cyrilzakka/clinical-trials huggingface dataset:
TVI-Brain-1 in Expanded Access Patient

TVI-Brain-1 is being offered as a potential treatment option to a Named Patient (Emergency Use Authorization IND) for recurrent glioblastoma as there is no effective systemic treatment available for this disease or patient. TVI-Brain-1 is an experimental treatment that takes advantage of the fact that your body can produce immune cells, called 'killer' white blood cells that have the ability to kill large numbers of the cancer cells that are present in your body. TVI-Brain-1 is designed to generate large numbers of those 'killer' white blood cells and to deliver those cells into your body so that they can kill your cancer cells.

The TVI-Brain-1 treatment involves several steps. First, the patient's cancer will be surgically removed to provide cells for the vaccine. Second, the patient will be vaccinated with the vaccine formulation. Third, the patient's blood will be filtered for killer T cell precursors which will then be cultured and stimulated to reach a higher (killer) activity level. Fourth, the activated cells will be infused into the patient's bloodstream so that they will be able to attack the cancer.

Eligibility Criteria:
Inclusion Criteria:

Recurrent glioblastoma diagnosis confirmed

* Age \> 18
* Informed consent
* Diagnosis of grade IV glioma with progression following standard treatment.
* Must be able to tolerate surgery to provide tumor tissue for vaccine.
* Must be able to produce viable vaccine from tumor tissue.
* Karnofsky Performance Status must be 70 or greater.
* Negative HIV test.
* Negative for hepatitis B and C virus.
* Respiratory reserve must be reasonable.
* Sufficient renal function.
* Satisfactory blood counts.
* Negative pregnancy test for women of childbearing potential.

Exclusion Criteria:

* Surgically removed cancer reveals that it is not grade IV glioma.
* Concomitant life-threatening disease.
* Active autoimmune disease.
* Currently receiving chemotherapy or biological therapy for the treatment of cancer.
* Currently receiving immunosuppressive drugs for any reason.
* Prior treatment with Avastin or other anti-angiogenesis treatment within 6 months.
* Prior treatment with Gliadel wafers.
* Corticosteroids beyond peri-operative period.
* Psychological, familial, sociological or geographical conditions that do not permit adequate medical follow-up and compliance with the study protocol.
Diaphragmatic Echography in Critically Ill patientS

Acute respiratory failure (ARF) is characterised by a discrepancy between load imposed on respiratory muscles and their capacity. Recently, diaphragmatic ultrasonography has been introduced in the clinical practice to evaluate diaphragmatic function. In particular, the investigators will focus on Diaphragmatic Displacement measured by M-mode ultrasonography. The aim of this study was to compare the diaphragmatic displacement with traditional weaning parameters in potentially ready to be extubated patients undergoing a spontaneous breathing trial (SBT).


Eligibility Criteria:
Inclusion Criteria:

* mechanically ventilated since more than 24 hours
* clinical improvement of the underlying acute cause of the respiratory failure
* adequate cough reflex
* absence of excessive and/or purulent tracheobronchial secretion
* stable cardiovascular status
* stable metabolic status
* adequate pulmonary function
* adequate mentation

Exclusion Criteria:

* age \<18 years
* pregnancy
* presence of thoracostomy, pneumothorax or pneumomediastinum
* presence of flail chest or rib fractures
* neuromuscular disease
* use of muscle-paralyzing agents within 48 hours before the study
* history or new detection of paralysis or paradoxical movement of a single hemi-diaphragm on diaphragm ultrasonography
A Retrospective Review of Enseal Laparoscopic Vaginal Assisted Hysterectomy (LAVH) Versus Traditional LAVH

Retrospective charts review from one surgeon to compare Group A- cases where the laparoscopic portion of the case used an EN\~SEAL device to Group B - the laparoscopic BSO was done using a 3mm EN-SEAL device through 2 lateral 5mm ports.

