cyrilzakka/clinical-trials huggingface dataset:
Perioperative Use of Serum Creatinine and Postoperative Acute Kidney Injury

The perioperative approach adopted in a cohort of adult oncological patients undergoing major abdominal surgery will be described. In particular, the physician's attitude toward use of sCr for identification of patients at risk for PO-AKI will be described, as well as the patients who should be reassessed in the long term for progression toward CKD. The incidence and risk factors associated with PO-AKI and renal function deterioration within a year postoperatively will be also evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* Scheduled for elective surgery
* Surgery for oncological disease

Exclusion Criteria:

* Patients undergoing postoperative chemotherapy
* Patients who died within 12 month after surgery
18F-mFBG PET Imaging in the Evaluation of Neuroblastoma

The aim of this study is to evaluate the diagnostic performance and tumor burden of 18F-metafluorobenzylguanidine (18F-MFBG) positron emission tomography (PET) in patients with neuroblastoma.

Neuroblastoma highly expresses norepinephrine transporter (NET) which is targeted by function alanalogue of norepinephrine, 123/131I-MlBG. However, low spatial resolution of 123/131I-MlBG and inaccurate attenuation correction of single photon emission tomography (SPECT/CT) will affect the image quality of MlBG SPECT and lead to poor diagnosis of small lesions. In addition, 123l-MlBG imaging is usually performed at 24h after injection, while 131I-MlBG is performed at 48h or even 72h after injection. The procedure is complicated and takes a long time, which limits clinical application. 18F-labeled MFBG is an ideal tracer to show the expression of NET. Preliminary data show that 18F-MFBG imaging is safe and has favorable biodistribution and kinetics with good targeting of lesions. Patients can undergo PET 0.5 hours after injection without special preparation. Our study will assess the safety profile, image quality and evaluate the diagnostic performance and tumor burden of 18F-MFBG. Patients with suspected or histologically confirmed neuroblastoma will be enrolled in this study.

Eligibility Criteria:
Inclusion Criteria:

1. Age 0-18 years old, with legal guardian;
2. Clinically suspected or confirmed patients with neuroblastoma;
3. If the patient is under 8 years old or unable to write, his/her guardian should understand and comply with the requirements of the study. If the patient is 8 years old or older and has written ability, both the patient and his/her guardian must sign the informed consent.

Exclusion Criteria:

1. Patients with severe primary diseases such as heart, brain, liver, kidney and hematopoietic system diseases;
2. Patients who have received ionizing radiation outside the scope of this experiment for other clinical medical or scientific research purposes within the past year, resulting in an annual radiation exposure dose exceeding 50 mSv.
3. Patients who have received experimental drugs or devices (with uncertain efficacy or safety) within one month;
4. Patients with any condition that the principal investigator of this study deems may cause harm or potential harm in any aspect related to this trial.
Evaluation of Atacand® (Candesartan) in Daily Medical Practice

This open label, non-interventional study is to show the efficacy of antihypertensive treatment with Atacand in hypertensive patients. Efficacy is to be evaluated based on the difference in systolic and diastolic blood pressure at baseline and at both follow-up visits.


Eligibility Criteria:
Inclusion Criteria:

* a patient with arterial hypertension who has been prescribed Atacand according to physician's judgement, irrespective of the inclusion in the study

Exclusion Criteria:

* hypersensitivity to candesartan or any other ingredient of Atacand
* liver function impairment and/or cholestasis
* severe renal insufficiency
* woman of child-bearing potential and not using appropriate contraceptive measures, pregnancy or lactation
the Clinical Performance of the Oxysoft Daily Disposable Silicone Hydrogel Soft Contact Lens

The objective of this study is to demonstrate that the OxySoft silicone hydrogel soft contact lens could be prescribed as a supportive care for myopes.

This is a double blind randomized control study to evaluate a daily disposable contact lens. It is planned to have 30 evaluable subjects at least divided evenly among 3 independent PIs. Each PI will enroll 12 subjects at least. The ration of evaluable test subjects to control subjects will be 2 to 1. The study lens will be dispensed randomly to subjects who have normal ocular health and conform to a set of criteria. It is necessary to wear the lens 8 hours a day and 5 days a week at least and follow up for one month (30 days). Data will be collected at baseline, 1 week, 2 week and 4 week of daily disposable modality including Adverse Reactions, Slit-lamp findings and Symptoms, Problems, and Complaints, vision acuity, keratometry change and reason for discontinuation.

