cyrilzakka/clinical-trials huggingface dataset:
Sepsis Pre-Alert Monitoring Intervention: Study to Investigate Targeted Enhanced Monitoring for Sepsis

Sepsis is a leading cause of death worldwide, and contributes to approximately 750,000 hospitalizations per year, a third of which may die. International guidelines recommend timely interventions, including cultures, fluid resuscitation and antibiotics. Following guideline bundles is associated with a decrease in mortality. Key to timely intervention is timely diagnosis.

Using the Epic sepsis predictive analytic tool, investigators will trigger vital sign and delirium monitoring in patients determined to be at increased risk for developing future sepsis.

The primary objective of this study is to demonstrate reduced mortality in patients for whom the pre-sepsis algorithm threshold is met, and who enhanced monitoring.

A means to identify patients before they become ill may improve the effectiveness of established therapies.Epic's electronic medical record (Epic systems, Verona, WI) contains a surveillance tool that uses predictive analytics to identify patients at risk of becoming septic four hours after the alert becomes active. This affords the opportunity to intervene sooner, but it remains unclear what the best course of action should be in a population at risk of sepsis, only some of which may go on to develop the illness. We propose an automatic intervention, consisting of enhanced monitoring, that is tied to the alert. No therapeutics will be mandated. Instead, additional monitoring information will lead to faster diagnosis and therapy, and improved clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* any inpatient at NYU Langone Health System

Exclusion Criteria:

* not an inpatient at NYU Langone Health System
the Optimal Surveillance Frequency for Stage II/III Gastric Cancer

Due to lacking of evidence on surveillance for gastric cancer (GC), this study aimed to determine the optimal postsurgical surveillance strategy for stage II/III GC patients and compare its cost-effectiveness with traditional surveillance strategies.

Background The development of existing follow-up strategies is mainly based on experts' consensus and researches on recurrence patterns due to the lack of direct evidence and unified standards. On the one hand, it is unreasonable to carry out the same postsurgical surveillance for all stage II/III GC patients. Additionally, In addition to the early detection of recurrence, the optimal follow-up strategy should also balance cost and effectiveness. There were no criteria for the arrangement of follow-up in different guidelines, and the optimal postoperative follow-up strategy for patients with stage II/III GC remains unclear.

Methods Prospectively collected data from stage II/III GC patients (n=1,661) who underwent gastrectomy at Fujian Medical University Union Hospital (FJMUUH) between January 2010 and October 2015. For external validation, two independent cohorts were included, which were composed of 380 stage II/III GC patients who underwent gastrectomy at the Mayo Clinic between July 1991 and July 2012 and 270 stage II/III GC patients at the Qinghai university affiliated hospital (QUAH) between May 2010 and Oct 2014. Random survival forest models were used to predict dynamic recurrence hazards and to construct individual surveillance strategies for stage II/III GC. Cost-effectiveness were assessed by Markov model.

Eligibility Criteria:
Inclusion Criteria:

* (1) Eastern Cooperative Oncology Group (ECOG) scores of 0 (asymptomatic) or 1 (symptomatic but completely ambulatory); (2) pathologically confirmed AGC (pStage II and III, except pT4b); (3) no distant metastasis or invasion of adjacent organs (e.g., pancreas, spleen, liver, and colon) detected intra- or post-operatively; and (4) D2 lymph node dissection of gastric cancer.

Exclusion Criteria:

* (1) American Society of Anesthesiologists (ASA) grade \>2; (2) remnant gastric or neuroendocrine cancer; (3) history of neoadjuvant chemotherapy; (4) palliative surgery; and (5) death within 30 days after surgery.
Sparing of the Fovea in Geographic Atrophy Progression

