cyrilzakka/clinical-trials huggingface dataset:
Comparison of Dural Puncture Epidural Versus Conventional Epidural for Labour Analgesia in Primigravida

This study aims to compare the analgesic efficacy and safety of the Dural Puncture Epidural (DPE) technique versus the Conventional Epidural (CE) technique for labor analgesia in primigravida.

The conventional epidural (CE) technique has been the gold standard for decades, providing continuous and adjustable pain relief during labor. However, the advent of new techniques, such as the Dural Puncture Epidural (DPE) technique, has led to ongoing research and debate over which method offers superior outcomes in terms of efficacy, onset of analgesia, maternal satisfaction, and safety.

The CE technique involves the placement of an epidural catheter into the epidural space, where local anesthetics and adjunctive drugs are administered to provide pain relief. While this technique is highly effective, it is not without limitations. Some parturients may experience a slow onset of analgesia, uneven drug distribution, or the need for frequent catheter adjustments, which can delay adequate pain relief and decrease maternal satisfaction . Furthermore, the CE technique has been associated with potential complications such as unilateral blocks, inadequate sacral analgesia, and the necessity for higher doses of local anesthetics, which may increase the risk of motor blockade and impact labor progression .

In contrast, the DPE technique is a novel approach that modifies the CE by incorporating an intentional dural puncture with a small-gauge spinal needle without administering intrathecal drugs. This modification is believed to facilitate the spread of epidurally administered drugs into the subarachnoid space, potentially enhancing the onset and quality of analgesia. The DPE technique aims to combine the benefits of both the CE and the Combined Spinal Epidural (CSE) techniques while minimizing their respective drawbacks, such as the hemodynamic instability associated with CSE and the slower onset of analgesia often seen with CE

Eligibility Criteria:
Inclusion Criteria:

1. Primigravida women aged 18-40 years.
2. Gestational age between 37 and 42 weeks.
3. Single pregnancy with vertex presentation.
4. Patients in active labor with cervical dilation of less than 5 cm at the time of epidural placement.
5. American Society of Anesthesiologist physical status I or II.
6. Patients who provide informed consent for participation in the study.

Exclusion Criteria:

1. Patients with contraindications to neuraxial anesthesia (e.g., coagulopathy, infection at the puncture site).
2. History of preeclampsia, gestational diabetes, or any other significant medical conditions that could influence labor or anesthesia outcomes.
3. Patients with a history of previous uterine surgery, including cesarean section.
4. Known fetal anomalies or non- vertex presentations.
5. Patients with morbid obesity (BMI \> 40 kg/m²).
6. Allergy or hypersensitivity to local anesthetic-s used in the study.
Traditional In-Person Vs. Remote AR Clinical Simulation

This is a non-inferiority, international, controlled trial that aims to evaluate the progression of physicians and residents through an Advanced Cardiac Life Support (ACLS) clinical simulated scenario. The study's primary objective is to compare the performance outcomes between two groups: participants in the traditional in-person simulation and those immersed in the Augmented Reality (AR) scenario


Eligibility Criteria:
Inclusion Criteria:

* Brazilian resident

Exclusion Criteria:

* a history of severe motion sickness
* currently have nausea
* a history of seizures
* wear corrective glasses.
Effect of Three Non-drug Intervention in Treatment of Children With Overweight

The purpose of this study is to compare the effect of three different non-pharmacological interventions (usually practiced in ambulatory care of Childhood Obesity (AmO), physical activity program (IFSP) and diet therapy adjusted estimate by indirect calorimetry) on the percentage of body fat and basal metabolism of children and Overweight and obesity in the metropolitan region of Porto Alegre (RS).


Eligibility Criteria:
Inclusion Criteria:

* age 8 to 15 years old with overweight (Z-score BMI +1 e +2) and obesity (Z-score BMI \> +2)

Exclusion Criteria:

* chronic diseases
Tunisian Lung Cancer Study

This is a prospective, multicenter, observational, national study. Eligible patients will be recruited consecutively among subjects with proven lung cancer, including any disease stage withclinical, therapeutic and evolutive discription.


Eligibility Criteria:
Inclusion Criteria:

* Age more than 18 years
* Patients receiving health care in the departments of pulmonology, oncology, radiation oncology and thoracic surgery, whose diagnosis is confirmed histologically and/or by cytology, at least 3 months before the inclusion date
* Informed consent

Exclusion Criteria:

* None
Efficacy of a Nasal Spray Containing Iota-Carrageenan in the Prophylaxis of COVID-19 Disease in Health Personnel Dedicated to Patients Care With COVID-19 Disease

Coronaviruses are enveloped viruses with an RNA genome. Carrageenans are sulfate polysaccharides synthesized by red algae. Studies conducted in adults and children with the common cold showed the effectiveness of the use of Carrageenan in nasal spray.

