cyrilzakka/clinical-trials huggingface dataset:
Cuff Pressure Control and Evacuation of Subglottic Secretions To Prevent Pneumonia

Multicenter, cluster randomized, controlled, open-label trial to assess if AnapnoGuard System can minimize tracheal microaspiration and the risk of ventilator-associated pneumonia when compared to standard treatment

Maintaining the endotracheal tube (ETT) cuff appropriately inflated plays a crucial role in the management of intubated patients because overinflation may cause tracheal wall damage, ulcerations and stenosis, and underinflation may results in fluid leakage and ventilator-associated pneumonia (VAP).

During mechanical ventilation, secretions contaminated with oropharyngeal and gastric pathogens pool in the subglottic space (tracheal region between the ETT cuff and the vocal cords) and enter the lower airways via microaspiration.

Subglottic secretion drainage (SSD) reduces the incidence of VAP and can be performed intermittently or continuously, with varying efficacy and often causing secondary tracheal mucosa lesions.

AnapnoGuard (AG) ETT has three dedicated lines (two suction lines and one sensing/venting/rinsing line) and can be connected to the AG 100 System, a new device which provides high-sensitive capnography of subglottic space and consequent adjustment of cuff pressure, to avoid fluid leakage and overinflation. It also evacuates secretions from the subglottic space by simultaneously rinsing/venting this space using the ETT dedicated line.

The hypothesis is that AG System may reduce the incidence of microaspiration, bacterial tracheal colonization and consequently the risk of VAP when compared to standard treatment (ETT with manually performed secretion drainage and cuff pressure control).

Eligibility Criteria:
Inclusion Criteria:

* Primary intubation with the study ETT
* Expected duration of mechanical ventilation \>48 hours
* Age older than 18 years

Exclusion Criteria:

* Invasive mechanical ventilation in the last 14 days,
* Contraindication for enteral feeding
* Clinical evidence of inhalation before intubation
* Pregnancy
* Enrolling in another study that may interfere with this trial
Dario Blood Glucose Monitoring System - Android Devices User Performance Study Report

The purpose of this study is to evaluate the accuracy of the Dario Blood Glucose Monitoring System as compared to a reference method (Yellow Springs Instrument 2300 STAT Plus) and to evaluate the usability of the device when used by laypersons.

The objectives for this study are to evaluate the blood glucose level results obtained from the subject's fingertip using the Dario Blood Glucose Monitoring System paired with a reference device from one of three Android smart mobile device families as compared to the results from the Yellow Springs Instrument 2300 STAT Plus. The usability of the Dario Blood Glucose Monitoring System when paired with a reference device from one of three Android smart mobile device families and used by laypersons is also evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Subject has Type 1 or Type II diabetes
* Subject speaks and reads English proficiently
* Subject is able and agrees to sign the informed consent form (minor subjects must be accompanied by a parent or legal guardian to provide consent for their participation in the study)

Exclusion Criteria:

* Subject has medical training or works in the field of blood glucose monitoring systems.
* Subject is critically ill.
* Subject has an impairment that prevents him/her from following the study procedures.
* Subject has any condition that the Principal Investigator believes may interfere in the subject's participation in the study.
* Hematocrit levels outside the range of 20%-60%.
The Effect of Oral Use of Lyophilised Royal Jelly on Cognitive Functions and Immune System in Elderly Individuals

Dementia is a significant public health problem, affecting 47 million people worldwide in 2015, according to World Health Organization data. It is expected to increase to 75 million in 2030 and reach 132 million in 2050.

Royal jelly is used as a supplement in treating of cancer, hypertension, diabetes and neurodegenerative diseases due to its antioxidant, anti-inflammatory, neuroprotective, cardioprotective, anti-proliferative and anti-fatigue properties. There are preclinical studies on the curative and protective effects of royal jelly on cognitive functions.

This randomized controlled, double-blind clinical trial is aimed to study the effect of oral use of lyophilized royal jelly for 4 weeks on immune system cytokine levels and cognitive functions in individuals aged 50-80 years without any neurological disease diagnosis.