Eligibility Criteria:
Inclusion Criteria:

* Subject should have normal eye and use no ocular medications
* VA correctable to 0.1 LogMAR or better, with spherical lenses ranging in power from -1.00 to -10.00 D myopia, astigmatism =\< 2.00 D
* Willing to comply with all study procedures and be available for the duration of the study.
* Provide signed and dated informed consent form.

Exclusion Criteria:

* Subjects have history of allergies that would contraindicate "normal" contact lens wear.
* Subjects have other active ocular or systemic disease such as, but not limited to: anterior uveitis (past or present), glaucoma, Sjögren's syndrome, lupus erythematosus, sclerodermas, keratoconus or type II diabetes, slip lamp findings greater than grade I (such as cornea or interstitial edema).
* Subjects have medications that would contraindicate contact lens wear.
* The presence of clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids, or associated structures.
* A known history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, corneal infiltrates or fungal infections.
* A history of papillary conjunctivitis that has interfered with contact lens wear.
* Any active participation in another clinical trial within 30 days prior to this study.
* Have had any cornea surgery.
* Currently pregnant (to the best of the subject's knowledge), is lactating or is planning a pregnancy within the next 1 month.
* Monocular or monovision fits
* Alcoholic or Drug Abused.
Cardiovascular Effects of Aerosols in Residences Study

This study is focused on the effects of HEPA filtration to reduce exposures to combustion-derived air pollution (CDAP). Specifically, the study will evaluate the health benefits of HEPA filters and compare the cardiovascular toxicity of two major sources of CDAP, specifically traffic and residential wood combustion.

Specifically, the purpose of this study is to evaluate the ability of portable high efficiency particle air (HEPA) filters to reduce exposures to PM2.5 and air pollution indoors and to improve subclinical indicators of microvascular function and systemic inflammation among healthy adult participants.

The investigators hypothesize that HEPA filter use will help decrease indoor concentrations of CDAP thereby helping to mitigate the associated cardiovascular risks.

To address knowledge gaps about health risks of specific pollution sources and to provide new evidence on the health benefits of air pollution interventions, the objectives of this study are: 1) quantify the relationship between low-level exposures to combustion-derived PM air pollution and subclinical indicators of cardiovascular disease risk; and 2) compare the relative impact of HEPA filtration for two major PM sources (traffic and residential wood combustion) on these indicators.

The use of HEPA filters may help to mitigate cardiovascular risks factors caused by combustion-derived air pollution (CDAP), (specifically woodstove and traffic emissions). We hypothesize that HEPA filter use and improved woodstove technology will help decrease indoor occurrences of CDAP. This project will help address knowledge gaps in CDAP-related health risks and benefits of interventions. Specific objectives include establishing a relationship between exposure to CDAP and biomarkers of cardiovascular risk and evaluating the impact of HEPA filter use towards improved indoor air quality and health indicators.

Eligibility Criteria:
Inclusion Criteria:

* 19 years or older
* non-smoking household
* lives within study boundaries and in areas of interest

Exclusion Criteria:

* COPD
* asthma
* diabetes
* heart disease
* hypertension
* arthritis
* gum disease
* occupationally exposed to traffic exposures \&/or woodsmoke
* if female, pregnant
Evaluate the Safety and Efficacy of Intrathecal Injection of RJK002 in Patients With Amyotrophic Lateral Sclerosis

The goal of the study aims to evaluate the safety and tolerability of a single intrathecal injection of RJK002 in subjects with amyotrophic lateral sclerosis (ALS), and to determine the recommended Phase II dose (RP2D).


