cyrilzakka/clinical-trials huggingface dataset:
Sildenafil to Reduce Vascular Remodeling During Left Ventricular Assist Device Support

Contemporary left ventricular assist device (LVAD) therapy improves survival during advanced heart failure but vascular aging develops rapidly leading to major adverse events including stroke and bleeding in nearly half of patients. In this study, the study team aims to investigate whether sildenafil pharmacotherapy, which has anti-fibrotic effects, can reduce vascular aging during LVAD support. An aim of this study is to compare changes in small blood vessels in the gastrointestinal tract between participants receiving sildenafil or placebo. Video capsule endoscopy (VCE) will be used to assess these changes in small blood vessels.

Over 6.5 million individuals in the United States suffer from heart failure (HF), with the burden of this disease expected to grow over the next decade. Approximately 300,000 of these patients have advanced HF and may benefit from durable left ventricular assist device (LVAD) therapy, which can improve outcomes during advanced HF. However, despite advancements in device design that have increased survival rates, large registries of real- world cases reveal that nearly half of patients experience severe vascular adverse events, including stroke and bleeding, during prolonged contemporary LVAD support. This elevated adverse-event rate remains a major barrier to safely expanding the use and durability of LVAD therapy. Vascular remodeling or aging of the large and small blood vessels is known to promote stroke and bleeding within the general population. Critically, such remodeling is rapidly accelerated under conditions of reduced pulsatility produced by LVADs, evidenced by large vessel stiffening and fibrosis, small vessel angiodysplasia, and endothelial dysfunction. Phosphodiesterase-5 inhibitors (PDE5i), such as sildenafil, are prescribed to select LVAD patients with pulmonary hypertension and right heart failure. However, given that these agents enhance nitric oxide-cGMP signaling in platelets and vascular smooth muscle cells, leading to anti-thrombotic and anti-fibrotic effects, they may also reduce vascular remodeling and related adverse events. Here, based on preliminary findings, a double-blind, randomized, placebo-controlled trial will be conducted to determine the effects of chronic sildenafil administration on vascular remodeling during LVAD support.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age
* Supported by a durable LVAD or planned to undergo placement of a durable LVAD
* Be able to give informed consent

Exclusion Criteria:

* History of pre-existing aortic valve prosthesis or an aortic graft
* Allergy to sildenafil
* Taking any nitric oxide (NO) donor medications
* History of complete carotid occlusion
Belgian Real Life Non-interventional Study (NIS) on Xarelto in Non-valvular Atrial Fibrillation (AF) Patients Treated for the Prevention of Stroke and Systemic Embolism

The objective of this NIS is to assess in a real-life setting, usage patterns and associated outcomes in the management (healthcare resource utilisation and associated costs) of patients with non-valvular AF treated with Xarelto, in accordance with the terms of the European marketing authorization and the Belgian reimbursement criteria.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients ≥ 18 years old with a confirmed diagnosis of non-valvular atrial fibrillation
* Patients must in addition present with at least one of following risk factors:

  * prior stroke, TIA (transient ischemic attack) or non-CNS (central nervous system) systemic embolism
  * left ventricular ejection fraction of \< 40%
  * symptomatic heart failure, New York Heart Association class 2 or higher
  * age ≥75 years
  * age ≥65 years in combination with either diabetes, coronary disease or arterial hypertension

Exclusion Criteria:

* Patients who do not fulfil the Belgian reimbursement criteria
Evaluating the Hemodynamic Effects of Ketamine Versus Etomidate During Rapid Sequence Intubation

The purpose of this study is to compare the hemodynamic effects of ketamine v etomidate during rapid sequence intubation (RSI) in the pre-hospital and emergency department setting.

This is a randomized prospective study evaluating the hemodynamic response in adult participants greater than or equal to 18 years of age undergoing RSI in the pre-hospital or emergency department setting. Hemodynamic response is the cardiology response of the circulatory system. The investigators will compare the drugs Ketamine and Etomidate in participants having RSI. Ketamine and Etomidate are immediately available for RSI in both settings as both are currently standards of care for RSI.

