cyrilzakka/clinical-trials huggingface dataset:
A Clinical Trial to Evaluate the Immunogenicity and Safety of PPV23 Vaccine Revaccinations in the Elderly

To evaluate the the immunogenicity and safety of 23-valent pneumococcal polysaccharide vaccine revaccinations in the elderly

1. Antibody double growth rate in 28-40 days after immunization;
2. Antibody GMC level in 28-40days after immunization;
3. Incidence of adverse reactions in 0-30days.

Eligibility Criteria:
Inclusion Criteria:

1.The age was 60-65 years old on the day of enrollment;2.The subjects have signed the informed consent and signed the date;3.The subjects are able to participate in all planned follow-up visits and were able to follow all trial procedures (e.g. complete diary card / contact card, return to visit);4.The subjects in the study group had been vaccinated with 23 valent pneumococcal polysaccharide vaccine made in China for more than 5 years; 5.The control group had never been vaccinated with any pneumococcal vaccine; 6.Axillary temperature ≤37.0℃.

Exclusion Criteria:

1.With a medical history with hypersensitiveness, eclampsia, epilepsy, cerebropathia and neurological illness; 2.Allergic to any ingredient of vaccine or with allergy history to any vaccine; 3.Subjects with immunodeficency or suspected impairment of immunologic function (e.g. caused by HIV), or subjects are in the process of immunosuppressor therapy(Taking orally injecting of steroid hormone); 4.Administration of immunoglobulins within 30 days prior to this study; 5.Acute febrile disease(temperature ≥ 37.0°C) or infectious disease; 6.With a clearly diagnosed history of thrombocytopenia or other coagulopathy, may cause contraindications for subcutaneous injection; 7.With any serious chronic illness, acute infectious diseases, or respiratory diseases; 8.Suffering from serious cardiovascular diseases (pulmonary heart disease, pulmonary edema, hypertension can not be controlled to normal by drugs), liver and kidney diseases, diabetes with complications;9.With any kind of infectious, purulent, or allergic skin diseases; 10.With any other factor that makes the investigator determines the subject is unsuitable for this study.
Therapist and Parent Delivered Reciprocal Imitation Training for Young Children With Autism Spectrum Disorder

The purpose of this study is to examine whether adding a parent education component to an existing intervention (Reciprocal Imitation Training) results in improved outcomes for children with Autism Spectrum Disorder. Reciprocal Imitation Training (RIT) is a behavioral intervention designed to improve spontaneous imitation skills in young children with Autism Spectrum Disorder (ASD). Previous research suggests that it can be effective when used by trained therapists, teachers, siblings, and parents of children with ASD. However, it is unclear to what extent training parents to use RIT strategies in the home environment may enhance outcomes, compared to having therapists implement RIT individually with the child. The study will compare two different versions of RIT for young children with ASD: (1) two 60-minute weekly sessions of therapist-implemented RIT and (2) one weekly 60-minute session of therapist-implemented RIT and one weekly 60-minute session of parent education about using RIT in the home environment. The investigators will examine child and family outcomes between these two intervention types. Outcomes examined will include: (1) spontaneous and prompted imitation skills in the child with ASD, (2) social communication skills in the child with ASD, (3) parent stress, and (4) parent and child behaviors during parent-child play interactions.


Eligibility Criteria:
Inclusion Criteria:

* have a community diagnosis of Autism Spectrum Disorder (as reported by parent)
* meet cutoff for "Autism" or "Autism Spectrum" on the Autism Diagnostic Observation Schedule, 2nd Edition
* be between 24 and 60 months of age at the time of study enrollment
* demonstrate difficulties with imitation skills on the Motor Imitation Scales and/or the Unstructured Imitation Assessment during pre-treatment assessments

Exclusion Criteria:

* Participants must not be the sibling of another study participant
Efficacy Study of EVT 201 in the Treatment of Elderly Patients With Daytime Sleepiness

