cyrilzakka/clinical-trials huggingface dataset:
Safety and Performance Evaluation of CircuLite Synergy

The purpose of the study is to demonstrate the safety and functionality of the CircuLite Synergy Pocket Circulatory Assist Device.

The CircuLite Synergy Pocket Circulatory Assist Device is an implantable miniature, mixed-flow blood pump designed o provide partial left ventricular support in patients with advanced heart failure. Treatment for this patient population currently include lifestyle changes, medicines, transcatheter interventions and surgery, including implantation of mechanical ventricular assist devices (VADs); most of the currently available VADs require highly invasive, high-risk surgical procedures to implant due to large device size, and are therefore generally limited to use in patients with terminal heart failure. The Synergy pump is intended for treatment of patients with New York Heart Association (NYHA) Class III and IV heart failure; it is expected that the pump will provide these patients with 2-3 L/min of additional blood flow, giving adequate cardiac support to increase exercise tolerance and improve patients' quality of life. The pump's small size will allow it to be implanted in a less surgically invasive procedure than used with previous VADs, which should result in a reduction of perioperative morbidity. The device wil be implanted in a left atrial to subclavian artery bypass with the pump being located in the infraclavicular fossa like a pacemaker.

Eligibility Criteria:
Inclusion Criteria:

* Maximum tolerable medical therapy including ACE inhibitors and Beta Blockers
* NYHA Class III or IV despite maximal tolerable medical therapy
* Ambulatory (inpatient or outpatient)
* Patients on the heart transplant list (or, not currently listed but otherwise suitable for heart transplant)
* Life expectancy of at least 6 months without full VAD support

Exclusion Criteria:

* Age \>75 years
* Exercise tolerance limited by factors other than heart failure
* Presence of intra-atrial thrombus
* Clinically significant right heart failure
* Serum creatinine \>/= 2.5 mg/dl or any dialysis in previous 3 months
* Evidence of intrinsic hepatic disease
* Previous episode of resuscitated sudden death without subsequent treatment with AICD
* Subclavian artery stenosis
* Low platelet count, INR that cannot be corrected prior to implant or contraindication to anticoagulation
Single-use Versus Reusable Gastroscopes in Patients With Upper Gastrointestinal Bleeding.

Controlled-randomized trial evaluating single-use versus reusable gastroscopes in patients with upper gastrointestinal bleeding.

Acute upper gastrointestinal bleeding is a common medical emergency. According to guidelines, endoscopic evaluation should be performed within 24 hours. With an overall high incidence and an overall high number of diagnostic and therapeutic endoscopic procedures, the introduction of new endoscopic concepts may have a profound impact on outcomes as well as cost-effectiveness in upper gastrointestinal bleeding. For this purpose, the use of single-use gastroscopes represents an interesting possibility. Hygiene issues in the emergency situation are also relevant. The previous feasibility study One-Scope I demonstrated that the diagnosis as well as the therapy of upper gastrointestinal bleeding is possible with single-use gastroscopes. In this follow-up study, the investigators compare the use of single-use versus reusable gastroscopes in participants with suspected upper gastrointestinal bleeding in a randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* Glasgow-Blatchford score (GBS) \>2
* Clinical signs of upper bleeding

Exclusion Criteria:

* pregnancy
* Unable to provide consent
Comparision Of The Effectiveness Of Physiotherapy Methods

A total of 28 patients who were followed-up in our clinic and received botulinum toxin injection of lower extremities in the last month were randomized to two groups in the study. Group 1 received conventional physiotherapy and Group 2 received robot-assisted gait training. The treatment period was 30 min/day, five sessions in a week, 15 sessions in total, for both groups. The study population was evaluated using range of joint motion evaluation chart, the Modified Ashworth Scale, The Gross Motor Function Classification System, The Berg Balance Scale, the functional independence measure for children, and the Edinburgh Visual Gait Score

A total of 28 patients who were followed-up in our clinic and received botulinum toxin injection of lower extremities in the last month were randomized to two groups in the study. Group 1 received conventional physiotherapy and Group 2 received robot-assisted gait training. The treatment period was 30 min/day, five sessions in a week, 15 sessions in total, for both groups. The study population was evaluated using range of joint motion evaluation chart, the Modified Ashworth Scale, The Gross Motor Function Classification System, The Berg Balance Scale, the functional independence measure for children, and the Edinburgh Visual Gait Score.

