cyrilzakka/clinical-trials huggingface dataset:
Post-marketing Study of Lyophilized Nasal Spray Live Attenuated Influenza Vaccine

To evaluate the protective effect 14 days after the live attenuated influenza vaccine; To evaluate the protective effect of vaccination with live attenuated influenza vaccine; To evaluate the safety of freeze-dried nasal spray live attenuated influenza vaccine; To evaluate the detoxification and genetic stability of lyophilized nasal spray vaccine.

To evaluate the protective effect of novel coronavirus after 14 days of inoculation with the live attenuated influenza vaccine.

Main end point:

Primary influenza protective effect endpoint Protective effect of 14 days on laboratory-confirmed influenza cases. Protective effect of 14 days after receiving lyophilized nasal spray live attenuated influenza vaccine on laboratory-confirmed serotype influenza cases.

Secondary endpoints:

Secondary point of secondary endpoint Protective effect of freeze-dried nasal spray live attenuated influenza vaccine 0 days later on laboratory-confirmed influenza cases.

Protective effect of freeze-dried nasal spray live attenuated influenza vaccine 14 days later on clinically diagnosed influenza cases.

Protective effect of live attenuated influenza-like vaccine 14 days against influenza-like cases.

safety Incidence of adverse events and serious adverse events within 0-30 days after immunization.

Study on detoxification Proproportion of vaccine attenuated proportion and vaccine attenuated content (titer) at different times after vaccination (days 3,7,15).

Exploration endpoint:

14 days after the freeze-dried nose vaccine, the vaccine was protective for the detection of COVID-19 cases.

Eligibility Criteria:
Inclusion Criteria:

1. Local residents aged between 3 and 17;
2. People who signed the informed consent form and could actively cooperate with the study；
3. Axillary body temperature of 37.0℃.

Exclusion Criteria:

1. Subjects who meet the contraindications and precautions specified in the vaccine instructions:

   1. Those known to be allergic to any ingredients of this product, including eggs, excipients, gentamycin sulfate;
   2. Patients with acute disease, severe chronic disease, the acute onset of chronic disease and fever;
   3. Women in pregnancy;
   4. Patients with Leigh syndrome treated with aspirin or aspirin-containing drugs;
   5. Immunodeficient, immunocompromised, or under immunosuppressive therapy;
   6. Patients with uncontrolled epilepsy and other progressive neurological diseases, patients with a history of Guillain-Barre syndrome; And g. patients with rhinitis (with a clear diagnosis and in the onset of rhinitis).
2. Have received other clinical study drugs or were participating in other clinical trials within 1 month before entering the cohort.
3. Have received any influenza vaccine during this natural year before entering the study
4. Those who have been diagnosed with influenza in this natural year before entering the study.
5. Any condition that the investigator judged to affect the trial.
Analyzing Genes That May Increase the Risk of Developing High Blood Pressure

High blood pressure is one of the most common health problems in the United States. Genetic variations may cause some people to be more susceptible to developing high blood pressure. This study will identify variations in genes known to play a part in the development of high blood pressure.

High blood pressure affects nearly one third of all individuals in the United States. It is especially common in African Americans, with more than 40% of African Americans diagnosed with this condition. High blood pressure usually develops earlier in life and is more severe in African Americans than in other racial or ethnic groups. Many factors can cause high blood pressure, including stress, diet, diabetes, kidney disease, or obesity. Previous studies have also shown that genetic variations on two regions of chromosomes 6 and 21 may predispose some people to develop high blood pressure. Admixture mapping is a type of genetic analysis that aims to identify disease-causing genetic variations across different populations of people. Using admixture mapping, this study will examine previously collected genetic samples from African American participants in the Family Blood Pressure Program (FBPP) study and from African American, Mexican American, Nigerian, and Jamaican participants enrolled in other clinical studies. Study researchers will analyze the samples to identify and characterize genetic variations that are associated with an increased risk of high blood pressure in the African American population, as well as other racial and ethnic groups.