The purpose of this study is to determine whether a compound known as EVT 201 is effective in treating elderly patients diagnosed with primary insomnia who also have moderate daytime sleepiness.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary insomnia according to DSM-IV
* Over the last three months for at least 5 nights per week, must have a normal bedtime of between 9 pm and 1 am and a time in bed of at least 7 hours
* A history of sleepiness, tiredness or unintentional napping during the daytime attributed to to poor sleep at night
* Able to attend the Sleep Center for five nights (two consecutive nights on two occasions and one night on one occasion)over a five week period
* Willing and able to complete a sleep diary and questionnaires

Exclusion Criteria:

* Clinically significant or unstable medical condition that may interfere with sleep
* Major psychiatric disorders (other than insomnia) such as depression, schizophrenia, bipolar disorder
* History of myocardial infarction, cardiac failure or clinically significant dysrhythmias in the previous 2 years or clinically significant ECG abnormalities at screening
* History of substance abuse
* Disorders that interfere with drug pharmacokinetics
* History of cancer, except basal cell carcinoma
* Use of hypnotics, anxiolytics, antidepressants, anticonvulsants, over-the-counter sleep aids, histamine-1 receptor antagonists (except for loratadine and fexofenadine), beta-adrenergic blockers (except for atenolol), respiratory stimulants and decongestants, systemic steroids, narcotic analgesics, any other compound which might impact sleep-wake function, or medication used for the treatment of Parkinson's disease such as dopamine agonists and L-dopa (e.g., Sinemet, Madopar or Requip)
* Use of hypnotics within the 2 weeks preceding the Screening Period or within five half-lives of the medication, whichever is longer
* Consuming ≥ 350 mg per day of xanthine-containing food or beverages
* Smoking ≥ 10 cigarettes per day and/or unable to refrain from smoking without distress or discomfort for the duration of visits to the sleep laboratory (i.e.≥ 20 hours)
* Body mass index \> 34 kg/m2;
* Performing night work or rotating shift work during the past month
* Traveling across \> 3 time zones in the past 2 weeks
* Participation in another trial of an investigational product or device within the previous 30 days
* Known allergy or sensitivity to benzodiazepines
Emergency Department Interventions to Improve Blood Pressure Follow-up

Hypertension affects approximately 65 million people in the United States and approximately 20 million individuals remain undiagnosed. In Emergency Room visits, many as one third of the patients were noted to have elevated BP readings, two thirds of which could benefit from further therapy or closer clinic follow-up. However primary care follow-up after discharge with an elevated BP is surprisingly low. The purpose of this study is to measure the follow-up rate after the Emergency Room visit in individuals identified with elevated blood pressure after a brief counseling regarding risks of elevated blood pressure.

Hypertension is a very common disease, affecting approximately 65 million people in the United States. As many as 30 % of people with hypertension, approximately 20 million individuals, remain undiagnosed. As many as one third of patients seen in ED were noted to have elevated BP readings in prior studies. Approximately 5% of emergency department (ED) patients have severely elevated blood pressure. Prior studies suggest that as many as two thirds of ED patients with elevated BP can benefit from further therapy or closer clinic follow-up. However primary care follow-up after ED discharge with an elevated BP is surprisingly low. The purpose of this study is to measure the follow-up rate after the ED visit in individuals identified with elevated blood pressure after a brief counseling regarding risks of elevated blood pressure.

Eligibility Criteria:
Inclusion Criteria:

* 19 years of age or older
* diastolic BP 90 mm Hg or systolic BP 140 mm Hg
* diabetes and chronic kidney disease who have a diastolic BP 80 mm Hg or systolic BP 130 mm Hg

Exclusion Criteria:

* unable/unwilling to provide informed consent
* acute anxiety state
* Any subject on pain medication which compromises their ability to consent
Study of Defibrillation Testing In Patients Undergoing Initial ICD Implantation

The primary objective of this study is to compare the composite outcome of total mortality and operative complications in patients who do not undergo defibrillation testing to those who do undergo defibrillation testing at the time of initial ICD implantation.