Eligibility Criteria:
Inclusion Criteria:

* Aged 4\>, \<16 with CP diagnosis
* Walking diffculties due to the spasticity of lower extremities,
* Level I-IV on the Gross Motor Function Classification System.

Exclusion Criteria:

* MAS Level IV spasticity, contractures, or rigidity in the lower extremities,
* A limb length inequality of \>2 cm,
* Hypotonic CP,
* Having drug-related refractory epilepsy,
* Undergoing intrathecal baclofen pump surgery,
* Surgical interventions in the lower extremities in the last year,
* Scoliosis angle of \>30°,
* Complicated osteoporosis (nontraumatic fracture...),
* Cardiovascular instability,
* GMFCS Level V,
* Metabolic disorder, genetic disease, neurodegenerative and neuromuscular diseases.
New Findings About Somatosensory Evoked Potentials (SEP) During Surgery for Cerebral Aneurysms

During surgery, electrophysiological signals will be acquired with the instrument (ISIS IOM, NeuroExplore, Software Version 4.4, Inomed) already in use at the Neurosurgery Service of the Neurocentro of the Hospital Civic Italian Switzerland in Lugano. Simultaneously to Somatosensorial Evoked Potential (SEP) will also be recorded the Electroencephalography (EEG) activity with the same detection of locations.

For the purposes of the study the signals transmitted to the neurosurgeon through the hardware and the corresponding assessments done by the neurophysiologist responsible for intraoperative monitoring will be recorded. It will also be kept track of procedures performed during surgery.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Patient bearer of a not broken cerebral aneurysm, which has been defined per size and morphology susceptible to surgery
* Aneurysms located on cerebral arteries of the anterior circulation (carotid, middle cerebral arteries, anterior cerebral, anterior communicating, pericallose); Cases of multiple aneurysms are also eligible
* Informed consent for participation in the study

Exclusion Criteria:

* Patient with an aneurysm of the posterior circulation (vertebrobasilar system)
* The aneurysm was a source of bleeding (subarachnoid hemorrhage, intracerebral, intraventricular).
* Patient with a pace-maker (for the risk that the electric currents used in the study could compromise the operation of the pace-maker)
Evaluations of Optimizing Perioperative Fluid Management on Postoperative Pain Outcomes

Patient characteristics, duration of surgery, and infusion volumes will be compared between the groups. Oxygen transport and organ function will be compared Length of hospital stay, morbidity, postoperative pain intensity were compared. Continuous variables will be analyzed using the student t-test and discrete variables will be analyzed using Chi-Square test. P-value \<0.05 will be considered significant, where appropriate 95% confidence intervals will be calculated. Statistical analysis will be carried out using standardize statistical programs SPSS 12.0 for windows.


Eligibility Criteria:
Inclusion Criteria:

* All patients are undergoing elective spine laminectomy

Exclusion Criteria:

* age \<20 yr
* emergency surgery
* coagulopathy
* renal and hepatic dysfunction
* hyperthyroidism, and cardiac rhythm other than sinus rhythm
Personalized Medicine Using Coronary Microvascular Function Measured in Patient With Percutaneous Coronary Intervention in Angina

The evidence demonstrating the importance of coronary microcirculation in the management of patients with coronary artery disease is growing. For example, in recent years, a number of studies have demonstrated that the presence of coronary microvascular disease (CMVD) contributes to increased cardiovascular morbidity and mortality independent of the extent and severity of coronary epicardial disease. The index of microcirculatory resistance (IMR) is an invasive index proposed for the diagnosis of CMVD. The ability of IMR to motivate therapeutic changes in order to subsequently reduce symptoms and improves the quality of life of our patients with stable coronary artery disease (CAD) was recently demonstrated. The prognostic value of IMR has also been shown in stable CAD with PCI. Thus, after optimal epicardial evaluation and if necessary revascularization according to FFR, IMR could represent a tool for personalized medicine adapted to the presence of severe CMVD.

