cyrilzakka/clinical-trials huggingface dataset:
Endoscopic Sub-mucosal Dissection With the Nestis® Jet Injector System With a Bi-functional Catheter: First Prospective Trial

ESD (Endoscopic Sub-mucosal Dissection)is the first-intent method to treat superficial neoplasms of the digestive tract at it allows an en-bloc R0 resection. Following marking of the lesion margins, ESD comprises 3 steps: 1) liquid injection into the sub-mucosal space 2) circumferential (complete or partial) incision and 3) dissection of the submucosa. Several tools are necessary to perform ESD with the standard technique. Development of water jet with bi functional (injection and cutting) catheter allows time and significant reduction of perforation risk (due to multiple changes of instruments). For this purpose, Nestis introduced the Enki 2 pulsed jet technology with high pressure system to inject efficiently and at any time viscous solutions in direct viewing and retroflexion. Preliminary pig studies indicate that injection of glycerol, hyaluronate and hydroxyethlstarch with Enki 2 are possible. In addition, preclinical studies on living pig colon models using saline solutions have demonstrated that perforation rates and operating times are significantly reduced compared to a standard electrosurgical knife. The present clinical study is being performed to confirm this system capability to perform ESD in humans.


Eligibility Criteria:
Inclusion Criteria:

* in the esophagus: squamous cell carcinoma (well differentiated G1) or high grade dysplasia or neoplasia on barrett esophagus with high grade dysplasia or adenocarcinoma confirmed by two different pathologists, with only superficial tissue (mucosal invasion (T1m) and no lymph nodes on EUS endoscopy radial and mini probe), larger than 15 mm of diameter, with an extension of less than 10 cm high and less than two thirds of the esophageal circumference
* in the stomach: superficial adenocarcinoma or high grade dysplasia (well differentiated G1) with no depth invasion of the sub mucosa in EUS endoscopy and no lymph nodes according to the recommendations of the Japanese gastric cancer association, and with a diameter of more than 15 mm
* in the colon and the rectum: sessile serrated adenomas, adenomas or superficial adenocarcinoma (well differentiated G1), larger than 15 mm, corresponding to non granular Lateral spreading tumor (NG-LST) or granular (G-LST) with a focal Kudo V zone in the lesion, with a circumferential extension of less than two thirds and with only a superficial extension (no sub mucosal invasion and no lymph nodes in EUS endoscopy of the rectum).
* Consent form signed
* Anesthesiology risk limited with ASA score 1 or 2
* Patients over 18 years old
* Affiliation to social safety system

Exclusion Criteria:

* other lesions of the digestive tract
* high anesthetic risk (ASA score \> 2)
* previous treatment of the lesion (radiotherapy, endoscopy, surgery, chemotherapy...)
* other malignant disease locally advanced or with metastasis
* hemostasis disorders
* pregnancy or breast feeding
* participation in another clinical trial
The Changes of Patterns of Microarray in Patients With Obstructive Sleep Apnea

The aim of this study are (1) To genome-wide profile the gene expression patterns of peripheral blood mononuclear cell (PBMC) in patients with obstructive sleep apnea (OSA) (2) To profile the gene expression patterns change before and after treatment with continuous positive airway pressure (CPAP) (3) To correlate the altered gene expression with the severity of the disease and outcome of OSA patients

Obstructive sleep apnea syndrome (OSAS) is characterized with recurrent collapse of upper airway during sleep and resulted in hypoxia and sleep fragmentation. Several systemic and cardiovascular complications have been attributed to OSAS, which is caused by hypoxia and bursts of sympathetic activity. Increase of inflammatory mediators, which included C-reactive protein, oxidative stress, adhesion molecules, vascular endothelial growth factor and proinflammatory cytokines, were thought to involve in the developments of cardiovascular diseases in patients with OSAS. In our preliminary study, both serum levels of IL-6 and CRP were higher in patients with OSAS than control subjects, and the levels were inversely correlated with the lowest pulse oxygen saturation. Factors triggering inflammatory cascades in OSAS included hypoxia and sympathetic hyperactivity.

