cyrilzakka/clinical-trials huggingface dataset:
The Role of a Device to Evaluate the Neuromuscular Function in Assessing Muscle in Facial Paralysis Patients

The objective of the research is to determine whether the MyotonPRO has a valid and reliable application in facial, head and neck surgery. In addition, the study aims to compare this new technology with current electromyography.

Facial paralysis has significant aesthetic, functional and psycho-social morbidity. The diagnosis and monitoring of neuromuscular recovery is limited to clinical examination, electromyography (EMG) and electroneurography (ENoG). EMG and ENoG is invasive for the patient and has practical and cost disadvantages. The MyotonPRO is a handheld device, which is pain-free and quick to use. Therefore this research is assessing MyotonPRO technology for this clinical application and may be effective at evaluating rehabilitative and surgical interventions. Phase 1 - Variation of measurements Phase 2 - Mimic muscle dysfunction assessment Phase 3 - Peri-operative Mimic and temporalis muscle assessment Phase 4 - Phase 3 including electromyography Phase 5 - Temporalis and mimic muscle assessment following facial reanimation surgery

Eligibility Criteria:
Inclusion Criteria:

1. unilateral peripheral facial nerve palsy
2. Mental capacity to give consent
3. The patient is able to sit independently

Exclusion Criteria:

1. Adults who have undertaken strenuous exercise within the last twenty-four hours
2. Adults taking prescription medication with a known effect on the mechanical properties of muscle (e.g. benzodiazepines) or receiving antispasmodic medications (e.g. botulinum A toxin)
3. Adults with poor mobility (unable to lie prone).
4. Adults with a body mass index (BMI) \>30 kg/m2 . Muscle measurements may be inaccurate with excessive subcutaneous tissue
Prospective Study to Compare the Efficacy of E.G.Scan to Detect Barrett's Esophagus Compared With Standard Endoscopy

The purpose of this study was to evaluate whether a disposable nasal endoscope called "E.G. Scan II" will visualize the esophagus as well as the standard test, sedated endoscopy.

All subjects underwent two procedures: the E.G.Scan II followed by standard endoscopy in a tandem design. The E.G. Scan II is a transnasal endoscope system to capture and transmit images of the esophagus. Captured images can be reviewed via the E.G. View for diagnosis of diseases related to the esophagus. Generally, the commercial esophagoscope system has reusable probes, but E.G. Scan™ II has a single use probe because reusable probes have the risk of infection and pollution.

Prior to the E.G.Scan, subjects received a standard prep for the procedure. The two procedures were performed by two different experienced endoscopists who were blinded to the indication of the procedure. At both procedures a note was made of any abnormality of the esophagus. Every subject with an endoscopic diagnosis of Barrett's Esophagus had clinical biopsies taken to confirm diagnosis. Subject tolerability was measured with a 10-point visual analog scale (VAS) where 0 represented the "worst experience" and 10 the "best experience."

Eligibility Criteria:
Inclusion Criteria:

1. Adult participants aged 18 years or above who are scheduled for routine upper GI endoscopy for Barrett's Esophagus surveillance, varices surveillance and dyspepsia.
2. Able and willing to give informed consent.

Exclusion Criteria:

1. Patients known to be intolerant to endoscopy.
2. Patients with frequent epistaxis.
3. Patients not clinically fit for endoscopy as judged by their care team.
4. Pregnant women.
5. Patients with allergy/sensitivity to Simethicone (Mylicon), Phenylephrine, Lidocaine nasal spray, Benzocaine spray (Topex)
6. Use of anticoagulants or antiplatelets.
LYmphangiogenesis FacTors in Heart Failure States

Heart failure often causes fluid to accumulate in the body, leading to congestion and swelling. However, some people who have had heart failure for a long time seem to have very little congestion or swelling, even when the heart failure is poorly treated. The investigators think that this is because lymphatic vessels are able to grow and remove fluid to prevent congestion. The investigators do not know how lymphatic vessels grow. This study will investigate the blood levels of various proteins to try to figure out how the lymph vessels of people with long-standing heart failure might grow.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing clinically indicated right heart catheterization.