Eligibility Criteria:
Main Inclusion Criteria:

1. Female or male subjects who are ≥ 18 years of age at screening;
2. Patients with a diagnosis consistent with clinically or laboratory-supported possible, probable, or definite sporadic or familial ALSALS in accordance with Revised EI Escorial diagnostic criteria published by the World Federation of Neurology (WFN);
3. The duration of the disease from the first symptom (any ALS symptom) prior to the screening visit must be less than 2 years (inclusive);
4. The Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) score ≥30 during the screening period, and the three respiratory scores (dyspnea, upright respiration, and respiratory insufficiency) must be ≥3;
5. The forced vital capacity (FVC) of predicted during the screening period is ≥70% at screening;
6. Body mass index (BMI) greater than 18 kg/m2 at screening;

Main Exclusion Criteria:

1. Subjects with other neurological diseases similar to ALS that affect the evaluation of drug efficacy, such as cervical spondylotic myelopathy, syringomyelia, spinal cord and brain stem tumors, hirayama disease, multifocal motor neuropathy, multiple sclerosis, Guillain-Barre syndrome, Parkinson's disease and dementia;
2. Patients with a diagnosis consistent with clinically or laboratory-supported possible, probable, or definite sporadic or familial ALSALS in accordance with Revised EI Escorial diagnostic criteria published by the World Federation of Neurology (WFN);
3. Subjects who refuse to take food and medication by nasal feeding tube during the study period due to swallowing dysfunction;
Airway Management During TCI vs RSI Anesthesia Induction

The aims of this observational study is to evaluate and compare feasibility of airway management during standardized TCI and RSI anesthesia induction.

The aims of this study are to evaluate and compare feasibility of airway management and risk for desaturation during standardized target controlled infusion (TCI) and rapid sequence induction (RSI) of anesthesia. A conventional way to induce anesthesia, i.e. manual injection of anesthetics, may be more accurate and predictable compared to dosing regimes based on complex mathematical algorithms used in TCI-systems. In addition, today many different models are presented and there is no consensus which kind of TCI-algorithm should be used universally. Moreover, dosing algorithms are most complex and challenging in underweight and morbid obesity. There are many publications on this field, but no data of feasibility of airway management can be found. Indeed, RSI induction is traditionally blamed to be risky and not recommended as a first choice.

Eligibility Criteria:
Inclusion Criteria:

* signed informed consent
* BMI \< 35 kg/m2
* preoperative assessment accepted by consultant anesthesiologist
* scheduled for breast cancer surgery, endocrinological surgery (thyroid, parathyroid) or minor general abdominal surgery.

Exclusion Criteria:

* not signed consent
* instable angina pectoris
* severe bronchial asthma
* severe chronic obstructive pulmonary disease
* dementia
* severe heart valve disease
* severe renal failure
* body mass index \> 35 kg/m2
Effects of Remifentanil on Respiratory Function in Mechanically Ventilated Patients

Sedation is widely used in mechanically ventilated patients. Propofol, benzodiazepines and opioids are the most used drugs. The study hypothesis is that sedation with remifentanil (an opioid drug) could improved respiratory pattern and effort in mechanically ventilated patients with rapid shallow breathing or high respiratory rate.


Eligibility Criteria:
Inclusion Criteria:

* pressure support ventilation or CPAP
* respiratory rate \> 35.min-1
* respiratory rate/tidal volume \> 105

Exclusion Criteria:

* vasoactive agents (dopamine lower than 5 mcg.kg-1.min-1 is not considered as vasoactive agent)
* body temperature \> 38 °C
* Glasgow Coma Scale \< 9
* FIO2 \> 0.6
* PEEP \> 10 cmH2O
* pH \< 7.30
Tactile Stimulus, Music Play and Virtual Reality Video Watching During Non-Stress Test on Maternal Anxiety and Fetal Parameters

The research was carried out to determine the effects of tactile stimulation, music listening and virtual reality video watched during the non-stress test on maternal anxiety level and fetal parameters.


Eligibility Criteria:
Inclusion Criteria:

* - Not having any risk factors (pre-eclampsia, IUGG, premature rupture of membranes, getational diabetes, etc.) during pregnancy
* Absence of uterine contraction as a result of NST,
* No cardiovascular disease diagnosed in the fetus,
* Being in the 18-49 age group

Exclusion Criteria:

* Any complications in pregnancy and fetus
* Refusal to accept the final test
Biomarkers of Insomnia and Fatigue in HIV/AIDS (Symptoms and Genetics Study)

The purpose of this study is to identify biological markers, including genes, associated with sleep disturbance and other symptoms among people with HIV.