Research thus far demonstrates that both Etomidate and ketamine are safe and effective for RSI. Despite the reported safety of Ketamine, Etomidate usage continues to far surpass that of ketamine. Both Etomidate and Ketamine are FDA-approved for induction of anesthesia. They are both ideal drugs for intubation due to their pharmacokinetic properties including a quick onset of less than 60 seconds, a short duration of about 10 minutes, and the minimal effect they have on the cardiovascular system. The neutral effect on the cardiovascular system is particularly important in the acute and traumatic setting when patients are often hypotensive.

However, there are some differences and disadvantages in the two medications. Due to these factors and limited data to support Ketamine as an equal or superior alternative to Etomidate, it has been difficult to clearly recommend one agent over the other for RSI.

Data will be analyzed using SPSS with a p-value of less than 0.05 being considered significant. The PI will consider a 20% decrease in systolic BP from a participant baseline as significant, and will compare the incidence of post RSI hypotension between the two groups. Several a priori subgroups will be evaluated to include patients greater than 70 years of age, trauma participants requiring RSI, and those participants whose shock index is less than 0.9 versus those whose shock index is greater than 0.9.

To maintain 80% power with a probability of 0.05, 200 participants will be needed in each arm to detect at 25% difference in SBP (baseline to post drug administration effects)

Eligibility Criteria:
Inclusion Criteria:

* Persons greater than 18yrs requiring rapid sequence intubation for any reason.

Exclusion Criteria:

* Pregnant patients
* Children under the age of 18
* Patients with a known hypersensitivity to etomidate or ketamine
Pediatric Intubation Among Nursing

The aim of this study was to compare time, success rates of video laryngoscope and direct laryngoscope for the emergency intubation with an immobilized cervical spine in a standardized pediatric manikin model.


Eligibility Criteria:
Inclusion Criteria:

* give voluntary consent to participate in the study
* minimum 1 year of work experience in nursing

Exclusion Criteria:

* not meet the above criteria
* wrist or low back diseases
A Population-Based Case-Control Study of Biliary Tract Cancers in Shanghai, China

The key aims of this study include estimation of possible risk associated with a history of gallstones, bacterial infection for the biliary tract, other medical history, diet, use of tobacco and alcohol, obesity, reproductive factors, and family history of cancer. Information will be used to examine risk patterns a) seperately by anatomic subsite; b) among patients with gallbladder cancer vs. controls undergoing cholecystectomy for gallstones; c) among the patients with bile duct cancer vs. Hospital controls without cancer who undergo surgery for removal of bile duct stones. We will also attempt to ascertain reasons for cancer who undergo surgery for removal of bile duct stones. We will also attempt to ascertain reasons for the rising incidence of biliary tract cancers in Shanghai. Serum collected from all subjects will be analyzed for estrogens and other hormones, vitamins C and E, cholesterol, and bacterial antibodies (including salmonella typhi, paratyphi, and escherischia coli). Bile fluid will be cultured for aerobic bacteria, and gallstones analyzed for color, cholesterol, and evidence of bacteria infection. A major challenge in biliary tract cancer research is to determine how cancer risk factors differ from those for gallstones or biliary duct stone disease, since many people have gallstones (or biliary duct stones) but few develop cancer....

The key aims of this study include estimation of possible risk associated with a history of gallstones, bacterial infection for the biliary tract, other medical history, diet, use of tobacco and alcohol, obesity, reproductive factors, and family history of cancer. Information will be used to examine risk patterns a) seperately by anatomic subsite; b) among patients with gallbladder cancer vs. controls undergoing cholecystectomy for gallstones; c) among the patients with bile duct cancer vs. Hospital controls without cancer who undergo surgery for removal of bile duct stones. We will also attempt to ascertain reasons for cancer who undergo surgery for removal of bile duct stones. We will also attempt to ascertain reasons for the rising incidence of biliary tract cancers in Shanghai. Serum collected from all subjects will be analyzed for estrogens and other hormones, vitamins C and E, cholesterol, and bacterial antibodies (including salmonella typhi, paratyphi, and escherischia coli). Bile fluid will be cultured for aerobic bacteria, and gallstones analyzed for color, cholesterol, and evidence of bacteria infection. A major challenge in biliary tract cancer research is to determine how cancer risk factors differ from those for gallstones or biliary duct stone disease, since many people have gallstones (or biliary duct stones) but few develop cancer.