Hypoxia was thought to be the trigger factor for the elevated production of inflammatory mediators. Through the induction of transcriptional factors and critical signaling pathways, hypoxia induces several physiologic responses, like increased anaerobic metabolism, angiogenesis, vasodilation, erythropoiesis and increased breathing.

Microarray is the more mature gene analysis techniques so far, which can allow high throughput analysis of the function of many genes. Microarray can be used to understand the disease mechanisms and is also very useful to improve disease diagnosis, disease classification, prognosis evaluation and to improve treatment outcome. In this project, we use oligo microarray to genome-wide profile the altered gene expressions in peripheral blood mononuclear cells of OSAS patients; and to correlate the dysregulations of gene expression with the clinical outcome. We will also examine the gene expression patterns change before and after treatment with CPAP. The information obtained by this approach will be very useful to understand the pathogenic mechanism of OSAS that leads to the systemic and cardiovascular complications. Further therapeutic intervention may therefore be possible.

Eligibility Criteria:
Inclusion Criteria:

* healthy control with age \> 18 y/o severe OSA (AHI\>=30/hr) with age\>18 y/o

Exclusion Criteria:

* chronic lung disease female refuse to receive CPAP treatment or poor compliant to CPAP neurologic event
The Effect of Fathers' Birth Experience on Paternal Attachment and Parenting Perception: Randomized Controlled Trial

In recent years, fathers have become increasingly involved in research, but research on fathers still lags behind research on mothers. During the transition to parenthood, a complex network of relationships emerges between father, mother and baby. During the process of becoming parents, mothers and fathers begin to bond with their unborn children. The prenatal period is hypothesized to be predictive of later postnatal attachment and perception of parenting. Paternal involvement at birth is associated with positive child health outcomes and parental well-being.


Eligibility Criteria:
Inclusion Criteria:

* Spouses of primiparous pregnant women who had spontaneous pregnancies and were admitted to the delivery room for normal labor were included in the study.

Exclusion Criteria:

* women without husbands
Safety and Efficacy of Autologous PRP and PPP Eye Drops in the Treatment of Ocular GVHD

The purpose of this study is to evaluate the safety and efficacy of autologous Platelet Rich Plasma (PRP) and Platelet Poor Plasma (PPP) eye drops four times a day in the treatment of ocular graft versus host disease (O-GVHD). In addition to their current medication (except autologous serum drops), patients will receive PRP and PPP drops.

Ocular involvement can be quite symptomatic in patients with chronic graft-versus-host disease (GVHD). The impact of ocular GVHD on quality of life (QOL) in patients with chronic GVHD has been studied in a prospective, multicenter, longitudinal, observational study and showed that ocular GVHD affects 57% of patients within 2 years of chronic GVHD diagnosis. Strong evidence suggested that ocular GVHD is associated with worse overall health-related QOL. Significant worsening of vision-related QOL in ocular GVHD has been reported. Ocular GVHD is devastating and there is no effective treatment available so far. The importance of this study is that for the first time in the nation, our institute will evaluate the safety and efficacy of topical autologous blood product (PRP and PPP) to treat ocular surface disease associated with ocular GVHD.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years.
* Willing and able to provide written informed consent.
* Willing and able to comply with study assessments for the full duration of the study.
* Diagnosis of ocular GVHD.
* Minimum corneal fluorescein staining of 4 (NEI grading scheme, 0-15) in at least one eye.
* In good stable overall health.

