cyrilzakka/clinical-trials huggingface dataset:
Osteoporosis Awareness Among Nursing Students

The aim of this clinical study is to determine the effect of scenario-based training of nursing students on awareness of osteoporosis.

To this end, the most important questions to be answered in the study are

* What is the level of osteoporosis awareness among nursing students at the start of the study?
* Does scenario-based education have an impact on osteoporosis awareness?

Participants:

All student nurses participating in the study will first receive theoretical training on osteoporosis. At the end of the training, a scenario example prepared by the researchers on the topic of osteoporosis is worked on with the students in the experimental group. No additional intervention is carried out with the control group.

In this study, 78 nursing students randomly assigned to the experimental and control groups are first interviewed using the personal information questionnaire and the Osteoporosis Awareness Scale. This is followed by a four-hour theoretical lesson prepared by the researchers in accordance with current literature and textbooks on osteoporosis as part of the Joint and Connective Tissue Diseases and Nursing course. At the end of the theoretical lessons, a scenario example prepared by the researchers, again using current literature and case presentations, will be worked on with the students in the experimental group. No other application is made for the control group. The Personal Information Questionnaire and the Osteoporosis Awareness Scale will be re-administered to both groups four weeks after the end of the theoretical lesson.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and above,
* Mersin University Faculty of Nursing 2nd year students,
* Have not received any other training on osteoporosis before,
* Willing to participate in the research,
* Have cognitive competence to fill out the data collection form,
* Those who sign the Informed Voluntary Consent Form will be included.

Exclusion Criteria:

* Those under the age of 18,
* Not a 2nd year student at Mersin University Faculty of Nursing,
* Have previously received different training on osteoporosis,
* Do not want to participate in the research,
* Do not have the cognitive ability to fill out the data collection form,
* Those who do not sign the Informed Consent Form will not be included.
Multicenter Study Using IMC to Analyze the Impact of ICANS on Microglia

Immunotherapy with chimeric antigen receptor (CAR) T cell therapy can cause immune effector cell-associated neurotoxicity syndrome (ICANS). However, the molecular mechanisms leading to ICANS are not well understood. In this study, the investigators plan to examine the role of microglia as the primary parenchymal immune cells of the central nervous system (CNS) during ICANS in human samples. The samples will be analyzed using imaging-mass-cytometry-based analysis (IMC). Single-cell data will be obtained through machine learning supervised segmentation of IMC data. Single-cell marker expression in all cells and in microglia (Iba1+ cells) will be analyzed in patients with ICANS.

Immunotherapy with chimeric antigen receptor (CAR) T cell therapy can cause immune effector cell-associated neurotoxicity syndrome (ICANS).

Previous studies have shown a role for IL-1beta and IL-6 in xenograft mouse models.

However, the molecular mechanisms leading to ICANS are not well understood. In this study, the investigators plan to examine the role of microglia as the primary parenchymal immune cells of the central nervous system (CNS) during ICANS in human samples. The samples will be analyzed using imaging-mass-cytometry-based analysis (IMC). Single-cell data will be obtained through machine learning supervised segmentation of IMC data. Single-cell marker expression in all cells and in microglia (Iba1+ cells) will be analyzed in patients with ICANS. The participants are patients treated with chimeric antigen receptor (CAR) T cell therapy. The patients will received TSPO-PET imaging if available and if an autopsy is performed underroutine conditions tissue is collected for IMC based analysis.

Eligibility Criteria:
Inclusion Criteria:

* Patients that had developed ICANS
* CAR T cell infusion for lymphoid malignancy (NHL or ALL)

Exclusion Criteria:

* Lack of consent of patient or legal guardian
Investigation of the Frequency of Hereditary Hyper Alpha-tryptasemia in Patients With Elevated Basal Tryptasemia

The aim of the study is to assess the number of patients with elevated blood tryptase for whom this elevation could be linked to a hereditary alpha-tryptase secretion abnormality or hyper-alpha-tryptasemia. This information will enable to better optimize the management and follow-up of patients who have experienced hypersensitivity reactions and have elevated basal blood tryptase levels. The patients will be offered the opportunity to take part in the study. If they consent to participate, they will be tested for hereditary hyper-alpha-tryptasemia. A blood sampling will be performed in the center. A few weeks after, the patient will be informed about the blood sample result during a medical consultation organized in the center.


