cyrilzakka/clinical-trials huggingface dataset:
Cardiac Biomarkers and Analytical Methods

In the western world the prevalence of myocardial infarction is estimated at around 1-2% of the population; increases progressively with age, reaching a percentage of 10% after the 75 years.

It is therefore considered the first cause of hospitalization and mortality in Western countries, as well as expenditure for the health system.

It is therefore very important to have cardiac biomarkers that allow to confirm the diagnostic suspicion of coronary heart disease and/or heart failure, carry out prognostic evaluations and stratify patients as precisely as possible in relation to their actual risk.

Currently as biomarkers of heart failure, natriuretic peptides (BNP and NT-proBNP) are widely used in clinical practice but, considering the complexity of heart failure and its clinical and pathophysiological heterogeneity, it is reasonable to think that a single biomarker is not sufficient . For these reasons, there is increasing interest in the scientific community in the search for new biomarkers useful for early diagnosis, for correct prognostic stratification and for evaluating the response to therapy.

The study aims to evaluate the analytical performance of different kits and molecular markers commercially available (or in pre-industrial development phase) for the assays of the cardiac biomarkers: cTnI , NT-proBNP and sST2.

500 samples (residual serum) from patients hospitalized and/or referred to the DEA Department, for which troponin and/or NT-proBNP tests have been requested routinely or urgently by clinicians, will be included in the study.

The analytical performance of the various kits and the intra- and interassay imprecision will be evaluated. Comparison of methods will be calculated by Passing-Bablok regression and graph by Bland-Altman.

Through the non-parametric Passing-Bablok model the obtained data will be compared with the various analytical methods, reporting them one in function of the other, together with the regression line.

From the regression equation, the proportional systematic error will be evaluated as angular coefficient of the straight line and the constant systematic error as an intercept of the equation

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years;
* Patients arriving in the emergency room with chest pain of presumable cardiac origin and uncertain etiological diagnosis
* Routine request for cardiac Troponin and NT-ProBNP

Exclusion Criteria:

* Age \<18 years;
* No requirement for cardiac Troponin and NT-ProBNP
The Prevalence Of Sacroiliac Joint Dysfunction In Patients With Lumbar Disc Hernia

In this study evaluated the prevalence of sacroiliac joint dysfunction in patients with lumbar disc hernia and examined the variations in clinical parameters cause by this combination.

Two hundred thirty-four patients already diagnosed with lumbar disc hernia were included in the study. During the evaluation, sacroiliac joint dysfunction was investigated using specific tests, pain levels with a Visual Analog Scale, and the presence of neuropathic pain using the Leeds Assessment of Neuropathic Symptoms and Signs Pain Scale. Other clinical assessments were performed using the Beck Depression Inventory, Health Assessment Questionnaire, and Tampa Kinesiophobia Scale. Positivity in three out of six provocation tests was adopted as a criterion for sacroiliac joint dysfunction.

Sample Size A power analysis using the formula n= t2pq / d2 was performed to determine the sample size. Based on those data the investigators concluded that a minimum of 174 and a maximum of 322 patients would be required to achieve significant results, and 234 patients were enrolled.

Statistical Analysis The study data were expressed as mean plus standard deviation (SD) for constant variables values and as number and percentage for categoric variables. The chi-square test was used to analyze categoric variables. Results were evaluated at a 95% confidence interval at a significance level of p˂0.05. The analysis was performed on Statistical Package for the Social Sciences (SPSS) for Windows 16.0 software.

The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guideline has been implemented in this manuscript.

Eligibility Criteria:
Inclusion Criteria:

* Between 20 - 60 years old
* Diagnosis of lumbar disc herniation
* To have sufficient cognitive level to fill clinical evaluation forms
* The patient agreed to participate in the study

Exclusion Criteria:

* Lumbar pain, the etiology of which was suspected to be inflammatory in character
* Structural vertebral deformity or fracture
* The severe and progressive neurological deficit
* A history of severe psychiatric disease
* Substance and/or alcohol dependence, with uncontrolled diabetes mellitus (DM), malignancy, spinal infection
* A history of vertebral surgery
* Pregnancy
Ectoin Lozenges (EHT02) in the Treatment of Oropharyngeal Allergic Symptoms

The goal of this multicentric, prospective, randomised, controlled study (§23b German Act on Medical Devices (MPG)) is to investigate the efficacy of Ectoin Lozenges (EHT02) in treatment and prevention of oropharyngeal allergic symptoms.

