cyrilzakka/clinical-trials huggingface dataset:
Nasal Mask Ventilation During the Induction of General Anesthesia

Recently, the investigators demonstrated that nasal route ventilation is superior to the nasal-oral combined ventilation in the absence of jaw thrust and chin up maneuvers. The investigators hypothesize nasal mask ventilation may reduce the incidence of difficult mask ventilation during the induction of general anesthesia by: 1) producing a better seal than full face mask, and 2)establishing a greater airway patency and more effectively ventilate than full face mask ventilation. The investigators intend to test this hypothesis on adult patients during the induction of general anesthesia in the absence of muscle relaxation.


Eligibility Criteria:
Inclusion Criteria:

* 18-65 years of age
* ASA physical status classification I-II
* general anesthesia
* elective surgery
* who are able to breathe through both their nose and mouth while awake

Exclusion Criteria:

* Patients with major cardiovascular disease, respiratory disease, cerebral vascular disease or American Society of Anesthesiologists physical status class III or greater.
* Abnormal vital signs on the day of admission for surgery \[heart rate (HR, \>100 bpm or \<40 bpm), blood pressure (BP, \>180/100 mmHg or \<90/60 mmHg), room air transcutaneous oxyhemoglobin saturation (SPO2) \<96%\] that are not correctable with his or her routine medication or commonly used pre-operative medication.
* Unable to open mouth (\<2.5 cm) or unable to breathe through their mouth or nose.
* Any person with an anticipated difficult airway. This will include subjects that require or may require either a fiberoptic intubation or intubation while awake.
* Gastric-esophageal reflex or a full stomach.
* Neurological symptoms associated with neck extension, a neurological deficit from a previous stroke or spinal cord injury, a recent stroke or Transient Ischemic Attack (TIA) within 2 weeks.
* Pregnant women and women less than one month post-partum. Ruling out pregnancy will be conducted by careful history and physical examination as performed routinely prior to surgery. If the history is believed to be unreliable, the patient will be excluded unless a pregnancy test is performed and the result of the test is negative.
* Emergency cases and subjects who have not adhered to the ASA NPO (Nil Per Os - Nothing By Mouth) guidelines.
Role of Hyoscine Bromide in Latent and Active Labor

The purpose of this study is to determine whether hyoscine bromide decreases the duration of the active phase of labor.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18 or more.
* Term pregnancy.
* Cephalic presentation.
* Oxytocin perfusion not present at the time of inclusion.
* Uterine dynamic established.
* Abscence of high risk factors or very high risk factors for pregnancy.
* Written informed consent

Exclusion Criteria:

* Induction of labor.
* Presence of risk factors.
* Patients with hypersensitivity to the active substance or to any of the excipients or any contraindication reflected in technical report.
Asymptomatic COVID-19 Infection Among Healthcare Workers

To assess the seroprevalence of SARS-CoV-2 IgG in Health care workers in three University Hospitals

The proposed study is a cross sectional study that will be carried out among HCWs in three University hospitals namely Kasr Alaini , Ain Shams , and Zagazeg Hospitals, employing a quantitative survey.

II-Study population Participants will be the HCWs at great risk of getting an infection which include those who are in direct contact with respiratory secretions.

Inclusion criteria Age: From 25 to 60 years old Department: physicians and nurses from the operating room, critical care department, emergency department, pulmonology department.

The potential participants will be given an information sheet and time to review this information before informed consent is sought. After the potential participants have agreed to be enrolled in the study, an informed consent will be obtained by the Investigator.

III- Procedures and Data collection:

Serum Collection and Interview A- Detecting Serum IgG against SARS-CoV2

Blood samples will be collected from the enrolled HCWs. Sample collection, processing, and laboratory testing will follow guidance from the World Health Organization.(5) The sensitivity and specificity reported by the manufacturer for IgM are 88.2% and 99.0% respectively, and for IgG are 97.8% and 97.9%.