Eligibility Criteria:
Inclusion Criteria:

* Patients who came in the pneumoallergology department of the CHU de Nice since January 2014 for an allergological workup
* Patients who have received at least one basal tryptase assay, according to recommendations
* informed consent signature

Exclusion Criteria:

* High tryptasemia (≥ 8ng/ml) synchronous with anaphylactic reaction and unconfirmed basally
* Known diagnosis of systemic mastocytosis
Diastolic Performance and Norepinephrine in Spinal-Induced Hypotension for Cesarean Delivery

Background and rationale: The best agent to prevent spinal-induced hypotension is still uncertain but norepinephrine showed fewer effects on heart rate and cardiac output. In septic patients norepinephrine has been shown to produce an "endogenous fluid challenge".

Objective: We aim to assess if patients with impaired diastolic function (46% of pregnant women at term) are less able to maintain indexed cardiac output in response to norepinephrine infusion during spinal-induced vasoplegia. We also aim to assess if fetal wellbeing is related to maternal cardiac output during spinal anesthesia for cesarean delivery.

Methods: We will assess by echocardiogram the diastolic function before surgery and will then start continuous non-invasive hemodynamic monitoring with a ClearSight® monitor (ClearSight®, Edwards Lifescience, Irvine, CA) and perform a fluid challenge to relate diastolic disfunction with fluid responsiveness. Hemodynamic monitoring will continue throughout the surgery. Norepinephrine infusion will start concomitantly to beginning of spinal anesthesia and will stop 5 minutes after uterotonic medication.

Outcome: We aim to assess if patients with diastolic disfunction are less able to maintain cardiac output in response to norepinephrine infusion during spinal anesthesia induced vasoplegia. We also aim to assess if fetal wellbeing is related to maternal cardiac output during spinal anesthesia for cesarean delivery.)


Eligibility Criteria:
Inclusion Criteria:

Pregnant women between the 36th and the 40th week of gestation undergoing spinal anesthesia for elective caesarian delivery.

Exclusion Criteria:

1. age \< 18 yo;
2. preeclampsia;
3. eclampsia;
4. atrial fibrillation and sinus tachycardia;
5. cardiovascular diseases;
6. neuromuscular disease;
7. emergent or urgent cesarean delivery;
8. coagulopathies;
9. contraindications to spinal anesthesia.
The Impact of Donor COVID-19 Infection Status on the Recipient in Allo-HSCT

This study was conducted to observe whether COVID-19 can be transmitted through stem cell transplantation and whether COVID-19-positive donors have an effect on early hematopoietic reconstitution and immune reconstitution in the recipients.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) induced COVID-19 infections are showing an explosive increase in China starting in late 2022. SARS-CoV-2 infections are characterized by an initial viral replication followed by an inflammatory phase with lymphocyte depletion in severe patients.

Past studies have shown that SARS-CoV -2 is detectable in the blood of 8%-15% of patients and that viremia occurs in the first 2-3 days after the onset of symptoms. EBMT, WMDA and other organizations have suggested that COVID-19 positive donors must be excluded or delayed from donation for safety reasons.

However, there have not been any reports of transmission from donor to recipient in blood product transfusion or cell therapy. In the only reported cases of allogeneic HSCT from SARS-CoV-2 positive donors, there was also no evidence of recipient infection from the graft.

In the current situation where the vast majority of people are infected with COVID-19 in the short term, many patients, such as those with leukemia, are in urgent need of transplantation due to the aggressive， hard-to-control，underlying disease. The investigators established this observational clinical trial to investigate whether COVID-19 is transmitted through stem cells and whether COVID-19 positive donors have an impact on early hematopoietic reconstitution and immune reconstitution in recipients.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 16 and 65 years old.
2. History of hematological malignancies (acute leukemias, myelodysplastic syndromes, myeloproliferative neoplasms, lymphomas, myeloma).
3. Allogeneic hematopoietic stem cell transplantation perform during the COVID19 pandemic.