Eligibility Criteria:
Inclusion Criteria:

* Participated in the FBPP study (African American \[800 people with high blood pressure and 800 control group participants\] and Mexican American participants)
* Participated in the American Family Study (African American participants)
* Participated in the Phenotyping Study (African American, Nigerian, and Jamaican participants)
Predictive Value of Renal Venous Flow Profiles for Adverse Outcomes in Right Heart Failure

Predictive value of renal venous flow profiles for adverse outcomes in patients with right heart failure

Persistent congestion with deteriorating renal function is an important cause of adverse outcomes in heart failure. The investigators aimed to characterize new Doppler ultrasonography approaches to evaluate the continuum of renal congestion. Pulmonary hypertension is the most common precursor to right heart failure and thus represents an ideal scenario to study congestion. The second cohort comprises consecutive Cardiology inpatients aged ≥18 years with a new or pre-existing diagnosis of heart failure who are referred to the consultant nephrologist with a history of diuretic-resistant fluid overload and impaired renal function. The investigators choose patients with heart failure to broaden the findings to the most common clinical entity of right ventricular failure.

Eligibility Criteria:
Pulmonary hypertension cohort:

Exclusion Criteria:

* CKD stage 5 (KDIGO)
* pre-existing acute kidney injury (acute kidney injury was defined as an increase in serum creatinine by ≥ 0.3 mg/dl within 48 hours or to ≥ 1.5 times baseline within the prior 7 days, as determined by all available serum creatinine values from hospital and outpatient medical records within the previous 90 days)
* Non-end stage renal disease patients with extracorporeal or peritoneal ultrafiltration for treatment of diuretic-resistant fluid overload
* Patients with primary kidney disease (e.g., glomerulonephritis, autosomal dominant polycystic kidney disease, postrenal obstruction)
* solid-organ transplant recipients
* use of non-steroidal inflammatory drugs within 72 hours before right heart catheterization

Heart failure cohort:

Exclusion criteria same as in the discovery cohort except pre-existing acute kidney injury

* Patients with mechanical assist devices are excluded
Diagnosis of Lung Complication After Allo-HSCT by Multiple Parameter System Through BAL

The aim of this study was to evaluate the diagnostic yield for lung complication after allo-HSCT by multiple parameter system through BAL.

一) Adult patients with hematology disease under allo-HSCT at any phase of treatment are enrolled according to the following criteria:

1. lung infiltration detection at computed tomography (CT) scan.
2. Patients with fever, cough, respiratory symptoms. According to the investigators, the patients fulfilling these criteria undergo BAL as soon as possible

二) The BALF samples were tested using such methods

1. classic microbiological cultures designed for bacteria, fungi, and mycobacteria.
2. Detection of human cytomegalovirus (CMV) and EB virus in serum and BAL was tested using a Real-time PCR kit.
3. Detection of aspergillus galactomannan antigen 1,3-beta-D-glucan in serum and BAL was performed using an enzyme immunoassay method.
4. Cytological and pathogenic microscopic evaluation in BALF
5. Flow cytological analysis of T lymphocyte subsets in BALF and serum
6. Cytokine detection in BALF and serum
7. Microbiology detection in BALF by mNGS

三) Pathogenic spectrum analysis and Targeted etiological therapy

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with hematological diseases.
2. Recipients of allogeneic peripheral blood stem cell transplantation.
3. Lung infiltration detection at computed tomography (CT) scan.
4. Patients with fever, cough, respiratory symptoms.
5. Consent to BAL and follow-up observation after BAL

Exclusion Criteria:

1. Severe bleeding tendency, platelet less than 20000/uL, or severe coagulation dysfunction;
2. Multiple bullae are at risk of rupture;
3. Untreated patients with active pulmonary tuberculosis;
4. Patients with severe consumptive diseases or conditions and various causes can not cooperate well
5. Cardiac insufficiency, severe pulmonary ventilation dysfunction
6. Recent massive hemoptysis
7. Aortic aneurysm and esophageal varices are at risk of rupture
Expanded Access For Lorlatinib For Patients With Non Small Cell Lung Cancer ALK Positive or ROS1 Positive

This expanded access study has being designed following a demand from the FDA, given the increase in the number of request for single patient INDs for lorlatinib

Given that an Expanded Access study does not meet the definition of a controlled clinical investigation, and as such, is not considered an applicable drug clinical trial per NIH, Basic Results for such studies are not required to be reported. Protocol B7461020 has been identified as an Expanded Access trial, and has been registered to ClinicalTrials.gov, however Basic Results will not be posted. This statement has been placed in the Detailed Description section of the protocol registration on ClinicalTrials.gov.