Eligibility Criteria:
* INCLUSION CRITERIA:

Cases of biliary tract cancer newly diagnosed between September 1, 1996 and August 31, 1999 among residents of urban Shanghai.

Must be under the age of 75 at the time of diagnosis.
The Effects of Neuroscience-Based Exercise

The aim of this study is to examine the effects of neuroscience-based exercise approaches on pain, disability and gait parameters in individuals with non-specific chronic neck pain.

Material- Methods Demographic data, gait parameters, Dizabilty level and craniovertebral angle values of individuals were evaluated with clinical data evaluation form, Spatio-Temporal Gait Analysis (LEGSystm), Neck Disability Index and photometer, respectively. The evaluations were performed 2 times before and after the treatment.

Neuroscience-based exercise approaches are a promising method that has been introduced in recent years in the treatment of non-specific musculoskeletal pain and related dysfunctions. The basis of this method is the exercises and trainings created by considering the neurobiological (changes in tissues) and neurophysiological basis (brain fog, somatosensory sensitization) of nociplastic pain in the musculoskeletal system. In the neuroscience-based exercise approach, it is aimed to reduce the increase in sensitivity in brain fog and somatosensory pathways. The main purpose is to teach the cortex that movement can be done painlessly and accurately and to alleviate the symptoms in the related tissues. It is aimed to perform the exercise painlessly and accurately by adding cognitive goals and changing the focus (14). In the literature, although there are very few studies showing that neuroscience education and therapeutic exercise combinations are effective on chronic nociplastic pain in patients with non-specific chronic neck pain, no studies examining the effects of neuroscience-based exercise approaches on gait parameters in individuals with non-specific chronic neck pain were found (15). ,16). Our study will contribute to the literature in this field and will reveal the effects of neuroscience-based exercise approaches more clearly. The aim of this study is to examine the effects of neuroscience-based exercise approaches on pain, disability and gait parameters in individuals with non-specific chronic neck pain.

Material- Methods Demographic data, gait parameters, Dizabilty level and craniovertebral angle values of individuals were evaluated with clinical data evaluation form, Spatio-Temporal Gait Analysis (LEGSystm), Neck Disability Index and photometer, respectively. The evaluations were performed 2 times before and after the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosing with chronic non-specific neck pain
* Volunteer to participate in the study
* beetwen 18-25 years old

Exclusion Criteria:

* have had any cervical area surgery
* having any disease that would affect the assessments
Increasing COVID-19 Vaccine Uptake in Developing Countries (Bihar)

Working with governments in Bihar, India, we will evaluate a number of mechanisms to increase vaccine uptake. These include household vaccination visits instead of community vaccination clinic.monetary and non-monetary incentives, and concurrent mask promotion. This ClinicalTrials entry contains results only for the study in Bihar.

The goal of the study is to identify strategies that best promote and support COVID vaccine uptake in developing countries, we propose to test a range of scalable social and behavioural interventions. This could help policy makers design and employ interventions that are effective. This is especially valuable in resource constrained contexts where funds and institutional resources can be diverted towards interventions that have proven to work.

In Bihar the intervention will be village-level social mobilization involving community promotion, including in-person vaccine reinforcement, and household-level social mobilization. Some treatment villages will receive household- level interventions with varying intensity (different proportion of households will be visited). There will also an accompanying mask distribution campaign during household visits where the importance of mask-wearing as a complement to vaccine use will be explained.

This ClinicalTrials entry contains results only for the study in Bihar.

Eligibility Criteria:
Inclusion Criteria:

* Lives in study village

Exclusion Criteria:

* Does not live in study village
Helping Moms Who Smoke

The purpose of this study is to learn how women's smoking changes during their pregnancy and as a new mom, and to assess the help they receive from their health care providers.

