cyrilzakka/clinical-trials huggingface dataset:
The COVID-19 Back-to-Normal Study: Analysis of Multiple Outcomes

During the study, members of different online and offline communities will be followed post COVID-19 vaccination.

Injection-site (local) and systemic reaction data will be assessed on vaccination day and afterwards using either web surveys or personal communication, depending on study participant preference.

Hypothesis to be tested: The safety profile and the magnitude and durability of immune responses to the COVID-19 vaccines as well as adverse reactions depend on health conditions, metabolism and microbiomes.

The outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was declared a Public Health Emergency of International Concern in January 2020 and upgraded to pandemic in March 2020. First vaccines to prevent COVID-19 were authorized for emergency use in the US in December 2020, but a number of unknowns still remains. One of these unknowns is the relationship of the microbiota, gut dysbiosis and impaired metabolism with active immunity to pathogens and vaccines and tolerance to antigens. Study groups will be based on age, metabolism, donated diagnostic test results and self-reported symptoms. Data will be collected continuously via surveys and investigator-participant interactions, as needed. Statistical methods used will be the ones with the greatest power.

Eligibility Criteria:
Inclusion Criteria:

* Individuals 18 or older at the time of consent
* Intention to vaccinate and of being available for entire study period

Exclusion Criteria:

* Any illness or condition that in the opinion of the investigator may affect the safety of the participant or the evaluation of any study endpoint.
Percutaneous Rupture of Zygapophyseal Joint Cysts

Lumbar zygapophyseal joint cysts can cause lower extremity radiculopathy. These cysts can be cured by a minimally invasive technique: percutaneous cyst distention and rupture

Lumbar zygapophyseal joint cysts can cause lower extremity radiculopathy. These cysts can be cured by a minimally invasive technique: percutaneous cyst distention and rupture.

30 patient with lower extremity radiculopathy caused by lumbar zygapophyseal joint cysts will be included in the study.

Eligibility Criteria:
Inclusion Criteria:

* Patients with lumbar zygapophyseal joint cyst and compression of a spinal nerve root with lower extremity radiculopathy proven by MRI.

Exclusion Criteria:

* Infection, uncontrollable bleeding disorder
Droplet Digital PCR and PCR-free BIOSensors for the Detection of Resistance-associated SNPs in Pneumocystis Jirovecii

The main objective of the proposed research is to identify Pneumocystis jirovecii mutant strains on 4 genes encoding therapeutic targets such as dihydropteroate synthase (DHPS), dihydrofolate reductase (DHFR), cytochrome b (CYB), inosine-5'-monophosphate dehydrogenase (IMPDH) and therefore to assess the prevalence of potentially resistant strains in patients infected with P. jirovecii.

Pneumocystis jirovecii (P. jirovecii) is an opportunistic pathogenic fungus responsible for pulmonary infection or Pneumocystis pneumonia (PCP) in immunocompromised patients. There is currently no system for its in vitro culture. The diagnostic methods used are mainly based on molecular biology techniques which also allow the detection and analysis of single nucleotide polymorphisms (SNPs), particularly at the level of genes coding for the targets of molecules widely used in the prevention and treatment of PCP. These SNPs may represent missense mutations potentially associated with treatment resistance. They may result from exposure of patients to these treatments before the development of P. jirovecii infection. However, data concerning the prevalence of these mutations remains scarce, particularly in France. Methods for detecting these mutations based on PCR followed by DNA sequencing have limitations in terms of sensitivity. The evaluation of new, more sensitive and rapid tools for the detection and characterization of pathogens in this context is necessary.

The main objective of the proposed research is to identify P. jirovecii mutant strains on 4 genes encoding therapeutic targets such as dihydropteroate synthase (DHPS), dihydrofolate reductase (DHFR), cytochrome b (CYB), inosine-5'-monophosphate dehydrogenase (IMPDH) and therefore to assess the prevalence of potentially resistant strains in patients infected with P. jirovecii.