79 women with benign uterine disease underwent laparoscopic assisted vaginal hysterectomy with or without bilateral salpingo-oophorectomy. Subjects charts were divided into two groups based on surgical technique and the following parameters were reviewed retrospectively: surgical time, blood loss, uterine weight, patient weight, patient age, post operative fever \>100.4 F, readmission to hospital within one week, return to operating room within 24 hours, length of hospital stay, and blood transfusion. Group A, N=35 used traditional suture technique vaginally. Group B, N=44 used Enseal coagulation cutting device vaginally.

Eligibility Criteria:
Inclusion Criteria:

* none, observational study

Exclusion Criteria:

* none, observational study
Individualized Radiation Dose Control

The adjustment of radiation dose in many CT protocol are based on body mass index(BMI) or weight of the patient.

In the literature, neck circumference (NC) has been reported as a new anthropometric parameter indicating the body mass for the upper body.

NC may be an important landmark in the determination of the low dose protocols for upper body CT examinations such as neck, chest and coronary CT.

Over the last few decades, MDCT(multidetector computed tomography), cardiac imaging, CT perfusion techniques, high-pitch CT, and dual-energy CT have been introduced to clinical practice, increasing the overall amount of radiation applied. There are two types of approaches in accordance with the "as low as reasonably achievable (ALARA)" principle in MDCT. One of them is related to new technology products and different imaging techniques such as dose modulation along the x-, y-, and z-axes (anatomical tube current modulation, ECG-controlled tube current modulation or dynamically adjustable pre-patient collimation of the X-ray beam in the z-axis direction, iterative reconstruction technique. The other strategy is individualized screening-dose protocols based on body size. However the radiologist is facing the challenge of providing diagnostic image quality at the lowest radiation dose.

Body mass index (BMI) is not only the most widely used anthropometric tool for defining overweight and obesity, but it is also the most commonly reported body index for adjusting low dose in MDCT.Despite this popularity of BMI, it is becoming increasingly more clear that BMI is not a good surrogate for regional adiposity. Regional fat deposition, especially in the upper body region, is a better predictor of some obesity related complications than BMI. Accordingly, it has been reported that several anthropometric parameters of the chest might serve as a surrogate instead of BMI for individualized dose settings Neck circumference(NC) is a kind of somatometric parameter like wrist or hip circumference that reflects the upper body size. NC may be an important landmark in the determination of the low dose protocols for upper body CT examinations such as neck, chest and coronary CT. Although investigators have not encountered studies in the literature, this point will be evaluated in our study.The purpose of this study is to evaluate if NC is an appropriate and a novel parameter for adjusting and reduction of the effective chest CT radiation doses in comparison with BMI or not.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of pulmonary diseases
* participants who can be referred to radiology for diagnostic imaging
* participants who allowed to be taken somatometric measurements

Exclusion Criteria:

* participants who did not allow to be taken somatometric measurements
* participants with incomplete data (such as missing weight or height data)
* pediatric and pregnant patients
BACTERIUM: Study for a Machine-learning-based Model to Predict Bloodstream Infections

An increase of healthcare-associated infections caused by multidrug- resistant organisms (MRDO) is currently observed. One of the main causes of the emergence of a MDRO infection is an overuse of antibiotics. Therefore, saving useless antibiotic treatment is currently a priority from a public health point of view. The evaluation of the risk of having a bloodstream infection will allow both activating faster treatment decisions (when the risk is significantly high) or to save useless resources in terms of diagnostic tests and treatments, also limiting the potential for side effects (when the risk is significantly low).


Eligibility Criteria:
Inclusion Criteria:

1. adult patients hospitalized at the Gemelli Polyclinic Foundation
2. having at least one performed blood culture
3. starting an antibiotic therapy

Exclusion Criteria:

1. blood cultures with contaminants
2. \<18 years old
3. died after less than 48 hours from blood cultures positivity
Use of Guidance Videos to Increase Engagement and Decrease Anxiety in Patients Undergoing Pleural Tap

Patients planned to undergo a pleural tap will get verbal explanation or watch a personalized guidance video in addition to verbal explanation. Questionnaires will be filled to assess the effect of the video training on understanding, cooperation and anxiety.

