cyrilzakka/clinical-trials huggingface dataset:
The Association Between Parent Anxiety and Sedation Anesthesia Doses in Pediatric Endoscopy

Our study was planned as a prospective, single-center study between 20 January 2022 and 20 April 2022. All patients between the ages of 1-18 who will undergo upper or lower gastrointestinal endoscopy and their parents will be included in our study. All patients and parents whose family did not give consent to participate in the study will be excluded from the study. All patients will be seen by an anesthesiologist before the procedure and it will be stated that there is no harm in taking anesthesia. Anesthesia consent form will be given by the family. Study participation consent will be obtained from parents before starting the procedure. The patient's age, gender, height, weight, ASA score, the procedure to be performed, the parent's educational status, occupation and income level will be recorded. Children's anxiety will be evaluated with the "Modified Yale Preoperative Anxiety Scale (mYPAS)" in the presence of their parents 15-30 minutes before the procedure. The agitation that occurs when the patient leaves the families for processing, with the "Parental Separation Anxiety Scale"; Parental anxiety will be evaluated with the "Stationary and Trait Anxiety Scale" filled by families after the child is processed.


Eligibility Criteria:
Inclusion Criteria:

* All patients between the ages of 1-18 who will undergo upper or lower gastrointestinal endoscopy and their parents will be included in our study.

Exclusion Criteria:

* All patients and parents whose family did not give consent to participate in the study will be excluded from the study.
The Immunological Profile of Nickel Dermatitis

A dose-response study on the immune phenotype of allergic nickel dermatitis on a previously exposed skin area.

Clinically controlled study comprising 15 people with known nickel allergy and 15 healthy persons as control group. At the Department of Allergy and Dermatology, Gentofte Hospital, test participants will be exposed to nickel sulfate in a patch test on their back, which will create an eczema reaction in people with nickel allergy and induce skin resident T-cells. The resident T-cells will enhance further exposure. The eczema is healed over 3-4 weeks, after which the same areas are again exposed to nickel sulfate at different concentrations in a patch test. Skin biopsies of the exposed areas are taken and the immune phenotype is analyzed trough Nanostring RNA technologies of around 600 immunerelated genes.

Eligibility Criteria:
inclusion criteria

* Must be able to understand the written and oral participant information in Danish.
* Previously proven nick allergy by patch testing within the last 5 years, for the nickel allergic test participants.

exclusion criteria

* Pregnancy and / or breastfeeding.
* Systemic immunomodulatory treatments within the last 14 days.
* Local treatments of selected skin areas, such as applying hormone cream within the last two weeks or applying cream / lotion within 24 hours up to sample collection.
* Allergy to local anesthesia.
* Exposed to solar or sunlight on the back within 21 days.
* History of inflammatory skin diseases, asthma, Diabetes Mellitus, hives or arthritis (exclusion criteria only for participation in the healthy control group).
* Participation in another scientific experiment within the last 4 weeks. risks,
Quantitative Real-time Ultrasound Elastography for Characterisation of Liver Tumors

Shear Wave Elastography (SWE™) is a quantitative elastography method for measuring tissue stiffness. The difference in stiffness between benign and malignant tumors has been demonstrated by other elastography methods (acoustic radiation force impulse imaging, transient elastography and/or magnetic resonance elastography). The investigators hypothesized that benign liver tumors are softer than malignant liver tumors measured by SWE™, allowing differentiation between the two by tumor stiffness expressed in kilopascal (kPa). In this study benign and malignant liver tumors will be evaluated in five groups: 1) hemangioma and 2) focal nodular hyperplasia (FNH) representing the most common benign liver tumors; 3) metastases and 4) cholangiocarcinoma (CCC), both presenting malignant tumors mostly appearing in otherwise healthy liver, and 5) hepatocellular carcinoma (HCC) mostly occurring in cirrhotic liver, which can potentially influence elastographic measurements therefore querying the appropriateness of comparison between tumors in healthy and cirrhotic liver. Enrolled patients will undergo transabdominal ultrasonography and SWE™ examination. The tumor stiffness will be measured five times for each tumor. Additionally, surrounding liver parenchyma stiffness will be measured. The nature of the liver tumor will be defined through a standard diagnostic workup according to current guidelines, including contrast enhanced multi-slice CT, MRI and/or cytology/histology, as applicable. In the final analysis the mean tumor stiffness and tumor-parenchyma ratio will be calculated for each group as well as for benign and malignant tumors separately, and cut-off values for the differentiation of various groups will be derived. The clinical value of the method will be appraised based on specificity, sensitivity, positive and negative predictive values, and AUC.