Primary outcome measures are the Mini-Mental State Examination, the Alzheimer's Disease Assessment Scale-Cognitive Subscale, and the Geriatric Depression Scale.

Secondary outcome measures are serum interleukin-1β, interleukin-6, interleukin-10, tumor necrosis factor-α and transforming growth factor-β levels.

Volunteers who apply to Bağcılar Medipol Mega University Hospital Neurology Polyclinic will be recruited, and their demographic information will be recorded.

Volunteers who meet eligibility criteria will be randomly divided into three groups considering age groups (50-64 years old and 65-80 years old).

Primary and secondary outcome measures will be evaluated in volunteers. The results obtained will be recorded.

Diet recommendations will be made to the volunteers for four weeks. The products detailed in the protocol will be used by the volunteers orally for four weeks on an empty stomach in the morning.

Primary and secondary outcome measures will be reassessed in volunteers on day 28. The results obtained will be recorded.

Obtained results will be evaluated statistically.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 55 and 70,
* Male or female,

Exclusion Criteria:

* History of allergy to bee products
* Known history of lactose allergy
* Diagnosed dementia,
* MMSE score below 21,
* ADAS-Cog score of 12 and above,
* Body Mass Index of 35 and above,
* Be taking any medical medication, herbal product or dietary supplement for dementia, except for those who stopped using it at least 1 month before inclusion in our study,
* Being or having been treated for acute acquired brain injuries such as acute traumatic brain injury, acute onset stroke,
* Being followed up due to inflammatory disease,
* Diagnosis of chronic or acute infection,
* Taking corticosteroids or non-steroidal anti-inflammatory drugs,
* Being or having been treated for a psychotic illness,
* Severe anaemia, vital organ dysfunction or critical illness.
The Influence of Type of Anesthesia on Postoperative Pain

The investigators designed a multi-center prospective randomized controlled trial to study the influence of the type of anesthesia on postoperative pain after laparoscopic colorectal cancer surgery. Half of the participants will be anesthetized with propofol and remifentanil, while the other half will be anesthetized with sevoflurane and remifentanil during the surgery. The investigators will measure opioid consumption and pain score in the acute postoperative phase.

Previous studies showed that patients receiving total intravenous anesthesia (TIVA) with propofol are associated with less postoperative pain and less opioid consumption compared with inhalation anesthesia. However, some studies showed conflicting results. In colorectal surgery, there are only retrospective studies that showed the analgesic effect of TIVA and inhalation anesthesia. The investigators designed a multi-center prospective randomized controlled trial and hypothesized that TIVA with propofol would be associated with reduced postoperative opioid consumption and less postoperative pain compared with sevoflurane in laparoscopic colorectal cancer surgery.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient scheduled for elective laparoscopic colorectal cancer surgery

Exclusion Criteria:

* Pregnant
* Conversion from laparoscopic to open surgery
* Allergy to anesthetics and analgesics
* Previous abdominal surgery
* Chronic pain
* Chronic analgesic usage
Teens Against Tobacco Use: A Tobacco Prevention Curriculum and Advocacy Initiative

This study evaluates the efficacy of Teens Against Tobacco Use anti-tobacco presentations on tobacco use susceptibility in 6th through 8th grade. Students will be randomly assigned to either receive 3 anti-tobacco presentations or 3 presentations on a different topic, unrelated to tobacco.

The investigators will collaborate with Austin High School, Wiggs Middle School, and Guillen Middle School of the El Paso Independent School District to implement smoke free youth coalitions as an after school activity. The coalitions will follow the Teens Against Tobacco Use (TATU) model developed by the American Lung Association, the American Cancer Society, and the American Heart Association. Participating youth will be trained to develop and deliver anti-tobacco presentations to younger students. Each school will have a separate youth coalition operating under the guidance of an adult coordinator. High school youth will present to middle school classes, whereas middle school youth will present to 4th and 5th graders.

To evaluate the efficacy of the TATU program, we will randomly assign students in physical education classes to receive TATU presentations or a control condition. Confidential surveys about tobacco will be administered at the beginning and end of the school year. Analyses will compare intervention and control students on smoking susceptibility, perceptions of harm from tobacco use, tobacco industry perceptions, and social norms on tobacco use.