Dry age-related macular degeneration (AMD) is a common cause for severe visual loss in the elderly and represents an unmet need. So far no treatment is available for geographic atrophy (GA), which represents the advanced dry form characterized by expanding areas of outer retinal atrophy with corresponding absolute scotoma. The foveal retina may be spared until late in the course of the disease, a phenomenon termed "foveal sparing". However, the disease process ultimately also involves the central retina leading to irreversible loss of central vision. While the natural history of eyes with GA has been extensively studied with regard to the entire atrophic area, morphology-function analyses for "foveal sparing" GA in particular are still missing. Such data are needed for various purposes including the future use in interventional pharmacological trials aiming to slow the progression of GA and to preserve the foveal retina. In this study, different imaging modalities for accurate detection and quantification of preserved foveal retinal areas will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* The study eye must have a contiguous well-demarcated area of GA either in a complete ring around the spared fovea or in a horseshoe pattern with a total atrophy size of ≤ 7 Disk Areas
* Patient is willing to undergo ocular examination

Exclusion Criteria:

* The presence or history of CNV (choroidal neovascular membrane) in the study eye
* Ocular disease in the study eye that may confound assessment of the retina, other than non-exudative AMD (e.g., diabetic retinopathy, uveitis)
* Cataract surgery or ocular surgery in the study eye within 30 days prior to the baseline visit
* Current or previous participation in clinical studies investigating drugs, medical devices or supplements within 30 days prior to enrolment in the study - Previous or concomitant therapy to reat AMD (investigational or FDA approved); oral supplements of vitamins and minerals are permitted
* Known medical history of allergy or sensitivity to tropicamide or fluorescein dye that is clinically relevant in the investigator's opinion
Improving Emergency Preparedness Among 9/11 Exposed Population: Implementation and Evaluation of an Emergency Preparedness Intervention

A two-arm parallel randomized controlled trial will be conducted to compare the effectiveness of a phone-based household emergency preparedness intervention with a mailed informational brochure on household emergency preparedness amongst a sample of World Trade Center Health Registry enrollees residing within New York City.

An intervention to enhance household emergency preparedness was developed to include the following topics: (1) an introduction to why emergency preparedness is important; (2) definition of what a disaster is; (3) family communication and evacuation plan (including, what is a family communication plan, why you should have one, communication plan checklist, family communication card); (4) disaster supplies (including, what types of supplies are needed, how long supplies should last, supply checklist; assembling a go bag , and storing supplies); and (5) The brochure included several resources, including disaster contact numbers for emergency and non-emergency calls: 911 or 311,, NYC Emergency Management, as well as website for additional information of preparedness: NYC.gov/hazards, which includes information specific to New York City hurricane evacuation zones.

The phone-based intervention consisted of a 15 - 20 minutes talk session completed over the phone following the format and topics noted above. The informational brochure intervention followed the format and topic above and was mailed to participants during the intervention period.

Eligibility Criteria:
Inclusion Criteria:

1. English or Spanish speaking World Trade Center Health Registry enrollees aged 18 or older at the time of 9/11 residing in New York City.
2. Completed Wave 4 (2015-2016)
3. Those who are not rescue/recovery workers in either the NYPD or FDNY.

   -

Exclusion Criteria:

1. World Trade Center Health Registry enrollees under the age of 18 at the time of 9/11
2. Those with proxy interview at Wave 1
3. Enrollee was a rescue and recovery work affiliated with FDNY or NYPD at Wave 1

   -
A Study of PD1 Combined With Dc-cik in the Treatment of Solid Tumors

This is a single center、single arm、open-label, to investigate the safety and efficacy of PD-1 and DC-CIK with anti-solid tumor


Eligibility Criteria:
Inclusion Criteria:

1. Previously receiving ≥ first-line regimen chemotherapy;
2. Age over 3 years old and less than 14 years old;
3. The expected survival period is more than 3 months;
4. ECOG≤2;
5. Vital organ function is satisfied: cardiac ultrasound indicates cardiac ejection fraction ≥ 50%, no obvious abnormality in ECG; blood oxygen saturation ≥ 90%; creatinine clearance calculated by Cockcroft-Gault formula ≥ 40ml/min; ALT and AST ≤ 3 times the normal range, total bilirubin ≤ 2.0 mg / dl;
6. Blood routine: Hgb≥80g/L, ANC≥1×109/L, PLT≥50×109/L;
7. There are measurable target lesions.