The immune system of humans can show an overreaction to proteins from the environment (allergic reaction). Triggers of these allergic reactions may be e.g. pollen, dust mites, mold or animal hair. Common allergic symptoms include itchy, stuffy, runny nose, sneezing, itchy and watery eyes and respiratory complaints. Allergen-specific immunotherapy is the only treatment that eliminates the causes of allergic disease. An example of such immunotherapies is the sublingual immunotherapy (SLIT). During SLIT, side effects may occur such as local oropharyngeal reactions, e.g. manifesting as itching, swelling or irritation.

The current study aims to investigate the efficacy of Ectoin Lozenges (EHT02) in patients suffering from oropharyngeal allergic symptoms. The symptoms are induced by SLIT.

Patients are dedicated to one of three groups: a) preventive application of Ectoin Lozenges before SLIT-initiation, b) therapeutic application of Ectoin Lozenges after SLIT-initiation or c) control: SLIT-initiation without application of Ectoin Lozenges.

The symptoms itching, swelling and irritation of mouth, lips and throat will be documented by the patients once 30 minutes after SLIT-initiation.

Eligibility Criteria:
Inclusion criteria:

* initiation of a SLIT
* minimum age of 18 years
* written consent of the patient

Exclusion criteria:

* Surgical Procedures in the mouth and throat region prior to the study
* patients with known intolerance to one of the substances used
* pregnant or breast-feeding women
Diagnostic Performance and Safety of 18F-NaF-PET/CT in Bone Metastases Compared With 99mTc⁃MDP-BS±SPECT

The goal of this clinical trial was to assess the diagnostic performance and safety of Sodium Fluoride F-18 Positron Emission Tomography / Computed Tomography (18F-NaF-PET/CT) in bone metastases of malignant tumors compared with Technetium\[99mTc\] Methylenediphosphonate Bone Scintigraphy ± Single Photon Emission Computed Tomography (99mTc-MDP-BS±SPECT).

The enrolled subjects were randomly assigned to two sequences A and B at a ratio of 1:1. Within 7 days, 18F-NaF-PET/CT and 99mTc-MDP-BS±SPECT bone imaging were performed alternately.

The sensitivity, specificity, positive and negative predictive value of 18F-NaF-PET/CT and 99mTc-MDP-BS±SPECT were calculated respectively based on the diagnostic data of standard of truth.


Eligibility Criteria:
1. Male or female, age 18 to 75 years, inclusive.
2. It is confirmed to be lung cancer, prostate cancer or breast cancer by combining medical history, imaging and pathological examination, and radionuclide bone imaging is required, and any one of the following is required:

   1. Bone imaging within 3 months before the signing the ICF cannot exclude bone metastasis.
   2. Associated with clinical manifestations related to bone metastasis, including bone pain, activity disorder, pathological fracture, spinal cord or spinal nerve compression symptoms, alkaline phosphatase elevation, hypercalcemia or Prostate Specific Antigen (PSA) \>10 ng / ml.
   3. Those with definite metastasis outside the primary tumor focus.
   4. Patients with a history of bone metastasis.
   5. Patients who need to confirm the status of bone metastasis for tumor staging.
3. According to the standard of the Eastern Cooperative Oncology Group (ECOG), the score was 0-1.
4. The expected survival of the Patients was \> 6 months.
Role of HLA Genes and Innate Immunity in the Phenotypic Variability of COVID-19

Case-control, prospective retrospective association study of patients infected with SARS-CoV2 and cured by COVID19. Recruited patients were divided into two cohorts (cases: patients with respiratory failure that required hospitalization and ventilatory assistance. Controls: patients who had oligo-asymptomatic forms of COVID19). Patients' blood samples were collected on bibula paper, from which genomic DNA was extracted. Next-generation sequencing of HLA and innate immunity genes was performed on these samples. Genetic risk and protective variants were identified, based on the distribution of allele frequencies in the two cohorts. The aim of the study is to evaluate the role of genes of the HLA system and innate immunity in modulating the host response to SARS-CoV2 infection. The identification of these factors is essential from the perspective of public health (identifying individuals most in need of protection from infection as they are at higher risk of severe forms), basic research (characterization of molecular mechanisms of disease) and therapeutics (through knowledge of basic mechanisms, identify potential therapeutic targets and optimize the protective efficacy of vaccines).