For decades, the antiviral action of Carrageenans has been described in numerous studies with different viruses that infect humans: herpes viruses types 1 and 2, human immunodeficiency virus, human papillomavirus, H1N1 influenza virus, dengue virus, rhinovirus, hepatitis A virus, and enteroviruses. Studies on the dynamics of COVID-19 disease show an intense and rapid pharyngeal multiplication in the first 3-5 days of the onset of symptoms, prior to the onset of pulmonary disease.

Finally, this molecule has shown a viricidal effect against SARS-Cov2 in vitro. All this underscores the potential value of a therapy that inhibits the virus in the rhinopharynx.

This is a multicenter, randomized, double-blind, placebo-controlled trial assessing the use a nasal spray containing Iota-Carrageenan in the prophylaxis of COVID-19 disease in health-workers.

Eligibility Criteria:
Inclusion Criteria:

* physician, nurses, and physical therapist who usually attend hospitalized COVID19 patients.
* No more than 48 hours since he/she assisted a COVID-19 patient
* Able to understand and give written informed consent

Exclusion Criteria:

* Participation in any other clinical trial of an experimental treatment for COVID-19
* Not having a cell phone with WhatsApp for remote monitoring
* Hypersensitivity or known allergy to any component of the product
* Pregnancy or lactation
Clinical and Imaging Biomarkers Associated With Plasma ad Cellular Determinants of Cardiovascular Disease at the Time of COVID 19

Acute and chronic cardiovascular complications of pneumonia are common and result from various mechanisms, including relative ischemia, systemic inflammation, and pathogen-mediated injury. However, there is only limited published data regarding on cardiovascular desease (CV) submissions in the wake of viral outbreaks. Data collected during the COVID-19 pandemic highlighted a number of possible determinants of adverse outcome in these patients, particularly with reference to cardio-respiratory complications.

The risk of death increases substantially after age 60, in men and in overweight patients. Cardiac involvement, characterized by elevation of cardiac Troponin I and brain-like natriuretic peptide, is frequent in COVID-19 patients and is associated with a worse prognosis. Finally, right ventricular (RV) dilatation and dysfunction is the most common echocardiographic abnormality in patients with COVID-19, at least in part due to a substantial incidence of pulmonary thromboembolism (PTE). Cardiac abnormalities in COVID-19 patients include changes in heart rate and cardiac autonomic modulation, as well as systemic activation of inflammatory processes, with endothelial damage and involvement of the CV and respiratory systems.

The research program will examine imaging and clinical biomarkers associated with plasma and cellular determinants of cardiovascular disease, taking into account the potential effects of COVID-19 infection. This will make it possible to re-evaluate the cardiovascular risk profile of subjects with cardiovascular diseases.

Eligibility Criteria:
Inclusion Criteria:

* Women and men between the ages of 45 and 90;
* Patients diagnosed with cardiovascular disease;
* Patients with diabetes;
* Patients with dyslipidemia;
* Patients with hypertension, myocardial infarction (pre-existing or acute STEMI or NSTEMI event) chronic stable angina, peripheral vascular disease, stroke or TIA

Exclusion Criteria:

* Inflammatory diseases and/or infections (except for the IMA-COVID-19 group);
* Tumors, immunological and/or hematological disorders;
* Ejection fraction less than 40%;
* Treatments with anti-inflammatory drugs, with the exception of low-dose aspirin, and antibiotic therapies up to 1 month before enrolment.
The Ageing in a Networked Society -Social Experiment Study

The Ageing in a Networked Society -Social Experiment study (ANS-SE) is a randomised controlled trial on older people residing in Abbiategrasso, a middle-size city located in the Milan area (Italy) and aims to assess the impact of SNS use on loneliness, that is the primary outcome of this study. The study is constituted of two stages, i.e. the baseline and the follow up. The experiment is structured into two treatment groups and a control group; the interventions are the attendance to a course on SNS use (T1) and lifestyle education and brain functioning (T2). The control group (C) is constituted of a waiting list. The study is part of the project "Aging in a networked society. Older people, social networks and well-being", funded by the Italian Fondazione Cariplo.

The objective of the study is to evaluate the short-term and long-term impact of Facebook use on physical and mental health of older people. The experiment is carried out on 180 participants of the Brain Aging in Abbiategrasso Study (InveCe).The InveCE study is a biannual cohort study of older people born between 1935 and 1939 and living in Abbiategrasso, a town near Milan, in northern Italy (NCT01345110, ClinicalTrials.gov). For more information, see http://www.golgicenci.it/en/studio-invece/.