Exclusion Criteria:

Hematological diseases, other than hematological malignancies.
Is Dexmedetomidine Associated With a Lower Incidence of Postoperative Delirium When Compared to Propofol or Midazolam in Cardiac Surgery Patients

The purpose of this chart review study is to determine whether the use of dexmedetomidine, a selective α2-adrenergic receptor agonist with sedative, analgesic, and antinociceptive properties, would be associated with a lower incidence of delirium when compared to propofol and midazolam. We hypothesize that sedation with dexmedetomidine following cardiac surgery with CPB will be associated with a lower incidence of postoperative delirium.

Delirium is the most common psychiatric syndrome found in the general hospital setting. Between 32 - 80% of cardiac surgery patients may experience post-operative delirium. Because failure to recognize delirium leads to increased morbidity and mortality and prolonged hospital stays, there are compelling clinical and financial reasons to improve the identification and treatment of delirium. Dexmedetomidine, a selective alpha2-adrenergic receptor agonist, may be an alternative to current postoperative sedation when it comes to lowering the incidence of delirium.

Comparisons: The use of postoperative (at sternal closure) dexmedetomidine will be compared to current standards of care propofol and midazolam for postoperative sedation.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of a coronary artery disease, cardiac valve disease, or vascular problems requiring elective surgical intervention
2. Age older than 18 years of age, less than 90 years of age
3. Fluency in English, and willingness to participate in the study
4. No history of recent (\< 3 months) of alcohol or drug abuse
5. No pre-operative evidence of heart block
6. No history of dementia, schizophrenia, or post-traumatic stress disorder

Exclusion Criteria:

1. A preexisting diagnoses of dementia, schizophrenia, active or recent alcohol or drug abuse/dependence; post-traumatic stress disorder; acute intoxication (i.e., positive urine drug and/or alcohol test at the time of initial evaluation or upon hospitalization for surgery)
2. Age younger than 18, or older than 89 years of age
3. Inability to understand enough English to complete required diagnostic testing
4. Unwillingness to participate in the study
5. Inability of subject or surrogate to consent.
6. Pregnancy
Comparison of Airway Ultrasound Measurements

Evaluating the success of measurements taken with ultrasound airway imaging in predicting difficult intubation by comparing conventional parameters in terms of difficult intubation and the proportion of patients encountered during intubation and characterised as difficult.

Clinical screening tests, which have long been routinely used for airway assessment, do not have sufficient sensitivity and specificity to detect difficult laryngoscopy. The Cormack-Lehane laryngoscopy classification, which can be assessed during direct laryngoscopy, is an invasive procedure and is not suitable for routine preoperative airway assessment. Preoperative airway assessment using ultrasound can help to predict a difficult laryngoscopy and/or difficult intubation and is growing in popularity as a non-invasive diagnostic tool. Several recent studies have emphasised the importance of various ultrasound-mediated airway measurements in predicting difficult intubation, and have shown that measurements with different parameters and data obtained by ratioing some measurements to each other may have an important role. However, the parameters obtained by ultrasound-mediated airway measurement can help determine airway anatomy and guide airway interventions with dynamic real-time images.

In this study, we used hyoid bone visibility obtained by preoperative ultrasound evaluation of the upper airway, followed by skin-hyoid distance, skin-cricothyroid membrane distance and length, hyomental distance measured in two different positions, neutral and extension, and the ratios of these two measurements to predict difficult intubation; traditional parameters used as indicators of difficult ventilation and/or intubation (Mallampati-Samsoon classification, upper lip bite test, thyromental distance, sternomental distance, neck circumference, maximum mouth opening, Wilson difficult intubation score and Han ventilation scale).

Eligibility Criteria:
Inclusion Criteria:

* Patients to be operated with endotracheal intubation under elective conditions
* Voluntary patients whose informed consent was obtained,
* Patients older than 18 years
* Patients evaluated in the 1-2-3 category of the American Society of Anaesthesiologist (ASA)

Exclusion Criteria:

* Patients with a history of difficult intubation
* Pregnant patients
* Patients with a history of surgery in the head and neck region
* Patients with a history of trauma or tumour in the head and neck region
* Presence of a syndrome that will cause difficult intubation
* Uncooperative patients,
* Patients with missing data
Intravitreal Bevacizumab and Low Fluence Photodynamic Therapy

The purpose of this study is to report the treatment effect and safety of combined intravitreal bevacizumab (IVB) and photodynamic therapy (PDT) with verteporfin using a reduced (RF) light fluence rate, in choroidal neovascularization (CNV) secondary to pathologic myopia.

