cyrilzakka/clinical-trials huggingface dataset:
Reduction of Inappropriate Shocks of Implantable Cardioverter Defibrillators (ICDs) With Enhanced SVT Discriminators

The purpose of this clinical investigation is the continued assessment of the decision accuracy of St. Jude Medical (SJM) ICD with enhanced SVT discriminators in the treatment of subjects with primary and secondary prevention of sudden cardiac death.

With Ellipse™ and Fortify Assura™ ICD family, St. Jude Medical introduced enhanced device algorithms that may be helpful to further improve SVT discrimination success: SecureSense™, Far field morphology, Chamber Onset. These algorithms in combination with a tailored device setting (primary or secondary prevention) will be prospectively investigated within this trial.

Eligibility Criteria:
Inclusion Criteria:

* Ischemic or nonischemic cardiomyopathy
* Primary prevention or secondary prevention of Sudden cardiac death (SCD)
* Indication for ICD/CRT-D new implantation per current guidelines (1, 2, 3-chamber)
* The patient is ≥ 18 years of age
* The patient is able to understand the patient information and is capable to provide informed consent.
* The patient has provided written informed consent prior to any investigational related procedure

Exclusion Criteria:

* Previously implanted ICD/CRT-D
* Hypertrophic (with or without obstructive) cardiomyopathy
* Ion channel disorders (Long/Short-QT, Brugada syndrome etc...)
* New York Heart Association (NYHA) Class IV
* Recent cardiac decompensation (within previous 3 months)
* The patient is unable to comply with the follow up schedule.
* The patient is participating in another investigational device or drug investigation.
* The patient is pregnant or is planning to become pregnant during the duration of the investigation
Effects of Photobiomodulation in Children With Down Syndrome and Possible Sleep Bruxism

The main characteristic of an individual with Trisomy 21 (T21), commonly known as Down Syndrome (DS), is muscular hypotonia, a characteristic that mainly affects the masticatory and oropharyngeal muscles, resulting in impairments in speech, swallowing, breathing and chewing, in addition to pain, noise and/or degeneration in the temporomandibular joints (TMJ), therefore, developing bruxism. The gold standard for the treatment and control of bruxism is the rigid plate, however, there is difficulty in developing treatment in children and adolescents with T21, therefore, photobiomodulation is a non-invasive intervention alternative already consolidated as an excellent option for modulation in muscle tissues. This study sought to evaluate the efficacy and safety of non-invasive intervention with red LED clusters for the control of bruxism in children and adolescents diagnosed with Down Syndrome. The present study is characterized as a pilot study, composed of individuals of both sexes, aged 4 to 17 years old, attended at the UNINOVE integrated health clinic and diagnosed with Down syndrome and bruxism. The treatment was carried out in a total of four sessions, one session per week, where in each session the LED plates were applied and post-application electromyographic collection was carried out.


Eligibility Criteria:
Inclusion Criteria:

* Children and adolescents with a diagnosis of Down syndrome
* Four to 17 years of age
* Bruxism, based on parental reports of the occurrence of grinding the teeth, incisal and/or occlusal tooth wear following the criteria of the American Academy of Sleep Medicine (AASM) and the questionnaire for the evaluation of bruxism validated by Serra Negra et al. (2014) and a systematic review performed by Manfredini et al. (2013).

Exclusion Criteria:

* Use of muscle relaxant
* Temporomandibular disorder
* Undergoing other therapy for bruxism
* Other associated neurological diseases
* Cognitive deficit that impedes understanding the evaluations.
Benefits of Coding Training on Young Adults with Developmental Disabilities

The purpose of the present study is to develop and evaluate the Technology Early Career Preparation Intervention (TECH-Prep) program with African American high school students with developmental disabilities. Developmental disabilities include conditions such as Autism spectrum disorders, seizure disorders, behavior disorders, brain injury, cerebral palsy, Down syndrome, and fetal alcohol syndrome/effects. This program is designed to increase technology career interests, self-efficacy, outcome expectancy, goal persistence, and increase entrance into post-secondary education or work subsequent to high school completion of African American youth with developmental disabilities.

