cyrilzakka/clinical-trials huggingface dataset:
Impact of Hybrid-ESD+ and LiftUp® on the en Bloc/R0 Rate in Colorectal Adenomas Between 2 and 3 cm

This study examines whether the use of Hybrid-ESD+ with LiftUp (Injection solution) results in a higher en bloc and/or R0 rate for non pedunculated colorectal adenomas between 2 and 3 cm than described in the literature for conventional EMR.

There are several options for endoscopic polypectomy of polyps between 2-3 cm, all of which have their advantages and disadvantages and none of which has yet become the established standard procedure.

Conventional EMR has the disadvantage of more frequent residuals and/or recurrences due to lack of en bloc resection, while ESD has the disadvantage of being more complex and complications more likely.

A possible alternative is the use of hybrid ESD+ with LiftUp subcutaneous injection. The method with the LiftUp gel forming a stable gel cushion under the lesion, in combination with the circular circumcision of the mucosa at this site and the AWC for the current loop and the grasper, could achieve a better en bloc resection rate with a low complication rate than other procedures mentioned above.

The higher effectiveness in terms of recurrences and complications could subsequently result in a reduction of endoscopic or surgical re-interventions.

In this study, non-pedunculated colorectal polyps between 2 and 3cm in size are resected using ESD+ method and lift up as an injection solution.

Methodological and clinical parameters are recorded. After 4 weeks, the patients are contacted by telephone to record possible late effects.

If an endoscopic control is performed after 6 months (according to the guideline or according to the investigator), the findings are also recorded.

Eligibility Criteria:
Inclusion Criteria:

* Non-pedunculated lesion in the colorectum (epithelial lesion, 2-3 cm).
* Ablation medically indicated and possible (coagulation, etc. - as determined by the center)

Exclusion Criteria:

* Age \< 18 years
* Pedunculated lesion (Paris0-Ip)
* Size of the lesion \<2cm or \>3cm
* Pregnant and breastfeeding women
* Patient not capable of informed consent / consent not possible
* Bioptic evidence of a carcinoma / high probability of the presence of a carcinoma
* Non-lifting sign / known recurrence after previous therapy
* Impassable stenosis in the colon / rectum
* Patients with compelling need for therapeutic anticoagulation or dual antiplatelet therapy that cannot be discontinued for resection
* As per contraindications from the AWC \& LiftUp Instructions for Use:
* The AWC is not to be used if flexible-endoscopic procedures are contraindicated.
* The LiftUp gel should not be used when flexible endoscopic procedures are contraindicated, especially in combination with submucosal endoscopic resection (EMR) or endoscopic submucosal dissection (ESD) injectables.
* LiftUp gel should not be used in patients with known sensitivity to any of the ingredients.
Physical Activity in Persons With Charcot-Marie-Tooth: Developing a Measurement Instrument

The project will develop knowledge about physical activity in persons with Charcot-Marie-Tooth (CMT) in Norway. We plan to explore instruments to measure physical activity level for the target-group at the community level. We want to understand which type of activities, activity intensities and how persons with CMT perform habitual physical activity. Subsequently, a physical activity measurement instrument adapted to persons with CMT will be developed. This instrument can be used in a future intervention project to promote physical activity in this group.

Charcot-Marie-Tooth (CMT) is a condition that potentially affects daily life function including physical activity. Currently, there is no specific treatment. To prevent physical deconditioning, physical activity recommended. Furthermore, other studies have found the benefit of being physically active, including people with neuromuscular disorders (NMD). .

Apart from the physical activity in a rehabilitation center, physical activity also needs to be maintained at the community level in people's everyday life. To measure physical activity level in the community, we need an instrument that is designed for doing so. A questionnaire can be used to collect information about type of activity, activity duration and intensity. The instruments available so far to measure physical activity at the community level are not specifically adapted to persons with CMT. Therefore, this study will focus on revising the questionnaire based on the inputs from persons with CMT themselves. Furthermore, the revised questionnaire will be compared with the original one in addition to yet another instrument.

Eligibility Criteria:
Inclusion Criteria:

* Adults with a genetically confirmed CMT diagnosis.
* Residing in Norway
* Age between 18 to 65 years old.

Exclusion Criteria:

* Had major surgery within three months prior to the study period.
* Experiencing serious illness (e.g. bedridden, hospitalized).
Emotional Care Competency Scale for Dementia: Development and Correlations With Knowledge, Attitudes, and Confidence

This study aims to develop an "Emotional Care Competency Scale for Dementia" targeting long-term care professionals and to explore the relationship between caregivers' emotional care competency and their knowledge, attitudes, and confidence in dementia care.