The secondary objectives are:

* to determine the factors associated (e.g. exposure to treatments) with mutant P. jirovecii strains
* to determine the impact of mutations on the effectiveness of anti-Pneumocystis treatment (e.g. favorable vs. unfavorable evolution of the infection)
* to evaluate two methods - digital droplet PCR and biosensors without PCR - for the detection and characterization of mutations associated with resistance in Pneumocystis jirovecii

Eligibility Criteria:
Inclusion Criteria:

* Patients in whom P. jirovecii was detected in a pulmonary sample (bronchoalveolar lavage, sputum, bronchial aspiration, oropharyngeal rinse, nasopharyngeal sample)
* No opposition
* Patient affiliated to a social security system

Exclusion Criteria:

* Patients under legal protection (guardianship, curatorship)
* Refusal to participate
Familial Pancreatic Cancer PROPHilation Program in Italy

The goal of the PROPH-ITA Study is to perform genetic testing in family members of pancreatic cancer patients who may have a genetic predisposition. The subjects belong to the Italian Registry of Families At Risk of Pancreatic Cancer (IRFARPC, #NCT04095195). This investigational study will assess the genetic background of subjects with familiarity with pancreatic cancer only.

Participants may accept to undergo genetic testing as part of the IRFARPC registry, through a saliva-swab-based 41-gene panel test.

Up to 3,000 participants will be enrolled in this study.


Eligibility Criteria:
Inclusion Criteria:

* Being enrolled on the IRFARPC registry
* Having familiarity for pancreatic cancer (according to the IRFARPC criteria, Capurso et al. Dig Liv Dis, 2020)
* Willingness to participate in saliva-swab-based genetic testing

Exclusion Criteria:

- Already known genetic mutation
Development of MRI Protocols and Associated Explorations (EEG, NIRS) in Healthy Volunteers

The main objective of the studies that will be carried out on volunteer patients who have given their consent will be the development and optimization of the sequence parameters or the design of the stimulation paradigms in order to optimize the quality and Relevance of the images realized taking into account anatomical, functional or metabolic parameters. These adjustments will be carried out without interfering with the management of voluntary patients

The pathologies that interest us in these refinements concern mainly the chronic (or sequellar) brain disorders which can be degenerative, developmental or vascular. The patients who will be recruited will be known patients of our Service (University Clinic of Neuroradiology and MRI) that we follow during checks. The type of examination that will be applied to them, between MRI, EEG and NIRS, will be specified in the consent form. These examinations will not be invoiced either to the patient or to the social security, and the related costs will be borne by our Federative Research Structure or sometimes, when these explorations are upstream of a defined research protocol and funded, They will be financed under this protocol.

Eligibility Criteria:
Inclusion Criteria:

* major
* socially insured persons
* given their consent.
* absence of contraindication to the MRI examination

Exclusion Criteria:

* Subjects under the age of 18
* pregnant women
* all other persons referred to in articles L1121-5 to L1121-8 of the CSP
Does Undercorrection of Myopia Retard Myopia Progression Among Kindergarten Children?

The purpose of this study is to find out if undercorrection of myopia slow down the progression of myopia in kindergarten children.


Eligibility Criteria:
Inclusion Criteria:

1. Children of chinese descent aged 5 - 6yrs
2. Refractive error of -1.00 to -3.00Ds
3. Less than 1.50 astigmatism in each eye. (No oblique axis)
4. Visual acuity is 6/6 or better in both eyes.
5. No binocular problems, no anisometropia \>1.50D
6. Will be staying in S'pore for at least 2 years.

Exclusion Criteria:

-
Masimo Radical-7 Monitor a Useful Adjuvant During Major Spine Surgery

This is a study designed to compare the agreement of hemoglobin (Hb) measurements, documented at specific time points (the time a blood sample was obtained by the standard clinical care after physician/nurse orders it and, during that same time, the Hb value recorded by the Masimo Radical-7 monitor); recorded several times throughout patient's major spine surgery procedure (depending on how many times the physician/nurse orders the Hb value to be tested), between the standard clinical practice {intermittent measure of Hb \[Cedar Sinai Medical Center (CSMC) Lab and outside lab) and Masimo radical-7 device (continuous, non-invasive Hb level measurements)\*.

