cyrilzakka/clinical-trials huggingface dataset:
Serum Vasohibin, Cardiotrophin, Endocan & Perinatal Outcomes

Investigation of the relationship between maternal serum vasohibin-1, vasohibin-2, cardiotrophin -1 and endocan concentrations at the 11th and 14th weeks of gestation and adverse perinatal outcomes.

Previous animal model studies in the literature have shown that vasohibin-1 released in endothelial cells inhibits angiogenesis, while vasohibin-2 stimulates angiogenesis. Additionally, immunohistochemical studies have shown that vasohibin-2 plays a role in the cellular fusion of trophoblasts in the placenta to form syncytiotrophoblasts.

Studies in the literature have shown that cardiotrophin-1 is expressed in cardiac myocytes and vascular endothelial cells and stimulates the synthesis and secretion of endothelin-1 in endothelial cells through the gp130 signaling pathway. Since endothelin 1 plays an important role in the regulation of vascular tone, cardiotrophin-1 can be considered to act as an endothelium-derived biological factor, possibly involved in the regulation of vascular tone under normal physiological conditions or secondary to pathological processes.

Studies in the literature have shown that maternal serum endocan levels are higher in pregnant women whose pregnancies were complicated by preeclampsia than in normotensive pregnant women, and that the endocan molecule may be effective in the etiopathogenesis of preeclampsia, especially if it develops early.

In the light of this above-mentioned information, we aim to investigate whether serum vasohibin-1, vasohibin-2, cardiotrophin-1 and endocan concentrations measured during the 11th to 14th weeks of pregnancy can be used to predict preeclampsia, gestational hypertension, fetal growth restriction, preterm birth and gestational diabetes mellitus.

Eligibility Criteria:
Inclusion Criteria:

* Those who had the first-trimester screening test between 11 and 14 weeks of pregnancy and are in the low-risk group
* Those with singleton pregnancy
* Those who did not conceive pregnancy with assisted reproductive treatment methods
* Those who do not have any pregestational diseases
* Those who do not have any uterine anomalies

Exclusion Criteria:

* Smokers
* Those who are in the high-risk group with the first trimester screening test
* Those with multiple pregnancies
* Those who conceive with assisted reproductive treatment methods
* Those who had any disease before pregnancy
* Those who have any uterine anomalies
Outcome After Lumbar Epidural Steroid Injection

prospectively validate a fibronectin-aggrecan complex as a biomarker for response to ESI for radiculopathy with HNP

We will measure levels of the protein complex in the epidural space of patients undergoing lumbar ESI for radiculopathy with HNP. We assess functional outcomes at baseline and after treatment with the Medical Outcomes Study Short Form-36 instrument (SF-36). Our hypothesis was that the complex is present in patients with clinically significant functional improvement after ESI.

Eligibility Criteria:
Inclusion Criteria:

* Acute onset of sensory symptoms with the primary complaint as pain as well as varying sensory symptoms (e.g. tingling, numbness) in one or more lumbar nerve root distributions
* Positive physical exam findings including sensory findings consistent with a spinal nerve root, a positive straight leg raise test, and/or a diminished patellar or Achilles DTR consistent with sensory symptoms; AND
* MRI of lumbar spine positive for HNP in a distribution correlating with physical examination

Exclusion Criteria:

* Plain radiography demonstrating severe loss of disc height, high grade DDD, spondylolisthesis greater than grade I
* A history of prior lumbar surgery or trauma, weakness in a consistent distribution (non-progressive with strength at least 4/5)
* Red flags including progressive weakness, bowel/bladder complaints, radiographic unknown mass, unexpected weight loss; AND
* Diagnosis of inflammatory arthritides, crystalline arthropathies, or other rheumatologic diseases
Developmental Outcomes

Determine whether the concentrations of UCH-L1 and GFAP measured in umbilical cord blood and in blood 0-6 hours postnatal accurately predict the extent of neurodevelopmental deficits and/or death at 18-20 months.

