cyrilzakka/clinical-trials huggingface dataset:
Diffuse Myocardial Fibrosis in Fontan Patients

The purpose of this protocol is to measure the relaxation of the heart in subjects with single ventricles who have undergone the surgical Fontan procedure. We will do this by measuring relaxation with MRI, echocardiography, and cardiac catheterization and compare to blood levels that measure heart scarring. We will also measure relaxation before and after boluses of intravenous (IV) fluids to see if the relaxation changes when there is more fluid in the heart. Measurements of heart relaxation will be obtained from the MRI, echocardiogram, and cardiac catheterization for each patient and compared to blood markers of heart scarring. We aim to compare all of these measurements to see if we can accurately identify heart scarring and, if present, how much it correlates with impaired heart relaxation.


Eligibility Criteria:
Inclusion criteria: adult patients (age ≥18) with a previous Fontan procedure (including all variants) referred for catheterization. This includes individuals with tricuspid atresia, double inlet left ventricle, unbalanced atrioventricular septal defect, and pulmonary atresia with intact septum. Control subjects will be selected from individuals referred to the lab for evaluation/closure of a patent foramen ovale (PFO). All subjects must be willing to participate in all portions of the study and provide written informed consent.

Exclusion criteria: contraindications to MRI such as ferromagnetic objects in the chest, claustrophobia, or contraindication to gadolinium contrast (estimated creatinine clearance \< 30 ml/min/1.73m2). Fontan patients with a morphologic right ventricle (namely hypoplastic left heart after a Norwood palliation) will be excluded, because of the disproportionate risk of systolic dysfunction in the morphologic right ventricle.33 Control patients with hypertension, diabetes, coronary disease, or reduced systolic function will be excluded.
Positron Emission Tomography (PET) Study for Staging of Muscle Invasive Bladder Cancer

This prospective pilot study will enroll 30 patients with cT2/T3-N0-M0 urothelial carcinoma of the bladder for whom radical cystectomy with pelvic lymph node dissection is planned. This pilot study is designed to provide preliminary information on the accuracy of \[18F\] Fluorodeoxyglucose Positron Emission Tomography MRI (FDG-PET-MRI) in the staging of muscle-invasive bladder cancer.

This prospective pilot study will enroll 30 patients with cT2/T3-N0-M0 urothelial carcinoma of the bladder for whom radical cystectomy with pelvic lymph node dissection is planned. This pilot study is designed to provide preliminary information on the accuracy of \[18F\] Fluorodeoxyglucose Positron Emission Tomography MRI (FDG-PET-MRI) in the staging of muscle-invasive bladder cancer. All patients will undergo baseline FDG-PET-MRI and routine (standard of care) contrast enhanced abdominal/pelvic multi-detector computed tomography (MDCT). The imaging results will ultimately be compared to final pathology as the gold standard. If the accuracy of FDG-PET-MRI is improved as compared to standard MDCT, the investigators plan to conduct a larger follow-up study to confirm the results of this pilot study. In addition, this pilot study will set the stage for the evaluation of novel PET tracers in the imaging of bladder cancer.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age (no upper age limit)
* Informed consent obtained and signed
* cT2/T3-N0-M0 urothelial carcinoma of the bladder
* Planned radical cystectomy with pelvic lymph node dissection
* No known local regional or distant metastatic disease
* Women of childbearing potential must have a negative serum or urine pregnancy test performed within 7 days prior to FDG-PET-MRI

Exclusion Criteria:

* History of severe reaction to contrast-enhanced CT scan
* Poorly controlled diabetes mellitus
* Inability to tolerate PET and/or MRI
* Presence of pacemaker or intracranial aneurysm clip
* Serum creatinine \>1.8 mg/dL OR GFR \< 30mL/min
* Pregnant or lactating female
* Inability to lie flat for \>1 hour
* Body Mass Index (BMI) \>35
* History of a prior malignancy within past 5 years are excluded unless they have been disease free for 3 or more years or unless they have a completely resected non-melanoma skin cancer.
* Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study
Registry for Quality Assessment With Ultrasound Imaging and TTFM in Cardiac Bypass Surgery

The purpose of the registry is to collect information regarding the number and type of coronary artery bypass (CAB) surgical procedure changes that are made based on intraoperative guidance information using transit time flow measurements (TTFM) and ultrasound image capabilities provided with the Medistim device.