100 patients with pleural effusion, planned to undergo a diagnostic or therapeutic pleural tap, will be randomized to watch a personalized custom video training, explaining the procedure, in addition to the verbal explanation given by the medical staff, or to get the standard verbal explanation alone. Questionnaires regarding their understanding of the procedure, their feelings and the level of anxiety will be filled before and after the video/verbal explanation, and after the procedure. the study aims to check whether the video training provides better understanding of the procedure, increases cooperation and engagement and decreases anxiety.

Eligibility Criteria:
Inclusion Criteria:

* patients hospitalized in Internal medicine C and D, Tel-Aviv Sourasky Medical Centers
* Patients with pleural effusion, planned to undergo diagnostic or therapeutic pleural tap
* Patients who can read and understand the questions
* Patients who were interested in participating in the clinical trial and signed an informed consent form

Exclusion Criteria:

* Minors \< 18 years of age
* Pregnant women
* Patients who cannot read and understand, at the discretion of the investigator
* Patients which their medical condition does not allow them to undergo the study procedure
Morphological Markers of Gastroesophageal Reflux Disease (GERD)

The purpose of this project is to learn more about a new and promising way to diagnose acid reflux disease using a very high-powered microscope. This special microscope provides much finer detail than typical microscopes previously used for diagnosing reflux, and may help doctors to better identify children with acid reflux.

This will be a prospective case control study. Children between the ages of 8 and 18 with suspected gastroesophageal reflux disease (GERD) or eosinophilic esophagitis (EoE) based on symptom criteria and who have been scheduled for esophagogastroduodenoscopy (EGD) by their primary gastroenterologist will be recruited.

Children who do not have any history of esophageal disease or esophageal symptoms and are scheduled for EGD for other clinical indications (e.g. rule out celiac disease) by their primary gastroenterologist will be recruited and act as controls. Control subjects will also be given the opportunity to undergo esophageal MII-pH monitoring as part of their medical evaluation, but will not be excluded from analysis should they opt out of this part of the study.

For all subjects, in addition to endoscopic evaluation, biopsies of the distal esophagus will be obtained for routine light microscopy (standard histology sample) as well as Transmission Electron Microscopy (TEM) analysis to determine the presence and magnitude of dilated intercellular spaces (DIS), and immunoblotting for e-cadherin cleavage

Eligibility Criteria:
Inclusion Criteria for GERD or EoE Subjects:

* Children between the ages of 8-18 years
* Suspected diagnosis of GERD or EoE based on symptom criteria
* Able to tolerate upper endoscopy examination with biopsies

Inclusion Criteria for Control Subjects:

* Children between the ages of 8-18
* Scheduled for EGD for clinical indications
* No history of esophageal disease of esophageal symptoms
* Able to tolerate upper endoscopy examination with biopsies

Exclusion Criteria for GERD or EoE Subjects:

* History of Barrett's esophagus
* Previous esophageal or gastric surgery
* History of congenital defect/malformation of the esophagus
* Diagnosis of Crohn disease

Exclusion Criteria for Control Subjects:

* Symptoms of GERD or EoE (including heartburn, regurgitation, difficulty swallowing, painful swallowing).
Zinc Dosing Trial - Does Dose Reduction Reduce Side Effects But Retain Efficacy in Diarrhoea Management

Diarrhoea continues to be a major cause of child deaths. Current treatment of acute watery diarrhoea includes oral rehydration solution (ORS), zinc and continued feeding. The use of zinc is based on a number of studies that showed that zinc reduces the duration and severity of diarrhoea. The recommended dose of zinc in 6-59 month old children is 20mg/day for 10-14 days. This dose is associated with an increased risk of vomiting. No dosing studies are available to determine the optimal dose of zinc, which while maintaining the benefits also has a low risk of vomiting.