Children born with Hypoxic Ischemic Encephalopathy (HIE) and already enrolled in IRB #504-2011 will be seen for a developmental follow-up at 18-20 months of age. The developmental assessment tool that will be used is called the Bayley Scales of Infant and Toddler Development: 3rd Edition (Bayley-III) Screening Test. The results of this test will then be compared to the child's HIE biomarkers concentrations already obtained at birth.

Eligibility Criteria:
Inclusion Criteria:

* children already enrolled in IRB#504-2011
* 18-20 months of age

Exclusion Criteria:

* none
Ultra-brief Online Mindfulness-based Intervention During COVID-19 Movement Control Order

The federal government of Malaysia implemented a nationwide Movement Control Order (MCO) to control the COVID-19 outbreak. The MCO, however, has been found to have a negative impact on people's mental wellbeing. Interventions that can improve mental health under restricted movement condition is urgently. The present study investigated the impact of a brief, online mindfulness-based intervention on mental health using two-arm randomized controlled trial design. A total of 161 participants self-reported their feeling, anxiety, psychological insecurity, and well-being at baseline (T1) and post-test (T2), while 61 of them answered the same set of measures and the fear of COVID-19 scale in a follow-up study two weeks later (T3).


Eligibility Criteria:
Inclusion Criteria:

* People residing in Malaysia during the Movement Control Order.

Exclusion Criteria:

* People who are unable to read or write in either Malay, English or Mandarin languages.
Study of Count Coughs in Subjects With Acute Upper Respiratory Tract Infections

The objectives of this study are: a) to assess the feasibility and sensitivity of manually count cough bouts over a 4-hour period; b) to assess the effects of buckwheat honey and guaifenesin 400 mg immediate release tablets compared to placebo on the frequency and severity of acute cough due to upper respiratory tract infection and c) to evaluate the correlation between cough bout frequency and subjective assessments of cough severity. The hypotheses to be tested is that 10 ml of buckwheat honey and 400 mg of immediate release guaifenesin will significantly reduce the frequency and severity of cough compared to placebo over a 4-hour evaluation period.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects at least 18 years of age and in generally good health who are experiencing an acute upper respiratory infection of 10 days or less in duration;
* Subjects currently have acute cough self-rated as at least moderate due to an acute Upper Respiratory Infection (URTI) (i.e., cold or flu) as established by a study physician, nurse practitioner, or physician's assistant;
* Subjects who have \> 5 cough bouts during the 30 minute baseline assessment period

Exclusion Criteria:

* Subjects who have acute, subchronic, or chronic cough due to any condition other than a URTI as established by the Investigator, nurse practitioner, or physician's assistant, in accordance with the American College of Chest Physicians (ACCP) Guidelines for Diagnosis and Management of Cough. Special attention should be paid to highly prevalent conditions commonly presenting with cough such as asthma, Chronic Obstructive Pulmonary Disease (COPD), and Gastroesophageal Reflux Disease (GERD) (N.B. Subjects with exercise-induced asthma may be eligible for the study as long as they have not experienced an episode of asthma within 24 hours of enrollment)
* In the opinion of a study physician, nurse practitioner, or physician's assistant, subjects with sinusitis or who have a history of (within the past 2 years) frequent clinically significant sinusitis;
* Subjects with a history (within the last 3 years) of alcohol abuse (i.e., consuming greater than or equal to 3 alcoholic drinks/day on a regular basis) or substance abuse (i.e., ingesting/smoking marijuana more than once a week at any time during the past 6 months or using any other recreational drug more than once during the past 6 months). (Note: One "drink" of alcohol=1 oz. liquor, 6 oz wine, 12 oz. beer.);
Viewing Movie Violence & Interest in Guns

More American children die by accidental gun use than children in other developed countries. One factor that can influence children's interest in guns is exposure to media containing guns. The objective of this study is to test whether children who see a movie containing guns will handle a real gun longer and will pull the trigger more times than children who see the same movie without guns.