Exclusion Criteria:

* Unable to provide consent.
* Use of medications which may alter lymphangiogenesis factor expression within 365 days
* Thalidomide, lenalidomide, pomalidomide
* Bevacizumab
* Any cytotoxic chemotherapy agents
* Pregnant
* Any potentially pregnant patient (based on age and gender) undergoes Beta Human chorionic gonadotropin testing as standard of care prior to any right heart catheterization.
* Active cancer within 365 days
* Diagnosis of familial or secondary lymphedema
* Treatment of active bacterial infection within 7 days
* Active inflammatory rheumatologic disease requiring anti-inflammatory therapy administration within 60 days
* Conditions
* Systemic lupus erythematosus
* Rheumatoid arthritis
* Scleroderma
* Inflammatory myositis
* Vasculitis
* Behcet's disease
Longitudinal Changes in Characteristics of COVID-19 Survivors and Their Long-term Follow-up Study

Follow-up study of Coronavirus disease 2019 (COVID-19) survivors has rarely been reported. We aimed to investigate longitudinal changes in the characteristics of COVID-19 survivors after discharge.

From December 2019, coronavirus disease 2019 (COVID-19), caused by a β-coronavirus known as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has spread across the globe. Numerous studies have been performed so far to investigate clinical characteristics, risk factors, potential treatment and pathogenesis of COVID-19. However, little information is available on the long-term prognosis and possible sequelae of COVID-19 survivors who have recovered and been discharged from hospital. Hence, the investigators conducted a prospective study to investigate the long-time prognosis and the possible sequelae of COVID-19 survivors. The investigators evaluated Demographic and clinical characteristics, laboratory and radiological findings,pulmonary function tests, electrocardiogram, complications as well as treatment and symptoms and signs of COVID-19 patients.

Eligibility Criteria:
Inclusion Criteria:

Patients with confirmed COVID-19 who have complete hospitalization data.

Exclusion Criteria:

Suspected cases of COVID-19.
Stem Cells in Umbilical Blood Infusion for CP

This study will investigate the safety of single dose intravenous infusion of cord blood cells which were cryopreserved after the birth of a brother or sister to a child with cerebral palsy.

Cerebral palsy (CP) is the most common physical disability of childhood, affecting 2 per 1000 live births across the world. CP describes permanent non-progressive motor disorders arising from damage to the developing brain.

Preclinical studies of different types of stem cells in models of acute brain injury similar to CP have shown significant functional improvement. The variety of stem cells available in umbilical cord blood (UCB), an ethically uncomplicated source of stem cells, has led to a focus on UCB stem cell therapy as a quick-to-clinic option. Previous studies indicate that autologous or unrelated donor UCBC infusion is safe and feasible for children with CP, and may lead to improved motor functioning, but there is no information about the safety and effects of matched sibling cord blood. Therefore, this trial will study the safety of infusing matched sibling cord blood cells to children with cerebral palsy.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of any type of CP
2. CP of any severity
3. A record of sibling CBU in storage at a TGA accredited private cord blood bank
4. Ability to travel to one of the trial centres
5. Ability to participate in assessments
6. Informed consent by parent/guardian

Exclusion Criteria:

1. presence of progressive neurological disease
2. known genetic disorder
3. known brain dysplasia
4. immune system disorder or immune deficiency syndrome
5. infectious disease markers showing up on virology screen
6. evidence of cord blood unit contamination, or fewer than 10\^7 cells/kg body mass
7. ventilator support
8. ill health, or if the participant's medical condition does not allow safe travel
9. previous cell therapy
10. Botulinum toxin A within 3 months before or after infusion
11. surgery within 3 months before or after infusion
12. cannot obtain parent/guardian consent
Eliciting Affect in Teens in a Virtual World (Project AVATAR)

The purpose of this study is to determine whether immersive virtual reality technology is an effective intervention tool for HIV Prevention with adolescents.

