cyrilzakka/clinical-trials huggingface dataset:
Endovascular Treatment for AIS in Chinese Municipal and County Hospitals： A "Real World" Study-ETERNITY Registry

To investigate the Endovascular Treatment difference between Chinese city and country hospital.

Endovascular Treatment for AIS in Chinese Municipal and County Hospitals： A "Real World" Study-ETERNITY Registry is an academic , independent, pragmatic , prospective , multicenter , observational registry study . Patients with acute ischemic stroke caused by anterior circulation intracranial large vessel occlusion and receiving EVT were included. Patients were divided into primary stroke center (county hospital) and senior stroke center (city hospital) groups. Acute ischemic stroke (AIS) workflow, EVT procedural details and clinical outcome were compared in two groups. The aim of the study was to explore the EVT difference in Chinese city and county hospital.

Eligibility Criteria:
Inclusion Criteria:

(1) age ≥18 years; (2) diagnosis of AIS caused by imaging-confirmed intracranial LVO, including isolated cervical internal carotid artery or tandem occlusion, intracranial internal carotid artery, middle cerebral artery (M1/M2), anterior cerebral artery (A1/A2); (3) initiation of any type of EVT, including mechanical thrombectomy, emergent angioplasty via balloon or/and stent; (4).Onset-to-presentation time with 24 hours; (5).Patients whose onset-to-presentation time surpass 6 hours should had CTP and fulfill with DAWN\[6\] or DEFUSE's\[7\] criteria.

Exclusion Criteria:

(1) Without follow up outcome; (2) posterior circulation stroke;(3)no evidence of LVO on angiogram.
A Study of Tepotinib Plus Osimertinib in Osimertinib Relapsed MET Amplified NSCLC (INSIGHT 2)

This study was to assess the antitumor activity, safety, tolerability, and pharmacokinetics (PK) of the Mesenchymal-epithelial Transition Factor (MET) inhibitor tepotinib combined with the 3rd generation EGFR inhibitor osimertinib in participants with advanced or metastatic non-small cell lung cancer (NSCLC).


Eligibility Criteria:
Inclusion Criteria:

* Locally advanced or metastatic Non-small Cell Lung Cancer (NSCLC) histology (confirmed by either histology or cytology) with documented activating Epidermal Growth Factor Receptor (EGFR) mutation
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and a minimum life expectancy of 12 weeks
* Acquired resistance on previous first-line osimertinib. Participants must meet both of the following 2 criteria:
* Radiological documentation of disease progression on first-line osimertinib
* Objective clinical benefit documented during previous osimertinib therapy, defined by either partial or complete radiological response, or durable stable disease (SD) (SD should last greater than (\>) 6 months after initiation of osimertinib
* Have received only first-line osimertinib as a prior line of therapy in the non curative advanced or metastatic NSCLC setting
* MET amplification as determined by either FISH testing (central or local) on tumor tissue (TBx) or central blood-based next generation sequencing (LBx). Tumor and blood samples must be collected following progression on prior first-line osimertinib at Prescreening
* Submission of tumor tissue and blood sample obtained after progression on first-line osimertinib, is mandatory for all patients for MET amplification testing
* Submission of tumor tissue during Prescreening or Screening is mandatory for patients with tumor tissue tested by local FISH, to confirm MET amplification status. Central confirmation is not mandated prior to the start of study treatment
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* Spinal cord compression or brain metastasis unless asymptomatic, stable or not requiring steroids for at least 2 weeks prior to start of study intervention
* Any unresolved toxicity Grade 2 or more according to National cancer institute common terminology criteria for adverse events( NCI-CTCAE) version 5, from previous anticancer therapy with the exception of alopecia
* Inadequate hematological, liver and renal function
* Impaired cardiac function
* History of interstitial lung disease(ILD) or interstitial pneumonitis including radiation pneumonitis that required steroid treatment
* Hypertension uncontrolled by standard therapies (not stabilized to \< 150/90 millimeter of mercury (mmHg)
* Contraindication to the administration of osimertinib
* Other protocol defined exclusion criteria could apply.
CirculAting Tumor DNA in Patients DIagnosed With Lung Metastasis From Colorectal Cancer: candiDate Selection for Local AblaTive thErapy

The investigators will detect circulating tumor DNA in blood of patients with lung metastases from colorectal cancer using NGS technology and intend to use it for predicting the outcome of local treatment (surgery or radiation) and recurrence of lung metastases.