Eligibility Criteria:
Inclusion Criteria:

* Subject has been scheduled for coronary bypass surgery
* Subject understands the nature of the procedure and has signed the subject informed consent prior to the procedure
* Subject has been diagnosed with 2-3 vessel disease

Exclusion Criteria:

* Subject is scheduled for other surgical procedures during the bypass surgery (valve replacement/repair, carotid endarterectomy, etc.)
* Subject is known to be suffering from any psychological, developmental, physical, or emotional disorder that the investigator feels would interfere with surgery or follow-up testing
* Subject is undergoing an emergency cardiac bypass surgery
* Subject has history or presence of muscle disease (i.e. myopathy, myalgia, myasthenia, rhabdomyolysis) with or without concomitant CK-elevation \> 5 ULN that cannot be ascribed to any other medical condition (e.g. myocardial infarction)
* Subject has any condition that the investigator believes should exclude him/her from this registry
Reducing Parental Stress Via Instant Messaging During COVID-19 Pandemic: A Randomized Controlled Trial

This research investigated the effects of mindfulness practice on mental wellbeing and parenting behaviour, with the instruction recordings delivered via existing instant messaging applications, including Whatsapp and Signal. The two-week mindfulness program targeted parents with children in Nursery, Kindergarten to Primary School. Due to the suspension of schools, work from home policies, parents spend increased amount of time with their children. News reports have indicated that with the mounting care taking responsibilities and downturn of economy amidst the epidemic, parents have been experiencing higher stress that may negatively impact their wellbeing and parent-child relationship. This study delivered an app-based intervention that aims at enhancing mindful parenting at the time of corona, where social distancing is emphasized.


Eligibility Criteria:
Inclusion Criteria:

Parents with at least one child who is in Primary School or below.
Abacavir, Dolutegravir and Lamivudine Dispersible Tablets (60 mg/5 mg/30 mg)

The rationale for this study is to evaluate and understand the variability of a generic alternative of abacavir, dolutegravir and lamivudine dispersible tablets for PEPFAR submission to aide in the development of pivotal studies.

This study is to investigate the bioequivalence of Mylan's abacavir, dolutegravir and lamivudine dispersible tablets, 60 mg/5 mg/30 mg to ViiV's Triumeq Dispersible Tablets (5 mg GSK1349572 \[dolutegravir\]/ 60 mg abacavir/ 30 mg lamivudine) following administration of a single, oral 60 mg/5 mg/30 mg (1 x 60 mg/5 mg/30 mg) dose of Mylan's abacavir, dolutegravir and lamivudine dispersible tablets or ViiV's Triumeq Dispersible Tablets administered under fasting and fed conditions.

Adverse events will be monitored to ensure the safety and well-being of the healthy volunteers.

Eligibility Criteria:
Inclusion Criteria - Subject candidates must fulfill all of the following inclusion criteria to be eligible for participation in the study, unless otherwise specified:

* 18 to 55 years old.
* Males and/or females not of child-bearing potential.
* Each subject is required to weigh at least 50 kg (110 lbs) for men and 48 kg (106 lbs) for women and have a Body Mass Index (BMI) value less than or equal to 30.0 kg/m2 but greater than or equal to 19.0 kg/m2.
* Adequate venous access in both arms.
* Only non-tobacco/non-nicotine subjects.
* Able to understand and sign the written Informed Consent Form.
* Willing to follow the protocol requirements and comply with protocol restrictions.
* All subjects should be judged by the Principal Investigator or Medical Sub- Investigator as normal and healthy during a pre-study medical evaluation performed within 28 days of the initial dose of study medication.