Implantable cardioverter-defibrillators (ICDs) are the most effective treatment for the primary and secondary prevention of sudden cardiac death (SCD). At the time of ICD implantation, ventricular fibrillation (VF) is typically induced to demonstrate effective arrhythmia termination by the implanted device. Although defibrillation threshold (DFT) testing with induction of VF at time of ICD insertion is currently considered the "standard of care," and instructions for usage of devices approved by the Food and Drug Administration (FDA) include labeling with DFT testing, the value of defibrillation testing with modern-day devices has been questioned. Defibrillation testing can be associated with serious complications and may add to the cost of the procedure.

It is hypothesized that patients who do not undergo defibrillation testing will have outcomes similar to those who do undergo defibrillation testing at the time of initial implantation. This pilot study is being performed to determine the feasibility of performing a larger, multi-center clinical trial with longer follow-up to investigate whether or not defibrillation testing will have any impact on overall mortality, implant complications, or long-term first shock efficacy during clinical follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Initial ICD implantation (single, dual, or CRT) for a standard Class I or Class II indication according to the ACC/AHA/HRS practice guidelines
* Anticipated life expectancy \>6 months

Exclusion Criteria:

* Contraindications to defibrillation testing as determined by the managing physician\*
* ICD replacement implants
* Right-sided pectoral implants
* Abdominal implants
* Chronic oral amiodarone therapy (for \>6 weeks and continued need for amiodarone)
* Inability to give informed consent

  * Contraindications to defibrillation testing include the following: hemodynamic instability, LA thrombus, atrial fibrillation without adequate anticoagulation, LV thrombus, recent CVA or TIA, severe unrevascularized coronary artery disease or unstable angina, severe aortic stenosis, inotropic dependence, patient refusal, other patient-specific medical conditions that are deemed as contraindications, as determined by the implanting physician.
Jump: MR Simulation For Radiation Therapy Master Protocol

This is a master protocol for a prospective Phase I-II study evaluating feasibility and efficacy of incorporating magnetic resonance imaging (MRI) simulation into the planning of radiation treatments.

This is a Phase I/II clinical trial. A Phase I clinical trial tests the feasibility and safety of an investigational intervention. "Investigational" means that the process targeting high doses of radiation to the tumor based on MRI is still being studied. This research study is a Feasibility Study, which means it is the first-time investigators at this institution are examining this type of MR-guided dose planning. The U.S. Food and Drug Administration (FDA) has cleared MRI planning for use.

* In Phase I of this study, will prospectively determine the feasibility of using an MRI simulator to plan radiation therapy.
* In Phase II, the efficacy of adjusting RT based on MRI simulation will be explored, either by utilizing an MRI-simulation and synthetic CT to plan treatment or by dose-painting based on functional MRI data

Eligibility Criteria:
Inclusion Criteria:

* Participants must have a confirmed malignancy requiring radiation therapy.
* Age: 18 years or older
* ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)
* Ability to understand and the willingness to sign a written informed consent document.
* Disease-specific eligibility criteria will be specified in the appropriate subprotocol.

Exclusion Criteria:

* For MRI involving contrast, history of allergic reactions attributed to gadolinium based IV contrast. Note: If patient will not receive contrast, this is not applicable
* Participants who cannot undergo an MRI
* Disease-specific exclusion criteria will be specified in the appropriate subprotocol
Magnetic Resonance (MR) Colonography With Fecal Tagging

The purpose of this study is to determine if MR colonography with fecal tagging is better using air or water for distension of the colon. Patients referred to colonoscopy are offered MR colonography before colonoscopy. Two days before colonography, patients ingest a 200 ml Barium sulfate solution 2% four times a day, which will render fecal masses "invisible" on the following MR colonography. Air or water (randomised trial) is used for distension of the colon. The examinations are evaluated by two independent blinded readers.


Eligibility Criteria:
Inclusion Criteria:

* Suspicion of colorectal polyps or cancer
* Referred for colonoscopy

Exclusion Criteria:

* Suspicion of IBD
* Pacemaker
* Metal in the body
* Claustrophobia
* Pregnancy
Evaluation of PET Scan Timing Relative to AV-45 Injection Time

This study will re-read 10-minute positron emission tomography (PET) scans acquired in previous clinical studies of AV-45 at 30 and 50 minutes after injection and compare the results.