Eligibility Criteria:
Inclusion Criteria:

* Oxygen saturation (SaO2) \<94% on room air; \<90% if known chronic hypoxic conditions or receiving chronic supplemental oxygen
* Respiratory rate \>24 breaths/min

Exclusion Criteria:

* Patients who still test positive for the presence of SARS-CoV-2 genome at the recruitment.
* Patients who cannot understand the meaning of the study and/or do not sign the informed consent form.
Intervention for Sleep and Pain in Youth: a Randomized Controlled Trial

Insomnia is a common comorbidity among adolescents with migraine. This randomized controlled clinical trial aims to determine efficacy of cognitive-behavioral therapy (CBT) for insomnia, as well as the combined effect of CBT insomnia and pain interventions, on reducing insomnia symptoms and headache-related disability in adolescents with migraine. The long-term goal is to offer effective, tailored self-management interventions that can address migraine and co-morbid sleep problems in adolescence and disrupt a cycle of persistent, disabling migraine from continuing into adulthood.

This aims of this study are to: 1) test efficacy of cognitive-behavioral therapy (CBT) insomnia intervention for youth with migraine and comorbid insomnia, and 2) investigate how changes in sleep may modify response to CBT pain intervention. Participants will include 250 youth and their parents. Youth will be ages 11-17 years, with migraine (with or without aura, chronic migraine) and comorbid insomnia. In Phase 1, participants will be randomly assigned to receive access to internet-delivered CBT insomnia intervention or internet-delivered sleep education control over 6 weeks. In Phase 2, all participants will receive access to internet-delivered CBT pain intervention over 6 weeks. Assessments will occur at baseline, immediately after Phase 1 intervention, immediately after Phase 2 intervention, and 6 month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* 11-17 years old
* Headache present for at least three months and insomnia symptoms for the past month
* Access to the Internet on any web-enabled device

Exclusion Criteria:

* Non-English speaking
* Diagnosed sleep disorder (e.g. sleep apnea, narcolepsy)
* Unable to read at 5th grade level or complete surveys independently
* A serious comorbid chronic condition (e.g., diabetes, arthritis, cancer)
Randomized Control Trial of Small-Molecule Natural Flavonoids Intervention for Neurodegenerative Diseases

1. Explore the effects of natural plant flavonoids on the positive intervention mechanism of neurotransmitter transmission physiological indicators changes (EEG) in the brain of the study subjects;
2. Investigate the effects of natural plant flavonoids in positively intervening clinical symptoms of the study subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Age: 25-70 years
2. Patients complaining of sleep disorders, mood disorders (unstable mood, irritability, depression, and anxiety), and cognitive decline (people with memory, decreased reaction time, BPSD symptoms) within one month
3. Montreal Cognitive Assessment Scale (MOCA) score ≤26; if the MOCA score is not satisfied, then Pittsburgh Sleep Quality Index (PSQI) score \>10 and Hamilton Anxiety Scale (HAMA) score \>14 or Hamilton Depression Scale (HAMD) score ≥8 are required
4. Patients who can understand and communicate in language, and complete aphasia patients are not included;
5. Patients who agree to participate in this clinical observation and sign the informed consent form.

Exclusion Criteria:

1. Patients with severe organ diseases such as heart, kidney, and liver failure, chronic lung diseases such as COPD, and severe diabetes;
2. Patients with severe uncontrolled hypertension;
3. Patients who have taken antipsychotic drugs within the past two weeks;
4. Patients with the core features of Lewy body dementia or significant behavioral variant frontotemporal dementia;
5. Patients with various malignant tumors;
6. Patients with progressive stroke, transient ischemic attack, cerebral hemorrhage after cerebral infarction, and cerebral arteritis;
7. Patients with brain tumors, brain trauma, cerebral parasitic diseases, and other conditions;
8. Pregnant or lactating women;
9. Patients allergic to the known ingredients used in this trial;
10. Patients with active ulcers or bleeding tendencies;
11. Patients with neurodegenerative diseases such as Huntington's disease, amyotrophic lateral sclerosis, and Pick's disease;
12. Other patients who are deemed unsuitable to participate in this trial by the investigators.
Use of v Care in Abdominal Hysterectomy

The investigators use v care during abdominal hysterectomy and evaluate its effect on duration of operation time, surgical complications and vaginal length.