Approximately 90% of women who smoked before pregnancy will be smokers within one year of delivery . This occurs even though half who smoke quit during the course of pregnancy. This is an observational, cohort study of pregnant women who smoked in the six months before becoming pregnant. Women will be followed from the first trimester to one year after the birth of their babies. The results of this study will help us to describe women's' views on the quality of tobacco counseling they receive from their doctors; understand patterns of smoking and quitting throughout pregnancy and after childbirth; and provide information needed to develop an intervention to help women quit.

Eligibility Criteria:
Inclusion Criteria:

* Smoked within six months prior to becoming pregnant or current smoking
* Smoked at least 100 cigarettes
* Pregnant
* English speaking
* Access to a cell phone
* Willing to receive and send text messages.

Exclusion Criteria:

* Quit for longer than 6 months before becoming pregnant
A Study to Evaluate the Efficacy and Safety of VB-201 in Patients With COVID-19

The purpose of this Phase 2 study is to test safety, efficacy, and tolerability of an oral preparation of VB-201 in patients with severe COVID-19


Eligibility Criteria:
Inclusion Criteria:

1. Signed and approved informed consent before initiation of protocol-specified procedures;
2. Male or female subjects, ≥18 to ≤80 years of age with COVID-19
3. SARS-2-CoV-2 infection confirmed by PCR in the last 8 days
4. Hospitalized
5. Symptoms of Severe COVID-19 as demonstrated by one of the following:

   * Respiratory frequency \>30 breaths per minute
   * SpO2 \<94% on room air at sea level
   * Ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) \<300 mmHg
   * lung infiltrates \>50%
6. For a female subject; either:

   * subject is of non-childbearing potential, defined as: menopause with amenorrhea \>1 years, hysterectomy, or bilateral oopherectomy or
   * agrees to continue to use highly effective methods of birth control defined as those alone or in combination that result in a low failure rate (\<1%) when used consistently and correctly throughout the study and for at least one month following treatment termination and have a negative pregnancy test at screening and before the first dose of study drug; Males must use at least one method of contraception (e.g. condom) throughout the study and for 90 days following the last dose of study drug;
7. In the opinion of the investigator, the subject will be compliant and have a high probability of completing the study and all required procedures.

Exclusion Criteria:

1. Evidence of critical COVID-19 based on any of the following

   * Admission to ICU
   * Assisted ventilation (invasive or non-invasive)
   * ECMO or hemofiltration required
   * ARDS
   * Shock
   * Acute Cardiac Failure
2. Dementia
3. Bacterial co-infection
4. Co-infection with other common viral pneumonias (e.g. Influenza)
5. Participation in another interventional clinical trial or intention to participate in another interventional study during the course of this study;
6. In the opinion of the investigator, unlikely to survive for at least 48 hours from screening or anticipate mechanical ventilation within 48 hours
7. Unable to take oral medication
8. History of gastrointestinal illness that may cause nausea and vomiting
9. Subjects with any laboratory test at screening that common medical practice would deem as significantly abnormal. For example:

   * Alanine transaminase (ALT), aspartate transaminase (AST), or alkaline phosphatase \>5.0 times the upper limit of normal (ULN) or
   * Creatinine clearance \<30 mL/min
10. The subject has a known allergy or sensitivity to the study treatment or to any of the excipients contained in the study drug formulation (see list of ingredients in the Investigator's Brochure);
11. Female subject with a positive pregnancy test or nursing, or planning a pregnancy during the course of the study;
12. Unwilling or unable to comply with study requirements
Closed Loop Ventilation in Patients With COVID-19

Transpulmonary pressure may be higher in ARDS patients due to decreased respiratory system compliance. The hypothesis is that tidal volumes which are generated by Intellivent- Adaptive support ventilation (ASV) are safe range by transpulmonary pressure.

Patients will be enrolled in the first 24 hours of admission to the intensive care unit. APACHE-2 and SAPS-2 scores will be noted 24 hours after admission. COVID-19 pneumonia will be confirmed according to World Health Organization (WHO) interim guidance. Level of sedation will be monitored with Ramsey Sedation Scale.

