cyrilzakka/clinical-trials huggingface dataset:
Syncope Prediction Study

The purpose of this study is to perform a prospective evaluation of the vasovagal syncope prediction algorithm, called Tilt Test Analyzer, during head up tilt testing tests in one center in the United Kingdom.

Vasovagal syncope (VVS) is a form of neurally-mediated reflex syncope, which is marked by a sudden fall in blood pressure with an associated fall in heart rate often resulting in syncope, head-up tilt (HUT) testing is commonly used to bring information about VVS using ECG and blood pressure monitoring with medical observation.

We developed an algorithm, called Tilt Test Analyzer, to predict VVS during HUT based on the simultaneous analysis of heart rate (RR interval), systolic blood pressure (SBP) and an indicator of autonomic modulation represented by heart rate and blood pressure variability (HRV and BPV).

The primary objective of this study is to evaluate the VVS prediction algorithm in a prospective cohort of patients in the tilt laboratory The primary endpoint is the VVS prediction algorithm performance by means of measuring the sensitivity and specificity values.

The study is designed to test if the prospective analysis of tilt-test patients can reproduce the results previously obtained in the published retrospective analysis on 1155 patients with a similar clinically relevant sensitivity and specificity.

Eligibility Criteria:
Inclusion Criteria:

* Patients referred to the center with vasovagal syncope for tilt testing.
* The patient is willing and able to cooperate with the study procedures.
* The subject or legal guardian is able to provide written informed consent

Exclusion Criteria:

* Patients under 18 years or over 90 years old.
* Women who are currently pregnant or have a positive pregnancy test.
* Patients who had a prior tilt test.
* Patients enrolled in another device or drug study.
Stockholm Myocardial Infarction With Normal Coronaries (SMINC)-2 Study on Diagnosis Made by Cardiac MRI

Myocardial infarction with angiographically normal coronary arteries (MINCA) is common (7-8 % of all myocardial infarctions). There are several different causes behind MINCA where "true infarction" due to thromboembolism, myocarditis or Takotsubo stress cardiomyopathy are the main findings. The underlying diagnosis is often made by clinical findings sometimes with the help of cardiac MRI (CMR). Investigators have previously shown that it was possible to give 50 % of the patients a diagnosis made by the combination of clinical findings and CMR made in median 12 days after the acute event. The present study aim at improve the diagnostic accuracy by an early CMR with latest technique.

The present study aim at improve the diagnostic accuracy in MINCA with an CMR made 2-4 days after the acute event. The aim is to give 70 % of all patients with MINCA (35-70 years old) a definitive diagnosis made by CMR only. One-hundred and fifty patients will be included and compared with a similar historical sample where 50 % of the patients received a diagnosis made by a late CMR and clinical findings. The study has 80 % power to detect this 20 % absolute difference (p \<0.05).

Eligibility Criteria:
Inclusion Criteria:

* 35-70 years
* Fullfill the diagnosic criteria of myocardial infarction
* Normal coronary angiography or minor atheromatosis
* Sinus rythm on ECG at admission

Exclusion Criteria:

* Previous myocardial infarction
* Known cardiomyopathy
* Pacemaker or claustrophobia
* Severe chronic obstructive lung or kidney disease
* Pulmonary embolism
Idiopathic Hypersomnia

Idiopathic hypersomnia (IH) is characterized by non-restoring night-time sleep, excessive daytime sleepiness, sleep inertia, impaired cognitive functioning and autonomic symptoms. IH seems to be long lasting, once established, but little is known about long-time consequences, and research on the relationship between idiopathic hypersomnia and all-cause mortality is however sparse. IH is thus a poorly characterized disorder of hypersomnolence, and the present study aims to answer the following research questions:

1. Are there subgroups within the IH-group, that can be retrospectively characterized out of data from polysomnography, PSG and MSLT.
2. What are the relationships between IH, and possible IH subgroups, and morbidity, mortality, and sick leave, using retrospective register data?
3. What is the natural course of IH, and possible IH subgroups, assessed with questionnaires that measures daytime sleepiness, depression, and insomnia?
4. How do subjects diagnosed with IH think about their disease, cope with it, and perceive the effects of treatments, using qualitative interviews? 185 individuals assessed and diagnosed at the Sleep unit, Uppsala university hospital between 2010-01-01 and 2019-12-31 will be contacted. After collecting informed consents, PSG and MSLT data will be analysed together with register data regarding morbidity, mortality, sick leave, and pharmacotherapy.Questionnaires used at the time of the original assessment will be reviewed and, to study the natural course of the syndrome, the same questionnaires will be sent to the participants by mail.