Exclusion Criteria:

1. Liver and kidney function:

   * Total bilirubin \> 2 x ULN (Gilbert syndrome \> 3 x ULN)
   * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \> 3 × ULN
   * Serum creatinine clearance \>60mL/min
2. Serological examination:

   * Absolute neutrophil count (ANC) \<0.75x109/L
   * Platelet count (PLT) \<50x109/L
3. Active hepatitis B (HBV-DNA \> 1000 copies / ml), hepatitis C, or uncontrolled infection;
4. The number of days of chemotherapy medication and the administration of hormones below 5mg is ≤3, and the number of days of withdrawal of hormones greater than 5mg is ≤5;
5. Active CNS disease (tumor cells in CSF);
6. Intracranial hypertension or unconsciousness; respiratory failure; diffuse vascular internal coagulation;
7. creatinine \> 1.5 times the upper limit of normal or ALT / AST \> 3 times the upper limit of normal or bilirubin \> 2 times the upper limit of normal;
8. The New York Heart Association (NYHA) is classified as Level III or higher;
9. Uncontrolled diabetes;
10. With other uncontrolled diseases, the investigator believes that it is not suitable for joining;
11. Any situation that the investigator believes may increase the risk of the subject or interfere with the test results.
Tooth Discoloration Induced by Pulpotomy Materials

Vital pulp therapy including pulpotomy is commonly used for managing teeth with carious pulp exposure instead of performing root canal therapy. The gold standard materials used in this procedure are the calcium silicate based materials, however recent case reports have shown tooth discoloration caused by these materials especially MTA which is of concern to the patients. The aim of this study is to compare tooth color changes and discoloration induced by 3 calcium silicate based materials used in pulpotomy over 6 months, 12 months and yearly up to 5 years.

Pulpotomy procedure involves removal of the coronal portion of the dental pulp followed by placement of a compatible material and subsequent coronal restoration of the tooth. Mineral trioxide aggregate is the gold standard material used in pulpotomy; however it has been implicated in tooth discoloration due to it radioopacifier. newer calcium silicate based materials including Biodentine and bioceramic have different opacifier and claimed not to cause tooth discoloration in laboratory studies.

In this clinical study tooth color measurement of teeth treated by pulpotomy using these 3 materials will be taken using vita easy shade device immediately after placement of the materials, 6 months and 12 months after the treatment then yearly up to 5 years. The discoloration potential of these 3 materials will be compared. Factors that may influence tooth discoloration will be also measured and analyzed including buccal wall thickness and time of bleeding control after pulpotomy.

Eligibility Criteria:
Inclusion Criteria:

* Vital tooth with carious pulp exposure to be treated by full pulpotomy
* Fully erupted upper or lower molar tooth with fully formed apex
* Tooth should have intact buccal wall (no caries or restoration)
* Tooth should be restorable by direct composite restoration

Exclusion Criteria:

* Partially erupted tooth
* Tooth has caries on the buccal surface
* Tooth has restoration on buccal surface
* Tooth has preoperative coronal staining compared to adjacent teeth
A Study To Access The Safety And Tolerability Of RN316 (PF-04950615) When Administered To Healthy Adult Subjects

The study is designed to determine the safety and tolerability of RN316 when administered intravenously to healthy adult subjects. This is the first time RN316 has been given to humans.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, ambulatory men and women (of non-childbearing potential) ages 18 -70 inclusive.
* Baseline total cholesterol ≥ 200 mg/dl, baseline LDL ≥ 130 mg/dl.
* BMI 18.5 to 35, and body weight ≤150 kg, inclusive.

Exclusion Criteria:

* Evidence of clinically significant disease that may increase the risk to the subject of study participation or interfere with interpretation of results.
* Secondary hyperlipidemia.
* Subjects who have taken lipid lowering compounds within the past 12 months prior to dosing.
Involvement of the Gut Microbiota in Calcified Aortic Stenosis

Calcific aortic stenosis (CAS) is a disease characterized by progressive calcification of the aortic valve, obstructing the passage of blood from the left ventricle into the general circulation. It is the most frequent cause of valve disease in the elderly. To date, no means of preventing the disease has been discovered, and the only treatment available is valve replacement during cardiac surgery, or percutaneous implantation of a valve prosthesis when the narrowing becomes severe and causes symptoms.