Eligibility Criteria:
Inclusion Criteria:

* Students from participating schools
* 6th to 8th grade students
* Classes must be willing to receive presentations in the fall and spring semesters.

Exclusion Criteria:

* Students from non-participating schools
* Students not able to read English or Spanish
A Drug Interaction Study of SLM0807 and HKB0701 in Healthy Subjects

The aim of this study is to assess whether HKB0701 alters pharmacokinetics of SLM0807.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers who are in age range of 20-50years and the weight range is not exceed ±20% of ideal weight. Ideal weight = \[height -100\]\*0.9
* Subjects with no history of any significant chronic disease
* Judged to be in good health on the basis of their vital sign, ECG, physical exam and routine laboratory data
* Available for the entire study period
* Willing to adhere to protocol requirements and sign a informed consent form.

Exclusion Criteria:

* Subjects who have taken any drugs to induce or inhibit hepatic enzyme activity within 30days prior to drug administration
* Subjects who have symptom of an acute illness within 4 weeks prior to drug administration
* Subjects with a history of clinically significant allergies including drug allergies
* Subjects whose clinical laboratory test values are outside the accepted normal range(Especially,AST or ALT \>1.25 times to normal range or total bilirubin \> 1.5times to normal range)
* Subjects with a history of drug, caffeine or alcohol abuse (caffeine drink \>5cups /day, alcohol \>30g/day)
* Heavy smoker ( \>10cigarettes/day)
* Subjects who have had a diet known to interfere with the absorption, distribution, metabolism or excretion of drugs (especially, consumption of grapefruit juice)
* Subjects who have donated plasma within 60days prior to drug administration
* Subjects who have participated in a clinical study within 90days prior to drug administration
* Subjects who have received any drugs that might confound the results of the trial in the opinion of principal investigator (cimetidine within 7days prior to drug administration)
* Female subjects who are pregnant, breastfeeding or not using medically acceptable birth control
Evaluation of the Efficacy of Laser Acupuncture on Uremic Pruritus

Sixty patients were randomly assigned to either the experimental group (n=30) receiving laser acupuncture or the control group (n=30) receiving sham laser acupuncture. Treatment sessions were conducted during dialysis sessions. The experimental group received laser acupuncture at Xuehai, Quchi, and Bai Chongwo acupoints three times per week for four weeks. The control group received sham laser acupuncture at the same acupoints. The 5-D Pruritus Scale and DLQI were used to assess pruritus severity before and after the intervention.

The subjects were divided into two groups to investigate whether laser acupuncture can improve uremic pruritus.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 20 years.
* Intact parathyroid hormone (iPTH) levels \< 68 pg/mL (patients with -thyroidectomy excluded).
* Urea nitrogen (BUN) clearance rate (Kt/V) ≥ 1.2 at each dialysis session.
* Serum phosphate levels \< 5.5 mg/dL.
* Receiving hemodialysis three times weekly for at least three consecutive months.
* No history of acute illnesses like infections or cardiovascular disease.
* Avoiding a high-phosphorus diet.
* Adjusting dialysate calcium concentration to 8.6-10 mg/dL.
* Replacing the artificial kidney or increasing dialysis blood flow

Exclusion Criteria:

* Pregnant or nursing.
* History of photosensitivity.
* Recent use of systemic or local medications for pruritus (e.g., immunosuppressants, opioid agonists/antagonists, glucocorticoids, antihistamines, ultraviolet B therapy).
* Hepatobiliary dysfunction based on medical history and liver function tests.
* Malignancies.
* Other itchy skin conditions diagnosed by a dermatologist.
* Wounds near acupuncture points, contraindicating laser acupuncture
HER2 Expression of CTC to Predict Response in HER2-low Advanced Breast Cancer Patients Treated With ADC

To evaluate the predictive and prognostic value of HER2 expression of circulating tumor cells in HER2-low advanced breast cancer patients treated with ADC


Eligibility Criteria:
Inclusion Criteria:

* Has pathologically documented breast cancer that:

