cyrilzakka/clinical-trials huggingface dataset:
Effect of Multi-media Health Education on Nurses' Workload and Patient's Satisfaction

Assessing whether multi-media health education reduce nurse workload and does not decrease the satisfaction of patients in surgical ward when admission.

Operation usually causes severe physical and mental stress to the patients, mainly because of fear and anxiety caused by patients worrying about the uncertainty about surgery, and finally affecting the patient's surgical efficacy and recovery. This is the main reason in terms of surgical nurse workload is much more than those internal medicine nurse.

As a major part of nursing work, health education has especially important to patients. The quality and efficiency of health education directly affects the rehabilitation of patients. It can help patients correctly understand the relevant knowledge of disease and master the skills of recovery.

At present, the health education in surgery department is mainly carried out by oral face-to-face communication and guidance from admission nurses. This kind of education method showed time-consuming and laborious.In addition, oral guidance is more reliable on nurse ability of expression and acknowledgement. Multimedia-based health education is an update mode combined with audio-visual stimulation and patients' own participation. Mobile terminal makes patient more acceptable, flexible, standardized in receiving the health education during hospitalization. This prospective study is aimed to assess whether multimedia-video education could reduce nurse workload and do not decrease the satisfaction of surgical patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years with general diseases and who need surgical treatment
* Primary school or above education history, with clear awareness, can cooperate with the collection of clinical data, and can communicate in Chinese
* Patients who signed the informed consent

Exclusion Criteria:

* Patients with visual and hearing impairment
* Patients with mental illness, dementia and other mental disorders
* Patients with complications of heart, brain and nephropathy
* Patients who cannot take care of themselves
* Emergency and critically ill patients
* Patients participated other research
Efficacy and Safety Study of TLC388 to Advanced Hepatocellular Carcinoma

The purpose of this study is to evaluate the safety and efficacy of TLC388 (Lipotecan) as a second line treatment in subjects with advanced Hepatocellular Carcinoma.

A Phase II, open-label, single-arm, two-stage, multicenter study to evaluate the efficacy and safety of Lipotecan® monotherapy in patients with advanced hepatocellular carcinoma (HCC) and had failed sorafenib treatment due to sorafenib intolerance or radiographic progressive disease (PD).

Eligible patients received 40 mg/m2 of Lipotecan®, given as a 30-minute (+3 minutes) intravenous infusion, on Days 1, 8, and 15 of a 28-day cycle for maximum 6 cycles. Inter-cycle and intra-cycle dose delays were allowed within 21 days of the scheduled date to be reduced to 35 mg/m2 and further to 30 mg/m2 if a treatment-related adverse event (TRAE) met the criteria for dose reduction.

Tumor response was assessed every 2 cycles until Cycle 6, or at the early termination according to RECIST Version 1.1 judged by site investigator. The favorable response of CR, PR or SD would be confirmed within 28-35 days. Safety evaluations were conducted on a weekly basis from the day study treatment administered throughout each cycle.

Eligibility Criteria:
Inclusion Criteria:

* Radiological diagnosis of hepatic tumor(s) by contrast-enhanced study
* Subjects with advanced HCC who are not eligible for surgical resection or loco-regional therapy.
* Subjects with sorafenib treatment failure due to sorafenib intolerance or radiographic PD (as per RECIST v1.1). Prior sorafenib use should be ≥ 400 mg/day for at least 14 days.
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
* Child Pugh Score ≤ 6;
* A life expectancy of at least 12 weeks or more

Exclusion Criteria:

* Subjects who have received any systemic target therapy or systemic chemotherapy other than sorafenib for the treatment of HCC.
* Subjects who have received sorafenib within 2 weeks prior to the initiation of the treatment dose, or have any sorafenib-related toxicities not yet resolved to grade 1 or baseline.
* Subjects who have undergone liver transplantation surgery.
* Major surgery within 4 weeks prior to the initiation of the treatment dose (excluding implantation of the intravenous infusion device). Percutaneous liver puncture within 2 weeks prior to the initiation of the treatment dose.
Smartwatch-Based AI Model for OSA Prediction (SWOSA)

This study aims to develop an artificial intelligence (AI) model for more accurately diagnosing obstructive sleep apnea (OSA) by collecting blood oxygen saturation and other health information during sleep using a smartwatch.