The aim of the study is to demonstrate a positive effect of personalized medicine on angina in patients with epicardial coronary network lesion assessment by FFR and with significant CMVD assessed by IMR.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years
* Symptomatology of angina pectoris
* Receiving invasive coronary angiography
* FFR and microcirculatory resistance index (MRI) measurement for at least one epicardial lesion ≥ 50% :
* For lesions with FFR ≤ 0.8, revascularization with the XIENCE Sierra stent and its evolutions will be performed. Optimization of this epicardial revascularization will be evidenced by a post-PCI FFR \> 0.8 on all major trunks and if an FFR measurement is not performed, absence of 50% or greater stenosis on two orthogonal views by quantitative coronary angiography \[QCA\] at the revascularization site.
* For lesions with FFR \> 0.8 revascularization will not be performed
* Written informed consent

Exclusion Criteria:

* A non-coronary indication for coronary angiography, e.g. valve disease, hypertrophic obstructive cardiomyopathy.
* Severe renal dysfunction (GFR \< 30 ml/min)
* Contraindications for adenosine: asthma, Second or third degree AV block without pacemaker or sick sinus syndrome, Systolic blood pressure less than 90 mm Hg, Recent use of dipyridamole or drugs containing dipyridamole, Methyl xanthenes such as caffeine aminophylline or theobromine block the effect of adenosine and should be stored at least 12 hours before testing, Known hypersensitivity to adenosine.
* Pregnant women, parturients and breastfeeding mothers
* Persons of full age who are subject to a legal protection measure or who are unable to express their consent
* Patient in a period of exclusion from another study
* Patient under administrative or judicial supervision
Effect of Acupuncture on Incomplete Fallopian Tube Obstructive Infertility: Study Protocol for Trial

Acupuncture is one of the traditional Chinese practices widely used in China for more than 3000 years. In recent years, the use of acupuncture within infertility has gained popularity all over the world, but there is no research describing the use of acupuncture in infertility of incompletely obstructive fallopian tube. In this paper, we present a research design evaluating the effects of acupuncture on incomplete fallopian tube obstructive infertility. This is a randomized, control acupuncture and signal-blind trial. A total of 120 patients will be enrolled in this study and will be randomized into two groups. True acupuncture plus hydrotubation or control acupuncture plus hydrotubation will be performed for 12 weeks. The purpose of this paper is to evaluate the additional value of acupuncture on the tubal patency rate and pregnancy rate beyond Hydrotubation ,therefore to guide clinical.


Eligibility Criteria:
Inclusion Criteria:

* I.Patients between 22 and 42 years of age with infertility II.diagnosis of incomplete Fallopian tube obstruction based on one of the following conditions: a. Tubal patency test: Hydrotubation , Hysterosalpingography (HSG) or Hysterosonosalpingography (HSS) shows incomplete bilateral Fallopian tube obstruction b. Hysteroscopy: Hysteroscopic tubal cannulation hydrotubation proves bilateral tube incompletely patent. c. Laparoscopy: incomplete bilateral tubal obstruction can be displayed by the methylene blue solution through the tubes III.Other relative treatments are not carried out within two weeks IV.willing to cooperate with us V. mean infertility time is 1-5 years.

Exclusion Criteria:

* I.allergic constitution or be allergic to diatrizoate or a variety of drugs II.the infertility is not leaded by tubal obstruction ,such as Congenital Physiological defects or malformation, genetic factors, immune factors and endocrine factors III.diagnosed with uterine lesions by auxiliary examinations (endometriosis ,adenomyosis , hysteromyoma or cancer and so on ) and infertility caused by tubal tuberculosis IV. infertility factor in their male partner V.people with Serious primary diseases of cardiovascular, liver, kidney and hematopoietic systems ,patients with mental illness VI.unable to judge the therapeutic efficacy or incomplete information VII.complete bilateral tubal obstruction VIII.bilateral tubes patent IX.Not willing to give written consent to the study X. people who are pregnant XI.people with acute infection .
Cholesterol Metabolism in Plasma and Interstitial Fluid Among Subjects Undergoing Hemodialysis.