Eligibility Criteria:
Inclusion Criteria:

* liver tumors detected on US examination of the liver
* compliance to the study protocol
* signed approval for the diagnostic ultrasound with SWE™

Exclusion Criteria:

* haemangioma, focal nodular hyperplasia (FNH), metastasis, cholangiocellular carcinoma (CCC) or hepatocellular carcinoma (HCC) in the proximity of liver capsule (less than 1 cm from the liver surface)
* haemangioma, FNH, metastasis, CCC or HCC deep in the lever parenchyma (more than 7 cm away from the surface)
* liver tumors other than haemangioma, FNH, metastasis, CCC and HCC
* severe hepatitis defined by alanine aminotransferase (ALT) values \> 5 x upper limit of normal (ULN)
* obstructive jaundice
* congestive heart failure
* pregnancy
Remote Ischemic Preconditioning With Postconditioning in Heart Transplantation Surgery

The purpose of this study is to determine whether remote ischemic preconditioning with postconditioning (RIPC+RIPostC) reduces myocardial injury and improves clinical outcomes in heart transplantation surgery.


Eligibility Criteria:
Inclusion Criteria:

* scheduled for elective orthotopic heart transplantation surgery

Exclusion Criteria:

* peripheral vascular disease affecting the upper arms
* mechanical circulatory support before surgery
* taking the antidiabetic sulphonylurea, glibenclamide
* cold ischemic time of donor heart \> 12 hours
* repeated heart surgery
LED Photobiomodulation Therapy for Non-specific LBP in Working Nurses

Background: Low back pain (LBP) affects approximately 51-57% of hospital nurses and nurses' aides in Europe. New high-risk groups include home- and long-term-care nurses and physiotherapists. A number of European countries are experiencing a shortage of healthcare workers. Light therapy has been shown to be an effective treatment for various musculoskeletal disorders, including lateral epicondylitis, temporomandibular joint pain, carpal tunnel syndrome, and delayed-onset muscle soreness. A systematic review and meta-analysis demonstrated that low-level laser therapy is an effective method for relieving non-specific chronic low back pain (NSCLBP). However, the efficacy of light-emitting diode (LED) therapy for NSCLBP is disputed. This study aims to evaluate the effect of LED therapy on NSCLBP.

Methods and analysis: The investigators conducted a prospective, double-blind, randomized placebo-controlled trial of 148 patients with NSCLBP. The patients were randomly assigned to two groups: intervention group, where patients received LED photobiomodulation therapy three times a week for 2 weeks, and the control group, where patients had sham treatment only three times a week for 2 weeks. Primary outcome measures included the visual analog scale for pain, lumbar active range of motion assessments, and chair-rising times. Secondary outcome measures included a Multidimensional Fatigue Inventory, Fear-Avoidance Beliefs Questionnaire, and the Oswestry Disability Index. The outcome measures were assessed before therapy and 2 weeks, 4 weeks, 8 weeks, 12 weeks, and 6 months after the first interventions were completed.

Discussion: This study is a prospective, single-center, double-blind, randomized, controlled study. This study aims to research the efficacy of a 2-week LED program for NSCLBP working nurse. The results will be useful for patients, working nurses, nurses' aides, and other healthcare workers with chronic low back pain.

Trial registration number: This protocol was registered in ClinicalTrials.gov, under the number 108-088-F.


Eligibility Criteria:
Inclusion Criteria:

* male or female registered nurses aged 18-65 years with non-specific chronic LBP, which is defined as pain or discomfort between the costal margins and inferior gluteal folds with or without referred pain to the lower limbs, and persistent LBP for at least 3 months

Exclusion Criteria:

* severe skin diseases (e.g., skin cancer, erysipelas, severe eczema, severe dermatitis, severe psoriasis, and severe hives lupus)
* LBP associated with nerve root compromise (measured by clinical examination of dermatomes, myotomes, and reflexes)
* serious spinal pathologies, such as fractures, tumors, and inflammatory and infectious diseases
* decompensated heart disease or metabolic disorders
* previous spinal surgery
* pregnancy.
14-Day Cumulative Irritation Patch Test in Subjects With Normal Skin

The objective of this study is to determine the ability of the study material to cause irritation to the skin of humans under controlled patch test conditions. Substances that come into contact with human skin need to be evaluated for their propensity to irritate and/or sensitize. This testing is a modified primary irritancy patch test that can detect weak irritants that require multiple applications to cause a skin reaction.


Eligibility Criteria:
Inclusion Criteria:

* Are a male or female, 18 years of age or older, in general good health;
* Have normal skin;
* Are free of any systemic or dermatologic disorder which, in the opinion of the investigative personnel, will interfere with the study results or increase the risk of adverse events;
* Are of any skin type or race providing the skin pigmentation will allow discernment of erythema;
* Complete a medical screening procedure; and
* Read, understand, and sign an informed consent.