Participants are selected among those who agreed to take part in the 4th wave of the InveCe.Ab study. Inclusion and exclusion criteria are specified in the Eligibility box below. The study is constituted of two stages, i.e. the baseline and the follow up. The experiment is structured into two treatment groups and a control group; the interventions are the attendance to a course on SNS use (T1) and lifestyle education and brain functioning (T2). The control group (C) is constituted of a waiting list. Participant are assigned to one of these three groups randomly. Before/after the intervention, researchers administered a questionaire to participants to measure levels of loneliness, depression and neuropsychological functioning (see the box "Outcome Measure" for the description of the scales and measures used), together with a medical examination. The same assessment will be performed after one year. Data collected will be analyzed using statistical techniques in order to evaluate the impact of Facebook use on well-being.

The study is part of the project "Aging in a networked society. Older people, social networks and well-being", funded by the Italian Fondazione Cariplo.

Eligibility Criteria:
Inclusion Criteria:

* Participants to the third follow-up of the Brain Ageing in Abbiategrasso Study (InveCe.Ab study)
* Good mental health
* No physical limitations
* Good cognitive health
* No experience in using Social Networks SItes (SNSs)

Exclusion Criteria:

* GDS (Geriatric Depression Score) score equal to or greater than 10 (no major depression)
* Hands functional limitations
* Visual or hearing impairment
* Dementia or Mild Cognitive Impairment (MCI),
* Mini-Mental State Examination (MMSE) lower than 24
* Used SNS at least one time in life
Biaxial Microincision Cataract Surgery Technique

To analyze and compare visual results, keratometry, SIA and HOAs outcomes of biaxial microincision cataract surgery in elderly population, including diabetic and non-diabetic patients.

Modern trends in cataract surgery is the bimanual MICS technique. MICS significant development for 15 years gives possibility to implant the intraocular lens by 1.4mm incision. This is not only a change in surgery technique, but it is a significant progress in safety and quality post-operative results. Bimanual cataract MICS technique gives the opportunity to reduce width of the corneal incision more than 40% comparing to the standard coaxial cataract surgery by use dedicated MICS IOL's. This allows to perform less traumatic surgery and provides the opportunity for fast visual rehabilitation from the first week after cataract surgery. The possibility of using multifocal and toric intraocular lenses in MICS technique fully meet the requirements of modern refractive intraocular surgery.

Eligibility Criteria:
Inclusion Criteria:

1.Clinical diagnose of senile cataract.

Exclusion Criteria:

1. Eye trauma in anamnesis.
2. Eye surgery in anamnesis.
3. Corneal surgery in anamnesis.
4. Corneal irregular astigmatism.
5. Corneal ectasia.
Endoscopic Goniotomy for Infantile Glaucoma

Glaucoma surgery is performed on children less than 3 years old for infantile glaucoma which untreated can cause blindness. Glaucoma is an uncontrolled high eye pressure in these children often due to incomplete development of the part of the eye which normally allows fluid to drain out of the eye. Two procedures are possible and equal in their success of lowering the eye pressure. However, one (the goniotomy procedure) is preferred since it takes 10 minutes rather than 1 hour (for the trabeculotomy procedure) to perform under general anesthesia. This is important in young children to reduce anesthesia exposure especially if both eyes need surgery. If the glaucoma has caused the cornea or front of the eye to become too cloudy, then the view is too poor to place a lens on the cornea and use a needle to perform the shorter procedure. However, a small endoscope which has been FDA approved for use in the eye will allow direct viewing of the area which needs treatment. A needle attached to this endoscope allows the shorter goniotomy to be performed rather than proceeding to the longer trabeculotomy procedure. The outcome measure of this study is anesthesia time and reduction in intraocular pressure .

b. The standard examination under anesthesia initially will be performed including measuring the child's intraocular pressure, measuring dimensions of the eye, examining the front of the eye under the operating microscope, examining the portion of the eye where the fluid drains, evaluating the back of the eye with an ultrasound, and possible documentation with photographs.

When the diagnosis is confirmed by this examination, the eye or eyes will be carefully evaluated for their clarity. If a standard goniotomy procedure can not be done, then the endoscopic goniotomy will be performed. The procedure is identical with: cleaning the eyelid skin, using a speculum to open the eyelids, making a small cut into the cornea, and placing a viscoelastic substance into the eye to maintain its shape. The procedure then differs since the inserted needle is attached to the viewing endoscope. I will then view the inside of the eye on a TV monitor in addition to looking through the operating microscope. This will allow me to directly see the structures which I will need to cut. Normally, I depend upon looking through a lens placed on the cornea which must be fairly clear so that I can see to cut the structures in the standard procedure. The procedure should not take much longer than the standard goniotomy and the same amount of tissue will be cut as in a standard goniotomy. The needle is then removed. The remainder of the procedure is identical which includes placing a stitch in the corneal incision, adjusting the amount of fluid in the eye so the pressure is not too low or high, giving a dilating drop, giving a steroid and antibiotic injection around the eye, giving steroid ointment and an eye patch.