The intestinal flora or microbiota, the reservoir of all the microorganisms in the gut, is implicated in numerous diseases, particularly of the intestine. But to date, no study has established a link between CAS and microbiota. The intestinal microbiota acts through molecules produced by itself or the host and passing into the bloodstream. In the pathophysiology of CAS, the valve leaflets are breached and do not heal. These molecules can enter and have beneficial or deleterious effects, in particular promoting calcification of aortic valve cells.

Concrete objectives:

Improve understanding of calcific aortic stenosis in humans Study the composition of intestinal flora in patients with aortic stenosis and compare it with healthy subjects Study the molecules in the intestinal flora likely to be involved in the development of aortic stenosis in humans.


Eligibility Criteria:
Inclusion Criteria:

* Group of patients with CAS:
* Calcified aortic stenosis diagnosed on a cardiac ultrasound or CT not older than 3 months
* Severe aortic stenosis: surgical indication based on symptoms and ultrasound data (high gradient aortic stenosis : Vmax\> 4m/s, mean gradient \> 40mmHg, area \< 1cm², low flow low-gradient CAS: left ventricular ejection fraction (LVEF) \< 40%, Vmax\< 4m/s, mean gradient \< 40mmHg, area \< 1cm², paradoxical low-gradient CAS: LVEF \> 55%, Vmax\< 4m/s, mean gradient \< 40mmHg, area \< 1cm²)
* Moderate CAS: 3m/s \<Vmax\< 4m/s, 20mmHg \< mean gradient \< 40mmHg
* Mild CAS: 2,6m/s \< Vmax \< 2.9m/s, mean gradient \< 20mmHg
* Aortic sclerosis: calcified remodeling of the aortic valve visible on ultrasound or CT.

Control group - free of CAS:

- No calcified aortic stenosis verified on a cardiac ultrasound or CT not older than 3 months

Exclusion Criteria:

* Treatment interfering with the composition of the intestinal microbiota: local or systemic corticosteroids within the last 3 months, antibiotics within the last 3 months, antiretrovirals, bile acid chelators (questran and colesevelam), HIV-targeted antiretroviral therapies, selective serotonin reuptake inhibitor-type antidepressants
* Clinical criteria: history of cholecystectomy, documented chronic liver disease in the patient, failure to fast on the day of the blood test, inflammatory bowel disease
* Patients requiring emergency intervention (myocardial infarction, acute aortic or mitral insufficiency, cardiogenic shock).
* AS of rheumatic origin, infective endocarditis.
Feasibility And Safety of Early Discharge After Transfemoral Transcatheter Aortic Valve Implantation

The hypothesis behind this study is that there is a proportion of patients considered high or intermediate risk for surgery, but relatively low risk for TAVI, which can be discharged early after the procedure (within the first 2-3 days) without additional risks. Therefore, when performed in safety, an early discharge may cut periprocedural TAVI costs significantly.

TAVI (Transcatheter aortic valve Implantation) - A viable alternative to surgical aortic valve replacement for patients with severe symptomatic aortic stenosis.

Considered as being at unacceptable surgical risk. Despite its widespread utilization, there are procedure specific complications and hospitalization associated costs that limit TAVI expansion into patient populations with lower risk.

Cost-effectiveness of TAVI has been investigated either compared with standard therapy for patients who are not candidates for surgical valve replacement or with conventional surgical replacement in high-risk patients.

Formal economic evaluation in inoperable patients demonstrated that the benefits of TAVI were achieved at an acceptable incremental cost to society, at least in the context of the U.S. and U.K. health systems.

In patients with severe, symptomatic AS who are at high but not prohibitive surgical risk, the PARTNER A trial demonstrated that TAVI appeared to be an economically attractive strategy compared with aortic valve replacement, provided that patients are suitable for a transfemoral approach. On the other hand, results for trans-apical TAVI compared with surgical replacement were economically unfavorable.