The investigators will conduct a double-blind randomized controlled trial of three doses of zinc (20mg/day, 10mg/day and 5mg/day) in two settings - one in Sub-Saharan Africa and the other in South Asia. The study population will be 4500 children with diarrhoea of less than 72 hours duration who are aged 6-59 months. They will be recruited from outpatient health facilities. All enrolled children will receive ORS and continued feeding as recommended by the World Health Organization. Those allocated to the standard zinc dose will receive an oral dispersible tablet with 20mg zinc daily for 14 days. Those allocated to lower dose zinc will receive identical tablets with either 10mg or 5mg zinc daily for 14 days. Enrolled children will be followed by until recovery from diarrhoea or 15 days after enrolment, whichever is later. In addition, study children will be assessed again at thirty (30), forty-five (45), and sixty (60) days to estimate impact on post illness outcomes. Primary outcomes will be mean duration of diarrhoea, proportion of episodes that last longer than 5 days, mean number of stools and proportion of children with vomiting.


Eligibility Criteria:
Inclusion Criteria:

* 6 to 59 completed months of age
* Acute diarrhoea of less than 3 days at the time of screening or dysentery, defined as visible blood in the stool, of less than 3 days at the time of screening
* Likely to stay within the study area for the next 2 months
* Written informed consent from caretaker

Exclusion Criteria:

* Presence of severe acute malnutrition (WHZ\<-3 or oedema)
* Presence of severe dehydration that cannot be corrected in 4 to 6 hours
* Signs of severe pneumonia (WHO definition of pneumonia with danger signs), sepsis, rapid diagnostic test (RDT) -confirmed malaria or other severe illness
* Previously or currently enrolled in the study
* Currently enrolled in another study
* Other child currently enrolled in the study in the same household
* Not intending to remain in study area for the duration of the study
* Parents refuse participation in the study
Goniocurettage as First Choice of Surgical Treatment in Chronic Open-Angle Glaucoma: Outcomes and Complications

The study has the purpose to evaluate the effectiveness and safety of the goniocurettage as a first choice of surgical treatment for primary open-angle glaucoma (POAG) in patients with good vision.

A prospective study in 33 eyes (32 patients) with uncontrolled open angle glaucoma under clinical treatment. The trabecular tissue was scraped away from the angle (goniocurettage) in about 100 degrees by means of an instrument similar to a microchalazion curette. The goniocurettage was done under direct visualization of the angle through a gonioscopy lens (Swan-Jacob) and a surgical microscope. Using the 17.0 SPSS software the investigators compared the intraocular pressure, the numbers of antiglaucomatous medications, the best correct visual acuity, the development of cataract, the central corneal thickness,the impact on the visual field, the impact on the optic nerve head and the central corneal endothelial cell density before and after the goniocurettage, and the intra and post operative complications.

Eligibility Criteria:
Inclusion Criteria:

* Disc and/or visual field findings consistent with Primary Open Angle Glaucoma
* Uncontrolled intraocular pressure (≥21 mm Hg) or progressive glaucomatous neuropathy despite maximum tolerated medical therapy
* 40 years old or over
* Visual acuity higher than 0.2
* Open angles (greater or equal to Shaffer grade II)

Exclusion Criteria:

* Previous ocular surgery
* History of glaucoma laser treatment
* History of ocular trauma
* Cyclodestructive procedures
* Corneal edema or opacities
* Endothelial decompensation
* History of uveitis
* Secondary glaucoma
* neovascularization of the iris or angle
* Congenital anterior segment abnormalities
* Anatomically confusing angles without clear definition of the scleral spur or meshwork and inability to maintain follow-up
Evaluating Fluid Strategies in Thoracic Surgery Patients Utilizing a Goal Directed Approach

The purpose of this study is to conduct a prospective, randomized, controlled trial comparing a restrictive vs. conservative fluid strategy in thoracic surgery patients. Excessive perioperative fluid has been retrospectively implicated in the development postoperative acute lung injury (PALI) and pulmonary edema following lung resection. However, fluid restriction in these patients is not without risk and may compromise end organ perfusion (i.e. acute kidney injury). The hypothesis is that a conservative fluid approach in thoracic surgery patients will result in better end organ perfusion with fewer occasions of acute kidney injury (AKI) without causing an increase in postoperative acute lung injury or pulmonary edema.