\*See whether or not the hemoglobin values recorded at the same time matches between the standard clinical practice (CSMC Lab and outside Lab) and the Masimo device

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled to undergo multiple level spine surgery procedures
* 18 - 80 years of age
* American Society of Anesthesiologists (ASA) Class I - III adults of either sex
* Pregnant women

Exclusion Criteria:

* Patients with a perfusion index less than 1 or low confidence reading
* Patients with nail polish and /or a nail deformity on a finger that would used for sensor placement
* Patient undergoing cardio-pulmonary bypass
Embolization of the Middle Meningeal Artery With ONYX™ Liquid Embolic System for Subacute and Chronic Subdural Hematoma

The purpose of this study is to evaluate the safety and efficacy of embolization of the middle meningeal artery (MMA) using the Onyx™ Liquid Embolic System (LES) for treatment of symptomatic subacute or chronic subdural hematoma (SDH)


Eligibility Criteria:
Inclusion Criteria:

* Pre-morbid Modified Rankin Score ≤3
* Confirmed diagnosis of subacute or chronic subdural hematoma
* Completed informed consent
* Meets criteria for Surgery or Observation Cohort

Exclusion Criteria:

* Life expectancy \<1 year
* Unable to complete follow-up
* Pregnant, lactating, or has a positive pregnancy test at time of admission
* Diagnosed with acute SDH
* Potentially dangerous anatomic variations leading to increased procedural risk or unsafe access for MMA embolization
* Pre-randomized Markwalder Grading Scale score ≥ 3
* Unmanaged, uncontrolled bleeding disorders/blood diathesis
* Presumed septic embolus, or suspicion of microbial superinfection
* Known active COVID-19 infection
* CT or MRI evidence of intra-cranial tumor or mass lesion Contraindication to angiography
* Participation in another clinical trial
* Contraindicated for the use of Onyx™ LES
* Cannot be taken off corticosteroids (intended to treat subacute or chronic SDH) for at least 90 days post-randomization
Psychological Interventions in Children After Road Traffic Accidents or Burns

Within a randomized controlled design the effects of a brief early psychological intervention (child, parents) after road traffic accidents or burns shall be examined in a sample of 120 children and adolescents (aged 2 to 16 years). During the first seven days after the accident a screening for the risk of developing a posttraumatic stress disorder is conducted to divide the participants into a "high risk" and a "low risk" group. Participants with a low risk are excluded from the intervention study but reassessed six months after their accident to validate the screening instrument. After a baseline assessment within 14 days after the accident participants of the high risk group are randomly assigned to an intervention group (n = 60) or a control group (n = 60). The latter receive standard medical care. Children of the intervention group are provided with a brief age appropriate two-session intervention that includes a detailed reconstruction of the accident, psychoeducation and discussion of helpful coping strategies. Both the control and the intervention group are reassessed by blind raters at 3 and 6 months after the accident. Assessment of outcome includes measures of posttraumatic stress symptoms, depression, anxiety, behavior, and health-related quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Age 2-16 years
* Glasgow Coma Scale (GCS) \> 8
* German speaking
* Burn accident or road traffic accident

Exclusion Criteria:

* Glasgow Coma Scale (GCS) \< 9
* more than 2 weeks in the Pediatric Intensive Care Unit
* no command of German
* previous mental retardation
Analgesic Effectiveness of Nefopam in Patients Undergoing Anterior Cervical Spine Surgery

Nefopam is a benzoxazocine derivative which is non-opioid and non NSAIDs. The previous studies showed that nefopam can inhibit reuptake of serotonin, norepinephrine and dopamine. It has no respiratory depression so may be useful in potential airway compromized surgery like anterior cervical discectomy and fusion (ACDF). This study aims to study the analgesic properties of nefopam after ACDF.

The investigators enroll 50 patient who admitted for ACDF. Standard general anesthesia will be performed in all of the patients. Then, an hour before finishing operation, the patients will be divided into two groups. The first group will receive Nefopam 20 mg infuse for 60 min. The another group or group NSS will receive the same amount of 0.9% sodium chloride. The recorded data include patient demographic data, intraoperative blood loss, hemodynamics and pre and postoperative pain scores and Thai version of the Neuropathic Pain Symptom Inventory (NPSI-T score).