An esophageal balloon will be inserted in order to measure transpulmonary pressure(Ptp). The proper localization will be estimated according to ear-nose-xiphoid length. Localization of the balloon will be confirmed with the Baydur maneuver. Mojoli methods will be used to optimize the balloon filling volume.

All patients will be mechanically ventilated under Intellivent-ASV mode. Initial settings will based on predicted body weight. 45 cmH2O will be determined as target end-tidal carbondiokside (ETCO2) but permissive hypercapnia will be allowed if necessary, to maintain lung protective ventilation. Safe pH value will be determined 7.25 independent from ETCO2 levels in patients who will be applied lung protective ventilation. FiO2 and PEEP will be set to maintain an SpO2 of 88-92%.

Ptpinsp will be calculated by subtracting the esophageal pressure from the alveolar pressure measured during inspiratory pause maneuver. Targeted inspiratory transpulmonary pressure (Ptpinsp) was determined to be below 20 cmH2O. If Ptpinsp exceeds 20 cmH2O, minute-volume (MinVol) will be decreased by 10%. Minvol will be reduced below 100% if necessary, to achieve the target. Expiratory transpulmonary pressure (Ptpexp) will be calculated by subtracting the esophageal pressure from the alveolar pressure measured during expiratory pause maneuver. Targeted Ptpexp was determined from 0 to 3 cmH2O. If Ptpexp is below 0 cmH2O, PEEP will be increased until Ptpexp is positive. If Ptpexp exceed 3 mH2O, PEEP will be decreased until Ptpexp is below 3 mH2O. Transpulmonary pressure will be recorded at the beginning after that at least twice daily morning and evening visits. All measurement will be made in passive condition. Transpulmonary pressure measurement will continue until the patient is awake.

Eligibility Criteria:
Inclusion Criteria:

* COVID-19 is confirmed with RT-PCR

  -\>18 years of age
* Being intubated less than 24 hours
* Not being planned to be extubated in 24 hours

Exclusion Criteria:

* COVID-19 is not confirmed with RT-PCR
* Having an impaired hemodynamic status
* Esophageal pathologies
* Bronchopleural fistula
Safety and Immunogenicity of an Adjuvanted Trivalent Influenza Vaccine in Children 6 to <72 Months of Age in Mexico.

The administration of adjuvanted Trivalent Influenza Vaccine (aTIV) has come to result in a more immunogenic and effective response compared with conventional influenza vaccines in elderly and adults.

The aim of this study is to evaluate safety and immunogenicity of Novartis aTIV in children 6 to \<72 months of age, Mexican population, in comparison to Fluzone, a non-adjuvanted trivalent influenza vaccine (TIV).


Eligibility Criteria:
Inclusion Criteria:

* Individuals of \>6 months through \<72 months of age on the day of informed consent.
* Individuals whose parent(s)/legal guardian(s) have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
* Individuals who can comply with study procedures.
* Willingness to allow for serum samples to be stored beyond the study period, for potential additional future testing to better characterize immune response.

Exclusion Criteria:

* Progressive, unstable or uncontrolled clinical conditions.
* Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study.
* History of progressive or severe neurologic disorder, seizure disorder or Guillain-Barré syndrome.
* Surgery planned during the study period that in the Investigator's opinion would interfere with the study visits schedule.
* Known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
* Any fatal prognosis of an underlying medical condition (\<12 month life expectancy).
* Clinical conditions representing a contraindication to intramuscular vaccination and blood draws.
* Abnormal function of the immune system resulting from:

  1. Clinical conditions.
  2. Systemic administration of corticosteroids (PO/IV/IM) for more than 14 consecutive days within 90 days prior to informed consent.
  3. Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent.
* Received immunoglobulins or any blood products within 180 days prior to informed consent.
* Received an investigational or non-registered medicinal product within 30 days prior to informed consent.
* Study personnel as an immediate family or household member.
* Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study.
* Received any influenza vaccine (licensed or investigational) or with laboratory confirmed influenza within 6 months prior enrollment.
* Received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrolment in this study or who are planning to receive any vaccine within 28 days from the study vaccines.