cyrilzakka/clinical-trials huggingface dataset:
The Feasibility Study of Recognition of Cardiac Arrest Using a Smart Watch

In this study, we want to find out whether the recognition of cardiac arrest using a smart watch is feasible or not. If this idea is possible, the recognition of cardiac arrest using the smart watch is easy and fast to the witness, like a general person. By using the smart watch, the emergency response system for cardiac arrest and the bystander CPR or BLS is beginning earlier than using conventional cardiac arrest recognition method in field.

In Korea, an out-of-hospital cardiac arrest (OHCA) was occurred twenty thousand person per year, and among them sixty percent was occurred in their home. We already knew that a survivor rate and neurological outcome of OHCA patient has a close relation with initial emergency management in field, like a bystander cardiopulmonary resuscitation (CPR), Basic Life Support (BLS), etc. However, in Korea, a witness almost did not the bystander CPR or BLS in field until highly trained rescuers arrived there. So, total survivor rate is just 2.4 % irrespective of neurologic outcome in Korea.

Generally, in Korea, a beginning of the bystander CPR progress throughout dispatcher's instruction of emergency response system. This system for OHCA patient activate only when the witness recognize cardiac arrest and call the emergency response system. Therefore, cardiac arrest recognition by the witness is very important.

However, a conventional recognition of cardiac arrest in field is often difficult, because there are no monitoring devices, healthcare providers. The conventional recognition method of cardiac arrest is that it is firstly to check mental status, secondly check pulse on patient's carotid artery and self-respiration. This method is too difficult for the witness, especially general persons. Even, it is difficult for an emergency physicians, too.

Consequentially, the recognition of cardiac arrest by the witness is generally delayed, a golden-time is running out until highly trained rescuers arrive there. An average arrival time of highly trained rescuers is eight to ten minutes. A hypoxic brain damage is begin from four minutes after cardiac arrest. As a result, this delayed time is already passed four minutes after cardiac arrest. So, the survivor rate and the neurologic outcome are not good enough.

In this study, we want to find out whether the recognition of cardiac arrest using a smart watch is feasible or not. If this idea is possible, the recognition of cardiac arrest using the smart watch is easy and fast to the witness, like a general person. By using the smart watch, the emergency response system for cardiac arrest and the bystander CPR or BLS is beginning earlier than using conventional cardiac arrest recognition method in field.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old
* Shock
* Cardiac arrest

Exclusion Criteria:

* Pregnancy
Evaluation of Correlation Between Oculometric Measures and Clinical Assessment in Parkinson's Disease

This is a multicenter longitudinal study in about 300 patients with Idiopathic Parkinson's disease, who will be evaluated in several clinical centers with a clinical assessment and an oculometric examination during a time period with specific intervals. This study aims to evaluate the correlation between oculometric measures and clinical assessment over time, as well as the potential to detect early change in clinical status using an oculometric assessment.

This is an multicenter longitudinal study, in about 300 patients with idiopathic PD in several centers. The aim of this study is to evaluate the correlations between oculometric measures and clinical assessment, e.g. the Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) and the MoCA score over time ,in subjects who meet the inclusion and exclusion criteria, and who provide a signed Informed Consent. In addition, the investigators aim to demonstrate that oculometric measures are able to detect patient deterioration faster than can be detected using the currently available clinical assessment tools. All patients will be assessed over a period of 12 months (5 assessments, at 0, 3, 6, 9, 12 months). During this time period, every subject who consents will undergo a NeuraLight session including oculometric measurements and eye-tracking recordings using a novel software-based platform and an eye- tracking system (Tobii, CE-marked class B approved device) (approx. 30 minutes). The oculometric evaluation will occur for every patient every 3 months. All assessments will be performed during a clinic visit unless authorized to be conducted remotely. During the study, the sponsor will be blinded to the private details of the subjects.