Eligibility Criteria:
Inclusion Criteria:

* Idiopathic hypersomnia, according to the The International Classification of Sleep Disorders - Third Edition (ICSD-3)

Exclusion Criteria:

* Other serious somatic or psychiatric disease
* Drug additction with drug seeking behaviour
Treatment Outcome Between Mycobacterium Abscessus Infection in Chronic Lung Disease and Acquired Interferon-gamma Autoantibody Syndrome

The treatment outcome of Mycobacterium abscessus infection in acquired interferon-gamma autoantibody syndrome has not been well studied. Investigators will perform a retrospective and prospective cohort study to determine the treatment outcome of Mycobacterium abscessus infection in patients with acquired interferon-gamma autoantibody syndrome compared with the infection in patients with chronic lung disease which is known to be the most common group of infection and have high rates of treatment failure. Investigators hypothesized that Mycobacterium abscessus infection in acquired interferon-gamma autoantibody syndrome has better outcome than infection in chronic lung disease.

The single center, retrospective and prospective cohort study including the patients, aged 18 years and over, with acquired interferon-gamma autoantibody syndrome or chronic lung disease diagnosed with M. abscessus infection in the tertiary hospital of Thailand from January 2014 to June 2023 will be perform. The enrolled M. abscessus infected patients will be divided into two groups which are acquired interferon-gamma autoantibody syndrome group and chronic lung disease group. The subjects' medical record will be reviewed for demographic data, underlying diseases, clinical signs and symptoms, laboratory and radiological investigation results, diagnosis, treatment that the patients received, clinical events during the treatment. The treatment outcome will be determined as unfavorable or favorable by present or absent of unfavorable events, settled by the investigators, within 1 years after the treatment. The treatment outcome and other secondary outcomes between the two groups will then be compared and analysed with chi-squared test for categorical variables and two-sample t-test for continuous variables.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or over
* Diagnosed with Mycobacterium abscessus pulmonary disease in chronic lung disease or Mycobacterium abscessus infection in acquired interferon-gamma autoantibody syndrome
* Receive appropriate treatment

Exclusion Criteria:

* Follow up time less than one year after the start of appropriate treatment
* Very incomplete medical record that the subject's history cannot be reviewed
* Appropriate treatment duration less than one year at the study completion
Microelectrode Brain-Machine Interface for Individuals With Tetraplegia

The purpose of this research study is to demonstrate the safety and efficacy of using two NeuroPort Arrays (electrodes) for long-term recording of brain activity.

Individuals with tetraplegia (paralysis caused by illness or injury that results in partial or total loss of use of the arms and legs) have intact brain function but are unable to move due to injury or disease affecting the spinal cord, nerves or muscles. Brain-machine interface (BMI) technology is based on the finding that with intact brain function, neural signals are generated even though they are not sent to the arms, hands and legs. By implanting electrodes in the brain, individuals can be trained to send neural signals which are interpreted by a computer and translated to movement which can then be used to control a variety of devices or computer displays.

Eligibility Criteria:
Inclusion Criteria:

* Limited or no ability to use both hands due to cervical spinal cord injury or brainstem or spinal stroke
* At least 1 year post-injury
* Live within 1 hour of the University of Pittsburgh and be willing to travel to the University of Pittsburgh once per week for BMI training
* Additional inclusion criteria must also be reviewed

Exclusion Criteria:

* Certain implanted devices
* Presence of other serious disease or disorder that could affect ability to participate in this study
* Individuals who are immunosuppressed or who have conditions that typically result in immunocompromise
* Additional exclusion criteria must also be reviewed
Clinical Characterisation of the Vascular Effects of Cis-platinum Based Chemotherapy in Patients With Testicular Cancer

incidence is increasing1,2. Whilst the prognosis is very good with the vast majority of patients cured with orchidectomy alone, those with high risk stage one non seminomatous germ cell cancer (NSCGT) or metastatic disease (NSCGT or seminoma) are treated by surgery followed by chemotherapy. Platinum based chemotherapy is associated with long-term cardiovascular sequelae.