Eligibility Criteria:
Inclusion Criteria:

* benign causes for hysterectomy

Exclusion Criteria:

* malignant causes for hysterectomy
Secondhand Effects of Hookah (i.e., Waterpipe) Smoke and Aerosol

In the United States, secondhand smoke is the third leading preventable cause of death. Flavored hookah (waterpipe) tobacco smoking, a highly social activity common in hookah bars, is a key source of SHS exposure. While smoke-free air laws have decreased exposure to secondhand smoke, the majority of laws do not include hookah smoking. Thus, as a social outlet for youth and young adults, hookah smoke exposure may harm non-smokers, including women of reproductive age or pregnant, hookah bar workers, children, and individuals with heart and lung disease. While more is known on the acute effects of active hookah smoking and the literature is emerging on active e-hookah vaping, little is known about the acute vascular effects of secondhand exposure to hookah smoke and aerosol. The study aims to examine the acute effects of secondhand exposure of hookah smoke and aerosol on endothelial and vascular function. Eligible volunteers will be invited to participate in a total of 3 study visits (2-3 hours each): e-hookah aerosol exposure, charcoal-heated hookah smoke exposure and smoke-free room air. Non-invasive blood pressure and blood flow measurements will be taken before and after the exposure sessions.


Eligibility Criteria:
Inclusion Criteria:

* 21-49 years old
* Never a smoker: do not use any tobacco products or nicotine delivery systems, including cigarettes, cigars (traditional and filtered), cigarillos, hookah, smokeless tobacco (i.e., loose snus, moist snuff, dip, spit, or chewing tobacco), pipe tobacco, snus pouches, dissolvable tobacco or vaping.
* no evidence of cardiopulmonary disease by history/physical
* blood pressure (BP) \< 140/90 mmHg
* resting heart rate (HR) \< 100 bpm
* BMI \>18 or \< 30kg•m2
* no prescription medication
* No exposure to environmental tobacco smoke for at least one week prior to the study date.

Exclusion Criteria:

* exhaled carbon monoxide \>6 ppm
* (+) pregnancy test
* other conditions deemed unsafe to participate, such as breastfeeding
A Study Assessing KB304 for the Treatment of Wrinkles in Women

The aim of this study is to investigate the safety and efficacy of KB304, an investigational gene therapy to correct moderate to severe wrinkles in the décolleté region (V-shaped chest area). KB304 is an investigational gene therapy that delivers functional, full-length human collagen (COL3) and elastin (tropoelastin) to the skin through small injections using the Sponsor's genetically engineered Herpes Simplex Virus (HSV-1) vector. The study is a randomized double-blind study and participants will receive either KB304 (active group) or placebo (inactive group).


Eligibility Criteria:
Inclusion Criteria:

* Female in good general health, as determined by the Investigator, aged ≥18 and ≤75 at the time of consent.
* Presence of moderate to severe dynamic wrinkles in the décolleté Target Area, as determined by the Investigator on the JDWS.
* A Fitzpatrick skin phototype score of I-IV.
* A negative urine pregnancy test at Screening and Day 1 (Visit 2) for subjects of child-bearing potential.
* Signed and dated informed consent and willingness to attend all study visits and complete all procedures required by the protocol.

Exclusion Criteria:

* Any transient or chronic skin condition, disorder, or infection within 20 cm of the Target Area at Day 1 (Visit 2) that, in the opinion of the Investigator, may interfere with the interpretation of study results.
* Scars, tattoos or tanned skin (defined as skin that is tanned from sun exposure, tanning beds, or an applied skin color such as a spray tan) within the Target Area at Day 1 (Visit 2).
* History of laser treatment, microneedling, chemical peels within 3 months of Day 1 (Visit 2), or botulinum toxin within 6 months of Day 1 (Visit 2) to the Target Area.
* History of surgical procedures to Target Area, including removal of benign or malignant skin cancers that, in the opinion of the Investigator, may interfere with the interpretation of study results.
* Administration of a cosmetic and/or investigational agent, in the Target Area within 6 months of Day 1 (Visit 2), that, in the opinion of the Investigator, may interfere with the interpretation of study results.
* Any condition (including a history or current evidence of substance abuse or dependence, ongoing systemic infection, infection local to the Target Area, immunosuppression, or recent history of or active malignancy in the Target Area) that, in the Investigator's opinion, would impact the subject's ability to complete all study-related procedures and/or poses an additional risk to the assessment of safety of the Investigational Product.
* Subject who is pregnant or nursing.
* Subject who is unwilling to comply with contraception requirements per-protocol.
* Subject is known to be noncompliant or is unlikely to comply with the requirements of the study protocol, in the opinion of the Investigator
Airway Dimension Study in Children Undergoing MRI Sedated With Propofol and Dexmedetomidine