Eligibility Criteria:
Inclusion Criteria:

* Men and women with idiopathic PD (Hoehn \& Yahr scale 1-2)
* Age between 40 and 85 years old
* 0 to 5 years' time since diagnosis
* Normal or corrected vision
* Ability to follow instructions
* Willing and able to sign an informed consent form
* No anticipated changes in PD medications from baseline throughout the study duration based on clinical status during screening
* If treated, stable on treatment for at least 3 months

Exclusion Criteria:

* Inability to sit for 40 minutes on a chair in a calm manner
* Personal or 1st degree relative history of epilepsy
* Additional neurological diseases
* Drug or alcohol abuse (except for using medical cannabis during 24 hours prior NL examination date)
* Pregnancy or a potential pregnancy (self-declaration)
Active Surveillance for Adverse Events Following Immunization With the Butantan Trivalent Influenza Vaccine (2018)

Rationale and Background: Since 2013, Butantan Institute has been performing passive pharmacovigilance activities related to its triavalent, fragmented and inactivated vaccine (IB TIV).

Objetive: To conduct an active surveillance study focusing on the elderly and health care professionals as part of Butantan pharmacovigilance plan, while passive surveillance activities will continue. The pharmacovigilance plan, via active surveillance, is being implemented in response to WHO requirements for pre-qualification of IB TIV.

Study Design: This is a prospective cohort study. Population: Target groups for vaccination defined by The National Immunization Program of Brazil: healthcare workers and elderly (people over 60 years old). Study Size: A total of 400 individuals (150 health care workers and 250 elderly), presenting for immunization with IB TIV, and who agree to participate after providing Informed Consent.

Eligibility Criteria:
Inclusion Criteria:

* Health Care Professional; or
* Elderly (age 60 or more); and
* To have indication to be vaccinated against influenza, according the the Brazilian National Immunazition Programme; and
* To be available to participate in the study throughout its duration (6 weeks after any vaccine dose administered); and
* To demonstrates interest to participate in the study as registered in the informed consent form (ICF).

Exclusion Criteria:

* Known systemic hypersensitivity to eggs or to any component of the vaccine;
* Suspected or confirmed fever in the 3 days prior to vaccination or axillary temperature greater than 37.8 ° C on the day of vaccination;
* History of severe adverse reaction after previous administration of an Influenza vaccine within 6 weeks following vaccination;
* History of Guillain-Barre Syndrome or other demyelinating disease;
* Behavioral, cognitive or psychiatric disease that in the opinion of the principal investigator or his representative physician, affects the participant ability to understand and cooperate with all study protocol requirements;
* Any other condition in the opinion of the investigator that justifies exclusion from participation.
Different Ribavirin Dosages and Different Duration of Treatment in Combination With PegInterferon in Patients With Genotype 2 and 3 (WRITE)

WRITE study aim at identifying the effectiveness of an innovative individualized schedule of treatment as compared to standard regimen in patients with chronic HCV genotype 2 and 3.

The investigators are going to compare weight-based dosages of ribavirin, in combination with Peginterferon alpha-2a, with standard fixed dosages of 800 mg. Patients will be evaluated at week 4 with an assay of sensitivity of 15 IU/ml. Patients with week 4 response will discontinue treatment at week 12 in both arms. Patients with HCV RNA still detectable at week 4 and receiving 1000-1200 mg of ribavirin in arm A will discontinue treatment at week 24, whereas patients with HCV RNA still detectable at week 4 and receiving 800 mg of ribavirin in arm B will be treated till week 48.

A standard treatment arm (C) including patients treated for 24 weeks with Peginterferon alpha-2a and fixed 800 mg ribavirin dosage will be used as control arm.

Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic hepatitis C virus (HCV) infection (both HCVAb and HCV RNA positive)
* Patients with HCV genotype 2 or 3
* Age 18-70 years
* Naïve patients or previously treated only with standard interferon monotherapy
* Female patients of childbearing age who agree to avoid pregnancy during the period of treatment and 24 weeks after the end of treatment

Exclusion Criteria:

* Previous treatment with ribavirin
* Cirrhosis (CHILD PUGH B and C)
* Evidence of Hepatocellular carcinoma
* Pregnancy
* Retinopathy class I or II
* Alcohol consumption \> 40 gr/day
* Chronic cardiac or respiratory diseases
* HIV or HBsAg or HDV positivity
* Hemoglobin \< 8.5 gr/dL
* WBC \< 3.500/mm3
* PLT \< 80.000/mm3
One, Two, or Three iStents for the Reduction of Intraocular Pressure in Open-angle Glaucoma Subjects

The purpose of this study is to evaluate the safety and efficacy of the intraocular pressure (IOP) lowering effect of one, two, or three iStent devices in eyes of subjects previously on two anti-glaucoma medications.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with primary open-angle glaucoma (POAG)
* Subject on two topical hypotensive medications

Exclusion Criteria:

* Traumatic, uveitic, neovascular, or angle closure glaucoma
* Fellow eye already enrolled
Galantamine-CR and Cognitive Dysfunction in Bipolar Disorder

The purpose of the study is to determine whether the investigational drug galantamine-CR (Reminyl- Controlled Release capsule) is useful in improving problems with memory in bipolar patients with stable mood. This study is being done because a large proportion of patients with bipolar disorder experience significant memory problems, even when their mood is stable, after adequate treatment. These memory problems have been associated with poor daily social functioning. Studying galantamine-CR in this population may provide a new clinical way to combat memory problems in stable patients with bipolar disorder.


Eligibility Criteria:
Inclusion Criteria:

* DSM-IV diagnostic criteria for bipolar disorder
* men or women aged 18-65
* a baseline Hamilton-D17 score of \< 10 at screen visit
* a baseline YMRS score of \< 10 at screen visit
* no acute episodes of depression or mania for the previous 12 weeks.
* written informed consent

Exclusion Criteria:

* Subjects with current suicidal ideation
* Pregnant women or women of childbearing potential
* Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease; History of seizure disorder, brain injury, any history of known neurological disease (multiple sclerosis, degenerative disease such as ALS, Parkinson disease and any movement disorders, etc)
* History or current diagnosis of any of the following DSM-IV psychiatric illnesses: organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, major depressive disorder, patients with mood congruent or mood incongruent psychotic features, patients with substance dependence disorders, including alcohol, active within the last 12 months
* History of multiple adverse drug reactions
* Patients with mood congruent or mood incongruent psychotic features Subjects who are active smokers or who stopped smoking less than 3 months prior to enrollment; Clinical or laboratory evidence of hypothyroidism
* Patients who have had an episode of acute depression or mania during the 12 weeks prior to enrollment
* Patients who have had electroconvulsive therapy (ECT) within the 6 months preceding enrollment
* Patients with physical contraindications to magnetic resonance spectroscopy (ferrous surgical clips, cardiac pacemakers, ferrous prosthesis)
* Patients taking any of the following medications: other cholinesterase inhibitors, succinylcholine, neuromuscular blocking agents, cholinergic agonists (e.g., bethanechol), cimetidine, ketoconazole, erythromycin, fluoxetine, paroxetine, and fluvoxamine
Omics Sequencing of Specimen Derived From Mother-Infant-Pairs

The investigators aim to collect breast-milk and feces from the participants, and apply culture techniques as well as omics sequencing technology to probe into the microbial and metabolomic signature of the specimens.


Eligibility Criteria:
Inclusion Criteria:

* healthy pregnant women aged between 20y and 40y.
* Vaginal birth
* BMI\<23.5 before pregnancy
* Infants' birth weight, between 2500g and 4000g.

Exclusion Criteria:

* gestational diabetes
* diagnosis of depressive disorder during pregnancy
* gestational hypertension
* diagnosis of other diseases during pregnancy
* Under probiotics or antibiotic treatment from 3 months prior to pregnancy till 3 months after delivery
* histrory of smoking and drinking alcohol
* history of diarrhea from 3 months prior to pregnancy till 3 months after delivery
The Effectiveness of Megadose Shinbaro Pharmacopuncture for Patients With Chronic Shoulder Pain

This study is a prospective, case-control observational trial. The investigators will compare the Megadose Shinbaro Pharmacopuncture group to the control group to analyze the effectiveness of shoulder Megadose Shinbaro Pharmacopuncture.

