cyrilzakka/clinical-trials huggingface dataset:
Pre-SunBeam TEWL AUC

Transepidermal Water Loss (TEWL) measurements are a valuable tool to determine the integrity of a person's skin barrier. In patients with skin conditions, like atopic dermatitis, skin barrier can be disrupted or weakened, leading to a more severe phenotype and disease characteristics. There are several commercially available TEWL measuring devices, including the Aquaflux AF200 and the GPSkin Barrier Pro. This study is a pilot study to determine if these two devices produce similar readings for TEWL/skin barrier on patients with and without atopic dematitis (AD). The research team would like to investigate whether these devices are comparable for initial TEWL readings as well as after several rounds of tape strips have been collected from the skin. Tape strips are small circular adhesives, much like tape, that remove the very outermost layers of skin cells. It will be important to know if both of these devices provide correlative values for TEWL once the outermost layers of the skin have been removed by tape stripping.


Eligibility Criteria:
Inclusion Criteria:

1. Parent guardian must be able to understand and provide informed consent and participant provide assent as applicable per Institutional Review Board (IRB) guidelines and regulations.
2. Male or female, less than or equal to 3 years of age inclusive at Screening
3. Active AD using Standard Diagnostic Criteria (AAD criteria, Eichenfield et al, 2014). Participant must have an area of non-lesional AD (EASI of 0) within 5 cm. of the measured lesional area within the same region. Participant must have lesional and nonlesional areas of at least 3 cm in diameter to allow for both devices to be tested in contiguous areas OR FOR HEALTHY CONTROLS
4. Participant must meet all of the following criteria:

   1. No personal history or current manifestations of AD; no current food allergy, asthma, allergic rhinitis (based on self-report)
   2. No evidence of dry skin or other skin issue (EASI score of 0)

Exclusion Criteria:

1. Inability or unwillingness of a parent guardian to give written informed consent, or participant to give assent, if applicable, or to comply with study protocol
2. Who have any skin disease other than AD that might compromise the stratum corneum barrier in infants and young children (e.g., ichthyosis, psoriasis, extensive seborrheic dermatitis, scabies)
3. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
4. Use of any topical product (e.g., emollient, topical corticosteroids, topical immunomodulatory agents, topical antibiotics) on extremity for testing within 2 hours of the Enrollment Visit.
Toxin Retrospective Study

Aims of this study were to assess the long-term outcomes of detrusor injection of OnabotulinumtoxinA (Botox® injection) associated with clean intermittent-catheterization (CIC) for the treatment of neurogenic detrusor overactivity (NDO) and to identify risk factors for failure.

Neurogenic detrusor overactivity (NDO) remains a major concern for patients with neurological diseases. Fifty to eighty percent of patients with multiple sclerosis (MS) or traumatic spinal cord injury (SCI) and more than 60% of patients with myelomeningocele suffer from urinary incontinence episodes (UI) due to NDO. NDO is characterized by involuntary detrusor contractions during the filling phase, leading to leakage and increase in bladder pressure, which can, precipitate renal failure. Detrusor injection of OnabotulinumtoxinA (Botox®), is licensed worldwide and recommended as a second line therapy for the treatment of urinary incontinence due to NDO after failure of anticholinergic drugs (Grade A).

These recommendations are based on the results of international multicentric, randomized controlled trials.

These studies established not only clinical benefits, with a significant decrease of urinary incontinence episodes, but also urodynamic benefits.

There are very few data about the real prevalence of failure of Botox® in the long term.

Thus, aims of this study were to assess the long-term outcomes of detrusor injections of Botox® associated with clean intermittent-catheterization (CIC) for the treatment of NDO and to identify risk factors for failure .

Eligibility Criteria:
Inclusion Criteria:

* NDO due to MS, SCI or spina-bifida.
* follow-up ≥3 years from the first Botox® injection.
* Performing clean intermittent catheterization

Exclusion Criteria:

* bladder surgery
Registrational Study With Omecamtiv Mecarbil (AMG 423) to Treat Chronic Heart Failure With Reduced Ejection Fraction

The purpose of this study is to determine if treatment with omecamtiv mecarbil when added to standard of care is well tolerated and superior to placebo in reducing the risk of cardiovascular death or heart failure events in adults with chronic heart failure with reduced ejection fraction (HFrEF).