Eligibility Criteria:
Eligibility for subjects scans to be used in this study is determined by subject's eligibility/enrollment in Study A01(NCT01565291) or A03(NCT01565330).

Inclusion Criteria (AD group):

* Greater than 50 years of age
* Probable AD according to the National Institute of Neurological and Communication Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
* Mild/moderate dementia as evidenced by a Mini-Mental State Examination (MMSE) score ranging from 10 to 24, boundaries included, at screening
* History of cognitive decline gradual in onset and progressive over a period of at least 6 months

Inclusion Criteria (A01\[NCT01565291\] healthy volunteer group):

* 50 years of age, inclusive

  * MMSE of 29 or greater

Inclusion Criteria (A03\[NCT01565330\] healthy volunteer group):

* 35 to 55 years of age, inclusive
* MMSE of 29 or greater

Exclusion Criteria (both groups):

* Neurodegenerative disorders other than AD, including, but not limited to Parkinson's disease, Pick's disease, fronto-temporal dementia, Huntington's chorea, Down syndrome, Creutzfeldt-Jacob disease, normal pressure hydrocephalus, and progressive supranuclear palsy
* Diagnosis of other dementing / neurodegenerative disease
* Diagnosis of mixed dementia
* Cognitive impairment resulting from trauma, hypoxic damage, vitamin deficiency, brain infection, brain cancer, endocrine disease, or mental retardation
* Clinically significant infarct or possible multi-infarct dementia as defined by the NINCDS criteria
* Evidence on screening MRI or other biomarker that suggests alternate etiology for cognitive deficit (for healthy controls, evidence suggesting the presence of AD pathology)
* Clinically significant psychiatric disease
* History of epilepsy or convulsions
* Clinically significant hepatic, renal, pulmonary, metabolic, or endocrine disturbances
* Current clinically significant cardiovascular disease
* Received investigational medication within the last 30 days
The Effect of Semi Fowler 30' Right Lateral on Cardiac Output in Acute Heart Failure

Heart failure is a special clinical syndrome such as difficulty breathing, fatigue, and swollen legs characterized by increased JVP, crackle lung sounds, and peripheral edema caused by heart disorders both structural and/or functional, resulting in decreased cardiac output and increased intracardiac pressure at rest and activity. Body positioning has been shown to affect stroke volume and parasympathetic modulating activity. The right lateral 30" semifowler position is a very safe position in heart failure patients admitted to the ICU. Although body positioning can affect stroke volume, and parasympathetic modulation, it is not yet clear what effect it has on cardiac output


Eligibility Criteria:
Inclusion Criteria:

* The patient was diagnosed with acute decompensated heart failure,
* fully conscious,
* not intubated,
* \>18 years old,
* had no mobility problems,
* palpable radial artery pulsation,
* was not under the influence of anti-hypotensive drugs,
* willing to be a respondent,
* LVEF \<50%.

Exclusion Criteria:

* Pulmonary edema,
* severe valve disease comorbidities,
* receiving high doses of anti-hypotensive treatment,
* heart failure readmission in the last 3 months,
* finger edema,
* use of mechanical circulatory support,
* irregular rhythms,
* artificial pacemaker attached,
* obesity
* peripheral perfusion disorders
* cardiogenic shock
Treatment Response Assessment Maps to Delineate Necrosis From Tumor After Stereotactic Radiation in Brain Metastases

This research study is investigating the value of an imaging study of the brain called an MRI (which stands for magnetic resonance imaging), utilized in unique way, to delineate whether the tumor has recurred or whether radiation changes have occurred after a brain metastasis treated with focused radiation has enlarged.

This research study is a Phase II clinical trial.

In this research study, the investigators are utilizing MRIs of the brain with additional post-imaging processing (called Treatment Response Assessment Maps or TRAMs) to try to delineate tumor recurrence from radiation changes. The investigators hope to understand whether such a test may allow future patients to avoid resection entirely.