Because the atherosclerosis process partly occur in the intercellular space of the vessel wall, the determination of the constitution of lipoproteins in the interstitial fluid may expand the knowledge about the atherosclerosis process and lead to a better understanding of what constitutes the increased risk of developing cardiovascular disease in patients with chronic diseases. The investigators hypothesize that the apoB-containing particles in T2D patients are more susceptible to be retained or consumed in the intercellular compartment, which in turn could be one explanation for the elevated risk of atherosclerosis. The investigators hypothesise that with the progression of chronic kidney disease this process is further increased. Patients undergoing dialysis are known to have a very high risk of cardiovascular disease. The investigators now want to study the cholesterol metabolism in interstitial fluid in subjects undergoing hemodialysis because of diabetic nephropathy and in subjects undergoing hemodialysis because of chronic kidney disease of other causes.


Eligibility Criteria:
Inclusion Criteria:

Diabetic nephropathy, because of type 2 diabetes, undergoing hemodialysis and subjects with chronic kidney disease of other causes undergoing hemodialysis.

Exclusion Criteria:

* Active infection that increases the risk of secondary infection in the skin where the vesicles containing interstitial fluid have been emptied of interstitial fluid with a fine needle and the bladder roof is intact.
* Treatment with Warfarin due to increased risk of Calciphylaxis (calcific uremic arteriolopathy, CUA)
Role of Cysteinyl Leukotrienes in the Pathogenesis of Asthma in Obesity

The purpose of this study is to examine whether there are higher levels of cysteinyl leukotrienes in obese subjects than in non-obese subjects. Cysteinyl leukotrienes are pro-inflammatory substances that cause asthma by narrowing the airways of the lung. The investigators want to see if subjects with increased fat stores and therefore increased leptin, which is a fat-related protein that regulates leukotrienes, have increased levels of leukotrienes in the blood, lung and urine. The investigators would also like to determine the relationship between cysteinyl leukotrienes and exhaled nitric oxide levels in asthmatics with and without obesity. Nitric oxide is anti-inflammatory and suppresses leukotriene synthesis.

This is a cross-sectional observational study to characterize the association between obese asthmatics and the inflammatory mediators cysteinyl leukotrienes. Our hypothesis is that altered adipokine levels in obesity result in augmented cysteinyl leukotriene synthesis that play a significant role in the pathogenesis of asthma in these subjects.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 yr old adults with asthma, non-smoking for at least one year
* Healthy non-smoking adults, aged 18-65 without asthma
* Heavy subjects with BMI \> 30 kg/m2
* Subjects with normal weight (BMI between 20-25 kg/m2)
* Subject not taking anti-leukotriene therapy (Singulair, Accolate, Zyflo)

Exclusion Criteria:

* No chronic oral steroid use
* No recent history of infection
* No recent history of flare of lung disease
Phenotyping Mechanistic Pathways for Adverse Health Outcomes in Sleep Apnea

Obstructive sleep apnea (OSA) is a highly prevalent disorder with adverse neurocognitive and cardio-metabolic outcomes. Continuous positive airway pressure (CPAP) is the gold standard therapeutic option to treat airway obstructions during sleep and thus, prevent its adverse cardiovascular and neurocognitive outcomes. Previous clinical trials, however, have largely failed to show a consistent impact of CPAP on these health outcomes.

One of the main limitations of these trials may be the inadequate characterization of OSA and its acute physiological consequences. By characterizing OSA based on the "apnea-hypopnea index (AHI)", there is a potential risk of negative results.

In this trial, the investigators intend to tackle this issue, by better characterization of OSA-related physiological consequences during sleep using physiologically driven metrics to capture the burden of OSA-related hypoxemia ("hypoxic burden"), autonomic response ("heart rate burden"), and sleep fragmentation ("arousal burden").