This study was conducted by Amgen as the IND holder, with Cytokinetics as a collaborator. Due to the termination of the collaboration agreement between Amgen and Cytokinetics in May 2021 and subsequent transfer of the omecamtiv mecarbil IND from Amgen to Cytokinetics, Cytokinetics is now listed as the sponsor.

Eligibility Criteria:
Key Inclusion Criteria:

* Subject has provided informed consent
* Male or female, ≥ 18 to ≤ 85 years
* History of chronic heart failure (HF), defined as requiring treatment for HF for a minimum of 30 days before randomization
* Left ventricle ejection fraction (LVEF) ≤ 35%, per subjects most recent medical record, within 12 months prior to screening.
* New York Heart Association (NYHA) class II to IV at most recent screening assessment.
* Managed with HF standard of care (SoC) therapies consistent with regional clinical practice guidelines according to investigator judgment of subject's clinical status
* Current hospitalization with primary reason of HF OR one of the following events within 1 year of screening: hospitalization with primary reason of HF; urgent visit to emergency department (ED) with primary reason of HF.
* Elevated B-type natriuretic peptide (BNP) or n-terminal-prohormone brain natriuretic peptide (NT-proBNP)

Other Inclusion Criteria May apply

Key Exclusion Criteria:

* Currently receiving treatment in another investigational device or drug study, or \< 30 days since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.
* Malignancy within 5 years prior to randomization with the following exceptions: localized basal or squamous cell carcinoma of the skin, cervical intraepithelial neoplasia, stage 1 prostate carcinoma, breast ductal carcinoma in situ.
* Subject has known sensitivity to any of the products or components to be administered during testing

Other Exclusion Criteria May apply
UPDRS-III Comparisons of DBS for PD Between Patients Receiving MAC and AAA Anesthesia

Compares the patients' scores of UPDRS-III before and six-month after receiving deep brain stimulation for Parkinson's disease under MAC or AAA anesthesia.

Compares the patients' scores of UPDRS-III before and six-month after receiving deep brain stimulation for Parkinson's disease under MAC or AAA anesthesia. Besides, the research also compares the adverse events, LED, dosage of anesthetic drugs, wake-up time, surgical time, Hoehn\&Yahr, PQD-39, MMSE, MoCA, HAMA, HAMD and patients' satisfaction between the two groups mentioned above.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18 years old
* Diagnosis of primary Parkinson's disease
* Parkinson's disease-related symptoms remain difficult to control with appropriate anti-parkinsonian medications.

Exclusion Criteria:

* Refusal to Participate in the research
* Patients with severe comorbidities such as severe sleep apnea syndrome and metal disorder
* Previous functional neurosurgery: DBS, thalamic incision, etc.
G6PD Deficiency in Infarction Patients in Shaanxi Province

Cerebral infarction brings heavy burden to patients and families with high morbidity, mortality, disability and recurrence rate. Anti-platelet aggregation therapy plays important role for secondary prevention of cerebral infarction. G6PD deficiency is a rare genetic disorder, patients with this disorder could suffer hemolysis after eating broad beans. Professor Zeng Jinsheng et al found that the hemolysis risk of G6PD deficiency patients was significantly increased when aspirin was applied in Guangdong Province. However, the prevalence of G6PD deficiency in northern China remains unknown, as well as the safety of antiplatelet therapy. To this end, 1000 patients with acute cerebral infarction will be continuously included in 30 second-level and above hospitals in 10 prefectures and cities of Shaanxi Province for observation and follow-up for 12 months, to explore the prevalence of G6PD deficiency in cerebral infarction patients in Shaanxi Province, and to analyze the relationship between G6PD deficiency and the clinical characteristics and prognosis of cerebral infarction. To clarify the efficacy and safety of antiplatelet therapy for G6PD patients with cerebral infarction is of great significance for guiding the individualized treatment of cerebral infarction.