  1. Is unresectable or metastatic
  2. Has low-HER2 expression defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested)
  3. Has progressed on, and would no longer benefit from, endocrine therapy
  4. Has been treated at least 1 prior line of chemotherapy in the metastatic setting
* Has protocol-defined adequate cardiac, bone marrow, renal, hepatic and blood clotting functions
* Receives anti-HER2 ADC treatment
* Life expectancy \> 3 months
* Evidence of measurable or evaluable disease (RECIST 1.1 criteria)in the 28 days before selection
* ECOG ≤2

Exclusion Criteria:

* Has breast cancer ever assessed with high-HER2 expression
* Has previously been treated with any anti-HER2 therapy, including an antibody drug conjugate
* Has history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening
* Has any medical history or condition that per protocol or in the opinion of the investigator is inappropriate for the study
Genetic Study of Familial and Sporadic ALS/Motor Neuron Disease, Miyoshi Myopathy and Other Neuromuscular Disorders

The investigators laboratory has been studying families with a history of ALS for more than 30 years and is continuing to use new ways to understand how genes may play a role in ALS, motor neuron disease and other neuromuscular disorders.

The purpose of this study is to identify additional genes that may cause or put a person at risk for either familial ALS (meaning 2 or more people in a family who have had ALS), sporadic ALS, or other forms of motor neuron disease in the hopes of improving diagnosis and treatment. As new genes are found that may be linked to ALS in families or individuals, the investigators can then further study how that gene may be contributing to the disease by studying it down to the protein and molecular level. This includes all forms of ALS, motor neuron disease and ALS with fronto-temporal dementia(ALS/FTD). We also continue to study other forms of neuromuscular disease such as Miyoshi myopathy, FSH dystrophy and other forms of muscular dystrophy by looking at the genes that may be associated with them.

There have been a number of genes identified that are associated with both familial and sporadic ALS, with the SOD1, C9orf72, and FUS genes explaining the majority of the cases. However, for about 25% of families with FALS, the gene(s) are still unknown.

The investigators also will continue to work with families already identified to carry one of the known genes associated with ALS.

Participants will be asked to provide a blood sample ( or sometimes saliva or skin sample) and to complete a couple of questionnaires regarding their overall medical health. Medical records will need to be reviewed for all those diagnosed with one of the study diseases to allow the researchers to review details of their clinical disease symptoms, neurological exams and test results.

Participants do not need to travel to Massachusetts for this study. Samples can be obtained locally at no costs to the participant. Family members may be included in the study depending on family history and their relationship to the affected individual.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of or family history of ALS,MND,ALS with dementia, or PLS.
* diagnosis of Miyoshi myopathy
* willingness to provide a blood sample for study use

Exclusion Criteria:

* unwilling to provide a blood or saliva sample
Efficacy of Combined Low- and High- Frequency Stimulation in Peripheral Muscle Function During Hemodialysis

Chronic kidney disease is a systemic disease that affects not only renal function, but also, several organs, bringing social, psychological and physical impact to the patients under this condition. Due to long periods of inactivity during hemodialysis, electrical stimulation becomes a feasible alternative for development physical activity in these patients. Objective: Assess the efficacy of combined low and high frequency electrical stimulation in peripheral muscle function during hemodialysis. Methods: A randomised double-blind clinical trial with chronic kidney disease patient's under hemodialysis, whose will be allocated in four groups: low frequency electrical stimulation (LF) ; high frequency (HF); low and high frequency (LHF); and sham electrical stimulation. The groups will receive quadriceps application bilaterally, for sixty minutes, three times a week, for two months. In the intervention groups will be used highest intensity tolerated by the individual, and in the sham will be maintained the minimum intensity after beginning of the perception of the electric current. The individuals will be evaluated for anthropometry, functional capacity, quality of life and biochemical parameters.

Patients in the present study will be submitted to an evaluation protocol that must be started after the consent of the responsible medical team, and the patient through the Informed Consent Term. On the first day, patients will be evaluated for their personal antecedents, life habits, inflammatory and nutritional status, quality of life, Medical Research Council (MRC) and biochemical markers. On the second day, anthropometry, body composition and functional capacity will be performed. On the third day, the muscular function will be assessed by isokinetic evaluation. After completing the evaluations, patients will be allocated into four groups: low frequency (LF), high frequency (HF), low and high frequency (LHF), and sham.