Eligibility Criteria:
Inclusion criteria:

* Adults aged 21-80 years.
* Participants with a previous diagnosis of moderate to severe obstructive sleep will be eligible to enroll and attend the baseline study. Patients with a total apnea-hypopnea index greater than 15 events/hr on the baseline study will be eligible for further participation.

Exclusion criteria:

* Current treatment for obstructive sleep apnea (including CPAP, oral appliances, supplemental oxygen). Patients must be untreated prior to the baseline visit.
* Use of medications that might depress respiration (including opioids, barbiturates, benzodiazepines, and Z drugs, including zolpidem, zopiclone, eszopiclone, and zaleplon).
* Active use of non-prescription opioids (e.g., cocaine, methamphetamine)
* Uncontrolled medical problem or major organ system disease, which, in the opinion of the investigators (PI and Co-Is), would interfere with the evaluation of the subject (e.g., uncontrolled hypertension, unstable coronary heart disease, etc.).
* History of congestive heart failure, renal insufficiency, systemic neurological condition that could affect respiration.
* Sleep disordered breathing or respiratory disorders other than obstructive sleep apnea:

  * central sleep apnea (\>50% of respiratory events scored as central),
  * chronic hypoventilation/hypoxemia (awake SaO2 \< 92% by oximetry) due to chronic obstructive pulmonary disease or other respiratory conditions.
* Other sleep disorders: periodic limb movements (periodic limb movement arousal index \> 10/hr), narcolepsy, or parasomnias.
* Patients unable or unwilling to use CPAP.
* Insomnia or insufficient sleep (self-reported inability to sleep \>6 hrs night).
* Pregnancy (women)
Biomarkers in the Retina for Prognosticating Mental Health Treatments

Title: ERG as a potential biomarker of SSRI-responsive PTSD: A pilot study

Posttraumatic stress disorder (PTSD) affects many individuals who experience a traumatic event. Previous studies suggest that there is a connection between the brain and the retina, and that the electroretinogram (ERG) may be a valuable biomarker to tell us more about signals in the brain that are related to mental health disorders like PTSD. The goal of this observational study is to examine the ERG waveform in veterans with PTSD before and after a single dose of the selective serotonin reuptake inhibitor (SSRI), sertraline. Sertraline is one of two FDA-approved medications for the treatment of PTSD. The main questions this pilot study aims to answer are:

1. How does sertraline, an SSRI, influence the ERG waveform in veterans with PTSD?
2. Is there a significant correlation between baseline ERG signals and the change in ERG following SSRI treatment?

Participants will be asked to:

* Undergo ERG recordings before and after a single dose of sertraline.
* Provide relevant clinical information related to PTSD symptoms and treatment history.

Following the initial study visits, participants will enter an optional open label phase of the study in which qualifying participants who initiate antidepressant treatment through routine clinical care will be invited back for a follow-up ERG recording.

In this study, individuals will undergo an assessment that includes taking a history of their previous exposure to traumatic events, an assessment of current mental health symptoms including those associated with PTSD, and an assessment of physiologic measures, including ERG as well as vital sign measurements, blood draw, and saliva sampling. Participants will be given a single dose of sertraline (50mg), and a repeat ERG will be administered. An optional open label phase of the study will follow, in which participants who undergo treatment with an antidepressant will be invited back for a follow-up assessment with repeat ERG.

Eligibility Criteria:
Inclusion Criteria:

* Veteran of the U.S. Armed Forces
* Current diagnosis of PTSD

Exclusion Criteria:

* Known diagnosis of a primary psychotic or major neurocognitive disorder
* Significant bilateral visual loss
* History of acute angle closure glaucoma
* Known inherited retinal disease
* Previous ERG deficits
* Known photosensitive epilepsy
* Known current pregnancy or lactation
* Allergy or previous adverse reaction to sertraline or SSRI
* Allergy to Sensor Strip gel
* Hepatic failure
* Damage to orbit structure or open lesion in soft tissue surrounding the eye
* Any use in the time period of at least 6 half-lives prior to baseline of sertraline or other drugs acting on serotonin and/or unwillingness to avoid these medications for the duration of the study.