Eligibility Criteria:
Inclusion Criteria:

* Ineligibility for participation in any ongoing clinical study of the investigational product
* Age ≥18 years
* Histologically or cytologically diagnosis of metastatic NSCLC that carries an ALK rearrangement or a ROS1 rearrangement
* For ALK positive patients: failure to prior treatment with at least one ALK-TKI. If prior ALK-TKI was crizotinib, additional prior treatment required with at least one second generation ALK-TKI registered and commercially available. For patients with resistance mutations not covered by other inhibitors (eg, ALK G1202R resistance mutation), prior treatment with an ALK/ROS1 inhibitor is not required.
* For ROS1 positive patients: failure to prior treatment with at least crizotinib
* Adequate bone marrow, liver, renal, pancreatic functions
* Negative pregnancy test at screening

Exclusion Criteria:

* Previous surgery, chemotherapy, radiotherapy or other anti cancer therapy or participation in other studies with investigational drugs within the timeframe indicated in the protocol
* History of interstitial fibrosis or interstitial lung disease
* Concomitant use of prohibited medication
* Clinically significant cardiovascular disease: cerebral vascular accident/stroke, myocardial infarction, unstable angina, congestive heart failure, second degree or third degree atrioventricular block (unless paced) or any AV block with PR \>220 msec
* Ongoing cardiac dysrhythmias, uncontrolled atrial fibrillation,bradycardia, ECG with QTc \>470 msec, or congenital long QT syndrome
* History of or predisposing characteristics for acute pancreatitis
Splanchnic X: Splanchnic Nerve Block in Heart Failure With Reduced Ejection Fraction

Heart failure (HF) affects more than 6 million adults in the U.S. alone, with increasing prevalence. Cardiovascular congestion with resultant limitation in physical activity is the hallmark of chronic and decompensated HF. The current HF physiologic model suggests that congestion is the result of volume retention and, therefore, therapies (such as diuretics) have generally been targeted at volume overload. Yet therapeutic approaches to reduce congestion have failed to show significant benefit on clinical outcomes, potentially due to an untargeted approach of decongestive therapies. The investigators' preliminary work suggested a complimentary contribution of volume redistribution to the mechanism of cardiac decompensation. The investigators identified the splanchnic nerves as a potential therapeutic target and showed that short-term interruption of the splanchnic nerve signaling could have favorable effects on cardiovascular hemodynamics and symptoms.

As part of the investigators' proposal, the investigators will test the safety and efficacy of prolonged splanchnic nerve block in a randomized, controlled, blinded study in patients with HF and reduced ejection fraction (HFrEF). The results will help test the hypothesis of volume redistribution as a driver of cardiovascular congestion and functional limitations and pave the way for splanchnic nerve blockade as a novel therapeutic approach to HF.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Established diagnosis of HFrEF with left ventricular ejection fraction \<50%
* NYHA II-III symptoms
* Stable HF drug regimen for the preceding 1 month
* Wedge pressure \>/=15 mmHg at rest or \>/=20 mmHg with peak stress on the initial invasive exercise testing
* Glomerular filtration rate ≥ 15 mL/min per 1.73 m2
* Heart rate with activity such as the 6 min walk increases by at least 10 beats

Exclusion Criteria:

* Type I myocardial infarction within 3 months
* Infiltrative (i.e., amyloid) or hypertrophic cardiomyopathy
* Uncontrolled atrial (heart rate \>100bpm) or ventricular arrhythmia
* Chronic oxygen use \>2L
* Hypersensitivity to albumin and pregnancy
* History or scoliosis
* Orthostatic hypotension (including a drop of pulse pressure with standing of more than 10)
Comparing Methods for Tracking Health Information at Home After Lung Transplant

The purpose of this randomized controlled trial is to test the efficacy of a novel intervention, Pocket PATH (Personal Assistant for Tracking Health) for promoting self-care agency, self-care behaviors, and transplant-related health.