In this retrospective interventional case series, 16 patients with myopic CNV were included. All patients were treated with 1.25 mg of intravitreal bevacizumab followed by RF-PDT (25 J/cm²), 2 days later. All patients were previously treated with IVB monotherapy and active leaking of CNV occurred 90 to 120 days after the treatment.

Best-corrected visual acuity (BCVA-ETDRS), foveal thickness (FT) on optical coherence tomography (OCT), and fluorescein and indocyanine green angiographic (FA; ICG) findings were recorded. Follow-up evaluations were carried out for 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Myopic CNV, CNV leakage

Exclusion Criteria:

* CNV not associated with high myopia
* No activity of CNV
The Impact of Noradrenaline on Ventriculo-arterial Coupling and Central Cardiovascular Energy Delivery

The study aims to examine how noradrenaline in combination with venous return influences the energy transmission from heart to central circulation and arteries - also called arterio-ventricular coupling.

After being informed about the study 40 elective CABG patients with written informed consent will undergo assessment of their arterio-ventricular coupling postoperatively after coronary bypass graft surgery. Whilst still in deep general anesthesia on the CT ICU the study population will be assessed by echocardiographic examination (transthoracic and transesophageal), blood pressure tracing by arterial line, respiratory data and ECG in 4 different situations.

Initially the individual patient is either considered fluid responsive (SVV \>13%) og non- responsive (SVV\<13%) by using stroke volume variation assessed by echocardiography.

In case of fluid responsiveness a fluid bolus of 4ml/kg of crystalloid fluid is given until SVV drops below 13% and the patient can be considered as fluid NON responder.

Right afterwards the study patient is stabilized with a baseline dose of noradrenaline (NA) intravenously in a supine position (situation 1). Situation 2 will be a slight increase in NA dose stabilizing mean arterial pressure in a "baseline + 20mmHg" state. After reversing the NA dose back to base line level the patient is allowed a short period of rest to wean of drug effect (4-5 x t1/2, appr. 12min). Subsequently the patient is to be placed in a 20% semi upright position (Anti-Trendelenburg) causing an increase in fluid responsiveness (situation 3). Following a phase of equilibration the dose of NA is again titrated up to obtain a 20mmHg increase in mean arterial pressure (situation 4).

There will be logging of arterial pressure curve and VTI-tracing I LVOT simultaneously (ultrapower, uPWR) as well as calculation of energy delivery, cardiac power, oscillatory power and -fraction and both arterial and ventricular elastance in every of those 4 situations.

Eligibility Criteria:
Inclusion Criteria:

* elective coronary artery bypass graft surgery
* requirement for Noradrenaline/Norepinephrine

Exclusion Criteria:

* lack of informed consent
* patient unsuitable for mean arterial pressure (MAP) elevation of 20mmHg
* patient requiring different blood pressure range due to medical/surgical needs
* poor image quality due to patient factors
Herniorrhaphy Study for Opioid Elimination

This is a Phase 3b, open-label study to assess postoperative opioid use in subjects undergoing unilateral open inguinal herniorrhaphy with intraoperative administration of HTX-011 and a postoperative non-opioid multimodal analgesic (MMA) regimen. The study will be conducted in 2 sequential parts: Part 1 is randomized and Part 2 is Investigator's preference for MMA regimen.


Eligibility Criteria:
Inclusion Criteria:

* Is scheduled and medically fit to undergo an elective unilateral open inguinal herniorrhaphy with mesh under deep sedation or general anesthesia; no neuraxial technique (eg, no spinal or epidural).
* Has an American Society of Anesthesiologists (ASA) Physical Status of I, II, or III.
* Female subjects are eligible only if not pregnant, not lactating, not planning to become pregnant during the study, sterile; or using acceptable contraceptives.