B- Structured Interview questionnaire

A structured - interview questionnaire using closed ended question format will be used to obtain information on:

1. Socio-demographic characteristics of the interviewees asking about age, sex, residence, education, occupation, department, Job title, hospital name, medical experience in years, marital status, living with family, and having children or not.
2. History of medical conditions, and history of performing procedures with transmission risk (date, place, type, duration, and frequency),
3. The use of personal protection, i.e., wearing of N95 masks, gloves, and gown, and consistent handwashing.
4. In addition, information will be collected regarding any clinical signs or symptoms in the worker past 3 months, including fever, cough, shortness of breath, or radiographically confirmed pneumonia.

Eligibility Criteria:
Inclusion Criteria:

* Age: From 25 to 60 years old
* Department: physicians and nurses from the operating room, critical care department, emergency department, pulmonology department.

Exclusion Criteria:

* pregnant
* Age over 60 years
Clinical Validation of Suntech Advantage MX With Suntech Neonate and Children Cuff Line

Patients will be selected according to specific criteria. Upon selection, patients with an existing intra-arterial line will have their blood pressure monitored with the SunTech Advantage MX module in addition to the reference data collected from intra-arterial line. Data collected from the Advantage MX module will be compared to the reference data from the intra-arterial line.


Eligibility Criteria:
Inclusion Criteria:

* At least 3 subjects shall be \< 1,000g in weight.
* At least 3 subjects shall be 1,000g to 2,000g in weight.
* At least 3 subjects shall be \>2,000g
* At least 3 subjects shall be ≥ 29 days and \< 1 year of age.
* At least 3 subjects shall be ≥ 1 year and \< 3 years of age.

Exclusion Criteria:

* Subjects who study personnel determine invasive blood pressure measurements will be unreliable
* Patients found to have a-fib, irregular heart rhythm, dysrhythmias, bigeminy, trigeminy, and isolated premature ventricular beats (VPBs) during the enrollment process are to be ineligibile to participate in the study
* Patients who are prescribed anti-coagulation medication during the enrollment process or begin anti-coagulation medication after enrollment are ineligible to participate in the study.
* Exclusions can also occur post-data review based on exclusion criteria according to ANSI/AAMI/ISO 81060-2:2019
Phytoestrogens and Colonic Adenomatous Polyps

INTRODUCTION: The data obtained by experimental studies about the influence of phytoestrogens on colorectal cancer (CRC) have been very promising. On the other hand, clinical trials have produced conflicting results. The literature suggests that some subclasses of phytoestrogens may have protective effects against CRC and colon adenomas, but most of these results come from population studies based on the dietary intake of phytoestrogens. On these premises, it is possible to hypothesize that the variability of the data reported in the literature may be due to the fact that the real absorption of phytoestrogens (by assessing their concentration in the serum or urine) and/or the ability of the single individual of producing equol was not evaluated.

PURPOSE: In the present study, the association between the phytoestrogens intake and the prevalence of colon adenomas was evaluated not only on the basis of the simply dietary intake but also on the measurement their intestinal absorption. Moreover, a specific evaluation of equol production by the intestinal flora was performed. Finally, intestinal bacteria involved in equol production were evaluated.

MATERIALS AND METHODS: Patients with sporadic colon adenomas were enrolled in group I (case) and patients without sporadic colorectal adenomas matched for sex, age and BMI were enrolled in group II (control). All participants underwent the following evaluations: BMI, dietary history (for quantitative and qualitative analysis of dietary habits), quantitative analysis of phytoestrogens (by dietary questionnaires), medications (chronic assumption of aspirin at low doses), characteristics of the polyps (for a calculation the cancer risk), analysis of urinary excretion of phytoestrogens \[by high pressure liquid chromatography (HPLC)\] and intestinal flora \[by mass spectrometry with Matrix Assisted Laser Desorption Ionization Time-of-Flight (MALDI-TOF) technology\]. At the enrolment, patients will be invited to assume a standard quantitative of phytoestrogens at 8:00 a.am. and collect both a fecal sample and the urine of the following 24 hrs.