Lung transplant recipients (LTR) experience more transplant-related complications, higher health resource utilization, and higher mortality than recipients of other solid organs. Prevention and detection of early complications is known to reduce the likelihood of future impairments in lung function and, therefore, morbidity and mortality. Despite the scarce donor organs and financial resources expended to support individuals throughout the lung transplant experience, no randomized controlled trials (RCT) have tested interventions designed to promote self-care behaviors with the aim of improving transplant-related health after lung transplant. The purpose of this RCT is to compare the efficacy of a novel behavioral intervention, Pocket PATH (Personal Assistant for Tracking Health) for promoting self-care and improving health outcomes relative to standard care after lung transplantation. Pocket PATH provides LTR a hand-held device with customized data recording, trending, and decision-support programs to promote their self-care behaviors. Based on the promising results from our early trials, a full-scale RCT has been designed to rigorously test the efficacy of Pocket PATH in promoting self-care agency, self-care behaviors, and hence improving transplant-related health. A sample of 214 LTR who survive the immediate intensive care unit recovery period will be randomly assigned to either the intervention group, who will be instructed to use the Pocket Path device and its programs designed for self-monitoring, adhering to the regimen, and communicating condition changes to the transplant team, or the control group who will receive standard instructions regarding the post-transplant regimen (including health monitoring). Information will be collected from participants at baseline and 1 week, 2, 6, and 12 months after discharge from the hospital following lung transplantation. Longitudinal, repeated-measures models with planned comparisons will be used to test the hypotheses for the primary aims. It is hypothesized that subjects in the Pocket PATH group will develop higher levels of self-care agency and perform self-care behaviors more often than subjects in the control group and, therefore, will experience fewer transplant-related complications, re-hospitalizations, and better health related quality of life.

Eligibility Criteria:
Inclusion Criteria:

* a recipient of a lung transplant
* 18 years of age or older
* stable enough to be transferred from the CTICU to the acute unit
* not been discharged from initial transplant hospitalization
* able to read and speak English

Exclusion Criteria:

* a recipient of any prior transplant
* a condition that precludes discharge from the hospital
* limited involvement in post-transplant care is anticipated (e.g., plan to discharge to skilled nursing facility)
PREventing Adverse Events Post-Discharge Through Proactive Identification, Multidisciplinary Communication, and Technology

The goal of this study is to expand the use of previously developed patient safety dashboards and patient-centered discharge checklists to three general medicine units in an affiliated community hospital. The safety dashboard and interactive pre-discharge checklist are cognitive aids for clinicians and patients, respectively, that serve to facilitate early detection of patients at risk for preventable harm, including suboptimal discharge preparation. The aims of this study are to:

1. Enhance the safety dashboard and interactive pre-discharge checklist to include "smart" notifications for hospital-based clinicians when patients are at high risk for adverse events or have identified specific concerns related to discharge based on their checklist responses.
2. Expand intervention to general medical units at our community hospital-affiliate, BWFH.
3. Evaluate impact on post-discharge AEs for patients discharged from BWFH who are at risk for preventable harm and hospital readmission.

Our project proposes to address gaps in functionality of commercially available EHR systems through evaluation of novel, EHR-integrated HIT tools. We previously designed, developed, and implemented the patient safety dashboard and interactive pre-discharge checklist to engage clinicians and patients in systematically addressing safety threats in each of several domains. By integrating clinical data of several different types, these tools serve to reduce cognitive load and improve decision-making for clinicians. In this way, these tools represent a preventative intervention that mitigates risk in each domain by suggesting corrective action corresponding to institutional safety guidelines.