Eligibility Criteria:
Inclusion Criteria:

* childhood glaucoma with corneal edema unable to perform goniotomy

Exclusion Criteria:

* older than 3 years
The Chinese STEMI PPCI Registry (CSPR)

The purpose of this study is to develop a risk score to predict the risks of in-hospital major adverse cardiac events in ST-segment elevation myocardial infarction patients treated by primary percutaneous coronary intervention.

The CSPR trial is an observational clinical trial to derive and validate a readily useable risk score to identify patients at high risk of in-hospital major adverse cardiac events in 5594 patients presenting with a ST-segment elevation myocardial infarction and treated by primary percutaneous coronary intervention.

Eligibility Criteria:
Inclusion Criteria:

1. Age≥18
2. ST-segment elevation myocardial infarction was defined according to the universal definition of myocardial infarction
3. STEMI treated by pPCI

Exclusion Criteria:

1. Patient with heart failure in admission
2. STEMI with symptom-onset-to-balloon time\>24h
3. pPCI was not successful or only underwent coronary angiography
4. Killip class ≥II in admission
Sponge and Eosinophil Peroxidase (EPO) Staining

Are we able to use the EPO staining technique using the sponge ?

EPO staining on esophageal sponge samples had a strong association with peak esophageal eosinophil counts on endoscopic biopsy specimens in a small study of 26 patients Using a cut-off of 1.1 absorbance units in a colorimetric assay at a wavelength of 492nm the EPO stain had sensitivity and specificity of 1105 and 83% respectively for a peak eosinophil count of 15 eos/hpf on histologic endoscopic obtained biopsy specimens. The technique of EPO staining is standardized and can be completed in 45 minutes time. Currently, we have found esophageal sponge cytology sensitive and specific for assessment of esophageal eosinophilia. It allows disease activity assessment without endoscopy is much preferred by patients over the standard endoscopic technique of disease assessment. The process of specimen preparation in fairly tedious and interpretation takes significant experience. If EPO staining on non-endoscopic esophageal sponge studies was accurate at assessing disease activity, this is a tool that could be easily performed and interpreted with a rapid turnaround time.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 70 years of age
* Diagnosed with Eosinophilic Esophagitis \> than 15 Eos phf and failed to respond to the PPI therapy
* Going through the six food elimination diet or have just completed elimination the six foods: fish, nuts, eggs, soy, wheat, and milk

Exclusion Criteria:

* Clinical evidence of infectious process potentially contributing to dysphagia (e.g. candidiasis, CMV, herpes)
* Other cause of dysphagia identified at endoscopy (e.g. reflux esophagitis, stricture, web, ring, achalasia, esophageal neoplasm)
* Esophageal minimal diameter \< 13 mm on structured barium esophagram
Evaluating the Safety and Efficacy of SB Injection in Patients With Advanced or Metastatic Gastric Cancer

The purpose of this study is to determine efficacy of SB injection in Gastric Cancer.

All eligible patients will receive SB injection therapy for 6 cycles (14\~21 days for each cycle). Efficacy will be evaluated every 3 cycles.

Eligibility Criteria:
Inclusion Criteria:

* Age of 18years or over
* Patients who had failed more than 1 cycle of standard therapy with advanced or metasatic stage and with measurable lesions
* Life expectancy \>/= 5 months
* Not available to any of resectable surgery or radiotherapy
* Patients with adequate organ(e.g. heart, kidney, liver)and bone marrow function, as defined by

  1. Absolute neutrophil count(ANC)\>/= 1.0 x 10\^9/L, Platelet count \>/= 75 x 10\^9/L
  2. Total bilirubin \< 2.0mg/dL
  3. Aspartate Aminotransferase(AST) and/or Alanine Aminotransferase(ALT) \< 5 x Upper Limit Normal(ULN)
  4. creatinine \< 2 x ULN
* ECOG status 0 to 2
* Female volunteers admitted to the study must be using a reliable means of contraception and must have a negative blood or urine pregnancy test at least 7days ago
* Patients or their legal representatives who have signed the informed consent form.

Exclusion Criteria:

* Known brain or spinal cord metastases
* Patients who have received chemotherapy within the previous 4 weeks
* Patients who have received radiotherapy related tp Gastric cancer within 4weeks
* Patients who have participated in other clinical study within the previous 4weeks
* Pregnancy (absence to be confirmed by ß-hCG test) or lactation period
* Human immunodeficiency virus(HIV) antibody (+)
* Have active infection or serious concomitant systemic disorder incompatible with the study
* Clinically hypertension or diabete mellitus not well controlled with medication
* Clinically significant cardiac disease(e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias) or myocardial infarction
* Presence or history of malignancy other than Gastirc cancer within 5years
* Have severe Neurologic or psychological disorder
* Patients who have history of allery with this investigational drug(SB injection)
* Obvious cognitive or physical impairment that would prevent participation