OSA is common but often underdiagnosed, and the gold-standard diagnostic test, polysomnography, is costly and time-consuming. Smartwatches can provide a variety of health data, such as sleep patterns, blood oxygen saturation, and heart rate, which can help detect key symptoms and signs of OSA.

By developing an AI model that uses smartwatch data to screen for OSA, this study seeks to offer a cost-effective and accessible diagnostic method, ultimately contributing to the early detection and improved treatment rates of OSA.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 22 to 85 years who visited Seoul National University Hospital with suspected sleep apnea due to symptoms such as snoring, apnea, or excessive daytime sleepiness.

Exclusion Criteria:

* Patients previously diagnosed with sleep apnea who are currently undergoing treatment (e.g., positive airway pressure \[PAP\] therapy, mechanical ventilation, oral appliances, or surgery).
* Patients with neuromuscular diseases or a history of chronic opioid medication use.
* Patients with severe insomnia that is not controlled by medication.
* Patients receiving supplemental oxygen therapy due to underlying conditions such as heart failure, chronic obstructive pulmonary disease, interstitial lung disease, hypoventilation syndrome, or stroke, or whose baseline oxygen saturation is less than 90%.
* Patients with implanted cardiac pacemakers, defibrillators, or other electronic devices.
* Patients inexperienced in using smartphones, apps, or smartwatches.
* Pregnant women.
* Patients unable or unwilling to provide written informed consent.
Differentiation of Aseptic From Septic Loosening by 18F-fluoride PET

In this study, the investigators utilized the 18F-fluoride PET method to evaluate THA cases with a stable, septic or septic loosened implant in order to differentiate these clinical settings using a novel uptake type classification approach.


Eligibility Criteria:
Exclusion Criteria:

* Within one year after surgery
DNA Repair Capacity of Afamelanotide on Ultraviolet Radiation-induced DNA Damage in Healthy Volunteers

This mechanistic study's aim is to assess the DNA damage repair capabilities of afamelanotide in healthy volunteers with skin type I-III following exposure to ultraviolet radiation (UVR)-induced DNA damage.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female volunteers (aged 18-45) with Fitzpatrick skin types I, II or III.
* Written informed consent obtained from volunteers prior to study-start.

Exclusion Criteria:

* Female who is pregnant or lactating.
* Females of child-bearing potential not using adequate contraceptive measures or a lifestyle excluding pregnancy.
* Sexually active man with a partner of child-bearing potential who is not using adequate contraceptive measures.
* Any significant illness during the four weeks before the study screening period.
* Taking known photosensitisers.
Bioavailability of a Fixed Dose Combination Tablet With Empagliflozin (BI 10773) and Metformin Compared With the Monocomponents and Effect of Food on Bioavailability

The objective of the current study is to determine the relative bioavailability of a BI 10773 / metformin fixed dose combination tablet compared to single tablets of BI 10773 and metformin when administered together and to assess the effect of food on the bioavailability the fixed dose combination tablet


Eligibility Criteria:
Inclusion criteria:

1. Healthy males and females according to the following criteria
2. Body Mass Index 18.5 to 29.9 kg/m2 (incl.)

Exclusion criteria:

1. Any finding of the medical examination (including Blood Pressure, Pulse Rate and electrocardiogram) deviating from normal and of clinical relevance
2. Any evidence of a clinically relevant concomitant disease
Swept-Source Optical Coherence Tomography for Noninvasive Retinal Vascular Imaging

This is a clinical pilot study to assess the feasibility of using a swept-source optical coherence tomography (SSOCT) system to perform noninvasive imaging of the retinal vasculature in patients with existing microvascular disease.