Exclusion Criteria:

* Have any visible skin disease at the study site which, in the opinion of the investigative personnel, will interfere with the evaluation;
* Are receiving systematic or topical drugs or medication which, in the opinion of the investigative personnel, will interfere with the study results;
* Have psoriasis and/or active atopic dermatitis/eczema; and/or
* Have a known sensitivity to cosmetics, skin care products, or topical drugs as related to the material being evaluated.
Studying Tumor Tissue Samples From Patients With Early-Stage Non-Small Cell Lung Cancer

This research trial studies biomarkers in predicting the risk of cancer returning after surgery in tissue samples of patients with early-stage non-small cell lung cancer. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer and predict how well patients will respond to treatment.

PRIMARY OBJECTIVES:

I. To develop and validate a clinically useful molecular prognostic signature based on ribonucleic acid (RNA)-expression arrays to accurately distinguish between good and poor outcome in patients with stage 1B non-small cell lung cancer (NSCLC) (T2aN0M0) by predicting the risk of cancer recurrence after surgery.

SECONDARY OBJECTIVES:

I. To develop and validate a clinically useful prognostic signature for stage 1A NSCLC (T1a-bN0M0) that accurately predicts the risk of post-operative cancer recurrence and is part of a prognostic classifier, which also includes histological, pathological, and demographic parameters as in the primary objective.

II. To determine the effects on test accuracy of the histological subtype (adenocarcinoma \[AC\] vs squamous cell \[SQA\]) for each of the stage specific prognostic classifiers.

III. To determine the relevant statistical features, including accuracy of predicting overall survival, cancer specific survival, and disease free survival at 3 and 5 years, for each of the prognostic classifiers validated.

IV. To utilize the validated prognostic signatures and classifiers in stage 1B NSCLC to determine whether these can reliably predict good outcome among stage II NSCLC patients.

OUTLINE:

RNA extracted from archived tumor tissue samples are analyzed for whole-genome expression by Affymetrix microarrays (Gene Profiling Array cGMP U133 P2) and reverse transcriptase-polymerase chain reaction (RT-PCR).

Eligibility Criteria:
Inclusion Criteria:

* Registration to CALGB-140202
* The subject population to be studied in this protocol includes patients selected from CALGB-140202; all such patients have signed a written informed consent document meeting all federal, state and institutional guidelines as part of entry into that trial; the CALGB does not require that a separate consent form be signed for this study
* All samples to be studied were obtained and stored as part of CALGB-140202; the material and data obtained from the patient's protocol record will be used to obtain appropriate clinical information; in no instance will the patient be contacted directly
* Tumor specimens need to have 40% tumor content to be included
Reconstruction of the Carotid Bifurcation in Patients With Arterial Hypertension of 2-3 Degrees

Carotid endarterectomy (CEA) is a well-established procedure for preventing ischemic brain damage. Stenosis of the precerebral vessels are often combined with arterial hypertension. In recent decades, many works have appeared that indicate that the course of arterial hypertension (AH) changes after CEA. However, it remains unknown how this is related to the choice of surgical tactics.

Purpose of the study: to substantiate the choice of the method of surgical treatment in patients with a combination of hemodynamically significant stenosis of the carotid bifurcation and arterial hypertension of 2-3 degrees.

Tasks:

1. To study the course of hypertension after carotid endarterectomy with removal of the carotid glomus.
2. To study the course of hypertension in patients after stenting of the internal carotid artery.
3. To substantiate the strategy for performing carotid endarterectomy in patients with bilateral significant lesions of the internal carotid artery.
4. To substantiate the choice of a surgical treatment strategy in patients with significant stenosis of the carotid bifurcation and 2-3 degree of hypertension.

Methods for examining patients: collection of complaints and anamnesis, objective examination, questioning of patients, instrumental examination (ultrasound of BCS, daily monitoring of blood pressure, CT of the brain, cerebral angiography).

As a result of the study, the optimal tactics of surgical treatment in patients with carotid artery stenosis and the presence of hypertension will be determined.

Eligibility Criteria:
Inclusion Criteria:

* Presence of symptomatic ICA stenosis 70-90%
* Arterial hypertension of 2 or 3 degrees
* CEA operation with carotid glomus removal or ICA stenting operation

Exclusion Criteria:

* severe diabetes
* traumatic brain injury in history
* IHD, stable angina pectoris 3-4 FC.
* presence of clinical signs of vertebrobasilar insufficiency
* the presence of significant stenosis of the renal arteries
* CKD stages 3b-5
Clinical Outcomes After Bilateral Implantation of ZEISS AT LISA TRI AND TRI TORIC IOL

The aim of this study is to evaluate the visual function of patients with bilateral implantation of the IOL trifocal ZEISS AT LISA TRI AND TRI TORIC by means of visual acuity tests with and without optical correction, sensitivity curve contrast, defocus curve and quality questionnaire visual function (VFQ-25).