Exclusion Criteria:

* Remission from primary cancer in more than 5 years.
* History of thrombocytopenia (platelet\<50,000) in the last 2 weeks before study entry.
* Ocular or periocular malignancy.
* Significant change, as judged by the PI, in systemic immunosuppressive regimen before 2 weeks of study entry.
* Any change in dosage of tetracycline compounds (tetracycline, doxycycline, and minocycline) within the last month.
* Any change in frequency of preserved anti-glaucoma medications before 2 weeks of study entry.
* Current use of topical steroids more than twice a day.
* Change in frequency of topical cyclosporine and/or topical kineret within the last month.
* Signs of current infection, including fever and current treatment with antibiotics.
* Intra-ocular surgery or ocular laser surgery within the last 3 months.
* Has worn contact lenses, except for bandage contact lens or rigid gas permeable lens or scleral contact lens, for the last 2 weeks prior to the study or would be unable to stay off contact lenses for the study duration.
* Any condition (including language barrier) that precludes patient's ability to comply with study requirements including completion of study.
Study on Two Different Formulations of 6-mercaptopurine. Tablet Versus Oral Liquid

Acute lymphoblastic leukemia (ALL) accounts for 30 % of all childhood malignancies. The patients undergo four phases of treatment, finishing with a late maintenance phase in which 6-mercaptopurine and Methotrexate are essential components. Insufficient treatment intensity in this phase is associated with increased risk of relapse. Excessive variation in the bioavailability of 6-mercaptopurine has been observed which can cause both risks of undertreatment/relapse as well as overtreatment with severe side effects.

In the attempt to achieve individualized 6-mercaptopurine dosing different approaches have been pursued. Nonetheless variation in bioavailability remains a problem.

Earlier, oral tablets of 50 mg (Purinethol) were the only administration form of 6-mercaptopurine and it was primarily designed for adult patients. Challenges with accurate dosing and getting the children to swallow the tablets have been a widespread problem, forcing the caregivers to divide or crush the tablets as well as having to administer different dosages over 2-3 days. Due to these problems, an oral liquid formulation of 6-mercaptopurine (Xaluprine) has been developed. However this oral liquid has only been tested on healthy adult volunteers, and not on the target group, childhood patients. This project will assess the bioavailability and plasma kinetics of oral liquid and tablet formulation of 6-mercaptopurine in children with acute lymphoblastic leukemia.

The investigators hypothesize to observe comparable plasma kinetics, in children with acute lymphoblastic leukemia when treated with 6-mercaptopurine in the form of a tablet and oral liquid formulation, as previously observed in healthy adults.


Eligibility Criteria:
Inclusion Criteria:

* Childhood acute lymphoblastic leukemia patients, age 0-18 years at diagnosis, treated at the department of pediatrics and adolescent medicine, Rigshospitalet.
* Informed consent

Exclusion Criteria:

* None
Screening Tool for Malnutrition, Sarcopenia, and Cachexia

There is an accumulating evidence of the overlap and frequent co-occurrence of twasting conditions in older adults. Those conditions include malnutrition, sarcopenia, and cachexia, Therefore , a tool capable of simultaneously screening for all three conditions is imperative. In this study, we developed and validated a new tool for the simultaneous screening of muscle wasting diseases in older adults. The diagnostic accuracy of the new tool was compared to other validated screening tools including the Mini Nutritional Assessment-Short Form (MNA-SF), the Short Nutritional Assessment Questionnaire (SNAQ), and the Simple Questionnaire to Rapidly Diagnose Sarcopenia (SARC-F).


Eligibility Criteria:
Inclusion Criteria:

* Participants Aged 65 years and older, who agree to participate

Exclusion Criteria:

* Patients with critical illness.
* Patients with severe cognitive, hearing or visual impairment hindering proper communication
* Patients with physical disability that interfere with physical performance assessment or hand grip measurement
* Patient with any contraindication of to the use of BIA) e.g. presence of a pacemaker, other implanted electrical devices, or metal implants, volume overload
Amyloid Imaging And Safety Study Of ACC-001 In Subjects With Early Alzheimer's Disease

This study in individuals with early Alzheimer's disease is designed to assess:(1) safety and tolerability (2) the capacity of ACC-001 and QS-21 adjuvant to reduce brain amyloid load as measured by positron emission tomography (PET) scans.