The investigators produce customized gene target panel by selecting genes that are commonly found in colorectal cancer and metastasis from existing literature.

In patients diagnosed with lung metastases from colorectal cancer, 20mL of whole blood is collected before and after local treatment (surgery or radiation) and cell-free DNA (cfDNA) is extracted from the collected blood. Thereafter, 20 mL of whole blood is additionally collected once after 3 months (±2 months) and once after 6 months (±2 months) during follow-up and cfDNA is extracted. The investigators perform sequencing from the extracted cfDNA.

The investigators compare the mutations detected in cfDNA before and after local treatment and identify the trend of reducing mutations in cfDNA after local treatment. So The investigators discover biomarkers for the outcome of local treatment. The investigators also search for mutations for target drugs from mutation profiling of cfDNA.

Eligibility Criteria:
Inclusion Criteria:

1. adults over 19 years of age
2. those who understand research and have written consent
3. cases diagnosed with lung metastases from colorectal cancer

Exclusion Criteria:

1. pregnant women, nursing women
2. those who lack the ability to voluntarily agree
3. participation in other clinical trials where drugs for clinical trials are administered within the past four weeks as of the date of participation in clinical trials
Continuous Positive Airway Pressure (CPAP) Compliance in Obstructive Sleep Apnea

This study aims to determine the average compliance of a patient under CPAP therapy for obstructive sleep apnea as well as the various factors that influence it.

Obstructive Sleep Apnea (OSA) is a frequent disease that affects 4% of the male population and 2% of the female population, with well known repercussions on the quality of life (daytime drowsiness, concentration issues, increased motor vehicle accidents, etc) and cardiovascular risk (increased risk of strokes, hypertension, diabetes, CAD, etc.). It is caused by an intermittent relaxation of the throat muscles during sleep, thus blocking the airways and leading to snoring and apnea.

Treatment can involve diets and sports, sleep hygiene techniques, mandibular advancement devices. But the CPAP (continuous positive airway pressure) device remains the first line therapy for OSA. It is very effective at reducing apnea-hypopnea (AHI) and oxygen desaturation indexes (ODI), but poor compliance is often noticed, with only 46% of patients still using the device at 6 months.

Despite numerous studies on the subject, very few have included a large number of patients(\>150) or long follow up time (\>1 year), or reached conclusive evidence concerning the factors that influence CPAP compliance.

In order to determine these factors, the investigators have taken into account approximately 450 patients over a timeframe of 5 years who have used a CPAP device during the course of their disorder, and established a Kaplan-Meyer estimation of their survival function. The investigators have then used anthropometry (BMI, neck circumference, sex, age, etc.), polysomnography (Epworth score, AHI, ODI, sleep efficiency, etc.) and CPAP (pressures, leaks, etc.) data with a Cox regression in order to determine the factors that influence the compliance of a patient.

The results will allow us to establish the average compliance of a patient under CPAP therapy, as well as the reasons leading to its termination, the factors predicting a decreased compliance and the consequences of stopping the treatment. This will allow us to set up multiple methods of improved follow-up in patients that are predicted recalcitrant to CPAP therapy.

Eligibility Criteria:
Inclusion Criteria:

* All HDF patients with OSA, treated for at least one day by CPAP, from the period of June 2008 to June 2013.

Exclusion Criteria:

* None
Can Hospital Acquired Pneumonia be Prevented in Patients Who Gurgle?

Hospital inpatients who have gurgling sounds heard during speech or breathing have been observed to have a higher risk of hospital acquired pneumonia. Patients who gurgle and who consent to participation will be randomized to receive routine clinical management or management to include measures employed to reduce risks of aspiration, namely, 1. head of bed up (30 degrees or higher), 2. swallowing evaluation by speech therapist (and feeding predicated on formal evaluation), 3. prompting managing physicians to reduce sedating medications to minimal effective dose.