A recent analysis of top selling films found that the depiction of guns in violent scenes in PG-13 films that target youth has increased from the level of G and PG files in 1985 when the rating was introduced, to the level of R films by 2005, to exceed the level of R films since 2012. By definition, a PG-13 movie is supposed to have less violence than an R-rated movie. The Motion Picture Association of America says on its website that the violence in a PG-13 movie "does not reach the restricted R category." Our study shows that it does. By including guns in violent scenes, film producers may be inadvertently increasing aggression in youth via a weapons effect. This experiment directly tests this hypothesis.

Eligibility Criteria:
Inclusion Criteria:

Age 8-12yrs, had not participated in study prior, was able to schedule participation with a known peer (8-12yo).

Exclusion Criteria:

Younger than 8yo, older than 12yo, had participated in study prior, could not schedule participation with a known peer (8-12yo)
ENTegral Artificial Larynx Clinical Trial

The objective of this clinical study is to evaluate the feasibility, safety and efficacy of the ENTegral Artificial Larynx (AL) in patients indicated for total laryngectomy.


Eligibility Criteria:
Inclusion Criteria:

* Age more than or equal to 18 years old
* Is indicated for total laryngectomy (first intention)
* Must be able to comply with study requirements
* Must be able to understand and be willing to provide written informed consent

Exclusion Criteria:

* Any condition that precludes the implantation of the ENTegral AL
* Existing coagulation disorder
* Contraindication for general anesthesia
* Tumoral extension outside of the larynx invading through extra-laryngeal structures
* Previous radiotherapy
* Life-expectancy \< 12 months
* Be pregnant of breastfeeding or intention to becoming pregnant during study
Central Obesity and Disease Risk in Japanese Americans

To conduct a longitudinal study of central obesity and related risk factors found to be associated with hypertension and atherosclerotic cardiovascular disease (ASCVD) in a previously-examined cross-sectional cohort of second-generation Japanese Americans and in a newly-recruited cohort of third generation Japanese Americans.

BACKGROUND:

The study was conducted in response to a program announcment issued in 1991 on obesity and tests the hypothesis that atherosclerotic cardiovascular disease (ASCVD), hypertension, and/or non-insulin dependent diabetes mellitus (NIDDM) develop in Japanese Americans when there is a truncal pattern of weight gain (central adiposity), which is in turn accompanied by insulin resistance, hyperinsulinemia, and lipid abnormalities. This cluster of abnormalities has been called 'Syndrome X'. It is postulated that 'Syndrome X' develops in Japanese Americans in response to environmental (behavioral) factors, many of which reflect 'westernization' in this ethnic group. The research plan focuses upon the relationship between central obesity and metabolic changes and disease outcomes associated with 'Syndrome X' along with the behavioral variables that potential risk factors for the development of this cluster of abnormalities.

DESIGN NARRATIVE:

The cohort was re-examined for diabetes, hypertension, coronary heart, disease, peripheral vascular disease, and a number of potential coronary heart disease risk factors including medical history, health practice, social history, diet, glycosylated hemoglobin, insulin, proinsulin, c-peptide, glucose, anthrometric measurements, lipids, and computed tomography on the thorax, abdomen, and thigh.

Eligibility Criteria:
No eligibility criteria
Trial of Vision Therapy for Intermittent Exotropia

The main objective of this randomized trial comparing vision therapy to observation is to determine the short-term effectiveness of vision therapy on distance intermittent exotropia control. The results will help determine whether to proceed to a full-scale, long-term randomized trial.

Vision therapy (VT) is a commonly prescribed treatment for children with intermittent exotropia (IXT). The effectiveness of VT as a treatment modality for children with IXT is unknown because previous studies have largely limited observational or retrospective case series without comparison groups. The objective of this multi-centered pilot randomized trial of VT for IXT compared to observation is to 1) determine the short-term effectiveness of VT on distance intermittent exotropia and 2) determine the feasibility of recruitment and retention of children aged 8 to 16 years old with IXT to participate in a randomized trial of 20 weeks of in-office VT. The results of this trial will provide the needed information to plan and conduct a large-scale randomized trial to determine short-term and long-term effectiveness of VT for IXT in children, with the full-scale randomized trial helping to fill in the gaps in scientific knowledge concerning VT as a treatment for IXT.