The investigator's goal is to recruit 30 African American high school students with developmental disabilities to participate in this TECH-Prep study each year for the next five years (2019-2024). The TECH-Prep program integrates many empirically supported strategies identified in the STEM education and the secondary transition research literature. The program will incorporate overview of coding careers, reviewing video testimonials of individuals working in technology fields, and reviewing/responding to training materials intended to facilitate workplace social skills development.

The program will require participants complete three surveys to track their progress. To receive incentives for completing program components, data on program component completion will be tracked of participants in the treatment group. This involves tracking data on when a participant completes review of the final segment of each learning module.

Data collection for this study will consist of three surveys completed at baseline, immediately after completion of the program, and six weeks after completion of the program.

Eligibility Criteria:
Inclusion Criteria:

* Individuals of diverse racial and cultural backgrounds
* Diagnosed with a developmental disability
* Over 18 but under 24
* Have the capacity to provide informed consent

Exclusion Criteria:

* Persons who are Caucasian
* Do not have a developmental disability
* Older than 24 years of age
* Unable to provide informed consent
Role OF Geometric Mean in Estimation OF Differential Renal Function in DMSA Scintigraphy

Renal scintigraphy is an imaging method that uses small amount of radioactive materials called radiotracers, a Gamma camera and a computer to evaluate kidney functions and its anatomy.

The relative renal function (RRF), expressed as a percent of total renal function, is important in the initial assessment and treatment of patients having renal diseases. RRF has traditionally been measured by radionuclide renal scintigraphies using different tracers for a long time . Different radiopharmaceuticals such as technetium-99m-diethylenetriaminepentaacetic acid (99mTc-DTPA), technetium-99m-dimercaptosuccinic acid (99mTc-DMSA), technetium-99m-mercaptoacetyltriglycine (99mTc-MAG3).

99mTc-DMSA is a static agent that is actively taken up by the proximal and distal renal tubular cells, directly from the peritubular vessels and accumulates in the renal cortex. Its binding level to protein in mammals is 90% which prevents significant glomerular filtration. DMSA renal scan images provide a good definition of the cortical outline, as well as they show the relative distribution of functional tissue.

Determination of the left to right dimercaptosuccinic acid (DMSA) uptake ratio is theoretically one of the easiest quantitative procedures in nuclear medicine. The quantification can be performed on the posterior view, with or without the lateral view for correction of kidney depth. The geometric mean can also be determined using both the anterior and the posterior views.


Eligibility Criteria:
Inclusion Criteria:

* Patients referred for renal DMSA scintigraphy
* Patients aging 2 to 70 years

Exclusion Criteria:

* Single kidney patients
* Patients with a major uncontrollable medical illness.
Erector Spinae Plane Block Versus Thoracic Paravertebral Block for Pain Control in Modified Radical Mastectomy

The aim of the study is to compare the effectiveness of the Erector spinae plane (ESP) block versus thoracic paravertebral (TPV) block in the post-operative pain control after radical mastectomy.

Primary outcome of our study is to compare the effectiveness of two regional anesthesia techniques, ESP block and TPV block, in the post-operative pain-control after radical mastectomy.

We will also evaluate both intra and post-operative opioid consumption, the incidence of PONV, the length of hospital stay, patient satisfaction with the anesthesiology technique and the incidence of chronic pain 6 months after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 18 and 85
* American Society of Anesthesiologists classification I - III
* Signature of consent to participate in the study

Exclusion Criteria:

* Coagulopathies and / or use of antiplatelet / anticoagulant drugs
* Infections and/or lesions at the puncture site,
* BMI ≥40
* allergies and / or contraindications to the administration of the drugs used in the study,
* use of chronic opioid therapy
Medication Adherence in Children Who Had a Liver Transplant

The purpose of this study is to evaluate the use of a novel method to measure adherence to immunosuppressant medications in predicting rejection episodes in children who had a liver transplant.