A mixed-methods approach will be employed in two exploratory phases:

Phase One: Scale Development Participants: Purposeful sampling will recruit experienced long-term care professionals.

Method: Conduct qualitative interviews; analyze the collected data using content analysis to code and categorize information; draft the initial version of the Emotional Care Competency Scale for Dementia based on the results.

Phase Two: Scale Validation and Relationship Analysis Objective: Validate the reliability and validity of the scale and examine the relationship between professionals' emotional care competency and their knowledge, attitudes, and confidence in dementia care.

Design: Longitudinal descriptive correlational study. Participants: Convenience sampling to recruit participants for two rounds of questionnaire surveys.

This study seeks to provide a comprehensive tool for assessing emotional care competencies among dementia care professionals and to understand how these competencies relate to their knowledge, attitudes, and confidence in delivering care.


Eligibility Criteria:
Inclusion Criteria:

- Aged 18 years or older. Currently working in a setting that provides dementia care. Currently engaged in nursing or caregiving services in the long-term care sector.

Able to communicate in Mandarin or Taiwanese. No history of mental illness.

Exclusion Criteria:

- Under 18 years of age. Suffering from significant physical or psychological illnesses.
Comparison of ACTIVA BioACTIVE Versus Compomer in Restoring Dental Decay in Primary Molar Teeth

A clinical trial to evaluate a filling material (ACTIVA) and compare it to a traditional filling material (compomer) to restore decayed deciduous teeth in children

A tooth decay in deciduous teeth has to be restored with proper filling material. ACTIVA™ BioACTIVE is a new filling material which has the ability to release and recharge fluoride in the oral cavity which is important for preventing further tooth decay. In this study we will compare this new filling material with Compomer (the traditional control filling material) by restoring decayed deciduous molars with one of the mentioned filling materials.

Both filling materials have no reported adverse effect and used regularly in the dental practice.

The treatment procedure is performed in healthy children from both genders with decayed deciduous molars aged between 5 to 10 years by one operator in the dental chair under local anesthesia in the department of pediatric dentistry and special care, Ghent University hospital, Ghent, Belgium.

At least 35 teeth is needed to demonstrate an effect. Each material is placed randomly based on randomization done by the computer. Each participant will receive both types of treatments, one type on each side of the mouth.

The participants will come back each six months to check the success of each treatment group by two trained dentists other than the operator. and to check whether the control group performs similar, better or worse than the control group.

The duration of treatment procedure of both treatment groups is recorded and compared to check if one filling material takes less time than the other to placed in the oral cavity.

Eligibility Criteria:
Inclusion Criteria:

* Healthy children with American Society of Anesthesiologists (ASA) I score from both gender aged between three and ten years
* Vital decayed deciduous molar with proximal enamel/dentine caries
* At least one decayed tooth on each side of the mouth (split mouth)
* Pt is treatable in the dental chair
* Parents agreed to participate in the study and signed the informed consent

Exclusion Criteria:

* Patients with medical conditions or systemic disease
* Anxious or uncooperative patients who are not treatable in the dental chair
* Any symptoms like: pain, swelling, abscess or fistula.
* Extensive caries, dental developmental disturbance, pathological mobility, pulp exposure or indication for pulp therapy
* Patients with one decayed tooth in the whole mouth (not split mouth)
Sinusitis in Children and the Nasopharyngeal Microbiome

The purpose of this study is to investigate the relationship between viral infections of the upper respiratory tract, perturbations of the nasopharyngeal microbiome in children, and the risk of acute bacterial sinusitis over a one year period. The investigators will determine the incidence of acute bacterial sinusitis post viral upper respiratory infection and identify the viral antecedent infections and other risk factors which predispose to infection and ultimately design strategies to reduce the burden of disease and antimicrobial resistance.


Eligibility Criteria:
Inclusion Criteria:

* Children 4 to 7 years of age
* Healthy
* English-speaking parent/guardian -

Exclusion Criteria:

* Any underlying condition which would predispose them to the development of sinusitis including congenital or acquired immunodeficiencies
* Craniofacial abnormalities
* Cystic fibrosis
* Allergic rhinitis or a previous episode of chronic sinusitis.
Post Market Clinical Follow-Up Study Protocol for PROFEMUR® L Revision Femoral Stems

MicroPort Orthopedics (MPO) is conducting this PMCF study to evaluate the safety and efficacy of its THA and resurfacing components marketed in the EU. These types of studies are required by regulatory authorities for all THA and resurfacing devices that do not have medium to long-term clinical evidence available at the time of gaining approval to market in the EU. This study has been designed in accordance with MEDDEV 2.12/2 rev 2.