Eligibility Criteria:
Inclusion Criteria:

* Gurglers who consent to participate

Exclusion Criteria:

* Non-gurglers
* Patients presenting with pneumonia prior to identification with gurgling
* Patients receiving comfort-care-only
A Goal-setting With Mentoring Lifestyle Modification Intervention to Reduce Risk of Dementia in Later Life

This is a 5-year project. In the 1st year of this study, a pilot randomized controlled trial evaluating the feasibility and acceptability of a goal-setting behavior change intervention aim at reducing modifiable risk factors for preventing cognitive decline. The aim of 2nd to 5th year of this study to investigate whether this multidomain intervention to optimize self-management of cognitive decline risk factors in older individuals, delivered through a mentor- supported interactive internet platform, can reduce the risk of cognitive decline.

Lifestyle factors playing a role in the development of late-life cognitive decline may be modifiable. There is a need for robust evidence about the potential for prevention of cognitive decline through behavior change interventions.

This study involves the development, implementation and initial testing of a behavior change intervention. At the 1st year, a small-scale randomized controlled trial (RCT) will investigate the implementation of a goal-setting intervention aim at promoting behavior change of personal modifiable risks for cognitive decline in the community for \>55 years with at least one of the 7 modifiable risk factors for dementia. These older participants in the community (n = 100) will be randomized to either control (had a discussion regarding health and daily activity) or goal-setting with mentoring (the goal-setting interview involving identification of up to five personal goals of personal modifiable risks). All participants will be reassessed after 12 months. The 2nd to the 5th year, is a multisite, prospective, RCT with 36 months intervention. Recruitment of 300 older people (≥55 years) with at least one of the 7 modifiable risk factors for dementia will take place in Northern Taiwan. Participants randomised to the intervention condition will have access to an interactive internet platform, stimulating self-management of dementia risk factors, with remote mentoring by a mentor.

Eligibility Criteria:
Inclusion Criteria:

* in Northern Taiwan
* at least one of the 8 modifiable risk factors for dementia (Hearing loss, Hypertension, Obesity, Smoking, Depression, Physical inactivity, Social isolation, and Diabetes)
* living independently
* in the local community

Exclusion Criteria:

* can't speak chinese
Ruxolitinib for Steroid-refractory GVHD

Steroid-refractory acute GVHD (srGVHD) is one of the causes of mortality after allogeneic stem cell transplantation, while steroid-refractory chronic GVHD significantly increases morbidity, aggravates quality of life and may also impact survival. Currently there is no standard treatment of srGVHD. One of the most promising agents is Janus kinase (JAK) inhibitor ruxolitinib, which in the retrospective study demonstrated excellent response rate and survival of patients with either acute or chronic srGVHD. This study prospectively evaluates the efficacy of ruxolitinib in srGVHD patients.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of graft-versus-host disease established based on tissue biopsy
* Steroid-refractory acute or chronic graft-versus-host disease according to EBMT/ELN criteria (T. Ruutu et al, 2014)
* Age 1 to 70 years
* Karnofsky index \>30%.
* Ability for oral drug intake
* Life expectancy \> 1 month
* Signed informed consent

Exclusion Criteria:

* Severe organ dysfunction: AST or ALT \>5 upper normal limits (excluding cases related to liver GVHD), creatinine \>2 upper normal limits
* Requirement for vasopressor support at the time of enrollment
* Uncontrolled bacterial or fungal infection at the time of enrollment
* Pregnancy
* Somatic or psychiatric disorder making the patient (or legal guardian) unable to sign informed consent
Neuroimaging Predictors of Treatment Failure in Adult New-onset Epilepsy

Epilepsy, defined as recurrent, unprovoked seizures, is a common condition, affecting 0.5-1% of the general population. People with uncontrolled epilepsy suffer poor health and increased mortality due to their condition. They frequently experience social stigma and are socioeconomically disadvantaged. It is therefore imperative to help them gain control of their seizures as quickly as possible. A wide range of antiepileptic drugs (AEDs) has become available to treat people with epilepsy. However, despite maximal therapy, approximately 20-40% show pharmacoresistance (PR) and thus continue to have seizures.