Eligibility Criteria:
Inclusion Criteria:

* None

Exclusion Criteria:

* None
* Beyond the applicable criteria of the IFU no further in- and exclusion criteria are defined.
Kangaroo Holding Effects on Breast Milk

Kangaroo holding is a skin-to-skin method of holding a baby. Many research studies have investigated the maternal and infant benefits associated with kangaroo holding. The purpose of this study is to determine if kangaroo holding a baby changes the amount and composition of breast milk pumped before and after the kangaroo holding session.

Hypotheses:

1. There is a significant difference in volume of maternal breast milk pumped after kangaroo holding premature infants as compared to maternal breast milk pumped after non-holding conditions
2. There is a significant difference in the composition of maternal breast milk pumped after kangaroo holding premature infants as compared to maternal breast milk pumped after non-holding condition.

This study will address two of the overwhelming challenges in the physiologic care of premature infants in the neonatal intensive care unit (NICU) environment. The first challenge is promoting neonatal growth through providing a careful balance of nutrition to caloric expenditure for premature infants. The second challenge is supporting parents in the intensive, technology driven environment of the NICU to merge physiologic care with parental-infant interaction through touch, communication, and maternal intervention. The vast majority of mothers with premature infants express breast milk for early feedings, however milk production tends to diminish three to four weeks after delivery. The practice of skin-to-skin holding is thought to promote the mother's ability to produce breast milk, but had not been empirically tested. This study will examine the relationship of kangaroo holding on mother's breast milk production and composition.

Eligibility Criteria:
Inclusion Criteria:

* Birth weight \</= 2000 grams
* Gestational age 26-34 weeks at birth
* Medically stable at start of study
* \< 14 days old at start of study

Exclusion Criteria:

* Infants receiving phototherapy
* Suspected congenital abnormalities
* Overwhelming sepsis
* Cardiac Abnormalities
* Suspected infections
Pulmonary Perfusion Heterogeneity in Patients With CTEPH Using Functional PET Imaging

This study with evaluate blood flow in the lungs of patients prior to and after surgery for treatment.

Specifically, we will evaluate the length-scale or size of blood flow alterations using filtering techniques with the objective of identifying the size of blood vessels that are obstructed by clot (large vessels versus small vessels).

Eligibility Criteria:
Inclusion Criteria:

1. Subject is diagnosed with chronic thromboembolic pulmonary hypertension (WHO Group IV) and planning to undergo pulmonary thromboendarterectomy.
2. Subject is male or female aged \> or =18 years of age and \< or = 70 years.
3. Subject has undergone RHC within six months of entering the study.
4. The subject is capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
5. A signed and dated written informed consent is obtained from the subject.
6. Available to complete the study.
7. Able to lie flat and able to perform a 30 second breath hold.

Exclusion Criteria:

1. FEV1 and/or TLC \< 70% predicted.
2. Inability to perform the study (by primary MD or investigator assessment).
3. Inability to perform the respiratory maneuvers necessary for the exam.
4. Subjects who have a past or present disease, which as judged by the Investigators may affect the outcome of this study.
5. The subject has suspected history of drugs or alcohol abuse within the six months prior to the screening visit.
6. The subject is a woman of childbearing potential who is pregnant, seeking to become pregnant, or has a positive pregnancy test.
7. Subject with clinical instability in the judgment of the investigator, with a heart rate \> 120 bpm, respiratory rate \> 24, SpO2 \< 88%, blood pressure \< 90/60 or \> 140/90 or fever \> 101, or subjects with hospitalization for progression of pulmonary hypertension or right heart failure in the three months prior to the study.
8. Subject with diagnosis of active tuberculosis, lung cancer, clinically overt bronchiectasis, allergic rhinitis, asthma, heart failure, ischemic heart disease, or COPD.
9. Subject that had a respiratory tract infection in the 4 weeks prior to the screening visit and throughout the duration of the study.
10. The subject has been exposed to a radiation dose over the past year that, when added to the radiation dose expected in this study, would exceed permissible yearly exposure as determined by the MGH radiation safety committee.