Eligibility Criteria:
Inclusion Criteria:

* Has undergone revision total hip arthroplasty
* Subject is implanted with the specified combination of components
* Subject is willing and able to complete required study visits or assessments

Exclusion Criteria:

* Subjects currently enrolled in another clinical study
* Subjects unwilling to sign the Informed Consent document
* Subjects with substance abuse issues
* Subjects who are incarcerated or have pending incarceration
Frequence of Dressing Change and Bacterial Colonization in Pediatric Intensive Care Unit

This study is non-inferiority trial design.The relationship between whether dressing change 24hrs after CVC (central venous catheter) catheterization and bacterial colonization of the skin.

Central venous catheter (CVC) was punctured directly through jugular vein, subclavian vein and femoral vein, and its tip is located in superior vena cava or inferior vena cava. CVC is widely used in ICU because of its kinds of advantages. However, CVC, as an invasive puncture method, may bring more complications. The incidence of central line associated bloodstream infection (CLABSI) was 1.33-31.6/1000 catheterization day , and the death rate due to CVC associated bloodstream infection is 3-5% . Therefore, various organizations have formulated guidelines for the prevention of CLABSI and best evidence summary . From October 2019 to April 2020, taking the children's hospital of Fudan University as the leading unit, PICU of children's Hospital Affiliated to Zhejiang University, Anhui children's Hospital, Xiamen children's Hospital, Shenzhen Children's Hospital and Guangzhou Women's and Children's medical center as the cooperation units, carried out children's central venous catheterization Multi center research on best practices of management and maintenance. It was found that changing dressings 24 hours after catheterization may increase the incidence of MARSI, and repeatedly exposing dressings may also increase the incidence of CLABSI. The research team returned to the original evidence and consulted the guidelines. It was found that: under the premise of achieving the maximum aseptic catheterization, the guidelines issued by various institutions did not mention that the application should be replaced 24 hours after catheterization; however, the evidence was mentioned in the evidence summary, but there was no support from the relevant original literature. Therefore, it is worth discussing whether children need to change dressings 24 hours after catheterization. This study is non-inferiority trial design.

Eligibility Criteria:
Inclusion Criteria:

* CVC catheter was placed in the research site (including the operating room and PICU);
* only one CVC catheter was placed during the research time

Exclusion Criteria:

* catheter was inserted from another hospital and in emergency;
* the tip of CVC catheter was not in the upper and lower vena cava;
* children had history of CLABSI before the study
Effect of Conditioning on Myocardial Damage in STEMI

The LIPSIA-Conditioning trial is an investigater initiated, randomized, single-center study that will assess the effect of different intrahospital conditioning protocols on myocardial damage assessed by MRI in patients with acute ST-elevation myocardial infarction.

The following groups will be compared:

1. Combined intrahospital pre- plus postconditioning versus
2. Postconditioning versus
3. Control

Rapid reperfusion of the infarct-related coronary artery is essential to salvage ischemic myocardium in patients with acute ST-elevation myocardial infarction (STEMI). Paradoxically, restoration of the blood flow to the ischemic area may result in further injury to the myocardium.

This phenomenon is described as 'ischemia/reperfusion injury' and the pathophysiological mechanisms are not fully elucidated. A cardioprotective effect of ischemic preconditioning as well for postconditioning (short repetitive cycles of reperfusion and re-occlusion) has been demonstrated in experimental studies and in pilot studies on patients with acute STEMI treated with primary percutaneous coronary intervention.

Aim of this study is to compare for the first time the combination of intrahospital pre- and postconditioning versus exclusive postconditioning versus control. The primary endpoint of this study will be the salvaged area at risk assessed by cardiac magnetic resonance imaging.

Eligibility Criteria:
Inclusion Criteria:

ST-elevation myocardial infarction \<12 hours

Exclusion Criteria:

* Age ≤ 18 years
* Patients presenting with pregnancy
* Thrombolysis \<12 hours
* Patients without informed consent
* Participation in another trial.
Evaluation of Sleep Pattern and Mood Profile in Hypertensive Patients

Introduction: Sleep disturbances may contribute to impairments in mood, occupational and intellectual performance, and social relationships, as well as being associated with cardiovascular diseases, such as arterial hypertension. Sedentary lifestyle has often been associated with poor sleep quality and hypertension; regular exercise has been studied as a coadjuvant therapy for hypertension and/or for some sleep disorders. Objective: To compare sleep pattern of active and inactive patients with arterial hypertension, as well as to evaluate complaints of depression and anxiety, and the mood profile. Material and Methods: Polysomnography, Pittsburgh Sleep Quality Index and Epworth Sleepiness Scale will be used to assess the sleep pattern. Depression will be assessed by the Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI) anxiety, and mood pattern by the State of Mood Profile (POMS). The level of physical activity will be recorded by the number of steps taken (pedometer). Participating in the study will be 60 hypertension patients (ACTIVE, n=30; INACTIVE, n=30). Hypothesis: Active hypertensive patients better quality of sleep, better mood profile, and fewer complaints of depression and anxiety when compared to physically inactive hypertensive patients.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of systemic arterial hypertension, according to the VII Brazilian Guidelines for Hypertension;
* male;
* BMI \<30;
* Age between 30 and 60 years;
* Minimum level of education: elementary school