This project is being conducted under an abbreviated IDE. Subjects with existing retinal microvascular disease will be recruited from among the patients of the Duke Eye Center and/or its associated satellite clinics. Following informed consent, subjects undergo imaging, per established standard operating procedure, at the Duke University Medical Center/Duke Center or at one of the Duke Eye Center satellite clinics. Pharmacologic dilation of eyes will not be necessary for completion of imaging and will not be used for the purposes of this study. The resulting images will not be used in the clinical care of any of the subjects recruited for this project.

Subjects will be identified from patients presenting for ophthalmologic consultation at the Duke Eye Center and/or its satellite clinic locations.

Eligibility Criteria:
Inclusion Criteria:

1. Capable and willing to provide consent
2. history of clinically-diagnosed retinal microvascular diseases, including but not limited to diabetic retinopathy, retinal vein occlusion, idiopathic macular telangiectasias, hypertensive retinopathy, and age-related macular degeneration
3. At least 18 years of age

Exclusion Criteria:

1. Unable or unwilling to give consent
2. Under 18 years of age
Sentinel Lymph Nodes Biopsy in Cervical Cancer

This study aims to compare sentinel lymph nodes biopsy versus comprehensive lymphadenectomy in patients with early stage cervical cancer who underwent radical hysterectomy.


Eligibility Criteria:
Inclusion Criteria:

Women aged 20 and above with clinical FIGO stage I-IIA cervical cancer

Exclusion Criteria:

Women did not receive surgical treatment
A Study Evaluating the Effect of Esomeprazole on SYN-004 Degradation of Ceftriaxone In Adults With an Ileostomy

A Phase 1b/2a, Multi-Center, Open-Label, 2-Period, Fixed-Sequence Study Evaluating the Effect of Esomeprazole on SYN-004 Degradation of Ceftriaxone In Healthy Adult Subjects with a Functioning Ileostomy

This is a Phase 1b/2a, randomized, multi-center, open-label study. Twenty otherwise healthy subjects with functioning ileostomies who are between the ages of 18 and 80 years, inclusive, will be enrolled. The entire duration of the study may be up to 63 days (from Screening to the end-of-study \[EOS\] visit).

Eligibility Criteria:
Inclusion Criteria:

* The subject has a functioning ileostomy that has been in place for ≥ 3 months.
* The subject is male or female between the ages of 18 and 80 years, inclusive.
* Other than a functioning ileostomy, the subject is free from clinically significant illnesses or disease.

Exclusion Criteria:

* Subjects who have active hepatic, small intestine, or biliary tract disease.
* Subjects who have active ulcerative colitis, Crohn's disease, other inflammatory bowel disease.
* Subjects with known malignancy requiring treatment \< 6 months prior to study screening.
* Subjects who have, in the opinion of the investigator, significant concurrent medical illness.
* Subjects who are currently taking concomitant medications which may interfere with study evaluation.
* Subjects who have received an investigational drug within 30 days or within a time period consistent with a washout period of 5 half-lives, whichever is longer, of the first dose of ceftriaxone.
* Subjects with a known history of allergy to any cephalosporin, penicillin or any β-lactam antibiotic.
* Subjects who have known active malabsorption syndromes(s) that, in the judgment of the investigator, could compromise the objectives of the study.
* Subjects who have used any oral, intramuscular, or IV anti-microbial medication during the last 3 week
A Study of Emibetuzumab in Non Small Cell Lung Cancer (NSCLC) Participants

The primary purpose of this study is to evaluate the efficacy of the study drug known as LY2875358, administered alone or in combination with a second drug named Erlotinib, in participants affected by a defined type of lung cancer (MET biomarker diagnostic positive Non-Small-Cell Lung Cancer) that experienced a disease progression during the most recent treatment with Erlotinib.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of metastatic Stage IV NSCLC
* At least 1 measurable extra-central nervous system (CNS) lesion
* Documented radiographic progression while on continuous treatment with erlotinib monotherapy
* Objective clinical benefit from erlotinib treatment as defined by either documented partial or complete response or stable disease ≥6 months or, if most recent erlotinib treatment has been initiated based on documented epidermal growth factor receptor mutation (EGFRmt) status, at least 12 weeks stable disease
* Determined to be MET diagnostic positive (+)
* Availability of a tumor sample post-erlotinib progression
* Eastern Cooperative Oncology Group (ECOG) performance status ≤2
* Have adequate organ function