Eligibility Criteria:
Inclusion Criteria:

* Concern about a change in cognition expressed by the subject or by an informant that knows the subject well
* Mini-Mental State Examination (MMSE) score ≥ 25
* Global Clinical Dementia Rating = 0.5.
* General cognition and functional performance sufficiently preserved such that a diagnosis of Alzheimer's dementia cannot not be made by the site physician at the time of screening.
* Amyloid burden detected on screening brain PET scan.
* Other inclusion criteria apply.

Exclusion Criteria:

* Significant neurological disease other than early Alzheimer's disease
* Major psychiatric disorder or symptom
* Contraindication to undergo brain MRI
* Unstable medical conditions
* Other exclusion criteria apply
Study on the Measurement of Retinal Blood Flow in Children

In order to provide reference for clinical application, the normal values of retinal blood flow parameters in Chinese healthy children were measured by oct-angiography. Meanwhile, the repeatability and consistency of retinal blood flow parameters measured by oct-angiography in children were further analyzed, and the correlation of retinal blood flow parameters with eye axis, choroidal thickness, age and diopter was analyzed, so as to provide basis for clinical diagnosis of children's ophthalmopathy. Objective to study the effect of short-term optical defocusing on retinal blood flow parameters, and analyze the correlation between the changes of posterior segment parameters before and after short-term optical defocusing, so as to provide the basis for the possible compensation mechanism of posterior segment optical defocusing, and further understand the possible physiological mechanism of myopia.


Eligibility Criteria:
Inclusion Criteria:

1. The subjects should be 6-18 years old, with parents' consent and be able to abide by the experimental rules;
2. uncorrected visual acuity or spectacle corrected visual acuity ≥ 1.0, and each eye can fix the target;
3. equivalent spherical lens range + 0.50D \~ - 6.00D, binocular spherical lens anisometropia ≤ 1D, anisometropia ≤ 1.5D;
4. frame glasses can be worn for patients with ametropia, and hard contact lenses can not be worn for at least 4 weeks, and anisometropia can not be worn for 2 weeks
5. intraocular pressure in the normal range (9mmhg-21mmhg)

Exclusion Criteria:

1. Patients with history of ocular trauma and surgery;
2. patients with ocular organic lesions or systemic diseases;
3. patients with dry eye;
4. patients in the treatment period using drugs (such as atropine eye drops);
5. patients with poor cooperation or unqualified image quality
DenHeart - Self-reported Health and Quality of Life at Hospital Discharge From a Heart Centre in Denmark

The objective of this study is to describe: 1) Differences in perceived health at hospital discharge between diagnostic groups and in-hospital predicting factors. 2) Perceived health at hospital discharge as a predictor of morbidity and mortality after 1 and 3 years. 3) The association between perceived health, sick leave and health care utilization.

The five heart centres in Denmark diagnose and treat about 50.000 patients with different diagnoses every year and offer both invasive and non-invasive treatment.

Perceived health status is measured by self-reported health, quality of life, anxiety and depression and symptoms. Knowledge about perceived health status can help to guide inpatient practise and outpatient follow-up. Furthermore, it can be used to evaluate differences between diagnostic groups, regional differences and predicting factors for perceived health status at hospital discharge and long term morbidity and mortality. Also economic analysis of healthcare utilisation and work ability status are possible.

Five Danish heart centres (Rigshospitalet, Gentofte Hospital, Odense University Hospital, Aarhus University Hospital and Aalborg University Hospital) are all including patients from April 2013 to April 2014. All patients discharged or transferred from one of the heart centres are potential participants in the study. Patients are unselected and consecutively included at hospital discharge. Included patients will be asked to complete and return a questionnaire before they leave the hospital.

The following questionnaires will be used to measure the perceived health status of the patients at hospital discharge: SF-12, Hospital Anxiety and Depression Scale, EQ-5D, Brief Illness Perception Questionnaire, HeartQoL and Edmonton Symptom Assessment Scale. Furthermore 14 ancillary about health and health behaviour are included in the questionnaire. This amounts to a total of 62 items in the questionnaire.