During the course of their illness as many as 50% of children who had a liver transplant stop taking their medications. Non-adherence is the most important reason for organ rejection in long term survivors of pediatric liver transplantation. In order to address this important risk-factor effectively, the first step is to evaluate a method that would identify non-adherence in these children. Medication blood levels that are obtained as a part of clinical practice in transplant centers can be used to determine whether the patient is adherent or not. This multi-center observational study tests the ability of an objective measure of adherence to immunosuppressant medications that involves the use of routinely obtained tacrolimus blood levels to predict organ rejection in children who had a liver transplant.

Eligibility Criteria:
Inclusion Criteria:

* The patient is between \> 1 year of age and less than 18 years of age at enrollment
* Guardian's consent, child assent (in accordance with each institution's IRB policies).
* The patient is prescribed tacrolimus (either brand or generic formulation).
* The patient has been seen in the enrolling center's clinic at least once in the last two years.

Exclusion Criteria:

* The patient received a liver transplant less than 1 year prior to enrollment.
* The patient has had more than one solid organ transplant (including marrow replacement).
* The patient has had biopsy-proven rejection within the past six months.
* The patient has been diagnosed with Hepatitis C.
* The guardian or child (in a developmentally-appropriate manner) do not understand the study procedures. This will be verified by asking both guardian and child (if 6 years old or older) to repeat the study procedures.
* The patient is only seen for consultation - most or all of the child's routine care is provided at another center (or in a community clinic).
* Either the patient or the guardian is actively psychotic or severely disoriented due to any cause, including hepatic encephalopathy (temporary exclusion) or severely mentally retarded as defined in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV).
* The patient is not medically stable or is hospitalized.
* The treating physician has instructed the participant not to obtain tacrolimus levels for at least one year.
Age-related Changes in Sleep-wake Regulation

A sleep deprivation protocol combined with state-of-the-art, simultaneous positron emission tomography and magnetic resonance spectroscopy imaging will be employed to investigate the effects of sleep deprivation and aging on hypothesized molecular markers of sleep need.


Eligibility Criteria:
Inclusion Criteria:

* healthy male individuals
* age: 20-35 or 60-70 years
* right-handed
* non-smokers
* moderate caffeine/alcohol consumption
* normal BMI

Exclusion Criteria:

* Sleep/circadian rhythms disturbances
* former brain injuries with loss of consciousness and brain anomalies
* drug intake/consumption
* medication intake
* cardiac pacemaker
* neurological disorders
* prior participation (during past 2 years) in radiological or nuclear experiment
Neurofeedback Removal of Emotional Information From Mind

This project will examine whether individuals can be trained, using real-time feedback about brain function during neuroimaging, to effectively remove thoughts from mind by providing them with a sense of what it feels like to successfully remove a thought.

On the first day, an anatomical MRI scan will be followed by a 12-min resting state scan, a 30-min item localizer task in which participants view a set of 80 scene stimuli 3 times each, and a 10-min memory test outside the scanner. The brain data from the localizer will be used to identify baseline measures of item-specific brain activity patterns. On 3 subsequent days (within the next 2 weeks), participants will receive neurofeedback training. In each 1-hr session, an anatomical scan will be followed by 8 runs (5 min each) of 20 trials, half with each operation, randomly ordered, and a 10-min behavioral memory test. In the scanner, participants will perform a working memory task in which they encode a scene image and then are instructed to either maintain that image in mind for a few seconds or to suppress that image from mind. At the end of each trial, neurofeedback will be provided to the participant visually to denote their "level of engagement" in the instructed operation on that trial. The neurofeedback is derived from the MRI classifier fit for the instructed operation (maintain or suppress) from a working memory operation classifier that is pre-trained on prior data. Participants (N=40) will be randomly assigned to either the positive or negative valence condition. They will encounter stimuli from their assigned valence only during the neuroimaging task, but from both valences during the behavioral tests, so that the investigators can evaluate whether any learning generalizes across emotional valence.