Exclusion Criteria:

* Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or non-approved use of a drug or device
* Have previously been treated with LY2875358 or any other MET-targeting experimental therapeutic
* Have a serious concomitant systemic disorder or significant cardiac disease
* Have interstitial pneumonia or interstitial fibrosis of the lung or have pleural effusion, pericardial fluids or ascites, requiring drainage every other week or more frequently
* Have a history of another malignancy except for basal or squamous cell skin cancer and/or in situ carcinoma of the cervix, or other solid tumors treated curatively and without evidence of recurrence for at least 3 years prior to the study
* Have major surgery less than 2 weeks prior initiation of study treatment therapy
* Pregnant or lactating women
* Have symptomatic CNS metastasis
Health Related Quality of Life in Children With Food Allergy: Comparison to Controls and Other Chronic Diseases

The number of studies concerning health related quality of life (HRQL) in children with food allergy is very limited.

Only one study to date has compared HRQL of a group of children with food allergy to data published on general population and other chronic diseases. This study concluded to lowest HRQL scores in food allergic children compared to type 1 diabetes mellitus with important impact on scores concerning social activities.

Primary aim:

To compare generic HRQL score in children with food allergy with other chronic diseases and with healthy chidren in an homogeneous socio-cultural context.

Secondary aims :

* To compare generic and specific HRQL scores in children with food allergy
* Identifify in chidren with food allergy, clinical factrors assocated with lowest scores in order to improve our management.

Methods

Generic HRQL questionnaire (CHQ-87) will be distributed :

* after hospital consultation for patients
* in schools for healthy children A specific HRQL questionnaire (FAQLQ-CF or TF) and the " Food Allergy Independent Measure " will also distributed to chidren with food allergy.

Eligibility Criteria:
Inclusion Criteria:

* Age between 8-18 year old
* IgE mediated food allergy diagnosed by a pediatric allergologist with following criteria:

Convincing history of allergic reaction with positive prick-test and specific IgE Or Open food challenge associated with positive prick-test and specific IgE

* Signed informed consent of the two parents
* Signed informed consent of the child
* Health insurance recipient

Exclusion Criteria:

* Association with another medical or psychiatric chronic disease (excepted for controlled asthma)
* Partially or not controlled asthma during last year
* No signed consent
Reversal of Atrial Substrate to Prevent Atrial Fibrillation Pilot Study

This is a pilot study to assess feasibility to conduct a multi-center, randomized trial to examine the effect of aggressive risk factor control and arrhythmia trigger-based intervention on the atrial substrate, which is involved in the development and maintenance of atrial fibrillation (AF).

Atrial fibrillation (AF) is a major health problem, with a prevalence of 0.4-1% of the population. It is associated with a six-fold risk of stroke and a two-fold increase in mortality, the main cardiac reason for death one year after presenting to the emergency department with AF is heart failure. It results in high healthcare costs, recurrent ED visits and hospitalizations. The burden of disability associated with AF has been found to increase by 20% from 1990-2010. AF was also cited as one of the seven causes of death that has been increasing worldwide. Prevention of AF has not been a focus of past treatments and it is well known that elevated body mass index, hypertension, smoking, increased alcohol intake, lack of exercise and sleep apnea are risk factors for AF. There is a lack of randomized, multicenter data proving that a strategy of aggressive risk factor modification will prevent and modify AF.

Upstream therapy for AF has been of considerable interest, and benefit has been demonstrated in primary prevention of AF. Catheter ablation has demonstrated success over current medical therapies for long-term rhythm control, but recurrence remains high, irrespective of ablation strategy. This study is a feasibility study to determine whether a complex and multi-component risk factor modification can be successfully implemented.

Eligibility Criteria:
Inclusion Criteria:

* Patients with symptomatic (CCS-SAF ≥2) recurrent paroxysmal or persistent nonvalvular atrial fibrillation despite rate control, desiring catheter ablation AND
* one of : BMI\>27, BP\>140/90 or history of hypertension, alcohol use \> recommended limit, current smoking, diabetes with HgA1C\>7%, physical inactivity (\<150 minutes/week).