Pharmacopuncture is a treatment that combines 2 of the most frequented Korean medicine treatment methods - traditional acupuncture and herbal medicine - by injecting herbal medicine extract at acupoints.

Shinbaro is a refined herbal formulation used to treat inflamed lesions and bone diseases.

This treatment is known to be an important part of Korean medicine treatment. However, there has been no specific value for the effect of this treatment.

Therefore, The investigators conducted observational trial to analyze the effectiveness of Megadose Shinbaro Pharmacopuncture on shoulder. From Dec 2019, The investigators will collect 80 patients with Chronic shoulder pain on both or each shoulder with the numeric rating scale(NRS) over 4.

The investigators will compare pain, dysfunction, quality of life and satisfaction of patients who are treated with Korean medical treatment including Megadose Shinbaro Pharmacopuncture and patients who are treated with Korean medical treatment not including Megadose Shinbaro Pharmacopuncture.

For these two groups, The investigators will compare NRS(Numeric Rating Scale), Visual Analogue Scale(VAS), Range Of Motion(ROM), Shoulder Pain and Disability Index(SPADI), Patient Global Impression of Change (PGIC) and EuroQol 5-Dimension (EQ-5D-5L).

Eligibility Criteria:
Inclusion Criteria:

* Patients with NRS ≥ 4 for shoulder pain over 3weeks
* Patients aged 19-70 years on the date they sign the consent form.
* Patients who provide consent to participate in the trial and return the informed consent form

Exclusion Criteria:

* Patients who have been diagnosed with a severe disease that may cause shoulder pain,
* Patients with progressive neurological deficit or with serious neurological symptoms caused by spinal cord compression.
* Patients who visited a hospital in pain caused by a traffic accident.
* Patients with a severe mental illness.
* Patients who are difficult to complete the research participation agreement
CK19 Combined With Contrast-enhanced Ultrasound: a Prediction System on Axillary Lymph Node Metastasis in Breast Cancer

To establish a predicting system on axillary lymph node metastasis based on peripheral blood CK19mRNA and contrast-enhanced ultrasound.

The feasibility and predictive accuracy of peripheral blood CK19mRNA and contrast-enhanced ultrasound of axillary lymph nodes metastasis in breast cancer were verified by the data of specimen bank; to establish the evaluation system of predicting the lymph node status based on CK19 and CEUS, validate the sensitivity, specificity, negative predictive value, positive predictive value and ROC curve of the system model and use Youden index, negative likelihood ratio, positive likelihood ratio to evaluate the diagnostic efficiency.

Eligibility Criteria:
Inclusion Criteria:

1. female, age 18\~70 years old
2. the test group should be in accordance with the pathological diagnosis of breast cancer, the clinical stage of breast cancer (stage cTis, cI, cII and cT3N1M0), the initial treatment to receive surgical treatment. Complete preoperative clinical diagnosis data, including the ipsilateral axillary lymph node CEUS data and peripheral blood sample; The negative-control group should comply with the pathological diagnosis, breast adenosis, fibrocystic lesions, breast cysts and other benign lesions, with complete preoperative clinical data, also including ipsilateral axillary lymph node CEUS data and peripheral blood sample

Exclusion criteria:

1. metastatic breast cancer, inflammatory breast disease, surgery without lymph node staging
2. pregnancy or lactation
3. patients with hematopoietic system disease or cancer, autoimmune diseases
4. preservation of substandard peripheral blood samples.
AL-38583 Ophthalmic Solution for Allergic Conjunctivitis Associated Inflammation

The purpose of this study is to assess the safety and efficacy of AL-38583 in the treatment of the signs of inflammation associated with allergic conjunctivitis.