Eligibility Criteria:
Inclusion Criteria:

* meets the diagnostic criteria of acute cerebral infarction established by Neurology Society of Chinese Medical Association, and confirmed by cranial Magnetic Resonance Imaging；
* Time from onset to enrollment ≤14 days;
* Volunteer to participate in the study and sign the informed consent.

Exclusion Criteria:

* Silent cerebral infarction with no symptoms and signs;
* Complicated with post-infarction hemorrhage;
* Cerebral hernia and other complications caused by massive cerebral infarction may lead to death in acute phase;
* Cardiogenic cerebral embolism caused by atrial fibrillation;
* Cerebral infarction caused by tumor, vasculitis and other special reasons;
* Complicated with serious systemic diseases, including liver and kidney insufficiency, respiratory failure, heart failure, infection, etc
RPCRC Validation Study

Prostate multiparametric MRI (mpMRI) can detect ISUP ≥2 prostate cancer with high sensitivity. Adding biopsies targeting suspicious lesions seen on mpMRI to the classical 'systematic biopsies' (that sample the gland in a blinded way) improves the detection of ISUP ≥2 cancers. As a result, it is now recommended to perform a prostate mpMRI before biopsy and to combine targeted and systematic biopsy.

However, mpMRI suffers from a lack of specificity. In a recent meta-analysis, the pooled sensitivity and specificity of prostate mpMRI for detecting ISUP ≥2 cancers were 0.91 (95% confidence interval, 0.83-0.95) and 0.37 (95% confidence interval, 0.29-0.46) respectively. Thus, accurate triage of patients suitable for biopsy might not be possible using mpMRI findings alone.

The Rotterdam Prostate Cancer Risk Calculator (RPCRC) combines mpMRI results (Prostate Imaging-Reporting And Database System score) and basic clinical and biochemical data to predict the results of prostate biopsy. If validated, this tool could help selecting patients for prostate biopsy.

In this study, the investigators propose to retrospectively use the data of the prospective multicentric MRI-FIRST trial (NCT0285379) to perform an external validation of the RPCRC.

In addition, the PCaRisk study has two secondary objectives:

* To confirm that Prostate Specific Antigen density (i.e. PSA level divided by prostate volume) can stratify the risk of ISUP ≥2 cancer in patients with negative (PI-RADS 1-2) or inconclusive (PI-RADS 3) mpMRI, as suggested by recent literature
* To perform a preliminary evaluation of a lobe-specific risk calculator developed by our group and combining mpMRI results and clinical and biochemical data to predict the risk of ISUP ≥2 cancer at the lobe level.


Eligibility Criteria:
Inclusion Criteria:

* Patient referred for mpMRI and prostate biopsy due to increased PSA level, abnormal DRE or family history of prostate cancer.
* Age ≤75 years
* PSA level ≤20 ng/mL
* Clinical stage ≤T2c

Exclusion Criteria:

* Contraindication for prostate mpMRI or biopsy
* History of hip prosthesis, androgen deprivation therapy, pelvic radiotherapy or prostate cancer diagnosed after trans-urethral resection of the prostate.
Prospective, Single-Arm, Multicenter Study to Evaluate the Effectiveness and Safety of Endovascular Treatment in Patients With Cerebral Aneurysms Using P64 and P48 Flow-Diverter Stents

The use of flow-diverting stents for the endovascular treatment of cerebral aneurysms has proven to be effective and efficient in several clinical studies, leading to its widespread adoption. Devices with a higher number of filaments have a greater flow-diverting effect and less variation when there are changes in the caliber of the underlying vessel or in curved vessels. However, ischemic complications secondary to their implantation have been reported, prompting the development of various strategies to reduce their thrombogenicity. Phenox is the only company to date that has developed an anti-thrombogenic coating, known as HPC (Hydrophilic Polymer Coating), which, when applied to the p64 MW HPC and p48 MW HPC devices, has shown to reduce the likelihood of thromboembolic complications associated with their implantation.