(Definitions: Recurrent paroxysmal - at least 4 episodes of symptomatic AF in the prior 6 months, with or without cardioversion; Persistent AF lasting greater than 7 days but less than 3 years; AF must be documented on a Holter, rhythm strip or electrocardiogram within the last 24 months.)

Exclusion Criteria:

* Permanent AF (AF lasting \> 3 years)
* Prior catheter ablation for AF
* Left ventricular ejection fraction \<30%
* Left atrial size \> 5.5 cm
* NYHA IV heart failure
* Participation in a cardiac rehabilitation program within the last year
* Currently performing exercise training 150 minutes/week of moderate to vigorous physical activity
* Unable to exercise
* Unable to give informed consent
* Other noncardiovascular medical condition making 1 year survival unlikely
Mothers' Breast Milk Expression Experiences, Infant Feeding Attitudes and Perceived Social Support Levels

Background: Expressing breast milk in cases where breastfeeding is interrupted is important for infants to be fed breast milk however, many factors can affect mothers' breastfeeding experience, such as feeding attitudes and the level of social support. The aim of this study is to determine the relationship mothers' breast milk expression experience between infant feeding attitudes and perceived social support level.

Methods: This cross-sectional study was carried out in the postpartum and lactation unit of a city hospital in Istanbul, between September-November 2022. The study included 455 women who were volunteering to participate in the research, 18 years of age or older, in the 0-6 months postpartum period, having a living baby, continuing to breastfeed, and expressing breast milk at least once after birth. Data were collected with Mother-Baby Introductory Information Form, Breast Milk Expression Experience Measure (BMEE), Iowa Infant Feeding Attitude Scale (IIFAS), and Multidimensional Scale of Perceived Social Support (MSPSS). The data were analyzed using the SPSS-21 statistical software package.

The main questions it aims to answer are:

* Which characteristics affect mothers' breast milk expression experiences, infant feeding attitudes, and perceived social support levels in the early postpartum period?
* Is there a relationship between mothers' experiences of breast milk expression and their infant feeding attitudes and social support levels in the early postpartum period?


Eligibility Criteria:
Inclusion Criteria:

* Volunteer to participate in the research
* 18 years of age or older
* In the 0-6 month postpartum period
* Must have a living baby
* Must continue breastfeeding
* Must express breast milk at least once after birth

Exclusion Criteria:

* Feeding the infant formula only
* Having hearing and/or speech impairments
A Single-Ascending-Dose Study of RO5469754 in Healthy Volunteers

This randomized, observer-blinded, placebo-controlled study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of RO5469754 in healthy volunteers. Subjects will be randomized in cohorts to receive single ascending intravenous or subcutaneous doses of RO5469754 or placebo. In-clinic period will be from Day -1 to Day 4, with a safety follow-up of 15 weeks after dosing.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female volunteers, 18 to 64 years of age, inclusive
* Body mass index (BMI) 18 to 32 kg/m2
* Women of child-bearing potential and their partners must be willing to use two highly effective forms of contraception, one of which must be a barrier method, for the entire duration of the study (through study discharge) or for up to five half-lives after the last dose
* Male subjects with female partners of child-bearing potential must be willing to use a condom during sexual activity for the duration of the study (through study discharge) or for up to five half-lives after the last dose

Exclusion Criteria:

* Pregnant or lactating women
* Positive test for drugs of abuse (including ethanol) as per local standards
* Willing to comply with a non-smoking policy during the in-clinic part of the study (Day -1 until discharge on Day 4)
* Positive for hepatitis B, hepatitis C or HIV infection
* History or presence of clinically significant disease or condition
* Participation in an investigational drug or device study within 60 days prior to dosing
* Current (or previous history of) exposure to therapeutic or investigational monoclonal antibody or chimeric biomolecule
* Any confirmed clinically significant previous allergic drug reaction, or history of anaphylaxis