Eligibility Criteria:
Major Inclusion Criteria-

* Age 8 - 16 years
* Intermittent exotropia meeting all of the following:

  * Distance exodeviation of 15∆ to 35∆ by prism alternating cover test (PACT)
  * IXT, exophoria, or orthophoria at near
  * Near exodeviation that does not exceed the distance exodeviation by more than 10∆
  * Mean distance control score of 2 points or more with at least one measure being 3 points or higher
  * Mean near control score less than 5 points
* Random dot stereopsis of 200" or better on Preschool Randot Stereotest
* Willingness to accept randomization and no plan to relocate in the next 6 months

Major Exclusion Criteria-

* Treatment for IXT or amblyopia (other than refractive correction) within 3 months prior to enrollment
* Office-based vision therapy for IXT within 6 months prior to enrollment
* Prior office-based vision therapy for IXT of ≥10 sessions
* Prior strabismus, intraocular, or refractive surgery (including BOTOX injection)
Screening and Intervention for AIS in Haikou, Hainan Province, China

This is a single-center, prospective, non-randomized, open-label, interventional, real-world study. The mild/moderate AIS patients will be recruited through screening of 250,000 primary and secondary school students in Haikou, Hainan Province. The patients will be treated with different non-surgical interventions (exercise intervention or brace intervention) according to the physician's recommendations and the patient's intention. Patients will be followed up for 36 months to evaluate the effectiveness and safety of non-surgical interventions in the real world.


Eligibility Criteria:
Inclusion Criteria:

1. 9 years ≤ age ≤ 16 years
2. Diagnosis of AIS
3. 10°≤Cobb's angle\<45°
4. Signed informed consent form

Exclusion Criteria:

1. With other developmental disorders, musculoskeletal disorders, nerve disorders, infection disorders, mental disorders, and other disorders
2. Obvious deformity of lower limbs and(or) feet
3. Previous or ongoing treatment of AIS
4. Difficulty to read, understanding, and complete the study questionnaires
5. Any criteria, which, in the opinion of the investigator, suggest that the subject would not be compliant with this study protocol
Ultrasound-guided Femoral Arterial Puncture for Interventional Neuro-radiology in Children

Using ultrasound to guide vascular catheterism in children is highly recommended for central venous access. It has been proven that central venous line is inserted faster, with fewer attempts and complications. Its interest in central arterial line insertion is less obvious. It seems to have benefits in adults, both for radial and femoral arterial insertion. But there is no study assessing the interest of ultrasound guided arterial puncture in children,.

The use of ultrasound to guide vascular catheterization in children is strongly recommended for central venous vascular access by several international learned societies. In fact, studies have found a reduction in the time it takes to install the central venous line, in the number of attempts and in complications.The benefit of ultrasound to guide catheterization of the arterial network is less documented.

In children, there is an inventory of the traditional approach guided by palpation, in children in intensive care (11). The analysis of 77 femoral puncture attempts in 74 children was carried out. Arterial cannulation was successful in 73 of 77 cases (95%), but only in 60% of cases at the first attempt. Ultrasound guidance appears beneficial in adults for both arterial sites, radial and femoral. On the other hand, in children, unlike radial catheterization, there is no study evaluating the contribution of ultrasound guidance for femoral catheterization.

Eligibility Criteria:
Inclusion Criteria:

* requirement of retrograde femoral arterial catheterism

Exclusion Criteria:

* none
Feasibility of Systematic Handgrip Strength (HGS) Testing and Short-term Changes in Muscle Strength in Digestive Cancer Patients Treated by Chemotherapy

Sarcopenia is defined as a loss in skeletal muscle mass and function (strength and/or performance). There is a high prevalence in elderly and in patients with cancer. Several mechanisms are known to explain sarcopenia (inflammation, neurodegenerative process, hormonal disorders, lack of exercise, malnutrition). The consequences were analysed in several studies where sarcopenia appeared to be an independent factor of mortality, and associated with cancer-related fatigue, nosocomial infections, cardio-vascular diseases, and chemotherapy toxicities.