Eligibility Criteria:
Inclusion Criteria:

* Right-handed
* Speak English fluently
* Minimum 8th grade education
* Good hearing
* Good vision or minimal correction with contacts or eyeglasses

Exclusion Criteria:

* History of significant illnesses (including cardiovascular disease, cancer, immunodeficiency disorders (including HIV infection)
* Diabetes
* Unstable endocrine disorders
* Neurological disorders
* Neuromuscular disorders
* Blood dyscrasias
* History of major psychiatric disorders (including schizophrenia, bipolar disorder, and dementia)
* Substance dependence
* History of head trauma with loss of consciousness
* Cerebrovascular accident
* Seizures
* Neurosurgical intervention
* Metal implants in the body (including pacemakers, neurostimulators, or other metal objects)
* Metal piercings that cannot be removed for the scan
* Women who are pregnant or who think they may be pregnant
A Randomized Trial to Evaluate Efficacy and Safety of Intracavernosal Injection of Platelet-Rich Plasma Versus Phosphodiesterase Type-5 Inhibitors for Treatment of Erectile Dysfunction.

The aim of this study is to evaluate the efficacy and safety of intracavernosal injection of PRP in patients with moderate to severe ED.


Eligibility Criteria:
Inclusion Criteria:

* 1) Signed an ethics committee-reviewed and approved informed consent form. 2) Subjects must meet all inclusion criteria to be eligible for study enrollment.

  3) Men between 30 and 75 years old, 4) Sexually active in a stable, heterosexual relationship of at least six months duration.

  5) ED for at least 6 months with an IIEF-EF between 5 and 16 points, inclusive. 6) ED of vascular origin. 7) Subjects agree to attempt vaginal intercourse at least 4 times every month after the end of the treatment and agree to document the outcome using the Sexual Encounter Profile (SEP) and the Erection Hardness Score (EHS).

  8) Commitment not to use other treatment for ED during the study (herbal, topical, intraurethral, intracavernosal, etc.).

  9) Willingness and ability to comply with study procedures, other measurements instruments and visit schedules and able to follow oral and written instructions.

Exclusion Criteria:

* 1) Refuse to complete study requirements. 2) Psychogenic ED as determined by study investigator. 3) ED of neurogenic origin (radical cystectomy, radical prostatectomy, pelvic surgery, spinal cord injury, multiple sclerosis, DM is not included unless documented diabetic neuropathy).

  4) Previous penile surgery of any kind (except circumcision, frenuloplasty and condyloma removal), such as penile prosthesis, penile lengthening, penile cancer surgery, penile plication, grafting.

  5) Previous history of penile fracture, Peyronie's disease or priapism. 6) Previous radiation to pelvis. 7) History of symptomatic hypogonadism (testosterone level \<346ng/dl) not treated.

  8) Major hematologic, renal, or hepatic abnormalities. 9) Severe decompensated cardiac, CNS or vascular insufficiency. 10) Poorly controlled hypertension or DM (HbA1c \>12%). 11) Neoplasm of any origin in active treatment or active progression or recovering from cancer within 12 months prior to enrollment.

  12) History of alcohol abuse or drug. 13) Treatment with oral anticoagulants, antiandrogens or nitrates. 14) Thrombopenia less than 100 x 103 / L. 15) Hemoglobin \<10g/dl. 16) Poor venous access or any other circumstance that preclude an apheresis procedure.

  17) Sexually inactive in recent months. 18) participation in another study that may interfere with the results or conclusions of this study.
Surgical Stages of Liver Cirrhosis In Patients With Hepatocellular Carcinoma

The investigators intend to perform a prospective, multicenter study to establish a set of clinical criteria for surgical stages of liver cirrhosis, which can be implemented to guide the surgical treatment of hepatocellular carcinoma (HCC).