Endothelial dysfunction is a key component of early atherogenesis and the later stages of obstructive atherosclerosis, plaque rupture and thrombus formation. Whilst endothelial toxic effects of BEP chemotherapy appear to be central in the pathophysiology of associated complications, abnormalities in endothelial function as assessed by measures of brachial artery flow-mediated dilatation (FMD) have not demonstrated a consistent effect over time. When assessed within ten weeks of platinum-based chemotherapy9, no change in FMD was observed whilst marked decreases are seen immediately following treatment11 and also one year following treatment12. Therefore, the time-course of endothelial vasomotor impairment remains incompletely defined in a single prospective cohort.

There remains an unmet need to identify a preventive treatment for patients with testicular cancer treated with platinum based chemotherapy to diminish the substantial risk of subsequent cardiovascular events. A future randomised trial of statin therapy in these patients is under consideration and results from this pilot study will inform its design.

Before moving towards interventional studies the proposed pilot study will enable a better understanding of the nature, time-course and dose-dependent effects of the mechanisms contributing to increased cardiovascular risk.

Single-centre, prospective pilot study assessing the cardiovascular effects of treatment with orchidectomy or orchidectomy plus cisplatin based chemotherapy for testicular cancer.

Eligibility Criteria:
Inclusion Criteria:

* Histological diagnosis of stage 1 or IGCCCG5good or intermediate prognosis metastatic testicular/retroperitoneal germ cell cancer with treatment plan that includes orchidectomy or orchidectomy plus cisplatin based chemotherapy
* Aged between 18 and 65 years inclusive

Exclusion Criteria:

* Unable to provide written, informed consent
* Unable or unwilling to attend for investigations
* Current involvement in a clinical trial
* Anti-platelet therapy at time of enrolment
* Statin or other lipid-lowering therapy at time of enrolment
* Recreational drug use
* Ongoing inflammatory, infective or autoimmune disease
* Other malignant disease diagnosed in previous 5 years
* Previous venous or arterial thrombotic/thromboembolic event
Observational Study of Cognitive Outcomes for Subjects Who Have Had Prior PET Amyloid Imaging With Florbetapir F 18 (18F-AV-45)

The primary objective of this protocol is to determine if brain amyloid imaged with florbetapir F 18 (18F-AV-45) PET scans is predictive of progressive cognitive impairment during the subsequent 36 months for groups of: normal controls, mild cognitive impairment and Alzheimer's disease.

Hypothesis 1: The probability a subject will experience progressive cognitive impairment within 36 months of imaging will be greater in subjects whose 18F-AV-45 PET scan was rated amyloid positive compared to subjects whose PET scan was rated amyloid negative.

The secondary objective is to determine the stability, over 36 months of a clinical diagnosis, of AD in patients with an amyloid positive 18F-AV-45 PET.

Hypothesis 2: The diagnosis of AD will remain unchanged in patients whose PET scan were rated as amyloid positive.

Study AV-45-A11 is designed to determine if brain amyloid aggregation imaged on 18F-AV-45 PET scans is predictive of progression of cognitive impairment during the subsequent 36 months. Approximately 180 subjects enrolled in a prior clinical study (AV-45-A05\[NCT00702143\]) will be offered an opportunity to be studied under this protocol. The initial visit will occur as soon as possible following the AV-45-A05(NCT00702143) imaging day. Subjects who qualify for the study and their caregiver/partners will be contacted approximately 6,12,18,24 and 36 months after PET imaging in study AV-45-A05(NCT00702143), and will undergo a standardized functional and psychometric evaluation.

NOTE: This study is a clinical follow-up of subjects previously enrolled in trial 18F-AV-45-A05(NCT00702143). No new patients are being enrolled in this trial.