Exclusion Criteria - Subject candidates must not be enrolled in the study if subject meet any of the following criteria:

* Institutionalized subjects.
* Social Habits, Medications and Diseases will be evaluated.
* Use of certain foods and processed candies, gums food/drinks that contain sugar alcohols.
* Liver function tests (ALT, AST and total bilirubin).
* Subjects who are positive for the HLA-B\*5701 allele.
* Subjects having Modified Patient Health Questionnaire (PHQ)-12 questionnaire score \> 4.
* Subject has a creatinine clearance \< 90 mL/min, as determined by the Cockroft-Gault equation.
* Any reason which, in the opinion of the Principal Investigator or Medical Sub- Investigator, would prevent the subject from safely participating in the study.
* Intolerance to venipuncture.
* Donation or loss of blood or plasma.
* Subjects who have received an investigational drug within 30 days prior to the initial dose of study medication.
* Any food allergy, intolerance, restriction or special diet that, in the opinion of the Principal Investigator or Medical Sub-Investigator, could contraindicate the subject's participation in this study.
* Allergy or hypersensitivity to abacavir, dolutegravir, lamivudine, other related products, or any inactive ingredients.
B2-Adrenergic Receptor Polymorphisms

Beta(2)-adrenergic receptor (BAR) agonists are the most important group of drugs used in the treatment of asthma. In children unresponsive to inhaled BAR agonist therapy, higher dose systemic BAR agonist therapy is frequently the next step in treatment. Despite the widespread use of intravenous BAR agonist therapy for pediatric status asthmaticus, there is controversy regarding the efficacy of this therapy. A number of studies have established that genetic variations of the BAR have important effects in modulating responses to BAR agonist therapy for asthma. In particular, changes in amino acid position 16 of the BAR gene are thought to be the most functionally important. Patients encoded for two glycine amino acids, rather than arginine, at this position appear to have more severe asthma and to respond differently to acute BAR agonist therapy.

Our hypothesis is that genotypic differences may contribute to poor response to acute BAR agonist treatment. We propose to conduct a prospective observational study to determine the influence of a patient's BAR genotype on the response to acute BAR agonist therapy.

Our specific hypothesis is that children with genetic polymorphisms of the gene encoding the BAR will have a decreased response to acute high-dose continuous BAR therapy (both inhaled and intravenous) compared to other children.

Our primary outcome is ICU length of stay. Secondary outcomes are

1. to assess the rate of improvement in clinical asthma score based on genotype, and
2. to attempt to correlate asthma phenotype with genotype by comparing demographic data and hospital course.

This study has both a prospective and a retrospective arm. In the retrospective arm, patients with a history of admission to the ICU with a severe asthma exacerbation are contacted by phone and mail and DNA samples are obtained via saliva. In the prospective arm, patients admitted to the ICU are contacted prospectively and DNA is obtained either via saliva or blood.

Eligibility Criteria:
Inclusion Criteria:

* (1) Admission to the CCMC PICU with a primary admission diagnosis of status asthmaticus. (2) Age between 2 years and 18 years.

Exclusion Criteria:

* Pre-existing chronic disease (other than asthma)
NIMH Clinical Pathway in Rural Appalachian School-based Health Clinics

This study will adapt and evaluate an evidence-based suicide risk screening and follow-up program in two school-based health centers in West Virginia. The suicide screening program is titled the "NIMH Clinical Pathway" and provides tools and procedures for routinely screening adolescents for suicide risk, completing risk assessments, safety planning, lethal means restriction, follow-up referrals, and other disposition planning as appropriate.

Investigators aim to do the following:

1. Gather formative data from providers, parents, and youth to inform ways to adapt and implement the NIMH Clinical Pathway so that it can be effectively implemented in rural, Appalachian School-Based Health Centers (SBHCs).
2. Gather preliminary data regarding the feasibility, acceptability, and effectiveness of the adapted intervention.


Eligibility Criteria:
Inclusion Criteria:

* Youth who are receiving services at the school-based health centers to participate
* Parents must be able to give legal consent for themselves and their children to participate
* Youth and Parent must be English-speaking
* Youth must also be able to give signed assent to participate
* Youth must be cognitively and medically able to participate in study activities

Exclusion Criteria:

* Youth in state custody will be excluded from study participation due to challenges related to obtaining legal consent.
Scintigraphic Evaluation of IPAA Function in Patients With Ulcerative Colitis

The aim of this study is to evaluate scintigraphic methods as objective factors for functional outcome in patients treated with ileal-pouch-anal anastomosis (IPAA). The gastrointestinal transit-time and the degree of evacuation are evaluated in relation to the functional outcome.