Eligibility Criteria:
Inclusion Criteria:

* Patients with cervical spondylosis or cervical spondylotic myelopathy undergoing elective anterior cervical spine surgery such as ACDF or anterior cervical corpectomy and fusion (ACCF)
* American Society of Anesthesiologists (ASA) class I-III
* Age 18-75 years old
* Body weight \> 50 kg, BMI \< 30 kg/m2

Exclusion Criteria:

* Convulsion or seizure
* Myocardial ischemia or infarction
* Risk of urinary retention from urethral disease or prostate disease
* Angle closure glaucoma
* Patients on monoamine oxidase inhibitor
* Psychiatric patients
* Pregnant or lactated woman
* Creatinine clearance \< 30 ml/min
* Allergic to nefopam
* Patients on pregabaline or gabapentin
* Poorly controlled hypertension
* Cannot understand or do the questionnaire of Thai version of Neuropathic pain symptom inventory (NPSI-T) score
Bilateral Superficial Cervical Block for Thyroidectomy

The objective of this study is to compare the postoperative analgesia afforded by bilateral superficial cervical block using different concentrations of local anesthetic (ropivacaine) in patients undergoing total thyroidectomy for the mini-incision technique, performed by the same surgical team.

In this study we will evaluate the efficacy of bilateral superficial cervical block associated with balanced general anesthesia with remifentanil as opioid of choice in preventing postoperative pain in patients who underwent total thyroidectomy with mini incision without neck dissection.A hundred and twenty patients ASA I - II will be assessed and allocated randomly (through a table of random numbers) into three groups for analgesia for post-operative:

Group 1: bilateral superficial cervical block with 20 ml of 0.9% saline (placebo); Group 2: bilateral superficial cervical block with 20 ml ropivacaine 0.25%; Group 3: bilateral superficial cervical block with 20 ml ropivacaine 0.5%.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18 years
* Agreed to participate in the study and sign the consent form
* ASA I-II
* Scheduled to undergo total thyroidectomy without neck dissection under general balanced anesthesia.

Exclusion Criteria:

* Clinical history or laboratory tests suggestive of bleeding disorder
* Mental or cognitive deficit in existence, which makes it impossible to understand the patient visual analog scale of pain or the study protocol
* Body mass index greater than 45
* History of allergy to local anesthetics
* Intolerance or contraindication to any medication used in the study
* Skin infection at the site of the blockade
* Patients requiring neck dissection
* Pregnancy
* Preoperative use of opioid analgesics or non-opioids, corticosteroids or anti inflammatory non steroidal
* Patient's refusal to participate in the study
* Need for emergency reintervention within the first 24 hours postoperatively
Influence of Air Quality on the Development and Progression of Premature Coronary Artery Disease

The new global guidelines from the World Health Organization on air quality provide evidence of the damage that air pollution inflicts on human health at even lower concentrations than previously thought. Different studies have shown an increase in the incidence of coronary artery disease (CAD) in young people in recent decades. The main objective of this project is to study the impact of environmental pollutants on the premature manifestation of CAD from different epidemiological approaches and their impact on the evolution of these patients with a gender perspective. It is a retrospective analytical case-control study nested in a cohort of patients ≤40 years old with a clinical history of CAD including: ST-segment elevation myocardial infarction, non-ST-segment elevation acute coronary syndrome, unstable angina, stable angina or silent angina according to the international classification of diseases.


Eligibility Criteria:
CASES:

Inclusion Criteria:

* Women and men between 18 and 40 years old with a diagnosis of coronary artery disease coded in their medical records in Galicia

Exclusion Criteria:

* Not having a postal code and primary care center assigned in their medical records in Galicia

CONTROL

Inclusion Criteria:

* Women and men between 18 and 40 years old with no diagnosis or history of CAD or other coronary disease coded in their medical records

Exclusion Criteria:

* Present with non-ischemic coronary diseas.
* Have a serious condition that affects or decreases life expectancy.
* Do not have a postal code or primary care center assigned in their medical records in Galicia
Efficiency of Radiofrequency Ablation for Surgical Treatment of Chronic Atrial Fibrillation With Rheumatic Valve Disease

The purpose of this study is to determine whether concomitant radiofrequency Maze procedure for surgical treatment of chronic atrial fibrillation with rheumatic valve disease could provide better sinus rhythm control, improved cardiac hemodynamic status and decreased thromboembolism events and to compare if biatrial is better than left atrial procedure? 150 rheumatic valve patients with chronic atrial fibrillation (AF) having concomitant valve surgery were randomized to three groups: left atrial ablation group, bi-atrial ablation group, and Amiodarone group. All patients were scheduled followed up before discharge and at 3rd, 6th and 12th postoperative months. Standard 12-lead electrocardiography (ECG), 24-hour Holter and transthoracic echocardiography were used to determine the rhythm and cardiac hemodynamic status.