Eligibility Criteria:
Inclusion Criteria:

* All subjects who enrolled in study AV-45-A05(NCT00702143), received 18F-AV-45, and completed a PET scan will be eligible to enroll in this trial.

Exclusion Criteria:
Hypoglossal Acupuncture for Dysgeusia in Patients Undergoing Chemotherapy

This randomized controlled trial aims to investigate hypoglossal acupuncture in comparison to sham acupuncture and standard medical treatment (dietary recommendations) in the treatment of dysgeusia in cancer patients undergoing chemotherapy.

Taste disorders are frequent side effects in patients undergoing chemotherapy (CTX). Dysguesia has prevalence rates of 16% to 1000% during CTX with sometimes also persistent courses. Impact of dysguesia on appetite, body weight as well as health-related quality of life was shown. Until now, evidence for adequate treatment options is limited to specific diary recommendations. Acupuncture in the treatment of side effects of chemotherapy was investigated for nausea and xerostomia, but not for dysguesia. Therefore, this randomized controlled trial aims to investigate hypoglossal acupuncture in comparison to sham acupuncture and standard medical treatment (dietary recommendations) in the treatment of dysgeusia in cancer patients undergoing chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Initial treatment with platinum-containing or taxane-based CTX (regardless of the the length of the CTX cycle)
* Senological, gynecological or internistic tumors
* Phantogeusia (on average ≥4 NRS)
* Willingness to participate in the study and written informed consent

Exclusion Criteria:

* Severe stomatitis
* Dysgeusia before the CTX based on neurological diseases, diabetes, or the ingestion of drugs with taste disorders as side effects
* Leucopenia/neutropenia
* Intake of anticoagulants
* Smoking
* Severe physical or mental comorbidity (due to which the patient is unable to participate in the study)
* Participation in other CAM treatments within the integrative oncology care
* Participation in other studies on the effectiveness of interventions for oral complications
NOTIFY (New Observations Taking Information From Yesterday)

This trial will investigate whether notifying patients and their clinicians of the presence of moderate or severe coronary artery calcium on a low-dose CT scan performed for lung cancer screening results in a lower incidence of death, nonfatal myocardial infarction, or nonfatal stroke as compared with practice guideline reminders.


Eligibility Criteria:
Inclusion Criteria:

* Age \>=18 years
* No known ASCVD
* Lung cancer screenee with low dose CT scan (LDCT) within the last 5 years
* Coronary artery calcium (CAC) score on LDCT \>100 Agatston units (AU)
* Not taking a statin or other lipid-lowering therapy (e.g., ezetimibe, bempedoic acid, or PCSK9-lowering therapy)

Exclusion Criteria:

* Dementia or other neuropsychiatric disorder that interferes with medication adherence
* CAC scan, coronary CT angiogram, or invasive angiogram since LDCT
* Statin medication intolerance or allergy
* Life expectancy \<2 years, e.g., metastatic cancer or active cancer undergoing chemotherapy
Genetic Analysis Using Blood or Bone Marrow From Participants With Neuroblastoma or Noncancerous Conditions

This laboratory study is looking at genes in participants with neuroblastoma or noncancerous conditions. Identifying genes related to cancer may help in the study of cancer. It may also help doctors predict who is at risk of developing neuroblastoma.

OBJECTIVES:

I. Perform a whole genome scan for association of neuroblastoma with single nucleotide polymorphisms (SNP) and SNP haplotypes.

II. Identify true disease-associated SNP alleles using a customized genotyping platform enriched for haplotype analyses in an independent sample set.

III. Validate disease-associated SNP alleles and haplotypes in a final independent sample set.

IV. Identify neuroblastoma predisposition genes.

OUTLINE: This is a multicenter study. Participants are stratified according to presence of high-risk disease (yes vs no) and MYCN amplification (yes vs no).

DNA samples are derived from participants' banked blood or uninvolved bone marrow. A whole genome scan of DNA samples is employed to identify candidate single nucleotide polymorphisms (SNPs). The candidate SNPs are investigated, using a gene-centric haplotyping approach, to identify 10-20 true disease-associated alleles. The disease-associated alleles are again investigated, using a gene-centric haplotyping approach, to validate 5-10 disease-associated SNPs. SNPs are then analyzed for heritable predisposition.