The project will examine the use of immersive virtual reality technology as an intervention tool for HIV Prevention with adolescents. Adolescents are at risk for contracting HIV while affect dysregulation is common among adolescents. Research has demonstrated connections between poor affect management abilities and risky sexual behavior among adolescents. This research suggests that the ability to regulate one's emotions is key to avoiding risk behaviors and that adolescents are at greater risk for poor affect management skills. Fortunately, these skills can be taught via teaching and modeling, making them an excellent target for intervention, which has previously been approached through role-playing. Immersive virtual reality offers many advantages over group based role-plays, used in HIV prevention interventions for adolescents, in its ability to simulate real-world environments and enhance the impact of HIV prevention interventions. Immersive virtual reality is a promising technology for giving teens the opportunity to experientially practice using effective affect regulation skills in a highly realistic, context specific virtual environment. Additional benefits of this technology will likely be increased engagement and retention in HIV prevention interventions among young adolescents. The overall aims of Phase I and Phase II of this project are to develop, refine, and evaluate virtual reality environments for adolescents targeting affect management. In Phase I, the research team developed and refined an immersive virtual environment that elicited affect in a high-risk situation. The final immersive virtual reality environments (completed in Phase II) can be used by health promotion interventionists in conjunction with an HIV prevention intervention manual as a means to elicit affect and provide adolescents with a "real world" environment in which to practice emotion regulation skills related to substance use and HIV prevention. These aims will be achieved through the collaboration of researchers at Rhode Island Hospital/Brown and Virtually Better, Inc. a small business that specializes in creating immersive virtual reality environments for treatment, education, and training purposes. This tool will represent a significant advance in the way in which affect regulation skills are practiced and honed, currently achieved via role plays or imaginal exposure, by increasing the salience of cues used to elicit affect, thus making it highly marketable to interventionists, schools, and mental health clinicians.

Eligibility Criteria:
Inclusion Criteria:

- 7th \& 8th graders at participating public schools.

Exclusion Criteria:

* Adolescent is illiterate.
* Adolescent has parent/guardian who does not speak English.
* Adolescents has high risk of motion sickness.
* For Phase II only, previous participation in Project Trac or Phase I.
Laparoscopic Training With Laser Guidance Trial

"Laparoscopic simulation training with or without laser visual guidance -A randomised study" which investigates if the use of laser visual guidance can help the novices to learn the laparoscopic skills.

Background: The loss of depth perception due to working in a three-dimensional space based on two-dimensional images is one of the challenging aspects of laparoscopy compared to conventional open surgery.

Objectives: To examine the effect of laser visual guidance on laparoscopic performance and cognitive load in a simulated setting for novices.

Methods: Randomised Clinical Trial- Laser visual guidance vs. normal 2 D vision.

Outcomes:

Primary outcome: Motor skills performance parameters-movement-time:

Cumulative instrument movement-time for both the right and left instrument for the test session,

Secondary outcome: 2) The overall composite score.

Exploratory outcomes: 3) The NASA Task Load index (NASA-TLX).

Eligibility Criteria:
Inclusion Criteria:

* Surgical novices / medical students enrolled at The Faculty of Health Science, University of Copenhagen.
* Participants are required to provide informed consent before inclusion.

Exclusion Criteria:

* Participation in prior studies involving laparoscopic training.
* Experience with laparoscopy surgery (having performed minimum one laparoscopic procedure as primary surgeon, including supervised procedures).
* No informed consent.
* Does not speak Danish on a conversational level.
Effectiveness of the FearNot!v.2.0 Software in Reducing Bullying Victimisation Among Primary School Children

This study will evaluate the effectiveness of a virtual learning treatment in reducing bullying among primary school children in the UK and Germany.

In this study, a virtual learning environment application called FearNot!v.2.0 will be evaluated as a way to improve the quality of life in schools by altering children's attitudes and behavior towards bullying.

Participants will be assigned to either the intervention or the control group. The intention was to assign randomly, however, only a minority of primary schools have the computer facilities to run the software with all pupils participating. Thus, assignment is based on the school computer compatibility with the FearNot!v.2.0 software for intervention versus control group controlling for social variables. Participants in the intervention group will interact with the software during 30-minute sessions once a week for a total of 3 weeks while participants in the control group will follow the normal curriculum.