The goal of this study is to evaluate the effectiveness and safety of endovascular treatment for cerebral aneurysms using the flow-diverting stents p64MW (flow modulation device) HPC and p48MW HPC in the routine clinical practice of several Spanish hospitals. It is therefore an observational study, carried out with devices already commercialized. The success rate of the intervention, the rate of hemorrhagic and thromboembolic complications, as well as variables related to the clinical and radiological follow-up of patients over a 12-month period, will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years old with incidental, symptomatic, and/or ruptured cerebral aneurysms.
* Signed informed consent by the patient or their representative.

Exclusion Criteria:

* Patients under 18 years of age.
* Absence of signed informed consent by the patient or their representative.
* Known, medically untreatable allergy to iodinated contrast.
* Pregnant women or those breastfeeding.
Study to Assess the Safety and Effectiveness of Beltavac® Polymerized With Cat Dander

Non-interventional Study to Assess the Safety and Effectiveness Profile of a SCIT Therapy With Beltavac® Polymerized With Cat Dander in allergic patients

This prospective open multi-centre non-interventional study assess the safety and effectiveness profile of the subcutaneous allergen-specific immunotherapy with Beltavac® Polymerized with cat dander allergic patients (children and adults) in routine medical care. Patients receive a rush schedule administration every month for a year. They attend at least 5 study visits to inform about the adverse reactions, the self reported symptoms and the medication intake.

Eligibility Criteria:
Inclusion Criteria:

* Patients of the age of 12 years and older suffering from a clinically relevant cat dander induced allergic rhinitis or rhinoconjunctivitis associated with or not with asthma
* Positive skin testing
* Positive Serum-Specific IgE determination
* Informed consent

Exclusion Criteria:

* Patients suffering from acute or chronic infections or inflammations
* Patients suffering from uncontrolled asthma
* Patients with a known autoimmune disease
* Patients with active malignant disease
* Patients requiring beta-blockers
* Patients having any contraindication for the use of adrenaline
* Patients with previous immunotherapy with this allergen or another allergen with cross-reaction
* Patients with immunotherapy treatment at the time of inclusion
EEG and ANI Guided Anesthesia and Quality of Recovery

This study aims to assess whether electroencephalogram (EEG) and nociception level-guided anesthesia can improve quality of recovery after laparoscopic gynecological surgery compared with standard care. Patients will be randomly assigned to either EEG and Analgesia Nociception Index (ANI)-guided anesthesia group (EEG-and-ANI-Guided group) or usual care group (control group). Primary outcome is 15-item Quality of Recovery (QoR-15) score at postoperative day (POD) 1. Secondary outcomes included remifentanil consumption during anesthesia, occurrence of awareness with recall, incidence of undesirable intraoperative movement, emergence time, postoperative pain scores, quality of recovery score at POD 2, and length of hospital stay.

Adult women scheduled to undergo laparoscopic gynecologic surgery will be screened for eligibility. Patients will be randomly allocate to either the EEG-and-ANI-guided group or usual care group.

In the guided group, sevoflurane concentration will be titrated according to EEG monitoring. Intraoperative infusion of remifentanil will be titrated by ANI monitoring.

In the usual care group, EEG and ANI sensor will be attached to patients, but EEG and ANI monitor will be blinded to the attending anesthesiologists. The anesthesiologists will provide a standard care of our institution for anesthetic and analgesic titration. In brief, hemodynamic variables and clinical situations will be used to titrate the anesthetic depth and analgesic dose.

Blinded investigator will assess quality of recovery questionnaire-15 at postoperative day 1 and 2.

Eligibility Criteria:
Inclusion Criteria:

Adult female patients who are scheduled to undergo laparoscopic gynecological surgery.