Eligibility Criteria:
Inclusion Criteria:

* subjects of both sexes aged between 50 and 75 years
* colonoscopy within 3 months from the study evaluation

Exclusion Criteria:

* age \< 50 and \> 75 years
* previous diagnosis of colon cancer or inflammatory bowel diseases (IBD)
* Hereditary intestinal tumors (FAP, HNPCC, ...)
* ongoing infections
* intake, in the last 4 weeks, of drugs that alter the intestinal bacterial flora
* creatinine clearance below 60 ml/min
* liver failure
Investigating the Influence of Catheter Advancement Techniques on Needle Tip Movement During Intravenous Insertion

This proposed study aims to fill this gap by investigating whether needle tip movement during catheter advancement is affected by whether the individual performing the insertion pushes the catheter off the needle themselves or if it is done by another person.

Participant arrives at the simulation setting. Participant undergoes orientation and consent. This includes orientation to study procedure and equipment, explanation of catheter advancement techniques, and informed consent process. Following consent, participant fills out Participant Questionnaire. Total time required: Approximately 10 minutes.

Participant performs IV catheter insertion using 3 techniques: 1 (Self-advancement single hand), technique 2 (Self-advancement both hands), and technique 3 (second person assisted) in randomized order. Total time required: Approximately 5 minutes. Participant completes Participant Questionnaire. Participant's participation is concluded.

In this study, the observation to be carried out is the total distance of needle tip movement while performing the initial intravenous catheter advancement off of the needle using three different catheter advancement techniques including: Self-advancement with one hand; Self-advancement with two hands; Catheter advancement by another individual.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older
2. Willing to consent to the study
3. has some experience placing IV catheters

Exclusion Criteria:

1. Subject refuses to consent
2. Younger than 18 years of age
3. No experience inserting IV catheters
Circadian Phase Assessments at Home

An estimated 23 million Americans, including adolescents and the elderly, suffer from circadian rhythm sleep disorders, such as delayed sleep phase disorder, advanced sleep phase disorder and winter depression. These conditions are characterized by persistent insomnia and/or excessive daytime sleepiness, impaired performance, reduced well being and lower quality of life. The negative symptoms result from a misalignment between the timing of sleep and the internal circadian clock. Clinical research has demonstrated that circadian rhythm sleep disorders are most effectively diagnosed (differentiated from other causes of insomnia) and treated if each individual patient's circadian phase is known. The timing of the master internal circadian clock is most reliably measured from the onset of the endogenous circadian rhythm of melatonin, a neuroendocrine hormone, as measured in dim light (dim light melatonin onset, or "DLMO"). However to date the reliable and valid assessment of the DLMO is limited to the research laboratory setting.

This study is to test a streamlined procedure for the accurate assessment of circadian phase (DLMO) outside of the laboratory that will provide clinicians and researchers with a novel diagnostic and research tool. In this way the underlying neurobiological cause of a patient's insomnia and/or circadian rhythm disorder can more readily be diagnosed and treated.

Specific Aim 1 is to validate procedures for at-home circadian phase assessment in a sample of healthy people. Validation will occur by (1) objectively measuring compliance to the at-home procedures and (2) comparing DLMOs collected at home to DLMOs collected in the laboratory, in a within-subjects counterbalanced design. Specific Aim 2 is to validate the same at home procedures in patients with delayed sleep phase disorder. Specific Aim 3 is to conduct rigorous analyses to inform future users which subject characteristics and light levels predict (1) compliance to the at home procedures and (2) valid at-home DLMOs.

The results of this 3 year study will have substantial implications for the translation of basic and clinical research to the community: (1) the diagnosis and treatment of insomnia and circadian rhythm sleep disorders will be significantly enhanced, thus improving public health and safety, mood and quality of life, (2) community participation in research will be improved, particularly in vulnerable and under represented populations, thus increasing scientific knowledge and (3) research and clinical costs will be substantially reduced.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult volunteers or people with Delayed Sleep Phase Disorder

Exclusion Criteria:

* Color blindness with the Ishihara test
Intensive Lipid-lowering in Patients With STEMI and NSTEMI (Germany on Target)

Intensive Lipid-Lowering Therapy guided by a cloud-based Software System (CLIMEDO GmbH) improves (European Society of Cardiolofgy/European Atherosclerosis Society) ESC/EAS-guideline recommended LDL-cholesterol target attainment and adherence in patients with ST-Elevation Myocardial (STEMI) and Non-ST-Elevation Myocardial Infarctions (NSTEMI).