The FearNot! narrative comprises a number of emergent episodes, which play out like an improvisational drama. During each of these emergent episodes, the characters will act out their roles resulting in a dramatic movie-like display on the computer's monitor. In between each of these episodes, the child can interact with the victim character. He/she can learn how the character feels, and offer them coping strategy advice as to how to behave in the following episode.

Outcomes will be assessed through student questionnaires at baseline, one week, and four weeks after treatment. In addition, classroom teachers will be asked to complete the Teacher Incidence of Bullying Scale at baseline and 4 weeks after the treatment.

Eligibility Criteria:
Inclusion Criteria for schools:

* Mixed
* Not currently involved in intervention studies specific to countering bullying
* Access to computers that are compatible to run FearNot!v.2.0 (for intervention schools)

Inclusion Criteria for participants:

* Age between 8-11
* Passive parental consent

Exclusion Criteria:

* Enrolled in special education schools
Risk of Acute Liver Failure Among Patients With Type 2 Diabetes Exposed to Oral Antidiabetic Treatments

The purpose of this study is to compare the incidence of hospitalization with acute liver failure among patients with type 2 diabetes who are new users of Saxagliptin and those who are new users of other oral antidiabetic drugs.

Prospectively designed retrospective database study. This study will be conducted using administrative claims data and electronic medical records that are collected as part of routine clinical practice

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Newly prescribed Saxagliptin or an Oral Antidiabetic Drug (OAD) in a class other than Dipeptidyl peptidase IV (DPP4) inhibitors
* Enrolled in the respective database for at least 180 days prior to the first prescription of new OAD
* Have at least one diagnostic code for a type 2 diabetes-related condition

Exclusion Criteria:

* Patients identified with a diagnostic code for acute liver failure within the 180-day baseline period
* Patients with DPP4 inhibitor exposure during the baseline period
Initial Evaluation of Ultra FAST Breast Magnetic Resonance in Breast Cancer Screening: Comparative Study With Mammography and Ultrasound.

Mammography remains an imperfect screening test especially in women with extremely dense breast tissue, missing biologically aggressive cancers especially in younger population and picking up indolent cancers that do not need treatment.

The most sensitive test for breast cancer detection at our disposal is magnetic resonance imaging (MRI). The preliminary study of Dr Kuhl provide strong arguments that Ultra FAST Breast Magnetic Resonance is suitable for breast cancer screening with high sensitivity and specificity values.

Data clearly demonstrates that FAST breast MRI could be the standard for breast cancer screening: it is safe, does not induce cancers, and can find more cancers than mammography.

However this study was performed in women with low to moderately increased risk.The value of FAST Breast Magnetic Resonance in normal screening population has to be assessed before a modification of current strategy of breast cancer screening with mammography.


Eligibility Criteria:
Inclusion Criteria:

* Women referred for routine breast cancer screening

Exclusion Criteria:

* Disabled women (eg, unable to stand)
* Pregnant women
* Allergy to Gadolinium
P53 in Differentiated Thyroid Cancer

In clinical practise patients with negative radioiodine scan with positive tyhroglobulin is considered as radioiodine resistant or in another words in the process of dedifferentiation. The aim of the present study was to search a simple blood test that could lead to early identification of patients with dedifferentiation. In this respect, we investigate whether the serum level of anti-p53 antibody has the diagnostic value in the follow-up of patients with high levels of thyroglobulin (tg) and negative I-131 scan.

In the present study enrolled were 171 patients with mean age of 47.7±13.5 yrs (range; 16-80yrs) and 28 healthy subjects with an age range of 18-52 yrs (mean: 36.0±9.8 yrs). 134 (78.4%) patients were female and 37 (21.6%) patients were male.

Eligibility Criteria:
Inclusion Criteria:

* Patients who were diagnosed with DTC
* Treated with total and/or near-total thyroidectomy
* Referred for I-131 ablation therapy or low dose I-131 whole body scan (WBS)
* Between December 2010 and January 2013.

