respiratory pattern. Correlation analysis is performed on the tidal volume and respiratory amplitude obtained through this comparison. Additionally, Bland-Altman analysis is conducted on the validation set, which is divided into an 8:2 training set and validation set, for the algorithm that predicts tidal volume and respiratory amplitude.

For patients with RASS -4 to -5 who are on a ventilator, the patch-type electrocardiogram device is attached for about 6 hours after the consent of the patient caregiver, and the data generated from the ECG patch and the ventilator are compared and analyzed. Based on the impedance obtained from the patch-type electrocardiogram, the data from the ventilator will be used as reference data related to respiratory rate. Mean Difference (MD), Standard Deviation (SD), degrees of freedom (df), bias, regression, and limits of agreement will be calculated through correlation analysis and Bland-Altman analysis on the obtained respiratory rate.

Eligibility Criteria:
Inclusion Criteria:

* Adults 19 and older

Exclusion Criteria:

* patients under the age of 19
* patients cannot apply the patch-type electrocardiogram device due to physical defects or contact allergic reactions
* patients do not consent to participate in the study
Clinical Evaluation of an Apnea Index for Diagnosis and Screening of Obstructive Sleep Apnea (OSA)

The study is designed to compare the apnea event recognition capability of the Capnostream 20 with investigational software to polysomnograph recordings scored by a trained analyst. The study will compare the apnea index score (AI) calculated by the Capnostream 20 algorithm based on capnography to that calculated by a trained analyst evaluating polysomnograph recordings.

To this aim, subjects will be connected to EMBLA N7000 Polysomnograph, and to the Capnostream 20, in order to monitor CO2 and SpO2 during routine overnight sleep studies.

The Capnostream, using both its USB Data Port and Analog output port will simultaneously provide the monitored data both to a USB flash memory device and Polysomnograph for storage for future analysis.

The data collected by the Polysomnograph including the Capnostream data will be analyzed by a trained expert for evaluation of apnea events obtained from both sources.

In parallel, the Capnostream data as collected with the USB flash memory, will be downloaded onto a PC, and using the Oridion software algorithm designed for evaluating the data (to be implemented in the monitor when validated), the Apnea Index and Oxygen Desaturation Index will be calculated. The results of the Apnea Index scores calculated from the Polysomnograph and from the DUT will be compared.

Based on the results, the study will then evaluate the ability of the Capnograph/Pulse-Oximeter as a tool for screening and assisting in the diagnosis of patients with obstructive sleep-apnea in the hospital environment, where it is being used as a ventilation monitor based on the demonstration of a high correlation with the gold standard in the sleep lab.

The clinical investigation will be conducted until enrollment of at least 30 adult and 30 Pediatric patients of both sexes with complete data sets are collected from three different sleep lab sites per the FDA guidance requirements. The enrollment time will last up to six (6) months. The overall number of enrolled patients (i.e. with complete/incomplete data) will not exceed 80 patients.

Eligibility Criteria:
Inclusion Criteria:

* All Adults \> 18 years old and able to understand and give consent per the IRB or a child above one years old consented by a parent or legal guardians.
* Patients consented or for whom legal guardians consented for the participation of this trial.
* Patient recommended for a Sleep assessment by medical staff.

Exclusion Criteria:

* Patients who in the opinion of the investigator should not participate.
Post-traumatic Neuropathy of the Trigeminal Nerve

This is retrospective research mainly aims to determine the patterns of symptoms, clinical and radiological findings and outcomes in patients with trigeminal neuropathy following trauma or iatrogenic damage and how this translates into costs for the patient and society, work disability and medication use.

The trigeminal nerve and its branches are at risk of damage during multiple dental and maxillofacial procedures: endodontics, extractions, removal of wisdom teeth, implant placement, use of local anaesthesia, orthognatic surgery.

In the event of damage to these nerve branches, there is a high risk of developing a neuropathic pain that is considered very disabling for patients and that interferes with daily activities (eating, drinking, speaking, kissing, etc.). Moreover, there are few medicinal or surgical techniques available to eliminate neuropathy or reduce the symptoms.

Causal procedures (e.g. the removal of wisdom teeth) are among the most frequently performed surgical procedures. The number of injuries increases every year, partly due to an increase in dental procedures. The often relatively minimal intervention combined with the major impact of these injuries on the patient's quality of life sometimes leads to medico-legal actions. The limited symptom control with current therapies of these post-traumatic neuropathies of the trigeminal nerve causes frustration and impotence in both the patient and the attending physician, which can also lead to medical shopping.

Based on chart analysis, this study will examine the causes, possible risk factors and presenting symptoms, how this is reflected in clinical research and examinations, and which treatments are being instituted. Patient records from the Oral and Maxillofacial Surgery department between January 2010 and October 2018 will be checked. In addition, we wish to check the costs incurred by these patients as well as the work disability. To this end, a collaboration is being organised with Christian Mutuality (CM), the largest health insurance provider in Belgium.

In order to increase the power of the study, the clinical data from the already coded, retrospective dataset of Prof. Tara Renton, co-investigator, will be transferred to the dataset of this new study.


Eligibility Criteria:
Inclusion Criteria:

* Presentation with post traumatic, iatrogenic, injury of the trigeminal nerve or its branches (eg. inferior alveolar nerve, lingual nerve)
* Iatrogenic nerve injury caused by M3 removal, implant placement, orthognathic surgery, endodontic therapy, non-M3 removal, local anesthesia injection, trauma.
* Clinical diagnosis of neurosensory deficit in the distribution of the trigeminal nerve caused by a previous dental or maxillofacial procedure in the vicinity of the affected branch.

Exclusion Criteria:

* Neuropathic pain in another region than the trigeminal nerve
* Neuropathic pain not caused by iatrogenic injury
Effects of Transcranial Direct Current Stimulation on Pain Perception

The purpose of this study is to determine whether a new medical technology can temporarily alter pain perception. The new technology is called Transcranial direct current stimulation (tDCS).

Healthy subjects underwent thermal pain tolerance testing pre- and post intervention. The intervention includes either anodal, cathodal, or sham tDCS for 20 minutes during a pain cognitive intervention \[either brief cognitive intervention (BCI) or general pain education\]. The tDCS brand was the Phoresor-II Auto (Model PM850, Iomed, Salt Lake City Utah, USA) and the current was set to 2.0mA. Electrodes were 4x4 cm sponge electrodes soaked in sterile saline. For anodal and cathodal tDCS, One electrode was placed over the left DLPFC (F3 from the EEG 10-20 system) located via the Beam F3 measurement system and the other electrode was attached to the right shoulder. For sham tDCS, the device was turned on for 30 seconds to temporarily mimic tingling and skin sensations of real tDCS and then ramped-down to 0mA for the duration of the 20-minute session.

Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria:

* 100 Health Individuals recruited from Charleston ,SC

Exclusion Criteria:

* Can not be pregnant
* No history of Depression, chronic pain, Seizers, suicidal implanted metal devices, history of brain surgery, loss of consciousness.