Exclusion Criteria:

* Present pathologies in the musculoskeletal and neurological systems, or incapacitating complaints in these systems;
* Diagnosis of psychiatric disorder;
* Being under medical treatment for insomnia or other psychiatric treatment.
The Prolonged Effect of Consumption of a Partially Hydrolyzed Infant Formula During the First 6 Months of Life on the Development of Allergic Manifestations At 5 Years of Age

The present study is a 5-year follow-up of the Allergy Reduction Trial (A.R.T.) birth cohort study of 551 infants at high-risk for allergy. The A.R.T. 5-year follow-up study, aims to investigate the prolonged effect of each feeding regimen \[formula-fed (exclusively or partially) with the partially hydrolyzed formula (pHF) or the standard formula (SF), or exclusively breastfed\] within the first 6 months of life on the development of any allergic manifestations up to the age of 5 years. Allergic manifestations within this time period will include the presence of any of the following: atopic dermatitis, food allergies, respiratory allergies, urticaria, drug allergy and insect venom allergy. In addition, differences on growth (weight, height, BMI) will be examined.

The present study is a 5-year follow-up of the Allergy Reduction Trial (A.R.T.) birth cohort study of 551 infants at high-risk for allergy. The A.R.T. 5-year follow-up study, aims to investigate the prolonged effect of each feeding regimen \[formula-fed (exclusively or partially) with the partially hydrolyzed formula (pHF) or the standard formula (SF), or exclusively breastfed\] within the first 6 months of life on the development of any allergic manifestations up to the age of 5 years. Allergic manifestations within this time period will include the presence of any of the following: atopic dermatitis, food allergies, respiratory allergies, urticaria, drug allergy and insect venom allergy. In addition, differences on growth (weight, height, BMI) will be examined.

Eligibility Criteria:
Inclusion Criteria:

* Children who were part of the Intention-to-Treat population of the A.R.T. study
* Children of the A.R.T. study ITT population within the age range of 5 years up to 5 years and 3 months
* Children of the A.R.T. study ITT population in whom at least one parent and/or legal guardian signed the written consent form

Exclusion Criteria:

* Children who did not participate in the A.R.T. study or who were not assigned to any of the 3 study arms
* Children of the A.R.T. study who are younger than 5 years of age or older than 5 years and 3 months of age
* Children of the A.R.T. study in whom parents and/or guardians do not agree to provide a written consent form
To Learn How Different Forms of Study Medicine Are Taken up Into the Blood and the Effect of Food on Study Medicine in Healthy Adults

The purpose of this study is to learn about the study medicine CTB-AVP for the treatment of severe urinary tract infections that require hospitalization.

This study is seeking for:

* adult male and female participants who are healthy and weigh more than 50 kg.
* participants who have normal blood pressure, normal kidney and liver function
* participants willing to stay away from caffeine and other medicines for the duration of the study.

Participants will be required to stay in the study clinic for two weeks. All participants in this study will receive study medicine CTB-AVP by mouth one time each day on four different days. Study medicine will be given in capsules or tablets, on an empty stomach or will be taken with a meal. The study will look at the experiences of people receiving the study medicine. This will help determine if the study medicine is safe and effective.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female participants aged 18 years or older at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs and standard 12-lead electrocardiogram (ECGs), and with eGFR ≥75 mL/min (estimated using the 2021 CKD-EPI equation).
2. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
3. Have a body-mass index (BMI) of 16 to 32 kg/m2; and a total body weight \>50 kg (110 lb).
4. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent document (ICD) and in this protocol.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease; including any condition affecting oral absorption or known allergy to cephalosporin group of antibiotics
* Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention or current use of any prohibited concomitant medications.
* Screening supine Blood Pressure (BP) ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic) for participants \<60 years; and ≥150/90 mm Hg for participants ≥60 years old, following at least 5 minutes of supine rest
* Participants with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study-specific laboratory and confirmed by a single repeat test, if deemed necessary: alanine aminotransferase (ALT), aspartate aminotransferase (AST), Bilirubin ≥1.5 x Upper Limit of Normal (ULN). Participants with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is ≤ ULN.