Exclusion Criteria:

* Dose 131-I given in another hospital
* Radioiodine treatment more than one year after thyroidectomy.
Effect of a High-Protein Diet and/or High-Intensity Training on Metabolic Syndrome

The objective of this study is to determine the combined effects of a high-protein diet and high-intensity training on metabolic syndrome risk factors in women aged 30-65.

High-protein diet interventions have been shown to be effective in reducing triglycerides and increasing high-density lipoprotein cholesterol concentrations. Low-volume, high-intensity cycling exercise has shown to elicit positive effects on metabolic syndrome risk factors such as triglyceride concentrations. The objective of this study was to determine the combined effects of a high-protein, reduced carbohydrate diet and high-intensity interval training on metabolic syndrome risk factors in women. The second primary aim is to investigate the effect of the macronutrient content of the post-exercise meal consumed following an acute bout of interval training on postprandial metabolism.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 30-65 yrs of age, inclusive
* Waist circumference \> 88 cm.
* Weight stable (within 2 kg) for past 6 mo
* Sedentary/Low-active (defined as \<300minutes/wk light or moderate activity, with no vigorous activity in last 6 months)
* At risk for MetS \[defined as having 2 of the following 4 factors: 1) hypertriglyceridemia defined as \> 150 mg/mL, 2) low HDL cholesterol defined \< 50 or on medication, 3) elevated blood pressure defined as \> 130/\>85 Hg or taking medications or 4) hyperglycemia defined as fasting blood glucose \> 100 or glycated hemoglobin \> 6.5 or taking medications.
* Willing to be randomized to the four treatment groups

Exclusion Criteria:

* Any chronic disease/condition that would not permit exercise or dietary restriction (including egg allergy or refusal to incorporate eggs into the diet) or alter interpretation of data. Examples include, but are not limited to:

  1. cardiopulmonary disease (e.g. recent myocardial infarction, unstable angina, stroke) or unstable disease; 2) severe orthopedic, musculoskeletal or neuromuscular impairments that would contradict exercise; 3) sensory impairments that interfere with following directions; 4) diagnosis of dementia; 5) history of malignancy during the past 5 yr; 6) medication use that impacts primary outcomes of interest (e.g. statins); 7) weight greater than 400 pounds due to DXA weight and size limitations; 8) Uncontrolled blood pressure defined as \> 160/\>100 Hg.
Study for Collection of Aflibercept Data in Routine Practice

The French CODEX study is designed as a national database to describe, in routine medical practice, functional and anatomical responses to intravitreal Aflibercept injection, in a large population of anti-VGEF-naïve patients presenting with wet Age-related Macular Degeneration (wAMD), Central Retinal Vein Occlusion (CRVO),Branch Retinal Vein Occlusion(BRVO), or Diabetic Macular Edema (DME). This national database will gather databases from French private and public ophthalmologic centers.

The retrospective data will be gathered from the first injection of Aflibercept for the indications macular edema following Branch Retinal Vein Occlusion (BRVO) directly by each physician. For each patient, the first injection date of Aflibercept is defined as the index date.

Electronic files from each ophthalmologist, containing patient medical records, will be periodically transmitted according to the milestones of the study with a maximum of 4 transfers (at Q2 2016 for the first transfer and then every 9 months thereafter).

As each electronic transfer will be independent of each other and as patients' data will be anonymized by physicians before each transfer, data comparisons will be not possible between the four electronic files transfers planned over the study period.

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥18 years old
* Anti-VEGF (Vascular Endothelial Growth Factor) treatment naïve
* Intravitreal (IVT) aflibercept injection treatment follows the recommendations made within the EYLEA Summary of Product Characteristics
* Diagnosed with wAMD (wet Age-related Macular Degeneration), macular edema following CRVO (Central Retinal Vein Occlusion), macular edema following BRVO (Branch Retinal Vein Occlusion), or DME (Diabetic Macular Edema).

Exclusion Criteria:

* Who have any contraindications listed in the EYLEA Summary of Product characteristics
* Participating in an investigational program with interventions outside of routine clinical practice.