Patients admitted to the Jena University Hospital (UKS) and 9 other University hospitals in Germany with an ST-elevation or Non-ST-elevation myocardial infarction (STEMI) will be randomized to standard care or a software-based tool (CLIMEDO GmbH) to monitor low-density cholesterol (LDL-C) levels and close follow-ups to achieve ESC/EAS-guideline recommended LDL-C goals.

In this multi-center, prospective, randomized, interventional trial we propose that using a cloud-based software system (CLIMEDO GmbH) is superior to standard care in terms of LDL-C target attainment at 6 months and adherence over a time period of 12 months.

In the software group LDL-C levels will be monitored on admission, after 1,6, 12, 16, 20 weeks and after 6, 12 and 24 months. In the standard care group patients' LDL-C levels will be determined on admission after 6, 12 and 24 months. The primary endpoint is LDL-C target attainment at 6 months in both groups.

Eligibility Criteria:
Inclusion Criteria:

* patients with ST- and Non-ST-elevation myocardial infarctions

Exclusion Criteria:

* patient without informed concent
* patients in cardiogenic shock
* patients with contraindication to lipid-lowering therapy
* patients on lipid-lowering medications on admission
The Effect of Different Types of Dietary Fiber on Satiation

It has been suggested that dietary fibers can affect food intake and satiation. Satiation, or meal termination, can be induced by sensory properties and energy density of fiber-rich food products, but also by the chemical/physical/rheological behavior of the fibers in the stomach and/or intestine. It is not clear which properties are the key regulators of satiation by fiber sources. There are many types of dietary fiber, which have diverse sensory and chemical properties, thus these might have different effects on satiation.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18-50 years
* BMI: 18-25 kg/m2
* Healthy: as judged by the participant

Exclusion Criteria:

* Weight loss or weight gain of more than 5 kg during the last 2 months
* Using an energy restricted diet during the last 2 months
* Lack of appetite for any (unknown) reason
* Having problems with chewing and swallowing
* Having problems with digestion
* Restrained eater
* Hypersensitivity for gluten or other ingredients of chocolate cookies
* Hypersensitivity for one of the fibers
Dexmedetomidine Pharmacokinetics in Neonates During Therapeutic Hypothermia

The goal of this proposal is to profile the pharmacokinetics of dexmedetomidine in newborns ≥36 weeks post-menstrual age during therapeutic hypothermia for hypoxic-ischemic encephalopathy.

The goal of this proposal is to determine the pharmacokinetics (PK) of dexmedetomidine (DEX) in newborns in the neonatal intensive care unit (NICU) receiving therapeutic hypothermia (TH) for moderate to severe hypoxic-ischemic encephalopathy (HIE). In newborns with HIE, TH for 72 hours is the standard therapy to mitigate brain damage. Most HIE patients receive mechanical ventilation during TH and are thus sedated with morphine. Unfortunately, morphine has negative side effects and does not specifically prevent shivering. Prevention of shivering is critical to success of TH, as shivering negates cooling. DEX is a particularly promising alternative sedative because it does prevent shivering and is already used in NICUs for sedation and pain management. In newborns, DEX PK data in the setting of TH is not available and needs to be determined to properly dose DEX for HIE patients.

Eligibility Criteria:
Inclusion Criteria:

1. Newborns 36 weeks gestation or older with moderate to severe hypoxic-ischemic encephalopathy identified and treated with therapeutic hypothermia in the Seattle Children's Hospital neonatal intensive care unit.
2. Cooled infants who are initially intubated and mechanically ventilated.
3. Infants anticipated to require 72 hrs of continuous sedation and/or treatment to prevent shivering.
4. Subject's parent(s) or legal guardian(s) has/have voluntarily signed and dated the informed consent document approved by the Institutional Review Board (IRB)/Independent Ethics Committee (IEC).