Eligibility Criteria:
Inclusion Criteria:

* Chronic kidney disease
* Classical hemodialysis
* Over 18 years old
* No pace maker
* Without cognitive or motor deficit
* No regular physical activity in the last six months

Exclusion Criteria:

* Abstention for more than two consecutive sessions or four in total
* Inability to perform the tests
Ultrasound Imaging Technique in Detecting Breast Microcalcifications in Patients Undergoing Biopsy for a Breast Abnormality

This clinical trial studies a new type of ultrasound technique, MicroPure, in detecting breast microcalcifications in patients undergoing biopsy for a breast abnormality. Ultrasound sends sound waves into the body, and the sound waves reflected back are interpreted by the machine into a grayscale image. MicroPure uses a filter that adjusts the brightness and gives color to the ultrasound images, which may allow doctors to better identify microcalcifications. Microcalcifications are tiny deposits of calcium in the breast that cannot be felt but can be detected by imaging. A group of microcalcifications may indicate that cancer is present.

PRIMARY OBJECTIVES:

I. Evaluate MicroPure relative to grayscale ultrasound imaging for the identification of microcalcifications with mammography as the reference standard.

SECONDARY OBJECTIVES:

I. Evaluate MicroPure compared to grayscale ultrasound imaging and mammography for the characterization of breast abnormalities associated with microcalcifications using biopsy results as the reference standard (sensitivity and specificity will be calculated).

II. Evaluate MicroPure relative to specimen x-ray imaging for the identification of breast microcalcifications with pathology as the reference standard.

III. Estimate the improvements in patient care that may be achievable if MicroPure guided core needle biopsy procedures can replace some surgical excisions for the evaluation of breast abnormalities.

Eligibility Criteria:
Inclusion Criteria:

* Give written informed consent
* Be scheduled for a sonographic or stereotactic guided core needle biopsy or surgical excision for the evaluation of a breast lesion or abnormality containing microcalcifications seen on mammography

Exclusion Criteria:

* Is clinically unstable, severely ill, or moribund
Flipped Classroom Approach on Nursing Students' Blood Pressure

Effects of the Flipped Learning Model on Blood Pressure Knowledge and Self-directed Learning Skills of First-Year Nursing Students: A Randomized Controlled Study

This study is to determine the effect of flipped learning model on blood pressure knowledge level and self-directed learning skills of first-year nursing students.

This study was a pre-post test open-label randomized controlled trial. Settings and Participants: This research was conducted with 94 first-year students (experimental group = 48, control group = 46) studying at a university in Turkey, Faculty of Health Sciences, Department of Nursing. The students were divided into experimental and control groups using a simple randomization method. The study data were collected using the Descriptive Characteristics Form, the Blood Pressure Knowledge Test, and the Self-Managed Learning Skills Scale. The students in the experimental group were trained using the flipped learning model. The students in the control group were trained using only a traditional education method.

Eligibility Criteria:
Inclusion Criteria:

* The first to enroll in the Fundamentals of Nursing course,
* Volunteer to participate in the research
* had continuous Internet Access

Exclusion Criteria:

* Having graduated from Health Vocational High School or having studied a health-related department,
* Have taken fundamentals of nursing course before
Ultrasonography in Confirming Proper Position of Endotracheal Tube

The purpose of this study is to assess the applicability of using ultrasonography in confirmation of the position of the endotracheal tube (ETT) after intubated to patients.

To assess the applicability of using ultrasonography as compared to routine portable CXR in confirmation of ETT position.

To determine the accuracy of ultrasonography in measuring the depth of ETT as compare to standard CXR method.

Eligibility Criteria:
Inclusion Criteria:

* age \>18 years old with either endotracheal or nasotracheal intubation
* having normal airway anatomy
* performed portable CXR after intubation

Exclusion Criteria:

* presence in history of neck radiation, cervical spine immobility/instability
* unstable vital signs
* unwilling to participate or denial of informed consent