The purpose of this study is to determine whether concomitant radiofrequency Maze procedure for surgical treatment of chronic atrial fibrillation with rheumatic valve disease could provide better sinus rhythm control,improved cardiac hemodynamic status and decreased thromboembolism events and to compare if biatrial is better than left atrial procedure?

150 patients with chronic AF having concomitant cardiac surgery will be enrolled. Patients will underwent bi-atrial radiofrequency,left atrial radiofrequency or no radiofrequency procedure randomly. All the patients will receipt amiodarone 200 mg/day for 12 months postoperatively.

All patients were scheduled followed before discharge and at 3rd, 6th and 12th postoperative months.The following diagnostic procedures were performed

1. Standard 12-lead electrocardiography
2. Holter-ECG
3. Transthoracic echocardiography

Eligibility Criteria:
Inclusion Criteria:

1. Patients with atrial fibrillation secondary to definite rheumatic valve disease
2. At least six months and no longer than 5 years of chronic atrial fibrillation
3. Age \>=18 years and \<=70 Patients who can give informed consent themselves in writing
4. No contraindication for amiodarone
5. Negative pregnancy test (in women with childbearing potential)

Exclusion Criteria:

Any one of the following exclusion criteria is sufficient to disqualify a patient from the study

1. Left atrial diameter(LAD)\>=70mm
2. Left ventricular eject fraction(LVEF)\<=30%
3. Atrial thrombus
4. Contraindication for anticoagulation therapy
5. Less than 6 months since last episode of cerebral infarction
6. Emergency operation
7. Patients with a malignant tumor
8. Pregnant or nursing patients, those who may be pregnant, or those who plan on becoming pregnant before the end of the study period.
9. Any other reason that the Clinical Supervisors or Clinical Researchers may have for considering a case unsuitable for the study.
Inflammatory Profiling in Chronic Lung Disease

The aim of this study is to investigate the underlying inflammatory profile in patients with chronic lung disease and determine the association pulmonary hypertension.

Chronic lung diseases (CLD), such as chronic obstructive pulmonary disease (COPD) and idiopathic pulmonary fibrosis (IPF) are often complicated by the presence of pulmonary hypertension (PH), where even a mild elevation of blood pressure in the pulmonary arteries is associated with an even poorer prognosis. In this study, we will investigate whether similarities exist in the inflammatory profile that could potentially underlie all forms of pulmonary hypertension. Inflammatory data will be generated using flow cytometry, expression profiling and histological analysis and compared to the associated clinical data.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing lung transplant with COPD or IPF, with associated PH
* Signed informed consent

Exclusion Criteria:

* patients without written informed consent
* Signs of any infection such as pneumonia, pulmonary tuberculosis or infections with pleural effusions.
From Variability to Standardization: The Impact of Breast Density on Background Parenchymal Enhancement in Contrast-Enhanced Mammography and the Need for a Structured Reporting System

This retrospective study includes 213 patients who underwent CEM, mammography (MG), and ultrasound (US) between May 2022 and June 2023 at the P.O. 'A. Perrino' Hospital, Brindisi. BPE was categorized into four levels (Minimal, Light, Moderate, and Marked), while breast density was rated according to the ACR BI-RADS (A-D) classification. A statistical analysis was performed to assess the correlation between BPE and breast density, supporting the development of the BPE-CEM Standard Scale (BCSS) to standardize reporting and improve interobserver agreement.


Eligibility Criteria:
Inclusion Criteria:

Patients who underwent CEM, mammography, and ultrasound between May 2022 and June 2023.

Availability of BPE assessment and BI-RADS density classification.

Complete imaging dataset available for analysis.

Exclusion Criteria:

Patients with prior breast cancer treatment that could alter BPE.

Incomplete imaging data or missing classification values.

Contraindications to contrast-enhanced imaging.