Exclusion Criteria:

1. Known chromosomal anomalies.
2. Newborns without central lines (e.g., lines not needed or unable to be successfully placed) or without a peripheral arterial line.
3. Patients with known cyanotic congenital heart defects
4. Patients who are participating in another clinical trial.
5. Patients who received DEX prior to enrollment in the study
6. At the discretion of the Investigator, subjects in whom the risk of Dexmedetomidine treatment is expected to exceed its benefits.
Home Air in Agriculture: Pediatric Intervention Trial

This study seeks to reduce exposure to asthmagens in the homes of a community of Latino children residing in an area of intense agricultural production in Eastern Washington by testing the effectiveness of an intervention (high efficiency particulate air filter- HEPA portable room air cleaners) plus asthma education to reduce indoor measures of particulate matter, ammonia, improve clinically relevant measures of asthma health, and reduce biomarkers of inflammation.

Over the course of five years, this project's specific aims are as follows:

1. Build on a well-established community based participatory research program to engage community partners in the design, implementation and evaluation of this asthma intervention study.
2. Conduct a year-long intervention study with longitudinal measurement of key asthmagen exposures and health outcome indicators with minimal participant burden.
3. Develop and characterize evaluation metrics for the process, impact and outcomes of this project in achievement of the aims.
4. Promote sustainable public health action via positive and transparent communications about the project to participants, local stakeholders, and state level policy makers through broad-based community outreach.

Eligibility Criteria:
Inclusion Criteria:

* Eligibility criteria include male and female, poorly controlled asthma, likely to stay in the area over the course of the study, having only one residence, no smokers in the household and residential proximity to dairy operations/crop production (\<400 meters) determined by the telephone screening questionnaire.

Exclusion Criteria:

* Prior participation in the Asthma Home Visiting Program, not from the northern third of the lower Yakima Valley, well controlled asthma, unlikely to stay in the are over the course of the study, smokers in the household, no residential proximity to dairy operations or crop production, having more than one residence and inability to communicate over the phone.
Effect of Non-invasive Magnetic Stimulation of the Brain on Breathlessness in Healthy Individuals.

The purpose of this study is to see if the front part of the brain called the "Dorsolateral Prefrontal Cortex" (DLPFC) has a role in our ability to feel breathlessness. The experiment will use a device that sits on the top of the head which produces a magnetic field that penetrates the scalp and excites the brain tissue directly under it. This procedure is called repetitive transcranial magnetic stimulation (rTMS), it is a painless procedure and known to be safe in healthy individuals. Previous research has shown that the pain felt when capsaicin, the active ingredient in 'chilli' powder, is applied to the hand is reduced by applying the rTMS on the scalp directly above the DLPFC part of the brain. In this experiment we want to see if breathlessness is also reduced. We will use a breathing task that will generate a moderate amount of breathlessness by adding a small amount of carbon dioxide to the inhaled air, while preventing the increase in the amount of breathing we would normally see in response to this. If we find that breathlessness produced by this breathing task is reduced after rTMS over the DLPFC, this may lead to new drugs that target this part of the brain in patients suffering from breathlessness due to heart or lung disease. The study will also improve our knowledge of how the brain enables us to feel breathlessness


Eligibility Criteria:
Inclusion Criteria:

healthy individuals, over 18 years old, with no history of heart, lung or neurological conditions

Exclusion Criteria:

* Any history of respiratory problems (including Asthma that involves regular use of inhalers)
* Any history of heart or circulatory problems (e.g. palpitations, arrhythmias, angina, BP)
* Any history of epilepsy, convulsions or seizures, migraines, or fainting
* Any history of anxiety disorders (e.g. panic attacks)
* Any history of serious head injury or brain surgery
* Any metal parts in the head (except dental wire)
* Any implants (e.g. pacemaker, insulin pump, neurostimulator)
* Pregnancy or problems with alcohol or drug abuse.