We do not understand why a significant proportion of people with epilepsy have PR. For any given patient presenting with a first unprovoked seizure, we are unable to predict PR at the time of presentation. At least 2 different AEDs must be tried at maximum doses for a year before we can diagnose PR. At this point, surgical therapies become an increasingly urgent consideration.

Retrospective magnetic resonance imaging (MRI) studies in the chronic stages of epilepsy have shown that patients with PR are more likely to have focal structural lesions in the brain, and in particular to have signs of damage to the hippocampi. For example, there are retrospective data suggesting that a decreased hippocampal N-acetylaspartate (NAA)/creatine ratio (measured by magnetic resonance spectroscopy \[MRS\]) and hippocampal atrophy (determined by hippocampal volumetry) correlate with PR. However, it is not clear whether these findings reflect the underlying pathophysiology of PR, or simply reflect the effects of chronic seizures and chronic drug treatment on the brain.

The First Seizure Clinic at the Halifax Infirmary represents a unique opportunity for prospective, longitudinal studies of patients who present with a first seizure or with newly diagnosed epilepsy. In these patients, advanced neuroimaging techniques at presentation might show changes that truly reflect the underlying pathophysiology of PR, rather than changes that develop as a consequence of prolonged seizures and drug treatment. Neuroimaging follow-up might help us to understand the pathophysiologic changes that accompany the evolution of PR. Ultimately, it is our hope to combine neuroimaging features and clinical features of patients with PR in a predictive model that would help us to predict PR at presentation.


Eligibility Criteria:
Inclusion Criteria:

* Age 17 years
* Newly diagnosed epilepsy or history of first unprovoked, witnessed seizure

Exclusion Criteria:

* Lack of consent provoked seizure due to obvious
* Acute lesion on CT (e.g. stroke, hemorrhage
* Provoked seizure due to obvious, chronic lesion on CT (e.g. vascular malformation, tumour)
* Progressive brain disease (e.g. neoplastic, infectious, demyelinating diseases)
* History of epilepsy longer than 1 year at presentation to FSC
* History of AED treatment for more than 4 weeks
* Contraindication to MRI
The Effect of Blended Sensor Efficiency on Relieving the Heart's Inability to Increase Its Rate During Exercise

The goal of this trial is to test the effect/benefit of a FDA approved blended pacemaker sensor which responds only by comparing physical activity, heart rate, and breathing rate; compared to the accelerometer pacemaker sensor which respond only by comparing physical activity and the heart rate in patients whose heart is unable increase its heart rate according to increase physical activity or demand (Chronotropic Incompetence). Only one pacemaker family will be used in this clinical trial whereas the "out of box" configuration is the blended sensor which can also be made to act only as an accelerometer.

Objective: The goal of this trial is to test the impact of individualized blended sensor optimization on chronotropic response, compared with accelerometer use alone, in patients with chronotropic incompetence who are planned to undergo permanent pacemaker (PPM) implantation.

Study Population: The study population will consist of patients who suffer from the heart's inability to increase its heart rate according to increased physical activity or demand (chronotropic incompetence). These patients are planned to undergo permanent pacemaker (PPM) implantation.

PRIMARY ENDPOINT: Improvement in chronotropic competence as defined as an increase in age-predicted maximum heart rate (APMHR) which is defined as 220 beats per minute (bpm) minus patient's age in years. Age-predicted heart rate reserve (APMHR) defined as APMHR minus patient's heart rate at rest. Observe the maximal heart rate during exercise test with decrease in oxygen consumption at each stage and also at peak effort.

SECONDARY ENDPOINT:

1. Quality of life.
2. Procedural safety as defined by the number of complications within 1week associated with the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Evidence of chronotropic incompetence on exercise or pharmacological stress test defined as the inability to achieve 85% or greater of Age-predicted heart rate reserve (APMHR)
* Legal status to give informed consent specific to state and national law.
* Planned for PPM implantation and meets current guidelines for PPM therapy.