Eligibility Criteria:
Inclusion Criteria:

* between 18-89 years of age
* undergoing pulmonary lobectomy with open or video assisted thoracotomy

Exclusion Criteria:

* patient refusal
* pregnancy
* cardiac arrhythmia
* pacemaker dependency
* severe aortic insufficiency
* idiopathic hypertrophic subaortic stenosis
* prisoners
* decisionally challenged
* patients that refuse to receive intravenous fluid products made from human plasma (Albumin 5%)
* patients with skin infection or breakdown on their fingers
* severe peripheral vascular disease
* evidence of compromised finger perfusion will be excluded
The Role of Cyberchondria Severity in the Relationship Between HPV Awareness and Vaccination Attitudes in Adult Women

Human papillomavirus (HPV) is a prevalent sexually transmitted infection linked to nearly all cases (99%) of cervical cancer. Prophylactic HPV vaccination is effective in preventing these cancers, complemented by HPV screening and treatment of precancerous lesions. The World Health Organization (WHO) aims to eliminate cervical cancer by 2030 through focused efforts on vaccination, diagnosis, and treatment.

Primary prevention strategies include reducing sexual risk factors and administering prophylactic vaccines. Despite awareness of HPV testing, many women lack understanding of its importance and fail to follow through with screenings and necessary treatments. Overall societal awareness of HPV remains inadequate.

Studies reveal disparities in HPV vaccine awareness: while 60.7% of women have heard of the vaccine, only 1% have received it. Awareness varies widely across regions, with Turkey reporting rates from 3.8% to 57%, and vaccine awareness ranging from 2.2% to 74.7% (Özdemir et al., 2020). In the UK, concerns over potential negative results lead many women to defer HPV testing.

Health anxiety, defined as interpreting minor symptoms as serious health issues, drives individuals to seek excessive online health information, a phenomenon known as cyberchondria. Studies link cyberchondria with heightened health anxiety, exacerbated by prolonged internet searches.

Barriers to HPV screening and vaccination include fear of side effects, lack of information, cost concerns, and anxiety over potential outcomes. While women testing positive for HPV show higher levels of cyberchondria, no direct correlation has been established between cyberchondria severity and HPV awareness or vaccination attitudes in adult women.

This summary encapsulates the key findings and insights from the referenced studies on HPV, vaccination, and health anxiety.


Eligibility Criteria:
Inclusion Criteria:

* Women aged 18-49 years old
* At least elementary school education

Exclusion Criteria:

* Individuals diagnosed with psychiatric disorders
* Women who are HPV (Human Papilloma Virus) positive
* Any condition that would hinder communication (e.g., language barrier)
Phase IV Trial,The Efficacy and Safety Study of Fuganlin Oral Liquid in Children With Acute Upper Respiratory Infection

Phase IV trial,Single-arm, multi-centre clinical trial to assess the efficacy and safety of Fuganlin Oral Liquid in children with acute upper respiratory infection

Low-dose group of Fuganlin Oral Liquid:dosage from 5 to 10 ml;

High-dose group of Fuganlin Oral Liquid:dosage from 10 to 20 ml;

Treatment for 1 week.Patients who were recovered within 1 week can withdrawal at any time.

Research purpose:

1. Evaluate the safety and efficacy of Fuganlin oral Liquid when expanding the designated indications(Qi deficiency wind-heat syndrome to wind-heat syndrome) .
2. Explore the relationship between elevated white blood cells and efficacy, age and efficacy, dose and efficacy,While treating with Fuganlin oral Liquid in children with acute respiratory infection.
3. Observe the antiviral and immunomodulatory effects of Fuganlin oral Liquid.
4. Provide data to support the clinical medicine guidelines and labels amendment of Fuganlin oral Liquid.

Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed as acute upper respiratory infection.
2. Patients with acute upper respiratory infection diagnosed as Tradition Chinese Medicine syndrome qi deficiency wind-heat.
3. Patients aged 1 to 12 years old.
4. Parents or guardians agreed to participate this study and signed the informed consent.

Exclusion Criteria:

1. Patients whose total numbers of white blood cells around above1.3ULN.
2. Patients diagnosed as suppurative tonsillitis, otitis media, bronchitis and other airway.
3. Patients allergic to the test drug.
4. Serious cardiovascular, liver,kidney and other primary systemic diseases.
5. Patients should not be included in group according to investigator's evaluation.