Eligibility Criteria:
Inclusion Criteria:

* Ulcerative colitis patients
Investigating Significant Health Trends in Idiopathic Pulmonary Fibrosis

Idiopathic pulmonary fibrosis (IPF), a manifestation of chronic progressive fibrosing interstitial pneumonia,ia a rare disease. Current treatment options are limited, and the mean survival time of the newly diagnosed (mostly elderly) patients is only about 2-3 years. As in Europe data are limited on the characteristics and management of such patients, INSIGHTS-IPF was initiated as a new registry that documents newly diagnosed (incident) and prevalent patients with confirmed IPF diagnosis prospectively.The registry will contribute to the optimization of the management of IPF patients in the long term.

INSIGHTS-IPF will report current and comprehensive data on Idiopathic Pulmonary Fibrosis (IPF) in the long-term.

Baseline (cross-sectional part): Description of characteristics of IPF patients in terms of

* key (socio-) demographic data
* IPF risk factors, comorbidities
* methods used for IPF diagnosis
* IPF disease severity and manifestation (including lung function, cardiopulmonary exercise testing and/or exercise capacity if available, laboratory values, biomarkers)
* IPF treatment (detailed information on prescribed drugs and doses; non-pharmacological treatment; listing and score for lung transplantation)
* assessment of patient-related outcomes (PRO) such as quality of life

Follow-up (prospectively up to at least 2 years after inclusion):

* Clinical course of IPF (e.g. in terms of symptoms, lung function, exercise capacity if available)
* Documentation of treatment pathways (switch/add-on/discontinuation of medication), and of non-pharmacological treatment (e.g. start of long term oxygen therapy; new listing for lung transplantation)Outcomes/events (such as acute respiratory worsening, exacerbations, hospitalisation due to any cause and due to IPF, other complications, survival)
* Patient-related outcomes such as quality of life, assessed once a year(for comparison with baseline)
* Resource use for pharmacoeconomic analyses.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Written informed consent for participation in the registry
* Newly diagnosed (incident) or known (prevalent) IPF (based on diagnosis of treating physician)

Exclusion Criteria:

* None
An Observational Registry of Chinese COPD Study

This is a multi-center, observational registry study involving secondary and tertiary hospitals across China. The objective is to study the disease burden, disease progression, comorbidities, treatment pattern and real-world cost, effectiveness and safety of different therapy options for COPD patients in Chinese clinical practice in China.

COPD is the most common chronic respiratory disease in China and has caused significant economic and humanistic burden. Patient reported outcomes (PRO) have been widely used to assess disease activity and quality of life for COPD patients. Wearable devices enable recording activity data of patients continuously and automatically. The objective of the study is to study the disease burden, disease progression, comorbidities, treatment pattern and real-world cost, effectiveness and safety of different therapy options for COPD patients in Chinese clinical practice in China. This is a multi-center, observational registry study involving secondary and tertiary hospitals across China. 3000-5000 participants are planned to be recruited. Each participant will be followed-up at baseline and every 3 months. Clinical assessment data, laboratory examination data and cost data are captured from electronic medical records (EMR). Patient-reported outcome (PRO) data are collected via smartphone app. Part of patients will receive wearable devices to record digital health technology (DHT) data. As the first ever observational registry focused on COPD stable-period management, this study can provide more information on these following issues. (1) Annual changes in COPD prevalence, treatment pattern and economic burden in China. (2) Assessing the real-world effectiveness and safety of different treatment patterns of COPD via EMR, PRO and DHT. (3) Cost-effectiveness and budget impact to the public healthcare funds of different treatment patterns of COPD.

Eligibility Criteria:
Inclusion Criteria:

1. Adults age 40 or older with a diagnosis of chronic obstructive pulmonary disease (COPD) having been prescribed any COPD treatment (initial or subsequent) outside of a clinical trial.
2. Have plans for future visits at the site for continued management of COPD.

Exclusion Criteria:

1. Inability to provide written informed consent/assent.
2. Being enrolled in any interventional study or trial for COPD treatment. Note: Patient may be enrolled in other registries or studies where COPD treatment outcomes are observed and/or reported (such as center-based registries).
High-dose Bevacizumab in Advanced Renal Carcinoma Patients

This trial will examine the effectiveness and the side effects of 2 higher dosing schedules of bevacizumab in patients that have advanced clear cell renal carcinoma.