Twenty patients (40 eyes) diagnosed with cataracts and cataract surgery indication will be selected to participate in this study. The surgery will be performed by the same surgeon with 2 week interval between surgery the first and second eye. After approval of the research project by the Research Ethics Committee all patients should understand and sign the Informed Consent and Informed (IC) before surgery.

All patients will be operated by conventional phacoemulsification with implantation of intraocular lens provided by the manufacturer.

Patients will have five study visits, including the preoperative visit, operative visit four postoperative visits.

All patients will be submitted to the following routine assessments preoperatively and demographic patient information will be recorded and a detailed medical history will be obtained.

* VFQ-25 Questionnaire
* Identification of the dominant eye;
* Visual acuity
* Refraction
* Slit lamp examination
* Tonometry
* Self-keratometry;
* Corneal topography;
* Microscopy speculate
* Fundus examination.

In addition, all routine preoperative measures will be performed. lens power calculations should be performed on both eyes to ensure qualification (lens power within the diopter range (D) available) and prepare for surgery (getting the lens). The emmetropia (± 0.5 D) should be the target of patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 50 years
* Cataract diagnosis indicating surgery in both eyes
* Corneal astigmatism to 12D (AT lisa tri toric)
* Corneal astigmatism less than 0,75D (AT lisa tri)
* Ability to provide consent and clarification for study participation

Exclusion Criteria:

* Significant irregular corneal astigmatism as shown by Corneal topography;
* Corneal astigmatism up 12D
* Patients diagnosed with severe visual degenerative disorders (e.g. macular degeneration or other disorder of the retina)
* Previous corneal surgery;
* Amblyopia
* Planning for multiple procedures, including IRL, LASIK, etc. during surgery or during the study
* Endothelial dystrophy clinically significant cornea (eg, Fuchs dystrophy)
* Corneal disease activity (eg, herpes simplex, herpes zoster, etc.)
* Severe diabetic retinopathy
* Retinal detachment
* Glaucoma
* Patients presenting illness or acute conditions or chronic severe that in the opinion of the investigator, would increase the surgical risk or confound the research results
* Any patient who is taking part in another study involving ocular surgery
A Multi-site Clinical Evaluation of Capillary Blood Samples Collected Using the Tasso+SST Device for Downstream Analyte Testing

This is a prospective, multi-center study within the U.S. Study participants will take part in two study visits a minimum of 14 days apart. During each visit, participants will self-collect capillary blood samples. Additionally, a healthcare provide will obtain capillary and venous serum samples. All capillary samples will be collected from the upper arm using the Tasso+ device paired with a commercially-available serum separator gel microtainer. The samples will be shipped to a clinical laboratory and tested for various analytes. Expected analyte values for each participant will be based on their venous sample results which will be compared to Tasso sample results


Eligibility Criteria:
Inclusion Criteria:

1. Adults aged 18 - 85 years
2. Willing and able to provide written informed consent prior to study entry
3. Willing and able to adhere to study assessments, schedule, prohibitions and restrictions as described in the protocol
4. Healthy individuals or patients with analyte values (verified or likely to be) within intended clinical reference ranges as indicated by standard of care testing and/or past medical history (which may be documented or self-reported)

Exclusion Criteria:

1. Present with abnormal skin integrity or atypical skin health near/on arm collection sites
2. Mental or physical impairment which would preclude participation in the judgement of the investigator or qualified designee
3. Laboratory and healthcare personnel.
4. Any condition which, in the opinion of the Investigator or delegate, makes the participant unsuitable for this study (including, but not limited to, any mental or physical impairment which would preclude provision of adequate and knowledgeable consent)
Effect of AO Training on Gross Motor Function in Children with Spastic Cerebral Palsy

The study was conducted to examine the impact of the action observation training (AOT) on gross motor function in children with spastic cerebral palsy.

Thirty children with spastic diplegic cerebral palsy aged from 4 to 7 years were randomly allocated into two groups of equal number; study group (A) and control group (B). Both groups received designed physical therapy program for 45 minutes, three times/ per week for two successive months. In addition, study group received action observation (AO) training for 30 minutes per session. All phases of gait cycle and functional ability of all children participating in both groups was assessed by kenovia software and gross motor function measure (GMFM) walking, running and jumping domain.

Eligibility Criteria:
Inclusion Criteria:

Age ranges from 4 - 7 years. Level Ι - Π according to Gross Motor Functional Classification System (GMFCS) (Appendix II).

Grade 1, +1 and 2 of the Modified Ashworth Scale (Appendix III). Able to follow verbal commands and instructions.

Exclusion Criteria:

* Significant visual or auditory impairments Structural or fixed soft tissue deformities of Lower extremities. Perception disorders. Botox injection in the lower extremity in the past 6 months.