Exclusion Criteria:

* Inability to give informed consent
* Inability to comply with the follow-up visit schedule.
* Unable to participate in stress testing (exercise or pharmacological).
* Previous PPM implantation
* A life expectancy of less than 12 months per physician discretion
* Enrolled in any concurrent study, without Boston Scientific written approval.
* Pregnancy
* Unstable chest pain
* Stroke within 30 days
* Heart attack within 90 days
* Stress Test Exclusion Criteria: No evidence of Chronotropic incompetence on exercise or pharmacological stress test, defined as the ability to achieve 85% or greater of APMHR.
Special Investigation Of Long Term Use Of Sertraline.

Special investigation of long term use of sertraline, 52 Week Observation, Long-Term Safety. The objective of this "Special investigation" is to collect information about 1) adverse drug reactions not expected from the LPD (unknown adverse drug reactions), 2) the incidence of adverse drug reactions in this surveillance, and 3) factors considered to affect the safety and/or efficacy of this drug regarding long time use.

All the patients for whom an investigator prescribes the first sertraline hydrochloride should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Eligibility Criteria:
Inclusion Criteria:

The patients who take sertraline hydrochloride for longer than the duration of 16 weeks among the patients enrolled in A0501090 (Drug Use Investigation of J Zoloft).

Exclusion Criteria:

Patients not taking sertraline hydrochloride.
Impact of Regional Vibration Application and Flow Mediated Dilation on Brachial Artery Hemodynamics

Application of vibration has been previously shown to affect tissue perfusion and utilized in different branches of medicine. Little is known about the acute impact of vibration application on peripheral artery hemodynamics. In this study, investigators intend to assess:

1. vibration induced hemodynamic changes in brachial artery in non-diabetic patients and compare the characteristics of these alterations with flow mediated dilation mediated changes in same cohort.
2. compare the characteristics of vibration mediated hemodynamic alterations in diabetic and non-diabetic subgroups.

Background and Rationale:

Vibration application has been previously shown to affect tissue perfusion and utilized in different branches of medicine. However, previous studies have mainly focused on the impact of vibration on skin perfusion or vibration with active muscle contractions, therefore couldn't truly demonstrate acute impact of local vibration application on peripheral arteries. In addition to that, as a population that is prone to develop vascular problems, it is not known whether diabetic patients have comparable response to vibration application with non-diabetic population.

Objectives:

In this study, investigators aim to demonstrate and compare hemodynamic alterations in brachial artery with paired measurements pre- and post- vibration application and compare the characteristics of these changes with those of flow-mediated dilation in a non-diabetic cohort. Additionally, differences and similarities in vascular hemodynamic response to vibration in diabetic and non-diabetic subgroups are intended to be elucidated.

Methods:

Flow mediated dilatation and vibration will be applied after the participants will abstain from alcohol, caffeine and nicotine for 24 hours. Flow mediated dilatation (FMD) will be induced via 5 min cuff inflation below left elbow at supra-systolic pressures (50mmHg above pre-application systolic pressure). Vibration will be applied with a commercially available vibration plate to forearm at 20 hz and 3 mm of vertical amplitude for 5 minutes, 30 minutes after termination of FMD. Left Brachial artery flow will be measured with pulsed Doppler and diameter will be measured via 2D ultrasonographic imaging at 0th, 2nd, 4th, 6th, 8th minutes.Throughout the entire application and measurement periods, patients will be continuously monitored with electrocardiogram.

Eligibility Criteria:
Inclusion Criteria:

* 18 - 80
* Sinus Rhythm in ECG
* Ejection Fraction \> %35
* Informed Consent

Exclusion Criteria:

* Unstabile angina
* Certain or suspected subclavian artery or brachial artery atherosclerotic disease (assessed with USG)
* Heart failure ( New York Heart Association III - IV)
* Atrial fibrillation or frequent extrasystoles in ECG.