HCC is the fifth most common malignancy in the world and ranks the third leading cause of tumor-related mortality. In China, more than 80% of HCC patients are accompanied by liver cirrhosis. Varied degrees of cirrhosis not only play an important role in selecting appropriate operative interventions for HCC patients, but are closely associated with tumor recurrence and long-term survival as well. Therefore, evaluating cirrhotic severity is essential for individualizing surgical modalities and predicting outcomes for patients with HCC. In recent years, investigators' group has proposed to stage the severity of liver cirrhosis through intraoperative liver morphological changes and preoperative cirrhotic severity scoring (TJ-CSS) model. Although the morphological classification of liver cirrhosis is of guiding significance for surgeons to determine the extent of hepatectomy, this method has some defects, such as subjectivity, lack of specific quantitative indicators and so on. Based on this, investigators propose to evaluate the severity of liver cirrhosis by measuring liver stiffness directly by Shaw hardmeter. Therefore, this prospective, multicenter clinical study intends to modify and perfect the preoperative cirrhotic severity scoring (TJ-CSS) and direct measurement of liver stiffness (DMS) grade established in the early period, so as to build a set of clinical standards for surgical liver cirrhosis classification, which can be used to guide the surgical treatment of HCC.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, 18 to 75 years of age, inclusive.
2. Patients who are clinically diagnosed as hepatocellular carcinoma and confirmed by postoperative pathology.
3. The liver function grade was Child-Pugh class A or class B, which can be restored to Child-Pugh class A within a short period of medical treatment.
4. Patients who undergo open surgery.
5. Patients have not been accompanied by serious physical diseases of heart, lung, brain, etc., and can generally tolerable for surgery.
6. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

1. Patients with tumors that oppress the main portal vein or main portal vein thrombus.
2. Patients that are accompanied with cavernous degeneration of portal vein.
3. Patients with hypersplenism caused by diseases of the blood system.
4. Patients suffer from serious acute and chronic diseases.
5. Patients with severe infectious diseases.
6. Patients with HIV-infectious or other AIDS-related disease.
7. Patients are drug abusers or have any psychological or mental conditions that potentially lead to poor study compliance.
8. Patients have any condition that in the judgement of the investigators would make the subject inappropriate for entry into this study.
A Study of Efficacy and Safety of Idebenone Vs. Placebo in Prodromal Parkinson Disease

To investigate whether 24 months of idebenone may reduce the progression from Prodromal Parkinson disease (PPD) to Parkinson disease (PD).

Number of people suffered from Parkinson disease (PD) is increasing every year. Contemporary medication has little neuroprotective effect, which may due to delayed treatment as over 50% neurons have lost when clinical diagnosed PD emerges. The concept of Prodromal Parkinson disease (PPD) is emphasized as it has become evident that there are several risk and clinical markers may occur years before the cardinal motor symptoms which allow clinical diagnosis. Rapid eye movement (REM) sleep behavior disorder and olfactory dysfunction are the most common PPD, and more than one third of patients may progress to PD and other neurodegenerative diseases. Mitochondrial injury is one of the pathogenesis of PD. Thus we design this trial to investigate whether idebenone, potent coenzyme Q10 analogue, could protect PPD develops into PD.

Eligibility Criteria:
Inclusion Criteria:

* Subjects are voluntary to participate and have signed informed consent
* Diagnosed as Rapid Eye movement (REM) Sleep Behavior Disorder by polysomnography

Exclusion Criteria:

* Subjects are pregnant, breastfeeding, or want to get pregnant or breastfeeding in 2 years
* Subjects have history of allergy to idebenone
* Difficulty to communicate
* Suffering from neurodegenerative diseases
* Having obvious brain imaging abnormalities (eg. severe brain atrophy, malformation, softening lesions, cerebrovascular disease, intracranial occupancy, giant large benign lesions, etc.)
* Having severe mental illness (eg. schizophrenia, manic depression, and severe depression)
* Long-term use of clonidine, dopamine antagonists, and serotonin reuptake inhibitors
* Suffering from other severe medical conditions
* Having difficulty in moving and are unable to come to the hospital
* Having claustrophobia
* Having contraindications to MRI tests
* Having history of olfactory disorders greater than 10 years
* Having history of color vision disorders greater than 10 years
* Life expectancy less than 2 years
* Having other situations which researchers consider is inappropriate to participate in this study