Eligibility Criteria:
Inclusion Criteria:

* Participants must have a histologically or cytologically confirmed solid malignancy of extracranial origin and radiographic evidence of at least one brain metastasis for which stereotactic radiation was utilized in the past. Patients with intracranial pathologic confirmation of a malignancy which originated extracranially but for which extracranial disease has not been biopsied are eligible.
* Participants must have an enlarging lesion in the brain at least 4 months after prior stereotactic radiation to the same site for which neurosurgical resection is planned as routine standard of care.
* Participants must be age 18 years or older.
* Participants must be willing to undergo study procedures.
* The effects of gadolinium / other MRI-based contrast agents on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately.
* Participants must possess the ability to understand and the willingness to sign a written informed consent document via ink on paper or via an electronic signature medium such as Adobe Sign.

Exclusion Criteria:

* Participants who have a contraindication to MRI (e.g. non compatible implanted metallic device for which MRI is absolutely contraindicated).
* Participants who have chronic kidney disease stage IV-V or end stage renal disease.
* Participants with a history of anaphylactic reactions to gadolinium.
* Pregnant women are excluded from this study because gadolinium-based agents have not been proven to be safe to administer to a developing fetus. Similarly, breastfeeding women will be excluded from this study.
Safety Study of Intravitreal EBI-031 Given as a Single or Repeat Injection to Subjects With Diabetic Macular Edema

The purpose of the study is to evaluate the safety, tolerability, immunogenicity, and pharmacokinetics of up to 3 dose levels of EBI-031 given as an intravitreal injection in subjects with diabetic macular edema. There are two arms to the study, a single dose arm (1 dose) and a repeat dose arm (1 dose each month for 3 months). Eligible subjects will initially enroll in the single dose arm and 3 to 6 subjects will be dosed at each of the 3 dose levels. Safety will be assessed over the 28 days after the single dose prior to moving to the next higher dose level. Once all subjects in the single dose arm have been dosed with EBI-031 and the safety has been assessed eligible subjects will begin enrolling in the repeat dose arm. Subjects in the repeat dose arm will receive one dose each month for 3 months and will be assessed for safety. Escalation to the next higher dose will occur once it is determined safe to proceed to the next dose level. Six subjects will be dosed at each of the 3 dose levels.


Eligibility Criteria:
Inclusion Criteria:

* Give written voluntary informed consent and any authorizations required by local law
* Have a diagnosis of Type 1 or 2 diabetes mellitus
* Have decreased vision determined primarily to be the result of DME in the study eye
* Mean central foveal thickness on Spectral Domain Ocular Coherence Tomography (SD-OCT)\> 325 in the study eye within 2 weeks of dosing
* Have best corrected Early Treatment of Diabetic Retinopathy Study (ETDRS) letter score of \<73 (\~20/40) and \>19 (\~20/400) in the study eye within 2 weeks of dosing.

Exclusion Criteria:

* Female that is pregnant and lactating
* Any prior history of anti-interleukin 6 (anti-IL-6) treatment, for example: tocilizumab, sirukumab, sarilumab, olokizumab
* Any concurrent biologics for immune disease such as anti-tumor necrosis factor (TNF): Enbrel (etanercept), Humira (adalimumab), Remicade (infliximab); an anti-interleukin 12 (anti-IL-12): Stelara (ustekinumab); or an anti-interleukin 1 (anti-IL-1): Kineret (anakinra), Ilaris (canakinumab), Arcalyst (rilonacept).
* Unstable, uncontrolled diabetes defined as hemoglobin A1C (HbA1C)≥10.5% within 3 months prior to dosing of EBI-031
* Received intravitreal anti-vascular endothelial growth factor (anti-VEGF) such as Eylea (aflibercept) within 8 weeks, Lucentis (ranibizumab) and Avastin (bevacizumab) within 4 months prior to EBI-031
* Significant renal disease, liver disease, or acute congestive heart failure
* History of myocardial infarction (MI), stroke, or transient ischemic attack (TIA)