This study will characterize insomnia subtypes and identify genetic markers and metabolic parameters associated with these subtypes. The results will be useful in later developing interventions to improve sleep, reduce fatigue, and thereby enhance the quality of life of HIV-infected persons.

A cross-sectional sample of 350 subjects will be recruited to describe relationships between biomarkers and insomnia subtypes. The initial assessment will include:

* wearing a wrist actigraph for 72 hours
* providing a fasting blood sample
* measuring blood pressure, height, weight, neck, waist, hip, and thigh
* completing questionnaires
* urine screening

Depending on the results of the initial assessment, approximately 200 subjects will be followed every month by telephone to assess symptoms and every 3 to 6 months with study visits similar to the initial assessment. Findings from this longitudinal part of the study will characterize the development of insomnia, fatigue, and daytime sleepiness over time in patients living with HIV.

Eligibility Criteria:
Inclusion Criteria:

* HIV infection
* Access to a telephone
* Able to read and write English

Exclusion Criteria:

* Current use of illicit drugs
* Currently pregnant or within the previous 3 months
* Working nightshift
* Diagnosis of sleep apnea, narcolepsy, restless legs syndrome, or periodic limb movements, dementia, or psychotic illness
Treatment of Depression With Mindfulness, Acceptance and Commitment

Randomized trial to proof the effects and efficacy of a new mindfulness and acceptance based group-treatment for depressive patients

In this study, a randomized trial is conducted in which the participants are allocated to two different care services (MAC-CBT® vs. progressive muscle relaxation). Participants are patients with depression who have been made aware of the group therapy by their treating physicians or psychotherapists or who have read the advertising in waiting areas or on the investigators homepage. An extensive psychometric survey will be conducted at the start of the study in an interview session with a psychotherapist, who also judges if the participants are able to participate in a therapy group. The MAC-CBT® group receives an eight-session group therapy, in which the aspects of mindfulness, acceptance and commitment are taught in detail. The control group will receive an eight-session treatment with progressive muscle relaxation. Input and output results are determined using validated survey instruments. In addition, the investigators will check the data for moderating variables (e.g. age, gender, previous treatments...).

Eligibility Criteria:
Inclusion Criteria:

* Depressive Disorder

Exclusion Criteria:

* Somatic disorder
* psychotic disorder
* personality disorder
Child Labour at Al-Sadat Neighborhood, Assiut City

General objective: To promote proper health status of working children in Assiut city.

Specific objectives:

1. To describe the socio-demographic characteristics of children working in car repair workshops in Al-Sadat area of Assiut city.
2. To describe the work environment.
3. To identify work related injuries and diseases among those working children.

Study population: Children working in car repair workshops in Al-Sadat area of Assiut city. Male children aged from 5 to 17 years will be included in this study.

Instrument: Data collection will be performed by using structured interview questionnaires. The questionnaire used for data collection will cover the following modules:

* Module (1): Socio-demographic characteristics (for example: age, family size, family residence, education and occupation of the parents, number of sibling, family income, etc).
* Module (2) :Occupational history : (Housing conditions and occupational features; age at the beginning of working, duration of working, working hours/day, weekend vacation, weekly income, causes of child work, nature of work, work hazards, type of exposure, health habits and practices such as smoking in addition to causes of school dropout.... etc)
* Module (3): Presence of work related injuries and diseases by history and observation.
* Module (4): Food frequency questionnaires (FFQ) during the past week: It will show the diet of working children if have a healthy and nutritious pattern or not.
* Module (5): Mental health screening: Self-reporting questionnaire 20 questions for assessment of mental health status of children.
* After collection of data the children will subjected to the following investigations:

HB level measurements - anthropometric measurements (weight and height) - pulmonary function tests (spirometry) and hearing level assessment by audiometry will be done only for children more than 12 years.