Studying the effectiveness of these tools on post-discharge outcomes will improve knowledge, technical capability, and clinical practice related to patient safety during transitions of care. Specifically, our project will advance scientific knowledge by quantifying the post-discharge impact of an intervention that changes clinical practice by enabling hospital-based clinicians to proactively institute corrective action for "at risk" patients who may require additional surveillance and supportive services during transitions. Also, we will establish the technical feasibility of spreading customized, third-party digital health applications that fill critical safety gaps in commercially available EHRs; expanding to a community hospital has clear implications for adoption and validation of this technology in different practice settings.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, \>18 years of age, English-speaking
* Caregivers \>18 years of age designated by patient or patient's healthcare proxy
* Two or more patient safety risk factors

Exclusion Criteria:

- Non-English speaking patients for whom we cannot identify an English-speaking healthcare proxy
IMFINZI Study in Patients With Extensive Stage Small Cell Lung Cancer

To capture safety(FN) when IMF is administered to patients with extensive stage small cell lung cancer in clinical practice after launch

To capture the onset (incidence, severity, intervention, outcome, and others) of febrile neutropenia in patients with extensive stage small cell lung cancer who receive durvalumab in combination with platinum agent and etoposide under the actual use.

Eligibility Criteria:
Inclusion Criteria:

-Patients with extensive stage small cell lung cancer who are receiving the product in combination with platinum agent and etoposide.

Exclusion Criteria:

-Patients who have no treatment history with the product (i.e.,durvalumab)
REmote MOnitoring Transmission Evaluation of IPGs

The purpose of this study is to evaluate the potential clinical and economic benefits of using CareLink remote management for pacemaker follow-up.

Study Objectives include:

1. To determine clinician perceived quality of care for CareLink remote follow-up.
2. To determine patient satisfaction with CareLink follow-up.
3. To estimate the time required to perform patient follow-up via CareLink remote transmissions.
4. To determine the percentage of regular CareLink follow-ups that do not require further in-clinic review of the patient.
5. To estimate potential patient cost avoidance for one year of follow up incorporating CareLink.
6. To evaluate compliance to scheduled CareLink transmissions with the remote management system

This is a non-randomized, multi-center, prospective study in which 120 patients who have a pacemaker are enrolled into the study and receive a CareLink monitor. Patients will replace their regularly scheduled pacemaker clinic follow-up visits with a CareLink remote transmission for 12months.

Patients will require a test transmission within 1 month after they receive their CareLink monitor. Afterwards, patients are followed via CareLink transmissions as per their usual clinic schedule for 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have received a market released Medtronic pacemaker with automatic threshold management features for all active leads.
* Patients who have been implanted with their current pacemaker for at least 3 months.
* Patients who are willing, or who have caregivers willing, to use the Medtronic CareLink Monitor.
* Patients who are willing and able to sign an IRB/MEC approved patient informed consent.

Exclusion Criteria:

* Patients participating in another study that would affect the objectives of this study
* Patients who have already previously used a Medtronic CareLink Monitor.
Syncytiotrophoblast-derived Extracellular Vesicles in Placenta Previa and Accreta Spectrum

The main goal of this case-control study is to quantify the levels of circulating syncytiotrophoblast-derived extracellular vesicles (STBEVs) in maternal blood in a population of women with placenta previa and placenta accreta spectrum.

The main goal of this case-control study is to quantify the levels of circulating syncytiotrophoblast-derived extracellular vesicles (STBEVs) in maternal blood in a population of women with ultrasound diagnosis of PP with and without postpartum histopathologic diagnosis of PAS, compared to pregnant women with normal placentation.

The secondary aim of this case-control study is to characterize the multi-omics profiling of STBEVs cargo's (proteins, gene and transcripts) isolated from patients diagnosed with PP and PAS compared to the control population.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women with diagnosis of placenta previa and accreta spectrum (cases)
* Healthy pregnant women
* \> 18 years

Exclusion Criteria:

* \< 18 years
* Twin pregnancies
* Chronic Infections
* Cancers
* Unable to give the written consent