Patients do not receive the results of the genetic testing. A certificate of confidentiality protecting the identity of research participants in this project has been issued by the Children's Oncology Group.

Eligibility Criteria:
Inclusion Criteria:

* Patient:

  * Diagnosis of neuroblastoma

    * Banked constitutional and genomic DNA within COG-ANBL00B1 Neuroblastoma Biology protocol or another COG Biology Protocol
    * At least 1.0 ?g of DNA available
* Control (age, race, and gender-matched):

  * No diagnosis of cancer
  * May have other conditions, including any of the following:

    * Asthma
    * Inflammatory bowel disease
    * Attention-deficit disorder
    * Obesity
An Investigational Drug Study to Treat Respiratory Symptoms Associated With Respiratory Syncytial Virus (RSV) Bronchiolitis (0476-272)

The purpose of this study is to look at whether an investigational drug can treat the breathing symptoms of RSV bronchiolitis in children 3 to 24 months of age.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized or in an urgent/emergent-care setting at least 24 hours for a first or second episode of RSV-induced bronchiolitis. Approximately twenty percent of patients will be allowed in the study with a stay of less than 24 hours but need to meet a minimum predefined Respiratory Severity Score as required by the study.

Exclusion Criteria:

* Asthma or other wheezing disorder. The Primary Investigator will evaluate whether there are other reasons why a child may not participate.
Virtual Reality on Pain, Stress, and Affect in the Infusion Clinic

This study will investigate the ability of virtual reality to function as a novel distraction intervention and improve the experience of patients who are receiving chemotherapy in the infusion clinic.

Objectives:

Primary Objective:

- To deploy and evaluate virtual reality as an intervention for stress, pain, and negative affect

Secondary Objective:

- To evaluate cyber sickness and patient satisfaction related to the virtual reality treatment

Eligibility Criteria:
Inclusion Criteria:

* At or above the age of 18
* English Speaking
* Diagnosed with cancer
* No previous history of seizures, losses of awareness, or other symptoms linked to an epileptic condition
* Not sensitive to motion sickness
* Not currently experiencing any contagious conditions, infections, or diseases (particularly of the eyes, skin, or scalp)
* Does not use a device to regulate heart rate or rhythm (such as a pacemaker)
* Not taking antiarrhythmic medications
* Not actively receiving radiopharmaceutical therapy

Exclusion:

* To ensure that there is sufficient time to complete the virtual reality treatment, patients who are scheduled for visits for periods of less than one hour will not be included in this study. Additionally, patients must consent to participating in the study on the day of the experience.
* Patients who are asleep prior to consenting will not be asked to participate in the study
Effect of the Transcranial Direct Current Stimulation (tDCS) on Dependent Smoking People

The purpose of this study is to evaluate the effect of 10 sessions of anodal transcranial Direct Current Stimulation (tDCS - 1 mA) applied to left vs right CDLPF of tobacco-dependent subjects compared to the application of a placebo tDCS (sham procedure) on the craving, which is evaluated by the item 1 of Fagerström test between day 1 and day 10. Craving is also evaluated 1 month post-treatment.

Tobacco is the second leading cause of death worldwide. It is currently responsible for the death of one in 10 adults (about 5 million deaths per year) and it is the fourth disease risk factor in the world. Many methods to quit smoking are available but in all cases, relapse is a common phenomena. The main risk factor for relapse is craving. So, acting on the craving seems essential to modulate tobacco consumption. Many functional neuroimaging studies have established a neuroanatomical substrate for craving process, in particularly dorsolateral prefrontal cortex (DLPFC), accessible par neuromodulation.

Eligibility Criteria:
Inclusion Criteria:

* Fagerström score ≥ 5
* Q-MAT score ≥ 6
* smoking subjects from 10 to 30 cigarettes a day
* right-handed subjects
* w/o severe progressive somatic pathology (especially tumor diseases, degenerative diseases)
* Hamilton Depression Rating Scale-17 score \<18

Exclusion Criteria:

* pregnancy and/or lactation
* presence of a specific contraindication for tDCS (e.g. personal history of epilepsy, metallic head implant, cardiac pacemaker...)