The DenHeart study data collection, database development and reporting of primary outcomes are funded by the five participating heart centres in Denmark. Further funding for registry data, analyses and reporting will be applied for in external funds.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized at one of the five heart centres
* Able to fill out the questionnaire

Exclusion Criteria:

* \<18 years
* No Danish CPR number
* For ethical reasons unconscious patients are also excluded.
CAUDAL EPIDURAL BLOCK in PEDIATRIC SURGERY CASES

Caudal epidural anesthesia was reported as the first epidural anesthesia technique in 1933, but its use began to become widespread after the 1960s (1). The procedure is reliable, easy to perform, the incidence of complications is low, and the total complication rate is 1.5/1000; Serious complications occur at a rate of 1/40000. There are many methods to demonstrate the success of caudal epidural block. Some of the common traditional methods are changes in mean arterial pressure and heart rate. These methods are sometimes not objective and take time. In this study, we will examine the block success in pediatric patients who underwent caudal epidural block, which is applied in our hospital, whether the Galvanic skin response measured with a finger probe, other than traditional methods, correlates with the block success, and whether it shows faster block success compared to other traditional methods.

A successful caudal epidural block can provide safe, effective regional anesthesia. (4). The overall failure rate of caudal epidural block in pediatric patients is approximately 4%, depending on the anatomical and developmental abnormalities of the caudal canal (5,6). Therefore, reliable and rapid evaluation of a successful caudal epidural block is important to optimize anesthesia management in pediatric patients. Evaluating the success of caudal epidural block with traditional methods such as mean arterial pressure (MAP) and heart rate (HR) does not give completely objective results and takes time. Galvanic Skin Response (GSR) is a parameter that shows sweat gland function related to the autonomic nervous system. Physically, the galvanic skin response is the change in the electrical structure of the skin in response to various stimuli (7).Changes in tension measured from the skin surface are recorded. The relaxation and calming response accompanies an increase in skin resistance, while the fight response accompanies a decrease in skin resistance. In general, low conductivity is a sign of relaxation. High conductivity is a sign of emotional, mental or physical arousal (8). Galvanic Skin Response (GSR) evaluation is a non-invasive measurement that allows us to observe skin resistance changes with two probes attached to the fingertip. The aim of this study is to evaluate whether using Galvanic skin response (GSR) values measured with a finger probe will detect the success of caudal epidural block more quickly than other traditional methods in pediatric patients who underwent surgery with caudal epidural block.

Eligibility Criteria:
Inclusion Criteria:

* lower abdominal/urogenital/lower extremity surgery
* Patients with ASA1-2

Exclusion Criteria:

* Those with neuromuscular disease
* PATIENTS WITH ASA3-4
* patients with cerebral palsy
* patients in mental reter
A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) in Participants With Familial Chylomicronemia Syndrome (FCS)

The purpose of this study is to evaluate the effect of olezarsen (formerly known as AKCEA-APOCIII-LRx) on the percent change in fasting triglycerides (TG) from baseline.

This is a multi-center, open-label extension (OLE) study of up to 60 participants with FCS rolling-over from Study ISIS 678354-CS3 (NCT04568434). Participants will receive olezarsen during a 157-week treatment period, followed by a 13-week post-treatment follow-up period. The length of participation in this study is approximately 201 weeks, which includes an up to 31-day qualification period, a 157-week treatment period, and a 13-week post-treatment evaluation period.

Treatment has been extended to obtain additional safety assessments and efficacy data and to provide patients with continued access to ISIS 678354 until the drug may be available commercially.

Eligibility Criteria:
Inclusion Criteria:

• Satisfactory completion of treatment with olezarsen in the index study (ISIS 678354-CS3, last dose as scheduled at Week 49) with an acceptable safety profile, per Investigator judgement.

Exclusion Criteria:

• Have any new condition or worsening of existing condition which in the opinion of the Investigator would make the participant unsuitable for enrollment, or could interfere with the patient participating in or completing the study, including need for treatment with medications disallowed in the index study (ISIS 678354-CS3).