Eligibility Criteria:
Inclusion Criteria:

* Presence of signs and symptoms of ocular inflammation in both eyes.
* Have a positive CAC response at Visit 1.
* Able to avoid the use of disallowed medications as well as contact lens wear for the specified period prior to Visit 1, and for the duration of the study.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Have known history or presence of persistent dry eye syndrome.
* Presence of any ophthalmic abnormality that may affect the study outcomes.
* Have a history of moderate to severe allergic asthma reaction to mountain cedar or the perennial allergens used in the study.
* Other protocol-defined exclusion criteria may apply.
The Context of Gambling Treatment: Towards Creating an Online Service to Reduce Problem Gambling - Part Five

This application involves a multi-stage study with the ultimate goal of developing an online treatment service for problem gamblers. We will recruit up to 100 problem gamblers, and offer problem gambling treatment services to them entirely over the internet. The program will be evaluated based on uptake, experience of the participants, and pre-test vs post-test differences in gambling and well-being.

Disordered gambling is now recognized as a behavioral addiction. Although the physical consequences of the disorder are very mild, the financial and emotional costs can be enormous. This application involves a multi-stage study with the ultimate goal of developing an online treatment service for problem gamblers. This project was originally designed to take place over a three-year period but has been condensed into two. Part one was scoping review. Part two involved focus groups with service providers and people experiencing gambling problems. Part three will gather some general population information on two on going population survey's run by our research team. Part four Involved key informant interviews, and part five would be the development and evaluation of a pilot online treatment service. This application deals with part five of the overall project, Parts two and four were conducted as 025-2017. In this study, we will recruit up to 100 problem gamblers, and offer problem gambling treatment services to them entirely over the internet. The program will be evaluated based on uptake, experience of the participants, and pre-test vs post-test differences in gambling and well-being. The data reported here are related to part 5 only. Due to funding cuts, we were only able to include 2 people in the completed study.

Eligibility Criteria:
Inclusion Criteria:

* problem gamblers seeking treatment who are 18 years and older must be willing to have therapy conducted online must have access to a computer and Internet be able to communicate in English.

Exclusion Criteria:

* not able to communicate in English, has current suicidal ideation, acute psychotic symptoms, current involvement in other gambling treatment, has severe substance abuse problem or complex mental health problems (as assessed by screening tools)
Sleeve-gastrectomy Efficacy in Morbid Obese Patient With a Focus on the Role of Inflammation

Despite the wide range of studies concerning the positive effects of bariatric surgery on metabolic state of morbid obese patient, it is necessary to further investigate the specific role of the "sleeve-gastrectomy" intervention, going not only to research results in terms of safety or efficacy on the treatment of comorbidities, but also aimed to understand whether the improvement of metabolic and cardiovascular parameters is due to total weight loss or rather to visceral fat loss, and how much of this improvement is attributable to changes in inflammatory status. The primary endpoint of the study is to evaluate the effect of sleeve-gastrectomy on metabolic parameters (glyco-lipidic assessment, vitamins), bone-remodelling parameters (vitamin D, parathormone) and cardiovascular parameters (blood pressure, flow-mediated dilation, indexed left ventricular mass, inter-ventricular septum, carotid intima-media thickness) in a large obese population on the basis of total weight loss (TWL), variation of visceral fat area (VFA), variation of peri-renal fat thickness and insulin resistance index ("Homeostasis Model Assessment-insulin resistance" - HOMA). In addition the investigators set themselves the objective of assessing whether the presence of comorbidities (diabetes and hypertension) can influence the effects of the intervention on the above parameters, and whether the levels of the NETs and of adipokines such as chemerin in the pre- and post-intervention can correlate with the metabolic-vascular dysfunction, and play a role in its eventual improvement.


Eligibility Criteria:
Inclusion Criteria:

- BMI ≥ 40 kg / m2 (or ≥ 35 kg / m2 with at least one comorbidity), aged between 18 and 65 years.

Exclusion Criteria:

* renal or hepatic impairment
* heart failure (New York Heart Association - NYHA II-IV)
* secondary causes of obesity
* major psychiatric disorders