Exclusion Criteria:

* Has a planned concurrent surgical procedure (eg, bilateral herniorrhaphy).
* Has a pre-existing concurrent acute or chronic painful physical/restrictive condition expected to require analgesic treatment in the postoperative period for pain.
* Has a contraindication or a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to required study medications.
* Part 1 only: Has known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months. Part 2 only: Has known or suspected history of persistent opioid use, defined as daily, or almost daily, use of opioids for a period of at least 30 days within the previous 6 months.
* Has taken any opioids within 24 hours prior to the scheduled surgery.
* Has a medical condition such that, in the opinion of the Investigator, participating in the study would pose a health risk to the subject or confound the postoperative assessments.
* Has uncontrolled anxiety, psychiatric, or neurological disorder.
* Has a known or suspected history of drug abuse, has a positive drug screen on the day of surgery, consumes 3 or more alcoholic drinks every day, or has a recent history of alcohol abuse.
Comparison of Early Versus Delay Reconstruction in Anterior Cruciate Ligament Tearing

The purpose of this study is to determine which surgical method is better for anterior cruciate ligament teas in outcomes.

The anterior cruciate ligament (ACL) is one of the most commonly injured ligaments of the knee. This study was conducted to determine whether the outcome of treatment is superior in early surgical reconstruction compared with optional delay reconstruction.

Eligibility Criteria:
Inclusion Criteria:

a. patients with confirmed anterior cruciate ligament tearing

Exclusion Criteria:

One of the following associated injuries to the index knee as visualized on MRI and/or arthroscopy:

1. An unstable longitudinal meniscus tear that requires repair and where the following postoperative treatment (i.e. bracing and limited ROM) interferes with the rehabilitation protocol
2. Bi-compartmental extensive meniscus resections
3. A cartilage injury representing a full thickness loss down to bone
4. A total rupture of MCL/LCL as visualized on MRI
ENDObesity® II Study: TransPyloric Shuttle® System for Weight Loss

The purpose of this clinical research trial is to study safety and effectiveness of the TransPyloric Shuttle System (TPSS) for weight reduction in patients who are considered medically obese.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects between the ages of 22 to 60
* A BMI between 30.0 to 40.0 kg/m2, inclusive. Subjects with a BMI of 30.0 kg/m2 to 34.9 kg/m2 are required to have one or more obesity-related comorbidities
* History of obesity for at least 2 years, with history of failure of medically or commercially supervised weight loss program
* \< 5% change in body weight for at least 3 months
* Negative pregnancy test, agree to be on birth control for the duration of participation
* Informed consent
* Willing and able to comply with study procedures

Exclusion Criteria:

* Pregnancy or nursing
* Hormonal or genetic cause for obesity
* Prior history of any GI surgery or endoscopic intervention
* Chronic use of medications likely to contribute to weight gain or prevent weight loss
* Gastric or duodenal ulcers
* Positive for H. pylori
* History of severe dyspepsia
* GI tract motility disorders
* History of inflammatory disease of GI tract, coeliac disease, pancreatitis, portal hypertension, cirrhosis, and/or varices
* Diabetes treated with insulin
* HbA1c \>7.5%
* Uncontrolled thyroid and adrenal gland disease or uncontrolled hypertension
* History of certain cardiac events
* Localized or systemic infection
* Anemia
* History of asthma likely to require systemic steroid therapy
* Autoimmune connective tissue disorders or immunocompromised
* History of malignancy except non-melanoma skin cancer
* Continuous use of ulcerogenic medication
* On anticoagulation or antiplatelet therapy
* Use of weight-loss medication
* In other weight-loss program
* Unable to take proton pump inhibitor
* Abnormal laboratory values or EKG
* Inability to walk at least 0.8 kilometers per day
* Planned surgical procedure that can impact the conduct of the study
* Known allergy to any component materials in the TPSS
* Smoker or user of nicotine product
* Substance abuse
* Severe, uncontrolled psychiatric illness
* Recent inpatient psychiatric treatment
* Moderate depression
* Bulimia nervosa or binge eating disorder
* Participation in another clinical study
* Employee or family member of Sponsor or study staff
* Have any endoscopic exclusion criteria