Eligibility Criteria:
Inclusion Criteria:

* Children working in car repair workshops in Al-Sadat area of Assiut city. Male children aged from 5 to 17 years

Exclusion Criteria:

* Children outside the age range (below 5 years),
* Female children
A Study to Determine the Immunogenicity and Safety Profile of CSL Limited's Influenza Virus Vaccine Compared to a US Licensed Comparator Influenza Virus Vaccine in a Pediatric Population

The purpose of this study is to determine the immunogenicity and safety profile of CSL Limited's Influenza Virus Vaccine compared to a US licensed comparator Influenza Virus Vaccine in a pediatric population aged greater than or equal to 6 months to less than 18 years.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or non-pregnant female participants aged ≥ 6 calendar months to \< 18 years at the time of the first study vaccination.
* For participants aged ≥ 6 months to \< 9 years, born after a normal gestation period (between 36 and 42 weeks).
* Females of childbearing potential (i.e., ovulating, pre-menopausal, not surgically sterile) must be abstinent or be willing to use a medically accepted contraceptive regimen for at least 2 months after vaccination. Females aged ≥ 9 years must also return a negative urine pregnancy test at enrollment.

Exclusion Criteria:

* Known hypersensitivity to a previous dose of influenza vaccine or allergy to eggs, chicken protein, neomycin, polymyxin, or any components of the Study Vaccine.
A Study to Investigate LYL797 in Adults With Solid Tumors

This study will evaluate the safety and tolerability of LYL797, a ROR1-targeted CAR T-cell therapy, in patients with ROR1+ relapsed or refractory triple negative breast cancer (TNBC), non-small cell lung cancer (NSCLC), platinum-resistant epithelial ovarian cancer/ fallopian tube cancer/ primary peritoneal cancer (Ovarian cancer), or Endometrial cancer. The first part of the study will determine the safe dose for the next part of the study, and will enroll patients with TNBC, NSCLC, Ovarian or Endometrial cancer. The second part of the study will test that dose in additional patients with TNBC, NSCLC, Ovarian or Endometrial cancer.

This Phase 1, single-arm, open-label, multi-center, dose-escalation and expansion study will evaluate the safety and tolerability of LYL797, ROR1- targeted CAR T cells, in adults with relapsed and/or refractory ROR1+ triple negative breast cancer (TNBC), non-small cell lung cancer (NSCLC), Ovarian cancer, or endometrial cancer. The dose-escalation phase includes patients with TNBC, NSCLC, Ovarian, or Endometrial cancer, and will investigate multiple dose levels to identify the recommended Phase 2 dose (RP2D). The dose-expansion phase will enroll patients with TNBC, NSCLC, Ovarian, or Endometrial cancer at the RP2D.

Eligibility Criteria:
IInclusion Criteria:

* ≥ 18 years of age at time of informed consent
* Confirmation of ROR1 expression from a pretreatment tumor sample
* Histologically confirmed TNBC or NSCLC that is relapsed or refractory, metastatic or locally advanced and unresectable
* Platinum-resistant epithelial ovarian cancer/ fallopian tube cancer/ primary peritoneal cancer.
* Endometrial cancer.
* Measurable disease including a target lesion and an additional lesion for biopsy
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Adequate organ and marrow function
* Women of childbearing potential must have a negative pregnancy test at screening
* All participants must agree to practice highly effective methods of contraception

Exclusion Criteria:

* Prior treatment with any adoptive T-cell therapy or other anti-ROR1 therapy
* Prior solid organ transplantation
* Active, untreated brain metastasis or leptomeningeal disease; however, stable, treated brain metastases are allowed
* Untreated or active infection at the time of screening or leukapheresis
* HIV-positive, HTLV-1-positive, active acute HAV, acute or chronic HBV or HCV, or active tuberculosis
* Impaired cardiac function or clinically significant cardiac disease
* Uncontrolled pleural effusion, pericardial effusion, ascites requiring recurrent drainage procedures (once monthly or more frequent), or lymphangitis carcinomatosis
* History of interstitial pneumonitis or pulmonary fibrosis.
* Systemic corticosteroids or other immunosuppressive medications within 14 days of leukapheresis
* Pregnant or lactating/nursing women