Diagnosis is based on the measure of the muscle mass performing an abdominal computed-tomography (CT) scan, and on the measure of the muscle strength using the handgrip test with a "Jamar®" hydraulic hand dynamometer. CT scan is more invasive and less easy to reach than handgrip test. This test is used to be performing in elderly but not in cancer patients having chemotherapy. Present prospective study explored the feasibility of systematic handgrip strength testing and short-term changes in muscle strength in digestive cancer patients treated by chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* patients with digestive cancer having a chemotherapy and/or biotherapy in the department of Reims
* \> 18 years old
* after patient agreement
* linked to social security system

Exclusion Criteria:

* legal guardianship
* \< 18 years old
* neuro-muscular issue
Dental Anxiety in During Different Dental Treatments (DENANX)

The aim of this observational cross-sectional study is to evaluate the dental anxiety levels of participants aged 18-70 years who will scheduled for different dental treatmentsThe main question it aims to answer is:

Does the type of dental treatment make a difference in the level of dental anxiety in participants? Within the scope of their dental treatment, participants who have already been planned to assign any of the filling, root canal treatments, scaling, tooth extraction and implant placement will have their anxiety levels recorded through a questionnaire just before starting treatment.


Eligibility Criteria:
Inclusion Criteria:

* voluntary participation
* sufficient Turkish literacy
* no recent psychiatric diagnoses within the previous year
* no psychotherapy in the past six months,
* and no use of psychotropic drugs or illicit substances that could affect mental health in the previous year.

Exclusion Criteria:

-To stop volunteering until the study is completed.
Covid-19 at the Regional Medical Center Metz-Thionville: a Descriptive Study

France and especially the region "Grand Est" have been damaged by the COVID-19 pandemic. This pandemic resulted in a reorganization of the hospitalization sectors.

In order to better understand the disease, the investigators wish to carry out a descriptive analysis of hospitalized patient data. This study would notably allow us to identify some prognostic factors.

The main objective of this study is to identify individual factors that are associated with a poor prognosis (with ICU admission or death).


Eligibility Criteria:
Inclusion Criteria:

* Patient hospitalized in COVID Unit at the Regional Hospital Center Metz-Thionville during the COVID 19 pandemic
* PCR positive or COVID confirmed with clinical evidence and CT scan

Exclusion Criteria:

* Patients not willing to participate via using their medical files
* Patient transferred after a brief stay in another hospital
Cell Block Immunohistochemistry in Effusion Cytology

Cytology is usually the first step in investigating serous effusions, to either detect or exclude an underlying malignancy. This study will try to answer the need for improved diagnostic yield of cytologic examination by cell block technique and immunohistochemical testing of three markers which are EZH2, Claudin-4 and MOC-31.

This is a prospective study that will be conducted at the pathology lab of Assiut University Hospital. The study will include effusion specimens (pleural, peritoneal \& pericardial) and the aspirated fluid will be examined for physical characters e.g. color and appearance.

The sample will be divided into 2 equal parts: one for conventional smear preparation, and the other for cell block. A minimum of 2 thin smears will be prepared and stained with Papanicolou stain.

Cell block sections of 4-6 μ thickness will be prepared and stained with the hematoxylin and eosin stain (H\&E).

For immunohistochemistry, cell blocks will be used. Expression of claudin 4, EZH2, and MOC-31 will be evaluated in benign and malignant cells by using immunoperoxidase technique.

Eligibility Criteria:
Inclusion Criteria:

* all cases with serous effusion of unknown aetiology including ascites, pleural or pericardial effusions.

Exclusion Criteria:

* No exclusion criteria from the histopathologist perspective, i.e. all cases that undergone diagnostic aspiration are eligible for the study.