Sedation is required in infants and children to successfully complete MRI while maintaining respiratory and hemodynamic stability. Limited access to the patient may pose a safety risk during MRI examination. Therefore, appropriate drugs need to be selected, administered, and titrated to achieve these objectives. Propofol is commonly used for sedation in children in the MRI setting because of its predictability, rapid onset, and offset of action. Dexmedetomidine has sedative and analgesic properties without affecting cardiovascular and respiratory stability. The rationale of this research is to assess the effect of these drugs on the upper airway and validate their use in children with upper airway disorders.

Objectives The objective of this study is to compare the changes in upper airway configuration at the level of soft palate, base of tongue and tip of the epiglottis in children sedated with dexmedetomidine and propofol in children undergoing MRI.

We hypothesize that the upper airway caliber will be smaller in children receiving propofol than with dexmedetomidine.

Primary Outcome To measure the cross-sectional area (CSA) of the upper airway at the level of soft palate, base of the tongue and epiglottis in both groups of children at high doses of propofol and dexmedetomidine and thus compare the decrease in CSA with increasing doses of both drugs.

Secondary Outcomes To measure the

* anteroposterior (AP) diameter
* transverse (Tr) diameter of the upper airway at the three levels in both groups of children at both low and high doses of propofol and dexmedetomidine and compare the decrease in AP and Tr diameter at increasing doses of dexmedetomidine.

Eligibility Criteria:
Inclusion Criteria:

* Children undergoing MRI brain
* Age 2 - 5 yrs
* ASA I - II

Exclusion Criteria:

* OSA
* Pathology of upper airway
* Craniofacial anomalies
* Gastroesophageal reflux
* Increased intracranial pressure
* Body weight of 20% more than ideal
* Contraindication to the use of either drug
* Failure to maintain a patent airway during the study
Preventing Pressure Injuries in Patients Undergoing Lumbar Spine Surgery

Background：Pressure injuries (PI) are one of the common comorbidities in surgery, meaning PI that occurs immediately after surgery or within hours to 3 days after surgery. The incidence of PI in spine surgery is about 5% \~ 66%.

Purpose：Comparison of the difference in pressure injury rates positioning device cotton roll-coated viscoelastic polymer pads versus viscoelastic polymer pads for pressure injuries undergoing lumbar spine surgery Methods：This experimental study used a split-body design with random assignment to compare the pressure-reducing effects of different materials on a patient's body contact points with a positioning device. The experimental group used a Relton-Hall prone frame with cotton roll-coated 3 cm viscoelastic polymer pads, while the control group used a Relton-Hall prone frame with a viscoelastic polymer pads.

The study focuses on patients undergoing lumbar surgery in a hospital in a certain area of northern Taiwan, with an intended recruitment of 50 participants randomized into experimental and control groups. The study will use the Pressure Injury grading system developed by the National Pressure Injury Advisory Panel to assess the severity of pressure injuries at pre-operation, immediate post-operation, 30 minutes post-operation, 24 hours post-operation, and 48 hours post-operation.

Eligibility Criteria:
Inclusion Criteria:

1. Patients receiving lumbar nerve decompression combined with internal fixation and bone fusion.
2. Use the positioning device Relton-Hall rack in prone position.
3. The operation time is more than 2.5 hours.
4. The surgical anesthesia is general anesthesia.
5. Routine surgery registered on the surgery schedule.
6. Before the operation, the skin was intact and there was no pressure injury.

Exclusion Criteria:

1. Emergency lumbar surgery patients.
2. Under the age of 18.
3. The operation time is less than 2.5 hours.
4. Preoperative skin incompleteness (obviously there is chest and iliac crest crush phenomenon).
5. Percutaneous minimally invasive disc herniation decompression (percutaneous endoscopic lumbar disc, PELD).