Bevacizumab is considered a targeted drug. Targeted drugs act on specific receptors on a cell. Bevacizumab blocks receptors that help cancer cells develop blood supplies so that the cancer can grow. These specific receptors are found in greater numbers in kidney cancer. In that regard bevacizumab will be tested in 2 doses that are higher than non-kidney cancer treatments with bevacizumab.

One group of patients will receive bevacizumab at 15 mg per kg by vein every 2 weeks. A total of 75 patients will be treated with this dose.

If this dose is well tolerated a second group of patients will receive bevacizumab at 15mg per kg by vein weekly.

Eligibility Criteria:
Inclusion Criteria:

* Histologically documented metastatic or unresectable locally recurrent clear cell renal carcinoma
* Previous kidney removal is required except if the primary tumor was smaller than 5 cm or there was extensive liver or bone metastasis
* Patients may have received a maximum of 1 prior systemic treatment of immunotherapy (Interferon, IL-2), chemotherapy, or combination chemo+immunotherapy for metastatic disease.
* No prior bevacizumab
* Measurable disease
* Adequate liver and kidney function
* Age 18 and older

Exclusion Criteria:

* Acute MI within the past 6 months
* Uncontrolled high blood pressure or history of hypertensive crisis
* Clinically significant cardiovascular disease
* Active brain cancer
* Meningeal metastasis
* Pregnant or lactating women
* Prior treatment for another cancer less than 5 years ago
* No diseases of the central nervous system (eg. uncontrolled seizures, strokes or TIAs
* No bleeding from the mouth, rectum or coughing up blood or history of other bleeding or clotting disorders
* No history of deep vein thrombosis less than 12 months ago or are currently requiring full dose anticoagulation
* No major surgical procedures, open biopsies or traumatic injury in past 28 days
* No patients with peg tubes or feeding tubes
* No patients with non healing wounds, ulcers or long bone fractures
* No history of abdominal fistulas, gastrointestinal perforation or intrabdominal abscess within 6 months
* No symptomatic peripheral vascular disease

Please note: there are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have. You can then decide if you wish to participate.
Mitochondrial DNA as a Biomarker of Sepsis Severity

Mitochondria are organelles (a specialized subunit of a cell) responsible for providing cells with energy. For reasons not yet understood, mitochondria will release their DNA into blood in response to cellular injury or cell death.

With a simple blood draw, investigators can measure the amount of mitochondrial DNA in a patient's blood.

The investigators' hypothesis, is that mitochondrial DNA can be used as a surrogate marker of cellular injury to predict patient outcomes. The investigators intend to test their hypothesis by measuring mitochondrial DNA in adult patients presenting to the Emergency Department with sepsis (a life-threatening condition due to an infection) and observing their hospital course.

Despite the advances of modern medicine, sepsis persists as one of the leading causes of death in the United States and poses a significant burden on U.S. health care, accounting for more than $24 billion of total hospital costs in 2013. The high mortality and cost of treating sepsis at least partially stems from the consequences of delayed diagnosis. Unfortunately, this delay is attributable to the broad clinical manifestations of the syndrome and the absence of a specific test for sepsis.

Realizing this, The Society of Critical Care Medicine and the European Society of Intensive Care Medicine have released guidelines emphasizing the need for diagnostic approaches aimed at the early detection of sepsis. The hope is that early recognition will allow for more aggressive upfront management thereby improving patient outcomes.

In 2013, Nakahira et al showed that circulating cell-free mitochondrial DNA levels are associated with sepsis and mortality in patients admitted to the ICU. In contrast to that study, the purpose here is to determine whether circulating cell-free mitochondrial DNA and other biomarkers are associated with the severity of sepsis and 28-day mortality in patients presenting to the ED with sepsis.

To accomplish this task, the investigators intend to prospectively collect specimens from patients presenting to NYP-Weill Cornell and NYP-Brooklyn Methodist with suspected sepsis.

Eligibility Criteria:
Inclusion Criteria:

* Adults presenting to the Emergency Department with suspected sepsis.

Exclusion Criteria:

* Pregnancy.
* Patients with limitations of care at the time of specimen collection.