1. Total laparoscopic hysterectomy with/without salpingo-oophorectomy
2. Laparoscopic myomectomy
3. Laparoscope-guided salpingo-oophorectomy
4. Laparoscope-guided ovarian cystectomy
5. Laparoscope-guided enucleation of ovarian cyst

Exclusion Criteria:

1. Patients with nonregular sinus cardiac rhythm
2. Patients with implanted pacemakers
3. Patients on antimuscarinic agents, α2-adrenergic agonists, β1-adrenergic antagonists, antiarrhythmic agents
4. pregnant or breastfeeding women
5. Patients who are unable to communicate
Effectiveness of Artificial Intelligence - Assisted Colonoscopy in Colorectal Neoplasms

The primary goal of this study is to estimate the effectiveness of a medical decision support system based on artificial intelligence in the endoscopic diagnosis of benign tumors.

Researchers will compare Adenoma detection rate between "artificial intelligence - assisted colonoscopy" and "conventional colonoscopy" groups to evaluate the clinical effectiveness of artificial intelligence model.

The primary outcome is adenoma detection rate per patient.

The secondary outcomes will be measured:

* Polyps detection rate (all type of lesions) per patient;
* Number of adenomas per patient;
* Number of polyps per patient;

Eligibility Criteria:
Inclusion Criteria:

* Screening coloscopy is needed

Exclusion Criteria:

* Indications for colonoscopy
* Previously detected colorectal neoplasms
* Previously performed colorectal surgery
* Colorectal cancer
* Inflammatory bowel disease
Multi-Organ Screening Recommendations in Patients With Lynch Syndrome

The purpose of this study is to examine how people with a family history of colon cancer and other related cancers respond to recommendations for cancer screening after genetic counseling. The purpose of your participation would be to help us learn more about whether people with a personal and/or family history of colorectal cancer and other cancers follow cancer screening recommendations.


Eligibility Criteria:
Inclusion Criteria:

* A patient will be eligible for enrollment if he/she is self-referred or physician-referred for genetic counseling at Memorial Sloan-Kettering Cancer Center's (MSKCC) Clinical Genetics Service due to a concern about increased risk for colon cancer or;
* An individual who presents for genetic counseling at MSKCC's Clinical Genetics Service after undergoing genetic testing at an outside institution with a documented mutation in any gene associated with Lynch Syndrome or;
* An individual who in the context of genetic counseling has received stricter colorectal and/or gynecologic screening recommendations than that of the general population regardless of genetic test results.
* DNA of patients who have been consented to protocol 93-102 ("Ascertainment of Peripheral Blood or Saliva Samples for Genetic Epidemiology Studies of Familial Cancers"), who meet the eligibility criteria listed above, will also be eligible for inclusion in this study.

Exclusion Criteria:

* Patients will be excluded from this study if: he/she has physical, cognitive or psychiatric conditions that interfere with ability to give meaningful informed consent; he/she cannot read, write or communicate in English; he/she is less than 18 years of age; he/she has received a diagnosis of FAP.
Evidence of Spreading Vasodilation in Human Gingiva

The aim of this study is to observe the mechanism of spreading vasodilatation on human healthy gingiva. Nitric-oxide donor solutions in lower and higher concentration are used to trigger the vasoactivity.

Spatial regulation of gingival microcirculation has not been revealed yet. Although this could be an important mechanism to protect gingiva as it is exposed to mechanical, chemical, thermal etc. irritation during whole life. It is especially important during flap surgery. Laser Speckle Contrast Imaging (LSCI) is novel non-invasive method with high spatio-temporal resolution, therefore it allows us to study remote effect of local vasodilation such as spreading vasodilation in human gingiva.

The vasodilatator nitric-oxide (NO) donor will be used to trigger remote effect on gingiva. NO donor solutions will be applied in 1 mg/ml and 8 mg/ml nitroglycerin concentrations. Solution will be dropped on the gingiva at tooth 12 in a fabricated leakage proof well attached to 2mm above the marginal gingiva. The change on blood flow will be monitor at the test well with surrounding gingival area spanning 3 tooth and at the contralateral side by LSCI.

Eligibility Criteria:
Inclusion Criteria:

* general health
* minimum 5 mm keratinized gingiva at upper front teeth

Exclusion Criteria:

* pregnancy and breast-feeding
* medication (except contraceptives)
* smoking
* periodontitis
* caries
* insufficient marginal integrity